0001104659-13-082284.txt : 20131107 0001104659-13-082284.hdr.sgml : 20131107 20131107161029 ACCESSION NUMBER: 0001104659-13-082284 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20130930 FILED AS OF DATE: 20131107 DATE AS OF CHANGE: 20131107 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENOMIC HEALTH INC CENTRAL INDEX KEY: 0001131324 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MEDICAL LABORATORIES [8071] IRS NUMBER: 770552594 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-51541 FILM NUMBER: 131200732 BUSINESS ADDRESS: STREET 1: 301 PENOBSCOT DRIVE CITY: REDWOOD CITY STATE: CA ZIP: 94063 BUSINESS PHONE: 650-556-9300 MAIL ADDRESS: STREET 1: 301 PENOBSCOT DRIVE CITY: REDWOOD CITY STATE: CA ZIP: 94063 10-Q 1 a13-18745_110q.htm 10-Q

Table of Contents

 

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

x

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

 

For the quarterly period ended September 30, 2013

 

Or

 

o

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

 

For the transition period from              to             

 

Commission File Number: 000-51541

 

GENOMIC HEALTH, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

77-0552594

(State or other jurisdiction of

 

(I.R.S. Employer Identification No.)

incorporation or organization)

 

 

 

301 Penobscot Drive

Redwood City, California 94063

(Address of principal executive offices, including Zip Code)

 

(650) 556-9300

(Registrant’s telephone number, including area code)

 

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

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). YES x NO o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer o

 

Accelerated filer x

 

 

 

Non-accelerated filer o

 

Smaller reporting company o

(Do not check if a smaller reporting company)

 

 

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES o NO x

 

The number of outstanding shares of the registrant’s Common Stock, $0.0001 par value, was 30,738,244 as of October 31, 2013.

 

 

 




Table of Contents

 

PART 1: FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

GENOMIC HEALTH, INC.

Condensed Consolidated Balance Sheets

(In thousands)

(Unaudited)

 

 

 

September 30,
2013

 

December 31,
2012

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

39,781

 

$

18,005

 

Short-term marketable securities

 

74,265

 

81,060

 

Accounts receivable (net of allowance for doubtful accounts; 2013 - $1,847, 2012 - $1,133)

 

25,594

 

22,253

 

Prepaid expenses and other current assets

 

9,314

 

8,891

 

Total current assets

 

148,954

 

130,209

 

Property and equipment, net

 

18,242

 

14,104

 

Other assets

 

9,504

 

9,421

 

Total assets

 

$

176,700

 

$

153,734

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

3,545

 

$

4,881

 

Accrued compensation

 

11,190

 

11,210

 

Accrued license fees

 

2,319

 

2,292

 

Accrued expenses and other current liabilities

 

10,451

 

6,340

 

Deferred revenues

 

1,134

 

374

 

Other current liabilities

 

292

 

243

 

Total current liabilities

 

28,931

 

25,340

 

 

 

 

 

 

 

Other liabilities

 

2,141

 

2,068

 

Commitments and contingencies

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Common stock

 

3

 

3

 

Additional paid-in capital

 

336,617

 

313,915

 

Accumulated other comprehensive income

 

18

 

15

 

Accumulated deficit

 

(160,900

)

(157,512

)

Treasury stock, at cost

 

(30,110

)

(30,095

)

Total stockholders’ equity

 

145,628

 

126,326

 

Total liabilities and stockholders’ equity

 

$

176,700

 

$

153,734

 

 

See accompanying notes.

 

3



Table of Contents

 

GENOMIC HEALTH, INC.

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

Revenues:

 

 

 

 

 

 

 

 

 

Product revenues

 

$

65,732

 

$

58,371

 

$

192,132

 

$

173,459

 

Contract revenues

 

258

 

277

 

644

 

1,287

 

Total revenues

 

65,990

 

58,648

 

192,776

 

174,746

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Cost of product revenues

 

10,781

 

9,037

 

31,285

 

27,377

 

Research and development

 

14,726

 

12,267

 

42,189

 

35,775

 

Selling and marketing

 

26,013

 

21,526

 

81,587

 

69,657

 

General and administrative

 

14,007

 

12,107

 

41,052

 

35,518

 

Total operating expenses

 

65,527

 

54,937

 

196,113

 

168,327

 

Income (loss) from operations

 

463

 

3,711

 

(3,337

)

6,419

 

Interest income

 

52

 

77

 

174

 

226

 

Other income (expense), net

 

89

 

33

 

(2

)

(112

)

Income (loss) before income taxes

 

604

 

3,821

 

(3,165

)

6,533

 

Income tax expense

 

116

 

109

 

223

 

243

 

Net income (loss)

 

$

488

 

$

3,712

 

$

(3,388

)

$

6,290

 

Basic net income (loss) per share

 

$

0.02

 

$

0.12

 

$

(0.11

)

$

0.21

 

Diluted net income (loss) per share

 

$

0.02

 

$

0.11

 

$

(0.11

)

$

0.20

 

Shares used in computing basic net income per share

 

30,661

 

30,580

 

30,368

 

30,233

 

Shares used in computing diluted net income per share

 

32,324

 

32,578

 

30,368

 

32,095

 

 

See accompanying notes.

 

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Table of Contents

 

GENOMIC HEALTH, INC.

Condensed Consolidated Statements of Comprehensive Income (Loss)

(In thousands)

(Unaudited)

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

488

 

$

3,712

 

$

(3,388

)

$

6,290

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on available-for-sale marketable securities, net of tax

 

(3

)

18

 

3

 

46

 

Comprehensive income (loss)

 

$

485

 

$

3,730

 

$

(3,385

)

$

6,336

 

 

See accompanying notes.

 

5



Table of Contents

 

GENOMIC HEALTH, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

Nine Months Ended
September 30,

 

 

 

2013

 

2012

 

Operating activities

 

 

 

 

 

Net income (loss)

 

$

(3,388

)

$

6,290

 

Adjustments to reconcile net income (loss) to net cash provided by operating activities:

 

 

 

 

 

Depreciation and amortization

 

4,770

 

3,974

 

Employee stock-based compensation

 

12,845

 

10,807

 

Outside director restricted stock awarded in lieu of fees

 

170

 

120

 

Gain on disposal of property and equipment

 

(5

)

(3

)

Share of loss of equity method investee

 

 

98

 

Changes in assets and liabilities:

 

 

 

 

 

Accounts receivable

 

(3,341

)

1,151

 

Prepaid expenses and other assets

 

(623

)

(1,269

)

Accounts payable

 

(1,396

)

(3,633

)

Accrued compensation

 

(20

)

62

 

Accrued expenses and other liabilities

 

2,977

 

3,046

 

Deferred revenues

 

760

 

(818

)

Net cash provided by operating activities

 

12,749

 

19,825

 

Investing activities

 

 

 

 

 

Purchases of property and equipment

 

(7,443

)

(6,170

)

Purchases of marketable securities

 

(71,914

)

(61,496

)

Maturities of marketable securities

 

78,712

 

60,125

 

Purchase of other investments

 

 

(1,409

)

Net cash used in investing activities

 

(645

)

(8,950

)

Financing activities

 

 

 

 

 

Net proceeds from issuance of common stock under stock plans

 

9,687

 

14,215

 

Repurchase of common stock

 

(15

)

 

Net cash provided by financing activities

 

9,672

 

14,215

 

Net increase in cash and cash equivalents

 

21,776

 

25,090

 

Cash and cash equivalents at the beginning of the period

 

18,005

 

32,869

 

Cash and cash equivalents at the end of the period

 

$

39,781

 

$

57,959

 

 

See accompanying notes.

 

6



Table of Contents

 

GENOMIC HEALTH, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2013

(Unaudited)

 

Note 1. Organization and Summary of Significant Accounting Policies

 

The Company

 

Genomic Health, Inc. (the “Company”) is a global healthcare company that provides actionable genomic information to personalize cancer treatment decisions. The Company develops and globally commercializes genomic-based clinical laboratory services that analyze the underlying biology of cancer, allowing physicians and patients to make individualized treatment decisions. The Company was incorporated in Delaware in August 2000. The Company’s first product, the Oncotype DX invasive breast cancer test, was launched in 2004 and is used for early stage invasive breast cancer patients to predict the likelihood of breast cancer recurrence and the likelihood of chemotherapy benefit. In January 2010, the Company launched its second product, the Oncotype DX colon cancer test, which is used to predict the likelihood of colon cancer recurrence in patients with stage II disease. In December 2011, the Company made the Oncotype DX breast cancer test available for patients with ductal carcinoma in situ (“DCIS”), a pre-invasive form of breast cancer. This test provides a DCIS score that is used to predict the likelihood of local recurrence. In June 2012, the Company began offering the Oncotype DX colon cancer test for use in patients with stage III disease treated with oxaliplatin-containing adjuvant therapy. In May 2013, the Company launched the Oncotype DX prostate cancer test. The test provides a Genomic Prostate Score, or GPS, to predict disease aggressiveness in men with low risk disease. This test may be used to improve treatment decisions for prostate cancer patients, in conjunction with the Gleason score, or tumor grading.

 

Principles of Consolidation

 

The condensed consolidated financial statements include all the accounts of the Company and its wholly-owned subsidiaries. The Company had three wholly-owned subsidiaries at September 30, 2013: Genomic Health International Sarl, which was established in Switzerland in 2009, and Genomic Health International Holdings, LLC, which was established in Delaware in 2010, both of which support the Company’s international sales and marketing efforts; and Oncotype Laboratories, Inc., which was established in 2003, and is inactive. Genomic Health International Holdings, LLC has five wholly-owned subsidiaries: Genomic Health U.K., Ltd. and Genomic Health Germany GmbH, both of which were established in 2011, Genomic Health Canada, which was established in 2012 and Genomic Health France and Genomic Health India, which were established in 2013. The functional currency for the Company’s wholly-owned subsidiaries incorporated outside the United States is the U.S. dollar. All significant intercompany balances and transactions have been eliminated.

 

Basis of Presentation and Use of Estimates

 

The accompanying interim period condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The condensed consolidated balance sheet as of September 30, 2013, condensed consolidated statements of operations, condensed consolidated statements of comprehensive income (loss) and condensed consolidated statements of cash flows for the three and nine months ended September 30, 2013 and 2012 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of its financial position, operating results and cash flows for the periods presented. The condensed consolidated balance sheet at December 31, 2012 has been derived from audited financial statements, but it does not include certain information and notes required by GAAP for complete consolidated financial statements.

 

The preparation of financial statements in conformity with GAAP requires management to make judgments, assumptions and estimates that affect the amounts reported in the Company’s condensed consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates.

 

The accompanying interim period condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012.

 

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Table of Contents

 

Revenue Recognition

 

The Company derives its revenues primarily from product sales and, to a lesser extent, contract research arrangements. The majority of the Company’s historical product revenues have been derived from the sale of the Oncotype DX breast cancer test. The Company generally bills third-party payors upon generation and delivery of a patient report to the physician. As such, the Company takes assignment of benefits and the risk of collection with the third-party payor. The Company usually bills the patient directly for amounts owed after multiple requests for payment have been denied or only partially paid by the insurance carrier. The Company pursues case-by-case reimbursement where policies are not in place or payment history has not been established.

 

The Company’s product revenues for tests performed are recognized when the following revenue recognition criteria are met: (1) persuasive evidence that an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectibility is reasonably assured. Criterion (1) is satisfied when the Company has an arrangement to pay or a contract with the payor in place addressing reimbursement for the Oncotype DX test. In the absence of such arrangements, the Company considers that criterion (1) is satisfied when a third-party payor pays the Company for the test performed. Criterion (2) is satisfied when the Company performs the test and generates and delivers to the physician, or makes available on its web portal, a patient report. Determinations of criteria (3) and (4) are based on management’s judgments regarding whether the fee charged for products or services delivered is fixed or determinable, and the collectibility of those fees under any contract or arrangement. When evaluating collectibility, the Company considers whether it has sufficient history to reliably estimate a payor’s individual payment patterns. Based upon at least several months of payment history, the Company reviews the number of tests paid against the number of tests billed and the payor’s outstanding balance for unpaid tests to determine whether payments are being made at a consistently high percentage of tests billed and at appropriate amounts given the contracted payment amount. To the extent all criteria set forth above are not met when test results are delivered, product revenues are recognized when cash is received from the payor.

 

The Company has exclusive distribution agreements for one or more of its Oncotype DX tests with approximately 20 distributors covering more than 80 countries. The distributor generally provides certain marketing and administrative services to the Company within its territory. As a condition of these agreements, the distributor generally pays the Company an agreed upon fee per test and the Company processes the tests. The same revenue recognition criteria described above generally apply to tests received through distributors. To the extent all criteria set forth above are not met when test results are delivered, product revenues are generally recognized when cash is received from the distributor.

 

From time to time, the Company receives duplicate payments or overpayments made by third-party payors or patients. When a duplicate payment or overpayment is identified, the Company establishes an accrued liability for the overpaid amount until such time as the Company determines whether or not a refund is due. Accrued refunds were $946,000 and $664,000 at September 30, 2013 and December 31, 2012, respectively, and included in accrued expenses and other current liabilities.

 

Contract revenues are generally derived from studies conducted with biopharmaceutical and pharmaceutical companies. The specific methodology for revenue recognition is determined on a case-by-case basis according to the facts and circumstances applicable to a given contract. Under certain contracts, the Company’s input, measured in terms of full-time equivalent level of effort or running a set of assays through its clinical reference laboratory under a contractual protocol, triggers payment obligations, and revenues are recognized as costs are incurred or assays are processed. Certain contracts have payments that are triggered as milestones are completed, such as completion of a successful set of experiments. Milestones are assessed on an individual basis and revenue is recognized when these milestones are achieved, as evidenced by acknowledgment from collaborators, provided that (1) the milestone event is substantive and its achievability was not reasonably assured at the inception of the agreement and (2) the milestone payment is non-refundable. Where separate milestones do not meet these criteria, the Company defaults to a performance-based model, such as revenue recognition following delivery of effort as compared to an estimate of total expected effort.

 

Advance payments received in excess of revenues recognized are classified as deferred revenue until such time as the revenue recognition criteria have been met.

 

Allowance for Doubtful Accounts

 

The Company accrues an allowance for doubtful accounts against its accounts receivable based on estimates consistent with historical payment experience. Bad debt expense is included in general and administrative expense on the Company’s condensed consolidated statements of operations. Accounts receivable are written off against the allowance when the appeals process is exhausted, when an unfavorable coverage decision is received or when there is other substantive evidence that the account will not be paid. The Company’s allowance for doubtful accounts as of September 30, 2013 and December 31, 2012 was $1.8 million and $1.1 million, respectively. Write-offs for doubtful accounts of $1.7 million and $4.1 million were recorded against the allowance during the three and nine months ended September 30, 2013, respectively, and write-offs of $972,000 and $2.6 million were recorded against the allowance during the three and nine months ended September 30, 2012, respectively. Bad debt expense was $1.8 million and $4.8 million for the three and nine months ended September 30, 2013, respectively, and $998,000 and $2.6 million for the three and nine months ended September 30, 2012, respectively.

 

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Table of Contents

 

Research and Development Expenses

 

Research and development expenses are comprised of costs incurred to develop technology and carry out clinical studies and include salaries and benefits, reagents and supplies used in research and development laboratory work, infrastructure expenses, including allocated facility occupancy and information technology costs, contract services, and other outside costs. Research and development expenses also include costs related to activities performed under contracts with biopharmaceutical and pharmaceutical companies. Research and development costs are expensed as incurred.

 

The Company enters into collaboration and clinical trial agreements with clinical collaborators and records the costs associated with these agreements as research and development expenses. The Company records accruals for estimated study costs comprised of work performed by its collaborators under contract terms. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized and recognized as expense as the goods are delivered or the related services are performed.

 

Income Taxes

 

The Company uses the liability method for income taxes, whereby deferred income taxes are provided on items recognized for financial reporting purposes over different periods than for income tax purposes. Valuation allowances are provided when the expected realization of tax assets does not meet a more-likely-than-not criterion.

 

The Company accounts for uncertain income tax positions using a benefit recognition model with a two-step approach, a more-likely-than-not recognition criterion and a measurement attribute that measures the position as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement, in accordance with the accounting guidance for uncertain tax positions. If it is not more likely than not that the benefit will be sustained on its technical merits, no benefit is recorded. Uncertain tax positions that relate only to timing of when an item is included on a tax return are considered to have met the recognition threshold. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in income tax expense when and if incurred. See Note 8, “Income Taxes,” for additional information regarding unrecognized tax benefits.

 

Investments in Privately Held Companies

 

The Company determines whether its investments in privately held companies are debt or equity based on their characteristics, in accordance with the applicable accounting guidance for such investments. The Company also evaluates the investee to determine if the entity is a variable interest entity (“VIE”) and, if so, whether the Company is the primary beneficiary of the VIE, in order to determine whether consolidation of the VIE is required in accordance with accounting guidance for consolidations. If consolidation is not required and the Company owns less than 50.1% of the voting interest of the entity, the investment is evaluated to determine if the equity method of accounting should be applied. The equity method applies to investments in common stock or in-substance common stock where the Company exercises significant influence over the investee, typically represented by ownership of 20% or more of the voting interests of an entity. If the equity method does not apply, investments in privately held companies determined to be equity securities are accounted for using the cost method. Investments in privately held companies determined to be debt securities are accounted for as available-for-sale or held-to-maturity securities, in accordance with accounting guidance for investments.

 

The Company reviews long-lived assets, which include investments in privately held companies, for impairment whenever events or changes in business circumstances indicate that the carrying amounts of the assets may not be fully recoverable. For investments in privately held companies, evidence of impairment might include the absence of an ability to recover the carrying amount of the investment or the inability of the investee to sustain an earnings capacity which would justify the carrying amount of the investment. The Company’s assessment as to whether any impairment is other than temporary is based on its ability and intent to hold the investment and whether evidence indicating the carrying value of the investment is recoverable within a reasonable period of time outweighs evidence to the contrary. If the fair value of the investment is determined to be less than the carrying value and the decline in value is considered to be other than temporary, the asset is written down to its fair value.

 

In December 2010, the Company invested $500,000 in the preferred stock of a private company representing 21% of the entity’s outstanding voting shares. The Company determined that it was not the primary beneficiary of this VIE and, accordingly, applied the equity method of accounting. In June 2012, the Company invested an additional $400,000 in the preferred stock of this company as part of a new equity financing which included other investors, and reduced the Company’s holdings to approximately 16%. As of June 30, 2012, the Company changed its method of accounting for this investment to the cost method because the Company’s ownership fell below 20% and the Company does not have the ability to exercise significant influence over the investee entity. As of September 30, 2013, the Company considered the investment to be temporarily impaired based on the private company’s low cash balances resulting from the delay of its commercial product launch. The private company is in the process of raising additional capital

 

9



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combined with executing new customer agreements and the Company has the ability and intent to hold the investment and expects the fair value of their investment to ultimately exceed the carrying value. The net carrying value of this investment was $643,000 at September 30, 2013 and at December 31, 2012, and no impairment was recognized through September 30, 2013.

 

In March 2011, the Company invested $2.3 million in the redeemable preferred stock of a private company representing 21% of the entity’s outstanding voting shares. The Company determined that the investment was a held-to-maturity debt security and that the investee was not subject to consolidation. In August 2012, the Company participated in the first tranche of a second preferred stock financing of this private company and purchased $1.0 million of preferred stock with no redemption privileges. In connection with this financing, the terms of the Company’s initial redeemable preferred stock investment were modified to become preferred stock with no redemption privileges. As a result of this transaction, the Company’s ownership interest was reduced to approximately 19% and the investment held by the Company is considered to be an investment in non-marketable equity securities. In October 2012, the Company participated in the second tranche of the second financing and purchased an additional $3.6 million of preferred stock, resulting in an ownership percentage of approximately 18%. In May 2013, the investee completed an additional round of financing to new investors. As of September 30, 2013, the Company’s ownership percentage was approximately 13%. The investee is not consolidated because the Company owns less than 20% of the investee and the Company does not have the ability to exercise significant influence over the investee. As a result, the Company will continue to use the cost method of accounting for this investment. The carrying value of this investment was $6.9 million at September 30, 2013 and at December 31, 2012, and no impairment was recognized through September 30, 2013.

 

The aggregate carryng value of the Company’s investments in privately held companies was $7.5 million at September 30, 2013 and at December 31, 2012, and were included in other assets in the accompanying condensed consolidated balance sheets. It is not practicable for the Company to estimate the fair value of its cost method investments in privately held companies since they are non-marketable securities and, therefore, quoted market prices are not available.

 

Recently Issued Accounting Pronouncements

 

In February 2013, the Financial Accounting Standards Board issued authoritative guidance requiring companies to report, in one place, information about reclassifications out of accumulated other comprehensive income (“AOCI”). Companies are also required to present reclassifications by component when reporting changes to AOCI balances. This guidance is effective for the Company for interim and annual periods beginning after December 15, 2012. As this guidance provides only presentation requirements, the adoption of this guidance does not impact the Company’s financial condition or results of operations. The Company adopted this standard in January 2013, as reflected by the inclusion of the Condensed Consolidated Statements of Comprehensive Income (Loss) as part of its Condensed Consolidated Financial Statements.

 

Note 2.  Net Income (Loss) Per Share

 

Basic net income (loss) per share is calculated by dividing net income (loss) for the period by the weighted-average number of common shares outstanding for the period without consideration of potential common shares. Diluted net income (loss) per share is calculated by dividing net income (loss) by the weighted-average number of common shares outstanding for the period and dilutive potential common shares for the period determined using the treasury-stock method. For purposes of this calculation, options to purchase common stock and restricted stock unit awards are considered to be potential common shares and are not included in the calculation of diluted net loss per share because their effect is anti-dilutive.

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

 

 

(In thousands)

 

Numerator:

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

488

 

$

3,712

 

$

(3,388

)

$

6,290

 

 

 

 

 

 

 

 

 

 

 

Denominator:

 

 

 

 

 

 

 

 

 

Weighted-average shares of common stock outstanding used in the calculation of basic net income (loss) per share

 

30,661

 

30,580

 

30,368

 

30,233

 

Effect of dilutive securities:

 

 

 

 

 

 

 

 

 

Options to purchase common stock

 

1,486

 

1,844

 

 

1,758

 

Restricted stock units

 

177

 

154

 

 

104

 

Total

 

1,663

 

1,998

 

 

1,862

 

Weighted-average shares of common stock outstanding used in the calculation of diluted net income (loss) per share

 

32,324

 

32,578

 

30,368

 

32,095

 

Basic net income (loss) per share

 

$

0.02

 

$

0.12

 

$

(0.11

)

$

0.21

 

Diluted net income (loss) per share

 

$

0.02

 

$

0.11

 

$

(0.11

)

$

0.20

 

 

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Options to purchase approximately 829,000 and 834,000 weighted average shares of the Company’s common stock that were outstanding during the three and nine months ended September 30, 2013, respectively, were not included in the computation of diluted net loss per share because their effect was anti-dilutive. Options to purchase approximately 556,000 and 486,000 weighted average shares of the Company’s common stock were outstanding during the three and nine months ended September 30, 2012, respectively, but were not included in the computation of diluted net income per share because their effect was anti-dilutive.

 

Note 3.  Fair Value Measurements

 

The Company measures certain financial assets, including cash equivalents and marketable securities, at their fair value on a recurring basis. The fair value of these financial assets was determined based on a hierarchy of three levels of inputs, of which the first two are considered observable and the last unobservable, as follows:

 

Level 1:  Quoted prices in active markets for identical assets or liabilities;

 

Level 2:  Observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and

 

Level 3:  Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. The Company did not have any non-financial assets or liabilities that were measured or disclosed at fair value on a recurring basis at September 30, 2013 and December 31, 2012, respectively. The following tables set forth the Company’s financial instruments that were measured at fair value on a recurring basis at September 30, 2013 and December 31, 2012 by level within the fair value hierarchy:

 

 

 

Actively Quoted
Markets for
Identical Assets
Level 1

 

Significant Other
Observable
Inputs
Level 2

 

Significant
Unobservable
Inputs
Level 3

 

Balance at
September 30,
2013

 

 

 

(In thousands)

 

As of September 30, 2013:

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

Money market deposits

 

$

9,357

 

$

 

$

 

$

9,357

 

U.S. Treasury securities

 

751

 

 

 

751

 

Debt securities of U.S. government-sponsored entities

 

 

1,107

 

 

1,107

 

Commercial paper

 

 

47,149

 

 

47,149

 

Corporate debt securities

 

 

30,358

 

 

30,358

 

Total

 

$

10,108

 

$

78,614

 

$

 

$

88,722

 

 

 

 

Actively Quoted
Markets for
Identical Assets
 Level 1

 

Significant Other
 Observable
 Inputs
 Level 2

 

Significant
 Unobservable
 Inputs
 Level 3

 

Balance at
 December 31,
 2012

 

 

 

(In thousands)

 

As of December 31, 2012:

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

Money market deposits

 

$

7,403

 

$

 

$

 

$

7,403

 

U.S. Treasury securities

 

1,276

 

 

 

1,276

 

Debt securities of U.S. government-sponsored entities

 

 

761

 

 

761

 

Commercial paper

 

 

33,888

 

 

33,888

 

Corporate debt securities

 

 

52,102

 

 

52,102

 

Total

 

$

8,679

 

$

86,751

 

$

 

$

95,430

 

 

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The Company’s debt securities of U.S. government-sponsored entities, commercial paper and corporate bonds are classified as Level 2 as they are valued using multi-dimensional relational pricing models that use observable market inputs, including benchmark yields, reported trades, broker-dealer quotes, issuer spreads, benchmark securities, bids, offers and reference data. Not all inputs listed are available for use in the evaluation process on any given day for each security evaluation. In addition, market indicators, industry and economic events are monitored and may serve as a trigger to acquire further corroborating market data. There were no transfers between Level 1 and Level 2 categories during the three and nine months ended September 30, 2013 and 2012, respectively.

 

All of the Company’s marketable securities are classified as available-for-sale. The following tables illustrate the Company’s available-for-sale marketable securities as of the dates indicated:

 

 

 

September 30, 2013

 

 

 

Amortized
Cost

 

Unrealized
Gains

 

Unrealized
Losses

 

Estimated
Fair Value

 

 

 

(In thousands)

 

U.S. Treasury securities

 

$

751

 

$

 

$

 

$

751

 

Debt securities of U.S. government-sponsored entities

 

1,106

 

1

 

 

1,107

 

Commercial paper

 

42,875

 

24

 

 

42,899

 

Corporate debt securities

 

29,515

 

4

 

(11

)

29,508

 

Total

 

$

74,247

 

$

29

 

$

(11

)

$

74,265

 

 

 

 

December 31, 2012

 

 

 

Amortized
Cost

 

Unrealized
Gains

 

Unrealized
Losses

 

Estimated
Fair Value

 

 

 

(In thousands)

 

U.S. Treasury securities

 

$

1,275

 

$

1

 

$

 

$

1,276

 

Debt securities of U.S. government-sponsored entities

 

761

 

 

 

761

 

Commercial paper

 

28,854

 

35

 

 

28,889

 

Corporate debt securities

 

50,155

 

2

 

(23

)

50,134

 

Total

 

$

81,045

 

$

38

 

$

(23

)

$

81,060

 

 

The Company had no realized gains or losses on available-for-sale marketable securities for the three and nine months ended September 30, 2013 and 2012, respectively.

 

All of the Company’s available-for-sale marketable securities had contractual maturities of one year or less as of September 30, 2013 and December 31, 2012, respectively.

 

Note 4. Collaboration and Commercial Technology Licensing Agreements

 

The Company has entered into a variety of collaboration and specimen transfer agreements relating to its development efforts. The Company recorded collaboration expenses of $1.0 million and $2.1 million for the three and nine months ended September 30, 2013 and $370,000 and $1.4 million for the three and nine months ended September 30, 2012, respectively, relating to services provided in connection with these agreements. In addition to these expenses, some of the agreements contain provisions for royalties from inventions resulting from these collaborations. The Company has specified options and rights relating to joint inventions arising out of the collaborations.

 

In August 2013, the Company entered into a collaboration agreement to conduct an additional large DCIS clinical study to validate the relationship between the Oncotype DX DCIS score and the likelihood of local recurrence in patients with DCIS. The agreement, which is estimated to be completed in 2017, includes a study fee and milestone payments dependent on the completion of certain key milestones. During the three and nine months ended September 30, 2013, the Company made milestone payments of $392,000 related to this agreement. All future milestone payments are contingent on certain milestone accomplishments, and therefore the timing for future milestone payments cannot be estimated.

 

The Company is a party to various agreements under which it licenses technology on a non-exclusive basis in the field of human diagnostics. Access to these licenses enables the Company to process its Oncotype DX tests. While certain agreements contain provisions for fixed annual payments, license fees are generally calculated as a percentage of product revenues, with rates that vary by agreement and may be tiered, and payments that may be capped at annual minimum or maximum amounts. The Company recognized costs recorded under these agreements totaling $2.2 million and $6.7 million for the three and nine months ended September 30, 2013 and $2.0 million and $6.0 million for the three and nine months ended September 30, 2012, respectively, which were included in cost of product revenues.

 

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At September 30, 2013, fixed future annual payments, exclusive of royalty payments, relating to the launch and commercialization of the Oncotype DX colon cancer test and the Oncotype DX prostate cancer test totaled $1.1 million and are payable as follows:

 

 

 

Fixed Future
Annual Payments

 

 

 

(In thousands)

 

Payment Due:

 

 

 

2014

 

$

550

 

2015

 

550

 

Total

 

$

1,100

 

 

These payments are recorded in cost of product revenues as license fees. Expense for payments included in the table above is recorded ratably over the year before the relevant payment is due. If at any time the Company discontinues the sale of the products covered by the agreement, no future annual payments will be payable and the Company will have no further obligation under the applicable agreement.

 

Contract Research Arrangements

 

In November 2007, the Company entered into a Collaborative Diagnostic Development Agreement with Pfizer Inc. to provide research and development services for the development of a diagnostic product for renal cell cancer. The Company received an initial payment of $1.5 million and was initially eligible to receive a payment of $2.2 million upon joint agreement on a gene identification plan, $5.0 million in additional payments upon the earlier of Pfizer’s election to initiate the next phase of development or a specified number of months from the date the Company received the sample set and related clinical data necessary to conduct the first phase of development, and a final payment of $1.5 million upon completion of clinical validation. Completion of clinical validation represents a substantive milestone and the Company will recognize the $1.5 million payment upon completion. All other payments were not considered substantive milestones as they are not based solely on the Company’s past performance. Such payments are recognized using a performance- based model and revenue is recognized following delivery of effort as compared to an estimate of total expected effort. The Company did not recognize any revenue related to substantive milestones under this agreement during the three and nine months ended and September 30, 2013 and 2012, respectively.

 

Note 5. Commitments

 

Lease Obligations

 

In September 2005, the Company entered into a non-cancelable lease for 48,000 square feet of laboratory and office space that the Company currently occupies in Redwood City, California. In November 2010, the Company executed an amendment to extend the term of the lease through March 2019, with an option to extend the term of the lease for an additional five years. The agreement included lease incentive obligations of $834,000 that are being amortized on a straight-line basis over the life of the lease.

 

In January 2007, the Company entered into a non-cancelable lease for an additional 48,000 square feet of laboratory and office space in a nearby location. In November 2010, the Company executed an amendment to extend the term of the lease through March 2018, with an option to extend the term of the lease for an additional five years. The agreement included lease incentive obligations totaling $283,000 that are being amortized on a straight-line basis over the life of the lease.

 

In October 2009, the Company entered into a non-cancelable agreement to lease an additional 30,500 square feet of office space near the locations the Company currently occupies. The lease expires in March 2018, with an option for the Company to extend the term of the lease for an additional five years. The agreement includes lease incentive obligations of $307,000 which are being amortized on a straight-line basis over the life of the lease.

 

In August 2013, the Company entered into a non-cancelable agreement to lease an additional 18,400 square feet of laboratory and office space near the locations the Company currently occupies. The lease expires in March 2019, with an option for the Company to extend the term of the lease for an additional five years. In addition, there is an additional 5,500 square feet that may become available during the initial term of the lease, which the Company has agreed to lease on the same terms. The agreement includes lease incentive obligations of $276,000 which are being amortized on a straight-line basis over the life of the lease.

 

In May 2010, the Company’s European subsidiary entered into a non-cancelable lease for approximately 2,500 square feet of office space in Geneva, Switzerland. The lease expires in May 2015.  Additionally, the Company has offices in the United Kingdom and Germany with short-term rental agreements.

 

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Future non-cancelable commitments under these operating leases at September 30, 2013 were as follows:

 

 

 

Annual
Payments

 

 

 

(In thousands)

 

Years Ending December 31,

 

 

 

2013 (remainder of year)

 

$

771

 

2014

 

3,603

 

2015

 

3,539

 

2016

 

3,597

 

2017

 

3,706

 

2018 and thereafter

 

2,771

 

Total minimum payments

 

$

17,987

 

 

Note 6. Stock-Based Compensation

 

The Company recognized employee stock-based compensation expense of $4.4 million and $12.8 million for the three and nine months ended September 30, 2013, respectively, and $3.4 million and $10.8 million for the three and nine months ended September 30, 2012, respectively. Employee stock-based compensation expense includes expense related to stock option grants, restricted stock unit (“RSU”) awards to employees, restricted stock issued in lieu of outside director fees and stock purchased under the Company’s Employee Stock Purchase Plan (“ESPP”). Stock-based compensation expense is calculated based on options and RSUs ultimately expected to vest and has been reduced for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

 

Stock Option Grants

 

The Company granted options to purchase 83,105 shares and 458,355 shares of common stock to employees during the three and nine months ended September 30, 2013, respectively and 41,500 shares and 608,000 shares of common stock to employees during the three and nine months ended September 30, 2012, respectively. For the three and nine months ended September 30, 2013, the Company issued 123,796 and 631,114 shares of common stock in connection with the exercise of stock options with a weighted-average exercise price of $15.37 and $16.44 per share, respectively. For the three and nine months ended September 30, 2012, the Company issued 303,577 and 835,865 shares of common stock in connection with the exercise of stock options with a weighted-average exercise price of $17.96 and $16.53 per share, respectively.

 

Restricted Stock Units

 

During the three and nine months ended September 30, 2013, the Company awarded 110,635 and 379,158 RSUs with a grant-date fair value equal to $3.9 million and $11.6 million, respectively. During the three and nine months ended September 30, 2012, the Company awarded 31,550 and 415,566 RSUs with a grant-date fair value equal to $1.1 million and $12.3 million, respectively. Each RSU entitles the recipient to receive one share of the Company’s common stock upon vesting. RSUs awarded to employees generally vest as to one-third of the total number of shares awarded annually over a three-year period. During the three and nine months ended September 30, 2013, the Company issued 12,328 and 223,791 shares of common stock in connection with the vesting of RSUs with a weighted-average grant date fair value of $31.35 and $26.94 per share, respectively. During the three and nine months ended September 30, 2012, the Company issued 2,819 and 64,909 shares of common stock, respectively, in connection with the vesting of RSUs with a weighted-average grant date fair value of $22.80 and $23.29 per share, respectively.

 

Restricted Stock in Lieu of Directors’ Fees

 

Outside members of the Company’s Board of Directors may elect to receive fully-vested restricted stock in lieu of cash compensation for services as a director. During the three and nine months ended September 30, 2013, the Company issued 1,818 and 5,795 shares of restricted stock to outside directors, with a grant date fair value of $60,000 and $170,000, respectively, and a weighted-average grant date fair value of $32.85 and $29.28 per share, respectively. During the three and nine months ended September 30, 2012, the Company issued 1,196 and 4,072 shares of restricted stock to outside directors, with a grant date fair value of $40,000 and $120,000, respectively, and a weighted-average grant date fair value of $33.40 and $29.41 per share, respectively.

 

Employee Stock Purchase Plan

 

During the nine months ended September 30, 2013, 86,683 shares were issued under the ESPP. There were no shares issued under the ESPP during the three months ended September 30, 2013. A total of 1,250,000 shares of common stock have been reserved for issuance under the ESPP, of which 1,017,254 shares were available for issuance as of September 30, 2013. As of September 30, 2013, there was $171,000 of unrecognized compensation expense related to the ESPP, which is expected to be recognized over an estimated weighted-average period of two months.

 

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Table of Contents

 

Valuation Assumptions

 

The Company values its stock option grants using the Black-Scholes option valuation model. Option valuation models require the input of highly subjective assumptions that can vary over time. The Company’s assumptions regarding expected volatility are based on the historical volatility of the Company’s common stock. The expected life of options granted is estimated based on historical option exercise data and assumptions related to unsettled options. The risk-free interest rate is estimated using published rates for U.S. Treasury securities with a remaining term approximating the expected life of the options granted. The Company uses a dividend yield of zero as it has never paid cash dividends and does not anticipate paying cash dividends in the foreseeable future. The weighted-average fair values and assumptions used in calculating such values during each period are as follows:

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

Expected volatility:

 

 

 

 

 

 

 

 

 

Stock options

 

45

%

45

%

46

%

46

%

ESPP

 

29

%

38

%

41

%

43

%

Risk-free interest rate:

 

 

 

 

 

 

 

 

 

Stock options

 

1.90

%

1.43

%

1.40

%

1.23

%

ESPP

 

0.08

%

0.12

%

0.11

%

0.08

%

Expected life in years:

 

 

 

 

 

 

 

 

 

Stock options

 

6.59

 

6.68

 

6.64

 

6.98

 

ESPP

 

0.50

 

0.50

 

0.50

 

0.50

 

Weighted-average fair value:

 

 

 

 

 

 

 

 

 

Stock options

 

$

15.83

 

$

18.40

 

$

14.11

 

$

14.51

 

ESPP

 

$

8.04

 

$

8.12

 

$

7.74

 

$

7.59

 

 

Note 7. Segment Information

 

The Company operates in one business segment, which primarily focuses on the development and global commercialization of genomic based clinical laboratory services that analyze the underlying biology of cancer. As of September 30, 2013, the majority of the Company’s product revenues have been derived from sales of one product, the Oncotype DX breast cancer test. All Oncotype DX tests are included in one segment, because they have similar economic and other characteristics, including the nature of the tests and laboratory processes, type of customers, distribution methods and regulatory environment.

 

The following table summarizes total revenues from customers and collaboration partners by geographic region. Product revenues are attributed to countries based on ship-to location. Contract revenues are attributed to countries based on the location of the collaboration partner.

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

 

 

(in thousands)

 

United States

 

$

55,890

 

$

50,564

 

$

164,973

 

$

155,798

 

Outside of the United States

 

10,100

 

8,084

 

27,803

 

18,948

 

Total revenues

 

$

65,990

 

$

58,648

 

$

192,776

 

$

174,746

 

 

Note 8. Income Taxes

 

The Company recorded income tax expense of $116,000 and $223,000 for the three and nine months ended September 30, 2013, respectively, which was computed using the “discrete” (or “cut-off”) method and was principally comprised of state income taxes and foreign taxes. The Company recorded income tax expense of $109,000 and $243,000 for the three and nine months ended September 30, 2012, respectively, which was computed using the same method and was principally comprised of California alternative minimum tax, other state income taxes and foreign taxes. The difference between the income tax expense actually recorded and the statutory rate applied to the Company’s income (loss) before income taxes was primarily due to the impact of nondeductible meals and entertainment for the three and nine months ended September 30, 2013 and nondeductible stock-based compensation expenses for the three and nine months ended September 30, 2012.

 

Based on all available objective evidence, the Company believes that it is more likely than not that its net deferred tax assets will not be fully realized. Accordingly, the Company maintained a valuation allowance against all of its net deferred tax assets as of both

 

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Table of Contents

 

September 30, 2013 and December 31, 2012. The Company will continue to maintain a full valuation allowance until there is sufficient evidence to support recoverability of its deferred tax assets.

 

The Company had $967,000 and $875,000 of unrecognized tax benefits as of September 30, 2013 and December 31, 2012, respectively. The Company does not anticipate a material change to its unrecognized tax benefits over the next twelve months. Unrecognized tax benefits may change during the next twelve months for items that arise in the ordinary course of business.

 

Accrued interest and penalties related to unrecognized tax benefits are recognized as part of the Company’s income tax provision in its condensed consolidated statements of operations. All tax years from 2000 forward remain subject to future examination by federal, state and foreign tax authorities.

 

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Table of Contents

 

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

 

This report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When used in this report, the words “expects,” “anticipates,” “intends,” “estimates,” “plans,” “believes,” and similar expressions are intended to identify forward-looking statements. These are statements that relate to future periods and include statements about our expectation that, for the foreseeable future, a significant amount of our revenues will be derived from Oncotype DX for breast cancer; the factors that may impact our financial results; our ability to achieve sustained profitability; our business strategy and our ability to achieve our strategic goals; our expectations regarding product revenues and the sources of those revenues; the amount of future revenues that we may derive from Medicare patients or categories of patients; our belief that we may become more dependent on Medicare reimbursement in the future; our plans to pursue reimbursement on a case-by-case basis; our ability, and expectations as to the amount of time it will take, to achieve reimbursement from third-party payors and government insurance programs for new indications of tests, new tests or in new markets; our expectations regarding our international expansion and opportunities; our expectations regarding reimbursement in international markets; our intent to enter into additional foreign distribution arrangements; our beliefs with respect to the benefit and attributes of our tests; the factors we believe drive demand for our tests and our ability to sustain or increase such demand; our success in increasing patient and physician demand as a result of our direct sales approach and our sales forces’ capacity to sell our tests; plans for, and the timeframe for the development or commercial launch of, future tests or enhancements to address different patient populations of breast, colon or prostate cancer, other types of cancer or specific cancer treatments; our ability to expand our commercial efforts beyond oncology and into urology; the factors that we believe will drive the establishment of coverage policies; the capacity of our clinical reference laboratory to process tests and our expectations regarding capacity; our dependence on collaborative relationships and the success of those relationships; whether any tests will result from our collaborations; the applicability of clinical results to actual outcomes; our estimates and assumptions with respect to disease incidence and potential market opportunities; the occurrence, timing, outcome or success of clinical trials or studies; our plans with respect to additional studies; our expectations regarding timing of the announcement or publication of research results; the benefits of our technology platform; the economic benefits of our tests to the healthcare system; the ability of our tests to impact treatment decisions; our beliefs regarding our competitive position; our expectations regarding our future technologies, including next generation sequencing, and their potential benefits; our beliefs regarding the benefits of genomic analysis in various patient populations; our expectations regarding clinical development processes future tests may follow; our beliefs regarding the benefits of individual gene reporting; our expectation that our research and development, general and administrative and sales and marketing expenses will increase and our anticipated uses of those funds; our expectations regarding capital expenditures; our ability to comply with the requirements of being a public company; our expectations regarding future levels of bad debt expense and billing and collections fees; our ability to attract and retain experienced personnel; the adequacy of our product liability insurance; our anticipated cash needs and our estimates regarding our capital requirements; our need for additional financing; our expected future sources of cash; our expectations regarding incurrence of debt; our compliance with federal, state and foreign regulatory requirements; the potential impact resulting from the regulation of our tests by the U.S. Food and Drug Administration, or FDA, and other non-U.S. regulators; our belief that our tests are properly regulated under the Clinical Laboratory Improvement Amendments of 1988, or CLIA; the impact of new or changing policies, regulation or legislation, or of judicial decisions, on our business; the impact of seasonal fluctuations and economic conditions on our business; our belief that we have taken reasonable steps to protect our intellectual property; the impact of changing interest rates; our beliefs regarding our unrecognized tax benefits or our valuation allowance; the impact of accounting pronouncements and our critical accounting policies, judgments, estimates, models and assumptions on our financial results; the impact of the economy on our business, patients and payors; and anticipated trends and challenges in our business and the markets in which we operate.

 

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expected. These risks and uncertainties include, but are not limited to, those risks discussed in Item 1A of this report, as well as our ability to develop and commercialize new products and product enhancements; the risk of unanticipated delays in research and development efforts; the risk that we may not obtain or maintain reimbursement for our existing tests or any future tests we may develop; the risk that reimbursement pricing or coverage may change; the risks and uncertainties associated with the regulation of our tests by the FDA or regulatory agencies outside of the U.S.; the success of our new technology; the results of clinical studies; the applicability of clinical results to actual outcomes; the impact of new legislation or regulations, or of judicial decisions, on our business; our ability to compete against third parties; our ability to obtain capital when needed; the economic environment; and our history of operating losses. These forward-looking statements speak only as of the date hereof. We expressly disclaim any obligation or undertaking to update any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

 

In this report, all references to “Genomic Health,” “we,” “us,” or “our” mean Genomic Health, Inc.

 

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Table of Contents

 

Genomic Health, the Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score and DCIS Score are trademarks or registered trademarks of Genomic Health, Inc. We also refer to trademarks of other corporations and organizations in this report.

 

Business Overview

 

We are a global healthcare company that provides actionable genomic information to personalize cancer treatment decisions. We develop and globally commercialize genomic-based clinical laboratory services that analyze the underlying biology of cancer, allowing physicians and patients to make individualized treatment decisions. We offer our Oncotype DX tests as a clinical laboratory service, where we analyze the expression levels of genes in tumor tissue samples and provide physicians with a quantitative gene expression profile expressed as a single quantitative score, which we call a Recurrence Score for invasive breast cancer and colon cancer, a DCIS Score for ductal carcinoma in situ, or DCIS, and a Genomic Prostate Score, or GPS, for prostate cancer.

 

In January 2004, we launched our first Oncotype DX test, which is used to predict the likelihood of cancer recurrence and the likelihood of chemotherapy benefit in early stage invasive breast cancer patients. In January 2010, we launched our second Oncotype DX test, the first multigene expression test developed to assess risk of recurrence in stage II colon cancer patients. In December 2011, we made the Oncotype DX breast cancer test available for patients with DCIS, a pre-invasive form of breast cancer. In June 2012, we extended our offering of the Oncotype DX colon cancer test to patients with stage III disease treated with oxaliplatin-containing adjuvant therapy. In May 2013, we launched our Oncotype DX prostate cancer test, which is used to predict disease aggressiveness in men with low risk disease. Effective July 1, 2013, the list price of our Oncotype DX breast cancer test increased from $4,290 to $4,380 and the list price of our Oncotype DX colon cancer test increased from $3,640 to $4,030. The list price of our Oncotype DX prostate cancer test is $3,820. The majority of our historical revenues have been derived from the sale of Oncotype DX breast cancer tests ordered by physicians in the United States.

 

For the three and nine months ended September 30, 2013, we delivered 21,790 and 62,780 Oncotype DX test reports for use in treatment planning, compared to more than 18,030 and 55,690 reports delivered for the three and nine months ended September 30, 2012. All of our tests are conducted at our clinical reference laboratory in Redwood City, California. Our clinical reference laboratory processing capacity is currently approximately 24,000 tests per calendar quarter. As test processing for our Oncotype DX breast, colon and prostate cancer tests is essentially the same, except that the tests use different RNA extraction methods and analyze different genes, we believe that we currently have sufficient capacity to process all of our tests. In connection with the May 2013 launch of our prostate cancer test, we are in the process of expanding our clinical laboratory processing capacity. We expect our initial commercialization efforts of our prostate cancer test will result in increased costs for laboratory testing, including staffing-related costs, incremental sales and marketing staffing to introduce our product to a new group of physicians and patients, costs for clinical utility studies and costs associated with obtaining reimbursement coverage.

 

We depend upon third-party payors to provide reimbursement for our tests. Accordingly, we have and expect to continue to focus substantial resources on obtaining reimbursement coverage from third-party payors.

 

We have continued to expand our business, both in the United States and internationally. We plan to continue to use essentially the same business model internationally as we use in the United States, however, there are significant differences between countries that need to be considered. For example, different countries may have a public healthcare system, a combination of public and private healthcare system or a cash-based payment system. We have a direct commercial presence with employees and have consultants in some countries, including Canada, France, Germany, Ireland, Italy, Japan, Switzerland and the United Kingdom. Additionally, we entered into exclusive distribution agreements for the sale of our tests with approximately 20 distributors covering more than 80 countries outside of the United States.

 

We expect that international sales of our Oncotype DX tests will be heavily dependent on the availability of reimbursement and sample access. In many countries, governments are primarily responsible for reimbursing diagnostic tests. Governments often have significant discretion in determining whether a test will be reimbursed at all, and if so, how much will be paid. In addition, certain countries, such as China, have prohibitions against exporting tissue samples which will limit our ability to offer our tests in those countries without local facilities or a method of test delivery which does not require samples to be transported to our U.S. facility.

 

The majority of our international Oncotype DX breast and colon cancer test revenues come from direct payor reimbursement, payments from our distributors, patient self-pay, and clinical collaborations in various countries. We have obtained some coverage for our breast cancer test outside of the United States, including in Argentina, Canada, Germany, Greece, Ireland, Israel, Saudi Arabia, Spain and the United Kingdom. In September 2013, we announced that the National Institute for Health and Care Excellence (NICE) in the United Kingdom issued its final guidance recommending Oncotype DX as the only multi-gene breast cancer test for use in clinical practice to guide chemotherapy treatment decisions for patients with early-stage, hormone receptor-positive, invasive breast cancer. We expect that it will take several years to establish broad coverage and reimbursement for our Oncotype DX breast, colon

 

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and prostate cancer tests with payors in countries outside of the United States and there can be no assurance that our efforts will be successful. In addition, we have initiated efforts to obtain reimbursement coverage for our prostate cancer test we launched in May 2013.

 

Oncotype DX Breast Cancer Test

 

We expect to continue to focus substantial resources on pursuing global adoption of and reimbursement for our Oncotype DX breast cancer test. We believe increased demand for our Oncotype DX breast cancer test resulted from our ongoing commercial efforts, expanded utility for new breast cancer patient groups, continued publication of peer-reviewed articles on studies we sponsored, conducted or collaborated on that support the use of and reimbursement for the test, clinical presentations at major symposia, and the inclusion of our breast cancer test in clinical practice guidelines for node negative, or N-, estrogen receptor positive, or ER+, invasive disease. However, this increased demand is not necessarily indicative of future growth rates, and we cannot provide assurance that this level of increased demand can be sustained or that publication of articles, future appearances or presentations at medical conferences, increased commercial efforts or expansion of utility to new breast cancer patient groups will have a similar impact on demand for our breast cancer test in the future. Sequential quarterly demand for our breast cancer test may also be impacted by other factors, including the economic environment and continued high unemployment levels, seasonal variations that have historically impacted physician office visits, our shift in commercial focus to our Oncotype DX colon and prostate cancer tests or any future products we may develop, patient enrollment in Oncotype DX clinical studies and the number of clinical trials in process by cooperative groups or makers of other tests conducting experience studies.

 

Most national and regional third-party payors in the United States, along with the designated national Medicare contractor for our tests, have issued positive coverage determinations for our Oncotype DX breast cancer test for patients with N-, ER+, invasive disease through contracts, agreements or policy decisions. The local carrier with jurisdiction for claims submitted by us for Medicare patients also provides coverage for our breast cancer test for ER+ patients with node positive, or N+, disease (up to three positive lymph nodes) and invasive breast cancer patients where a lymph node status is unknown or not accessible due to a prior surgical procedure, or when the test is used to guide a neoadjuvant treatment decision. Additionally, some payors provide policy coverage for the use of our test in ER+ patients with N+ disease, including lymph node micro-metastasis (greater than 0.2 mm, but not greater than 2.0 mm in size). In July 2011, the American Journal of Managed Care published results of an economic assessment suggesting use of Oncotype DX in breast cancer patients with 1-3 positive nodes may improve health outcomes without adding incremental cost. However, we may not be able to obtain reimbursement coverage from other payors for our test for breast cancer patients with N+, ER+ disease.

 

In December 2011, we made the Oncotype DX breast cancer test available for patients with DCIS, a pre-invasive form of breast cancer. The launch of Oncotype DX for DCIS patients was based upon presented positive results from a clinical validation study of the Oncotype DX breast cancer test in patients with DCIS, conducted by the Eastern Cooperative Oncology Group, or ECOG, a clinical trials cooperative group supported by the National Cancer Institute. The study met its primary endpoint by demonstrating that a pre-specified Oncotype DX DCIS Score derived from the Oncotype DX breast cancer test outperforms traditional clinical and pathologic measures to predict the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast. In May 2013, our Oncotype DX DCIS clinical validation study was published online in the Journal of National Cancer Institute. Following the publication of the results of this study, the Medicare contractor for our Oncotype DX breast cancer test expanded coverage to include patients with DCIS. We expect that it may take several years to establish coverage with a majority of public and private payors for use of our test in DCIS patients and we may not be able to obtain such coverage.

 

Oncotype DX Colon Cancer Test

 

We expect to continue to focus substantial resources on pursuing global adoption of and reimbursement for our Oncotype DX colon cancer test. We believe the key factors that will drive further adoption of this test include results from additional studies we sponsor, conduct or collaborate on that support the use of and increased coverage and reimbursement for the test, clinical presentations at major symposia, publications and our ongoing commercial efforts. In June 2011, at the American Society of Clinical Oncology, or ASCO, Annual Meeting, a second large study confirming that the Oncotype DX colon cancer test independently predicts individualized recurrence risk for stage II colon cancer was presented. In November 2011, positive results from the QUASAR clinical validation study were published online by the Journal of Clinical Oncology. Current or future studies of our colon cancer test may lead to inclusion of the test in clinical guidelines and as standard of care for indicated patients.

 

Effective September 18, 2011, the designated national Medicare contractor for our tests established a formal coverage policy for our Oncotype DX colon cancer test for patients with stage II colon cancer. We are working with additional public and private payors and health plans to secure coverage for our colon cancer test based upon clinical evidence showing the utility of the test, and we have obtained reimbursement coverage for our Oncotype DX colon cancer test from certain other third-party payors. As a relatively new test, our colon cancer test may be considered investigational by payors and therefore may not be covered under their reimbursement policies. Consequently, we intend to pursue case-by-case reimbursement and expect that this test will continue to be reviewed on this

 

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basis until policy decisions have been made by individual payors. We believe it may take several years to achieve reimbursement with a majority of third-party payors for our colon cancer test. However, we cannot predict whether, at what rate, or under what circumstances, payors will reimburse for this test. Based upon our experience in obtaining adoption of and reimbursement for our Oncotype DX breast cancer test, we do not expect product revenues from our colon cancer test to comprise more than 10% of our total revenues for at least the next year or more.

 

In June 2012, based on the positive results of the landmark randomized NSABP C-07 validation study, we began offering the Oncotype DX colon cancer test for use in patients with stage III disease treated with oxaliplatin-containing adjuvant therapy. In September 2012, at the European Society for Medical Oncology Congress, we presented these positive results from the NSABP C-07 study, including prediction of risk of recurrence, disease-free survival and overall survival in stage II and stage III colon cancer patients. In October 2013, the Journal of Clinical Oncology accepted for publication positive results of the third successful validation of the Oncotype DX colon cancer test in patients with stage II disease and the first validation study in patients with stage III disease.  In November 2013, the Current Medical Research & Opinion published positive results from the Partnership for Health Analytic Research clinical utility analysis of the Oncotype DX colon cancer test, demonstrating that use of the assay changes treatment recommendations in 29 percent of stage II colon cancer patients.

 

In an exploratory component of the NSABP C-07 clinical trial, researchers analyzed 735 genes and identified 16 genes as being predictive of oxaliplatin benefit when added to adjuvant therapy for use in patients with stage III colon cancer.  In September 2013, we delayed our plan to utilize these results and initiate a validation study in 2013. The decision to delay was based on analytical performance during the pre-validation phase that did not meet our standards for a subset of the candidate predictive genes.

 

Oncotype DX Prostate Cancer Test

 

In February 2011, at the ASCO Genitourinary Cancer Symposium and the United States and Canadian Academy of Pathology meeting, we presented positive full results from our prostate cancer gene identification study. The study, which applied the same reverse transcription polymerase chain reaction, or RT-PCR, technology used in our Oncotype DX breast and colon cancer tests, identified 295 genes strongly associated with clinical recurrence of prostate cancer following radical prostatectomy. In June 2012, we presented results of our first development study in prostate tissue obtained from needle biopsies. The study, an analysis of biopsy samples from men with conventionally defined low/intermediate risk prostate cancer, showed that genes and biological pathways associated with clinically-aggressive prostate cancer in radical prostatectomy specimens can be reliably measured by quantitative RT-PCR from fixed prostate needle biopsies. Based on the results of this and multiple prior studies, we initiated a large clinical validation study in early 2012.

 

In September 2012, we announced positive top line results from this clinical validation study of our biopsy-based prostate cancer test. As a result of this clinical validation study meeting its primary end point, we completed the necessary work in our clinical reference laboratory for the May 2013 worldwide commercial launch of our Oncotype DX prostate cancer test. The test provides a Genomic Prostate Score, or GPS, that predicts disease aggressiveness in men with low risk disease. This test may be used to improve treatment decisions for prostate cancer patients, in conjunction with the Gleason score, or tumor grading.

 

We expect to incur additional expenses related to continued clinical studies and the commercial launch of our prostate cancer test, including infrastructure costs, information technology costs, and selling and marketing costs. We have initiated efforts to obtain reimbursement coverage for this test. Based upon our experience in obtaining adoption and reimbursement for our Oncotype DX breast and colon cancer tests, we do not expect product revenues from our prostate cancer test to comprise more than 10% of our total revenues for at least a year or more following our launch.

 

Product Development Opportunities

 

In addition to developing products to address new cancer areas, we continually look to expand the clinical utility and addressable patient populations for our existing cancer tests. These developments efforts may lead to a wide variety of possible new products covering various treatment decisions, including:

 

·              Risk assessment;

 

·              Screening and prevention;

 

·              Early disease diagnosis;

 

·              Adjuvant disease diagnosis;

 

·              Metastatic treatment selection; and

 

·              Treatment monitoring.

 

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Our new products may address a specific clinical need or guide a targeted therapy decision and may also leverage our “next generation” sequencing, or NGS, capabilities to expand our product opportunities.

 

Technology

 

In our Oncotype DX platform we utilize existing technologies, such as RT-PCR, and information technologies and optimize and integrate them into new processes. We are also incorporating new technologies, such as high-throughput NGS, in our research and development laboratory. NGS technologies parallelize the sequencing process, producing millions of sequences at once. These technologies are intended to provide DNA and RNA sequence information in greater amounts and at lower cost than standard methods. We have created proprietary methods for NGS analysis of fixed paraffin embedded, or FPE, tissue nucleic acids, created bioinformatics programs and infrastructure for data storage and analysis, and plan to rely on NGS as the technological source of new biomarkers in the future. We expect to continue to develop the capabilities of various technologies to create new products.

 

Economic Environment

 

Continuing concerns over prolonged high unemployment levels, the availability and cost of credit, the U.S. real estate market, Federal budget negotiations, entitlement and health care reform efforts, proposed regulatory changes and taxation issues, inflation, deflation, energy costs and geopolitical issues have contributed to increased volatility and uncertain expectations both for the U.S. and global economies. These factors, combined with uncertainties in business and consumer confidence, a volatile stock market, the European sovereign debt crisis, continued concerns regarding the stability of the Euro currency and some European Union member countries and slowing growth in China, have precipitated an economic slowdown and expectations of slower global economic growth and possibly another recession going forward. We periodically evaluate the impact of the economic environment on our cash management, cash collection activities and volume of tests delivered.

 

As of the date of this report, we have not experienced a loss of principal on any of our investments, and we expect that we will continue to be able to access or liquidate these investments as needed to support our business activities. We periodically monitor the financial position of our significant third-party payors, which include Medicare and managed care companies. As of the date of this report, we do not expect the current economic environment to have a material negative impact on our ability to collect payments from third-party payors in the foreseeable future. The economic environment continued to impact growth in tests delivered and revenue generated during the three and nine months ended September 30, 2013. Specifically, the economic impact of the recent implementation of healthcare reform and the sequester resulting from the Budget Control Act of 2011, discussed in detail below, resulted in a negative impact on our product revenues for the three and nine months ended September 30, 2013. We intend to continue to assess the impact of the economic environment on our business activities. If the economic environment does not improve or deteriorates, our business including our patient population, government and third-party payors and our distributors and suppliers could be negatively affected, resulting in a negative impact on our product revenues.

 

U.S. Healthcare Legislation

 

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or, collectively, the PPACA, enacted in March 2010, makes changes that are expected to significantly impact the pharmaceutical and medical device industries and clinical laboratories. The PPACA contains a number of provisions designed to generate the revenues necessary to fund expanded health insurance coverage, including new fees or taxes on certain health related industries, including medical device manufacturers. Beginning in 2013, each medical device manufacturer will have to pay sales tax in an amount equal to 2.3% of the price for which such manufacturer sells its medical devices that are listed with the FDA. Although the Food and Drug Administration, or FDA, has contended that clinical laboratory tests that are developed and validated by a laboratory for its own use, referred to as LDTs, such as our Oncotype DX breast, colon and prostate cancer tests, are medical devices, none of our products are currently listed with the FDA. We cannot assure you that the tax will not be extended to services such as ours in the future.

 

The PPACA also mandates a reduction in payments for clinical laboratory services paid under the Medicare Clinical Laboratory Fee Schedule, or CLFS, of 1.75% for the years 2011 through 2015 and a productivity adjustment to the CLFS. In addition, the PPACA establishes a board that is charged with reducing the per capita rate of growth in Medicare spending. We are monitoring the impact of the PPACA in order to enable us to determine the trends and changes that may be necessitated by the legislation that may potentially impact on our business over time.

 

In February 2012, Congress passed the “Middle Class Tax Relief and Job Creation Act of 2012” which in part reduced the potential future cost-based increases to the Medicare CLFS by 2%. Overall, the total fee cut to the CLFS for 2013 is 2.95% not considering the further reduction of 2% from implementation of the automatic expense reductions (sequester) under the Budget Control Act of 2011, which went into effect for dates of service on or after April 1, 2013. Reductions made by the Congressional sequester are applied to total claims payments made. While these reductions do not result in a rebasing of the negotiated or established Medicare or Medicaid reimbursement rates, rebasing could occur as a result of future legislation.

 

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The Centers for Medicare and Medicaid Services, CMS, sought public input through the notice and comment period for the proposed Medicare Physician Fee Schedule, on whether all new AMA Molecular Diagnostic codes be placed on either the Medicare Physician Fee Schedule, which would likely require a 20% patient co-payment for such services, or remain on the CLFS. On November 1, 2012, CMS issued a final rule on the Physician Fee Schedule which stated that these new codes would be placed on the CLFS. On August 31, 2012, the Centers for Medicare and Medicaid Services, CMS issued a preliminary determination for the 2013 CLFS which proposed not to recognize Multi-Analyte codes with Algorithmic Analyses, or MAAA, and questioned whether algorithm-based tests are covered benefits for Medicare beneficiaries. However, in its final determination released on November 6, 2012, CMS deleted the statement about not covering algorithmic analysis, and stated that laboratories performing MAAA tests for Medicare beneficiaries should continue to bill for these tests in 2013 as they are currently billed under the CLFS. CMS is again reconsidering its payment policy for MAAAs and in September 2013 announced a preliminary determination not to pay for any MAAA tests in 2014. CMS indicated, however, that it will continue to consider each individual test that comprises an MAAA code on its own merits. In July 2013, CMS issued two proposed rules that could, in the future, impact payments for clinical laboratory tests, like ours, if implemented.  First, CMS announced plans to review payments under the CLFS for all of the approximately 1,250 codes currently paid under the CLFS.  CMS announced that it would conduct this review over a 5 year period starting with the oldest tests currently paid under the CLFS.  Insofar as our tests are paid under unlisted codes at this time, it is unclear whether or not this review, if implemented, would impact payment rates for our tests, but it is possible that it could during the initial 5 year review or during subsequent periodic reviews.  Second, CMS announced plans to package or bundle payments for clinical laboratory tests together with other services performed during hospital outpatient visits under the Hospital Outpatient Prospective Payment System.  In its proposal, CMS indicated that it intends to exempt molecular diagnostic tests from this packaging proposal.  Although our tests are generally not paid in the hospital outpatient setting and even when paid in such setting should be exempted as molecular diagnostic tests, it is possible that this proposal could impact payment for some portion of our tests in the future. Our current Medicare reimbursement determination was set by a local coverage decision and not set nationally by CMS. These or any future changes in covered benefit determination, proposed fees or mandated reductions in payments may apply to some or all of our clinical laboratory tests delivered to Medicare, Medicare Advantage and Medicaid beneficiaries.

 

Changes in Medicare Administrative Contractor (MAC) Services

 

On a five year rotational basis, Medicare requests bids for its regional MAC services. In 2008, we were notified of the transition from our initial MAC, to Palmetto GBA as a result of this bidding process. Palmetto GBA has issued coverage and payment determinations on our Oncotype DX tests since that transition. In September 2012, Medicare notified us that the next successor MAC for our region would be Noridian Healthcare Solutions. The full transition took place in September 2013. Operational changes in contractors processing claims have affected providers in the past, in some cases delaying payment for covered services while claims payment systems are brought on line and fully operational. Palmetto and Noridian have stated that they intend to operate a joint program whereby Noridian will process claims for laboratories located in the jurisdiction applicable to our tests. Palmetto GBA under their MolDx Program is expected to continue to establish coverage, coding and reimbursement policies for molecular diagnostics located within the jurisdiction applicable to our tests. A change in the MAC processing Medicare claims for our Oncotype DX tests could impact the coverage or payment rates for our current tests and our ability to obtain Medicare coverage for products for which we do not yet have coverage or any products we may launch in the future or delay payments.

 

Critical Accounting Policies

 

This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as revenues and expenses during the reporting periods. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results could therefore differ materially from those estimates under different assumptions or conditions.

 

We believe the following critical accounting policies reflect our more significant estimates and assumptions used in the preparation of our financial statements.

 

Revenue Recognition

 

We determine whether revenue is recognized on an accrual basis when test results are delivered or on a cash basis when cash is received from the payor. Our revenues for tests performed are recognized on an accrual basis when the following criteria are met: (1) persuasive evidence that an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectibility is reasonably assured. We assess whether the fee is fixed or determinable based on the nature of the

 

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fee charged for the products or services delivered and existing arrangements or contractual agreements. When evaluating collectibility, we consider whether we have sufficient history to reliably estimate a payor’s individual payment patterns. Based upon at least several months of payment history, we review the number of tests paid against the number of tests billed and the payor’s outstanding balance for unpaid tests to determine whether payments are being made at a consistently high percentage of tests billed and at appropriate amounts given the contracted payment amount. To the extent all criteria set forth above are not met, including where there is no evidence of payment history at the time test results are delivered, product revenues are recognized on a cash basis when cash is received from the payor.

