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 March 31, 2012

 

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 001-13111

 

DEPOMED, INC.

(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)

 

CALIFORNIA

 

94-3229046

(STATE OR OTHER JURISDICTION OF

 

(I.R.S. EMPLOYER

INCORPORATION OR ORGANIZATION)

 

IDENTIFICATION NUMBER)

 

1360 O’BRIEN DRIVE

MENLO PARK, CALIFORNIA 94025

(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES, INCLUDING ZIP CODE)

 

(650) 462-5900

(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 Exchange Act 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 (§232.405 of this chapter) 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, as defined in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer o

 

Accelerated filer x

 

 

 

Non-accelerated filer o

 

Smaller reporting company o

 

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

 

The number of issued and outstanding shares of the Registrant’s Common Stock, no par value, as of May 3, 2012 was 55,728,095.

 

 

 



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DEPOMED, INC.

 

 

 

PAGE

 

 

 

PART I — FINANCIAL INFORMATION

 

 

 

 

 

Item 1. Condensed Financial Statements:

 

 

 

 

 

Condensed Balance Sheets at March 31, 2012 (unaudited) and December 31, 2011

 

3

 

 

 

Condensed Statements of Operations and Comprehensive Income for the three months ended March 31, 2012 and 2011 (unaudited)

 

4

 

 

 

Condensed Statements of Cash Flows for the three months ended March 31, 2012 and 2011 (unaudited)

 

5

 

 

 

Notes to Condensed Financial Statements (unaudited)

 

6

 

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

16

 

 

 

Item 3. Quantitative and Qualitative Disclosure About Market Risk

 

27

 

 

 

Item 4. Controls and Procedures

 

27

 

 

 

PART II — OTHER INFORMATION

 

 

 

 

 

Item 1. Legal Proceedings

 

28

 

 

 

Item 1A. Risk Factors

 

28

 

 

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

39

 

 

 

Item 3. Defaults upon Senior Securities

 

39

 

 

 

Item 4. Mine Safety Disclosures

 

39

 

 

 

Item 5. Other Information

 

39

 

 

 

Item 6. Exhibits

 

39

 

 

 

Signatures

 

40

 

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PART I — FINANCIAL INFORMATION

ITEM 1. CONDENSED FINANCIAL STATEMENTS

 

DEPOMED, INC.

CONDENSED BALANCE SHEETS

(in thousands, except share amounts)

 

 

 

March 31,

 

December 31,

 

 

 

2012

 

2011

 

 

 

(Unaudited)

 

(1)

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

40,211

 

$

24,043

 

Marketable securities

 

52,726

 

62,106

 

Accounts receivable

 

486

 

4,420

 

Receivables from collaborative partners

 

10,136

 

8,135

 

Inventories

 

6,554

 

5,395

 

Prepaid and other current assets

 

5,112

 

5,390

 

Total current assets

 

115,225

 

109,489

 

Marketable securities, long-term

 

35,634

 

53,644

 

Property and equipment, net

 

1,099

 

1,070

 

Other assets

 

1

 

169

 

 

 

$

151,959

 

$

164,372

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

24,811

 

$

26,784

 

Deferred product sales

 

5,047

 

6,960

 

Deferred license revenue

 

5,791

 

6,032

 

Other current liabilities

 

53

 

64

 

Total current liabilities

 

35,702

 

39,840

 

Deferred license revenue, non-current portion

 

16,545

 

17,932

 

Other long-term liabilities

 

677

 

682

 

Commitments

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

Preferred stock, no par value, 5,000,000 shares authorized; Series A convertible preferred stock, 25,000 shares designated, 18,158 shares issued and surrendered, and zero shares outstanding at March 31, 2012 and December 31, 2011

 

 

 

Common stock, no par value, 100,000,000 shares authorized; 55,640,181 and 55,506,120 shares issued and outstanding at March 31, 2012 and December 31, 2011, respectively

 

205,339

 

203,511

 

Accumulated deficit

 

(106,384

)

(97,580

)

Accumulated other comprehensive gain (loss)

 

80

 

(13

)

Total shareholders’ equity

 

99,035

 

105,918

 

 

 

$

151,959

 

$

164,372

 

 


(1) Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2011.

 

See accompanying notes to Condensed Financial Statements.