 

As of September 30, 2013, we have exclusive distribution agreements for one or more of our Oncotype DX tests with approximately 20 distributors covering more than 80 countries. The distributor generally provides us with certain marketing and administrative services within its territory. As a condition of these agreements, the distributor generally pays us an agreed upon fee per test and we process the tests. The same revenue recognition criteria described above generally apply to tests received through distributors. To the extent all criteria set forth above are not met when test results are delivered, product revenues are generally recognized when cash is received from the distributor.

 

Test revenue recognized on an accrual basis is recorded upon delivery of each test performed, net of any contractual discount at the amount that we expect to collect. We determine the amount we expect to collect on a per payor, per contract or arrangement basis, based on our analysis of historical average payments. This average amount is typically lower than the agreed upon amount due to several factors, such as the amount of patient co-payments, the existence of secondary payors and claim denials. We typically review our analysis annually, or at the time a contractual price change is implemented or when information comes to our attention that leads us to believe an adjustment may be warranted.

 

As of September 30, 2013, amounts outstanding for tests delivered, net of write-downs and adjustments, which were not recognized as revenue upon delivery because our accrual revenue recognition criteria were not met and which had not been collected, totaled approximately $43 million. We cannot provide any assurance as to when, if ever, and to what extent these amounts will be collected.

 

From time to time, we receive requests for refunds of payments, generally due to overpayments made by third-party payors. Upon becoming aware of a refund request, we establish an accrued liability for tests covered by the refund request until such time as we determine whether or not a refund is due. If we determine that a refund is due, we credit cash and reduce the accrued liability. Accrued refunds were $946,000 and $664,000 at September 30, 2013 and December 31, 2012, respectively.

 

Contract revenues are generally derived from studies conducted with biopharmaceutical and pharmaceutical companies and are recognized on a contract-specific basis. Under certain contracts, revenues are recognized as costs are incurred or assays are processed. We may exercise judgment when estimating full-time equivalent level of effort, costs incurred and time to project completion. For certain contracts, we utilize the performance-based method of revenue recognition, which requires that we estimate the total amount of costs to be expended for a project and recognize revenue equal to the portion of costs expended to date. The estimated total costs to be expended are necessarily subject to revision from time-to-time as the underlying facts and circumstances change.

 

Accounts Receivable

 

We accrue an allowance for doubtful accounts against our accounts receivable based on estimates consistent with historical payment experience. Our allowance for doubtful accounts is evaluated quarterly and adjusted when trends or significant events indicate that a change in estimate is appropriate. Historically, the amounts of uncollectible accounts receivable that have been written off have been consistent with management’s expectations. We cannot assure you that we will not experience higher than expected write-offs in the future. As of September 30, 2013 and December 31, 2012, our allowance for doubtful accounts was $1.8 million and $1.1 million, respectively. See “Liquidity and Capital Resources” for additional information, including a summary of accounts receivable aging by payor mix.

 

Research and Development Expenses

 

We enter into collaboration and clinical trial agreements with clinical collaborators and record these costs as research and development expenses. We record accruals for estimated study costs comprised of work performed by our collaborators under contract terms. The financial terms of these agreements are subject to negotiation, may vary from contract to contract, and may result in uneven payment flows. We determine our estimates through discussion with internal clinical development personnel and outside service providers as to the progress or stage of completion of services provided and the agreed upon fee to be paid for such services. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized and recognized as an expense as the goods are delivered or the related services are performed.

 

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All potential future product programs outside of breast, colon and prostate cancer are in the research or development phase. Although we have estimated the time frame in which some of these products may be brought to market, the timing is uncertain given the technical challenges and clinical variables that exist between different types of cancers. We maintain information regarding costs incurred for activities performed under certain contracts with biopharmaceutical and pharmaceutical companies. However, we do not generally record or maintain information regarding costs incurred in research and development on a program-specific basis. Our research and development staff and associated infrastructure resources are deployed across several programs. Many of our costs are thus not attributable to individual programs. As a result, we are unable to determine the duration and completion costs of our research and development programs or when, if ever, and to what extent we will receive cash inflows from the commercialization and sale of a product.

 

Stock-based Compensation Expense

 

We measure all stock-based payments to employees and directors, including grants of stock options, based on their relative fair values. Fair values of awards granted under our stock option plans and Employee Stock Purchase Plan, or ESPP, were estimated at grant or purchase rights offering dates using a Black Scholes option valuation model. Stock-based compensation expense related to stock option grants is estimated at the date of grant and stock-based compensation expense related to ESPP purchases is estimated at the beginning of each offering period based on these fair value calculations. The expense is recognized ratably over the requisite service period. The application of option valuation models requires significant judgment and the use of estimates, particularly surrounding assumptions used in determining fair value. The Black Scholes option valuation model requires the use of estimates such as stock price volatility and expected option lives to value stock-based compensation. Our assumptions regarding expected volatility are based on the historical volatility of our common stock. The expected life of options is estimated based on historical option exercise data and assumptions related to unsettled options. The expected life of stock issuable pursuant to the ESPP is six months, or the duration of the purchase period. Expected forfeiture rates for stock option grants are based on historical data, and compensation expense is adjusted for actual results. We do not include expected forfeiture rates when calculating stock-based compensation expense for stock issuable pursuant to the ESPP due to the short duration of the purchase period; however, we do adjust the expense for actual results.

 

Stock-based compensation expense related to restricted stock unit, or RSU, awards is based on the market value of our common stock at the date of grant and is recognized as expense ratably over the requisite service period. Expected forfeiture rates for RSUs are based on historical data, and compensation expense is adjusted for actual results.

 

We review our valuation assumptions on an ongoing basis, and, as a result, our assumptions used to value stock awards granted in future periods may change. See Note 6, “Stock-Based Compensation,” in the Notes to Condensed Consolidated Financial Statements in Part I, Item 1 of this Quarterly Report on Form 10-Q for more information.

 

Deferred Tax Assets

 

We are required to reduce our deferred tax assets by a valuation allowance if it is more likely than not that some or all of our deferred tax assets will not be realized. We must use judgment in assessing the potential need for a valuation allowance, which requires an evaluation of both negative and positive evidence. The weight given to the potential effect of negative and positive evidence should be commensurate with the extent to which it can be objectively verified. In determining the need for and amount of our valuation allowance, if any, we assess the likelihood that we will be able to recover our deferred tax assets using historical levels of income, estimates of future income and tax planning strategies. As a result of historical cumulative losses and, based on all available evidence, we believe it is more likely than not that our recorded net deferred tax assets will not be realized. Accordingly, we recorded a valuation allowance against all of our net deferred tax assets at both September 30, 2013 and December 31, 2012. We will continue to maintain a full valuation allowance on our deferred tax assets until there is sufficient evidence to support the reversal of all or some portion of this valuation allowance.

 

Results of Operations

 

Three and Nine Months Ended September 30, 2013 and 2012

 

We recorded net income of $488,000 and a net loss of $3.4 million for the three and nine months ended September 30, 2013, respectively, compared to net income of $3.7 million and $6.3 million for the three and nine months ended September 30, 2012, respectively. On a basic per share basis, net income per share was $0.02 and net loss per share was $0.11 for the three and nine months ended September 30, 2013, respectively. On a diluted per share basis, net income was $0.02 and net loss was $0.11 for the three and nine months ended September 30, 2013, respectively.On a basic per share basis, net income was $0.12 and $0.21 for the three and nine months ended September 30, 2012. On a diluted per share basis, net income was $0.11 and $0.20 for the three and nine months ended

 

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September 30, 2012. We may incur net losses in future periods due to future spending and fluctuations in our business, and we may not achieve or maintain sustained profitability in the future.

 

Revenues

 

We derive our revenues primarily from product sales and, to a lesser extent, from contract research arrangements. We operate in one industry segment. As of September 30, 2013, substantially all of our product revenues have been derived from the sale of our Oncotype DX breast cancer test. Payors are billed upon generation and delivery of a test report to the physician. Product revenues are recorded on a cash basis unless a contract or arrangement to pay is in place with the payor at the time of billing and collectibility is reasonably assured. Contract revenues are derived from studies conducted with biopharmaceutical and pharmaceutical companies and are recorded as contractual obligations are completed.

 

 

 

For the Three Months Ended

 

For the Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

 

 

(In thousands)

 

Product revenues

 

$

65,732

 

$

58,371

 

$

192,132

 

$

173,459

 

Contract revenues

 

258

 

277

 

644

 

1,287

 

Total revenues

 

$

65,990

 

$

58,648

 

$

192,775

 

$

174,746

 

Period over period dollar increase in product revenues

 

$

7,361

 

 

 

$

18,673

 

 

 

Period over period percentage increase in product revenues

 

13

%

 

 

11

%

 

 

 

The increase in product revenues for the three and nine months ended September 30, 2013 compared to the three and nine months ended September 30, 2012 resulted, in part, from increased adoption, as evidenced by a 21% and 13% period over period increase in test volume, respectively. Test volume increases exceeded revenue increases primarily due to the tests delivered for our recently launched Oncotype DX prostate cancer test which does not yet have established reimbursement. We also experienced a seasonal decrease in test volume in the quarter ended September 30, 2012 compared to the previous quarter. For the nine months ended September 30, 2013 compared to the same period in 2012, the increase in product revenue was partially offset by payments from Medicare totaling $1.2 million for colon cancer tests performed prior to the establishment of coverage. We also experienced an increase in revenues recorded on an accrual basis. Approximately $46.5 million, or 71%, and $137.6 million, or 72%, of product revenues for the three and nine months ended September 30, 2013, respectively, were recorded on an accrual basis and recognized at the time the test results were delivered, compared to $36.4 million, or 62%, and $113.5 million, or 65%, of product revenues for the three and nine months ended September 30, 2012, respectively. For both periods, the balance of product revenues was recognized upon cash collection as payments were received. The timing of recognition of revenues related to third-party payments may cause fluctuations in product revenues from period to period.

 

Product revenues related to Medicare patients for the three and nine months ended September 30, 2013 were $13.7 million, or 21%, and $43.2 million, or 22%, of product revenues, respectively, compared to $12.3 million, or 21%, and $39.5 million, or 23%, of product revenues for the three and nine months ended September 30, 2012, respectively. There were no other third-party payors comprising product revenues of 10% or more for those periods. International product revenues increased to $10.1 million, or 15%, and $27.8 million, or 14%, of product revenues for the three and nine months ended September 30, 2013, respectively, from $8.1 million, or 14%, and $18.9 million, or 11%, of product revenues for the three and nine months ended September 30, 2012, respectively.

 

Contract revenues were $258,000 for the three months ended September 30, 2013, compared to $277,000 for the three months ended September 30, 2012. Contract revenues were $644,000 for the nine months ended September 30, 2013, compared to $1.3 million for nine months ended September 30, 2012. Contract revenues represented studies assessing our gene expression technology or collaborative work in gene selection and protocol design with our pharmaceutical partners. The decrease in contract revenues for the 2013 period compared to the 2012 period was due to a decrease in activities with collaboration partners. We expect that our contract revenues will continue to fluctuate based on the number and timing of studies being conducted.

 

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Cost of Product Revenues

 

 

 

For the Three Months Ended

 

For the Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

 

 

(In thousands)

 

Tissue sample processing costs

 

$

8,440

 

$

6,929

 

$

24,255

 

$

21,086

 

Stock-based compensation

 

115

 

100

 

362

 

309

 

Total tissue sample processing costs

 

8,555

 

7,029

 

24,617

 

21,395

 

License fees

 

2,226

 

2,008

 

6,668

 

5,982

 

Total cost of product revenues

 

$

10,781

 

$

9,037

 

$

31,285

 

$

27,377

 

Period over period dollar increase

 

$

1,744

 

 

 

$

3,907

 

 

 

Period over period percentage increase

 

19

%

 

 

14

%

 

 

 

Cost of product revenues represents the cost of materials, direct labor, equipment and infrastructure expenses associated with processing tissue samples (including sample accessioning, histopathology, anatomical pathology, paraffin extraction, RT-PCR, quality control analyses and shipping charges to transport tissue samples) and license fees. Infrastructure expenses include allocated facility occupancy and information technology costs. Costs associated with performing our tests are recorded as tests are processed. Costs recorded for tissue sample processing represent the cost of all the tests processed during the period regardless of whether revenue was recognized with respect to that test. Royalties for licensed technology calculated as a percentage of product revenues and fixed annual payments relating to the launch and commercialization of Oncotype DX tests are recorded as license fees in cost of product revenues at the time product revenues are recognized or in accordance with other contractual obligations. While license fees are generally calculated as a percentage of product revenues, the percentage increase in license fees does not correlate exactly to the percentage increase in product revenues because certain agreements contain provisions for fixed annual payments and other agreements have tiered rates and payments that may be capped at annual minimum or maximum amounts. License fees represent a significant component of our cost of product revenues and are expected to remain so for the foreseeable future.

 

Tissue sample processing costs increased $1.5 million, or 22%, for the three months ended September 30, 2013 compared to the three months ended September 30, 2012. Tissue sample processing costs increased $3.2 million, or 15%, for the nine months ended September 30, 2013 compared to the nine months ended September 30, 2012. These increases were primarily due to increases in test volume combined with incremental costs related to test processing associated with the launch of our prostate cancer test and enhancements to our laboratory information management system. The $218,000, or 11%, and $686,000, or 11%, increase in license fees for the three and nine months ended September 30, 2013 primarily resulted from a 13% and 11% period over period increase in product revenue in each of these periods. Also, for the nine months ended September 30, 2013, the increase in license fees includes a $150,000 milestone license fee paid in connection with the launch of our prostate cancer test in May 2013. We expect the cost of product revenues to increase in future periods to the extent we process more tests.

 

Research and Development Expenses

 

 

 

For the Three Months Ended

 

For the Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

 

 

(In thousands)

 

Personnel-related expenses

 

$

7,606

 

$

6,240

 

$

21,939

 

$

18,325

 

Stock-based compensation

 

1,260

 

961

 

3,553

 

2,821

 

Reagents and laboratory supplies

 

980

 

696

 

2,610

 

2,209

 

Collaboration expenses

 

1,000

 

370

 

2,098

 

1,388

 

Allocated information technology, facilities and other costs

 

2,614

 

3,037

 

8,128

 

7,998

 

Other expenses

 

1,266

 

963

 

3,861

 

3,034

 

Total research and development expenses

 

$

14,726

 

$

12,267

 

$

42,189

 

$

35,775

 

Period over period dollar increase

 

$

2,459

 

 

 

$

6,414

 

 

 

Period over period percentage increase

 

20

%

 

 

18

%

 

 

 

Research and development expenses represent costs incurred to develop our technology, such as NGS and continuous process improvement, and carry out clinical studies, primarily related to our ongoing work in breast, colon and prostate cancer. Research and development expenses include personnel-related expenses, reagents and supplies used in research and development laboratory work, infrastructure expenses, including allocated overhead and facility occupancy costs, contract services and other outside costs. Research and development expenses also include costs related to activities performed under contracts with biopharmaceutical and pharmaceutical companies.

 

The $2.5 million, or 20%, increase in research and development expenses for the three months ended September 30, 2013 compared to the three months ended September 30, 2012 included a $1.4 million increase in personnel-related expenses, and a

 

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$629,000 increase in collaboration expenses, a $303,000 increase in other expenses, a $299,000 increase in stock-based compensation expense, and other costs and a $284,000 increase in reagents and laboratory supplies expense partially offset by a $424,000 decrease in allocated information technology, facilities. The increase in personnel-related expenses was primarily attributable to increases in salaries and benefits due to increased headcount to support the commercial launch of our test for prostate cancer, as well as projects related to our product pipeline and ongoing work in NGS. The decrease in allocated information technology, facilities and other costs is primarily due to increased project work from our various information technology groups, allocated based on specific departmental projects.

 

The $6.4 million, or 18%, increase in research and development expenses for the nine months ended September 30, 2013 compared to the nine months ended September 30, 2012 included a $3.6 million increase in personnel-related expenses, a $827,000 increase in other expenses, a $731,000 increase in stock-based compensation expense, a $710,000 increase in collaboration expenses, a $401,000 increase in reagents and laboratory supplies expense and a $130,000 increase in allocated information technology, facilities and other costs. The increase in personnel-related expenses was primarily attributable to increases in salaries and benefits due to increased headcount to support projects related to our growing pipeline and ongoing work in NGS. The increase in allocated information technology, facilities and other costs is primarily due to increased project work from our various information technology groups, allocated based on specific departmental projects.

 

We expect our research and development expenses to increase in future periods due to increased investment in our new product pipeline for breast, colon, prostate, renal and other cancers, along with increased investment in NGS.

 

Selling and Marketing Expenses

 

 

 

For the Three Months Ended

 

For the Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

 

 

(In thousands)

 

Personnel-related expenses

 

$

13,814

 

$

11,503

 

$

41,346

 

$

36,000

 

Stock-based compensation

 

1,033

 

1,006

 

3,231

 

2,987

 

Promotional and marketing materials

 

3,616

 

2,947

 

13,063

 

10,598

 

Travel, meetings and seminars

 

2,881

 

2,616

 

9,922

 

8,413

 

Allocated information technology, facilities and other costs

 

3,989

 

2,752

 

11,796

 

9,414

 

Other expenses

 

679

 

702

 

2,229

 

2,245

 

Total selling and marketing expenses

 

$

26,013

 

$

21,526

 

$

81,587

 

$

69,657

 

Period over period dollar increase

 

$

4,487

 

 

 

$

11,930

 

 

 

Period over period percentage increase

 

21

%

 

 

17

%

 

 

 

Our selling and marketing expenses consist primarily of personnel-related expenses, education and promotional expenses, market analysis and development expenses and infrastructure expenses, including allocated facility occupancy and information technology costs. These expenses include the costs of educating physicians, laboratory personnel and other healthcare professionals regarding our genomic technologies, how our Oncotype DX tests are developed and validated and the value of the quantitative information that our tests provide. Selling and marketing expenses also include the costs of sponsoring continuing medical education, medical meeting participation and dissemination of scientific and economic publications related to our Oncotype DX tests. Our sales force compensation includes annual salaries and eligibility for quarterly commissions based on the achievement of predetermined sales goals and other management objectives.

 

The $4.5 million, or 21%, increase in selling and marketing expenses for the three months ended September 30, 2013 compared to the three months ended September 30, 2012 was due to a $2.3 million increase in personnel-related expenses, a $1.2 million increase in allocated information technology, facilities and other costs, a $669,000 increase in promotional and marketing materials primarily related to the expansion of our international operations and preparing for and executing our prostate cancer product launch and a $266,000 increase in travel, meetings and seminars expenses primarily related to our international expansion efforts and travel primarily related to our prostate cancer product launch. Of the $2.3 million increase in personnel-related expenses, $1.3 million was attributable to increases in salaries, benefits and related expenses due primarily to increased headcount, including new hires related to the launch of our prostate cancer test in May 2013 and annual salary increases and $808,000 was attributable to higher commissions and bonus payments and an increase of $239,000 attributable to consulting expenses. The increase in allocated information technology, facilities and other costs is primarily due to increased project work from our various information technology groups, allocated based on specific departmental projects.

 

The $11.9 million, or 17%, increase in selling and marketing expenses for the nine months ended September 30, 2013 compared to the nine months ended September 30, 2012 was due to a $5.3 million increase in personnel-related expenses, a $2.5 million increase in

 

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promotional and marketing materials related to the expansion of our international commercial business and our prostate cancer product launch, a $2.4 million increase in allocated information technology, facilities and other costs, a $1.5 million increase in travel, meetings and seminars expenses primarily related to our international expansion efforts and travel primarily related to our prostate cancer product launch, and a $244,000 increase in stock-based compensation expense. Of the $5.3 million increase in personnel-related expenses, $3.8 million was attributable to increases in salaries, benefits and related expenses due primarily to increased headcount, including new hires related to the launch of our prostate cancer test and annual salary increases, $1.3 million was attributable to higher commissions and bonus payments and $192,000 was attributable to increased consulting expenses. The increase in allocated information technology, facilities and other costs is primarily due to increased project work from our various information technology groups, allocated based on specific departmental projects.

 

We expect selling and marketing expenses will continue to increase in future periods due to our efforts to establish adoption of and reimbursement for our new products, continued investment in our global commercial infrastructure and increases in our sales force.

 

General and Administrative Expenses

 

 

 

For the Three Months Ended

 

For the Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

 

 

(In thousands)

 

Personnel-related expenses

 

$

9,155

 

$

8,825

 

$

28,258

 

$

25,322

 

Stock-based compensation

 

1,954

 

1,334

 

5,705

 

4,691

 

Occupancy and equipment expenses

 

4,872

 

3,700

 

13,249

 

11,921

 

Billing and collection fees

 

2,247

 

2,353

 

6,761

 

6,514

 

Bad debt expense

 

1,843

 

998

 

4,764

 

2,571

 

Professional fees and other expenses

 

1,977

 

1,867

 

6,080

 

5,698

 

Information technology, facilities and other cost allocations

 

(8,041

)

(6,970

)

(23,765

)

(21,199

)

Total general and administrative expenses

 

$

14,007

 

$

12,107

 

$

41,052

 

$

35,518

 

Period over period dollar increase

 

$

1,900

 

 

 

$

5,535

 

 

 

Period over period percentage increase

 

16

%

 

 

16

%

 

 

 

Our general and administrative expenses consist primarily of personnel-related expenses, occupancy and equipment expenses, including rent and depreciation expenses, billing and collection fees, bad debt expense, professional fees and other expenses, including intellectual property defense and prosecution costs, and other administrative costs, partially offset by cost allocations to our commercial laboratory operations, research and development, and sales and marketing functions, including allocated information technology and facility occupancy costs.

 

The $1.9 million, or 16%, increase in general and administrative expenses for the three months ended September 30, 2013 compared to the three months ended September 30, 2012 included a $1.2 million increase in occupancy and equipment expenses, a $845,000 increase in bad debt expense, a $619,000 increase in stock-based compensation expense, a $329,000 increase in personnel-related expenses, a $110,000 increase in professional fees and other expenses, partially offset by a $1.1 million increase in information technology, facilities and other costs allocated to other functional areas and a $106,000 decrease in billing and collection fees. Of the $329,000 increase in personnel-related expenses, $244,000 was attributable to annual increases in salaries and benefits expenses, primarily resulting from increased headcount and $215,000 was attributable to higher bonus payments partially offset by $129,000 attributable to a reduction in consulting expenses.

 

The $5.5 million, or 16%, increase in general and administrative expenses for the nine months ended September 30, 2013 compared to the nine months ended September 30, 2012 included a $2.9 million increase in personnel-related expenses, a $2.2 million increase in bad debt expense, a $1.3 million increase in occupancy and equipment expenses, a $1.0 million increase in stock-based compensation expense, a $381,000 increase in professional fees and other expenses and a $247,000 increase in billing and collection fees, partially offset by a $2.6 million increase in information technology, facilities and other costs allocated to other functional areas. Of the $2.9 million increase in personnel-related expenses, $2.2 million was attributable to annual increases in salaries and benefits expenses, $610,000 was attributable to higher bonus payments and $146,000 was attributable to higher consulting expenses.

 

We expect general and administrative expenses to increase in future periods as we hire additional staff and incur other expenses to support the growth of our business, and to the extent we spend more on billing and collections fees and bad debt expense.

 

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Table of Contents

 

Interest and Other Income

 

Interest and other income was $52,000 and $174,000 for the three and nine months ended September 30, 2013 compared to $77,000 and $226,000 for the three and nine months ended September 30, 2012. The decrease was primarily due to lower average balances in our investments in marketable securities during the three and nine months ended September 30, 2013. We expect our interest income will remain nominal if the current low interest rate environment continues.

 

Other Income (Expense), Net

 

Other income (expense), net was $89,000 and $(2,000) for the three and nine months ended September 30, 2013, respectively, compared to $33,000 and $(112,000) for the three and nine months ended September 30, 2012, respectively. The decrease in net expense for the nine months ended September 30, 2013 was due primarily to a $98,000 loss on an investment in a private company accounted for using the equity method during the six months ended June 30, 2012. There were no losses on investments in private companies during the three or nine months ended September 30, 2013 or the three months ended September 30, 2012. We expect other income (expense), net to continue to fluctuate based on fluctuations in exchange rates that impact our foreign exchange transaction gains and losses and both the level and performance of investments accounted for under the equity method.

 

Income Tax Expense

 

Income tax expense was $116,000 and $223,000 for the three and nine months ended September 30, 2013, respectively, compared to $109,000 and $243,000 for the three and nine months ended September 30, 2012. Income tax expense for both periods was principally comprised of state income taxes and foreign taxes and was computed using the discrete, or “cut-off”, method.

 

Based on all available objective evidence, we believe it is more likely than not that our recorded net deferred tax assets will not be realized. Accordingly, we recorded a full valuation allowance on our net deferred tax assets for the three and nine months ended September 30, 2013 and 2012, respectively. We will continue to maintain a full valuation allowance on our deferred tax assets until there is sufficient evidence to support the reversal of all or some portion of this allowance.

 

Liquidity and Capital Resources

 

As of September 30, 2013, we had an accumulated deficit of $160.9 million. We may incur net losses in the future, and we cannot provide assurance as to when, if ever, we will achieve sustained profitability. We expect that our research and development, selling and marketing and general and administrative expenses will increase in future periods and, as a result, we will need to continue to generate significant product revenues to achieve sustained profitability.

 

 

 

2013

 

2012

 

 

 

(In thousands)

 

As of September 30:

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

114,046

 

$

126,981

 

Working capital

 

120,023

 

130,641

 

For the nine months ended September 30:

 

 

 

 

 

Cash provided by (used in):

 

 

 

 

 

Operating activities

 

12,749

 

19,705

 

Investing activities

 

(645

)

(8,950

)

Financing activities

 

9,672

 

14,335

 

Capital expenditures (included in investing activities above)

 

(7,443

)

(6,170

)

 

Sources of Liquidity

 

At September 30, 2013, we had cash, cash equivalents and short-term marketable securities of $114.0 million compared to $127.0 million at September 30, 2012. The $13.0 million decrease was attributable to a $30.0 million accelerated share repurchase program in late 2012 and investments in the growth of our business, including research and development, U.S. and international expansion, activities related to reimbursement coverage of our various cancer tests and investments in privately held companies offset by increased cash collections from increased sales of our tests, payments from collaborators and cash received from the exercise of employee stock options. In accordance with our investment policy, available cash is invested in short-term, low-risk, investment-grade debt instruments. Our cash and short-term investments are held in a variety of interest-bearing instruments including money market accounts, U.S. Treasury securities, debt obligations of U.S. government-sponsored entities, and high-grade commercial paper and corporate bonds.

 

Historically we have financed our operations primarily through sales of our equity securities and cash received in payment for our tests.

 

In December 2012, we entered into a collared accelerated share repurchase agreement with a financial institution for the purpose of repurchasing up to $30.0 million of our outstanding shares of common stock.  Under the terms of this agreement, in December 2012,

 

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Table of Contents

 

we paid $30.0 million to a financial institution and received 984,074 shares of our common stock, representing the minimum number of shares deliverable under the agreement. In February 2013, upon termination of the agreement and in accordance with the share delivery provisions of the agreement, we received an additional 77,257 shares of our common stock based on the average of the daily volume weighted-average prices of our common stock during a specified period.

 

Accounts Receivable

 

At September 30, 2013 and December 31, 2012, $25.6 million, or 14%, and $22.3 million, or 14%, respectively, of our total assets consisted of accounts receivable. The $3.3 million increase in accounts receivable from December 31, 2012 to September 30, 2013 was attributable to a 13% increase in the volume of accrual tests delivered as well as an increase in the number of payors on accrual. Days sales outstanding, or DSOs, is a measure of the average number of days it takes for us to collect our accounts receivable, calculated from the date that tests are billed. At September 30, 2013 and December 31, 2012, our weighted average DSOs were 67 days and 63 days, respectively. The increase in DSOs is primarily a result of the overall increase in accounts receivable, the increase in the number of accrual payors and the variation in the typical payment cycle of these payors. The timing of our billing and cash collections also causes fluctuations in our monthly DSOs and accounts receivable.

 

The following tables summarize accounts receivable by payor mix at September 30, 2013 and December 31, 2012:

 

 

 

September 30, 2013

 

 

 

Total

 

% of
Total

 

Current

 

31-60
Days

 

61-90
Days

 

91-120
Days

 

121 to 180
Days

 

Over 180
Days

 

 

 

(In thousands)

 

Managed care and other

 

$

21,986

 

80

%

$

8,880

 

$

4,419

 

$

2,193

 

$

1,403

 

$

1,910

 

$

3,181

 

Medicare

 

5,455

 

20

 

4,639

 

147

 

100

 

65

 

78

 

426

 

Total

 

27,441

 

100

%

$

13,519

 

$

4,566

 

$

2,293

 

$

1,468

 

$

1,988

 

$

3,607

 

Allowance for doubtful accounts

 

(1,847

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net accounts receivable

 

$

25,594

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2012

 

 

 

Total

 

% of
Total

 

Current

 

31-60
Days

 

61-90
Days

 

91-120
Days

 

121 to 180
Days

 

Over 180
Days

 

 

 

(In thousands)

 

Managed care and other

 

$

18,373

 

79

%

$

8,033

 

$

3,760

 

$

2,183

 

$

1,299

 

$

1,255

 

$

1,843

 

Medicare

 

5,013

 

21

 

3,903

 

416

 

51

 

44

 

61

 

538

 

Total

 

23,386

 

100

%

$

11,936

 

$

4,176

 

$

2,234

 

$

1,343

 

$

1,316

 

$

2,381

 

Allowance for doubtful accounts

 

(1,133

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net accounts receivable

 

$

22,253

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash Flows

 

Net cash provided by operating activities was $12.7 million for the nine months ended September 30, 2013, compared to $19.7 million for the nine months ended September 30, 2012. Net cash provided by operating activities includes net income (loss) adjusted for certain non-cash items and changes in assets and liabilities. Net cash provided by operating activities for the nine months ended September 30, 2013 reflected net loss of $3.4 million, adjusted for $17.6 million of stock-based compensation and depreciation and amortization expense, a $3.0 million increase in accrued expenses and other liabilities, a $760,000 increase in deferred revenues and $170,000 of expense for restricted stock issued to outside directors in lieu of fees offset by a $3.3 million increase in accounts receivable, a $1.4 million decrease in accounts payable and a $623,000 increase in prepaid expenses and other assets. Net cash provided by operating activities for the nine months ended September 30, 2012 reflected net income of $6.3 million, adjusted for $14.8 million of stock-based compensation and depreciation and amortization expense, a $3.0 million increase in accrued expenses and other liabilities and a $1.2 million decrease in accounts receivable, partially offset by a $3.6 million decrease in accounts payable, a $1.3 million increase in prepaid expenses and other assets and a $818,000 decrease in deferred revenues.

 

Net cash used in investing activities was $645,000 for the nine months ended September 30, 2013, compared to $9.0 million for the nine months ended September 30, 2012. Our investing activities have consisted predominately of purchases and maturities of marketable securities and capital expenditures. Net cash used in investing activities for the nine months ended September 30, 2013 included $7.4 million in capital expenditures partially offset by $6.8 million in net maturities of marketable securities. Net cash used in investing activities for the nine months ended September 30, 2012 included $6.2 million in capital expenditures, $1.4 million in net maturities of marketable securities and $1.4 million of investments in privately held companies.

 

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Net cash provided by financing activities was $9.7 million for the nine months ended September 30, 2013, compared to $14.3 million for the nine months ended September 30, 2012. Our financing activities have historically included sales of our equity securities. Net cash provided by financing activities for the nine months ended September 30, 2013 included $12.4 million in proceeds from the issuance of our common stock upon the exercise of employee stock options and stock purchased pursuant to our ESPP, partially offset by cash paid for tax withholdings in the amount of $2.7 million related to net share settlements of restricted stock units and awards. Net cash provided by financing activities for the nine months ended September 30, 2012 included $15.5 million in proceeds from the issuance of our common stock upon the exercise of employee stock options, partially offset by cash paid for tax withholdings in the amount of $1.2 million related to net share settlements of restricted stock units and awards.

 

Contractual Obligations

 

The following table summarizes our significant contractual obligations as of September 30, 2013 and the effect those obligations are expected to have on our liquidity and cash flows in future periods:

 

 

 

Payments Due by Period

 

 

 

Total

 

Less than
 1 Year

 

1-3 Years

 

3-5 Years

 

More
than
5 Years

 

 

 

(In thousands)

 

Non-cancelable operating lease obligations

 

$

17,987

 

$

3,493

 

$

7,113

 

$

6,462

 

$

919

 

 

Our non-cancelable operating lease obligations are for laboratory and office space. We lease various facilities in Redwood City, California, totaling 144,900 square feet. The lease terms expire between March 2018 and March 2019, each with an option for us to extend the terms of the lease for an additional five years. Included in our operating lease obligations is a non-cancelable agreement we entered into in August 2013 for an additional 18,400 square feet of laboratory and office space near our current locations, which commences in January 2014. We also have lease obligations for our international operations, including 2,500 square feet of space in Geneva, Switzerland and short-term office rental arrangements in London, England and Munich, Germany. The Geneva lease expires in May 2015.

 

We are required to make a series of fixed annual payments under a collaboration agreement beginning with the January 2010 launch of our Oncotype DX colon cancer test. We made payments under this agreement of $450,000, $300,000 and $200,000 in 2013, 2012 and 2011, respectively. We are also required to make a series of fixed annual payments under a collaboration agreement beginning with the May 2013 commercial launch of our Oncotype DX prostate cancer test. We made a payment under this agreement of $150,000 in 2013. As of September 30, 2013, future annual payments under these agreements totaled $1.1 million, of which $550,000 is due in each of 2014 and 2015. However, because these agreements may be terminated by either party upon 30 days’ prior written notice, these payments are not included in the table above.

 

We have also committed to make potential future payments to third parties as part of our collaboration agreements. Payments under these agreements generally become due and payable only upon achievement of specific project milestones. Because the achievement of these milestones is generally neither probable nor reasonably estimable, such commitments have not been included in the table above.

 

Operating Capital and Capital Expenditure Requirements

 

We achieved positive operating cash flow for the nine months ended September 30, 2013 and the year ended December 31, 2012. We currently anticipate that our cash, cash equivalents and short-term marketable securities, together with payments for our Oncotype DX tests, will be sufficient to fund our operations and facilities expansion plans for at least the next 12 months, including the expansion of our research and development programs, our NGS development efforts, our efforts to expand of adoption of and reimbursement for our Oncotype DX colon cancer and DCIS tests, the launch of our Oncotype DX prostate cancer test and our international expansion efforts. We expect to spend approximately $15 million over the next 12 months for planned laboratory equipment, information technology expansion and facilities expansion. We may also use cash to acquire or invest in complementary businesses, technologies, services or products. We expect that our cash, cash equivalents and short-term marketable securities will also be used to fund working capital and for other general corporate purposes, such as licensing technology rights, distribution arrangements for our tests both within and outside of the United States or expanding our direct sales capabilities outside of the U.S.

 

The amount and timing of actual expenditures may vary significantly depending upon a number of factors, such as the amount of cash provided by our operations, the progress of our commercialization efforts, product development, regulatory requirements, progress in obtaining reimbursement for our tests and available strategic opportunities for acquisition of or investment in complementary businesses, technologies, services or products.

 

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We cannot be certain that our international expansion plans, efforts to expand adoption of and reimbursement for our Oncotype DX colon, DCIS and prostate cancer tests or the development of future products or technologies will be successful or that we will be able to raise sufficient additional funds to see these activities through to a successful result. It may take years to move any one of a number of product candidates in research through development and validation to commercialization.

 

Our future funding requirements will depend on many factors, including the following:

 

·                  the rate of progress in establishing and maintaining reimbursement arrangements with domestic and international third-party payors;

 

·                  the cost of expanding our commercial and laboratory operations, including our selling and marketing efforts;

 

·                  the rate of progress and cost of research and development activities associated with expansion of our Oncotype DX breast, colon and prostate cancer tests;

 

·                  the rate of progress and cost of selling and marketing activities associated with expanding adoption of and reimbursement for our Oncotype DX colon, and prostate cancer and DCIS tests;

 

·                  the rate of progress and cost of research and development activities associated with products in research and development focused on cancers other than breast, colon and prostate;

 

·                  the rate of progress and cost of research and development activities associated with next generation sequencing;

 

·                  the cost of acquiring, licensing or investing in technologies, including next generation sequencing;

 

·                  the cost of acquiring or investing in complementary businesses or assets;

 

·                  costs related to the launch of our Oncotype DX prostate cancer test and other future product launches;

 

·                  the cost of acquiring or achieving access to tissue samples and technologies;

 

·                  the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

 

·                  the effect of competing technological and market developments;

 

·                  costs related to international expansion;

 

·                  costs and delays in product development as a result of any changes in regulatory oversight applicable to our products or operations;

 

·                  the impact of changes in Federal, state and international taxation; and

 

·                  the economic and other terms and timing of any collaborations, licensing or other arrangements into which we may enter or investments or acquisitions we might seek to effect.

 

If we are not able to generate and maintain sustained product revenues to finance our cash requirements, we will need to finance future cash needs primarily through public or private equity offerings, debt financings, borrowings or strategic collaborations or licensing arrangements. If we raise funds by issuing equity securities, dilution to stockholders may result. Any equity securities issued may also provide for rights, preferences or privileges senior to those of holders of our common stock. If we raise funds by issuing debt securities, these debt securities would have rights, preferences and privileges senior to those of holders of our common stock. The terms of debt securities or borrowings could impose significant restrictions on our operations. If we raise funds through collaborations and licensing arrangements, we might be required to relinquish significant rights to our technologies or products, or grant licenses on terms that are not favorable to us. The credit market and financial services industry have in the past, and may in the future, experience periods of upheaval that could impact the availability and cost of equity and debt financing. If we are not able to secure additional funding when needed, on acceptable terms, we may have to delay, reduce the scope of or eliminate one or more research and development programs or selling and marketing initiatives. In addition, we may have to work with a partner on one or more of our product or market development programs, which could lower the economic value of those programs to us.

 

Off-Balance Sheet Arrangements

 

As of September 30, 2013, we had no material off-balance sheet arrangements.

 

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Recently Issued Accounting Pronouncements

 

In February 2013, the Financial Accounting Standards Board issued authoritative guidance requiring companies to report, in one place, information about reclassifications out of accumulated other comprehensive income (“AOCI”). Companies are also required to present reclassifications by component when reporting changes to AOCI balances. This guidance is effective for interim and annual periods beginning after December 15, 2012. As this guidance provides only presentation requirements, the adoption of this guidance does not impact our financial condition or results of operations. We adopted this standard in January 2013, as reflected by the inclusion of the Condensed Consolidated Statements of Comprehensive Income (Loss) as part of our Condensed Consolidated Financial Statements.

 

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ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Interest Rate Risk

 

Our exposure to market risk for changes in interest rates relates primarily to interest earned on our cash equivalents and marketable securities. The primary objective of our investment activities is to preserve our capital to fund operations. We also seek to maximize income from our investments without assuming significant risk. Our investment policy provides for investments in short-term, low-risk, investment-grade debt instruments. Our investments in marketable securities, which are comprised primarily of money market funds, obligations of U.S. Government agencies and government-sponsored entities, commercial paper and corporate bonds, are subject to default, changes in credit rating and changes in market value. These investments are subject to interest rate risk and will decrease in value if market interest rates increase.

 

Our cash, cash equivalents and marketable securities, totaling $114.0 million at September 30, 2013, did not include any auction preferred stock, auction rate securities or mortgage-backed investments. We currently do not hedge interest rate exposure, and we do not have any foreign currency or other derivative financial instruments. The securities in our investment portfolio are classified as available for sale and are, due to their short-term nature, subject to minimal interest rate risk. To date, we have not experienced a loss of principal on any of our investments. Although we currently expect that our ability to access or liquidate these investments as needed to support our business activities will continue, we cannot ensure that this will not change. We believe that, if market interest rates were to change immediately and uniformly by 10% from levels at September 30, 2013, the impact on the fair value of these securities or our cash flows or income would not be material.

 

Foreign Currency Exchange Risk

 

Substantially all of our revenues are recognized in U.S. dollars. Certain expenses related to our international activities are payable in foreign currencies. As a result, factors such as changes in foreign currency exchange rates or weak economic conditions in foreign markets will affect our financial results. We recognized net foreign exchange transaction gains of $85,000 and losses of $7,000 for the three and nine months ended September 30, 2013, respectively, compared to net foreign exchange transaction gains of $30,000 and losses of $17,000 for the three and nine months ended September 30, 2012, respectively. The functional currency of our wholly-owned subsidiaries is the U.S. dollar, so we are not currently subject to gains and losses from foreign currency translation of the subsidiary financial statements. We currently do not hedge foreign currency exchange rate exposure. Although the impact of currency fluctuations on our financial results has been immaterial in the past, there can be no guarantee that the impact of currency fluctuations related to our international activities will not be material in the future.

 

ITEM 4.  CONTROLS AND PROCEDURES.

 

(a) Evaluation of disclosure controls and procedures. We maintain “disclosure controls and procedures,” as such term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, or Exchange Act, that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Our disclosure controls and procedures have been designed to meet reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

 

Based on their evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q, our Chief Executive Officer and Chief Financial Officer have concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

 

(b) Changes in internal control over financial reporting. There was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) that occurred during our last fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II. OTHER INFORMATION

 

ITEM 1A. RISK FACTORS.

 

We have a history of net losses, we may incur net losses in the future, and we expect to continue to incur significant expenses to develop and market our tests, which may make it difficult for us to achieve sustained profitability.

 

We have historically incurred net losses. From our inception in August 2000 through September 30, 2013, we had an accumulated deficit of $160.9 million. We expect to continue to invest in our product pipeline, including our current Oncotype DX tests and future products, and in our global commercial infrastructure, our laboratory operations and next generation sequencing development. For the three and nine months ended September 30, 2013, our research and development expenses were $14.7 million and $42.2 million, respectively, and our selling and marketing expenses were $26.0 million and $81.6 million, respectively. We expect our expense levels to continue to increase for the foreseeable future as we seek to expand the clinical utility and reimbursement of our Oncotype DX breast cancer test, drive adoption of and reimbursement for our Oncotype DX colon and prostate cancer tests and develop new tests. As a result, we will need to generate significant revenues in order to achieve sustained profitability. Our failure to achieve sustained profitability in the future could cause the market price of our common stock to decline.

 

Continued weak general economic or business conditions could have a negative impact on our business.

 

Continuing concerns over prolonged high unemployment levels, the availability and cost of credit, the U.S. real estate market, Federal budget deficits and related negotiations, proposed regulatory changes and taxation issues, inflation, deflation, energy costs and geopolitical issues have contributed to increased volatility and uncertain expectations for both the U.S. and global economies. These factors, combined with uncertainties in business and consumer confidence, volatile stock market, the European sovereign debt crisis and continued concerns regarding the stability of the Euro currency and some European Union member countries, and slowing economic growth in China, have precipitated an economic slowdown and expectations of slower global economic growth and possibly another recession going forward. These economic conditions continued to impact growth in tests delivered and revenues generated during the three and nine months ended September 30, 2013. If the economic environment does not improve or deteriorates, our business, including our patient population, our suppliers and our third party payors, could be negatively affected, resulting in a negative impact on our product revenues.

 

Healthcare policy changes, including recently enacted legislation reforming the U.S. healthcare system, may have a material adverse effect on our financial condition and results of operations.

 

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, collectively, the PPACA, enacted in March 2010, makes changes that are expected to significantly impact the pharmaceutical and medical device industries and clinical laboratories. Beginning in 2013, each medical device manufacturer pays a sales tax in an amount equal to 2.3% of the price for which such manufacturer sells its medical devices that are listed with the FDA. Although the FDA has contended that clinical laboratory tests that are developed and validated by a laboratory for its own use, or LDTs, such as our Oncotype DX breast, colon and prostate cancer tests are medical devices, none of our products are currently listed with the FDA. We cannot assure you that the tax will not be extended to services such as ours in the future. The PPACA also mandates a reduction in payments for clinical laboratory services paid under the Medicare Clinical Laboratory Fee Schedule, or CLFS, of 1.75% for the years 2011 through 2015 and a productivity adjustment to the CLFS.

 

Other significant measures contained in the PPACA include, for example, coordination and promotion of research on comparative clinical effectiveness of different technologies and procedures, initiatives to revise Medicare payment methodologies, such as bundling of payments across the continuum of care by providers and physicians, and initiatives to promote quality indicators in payment methodologies. The PPACA also includes significant new fraud and abuse measures, including required disclosures of financial arrangements with physician customers, lower thresholds for violations and increasing potential penalties for such violations. In addition, the PPACA establishes an Independent Payment Advisory Board, or IPAB, to reduce the per capita rate of growth in Medicare spending. The IPAB has broad discretion to propose policies to reduce expenditures, which may have a negative impact on payment rates for services. The IPAB proposals may impact payments for clinical laboratory services beginning in 2016 and for hospital services beginning in 2020. We are monitoring the impact of the PPACA in order to enable us to determine the trends and changes that may be necessitated by the legislation that may potentially impact our business over time.

 

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In addition to the PPACA, the effect of which cannot presently be fully quantified given its recent enactment, various healthcare reform proposals have also emerged from federal and state governments. For example, in February 2012, Congress passed the “Middle Class Tax Relief and Job Creation Act of 2012” which in part reduced the potential future cost-based increases to the Medicare CLFS by 2%. Overall the expected total fee cut to the CLFS for 2013 is 2.95% not including the further reduction of 2% from implementation of the automatic expense reductions (sequester) under the Budget Control Act of 2011, which went into effect for dates of service on or after April 1, 2013. Reductions made by the Congressional sequester are applied to total claims payment made. While these reductions do not result in a rebasing of the negotiated or established Medicare or Medicaid reimbursement rates, rebasing could occur as a result of future legislation.

 

State legislation on reimbursement applies to Medicaid reimbursement and Managed Medicaid reimbursement rates within that state. Some states have passed or proposed legislation that would revise reimbursement methodology for clinical laboratory payment rates under those Medicaid programs. In October 2011, CMS approved California’s plan to reduce certain Medi-Cal payments by 10% retroactive to June 1, 2011. According to the California Department of Health Care Services, the cut would apply to various healthcare providers and outpatient services including laboratory services. In December 2012, a three-judge panel of the 9th Circuit Court of Appeals overturned a district court ruling to stop the retroactive 10% cut. Healthcare providers asked the full 9th Circuit court to review the case. In May, the full 9th Circuit Court upheld the cut. As a result of the ruling, the retroactive reduction now must be implemented unless plaintiffs appeal the case to the U.S. Supreme Court and the high court blocks the cut while the case is heard and decided. If implemented as proposed, the retroactive price cut would result in a continued reduction of our product revenues.

 

Although recent changes to reimbursement methodology in states outside of California have not changed the payment rate for our tests, we cannot be certain that these or future changes will not affect payment rates in the future. We also cannot predict whether future healthcare initiatives will be implemented at the federal or state level or in countries outside of the United States in which we may do business, or the effect any future legislation or regulation will have on us. The taxes imposed by the new federal legislation, cost reduction measures and the expansion in government’s role in the U.S. healthcare industry may result in decreased profits to us, lower reimbursements by payors for our products or reduced medical procedure volumes, all of which may adversely affect our business, financial condition and results of operations. In addition, sales of our tests outside the United States make us subject to foreign regulatory requirements and cost-reduction measures, which may also change over time.

 

If the FDA were to begin regulating our tests, we could incur substantial costs and time delays associated with meeting requirements for pre-market clearance or approval or we could experience decreased demand for or reimbursement of our tests.

 

Clinical laboratory tests like ours are regulated under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, as well as by applicable state laws. Diagnostic kits that are sold and distributed through interstate commerce are regulated as medical devices by the FDA. Most LDTs are not currently subject to FDA regulation, although reagents or software provided by third parties and used to perform LDTs may be subject to regulation. We believe that our Oncotype DX tests are not diagnostic kits and also believe that they are LDTs. As a result, we believe our tests should not be subject to regulation under established FDA policies. The container we provide for collection and transport of tumor samples from a pathology laboratory to our clinical reference laboratory may be a medical device subject to FDA regulation but is currently exempt from pre-market review by the FDA.

 

At various times since 2006, the FDA has issued guidance documents or announced draft guidance regarding initiatives that may require varying levels of FDA oversight of our tests. Legislative proposals addressing oversight of genetic testing and LDTs were introduced in the previous two Congresses and we expect that new legislative proposals will be introduced from time to time. In October 2011, Congress introduced the Modernizing of Laboratory Standards Act for Patients aimed at confirming CLIA as the appropriate mechanism for improving regulation of laboratory tests such as ours. We cannot provide any assurance that FDA regulation, including pre-market review, will not be required in the future for our tests, whether through additional guidance issued by the FDA, new enforcement policies adopted by the FDA or new legislation enacted by Congress. It is possible that legislation will be enacted into law or guidance could be issued by the FDA which may result in increased regulatory burdens for us to continue to offer our tests or to develop and introduce new tests.

 

In addition, the Secretary of the Department of Health and Human Services, or HHS, requested that its Advisory Committee on Genetics, Health and Society make recommendations about the oversight of genetic testing. A final report was published in April 2008. If the report’s recommendations for increased oversight of genetic testing were to result in further regulatory burdens, it could have a negative impact on our business and could delay the commercialization of tests in development.

 

If pre-market review is required, our business could be negatively impacted until such review is completed and clearance to market or approval is obtained, and the FDA could require that we stop selling our tests pending pre-market clearance or approval. If our tests are allowed to remain on the market but there is uncertainty about our tests, if they are labeled investigational by the FDA, or if labeling claims the FDA allows us to make are very limited, orders or reimbursement may decline. The regulatory approval process may involve, among other things, successfully completing additional clinical trials and submitting a pre-market clearance notice or

 

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filing a pre-market approval application with the FDA. If pre-market review is required by the FDA, there can be no assurance that our tests will be cleared or approved on a timely basis, if at all, nor can there be assurance that labeling claims will be consistent with our current claims or adequate to support continued adoption of and reimbursement for our tests. Ongoing compliance with FDA regulations would increase the cost of conducting our business, and subject us to inspection by and the regulatory requirements of the FDA and penalties for failure to comply with these requirements. We may also decide voluntarily to pursue FDA pre-market review of our tests if we determine that doing so would be appropriate.

 

In June 2011, the FDA issued draft guidance regarding “Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only.” In addition, during 2011 the FDA also issued other draft guidance documents which may impact our tests or our future tests, including draft guidance regarding Mobile Medical Applications which is directed at patient management tools. The Mobile Medical Application guidance document was finalized in September 2013, but it does not address laboratory-developed tests like ours, leaving our tests under enforcement discretion by the FDA. In October 2012, the FDA published a list of planned guidance documents that the agency stated it plans to focus on in its fiscal year 2013, including the finalization of previously issued draft guidance which could include guidance documents addressing FDA regulation of laboratory tests such as ours. To date, the FDA has not issued any of these planned guidance documents. We cannot predict the ultimate timing or form of any such guidance or regulation and the potential impact on our existing tests, our tests in development or the materials used to perform our tests. While we qualify all materials used in our tests according to CLIA regulations, we cannot be certain that the FDA might not enact rules or guidance documents which could impact our ability to purchase materials necessary for the performance of our tests. Should any of the reagents obtained by us from suppliers and used in conducting our tests be affected by future regulatory actions, our business could be adversely affected by those actions, including increasing the cost of testing or delaying, limiting or prohibiting the purchase of reagents necessary to perform testing.

 

If we were required to conduct additional clinical trials prior to continuing to sell our breast, colon and prostate cancer tests or launching any other tests we may develop, those trials could result in delays or failure to obtain necessary regulatory approvals, which could harm our business.

 

If the FDA decides to regulate our tests, it may require additional pre-market clinical testing prior to submitting a regulatory notification or application for commercial sales. If we are required to conduct pre-market clinical trials, whether using prospectively acquired samples or archival samples, delays in the commencement or completion of clinical testing could significantly increase our test development costs and delay commercialization of any future tests, and interrupt sales of our current tests. Many of the factors that may cause or lead to a delay in the commencement or completion of clinical trials may also ultimately lead to delay or denial of regulatory clearance or approval. The commencement of clinical trials may be delayed due to insufficient patient enrollment, which is a function of many factors, including the size of the patient population, the nature of the protocol, the proximity of patients to clinical sites and the eligibility criteria for the clinical trial.

 

We may find it necessary to engage contract research organizations to perform data collection and analysis and other aspects of our clinical trials, which might increase the cost and complexity of our trials. We may also depend on clinical investigators, medical institutions and contract research organizations to perform the trials. If these parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, or if the quality, completeness or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or for other reasons, our clinical trials may have to be extended, delayed or terminated. Many of these factors would be beyond our control. We may not be able to enter into replacement arrangements without undue delays or considerable expenditures. If there are delays in testing or approvals as a result of the failure to perform by third parties, our research and development costs would increase, and we may not be able to obtain regulatory clearance or approval for our tests. In addition, we may not be able to establish or maintain relationships with these parties on favorable terms, if at all. Each of these outcomes would harm our ability to market our tests, or to achieve sustained profitability.

 

If third-party payors, including managed care organizations and Medicare, do not provide reimbursement, breach, rescind or modify their contracts or reimbursement policies or delay payments for our Oncotype DX tests, or we are unable to successfully renegotiate reimbursement contracts, our commercial success could be compromised.

 

Physicians and patients may not order our Oncotype DX tests unless third-party payors, such as managed care organizations as well as government payors such as Medicare and Medicaid and governmental payors outside of the United States, pay a substantial portion of the test price. Reimbursement by a payor may depend on a number of factors, including a payor’s determination that tests using our technologies are:

 

·             not experimental or investigational,

 

·             medically necessary,

 

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·             appropriate for the specific patient,

 

·             cost-effective,

 

·             supported by peer-reviewed publications, and

 

·             included in clinical practice guidelines.

 

There is uncertainty concerning third-party payor reimbursement of any test incorporating new technology, including tests developed using our Oncotype DX platform. Several entities conduct technology assessments of new medical tests and devices and provide the results of their assessments for informational purposes to other parties. These assessments may be used by third-party payors and health care providers as grounds to deny coverage for a test or procedure. Although there are a number of favorable assessments of our Oncotype DX breast cancer test, the test has received negative assessments in the past and our tests may receive negative assessments in the future. For example, in November 2010, the Medical Advisory Panel of the Blue Cross and Blue Shield Association’s Technology Evaluation Center, a technology assessment group, published its conclusion that the existing clinical data in support of our Oncotype DX breast cancer test did not meet the panel’s technology criteria for clinical effectiveness and appropriateness for usage in patients with N+ disease.

 

Since each payor makes its own decision as to whether to establish a policy to reimburse our test, seeking these approvals is a time-consuming and costly process. To date, we have positive coverage determinations for our Oncotype DX breast cancer test for N-, ER+ patients from most third-party payors in the United States through contracts, agreements or policy decisions. We cannot be certain that coverage for this test will be provided in the future by additional third-party payors or that existing contracts, agreements or policy decisions or reimbursement levels, including tests processed as out of network, will remain in place or be fulfilled within existing terms and provisions. From time to time payors change processes that may affect timely payment. These changes may result in uneven cash flow or impact the timing of revenue recognized with these payors.

 

We have obtained limited reimbursement from private third-party payors in the United States for our Oncotype DX colon cancer test launched in January 2010. We expect to focus substantial resources on obtaining adoption of and reimbursement coverage for this test. Until further clinical data is presented, our colon cancer test may be considered investigational by payors and therefore may not be covered under their reimbursement policies.

 

We believe it may take several years to achieve reimbursement with a majority of third-party payors for our colon cancer test. In addition, the launch of our test for prostate cancer in May 2013 will require us to expend substantial time and resources in order to drive adoption of and reimbursement for this test. We cannot predict whether, under what circumstances, or at what payment levels payors will reimburse for these tests. If we fail to establish broad adoption of and reimbursement for our colon cancer and prostate cancer tests, our reputation could be harmed and our future prospects and our business could suffer.

 

Based upon our experience in obtaining adoption and reimbursement for our Oncotype DX breast and colon cancer tests, we do not expect product revenues from our prostate cancer test to comprise more than 10% of our total revenues for at least a year or more following commercial availability. We may not be able to obtain Medicare reimbursement coverage for our prostate cancer test, or obtain third-party payor reimbursement for patients with colon or prostate cancer or with DCIS that is similar to the coverage we have obtained for our breast cancer test.

 

If we are unable to obtain or maintain reimbursement from private payors, such as the Blue Cross/Blue Shield family, and public payors, such as Medicare and Medicaid programs, for our existing tests or new tests or test enhancements we may develop in the future, our ability to generate revenues could be limited. We have in the past, and will likely in the future, experience delays and temporary interruptions in the receipt of payments from third-party payors due to modifications in existing contracts or arrangements, contract implementation steps, documentation requirements and other issues, which could cause our revenues to fluctuate from period to period.

 

If we are unable to obtain or maintain adequate reimbursement for our tests outside of the United States, our ability to expand internationally will be compromised.

 

The majority of our international Oncotype DX breast and colon cancer test revenues come from direct payor reimbursement, payments from our distributors, patient self-pay, and clinical collaborations in various countries. In many countries outside of the United States, various coverage, pricing and reimbursement approvals are required. We expect that it will take several years to establish broad coverage and reimbursement for our tests with payors in countries outside of the United States, and our efforts may not be successful. Once established, reimbursement levels outside of the United States may vary considerably from the domestic reimbursement amounts we receive. In addition, because we rely on distributors to obtain reimbursement for our tests, to the extent we do not have direct reimbursement arrangements with payors, we may not be able to retain reimbursement coverage in certain countries with a particular payor if our agreement with a distributor is terminated or expires or a distributor fails to pay us for other reasons.

 

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Distributors of our tests may also be negatively affected by the financial instability of, and austerity measures implemented by, several countries in the European Union.

 

The prices at which our tests are reimbursed may be reduced by Medicare and private and other payors, and any such changes could have a negative impact on our revenues.

 

Even if we are being reimbursed for our tests, Medicare, Medicaid and private and other payors may withdraw their coverage policies, cancel their contracts with us at any time, review and adjust the rate of reimbursement, require co-payments from patients or stop paying for our tests, which would reduce our revenues. In addition, insurers, including managed care organizations as well as government payors such as Medicare and Medicaid, have increased their efforts to control the cost, utilization and delivery of healthcare services. These measures have resulted in reduced payment rates and decreased utilization for the clinical laboratory industry. Noridian, Palmetto GBA and other Medicare contractors review coverage and reimbursement rates annually. Furthermore, Congress has considered and implemented changes to the Medicare fee schedules in conjunction with budgetary legislation, and pricing and payment terms, including the possible requirement of a patient co-payment for Medicare beneficiaries for tests covered by Medicare, are subject to change at any time. Reductions in the reimbursement rate of payors may occur in the future. Reductions in the prices at which our tests are reimbursed could have a negative impact on our revenues.

 

There is no specific Current Procedural Terminology, or CPT, procedure code or group of codes to report the Oncotype DX breast, colon or prostate cancer tests. The tests are reported under a non-specific, unlisted procedure code, which is subject to manual review of each claim. With regard to Medicare’s current reimbursement of our Oncotype DX breast cancer test, we were informed that, under the local coverage determination, claims are to be paid consistent with the average allowed reimbursement rate for claims that were billed and processed to completion as of September 30, 2005. This reimbursement rate remains in effect as of the date of this report, but is subject to review and adjustment. A Healthcare Common Procedure Coding System, or HCPCS, code has been issued effective January 1, 2006 for the Oncotype DX breast cancer test that some private third-party payors may accept on claims for the test. However, Medicare will not accept this HCPCS code. The American Medical Association, which has the copyright on the CPT coding system, established a work group to develop a new coding framework for non-infectious disease molecular pathology testing and recommend new codes to the panel, which determines new and revised codes and descriptors. Whether or not we obtain a specific CPT code for our tests, there can be no assurance that an adequate payment rate will continue to be assigned to the tests, which could have a negative impact on our revenues.

 

Additionally, on a five year rotational basis, Medicare requests bids for its regional MAC services. In 2008, we were notified of the transition from our initial MAC to Palmetto GBA as a result of this bidding process. Palmetto GBA has issued coverage and payment determinations on our Oncotype DX tests since that transition. In September 2012, Medicare notified us that the next successor MAC for our region will be Noridian Healthcare Solutions. The claims processing function transitioned to Noridian in September 2013. A change in the MAC processing the Medicare claims for our Oncotype DX tests could impact reimbursement timing and our ability to obtain Medicare coverage for products for which we do not yet have coverage or any products we may launch in the future or delay payments, including but not limited to payments for our Oncotype DX prostate cancer test.

 

Because of Medicare billing rules, we may not receive reimbursement for all tests provided to Medicare patients.

 

Under current Medicare billing rules, claims for our Oncotype DX tests performed on Medicare beneficiaries who were hospital inpatients at the time the tumor tissue samples were obtained and whose tests were ordered less than 14 days from discharge must be incorporated in the payment that the hospital receives for the inpatient services provided. Medicare billing rules also require hospitals to bill for the test when ordered for hospital outpatients less than 14 days following the date of the hospital procedure where the tumor tissue samples were obtained. Accordingly, we are required to bill individual hospitals for tests performed on Medicare beneficiaries during these time frames. Because we generally do not have written agreements in place with these hospitals to pay for these tests, we may not be paid or may have to pursue payment from the hospital on a case-by-case basis. Although we believe patients coming under this rule represent less than 1% of our total testing population, these billing rules may lead to confusion regarding whether Medicare provides adequate reimbursement for our tests, and could discourage Medicare patients from using our test. In addition, a greater proportion of eligible patients for our colon and prostate tests are covered by Medicare. We cannot assure you that Medicare will reverse these billing rules or that Medicare will not extend this limitation in the future and we also cannot ensure that hospitals will agree to arrangements to pay us for Oncotype DX tests performed on patients falling under these rules.

 

We depend on Medicare for a significant portion of our product revenues and if Medicare or other significant payors stop providing reimbursement or decrease the amount of reimbursement for our tests, our revenues could decline.

 

Reimbursement on behalf of patients covered by Medicare accounted for 21% and 22% of our product revenues for the three and nine months ended September 30, 2013, and 23% and 21% of our product revenues for the three and nine months ended September 30, 2012, respectively. Accounts receivable on behalf of patients covered by Medicare represented 20% and 21% of our net

 

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accounts receivable at September 30, 2013 and December 31, 2012, respectively. While there were no other third-party payors representing 10% or more of our product revenues for these periods, there have been in the past, and may be in the future, other payors accounting for 10% or more of our product revenues. Because the majority of stage II and stage III colon cancer patients and prostate cancer patients in the United States are age 65 and over, and thus insured by Medicare, we may become more dependent on Medicare reimbursement in the future. It is possible that Medicare or other third-party payors that provide reimbursement for our tests may suspend, revoke or discontinue coverage at any time, may require co-payments from patients, or may reduce the reimbursement rates payable to us. Any such action could have a negative impact on our revenues.

 

Our financial results depend largely on the sales of one test, our Oncotype DX breast cancer test, and we will need to generate sufficient revenues from this and other tests to run our business.

 

For the near future, we expect to continue to derive a substantial majority of our revenues from sales of one test, our Oncotype DX test for invasive breast cancer. While we launched our test for colon cancer in January 2010, we do not expect to recognize significant revenues from this test until significant levels of adoption and reimbursement for this test have been established. We have similar expectations for revenue related to our DCIS breast cancer test, which was launched in December 2011, and our prostate cancer test, which was launched in May 2013. We are in various stages of research and development for other tests that we may offer as well as for enhancements to our existing tests. We may not be able to successfully commercialize tests for other cancers or diseases. If we are unable to increase sales of our test for invasive breast cancer, establish adoption of and reimbursement for our colon, or prostate cancer or DCIS tests, or successfully develop and commercialize other tests or enhancements, our revenues and our ability to achieve sustained profitability would be impaired.

 

Complying with numerous regulations pertaining to our business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties.

 

We are subject to CLIA, a federal law that regulates clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease. CLIA regulations mandate specific standards in the areas of personnel qualifications, administration, and participation in proficiency testing, patient test management, quality control, quality assurance and inspections. We have a current certificate of accreditation under CLIA to perform testing through our accreditation by the College of American Pathologists, or CAP. To renew this certificate, we are subject to survey and inspection every two years. Moreover, CLIA inspectors may make random inspections of our clinical reference laboratory.

 

Although we are required to hold a certificate of accreditation or compliance under CLIA that allows us to perform high complexity testing, we are not required to hold a certificate of accreditation through CAP. We could alternatively maintain a certificate of accreditation from another accrediting organization or a certificate of compliance through inspection by surveyors acting on behalf of the CLIA program. If our accreditation under CAP were to terminate, either voluntarily or involuntarily, we would need to convert our certification under CLIA to a certificate of compliance (or to a certificate of accreditation with another accreditation organization) in order to maintain our ability to perform clinical testing and to continue commercial operations. Whether we would be able to successfully maintain operations through either of these alternatives would depend upon the facts and circumstances surrounding termination of our CAP accreditation, such as whether any deficiencies were identified by CAP as the basis for termination and, if so, whether these were addressed to the satisfaction of the surveyors for the CLIA program (or another accrediting organization).

 

We are also required to maintain a license to conduct testing in California. California laws establish standards for day-to-day operation of our clinical reference laboratory, including the training and skills required of personnel and quality control. In addition, our clinical reference laboratory is required to be licensed on a product-specific basis by New York State. New York law also mandates proficiency testing for laboratories licensed under New York state law, regardless of whether or not such laboratories are located in New York. Moreover, several other states require that we hold licenses to test specimens from patients in those states. Other states may have similar requirements or may adopt similar requirements in the future. Finally, we may be subject to regulation in foreign jurisdictions as we seek to expand international distribution of our tests, which may require review of our tests in order to offer our services or may have other limitations such as prohibitions on the export of tissue necessary for us to perform our tests that may limit our ability to distribute outside of the United States.

 

If we were to lose our CLIA accreditation or California license, whether as a result of a revocation, suspension or limitation, we would no longer be able to sell our tests, which would limit our revenues and harm our business. If we were to lose our license in New York or in other states where we are required to hold licenses, we would not be able to test specimens from those states.