 

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DEPOMED, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME

(in thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2012

 

2011

 

Revenues:

 

 

 

 

 

Product sales

 

$

2,109

 

$

15,311

 

Royalties

 

9,421

 

165

 

License and collaborative revenue

 

5,305

 

67,625

 

Total revenues

 

16,835

 

83,101

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

Cost of sales

 

518

 

1,635

 

Research and development expense

 

3,482

 

5,154

 

Selling, general and administrative expense:

 

 

 

 

 

Promotion fee expense

 

 

10,262

 

Other selling, general and administrative expense

 

21,773

 

7,241

 

Total selling, general and administrative expense

 

21,773

 

17,503

 

Gain on settlement agreement

 

 

(40,000

)

Total costs and expenses

 

25,773

 

(15,708

)

 

 

 

 

 

 

Income (loss) from operations

 

(8,938

)

98,809

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

Interest and other income

 

143

 

79

 

Interest expense

 

 

(69

)

Total other income (expense)

 

143

 

10

 

 

 

 

 

 

 

Net income (loss) before income taxes

 

(8,795

)

98,819

 

 

 

 

 

 

 

Provision for income taxes

 

(9

)

(2

)

 

 

 

 

 

 

Net income (loss)

 

$

(8,804

)

$

98,817

 

 

 

 

 

 

 

Basic net income (loss) per common share

 

$

(0.16

)

$

1.85

 

Diluted net income (loss) per common share

 

$

(0.16

)

$

1.77

 

 

 

 

 

 

 

Shares used in computing basic net income (loss) per common share

 

55,554,579

 

53,353,287

 

Shares used in computing diluted net income (loss) per common share

 

55,554,579

 

55,754,051

 

 

 

 

 

 

 

Comprehensive income (loss)

 

$

(8,711

)

$

98,806

 

 

See accompanying notes to Condensed Financial Statements.

 

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DEPOMED, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2012

 

2011

 

Operating Activities

 

 

 

 

 

Net income (loss)

 

$

(8,804

)

$

98,817

 

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

 

 

 

 

 

Depreciation and amortization

 

238

 

149

 

Stock-based compensation

 

1,359

 

702

 

Changes in assets and liabilities:

 

 

 

 

 

Accounts receivable

 

1,935

 

(10,430

)

Inventories

 

(1,158

)

(1,894

)

Prepaid and other assets

 

446

 

(998

)

Accounts payable and other accrued liabilities

 

(729

)

1,498

 

Accrued compensation

 

(1,260

)

(1,390

)

Deferred revenue

 

(3,542

)

(6,656

)

Net cash provided by (used in) operating activities

 

(11,515

)

79,798

 

 

 

 

 

 

 

Investing Activities

 

 

 

 

 

Purchases of property and equipment

 

(134

)

(162

)

Purchases of marketable securities

 

(24,614

)

(31,627

)

Maturities of marketable securities

 

26,297

 

11,991

 

Sales of marketable securities

 

25,666

 

 

Net cash provided by (used in) investing activities

 

27,215

 

(19,798

)

 

 

 

 

 

 

Financing Activities

 

 

 

 

 

Principal payments on long-term debt

 

 

(1,034

)

Proceeds from issuance of common stock

 

468

 

2,358

 

Net cash provided by financing activities

 

468

 

1,324

 

 

 

 

 

 

 

Net increase in cash and cash equivalents

 

16,168

 

61,324

 

Cash and cash equivalents at beginning of period

 

24,043

 

22,526

 

Cash and cash equivalents at end of period

 

$

40,211

 

$

83,850

 

 

See accompanying notes to Condensed Financial Statements.

 

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DEPOMED, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

 

NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Basis of Presentation

 

These unaudited condensed financial statements and the related footnote information of Depomed, Inc. (the Company or Depomed) have been prepared pursuant to the requirements of the Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information that are normally required by U.S. generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. In the opinion of the Company’s management, the accompanying interim unaudited condensed financial statements include all adjustments (consisting only of normal recurring adjustments) necessary for a fair presentation of the information for the periods presented. The results for the interim period ended March 31, 2012 are not necessarily indicative of results to be expected for the entire year ending December 31, 2012 or future operating periods.

 

The accompanying condensed financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2011, included in the Company’s Annual Report on Form 10-K filed with the SEC. The balance sheet at December 31, 2011 has been derived from the audited financial statements at that date.

 

Use of Estimates

 

The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.

 

Revenue Recognition

 

The Company recognizes revenue from the sale of its products, royalties earned, and on payments received and services performed under contractual arrangements. Revenue arrangements with multiple elements are evaluated to determine whether the multiple elements met certain criteria for dividing the arrangement into separate units of accounting, including whether the delivered element(s) have stand-alone value to the Company’s customer or licensee. Where there are multiple deliverables combined as a single unit of accounting, revenues are deferred and recognized over the period that we remain obligated to perform services.

 

Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred and title has passed, the price is fixed or determinable and the Company is reasonably assured of collecting the resulting receivable.

 

·                   Product Sales:

 

·                   Gralise : The Company sells Gralise (gabapentin) once-daily tablets to wholesalers and retail pharmacies and began shipping to customers in October 2011. The Company accepts returns of unsalable product from customers within a return period of six months prior to, and twelve months following product expiration. Gralise tablets currently have a shelf-life of 24 months from date of manufacture. In October 2011, the Company offered launch incentives for customers to stock Gralise at pharmacies and wholesalers, which included discounts and extended payment terms. Given the limited history of prescriptions of Gralise and launch incentives associated with stocking Gralise, the Company currently cannot reliably estimate expected returns of the product at the time of shipment. Accordingly, the Company defers recognition of revenue on product shipments of Gralise until the right of return no longer exists, which occurs at the earlier of the time Gralise units are dispensed through patient prescriptions or expiration of the right of return. The Company estimates patient prescriptions dispensed using an analysis of third-party information, including third-party market research data and information obtained from wholesalers with respect to inventory levels and inventory movement. As a result of this policy, the Company has a deferred revenue balance of $5.0 million at March 31, 2012 related to Gralise product shipments that have not been recognized as revenue, which is net of wholesaler fees, retail pharmacy discounts, launch discounts and prompt payment discounts. The Company has recognized $1.7 million in product sales, which is net of wholesaler fees, retail pharmacy discounts, prompt payment discounts, patient support programs, and government chargebacks and rebates for the quarter ended March 31, 2012. If the Company underestimates or overestimates patient prescriptions dispensed for a given period, adjustments to revenue may

 

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be necessary in future periods.

 

In addition, the costs of manufacturing Gralise associated with the deferred revenue are recorded as deferred costs, which are included in inventory until the related deferred revenue is recognized.

 

·                   Glumetza ® : The Company sold and recorded product sales on shipments of Glumetza (metformin hydrochloride extended release tablets) to wholesalers and retail pharmacies through August 2011.  The Company and Santarus entered into a commercialization agreement in August 2011 under which Depomed transferred the rights to manufacture and distribute Glumetza in the United States to Santarus. Santarus commenced selling Glumetza in September 2011 and began recording product sales.  See Note 4 for further information on the Santarus commercialization agreement.

 

Product distributed by Depomed through August 2011 is subject to rights of return six months before product expiration and up to twelve months after product expiration. The Company recognized revenue for Glumetza sales at the time title transferred to its customers, which occurred at the time product was delivered to its customers.  Revenue from sales of Glumetza was recorded net of estimated allowances for returns, wholesaler and retail pharmacy fees, prompt pay discounts, patient discount programs, government rebates and chargebacks and managed care rebates.

 

·                   Product Sales Allowances - The Company recognizes product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on related sales. These estimates take into consideration the terms of the Company’s agreements with customers, historical product returns, rebates or discounts taken, estimated levels of inventory in the distribution channel, the shelf life of the product, and specific known market events, such as competitive pricing and new product introductions. If actual future results vary from the Company’s estimates, the Company may adjust these estimates, which could have an effect on product sales and earnings in the period of adjustment. The Company’s product sales allowances include:

 

·                   Product Returns - The Company estimates product returns on sales of Glumetza that was distributed by the Company. The Company allows customers to return product that is within six months before, and up to twelve months after, its product expiration date.  The shelf life of the 500mg Glumetza is currently 48 months from the date of tablet manufacture. On product launch in August 2006 and through the second quarter of 2008, the shelf life of 500mg Glumetza product shipped was 36 months from the date of tablet manufacture. The shelf life of the 1000mg Glumetza is 24 to 36 months from the date of tablet manufacture. The Company monitors actual return history on an individual product lot basis since product launch, which provides it with a basis to reasonably estimate future product returns, taking into consideration the shelf life of product, shipment and prescription trends, estimated distribution channel inventory levels, and consideration of the introduction of competitive products. As noted earlier, the Company currently does not estimate product returns on sales of Gralise.