 

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We are subject to other regulation in the United States by both the federal government and the states in which we conduct our business, as well as in other jurisdictions outside of the United States, including:

 

·             Medicare billing and payment regulations applicable to clinical laboratories;

 

·             the Federal Anti-kickback Law and state anti-kickback prohibitions;

 

·             the Federal physician self-referral prohibition, commonly known as the Stark Law, and the state equivalents;

 

·             the Federal Health Insurance Portability and Accountability Act of 1996;

 

·             the Medicare civil money penalty and exclusion requirements;

 

·             the Federal False Claims Act civil and criminal penalties and state equivalents; and

 

·             the Foreign Corrupt Practices Act, the United Kingdom Anti-bribery Act and the European Data Protection Directive, all of which apply to our international activities.

 

We have adopted policies and procedures designed to comply with these laws. In the ordinary course of our business, we conduct internal reviews of our compliance with these laws. Our compliance is also subject to governmental review. The growth of our business and sales organization and our expansion outside of the United States may increase the potential of violating these laws or our internal policies and procedures. The risk of our being found in violation of these or other laws and regulations is further increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Any action brought against us for violation of these or other laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If our operations are found to be in violation of any of these laws and regulations, we may be subject to any applicable penalty associated with the violation, including civil and criminal penalties, damages and fines, we could be required to refund payments received by us, and we could be required to curtail or cease our operations. Any of the foregoing consequences could seriously harm our business and our financial results.

 

New test development involves a lengthy and complex process, and we may be unable to commercialize on a timely basis, or at all, any new tests we may develop.

 

We have multiple tests in development and devote considerable resources to research and development. There can be no assurance that our technologies will be capable of reliably predicting the recurrence of cancers other than breast, colon and prostate cancer with the sensitivity and specificity necessary to be clinically and commercially useful, or that our colon or prostate cancer tests will result in commercially successful products. In addition, before we can develop diagnostic tests for new cancers or other diseases and commercialize any new products, we will need to:

 

·             conduct substantial research and development;

 

·             conduct validation studies;

 

·             expend significant funds;

 

·             develop and scale our laboratory processes to accommodate different tests; and

 

·             develop and scale our infrastructure to be able to analyze increasingly large amounts of data.

 

Our product development process involves a high degree of risk and may take several years. Our product development efforts may fail for many reasons, including:

 

·             failure of the product at the research or development stage;

 

·             difficulty in accessing archival tissue samples, especially tissue samples with known clinical results; or

 

·             lack of clinical validation data to support the effectiveness of the product.

 

Few research and development projects result in commercial products, and success in early clinical trials often is not replicated in later studies. At any point, we may abandon development of a product candidate or we may be required to expend considerable resources repeating clinical trials, which would adversely impact the timing for generating potential revenues from those product candidates. In addition, as we develop products, we will have to make significant investments in product development, marketing and selling resources. If a clinical validation study fails to demonstrate the prospectively defined endpoints of the study, we might choose

 

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to abandon the development of the product or product feature that was the subject of the clinical trial, which could harm our business. For example, in September 2013 we delayed our plan to initiate a validation study in 2013 utilizing results from our NSABP C-07 clinical trial. The decision to delay was based on analytical performance, during the pre-validation phase, that did not meet our standards for a subset of the candidate predictive genes. In addition, competitors may develop and commercialize competing products faster than we are able to do so.

 

If we are unable to support demand for our tests, including successfully managing the evolution of our technology and manufacturing platforms, our business could suffer.

 

As our test volume grows, we will need to continue to ramp up our testing capacity, implement increases in scale and related processing, customer service, billing and systems process improvements, and expand our internal quality assurance program, technology and manufacturing platforms to support testing on a larger scale. We will also need additional certified laboratory scientists and other scientific and technical personnel to process higher volumes of our tests. We cannot assure you that any increases in scale, related improvements and quality assurance will be successfully implemented or that appropriate personnel will be available. As additional products are commercialized, such as our prostate cancer test, we will need to bring new equipment on-line, implement new systems, technology, controls and procedures and hire personnel with different qualifications. In addition, we recently began to implement a plan to migrate from our existing quantitative polymerase chain reaction, or qPCR, equipment to new equipment. We cannot assure you that this transition will not result in delays. Failure to implement necessary procedures, transition to new equipment or processes or to hire the necessary personnel could result in higher cost of processing or an inability to meet market demand. There can be no assurance that we will be able to perform tests on a timely basis at a level consistent with demand, that our efforts to scale our commercial operations will not negatively affect the quality of test results, or that we will be successful in responding to the growing complexity of our testing operations. If we encounter difficulty meeting market demand or quality standards for our tests, our reputation could be harmed and our future prospects and our business could suffer.

 

We may experience limits on our revenues if physicians decide not to order our tests.

 

If medical practitioners do not order our Oncotype DX tests or any future tests developed or offered by us, we will likely not be able to create or maintain demand for our products in sufficient volume for us to achieve sustained profitability. To generate demand, we will need to continue to make oncologists, urologists, surgeons and pathologists aware of the benefits of each type of test through published papers, presentations at scientific conferences and one-on-one education by our sales force. In addition, we will need to demonstrate our ability to obtain and maintain adequate reimbursement coverage from third-party payors.

 

Prior to the inclusion of our Oncotype DX breast cancer test in clinical guidelines for treatment of N-, ER+ breast cancer, guidelines and practices regarding the treatment of breast cancer recommended that chemotherapy be considered in most cases, including many cases in which our test might indicate that, based on our clinical trial results, chemotherapy would be of little or no benefit. Accordingly, physicians may be reluctant to order a test that may suggest recommending against chemotherapy in treating breast cancer. Moreover, our test provides quantitative information not currently provided by pathologists and it is performed at our facility rather than by the pathologist in a local laboratory, so pathologists may be reluctant to support our test. These facts may make it difficult for us to convince medical practitioners to order our test for their patients, which could limit our ability to generate revenues and achieve sustained profitability.

 

Our Oncotype DX colon cancer test predicts recurrence but, unlike our test for invasive breast cancer, does not predict chemotherapy benefit. Our new Oncotype DX prostate cancer test provides physicians and patients with a new way to assess the aggressiveness of a patient’s prostate cancer. We will need to educate physicians, patients and payors about the benefits and cost-effectiveness of these tests and to establish reimbursement arrangements for these tests with payors. We may need to hire additional commercial, sales, scientific, technical and other personnel to support this process. If our marketing and educational efforts do not result in sufficient physician or patient demand, we may not be able to obtain adequate reimbursement for these tests. If we fail to successfully establish adoption of and additional reimbursement beyond Medicare for our colon cancer test, our reputation could be harmed and our business could suffer. If we fail to successfully establish adoption of and reimbursement for our prostate cancer test, our reputation could be harmed and our business could suffer.

 

We may experience limits on our revenues if patients decide not to use our tests.

 

Some patients may decide not to use our Oncotype DX tests due to their price, all or part of which may be payable directly by the patient if the applicable payor denies reimbursement in full or in part. Even if medical practitioners recommend that their patients use our tests, patients may still decide not to use our tests, either because they do not want to be made aware of the likelihood of recurrence or they wish to pursue a particular course of therapy regardless of test results. Additionally, the current economic environment in the United States and abroad could continue to negatively impact patients, resulting in higher co-payments and insurance premiums or the loss of healthcare coverage, which may result in delayed medical checkups or an inability to pay for our tests. If only a small portion of the patient population decides to use our tests, we will experience limits on our revenues and our ability to achieve sustained profitability.

 

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Our rights to use technologies licensed from third parties are not within our control, and we may not be able to sell our products if we lose our existing rights or cannot obtain new rights on reasonable terms.

 

We license from third parties technology necessary to develop our products. For example, we license technology from Roche Molecular Systems, Inc. that we use to analyze genes in our clinical reference laboratory to conduct our tests. In return for the use of a third party’s technology, we may agree to pay the licensor royalties based on sales of our products. Royalties are a component of cost of product revenues and impact the margins on our tests. We may need to license other technologies to commercialize future products. We may also need to negotiate licenses to patents and patent applications after launching any of our commercial products. Our business may suffer if these licenses terminate, if the licensors fail to abide by the terms of the license or fail to prevent infringement by third parties, if the licensed patents or other rights are found to be invalid, if the patents or patent applications are unavailable for license or if we are unable to enter into necessary licenses on acceptable terms. Companies that attempt to replicate our tests could be set up in countries that do not recognize our intellectual property. Such companies could send test results into the United States and therefore reduce sales of our tests.

 

If we are unable to develop products to keep pace with rapid technological, medical and scientific change, our operating results and competitive position could be harmed.

 

In recent years, there have been numerous advances in technologies relating to the diagnosis and treatment of cancer. For example, technologies in addition to ours now permit measurement of gene expression in fixed paraffin-embedded tissue specimens. New chemotherapeutic or biologic strategies are being developed that may increase survival time and reduce toxic side effects. There have also been advances in methods used to analyze very large amounts of genomic information, specifically next generation sequencing, or NGS. These advances require us to continuously develop our technology, develop new products and enhance existing products to keep pace with evolving standards of care. Our tests could become obsolete unless we continually innovate and expand our products to demonstrate recurrence and treatment benefit in patients treated with new therapies. New treatment therapies typically have only a few years of clinical data associated with them, which limits our ability to perform clinical studies and correlate sets of genes to a new treatment’s effectiveness. If we are unable to demonstrate the applicability of our tests to new treatments, sales of our test could decline, which would harm our revenues.

 

If we are unable to maintain intellectual property protection, our competitive position could be harmed.

 

Our ability to compete and to achieve sustained profitability is impacted by our ability to protect our proprietary discoveries and technologies. We currently rely on a combination of patent applications, copyrights, trademarks, and confidentiality, material data transfer, license and invention assignment agreements to protect our intellectual property rights. We also rely upon trade secret laws to protect unpatented know-how and continuing technological innovation. Our intellectual property strategy is intended to develop and maintain our competitive position. Patents may be granted to us jointly with other organizations, and while we may have a right of first refusal, we cannot guarantee that a joint owner will not license rights to another party, and we cannot guarantee that a joint owner will cooperate with us in the enforcement of patent rights.

 

Our pending patent applications may not result in issued patents, and we cannot assure you that our issued patents or any patents that might ultimately be issued by the U.S. Patent and Trademark Office, or USPTO, will protect our technology. Any patents that may be issued to us might be challenged by third parties as being invalid or unenforceable, or third parties may independently develop similar or competing technology that avoids our patents.

 

We cannot be certain that the steps we have taken will prevent the misappropriation and use of our intellectual property, particularly in foreign countries where the laws may not protect our proprietary rights as fully as in the United States.

 

If patent regulations or standards are modified, such changes could have a negative impact on our business.

 

From time to time, the U.S. Supreme Court, other federal courts, the U.S. Congress or the USPTO may change the standards of patentability and validity and any such changes could have a negative impact on our business. In addition, competitors may develop their own versions of our test in countries where we did not apply for patents or where our patents have not issued and compete with us in those countries, including encouraging the use of their test by physicians or patients in other countries.

 

There have been several cases involving “gene patents” and diagnostic claims that have been considered by the U.S. Supreme Court. A suit brought by multiple plaintiffs, including the American Civil Liberties Union, or ACLU, against Myriad Genetics, or Myriad, and the USPTO involves certain of Myriad’s U.S. patents related to the breast cancer susceptibility genes BRCA1 and BRCA2. The Federal Circuit issued a written decision on July 29, 2011 that reversed the U.S. District Court for the Southern District of New York holding instead that the breast cancer genes are patentable subject matter. Subsequently, on March 20, 2012, the Supreme Court issued a decision in Mayo Collaborative v. Prometheus Laboratories, or Prometheus, a case involving patent claims

 

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directed to optimizing the amount of drug administered to a specific patient. According to that decision, Prometheus’ claims failed to add enough inventive content to the underlying correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws.  The Supreme Court subsequently granted certiorari in the Myriad case, vacated the judgment, and remanded the case back to the Federal Circuit for further consideration in light of their decision in the Prometheus case.  The Federal Circuit issued a decision on August 16, 2012, reaffirming its earlier decision.

 

On July 3, 2012, the USPTO issued a memorandum to patent examiners providing guidelines for examining process claims for patent eligibility in view of the Supreme Court decision in Prometheus.  The guidance indicates that claims directed to a law of nature, a natural phenomenon, or an abstract idea that do not meet the eligibility requirements should be rejected as non-statutory subject matter.  We cannot assure you that our patent portfolio will not be negatively impacted by the decision described above, rulings in other cases or changes in guidance or procedures issued by the USPTO.

 

The Supreme Court granted ACLU’s petition for a writ of certiorari and issued a decision on June 13, 2013.  In the ruling, the Supreme Court held that claims to “isolated” DNA molecules and the information they encode are not patent eligible, whereas cDNA, not a “product of nature,” is patent eligible.  On July 12, 2013, Senator Patrick Leahy wrote to the National Institutes of Health, or NIH, urging that the NIH take the extremely unusual step of exercising its “march in” rights to force Myriad to license certain patents to others on “reasonable” terms due to the public health and cost considerations.

 

Congress directed the USPTO to study effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist.  This study will examine the impact that independent second opinion testing has on providing medical care to patients; the effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test; the impact of current practices on testing results and performance; and the role of insurance coverage on the provision of genetic diagnostic tests.  The USPTO was directed to report the findings of the study to Congress and provide recommendations for establishing the availability of independent confirming genetic diagnostic test activity by June 16, 2012. In August 2012, the Department of Commerce advised the House and Senate Judiciary Committee leadership that given the complexity and significant policy implications, that further review, discussion and analysis are required before a final report can be submitted to Congress. To that end, the USPTO held an additional public hearing in late fall 2012, plans to review the comments received during the last year, and then plans to finalize its recommendations to Congress. It is unclear whether the results of this study will be acted upon by the USPTO or result in Congressional efforts to change the law or process in a manner that could negatively impact our patent portfolio or our future research and development efforts.

 

In addition, the Leahy-Smith America Invents Act, or the America Invents Act, which was signed into law in 2011, includes a number of significant changes to U.S. patent law.  These include changes to transition from a “first-to-invent” system to a “first-to-file” system, changes to the way issued patents are challenged and changes to the way patent applications are disputed during the examination process. These changes may favor larger and more established companies that have more resources to devote to patent application filing and prosecution. The USPTO has developed new regulations and procedures to govern the full implementation of the America Invents Act, and many of the substantive changes to patent law associated with the Act, and in particular the first to file provisions, which became effective in March 2013.  Substantive changes to patent law associated with the Act may affect our ability to obtain, enforce or defend our patents. Accordingly, it is not clear what, if any, impact the America Invents Act will ultimately have on the cost of prosecuting our patent applications, our ability to obtain patents based on our discoveries and our ability to enforce or defend our issued patents, all of which could have a material adverse effect on our business.

 

We may face intellectual property infringement claims that could be time-consuming and costly to defend, and could result in our loss of significant rights and the assessment of treble damages.

 

We have received notices of claims of infringement and misappropriation or misuse of other parties’ proprietary rights and may from time to time receive additional notices. Some of these claims may lead to litigation. We cannot assure you that we will prevail in such actions, or that other actions alleging misappropriation or misuse by us of third-party trade secrets, infringement by us of third-party patents and trademarks or the validity of our patents, will not be asserted or prosecuted against us.

 

We may also initiate claims to defend our intellectual property or to seek relief on allegations that we use, sell, or offer to sell technology that incorporates third party intellectual property. Intellectual property litigation, regardless of outcome, is expensive and time-consuming, could divert management’s attention from our business and have a material negative effect on our business, operating results or financial condition. If there is a successful claim of infringement against us, we may be required to pay substantial damages (including treble damages if we were to be found to have willfully infringed a third party’s patent) to the party claiming infringement, develop non-infringing technology, stop selling our tests or using technology that contains the allegedly infringing intellectual property or enter into royalty or license agreements that may not be available on acceptable or commercially practical terms, if at all. Our failure to develop non-infringing technologies or license the proprietary rights on a timely basis could harm our business. In addition, revising our tests to include the non-infringing technologies would require us to re-validate our tests, which

 

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would be costly and time consuming. Also, we may be unaware of pending patent applications that relate to our tests. Parties making infringement claims on future issued patents may be able to obtain an injunction that could prevent us from selling our tests or using technology that contains the allegedly infringing intellectual property, which could harm our business.

 

It is possible that a third party or patent office might take the position that one or more patents or patent applications constitute prior art in the field of genomic-based diagnostics. In such a case, we might be required to pay royalties, damages and costs to firms who own the rights to these patents, or we might be restricted from using any of the inventions claimed in those patents.

 

If we are unable to compete successfully, we may be unable to increase or sustain our revenues or achieve sustained profitability.

 

Our principal competition for our breast, colon and prostate cancer tests comes from existing diagnostic methods used by pathologists and oncologists. These methods have been used for many years and are therefore difficult to change or supplement. In addition, companies offering capital equipment and kits or reagents to local pathology laboratories represent another source of potential competition. These kits are used directly by the pathologist, which facilitates adoption more readily than tests like ours that are performed outside the pathology laboratory.

 

We also face competition from companies that offer products or have conducted research to profile genes, gene expression or protein expression in breast, colon or prostate cancer, including public companies such as GE Healthcare, a business unit of General Electric Company, Hologic, Inc., Myriad Genetics, Inc., NanoString Technologies, Inc., Novartis AG, Qiagen N.V. and Response Genetics, Inc., and many private companies. We also face competition from commercial laboratories with strong distribution networks for diagnostic tests, such as Laboratory Corporation of America Holdings and Quest Diagnostics Incorporated. We may also face competition from Life Technologies Corporation, which has announced its pending acquisition by Thermo Fisher Scientific Inc, and Illumina, Inc., both of which have recently announced their intention to enter the clinical diagnostics market. Other potential competitors include companies that develop diagnostic tests such as Roche Diagnostics, a division of Roche Holding, Ltd, Siemens AG and Veridex LLC, a Johnson & Johnson company, as well as other companies and academic and research institutions. Others may invent and commercialize technology platforms such as next generation sequencing approaches that will compete with our test. Projects related to cancer genomics have received government funding, both in the United States and internationally. As more information regarding cancer genomics becomes available to the public, we anticipate that more products aimed at identifying targeted treatment options will be developed and that these products may compete with ours. In addition, competitors may develop their own versions of our tests in countries where we did not apply for patents, where our patents have not been issued or where our intellectual property rights are not recognized and compete with us in those countries, including encouraging the use of their test by physicians or patients in other countries.

 

We have changed the list price of our tests in the past and we expect to change prices for our tests in the future. Any increase or decrease in pricing could impact reimbursement of and demand for our tests. Many of our present and potential competitors have widespread brand recognition and substantially greater financial and technical resources and development, production and marketing capabilities than we do. Others may develop lower-priced tests that could be viewed by physicians and payors as functionally equivalent to our tests, or offer tests at prices designed to promote market penetration, which could force us to lower the list prices of our tests and impact our operating margins and our ability to achieve sustained profitability. Some competitors have developed tests cleared for marketing by the FDA. There may be a marketing differentiation or perception that an FDA-cleared test is more desirable than Oncotype DX tests, and that may discourage adoption of and reimbursement for our tests. If we are unable to compete successfully against current or future competitors, we may be unable to increase market acceptance for and sales of our tests, which could prevent us from increasing or sustaining our revenues or achieving sustained profitability and could cause the market price of our common stock to decline.

 

Our research and development efforts will be hindered if we are not able to contract with third parties for access to archival tissue samples.

 

Under standard clinical practice, tumor biopsies removed from patients are typically chemically preserved and embedded in paraffin wax and stored. Our clinical development relies on our ability to secure access to these archived tumor biopsy samples, as well as information pertaining to their associated clinical outcomes. Generally, the agreements under which we gain access to archival samples are nonexclusive. Other companies study archival samples and often compete with us for access. Additionally, the process of negotiating access to archived samples is lengthy since it typically involves numerous parties and approval levels to resolve complex issues such as usage rights, institutional review board approval, privacy rights, publication rights, intellectual property ownership and research parameters. If we are not able to negotiate access to archival tumor tissue samples with hospitals, clinical partners, pharmaceutical companies, or companies developing therapeutics on a timely basis, or at all, or if other laboratories or our competitors secure access to these samples before us, our ability to research, develop and commercialize future products will be limited or delayed.

 

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If we cannot maintain our current clinical collaborations and enter into new collaborations, our product development could be delayed.

 

We rely on and expect to continue to rely on clinical collaborators to perform a substantial portion of our clinical trial functions. If any of our collaborators were to breach or terminate its agreement with us or otherwise fail to conduct the contracted activities successfully and in a timely manner, the research, development or commercialization of the products contemplated by the collaboration could be delayed or terminated. If any of our collaboration agreements are terminated, or if we are unable to renew those agreements on acceptable terms, we would be required to seek alternatives. We may not be able to negotiate additional collaborations on acceptable terms, if at all, and these collaborations may not be successful.

 

In the past, we have entered into clinical trial collaborations with highly regarded organizations in the cancer field including, for example, the National Surgical Adjuvant Breast and Bowel Project, or NSABP. Our success in the future depends in part on our ability to enter into agreements with other leading cancer organizations. This can be difficult due to internal and external constraints placed on these organizations. Some organizations may limit the number of collaborations they have with any one company so as to not be perceived as biased or conflicted. Organizations may also have insufficient administrative and related infrastructure to enable collaborations with many companies at once, which can prolong the time it takes to develop, negotiate and implement a collaboration. Additionally, organizations often insist on retaining the rights to publish the clinical data resulting from the collaboration. The publication of clinical data in peer-reviewed journals is a crucial step in commercializing and obtaining reimbursement for tests such as ours, and our inability to control when, if ever, results are published may delay or limit our ability to derive sufficient revenues from any product that may result from a collaboration.

 

From time to time we expect to engage in discussions with potential clinical collaborators which may or may not lead to collaborations. However, we cannot guarantee that any discussions will result in clinical collaborations or that any clinical studies which may result will be enrolled or completed in a reasonable time frame or with successful outcomes. Once news of discussions regarding possible collaborations are known in the medical community, regardless of whether the news is accurate, failure to announce a collaboration agreement or the entity’s announcement of a collaboration with an entity other than us could result in adverse speculation about us, our product or our technology, resulting in harm to our reputation and our business.

 

The loss of key members of our senior management team or our inability to attract and retain highly skilled scientists, clinicians and salespeople could adversely affect our business.

 

Our success depends largely on the skills, experience and performance of key members of our executive management team and others in key management positions. The efforts of each of these persons together will be critical to us as we continue to develop our technologies and testing processes, continue our international expansion and transition to a company with multiple commercialized products. If we were to lose one or more of these key employees, we may experience difficulties in competing effectively, developing our technologies and implementing our business strategies.

 

Our research and development programs and commercial laboratory operations depend on our ability to attract and retain highly skilled scientists and technicians, including licensed laboratory technicians, chemists, biostatisticians and engineers. We may not be able to attract or retain qualified scientists and technicians in the future due to the competition for qualified personnel among life science businesses, particularly in the San Francisco Bay Area. In addition, it is expected that there will be a shortage of clinical laboratory scientists in coming years, which would make it more difficult to hire sufficient numbers of qualified personnel. We also face competition from universities and public and private research institutions in recruiting and retaining highly qualified scientific personnel. In addition, our success depends on our ability to attract and retain salespeople with extensive experience in oncology and urology and close relationships with medical oncologists, urologists, surgeons, pathologists and other hospital personnel. We may have difficulties locating, recruiting or retaining qualified salespeople, which could cause a delay or decline in the rate of adoption of our tests. If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we may experience constraints that could adversely affect our ability to support our research and development and sales programs. All of our employees are at-will, which means that either we or the employee may terminate their employment at any time.

 

If our sole laboratory facility becomes inoperable, we will be unable to perform our tests and our business will be harmed.

 

We do not have redundant clinical reference laboratory facilities outside of Redwood City, California. Redwood City is situated near active earthquake fault lines. Our facility and the equipment we use to perform our tests would be costly to replace and could require substantial lead time to repair or replace. The facility may be harmed or rendered inoperable by natural or man-made disasters, including earthquakes, flooding and power outages, which may render it difficult or impossible for us to perform our tests for some period of time. The inability to perform our tests or the backlog of tests that could develop if our facility is inoperable for even a short period of time may result in the loss of customers or harm our reputation, and we may be unable to regain those customers in the future. Although we possess insurance for damage to our property and the disruption of our business, this insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, if at all.

 

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In order to rely on a third party to perform our tests, we could only use another facility with established state licensure and CLIA accreditation under the scope of which Oncotype DX tests could be performed following validation and other required procedures. We cannot assure you that we would be able to find another CLIA-certified facility willing to comply with the required procedures, that this laboratory would be willing to perform the tests for us on commercially reasonable terms, or that it would be able to meet our quality standards. In order to establish a redundant clinical reference laboratory facility, we would have to spend considerable time and money securing adequate space, constructing the facility, recruiting and training employees, and establishing the additional operational and administrative infrastructure necessary to support a second facility. We may not be able, or it may take considerable time, to replicate our testing processes or results in a new facility. Additionally, any new clinical reference laboratory facility opened by us would be subject to certification under CLIA and licensing by several states, including California and New York, which could take a significant amount of time and result in delays in our ability to begin operations.

 

International expansion of our business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.

 

Our business strategy incorporates international expansion, including increasing the size of and maintaining direct sales and physician outreach and education capabilities outside of the United States and expanding our relationships with international payors and distributors. Doing business internationally involves a number of risks, including:

 

·             multiple, conflicting and changing laws and regulations such as tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;

 

·             failure by us or our distributors to obtain regulatory approvals for the use of our tests in various countries;

 

·             difficulties in staffing and managing foreign operations;

 

·             complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;

 

·             logistics and regulations associated with shipping tissue samples, including infrastructure conditions and transportation delays;

 

·             limits in our ability to penetrate international markets if we are not able to process tests locally;

 

·             financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our tests and exposure to foreign currency exchange rate fluctuations;

 

·             natural disasters, political and economic instability, including wars, terrorism, and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions; and

 

·             regulatory and compliance risks that relate to maintaining accurate information and control over the activities of our sales force and distributors that may fall within the purview of the FCPA, its books and records provisions or its anti-bribery provisions.

 

Any of these factors could significantly harm our future international expansion and operations and, consequently, our revenues and results of operations.

 

Our dependence on distributors for sales of our Oncotype DX tests outside of the U.S. could limit or prevent us from selling our test in foreign markets and impact our revenue.

 

As of June 30, 2013, we have entered into exclusive distribution agreements for the sale of our breast, colon and prostate cancer tests with approximately 20 distributors covering more than 80 countries. We may enter into other similar arrangements to distribute our tests in other countries in the future. We intend to continue to grow our business internationally, and to do so we may need to attract additional distributors to expand the territories in which we sell our tests. Distributors may not commit the necessary resources to market and sell our tests to the level of our expectations. If current or future distributors do not perform adequately, or we are unable to enter into arrangements with distributors to market our tests in particular geographic areas, we may not realize long-term international revenue growth. In addition, our revenue from distributors could be negatively impacted as a result of changes in business cycles, business or economic conditions or other factors that could affect their ability to pay us for tests on a timely basis or at all. Regulatory requirements, costs of doing business outside of the United States and the reimbursement process in foreign markets may also impact our revenues from international sales or impact our ability to increase international sales in the future.

 

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We may acquire other businesses, form joint ventures or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.

 

As part of our business strategy, we may pursue acquisitions of complementary businesses and assets, as well as technology licensing arrangements. We also may pursue strategic alliances that leverage our core technology and industry experience to expand our product offerings or distribution, or make investments in other companies. We have recently experienced and may in the future experience losses related to the recognition of our portion of the net losses of equity method investees, and we may in the future experience impairment losses related to our investments in companies if we determine that the value of an investment is impaired. Losses related to our investments in other companies could have a material negative effect on our results of operations. We have no experience with respect to acquiring other companies and limited experience with respect to the formation of strategic alliances and joint ventures. If we make any acquisitions, we may not be able to integrate these acquisitions successfully into our existing business, and we could assume unknown or contingent liabilities. Any future acquisitions by us also could result in significant write-offs or the incurrence of debt and contingent liabilities, any of which could harm our operating results. Integration of an acquired company also may require management resources that otherwise would be available for ongoing development of our existing business. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and we may not realize the anticipated benefits of any acquisition, technology license, strategic alliance, joint venture or investment.

 

To finance any acquisitions or investments, we may choose to issue shares of our common stock as consideration, which would dilute the ownership of our stockholders. Periods of upheaval in the capital markets and world economy have in the past, and may in the future, cause volatility in the market price of our common stock. If the price of our common stock is low or volatile, we may not be able to acquire other companies for stock. Alternatively, it may be necessary for us to raise additional funds for acquisitions through public or private financings. Additional funds may not be available on terms that are favorable to us, or at all.

 

Our marketable securities are subject to risks that could adversely affect our overall financial position.

 

We invest our cash in accordance with an established internal policy in instruments which historically have been highly liquid and carried relatively low risk. However, similar types of investments have in the past and may in the future experience losses in value or liquidity issues which differ from historical patterns. Should a portion of our marketable securities lose value or have their liquidity impaired, it could adversely affect our overall financial position by imperiling our ability to fund our operations and forcing us to seek additional financing sooner than we would otherwise. Such financing, if available, may not be available on commercially attractive terms.

 

Our inability to raise additional capital on acceptable terms in the future may limit our ability to develop and commercialize new tests and technologies and expand our operations.

 

We expect capital outlays and operating expenditures to increase over the next several years as we expand our infrastructure, commercial operations and research and development activities. Specifically, we may need to raise capital to, among other things:

 

·             sustain commercialization of our Oncotype DX tests and enhancements to those tests;

 

·             fund commercialization of any future tests we may develop;

 

·             increase our selling and marketing efforts to drive market adoption and address competitive developments;

 

·             further expand our clinical laboratory operations;

 

·             expand our technologies into other areas of cancer or other diseases;

 

·             expand our research and development activities;

 

·             acquire, license or invest in technologies, including next generation sequencing;

 

·             acquire or invest in complementary businesses or assets; and

 

·             finance capital expenditures and general and administrative expenses.

 

Our present and future funding requirements will depend on many factors, including:

 

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·             the rate of progress in establishing and maintaining reimbursement arrangements with domestic and international third-party payors;

 

·             the cost of expanding our commercial and laboratory operations, including our selling and marketing efforts;

 

·             the rate of progress and cost of research and development activities associated with expansion of our Oncotype DX breast, colon and prostate cancer tests;

 

·             the rate of progress and cost of selling and marketing activities associated with establishing adoption of and reimbursement for our Oncotype DX colon and prostate cancer and DCIS tests;

 

·             costs related to launching our prostate cancer test and other future product launches;

 

·             the rate of progress and cost of research and development activities associated with products in research and development focused on cancers other than breast, colon and prostate cancer;

 

·             the rate of progress and cost of research and development activities associated with next generation sequencing;

 

·             the costs of acquiring, licensing or investing in technologies, including next generation sequencing;

 

·             the cost of acquiring or investing in complementary businesses or assets;

 

·             the cost of acquiring or achieving access to tissue samples and technologies;

 

·             the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

 

·             the effect of competing technological and market developments;

 

·             costs related to international expansion;

 

·             costs and delays in product development as a result of any changes in regulatory oversight applicable to our products or operations;

 

·             the impact of changes in Federal, state and international taxation; and

 

·             the economic and other terms and timing of any collaborations, licensing or other arrangements into which we may enter or investments or acquisitions we may seek to effect.

 

If we raise funds by issuing equity securities, dilution to our stockholders could result. Any equity securities issued also may provide for rights, preferences or privileges senior to those of holders of our common stock. If we raise funds by issuing debt securities, these debt securities would have rights, preferences and privileges senior to those of holders of our common stock. The terms of debt securities issued or borrowings could impose significant restrictions on our operations. If we raise funds through collaborations and licensing arrangements, we might be required to relinquish significant rights to our technologies or products, or grant licenses on terms that are not favorable to us. The credit markets and the financial services industry have been experiencing a period of unprecedented turmoil and upheaval characterized by the bankruptcy, failure, collapse or sale of various financial institutions and an unprecedented level of intervention from the U.S. federal government. These events, along with the recent downgrade of debt issued by the United States and the European sovereign debt crisis, have generally made equity and debt financing more difficult to obtain. Accordingly, additional equity or debt financing might not be available on reasonable terms, if at all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more research and development programs or selling and marketing initiatives. In addition, we may have to work with a partner on one or more of our product or market development programs, which could lower the economic value of those programs to us.

 

We are dependent on our information technology and telecommunications systems, and any failure of these systems could harm our business.

 

We depend on information technology, or IT, and telecommunications systems for significant aspects of our operations. In addition, our third-party billing and collections provider is dependent upon telecommunications and data systems provided by outside vendors and information it receives from us on a regular basis. These IT and telecommunications systems support a variety of

 

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functions, including test processing, sample tracking, quality control, customer service and support, billing and reimbursement, research and development activities, and our general and administrative activities. Failures or significant downtime of our IT or telecommunications systems or those used by our third-party service providers could prevent us from processing tests, providing test results to physicians, billing payors, processing reimbursement appeals, handling patient or physician inquiries, conducting research and development activities, and managing the administrative aspects of our business. Any disruption or loss of IT or telecommunications systems on which critical aspects of our operations depend could have an adverse effect on our business and our product revenues.

 

Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.

 

In the ordinary course of our business, we and our third party billing and collections provider collect and store sensitive data, including legally protected health information, credit card information, personally identifiable information about our employees, intellectual property, and our proprietary business information and that of our customers, payors and collaboration partners. We manage and maintain our applications and data utilizing a combination of on-site systems, managed data center systems and cloud-based data center systems. These applications and data encompass a wide variety of business critical information including research and development information, commercial information and business and financial information. We face four primary risks relative to protecting this critical information, including loss of access risk, inappropriate disclosure risk and inappropriate modification risk combined with the risk of our being able to identify and audit our controls over the first three risks.

 

The secure processing, storage, maintenance and transmission of this critical information is vital to our operations and business strategy, and we devote significant resources to protecting such information. Although we take measures to protect sensitive information from unauthorized access or disclosure, our information technology and infrastructure, and that of our third party billing and collections provider, may be vulnerable to attacks by hackers or viruses or breached due to employee error, malfeasance or other disruptions. Any such breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, such as the Health Insurance Portability and Accountability Act of 1996, and regulatory penalties. Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to process tests, provide test results, bill payors or patients, process claims and appeals, provide customer assistance services, conduct research and development activities, collect, process and prepare company financial information, provide information about our tests and other patient and physician education and outreach efforts through our website, manage the administrative aspects of our business and damage our reputation, any of which could adversely affect our business.

 

In addition, the interpretation and application of consumer, health-related and data protection laws in the U.S., Europe and elsewhere are often uncertain, contradictory and in flux. It is possible that these laws may be interpreted and applied in a manner that is inconsistent with our practices. If so, this could result in government imposed fines or orders requiring that we change our practices, which could adversely affect our business. Complying with these various laws could cause us to incur substantial costs or require us to change our business practices and compliance procedures in a manner adverse to our business.

 

We rely on a limited number of suppliers or, in some cases, a sole supplier, for some of our laboratory instruments and materials and may not be able to find replacement suppliers or immediately transition to alternative suppliers.

 

We rely on certain sole suppliers to supply and service some of the laboratory equipment on which we perform our tests. We believe that there are relatively few equipment manufacturers that are currently capable of supplying and servicing the equipment necessary for our tests. Although we have identified alternative suppliers, transition to a new supplier will be time consuming and expensive, and there can be no assurance that we will be able to secure alternative equipment and bring that equipment on line without experiencing interruptions in testing. If we should encounter delays or difficulties in securing the quality and quantity of equipment we require for our tests, we may need to reconfigure our test processes, which could result in an interruption in sales. If any of these events occur, our business and operating results could be harmed.

 

We also rely on several sole suppliers for certain laboratory reagents and materials which we use to perform our tests. While we have developed alternate sourcing strategies for these materials, we cannot be certain that these strategies will be effective. If we should encounter delays or difficulties in securing these laboratory materials, if the materials do not meet our quality specifications, or if we cannot obtain acceptable substitute materials, an interruption in test processing could occur. Any such interruption may significantly affect future product revenues.

 

We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy.

 

Future growth will impose significant added responsibilities on management, including the need to identify, recruit, train and integrate additional employees. In addition, rapid and significant growth may place strain on our administrative and operational infrastructure, including customer service and our clinical reference laboratory. Our ability to manage our operations and growth will require us to continue to improve our operational, financial and management controls, reporting systems and procedures. We plan to implement new enterprise software affecting a broad range of business processes and functional areas including order fulfillment,

 

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sample processing, customer service, supply chain management, and others.  The time and resources required to implement these new systems is uncertain, and failure to complete this in a timely and efficient manner could adversely affect our operations. If we are unable to manage our growth effectively, it may be difficult for us to execute our business strategy.

 

If we were sued for product liability or professional liability, we could face substantial liabilities that exceed our resources.

 

The marketing, sale and use of our tests could lead to the filing of product liability claims if someone were to allege that our tests failed to perform as it was designed. We may also be subject to liability for errors in the test results we provide to physicians or for a misunderstanding of, or inappropriate reliance upon, the information we provide. For example, physicians sometimes order our Oncotype DX breast cancer test for patients who do not have the same specific clinical attributes indicated on the report form as those for which the test provides clinical experience information from validation studies. It is our practice to offer medical consultation to physicians ordering our test for such patients, including patients with ER- breast cancers. A product liability or professional liability claim could result in substantial damages and be costly and time consuming for us to defend. Although we maintain product and professional liability insurance, we cannot assure you that our insurance would fully protect us from the financial impact of defending against product liability or professional liability claims or any judgments, fines or settlement costs arising out of any such claims. Any product liability or professional liability claim brought against us, with or without merit, could increase our insurance rates or prevent us from securing insurance coverage in the future. Additionally, any product liability lawsuit could cause injury to our reputation, result in the recall of our products, or cause current clinical partners to terminate existing agreements and potential clinical partners to seek other partners, any of which could impact our results of operations.

 

If we use hazardous materials in a manner that causes injury, we could be liable for damages.

 

Our activities currently require the use of hazardous chemicals. We cannot eliminate the risk of accidental contamination or injury to employees or third parties from the use, storage, handling or disposal of these materials. In the event of contamination or injury, we could be held liable for any resulting damages, and any liability could exceed our resources or any applicable insurance coverage we may have. Additionally, we are subject on an ongoing basis to federal, state and local laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. The cost of compliance with these laws and regulations may become significant and could negatively affect our operating results.

 

We must implement additional and expensive finance and accounting systems, procedures and controls as we grow our business and organization and to satisfy public company reporting requirements, which will increase our costs and require additional management resources.

 

As a public reporting company, we are required to comply with the Sarbanes-Oxley Act of 2002 and the related rules and regulations of the Securities and Exchange Commission. Compliance with Section 404 of the Sarbanes-Oxley Act and other requirements has increased our costs and required additional management resources. We will need to continue to implement additional finance, accounting, and business operating systems, procedures and controls as we grow our business and organization and to satisfy existing reporting requirements. If we fail to maintain or implement adequate controls, if we are unable to complete the required Section 404 assessment as to the adequacy of our internal control over financial reporting in future Form 10-K filings, or if our independent registered public accounting firm is unable to provide us with an unqualified report as to the effectiveness of our internal control over financial reporting in future Form 10-K filings, our ability to obtain additional financing could be impaired. In addition, investors could lose confidence in the reliability of our internal control over financial reporting and in the accuracy of our periodic reports filed under the Exchange Act. A lack of investor confidence in the reliability and accuracy of our public reporting could cause our stock price to decline.

 

We are subject to increasingly complex taxation rules and practices, which may affect how we conduct our business and our results of operations.

 

As our business grows, we are required to comply with increasingly complex taxation rules and practices. We are subject to tax in multiple U.S. tax jurisdictions and in foreign tax jurisdictions as we expand internationally. The development of our tax strategies requires additional expertise and may impact how we conduct our business. Our future effective tax rates could be unfavorably affected by changes in, or interpretations of, tax rules and regulations in the jurisdictions in which we do business, by lapses of the availability of the U.S. research and development tax credit or by changes in the valuation of our deferred tax assets and liabilities. Furthermore, we provide for certain tax liabilities that involve significant judgment. We are subject to the examination of our tax returns by federal, state and foreign tax authorities, which could focus on our intercompany transfer pricing methodology as well as other matters. The Internal Revenue Service was auditing our 2010 federal tax return at September 30, 2013. If our tax strategies are ineffective or we are not in compliance with domestic and international tax laws, our financial position, operating results and cash flows could be adversely affected.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

None.

 

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ITEM 6. EXHIBITS

 

Exhibit
Number

 

Description

 

 

 

10.1

 

Lease dated August 30, 2013 between the Company and Metropolitan Life Insurance Company.

10.2#

 

Amendment to Genomic Health, Inc. 2005 Stock Incentive Plan.

31.1

 

Rule 13a-14(a) Certification of Chief Executive Officer.

31.2

 

Rule 13a-14(a) Certification of Chief Financial Officer.

32.1##

 

Statement of Chief Executive Officer under Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. §1350).

32.2##

 

Statement of Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. §1350).

101.INS

 

XBRL Instance Document

101.SCH

 

XBRL Taxonomy Extension Schema

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase

101.LAB

 

XBRL Taxonomy Extension Label Linkbase

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase

 


#Indicates management contract or compensatory plan or arrangement.

 

##In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release No. 34-47986, the certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Exchange Act.

 

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SIGNATURES

 

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

 

 

GENOMIC HEALTH, INC.

 

 

 

Date: November 7, 2013

By:

/s/ Kimberly J. Popovits

 

 

Kimberly J. Popovits

 

 

President and Chief Executive Officer

 

 

(Principal Executive Officer)

 

 

 

Date: November 7, 2013

By:

/s/ Dean L. Schorno

 

 

Dean L. Schorno

 

 

Chief Financial Officer

 

 

(Principal Financial Officer and Principal Accounting Officer)

 

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GENOMIC HEALTH, INC.

 

EXHIBIT INDEX

 

Exhibit
Number

 

Description

 

 

 

10.1

 

Lease dated August 30, 2013 between the Company and Metropolitan Life Insurance Company.

10.2#

 

Amendment to Genomic Health, Inc. 2005 Stock Incentive Plan.

31.1

 

Rule 13a-14(a) Certification of Chief Executive Officer.

31.2

 

Rule 13a-14(a) Certification of Chief Financial Officer.

32.1##

 

Statement of Chief Executive Officer under Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. §1350).

32.2##

 

Statement of Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. §1350).

101.INS

 

XBRL Instance Document

101.SCH

 

XBRL Taxonomy Extension Schema

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase

101.LAB

 

XBRL Taxonomy Extension Label Linkbase

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase

 


#Indicates management contract or compensatory plan or arrangement.

 

##In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release No. 34-47986, the certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Exchange Act.

 

54


EX-10.1 2 a13-18745_1ex10d1.htm EX-10.1

Exhibit 10.1

 

LEASE

 

BETWEEN

 

METROPOLITAN LIFE INSURANCE COMPANY (LANDLORD)

 

AND

 

GENOMIC HEALTH, INC. (TENANT)

 

SEAPORT CENTRE

 

Redwood City, California

 



 

TABLE OF CONTENTS

 

 

 

PAGE

 

 

ARTICLE ONE - BASIC LEASE PROVISIONS

1

 

1.01 BASIC LEASE PROVISIONS

1

 

1.02 ENUMERATION OF EXHIBITS & RIDER(S)

2

 

1.03 DEFINITIONS

2

 

 

 

ARTICLE TWO - PREMISES, TERM, FAILURE TO GIVE POSSESSION, COMMON AREAS AND PARKING

6

 

2.01 LEASE OF PREMISES

6

 

2.02 TERM

6

 

2.03 FAILURE TO GIVE POSSESSION

6

 

2.04 AREA OF PREMISES

6

 

2.05 CONDITION OF PREMISES

6

 

2.06 COMMON AREAS & PARKING

6

 

 

 

ARTICLE THREE - RENT

6

 

 

ARTICLE FOUR - OPERATING EXPENSES RENT ADJUSTMENTS AND PAYMENTS

7

 

4.01 TENANT’S SHARE OF OPERATING EXPENSES

7

 

4.02 RENT ADJUSTMENTS

7

 

4.03 STATEMENT OF LANDLORD

8

 

4.04 BOOKS AND RECORDS

8

 

4.05 TENANT OR LEASE SPECIFIC TAXES

8

 

 

 

ARTICLE FIVE - SECURITY

8

 

 

ARTICLE SIX -UTILITIES & SERVICES

10

 

6.01 LANDLORD’S GENERAL SERVICES

10

 

6.02 TENANT TO OBTAIN & PAY DIRECTLY

10

 

6.03 TELEPHONE SERVICES

10

 

6.04 FAILURE OR INTERRUPTION OF UTILITY OR SERVICE

10

 

6.05 INTENTIONALLY OMITTED

11

 

6.06 SIGNAGE

11

 

 

 

ARTICLE SEVEN - POSSESSION, USE AND CONDITION OF PREMISES

11

 

7.01 POSSESSION AND USE OF PREMISES

11

 

7.02 HAZARDOUS MATERIAL

11

 

7.03 LANDLORD ACCESS TO PREMISES; APPROVALS

13

 

7.04 QUIET ENJOYMENT

13

 

 

 

ARTICLE EIGHT — MAINTENANCE & HVAC

14

 

8.01 LANDLORD’S MAINTENANCE

14

 

8.02 TENANT’S MAINTENANCE

14

 

 

 

ARTICLE NINE - ALTERATIONS AND IMPROVEMENTS

14

 

9.01 TENANT ALTERATIONS

14

 

9.02 LIENS

15

 

 

 

ARTICLE TEN - ASSIGNMENT AND SUBLETTING

15

 

10.01 ASSIGNMENT AND SUBLETTING

15

 

10.02 RECAPTURE

17

 

10.03 EXCESS RENT

17

 

10.04 TENANT LIABILITY

17

 

10.05 ASSUMPTION AND ATTORNMENT

18

 

 

 

ARTICLE ELEVEN - DEFAULT AND REMEDIES

18

 

11.01 EVENTS OF DEFAULT

18

 

11.02 LANDLORD’S REMEDIES

18

 

11.03 ATTORNEY’S FEES

20

 

11.04 BANKRUPTCY

20

 

11.05 LANDLORD’S DEFAULT

20

 

 

 

ARTICLE TWELVE - SURRENDER OF PREMISES

20

 

12.01 IN GENERAL

20

 

12.02 LANDLORD’S RIGHTS

21

 

 

 

ARTICLE THIRTEEN - HOLDING OVER

21

 



 

ARTICLE FOURTEEN - DAMAGE BY FIRE OR OTHER CASUALTY

21

 

14.01 SUBSTANTIAL UNTENANTABILITY

21

 

14.02 INSUBSTANTIAL UNTENANTABILITY

22

 

14.03 RENT ABATEMENT

22

 

14.04 WAIVER OF STATUTORY REMEDIES

22

 

 

 

ARTICLE FIFTEEN - EMINENT DOMAIN

22

 

15.01 TAKING OF WHOLE OR SUBSTANTIAL PART

22

 

15.02 TAKING OF PART

22

 

15.03 COMPENSATION

23

 

 

 

ARTICLE SIXTEEN - INSURANCE

23

 

16.01 TENANT’S INSURANCE

23

 

16.02 FORM OF POLICIES

23

 

16.03 LANDLORD’S INSURANCE

23

 

16.04 WAIVER OF SUBROGATION

23

 

16.05 NOTICE OF CASUALTY

24

 

 

 

ARTICLE SEVENTEEN - WAIVER OF CLAIMS AND INDEMNITY

24

 

17.01 WAIVER OF CLAIMS

24

 

17.02 INDEMNITY BY TENANT

24

 

17.03 WAIVER OF CONSEQUENTIAL DAMAGES

25

 

 

 

ARTICLE EIGHTEEN - RULES AND REGULATIONS

25

 

18.01 RULES

25

 

18.02 ENFORCEMENT

25

 

 

 

ARTICLE NINETEEN - LANDLORD’S RESERVED RIGHTS

25

 

 

ARTICLE TWENTY - ESTOPPEL CERTIFICATE

25

 

20.01 IN GENERAL

25

 

20.02 ENFORCEMENT

25

 

 

 

ARTICLE TWENTY-ONE — INTENTIONALLY OMITTED

26

 

 

ARTICLE TWENTY-TWO - REAL ESTATE BROKERS

26

 

 

ARTICLE TWENTY-THREE - MORTGAGEE PROTECTION

26

 

23.01 SUBORDINATION AND ATTORNMENT

26

 

23.02 MORTGAGEE PROTECTION

26

 

 

 

ARTICLE TWENTY-FOUR - NOTICES

27

 

 

ARTICLE TWENTY-FIVE - EXERCISE FACILITY

27

 

 

ARTICLE TWENTY-SIX — OFAC

27

 

 

ARTICLE TWENTY-SEVEN - MISCELLANEOUS

28

 

27.01 LATE CHARGES

28

 

27.02 NO JURY TRIAL; VENUE; JURISDICTION

28

 

27.03 DEFAULT UNDER OTHER LEASE

28

 

27.04 OPTION

28

 

27.05 TENANT AUTHORITY

28

 

27.06 ENTIRE AGREEMENT

28

 

27.07 MODIFICATION OF LEASE FOR BENEFIT OF MORTGAGEE

29

 

27.08 EXCULPATION

29

 

27.09 ACCORD AND SATISFACTION

29

 

27.10 LANDLORD’S OBLIGATIONS ON SALE OF BUILDING

29

 

27.11 BINDING EFFECT

29

 

27.12 CAPTIONS

29

 

27.13 TIME; APPLICABLE LAW; CONSTRUCTION

29

 

27.14 ABANDONMENT

29

 

27.15 LANDLORD’S RIGHT TO PERFORM TENANT’S DUTIES

29

 

27.16 SECURITY SYSTEM

30

 

27.17 NO LIGHT, AIR OR VIEW EASEMENTS

30

 

27.18 RECORDATION

30

 

27.19 SURVIVAL

30

 

27.20 EXHIBITS OR RIDERS

30

 

27.21 DISCLOSURE REGARDING CERTIFIED ACCESS SPECIALIST

30

 

27.22 UTILITY USAGE INFORMATION

30

 



 

LEASE

 

ARTICLE ONE

BASIC LEASE PROVISIONS

 

1.01                        BASIC LEASE PROVISIONS

 

In the event of any conflict between these Basic Lease Provisions and any other Lease provision, such other Lease provision shall control.

 

(1)                                 BUILDING AND ADDRESS: Building Number 8, located in Phase I (“Tenant’s Phase”) of Seaport Centre. As of the Date of Lease, the Building has a street address of 701 Galveston Drive, Redwood City, California 94063

 

(2)                                 LANDLORD AND ADDRESS:

 

Metropolitan Life Insurance Company,

a New York corporation

 

Notices to Landlord shall be addressed:

 

Metropolitan Life Insurance Company

c/o Seaport Centre Manager

701 Chesapeake Drive

Redwood City, CA 94063

 

with copies to the following:

 

Metropolitan Life Insurance Company

425 Market Street, Suite 1050

San Francisco, CA 94105

Attention: Director, EIM

 

and

 

Metropolitan Life Insurance Company

425 Market Street, Suite 1050

San Francisco, CA 94105

Attention: Associate General Counsel

 

(3)                                 TENANT; CURRENT ADDRESS & TAX ID:

 

(a)

Name:

Genomic Health, Inc. (“Genomic Health”)

(b)

State of incorporation:

a Delaware corporation

(c)

Tax Identification Number:

77-0552594

Tenant shall notify Landlord of any change in the foregoing.

 

Notices to Tenant shall be addressed:

 

Genomic Health, Inc.

301 Penobscot Drive

Redwood City, CA 94063

Attention: Chief Financial Officer

 

(4)                                 DATE OF LEASE: as of August 30, 2013

 

(5)                                 LEASE TERM: From the Commencement Date until March 31, 2019

 

(6)                                 COMMENCEMENT DATE: The date which is the earlier to occur of (i) the date Tenant commences its business operations in the Premises, or (ii) one hundred twenty (120) days after the Delivery Date.

 

(7)                                 EXPIRATION DATE: March 31, 2019

 

(8)                                 MONTHLY BASE RENT (initial monthly installment due upon Tenant’s execution):

 

Period from/to

 

Monthly

 

 

 

 

 

 

Months 01 — 12*

 

$

41,433.75

 

Months 13 — 24

 

$

42,676.76

 

Months 25 — 36

 

$

43,957.07

 

Months 37 — 48

 

$

45,275.78

 

Months 49 — 60

 

$

46,634.05

 

Months 61 —March 31, 2019

 

$

48,033.07

 

 

1



 

(9)                                 RENT ADJUSTMENT DEPOSIT: The Rent Adjustment Deposit (at the initial monthly rate, until further notice) shall be Nine Thousand Seven Hundred Fifty-Nine and 95/100 Dollars ($9,759.95) and is due upon Tenant’s execution.

 

(10)                          RENTABLE AREA OF THE PREMISES:                18,415 square feet

 

(11)                          RENTABLE AREA OF THE BUILDING                    23,880 square feet

 

(12)                          RENTABLE AREA OF THE PHASE:                                      301,852 square feet

 

(13)                          RENTABLE AREA OF THE PROJECT:                        537,444 square feet

 

(14)                          SECURITY: The cash and/or Letter of Credit in the amount of One Hundred Forty-Four Thousand Ninety-Nine Dollars ($144,099.00) (and any proceeds of the Letter of Credit drawn and held by Landlord) as provided in Article Five.

 

(15)                          SUITE NUMBER &/OR ADDRESS OF PREMISES: 701 Galveston Drive, Redwood City, CA 94063

 

(16)                          TENANT’S SHARE:

 

Tenant’s Building Share:

 

77.11

%

Tenant’s Phase Share:

 

6.10

%

Tenant’s Project Share:

 

3.43

%

 

(17)                          TENANT’S USE OF PREMISES: General office use; biotechnology/pharmaceutical research and development, assembly, biotechnical or pharmaceutical manufacturing, and warehousing.

 

(18)                          PARKING SPACES:

 

60

 

 

 

(19)                          BROKERS:

 

Landlord’s Broker:                                         Cornish & Carey Commercial

 

Tenant’s Broker:                                                    GVA Kidder Mathews

 

1.02                        ENUMERATION OF EXHIBITS & RIDER(S)

 

The Exhibits and Rider(s) set forth below and attached to this Lease are incorporated in this Lease by this reference:

 

EXHIBIT A

Plan of Premises

EXHIBIT B

Workletter Agreement

EXHIBIT C

Site Plan of Project

EXHIBIT D

Permitted Hazardous Material

EXHIBIT E

Form of Letter of Credit Acceptable from Silicon Valley Bank

EXHIBIT F

Fair Market Rental Rate

EXHIBIT G

Tenant’s Personal Property

EXHIBIT H 

Form of Letter of Credit

 

 

RIDER 1

Commencement Date Agreement

RIDER 2

Additional Provisions

 

1.03                        DEFINITIONS

 

For purposes hereof, the following terms shall have the following meanings:

 

ADJUSTMENT YEAR: The applicable calendar year or any portion thereof after the Commencement Date of this Lease for which a Rent Adjustment computation is being made.

 

AFFILIATE: Any Person (as defined below) which is controlled by, controls, or is under common control with Tenant. The word Person means an individual, partnership, trust, corporation, limited liability company, firm or other entity. For purposes of this definition, the word “control,” means, with respect to a Person that is a corporation or a limited liability company, the right to exercise, directly or indirectly, more than sixty percent (60%) of the voting rights attributable to the shares or membership interests of the controlled Person and, with respect to a Person that is not a corporation, the possession, directly or indirectly, of the power at all times to direct or cause the direction of the management of the controlled Person.

 

BUILDING: Each building in which the Premises is located, as specified in Section 1.01(1).

 

BUILDING OPERATING EXPENSES: Those Operating Expenses described in Section 4.01.

 

COMMENCEMENT DATE: The date specified in Section 1.01(6).

 

COMMON AREAS: All areas of the Project made available by Landlord from time to time for the general common use or benefit of the tenants of the Building or Project, and their employees and invitees, or the public, as such areas currently exist and as they may be changed from time to time.

 

2



 

DECORATION: Tenant Alterations which do not require a building permit and which do not affect the facade or roof of the Building, or involve any of the structural elements of the Building, or involve any of the Building’s systems, including its electrical, mechanical, plumbing, security, heating, ventilating, air-conditioning, communication, and fire and life safety systems.

 

DEFAULT RATE: Two (2) percentage points above the rate then most recently announced by Bank of America N.T.& S.A. at its San Francisco main office as its corporate base lending rate, from time to time announced, but in no event higher than the maximum rate permitted by Law.

 

DELIVERY DATE: The date for Landlord’s delivery to Tenant of possession of the Premises, if different from the Commencement Date, as provided in Rider 2.

 

ENVIRONMENTAL LAWS: All Laws governing the use, storage, disposal or generation of any Hazardous Material or pertaining to environmental conditions on, under or about the Premises or any part of the Project, including the Comprehensive Environmental Response Compensation and Liability Act of 1980, as amended (42 U.S.C. Section 9601 et seq.), and the Resource Conservation and Recovery Act of 1976, as amended (42 U.S.C. Section 6901 et seq.).

 

EXPIRATION DATE: The date specified in Section 1.01(7) unless changed by operation of Article Two or Rider 2.

 

FORCE MAJEURE: Any accident, casualty, act of God, war or civil commotion, strike or labor troubles, or any cause whatsoever beyond the reasonable control of Landlord, including water shortages, energy shortages or governmental preemption in connection with an act of God, a national emergency, or by reason of Law, or by reason of the conditions of supply and demand which have been or are affected by act of God, war or other emergency.

 

HAZARDOUS MATERIAL: Such substances, material and wastes which are or become regulated under any Environmental Law; or which are classified as hazardous or toxic or medical waste or biohazardous waste under any Environmental Law; and explosives, firearms and ammunition, flammable material, radioactive material, asbestos, polychlorinated biphenyls and petroleum and its byproducts.

 

INDEMNITEES: Collectively, Landlord, any Mortgagee or ground lessor of the Property, the property manager and the leasing manager for the Property and their respective directors, officers, agents and employees.

 

LAND: The parcel(s) of real estate on which the Building and Project are located.

 

LANDLORD WORK: The construction or installation of improvements to be furnished by Landlord, if any, specifically described in Rider 2 attached hereto.

 

LAWS OR LAW: All laws, ordinances, rules, regulations, other requirements, orders, rulings or decisions adopted or made by any governmental body, agency, department or judicial authority having jurisdiction over the Property, the Premises or Tenant’s activities at the Premises and any covenants, conditions or restrictions of record which affect the Property.

 

LEASE: This instrument and all exhibits and riders attached hereto, as may be amended from time to time.

 

LEASE YEAR: The twelve month period beginning on the first day of the first month following the Commencement Date (unless the Commencement Date is the first day of a calendar month in which case beginning on the Commencement Date), and each subsequent twelve month, or shorter, period until the Expiration Date.

 

MONTHLY BASE RENT: The monthly rent specified in Section 1.01(8).

 

MORTGAGEE: Any holder of a mortgage, deed of trust or other security instrument encumbering the Property.

 

NATIONAL HOLIDAYS: New Year’s Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day and Christmas Day and other holidays recognized by the Landlord and the janitorial and other unions servicing the Building in accordance with their contracts.

 

OPERATING EXPENSES: All Taxes, costs, expenses and disbursements of every kind and nature which Landlord shall pay or become obligated to pay in connection with the ownership, management, operation, maintenance, replacement and repair of the Property (including the amortized portion of any capital expenditure or improvement, together with interest thereon, expenses of changing utility service providers, and any dues, assessments and other expenses pursuant to any covenants, conditions and restrictions, or any reciprocal easements, or any owner’s association now or hereafter affecting the Project; provided however that with respect to any expenses, dues, assessments and other expenses pursuant to any covenants, conditions and restrictions, or any reciprocal easements, or any owner’s association hereafter affecting the Project, then such costs and expenses shall only be deemed to be Operating Expenses to the extent that such costs or expenses could otherwise be deemed to be Operating Expenses pursuant to the provisions set forth in this section). Operating Expenses shall be allocated among the categories of Project Operating Expenses, Building Operating Expenses or Phase Operating Expenses as provided in Article Four. If any Operating Expense relates to more than one calendar year, such expense shall be proportionately allocated among such related calendar years. Operating Expenses shall include the following, by way of illustration only and not limitation: (1) all Taxes; (2) all insurance premiums and other costs (including deductibles), including the cost of rental insurance; (3) all license, permit and inspection fees; (4) all costs of utilities, fuels and related services, including water, sewer, light, telephone, power and steam connection, service and related charges; (5) all costs to repair, maintain and operate heating, ventilating and air conditioning systems, including preventive maintenance incurred by Landlord, if any;

 

3



 

(6) all janitorial, landscaping and security services; (7) all wages, salaries, payroll taxes, fringe benefits and other labor costs, including the cost of workers’ compensation and disability insurance; (8) all costs of operation, maintenance and repair of all parking facilities and other common areas; (9) all supplies, materials, equipment and tools; (10) dues, assessments and other expenses pursuant to any covenants, conditions and restrictions, or any reciprocal easements, or any owner’s association now or hereafter affecting the Project; (11) modifications to the Building or the Project occasioned by Laws now or hereafter in effect, but only as amortized over the useful life of the capital item as reasonably determined by Landlord; (12) the total charges of any independent contractors employed in the care, operation, maintenance, repair, leasing and cleaning of the Project, including landscaping, roof maintenance, and repair, maintenance and monitoring of life-safety systems, plumbing systems, electrical wiring and Project signage; (13) the cost of accounting services necessary to compute the rents and charges payable by tenants at the Project; (14) exterior window and exterior wall cleaning and painting; (15) managerial and administrative expenses; (16) all costs in connection with the exercise facility at the Project; (17) all costs and expenses related to Landlord’s retention of consultants in connection with the routine review, inspection, testing, monitoring, analysis and control of Hazardous Material, and retention of consultants in connection with the clean-up of Hazardous Material (to the extent not recoverable from a particular tenant of the Project), and all costs and expenses related to the implementation of recommendations made by such consultants concerning the use, generation, storage, manufacture, production, storage, release, discharge, disposal or clean-up of Hazardous Material on, under or about the Premises or the Project (to the extent not recoverable from a particular tenant of the Project); (18) all capital improvements made for the purpose of reducing or controlling other Operating Expenses, and all other capital expenditures, but only as amortized over the useful life of such capital improvement as reasonably determined by Landlord, together with interest on the unamortized portion; (19) all property management costs and fees, including all costs in connection with the Project property management office; and (20) all fees or other charges incurred in conjunction with voluntary or involuntary membership in any energy conservation, air quality, environmental, traffic management or similar organizations. Operating Expenses shall not include: (a) costs of alterations of space to be occupied by new or existing tenants of the Project; (b) depreciation charges; (c) interest and principal payments on loans (except for loans for capital expenditures or improvements which Landlord is allowed to include in Operating Expenses as provided above); (d) ground rental payments; (e) real estate brokerage and leasing commissions; (f) advertising and marketing expenses; (g) costs of Landlord reimbursed by insurance proceeds; (h) costs for which the Landlord is reimbursed by any other tenant or occupant of the Building (other than payments comparable to Rent Adjustments hereunder) or by any tenant’s insurance carrier or by anyone else, and electric power costs for which any tenant directly contracts with the local public service company; (i) expenses incurred in negotiating leases of other tenants in the Project or enforcing lease obligations of other tenants in the Project; (j) Landlord’s property manager’s corporate general overhead or corporate general administrative expenses; (k) the wages and benefits of any employee who does not devote substantially all of his or her employed time to the Building, Project or Phase, unless such wages and benefits are prorated to reflect time spent on operation and managing the Building, Project or Phase; (l) Landlord’s corporate general overhead or corporate general administrative expenses associated with the operation of the business of the entity which constitutes the Landlord, as the same are distinguished from the costs of operation of the Building, Project or Phase; (m) executives’ salaries; (n) any bad debt loss, rent loss, or reserves for bad debts or rent loss; (o) costs of Landlord’s charitable or political contributions; (p) the costs of any Tenant Work (as defined in the Workletter), and (q) costs incurred in connection with Hazardous Materials to the extent such Hazardous Materials were present on the Project prior to the Delivery Date.

 

PHASE: Phase means any individual Phase of the Project, as more particularly described in the definition of Project.

 

PHASE OPERATING EXPENSES: Those Operating Expenses described in Section 4.01.

 

PREMISES: The Premises consists of the portion of the Building consisting of 18,415 square feet of Rentable Area as depicted on Exhibit A attached hereto.

 

PROJECT or PROPERTY: As of the date hereof, the Project is known as Seaport Centre and consists of those buildings (including the Building) whose general location is shown on the Site Plan of the Project attached as Exhibit C, located in Redwood City, California, associated vehicular and parking areas, landscaping and improvements, together with the Land, any associated interests in real property, and the personal property, fixtures, machinery, equipment, systems and apparatus located in or used in conjunction with any of the foregoing. The Project may also be referred to as the Property. As of the date hereof, the Project is divided into Phase I and Phase II, which are generally designated on Exhibit C, each of which may individually be referred to as a Phase. Landlord reserves the right from time to time to add or remove buildings, areas and improvements to or from a Phase or the Project, or to add or remove a Phase to or from the Project. In the event of any such addition or removal which affects Rentable Area of the Project or a Phase, Landlord shall make a corresponding recalculation and adjustment of any affected Rentable Area and Tenant’s Share.

 

PROJECT OPERATING EXPENSES: Those Operating Expenses described in Section 4.01.

 

REAL PROPERTY: The Property excluding any personal property.

 

RENT: Collectively, Monthly Base Rent, Rent Adjustments and Rent Adjustment Deposits, and all other charges, payments, late fees or other amounts required to be paid by Tenant under this Lease.

 

RENT ADJUSTMENT: Any amounts owed by Tenant for payment of Operating Expenses. The Rent Adjustments shall be determined and paid as provided in Article Four.

 

RENT ADJUSTMENT DEPOSIT: An amount equal to Landlord’s estimate of the Rent Adjustment attributable to each month of the applicable Adjustment Year. On or before the Commencement Date and the beginning of each subsequent Adjustment Year or with Landlord’s Statement (defined in Article Four), Landlord may estimate and notify Tenant in writing of its estimate of Operating Expenses, including Project Operating Expenses, Building Operating Expenses and Phase Operating Expenses, and Tenant’s Share of each, for the applicable Adjustment Year. The Rent

 

4



 

Adjustment Deposit applicable for the calendar year in which the Commencement Date occurs shall be the amount, if any, specified in Section 1.01(9). Nothing contained herein shall be construed to limit the right of Landlord from time to time during any calendar year to revise its estimates of Operating Expenses and to notify Tenant in writing thereof and of revision by prospective adjustments in Tenant’s Rent Adjustment Deposit payable over the remainder of such year. The last estimate by Landlord shall remain in effect as the applicable Rent Adjustment Deposit unless and until Landlord notifies Tenant in writing of a change.

 

RENTABLE AREA OF THE BUILDING: The amount of square footage set forth in Section 1.01(11)

 

RENTABLE AREA OF THE PHASE: The amount of square footage set forth in Section 1.01(12)

 

RENTABLE AREA OF THE PREMISES: The amount of square footage set forth in Section 1.01(10).

 

RENTABLE AREA OF THE PROJECT: The amount of square footage set forth in Section 1.01(13), which represents the sum of the rentable area of all space intended for occupancy in the Project.

 

SECURITY: The cash and/or Letter of Credit specified in Section 1.01, if any, paid or delivered to Landlord as security for Tenant’s performance of its obligations under this Lease, and any proceeds of the Letter of Credit drawn and held by Landlord, all as more particularly provided in Article Five.

 

SUBSTANTIALLY COMPLETE: The completion of the Landlord Work or Tenant Work, as the case may be, except for minor insubstantial details of construction, decoration or mechanical adjustments which remain to be done.

 

TAXES: All federal, state and local governmental taxes, assessments (including assessment bonds) and charges of every kind or nature, whether general, special, ordinary or extraordinary, which Landlord shall pay or become obligated to pay because of or in connection with the ownership, leasing, management, control or operation of the Property or any of its components (including any personal property used in connection therewith), which may also include any rental or similar taxes levied in lieu of or in addition to general real and/or personal property taxes. For purposes hereof, Taxes for any year shall be Taxes which are assessed for any period of such year, whether or not such Taxes are billed and payable in a subsequent calendar year. There shall be included in Taxes for any year the amount of all fees, costs and expenses (including reasonable attorneys’ fees) paid by Landlord during such year in seeking or obtaining any refund or reduction of Taxes. Taxes for any year shall be reduced by the net amount of any tax refund received by Landlord attributable to such year. If a special assessment payable in installments is levied against any part of the Property, Taxes for any year shall include only the installment of such assessment and any interest payable or paid during such year. Taxes shall not include any federal or state inheritance, general income, gift or estate taxes, except that if a change occurs in the method of taxation resulting in whole or in part in the substitution of any such taxes, or any other assessment, for any Taxes as above defined, such substituted taxes or assessments shall be included in the Taxes.

 

TENANT ADDITIONS: Collectively, Landlord Work, Tenant Work and Tenant Alterations. Tenant’s Personal Property (as set forth in Exhibit G hereto) shall not be deemed to be included in the definition of Tenant Additions.

 

TENANT ALTERATIONS: Any alterations, improvements, additions, installations or construction in or to the Premises or any Real Property systems serving the Premises done or caused to be done by Tenant after the date hereof, whether prior to or after the Commencement Date (including Tenant Work, but excluding Landlord Work).

 

TENANT DELAY: Any event or occurrence which delays the Substantial Completion of the Landlord Work which is caused by or is described as follows:

 

(i)             special work, changes, alterations or additions requested or made by Tenant in the design or finish in any part of the Premises after approval of the plans and specifications (as described in the Rider 2);

 

(ii)          Tenant’s delay in submitting plans, supplying information, approving plans, specifications or estimates, giving authorizations or otherwise;

 

(iii)       failure to approve and pay for such work as Landlord undertakes to complete at Tenant’s expense;

 

(iv)      the performance or completion by Tenant or any person engaged by Tenant of any work in or about the Premises; or

 

(v)         failure to perform or comply with any obligation or condition binding upon Tenant pursuant to Rider 2, including the failure to approve and pay for such Landlord Work or other items if and to the extent Rider 2 provides they are to be approved or paid by Tenant.

 

TENANT’S FF&E: The property of Tenant described in Section 5 of the Workletter.

 

TENANT’S PERSONAL PROPERTY: Tenant’s property described on Exhibit G hereto.

 

TENANT WORK: All work installed or furnished to the Premises by Tenant in connection with Tenant’s initial occupancy pursuant to Rider 2 and the Workletter.

 

TENANT’S BUILDING SHARE: The share as specified in Section 1.01(16) and Section 4.01.

 

TENANT’S PHASE: The Phase in which the Premises is located, as indicated in Section 1.01(1).

 

5



 

TENANT’S PHASE SHARE: The share as specified in Section 1.01(16) and Section 4.01.

 

TENANT’S PROJECT SHARE: The share as specified in Section 1.01(16) and Section 4.01.

 

TENANT’S SHARE: Shall mean collectively, Tenant’s respective shares of the respective categories of Operating Expenses, as provided in Section 1.01(16) and Section 4.01.

 

TERM: The term of this Lease commencing on the Commencement Date and expiring on the Expiration Date.

 

TERMINATION DATE: The Expiration Date or such earlier date as this Lease terminates or Tenant’s right to possession of the Premises terminates.

 

WORKLETTER: The Agreement regarding the completion of Tenant Work and Landlord Work, if any, set forth in Rider 2 and Exhibit B hereto.

 

ARTICLE TWO

PREMISES, TERM, FAILURE TO GIVE POSSESSION, COMMON AREAS AND PARKING

 

2.01                        LEASE OF PREMISES

 

Landlord hereby leases to Tenant and Tenant hereby leases from Landlord the Premises for the Term and upon the terms, covenants and conditions provided in this Lease.

 

2.02                        TERM (See Rider 2)

 

2.03                        FAILURE TO GIVE POSSESSION (See Rider 2)

 

2.04                        AREA OF PREMISES

 

Landlord and Tenant agree that for all purposes of this Lease the Rentable Area of the Premises, the Rentable Area of the Building, the Rentable Area of the Phase and the Rentable Area of the Project as set forth in Article One are controlling, and are not subject to revision after the date of this Lease, except as otherwise provided herein.

 

2.05                        CONDITION OF PREMISES (See Rider 2)

 

2.06                        COMMON AREAS & PARKING

 

(a)                                 Right to Use Common Areas. Tenant shall have the non-exclusive right, in common with others, to the use of any common entrances, ramps, drives and similar access and serviceways and other Common Areas in the Project. The rights of Tenant hereunder in and to the Common Areas shall at all times be subject to the rights of Landlord and other tenants and owners in the Project who use the same in common with Tenant, and it shall be the duty of Tenant to keep all the Common Areas free and clear of any obstructions created or permitted by Tenant or resulting from Tenant’s operations. Tenant shall not use the Common Areas or common facilities of the Building or the Project, including the Building’s electrical room, parking lot or trash enclosures, for storage purposes. Nothing herein shall affect the right of Landlord at any time to remove any persons not authorized to use the Common Areas or common facilities from such areas or facilities or to prevent their use by unauthorized persons.

 

(b)                                 Changes in Common Areas. Landlord reserves the right, at any time and from time to time to (i) make alterations in or additions to the Common Areas or common facilities of the Project, including constructing new buildings or changing the location, size, shape or number of the driveways, entrances, parking spaces, parking areas, loading and unloading areas, landscape areas and walkways, (ii) designate property to be included in or eliminate property from the Common Areas or common facilities of the Project, (iii) close temporarily any of the Common Areas or common facilities of the Project for maintenance purposes, and (iv) use the Common Areas and common facilities of the Project while engaged in making alterations in or additions and repairs to the Project; provided, however, that (x) such changes do not materially adversely affect Tenant’s use of the Premises or increase Tenant’s costs hereunder, and (y) reasonable access to the Premises and parking at or near the Project remains available.

 

(c)                                  Parking. During the Term, Tenant shall have the right to use the number of Parking Spaces specified in Section 1.01(18) for parking on an unassigned basis on that portion of the Project designated by Landlord from time to time for parking. Tenant acknowledges and agrees that the parking spaces in the Project’s parking facility may include a mixture of spaces for compact vehicles as well as full-size passenger automobiles, and that Tenant shall not use parking spaces for vehicles larger than the striped size of the parking spaces. Tenant shall comply with any and all parking rules and regulations if and as from time to time established by Landlord. Tenant shall not allow any vehicles using Tenant’s parking privileges to be parked, loaded or unloaded except in accordance with this Section, including in the areas and in the manner designated by Landlord for such activities. If any vehicle owned or operated by Tenant or any Tenant Parties (as defined in Article Seven) is using the parking or loading areas contrary to any provision of this Section, Landlord shall have the right, in addition to all other rights and remedies of Landlord under this Lease, to remove or tow away the vehicle without prior notice to Tenant, and the cost thereof shall be paid to Landlord within ten (10) business days after notice from Landlord to Tenant.

 

ARTICLE THREE

RENT

 

Tenant agrees to pay to Landlord via wire transfer in accordance with instructions set forth below (as modified by Landlord from time to time), or to such other persons, or at such other places or in such manner designated by

 

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Landlord, without any prior demand therefor in immediately available funds and without any deduction or offset whatsoever, Rent, including Monthly Base Rent and Rent Adjustments in accordance with Article Four, during the Term. Monthly Base Rent shall be paid monthly in advance on the first day of each month of the Term, except that the first installment of Monthly Base Rent shall be paid by Tenant to Landlord concurrently with execution of this Lease by means of Tenant’s check payable to the order of Metropolitan Life Insurance Company. Monthly Base Rent shall be prorated for partial months within the Term. Unpaid Rent shall bear interest at the Default Rate from the date due until paid. Tenant’s covenant to pay Rent shall be independent of every other covenant in this Lease. Until further notice to Tenant, Rent paid by wire transfer shall be wired to:

 

Bank: JP Morgan Chase Bank, N.A.

Address: PO Box 659754 San Antonio, TX 78265-9754

Account Name: MLIC Seaport Centre II CBRE

Account number: 9132219065

ACH ABA #: 021000021

 

ARTICLE FOUR

OPERATING EXPENSES, RENT ADJUSTMENTS AND PAYMENTS

 

4.01                        TENANT’S SHARE OF OPERATING EXPENSES

 

Tenant shall pay Tenant’s Share of Operating Expenses in the respective shares of the respective categories of Operating Expenses as set forth below.

 

(a)         Tenant’s Project Share of Project Operating Expenses, which is the percentage obtained by dividing the rentable square footage of the Premises by the rentable square footage of the Project and as of the date hereof equals the percentage set forth in Section 1.01(16);

 

(b)         Tenant’s Building Share of Building Operating Expenses, which is the percentage obtained by dividing the rentable square footage of the Premises respectively for each building in which the Premises is located by the total rentable square footage of such building and as of the date hereof equals the percentage set forth in Section 1.01(16);

 

(c)          Tenant’s Phase Share of Phase Operating Expenses, which is the percentage obtained by dividing the aggregate rentable square footage of the Premises by the total rentable square footage of Tenant’s Phase and as of the date hereof equals the percentage set forth in Section 1.01(16);

 

(d)         Project Operating Expenses shall mean all Operating Expenses that are not included as Phase Operating Expenses (defined below) and that are not either Building Operating Expenses or operating expenses directly and separately identifiable to the operation, maintenance or repair of any other building located in the Project, but Project Operating Expenses includes operating expenses allocable to any areas of the Building or any other building during such time as such areas are made available by Landlord for the general common use or benefit of all tenants of the Project, and their employees and invitees, or the public, as such areas currently exist and as they may be changed from time to time;

 

(e)          Building Operating Expenses shall mean Operating Expenses that are directly and separately identifiable to each building in which the Premises or part thereof is located;

 

(f)           Phase Operating Expenses shall mean Operating Expenses that Landlord may allocate to a Phase as directly and separately identifiable to all buildings located in the Phase (including but not limited to the Building) and may include Project Operating Expenses that are separately identifiable to a Phase;

 

(g)          Landlord shall have the right to allocate a particular item or portion of Operating Expenses as any one of Project Operating Expenses, Building Operating Expenses or Phase Operating Expenses; however, in no event shall any portion of Building Operating Expenses, Project Operating Expenses or Phase Operating Expenses be assessed or counted against Tenant more than once; and.

 

(h)         Notwithstanding anything to the contrary contained in this Section 4.01, as to each specific category of Operating Expense which one or more tenants of the Building either pays directly to third parties or specifically reimburses to Landlord (for example, separately contracted janitorial services or property taxes directly reimbursed to Landlord), then, on a category by category basis, the amount of Operating Expenses for the affected period shall be adjusted as follows: (1) all such tenant payments with respect to such category of expense and all of Landlord’s costs reimbursed thereby shall be excluded from Operating Expenses and Tenant’s Building Share, Tenant’s Phase Share or Tenant’s Project Share, as the case may be, for such category of Operating Expense shall be adjusted by excluding the square footage of all such tenants, and (2) if Tenant pays or directly reimburses Landlord for such category of Operating Expense, such category of Operating Expense shall be excluded from the determination of Operating Expenses for the purposes of this Lease.

 

4.02                        RENT ADJUSTMENTS

 

Tenant shall pay to Landlord Rent Adjustments with respect to each Adjustment Year as follows:

 

(a)         The Rent Adjustment Deposit shall be paid monthly during the Term with the payment of Monthly Base Rent, except the first installment which shall be paid by Tenant to Landlord concurrently with execution of this Lease. The Rent Adjustment Deposit represents, on a monthly basis, Tenant’s Share of Landlord’s

 

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estimate of Operating Expenses, as described in Section 4.01, for the applicable Adjustment Year (or portion thereof); and

 

(b)         Any Rent Adjustments due in excess of the Rent Adjustment Deposits in accordance with Section 4.03.

 

4.03                        STATEMENT OF LANDLORD

 

Within one hundred twenty (120) days after the end of each calendar year or as soon thereafter as reasonably possible, Landlord will furnish Tenant a statement (“Landlord’s Statement”) showing the following:

 

(a)         Operating Expenses for the last Adjustment Year showing in reasonable detail the actual Operating Expenses categorized among Project Operating Expenses, Building Operating Expenses and Phase Operating Expenses for such period and Tenant’s Share of each as described in Section 4.01 above;

 

(b)         The amount of Rent Adjustments due Landlord for the last Adjustment Year, less credit for Rent Adjustment Deposits paid, if any; and

 

(c)          Any change in the Rent Adjustment Deposit due monthly in the current Adjustment Year, including the amount or revised amount due for months preceding any such change pursuant to Landlord’s Statement.

 

Tenant shall pay to Landlord within ten (10) days after receipt of such statement any amounts for Rent Adjustments then due in accordance with Landlord’s Statement. Any amounts due from Landlord to Tenant pursuant to this Section shall be credited to the Rent Adjustment Deposit next coming due, or refunded to Tenant if the Term has already expired provided Tenant is not in default hereunder. No interest or penalties shall accrue on any amounts which Landlord is obligated to credit or refund to Tenant by reason of this Section 4.03. Landlord’s failure to deliver Landlord’s Statement or to compute the amount of the Rent Adjustments shall not constitute a waiver by Landlord of its right to deliver such items nor constitute a waiver or release of Tenant’s obligations to pay such amounts. The Rent Adjustment Deposit shall be credited against Rent Adjustments due for the applicable Adjustment Year. During the last complete calendar year or during any partial calendar year in which the Lease terminates, Landlord may include in the Rent Adjustment Deposit its estimate of Rent Adjustments which may not be finally determined until after the termination of this Lease. Tenant’s obligation to pay Rent Adjustments survives the expiration or termination of the Lease. Notwithstanding the foregoing, in no event shall the sum of Monthly Base Rent and the Rent Adjustments be less than the Monthly Base Rent payable.

 

4.04                        BOOKS AND RECORDS

 

Landlord shall maintain books and records showing Operating Expenses and Taxes in accordance with sound accounting and management practices, consistently applied. The Tenant or its representative (which representative shall be a certified public accountant licensed to do business in the state in which the Property is located and whose primary business is certified public accounting) shall have the right, for a period of thirty (30) days following the date upon which Landlord’s Statement is delivered to Tenant, to examine the Landlord’s books and records with respect to the items in the foregoing statement of Operating Expenses and Taxes during normal business hours, upon written notice, delivered at least three (3) business days in advance. If Tenant does not object in writing to Landlord’s Statement within sixty (60) days of Tenant’s receipt thereof, specifying the nature of the item in dispute and the reasons therefor, then Landlord’s Statement shall be considered final and accepted by Tenant. Any amount due to the Landlord as shown on Landlord’s Statement, whether or not disputed by Tenant as provided herein shall be paid by Tenant when due as provided above, without prejudice to any such written exception.

 

4.05                        TENANT OR LEASE SPECIFIC TAXES

 

In addition to Monthly Base Rent, Rent Adjustments, Rent Adjustment Deposits and other charges to be paid by Tenant, Tenant shall pay to Landlord, upon demand, any and all taxes payable by Landlord (other than federal or state inheritance, general income, gift or estate taxes) whether or not now customary or within the contemplation of the parties hereto: (a) upon, allocable to, or measured by the Rent payable hereunder, including any gross receipts tax or excise tax levied by any governmental or taxing body with respect to the receipt of such rent; or (b) upon or with respect to the possession, leasing, operation, management, maintenance, alteration, repair, use or occupancy by Tenant of the Premises or any portion thereof; or (c) upon the measured value of Tenant’s personal property or trade fixtures located in the Premises or in any storeroom or any other place in the Premises or the Property, or the areas used in connection with the operation of the Property, it being the intention of Landlord and Tenant that, to the extent possible, Tenant shall cause such taxes on personal property or trade fixtures to be billed to and paid directly by Tenant; (d) resulting from Landlord Work, Tenant Work or Tenant Alterations to the Premises, whether title thereto is in Landlord or Tenant; or (e) upon this transaction. Taxes paid by Tenant pursuant to this Section 4.05 shall not be included in any computation of Taxes as part of Operating Expenses.

 

ARTICLE FIVE

SECURITY

 

(a)                                 Tenant, at Tenant’s sole cost and expense, concurrently with execution of this Lease, shall either (1) pay Landlord in cash or immediately available funds or (2) provide Landlord the Letter of Credit (defined below) as more particularly described below, in each case in the amount of the Security specified in Section 1.01 as security (“Security”) for the full and faithful performance by Tenant of each and every term, provision, covenant, and condition of this Lease. If Tenant fails timely to perform any of the terms, provisions, covenants and conditions of this Lease or any other document executed by Tenant in connection with this Lease, including, but not limited to, the payment of the Monthly Base Rent, Rent Adjustment Deposits, Rent Adjustments or the repair of damage to the Premises caused by

 

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Tenant (excluding normal wear and tear), then Landlord may use, apply, or retain the whole or any part of the Security for the payment of any such Monthly Base Rent, Rent Adjustment Deposits or Rent Adjustments not paid when due, for the cost of repairing such damage, for the cost of cleaning the Premises, for the payment of any other sum which Landlord may expend or may be required to expend by reason of Tenant’s failure to perform, and otherwise for compensation of Landlord for any other loss or damage to Landlord occasioned by Tenant’s failure to perform, including, but not limited to, any loss of future Rent and any damage or deficiency in the reletting of the Premises (whether such loss, damages or deficiency accrue before or after summary proceedings or other reentry by Landlord) and the amount of the unpaid past Rent, future Rent loss, and all other losses, costs and damages, that Landlord would be entitled to recover if Landlord were to pursue recovery under California Civil Code Section 1951.2 or 1951.4. If Landlord so uses, applies or retains all or part of the Security, Tenant shall within five (5) business days after demand pay or deliver to Landlord in immediately available funds the sum necessary to replace the amount used, applied or retained, except as specified in (e) below. If Tenant has fully and faithfully performed and observed all of Tenant’s obligations under the terms, provisions, covenants and conditions of this Lease, the Security (except any amount retained for application by Landlord as provided herein) shall be returned or paid over to Tenant no later than ninety (90) days after the latest of: (i) the Termination Date; (ii) the removal of Tenant from the Premises; or (iii) the surrender of the Premises by Tenant to Landlord in accordance with this Lease. Provided, however, in no event shall any such return be construed as an admission by Landlord that Tenant has performed all of its obligations hereunder.

 

(b)                                 The Security, whether in the form of cash, Letter of Credit (defined below) and/or Letter of Credit Proceeds (defined below), shall not be deemed an advance rent deposit or an advance payment of any kind, or a measure of Landlord’s damages with respect to Tenant’s failure to perform, nor shall any action or inaction of Landlord with respect to it or its use or application be a waiver of, or bar or defense to, enforcement of any right or remedy of Landlord. Landlord shall not be required to keep the Security separate from its general funds and shall not have any fiduciary duties or other duties (except as set forth in this Section) concerning the Security. Tenant shall not be entitled to any interest on the Security. In the event of any sale, lease or transfer of Landlord’s interest in the Building, Landlord shall have the right to transfer the Security, or balance thereof, to the vendee, transferee or lessee and any such transfer shall release Landlord from all liability for the return of the Security. Tenant thereafter shall look solely to such vendee, transferee or lessee for the return or payment of the Security. Tenant shall not assign or encumber or attempt to assign or encumber the Security or any interest in it and Landlord shall not be bound by any such assignment, encumbrance, attempted assignment or attempted encumbrance, and regardless of one or more assignments of this Lease, Landlord may return the Security to the original Tenant without liability to any assignee. Tenant hereby waives any and all rights of Tenant under the provisions of Section 1950.7 of the California Civil Code, and any and all rights of Tenant under all other provisions of law, now or hereafter enacted, regarding security deposits.

 

(c)                                  If Tenant fails timely to perform any obligation under this Article Five, such breach shall constitute a Default by Tenant under this Lease without any right to or requirement of any further notice or cure period under any other Article of this Lease, except such notice and cure period expressly provided under this Article Five.

 

(d)                                 During the first six months after the date on which this Lease has been executed by both Tenant and Landlord, Tenant shall have the right, at Tenant’s sole cost and expense, to provide Landlord with the Letter of Credit (defined below) as the Security required under this Lease in substitution for the cash then held by Landlord as Security. In the event that Tenant first delivered the Security in the form of cash or immediately available funds prior to delivering the Letter of Credit, then, within thirty (30) days after Tenant’s delivery to Landlord of the Letter of Credit, Landlord shall refund to Tenant the amount of cash held by Landlord as Security, less any amounts thereof used, applied or retained by Landlord pursuant to the provisions of Subsection (a) and not replenished by Tenant.

 

(e)                                  As used herein, “Letter of Credit” shall mean an unconditional, irrevocable sight draft letter of credit issued, presentable and payable at the San Francisco, California or San Jose, California office of a major national bank satisfactory to Landlord in its sole discretion (the “Bank”), naming Landlord as beneficiary, in the amount specified in Section 1.01(14) above. The Letter of Credit shall provide: (i) that Landlord may make partial and multiple draws thereunder, up to the face amount thereof, and that Landlord may draw upon the Letter of Credit up to the full amount thereof, as determined by Landlord, and the Bank will pay to Landlord the amount of such draw upon receipt by the Bank of a sight draft signed by Landlord without requirement for any additional documents or statements by Landlord; and (ii) that, in the event of assignment or other transfer of either Landlord’s interest in this Lease or of any interest in Landlord (including, without limitation, consolidations, mergers, reorganizations or other entity changes), the Letter of Credit shall be freely transferable by Landlord, without charge to Landlord and without recourse, to the assignee or transferee of such interest and the Bank shall confirm the same to Landlord and such assignee or transferee. The Letter of Credit shall be in the form attached as Exhibit H hereto. Provided however, if Tenant proposes to use Silicon Valley Bank as the issuer of the Letter of Credit, the form of Letter of Credit set forth in Exhibit E hereto will be acceptable to Landlord. Landlord may (but shall not be required to) draw upon the Letter of Credit and use the proceeds therefrom (the “Letter of Credit Proceeds”) or any portion thereof in any manner Landlord is permitted to use the Security under this Article Five. In the event Landlord draws upon the Letter of Credit and elects not to terminate the Lease, but to use the Letter of Credit Proceeds, then within five (5) business days after Landlord gives Tenant written notice specifying the amount of the Letter of Credit Proceeds so utilized by Landlord, Tenant shall deliver to Landlord an amendment to the Letter of Credit or a replacement Letter of Credit in an amount equal to one hundred percent (100%) of the then-required amount of the Letter of Credit. Tenant’s failure to deliver such amendment or replacement of the Letter of Credit to Landlord within five (5) business days after Landlord’s notice shall constitute a Default by Tenant under this Lease. The Letter of Credit shall have an initial term of no longer than one (1) year, shall be “evergreen”, and shall be extended, reissued or replaced by Tenant, in each case at least thirty (30) days prior to its expiration in a manner that fully complies with the requirements of this Article Five, so that in all events the Letter of Credit required hereunder shall be in full force and effect continuously until the date (the “L/C Expiration Date”) for return of the Security described in Subsection (a) above. No more often than once per year, Landlord shall have the right to require Tenant to deliver to Landlord, on 15 days prior notice, a replacement Letter of Credit on the same terms and conditions set forth in this Article Five, in the event that Landlord determines, in its good faith judgment, that the issuing Bank is no longer satisfactory to remain as the issuer of the Letter of Credit. Any advice from the issuer that it

 

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intends to withdraw or not extend the Letter of Credit prior to any scheduled annual expiration or the L/C Expiration Date shall entitle the Landlord to immediately draw upon the Letter of Credit.

 

ARTICLE SIX

UTILITIES & SERVICES

 

6.01                        LANDLORD’S GENERAL SERVICES

 

Landlord shall provide maintenance and services as provided in Article Eight.

 

6.02                        TENANT TO OBTAIN & PAY DIRECTLY

 

(a)                                 Tenant shall be responsible for and shall pay promptly all charges for gas, electricity, sewer, heat, light, power, telephone, refuse pickup (to be performed on a regularly scheduled basis so that accumulated refuse does not exceed the capacity of Tenant’s refuse bins), janitorial service and all other utilities, materials and services furnished directly to or used by Tenant in, on or about the Premises, together with all taxes thereon. Tenant shall contract directly with the providing companies for such utilities and services.

 

(b)                                 Notwithstanding any provision of the Lease to the contrary, without, in each instance, the prior written consent of Landlord, as more particularly provided in Article Nine, Tenant shall not: (i) make any alterations or additions to the electric or gas equipment or systems or other Building systems. Tenant’s use of electric current shall at no time exceed the capacity of the wiring, feeders and risers providing electric current to the Premises or the Building. The consent of Landlord to the installation of electric equipment shall not relieve Tenant from the obligation to limit usage of electricity to no more than such capacity.

 

6.03                        TELEPHONE SERVICES

 

All telegraph, telephone, and communication connections which Tenant may desire outside the Premises shall be subject to Landlord’s prior written approval, in Landlord’s sole discretion, and the location of all wires and the work in connection therewith shall be performed by contractors approved by Landlord and shall be subject to the direction of Landlord, except that such approval is not required as to Tenant’s cabling from the Premises in a route designated by Landlord to any telephone cabinet or panel provided for Tenant’s connection to the telephone cable serving the Building, so long as Tenant’s equipment does not require connections different than or additional to those to the telephone cabinet or panel provided. As to any such connections or work outside the Premises requiring Landlord’s approval, Landlord reserves the right reasonably to approve the entity or entities providing telephone or other communication cable installation, removal, repair and maintenance outside the Premises and reasonably to restrict and control access to telephone cabinets or panels outside the Premises. Tenant shall be responsible for and shall pay all costs incurred in connection with the installation of telephone cables and communication wiring in the Premises, including any hook-up, access and maintenance fees related to the installation of such wires and cables in the Premises and the commencement of service therein, and the maintenance thereafter of such wire and cables; and there shall be included in Operating Expenses for the Building all installation, removal, hook-up or maintenance costs incurred by Landlord in connection with telephone cables and communication wiring serving the Building which are not allocable to any individual users of such service but are allocable to the Building generally. If Tenant fails to maintain all telephone cables and communication wiring in the Premises and such failure affects or interferes with the operation or maintenance of any other telephone cables or communication wiring serving the Building, Landlord or any vendor hired by Landlord may enter into and upon the Premises forthwith and perform such repairs, restorations or alterations as Landlord deems necessary in order to eliminate any such interference (and Landlord may recover from Tenant all of Landlord’s costs in connection therewith). No later than the Termination Date, Tenant agrees to remove all telephone cables and communication wiring installed by Tenant for and during Tenant’s occupancy, which Landlord shall request Tenant to remove. Tenant agrees that neither Landlord nor any of its agents or employees shall be liable to Tenant, or any of Tenant’s employees, agents, customers or invitees or anyone claiming through, by or under Tenant, for any damages, injuries, losses, expenses, claims or causes of action because of any interruption, diminution, delay or discontinuance at any time for any reason in the furnishing of any telephone or other communication service to the Premises and the Building.

 

6.04                        FAILURE OR INTERRUPTION OF UTILITY OR SERVICE

 

To the extent that any equipment or machinery furnished or maintained by Landlord outside the Premises is used in the delivery of utilities directly obtained by Tenant pursuant to Section 6.02 and breaks down or ceases to function properly, Landlord shall use reasonable diligence to repair same promptly. In the event of any failure, stoppage or interruption of, or change in, any utilities or services supplied by Landlord which are not directly obtained by Tenant, Landlord shall use reasonable diligence to have service promptly resumed. In either event covered by the preceding two sentences, if the cause of any such failure, stoppage or interruption of, or change in, utilities or services is within the control of a public utility, other public or quasi-public entity, or utility provider outside Landlord’s control, notification to such utility or entity of such failure, stoppage or interruption and request to remedy the same shall constitute “reasonable diligence” by Landlord to have service promptly resumed. Notwithstanding any other provision of this Section to the contrary; in the event of any failure, stoppage or interruption of, or change in, any utility or other service furnished to the Premises or the Project resulting from any cause other than the gross negligence or willful and wrongful act of Landlord or its agents or contractors, including changes in service provider or Landlord’s compliance with any voluntary or similar governmental or business guidelines now or hereafter published or any requirements now or hereafter established by any governmental agency, board or bureau having jurisdiction over the operation of the Property: (a) Landlord shall not be liable for, and Tenant shall not be entitled to, any abatement or reduction of Rent; (b) no such failure, stoppage, or interruption of any such utility or service shall constitute an eviction of Tenant or relieve Tenant of the obligation to perform any covenant or agreement of this Lease to be performed by Tenant; (c) Landlord shall not be in breach of this Lease nor be liable to Tenant for damages or otherwise.

 

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6.05                        INTENTIONALLY OMITTED

 

6.06                        SIGNAGE

 

Except as set forth in Rider 2, Tenant shall not install any signage within the Project, the Building or the Premises without obtaining the prior written approval of Landlord, and Tenant shall be responsible for procurement, installation, maintenance and removal of any such signage installed by Tenant, and all costs in connection therewith. Any such signage shall comply with Landlord’s current Project signage criteria and all Laws.

 

ARTICLE SEVEN

POSSESSION, USE AND CONDITION OF PREMISES

 

7.01                        POSSESSION AND USE OF PREMISES

 

(a)                                 Tenant shall occupy and use the Premises only for the uses specified in Section 1.01(17) to conduct Tenant’s business. Tenant shall not occupy or use the Premises (or permit the use or occupancy of the Premises) for any purpose or in any manner which: (1) is unlawful or in violation of any Law or Environmental Law; (2) may be dangerous to persons or property or which may increase the cost of, or invalidate, any policy of insurance carried on the Building or covering its operations; (3) is contrary to or prohibited by the terms and conditions of this Lease or the rules and regulations as provided in Article Eighteen; (4) contrary to or prohibited by the articles, bylaws or rules of any owner’s association affecting the Project; (5) would obstruct or interfere with the rights of other tenants or occupants of the Building or the Project, or injure or annoy them, or would tend to create or continue a nuisance; or (6) would constitute any waste in or upon the Premises or Project.

 

(b)                                 Landlord and Tenant acknowledge that the Americans With Disabilities Act of 1990 (42 U.S.C. §12101 et seq.) and regulations and guidelines promulgated thereunder, as all of the same may be amended and supplemented from time to time (collectively referred to herein as the “ADA”) establish requirements for business operations, accessibility and barrier removal, and that such requirements may or may not apply to the Premises, the Building and the Project depending on, among other things: (1) whether Tenant’s business is deemed a “public accommodation” or “commercial facility”, (2) whether such requirements are “readily achievable”, and (3) whether a given alteration affects a “primary function area” or triggers “path of travel” requirements. The parties hereby agree that: (a) Landlord shall be responsible for ADA Title III compliance in the Common Areas, except as provided below, (b) Tenant shall be responsible for ADA Title III compliance in the Premises, including any leasehold improvements or other work to be performed in the Premises under or in connection with this Lease, (c) Landlord may perform, or require that Tenant perform, and Tenant shall be responsible for the cost of, ADA Title III “path of travel” requirements triggered by Tenant Additions in the Premises, and (d) Landlord may perform, or require Tenant to perform, and Tenant shall be responsible for the cost of, ADA Title III compliance in the Common Areas necessitated by the Building being deemed to be a “public accommodation” instead of a “commercial facility” as a result of Tenant’s use of the Premises. To the extent Tenant shall occupy the entire Building or an entire floor in the Building, all ADA Title III requirements relating to the restrooms, elevator lobbies and corridors on such floor shall be the responsibility of Tenant. In such event, all matters related to “life safety” on such floor shall also be the responsibility of Tenant. Tenant shall be solely responsible for requirements under Title I of the ADA relating to Tenant’s employees. Notwithstanding any provision of the foregoing to the contrary, Landlord shall perform and be responsible for any ADA Title III compliance outside the Building (the cost of which shall be included in Operating Expenses unless expressly excluded from the definition of Operating Expenses), but Landlord shall not be obligated to pay for any compliance outside the Building to the extent that Tenant is responsible for such compliance pursuant to items (c) or (d) above.

 

(c)                                  Landlord and Tenant agree to cooperate and use commercially reasonable efforts to participate in traffic management programs generally applicable to businesses located in or about the area and Tenant shall encourage and support van and carpooling by, and staggered and flexible working hours for, its office workers and service employees to the extent reasonably permitted by the requirements of Tenant’s business. Neither this Section or any other provision of this Lease is intended to or shall create any rights or benefits in any other person, firm, company, governmental entity or the public.

 

(d)                                 Tenant agrees to cooperate with Landlord and to comply with any and all guidelines or controls concerning energy management imposed upon Landlord by federal or state governmental organizations or by any energy conservation association to which Landlord is a party or which is applicable to the Building.

 

7.02                        HAZARDOUS MATERIAL

 

(a)                                 Tenant shall not use, generate, manufacture, produce, store, handle, release, discharge, or dispose of, on, under or about the Premises or any part of the Project, or transport to or from the Premises or any part of the Project, any Hazardous Material, or allow its employees, agents, contractors, licensees, invitees or any other person or entity under Tenant’s control (“Tenant Parties”) to do so except to the extent expressly provided below. Provided that the Premises are used only for the uses specified in Section 1.01(17) above, Tenant shall be permitted to use and store in, and transport to and from, the Premises Hazardous Material identified on Exhibit D hereto and by this reference incorporated herein (“Permitted Hazardous Material”) so long as: (i) each item of the Permitted Hazardous Material is used or stored in, or transported to and from, the Premises only to the extent necessary for Tenant’s operation of its business at the Premises; (ii) at no time shall any Permitted Hazardous Material be in use or storage at the Premises in excess of the quantity specified therefor in Exhibit D; (iii) Tenant shall not install any underground tanks of any type; and (iv) the conditions and provisions set forth in this Section 7.02 are complied with. If Tenant desires to add additional types or quantities of Hazardous Materials to the list of Permitted Hazardous Materials specified in Exhibit D, Tenant shall give Landlord notice of the Hazardous Materials and quantities thereof that Tenant desires to use at the Premises and Landlord shall thereafter have the right to approve or disapprove such

 

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additional Hazardous Materials in Landlord’s sole discretion within ten (10) days after receipt of such notice. Failure to notify Tenant in writing of its decision within said ten (10) day period shall be deemed disapproval by Landlord. Tenant shall comply with and shall cause all Tenant Parties to comply with all Environmental Laws and other Laws pertaining to Tenant’s occupancy and use of the Premises and concerning the proper use, generation, manufacture, production, storage, handling, release, discharge, removal and disposal of any Hazardous Material introduced to the Premises, the Building or the Property by Tenant or any of the Tenant Parties. Without limiting the generality of the foregoing:

 

(1)         Tenant shall provide Landlord promptly with copies of: (x) all permits, licenses and other governmental and regulatory approvals with respect to the use, generation, manufacture, production, storage, handling, release, discharge, removal and disposal by Tenant or any of the Tenant Parties of Hazardous Material at the Project; and (y) each hazardous material management plan or similar document (“Plan(s)”) with respect to use, generation, manufacture, production, storage, handling, release, discharge, removal or disposal of Hazardous Material by Tenant or any of the Tenant Parties necessary to comply with Environmental Laws or other Laws prepared by or on behalf of Tenant or any of the Tenant Parties (whether or not required to be submitted to a governmental agency) and updates thereof in the event of any change in the Permitted Hazardous Materials used by Tenant or when otherwise required by Law.

 

(2)         If Tenant is notified of any investigation or violation of any Environmental Laws or other Laws arising from any activity of Tenant or any of the Tenant Parties at the Property, or if Tenant knows, or has reasonable cause to believe, that a Hazardous Material has come to be located in, on, under or about the Premises or the Project, other than as previously consented to by Landlord, Tenant shall immediately give written notice of such fact to Landlord, and provide Landlord with a copy of all reports, notices, claims or other documentation which it has concerning the presence of such Hazardous Material. In such event Landlord may conduct, at Tenant’s expense, such tests and studies as Landlord deems desirable relating to compliance by Tenant or any of the Tenant Parties with this Lease, Environmental Laws, other Laws, or relating to the alleged presence of Hazardous Material introduced to the Premises, the Building or the Property by Tenant or any of the Tenant Parties. Further, Landlord may conduct, at Landlord’s expense, such tests and studies as Landlord deems desirable relating to compliance by Tenant or any of the Tenant Parties with this Lease, Environmental Laws, other Laws, or relating to the alleged presence of Hazardous Material introduced to the Premises, the Building or the Property by Tenant or any of the Tenant Parties. In the event such tests and studies done at Landlord’s expense reasonably indicate that Tenant or Tenant Parties have violated Environmental Laws or caused a release of Hazardous Material, then Tenant shall reimburse Landlord the cost of such tests and studies.

 

(3)         Neither Tenant nor any of the Tenant Parties shall cause or permit any Hazardous Material to be released, discharged or disposed of in, on, under, or about the Premises or the Project (including through the plumbing or sanitary sewer system) and shall promptly, at Tenant’s expense, take all investigatory and/or remedial action reasonably recommended, whether or not formally ordered or required, for the cleanup of any contamination of, and for the maintenance, security and/or monitoring of the Premises, the Project or neighboring properties, that was caused or materially contributed to by Tenant, or pertaining to or involving any Hazardous Material brought onto the Premises or the Project by Tenant or any of the Tenant Parties.

 

(4)         Tenant shall, no later than the Termination Date, surrender the Premises to Landlord free of Hazardous Material and with all remedial and/or closure plans completed (and deliver evidence thereof to Landlord).

 

(b)                                 To the extent permitted by law, Tenant hereby indemnifies and agrees to protect, defend and hold the Indemnitees harmless against all actions, claims, demands, liability, costs and expenses, including reasonable attorneys’ fees and expenses for the defense thereof, arising from the use, generation, manufacture, production, storage, handling, release, threatened release, discharge, disposal, transportation to or from, or presence of any Hazardous Material on, under or about the Premises or any part of the Project caused by Tenant or by any of the Tenant Parties, whether before, during or after the Term. Tenant’s obligations under this Section 7.02 shall survive the expiration or earlier termination of this Lease. In case of any action or proceeding brought against the Indemnitees by reason of any such claim, upon notice from Landlord, Tenant covenants to defend such action or proceeding by counsel chosen by Landlord, in Landlord’s sole discretion. Landlord reserves the right to settle, compromise or dispose of any and all actions, claims and demands related to the foregoing indemnity, subject to the prior written approval of Tenant, which may not unreasonably be withheld. Landlord acknowledges that the sewer system for the Premises joins a common sewer discharge line shared by other tenants of the Building and confirms that notwithstanding that some elements of the Building sewer discharge line are shared, Tenant shall be responsible only for materials actually discharged by Tenant or the Tenant Parties.

 

(c)                                  The right to use and store in, and transport to and from, the Premises the Permitted Hazardous Material is personal to Genomic Health and may not be assigned or otherwise transferred by it without the prior written consent of Landlord, which consent may be withheld in Landlord’s sole discretion, except (i) to a Permitted Transferee which is an assignee of the Lease and which has satisfied the requirements of Sections 10.01 and 10.05 of this Lease; and (ii) Genomic Health may permit a Permitted Transferee which is a sublessee to use and store in, and transport to and from, the Premises the Permitted Hazardous Material to the same extent as Genomic Health has such right under this Lease, subject to all the provisions of this Lease. Any consent by Landlord pursuant to Article Ten to an assignment, transfer, subletting, mortgage, pledge, hypothecation or encumbrance of this Lease, and any interest therein or right or privilege appurtenant thereto, shall not constitute consent by Landlord to the use or storage at, or transportation to, the Premises of any Hazardous Material (including a Permitted Hazardous Material) by any such assignee, sublessee or transferee unless Landlord expressly agrees otherwise in writing. Provided however, at the time Tenant requests approval of any proposed assignment or sublease of this Lease by Tenant, Tenant shall submit to Landlord the proposed Permitted Hazardous Material list of the proposed assignee or sublessee. Landlord shall have the right, in its sole discretion, to approve the proposed assignee’s or sublessee’s proposed Permitted Hazardous Material list, or to require modifications to said list. In the event that Landlord does not approve of the proposed

 

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assignee’s or sublessee’s Permitted Hazardous Material list, or the proposed assignee or sublessee cannot or will not modify said list, then it shall be reasonable for purposes of Article Ten hereof for Landlord to refuse its consent to the proposed assignee or sublessee. In the event that the proposed Hazardous Material list of the assignee or sublessee includes any Hazardous Material different from or in greater quantity than those on Tenant’s Permitted Hazardous Material list, Tenant shall pay Landlord, whether or not Landlord consents to the proposed list of Permitted Hazardous Materials and/or to the proposed assignment or sublease, (i) a processing fee of Three Thousand Dollars ($3,000.00) at the time Tenant submits the request for approval, and (ii) the reasonable fees and expenses of any consultants retained by Landlord in connection with review of the proposed Permitted Hazardous Material list and use thereof by the proposed assignee or sublessee. Any consent by Landlord to the use or storage at, or transportation to or from the Premises, of any Hazardous Material (including a Permitted Hazardous Material) by an assignee, sublessee or transferee of Tenant shall not constitute a waiver of Landlord’s right to refuse such consent as to any subsequent assignee or transferee.

 

(d)                                 Tenant acknowledges that the sewer piping at the Project is made of ABS plastic. Accordingly, without Landlord’s prior written consent, which may be given or withheld in Landlord’s sole discretion, only ordinary domestic sewage is permitted to be put into the drains at the Premises. UNDER NO CIRCUMSTANCES SHALL Tenant EVER DEPOSIT ANY ESTERS OR KETONES (USUALLY FOUND IN SOLVENTS TO CLEAN UP PETROLEUM PRODUCTS) IN THE DRAINS AT THE PREMISES. If Tenant desires to put any substances other than ordinary domestic sewage into the drains, it shall first submit to Landlord a complete description of each such substance, including its chemical composition, and a sample of such substance suitable for laboratory testing. Landlord shall promptly determine whether or not the substance can be deposited into the drains and its determination shall be absolutely binding on Tenant. Upon demand, Tenant shall reimburse Landlord for expenses incurred by Landlord in making such determination. If any substances not so approved hereunder are deposited in the drains in Tenant’s Premises, Tenant shall be liable to Landlord for all damages resulting therefrom, including but not limited to all costs and expenses incurred by Landlord in repairing or replacing the piping so damaged.

 

7.03                        LANDLORD ACCESS TO PREMISES; APPROVALS

 

(a)                                 Tenant shall permit Landlord to erect, use and maintain pipes, ducts, wiring and conduits in and through the Premises, so long as Tenant’s use, layout or design of the Premises is not materially affected or altered. Landlord or Landlord’s agents shall have the right to enter upon the Premises (i) in the event of an emergency, without prior notice, or (ii) with 24-hour prior notice to inspect the Premises, to perform janitorial and other services (if any), to conduct safety and other testing in the Premises and to make such repairs, alterations, improvements or additions to the Premises or the Building or other parts of the Property as Landlord may deem necessary or desirable (including all alterations, improvements and additions in connection with a change in service provider or providers). Janitorial and cleaning services (if any) shall be performed after normal business hours. Any entry or work by Landlord may be during normal business hours and Landlord may use reasonable efforts to ensure that any entry or work shall not materially interfere with Tenant’s occupancy of the Premises.

 

(b)                                 If Tenant or its agents shall not be personally present to permit an entry into the Premises when for any reason an entry therein shall be necessary or permissible, Landlord (or Landlord’s agents), after having properly notified Tenant (unless Landlord believes an emergency situation exists), may enter the Premises without rendering Landlord or its agents liable therefor, and without relieving Tenant of any obligations under this Lease.

 

(c)                                  Landlord may enter the Premises for the purpose of conducting such inspections, tests and studies as Landlord may deem desirable or necessary to confirm Tenant’s compliance with all Laws and Environmental Laws or for other purposes necessary in Landlord’s reasonable judgment to ensure the sound condition of the Properly and the systems serving the Property. Landlord’s rights under this Section 7.03 (c) are for Landlord’s own protection only, and Landlord has not, and shall not be deemed to have assumed, any responsibility to Tenant or any other party as a result of the exercise or non-exercise of such rights, for compliance with Laws or Environmental Laws or for the accuracy or sufficiency of any item or the quality or suitability of any item for its intended use.

 

(d)                                 Landlord may do any of the foregoing, or undertake any of the inspection or work described in the preceding paragraphs without such action constituting an actual or constructive eviction of Tenant, in whole or in part, or giving rise to an abatement of Rent by reason of loss or interruption of business of the Tenant, or otherwise.

 

(e)                                  The review, approval or consent of Landlord with respect to any item required or permitted under this Lease is for Landlord’s own protection only, and Landlord has not, and shall not be deemed to have assumed, any responsibility to Tenant or any other party, as a result of the exercise or non-exercise of such rights, for compliance with Laws or Environmental Laws or for the accuracy or sufficiency of any item or the quality or suitability of any item for its intended use.

 

7.04                        QUIET ENJOYMENT

 

Landlord covenants, in lieu of any implied covenant of quiet possession or quiet enjoyment, that so long as Tenant is in compliance with the covenants and conditions set forth in this Lease, Tenant shall have the right to quiet enjoyment of the Premises without hindrance or interference from Landlord or those claiming through Landlord, and subject to the covenants and conditions set forth in the Lease and to the rights of any Mortgagee or ground lessor.

 

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ARTICLE EIGHT

MAINTENANCE & HVAC

 

8.01                        LANDLORD’S MAINTENANCE

 

Subject to Article Fourteen and Section 8.02, Landlord shall maintain the structural portions of the Building, the roof, exterior walls and exterior doors, foundation, and underslab standard sewer system of the Building in good, clean and safe condition. Notwithstanding the foregoing, Landlord shall have no responsibility to perform preventive maintenance or service for, or to repair any heating, ventilation and air conditioning equipment and systems serving the Premises (“HVAC”), and all such preventive maintenance, service, and repairs shall be performed by Tenant pursuant to the terms of Section 8.02. Landlord shall also (a) maintain the landscaping, parking facilities and other Common Areas of the Project, and (b) wash the outside of exterior windows at intervals determined by Landlord. Except as provided in Article Fourteen and Article Fifteen, there shall be no abatement of rent, no allowance to Tenant for diminution of rental value and no liability of Landlord by reason of inconvenience, annoyance or any injury to or interference with Tenant’s business arising from the making of or the failure to make any repairs, alterations or improvements in or to any portion of the Project or in or to any fixtures, appurtenances or equipment therein. Tenant waives the right to make repairs at Landlord’s expense under any law, statute or ordinance now or hereafter in effect.

 

8.02                        TENANT’S MAINTENANCE

 

(a)                                 Subject to the provisions of Article Fourteen, Tenant shall, at Tenant’s sole cost and expense, maintain and make all repairs to the Premises and fixtures therein which Landlord is not required to make pursuant to Section 8.01, including repairs to the interior walls, ceilings and windows of the Premises, the interior doors, Tenant’s signage, and the electrical, life-safety, plumbing located within the Premises and any HVAC serving only the Premises, and shall maintain the Premises, the fixtures, HVAC systems serving only the Premises, utilities systems or portions thereof serving only the Premises, and garbage enclosures, if any, for Tenant’s exclusive use outside the Premises, in a good, clean and safe condition. Tenant shall deliver to Landlord a copy of any maintenance contract entered into by Tenant with respect to the Premises. Tenant shall also, at Tenant’s expense, keep any non-standard heating, ventilating and air conditioning equipment and other non-standard equipment installed by or on behalf of Tenant in good condition and repair, using contractors approved in advance, in writing, by Landlord, which approval shall not be unreasonably withheld. Notwithstanding Section 8.01 above, to the extent that Landlord is not reimbursed by insurance and no waiver set forth in Section 16.04 is applicable, Tenant will pay for any repairs to the Building or the Project which are caused by any negligence or willful and wrongful act, of Tenant or its assignees, subtenants or employees, or of the respective agents of any of the foregoing persons, or of any other persons permitted in the Building or elsewhere in the Project by Tenant or any of them. Tenant will maintain the Premises, and will leave the Premises upon termination of this Lease, in a safe, clean, neat and sanitary condition.

 

(b)                                 With respect to HVAC, Tenant, at Tenant’s sole cost and expense, shall enter into contracts (“HVAC Service Contracts”) for regularly scheduled inspections and preventive maintenance and service, as to which the contractors, scope of work, frequency of inspection, maintenance or service, shall be subject to Landlord’s prior written approval, in its sole discretion. If requested by Landlord, Tenant shall cause the contractor for such HVAC Service Contracts to deliver written reports or service records, as applicable, to Landlord within ten (10) days after the date of such inspection, maintenance and/or service. Tenant shall deliver to Landlord a copy of the initial HVAC Service Contracts within sixty (60) days after the Commencement Date and of subsequent HVAC Service Contracts entered into by Tenant within ten (10) days after execution thereof (which subsequent HVAC Service Contracts shall be subject to the same approval standards and requirements as set forth above with respect to the initial contract). In the event Tenant fails, in the reasonable judgment of Landlord, to meet the requirements for such HVAC Service Contracts and cause such inspections, maintenance and service to be performed, which failure continues at the end of fifteen (15) days following written notice given by Landlord stating the nature of the failure, Landlord shall have the right (but shall not be obligated) to obtain such HVAC Service Contracts and to enter the Premises and perform such inspection, maintenance and service, at Tenant’s sole cost and expense; provided, however, if the nature of the maintenance or repair is such that it cannot, with the exercise of reasonable diligence, be completed within fifteen (15) days of Tenant’s receipt of Landlord’s notice, Landlord shall not undertake such inspection, maintenance and service at Tenant’s expense provided Tenant commences such inspection, maintenance and service in the manner required above within said 15-day period and thereafter diligently and continuously prosecutes the same to completion and provided further, however, that in the event of an emergency condition, Landlord shall have the right to make such inspection, maintenance, service and/or repairs on behalf of Tenant at Tenant’s sole cost and expense after giving Tenant such notice, if any, as is reasonable under the circumstances. Landlord’s right of entry pursuant to Section 7.03 shall include the right to enter and inspect the Premises for violations of Tenant’s covenants herein. Tenant shall maintain written records of HVAC inspection, maintenance, service repairs, and shall use certified technicians approved in writing by Landlord to perform such maintenance and repairs.

 

ARTICLE NINE

ALTERATIONS AND IMPROVEMENTS

 

9.01                        TENANT ALTERATIONS

 

(a)                                 The following provisions shall apply to the completion of any Tenant Alterations:

 

(1)                                 Tenant shall not, except as provided herein, without the prior written consent of Landlord, which consent shall not be unreasonably withheld, make or cause to be made any Tenant Alterations in or to the Premises or any Property systems serving the Premises. Prior to making any Tenant Alterations, Tenant shall give Landlord ten (10) days prior written notice (or such earlier notice as would be necessary pursuant to applicable Law) to permit Landlord sufficient time to post appropriate notices of non-responsibility. Subject to all other requirements of this Article Nine, Tenant may, without Landlord’s prior written consent, undertake (i)

 

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Decoration work and/or (ii) any Alterations that (x) do not adversely affect the roof, structural portions or the systems or equipment of the Building, (y) are not visible from the exterior of the Building, and (z) do not cost, in the aggregate, over the Term of the Lease, in excess of $50,000. Tenant shall furnish Landlord with the names and addresses of all contractors and subcontractors and copies of all contracts. All Tenant Alterations shall be completed at such time and in such manner as Landlord may from time to time designate, and only by contractors or mechanics approved by Landlord, which approval shall not be unreasonably withheld. The contractors, mechanics and engineers who may be used are further limited to those whose work will not cause or threaten to cause disharmony or interference with Landlord or other tenants in the Building and their respective agents and contractors performing work in or about the Building. Landlord may further condition its consent upon Tenant furnishing to Landlord and Landlord approving prior to the commencement of any work or delivery of materials to the Premises related to the Tenant Alterations such of the following as specified by Landlord: architectural plans and specifications, opinions from Landlord’s engineers stating that the Tenant Alterations will not in any way adversely affect the Building’s systems, necessary permits and licenses, certificates of insurance, and such other documents in such form reasonably requested by Landlord. Landlord may, in the exercise of reasonable judgment, request that Tenant provide Landlord with appropriate evidence of Tenant’s ability to complete and pay for the completion of the Tenant Alterations such as a performance bond or letter of credit. Upon completion of the Tenant Alterations, Tenant shall deliver to Landlord an as-built mylar and digitized (if available) set of plans and specifications for the Tenant Alterations.

 

(2)                                 Tenant shall pay the cost of all Tenant Alterations and the cost of decorating the Premises and any work to the Property occasioned thereby. In connection with completion of any Tenant Alterations, Tenant shall, upon receipt of Landlord’s itemized invoice therefor, pay Landlord’s actual and reasonable costs to review the plans and specifications for such Tenant Alterations and to monitor the performance thereof, including a construction administration fee and all elevator and hoisting charges at Landlord’s then standard rate. Upon completion of Tenant Alterations, Tenant shall furnish Landlord with contractors’ affidavits and full and final waivers of lien and receipted bills covering all labor and materials expended and used in connection therewith and such other documentation reasonably requested by Landlord or Mortgagee.

 

(3)                                 Tenant agrees to complete all Tenant Alterations (i) in accordance with all Laws, Environmental Laws, all requirements of applicable insurance companies and in accordance with Landlord’s standard construction rules and regulations, and (ii) in a good and workmanlike manner with the use of good grades of materials. Tenant shall notify Landlord immediately if Tenant receives any notice of violation of any Law in connection with completion of any Tenant Alterations and shall immediately take such steps as are necessary to remedy such violation. In no event shall such supervision or right to supervise by Landlord nor shall any approvals given by Landlord under this Lease constitute any warranty by Landlord to Tenant of the adequacy of the design, workmanship or quality of such work or materials for Tenant’s intended use or of compliance with the requirements of Section 9.01(a)(3)(i) and (ii) above or impose any liability upon Landlord in connection with the performance of such work.

 

(b)                                 All Tenant Additions to the Premises whether installed by Landlord or Tenant, shall without compensation or credit to Tenant, become part of the Premises and the property of Landlord at the time of their installation and shall remain in the Premises, unless pursuant to Article Twelve, Tenant may remove them or is required to remove them at Landlord’s request. Tenant’s Personal Property, as set forth in Exhibit G, shall at all times remain the property of Tenant and Tenant shall remove such property at the expiration or earlier termination of this Lease.

 

9.02                        LIENS

 

Tenant shall not permit any lien or claim for lien of any mechanic, laborer or supplier or any other lien to be filed against the Building, the Land, the Premises, or any other part of the Property arising out of work performed, or alleged to have been performed by, or at the direction of, or on behalf of Tenant. If any such lien or claim for lien is filed, Tenant shall within ten (10) days of receiving notice of such lien or claim (a) have such lien or claim for lien released of record or (b) deliver to Landlord a bond in form, content, amount, and issued by surety, satisfactory to Landlord, indemnifying, protecting, defending and holding harmless the Indemnitees against all costs and liabilities resulting from such lien or claim for lien and the foreclosure or attempted foreclosure thereof. If Tenant fails to take any of the above actions, Landlord, in addition to its rights and remedies under Article Eleven, without investigating the validity of such lien or claim for lien, may pay or discharge the same and Tenant shall, as payment of additional Rent hereunder, reimburse Landlord upon demand for the amount so paid by Landlord, including Landlord’s expenses and reasonable attorneys’ fees.

 

ARTICLE TEN

ASSIGNMENT AND SUBLETTING

 

10.01                 ASSIGNMENT AND SUBLETTING

 

(a)                                 Without the prior written consent of Landlord, which may be withheld in Landlord’s sole discretion, Tenant may not sublease, assign, mortgage, pledge, hypothecate or otherwise transfer or permit the transfer of this Lease or the encumbering of Tenant’s interest therein in whole or in part, by operation of Law or otherwise or permit the use or occupancy of the Premises, or any part thereof, by anyone other than Tenant, provided, however, if Landlord chooses not to recapture the space proposed to be subleased or assigned as provided in Section 10.02, Landlord shall not unreasonably withhold its consent to a subletting or assignment under this Section 10.01. Tenant agrees that the provisions governing sublease and assignment set forth in this Article Ten shall be deemed to be reasonable. If Tenant desires to enter into any sublease of the Premises or assignment of this Lease, Tenant shall deliver written notice thereof to Landlord (“Tenant’s Notice”), together with the identity of the proposed subtenant or assignee and the proposed principal terms thereof and financial and other information sufficient for Landlord to make an informed

 

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judgment with respect to such proposed subtenant or assignee at least sixty (60) days prior to the commencement date of the term of the proposed sublease or assignment. If Tenant proposes to sublease less than all of the Rentable Area of the Premises, the space proposed to be sublet and the space retained by Tenant must each be a marketable unit as reasonably determined by Landlord and otherwise in compliance with all Laws; provided however, so long as the Tenant is Genomic Health or a Permitted Transferee which is an assignee of the Lease which has satisfied the requirements of Sections 10.01 and 10.05 below, the foregoing shall not apply to a sublease for a sublease term of a year or less, for undemised space in the aggregate (for one or more such subleases in effect at any one time) up to 3,000 square feet of Rentable Area. Landlord shall notify Tenant in writing of its approval or disapproval of the proposed sublease or assignment or its decision to exercise its rights under Section 10.02 within thirty (30) days after receipt of Tenant’s Notice (and all required information). In no event may Tenant sublease any portion of the Premises or assign the Lease to any other tenant of the Project. Tenant shall submit for Landlord’s approval (which approval shall not be unreasonably withheld) any advertising which Tenant or its agents intend to use with respect to the space proposed to be sublet.

 

(b)                                 With respect to Landlord’s consent to an assignment or sublease, Landlord may take into consideration any factors which Landlord may deem relevant, and the reasons for which Landlord’s denial shall be deemed to be reasonable shall include, without limitation, the following:

 

(i)                                     the business reputation or creditworthiness of any proposed subtenant or assignee is not acceptable to Landlord; or

 

(ii)                                  in Landlord’s reasonable judgment the proposed assignee or subtenant would diminish the value or reputation of the Building or Landlord; or

 

(iii)                               any proposed assignee’s or subtenant’s use of the Premises would violate Section 7.01 of the Lease or would violate the provisions of any other leases of tenants in the Project;

 

(iv)                              the proposed assignee or subtenant is either a governmental agency, a school or similar operation, or a medical related practice; or

 

(v)                                 the proposed subtenant or assignee is a bona fide prospective tenant of Landlord in the Project as demonstrated by a written proposal dated within ninety (90) days prior to the date of Tenant’s request; or

 

(vi)                              the proposed subtenant or assignee would materially increase the estimated pedestrian and vehicular traffic to and from the Premises and the Building.

 

In no event shall Landlord be obligated to consider a consent to any proposed assignment of the Lease which would assign less than the entire Premises. In the event Landlord wrongfully withholds its consent to any proposed sublease of the Premises or assignment of the Lease, Tenant’s sole and exclusive remedy therefor shall be to seek specific performance of Landlord’s obligations to consent to such sublease or assignment.

 

(c)                                  Any sublease or assignment shall be expressly subject to the terms and conditions of this Lease. Any subtenant or assignee shall execute such documents as Landlord may reasonably require to evidence such subtenant or assignee’s assumption of the obligations and liabilities of Tenant under this Lease. Tenant shall deliver to Landlord a copy of all agreements executed by Tenant and the proposed subtenant and assignee with respect to the Premises. Landlord’s approval of a sublease, assignment, hypothecation, transfer or third party use or occupancy shall not constitute a waiver of Tenant’s obligation to obtain Landlord’s consent to further assignments or subleases, hypothecations, transfers or third party use or occupancy.

 

(d)                                 For purposes of this Article Ten, an assignment shall be deemed to include a change in the majority control of Tenant, resulting from any transfer, sale or assignment of shares of stock or membership interests of Tenant occurring by operation of Law or otherwise, and includes any merger, acquisition, consolidation or reorganization, except as otherwise provided in this Subsection below. Notwithstanding any provision of this Section to the contrary, an assignment for purposes of this Article does not include any transfer of control of the stock or membership interests of Tenant through (i) any public offering of shares of stock in Tenant in accordance with applicable State and Federal law rules, regulations and orders if thereafter the stock shall be listed and publicly traded through the New York Stock Exchange or the NASDAQ national market; or (ii) public sale of such stock effected through such Exchange or the NASDAQ national market. If Tenant is a partnership, any change in the partners of Tenant shall be deemed to be ah assignment.

 

(e)                                  For purposes of this Lease, a “Permitted Transferee” shall mean any Person which: (i) is an Affiliate of Tenant; or (ii) is the corporation or other entity (the “Successor”) resulting from a merger, conversion, consolidation or non-bankruptcy reorganization with Tenant; or (iii) is not a Successor but is otherwise a deemed assignee due to a change of control under section 10.01(d) above; or (iv) purchases, leases or acquires by way of exchange all or substantially all the assets of Tenant as a going concern (the “Purchaser”). Notwithstanding anything to the contrary in Sections 10.01(a) and (b), 10.02 and 10.03, provided there is no uncured Default under this Lease, Tenant shall have the right, without the prior written consent of Landlord, to assign this Lease to a Permitted Transferee or to sublease the Premises or any part thereof to a Permitted Transferee provided that: (1) Landlord receives thirty (30) days prior written notice of an assignment or sublease (including a pending transaction described in subparts (i), (ii), (iii) or (iv) of this Section 10.01(e)); provided that Tenant may give notice in less than thirty (30) days in connection with a pending transaction described in subparts (ii) and (iv) of this Section 10.01(e) to the extent that Tenant is precluded, by the terms of the transaction or, if Tenant’s stock is publicly traded, by applicable securities’ laws, from making disclosure of the transaction itself; (2) with respect to an assignment of the Lease or a sublease of more than half the Premises to an entity described in subparts (ii) or (iv) of this Section 10.01(e), the Permitted Transferee’s net worth is not less than Tenant’s net worth (measured as of the most recent date for which financial statements prepared in accordance with

 

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GAAP are available); (3) with respect to an assignment of the Lease or a sublease of more than half the Premises to an entity described in subparts (i) or (iii) of this Section 10.01(e), Tenant (as the assignor or sublandord) continues in existence with a net worth not less than Tenant’s net worth immediately prior to such assignment or subletting; (4) the Permitted Transferee expressly assumes (except a Permitted Transferee which is a deemed assignee under subpart (iii) of this Section 10.01(e) or which is a sublessee in the event of a sublease under this Section 10.01(e)) in writing reasonably satisfactory to Landlord all of the obligations of Tenant under this Lease and delivers such assumption to Landlord no later than fifteen (15) days (or such lesser time as is appropriate in connection with a pending transaction described in subparts (ii) and (iv) of this Section 10.01(e) to the extent that Tenant is precluded, by the terms of the transaction or, if Tenant’s stock is publicly traded, by applicable securities’ laws, from making disclosure of the transaction itself) prior to the effective date of the assignment; (5) Landlord receives no later than five (5) days before the effective date a fully executed copy of the applicable assignment or sublease agreement between Tenant and the Permitted Transferee; and (6) promptly after Landlord’s written request, Tenant and the Permitted Transferee provide such reasonable documents and information which Landlord reasonably requests for the purpose of substantiating whether or not the assignment or sublease is to a Permitted Transferee. All determinations of net worth for purposes of this Subsection shall exclude any value attributable to goodwill or going concern value. With respect to any proposed assignment under subparts (ii) or (iv) of this Section 10.01(e), Tenant shall pay Landlord, no later than fifteen (15) days prior to the effective date of such proposed assignment or sublease, a processing fee of Three Thousand Dollars ($3,000.00), which shall be Landlord’s earned fee whether or not the proposed assignment or sublease is completed by Tenant.

 

(f)                                   With respect to any sublease to a Permitted Transferee pursuant to Subsection (e) above, Tenant hereby irrevocably assigns to Landlord, effective upon any such sublease, all rent and other payments due from subtenant under the sublease, provided however, that Tenant shall have a license to collect such rent and other payments until the occurrence of a default by Tenant under any of the provisions of the Lease, and notice to Tenant of such default shall not be a prerequisite to Landlord’s right to collect subrent. At any time at Landlord’s option, Landlord shall have the right to give notice to the subtenant of such assignment. Landlord shall credit Tenant with any rent received by Landlord under such assignment but the acceptance of any payment on account of rent from the subtenant as the result of any such default shall in no manner whatsoever serve to release Tenant from any liability under the terms, covenants, conditions, provisions or agreement under the Lease. No such payment of rent or any other payment by the subtenant directly to Landlord and/or acceptance of such payment(s) by Landlord, regardless of the circumstances or reasons therefor, shall in any manner whatsoever be deemed an attornment by the subtenant to Landlord in the absence of a specific written agreement signed by Landlord to such an effect. For purposes of this Subsection, any use or occupancy by a Permitted Transferee (unless it is an assignee) without a formal sublease shall for the purposes of this Subsection be deemed to be a sublease at the same rental rate as provided in the Lease.

 

10.02                 RECAPTURE

 

Landlord shall have the option to exclude from the Premises covered by this Lease (“recapture”), the space proposed to be sublet or subject to the assignment, so long as (i) the proposed transfer is not to a Permitted Transferee in accordance with the provisions of Section 10.01(e), and (ii) the proposed sublease is for the remainder of the term of this Lease and Landlord recaptures the entire portion of the Premises subject to the proposed sublease. If Landlord elects to recapture, such recapture shall be effective as of the commencement date of such sublease or assignment, Tenant shall surrender possession of the space proposed to be subleased or subject to the assignment to Landlord on the effective date of recapture of such space from the Premises, such date being the Termination Date for such space. Effective as of the date of recapture of any portion of the Premises pursuant to this section, the Monthly Base Rent, Rentable Area of the Premises and Tenant’s Share shall be adjusted accordingly.

 

10.03                 EXCESS RENT

 

Except with respect to an assignment or sublease to a Permitted Transferee in accordance with the provisions of Section 10.01(e), Tenant shall pay Landlord on the first day of each month during the term of the sublease or assignment, fifty percent (50%) of the amount by which the sum of all rent and other consideration (direct or indirect) due from the subtenant or assignee for such month exceeds: (i) that portion of the Monthly Base Rent and Rent Adjustments due under this Lease for said month which is allocable to the space sublet or assigned; and (ii) the following costs and expenses for the subletting or assignment of such space: (1) brokerage commissions and reasonable attorneys’ fees and expenses, (2) the actual costs paid in making any improvements or substitutions in the Premises required by any sublease or assignment; and (3) “free rent” periods, costs of any inducements or concessions given to subtenant or assignee, moving costs, and other amounts in respect of such subtenant’s or assignee’s other leases or occupancy arrangements. All such costs and expenses shall be amortized over the term of the sublease or assignment pursuant to sound accounting principles.

 

10.04                 TENANT LIABILITY

 

In the event of any sublease or assignment, whether or not with Landlord’s consent, Tenant shall not be released or discharged from any liability, whether past, present or future, under this Lease, including any liability arising from the exercise of any renewal or expansion option, to the extent such exercise is expressly permitted by Landlord. Tenant’s liability shall remain primary, and in the event of default by any subtenant, assignee or successor of Tenant in performance or observance of any of the covenants or conditions of this Lease, Landlord may proceed directly against Tenant without the necessity of exhausting remedies against said subtenant, assignee or successor. After any assignment, Landlord may consent to subsequent assignments or subletting of this Lease, or amendments or modifications of this Lease with assignees of Tenant, without notifying Tenant, or any successor of Tenant, and without obtaining its or their consent thereto, and such action shall not relieve Tenant or any successor of Tenant of liability under this Lease. If Landlord grants consent to such sublease or assignment, Tenant shall pay all reasonable attorneys’ fees and expenses incurred by Landlord with respect to such assignment or sublease. In addition, if Tenant

 

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has any options to extend the term of this Lease or to add other space to the Premises, such options shall not be available to any subtenant or assignee, directly or indirectly without Landlord’s express written consent, which may be withheld in Landlord’s sole discretion.

 

10.05                 ASSUMPTION AND ATTORNMENT

 

If Tenant shall assign this Lease as permitted herein, the assignee shall expressly assume all of the obligations of Tenant hereunder in a written instrument satisfactory to Landlord and furnished to Landlord not later than fifteen (15) days prior to the effective date of the assignment. If Tenant shall sublease the Premises as permitted herein, Tenant shall, at Landlord’s option, within fifteen (15) days following any request by Landlord, obtain and furnish to Landlord the written agreement of such subtenant to the effect that the subtenant will attorn to Landlord and will pay all subrent directly to Landlord.

 

ARTICLE ELEVEN

DEFAULT AND REMEDIES

 

11.01                 EVENTS OF DEFAULT

 

The occurrence or existence of any one or more of the following shall constitute a material default and breach of the Lease (a “Default”) by Tenant under this Lease:

 

(i)                                     Tenant fails to pay any installment or other payment of Rent, including Rent Adjustment Deposits or Rent Adjustments, within three business (3) days after written notice to Tenant of such failure to pay, provided that after Landlord has twice sent such notice to Tenant for failure to pay, thereafter such failure shall be a Default if Tenant fails to pay any such installment or other payment of Rent, including Rent Adjustment Deposits or Rent Adjustments, within three (3) business days after the date when the same are due;

 

(ii)                                  Tenant fails to observe or perform any of the other covenants, conditions or provisions of this Lease or the Workletter and, unless the default involves a hazardous condition, which shall be cured forthwith or unless the failure to perform is a Default for which this Lease specifies there is no cure or grace period, fails to cure such default within thirty (30) days after written notice thereof to Tenant, provided that, if Tenant has exercised reasonable diligence to cure such failure and such failure cannot reasonably be cured within such thirty (30) day period despite reasonable diligence, Tenant shall not be in default under this subsection so long as Tenant diligently and continuously prosecutes the cure to completion;

 

(iii)                               the interest of Tenant in this Lease is levied upon under execution or other legal process;

 

(iv)                              a petition is filed by or against Tenant to declare Tenant bankrupt or seeking a plan of reorganization or arrangement under any Chapter of the Bankruptcy Act, or any amendment, replacement or substitution therefor, or to delay payment of, reduce or modify Tenant’s debts, which in the case of an involuntary action is not discharged within thirty (30) days;

 

(v)                                 Tenant is declared insolvent by Law or any assignment of Tenant’s property is made for the benefit of creditors;

 

(vi)                              a receiver is appointed for Tenant or Tenant’s property, which appointment is not discharged within thirty (30) days;

 

(vii)                           any action taken by or against Tenant to reorganize or modify Tenant’s capital structure in a materially adverse way which in the case of an involuntary action is not discharged within thirty (30) days; or

 

(viii)                        upon the dissolution of Tenant.

 

11.02                 LANDLORD’S REMEDIES

 

(a)                                 A Default shall constitute a breach of the Lease for which Landlord shall have the rights and remedies set forth in this Section 11.02 and all other rights and remedies set forth in this Lease or now or hereafter allowed by Law, whether legal or equitable, and all rights and remedies of Landlord shall be cumulative and none shall exclude any other right or remedy.

 

(b)                                 With respect to a Default, at any time Landlord may terminate Tenant’s right to possession by written notice to Tenant stating such election. Upon the termination of Tenant’s right to possession pursuant to this Section 11.02, Tenant’s right to possession shall terminate and this Lease shall terminate, and Tenant shall remain liable as hereinafter provided. Upon such termination, Landlord shall have the right, subject to applicable Law, to re-enter the Premises and dispossess Tenant and the legal representatives of Tenant and all other occupants of the Premises by unlawful detainer or other summary proceedings, or otherwise as permitted by Law, regain possession of the Premises and remove their property (including their trade fixtures, personal property and those Tenant Additions which Tenant is required or permitted to remove under Article Twelve), but Landlord shall not be obligated to effect such removal, and such property may, at Landlord’s option, be stored elsewhere, sold or otherwise dealt with as permitted by Law, at the risk of, expense of and for the account of Tenant, and the proceeds of any sale shall be applied pursuant to Law. Landlord shall in no event be responsible for the value, preservation or safekeeping of any such property. Tenant hereby waives all claims for damages that may be caused by Landlord’s removing or storing Tenant’s personal property pursuant to this Section or Section 12.01, and Tenant hereby indemnifies, and agrees to defend, protect and hold harmless, the Indemnitees from any and all loss, claims, demands, actions, expenses, liability and cost (including reasonable attorneys’ fees and expenses) arising out of or in any way related to such removal or storage. Upon such

 

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written termination of Tenant’s right to possession and this Lease, Landlord shall have the right to recover damages for Tenant’s Default as provided herein or by Law, including the following damages provided by California Civil Code Section 1951.2:

 

(1) the worth at the time of award of the unpaid Rent which had been earned at the time of termination;

 

(2) the worth at the time of award of the amount by which the unpaid Rent which would have been earned after termination until the time of award exceeds the amount of such Rent loss that Tenant proves could reasonably have been avoided;

 

(3) the worth at the time of award of the amount by which the unpaid Rent for the balance of the term of this Lease after the time of award exceeds the amount of such Rent loss that Tenant proves could be reasonably avoided; and

 

(4) any other amount necessary to compensate Landlord for all the detriment proximately caused by Tenant’s failure to perform its obligations under this Lease or which in the ordinary course of things would be likely to result therefrom. The word “rent” as used in this Section 11.02 shall have the same meaning as the defined term Rent in this Lease. The “worth at the time of award” of the amount referred to in clauses (1) and (2) above is computed by allowing interest at the Default Rate. The worth at the time of award of the amount referred to in clause (3) above is computed by discounting such amount at the discount rate of the Federal Reserve Bank of San Francisco at the time of award plus one percent (1%). For the purpose of determining unpaid Rent under clause (3) above, the monthly Rent reserved in this Lease shall be deemed to be the sum of the Monthly Base Rent, and monthly Storage Space Rent, if any, and the amounts last payable by Tenant as Rent Adjustments for the calendar year in which Landlord terminated this Lease as provided hereinabove.

 

(c)                                  Even if Tenant is in Default and/or has abandoned the Premises, this Lease shall continue in effect for so long as Landlord does not terminate Tenant’s right to possession by written notice as provided in Section 11.02(b) above, and Landlord may enforce all its rights and remedies under this Lease, including the right to recover Rent as it becomes due under this Lease. In such event, Landlord shall have all of the rights and remedies of a landlord under California Civil Code Section 1951.4 (lessor may continue Lease in effect after Tenant’s Default and abandonment and recover Rent as it becomes due, if Tenant has the right to sublet or assign, subject only to reasonable limitations), or any successor statute. During such time as Tenant is in Default, if Landlord has not terminated this Lease by written notice and if Tenant requests Landlord’s consent to an assignment of this Lease or a sublease of the Premises, Subject to Landlord’s option to recapture pursuant to Section 10.02, Landlord shall not unreasonably withhold its consent to such assignment or sublease. Tenant acknowledges and agrees that the provisions of Article Ten shall be deemed to constitute reasonable limitations of Tenant’s right to assign or sublet. Tenant acknowledges and agrees that in the absence of written notice pursuant to Section 11.02(b) above terminating Tenant’s right to possession, no other act of Landlord shall constitute a termination of Tenant’s right to possession or an acceptance of Tenant’s surrender of the Premises, including acts of maintenance or preservation or efforts to relet the Premises or the appointment of a receiver upon initiative of Landlord to protect Landlord’s interest under this Lease or the withholding of consent to a subletting or assignment, or terminating a subletting or assignment, if in accordance with other provisions of this Lease.

 

(d)                             In the event that Landlord seeks an injunction with respect to a breach or threatened breach by Tenant of any of the covenants, conditions or provisions of this Lease, Tenant agrees to pay the premium for any bond required in connection with such injunction.

 

(e)                                  Tenant hereby waives any and all rights to relief from forfeiture, redemption or reinstatement granted by Law (including California Civil Code of Procedure Sections 1174 and 1179) in the event of Tenant being evicted or dispossessed for any cause or in the event of Landlord obtaining possession of the Premises by reason of Tenant’s Default or otherwise;

 

(f)                                   When this Lease requires giving or service of a notice of Default or of a failure of Tenant to observe or perform any covenant, condition or provision of this Lease which will constitute a Default unless Tenant so observes or performs within any applicable cure period, and so long as the notice given or served provides Tenant the longer of any applicable cure period required by this Lease or by statute, then the giving of any equivalent or similar statutory notice, including any equivalent or similar notices required by California Code of Civil Procedure Section 1161 or any similar or successor statute, shall replace and suffice as any notice required under this Lease. When a statute requires service of a notice in a particular manner, service of that notice (or a similar notice required by this Lease) in the manner required by Article Twenty-four shall replace and satisfy the statutory service—of—notice procedures, except that any notice of unlawful detainer required by California Code of Civil Procedure Section 1161 or any similar or successor statute shall be served as required by Code of Civil Procedure Section 1162 or any similar or successor statute, and for purposes of Code of Civil Procedure Section 1162 or any similar or successor statute, Tenant’s “place of residence” and “usual place of business” shall mean the address specified by Tenant for notice pursuant to Section 1.01 of this Lease, as changed by Tenant pursuant to Article Twenty-four of this Lease.

 

(g)                                  The voluntary or other surrender or termination of this Lease, or a mutual termination or cancellation thereof, shall not work a merger and shall terminate all or any existing assignments, subleases, subtenancies or occupancies permitted by Tenant, except if and as otherwise specified in writing by Landlord.

 

(h)                                 No delay or omission in the exercise of any right or remedy of Landlord upon any default by Tenant, and no exercise by Landlord of its rights pursuant to Section 26.15 to perform any duty which Tenant fails timely to perform, shall impair any right or remedy or be construed as a waiver. No provision of this Lease shall be deemed waived by Landlord unless such waiver is in a writing signed by Landlord. The waiver by Landlord of any breach of any provision of this Lease shall not be deemed a waiver of any subsequent breach of the same or any other provision of this Lease.

 

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11.03                 ATTORNEY’S FEES

 

In the event any party brings any suit or other proceeding with respect to the subject matter or enforcement of this Lease, the prevailing party (as determined by the court, agency or other authority before which such suit or proceeding is commenced) shall, in addition to such other relief as may be awarded, be entitled to recover reasonable attorneys’ fees, expenses and costs of investigation as actually incurred, including court costs, expert witness fees, costs and expenses of investigation, and all reasonable attorneys’ fees, costs and expenses in any such suit or proceeding (including in any action or participation in or in connection with any case or proceeding under the Bankruptcy Code, 11 United States Code Sections 101 et seq., or any successor statutes, in establishing or enforcing the right to indemnification, in appellate proceedings, or in connection with the enforcement or collection of any judgment obtained in any such suit or proceeding).

 

11.04                 BANKRUPTCY

 

The following provisions shall apply in the event of the bankruptcy or insolvency of Tenant:

 

(a)                                 In connection with any proceeding under Chapter 7 of the Bankruptcy Code where the trustee of Tenant elects to assume this Lease for the purposes of assigning it, such election or assignment, may only be made upon compliance with the provisions of (b) and (c) below, which conditions Landlord and Tenant acknowledge to be commercially reasonable. In the event the trustee elects to reject this Lease then Landlord shall immediately be entitled to possession of the Premises without further obligation to Tenant or the trustee.

 

(b)                                 Any election to assume this Lease under Chapter 11 or 13 of the Bankruptcy Code by Tenant as debtor-in-possession or by Tenant’s trustee (the “Electing Party”) must provide for:

 

The Electing Party to cure or provide to Landlord adequate assurance that it will cure all monetary defaults under this Lease within fifteen (15) days from the date of assumption and it will cure all nonmonetary defaults under this Lease within thirty (30) days from the date of assumption. Landlord and Tenant acknowledge such condition to be commercially reasonable.

 

(c)                                  If the Electing Party has assumed this Lease or elects to assign Tenant’s interest under this Lease to any other person, such interest may be assigned only if the intended assignee has provided adequate assurance of future performance (as herein defined), of all of the obligations imposed on Tenant under this Lease.

 

For the purposes hereof, “adequate assurance of future performance” means that Landlord has ascertained that each of the following conditions has been satisfied:

 

(i)             The assignee has submitted a current financial statement, certified by its chief financial officer, which shows a net worth and working capital in amounts sufficient to assure the future performance by the assignee of Tenant’s obligations under this Lease; and

 

(ii)          Landlord has obtained consents or waivers from any third parties which may be required under a lease, mortgage, financing arrangement, or other agreement by which Landlord is bound, to enable Landlord to permit such assignment.

 

(d)                                 Landlord’s acceptance of rent or any other payment from any trustee, receiver, assignee, person, or other entity will not be deemed to have waived, or waive, the requirement of Landlord’s consent, Landlord’s right to terminate this Lease for any transfer of Tenant’s interest under this Lease without such consent, or Landlord’s claim for any amount of Rent due from Tenant.

 

11.05                 LANDLORD’S DEFAULT

 

Landlord shall be in default hereunder in the event Landlord has not begun and pursued with reasonable diligence the cure of any failure of Landlord to meet its obligations hereunder within thirty (30) days after the receipt by Landlord of written notice from Tenant of the alleged failure to perform. In no event shall Tenant have the right to terminate or rescind this Lease as a result of Landlord’s default as to any covenant or agreement contained in this Lease. Tenant hereby waives such remedies of termination and rescission and hereby agrees that Tenant’s remedies for default hereunder and for breach of any promise or inducement shall be limited to a suit for damages and/or injunction. In addition, Tenant hereby covenants that, prior to the exercise of any such remedies, it will give Mortgagee notice and a reasonable time to cure any default by Landlord.

 

ARTICLE TWELVE

SURRENDER OF PREMISES

 

12.01                 IN GENERAL

 

Upon the Termination Date, Tenant shall surrender and vacate the Premises immediately and deliver possession thereof to Landlord in a clean, good and tenantable condition, ordinary wear and tear, and damage caused by Landlord excepted. Tenant shall deliver to Landlord all keys to the Premises. Tenant shall remove from the Premises all movable personal property of Tenant and Tenant’s trade fixtures, including, subject to Section 6.04, cabling for any of the foregoing. Tenant shall be entitled to remove such Tenant Additions which at the time of their installation Landlord and Tenant agreed may be removed by Tenant. Tenant shall also remove such other Tenant Additions as required by Landlord, including any Tenant Additions containing Hazardous Material. Tenant immediately shall repair all damage resulting from removal of any of Tenant’s property, furnishings, Tenant’s Personal Property or Tenant Additions, shall

 

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close all floor, ceiling and roof openings and shall restore the Premises to a tenantable condition as reasonably determined by Landlord. If any of the Tenant Additions which were installed by Tenant involved the lowering of ceilings, raising of floors or the installation of specialized wall or floor coverings or lights, then Tenant shall also be obligated to return such surfaces to their condition prior to the commencement of this Lease. Tenant shall also be required to close any staircases or other openings between floors. Notwithstanding any of the foregoing to the contrary, if so requested by Tenant in writing (and prominently in all capital and bold lettering which also states that such request is pursuant to Section 12.01 of the Lease) at the time Tenant requests approval of any Tenant Work or subsequent Tenant Alterations, Landlord shall advise Tenant at the time of Landlord’s approval of such Tenant Work or Tenant Alterations as to whether Landlord will require that such Tenant Work or Tenant Alterations be removed by Tenant from the Premises; provided, however, regardless of the foregoing, in any event, Landlord may require removal of any Tenant Additions containing Hazardous Material and all Tenant’s trade fixtures, and, subject to Section 6.03, cabling and wiring installed for Tenant’s personal property or trade fixtures. In the event possession of the Premises is not delivered to Landlord when required hereunder, or if Tenant shall fail to remove those items described above, Landlord may (but shall not be obligated to), at Tenant’s expense, remove any of such property and store, sell or otherwise deal with such property as provided in Section 11.02(b), including the waiver and indemnity obligations provided in that Section, and undertake, at Tenant’s expense, such restoration work as Landlord deems necessary or advisable.

 

12.02                 LANDLORD’S RIGHTS

 

All property which may be removed from the Premises by Landlord shall be conclusively presumed to have been abandoned by Tenant and Landlord may deal with such property as provided in Section 11.02(b), including the waiver and indemnity obligations provided in that Section. Tenant shall also reimburse Landlord for all costs and expenses incurred by Landlord in removing any of Tenant Additions required to be removed pursuant to Section 12.01 above and in restoring the Premises to the condition required by this Lease at the Termination Date.

 

ARTICLE THIRTEEN

HOLDING OVER

 

Tenant shall pay Landlord the greater of (i) 150% of the monthly Rent payable for the month immediately preceding the holding over (including increases for Rent Adjustments which Landlord may reasonably estimate) or, (ii) 150% of the fair market rental value of the Premises as reasonably determined by Landlord for each month or portion thereof that Tenant retains possession of the Premises, or any portion thereof, after the Termination Date (without reduction for any partial month that Tenant retains possession). Tenant shall also pay all damages sustained by Landlord by reason of such retention of possession. The provisions of this Article shall not constitute a waiver by Landlord of any re-entry rights of Landlord and Tenant’s continued occupancy of the Premises shall be as a tenancy in sufferance.

 

ARTICLE FOURTEEN

DAMAGE BY FIRE OR OTHER CASUALTY

 

14.01                 SUBSTANTIAL UNTENANTABILITY

 

(a)                                 If any fire or other casualty (whether insured or uninsured) renders all or a substantial portion of the Premises or the Building untenantable, Landlord shall, with reasonable promptness after the occurrence of such damage, estimate the length of time that will be required to substantially complete the repair and restoration and shall by notice advise Tenant of such estimate (“Landlord’s Notice”). if Landlord estimates that the amount of time required to substantially complete such repair and restoration will exceed one hundred eighty (180) days from the date such damage occurred, then Landlord, or Tenant if all or a substantial portion of the Premises is rendered untenantable, shall have the right to terminate this Lease as of the date of such damage upon giving written notice to the other at any time within twenty (20) days after delivery of Landlord’s Notice, provided that if Landlord so chooses, Landlord’s Notice may also constitute such notice of termination.

 

(b)                                 In the event that the Building is damaged or destroyed to the extent of more than twenty-five percent (25%) of its replacement cost or to any extent if no insurance proceeds or insufficient insurance proceeds are receivable by Landlord, or if the buildings at the Project shall be damaged to the extent of fifty percent (50%) or more of the replacement value or to any extent if no insurance proceeds or insufficient insurance proceeds are receivable by Landlord, and regardless of whether or not the Premises be damaged, Landlord may elect by written notice to Tenant given within thirty (30) days after the occurrence of the casualty to terminate this Lease in lieu of so restoring the Premises, in which event this Lease shall terminate as of the date specified in Landlord’s notice, which date shall be no later than sixty (60) days following the date of Landlord’s notice.

 

(c)                                  Unless this Lease is terminated as provided in the preceding Subsections 14.01 (a) and (b), Landlord shall proceed with reasonable promptness to repair and restore the Premises to its condition as existed prior to such casualty, subject to reasonable delays for insurance adjustments and Force Majeure delays, and also subject to zoning Laws and building codes then in effect. Landlord shall have no liability to Tenant, and Tenant shall not be entitled to terminate this Lease if such repairs and restoration are not in fact completed within the time period estimated by Landlord so long as Landlord shall proceed with reasonable diligence to complete such repairs and restoration.

 

(d)                                 Tenant acknowledges that Landlord shall be entitled to the full proceeds of any insurance coverage, whether carried by Landlord or Tenant, for damages to the Premises, except for those proceeds of Tenant’s insurance of its own personal property and equipment which would be removable by Tenant at the Termination Date. All such insurance proceeds shall be payable to Landlord whether or not the Premises are to be repaired and restored, provided, however, if this Lease is not terminated and the parties proceed to repair and restore Tenant Additions at Tenant’s cost, to the extent Landlord received proceeds of Tenant’s insurance covering Tenant Additions, such proceeds shall be applied to reimburse Tenant for its cost of repairing and restoring Tenant Additions.

 

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(e)                                  Notwithstanding anything in this Article Fourteen to the contrary: (i) Landlord shall have no duty pursuant to this Section to repair or restore any portion of any Tenant Additions or to expend for any repair or restoration of the Premises or Building amounts in excess of insurance proceeds paid to Landlord and available for repair or restoration; and (ii) Tenant shall not have the right to terminate this Lease pursuant to this Section if any damage or destruction was caused by the gross negligence or willful and wrongful act of Tenant, its agent or employees. Whether or not the Lease is terminated pursuant to this Article Fourteen, in no event shall Tenant be entitled to any compensation or damages for loss of the use of the whole or any part of the Premises or for any inconvenience or annoyance occasioned by any such damage, destruction, rebuilding or restoration of the Premises or the Building or access thereto.

 

(f)                                   Any repair or restoration of the Premises performed by Tenant shall be in accordance with the provisions of Article Nine hereof.

 

14.02                 INSUBSTANTIAL UNTENANTABILITY

 

Unless this Lease is terminated as provided in the preceding Subsections 14.01 (a) and (b), then Landlord shall proceed to repair and restore the Building or the Premises other than Tenant Additions, with reasonable promptness, unless such damage is to the Premises and occurs during the last six (6) months of the Term, in which event either Tenant or Landlord shall have the right to terminate this Lease as of the date of such casualty by giving written notice thereof to the other within twenty (20) days after the date of such casualty. Notwithstanding the foregoing, Landlord’s obligation to repair shall be limited in accordance with the provisions of Section 14.01 above.

 

14.03                 RENT ABATEMENT

 

Except for (i) the willful and wrongful act of Tenant or its agents, employees, contractors or invitees, or (ii) the gross negligence of Tenant or its agents, employees, contractors or invitees only if and to the extent Landlord receives rental abatement insurance proceeds covering abatement of the Rent hereunder, then, if all or any part of the Premises are rendered untenantable by fire or other casualty and this Lease is not terminated, Monthly Base Rent and Rent Adjustments shall abate for that part of the Premises which is untenantable on a per diem basis from the date of the casualty until Landlord has Substantially Completed the repair and restoration work in the Premises which it is required to perform, provided, that as a result of such casualty, Tenant does not occupy the portion of the Premises which is untenantable during such period.

 

14.04                 WAIVER OF STATUTORY REMEDIES

 

The provisions of this Lease, including this Article Fourteen, constitute an express agreement between Landlord and Tenant with respect to any and all damage to, or destruction of, the Premises or the Property or any part of either, and any Law, including Sections 1932(2), 1933(4), 1941 and 1942 of the California Civil Code, with respect to any rights or obligations concerning damage or destruction shall have no application to this Lease or to any damage to or destruction of all or any part of the Premises or the Property or any part of either, and are hereby waived.

 

ARTICLE FIFTEEN

EMINENT DOMAIN

 

15.01                 TAKING OF WHOLE OR SUBSTANTIAL PART

 

In the event the whole or any substantial part of the Building or of the Premises is taken or condemned by any competent authority for any public use or purpose (including a deed given in lieu of condemnation) and is thereby rendered untenantable, this Lease shall terminate as of the date title vests in such authority or any earlier date on which possession is required to be surrendered to such authority, and Monthly Base Rent and Rent Adjustments shall be apportioned as of the Termination Date. Further, if at least twenty-five percent (25%) of the rentable area of the Project is taken or condemned by any competent authority for any public use or purpose (including a deed given in lieu of condemnation), and regardless of whether or not the Premises be so taken or condemned, Landlord may elect by written notice to Tenant to terminate this Lease as of the date title vests in such authority or any earlier date on which possession is required to be surrendered to such authority, and Monthly Base Rent and Rent Adjustments shall be apportioned as of the Termination Date. Landlord may, without any obligation to Tenant, agree to sell or convey to the taking authority the Premises, the Building, Tenant’s Phase, the Project or any portion thereof sought by the taking authority, free from this Lease and the right of Tenant hereunder, without first requiring that any action or proceeding be instituted or, if instituted, pursued to a judgment. Notwithstanding anything to the contrary herein set forth, in the event the taking of the Building or Premises is temporary (for less than the remaining term of the Lease), Landlord may elect either (i) to terminate this Lease or (ii) permit Tenant to receive the entire award attributable to the Premises in which case Tenant shall continue to pay Rent and this Lease shall not terminate.

 

15.02                 TAKING OF PART

 

In the event a part of the Building or the Premises is taken or condemned by any competent authority (or a deed is delivered in lieu of condemnation) and this Lease is not terminated, the Lease shall be amended to reduce or increase, as the case may be, the Monthly Base Rent and Tenant’s Share to reflect the Rentable Area of the Premises or Building, as the case may be, remaining after any such taking or condemnation. Landlord, upon receipt and to the extent of the award in condemnation (or proceeds of sale) shall make necessary repairs and restorations to the Premises (exclusive of Tenant Additions) and to the Building to the extent necessary to constitute the portion of the Building not so taken or condemned as a complete architectural and economically efficient unit. Notwithstanding the foregoing, if as a result of any taking, or a governmental order that the grade of any street or alley adjacent to the Building is to be changed and such taking or change of grade makes it necessary or desirable to substantially remodel

 

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or restore the Building or prevents the economical operation of the Building, Landlord shall have the right to terminate this Lease upon ninety (90) days prior written notice to Tenant.

 

15.03                 COMPENSATION

 

Landlord shall be entitled to receive the entire award (or sale proceeds) from any such taking, condemnation or sale without any payment to Tenant, and Tenant hereby assigns to Landlord Tenant’s interest, if any, in such award; provided, however, Tenant shall have the right separately to pursue against the condemning authority a separate award in respect of the loss, if any, to Tenant Additions paid for by Tenant without any credit or allowance from Landlord, for fixtures or personal property of Tenant, or for relocation or business interruption expenses, so long as there is no diminution of Landlord’s award as a result.

 

ARTICLE SIXTEEN

INSURANCE

 

16.01                 TENANT’S INSURANCE

 

Tenant, at Tenant’s expense, agrees to maintain in force, with a company or companies acceptable to Landlord, during the Term: (a) Commercial General Liability Insurance on a primary basis and without any right of contribution from any insurance carried by Landlord covering the Premises on an occurrence basis against all claims for personal injury, bodily injury, death and property damage, including contractual liability covering the indemnification provisions in this Lease. Such insurance shall be for such limits that are reasonably required by Landlord from time to time but not less than a combined single limit of Five Million and No/100 Dollars ($5,000,000.00); (b) Workers’ Compensation and Employers’ Liability Insurance to the extent required by and in accordance with the Laws of the State of California; (c) “All Risks” property insurance in an amount adequate to cover the full replacement cost of all Tenant Additions to the Premises, equipment, installations, fixtures and contents of the Premises in the event of loss; (d) In the event a motor vehicle is to be used by Tenant in connection with its business operation from the Premises, Comprehensive Automobile Liability Insurance coverage with limits of not less than Three Million and No/100 Dollars ($3,000,000.00) combined single limit coverage against bodily injury liability and property damage liability arising out of the use by or on behalf of Tenant, its agents and employees in connection with this Lease, of any owned, non-owned or hired motor vehicles; and (e) such other insurance or coverages as Landlord reasonably requires.

 

16.02                 FORM OF POLICIES

 

Each policy referred to in 16.01 shall satisfy the following requirements. Each policy shall (i) name Landlord and the Indemnitees as additional insureds (except Workers’ Compensation and Employers’ Liability Insurance), (ii) be issued by one or more responsible insurance companies licensed to do business in the State of California reasonably satisfactory to Landlord, (iii) where applicable, provide for deductible amounts satisfactory to Landlord and not permit co-insurance, (iv) shall provide that such insurance may not be canceled or amended without thirty (30) days’ prior written notice to the Landlord, and (v) each policy of “All-Risks” property insurance shall provide that the policy shall not be invalidated should the insured waive in writing prior to a loss, any or all rights of recovery against any other party for losses covered by such policies. Tenant shall deliver to Landlord, certificates of insurance and at Landlord’s request, copies of all policies and renewals thereof to be maintained by Tenant hereunder, not less than ten (10) days prior to the Commencement Date and not less than ten (10) days prior to the expiration date of each policy.

 

16.03                 LANDLORD’S INSURANCE

 

Landlord agrees to purchase and keep in full force and effect during the Term hereof, including any extensions or renewals thereof, insurance under policies issued by insurers of recognized responsibility, qualified to do business in the State of California on the Building in amounts not less than the greater of eighty (80%) percent of the then full replacement cost (without depreciation) of the Building (above foundations and excluding Tenant Additions to the Premises) or an amount sufficient to prevent Landlord from becoming a co-insurer under the terms of the applicable policies, against fire and such other risks as may be included in standard forms of all risk coverage insurance reasonably available from time to time. Landlord agrees to maintain in force during the Term, Commercial General Liability Insurance covering the Building on an occurrence basis against all claims for personal injury, bodily injury, death and property damage. Such insurance shall be for a combined single limit of Five Million and No/100 Dollars ($5,000,000.00). Neither Landlord’s obligation to carry such insurance nor the carrying of such insurance shall be deemed to be an indemnity by Landlord with respect to any claim, liability, loss, cost or expense due, in whole or in part, to Tenant’s negligent acts or omissions or willful misconduct. Without obligation to do so, Landlord may, in its sole discretion from time to time, carry insurance in amounts greater and/or for coverage additional to the coverage and amounts set forth above.

 

16.04                 WAIVER OF SUBROGATION

 

(a)                                 Landlord agrees that, if obtainable at no, or minimal, additional cost, and so long as the same is permitted under the laws of the State of California, it will include in its “All Risks” policies appropriate clauses pursuant to which the insurance companies (i) waive all right of subrogation against Tenant with respect to losses payable under such policies and/or (ii) agree that such policies shall not be invalidated should the insured waive in writing prior to a loss any or all right of recovery against any party for losses covered by such policies.

 

(b)                                 Tenant agrees to include, if obtainable at no, or minimal, additional cost, and so long as the same is permitted under the laws of the State of California, in its “All Risks” insurance policy or policies on Tenant Additions to the Premises, whether or not removable, and on Tenant’s furniture, furnishings, fixtures and other property removable by Tenant under the provisions of this Lease appropriate clauses pursuant to which the insurance company or companies (i) waive the right of subrogation against Landlord and/or any tenant of space in the Building with respect to

 

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losses payable under such policy or policies and/or (ii) agree that such policy or policies shall not be invalidated should the insured waive in writing prior to a loss any or all right of recovery against any party for losses covered by such policy or policies. If Tenant is unable to obtain in such policy or policies either of the clauses described in the preceding sentence, Tenant shall, if legally possible and without necessitating a change in insurance carriers, have Landlord named in such policy or policies as an additional insured. If Landlord shall be named as an additional insured in accordance with the foregoing, Landlord agrees to endorse promptly to the order of Tenant, without recourse, any check, draft, or order for the payment of money representing the proceeds of any such policy or representing any other payment growing out of or connected with said policies, and Landlord does hereby irrevocably waive any and all rights in and to such proceeds and payments.

 

(c)                                  Provided that Landlord’s right of full recovery under its policy or policies aforesaid is not adversely affected or prejudiced thereby, Landlord hereby waives any and all right of recovery which it might otherwise have against Tenant, its servants, agents and employees, for loss or damage occurring to the Real Property and the fixtures, appurtenances and equipment therein, except Tenant Additions, to the extent the same is covered by Landlord’s insurance, notwithstanding that such loss or damage may result from the negligence or fault of Tenant, its servants, agents or employees. Provided that Tenant’s right of full recovery under its aforesaid policy or policies is not adversely affected or prejudiced thereby, Tenant hereby waives any and all right of recovery which it might otherwise have against Landlord, its servants, and employees and against every other tenant in the Real Property who shall have executed a similar waiver as set forth in this Section 16.04 (c) for loss or damage to Tenant Additions, whether or not removable, and to Tenant’s furniture, furnishings, fixtures and other property removable by Tenant under the provisions hereof to the extent the same is covered or coverable by Tenant’s insurance required under this Lease, notwithstanding that such loss or damage may result from the negligence or fault of Landlord, its servants, agents or employees, or such other tenant and the servants, agents or employees thereof.

 

(d)                                 Landlord and Tenant hereby agree to advise the other promptly if the clauses to be included in their respective insurance policies pursuant to subparagraphs (a) and (b) above cannot be obtained on the terms hereinbefore provided and thereafter to furnish the other with a certificate of insurance or copy of such policies showing the naming of the other as an additional insured, as aforesaid. Landlord and Tenant hereby also agree to notify the other promptly of any cancellation or change of the terms of any such policy which would affect such clauses or naming. All such policies which name both Landlord and Tenant as additional insureds shall, to the extent obtainable, contain agreements by the insurers to the effect that no act or omission of any additional insured will invalidate the policy as to the other additional insureds.

 

16.05                 NOTICE OF CASUALTY

 

Tenant shall give Landlord notice in case of a fire or accident in the Premises promptly after Tenant is aware of such event.

 

ARTICLE SEVENTEEN

WAIVER OF CLAIMS AND INDEMNITY

 

17.01                 WAIVER OF CLAIMS

 

To the extent permitted by Law, Tenant releases the Indemnitees from, and waives all claims for, damage to person or property sustained by the Tenant or any occupant of the Premises or the Property resulting directly or indirectly from any existing or future condition, defect, matter or thing in and about the Premises or the Property, or any part of either, or any equipment or appurtenance therein, or resulting from any accident in or about the Premises or the Property, or resulting directly or indirectly from any act or neglect of any tenant or occupant of the Property or of any other person, including Landlord’s agents and servants, except to the extent caused by the gross negligence or willful and wrongful act of any of the Indemnitees. If any such damage, whether to the Premises or the Property or any part of either, or whether to Landlord or to other tenants in the Property, results from any act or neglect of Tenant, its employees, servants, agents, contractors, invitees or customers, Tenant shall be liable therefor and Landlord may, at Landlord’s option, repair such damage and Tenant shall, upon demand by Landlord, as payment of additional Rent hereunder, reimburse Landlord within ten (10) days of demand for the total cost of such repairs, in excess of amounts, if any, paid to Landlord under insurance covering such damages. Tenant shall not be liable for any such damage caused by its acts or neglect to the extent that Landlord or a tenant has recovered any amount of the damage from proceeds of insurance policies and the insurance company has waived its right of subrogation against Tenant.

 

17.02                 INDEMNITY BY TENANT

 

To the extent permitted by Law, Tenant hereby indemnifies, and agrees to protect, defend and hold the Indemnitees harmless, against any and all actions, claims, demands, liability, costs and expenses, including reasonable attorneys’ fees and expenses for the defense thereof, arising from Tenant’s occupancy of the Premises, from the undertaking of any Tenant Additions or repairs to the Premises, from the conduct of Tenant’s business on the Premises, or from any breach or default on the part of Tenant in the performance of any covenant or agreement on the part of Tenant to be performed pursuant to the terms of this Lease, or from any willful act or negligence of Tenant, its agents, contractors, servants, employees, customers or invitees, in or about the Premises or the Property or any part of either. In case of any action or proceeding brought against the Indemnitees by reason of any such claim, upon notice from Landlord, Tenant covenants to defend such action or proceeding by counsel chosen by Landlord, in Landlord’s sole discretion. Landlord reserves the right to settle, compromise or dispose of any and all actions, claims and demands related to the foregoing indemnity. The foregoing indemnity shall not operate to relieve an Indemnitee of liability to the extent such liability is caused by the gross negligence or willful and wrongful act of such Indemnitee. Further, the foregoing indemnity is subject to and shall not diminish any waivers in effect in accordance with Section 16.04 by Landlord or its insurers to the extent of amounts, if any, paid to Landlord under its “All-Risks” property insurance.

 

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17.03                 WAIVER OF CONSEQUENTIAL DAMAGES

 

To the extent permitted by law, Tenant hereby waives and releases the Indemnitees from any consequential damages, compensation or claims for inconvenience or loss of business, rents or profits as a result of any injury or damage, whether or not caused by the willful and wrongful act of any of the Indemnitees.

 

ARTICLE EIGHTEEN

RULES AND REGULATIONS

 

18.01                 RULES

 

Tenant agrees for itself and for its subtenants, employees, agents, and invitees to comply with all reasonable rules and regulations for use of the Premises, the Building, the Phase and the Project imposed by Landlord, as the same may be revised from time to time, including the following: (a) Tenant shall comply with all of the requirements of Landlord’s emergency response plan, as the same may be amended from time to time; and (b) Tenant shall not place any furniture, furnishings, fixtures or equipment in the Premises in a manner so as to obstruct the windows of the Premises to cause the Building, in Landlord’s good faith determination, to appear unsightly from the exterior. Such rules and regulations are and shall be imposed for the cleanliness, good appearance, proper maintenance, good order and reasonable use of the Premises, the Building, the Phase and the Project and as may be necessary for the enjoyment of the Building and the Project by all tenants and their clients, customers, and employees.

 

18.02                 ENFORCEMENT

 

Nothing in this Lease shall be construed to impose upon the Landlord any duty or obligation to enforce the rules and regulations as set forth above or as hereafter adopted, or the terms, covenants or conditions of any other lease as against any other tenant, and the Landlord shall not be liable to the Tenant for violation of the same by any other tenant, its servants, employees, agents, visitors or licensees. Landlord shall use reasonable efforts to enforce the rules and regulations of the Building in a uniform and non-discriminatory manner.

 

ARTICLE NINETEEN

LANDLORD’S RESERVED RIGHTS

 

Landlord shall have the following rights exercisable without notice to Tenant and without liability to Tenant for damage or injury to persons, property or business and without being deemed an eviction or disturbance of Tenant’s use or possession of the Premises or giving rise to any claim for offset or abatement of Rent: (1) to change the Building’s name or street address upon thirty (30) days’ prior written notice to Tenant; (2) to install, affix and maintain all signs on the exterior and/or interior of the Building; (3) to designate and/or approve prior to installation, all types of signs, window shades, blinds, drapes, awnings or other similar items, and all internal lighting that may be visible from the exterior of the Premises; (4) upon reasonable notice to Tenant, to display the Premises to prospective purchasers at reasonable hours at any time during the Term and to prospective tenants at reasonable hours during the last twelve (12) months of the Term; (5) to grant to any party the exclusive right to conduct any business or render any service in or to the Building, provided such exclusive right shall not operate to prohibit Tenant from using the Premises for the purpose permitted hereunder; (6) to change the arrangement and/or location of entrances or passageways, doors and doorways, corridors, elevators, stairs, washrooms or public portions of the Building, and to close entrances, doors, corridors, elevators or other facilities, provided that such action shall not materially and adversely interfere with Tenant’s access to the Premises or the Building; (7) to have access for Landlord and other tenants of the Building to any mail chutes and boxes located in or on the Premises as required by any applicable rules of the United States Post Office; and (8) to close the Building after Standard Operating Hours, except that Tenant and its employees and invitees shall be entitled to admission at all times, under such regulations as Landlord prescribes for security purposes.

 

ARTICLE TWENTY

ESTOPPEL CERTIFICATE

 

20.01                 IN GENERAL

 

Within fifteen (15) days after request therefor by Landlord, Mortgagee or any prospective mortgagee or owner, Tenant agrees as directed in such request to execute an Estoppel Certificate in recordable form, binding upon Tenant, certifying (i) that this Lease is unmodified and in full force and effect (or if there have been modifications, a description of such modifications and that this Lease as modified is in full force and effect); (ii) the dates to which Rent has been paid; (iii) that Tenant is in the possession of the Premises if that is the case; (iv) that Landlord is not in default under this Lease, or, if Tenant believes Landlord is in default, the nature thereof in detail; (v) that Tenant has no offsets or defenses to the performance of its obligations under this Lease (or if Tenant believes there are any offsets or defenses, a full and complete explanation thereof); (vi) that the Premises have been completed in accordance with the terms and provisions hereof, that Tenant has accepted the Premises and the condition thereof and of all improvements thereto and has no claims against Landlord or any other party with respect thereto; (vii) that if an assignment of rents or leases has been served upon the Tenant by a Mortgagee, Tenant will acknowledge receipt thereof and agree to be bound by the provisions thereof; (viii) that Tenant will give to the Mortgagee copies of all notices required or permitted to be given by Tenant to Landlord; and (ix) to any other information reasonably requested.

 

20.02                 ENFORCEMENT

 

In the event that Tenant fails to deliver an Estoppel Certificate within three (3) business days after Tenant has received notice from Landlord of Tenant’s failure to deliver an Estoppel Certificate within the time prescribed in Section 20.01 above, then such failure shall be a Default for which there shall be no additional cure or grace period. In addition to any other remedy available to Landlord, Landlord may impose a charge equal to $500.00 for each day that Tenant fails to

 

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deliver an Estoppel Certificate and Tenant shall be deemed to have irrevocably appointed Landlord as Tenant’s attorney-in-fact to execute and deliver the subject Estoppel Certificate that Tenant has failed to deliver.

 

ARTICLE TWENTY-ONE

INTENTIONALLY OMITTED

 

ARTICLE TWENTY-TWO

REAL ESTATE BROKERS

 

Landlord and Tenant represent to each other that in connection with this Lease they are represented by Tenant’s Broker identified in Section 1.01(19) and Landlord’s Broker identified in Section 1.01(19), and that except for Tenant’s Broker and Landlord’s Broker, neither has dealt with any real estate broker, sales person, or finder in connection with this Lease, and no such person initiated or participated in the negotiation of this Lease. Landlord and Tenant hereby indemnify and agree to protect, defend and hold the other harmless from and against all claims, losses, damages, liability, costs and expenses (including, without limitation, reasonable attorneys’ fees and expenses) by virtue of any broker, agent or other person claiming a commission or other form of compensation by virtue of alleged representation of, or dealings or discussions with, Landlord or Tenant, as applicable, with respect to the subject matter of this Lease, except for Landlord’s Broker and except for a commission payable to Tenant’s Broker to the extent provided for in a separate written agreement between Tenant’s Broker and Landlord’s Broker. Tenant is not obligated to pay or fund any amount to Landlord’s Broker, and Landlord hereby agrees to pay such commission, if any, to which Landlord’s Broker is entitled in connection with the subject matter of this Lease pursuant to Landlord’s separate written agreement with Landlord’s Broker. Such commission shall include an amount to be shared by Landlord’s Broker with Tenant’s broker to the extent that Tenant’s Broker and Landlord’s Broker have entered into a separate agreement between themselves to share the commission paid to Landlord’s Broker by Landlord. The provisions of this Section shall survive the expiration or earlier termination of the Lease.

 

ARTICLE TWENTY-THREE

MORTGAGEE PROTECTION

 

23.01                 SUBORDINATION AND ATTORNMENT

 

This Lease is and shall be expressly subject and subordinate at all times to (i) any ground or underlying lease of the Real Property, now or hereafter existing, and all amendments, extensions, renewals and modifications to any such lease, and (ii) the lien of any mortgage or trust deed now or hereafter encumbering fee title to the Real Property and/or the leasehold estate under any such lease, and all amendments, extensions, renewals, replacements and modifications of such mortgage or trust deed and/or the obligation secured thereby, unless such ground lease or ground lessor, or mortgage, trust deed or Mortgagee, expressly provides or elects that the Lease shall be superior to such lease or mortgage or trust deed. If any such mortgage or trust deed is foreclosed (including any sale of the Peal Property pursuant to a power of sale), or if any such lease is terminated, upon request of the Mortgagee or ground lessor, as the case may be, Tenant shall attorn to the purchaser at the foreclosure sale or to the ground lessor under such lease, as the case may be, provided, however, that such purchaser or ground lessor shall not be (i) bound by any payment of Rent for more than one month in advance except payments in the nature of security for the performance by Tenant of its obligations under this Lease; (ii) subject to any offset, defense or damages arising out of a default of any obligations of any preceding Landlord; or (iii) bound by any amendment or modification of this Lease made without the written consent of the Mortgagee or ground lessor; or (iv) liable for any security deposits not actually received in cash by such purchaser or ground lessor. This subordination shall be self-operative and no further certificate or instrument of subordination need be required by any such Mortgagee or ground lessor. In confirmation of such subordination, however, Tenant shall execute promptly any reasonable certificate or instrument that Landlord, Mortgagee or ground lessor may request. Tenant hereby constitutes Landlord as Tenant’s attorney-in-fact to execute such certificate or instrument for and on behalf of Tenant upon Tenant’s failure to do so within fifteen (15) days of a request to do so. Upon request by such successor in interest, Tenant shall execute and deliver reasonable instruments confirming the attornment provided for herein.

 

23.02                 MORTGAGEE PROTECTION

 

Tenant agrees to give any Mortgagee or ground lessor, by registered or certified mail, a copy of any notice of default served upon the Landlord by Tenant, provided that prior to such notice Tenant has received notice (by way of service on Tenant of a copy of an assignment of rents and leases, or otherwise) of the address of such Mortgagee or ground lessor. Tenant further agrees that if Landlord shall have failed to cure such default within the time provided for in this Lease, then the Mortgagee or ground lessor shall have an additional thirty (30) days after receipt of notice thereof within which to cure such default or if such default cannot be cured within that time, then such additional notice time as may be necessary, if, within such thirty (30) days, any Mortgagee or ground lessor has commenced and is diligently pursuing the remedies necessary to cure such default (including commencement of foreclosure proceedings or other proceedings to acquire possession of the Real Property, if necessary to effect such cure). Such period of time shall be extended by any period within which such Mortgagee or ground lessor is prevented from commencing or pursuing such foreclosure proceedings or other proceedings to acquire possession of the Real Property by reason of Landlord’s bankruptcy. Until the time allowed as aforesaid for Mortgagee or ground lessor to cure such defaults has expired without cure, Tenant shall have no right to, and shall not, terminate this Lease on account of default. This Lease may not be modified or amended so as to reduce the Rent or shorten the Term, or so as to adversely affect in any other respect to any material extent the rights of the Landlord, nor shall this Lease be canceled or surrendered, without the prior written consent, in each instance, of the ground lessor or the Mortgagee.

 

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ARTICLE TWENTY-FOUR

NOTICES

 

(a)                                 All notices, demands or requests provided for or permitted to be given pursuant to this Lease must be in writing and shall be personally delivered, sent by Federal Express or other reputable overnight courier service, or mailed by first class, registered or certified United States mail, return receipt requested, postage prepaid.

 

(b)                                 All notices, demands or requests to be sent pursuant to this Lease shall be deemed to have been properly given or served by delivering or sending the same in accordance with this Section, addressed to the parties hereto at their respective addresses listed in Sections 1.01(2) and (3).

 

(c)                                  Notices, demands or requests sent by mail or overnight courier service as described above shall be effective upon deposit in the mail or with such courier service. However, the time period in which a response to any such notice, demand or request must be given shall commence to run from (i) in the case of delivery by mail, the date of receipt on the return receipt of the notice, demand or request by the addressee thereof, or (ii) in the case of delivery by Federal Express or other overnight courier service, the date of acceptance of delivery by an employee, officer, director or partner of Landlord or Tenant. Rejection or other refusal to accept or the inability to deliver because of changed address of which no notice was given, as indicated by advice from Federal Express or other overnight courier service or by mail return receipt, shall be deemed to be receipt of notice, demand or request sent. Notices may also be served by personal service upon any officer, director or partner of Landlord or Tenant, and shall be effective upon such service.

 

(d)                                 By giving to the other party at least thirty (30) days written notice thereof, either party shall have the right from time to time during the term of this Lease to change their respective addresses for notices, statements, demands and requests, provided such new address shall be within the United States of America.

 

ARTICLE TWENTY-FIVE

EXERCISE FACILITY

 

Tenant agrees to inform all employees of Tenant of the following: (i) the exercise facility is available for the use of the employees of tenants of the Project only and for no other person; (ii) use of the facility is at the risk of Tenant or Tenant’s employees, and all users must sign a release; (iii) the facility is unsupervised; and (iv) users of the facility must report any needed equipment maintenance or any unsafe conditions to the Landlord immediately. Landlord may discontinue providing such facility at Landlord’s sole option at any time without incurring any liability. As a condition to the use of the exercise facility, Tenant and each of Tenant’s employees that uses the exercise facility shall first sign a written release in form and substance acceptable to Landlord. Landlord may change the rules and/or hours of the exercise facility at any time, and Landlord reserves the right to deny access to the exercise facility to anyone due to misuse of the facility or noncompliance with rules and regulations of the facility. To the extent permitted by Law, Tenant hereby indemnifies, and agrees to protect, defend and hold the Indemnitees harmless, against any and all actions, claims, demands, liability, costs and expenses, including reasonable attorneys’ fees and expenses for the defense thereof, arising from use of the exercise facility in the Project by Tenant, Tenant’s employees or invitees, except to the extent due to the gross negligence or willful and wrongful act of Landlord or Indemnitees. In case of any action or proceeding brought against the Indemnitees by reason of any such claim, upon notice from Landlord, Tenant covenants to defend such action or proceeding by counsel chosen by Landlord, in Landlord’s sole discretion. Landlord reserves the right to settle, compromise or dispose of any and all actions, claims and demands related to the foregoing indemnity.

 

ARTICLE TWENTY-SIX

OFAC

 

Landlord advises Tenant hereby that the purpose of this Article is to provide to the Landlord information and assurances to enable Landlord to comply with the law relating to OFAC.

 

Tenant hereby represents, warrants and covenants to Landlord, either that (i) Tenant is regulated by the SEC, FINRA or the Federal Reserve (a “Regulated Entity”) or (ii) neither Tenant nor any person or entity that directly or indirectly (a) controls Tenant or (b) has an ownership interest in Tenant of twenty-five percent (25%) or more, appears on the list of Specially Designated Nationals and Blocked Persons (“OFAC List”) published by the Office of Foreign Assets Control (“OFAC”) of the U.S. Department of the Treasury.

 

If, in connection with this Lease, there is one or more Guarantors of Tenant’s obligations under this Lease, then Tenant further represents, warrants and covenants either that (i) any such Guarantor is a Regulated Entity or (ii) neither Guarantor nor any person or entity that directly or indirectly (a) controls such Guarantor or (b) has an ownership interest in such Guarantor of twenty-five percent (25%) or more, appears on the OFAC List.

 

Tenant covenants that during the term of this Lease to provide to Landlord information reasonably requested by Landlord including without limitation, organizational structural charts and organizational documents which Landlord may deem to be necessary (“Tenant OFAC Information”) in order for Landlord to confirm Tenant’s continuing compliance with the provisions of this Article. Tenant represents and warrants that the Tenant OFAC Information it has provided or to be provided to Landlord or Landlord’s Broker in connection with the execution of this Lease is true and complete.

 

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ARTICLE TWENTY-SEVEN

MISCELLANEOUS

 

27.01                 LATE CHARGES

 

(a)                                 The Monthly Base Rent, Rent Adjustments and Rent Adjustment Deposits shall be due when and as specifically provided above. Except for such payments and late charges described below, which late charge shall be due when provided below (without notice or demand), all other payments required hereunder to Landlord shall be paid within ten (10) days after Landlord’s demand therefor. All Rent and charges, except late charges, not paid when due shall bear interest from the date due until the date paid at the Default Rate in effect on the date such payment was due.

 

(b)                                 In the event Tenant is more than five (5) days late in paying any installment of Rent due under this Lease, Tenant shall pay Landlord a late charge equal to five percent (5%) of the delinquent installment of Rent. The parties agree that (i) such delinquency will cause Landlord to incur costs and expenses not contemplated herein, the exact amount of which will be difficult to calculate, including the cost and expense that will be incurred by Landlord in processing each delinquent payment of rent by Tenant, and (ii) the amount of such late charge represents a reasonable estimate of such costs and expenses and that such late charge shall be paid to Landlord for each delinquent payment in addition to all Rent otherwise due hereunder. The parties further agree that the payment of late charges and the payment of interest provided for in subparagraph (a) above are distinct and separate from one another in that the payment of interest is to compensate Landlord for its inability to use the money improperly withheld by Tenant, while the payment of late charges is to compensate Landlord for its additional administrative expenses in handling and processing delinquent payments.

 

(c)                                  Payment of interest at the Default Rate and/or of late charges shall not excuse or cure any default by Tenant under this Lease, nor shall the foregoing provisions of this Article or any such payments prevent Landlord from exercising any right or remedy available to Landlord upon Tenant’s failure to pay Rent when due, including the right to terminate this Lease.

 

27.02                 NO JURY TRIAL; VENUE; JURISDICTION

 

Each party hereto (which includes any assignee, successor, heir or personal representative of a party) shall not seek a jury trial, hereby waives trial by jury, and hereby further waives any objection to venue in the County in which the Project is located, and agrees and consents to personal jurisdiction of the courts of the State of California, in any action or proceeding or counterclaim brought by any party hereto against the other on any matter whatsoever arising out of or in any way connected with this Lease, the relationship of Landlord and Tenant, Tenant’s use or occupancy of the Premises, or any claim of injury or damage, or the enforcement of any remedy under any statute, emergency or otherwise, whether any of the foregoing is based on this Lease or on tort law. No party will seek to consolidate any such action in which a jury has been waived with any other action in which a jury trial cannot or has not been waived. It is the intention of the parties that these provisions shall be subject to no exceptions. By execution of this Lease the parties agree that this provision may be filed by any party hereto with the clerk or judge before whom any action is instituted, which filing shall constitute the written consent to a waiver of jury trial pursuant to and in accordance with Section 631 of the California Code of Civil Procedure. No party has in any way agreed with or represented to any other party that the provisions of this Section will not be fully enforced in all instances. The provisions of this Section shall survive the expiration or earlier termination of this Lease.

 

27.03                 DEFAULT UNDER OTHER LEASE

 

It shall be a Default under this Lease if Tenant or any Affiliate holding any other lease with Landlord for premises in the Project defaults under such lease and as a result thereof such lease is terminated or terminable.

 

27.04                 OPTION

 

This Lease shall not become effective as a lease or otherwise until executed and delivered by both Landlord and Tenant. The submission of the Lease to Tenant does not constitute a reservation of or option for the Premises, but when executed by Tenant and delivered to Landlord, the Lease shall constitute an irrevocable offer by Tenant in effect for fifteen (15) days to lease the Premises on the terms and conditions herein contained.

 

27.05                 TENANT AUTHORITY

 

Tenant represents and warrants to Landlord that it has full authority and power to enter into and perform its obligations under this Lease, that the person executing this Lease is fully empowered to do so, and that no consent or authorization is necessary from any third party. Landlord may request that Tenant provide Landlord evidence of Tenant’s authority.

 

27.06                 ENTIRE AGREEMENT

 

This Lease, the Exhibits and Riders attached hereto contain the entire agreement between Landlord and Tenant concerning the Premises and there are no other agreements, either oral or written, and no other representations or statements, either oral or written, on which Tenant has relied. This Lease shall not be modified except by a writing executed by Landlord and Tenant.

 

28



 

27.07                 MODIFICATION OF LEASE FOR BENEFIT OF MORTGAGEE

 

If Mortgagee of Landlord requires a modification of this Lease which shall not result in any increased cost or expense to Tenant or in any other material and adverse change in the rights and obligations of Tenant hereunder, then Tenant agrees that the Lease may be so modified.

 

27.08                 EXCULPATION

 

Tenant agrees, on its behalf and on behalf of its successors and assigns, that any liability or obligation of Landlord in connection with this Lease shall only be enforced against Landlord’s equity interest in the Property up to a maximum of Five Million Dollars ($5,000,000.00) and in no event against any other assets of the Landlord, or Landlord’s officers or directors or partners, and that any liability of Landlord with respect to this Lease shall be so limited and Tenant shall not be entitled to any judgment in excess of such amount.

 

27.09                 ACCORD AND SATISFACTION

 

No payment by Tenant or receipt by Landlord of a lesser amount than any installment or payment of Rent due shall be deemed to be other than on account of the amount due, and no endorsement or statement on any check or any letter accompanying any check or payment of Rent shall be deemed an accord and satisfaction, and Landlord may accept such check or payment without prejudice to Landlord’s right to recover the balance of such installment or payment of Rent or pursue any other remedies available to Landlord. No receipt of money by Landlord from Tenant after the termination of this Lease or Tenant’s right of possession of the Premises shall reinstate, continue or extend the Term. Receipt or acceptance of payment from anyone other than Tenant, including an assignee of Tenant, is not a waiver of any breach of Article Ten, and Landlord may accept such payment on account of the amount due without prejudice to Landlord’s right to pursue any remedies available to Landlord.

 

27.10                 LANDLORD’S OBLIGATIONS ON SALE OF BUILDING

 

In the event of any sale or other transfer of the Building, Landlord shall be entirely freed and relieved of all agreements and obligations of Landlord hereunder accruing or to be performed after the date of such sale or transfer (provided, however, that Landlord shall not be freed and relieved of its obligation for reimbursement of the Security to Tenant unless Landlord has transferred to such transferee the unapplied balance of Tenant’s Security held by Landlord at such time), and any remaining liability of Landlord with respect to this Lease shall be limited to Five Million Dollars ($5,000,000.00) and Tenant shall not be entitled to any judgment in excess of such amount.

 

27.11                 BINDING EFFECT

 

Subject to the provisions of Article Ten, this Lease shall be binding upon and inure to the benefit of Landlord and Tenant and their respective heirs, legal representatives, successors and permitted assigns.

 

27.12                 CAPTIONS

 

The Article and Section captions in this Lease are inserted only as a matter of convenience and in no way define, limit, construe, or describe the scope or intent of such Articles and Sections.

 

27.13                 TIME; APPLICABLE LAW; CONSTRUCTION

 

Time is of the essence of this Lease and each and all of its provisions. This Lease shall be construed in accordance with the Laws of the State of California. If more than one person signs this Lease as Tenant, the obligations hereunder imposed shall be joint and several. If any term, covenant or condition of this Lease or the application thereof to any person or circumstance shall, to any extent, be invalid or unenforceable, the remainder of this Lease, or the application of such term, covenant or condition to persons or circumstances other than those as to which it is held invalid or unenforceable, shall not be affected thereby and each item, covenant or condition of this Lease shall be valid and be enforced to the fullest extent permitted by Law. Wherever the term “including” or “includes” is used in this Lease, it shall have the same meaning as if followed by the phrase “but not limited to”. The language in all parts of this Lease shall be construed according to its normal and usual meaning and not strictly for or against either Landlord or Tenant.

 

27.14                 ABANDONMENT

 

In the event Tenant vacates or abandons the Premises but is otherwise in compliance with all the terms, covenants and conditions of this Lease, Landlord shall (i) have the right to enter into the Premises in order to show the space to prospective tenants, (ii) have the right to reduce the services provided to Tenant pursuant to the terms of this Lease to such levels as Landlord reasonably determines to be adequate services for an unoccupied premises and (iii) during the last six (6) months of the Term, have the right to prepare the Premises for occupancy by another tenant upon the end of the Term. Tenant expressly acknowledges that in the absence of written notice pursuant to Section 11.02(b) or pursuant to California Civil Code Section 1951.3 terminating Tenant’s right to possession, none of the foregoing acts of Landlord or any other act of Landlord shall constitute a termination of Tenant’s right to possession or an acceptance of Tenant’s surrender of the Premises, and the Lease shall continue in effect.

 

27.15                 LANDLORD’S RIGHT TO PERFORM TENANT’S DUTIES

 

If Tenant fails timely to perform any of its duties under this Lease, Landlord shall have the right (but not the obligation), to perform such duty on behalf and at the expense of Tenant without prior notice to Tenant, and all sums expended or expenses incurred by Landlord in performing such duty shall be deemed to be additional Rent under this Lease and shall be due and payable upon demand by Landlord.

 

29



 

27.16                 SECURITY SYSTEM

 

Landlord shall not be obligated to provide or maintain any security patrol or security system. Landlord shall not be responsible for the quality of any such patrol or system which may be provided hereunder or for damage or injury to Tenant, its employees, invitees or others due to the failure, action or inaction of such patrol or system.

 

27.17                 NO LIGHT, AIR OR VIEW EASEMENTS

 

Any diminution or shutting off of light, air or view by any structure which may be erected on lands of or adjacent to the Project shall in no way affect this Lease or impose any liability on Landlord.

 

27.18                 RECORDATION

 

Neither this Lease, nor any notice nor memorandum regarding the terms hereof, shall be recorded by Tenant. Any such unauthorized recording shall be a Default for which there shall be no cure or grace period. Tenant agrees to execute and acknowledge, at the request of Landlord, a memorandum of this Lease, in recordable form.

 

27.19                 SURVIVAL

 

The waivers of the right of jury trial, the other waivers of claims or rights, the releases and the obligations of Tenant under this Lease to indemnify, protect, defend and hold harmless Landlord and/or Indemnitees shall survive the expiration or termination of this Lease, and so shall all other obligations or agreements which by their terms survive expiration or termination of the Lease.

 

27.20                 EXHIBITS OR RIDERS

 

All exhibits, riders and/or addenda referred to in this Lease as an exhibit, addenda or rider hereto or attached hereto, are hereby incorporated into and made a part of this Lease.

 

27.21                 DISCLOSURE REGARDING CERTIFIED ACCESS SPECIALIST

 

Pursuant to California Civil Code Section 1938, Landlord hereby notifies Tenant that as of the date of this Lease, the Premises has not undergone inspection by a “Certified Access Specialist” to determine whether the Premises meet all applicable construction-related accessibility standards under California Civil Code Section 55.53.

 

27.22                 UTILITY USAGE INFORMATION

 

If Tenant is billed directly by a public utility with respect to Tenant’s electrical usage at the Premises, then, upon request, Tenant shall provide monthly electrical utility usage for the Premises to Landlord for the period of time requested by Landlord (in electronic or paper format) or, at Landlord’s option, provide any written authorization or other documentation required for Landlord to request information regarding Tenant’s electricity usage with respect to the Premises directly from the applicable utility company.

 

[signature page follows]

 

30



 

IN WITNESS WHEREOF, this Lease has been executed as of the date set forth in Section 1.01(4) hereof.

 

TENANT:

 

LANDLORD:

 

 

 

GENOMIC HEALTH, INC.,

 

METROPOLITAN LIFE INSURANCE COMPANY,

a Delaware corporation

 

a New York corporation

 

 

 

 

 

 

By

/s/ Brad Cole

 

By

/s/ Joel R. Redmon

 

 

 

 

Joel R. Redmon

 

Brad Cole

 

 

Managing Director

 

Print name

 

 

Print name

Its

 

 

Its

 

(Chairman of Board, President or Vice President)

 

 

 

 

 

 

 

 

By

/s/ Dean Schorno

 

 

 

 

 

 

 

Dean Schorno

 

 

 

Print name

 

 

Its

 

 

 

(Secretary, Assistant Secretary, CFO or Assistant Treasurer)

 

 

 

31



 

EXHIBIT A

Plan of Premises

 

 

Exhibit A - Page 1



 

EXHIBIT B

WORKLETTER AGREEMENT

 

This Workletter Agreement (“Workletter”) is attached to and a part of a certain Lease by and between Metropolitan Life Insurance Company, a New York corporation, as Landlord, and Genomic Health, Inc., a Delaware corporation, as Tenant, for the Premises (the “Lease”). Terms used herein and not defined herein shall have the meaning of such terms as defined elsewhere in the Lease. For purposes of this Workletter, references to “State” and “City” shall mean the State and City in which the Building is located.

 

1.                                      AS IS Condition: Delivery.

 

Landlord shall deliver the Premises broom clean in its current “as built” configuration with existing build-out of the tenant space, with the Premises and the Building (including the “Base Building”, as defined below) in their AS IS condition, without any express or implied representations or warranties of any kind by Landlord, its brokers, manager or agents, or the employees of any of them; and Landlord shall not have any obligation to construct or install any tenant improvements or alterations or to pay for any such construction or installation except to the extent expressly provided in this Workletter. For purposes hereof, the “Base Building” (sometimes also referred to as the “Base Building Work”) shall mean the improvements made and work performed during the Building’s initial course of construction and modifications thereto, excluding all original and modified build-outs of any tenant spaces.

 

Notwithstanding any provision of this Workletter or the Lease to the contrary, if and to the extent that upon delivery of the Premises,

 

(i) the roof and roof membrane above the Premises;

 

(ii) foundation (excluding slab) and structural components of the Base Building;

 

(iii) Landlord’s fire sprinkler and life-safety systems, if any, of the Base Building; and

 

(iv) the electrical, water, sewer and plumbing systems of the Base Building serving the Premises (but only from the local utility’s systems to the point of entry into the Premises or to the meter or other point after which such system serves exclusively the Premises).

 

are not in good working order and condition, and if and to the extent that there is any water damage to the walls, hard lid ceilings or ceiling tiles, except to the extent any of the foregoing are to be removed, demolished or altered by Tenant, and within twenty (20) days after the Delivery Date (as defined in Section 2 of Rider 2) Tenant gives Landlord written notice specifying what is not in good operating condition, Landlord shall make necessary repairs to put such item or items in good operating condition; provided, however, that Landlord shall have no obligation under this paragraph to the extent any of the foregoing conditions are caused by or resulting from any act or omission of Tenant or any of Tenant’s contractors, employees, agents, customers or invitees, including, without limitation, any work performed by or on behalf of Tenant.

 

2.                                      Landlord Work.

 

Landlord shall have no obligation to perform any work.

 

3.                                      Tenant’s Plans.

 

3.1.                            Description. At its expense, Tenant shall employ:

 

(i) one or more architects reasonably satisfactory to Landlord and licensed by the State (“Tenant’s Architect”) to prepare architectural drawings and specifications for all layout and Premises improvements not included in, or requiring any change or addition to, the AS IS condition and Landlord Work, if any.

 

(ii) one or more engineers reasonably satisfactory to Landlord and licensed by the State (“Tenant’s Engineers”) to prepare structural, mechanical and electrical working drawings and specifications for all Premises improvements not included in, or requiring any change or addition to, the AS IS condition and Landlord Work, if any.

 

All such drawings and specifications are referred to herein as “Tenant’s Plans”. Tenant’s Plans shall be in form and detail sufficient to secure all applicable governmental approvals. Tenant’s Architect shall be responsible for coordination of all engineering work for Tenant’s Plans and shall coordinate with any consultants retained by Tenant in connection with the design and installation of improvements to the Premises (the use of such consultants is subject to Landlord’s consent), and Landlord’s architect or other representative to assure the consistency of Tenant’s Plans with the Base Building Work and Landlord Work (if any).

 

Tenant shall pay Landlord, within ten (10) days of receipt of each invoice from Landlord, the cost incurred by Landlord for Landlord’s architects and engineers to review Tenant’s Plans for consistency of same with the Base Building Work and Landlord Work, if any. Tenant’s Plans shall also include the following:

 

(a)                                 Final Space Plan: The “Final Space Plan” for the Premises shall include a full and accurate description of room titles, floor loads, alterations to the Base Building or Landlord Work (if any) or requiring any change or addition to the AS IS condition, and the dimensions and location of all partitions, doors, aisles, plumbing (and furniture and equipment to the extent same affect floor loading). The Final Space Plan shall (i) be compatible with the design, construction, systems and equipment of the Base Building and Landlord Work,

 

Exhibit B - 1



 

if any; (ii) specify only materials, equipment and installations which are new and of a grade and quality no less than existing components of the Building when they were originally installed (collectively, (i) and (ii) may be referred to as “Building Standard” or “Building Standards”); (iii) comply with Laws, (iv) be capable of logical measurement and construction, and (v) contain all such information as may be required for the preparation of the Mechanical and Electrical Working Drawings and Specifications (including, without limitation, a capacity and usage report, from engineers designated by Landlord pursuant to Section 3.1(b). below, for all mechanical and electrical systems in the Premises).

 

(b)                                 Mechanical and Electrical Working Drawings and Specifications: Tenant shall employ engineers approved by Landlord to prepare Mechanical and Electrical Working Drawings and Specifications showing complete plans for electrical, life safety, automation, plumbing, water, and air cooling, ventilating, heating and temperature control and shall employ engineers designated by Landlord to prepare for Landlord a capacity and usage report (“Capacity Report”) for all mechanical and electrical systems in the Premises.

 

(c)                                  Issued for Construction Documents: The “Issued for Construction Documents” shall consist of all drawings (1/8” scale) and specifications necessary to construct all Premises improvements including, without limitation, architectural and structural working drawings and specifications and Mechanical and Electrical Working Drawings and Specifications and all applicable governmental authorities plan check corrections.

 

3.2.                            Approval by Landlord. Tenant’s Plans and any revisions thereof shall be subject to Landlord’s approval, which approval or disapproval:

 

(i) shall not be unreasonably withheld, provided however, that Landlord may disapprove Tenant’s Plans in its sole and absolute discretion if they (a) adversely affect the structural integrity of the Building, including applicable floor loading capacity; (b) adversely affect any of the Building Systems (as defined below), the Common Areas or any other tenant space (whether or not currently occupied); (c) fail to fully comply with Laws, (d) affect the exterior appearance of the Building; (e) provide for improvements which do not meet or exceed the Building Standards; or (f) involve any installation on the roof, or otherwise affect the roof, roof membrane or any warranties regarding either. Building Systems collectively shall mean the structural, electrical, mechanical (including, without limitation, heating, ventilating and air conditioning), plumbing, fire and life-safety (including, without limitation, fire protection system and any fire alarm), communication, utility, gas (if any), and security (if any) systems in the Building.

 

(ii) shall not be delayed beyond ten (10) business days with respect to initial submissions and major change orders (those which impact Building Systems or any other item listed in subpart (i) of Section 3.2 above) and beyond five (5) business days with respect to required revisions and any other change orders.

 

If Landlord disapproves of any of Tenant’s Plans, Landlord shall advise Tenant of what Landlord disapproves in reasonable detail. After being so advised by Landlord, Tenant shall submit a redesign, incorporating the revisions required by Landlord, for Landlord’s approval. The approval procedure shall be repeated as necessary until Tenant’s Plans are ultimately approved. Approval by Landlord shall not be deemed to be a representation or warranty by Landlord with respect to the safety, adequacy, correctness, efficiency or compliance with Laws of Tenant’s Plans. Tenant shall be fully and solely responsible for the safety, adequacy, correctness and efficiency of Tenant’s Plans and for the compliance of Tenant’s Plans with any and all Laws.

 

3.3.                            Landlord Cooperation. Landlord shall cooperate with Tenant and make good faith efforts to coordinate Landlord’s construction review procedures to expedite the planning, commencement, progress and completion of Tenant Work. Landlord shall complete its review of each stage of Tenant’s Plans and any revisions thereof and communicate the results of such review within the time periods set forth in Section 3.2 above.

 

3.4.                            City Requirements. Any changes in Tenant’s Plans which are made in response to requirements of the applicable governmental authorities and/or changes which affect the Base Building Work shall be immediately submitted to Landlord for Landlord’s review and approval.

 

3.5.                            “As-Built” Drawings and Specifications. A CADD-DXF diskette file and a set of black line drawings of all “as-built” drawings and specifications of Tenant’s Work in the Premises (reflecting all field changes and including, without limitation, architectural, structural, mechanical and electrical drawings and specifications) prepared by Tenant’s Architect and Engineers or by Contractors (defined below) shall be delivered by Tenant at Tenant’s expense to the Landlord within thirty (30) days after completion of the Tenant Work. If Landlord has not received such drawings and diskette(s) within thirty (30) days, Landlord may give Tenant written notice of such failure. If Tenant does not produce the drawings and diskette(s) within ten (10) days after Landlord’s written notice, Landlord may, at Tenant’s sole cost which may be deducted from the Allowance, produce the drawings and diskette(s) using Landlord’s personnel, managers, and outside consultants and contractors. Landlord shall receive an hourly rate reasonable for such production.

 

4.                                      Tenant Work.

 

4.1.                            Tenant Work Defined. All tenant improvement work required by the Issued for Construction Documents (including, without limitation, any approved changes, additions or alterations pursuant to Section 7 below) is referred to in this Workletter as “Tenant Work.”

 

4.2.                            Tenant to Construct. Tenant shall construct all Tenant Work pursuant to this Workletter, and except to the extent modified by or inconsistent with express provisions of this Workletter, pursuant with the provisions of the

 

Exhibit B - 2



 

terms and conditions of Article Nine of the Lease, governing Tenant Alterations (except to the extent modified by this Workletter) and all such Tenant Work shall be considered “Tenant Alterations” for purposes of the Lease.

 

4.3.                            Construction Contract. All contracts and subcontracts for Tenant Work shall include any terms and conditions reasonably required by Landlord.

 

4.4.                            Contractor. Tenant shall select one or more contractors to perform the Tenant Work (“Contractor”) subject to Landlord’s prior written approval, which shall not unreasonably be withheld.

 

4.5.                            Division of Landlord Work and Tenant Work. Tenant Work is defined in Section 4.1. above and Landlord Work, if any, is defined in Section 2.

 

5.                                      Tenant’s Expense.

 

Tenant agrees to pay for all Tenant Work, including, without limitation, the costs of design thereof, whether or not all such costs are included in the “Permanent Improvement Costs” (defined below). Subject to the terms and conditions of this Workletter, Tenant shall apply the “Allowance” (defined below) to payment of the Permanent Improvement Costs. Landlord shall provide Tenant a tenant improvement allowance (“Allowance”) at the rate of Fifteen Dollars ($15.00) per square foot of Rentable Area of the Premises, of which Five Dollars ($5.00) ) per square foot shall be used only on replacement or repairs to the HVAC serving the Premises. The Allowance shall be used solely to reimburse Tenant for the Permanent Improvement Costs. The term “Permanent Improvement Costs” shall mean the actual and reasonable costs of construction of that Tenant Work which constitutes permanent improvements to the Premises, actual and reasonable costs of design thereof and governmental permits therefor, costs incurred by Landlord for Landlord’s architects and engineers pursuant to Section 3.1, and Landlord’s construction administration fee (defined in Section 8.10 below). Provided, however, Permanent Improvement Costs shall exclude costs of “Tenant’s FF&E” (defined below). For purposes of this Workletter, “Tenant’s FF&E” shall mean Tenant’s furniture, furnishings, telephone systems, computer systems, equipment, any other personal property or fixtures, and installation thereof, including, without limitation, “Tenant’s Personal Property” described on Exhibit G hereto. If Tenant does not utilize one hundred percent (100%) of the Allowance for Permanent Improvement Costs no later than the date that is one full calendar year following the Delivery Date, Tenant shall have no right to the unused portion of the Allowance.

 

6.                                      Application and Disbursement of the Allowance.

 

6.1.                            Tenant shall prepare a budget for all Tenant Work, including the Permanent Improvement Costs and all other costs of the Tenant Work (“Budget”), which Budget shall be subject to the reasonable approval of Landlord. Such Budget shall be supported by a guaranteed maximum price construction contract and such other documentation as Landlord may require to evidence the total costs. To the extent the Budget exceeds the available Allowance (“Excess Cost”), Tenant shall be solely responsible for payment of such Excess Cost. Further, prior to any disbursement of the Allowance by Landlord, Tenant shall pay and disburse its own funds for all that portion of the Permanent Improvement Costs equal to the sum of (a) the Permanent Improvement Costs in excess of the Allowance; plus (b) the amount of “Landlord’s Retention” (defined below). “Landlord’s Retention” shall mean an amount equal to fifteen percent (15%) of the Allowance, which Landlord shall retain out of the Allowance and shall not be obligated to disburse unless and until after Tenant has completed the Tenant Work and complied with Section 6.4 below. Further, Landlord shall not be obligated to make any disbursement of the Allowance unless and until Tenant has provided Landlord with (i) bills and invoices covering all labor and material expended and used in connection with the particular portion of the Tenant Work for which Tenant has requested reimbursement, (ii) an affidavit from Tenant stating that all of such bills and invoices have either been paid in full by Tenant or are due and owing, and all such costs qualify as Permanent Improvement Costs, (iii) contractors affidavit covering all labor and materials expended and used, (iv) Tenant, contractors and architectural completion affidavits (as applicable), and (v) valid mechanics’ lien releases and waivers pertaining to any completed portion of the Tenant Work which shall be conditional or unconditional, as applicable, all as provided pursuant to Section 6.2 and 6.4 below.

 

6.2.                            Upon Tenant’s full compliance with the provisions of Section 6, and if Landlord determines that there are no applicable or claimed stop notices (or any other statutory or equitable liens of anyone performing any of Tenant Work or providing materials for Tenant Work) or actions thereon, Landlord shall disburse the applicable portion of the Allowance as follows:

 

(a)                            In the event of conditional releases, to the respective contractor, subcontractor, vendor, or other person who has provided labor and/or services in connection with the Tenant Work, upon the following terms and conditions: (i) such costs are included in the Budget, are Permanent Improvement Costs, are covered by the Allowance, and Tenant has completed and delivered to Landlord a written request for payment, in form reasonably approved by Landlord, setting forth the exact name of the contractor, subcontractor or vendor to whom payment is to be made and the date and amount of the bill or invoice, (ii) the request for payment is accompanied by the documentation set forth in Section 6.1; and (iii) Landlord, or Landlord’s appointed representative, has inspected and approved the work for which Tenant seeks payment; or

 

(b)                                 In the event of unconditional releases, directly to Tenant upon the following terms and conditions: (i) Tenant seeks reimbursement for costs of Tenant Work which have been paid by Tenant, are included in the Budget, are Permanent Improvement Costs, and are covered by the Allowance; (ii) Tenant has completed and delivered to Landlord a request for payment, in form reasonably approved by Landlord, setting forth the name of the contractor, subcontractor or vendor paid and the date of payment, (iii) the request for payment is accompanied by the documentation set forth in Section 6.1; and (iv) Landlord, or Landlord’s appointed representative, has inspected and approved the work for which Tenant seeks reimbursement.

 

Exhibit B - 3



 

6.3.                            Tenant shall provide Landlord with the aforementioned documents by the 15th of the month and payment shall be made by the 30th day of the month following the month in which such documentation is provided.

 

6.4.                            Prior to Landlord disbursing the Landlord’s Retention to Tenant, Tenant shall submit to Landlord the following items within thirty (30) days after completion of the Tenant Work or such longer period as Landlord may permit: (i) “As Built” drawings and specifications pursuant to Section 3.5 above, (ii) all unconditional lien releases from all general contractor(s) and subcontractor(s) performing work, (iii) a “Certificate of Completion” prepared by Tenant’s Architect, and (iv) a final budget with supporting documentation detailing all costs associated with the Permanent Improvement Costs.

 

7.                                      Changes, Additions or Alterations.

 

If Tenant desires to make any non-de minimis change, addition or alteration or desires to make any change, addition or alteration to any of the Building Systems after approval of the Issued for Construction Documents, Tenant shall prepare and submit to Landlord plans and specifications with respect to such change, addition or alteration. Any such change, addition or alteration shall be subject to Landlord’s approval in accordance with the provisions of Section 3.2 of this Workletter. Tenant shall be responsible for any submission to and plan check and permit requirements of the applicable governmental authorities. Tenant shall be responsible for payment of the cost of any such change, addition or alteration if it would increase the Budget and Excess Cost previously submitted and approved pursuant to Section 6 above.

 

8.                                      Miscellaneous.

 

8.1.                            Scope. Except as otherwise set forth in the Lease, this Workletter shall not apply to any space added to the Premises by Lease option or otherwise.

 

8.2.                            Tenant Work shall include (at Tenant’s expense subject to application of the Allowance towards the costs of such items) for all of the Premises:

 

(a)                                 Landlord approved lighting sensor controls as necessary to meet applicable Laws;

 

(b)                                 Building Standard fluorescent fixtures in all Building office areas;

 

(c)                                  Building Standard meters for each of electricity and chilled water used by Tenant shall be connected to the Building’s system and shall be tested and certified prior to Tenant’s occupancy of the Premises by a State certified testing company;

 

(d)                                 Building Standard ceiling systems (including tile and grid) and;

 

(e)                                  Building Standard air conditioning distribution and Building Standard air terminal units.

 

8.3.                            Sprinklers. Subject to any terms, conditions and limitations set forth herein, Landlord shall provide an operative sprinkler system consisting of mains, laterals, and heads “AS IS” on the date of delivery of the Premises to Tenant. Tenant shall pay for piping distribution, drops and relocation of, or additional, sprinkler system heads and Building firehose or firehose valve cabinets, if Tenant’s Plans and/or any applicable Laws necessitate such.

 

8.4.                            Floor Loading. Floor loading capacity shall be within building design capacity. Tenant may exceed floor loading capacity with Landlord’s consent, at Landlord’s sole discretion and must, at Tenant’s sole cost and expense, reinforce the floor as required for such excess loading.

 

8.5.                            Work Stoppages. If any work on the Real Property other than Tenant Work is delayed, stopped or otherwise affected by construction of Tenant Work, Tenant shall immediately take those actions necessary or desirable to eliminate such delay, stoppage or effect on work on the Real Property other than Tenant Work.

 

8.6.                            Life Safety. Tenant (or Contractor) shall employ the services of a fire and life-safety subcontractor reasonably satisfactory to Landlord for all fire and life-safety work at the Building.

 

8.7.                            Locks. Tenant may purchase locks, cylinders and keys for the Premises from its own vendor, provided that (a) such vendor and the locks, cylinders and keys to be used are subject to Landlord’s prior written approval; (b) of a make and model which are functional, operable and compatible with Landlord’s master key system; (c) a master key or keys are provided to Landlord, of which Landlord may place one such master key in the “knox box” for use by the fire department and emergency personnel in the event of an emergency and may retain another key for Landlord’s use for entry permitted under the Lease; and (d) the contact information for Tenant’s vendor for locks, cylinders and keys used in the Premises shall be provided to Landlord with Tenant’s request for approval.

 

8.8.                            Authorized Representatives. Tenant has designated David Quinn to act as Tenant’s representative with respect to the matters set forth in this Workletter. Such representative(s) shall have full authority and responsibility to act on behalf of Tenant as required in this Workletter. Tenant may add or delete authorized representatives upon five (5) business days’ notice to Landlord.

 

8.9.                            Access to Premises. After Landlord has recovered possession of the Premises from any prior Tenant, prior to delivery of possession to Tenant, Tenant and its architects, engineers, consultants, and contractors shall have access at reasonable times and upon advance notice and coordination with the Building management, to the Premises for the purpose of planning Tenant Work. Such access shall not in any manner interfere with Landlord Work, if any. Such access, and all acts and omissions in connection with it, shall be subject to and

 

Exhibit B - 4



 

governed by all other provisions of the Lease, including, without limitation, Tenant’s indemnification obligations, insurance obligations, etc., except for the payment of Base Rent and Additional Rent. To the extent that such access by Tenant delays the Substantial Completion of the Landlord Work (if any), such delay shall be a Tenant Delay and the Landlord Work shall be deemed Substantially Complete on the date such Landlord Work would have been completed but for such access.

 

8.10.                     Fee. Landlord shall receive a fee equal to two percent (2.0%) of the Allowance for Landlord’s review and supervision of construction of the Tenant Work, which fee shall be paid by Landlord applying two percent (2.0%) of the Allowance in payment thereof. Such fee is in addition to Tenant’s reimbursement of costs incurred by Landlord pursuant to other provisions hereof, including, without limitation, for Landlord’s architects and engineers to review Tenant’s Plans.

 

9.                                      Force and Effect.

 

The terms and conditions of this Workletter shall be construed to be a part of the Lease and shall be deemed incorporated in the Lease by this reference. Should any inconsistency arise between this Workletter and the Lease as to the specific matters which are the subject of this Workletter, the terms and conditions of this Workletter shall control.

 

Exhibit B - 5



 

EXHIBIT “C”

SITE PLAN OF PROJECT

 

Phase III, its buildings and square footages are not a part of the Project as defined in this Lease, and are shown in this Exhibit for illustration only.

 

 

 

Phase I:

Buildings 1-8

 

 

Phase II:

Buildings 9-12, 27

 

 

Phase III:

Buildings 14-26

 

 

Exhibit C - Page 1



 

EXHIBIT D

PERMITTED HAZARDOUS MATERIAL

 

Permitted Hazardous Material includes insignificant amounts of substances listed below so long as (i) such substances are maintained only in such quantities as are reasonably necessary for Tenant’s operations in the Premises, or such other specific quantity limit as specified below, (ii) such substances are used, stored and handled strictly in accordance with the manufacturers’ instructions, industry standards and all applicable laws, (iii) such substances are not disposed of in or about the Building or the Project in a manner which would constitute a release or discharge thereof, and (iv) all such substances are removed from the Building and the Project by Tenant no later than the Termination Date.

 

Type:

 

Quantity:

 

 

 

Substances typically found or used in general office applications, to the extent the Premises is used for general offices

 

as noted above

 

Exhibit D - 1



 

TENANT CHEMICAL INVENTORY

MetLife Real Estate Investments — Attn: Regional Architect

Seaport Centre — Redwood City CA

425 Market St., #1050, San Francisco, CA 94105 (415) 536-1074 Fax: 536-1098

Rev 5/24/07

 

 

Tenant/Company Name: Genomic Health

Address:

701 Galveston Drive, Redwood City, CA 94063

Contact Name: David Quinn

Telephone:

650-569-2212 (o)/650-207-2812 (c)

 

PLEASE CHECK BELOW:

 

1. No: o  or  Yes x: ( if ‘No’, do not proceed further )

Do you use and/or store hazardous materials beyond typical household cleaning products ?

 

2. No: o  or  Yes x:

Have you, or do you plan to submit a ‘Hazardous Materials Business Plan? (San Mateo OES Form 2370) to the San Mateo County Environmental Health Services Division?

 

3. Please fill out the following for your list of chemicals (See OES Form 2731 for definitions and number references):

 

 

 

 

 

Physical

 

Single

 

Average

 

Max

 

Location(s) Stored:

 

 

 

 

State

 

Largest

 

Daily

 

Storage

 

(Interior, Exterior-

Common Name

 

Chemical Name

 

(Sol/Liq/Gas)

 

Container

 

Amount

 

Amount

 

existing shed, Exterior-

*(207)

 

*(205)

 

*(214)

 

*(215)

 

*(217)

 

*(218)

 

proposed shed, Other)

Acetic Acid

 

Acetic Acid

 

Liq

 

1 L

 

2 L

 

4 L

 

Interior

Americlear Clearing Solvent

 

(+/-)-Limonene

 

Liq

 

1 L

 

6 gal

 

10 gal

 

Interior

BlOstic Paraffin Removal Agent

 

BlOstic Paraffin Removal Agent

 

Liq

 

1 gal

 

1 gal

 

2 gal

 

Interior

Decane

 

Decane

 

Liq

 

1 gal

 

5 gal

 

10 gal

 

Interior

Diesel Fuel

 

Diesel Fuel

 

Liq

 

300 gal

 

280 gal

 

300 gal

 

Exterior. The generator set sits on top of an above-ground belly tank that can hold up to 300 gallons of diesel fuel

Envirene

 

Isoalkene

 

Liq

 

1 gal

 

1 gal

 

2 gal

 

Interior

Isoamyl Alcohol

 

Isoamyl Alcohol

 

Liq

 

1 L

 

1 L

 

1 L

 

Interior

Mineral Spirits

 

Aliphatic and alicyclic hydrocarbons

 

Liq

 

4 L

 

30 L

 

40 L

 

Interior

Paraclear Xylene Substitute

 

Petroleum Naptha

 

Liq

 

4 L

 

4 L

 

4 L

 

Interior

Shandon Xylene Substitute

 

Stoddard Solvent

 

Liq

 

1 gal

 

15 gal

 

20 gal

 

Interior

Soltrol 100

 

Isoparaffin

 

Liq

 

4 L

 

20 L

 

40 L

 

Interior

 

For Property Management Use:

o

 

Received Emergency Response Plan

 

Date Rec’d:

 

Comments:

 

o

 

Received Hazardous Materials Business Plan

 

Date Rec’d:

 

Comments:

 

o

 

Received Annual HazMat Certifications

 

Date Rec’d:

 

Comments:

 

 



 

TENANT CHEMICAL INVENTORY

MetLife Real Estate Investments — Attn: Regional Architect

Seaport Centre — Redwood City CA

425 Market St., #1050, San Francisco, CA 94105 (415) 536-1074 Fax: 536-1098

Rev 5/24/07

 

 

Soltrol 250

 

Isoparaffin

 

Liq

 

4 L

 

20 L

 

40 L

 

Interior

1, 3-Diaminopropane

 

1, 3-Diaminopropane

 

Liq

 

1 L

 

1 L

 

2 L

 

Interior

Ethylenediamine

 

Ethylenediamine

 

Liq

 

1 L

 

1 L

 

1 L

 

Interior

Diethyl pyrocarbonate

 

Diethyl pyrocarbonate

 

Liq

 

0.5 L

 

0.5 L

 

0.5 L

 

Interior

Dimethylsulfoxide

 

Dimethylsulfoxide

 

Liq

 

1 L

 

1 L

 

2 L

 

Interior

RNaseZap

 

RNaseZap

 

Liq

 

0.5 L

 

2 L

 

3.5 L

 

Interior

Slidebrite

 

Slidebrite

 

Liq

 

4 L

 

4 L

 

4 L

 

Interior

Soltrol 130

 

Isoparaffin

 

Liq

 

4 L

 

20 L

 

40 L

 

Interior

Triethylamine Acetate Buffer

 

Triethylammonium acetate

 

Liq

 

0.5 L

 

0.5 L

 

0.5 L

 

Interior

Accustain Xylene Substitute

 

Accustain Xylene Substitute

 

Liq

 

1 gal

 

1gal

 

2 gal

 

Interior

Tridecane

 

Tridecane

 

Liq

 

4 L

 

4 L

 

4 L

 

Interior

Ammonium Hydroxide Solution

 

Ammonium Hydroxide

 

Liq

 

0.5 L

 

0.5 L

 

0.5 L

 

Interior

Bradford Reagent

 

Phosphoric Acid Solution

 

Liq

 

0.5 L

 

0.5 L

 

0.5 L

 

Interior

Formic Acid

 

Formic Acid

 

Liq

 

1 L

 

1 L

 

1 L

 

Interior

Hydrochloric Acid

 

Hydrochloric Acid

 

Liq

 

4 L

 

4 L

 

6 L

 

Interior

N,N’-Dimethyl ethylenediamine

 

N,N’-Dimethyl ethylenediamine

 

Liq

 

0.025 kg

 

0.025 kg

 

0.025 kg

 

Interior

Perchloric Acid Solution

 

Perchloric Acid Solution

 

Liq

 

0.5 L

 

1 L

 

1 L

 

Interior

Phosphoric Acid Solution

 

Phosphoric Acid Solution

 

Liq

 

1 L

 

2 gal

 

2 gal

 

Interior

RNaseZap Wipes

 

RNaseZap

 

Liq

 

0.25 kg

 

1 kg

 

1 kg

 

Interior

Sodium Hydroxide Solution

 

Sodium Hydroxide

 

Liq

 

1 L

 

1.5 gal

 

2 gal

 

Interior

Spermidine

 

4-Azaoctamethylenediamine

 

Liq

 

0.05 kg

 

0.2 kg

 

0.5 kg

 

Interior

Trifluoroacetic Acid

 

Trifluoroacetic Acid

 

Liq

 

1 L

 

1 L

 

1 L

 

Interior

Monoethanolamine

 

Monoethanolamine

 

Liq

 

1 L

 

2 L

 

4 L

 

Interior

Chloroform/ Phenol/ Adipoyl Chloride Solution

 

Chloroform, Phenol and Adipoyl Chloride

 

Liq

 

0.4 L

 

2 gal

 

3 gal

 

Interior

Phenol/ Chloroform Solution

 

Phenol and Chloroform

 

Liq

 

0.4 L

 

2 gal

 

3 gal

 

Interior

Phenol

 

Phenol

 

Liq

 

1 L

 

2 L

 

4 L

 

Interior

Sodium Hydroxide, Pellets

 

Sodium Hydroxide

 

Sol

 

1 kg

 

1 kg

 

2 kg

 

Interior

Tris(2-carboxyethyl) — phosphine Hydrochloride

 

Tris(2-carboxyethyl) — phosphine Hydrochloride

 

Sol

 

0.01 kg

 

0.01 kg

 

0.01 kg

 

Interior

Dry Ice

 

Carbon Dioxide

 

Sol

 

250 Ib

 

200 Ib

 

250 Ib

 

Interior

Liquid Nitrogen

 

Nitrogen

 

Liq

 

400 L

 

720 L

 

720 L

 

Interior

Acetone

 

Acetone

 

Liq

 

1 L

 

4 L

 

4 L

 

Interior

 

For Property Management Use:

o

 

Received Emergency Response Plan

 

Date Rec’d:

 

 

Comments:

o

 

Received Hazardous Materials Business Plan

 

Date Rec’d:

 

 

Comments:

o

 

Received Annual HazMat Certifications

 

Date Rec’d:

 

 

Comments:

 



 

TENANT CHEMICAL INVENTORY

MetLife Real Estate Investments — Attn: Regional Architect

Seaport Centre — Redwood City CA

425 Market St., #1050, San Francisco, CA 94105 (415) 536-1074 Fax: 536-1098

Rev 5/24/07

 

 

Acetonitrile

 

Acetonitrile

 

Liq

 

2 L

 

12 L

 

16 L

 

Interior

Mounting Medium

 

Xylene or Butyl Methacrylate

 

Liq

 

1 L

 

2 gal

 

2 gal

 

Interior

(+/-) 2-Butanol

 

Butanol

 

Liq

 

0.5 L

 

1 L

 

2 L

 

Interior

2,2,4-Trimethyl pentane

 

2,2,4-Trimethyl pentane

 

Liq

 

1 L

 

2 L

 

4 L

 

Interior

Wash Buffer, RW1

 

Ethanol

 

Liq

 

1 L

 

1 L

 

1 L

 

Interior

Clear Advantage Xylene Substitute

 

Napthenic Hydrocarbon Blend

 

Liq

 

4 L

 

4 L

 

4 L

 

Interior

Cytoseal XYL, Mounting Medium

 

Xylenes

 

Liq

 

0.1 L

 

3 L

 

5 L

 

Interior

Eosin Y

 

2’,4’,5’,7’- Tetrabromofluorescein

 

Liq

 

0.05 kg

 

0.05 kg

 

0.05 kg

 

Interior

Eosin Y, 1% Alcoholic Solution

 

Eosin Y

 

Liq

 

1 gal

 

3 gal

 

7 gal

 

Interior

Ethyl Alcohol, 70-100%, Blends

 

Ethyl Alcohol

 

Liq

 

0.25 gal

 

120 gal

 

240 gal

 

Interior

EZ-DeWax, Tissue Deparaffinization Solution, Ready-to-Use

 

Isoparaffinic hydrocarbons

 

Liq

 

1 L

 

1 L

 

1 L

 

Interior

Harris Hematoxylin

 

Ethylene Glycol

 

Liq

 

1 gal

 

5 gal

 

10 gal

 

Interior

Isopropyl Alcohol

 

Isopropyl Alcohol

 

Liq

 

1 gal

 

75 gal

 

150 gal

 

Interior

Methyl Alcohol

 

Methyl Alcohol

 

Liq

 

1 L

 

4 L

 

8 L

 

Interior

Soltrol 10 Isoparaffin

 

Isoparaffin

 

Liq

 

1 L

 

20 L

 

40 L

 

Interior

Triethylamine

 

Triethylamine

 

Liq

 

1 L

 

1 L

 

2.5 L

 

Interior

Xylenes

 

o- m- and p-Xylene

 

Liq

 

1 gal

 

45 gal

 

90 gal

 

Interior

Isoamyl Acetate

 

Isoamyl Acetate

 

Liq

 

500 mL

 

1 L

 

1 L

 

Interior

n-Butanol

 

n-Butanol

 

Liq

 

500 mL

 

1 L

 

2 L

 

Interior

Xylene Substitute, Neo-Clear

 

Isoalkanes

 

Liq

 

1 L

 

20 L

 

40 L

 

Interior

Chloroform

 

Chloroform

 

Liq

 

1 L

 

3 L

 

6 L

 

Interior

Chloroform/lsoamyl Alcohol

 

Chloroform/lsoamyl Alcohol

 

Liq

 

500 mL

 

1 L

 

1 L

 

Interior

Ethidium Bromide Solution

 

Ethidium Bromide

 

Liq

 

100 mL

 

0.1 L

 

0.1 L

 

Interior

Tetramethylammonium Chloride Solution

 

Tetramethylammonium Chloride Solution

 

Liq

 

500 mL

 

1 L

 

2.5 L

 

Interior

Cis-Platinum (II) Diammine Dichloride

 

Cis-Platinum (II) Diammine Dichloride

 

Sol

 

1 g

 

2 g

 

5 g

 

Interior

 

For Property Management Use:

o

 

Received Emergency Response Plan

 

Date Rec’d:

 

Comments:

 

o

 

Received Hazardous Materials Business Plan

 

Date Rec’d:

 

Comments:

 

o

 

Received Annual HazMat Certifications

 

Date Rec’d:

 

Comments:

 

 



 

TENANT CHEMICAL INVENTORY

MetLife Real Estate Investments — Attn: Regional Architect

Seaport Centre — Redwood City CA

425 Market St., #1050, San Francisco, CA 94105 (415) 536-1074 Fax: 536-1098

Rev 5/24/07

 

 

Sodium Azide

 

Sodium Azide

 

Sol

 

0.05 kg

 

0.1 kg

 

0.1kg

 

Interior

Air, Compressed Gas

 

Air

 

Gas

 

300 ft3

 

1000 ft3

 

2000 ft3

 

Interior

 

For Property Management Use:

o

 

Received Emergency Response Plan

 

Date Rec’d:

 

Comments:

 

o

 

Received Hazardous Materials Business Plan

 

Date Rec’d:

 

Comments:

 

o

 

Received Annual HazMat Certifications

 

Date Rec’d:

 

Comments:

 

 



 

TENANT CHEMICAL INVENTORY

MetLife Real Estate Investments — Attn: Regional Architect

Seaport Centre — Redwood City CA

425 Market St., #1050, San Francisco, CA 94105 (415) 536-1074 Fax: 536-1098

Rev 5/24/07

 

 

Carbon Dioxide, Compressed Gas

 

Carbon Dioxide

 

Gas

 

300 ft3

 

1800 ft3

 

3700 ft3

 

Interior

Helium, Compressed Gas

 

Helium

 

Gas

 

300 ft3

 

600 ft3

 

900 ft3

 

Interior

Nitrogen, Compressed Gas

 

Nitrogen

 

Gas

 

300 ft3

 

600 ft3

 

1800 ft3

 

Interior

Hydrogen Peroxide, <30%

 

Hydrogen Peroxide

 

Liq

 

0.1 L

 

0.1 L

 

0.1 L

 

Interior

Bleach, Household

 

Sodium Hypochlorite

 

Liq

 

500 mL

 

10 L

 

20 L

 

Interior

Nitric Acid

 

Nitric Acid

 

Liq

 

1 L

 

2 L

 

4 L

 

Interior

Sodium Perchlorate

 

Sodium Perchlorate

 

Sol

 

500 g

 

1 kg

 

2.5 kg

 

Interior

1,4-Dithiothreitol

 

1,4-Dithiothreitol

 

Liq

 

0.025 L

 

0.05 L

 

0.1 L

 

Interior

2-Mercaptoethanol

 

2-Mercaptoethanol

 

Liq

 

0.25 L

 

0.5 L

 

1 L

 

Interior

DAB Chromagen

 

Diaminobenzidine

 

Liq

 

0.25 L

 

0.5 L

 

1 L

 

Interior

Formaldehyde Solutions (<12% formaldehyde)

 

Formaldehyde

 

Liq

 

1 gal

 

12 gal

 

24 gal

 

Interior

Formamide

 

Formamide

 

Liq

 

500 g

 

1 kg

 

2 L

 

Interior

Glutaraldehyde Solutions

 

Glutaraldehyde Solutions

 

Liq

 

1 gal

 

5 gal

 

10 gal

 

Interior

N,N-Dimethylformamide

 

N,N-Dimethylformamide

 

Liq

 

0.25 kg

 

0.5 kg

 

1 kg

 

Interior

Zenker’s Fixative Solution

 

Mercuric Chloride

 

Liq

 

1 gal

 

1 gal

 

2 gal

 

Interior

5-Fluorouracil

 

5-Fluorouracil

 

Sol

 

5 g

 

10 g

 

25 g

 

Interior

Actinomycin D-Mannitol

 

Actinomycin D-Mannitol

 

Sol

 

0.25 g

 

0.5 g

 

1 g

 

Interior

Carboplatin

 

Carboplatin

 

Sol

 

0.25 g

 

0.5 g

 

1 g

 

Interior

Diethylenetriaminepentaacetic Acid

 

Diethylenetriaminepentaacetic Acid

 

Sol

 

2.5 g

 

5 g

 

0.01 kg

 

Interior

Finasteride

 

Finasteride

 

Sol

 

0.25 g

 

0.5 g

 

1 g

 

Interior

Hexadecyltrimethylammonium Bromide

 

Hexadecyltrimethylammonium Bromide

 

Sol

 

0.25 kg

 

0.5 kg

 

1 kg

 

Interior

Lithium Chloride

 

Lithium Chloride

 

Sol

 

0.25 kg

 

0.25 kg

 

0.5 kg

 

Interior

o-Phenylenediamine

 

o-Phenylenediamine

 

Sol

 

100 mL

 

100 mL

 

0.25 L

 

Interior

Oxaliplatin

 

Oxaliplatin

 

Sol

 

100 mg

 

100 mg

 

250 mg

 

Interior

Picoplatin

 

Picoplatin

 

Sol

 

100 mg

 

100 mg

 

250 mg

 

Interior

Potassium Dichromate

 

Potassium Dichromate

 

Sol

 

0.25 kg

 

0.5 kg

 

1 kg

 

Interior

Phenylmethanesulfonyl Fluoride

 

Phenylmethanesulfonyl Fluoride

 

Sol

 

1 g

 

10 g

 

10 g

 

Interior

 


* For reference to Item number in OES Form 2731

 

For Property Management Use:

o

 

Received Emergency Response Plan

 

Date Rec’d:

 

Comments:

 

o

 

Received Hazardous Materials Business Plan

 

Date Rec’d:

 

Comments:

 

o

 

Received Annual HazMat Certifications

 

Date Rec’d:

 

Comments:

 

 



 

EXHIBIT E

FORM OF LETTER OF CREDIT ACCEPTABLE FROM SILICON VALLEY BANK

 

IRREVOCABLE STANDBY LETTER OF CREDIT NO. SVBSF

 

DATED:                 , 20

 

BENEFICIARY:

METROPOLITAN LIFE INSURANCE COMPANY

REAL ESTATE INVESTMENTS

425 MARKET STREET, SUITE 1050

SAN FRANCISCO, CA 94105

 

APPLICANT:

GENOMIC HEALTH, INC.

301 PENOBSCOT DRIVE

REDWOOD CITY, CA 94063

 

AMOUNT:                                    US$144,099.00 (One Hundred Forty-Four Thousand Ninety-Nine Dollars)

 

EXPIRATION DATE:                        , 201

 

LOCATION:                                                            AT OUR COUNTERS IN SANTA CLARA, CALIFORNIA

 

DEAR SIR/MADAM:

 

WE HEREBY ESTABLISH THIS IRREVOCABLE STANDBY LETTER OF CREDIT IN FAVOR OF THE AFORESAID ADDRESSEE (“BENEFICIARY”) FOR DRAWINGS UP TO US$305,919.45 (THREE HUNDRED FIVE THOUSAND NINE HUNDRED NINETEEN AND 45/100 DOLLARS) EFFECTIVE IMMEDIATELY. THIS LETTER OF CREDIT IS ISSUED, PRESENTABLE AND PAYABLE AT OUR OFFICE AT: 3003 TASMAN DRIVE, MAIL SORT HF210, SANTA CLARA, CA 95054 ATTENTION: GLOBAL FINANCIAL SERVICES — STANDBY LETTER OF CREDIT DEPARTMENT (THE BANK’S OFFICE), AND EXPIRES WITH OUR CLOSE OF BUSINESS ON                         , 201 .

 

THE TERM “BENEFICIARY” INCLUDES ANY SUCCESSOR BY OPERATION OF LAW OF THE NAMED BENEFICIARY INCLUDING, WITHOUT LIMITATION, ANY LIQUIDATOR, REHABILITATOR, RECEIVER OR CONSERVATOR.

 

WE HEREBY UNDERTAKE TO PROMPTLY HONOR YOUR SIGHT DRAFT(S) DRAWN ON US, INDICATING OUR CREDIT NO. SVBSF               , FOR ALL OR ANY PART OF THIS CREDIT IF PRESENTED AT OUR OFFICE SPECIFIED IN PARAGRAPH ONE ON OR BEFORE THE EXPIRY DATE OR ANY AUTOMATICALLY EXTENDED EXPIRY DATE TOGETHER WITH THE ORIGINAL LETTER OF CREDIT AND ALL AMENDMENTS, IF ANY.

 

EXCEPT AS EXPRESSLY STATED HEREIN, THIS UNDERTAKING IS NOT SUBJECT TO ANY AGREEMENT, CONDITION OR QUALIFICATION. THE OBLIGATION OF SILICON VALLEY BANK UNDER THIS LETTER OF CREDIT IS THE INDIVIDUAL OBLIGATION OF SILICON VALLEY BANK, AND IS IN NO WAY CONTINGENT UPON REIMBURSEMENT WITH RESPECT THERETO.

 

IT IS A CONDITION OF THIS LETTER OF CREDIT THAT IT IS DEEMED TO BE AUTOMATICALLY EXTENDED WITHOUT AMENDMENT FOR ONE YEAR FROM THE EXPIRY DATE HEREOF, OR ANY FUTURE EXPIRATION DATE, UNLESS AT LEAST THIRTY (30) DAYS PRIOR TO AN EXPIRATION DATE WE NOTIFY YOU BY REGISTERED MAIL/COURIER THAT WE ELECT NOT TO CONSIDER THIS LETTER OF CREDIT EXTENDED FOR ANY SUCH ADDITIONAL PERIOD.

 

PARTIAL DRAWS ARE ALLOWED.

 

THIS ORIGINAL LETTER OF CREDIT MUST ACCOMPANY ANY DRAWINGS HEREUNDER FOR ENDORSEMENT OF THE DRAWING AMOUNT AND WILL BE RETURNED TO THE BENEFICIARY UNLESS IT IS FULLY UTILIZED.

 

THIS LETTER OF CREDIT MAY BE TRANSFERRED ONE OR MORE TIMES BUT IN EACH INSTANCE TO A SINGLE BENEFICIARY AND ONLY IN THE FULL AMOUNT AVAILABLE TO BE DRAWN UNDER THIS LETTER OF CREDIT. ANY SUCH TRANSFER MAY BE EFFECTED ONLY UPON PRESENTATION TO US, THE ISSUING BANK, AT THE BANK’S OFFICE SPECIFIED IN THE FIRST PARAGRAPH ABOVE, OF THE ATTACHED EXHIBIT “A” DULY COMPLETED AND EXECUTED BY THE BENEFICIARY AND ACCOMPANIED BY THE ORIGINAL LETTER OF CREDIT AND ALL AMENDMENT(S), IF ANY. ANY TRANSFER OF THIS LETTER OF CREDIT MAY NOT CHANGE THE PLACE OF EXPIRATION OF THE LETTER OF CREDIT FROM OUR SPECIFIED OFFICE. EACH TRANSFER SHALL BE EVIDENCED BY OUR ENDORSEMENT ON THE REVERSE OF THE ORIGINAL LETTER OF CREDIT AND WE SHALL FORWARD THE ORIGINAL LETTER OF CREDIT SO ENDORSED TO THE TRANSFEREE. EACH SUCH TRANSFER WILL BE EFFECTED AT NO COST TO THE BENEFICIARY OR TRANSFEREE. OUR TRANSFER FEE 1/4 OF 1% OF THE TRANSFER

 

Exhibit E - 1



 

AMOUNT (MINIMUM US$250.00) WILL BE FOR THE ACCOUNT OF THE APPLICANT. HOWEVER, ANY TRANSFER IS NOT CONTINGENT UPON APPLICANT’S ABILITY TO PAY OUR TRANSFER FEE.

 

DRAFT(S) AND DOCUMENTS MUST INDICATE THE NUMBER AND DATE OF THIS LETTER OF CREDIT.

 

THIS LETTER OF CREDIT IS SUBJECT TO AND GOVERNED BY THE UNIFORM CUSTOMS AND PRACTICE FOR DOCUMENTARY CREDITS (1993 REVISION), INTERNATIONAL CHAMBER OF COMMERCE, PUBLICATION NO. 500 AND THE LAWS OF THE STATE OF NEW YORK AND, IN THE EVENT OF ANY CONFLICT, THE LAWS OF THE STATE OF NEW YORK WILL CONTROL. IF THIS CREDIT EXPIRES DURING AN INTERRUPTION OF BUSINESS AS DESCRIBED IN ARTICLE 17 OF SAID PUBLICATION 500, THE BANK HEREBY SPECIFICALLY AGREES TO EFFECT PAYMENT IF THIS CREDIT IS DRAWN AGAINST WITHIN 30 DAYS AFTER THE RESUMPTION OF BUSINESS.

 

 

SILICON VALLEY BANK,

 

 

 

 

 

 

 

 

AUTHORIZED SIGNATURE

 

AUTHORIZED SIGNATURE

 

Exhibit E - 2



 

EXHIBIT “A”

 

DATE:

 

TO: SILICON VALLEY BANK

3003 TASMAN DRIVE SANTA CLARA, CA 95054

ATTN: GLOBAL FINANCIAL SERVICES

 

RE:                           SILICON VALLEY BANK, SANTA CLARA, CALIFORNIA

IRREVOCABLE STANDBY LETTER OF CREDIT NO. SVBSF

DATED                   , 20    AMOUNT: US$                      .

 

GENTLEMEN:

 

FOR VALUE RECEIVED, THE UNDERSIGNED BENEFICIARY HEREBY IRREVOCABLY TRANSFERS TO:

 

 

(NAME OF TRANSFEREE)

 

 

(ADDRESS)

 

ALL RIGHTS OF THE UNDERSIGNED BENEFICIARY TO DRAW UNDER THE ABOVE LETTER OF CREDIT UP TO ITS AVAILABLE AMOUNT AS SHOWN ABOVE AS OF THE DATE OF THIS TRANSFER.

 

BY THIS TRANSFER, ALL RIGHTS OF THE UNDERSIGNED BENEFICIARY IN SUCH LETTER OF CREDIT ARE TRANSFERRED TO THE TRANSFEREE. TRANSFEREE SHALL HAVE THE SOLE RIGHTS AS BENEFICIARY THEREOF, INCLUDING SOLE RIGHTS RELATING TO ANY AMENDMENTS, WHETHER INCREASES OR EXTENSIONS OR OTHER AMENDMENTS, AND WHETHER NOW EXISTING OR HEREAFTER MADE. ALL AMENDMENTS ARE TO BE ADVISED DIRECT TO THE TRANSFEREE WITHOUT NECESSITY OF ANY CONSENT OF OR NOTICE TO THE UNDERSIGNED BENEFICIARY.

 

THE ORIGINAL OF SUCH LETTER OF CREDIT IS RETURNED HEREWITH, AND WE ASK YOU TO ENDORSE THE TRANSFER ON THE REVERSE THEREOF, AND FORWARD IT DIRECTLY TO THE TRANSFEREE WITH YOUR CUSTOMARY NOTICE OF TRANSFER.

 

SINCERELY,

 

METROPOLITAN LIFE INSURANCE COMPANY

 

 

 

 

 

(SIGNATURE OF BENEFICIARY)**

 

 


**THIS TRANSFER FORM, EXHIBIT “A”, MUST BE NOTARIZED BY A NOTARY PUBLIC

 

Exhibit E - 3



 

EXHIBIT F

FAIR MARKET RENTAL RATE

 

1.                                      Definition of Fair Market Rental Rate. “Fair Market Rental Rate” shall mean the Monthly Base Rent equal to the monthly base rental per rentable square foot which a tenant would pay and which a willing landlord would accept for first class office/R&D/laboratory space comparable to the Premises in the Building and in other buildings of class A standards in Seaport Centre, including for purposes of this Exhibit Phases I, II and III as described on Exhibit C and excluding Seaport Plaza (“Applicable Market”) for the period for which such rental is to be paid and for a lease on terms substantially similar to those of the Lease (including, without limitation, those applicable to Taxes, Operating Expenses and exclusions, but also considering so-called net and triple net leases, and leases utilizing operating expense stops or base years, and making appropriate adjustment between such leases and this Lease, as described below), based on prevailing market conditions in the Building and in other buildings of class A standards in the Applicable Market at the time such determination is made (“Comparable Transactions”). Without limiting the generality of the foregoing, Comparable Transactions shall be for a term similar to the term of tenancy and for space comparable in use, floor levels, square footage and location within the Building and in other buildings of class A standards in the Applicable Market as the transaction for which Fair Market Rental Rate is being determined; however, leases of unusual or odd shaped spaces shall not be considered. In any determination of Fair Market Rental Rate, the stated or contract monthly net or base rental in Comparable Transactions shall be appropriately adjusted to take into account the different terms and conditions prevailing in such transactions and those present in the Lease, including, without limitation: (a) the extent to which average annual expenses and taxes per rentable square foot payable by tenants in Comparable Transactions vary from those payable by Tenant under the Lease, and so, for example, if the Lease provides for payment of Rent Adjustments and/or certain Operating Expenses on the basis of increases over a base year, then the rate of Monthly Base Rent under the Lease shall be based upon a step-up to change the calendar year which serves as the base year for calculation of the base for such Operating Expenses for the Option Term to be the full calendar year in which the Option Term commences, and such step-up shall be considered in the determination of the Fair Market Rental Rate; (b) tenant improvements, value of existing tenant improvements, the concessions, if any, being given by landlords in Comparable Transactions, such as parking charge abatement, free rent or rental abatement applicable after substantial completion of any tenant improvements (and no adjustment shall be made for any free or abated rent during any construction periods), loans at below-market interest rates, moving allowances, space planning allowances, lease takeover payments and work allowances, as compared to any tenant improvement, refurbishment or repainting allowance given to Tenant under the Lease for the space for which Fair Market Rental Rate is being determined; (c) the brokerage commissions, fees and bonuses payable by landlords in Comparable Transactions (whether to tenant’s agent, such landlord or any person or entity affiliated with such landlord), as compared to any such amounts payable by Landlord to the broker(s) identified with respect to the transaction for which Fair Market Rental Rate is being determined; (d) the time value of money; (e) any material difference between the definition of rentable area and the ratio of project rentable to useable square feet in Comparable Transactions, as compared to such figures applicable to the space for which Fair Market Rental Rate is being determined; and (f) the extent to which charges for parking by tenants in Comparable Transactions vary from those payable by Tenant under the Lease.

 

2.                                      Sealed Estimates. In the event the Lease requires Fair Market Rental Rate to be determined in accordance with this Exhibit, Landlord and Tenant shall meet within ten (10) business days thereafter and each simultaneously submit to the other in a sealed envelope its good faith estimate of Fair Market Rental Rate (the “Estimates”). If the higher Estimate is not more than one hundred five percent (105%) of the lower Estimate, then Fair Market Rental Rate shall be the average of the two Estimates. If such simultaneous submission of Estimates does not occur within such ten (10) business day period, then either party may by notice to the other designate any reasonable time within five (5) business days thereafter and any reasonable place at or near the Building for such meeting to take place. In the event only one party submits an Estimate at that meeting, such Estimate shall be Fair Market Rental. In the event neither party submits an Estimate at that meeting, the transaction for which Fair Market Rental Rate is being determined shall be deemed cancelled and of no further force or effect.

 

3.                                      Selection of Arbitrators. If the higher Estimate is more than one hundred five percent (105%) of the lower Estimate, then either Landlord or Tenant may, by written notice to the other within five (5) business days after delivery of Estimates at the meeting, require that the disagreement be resolved by arbitration. In the event neither party gives such notice, the transaction for which Fair Market Rental Rate is being determined shall be deemed cancelled and of no further force or effect. Within five (5) business days after such notice, the parties shall select as arbitrators three (3) mutually acceptable independent MAI appraisers with experience in real estate activities, including at least five (5) years’ experience in appraising comparable space in the Applicable Market (“Qualified Appraisers”). If the parties cannot timely agree on such arbitrators, then within the following five (5) business days, each shall select and inform the other party of one (1) Qualified Appraiser and within a third period of five (5) business days, the two appraisers (or if only one (1) has been duly selected, such single appraiser) shall select as arbitrators a panel of three additional Qualified Appraisers, which three arbitrators shall proceed to determine Fair Market Rental Rate pursuant to Section 4 of this Exhibit. Both Landlord and Tenant shall be entitled to present evidence supporting their respective positions to the panel of three arbitrators.

 

4.                                      Arbitration Procedure. Once a panel of arbitrators has been selected as provided above, then as soon thereafter as practicable each arbitrator shall select one of the two Estimates as the one which, in its opinion, is closer to Fair Market Rental Rate. Upon an Estimate’s selection by two (2) of the arbitrators, it shall be the applicable Fair Market Rental Rate and such selection shall be binding upon Landlord and Tenant. If the arbitrators collectively determine that expert advice is reasonably necessary to assist them in determining Fair Market Rental Rate, then they may retain one or more qualified persons, including but not limited to legal counsel, brokers, architects or engineers, to provide such expert advice. The party whose Estimate is not chosen by the arbitrators shall pay the costs of the arbitrators and any experts retained by the arbitrators. Any

 

Exhibit F - 1



 

fees of any counsel or expert engaged directly by Landlord or Tenant, however, shall be borne by the party retaining such counsel or expert.

 

5.                                      Rent Pending Determination of Fair Market Rental Rate. In the event that the determination of Fair Market Rental Rate has not been concluded prior to commencement of the applicable rental period for the applicable space for which the Fair Market Rental Rate is being determined, Tenant shall pay Landlord Monthly Base Rent and Rent Adjustment Deposits as would apply under Landlord’s Estimate pursuant to Section 2 of this Exhibit until the Fair Market Rental Rate is determined. In the event that the Fair Market Rental Rate subsequently determined is different from the amount paid for the applicable period, then within thirty (30) days after such determination, Tenant shall pay Landlord any greater amounts due and Landlord shall credit Tenant (against the next Monthly Base Rent installments due) for any reduction in the amounts due.

 

Exhibit F - 2



 

EXHIBIT G

TENANT’S PERSONAL PROPERTY

 

Tenant’s Personal Property shall mean the following items belonging to Tenant, it being acknowledged that if any of the following are affixed to the Premises in the normal manner for such item, it shall still be deemed to be Tenant’s Personal Property:

 

1.              Water deionization/purification systems;

2.              Facility vacuum system;

3.              Facility clean dry air system;

4.              Telecommunications systems;

5.              Computer, storage, and networking systems;

6.              Waste neutralization and monitoring systems;

7.              Trash compactor system;

8.              Satellite and/or radio frequency signal receivers/transmitters;

9.              Compressed gas distribution system;

10.       Audio-visual equipment;

11.       Electronic security and monitoring systems;

12.       Back-up and emergency electrical power equipment;

13.       Laboratory casework including fume hoods;

14.       Moveable benches and tables;

15.       Office furniture and equipment;

16.       Bicycle lockers;

17.       Shower room lockers;

18.       Laboratory equipment including autoclaves, glass washers, ice makers, cage washers, dryers, environmental chambers;

19.       Servery equipment (i.e., equipment used in food service, in the break area or kitchen area)

20.       Fermentation system equipment;

21.       Such other items installed in the Premises by Tenant at Tenant’s expense during the term of the Lease as are agreed to in writing by Tenant and Landlord to be Tenant’s Personal Property.

 

Exhibit G - 1



 

EXHIBIT H

FORM OF LETTER OF CREDIT

 

FOR INTERNAL IDENTIFICATION PURPOSES ONLY

 

Our No.                              Other                         

 

Applicant

 

TO:                           Metropolitan Life Insurance Company

[Address]

Attention: Director, EIM

 

IRREVOCABLE LETTER OF CREDIT NO.

 

We hereby establish this irrevocable Letter of Credit in favor of the aforesaid addressee (“Beneficiary”) for drawings up to UNITED STATES $144,099.00 (ONE HUNDRED FORTY-FOUR THOUSAND NINETY-NINE DOLLARS) effective immediately. This Letter of Credit is issued, presentable and payable at our office at [issuing bank’s address in either San Francisco or San Jose] and expires with our close of business on              , 20  .

 

The term “Beneficiary” includes any successor by operation of law of the named Beneficiary including, without limitation, any liquidator, rehabilitator, receiver or conservator.

 

We hereby undertake to promptly honor your sight draft(s) drawn on us, indicating our Credit No.            , for all or any part of this Credit if presented at our office specified in paragraph one on or before the expiry date or any automatically extended expiry date.

 

Except as expressly stated herein, this undertaking is not subject to any agreement, condition or qualification. The obligation of [issuing bank] under this Letter of Credit is the individual obligation of [issuing bank], and is in no way contingent upon reimbursement with respect thereto.

 

It is a condition of this Letter of Credit that it is deemed to be automatically extended without amendment for one year from the expiry date hereof, or any future expiration date, unless at least thirty (30) days prior to an expiration date we notify you by registered mail that we elect not to consider this Letter of Credit renewed for any such additional period.

 

This Letter of Credit is transferable by the Beneficiary and by any successive transferees at no charge or cost to Beneficiary or any transferee. Transfers of this Letter of Credit are subject to receipt of Beneficiary’s (and subsequently, transferee’s) instructions in the form attached hereto as Schedule 1 accompanied by the original Letter of Credit and amendments(s) if any.

 

This Letter of Credit is subject to and governed by the Laws of the State of New York and the 1993 revision of the Uniform Customs and Practice for Documentary Credits of the International Chamber of Commerce (Publication 500) and, in the event of any conflict, the Laws of the State of New York will control. If this Credit expires during an interruption of business as described in article 17 of said Publication 500, the bank hereby specifically agrees to effect payment if this Credit is drawn against within 30 days after the resumption of business.

 

 

Very truly yours,

 

 

 

 

 

[issuing bank]

 

Exhibit H - 1



 

Schedule 1 to Letter of Credit

 

[Bank — then current issuer of Letter of Credit]

 

c/o

 

 

 

Attention:

 

Re: irrevocable Letter of Credit No.

 

Ladies & Gentlemen:

 

The undersigned acknowledges receipt of your advice No.            of a credit issued in our favor, the terms of which are satisfactory. We now irrevocably transfer the said credit and all amendments and extensions thereof, if any, to:

 

 

 

[Name of Transferee]

 

 

 

[Address]

 

You are to inform the transferee of this transfer and such transferee shall have sole rights as beneficiary under the credit, including any amendments, extension or increases thereof, without notice to or further assent from us.

 

This transfer is at no charge or cost to Beneficiary or the transferee.

 

 

Yours very truly,

 

 

 

Beneficiary

 

 

 

By:

 

 

Exhibit H - 2



 

RIDER 1

COMMENCEMENT DATE AGREEMENT

 

METROPOLITAN LIFE INSURANCE COMPANY, a New York corporation (“Landlord”), and GENOMIC HEALTH, INC., a Delaware corporation (“Tenant”), have entered into a certain Lease dated                       , 2012 (the “Lease”).

 

WHEREAS, Landlord and Tenant wish to confirm and memorialize the Commencement Date and Expiration Date of the Lease as provided for in Section 2.02(b) of the Lease;

 

NOW, THEREFORE, in consideration of the foregoing and the mutual covenants contained herein and in the Lease, Landlord and Tenant agree as follows:

 

1.                                      Unless otherwise defined herein, all capitalized terms shall have the same meaning ascribed to them in the Lease.

 

2.                                      The Commencement Date of the Term of the Lease is.

 

3.                                      The Expiration Date of the Term of the Lease is.

 

4.                                      Tenant hereby confirms the following:

 

(a)                                 That it has accepted possession of the Premises pursuant to the terms of the Lease;

 

(b)                                 That the Landlord Work, if any, is Substantially Complete; and

 

(c)                                  That the Lease is in full force and effect.

 

5.                                      Except as expressly modified hereby, all terms and provisions of the Lease are hereby ratified and confirmed and shall remain in full force and effect and binding on the parties hereto.

 

6.                                      The Lease and this Commencement Date Agreement contain all of the terms, covenants, conditions and agreements between the Landlord and the Tenant relating to the subject matter herein. No prior other agreements or understandings pertaining to such matters are valid or of any force and effect.

 

IN WITNESS WHEREOF, Landlord and Tenant have executed this Commencement Date Agreement and such execution and delivery have been duly authorized.

 

TENANT:

 

LANDLORD:

 

 

 

GENOMIC HEALTH, INC.,

 

METROPOLITAN LIFE INSURANCE COMPANY,

a Delaware corporation

 

a New York corporation

 

 

 

 

 

 

By

 

 

By

 

 

 

 

 

 

 

 

 

 

 

 

Print name

 

 

Print name

Its

 

 

Its

 

(Chairman of Board, President or Vice President)

 

 

 

 

 

By

 

 

 

 

 

 

 

 

 

 

 

 

Print name

 

 

Its

 

 

 

(Secretary, Assistant Secretary, CFO or Assistant Treasurer)

 

 

 

Rider 1 - 1



 

RIDER 2

ADDITIONAL PROVISIONS

 

This Rider 2 (“Rider”) is attached to and a part of a certain Lease by METROPOLITAN LIFE INSURANCE COMPANY, a New York corporation, as Landlord, and GENOMIC HEALTH, INC., a Delaware corporation, as Tenant, for the Premises as described therein (the “Lease”).

 

SECTION 1.                            DEFINED TERMS; FORCE AND EFFECT

 

Capitalized terms used in this Rider shall have the same meanings set forth in the Lease except as otherwise specified herein and except for terms capitalized in the ordinary course of punctuation. This Rider forms a part of the Lease. Should any inconsistency arise between this Rider and any other provision of the Lease as to the specific matters which are the subject of this Rider, the terms and conditions of this Rider shall control.

 

SECTION 2.                            PREMISES; CONDITION; DELIVERY; CONSTRUCTION PERIOD; COMMENCEMENT DATE

 

(a)                               Landlord shall tender to Tenant possession of the Premises in the condition specified in the Workletter (free of all prior occupants and their personal property) within five (5) days after the Lease has been executed by both Tenant and Landlord (the “Projected Delivery Date”). On the date Landlord actually tenders to Tenant possession of the Premises (the “Delivery Date”), all the conditions and covenants of the Lease shall apply, and Tenant shall observe and perform all conditions and covenants of the Lease, including all that are specified to apply during the Term (for example only, Tenant’s insurance and indemnification obligations), except as otherwise expressly provided in this Rider. During the period (the “Construction Period”) from the Delivery Date until the Commencement Date, in recognition of Tenant’s construction and installations in, and preparation of, the Premises for the use and occupancy permitted by this Lease, Tenant shall not be obligated to pay Monthly Base Rent, Rent Adjustment Deposits or Rent Adjustments. The Term of this Lease shall be as shown in Section 1.01(5) of the Basic Lease Provisions and the “Commencement Date” of the Term shall be as set forth in Section 1.01(6). To the extent permitted by Law and that Tenant obtains any and all necessary approvals and permits for such use, during the Construction Period Tenant may use part of the Premises for the conduct of business by up to thirty (30) employees of Tenant without obligation to pay Monthly Base Rent, Rent Adjustment Deposits or Rent Adjustments for the space so used (“Temporary Space”), but Tenant shall be obligated to pay all utility costs and charges associated with the use of such Temporary Space.

 

(b)                                 Within thirty (30) days following the occurrence of the Commencement Date, upon request by Landlord or Tenant, Tenant and Landlord shall enter into an agreement (which is attached to this Lease as Rider 1) confirming the Commencement Date and the Expiration Date. If Tenant fails to enter into such agreement, then the Commencement Date and the Expiration Date shall be the dates designated by Landlord in such agreement.

 

(c)                                  If Landlord shall be unable to give possession of the Premises on the Projected Delivery Date by reason of the following: (i) the holding over or retention of possession of any tenant, tenants or occupants, or (ii) for any other reason beyond Landlord’s reasonable control, then Landlord shall not be subject to any liability for the failure to give possession on said date. Under such circumstances, the Commencement Date shall be delayed by a number of days equal to the days of delay in Landlord’s delivery of possession to Tenant. No such failure to deliver possession on the originally scheduled Projected Delivery Date shall affect the validity of this Lease or the obligations of the Tenant hereunder.

 

SECTION 3.                            MUST-TAKE EXPANSION.

 

(a)                                 Tenant shall have the one-time right and obligation (the “Must-Take Expansion”) to lease all (and not less than all) of the Must-Take Space (defined below) in the event that the Must-Take Space becomes “Available” (as Available is defined below) on or before the date that is five hundred forty (540) days following execution and delivery of this Lease (the “Must-Take Outside Date”). The “Must-Take Space” shall mean the space designated as the Must-Take Space adjacent to the Premises, as shown on Exhibit A hereto, which Must-Take Space is conclusively deemed to be 5,465 square feet of Rentable Area.

 

(b)                                 In the event that the Must-Take Space becomes Available, then within thirty (30) days after such space becomes vacant and free and clear of all “Prior Rights”, Landlord shall give Tenant written notice (“Landlord’s Notice”) that the Must-Take Space is Available and Landlord’s estimate of the projected date such space will be vacant and deliverable to Tenant. The term “Available” shall mean that the space in question is either: (1) vacant and free and clear of all “Prior Rights” (defined below); or (2) space as to which Landlord has received a proposal, or Landlord is making a proposal, for a lease or rights of any nature applicable in the future when such space would be free and clear of all Prior Rights. The term “Prior Rights” shall mean the rights of the existing tenant under that certain written lease dated as of November 21, 2012, between Landlord, as landlord, and Teva Pharmaceuticals, as tenant.

 

(c)                                  Giving of Landlord’s Notice shall thereby create and constitute a binding lease of the Must-Take Space by and to Tenant, upon and subject to the same terms and conditions contained in the Lease except as follows (the “Must-Take Terms”): (i) Tenant shall accept the Must-Take Space in its then “AS IS” condition, but broom clean and free of all tenants or occupants, without any obligation of Landlord to repaint, remodel, improve or alter such space for Tenant’s occupancy or to provide Tenant any allowance therefor, except that Landlord shall provide an allowance at the same rate as the Allowance applicable for the initial Premises set forth in Section 5 of Exhibit B (which shall be prorated in the event the term for the Must-Take Space is thirty-six (36) months or less); (ii) Landlord shall deliver the Must-Take Space to Tenant no later than thirty (30) days after the later of the date on which Landlord regains possession of such space; (iii) upon such delivery, the Must-Take Space shall be part of the

 

Rider 2 - Page 1



 

Premises under the Lease, such that the term “Premises” in the Lease thereafter shall mean both the space leased immediately prior to such delivery and the Must-Take Space, and shall be leased for the remaining term of the Lease (including any extension pursuant to the Option to Extend); (iv) starting on the “Must-Take Rent Commencement Date”, which shall be the earlier to occur of (A) ninety (90) days after the Must-Take Space is delivered to Tenant, or (B) the date Tenant commences its business operations in the Must-Take Space, Tenant shall pay Monthly Base Rent with respect to the Must-Take Space at the same rate then and thereafter applicable for the initial Premises as set forth in Section 1.01 of the Lease; (v) starting on the Must-Take Rent Commencement Date, with respect to the Must-Take Space Tenant shall additionally pay Tenant’s Share of Operating Expenses and Taxes, or increases therein, as applicable under the Lease, with Tenant’s Share recalculated to reflect addition of the Must-Take Space; (vi) starting on such delivery date, Tenant shall additionally pay other charges payable by Tenant for utilities and otherwise with respect to the Must-Take Space; (vii) starting on the Must-Take Rent Commencement Date, with respect to the Must-Take Space, Tenant shall additionally have the right to use (pursuant to the terms of 2.06(c) of the Lease) additional unreserved parking spaces at the rate of three and three tenths (3.3) spaces per one thousand (1,000) square feet of Rentable Area; and (vii) the Security Deposit shall be increased to an amount that is the same percentage or proportion of Rent (after including Rent for the Must-Take Space) as the prior amount of Security Deposit was in relation to prior Rent.

 

Notwithstanding any provision of this Section 3 or the Lease to the contrary, if and to the extent that upon delivery of the Must-Take Space,

 

(i)                                     the roof and roof membrane above the Must-Take Space;

(ii)                                  foundation (excluding slab) and structural components of the Base Building;

(iii)                               Landlord’s fire sprinkler and life-safety systems, if any, of the Base Building; and

(iv)                              the electrical, water, sewer and plumbing systems of the Base Building serving the Must-Take Space (but only from the local utility’s systems to the point of entry into the Must-Take Space or to the meter or other point after which such system serves exclusively the Must-Take Space).

 

are not in good working order and condition, and if and to the extent that there is any water damage to the walls, hard lid ceilings or ceiling tiles, and provided that within twenty (20) days after Landlord’s delivery of the Must-Take Space to Tenant, Tenant gives Landlord written notice specifying what is not in good operating condition, Landlord shall make necessary repairs to put such item or items in good operating condition; provided, however, that Landlord shall have no obligation under this paragraph (A) to the extent any of the foregoing are to be removed, demolished or altered by Tenant prior to Landlord’s delivery of the Must-Take Space, and (B) to the extent any of the foregoing conditions are caused by or resulting from any act or omission of Tenant or any of Tenant’s contractors, employees, agents, customers or invitees, including, without limitation, any work performed by or on behalf of Tenant in the Must-Take Space or the original Premises.

 

(d)                                 Promptly after giving Landlord’s Notice, Landlord shall prepare a memorandum confirming the specific dates, amounts and terms of the lease of the subject Must-Take Space in accordance with the terms and conditions of this Must-Take Expansion, in the form of an amendment to the Lease, and Tenant shall execute such amendment within ten (10) business days after Landlord and Tenant agree to the form of the proposed amendment and Landlord shall execute it promptly after Tenant. Notwithstanding any of the foregoing to the contrary, the failure of Landlord to prepare such amendment or of either party to execute an amendment shall not affect the validity and effectiveness of the lease of the Must-Take Space in accordance with the terms and conditions of this Must-Take Expansion.

 

SECTION 4.                            OFFER RIGHT.

 

(a)                                 Provided that the Must-Take Space was not Available on or before the Must-Take Outside Date and Tenant has not leased the Must-Take Space, Tenant shall have a one-time right to lease the Offer Space (defined below) if and to the extent such space is Available (as defined in Section 3(b) above) during the period beginning on the Must-Take Outside Date and ending nine (9) months prior to the Expiration Date of the Term (the “Offer Period”), upon and subject to the terms and conditions of this Section (the “Offer Right”), and provided that at the time of exercise of such right: (i) Tenant or a Permitted Transferee which has satisfied the requirements of Sections 10.01 and 10.05 of the Lease must be conducting regular, active, ongoing business in, and be in occupancy (and occupancy by a subtenant, licensee or other party permitted or suffered by Tenant shall not satisfy such condition) of the entire Premises; and (ii) there has been no material adverse change in Tenant’s financial position from such position as of the date of execution of the Lease, as certified by Tenant’s independent certified public accountants, and as supported by Tenant’s certified financial statements, copies of which shall be delivered to Landlord with Tenant’s written notice exercising its right hereunder. Without limiting the generality of the foregoing, Landlord may reasonably conclude there has been a material adverse change if Tenant’s independent certified public accountants do not certify there has been no such change.

 

(b)                                 “Offer Space” shall mean the Must-Take Space.

 

(c)                                  Nothing herein shall be deemed to limit or prevent Landlord from marketing, discussing or negotiating with any other party for a lease of, or rights of any nature as to, any part of the Offer Space, but during the Offer Period before Landlord makes any written proposal to any other party (other than a party with Prior Rights) for any Offer Space which becomes Available (including giving a written response to any proposal or offer received from another party), or contemporaneously with making any such proposal, and in any event within thirty (30) days after such space becomes vacant and free and clear of all “Prior Rights”, Landlord shall give Tenant written notice Landlord’s Notice (as defined in Section 3(b) above. For the period of seven (7) business days after Landlord gives Landlord’s Notice (the “Election Notice Period”), Tenant shall have the right to give Landlord irrevocable written notice (“Election Notice”) of Tenant’s election to lease all (and not less than all) the Offer Space identified in

 

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Landlord’s Notice.

 

(d)                                 In the event Tenant duly and timely delivers its Election Notice to Landlord, such exercise shall thereby create and constitute a binding lease of the Offer Space by and to Tenant, subject to suspension or termination of such right pursuant to Subsection (h) below, upon and subject to the same Must-Take Terms set forth in clause 3(c) above.

 

(e)                                  If Tenant either fails or elects not to exercise its Offer Right as to the Offer Space covered by Landlord’s Notice by not giving its Election Notice within the Election Notice Period, then Tenant’s Offer Right shall terminate, and be null and void, as to the subject space identified in the applicable Landlord’s Notice (but not as to any Offer Space subject to this Offer Right which has not become Available and been included in a Landlord’s Notice), and at any time thereafter Landlord shall be free to lease and/or otherwise grant options or rights to the subject space on any terms and conditions whatsoever free and clear of the Offer Right.

 

(f)                                   During any period that Tenant does not occupy the entire Premises or that there is an uncured default by Tenant under the Lease, or any state of facts which with the passage of time or the giving of notice, or both, would constitute such a default, the Offer Right shall not apply and shall be ineffective and suspended, and Landlord shall not be obligated to give a Landlord’s Notice as to any space which becomes Available during such suspension period, and Landlord shall not be obligated to negotiate (or enter any amendment) with respect to any Offer Space which was the subject of a pending Landlord’s Notice for which an amendment has not been fully executed, and during such suspension period Landlord shall be free to lease and/or otherwise grant options or rights to such space on any terms and conditions whatsoever free and clear of the Offer Right. The Offer Right shall terminate upon any of the following: (1) the termination of the Lease upon the occurrence of a Tenant default or otherwise; (2) Landlord’s recovery of possession of the Premises upon the occurrence of a Tenant default or otherwise; (3) rejection of the Lease in any bankruptcy proceeding; or (4) the failure of Tenant timely to exercise, give any notices, perform or agree, within any applicable time period specified above, with respect to any Offer Space which was the subject of any Landlord’s Notice.

 

(g)                                  The Offer Right is personal to Genomic, and may not be used by, and shall not be transferable or assignable (voluntarily or involuntarily) to any person or entity other than a Permitted Transferee which is an assignee of the Lease and which has satisfied the requirements of Sections 10.01 and 10.05 of the Lease, and such Permitted Transferee may exercise the right without Tenant joining in or consenting to such exercise, and notwithstanding anything to the contrary, Tenant shall remain liable for all obligations under the Lease, including those resulting from any such exercise with the same force and effect as if Tenant had joined in such exercise.

 

SECTION 5.                            MONUMENT SIGNAGE.

 

(a)                                 Grant of Right. Notwithstanding any provision of Section 6.06 of the Lease to the contrary, Tenant shall have the right to place Tenant identification on one line of the existing, exterior monument sign (located on Penobscot Drive) for the Building, subject to the terms and conditions set forth in this Section (“Exterior Sign Right”).

 

(b)                                 General Conditions & Requirements. The size, type, style, materials, color, method of installation and exact location of the sign, and the contractor for and all work in connection with the sign, contemplated by this Section shall (i) be subject to Tenant’s compliance with all applicable laws, regulations and ordinances and with any covenants, conditions and restrictions of record which affect the Property; (ii) be subject to Tenant’s compliance with all requirements of Landlord’s current Project signage criteria at the time of installation; (iii) be consistent with the design of the Building and the Project; (iv) be further subject to Landlord’s prior written consent. Tenant shall, at its sole cost and expense, procure, install, maintain in first class appearance and condition, and remove such sign.

 

(c)                                  Removal & Restoration. Upon the expiration or termination of the Exterior Sign Right, but in no event later than the expiration of the Term or earlier termination of the Lease, Tenant shall, at its sole cost and expense, remove such sign and shall repair and restore the area in which the sign was located to its condition prior to installation of such sign.

 

(d)                                 Right Personal. The Exterior Sign Right under this Section is personal to Genomic, and may not be used by, and shall not be transferable or assignable (voluntarily or involuntarily) to any person or entity.

 

SECTION 6.                            OPTION TO EXTEND.

 

(a)                                 Landlord hereby grants Tenant a single option to extend the Term of the Lease for an additional period of five (5) years (such period may be referred to as the “Option Term”), as to the entire Premises as it then exists, upon and subject to the terms and conditions of this Section (the “Option To Extend”), and provided that at the time of exercise of such option (and each Option, if more than one Option is granted): (i) Tenant or a Permitted Transferee which has satisfied the requirements of Sections 10.01 and 10.05 of the Lease must be conducting regular, active, ongoing business in, and be in occupancy (and occupancy by a subtenant, licensee or other party permitted or suffered by Tenant shall not satisfy such condition) of the entire Premises; and (ii) there has been no material adverse change in Tenant’s financial position from such position as of the date of execution of the Lease, as certified by Tenant’s independent certified public accountants, and as supported by Tenant’s certified financial statements, copies of which shall be delivered to Landlord with Tenant’s written notice exercising its right hereunder. Without limiting the generality of the foregoing, Landlord may reasonably conclude there has been a material adverse change if Tenant’s independent certified public accountants do not certify there has been no such change.

 

(b)                                 Tenant’s election (the “Election Notice”) to exercise the Option To Extend must be given to Landlord in writing during the period starting twelve (12) months before and ending nine (9) months before the

 

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scheduled Expiration Date of the initial Term. If Tenant either fails or elects not to exercise the Option to Extend by not timely giving its Election Notice, then the Option to Extend shall be null and void, including, if more than one Option, is granted, the then applicable Option to Extend and all further Options to Extend.

 

(c)                                  The Option Term (and each Option Term, if more than one Option is granted) shall commence immediately after the expiration of the preceding Term of the Lease. Tenant’s leasing of the Premises during the Option Term shall be upon and subject to the same terms and conditions contained in the Lease except that (i) Tenant shall pay the “Option Term Rent”, defined and determined in the manner set forth in the immediately following Subsection; (ii) the Security shall be increased to an amount that is the same percentage or proportion of Option Term Rent as the prior amount of Security was in relation to Rent for the Term prior to the Option Term, but in no event shall the Security be decreased; and (iii) Tenant shall accept the Premises in its “as is” condition without any obligation of Landlord to repaint, remodel, repair, improve or alter the Premises or to provide Tenant any allowance therefor, except to the extent tenants leasing space in Comparable Transactions receive an allowance pursuant to the definition of Fair Market Rental Rate defined in Exhibit F hereto, provided, however, Landlord by notice given to Tenant within thirty (30) days after final determination of the Fair Market Rental Rate, may elect to provide, in lieu of such allowance for alterations to the Premises, a rent credit equal to the amount of the allowance that would have otherwise been given, credited toward the rents applicable only to the Premises and due starting after such rent obligation commences. If Tenant timely and properly exercises the Option To Extend, references in the Lease to the Term shall be deemed to mean the preceding Term as extended by the Option Term unless the context clearly requires otherwise.

 

(d)                                 The Option Term Rent shall mean the sum of the Monthly Base Rent at the Fair Market Rental Rate (as defined in Exhibit F) plus Rent Adjustments and/or certain Operating Expenses (if applicable, based upon a step-up to change the base year or base amount for calculation of Operating Expenses in connection with determination of the Fair Market Rental Rate) plus other charges pursuant to the Lease payable to Landlord. The determination of Fair Market Rental Rate and Option Term Rent shall be made by Landlord, in the good faith exercise of Landlord’s business judgment. Within forty-five (45) days after Tenant’s exercise of the Option To Extend, Landlord shall notify Tenant of Landlord’s determination of the Fair Market Rental Rate and Option Term Rent for the Premises. Tenant may, within fifteen (15) days after receipt thereof, deliver to Landlord a written notice either: (i) accepting Landlord’s determination, in which case the extension shall be effective and binding (subject to Subsection (f) below) at the accepted rate; or (ii) setting forth Tenant’s good faith estimate, in which case Landlord and Tenant will promptly confer and attempt to agree upon the Fair Market Rental Rate and Option Term Rent. Tenant’s failure to timely deliver such notice within such fifteen (15) day period shall be deemed its cancellation of the Option. In the event Tenant has delivered notice setting forth Tenant’s different estimate, but no agreement in writing between Tenant and Landlord on Fair Market Rental Rate and Option Term Rent is reached within thirty (30) days after Landlord’s receipt of Tenant’s estimate, the Fair Market Rental Rate shall be determined in accordance with the terms of Exhibit F. Notwithstanding any of the foregoing to the contrary, at no time during the Option Term shall the Option Term Rent be less than the “Preceding Rent” (defined below). The Preceding Rent shall mean the sum of the Monthly Base Rent payable by Tenant under this Lease calculated at the rate applicable for the last full month of the Term preceding the Option Term plus the Rent Adjustments payable by Tenant under the Lease (if applicable, using the base year for calculation of Base Operating Expenses applicable for the last full month of the Term preceding the Option Term), plus other charges pursuant to the Lease payable to Landlord. To the extent that Tenant pays directly the utility or service provider for utilities or services which Tenant is to obtain directly pursuant to the Lease, Tenant shall continue to pay such amounts, but such amounts shall not be counted as part of the Preceding Rent or the Fair Market Rental Rate as used herein. Further, in the event that Landlord notifies Tenant that the Option Term Rent shall equal the Preceding Rent, such determination shall be conclusive and binding to set the Preceding Rent as the Option Term Rent for the Option Term, Tenant shall not be entitled to dispute or contest such determination, and the extension shall be effective and binding (subject to Subsection (f) below).

 

(e)                                  Promptly after final determination of the Fair Market Rental Rate, Landlord shall prepare a memorandum confirming the specific dates, amounts and terms of the extension for the Option Term in accordance with the terms and conditions of this Option to Extend, in the form of an amendment to the Lease, and Tenant shall execute such amendment within five (5) business days after Landlord and Tenant agree to the form of the proposed amendment and Landlord shall execute it promptly after Tenant. Notwithstanding any of the foregoing to the contrary, the failure of Landlord to prepare such amendment or of either party to execute an amendment shall not affect the validity and effectiveness of the extension for the Option Term in accordance with the terms and conditions of this Option to Extend.

 

(f)                                   Upon the occurrence of any of the following events, Landlord shall have the option, exercisable at any time prior to commencement of the Option Term, to terminate all of the provisions of this Section with respect to the Option to Extend, whereupon any prior or subsequent exercise of this Option to Extend shall be of no force or effect:

 

(i)                                     Tenant’s failure to timely exercise or timely to perform the Option to Extend in strict accordance with the provisions of this Section.

 

(ii)                                  The existence at the time Tenant exercises the Option to Extend or at the commencement of the Option Term of a Default on the part of Tenant under the Lease or of any state of facts which with the passage of time or the giving of notice, or both, would constitute such a Default.

 

(iii)                               Tenant’s third Default under the Lease prior to the commencement of the Option Term, notwithstanding that all such Defaults may subsequently be cured.

 

(g)                                  Without limiting the generality of any provision of the Lease, time shall be of the essence with respect to all of the provisions of this Section.

 

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(h)                                 This Option to Extend is personal to Genomic, and may not be used by, and shall not be transferable or assignable (voluntarily or involuntarily) to any person or entity other than a Permitted Transferee which is an assignee of the Lease and which has satisfied the requirements of Sections 10.01 and 10.05 of this Lease, and such Permitted Transferee may exercise the right without Tenant joining in or consenting to such exercise, and notwithstanding anything to the contrary, Tenant shall remain liable for all obligations under the Lease, including those resulting from any such exercise with the same force and effect as if Tenant had joined in such exercise.

 

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EX-10.2 3 a13-18745_1ex10d2.htm EX-10.2

Exhibit 10.2

 

AMENDMENT TO THE

GENOMIC HEALTH, INC.

2005 STOCK INCENTIVE PLAN

 

This Amendment amends the Genomic Health, Inc. 2005 Stock Incentive Plan, as amended and restated on January 28, 2009 (the “Plan”).

 

The Plan is hereby amended effective July 25, 2013, as follows:

 

The first sentence of Section 4(b)(i) of the Plan is amended by replacing “16,500” with “20,000” where it appears therein.

 

The first sentence of Section 4(b)(ii) of the Plan is amended by replacing “8,250” with “10,000” where it appears therein.

 

To record the adoption of this Amendment by the Board of Directors of Genomic Health, Inc. (the “Company”) on July 25, 2013, the Company has caused its authorized officer to execute the same.

 

 

 

GENOMIC HEALTH, INC.

 

 

 

By:

/s/ Kimberly J. Popovits

 

 

 

 

Name:

Kimberly J. Popovits

 

 

 

 

Title:

President and Chief Executive Officer

 


EX-31.1 4 a13-18745_1ex31d1.htm EX-31.1

Exhibit 31.1

 

Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

CERTIFICATION

 

I, Kimberly J. Popovits, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Genomic Health, Inc. for the period ended September 30, 2013;

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Date: November 7, 2013

/s/ Kimberly J. Popovits

 

Kimberly J. Popovits

 

Chief Executive Officer

 


EX-31.2 5 a13-18745_1ex31d2.htm EX-31.2

Exhibit 31.2

 

Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

CERTIFICATION

 

I, Dean L. Schorno, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Genomic Health, Inc. for the period ended September 30, 2013;

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Date: November 7, 2013

/s/ Dean L. Schorno

 

Dean L. Schorno

 

Chief Financial Officer

 


EX-32.1 6 a13-18745_1ex32d1.htm EX-32.1

Exhibit 32.1

 

STATEMENT OF CHIEF EXECUTIVE OFFICER

UNDER 18 U.S.C. § 1350

 

I, Kimberly J. Popovits, the chief executive officer of Genomic Health, Inc. (the “Company”), certify for the purposes of section 1350 of chapter 63 of title 18 of the United States Code that, to the best of my knowledge,

 

(i) the Quarterly Report of the Company on Form 10-Q for the period ended September 30, 2013 (the “Report”) fully complies with the requirements of section 13(a) of the Securities Exchange Act of 1934, and

 

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

 

Date: November 7, 2013

/s/ Kimberly J. Popovits

 

Kimberly J. Popovits

 

Chief Executive Officer

 


EX-32.2 7 a13-18745_1ex32d2.htm EX-32.2

Exhibit 32.2

 

STATEMENT OF CHIEF FINANCIAL OFFICER

UNDER 18 U.S.C. § 1350

 

I, Dean L. Schorno, the chief financial officer of Genomic Health, Inc. (the “Company”), certify for the purposes of section 1350 of chapter 63 of title 18 of the United States Code that, to the best of my knowledge,

 

(i) the Quarterly Report of the Company on Form 10-Q for the period ended September 30, 2013 (the “Report”) fully complies with the requirements of section 13(a) of the Securities Exchange Act of 1934, and

 

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

 

Date: November 7, 2013

/s/ Dean L. Schorno

 

Dean L. Schorno

 

Chief Financial Officer

 


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The Company&#8217;s first product, the Onco<i>type</i> DX invasive breast cancer test, was launched in 2004 and is used for early stage invasive breast cancer patients to predict the likelihood of breast cancer recurrence and the likelihood of chemotherapy benefit. In January&#160;2010, the Company launched its second product, the Onco<i>type</i> DX colon cancer test, which is used to predict the likelihood of colon cancer recurrence in patients with stage&#160;II disease. In December&#160;2011, the Company made the Onco<i>type</i> DX breast cancer test available for patients with ductal carcinoma in situ (&#8220;DCIS&#8221;), a pre-invasive form of breast cancer. This test provides a DCIS score that is used to predict the likelihood of local recurrence. In June&#160;2012, the Company began offering the Onco<i>type</i> DX colon cancer test for use in patients with stage III disease treated with oxaliplatin-containing adjuvant therapy. In May&#160;2013, the Company launched the Onco<i>type</i> DX prostate cancer test. The test provides a Genomic Prostate Score, or GPS, to predict disease aggressiveness in men with low risk disease. This test may be used to improve treatment decisions for prostate cancer patients, in conjunction with the Gleason score, or tumor grading.</font></p> <p style="TEXT-INDENT: 13.75pt; MARGIN: 0in 0in 0pt;">&#160;</p> <p style="TEXT-INDENT: 0.1in; MARGIN: 0in 0in 0pt;"><b><i><font style="FONT-STYLE: italic; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold;" size="2">Principles of Consolidation</font></i></b></p> <p style="TEXT-INDENT: 0.1in; MARGIN: 0in 0in 0pt;">&#160;</p> <p style="TEXT-INDENT: 0.2in; MARGIN: 0in 0in 0pt;"><font style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt;" size="2">The condensed consolidated financial statements include all the accounts of the Company and its wholly-owned subsidiaries. The Company had three wholly-owned subsidiaries at September&#160;30, 2013: Genomic Health International Sarl, which was established in Switzerland in 2009, and Genomic Health International Holdings, LLC, which was established in Delaware in 2010, both of which support the Company&#8217;s international sales and marketing efforts; and Oncotype Laboratories,&#160;Inc., which was established in 2003, and is inactive. Genomic Health International Holdings, LLC has five wholly-owned subsidiaries: Genomic Health U.K.,&#160;Ltd. and Genomic Health Germany GmbH, both of which were established in 2011, Genomic Health Canada, which was established in 2012 and Genomic Health France and Genomic Health India, which were established in 2013. The functional currency for the Company&#8217;s wholly-owned subsidiaries incorporated outside the United States is the U.S. dollar. 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A collaborative arrangement is a contractual arrangement with a specific party or parties that both: (i) actively participate in a joint operating activity and (ii) is (are) exposed to significant risks and rewards that depend on the commercial success of the joint operating activity. Collaborative Arrangement 1 [Member] Various agreements under which the entity licenses technology on a non-exclusive basis in the field of human diagnostics. A collaborative arrangement is a contractual arrangement with a specific party or parties that both: (i) actively participate in a joint operating activity and (ii) is (are) exposed to significant risks and rewards that depend on the commercial success of the joint operating activity. Collaborative Arrangement 2 [Member] Technology license agreements Collaborative Arrangement 3 [Member] Oncotype DX colon cancer test and Oncotype DX prostate cancer test Collaborative arrangements for the launch and commercialization of the entity's Oncotype DX colon cancer test and Oncotype DX prostate cancer test. A collaborative arrangement is a contractual arrangement with a specific party or parties that both: (i) actively participate in a joint operating activity and (ii) is (are) exposed to significant risks and rewards that depend on the commercial success of the joint operating activity. Document and Entity Information Minimum Number of Tests by Exclusive Distribution Agreements Minimum number of Oncotype DX tests by exclusive distribution agreements Represents the minimum number of tests by exclusive distribution agreements for the entity. Area covered under non-cancelable operating lease agreement (in square feet) Area of Real Estate Property Number of separate transactions Represents the number of separate transactions the entity used for accounting for the accelerated share repurchase. Number of Separate Transactions This element represents the carrying value as of the balance sheet date of license fees incurred and payable within one year or within the normal operating cycle if longer. Accrued License Fees, Current Accrued license fees Collaboration and Commercial Technology Licensing Agreements Collaboration and Commercial Technology Licensing Agreements [Text Block] Collaboration and Commercial Technology Licensing Agreements Description of expenses related to research and development collaboration contracts and commercial technology licensing agreements with third parties. Basis of Presentation and Use of Estimates [Policy Text Block] Basis of Presentation and Use of Estimates Disclosure for the basis of presentation, which describes the underlying basis used to prepare the financial statements (for example, U.S. Generally Accepted Accounting Principles, other comprehensive basis of accounting, IFRS). It also includes the disclosure of accounting policy for the use of estimates in the preparation of financial statements in conformity with generally accepted accounting principles. Organization and summary of significant accounting policies Organization and Summary of Significant Accounting Policies [Line Items] Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. Current Fiscal Year End Date Award Type [Axis] Describes the information pertaining to organization and summary of significant accounting policies. Organization and Summary of Significant Accounting Policies [Table] Number of Wholly Owned Subsidiaries Represents the number of wholly owned subsidiaries of the entity. Number of wholly-owned subsidiaries Number of Distributors for Exclusive Distribution Agreements Approximate number of distributors with exclusive distribution agreements Represents the distributors in various countries with whom the entity had exclusive distribution agreements. Held To Maturity Securities Percentage Voting Interest Investment in the redeemable preferred stock of a private company, percent of the entity's outstanding voting shares The percentage of ownership of voting shares in a held-to-maturity security. Initial payment received upon joint agreement Represents the initial amount received under the entity's joint agreement. Research and Development Arrangement Initial Amount Received upon Joint Agreement Payment receivable upon joint agreement on gene identification plan Represents the amount initially receivable under the entity's joint agreement. Research and Development Arrangement Amount Receivable upon Joint Agreement on Gene Identification Plan Additional payments receivable to conduct next phase of development Represents the additional amount receivable under the entity's joint agreement. Research and Development Arrangement Additional Amount Receivable Final payment receivable upon completion of clinical validation Represents the final payment receivable upon completion of clinical validation under the entity's joint agreement. Research and Development Arrangement Final Payment Receivable upon Completion of Clinical Validation Collaboration expense Represents the details pertaining to collaboration expense relating to the entity's development efforts. Collaborative Arrangements and Noncollaborative Arrangement Collaboration Expense Costs recorded under collaborative arrangements Represents the details pertaining to costs recorded under collaborative arrangements. Collaborative Arrangements and Noncollaborative Arrangement Costs Recorded Collaborative Arrangements and Noncollaborative Arrangement Future Fixed Annual Payments Excluding Royalty Payments [Abstract] Fixed future annual payments, exclusive of royalty payments Document Period End Date January 2013 Represents the amount of fixed annual payments, exclusive of royalty payments under the collaborative arrangements, payable in the next fiscal year following the latest fiscal year. Collaborative Arrangements and Noncollaborative Arrangement Future Fixed Annual Payments Excluding Royalty Payments Current 2014 Represents the amount of fixed annual payments, exclusive of royalty payments under the collaborative arrangements, payable in the second fiscal year following the latest fiscal year. Collaborative Arrangements and Noncollaborative Arrangement Future Fixed Annual Payments Excluding Royalty Payments in Two Years Represents the amount of fixed annual payments, exclusive of royalty payments under the collaborative arrangements, payable in the third fiscal year following the latest fiscal year. Collaborative Arrangements and Noncollaborative Arrangement Future Fixed Annual Payments Excluding Royalty Payments in Three Years 2015 Total Represents the total amount payable of fixed annual payments, exclusive of royalty payments under the collaborative arrangements. Collaborative Arrangements and Noncollaborative Arrangement Future Fixed Annual Payments Excluding Royalty Payments Term of Extension for Non Cancelable Operating Lease Represents the period of time for which entity has an option to extend the term of non-cancelable operating lease. Period of time for which entity has an option to extend lease term 2017 Amount of required minimum rental payments maturing in the fifth fiscal year and thereafter following the latest fiscal year for operating leases having initial or remaining non-cancelable letter-terms in excess of one year. Operating Leases Future Minimum Payments Due in Five Years and Thereafter Stock awards other than options Share Based Compensation Arrangement by Share Based Payment Award Equity Instruments Other than Options [Abstract] Represents the maximum period for offerings determined by the compensation committee of the entity's Board of Directors under the Employee Stock Purchase Plan ("ESPP"). Share Based Compensation Arrangement by Share Based Payment Award Maximum Period for Offerings under ESPP Maximum period for offerings under ESPP Represents the length of purchase period determined by the entity's Board of Directors under its Employee Stock Purchase Plan ("ESPP"). Share Based Compensation Arrangement by Share Based Payment Award Length of Purchase Period Length of purchase period under ESPP Entity [Domain] Schedule of Share Based Payment Award Stock Options and Employee Stock Purchase Plan Valuation Assumptions [Table Text Block] Schedule of weighted-average fair values and assumptions used in calculation of fair value of stock options and employee stock purchase plan Tabular disclosure of the significant assumptions used during the year to estimate the fair value of stock options and employee stock purchase plans, including, but not limited to: (a) expected term, (b) expected volatility of the entity's shares, (c) expected dividends, (d) risk-free rate(s), and (e) discount for post-vesting restrictions. Represents the amount of additional investment made by the entity accounted for under the cost method of accounting. Cost Method Investment Amount Additional investment made in preferred stock of a private company The percentage of ownership of common stock or equity participation in the investee accounted for under the cost method of accounting. Cost Method Investments Ownership Percentage Percentage of ownership interest in private company accounted for under the cost method of accounting Arrangements and Non-arrangement Transactions [Domain] Medicare [Member] Medicare Represents information pertaining to Medicare. Employee [Member] Represents individuals who are an employee of the entity. Employees Number of Products Number of products from which the majority of the entity's product revenues have been derived Number of products from which the majority of the entity's product revenues have been derived. Number of Segments in which Product Tests are Included Number of segments in which product tests are included Represents the number of segments in which the product tests are included. Property and Equipment [Member] Property and equipment Represents the property and equipment. Laboratory Equipment [Member] Laboratory equipment Represents information pertaining to laboratory equipment. Accrued Expenses Current Accrued expenses Represents the carrying value, as of the balance sheet date, of obligations incurred through that date and payable for expenses. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle, if longer). Accrued Professional and Other Service Fees Current Accrued professional and other service fees Represents the carrying value, as of the balance sheet date, of obligations incurred through that date and payable for professional and other service fees. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle, if longer). Accrued Collaboration Expense Current Accrued collaboration expense Represents the carrying value, as of the balance sheet date, of obligations incurred through that date and payable for collaboration expense. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle, if longer). Collaborative Arrangements and Noncollaborative Arrangement Reduction in License Costs Due to Legal Settlement Reduction in license fees due to legal settlement related to the abandonment of a patent Represents reduction in license fees due to a legal settlement related to the abandonment of a patent. Represents reduction in license fees due to the execution of an amendment. Collaborative Arrangements and Noncollaborative Arrangement Reduction in License Costs Due to Execution of Amendment Reduction in license fees from the execution of an amendment Exercise of outstanding stock options and vesting of restricted stock units ("RSUs") Stock Options and Restricted Stock Units [Member] Contract that gives the holder the right, but not the obligation, either to purchase or to sell a certain number of shares of stock at a predetermined price for a specified period of time and share instrument which is convertible to stock or an equivalent amount of cash, after a specified period of time or when specified performance conditions are met. Stock Options Restricted Stock Units Employee Stock Purchase Plan and Restricted Stock [Member] Stock option and restricted stock unit grants, settlement of employee stock purchase plan and restricted stock to be issued to outside directors in lieu of director fees Information pertaining to stock option and restricted stock unit grants, settlement of employee stock purchase plan and restricted stock issued to outside directors in-lieu of director fees. Incentive Stock Options [Member] Incentive stock options Represents information pertaining to the incentive stock options awarded by the entity. Non Statutory Stock Options [Member] Nonstatutory stock options Represents information pertaining to the nonstatutory stock options awarded by the entity. Vice President and above Ranking Other than Executive Officers [Member] Vice president and above ranking other than executive officers Represents information pertaining to the vice president and above ranking other than executive officers. Represents details regarding each outside director who is continuing board service and who was not initially elected to the board at the annual meeting. Outside Directors Not Initially Elected at Annual Meeting [Member] Outside directors not initially elected at annual meeting The term of equity-based award agreement, after termination of outside directors service, which may be presented in a variety of ways (for example, year, month and year, day, month and year, quarter of a year). Share Based Compensation Arrangement by Share Based Payment Award Term after Termination of Outside Directors Service Term of stock options after termination of the outside directors' service Share Based Compensation Arrangement by Share Based Payment Award Target Percentage of Equity Grant Value Target percentage of equity grant value Represents the target percentage of equity grant value. Share Based Compensation Arrangement by Share Based Payment Award Options Weighted Average Remaining Contractual Term [Abstract] Weighted-Average Remaining Contractual Life Share Based Compensation Arrangement by Share Based Payment Award Options Intrinsic Value [Abstract] Aggregate Intrinsic Value Nonvested Stock Options and Restricted Stock Units [Member] Unvested stock options and RSUs Represents the nonvested stock options and restricted stock units awarded by the entity. Net operating losses used Represents the portion of the difference between total income tax expense or benefit as reported in the Income Statement and the expected income tax expense or benefit computed by applying the domestic federal statutory income tax rates to pretax income from continuing operations attributable to net operating losses not used or used under enacted tax laws during the period. Income Tax Reconciliation Net Operating (Loss) Represents the portion of the difference between total income tax expense or benefit as reported in the Income Statement and the expected income tax expense or benefit computed by applying the domestic federal statutory income tax rates to pretax income from continuing operations attributable to federal alternative minimum tax under enacted tax laws during the period. Income Tax Reconciliation Federal Alternative Minimum Tax Federal alternative minimum tax Deferred Tax Assets Capitalized Costs Capitalized costs Represents the amount before allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences from capitalized costs. Operating (Loss) Carryforwards Related to Stock Option Benefits Net operating loss related to stock option benefits Represents the sum of domestic, foreign and state and local operating loss carryforwards relating to stock option benefits, before tax effects, available to reduce future taxable income under enacted tax laws. Number of Equal Annual Installments Represents the number of equal annual installments that relate to the vesting of restricted stock units. Number of equal annual installments Stock Incentive Plan 2005 [Member] 2005 Stock Incentive Plan Represents details regarding the 2005 Stock Incentive Plan. Stock Incentive Plan and ESPP 2005 [Member] 2005 Stock Incentive Plan And ESPP Represents details regarding the 2005 Stock Incentive Plan and Employee Stock Purchase Plan. Stock Issued During Period Value Restricted Stock Award to Directors in Lieu of Fees Issuance of restricted stock to directors in lieu of fees Represents the value of stock related to Restricted Stock Awards issued during the period to directors in lieu of fees. Stock Issued During Period Shares Restricted Stock Award to Directors in Lieu of Fees Issuance of restricted stock to directors in lieu of fees (in shares) Represents the number of shares related to Restricted Stock Awards issued during the period to directors in lieu of fees. Minimum number of countries covered for distribution agreements establishment Represents the minimum number of countries covered for distribution agreements establishment. Minimum Number of Countries Covered for Exclusive Distribution Agreements Treasury Stock [Abstract] Treasury Stock Stock Issued During Period Shares Stock Options Exercised and Vesting of Restricted Stock Units Issuance of common stock upon exercise of stock options for cash and vesting of restricted stock units (in shares) Represents the number of shares of common stock issued upon exercise of stock options for cash and vesting of restricted stock units. Represents the value of issuance of shares of common stock upon exercise of stock options for cash and vesting of restricted stock units. Stock Issued During Period Value Stock Options Exercised and Vesting of Restricted Stock Units Issuance of common stock upon exercise of stock options for cash and vesting of restricted stock units Payments Received for Colon Cancer Tests Performed Prior to Establishment of Coverage Medicare payments received for colon cancer tests performed prior to establishment of coverage Represents the payments received for colon cancer tests performed prior to establishment of coverage. Sales Revenue Goods, Net Excluding Incremental Payments for Colon Cancer Tests Performed Product revenues excluding incremental payments Represents the aggregate revenue earned during the period from sale of goods in the normal course of business, after deducting returns, allowances and discounts and excluding incremental payments received for colon cancer tests performed. Share Based Compensation Arrangement by Share Based Payment Award Options [Abstract] Stock Option Grants Represents the number of shares of common stock the holder is entitled to receive upon vesting for each restricted stock unit held. Share Based Compensation Arrangement by Share Based Payment Award Number of Shares of Common Stock Entitled to Per Unit of Award Held Number of shares of common stock to be received for each restricted stock unit Outside Director [Member] Outside directors A person who is not an employee of the entity and is serving on the board of directors. Available For Sale Marketable Securities Maturity Maximum Maximum contractual maturities of available-for-sale marketable securities held by entity in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Maximum contractual maturities of Company's available-for-sale marketable securities Entity Well-known Seasoned Issuer Represents the additional area that may become available during the initial term of lease under the non-cancelable operating lease agreement. Additional Area of Real Property may become Available During Initial Term of Lease Additional area that may become available during initial term of lease (in square feet) Entity Voluntary Filers Unrealized Gains Available for Sale Securities Gross Unrealized Gain Accumulated in Investments Amount of accumulated unrealized gain before deducting unrealized loss on investments in available-for-sale securities impacting investments. Entity Current Reporting Status Entity Filer Category Annual Vesting Over Vesting Period [Member] Annual vesting over vesting period Percentage of vesting of share-based compensation awards. Entity Public Float Portion Vesting at end of First Year After Grant [Member] Vesting at the end of the first year after grant Vesting of award where a percentage vests at the end of the first year after grant. Entity Registrant Name Collaborative Arrangement 4 [Member] Oncotype DX DCIS score A collaboration agreement entered into by the entity with specified number of parties to clinically validate the relationship between the Oncotype DX DCIS score and the likelihood of local recurrence in patients with DCIS. A collaborative arrangement is a contractual arrangement with a specific party or parties that both: (i) actively participate in a joint operating activity and (ii) is (are) exposed to significant risks and rewards that depend on the commercial success of the joint operating activity. Entity Central Index Key Laboratory and Office Space Location 3 [Member] Second leased laboratory and office space located near the leased facility in Redwood City, California Represents the second leased laboratory and office space located near the leased facility in Redwood City, California. Entity Common Stock, Shares Outstanding Document Fiscal Year Focus Document Fiscal Period Focus Legal Entity [Axis] Document Type Organization and Summary of Significant Accounting Policies Accounts receivable (net of allowance for doubtful accounts; 2013 - $1,847, 2012 - $1,133) Accounts Receivable, Net, Current Accrued Expenses and Other Current Liabilities Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block] Accounts Payable, Current Accounts payable Allowance for Doubtful Accounts Accounts, Notes, Loans and Financing Receivable, Net, Current [Abstract] Net accounts receivable Accounts Receivable [Member] United States UNITED STATES Accrued expenses and other current liabilities Total Accrued Liabilities, Current Less accumulated depreciation and amortization Accumulated Depreciation, Depletion and Amortization, Property, Plant, and Equipment Accumulated other comprehensive income Accumulated Other Comprehensive Income (Loss), Net of Tax Accumulated Other Comprehensive Income (Loss) Accumulated Other Comprehensive Income (Loss) [Member] Additional paid-in capital Additional Paid in Capital, Common Stock Additional Paid-In Capital Additional Paid-in Capital [Member] Stock-based compensation expense related to employee stock options Adjustments to Additional Paid in Capital, Share-based Compensation, Stock Options, Requisite Service Period Recognition Adjustments to reconcile net income (loss) to net cash provided by operating activities: Adjustments to Reconcile Net Income (Loss) to Cash Provided by (Used in) Operating Activities [Abstract] Stock-based compensation expense related to consultant stock options Adjustments to Additional Paid in Capital, Share-based Compensation, Other Long-term Incentive Plans, Requisite Service Period Recognition Stock-based compensation expense (in dollars) Allocated Share-based Compensation Expense Accounts receivable, allowance for doubtful accounts Allowance for doubtful accounts Allowance for Doubtful Accounts Receivable, Current Allowance for Doubtful Accounts: Allowance for Doubtful Accounts [Member] Write-offs for doubtful accounts recorded against allowance Allowance for Doubtful Accounts Receivable, Write-offs Outstanding options to purchase shares of common stock not included in the computation of diluted net loss per share (in shares) Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount Total assets Assets Current assets: Assets, Current [Abstract] ASSETS Assets [Abstract] Total current assets Assets, Current Total assets at fair value Assets, Fair Value Disclosure In a Loss Position for Less Than 12 Months, Estimated Fair Value Available-for-sale Securities, Continuous Unrealized Loss Position, Less than Twelve Months, Fair Value Estimated Fair Value Available-for-sale Securities Short-term marketable securities Available-for-sale Securities, Current Available-for-sale Securities, Amortized Cost Basis Amortized Cost Schedule of the breakdown of available-for-sale marketable securities with unrealized losses Available-for-sale Securities, Continuous Unrealized Loss Position, Fair Value [Table Text Block] Realized losses on available-for-sale marketable securities Available-for-sale Securities, Gross Realized Losses Realized gains on available-for-sale marketable securities Available-for-sale Securities, Gross Realized Gains Impairment recognized Cost-method Investments, Other than Temporary Impairment Cash and cash equivalents Cash and cash equivalents at the beginning of the period Cash and cash equivalents at the end of the period Cash and Cash Equivalents, at Carrying Value Cash Equivalents Cash and Cash Equivalents, Policy [Policy Text Block] Capital Stock Class of Stock [Line Items] Collaboration and Commercial Technology Licensing Agreements Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] Collaboration and specimen transfer agreements Oncotype DX colon cancer test and Oncotype DX prostate cancer test Commercial paper Commercial Paper [Member] Commitments Commitments Disclosure [Text Block] Commitments Commitments and contingencies Commitments and Contingencies Common stock, par value (in dollars per share) Common Stock, Par or Stated Value Per Share Common Stock Common Stock [Member] Common stock Common Stock, Value, Issued Common stock, shares issued Common Stock, Shares, Issued Common stock, shares authorized Common Stock, Shares Authorized Shares of common stock reserved for future issuance Common Stock, Capital Shares Reserved for Future Issuance Common stock outstanding (in shares) Common stock, shares outstanding Balance (in shares) Balance (in shares) Common Stock, Shares, Outstanding Comprehensive Gain or Loss Comprehensive Income, Policy [Policy Text Block] Comprehensive income (loss) Comprehensive Income (Loss), Net of Tax, Attributable to Parent Computer equipment Computer Equipment [Member] Concentration Risk Type [Domain] Concentration of Risk Concentration Risk [Line Items] Concentration Risk Benchmark [Domain] Concentration of Risk Concentration Risk, Credit Risk, Policy [Policy Text Block] Concentration Risk Type [Axis] Concentration Risk [Table] Concentration Risk Benchmark [Axis] Concentration risk percentage Revenues from major customers as a percentage of product revenues Concentration Risk, Percentage Principles of Consolidation Consolidation, Policy [Policy Text Block] Work in progress Construction in Progress [Member] Contract revenues Contracts Revenue Corporate debt securities Corporate Debt Securities [Member] Cost of product revenues Cost of Goods Sold Carrying value of investments in privately held companies Cost Method Investments Cost of Product Revenues Cost of Sales, Policy [Policy Text Block] Cost of product revenues Cost of Sales [Member] Operating expenses: Costs and Expenses [Abstract] Total operating expenses Costs and Expenses State Current State and Local Tax Expense (Benefit) Current expense (benefit): Current Income Tax Expense (Benefit), Continuing Operations [Abstract] Foreign Current Foreign Tax Expense (Benefit) Federal Current Federal Tax Expense (Benefit) Third-party payor Customer Concentration Risk [Member] Accrued refunds Customer Refund Liability, Current Fixed assets Deferred Tax Assets, Property, Plant and Equipment Significant components of deferred tax assets and liabilities Deferred Tax Assets, Net of Valuation Allowance [Abstract] Deferred revenues Deferred Revenue, Current Deferred tax assets: Deferred Tax Assets, Gross [Abstract] Deferred revenues - long-term portion Deferred Revenue, Noncurrent Total deferred tax assets Deferred Tax Assets, Gross Stock-based compensation Deferred Tax Assets, Tax Deferred Expense, Compensation and Benefits, Share-based Compensation Cost Other Deferred Tax Assets, Other Research tax credits Deferred Tax Assets, Tax Credit Carryforwards, Research Net operating loss carryforwards Deferred Tax Assets, Operating Loss Carryforwards Valuation allowance Deferred Tax Assets, Valuation Allowance Contributions expensed Defined Contribution Plan, Cost Recognized 401(k) Plan Defined Contribution Pension and Other Postretirement Plans Disclosure [Abstract] Depreciation and amortization expense Depreciation, Depletion and Amortization, Nonproduction Depreciation and amortization Depreciation, Depletion and Amortization Outside directors Director [Member] Stock-Based Compensation Disclosure of Compensation Related Costs, Share-based Payments [Text Block] Stock-Based Compensation Federal Domestic Tax Authority [Member] Net Income (Loss) Per Share Earnings Per Share [Text Block] Basic net income per share (in dollars per share) Basic net income (loss) per share (in dollars per share) Earnings Per Share, Basic Diluted net income per share (in dollars per share) Diluted net income (loss) per share (in dollars per share) Earnings Per Share, Diluted Net Income (Loss) Per Share Accrued compensation Employee-related Liabilities, Current Employee Stock Based Compensation Expense Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] Employee Stock Options Employee Stock Option [Member] Employee Stock Purchase Plan Restricted stock units granted to outside directors Employee Stock [Member] Unrecognized compensation expense (in dollars) Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Share-based Awards Other than Options Weighted-average period of recognition of unrecognized stock-based compensation expense Weighted-average period of recognition of unrecognized stock-based compensation expense Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition Stock Options Granted to Non-employees Unrecognized compensation expense Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options Revenues by major customer Revenue, Major Customer [Line Items] Percentage of ownership interest in private company Equity Method Investment, Ownership Percentage Investment, Name [Domain] Amount invested in preferred stock of a private company Equity Method Investment, Aggregate Cost Equity Component [Domain] Fair value Estimate of Fair Value Measurement [Member] Executive officers Executive Officer [Member] Measurement Frequency [Axis] Expected volatility (as a percent) Fair Value Assumptions, Expected Volatility Rate Fair Value Measurements, Recurring and Nonrecurring [Table] Fair Value, Hierarchy [Axis] Recurring basis Fair Value, Measurements, Recurring [Member] Transfer of assets from level 2 to level 1 Fair Value, Assets, Level 2 to Level 1 Transfers, Amount Fair Value, Measurement Frequency [Domain] Risk-free interest rate (as a percent) Fair Value Assumptions, Risk Free Interest Rate Transfer of liabilities from level 1 to level 2 Fair Value, Liabilities, Level 1 to Level 2 Transfers, Amount Expected life Fair Value Assumptions, Expected Term Transfer of assets from level 1 to level 2 Fair Value, Assets, Level 1 to Level 2 Transfers, Amount Assets measured at fair value on a recurring basis: Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] Transfer of liabilities from level 2 to level 1 Fair Value, Liabilities, Level 2 to Level 1 Transfers, Amount Fair Value Measurements Fair Value Hierarchy [Domain] Fair Value of Financial Instruments Fair Value of Financial Instruments, Policy [Policy Text Block] Schedule of financial instruments measured at fair value on recurring basis Fair Value, Assets Measured on Recurring Basis [Table Text Block] Fair Value Measurements Fair Value Disclosures [Text Block] Actively Quoted Markets for Identical Assets Level 1 Fair Value, Inputs, Level 1 [Member] Significant Other Observable Inputs Level 2 Fair Value, Inputs, Level 2 [Member] Foreign Currency Transactions Foreign Currency Transactions and Translations Policy [Policy Text Block] Net transaction losses Foreign Currency Transaction Gain (Loss), before Tax Foreign Currency Transactions Foreign Currency Transaction [Abstract] Furniture and fixtures Furniture and Fixtures [Member] Gain on disposal of property and equipment Gain (Loss) on Disposition of Property Plant Equipment General and administrative General and Administrative Expense General and administrative General and Administrative Expense [Member] Guarantees and Indemnifications Guarantees, Indemnifications and Warranties Policies [Policy Text Block] Investment in redeemable preferred stock Investment in preferred stock of a private company Held-to-maturity Securities, Amortized Cost before Other than Temporary Impairment Carrying value of investment in the preferred stock of a private company Held-to-maturity Securities, Noncurrent Impairment of Long-lived Assets Impairment or Disposal of Long-Lived Assets, Including Intangible Assets, Policy [Policy Text Block] Share of loss of equity method investee Income (Loss) from Equity Method Investments Income (loss) before income taxes Income (Loss) from Continuing Operations before Income Taxes, Extraordinary Items, Noncontrolling Interest Components of income (loss) before income taxes Income (Loss) from Continuing Operations before Equity Method Investments, Income Taxes, Extraordinary Items, Noncontrolling Interest [Abstract] Condensed Consolidated Statements of Operations Income Statement Location [Axis] Income Taxes Income Tax Authority [Domain] Foreign Income (Loss) from Continuing Operations before Income Taxes, Foreign Income Tax Authority [Axis] Domestic Income (Loss) from Continuing Operations before Income Taxes, Domestic Income Taxes Income Tax Disclosure [Text Block] Income Statement Location [Domain] Components of income tax expense (benefit) Income Tax Expense (Benefit), Continuing Operations [Abstract] Income tax expense Total income tax expense (benefit) Income Tax Expense (Benefit) Reconciliation of income tax expense (benefit) and the amount computed by applying the statutory federal income tax rate Effective Income Tax Rate Reconciliation, Amount [Abstract] Cash paid for income taxes Income Taxes Paid Stock-based compensation Effective Income Tax Rate Reconciliation, Nondeductible Expense, Share-based Compensation Cost, Amount Non-deductible meals and entertainment Effective Income Tax Rate Reconciliation, Nondeductible Expense, Meals and Entertainment, Amount Federal tax at statutory rate Effective Income Tax Rate Reconciliation at Federal Statutory Income Tax Rate, Amount Income Taxes Income Tax, Policy [Policy Text Block] State tax, net of federal benefit Effective Income Tax Rate Reconciliation, State and Local Income Taxes, Amount Other Effective Income Tax Rate Reconciliation, Other Adjustments, Amount Accrued expenses and other liabilities Increase (Decrease) in Accrued Liabilities and Other Operating Liabilities Accounts receivable Increase (Decrease) in Accounts Receivable Accounts payable Increase (Decrease) in Accounts Payable Deferred revenues Increase (Decrease) in Deferred Revenue Changes in assets and liabilities: Increase (Decrease) in Operating Capital [Abstract] Accrued compensation Increase (Decrease) in Employee Related Liabilities Prepaid expenses and other assets Increase (Decrease) in Prepaid Expense and Other Assets Increase (Decrease) in Stockholders' Equity Increase (Decrease) in Stockholders' Equity [Roll Forward] Effect of dilutive securities (in shares) Incremental Common Shares Attributable to Dilutive Effect of Share-based Payment Arrangements Intangible Assets Intangible Assets, Finite-Lived, Policy [Policy Text Block] Cash paid for interest Interest Paid Investments in Privately Held Companies Investment, Policy [Policy Text Block] Interest income Investment Income, Nonoperating Investments in Privately Held Companies Investments [Abstract] Outside director restricted stock awarded in lieu of fees Issuance of Stock and Warrants for Services or Claims Lease incentive obligations Lease Incentive, Payable Leases Lease, Policy [Policy Text Block] Leasehold improvements Leasehold Improvements [Member] Total current liabilities Liabilities, Current Total liabilities and stockholders' equity Liabilities and Equity Current liabilities: Liabilities, Current [Abstract] LIABILITIES AND STOCKHOLDERS' EQUITY Liabilities and Equity [Abstract] Major Types of Debt and Equity Securities [Axis] Major Types of Debt and Equity Securities [Domain] Customer [Axis] Marketable Securities Marketable Securities, Policy [Policy Text Block] Maximum Maximum [Member] Minimum Minimum [Member] Money market deposits Money Market Funds [Member] Movement in valuation and qualifying accounts Movement in Valuation Allowances and Reserves [Roll Forward] Customer [Domain] Financing activities Net Cash Provided by (Used in) Financing Activities, Continuing Operations [Abstract] Operating activities Net Cash Provided by (Used in) Operating Activities, Continuing Operations [Abstract] Net increase in cash and cash equivalents Net Cash Provided by (Used in) Continuing Operations Net income (loss) Net income (loss) Net income (loss) (in dollars) Net Income (Loss) Available to Common Stockholders, Basic Net cash provided by operating activities Net Cash Provided by (Used in) Operating Activities, Continuing Operations Numerator: Net Income (Loss) Available to Common Stockholders, Basic [Abstract] Net cash provided by financing activities Net Cash Provided by (Used in) Financing Activities, Continuing Operations Net cash used in investing activities Net Cash Provided by (Used in) Investing Activities, Continuing Operations Investing activities Net Cash Provided by (Used in) Investing Activities, Continuing Operations [Abstract] Recently Issued Accounting Pronouncements New Accounting Pronouncements, Policy [Policy Text Block] Number of business segments in which the entity operates Number of Operating Segments 2018 and thereafter Operating Leases, Future Minimum Payments, Due Thereafter Non-cancelable commitments under operating leases Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] 2016 Operating Leases, Future Minimum Payments, Due in Four Years 2017 Operating Leases, Future Minimum Payments, Due in Five Years 2015 Operating Leases, Future Minimum Payments, Due in Three Years Rent expense Operating Leases, Rent Expense, Net 2014 Operating Leases, Future Minimum Payments Due, Next Twelve Months 2013 (remainder of year) Operating Leases, Future Minimum Payments, Remainder of Fiscal Year Income (loss) from operations Operating Income (Loss) Operating Loss Carryforwards [Table] Net operating loss carryforwards Operating Loss Carryforwards [Line Items] 2014 Operating Leases, Future Minimum Payments, Due in Two Years Non-cancelable operating leases Operating Leased Assets [Line Items] Total minimum payments Operating Leases, Future Minimum Payments Due Net operating loss carryforwards Operating Loss Carryforwards Principles of Consolidation Organization, Consolidation and Presentation of Financial Statements [Abstract] Organization and Summary of Significant Accounting Policies Organization, Consolidation, Basis of Presentation, Business Description and Accounting Policies [Text Block] Comprehensive income (loss) Other assets Other Assets, Noncurrent Other income (expense), net Other Nonoperating Income (Expense) Other liabilities Other Liabilities, Noncurrent Other current liabilities Other Liabilities, Current Other current liabilities Other Accrued Liabilities, Current Other comprehensive income (loss): Other Comprehensive Income (Loss), Net of Tax, Portion Attributable to Parent [Abstract] Unrealized gain (loss) on available-for-sale marketable securities, net of tax Other Comprehensive Income (Loss), Available-for-sale Securities Adjustment, Net of Tax, Portion Attributable to Parent Accrued Expenses and Other Current Liabilities Repurchase of common stock Amount paid to the financial institution to settle the initial purchase transaction Payments for Repurchase of Common Stock Purchases of marketable securities Payments to Acquire Available-for-sale Securities Purchases of property and equipment Payments to Acquire Property, Plant, and Equipment Purchase of other investments Investment in redeemable preferred stock Payments to Acquire Other Investments 401(k) Plan Pension and Other Postretirement Plans, Policy [Policy Text Block] Plan Name [Domain] Plan Name [Axis] Preferred stock, par value (in dollars per share) Preferred Stock, Par or Stated Value Per Share Preferred stock, $0.0001 par value, 5,000,000 shares authorized, none issued and outstanding at December 31, 2012 and 2011 Preferred Stock, Value, Issued Preferred stock, shares issued Preferred Stock, Shares Issued Preferred stock, shares authorized Preferred Stock, Shares Authorized Preferred stock, shares outstanding Preferred Stock, Shares 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Fair Value Measurements (Tables)
9 Months Ended
Sep. 30, 2013
Fair Value Measurements  
Schedule of financial instruments measured at fair value on recurring basis

 

 

 

Actively Quoted
Markets for
Identical Assets
Level 1

 

Significant Other
Observable
Inputs
Level 2

 

Significant
Unobservable
Inputs
Level 3

 

Balance at
September 30,
2013

 

 

 

(In thousands)

 

As of September 30, 2013:

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

Money market deposits

 

$

9,357

 

$

 

$

 

$

9,357

 

U.S. Treasury securities

 

751

 

 

 

751

 

Debt securities of U.S. government-sponsored entities

 

 

1,107

 

 

1,107

 

Commercial paper

 

 

47,149

 

 

47,149

 

Corporate debt securities

 

 

30,358

 

 

30,358

 

Total

 

$

10,108

 

$

78,614

 

$

 

$

88,722

 

 

 

 

Actively Quoted
Markets for
Identical Assets
 Level 1

 

Significant Other
 Observable
 Inputs
 Level 2

 

Significant
 Unobservable
 Inputs
 Level 3

 

Balance at
 December 31,
 2012

 

 

 

(In thousands)

 

As of December 31, 2012:

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

Money market deposits

 

$

7,403

 

$

 

$

 

$

7,403

 

U.S. Treasury securities

 

1,276

 

 

 

1,276

 

Debt securities of U.S. government-sponsored entities

 

 

761

 

 

761

 

Commercial paper

 

 

33,888

 

 

33,888

 

Corporate debt securities

 

 

52,102

 

 

52,102

 

Total

 

$

8,679

 

$

86,751

 

$

 

$

95,430

 

Summary of available-for-sale marketable securities

 

 

 

September 30, 2013

 

 

 

Amortized
Cost

 

Unrealized
Gains

 

Unrealized
Losses

 

Estimated
Fair Value

 

 

 

(In thousands)

 

U.S. Treasury securities

 

$

751

 

$

 

$

 

$

751

 

Debt securities of U.S. government-sponsored entities

 

1,106

 

1

 

 

1,107

 

Commercial paper

 

42,875

 

24

 

 

42,899

 

Corporate debt securities

 

29,515

 

4

 

(11

)

29,508

 

Total

 

$

74,247

 

$

29

 

$

(11

)

$

74,265

 

 

 

 

December 31, 2012

 

 

 

Amortized
Cost

 

Unrealized
Gains

 

Unrealized
Losses

 

Estimated
Fair Value

 

 

 

(In thousands)

 

U.S. Treasury securities

 

$

1,275

 

$

1

 

$

 

$

1,276

 

Debt securities of U.S. government-sponsored entities

 

761

 

 

 

761

 

Commercial paper

 

28,854

 

35

 

 

28,889

 

Corporate debt securities

 

50,155

 

2

 

(23

)

50,134

 

Total

 

$

81,045

 

$

38

 

$

(23

)

$

81,060

 

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Condensed Consolidated Statements of Operations (USD $)
In Thousands, except Per Share data, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Revenues:        
Product revenues $ 65,732 $ 58,371 $ 192,132 $ 173,459
Contract revenues 258 277 644 1,287
Total revenues 65,990 58,648 192,776 174,746
Operating expenses:        
Cost of product revenues 10,781 9,037 31,285 27,377
Research and development 14,726 12,267 42,189 35,775
Selling and marketing 26,013 21,526 81,587 69,657
General and administrative 14,007 12,107 41,052 35,518
Total operating expenses 65,527 54,937 196,113 168,327
Income (loss) from operations 463 3,711 (3,337) 6,419
Interest income 52 77 174 226
Other income (expense), net 89 33 (2) (112)
Income (loss) before income taxes 604 3,821 (3,165) 6,533
Income tax expense 116 109 223 243
Net income (loss) $ 488 $ 3,712 $ (3,388) $ 6,290
Basic net income (loss) per share (in dollars per share) $ 0.02 $ 0.12 $ (0.11) $ 0.21
Diluted net income (loss) per share (in dollars per share) $ 0.02 $ 0.11 $ (0.11) $ 0.20
Shares used in computing basic net income per share (in shares) 30,661 30,580 30,368 30,233
Shares used in computing diluted net income per share (in shares) 32,324 32,578 30,368 32,095
XML 19 R10.htm IDEA: XBRL DOCUMENT v2.4.0.8
Collaboration and Commercial Technology Licensing Agreements
9 Months Ended
Sep. 30, 2013
Collaboration and Commercial Technology Licensing Agreements  
Collaboration and Commercial Technology Licensing Agreements

Note 4. Collaboration and Commercial Technology Licensing Agreements

 

The Company has entered into a variety of collaboration and specimen transfer agreements relating to its development efforts. The Company recorded collaboration expenses of $1.0 million and $2.1 million for the three and nine months ended September 30, 2013 and $370,000 and $1.4 million for the three and nine months ended September 30, 2012, respectively, relating to services provided in connection with these agreements. In addition to these expenses, some of the agreements contain provisions for royalties from inventions resulting from these collaborations. The Company has specified options and rights relating to joint inventions arising out of the collaborations.

 

In August 2013, the Company entered into a collaboration agreement to conduct an additional large DCIS clinical study to validate the relationship between the Oncotype DX DCIS score and the likelihood of local recurrence in patients with DCIS. The agreement, which is estimated to be completed in 2017, includes a study fee and milestone payments dependent on the completion of certain key milestones. During the three and nine months ended September 30, 2013, the Company made milestone payments of $392,000 related to this agreement. All future milestone payments are contingent on certain milestone accomplishments, and therefore the timing for future milestone payments cannot be estimated.

 

The Company is a party to various agreements under which it licenses technology on a non-exclusive basis in the field of human diagnostics. Access to these licenses enables the Company to process its Oncotype DX tests. While certain agreements contain provisions for fixed annual payments, license fees are generally calculated as a percentage of product revenues, with rates that vary by agreement and may be tiered, and payments that may be capped at annual minimum or maximum amounts. The Company recognized costs recorded under these agreements totaling $2.2 million and $6.7 million for the three and nine months ended September 30, 2013 and $2.0 million and $6.0 million for the three and nine months ended September 30, 2012, respectively, which were included in cost of product revenues.

 

At September 30, 2013, fixed future annual payments, exclusive of royalty payments, relating to the launch and commercialization of the Oncotype DX colon cancer test and the Oncotype DX prostate cancer test totaled $1.1 million and are payable as follows:

 

 

 

Fixed Future
Annual Payments

 

 

 

(In thousands)

 

Payment Due:

 

 

 

2014

 

$

550

 

2015

 

550

 

Total

 

$

1,100

 

 

These payments are recorded in cost of product revenues as license fees. Expense for payments included in the table above is recorded ratably over the year before the relevant payment is due. If at any time the Company discontinues the sale of the products covered by the agreement, no future annual payments will be payable and the Company will have no further obligation under the applicable agreement.

 

Contract Research Arrangements

 

In November 2007, the Company entered into a Collaborative Diagnostic Development Agreement with Pfizer Inc. to provide research and development services for the development of a diagnostic product for renal cell cancer. The Company received an initial payment of $1.5 million and was initially eligible to receive a payment of $2.2 million upon joint agreement on a gene identification plan, $5.0 million in additional payments upon the earlier of Pfizer’s election to initiate the next phase of development or a specified number of months from the date the Company received the sample set and related clinical data necessary to conduct the first phase of development, and a final payment of $1.5 million upon completion of clinical validation. Completion of clinical validation represents a substantive milestone and the Company will recognize the $1.5 million payment upon completion. All other payments were not considered substantive milestones as they are not based solely on the Company’s past performance. Such payments are recognized using a performance- based model and revenue is recognized following delivery of effort as compared to an estimate of total expected effort. The Company did not recognize any revenue related to substantive milestones under this agreement during the three and nine months ended and September 30, 2013 and 2012, respectively.

 

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Fair Value Measurements (Details) (USD $)
In Thousands, unless otherwise specified
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Recurring basis
Actively Quoted Markets for Identical Assets Level 1
Dec. 31, 2012
Recurring basis
Actively Quoted Markets for Identical Assets Level 1
Sep. 30, 2013
Recurring basis
Actively Quoted Markets for Identical Assets Level 1
Money market deposits
Dec. 31, 2012
Recurring basis
Actively Quoted Markets for Identical Assets Level 1
Money market deposits
Sep. 30, 2013
Recurring basis
Actively Quoted Markets for Identical Assets Level 1
U.S. Treasury securities
Dec. 31, 2012
Recurring basis
Actively Quoted Markets for Identical Assets Level 1
U.S. Treasury securities
Sep. 30, 2013
Recurring basis
Significant Other Observable Inputs Level 2
Dec. 31, 2012
Recurring basis
Significant Other Observable Inputs Level 2
Sep. 30, 2013
Recurring basis
Significant Other Observable Inputs Level 2
Debt securities of U.S. government-sponsored entities
Dec. 31, 2012
Recurring basis
Significant Other Observable Inputs Level 2
Debt securities of U.S. government-sponsored entities
Sep. 30, 2013
Recurring basis
Significant Other Observable Inputs Level 2
Commercial paper
Dec. 31, 2012
Recurring basis
Significant Other Observable Inputs Level 2
Commercial paper
Sep. 30, 2013
Recurring basis
Significant Other Observable Inputs Level 2
Corporate debt securities
Dec. 31, 2012
Recurring basis
Significant Other Observable Inputs Level 2
Corporate debt securities
Sep. 30, 2013
Recurring basis
Fair value
Dec. 31, 2012
Recurring basis
Fair value
Sep. 30, 2013
Recurring basis
Fair value
Money market deposits
Dec. 31, 2012
Recurring basis
Fair value
Money market deposits
Sep. 30, 2013
Recurring basis
Fair value
U.S. Treasury securities
Dec. 31, 2012
Recurring basis
Fair value
U.S. Treasury securities
Sep. 30, 2013
Recurring basis
Fair value
Debt securities of U.S. government-sponsored entities
Dec. 31, 2012
Recurring basis
Fair value
Debt securities of U.S. government-sponsored entities
Sep. 30, 2013
Recurring basis
Fair value
Commercial paper
Dec. 31, 2012
Recurring basis
Fair value
Commercial paper
Sep. 30, 2013
Recurring basis
Fair value
Corporate debt securities
Dec. 31, 2012
Recurring basis
Fair value
Corporate debt securities
Assets measured at fair value on a recurring basis:                                                        
Total assets at fair value     $ 10,108 $ 8,679 $ 9,357 $ 7,403 $ 751 $ 1,276 $ 78,614 $ 86,751 $ 1,107 $ 761 $ 47,149 $ 33,888 $ 30,358 $ 52,102 $ 88,722 $ 95,430 $ 9,357 $ 7,403 $ 751 $ 1,276 $ 1,107 $ 761 $ 47,149 $ 33,888 $ 30,358 $ 52,102
Transfer of assets from level 1 to level 2 0 0                                                    
Transfer of assets from level 2 to level 1 0 0                                                    
Transfer of liabilities from level 1 to level 2 0 0                                                    
Transfer of liabilities from level 2 to level 1 $ 0 $ 0                                                    
XML 22 R18.htm IDEA: XBRL DOCUMENT v2.4.0.8
Collaboration and Commercial Technology Licensing Agreements (Tables)
9 Months Ended
Sep. 30, 2013
Collaboration and Commercial Technology Licensing Agreements  
Schedule of fixed future annual payments, exclusive of royalty payments

 

 

 

Fixed Future
Annual Payments

 

 

 

(In thousands)

 

Payment Due:

 

 

 

2014

 

$

550

 

2015

 

550

 

Total

 

$

1,100

 

XML 23 R27.htm IDEA: XBRL DOCUMENT v2.4.0.8
Collaboration and Commercial Technology Licensing Agreements (Details 2) (Collaborative Diagnostic Development Agreement with Pfizer Inc., USD $)
In Millions, unless otherwise specified
1 Months Ended
Nov. 30, 2007
Collaborative Diagnostic Development Agreement with Pfizer Inc.
 
Contract research arrangements  
Initial payment received upon joint agreement $ 1.5
Payment receivable upon joint agreement on gene identification plan 2.2
Additional payments receivable to conduct next phase of development 5.0
Final payment receivable upon completion of clinical validation $ 1.5
XML 24 R26.htm IDEA: XBRL DOCUMENT v2.4.0.8
Collaboration and Commercial Technology Licensing Agreements (Details) (USD $)
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Specimen transfer agreements
       
Collaboration and Commercial Technology Licensing Agreements        
Collaboration expense $ 1,000,000 $ 370,000 $ 2,100,000 $ 1,400,000
Oncotype DX DCIS score
       
Collaboration and Commercial Technology Licensing Agreements        
Milestone payment 392,000   392,000  
Technology license agreements
       
Collaboration and Commercial Technology Licensing Agreements        
Costs recorded under collaborative arrangements 2,200,000 2,000,000 6,700,000 6,000,000
Oncotype DX colon cancer test and Oncotype DX prostate cancer test
       
Fixed future annual payments, exclusive of royalty payments        
2014 550,000   550,000  
2015 550,000   550,000  
Total $ 1,100,000   $ 1,100,000  
XML 25 R31.htm IDEA: XBRL DOCUMENT v2.4.0.8
Income Taxes (Details) (USD $)
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Dec. 31, 2012
Income Taxes          
Income tax expense $ 116,000 $ 109,000 $ 223,000 $ 243,000  
Unrecognized tax benefits $ 967,000   $ 967,000   $ 875,000
XML 26 R25.htm IDEA: XBRL DOCUMENT v2.4.0.8
Fair Value Measurements (Details 2) (USD $)
In Thousands, unless otherwise specified
3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Dec. 31, 2012
Marketable securities classified as available-for-sale          
Amortized Cost $ 74,247   $ 74,247   $ 81,045
Unrealized Gains 29   29   38
Unrealized Losses (11)   (11)   (23)
Estimated Fair Value 74,265   74,265   81,060
Realized gains on available-for-sale marketable securities 0 0 0 0  
Realized losses on available-for-sale marketable securities 0 0 0 0  
Maximum contractual maturities of Company's available-for-sale marketable securities     1 year   1 year
U.S. Treasury securities
         
Marketable securities classified as available-for-sale          
Amortized Cost 751   751   1,275
Unrealized Gains         1
Estimated Fair Value 751   751   1,276
Debt securities of U.S. government-sponsored entities
         
Marketable securities classified as available-for-sale          
Amortized Cost 1,106   1,106   761
Unrealized Gains 1   1    
Estimated Fair Value 1,107   1,107   761
Commercial paper
         
Marketable securities classified as available-for-sale          
Amortized Cost 42,875   42,875   28,854
Unrealized Gains 24   24   35
Estimated Fair Value 42,899   42,899   28,889
Corporate debt securities
         
Marketable securities classified as available-for-sale          
Amortized Cost 29,515   29,515   50,155
Unrealized Gains 4   4   2
Unrealized Losses (11)   (11)   (23)
Estimated Fair Value $ 29,508   $ 29,508   $ 50,134
XML 27 R6.htm IDEA: XBRL DOCUMENT v2.4.0.8
Condensed Consolidated Statements of Cash Flows (USD $)
In Thousands, unless otherwise specified
9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Operating activities    
Net income (loss) $ (3,388) $ 6,290
Adjustments to reconcile net income (loss) to net cash provided by operating activities:    
Depreciation and amortization 4,770 3,974
Employee stock-based compensation 12,845 10,807
Outside director restricted stock awarded in lieu of fees 170 120
Gain on disposal of property and equipment (5) (3)
Share of loss of equity method investee   98
Changes in assets and liabilities:    
Accounts receivable (3,341) 1,151
Prepaid expenses and other assets (623) (1,269)
Accounts payable (1,396) (3,633)
Accrued compensation (20) 62
Accrued expenses and other liabilities 2,977 3,046
Deferred revenues 760 (818)
Net cash provided by operating activities 12,749 19,825
Investing activities    
Purchases of property and equipment (7,443) (6,170)
Purchases of marketable securities (71,914) (61,496)
Maturities of marketable securities 78,712 60,125
Purchase of other investments   (1,409)
Net cash used in investing activities (645) (8,950)
Financing activities    
Net proceeds from issuance of common stock under stock plans 9,687 14,215
Repurchase of common stock (15)  
Net cash provided by financing activities 9,672 14,215
Net increase in cash and cash equivalents 21,776 25,090
Cash and cash equivalents at the beginning of the period 18,005 32,869
Cash and cash equivalents at the end of the period $ 39,781 $ 57,959
XML 28 R8.htm IDEA: XBRL DOCUMENT v2.4.0.8
Net Income (Loss) Per Share
9 Months Ended
Sep. 30, 2013
Net Income (Loss) Per Share  
Net Income (Loss) Per Share

Note 2.  Net Income (Loss) Per Share

 

Basic net income (loss) per share is calculated by dividing net income (loss) for the period by the weighted-average number of common shares outstanding for the period without consideration of potential common shares. Diluted net income (loss) per share is calculated by dividing net income (loss) by the weighted-average number of common shares outstanding for the period and dilutive potential common shares for the period determined using the treasury-stock method. For purposes of this calculation, options to purchase common stock and restricted stock unit awards are considered to be potential common shares and are not included in the calculation of diluted net loss per share because their effect is anti-dilutive.

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

 

 

(In thousands)

 

Numerator:

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

488

 

$

3,712

 

$

(3,388

)

$

6,290

 

 

 

 

 

 

 

 

 

 

 

Denominator:

 

 

 

 

 

 

 

 

 

Weighted-average shares of common stock outstanding used in the calculation of basic net income (loss) per share

 

30,661

 

30,580

 

30,368

 

30,233

 

Effect of dilutive securities:

 

 

 

 

 

 

 

 

 

Options to purchase common stock

 

1,486

 

1,844

 

 

1,758

 

Restricted stock units

 

177

 

154

 

 

104

 

Total

 

1,663

 

1,998

 

 

1,862

 

Weighted-average shares of common stock outstanding used in the calculation of diluted net income (loss) per share

 

32,324

 

32,578

 

30,368

 

32,095

 

Basic net income (loss) per share

 

$

0.02

 

$

0.12

 

$

(0.11

)

$

0.21

 

Diluted net income (loss) per share

 

$

0.02

 

$

0.11

 

$

(0.11

)

$

0.20

 

 

Options to purchase approximately 829,000 and 834,000 weighted average shares of the Company’s common stock that were outstanding during the three and nine months ended September 30, 2013, respectively, were not included in the computation of diluted net loss per share because their effect was anti-dilutive. Options to purchase approximately 556,000 and 486,000 weighted average shares of the Company’s common stock were outstanding during the three and nine months ended September 30, 2012, respectively, but were not included in the computation of diluted net income per share because their effect was anti-dilutive.

 

XML 29 R11.htm IDEA: XBRL DOCUMENT v2.4.0.8
Commitments
9 Months Ended
Sep. 30, 2013
Commitments  
Commitments

Note 5. Commitments

 

Lease Obligations

 

In September 2005, the Company entered into a non-cancelable lease for 48,000 square feet of laboratory and office space that the Company currently occupies in Redwood City, California. In November 2010, the Company executed an amendment to extend the term of the lease through March 2019, with an option to extend the term of the lease for an additional five years. The agreement included lease incentive obligations of $834,000 that are being amortized on a straight-line basis over the life of the lease.

 

In January 2007, the Company entered into a non-cancelable lease for an additional 48,000 square feet of laboratory and office space in a nearby location. In November 2010, the Company executed an amendment to extend the term of the lease through March 2018, with an option to extend the term of the lease for an additional five years. The agreement included lease incentive obligations totaling $283,000 that are being amortized on a straight-line basis over the life of the lease.

 

In October 2009, the Company entered into a non-cancelable agreement to lease an additional 30,500 square feet of office space near the locations the Company currently occupies. The lease expires in March 2018, with an option for the Company to extend the term of the lease for an additional five years. The agreement includes lease incentive obligations of $307,000 which are being amortized on a straight-line basis over the life of the lease.

 

In August 2013, the Company entered into a non-cancelable agreement to lease an additional 18,400 square feet of laboratory and office space near the locations the Company currently occupies. The lease expires in March 2019, with an option for the Company to extend the term of the lease for an additional five years. In addition, there is an additional 5,500 square feet that may become available during the initial term of the lease, which the Company has agreed to lease on the same terms. The agreement includes lease incentive obligations of $276,000 which are being amortized on a straight-line basis over the life of the lease.

 

In May 2010, the Company’s European subsidiary entered into a non-cancelable lease for approximately 2,500 square feet of office space in Geneva, Switzerland. The lease expires in May 2015.  Additionally, the Company has offices in the United Kingdom and Germany with short-term rental agreements.

 

Future non-cancelable commitments under these operating leases at September 30, 2013 were as follows:

 

 

 

Annual
Payments

 

 

 

(In thousands)

 

Years Ending December 31,

 

 

 

2013 (remainder of year)

 

$

771

 

2014

 

3,603

 

2015

 

3,539

 

2016

 

3,597

 

2017

 

3,706

 

2018 and thereafter

 

2,771

 

Total minimum payments

 

$

17,987

 

XML 30 R9.htm IDEA: XBRL DOCUMENT v2.4.0.8
Fair Value Measurements
9 Months Ended
Sep. 30, 2013
Fair Value Measurements  
Fair Value Measurements

Note 3.  Fair Value Measurements

 

The Company measures certain financial assets, including cash equivalents and marketable securities, at their fair value on a recurring basis. The fair value of these financial assets was determined based on a hierarchy of three levels of inputs, of which the first two are considered observable and the last unobservable, as follows:

 

Level 1:  Quoted prices in active markets for identical assets or liabilities;

 

Level 2:  Observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and

 

Level 3:  Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. The Company did not have any non-financial assets or liabilities that were measured or disclosed at fair value on a recurring basis at September 30, 2013 and December 31, 2012, respectively. The following tables set forth the Company’s financial instruments that were measured at fair value on a recurring basis at September 30, 2013 and December 31, 2012 by level within the fair value hierarchy:

 

 

 

Actively Quoted
Markets for
Identical Assets
Level 1

 

Significant Other
Observable
Inputs
Level 2

 

Significant
Unobservable
Inputs
Level 3

 

Balance at
September 30,
2013

 

 

 

(In thousands)

 

As of September 30, 2013:

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

Money market deposits

 

$

9,357

 

$

 

$

 

$

9,357

 

U.S. Treasury securities

 

751

 

 

 

751

 

Debt securities of U.S. government-sponsored entities

 

 

1,107

 

 

1,107

 

Commercial paper

 

 

47,149

 

 

47,149

 

Corporate debt securities

 

 

30,358

 

 

30,358

 

Total

 

$

10,108

 

$

78,614

 

$

 

$

88,722

 

 

 

 

Actively Quoted
Markets for
Identical Assets
 Level 1

 

Significant Other
 Observable
 Inputs
 Level 2

 

Significant
 Unobservable
 Inputs
 Level 3

 

Balance at
 December 31,
 2012

 

 

 

(In thousands)

 

As of December 31, 2012:

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

Money market deposits

 

$

7,403

 

$

 

$

 

$

7,403

 

U.S. Treasury securities

 

1,276

 

 

 

1,276

 

Debt securities of U.S. government-sponsored entities

 

 

761

 

 

761

 

Commercial paper

 

 

33,888

 

 

33,888

 

Corporate debt securities

 

 

52,102

 

 

52,102

 

Total

 

$

8,679

 

$

86,751

 

$

 

$

95,430

 

 

The Company’s debt securities of U.S. government-sponsored entities, commercial paper and corporate bonds are classified as Level 2 as they are valued using multi-dimensional relational pricing models that use observable market inputs, including benchmark yields, reported trades, broker-dealer quotes, issuer spreads, benchmark securities, bids, offers and reference data. Not all inputs listed are available for use in the evaluation process on any given day for each security evaluation. In addition, market indicators, industry and economic events are monitored and may serve as a trigger to acquire further corroborating market data. There were no transfers between Level 1 and Level 2 categories during the three and nine months ended September 30, 2013 and 2012, respectively.

 

All of the Company’s marketable securities are classified as available-for-sale. The following tables illustrate the Company’s available-for-sale marketable securities as of the dates indicated:

 

 

 

September 30, 2013

 

 

 

Amortized
Cost

 

Unrealized
Gains

 

Unrealized
Losses

 

Estimated
Fair Value

 

 

 

(In thousands)

 

U.S. Treasury securities

 

$

751

 

$

 

$

 

$

751

 

Debt securities of U.S. government-sponsored entities

 

1,106

 

1

 

 

1,107

 

Commercial paper

 

42,875

 

24

 

 

42,899

 

Corporate debt securities

 

29,515

 

4

 

(11

)

29,508

 

Total

 

$

74,247

 

$

29

 

$

(11

)

$

74,265

 

 

 

 

December 31, 2012

 

 

 

Amortized
Cost

 

Unrealized
Gains

 

Unrealized
Losses

 

Estimated
Fair Value

 

 

 

(In thousands)

 

U.S. Treasury securities

 

$

1,275

 

$

1

 

$

 

$

1,276

 

Debt securities of U.S. government-sponsored entities

 

761

 

 

 

761

 

Commercial paper

 

28,854

 

35

 

 

28,889

 

Corporate debt securities

 

50,155

 

2

 

(23

)

50,134

 

Total

 

$

81,045

 

$

38

 

$

(23

)

$

81,060

 

 

The Company had no realized gains or losses on available-for-sale marketable securities for the three and nine months ended September 30, 2013 and 2012, respectively.

 

All of the Company’s available-for-sale marketable securities had contractual maturities of one year or less as of September 30, 2013 and December 31, 2012, respectively.

 

XML 31 R28.htm IDEA: XBRL DOCUMENT v2.4.0.8
Commitments (Details) (USD $)
1 Months Ended 1 Months Ended 1 Months Ended
Sep. 30, 2013
Nov. 30, 2010
Leased laboratory and office space located in Redwood City, California
Sep. 30, 2005
Leased laboratory and office space located in Redwood City, California
sqft
Nov. 30, 2010
Leased laboratory and office space located near the leased facility in Redwood City, California
Jan. 31, 2007
Leased laboratory and office space located near the leased facility in Redwood City, California
sqft
Oct. 31, 2009
Leased office space located near the leased facility in Redwood City, California
sqft
Aug. 31, 2013
Second leased laboratory and office space located near the leased facility in Redwood City, California
sqft
May 31, 2010
Leased office space located in Geneva, Switzerland
European subsidiary
sqft
Non-cancelable operating leases                
Area covered under non-cancelable operating lease agreement (in square feet)     48,000   48,000 30,500 18,400 2,500
Period of time for which entity has an option to extend lease term   5 years   5 years   5 years 5 years  
Additional area that may become available during initial term of lease (in square feet)             5,500  
Lease incentive obligations     $ 834,000   $ 283,000 $ 307,000 $ 276,000  
Non-cancelable commitments under operating leases                
2013 (remainder of year) 771,000              
2014 3,603,000              
2015 3,539,000              
2016 3,597,000              
2017 3,706,000              
2018 and thereafter 2,771,000              
Total minimum payments $ 17,987,000              
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Process Flow-Through: 0010 - Statement - Condensed Consolidated Balance Sheets Process Flow-Through: Removing column 'Sep. 30, 2012' Process Flow-Through: Removing column 'Dec. 31, 2011' Process Flow-Through: 0015 - Statement - Condensed Consolidated Balance Sheets (Parenthetical) Process Flow-Through: 0020 - Statement - Condensed Consolidated Statements of Operations Process Flow-Through: 0030 - Statement - Condensed Consolidated Statements of Comprehensive Income (Loss) Process Flow-Through: 0040 - Statement - Condensed Consolidated Statements of Cash Flows ghdx-20130930.xml ghdx-20130930.xsd ghdx-20130930_cal.xml ghdx-20130930_def.xml ghdx-20130930_lab.xml ghdx-20130930_pre.xml true true XML 35 R3.htm IDEA: XBRL DOCUMENT v2.4.0.8
Condensed Consolidated Balance Sheets (Parenthetical) (USD $)
In Thousands, unless otherwise specified
Sep. 30, 2013
Dec. 31, 2012
Condensed Consolidated Balance Sheets    
Accounts receivable, allowance for doubtful accounts $ 1,847 $ 1,133

XML 36 R14.htm IDEA: XBRL DOCUMENT v2.4.0.8
Income Taxes
9 Months Ended
Sep. 30, 2013
Income Taxes  
Income Taxes

Note 8. Income Taxes

 

The Company recorded income tax expense of $116,000 and $223,000 for the three and nine months ended September 30, 2013, respectively, which was computed using the “discrete” (or “cut-off”) method and was principally comprised of state income taxes and foreign taxes. The Company recorded income tax expense of $109,000 and $243,000 for the three and nine months ended September 30, 2012, respectively, which was computed using the same method and was principally comprised of California alternative minimum tax, other state income taxes and foreign taxes. The difference between the income tax expense actually recorded and the statutory rate applied to the Company’s income (loss) before income taxes was primarily due to the impact of nondeductible meals and entertainment for the three and nine months ended September 30, 2013 and nondeductible stock-based compensation expenses for the three and nine months ended September 30, 2012.

 

Based on all available objective evidence, the Company believes that it is more likely than not that its net deferred tax assets will not be fully realized. Accordingly, the Company maintained a valuation allowance against all of its net deferred tax assets as of both September 30, 2013 and December 31, 2012. The Company will continue to maintain a full valuation allowance until there is sufficient evidence to support recoverability of its deferred tax assets.

 

The Company had $967,000 and $875,000 of unrecognized tax benefits as of September 30, 2013 and December 31, 2012, respectively. The Company does not anticipate a material change to its unrecognized tax benefits over the next twelve months. Unrecognized tax benefits may change during the next twelve months for items that arise in the ordinary course of business.

 

Accrued interest and penalties related to unrecognized tax benefits are recognized as part of the Company’s income tax provision in its condensed consolidated statements of operations. All tax years from 2000 forward remain subject to future examination by federal, state and foreign tax authorities.

 

XML 37 R5.htm IDEA: XBRL DOCUMENT v2.4.0.8
Condensed Consolidated Statements of Comprehensive Income (Loss) (USD $)
In Thousands, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Condensed Consolidated Statements of Comprehensive Income (Loss)        
Net income (loss) $ 488 $ 3,712 $ (3,388) $ 6,290
Other comprehensive income (loss):        
Unrealized gain (loss) on available-for-sale marketable securities, net of tax (3) 18 3 46
Comprehensive income (loss) $ 485 $ 3,730 $ (3,385) $ 6,336
XML 38 R2.htm IDEA: XBRL DOCUMENT v2.4.0.8
Condensed Consolidated Balance Sheets (USD $)
In Thousands, unless otherwise specified
Sep. 30, 2013
Dec. 31, 2012
Current assets:    
Cash and cash equivalents $ 39,781 $ 18,005
Short-term marketable securities 74,265 81,060
Accounts receivable (net of allowance for doubtful accounts; 2013 - $1,847, 2012 - $1,133) 25,594 22,253
Prepaid expenses and other current assets 9,314 8,891
Total current assets 148,954 130,209
Property and equipment, net 18,242 14,104
Other assets 9,504 9,421
Total assets 176,700 153,734
Current liabilities:    
Accounts payable 3,545 4,881
Accrued compensation 11,190 11,210
Accrued license fees 2,319 2,292
Accrued expenses and other current liabilities 10,451 6,340
Deferred revenues 1,134 374
Other current liabilities 292 243
Total current liabilities 28,931 25,340
Other liabilities 2,141 2,068
Commitments and contingencies      
Stockholders' equity:    
Common stock 3 3
Additional paid-in capital 336,617 313,915
Accumulated other comprehensive income 18 15
Accumulated deficit (160,900) (157,512)
Treasury stock, at cost (30,110) (30,095)
Total stockholders' equity 145,628 126,326
Total liabilities and stockholders' equity $ 176,700 $ 153,734
XML 39 R29.htm IDEA: XBRL DOCUMENT v2.4.0.8
Stock-Based Compensation (Details) (USD $)
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Stock-Based Compensation        
Stock-based compensation expense (in dollars) $ 4,400,000 $ 3,400,000 $ 12,800,000 $ 10,800,000
Employee Stock Purchase Plan
       
Employee Stock Purchase Plan        
Number of shares issued 0   86,683  
Shares of common stock reserved for issuance under the ESPP 1,250,000   1,250,000  
Shares available for issuance 1,017,254   1,017,254  
Unrecognized compensation expense (in dollars) 171,000   171,000  
Weighted-average period of recognition of unrecognized stock-based compensation expense     2 months  
Weighted-average fair values and assumptions used in calculation of fair value        
Expected volatility (as a percent) 29.00% 38.00% 41.00% 43.00%
Risk-free interest rate (as a percent) 0.08% 0.12% 0.11% 0.08%
Expected life 6 months 6 months 6 months 6 months
Weighted-average fair value (in dollars per share) $ 8.04 $ 8.12 $ 7.74 $ 7.59
Stock Options
       
Stock Option Grants        
Common stock issued in connection with the exercise of stock options (in shares) 123,796 303,577 631,114 835,865
Weighted-average exercise price of common stock issued (in dollars per share) $ 15.37 $ 17.96 $ 16.44 $ 16.53
Weighted-average fair values and assumptions used in calculation of fair value        
Dividend yield (as a percent) 0.00% 0.00% 0.00% 0.00%
Expected volatility (as a percent) 45.00% 45.00% 46.00% 46.00%
Risk-free interest rate (as a percent) 1.90% 1.43% 1.40% 1.23%
Expected life 6 years 7 months 2 days 6 years 8 months 5 days 6 years 7 months 20 days 6 years 11 months 23 days
Weighted-average fair value (in dollars per share) $ 15.83 $ 18.40 $ 14.11 $ 14.51
Employee Stock Options
       
Stock Option Grants        
Options granted to purchase shares of common stock to employees (in shares) 83,105 41,500 458,355 608,000
Restricted Stock Units
       
Stock awards other than options        
Stock awards (in shares) 110,635 31,550 379,158 415,566
Grant-date fair value (in dollars) 3,900,000 1,100,000 11,600,000 12,300,000
Number of shares of common stock to be received for each restricted stock unit     1  
Shares of common stock issued in connection with the vesting of the stock award 12,328 2,819 223,791 64,909
Weighted-average fair values and assumptions used in calculation of fair value        
Weighted-average fair value (in dollars per share) $ 31.35 $ 22.80 $ 26.94 $ 23.29
Restricted Stock Units | Employees
       
Stock awards other than options        
Vesting period     3 years  
Restricted Stock Units | Employees | Annual vesting over vesting period
       
Stock awards other than options        
Vesting percentage     33.00%  
Restricted Stock | Outside directors
       
Stock awards other than options        
Stock awards (in shares) 1,818 1,196 5,795 4,072
Grant-date fair value (in dollars) $ 60,000 $ 40,000 $ 170,000 $ 120,000
Weighted-average fair values and assumptions used in calculation of fair value        
Weighted-average fair value (in dollars per share) $ 32.85 $ 33.40 $ 29.28 $ 29.41
XML 40 R23.htm IDEA: XBRL DOCUMENT v2.4.0.8
Net Income (Loss) Per Share (Details) (USD $)
In Thousands, except Share data, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Numerator:        
Net income (loss) (in dollars) $ 488 $ 3,712 $ (3,388) $ 6,290
Denominator:        
Weighted-average shares of common stock outstanding used in the calculation of basic net income (loss) per share 30,661,000 30,580,000 30,368,000 30,233,000
Effect of dilutive securities:        
Effect of dilutive securities (in shares) 1,663,000 1,998,000   1,862,000
Weighted-average shares of common stock outstanding used in the calculation of diluted net income (loss) per share 32,324,000 32,578,000 30,368,000 32,095,000
Basic net income (loss) per share (in dollars per share) $ 0.02 $ 0.12 $ (0.11) $ 0.21
Diluted net income (loss) per share (in dollars per share) $ 0.02 $ 0.11 $ (0.11) $ 0.20
Options to purchase common stock
       
Effect of dilutive securities:        
Effect of dilutive securities (in shares) 1,486,000 1,844,000   1,758,000
Outstanding options to purchase shares of common stock not included in the computation of diluted net loss per share (in shares) 829,000 556,000 834,000 486,000
Restricted stock units
       
Effect of dilutive securities:        
Effect of dilutive securities (in shares) 177,000 154,000   104,000
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Segment Information
9 Months Ended
Sep. 30, 2013
Segment Information  
Segment Information

Note 7. Segment Information

 

The Company operates in one business segment, which primarily focuses on the development and global commercialization of genomic based clinical laboratory services that analyze the underlying biology of cancer. As of September 30, 2013, the majority of the Company’s product revenues have been derived from sales of one product, the Oncotype DX breast cancer test. All Oncotype DX tests are included in one segment, because they have similar economic and other characteristics, including the nature of the tests and laboratory processes, type of customers, distribution methods and regulatory environment.

 

The following table summarizes total revenues from customers and collaboration partners by geographic region. Product revenues are attributed to countries based on ship-to location. Contract revenues are attributed to countries based on the location of the collaboration partner.

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

 

 

(in thousands)

 

United States

 

$

55,890

 

$

50,564

 

$

164,973

 

$

155,798

 

Outside of the United States

 

10,100

 

8,084

 

27,803

 

18,948

 

Total revenues

 

$

65,990

 

$

58,648

 

$

192,776

 

$

174,746

 

XML 42 R30.htm IDEA: XBRL DOCUMENT v2.4.0.8
Segment Information (Details) (USD $)
In Thousands, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2013
product
segment
Sep. 30, 2012
Sep. 30, 2013
segment
product
Sep. 30, 2012
Segment Information        
Number of business segments in which the entity operates     1  
Number of products from which the majority of the entity's product revenues have been derived 1   1  
Number of segments in which product tests are included 1   1  
Segment information        
Total revenues $ 65,990 $ 58,648 $ 192,776 $ 174,746
United States
       
Segment information        
Total revenues 55,890 50,564 164,973 155,798
Outside of the United States
       
Segment information        
Total revenues $ 10,100 $ 8,084 $ 27,803 $ 18,948
XML 43 R16.htm IDEA: XBRL DOCUMENT v2.4.0.8
Net Income (Loss) Per Share (Tables)
9 Months Ended
Sep. 30, 2013
Net Income (Loss) Per Share  
Schedule of reconciliation of numerator and denominator used in calculation of basic and diluted net income (loss) per share

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

 

 

(In thousands)

 

Numerator:

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

488

 

$

3,712

 

$

(3,388

)

$

6,290

 

 

 

 

 

 

 

 

 

 

 

Denominator:

 

 

 

 

 

 

 

 

 

Weighted-average shares of common stock outstanding used in the calculation of basic net income (loss) per share

 

30,661

 

30,580

 

30,368

 

30,233

 

Effect of dilutive securities:

 

 

 

 

 

 

 

 

 

Options to purchase common stock

 

1,486

 

1,844

 

 

1,758

 

Restricted stock units

 

177

 

154

 

 

104

 

Total

 

1,663

 

1,998

 

 

1,862

 

Weighted-average shares of common stock outstanding used in the calculation of diluted net income (loss) per share

 

32,324

 

32,578

 

30,368

 

32,095

 

Basic net income (loss) per share

 

$

0.02

 

$

0.12

 

$

(0.11

)

$

0.21

 

Diluted net income (loss) per share

 

$

0.02

 

$

0.11

 

$

(0.11

)

$

0.20

 

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Stock-Based Compensation
9 Months Ended
Sep. 30, 2013
Stock-Based Compensation  
Stock-Based Compensation

Note 6. Stock-Based Compensation

 

The Company recognized employee stock-based compensation expense of $4.4 million and $12.8 million for the three and nine months ended September 30, 2013, respectively, and $3.4 million and $10.8 million for the three and nine months ended September 30, 2012, respectively. Employee stock-based compensation expense includes expense related to stock option grants, restricted stock unit (“RSU”) awards to employees, restricted stock issued in lieu of outside director fees and stock purchased under the Company’s Employee Stock Purchase Plan (“ESPP”). Stock-based compensation expense is calculated based on options and RSUs ultimately expected to vest and has been reduced for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

 

Stock Option Grants

 

The Company granted options to purchase 83,105 shares and 458,355 shares of common stock to employees during the three and nine months ended September 30, 2013, respectively and 41,500 shares and 608,000 shares of common stock to employees during the three and nine months ended September 30, 2012, respectively. For the three and nine months ended September 30, 2013, the Company issued 123,796 and 631,114 shares of common stock in connection with the exercise of stock options with a weighted-average exercise price of $15.37 and $16.44 per share, respectively. For the three and nine months ended September 30, 2012, the Company issued 303,577 and 835,865 shares of common stock in connection with the exercise of stock options with a weighted-average exercise price of $17.96 and $16.53 per share, respectively.

 

Restricted Stock Units

 

During the three and nine months ended September 30, 2013, the Company awarded 110,635 and 379,158 RSUs with a grant-date fair value equal to $3.9 million and $11.6 million, respectively. During the three and nine months ended September 30, 2012, the Company awarded 31,550 and 415,566 RSUs with a grant-date fair value equal to $1.1 million and $12.3 million, respectively. Each RSU entitles the recipient to receive one share of the Company’s common stock upon vesting. RSUs awarded to employees generally vest as to one-third of the total number of shares awarded annually over a three-year period. During the three and nine months ended September 30, 2013, the Company issued 12,328 and 223,791 shares of common stock in connection with the vesting of RSUs with a weighted-average grant date fair value of $31.35 and $26.94 per share, respectively. During the three and nine months ended September 30, 2012, the Company issued 2,819 and 64,909 shares of common stock, respectively, in connection with the vesting of RSUs with a weighted-average grant date fair value of $22.80 and $23.29 per share, respectively.

 

Restricted Stock in Lieu of Directors’ Fees

 

Outside members of the Company’s Board of Directors may elect to receive fully-vested restricted stock in lieu of cash compensation for services as a director. During the three and nine months ended September 30, 2013, the Company issued 1,818 and 5,795 shares of restricted stock to outside directors, with a grant date fair value of $60,000 and $170,000, respectively, and a weighted-average grant date fair value of $32.85 and $29.28 per share, respectively. During the three and nine months ended September 30, 2012, the Company issued 1,196 and 4,072 shares of restricted stock to outside directors, with a grant date fair value of $40,000 and $120,000, respectively, and a weighted-average grant date fair value of $33.40 and $29.41 per share, respectively.

 

Employee Stock Purchase Plan

 

During the nine months ended September 30, 2013, 86,683 shares were issued under the ESPP. There were no shares issued under the ESPP during the three months ended September 30, 2013. A total of 1,250,000 shares of common stock have been reserved for issuance under the ESPP, of which 1,017,254 shares were available for issuance as of September 30, 2013. As of September 30, 2013, there was $171,000 of unrecognized compensation expense related to the ESPP, which is expected to be recognized over an estimated weighted-average period of two months.

 

Valuation Assumptions

 

The Company values its stock option grants using the Black-Scholes option valuation model. Option valuation models require the input of highly subjective assumptions that can vary over time. The Company’s assumptions regarding expected volatility are based on the historical volatility of the Company’s common stock. The expected life of options granted is estimated based on historical option exercise data and assumptions related to unsettled options. The risk-free interest rate is estimated using published rates for U.S. Treasury securities with a remaining term approximating the expected life of the options granted. The Company uses a dividend yield of zero as it has never paid cash dividends and does not anticipate paying cash dividends in the foreseeable future. The weighted-average fair values and assumptions used in calculating such values during each period are as follows:

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

Expected volatility:

 

 

 

 

 

 

 

 

 

Stock options

 

45

%

45

%

46

%

46

%

ESPP

 

29

%

38

%

41

%

43

%

Risk-free interest rate:

 

 

 

 

 

 

 

 

 

Stock options

 

1.90

%

1.43

%

1.40

%

1.23

%

ESPP

 

0.08

%

0.12

%

0.11

%

0.08

%

Expected life in years:

 

 

 

 

 

 

 

 

 

Stock options

 

6.59

 

6.68

 

6.64

 

6.98

 

ESPP

 

0.50

 

0.50

 

0.50

 

0.50

 

Weighted-average fair value:

 

 

 

 

 

 

 

 

 

Stock options

 

$

15.83

 

$

18.40

 

$

14.11

 

$

14.51

 

ESPP

 

$

8.04

 

$

8.12

 

$

7.74

 

$

7.59

 

XML 45 R7.htm IDEA: XBRL DOCUMENT v2.4.0.8
Organization and Summary of Significant Accounting Policies
9 Months Ended
Sep. 30, 2013
Organization and Summary of Significant Accounting Policies  
Organization and Summary of Significant Accounting Policies

Note 1. Organization and Summary of Significant Accounting Policies

 

The Company

 

Genomic Health, Inc. (the “Company”) is a global healthcare company that provides actionable genomic information to personalize cancer treatment decisions. The Company develops and globally commercializes genomic-based clinical laboratory services that analyze the underlying biology of cancer, allowing physicians and patients to make individualized treatment decisions. The Company was incorporated in Delaware in August 2000. The Company’s first product, the Oncotype DX invasive breast cancer test, was launched in 2004 and is used for early stage invasive breast cancer patients to predict the likelihood of breast cancer recurrence and the likelihood of chemotherapy benefit. In January 2010, the Company launched its second product, the Oncotype DX colon cancer test, which is used to predict the likelihood of colon cancer recurrence in patients with stage II disease. In December 2011, the Company made the Oncotype DX breast cancer test available for patients with ductal carcinoma in situ (“DCIS”), a pre-invasive form of breast cancer. This test provides a DCIS score that is used to predict the likelihood of local recurrence. In June 2012, the Company began offering the Oncotype DX colon cancer test for use in patients with stage III disease treated with oxaliplatin-containing adjuvant therapy. In May 2013, the Company launched the Oncotype DX prostate cancer test. The test provides a Genomic Prostate Score, or GPS, to predict disease aggressiveness in men with low risk disease. This test may be used to improve treatment decisions for prostate cancer patients, in conjunction with the Gleason score, or tumor grading.

 

Principles of Consolidation

 

The condensed consolidated financial statements include all the accounts of the Company and its wholly-owned subsidiaries. The Company had three wholly-owned subsidiaries at September 30, 2013: Genomic Health International Sarl, which was established in Switzerland in 2009, and Genomic Health International Holdings, LLC, which was established in Delaware in 2010, both of which support the Company’s international sales and marketing efforts; and Oncotype Laboratories, Inc., which was established in 2003, and is inactive. Genomic Health International Holdings, LLC has five wholly-owned subsidiaries: Genomic Health U.K., Ltd. and Genomic Health Germany GmbH, both of which were established in 2011, Genomic Health Canada, which was established in 2012 and Genomic Health France and Genomic Health India, which were established in 2013. The functional currency for the Company’s wholly-owned subsidiaries incorporated outside the United States is the U.S. dollar. All significant intercompany balances and transactions have been eliminated.

 

Basis of Presentation and Use of Estimates

 

The accompanying interim period condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The condensed consolidated balance sheet as of September 30, 2013, condensed consolidated statements of operations, condensed consolidated statements of comprehensive income (loss) and condensed consolidated statements of cash flows for the three and nine months ended September 30, 2013 and 2012 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of its financial position, operating results and cash flows for the periods presented. The condensed consolidated balance sheet at December 31, 2012 has been derived from audited financial statements, but it does not include certain information and notes required by GAAP for complete consolidated financial statements.

 

The preparation of financial statements in conformity with GAAP requires management to make judgments, assumptions and estimates that affect the amounts reported in the Company’s condensed consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates.

 

The accompanying interim period condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012.

 

Revenue Recognition

 

The Company derives its revenues primarily from product sales and, to a lesser extent, contract research arrangements. The majority of the Company’s historical product revenues have been derived from the sale of the Oncotype DX breast cancer test. The Company generally bills third-party payors upon generation and delivery of a patient report to the physician. As such, the Company takes assignment of benefits and the risk of collection with the third-party payor. The Company usually bills the patient directly for amounts owed after multiple requests for payment have been denied or only partially paid by the insurance carrier. The Company pursues case-by-case reimbursement where policies are not in place or payment history has not been established.

 

The Company’s product revenues for tests performed are recognized when the following revenue recognition criteria are met: (1) persuasive evidence that an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectibility is reasonably assured. Criterion (1) is satisfied when the Company has an arrangement to pay or a contract with the payor in place addressing reimbursement for the Oncotype DX test. In the absence of such arrangements, the Company considers that criterion (1) is satisfied when a third-party payor pays the Company for the test performed. Criterion (2) is satisfied when the Company performs the test and generates and delivers to the physician, or makes available on its web portal, a patient report. Determinations of criteria (3) and (4) are based on management’s judgments regarding whether the fee charged for products or services delivered is fixed or determinable, and the collectibility of those fees under any contract or arrangement. When evaluating collectibility, the Company considers whether it has sufficient history to reliably estimate a payor’s individual payment patterns. Based upon at least several months of payment history, the Company reviews the number of tests paid against the number of tests billed and the payor’s outstanding balance for unpaid tests to determine whether payments are being made at a consistently high percentage of tests billed and at appropriate amounts given the contracted payment amount. To the extent all criteria set forth above are not met when test results are delivered, product revenues are recognized when cash is received from the payor.

 

The Company has exclusive distribution agreements for one or more of its Oncotype DX tests with approximately 20 distributors covering more than 80 countries. The distributor generally provides certain marketing and administrative services to the Company within its territory. As a condition of these agreements, the distributor generally pays the Company an agreed upon fee per test and the Company processes the tests. The same revenue recognition criteria described above generally apply to tests received through distributors. To the extent all criteria set forth above are not met when test results are delivered, product revenues are generally recognized when cash is received from the distributor.

 

From time to time, the Company receives duplicate payments or overpayments made by third-party payors or patients. When a duplicate payment or overpayment is identified, the Company establishes an accrued liability for the overpaid amount until such time as the Company determines whether or not a refund is due. Accrued refunds were $946,000 and $664,000 at September 30, 2013 and December 31, 2012, respectively, and included in accrued expenses and other current liabilities.

 

Contract revenues are generally derived from studies conducted with biopharmaceutical and pharmaceutical companies. The specific methodology for revenue recognition is determined on a case-by-case basis according to the facts and circumstances applicable to a given contract. Under certain contracts, the Company’s input, measured in terms of full-time equivalent level of effort or running a set of assays through its clinical reference laboratory under a contractual protocol, triggers payment obligations, and revenues are recognized as costs are incurred or assays are processed. Certain contracts have payments that are triggered as milestones are completed, such as completion of a successful set of experiments. Milestones are assessed on an individual basis and revenue is recognized when these milestones are achieved, as evidenced by acknowledgment from collaborators, provided that (1) the milestone event is substantive and its achievability was not reasonably assured at the inception of the agreement and (2) the milestone payment is non-refundable. Where separate milestones do not meet these criteria, the Company defaults to a performance-based model, such as revenue recognition following delivery of effort as compared to an estimate of total expected effort.

 

Advance payments received in excess of revenues recognized are classified as deferred revenue until such time as the revenue recognition criteria have been met.

 

Allowance for Doubtful Accounts

 

The Company accrues an allowance for doubtful accounts against its accounts receivable based on estimates consistent with historical payment experience. Bad debt expense is included in general and administrative expense on the Company’s condensed consolidated statements of operations. Accounts receivable are written off against the allowance when the appeals process is exhausted, when an unfavorable coverage decision is received or when there is other substantive evidence that the account will not be paid. The Company’s allowance for doubtful accounts as of September 30, 2013 and December 31, 2012 was $1.8 million and $1.1 million, respectively. Write-offs for doubtful accounts of $1.7 million and $4.1 million were recorded against the allowance during the three and nine months ended September 30, 2013, respectively, and write-offs of $972,000 and $2.6 million were recorded against the allowance during the three and nine months ended September 30, 2012, respectively. Bad debt expense was $1.8 million and $4.8 million for the three and nine months ended September 30, 2013, respectively, and $998,000 and $2.6 million for the three and nine months ended September 30, 2012, respectively.

 

Research and Development Expenses

 

Research and development expenses are comprised of costs incurred to develop technology and carry out clinical studies and include salaries and benefits, reagents and supplies used in research and development laboratory work, infrastructure expenses, including allocated facility occupancy and information technology costs, contract services, and other outside costs. Research and development expenses also include costs related to activities performed under contracts with biopharmaceutical and pharmaceutical companies. Research and development costs are expensed as incurred.

 

The Company enters into collaboration and clinical trial agreements with clinical collaborators and records the costs associated with these agreements as research and development expenses. The Company records accruals for estimated study costs comprised of work performed by its collaborators under contract terms. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized and recognized as expense as the goods are delivered or the related services are performed.

 

Income Taxes

 

The Company uses the liability method for income taxes, whereby deferred income taxes are provided on items recognized for financial reporting purposes over different periods than for income tax purposes. Valuation allowances are provided when the expected realization of tax assets does not meet a more-likely-than-not criterion.

 

The Company accounts for uncertain income tax positions using a benefit recognition model with a two-step approach, a more-likely-than-not recognition criterion and a measurement attribute that measures the position as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement, in accordance with the accounting guidance for uncertain tax positions. If it is not more likely than not that the benefit will be sustained on its technical merits, no benefit is recorded. Uncertain tax positions that relate only to timing of when an item is included on a tax return are considered to have met the recognition threshold. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in income tax expense when and if incurred. See Note 8, “Income Taxes,” for additional information regarding unrecognized tax benefits.

 

Investments in PrivatelyHeld Companies

 

The Company determines whether its investments in privately held companies are debt or equity based on their characteristics, in accordance with the applicable accounting guidance for such investments. The Company also evaluates the investee to determine if the entity is a variable interest entity (“VIE”) and, if so, whether the Company is the primary beneficiary of the VIE, in order to determine whether consolidation of the VIE is required in accordance with accounting guidance for consolidations. If consolidation is not required and the Company owns less than 50.1% of the voting interest of the entity, the investment is evaluated to determine if the equity method of accounting should be applied. The equity method applies to investments in common stock or in-substance common stock where the Company exercises significant influence over the investee, typically represented by ownership of 20% or more of the voting interests of an entity. If the equity method does not apply, investments in privately held companies determined to be equity securities are accounted for using the cost method. Investments in privately held companies determined to be debt securities are accounted for as available-for-sale or held-to-maturity securities, in accordance with accounting guidance for investments.

 

The Company reviews long-lived assets, which include investments in privately held companies, for impairment whenever events or changes in business circumstances indicate that the carrying amounts of the assets may not be fully recoverable. For investments in privately held companies, evidence of impairment might include the absence of an ability to recover the carrying amount of the investment or the inability of the investee to sustain an earnings capacity which would justify the carrying amount of the investment. The Company’s assessment as to whether any impairment is other than temporary is based on its ability and intent to hold the investment and whether evidence indicating the carrying value of the investment is recoverable within a reasonable period of time outweighs evidence to the contrary. If the fair value of the investment is determined to be less than the carrying value and the decline in value is considered to be other than temporary, the asset is written down to its fair value.

 

In December 2010, the Company invested $500,000 in the preferred stock of a private company representing 21% of the entity’s outstanding voting shares. The Company determined that it was not the primary beneficiary of this VIE and, accordingly, applied the equity method of accounting. In June 2012, the Company invested an additional $400,000 in the preferred stock of this company as part of a new equity financing which included other investors, and reduced the Company’s holdings to approximately 16%. As of June 30, 2012, the Company changed its method of accounting for this investment to the cost method because the Company’s ownership fell below 20% and the Company does not have the ability to exercise significant influence over the investee entity. As of September 30, 2013, the Company considered the investment to be temporarily impaired based on the private company’s low cash balances resulting from the delay of its commercial product launch. The private company is in the process of raising additional capital combined with executing new customer agreements and the Company has the ability and intent to hold the investment and expects the fair value of their investment to ultimately exceed the carrying value. The net carrying value of this investment was $643,000 at September 30, 2013 and at December 31, 2012, and no impairment was recognized through September 30, 2013.

 

In March 2011, the Company invested $2.3 million in the redeemable preferred stock of a private company representing 21% of the entity’s outstanding voting shares. The Company determined that the investment was a held-to-maturity debt security and that the investee was not subject to consolidation. In August 2012, the Company participated in the first tranche of a second preferred stock financing of this private company and purchased $1.0 million of preferred stock with no redemption privileges. In connection with this financing, the terms of the Company’s initial redeemable preferred stock investment were modified to become preferred stock with no redemption privileges. As a result of this transaction, the Company’s ownership interest was reduced to approximately 19% and the investment held by the Company is considered to be an investment in non-marketable equity securities. In October 2012, the Company participated in the second tranche of the second financing and purchased an additional $3.6 million of preferred stock, resulting in an ownership percentage of approximately 18%. In May 2013, the investee completed an additional round of financing to new investors. As of September 30, 2013, the Company’s ownership percentage was approximately 13%. The investee is not consolidated because the Company owns less than 20% of the investee and the Company does not have the ability to exercise significant influence over the investee. As a result, the Company will continue to use the cost method of accounting for this investment. The carrying value of this investment was $6.9 million at September 30, 2013 and at December 31, 2012, and no impairment was recognized through September 30, 2013.

 

The aggregate carryng value of the Company’s investments in privately held companies was $7.5 million at September 30, 2013 and at December 31, 2012, and were included in other assets in the accompanying condensed consolidated balance sheets. It is not practicable for the Company to estimate the fair value of its cost method investments in privately held companies since they are non-marketable securities and, therefore, quoted market prices are not available.

 

Recently Issued Accounting Pronouncements

 

In February 2013, the Financial Accounting Standards Board issued authoritative guidance requiring companies to report, in one place, information about reclassifications out of accumulated other comprehensive income (“AOCI”). Companies are also required to present reclassifications by component when reporting changes to AOCI balances. This guidance is effective for the Company for interim and annual periods beginning after December 15, 2012. As this guidance provides only presentation requirements, the adoption of this guidance does not impact the Company’s financial condition or results of operations. The Company adopted this standard in January 2013, as reflected by the inclusion of the Condensed Consolidated Statements of Comprehensive Income (Loss) as part of its Condensed Consolidated Financial Statements.

 

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Commitments (Tables)
9 Months Ended
Sep. 30, 2013
Commitments  
Schedule of future non-cancelable commitments under operating leases

 

 

 

Annual
Payments

 

 

 

(In thousands)

 

Years Ending December 31,

 

 

 

2013 (remainder of year)

 

$

771

 

2014

 

3,603

 

2015

 

3,539

 

2016

 

3,597

 

2017

 

3,706

 

2018 and thereafter

 

2,771

 

Total minimum payments

 

$

17,987

 

XML 48 R15.htm IDEA: XBRL DOCUMENT v2.4.0.8
Organization and Summary of Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2013
Organization and Summary of Significant Accounting Policies  
Principles of Consolidation

Principles of Consolidation

 

The condensed consolidated financial statements include all the accounts of the Company and its wholly-owned subsidiaries. The Company had three wholly-owned subsidiaries at September 30, 2013: Genomic Health International Sarl, which was established in Switzerland in 2009, and Genomic Health International Holdings, LLC, which was established in Delaware in 2010, both of which support the Company’s international sales and marketing efforts; and Oncotype Laboratories, Inc., which was established in 2003, and is inactive. Genomic Health International Holdings, LLC has five wholly-owned subsidiaries: Genomic Health U.K., Ltd. and Genomic Health Germany GmbH, both of which were established in 2011, Genomic Health Canada, which was established in 2012 and Genomic Health France and Genomic Health India, which were established in 2013. The functional currency for the Company’s wholly-owned subsidiaries incorporated outside the United States is the U.S. dollar. All significant intercompany balances and transactions have been eliminated.

 

Basis of Presentation and Use of Estimates

Basis of Presentation and Use of Estimates

 

The accompanying interim period condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The condensed consolidated balance sheet as of September 30, 2013, condensed consolidated statements of operations, condensed consolidated statements of comprehensive income (loss) and condensed consolidated statements of cash flows for the three and nine months ended September 30, 2013 and 2012 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of its financial position, operating results and cash flows for the periods presented. The condensed consolidated balance sheet at December 31, 2012 has been derived from audited financial statements, but it does not include certain information and notes required by GAAP for complete consolidated financial statements.

 

The preparation of financial statements in conformity with GAAP requires management to make judgments, assumptions and estimates that affect the amounts reported in the Company’s condensed consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates.

 

The accompanying interim period condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012.

 

Revenue Recognition

Revenue Recognition

 

The Company derives its revenues primarily from product sales and, to a lesser extent, contract research arrangements. The majority of the Company’s historical product revenues have been derived from the sale of the Oncotype DX breast cancer test. The Company generally bills third-party payors upon generation and delivery of a patient report to the physician. As such, the Company takes assignment of benefits and the risk of collection with the third-party payor. The Company usually bills the patient directly for amounts owed after multiple requests for payment have been denied or only partially paid by the insurance carrier. The Company pursues case-by-case reimbursement where policies are not in place or payment history has not been established.

 

The Company’s product revenues for tests performed are recognized when the following revenue recognition criteria are met: (1) persuasive evidence that an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectibility is reasonably assured. Criterion (1) is satisfied when the Company has an arrangement to pay or a contract with the payor in place addressing reimbursement for the Oncotype DX test. In the absence of such arrangements, the Company considers that criterion (1) is satisfied when a third-party payor pays the Company for the test performed. Criterion (2) is satisfied when the Company performs the test and generates and delivers to the physician, or makes available on its web portal, a patient report. Determinations of criteria (3) and (4) are based on management’s judgments regarding whether the fee charged for products or services delivered is fixed or determinable, and the collectibility of those fees under any contract or arrangement. When evaluating collectibility, the Company considers whether it has sufficient history to reliably estimate a payor’s individual payment patterns. Based upon at least several months of payment history, the Company reviews the number of tests paid against the number of tests billed and the payor’s outstanding balance for unpaid tests to determine whether payments are being made at a consistently high percentage of tests billed and at appropriate amounts given the contracted payment amount. To the extent all criteria set forth above are not met when test results are delivered, product revenues are recognized when cash is received from the payor.

 

The Company has exclusive distribution agreements for one or more of its Oncotype DX tests with approximately 20 distributors covering more than 80 countries. The distributor generally provides certain marketing and administrative services to the Company within its territory. As a condition of these agreements, the distributor generally pays the Company an agreed upon fee per test and the Company processes the tests. The same revenue recognition criteria described above generally apply to tests received through distributors. To the extent all criteria set forth above are not met when test results are delivered, product revenues are generally recognized when cash is received from the distributor.

 

From time to time, the Company receives duplicate payments or overpayments made by third-party payors or patients. When a duplicate payment or overpayment is identified, the Company establishes an accrued liability for the overpaid amount until such time as the Company determines whether or not a refund is due. Accrued refunds were $946,000 and $664,000 at September 30, 2013 and December 31, 2012, respectively, and included in accrued expenses and other current liabilities.

 

Contract revenues are generally derived from studies conducted with biopharmaceutical and pharmaceutical companies. The specific methodology for revenue recognition is determined on a case-by-case basis according to the facts and circumstances applicable to a given contract. Under certain contracts, the Company’s input, measured in terms of full-time equivalent level of effort or running a set of assays through its clinical reference laboratory under a contractual protocol, triggers payment obligations, and revenues are recognized as costs are incurred or assays are processed. Certain contracts have payments that are triggered as milestones are completed, such as completion of a successful set of experiments. Milestones are assessed on an individual basis and revenue is recognized when these milestones are achieved, as evidenced by acknowledgment from collaborators, provided that (1) the milestone event is substantive and its achievability was not reasonably assured at the inception of the agreement and (2) the milestone payment is non-refundable. Where separate milestones do not meet these criteria, the Company defaults to a performance-based model, such as revenue recognition following delivery of effort as compared to an estimate of total expected effort.

 

Advance payments received in excess of revenues recognized are classified as deferred revenue until such time as the revenue recognition criteria have been met.

 

Allowance for Doubtful Accounts

Allowance for Doubtful Accounts

 

The Company accrues an allowance for doubtful accounts against its accounts receivable based on estimates consistent with historical payment experience. Bad debt expense is included in general and administrative expense on the Company’s condensed consolidated statements of operations. Accounts receivable are written off against the allowance when the appeals process is exhausted, when an unfavorable coverage decision is received or when there is other substantive evidence that the account will not be paid. The Company’s allowance for doubtful accounts as of September 30, 2013 and December 31, 2012 was $1.8 million and $1.1 million, respectively. Write-offs for doubtful accounts of $1.7 million and $4.1 million were recorded against the allowance during the three and nine months ended September 30, 2013, respectively, and write-offs of $972,000 and $2.6 million were recorded against the allowance during the three and nine months ended September 30, 2012, respectively. Bad debt expense was $1.8 million and $4.8 million for the three and nine months ended September 30, 2013, respectively, and $998,000 and $2.6 million for the three and nine months ended September 30, 2012, respectively.

 

Research and Development Expenses

Research and Development Expenses

 

Research and development expenses are comprised of costs incurred to develop technology and carry out clinical studies and include salaries and benefits, reagents and supplies used in research and development laboratory work, infrastructure expenses, including allocated facility occupancy and information technology costs, contract services, and other outside costs. Research and development expenses also include costs related to activities performed under contracts with biopharmaceutical and pharmaceutical companies. Research and development costs are expensed as incurred.

 

The Company enters into collaboration and clinical trial agreements with clinical collaborators and records the costs associated with these agreements as research and development expenses. The Company records accruals for estimated study costs comprised of work performed by its collaborators under contract terms. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized and recognized as expense as the goods are delivered or the related services are performed.

 

Income Taxes

Income Taxes

 

The Company uses the liability method for income taxes, whereby deferred income taxes are provided on items recognized for financial reporting purposes over different periods than for income tax purposes. Valuation allowances are provided when the expected realization of tax assets does not meet a more-likely-than-not criterion.

 

The Company accounts for uncertain income tax positions using a benefit recognition model with a two-step approach, a more-likely-than-not recognition criterion and a measurement attribute that measures the position as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement, in accordance with the accounting guidance for uncertain tax positions. If it is not more likely than not that the benefit will be sustained on its technical merits, no benefit is recorded. Uncertain tax positions that relate only to timing of when an item is included on a tax return are considered to have met the recognition threshold. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in income tax expense when and if incurred. See Note 8, “Income Taxes,” for additional information regarding unrecognized tax benefits.

 

Investments in Privately Held Companies

Investments in PrivatelyHeld Companies

 

The Company determines whether its investments in privately held companies are debt or equity based on their characteristics, in accordance with the applicable accounting guidance for such investments. The Company also evaluates the investee to determine if the entity is a variable interest entity (“VIE”) and, if so, whether the Company is the primary beneficiary of the VIE, in order to determine whether consolidation of the VIE is required in accordance with accounting guidance for consolidations. If consolidation is not required and the Company owns less than 50.1% of the voting interest of the entity, the investment is evaluated to determine if the equity method of accounting should be applied. The equity method applies to investments in common stock or in-substance common stock where the Company exercises significant influence over the investee, typically represented by ownership of 20% or more of the voting interests of an entity. If the equity method does not apply, investments in privately held companies determined to be equity securities are accounted for using the cost method. Investments in privately held companies determined to be debt securities are accounted for as available-for-sale or held-to-maturity securities, in accordance with accounting guidance for investments.

 

The Company reviews long-lived assets, which include investments in privately held companies, for impairment whenever events or changes in business circumstances indicate that the carrying amounts of the assets may not be fully recoverable. For investments in privately held companies, evidence of impairment might include the absence of an ability to recover the carrying amount of the investment or the inability of the investee to sustain an earnings capacity which would justify the carrying amount of the investment. The Company’s assessment as to whether any impairment is other than temporary is based on its ability and intent to hold the investment and whether evidence indicating the carrying value of the investment is recoverable within a reasonable period of time outweighs evidence to the contrary. If the fair value of the investment is determined to be less than the carrying value and the decline in value is considered to be other than temporary, the asset is written down to its fair value.

 

In December 2010, the Company invested $500,000 in the preferred stock of a private company representing 21% of the entity’s outstanding voting shares. The Company determined that it was not the primary beneficiary of this VIE and, accordingly, applied the equity method of accounting. In June 2012, the Company invested an additional $400,000 in the preferred stock of this company as part of a new equity financing which included other investors, and reduced the Company’s holdings to approximately 16%. As of June 30, 2012, the Company changed its method of accounting for this investment to the cost method because the Company’s ownership fell below 20% and the Company does not have the ability to exercise significant influence over the investee entity. As of September 30, 2013, the Company considered the investment to be temporarily impaired based on the private company’s low cash balances resulting from the delay of its commercial product launch. The private company is in the process of raising additional capital combined with executing new customer agreements and the Company has the ability and intent to hold the investment and expects the fair value of their investment to ultimately exceed the carrying value. The net carrying value of this investment was $643,000 at September 30, 2013 and at December 31, 2012, and no impairment was recognized through September 30, 2013.

 

In March 2011, the Company invested $2.3 million in the redeemable preferred stock of a private company representing 21% of the entity’s outstanding voting shares. The Company determined that the investment was a held-to-maturity debt security and that the investee was not subject to consolidation. In August 2012, the Company participated in the first tranche of a second preferred stock financing of this private company and purchased $1.0 million of preferred stock with no redemption privileges. In connection with this financing, the terms of the Company’s initial redeemable preferred stock investment were modified to become preferred stock with no redemption privileges. As a result of this transaction, the Company’s ownership interest was reduced to approximately 19% and the investment held by the Company is considered to be an investment in non-marketable equity securities. In October 2012, the Company participated in the second tranche of the second financing and purchased an additional $3.6 million of preferred stock, resulting in an ownership percentage of approximately 18%. In May 2013, the investee completed an additional round of financing to new investors. As of September 30, 2013, the Company’s ownership percentage was approximately 13%. The investee is not consolidated because the Company owns less than 20% of the investee and the Company does not have the ability to exercise significant influence over the investee. As a result, the Company will continue to use the cost method of accounting for this investment. The carrying value of this investment was $6.9 million at September 30, 2013 and at December 31, 2012, and no impairment was recognized through September 30, 2013.

 

The aggregate carryng value of the Company’s investments in privately held companies was $7.5 million at September 30, 2013 and at December 31, 2012, and were included in other assets in the accompanying condensed consolidated balance sheets. It is not practicable for the Company to estimate the fair value of its cost method investments in privately held companies since they are non-marketable securities and, therefore, quoted market prices are not available.

 

Recently Issued Accounting Pronouncements

Recently Issued Accounting Pronouncements

 

In February 2013, the Financial Accounting Standards Board issued authoritative guidance requiring companies to report, in one place, information about reclassifications out of accumulated other comprehensive income (“AOCI”). Companies are also required to present reclassifications by component when reporting changes to AOCI balances. This guidance is effective for the Company for interim and annual periods beginning after December 15, 2012. As this guidance provides only presentation requirements, the adoption of this guidance does not impact the Company’s financial condition or results of operations. The Company adopted this standard in January 2013, as reflected by the inclusion of the Condensed Consolidated Statements of Comprehensive Income (Loss) as part of its Condensed Consolidated Financial Statements.

 

XML 49 R22.htm IDEA: XBRL DOCUMENT v2.4.0.8
Organization and Summary of Significant Accounting Policies (Details) (USD $)
3 Months Ended 9 Months Ended 1 Months Ended 9 Months Ended 1 Months Ended 9 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
country
subsidiary
test
distributor
Sep. 30, 2012
Dec. 31, 2012
Jun. 30, 2012
Private company 1, Cost Method Investment
Sep. 30, 2013
Private company 1, Cost Method Investment
Dec. 31, 2012
Private company 1, Cost Method Investment
Oct. 31, 2012
Private company 2
Aug. 31, 2012
Private company 2
Sep. 30, 2013
Private company 2
Dec. 31, 2012
Private company 2
Mar. 31, 2011
Private company 2
Dec. 31, 2010
Private company 1, Equity Method Investment
Sep. 30, 2013
Genomic Health International Holdings, LLC
subsidiary
Organization and summary of significant accounting policies                              
Number of wholly-owned subsidiaries     3                       5
Revenue Recognition                              
Minimum number of Oncotype DX tests by exclusive distribution agreements     1                        
Approximate number of distributors with exclusive distribution agreements     20                        
Minimum number of countries covered for distribution agreements establishment     80                        
Accrued refunds $ 946,000   $ 946,000   $ 664,000                    
Allowance for Doubtful Accounts                              
Allowance for doubtful accounts 1,847,000   1,847,000   1,133,000                    
Write-offs for doubtful accounts recorded against allowance 1,700,000 972,000 4,100,000 2,600,000                      
Bad debt expense 1,800,000 998,000 4,800,000 2,600,000                      
Investments in Privately Held Companies                              
Amount invested in preferred stock of a private company                           500,000  
Percentage of ownership interest in private company                           21.00%  
Additional investment made in preferred stock of a private company           400,000     3,600,000 1,000,000          
Percentage of ownership interest in private company accounted for under the cost method of accounting           16.00%     18.00% 19.00% 13.00%        
Investment in redeemable preferred stock                         2,300,000    
Investment in the redeemable preferred stock of a private company, percent of the entity's outstanding voting shares                         21.00%    
Carrying value of investments in privately held companies 7,500,000   7,500,000   7,500,000   643,000 643,000     6,900,000 6,900,000      
Impairment recognized             $ 0       $ 0        
XML 50 R20.htm IDEA: XBRL DOCUMENT v2.4.0.8
Stock-Based Compensation (Tables)
9 Months Ended
Sep. 30, 2013
Stock-Based Compensation  
Schedule of weighted-average fair values and assumptions used in calculation of fair value of stock options and employee stock purchase plan

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

Expected volatility:

 

 

 

 

 

 

 

 

 

Stock options

 

45

%

45

%

46

%

46

%

ESPP

 

29

%

38

%

41

%

43

%

Risk-free interest rate:

 

 

 

 

 

 

 

 

 

Stock options

 

1.90

%

1.43

%

1.40

%

1.23

%

ESPP

 

0.08

%

0.12

%

0.11

%

0.08

%

Expected life in years:

 

 

 

 

 

 

 

 

 

Stock options

 

6.59

 

6.68

 

6.64

 

6.98

 

ESPP

 

0.50

 

0.50

 

0.50

 

0.50

 

Weighted-average fair value:

 

 

 

 

 

 

 

 

 

Stock options

 

$

15.83

 

$

18.40

 

$

14.11

 

$

14.51

 

ESPP

 

$

8.04

 

$

8.12

 

$

7.74

 

$

7.59

 

XML 51 R1.htm IDEA: XBRL DOCUMENT v2.4.0.8
Document and Entity Information
9 Months Ended
Sep. 30, 2013
Oct. 31, 2013
Document and Entity Information    
Entity Registrant Name GENOMIC HEALTH INC  
Entity Central Index Key 0001131324  
Document Type 10-Q  
Document Period End Date Sep. 30, 2013  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Entity Current Reporting Status Yes  
Entity Filer Category Accelerated Filer  
Entity Common Stock, Shares Outstanding   30,738,244
Document Fiscal Year Focus 2013  
Document Fiscal Period Focus Q3  
XML 52 R21.htm IDEA: XBRL DOCUMENT v2.4.0.8
Segment Information (Tables)
9 Months Ended
Sep. 30, 2013
Segment Information  
Summary of total revenues from customers and collaboration partners by geographic region

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

 

 

(in thousands)

 

United States

 

$

55,890

 

$

50,564

 

$

164,973

 

$

155,798

 

Outside of the United States

 

10,100

 

8,084

 

27,803

 

18,948

 

Total revenues

 

$

65,990

 

$

58,648

 

$

192,776

 

$

174,746