 

·                   Managed Care Rebates - The Company offers rebates under contracts with certain managed care organizations. The Company establishes an accrual equal to its estimates of future managed care rebates attributable to sales and recognizes the estimated rebates as a reduction of revenue in the same period the related revenue is recognized. The Company estimates its managed care rebates based on the terms of each agreement, estimated levels of inventory in the distribution channel, and historical and expected future utilization of product by the managed care organization.

 

·                   Wholesaler and Retail Pharmacy Discounts - The Company offers discounts to certain wholesale distributors and retail pharmacies based on contractually determined rates. The Company accrues the applicable contractual discount on shipment to wholesale distributors and retail pharmacies and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized.

 

·                   Prompt Pay Discounts - The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for prompt payment. Based on the Company’s experience, the Company expects its customers to comply with the prompt payment terms to earn the cash discount. The Company accounts for cash discounts by reducing accounts receivable by the full amount and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized.

 

·                   Medicaid Rebates - The Company participates in Medicaid rebate programs, which provide assistance to eligible low-income patients based on each individual state’s guidelines regarding eligibility and services.

 

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Under the Medicaid rebate programs, the Company pays a rebate to each participating state, generally two to three months after the quarter in which the prescription is filled. The Company estimates and accrues Medicaid rebates based on product pricing, current rebates and changes in the level of discounts the Company offers that may affect the level of Medicaid discount, historical and estimated future percentages of product sold to Medicaid recipients and estimated levels of inventory in the distribution channel.

 

·                   Chargebacks - The Company provides discounts to authorized users of the Federal Supply Schedule (FSS) of the General Services Administration under an FSS contract with the Department of Veterans Affairs.  These federal entities purchase products from wholesale distributors at a discounted price, and the wholesale distributors then charge back to the Company the difference between the current retail price and the price the federal entity paid for the product.  The Company estimates and accrues chargebacks based on estimated wholesaler inventory levels, current contract prices and historical chargeback activity.

 

·                   Medicare Part D Coverage Gap - The Company participates in the Medicare Part D Coverage Gap Discount Program under which the Company provides rebates on prescriptions that fall within the “donut hole” coverage gap. The Company estimates and accrues rebates based on historical utilization and recognizes the rebate as a reduction of revenue in the same period the related revenue is recognized.

 

·                   Patient Discount Programs - The Company offers patient discount card programs in which patients receive discounts at participating retail pharmacies that are reimbursed by the Company.  The Company estimates and accrues future redemptions based on historical redemption activity.

 

·                   Royalties - Royalties are recognized as earned in accordance with the contract terms when royalties from licensees can be reliably measured and collectability is reasonably assured.

 

Under the commercialization agreement between the Company and Santarus, the Company receives royalties on net sales of Glumetza distributed by Santarus in the United States. Santarus commenced distributing and recording product sales on shipments of Glumetza in September 2011. See Note 4 for further information on the Santarus commercialization agreement.

 

Royalties received from Santarus and Merck, Inc. (Merck) are recognized in the period earned as the royalty amounts can be estimated and collectability is reasonably assured.

 

Royalties received under the Company’s agreements with Valeant Pharmaceuticals International, Inc. (Valeant) and LG Life Sciences (LG) are recognized when the royalty payments are received as they cannot reliably be estimated.

 

·                   License and Collaborative Arrangements - Revenue from license and collaborative arrangements is recognized when the Company has substantially completed its obligations under the terms of the arrangement and the Company’s remaining involvement is inconsequential and perfunctory. If the Company has significant continuing involvement under such an arrangement, license and collaborative fees are recognized over the estimated performance period. The Company recognizes milestone payments for its research and development collaborations upon the achievement of specified milestones if (1) the milestone is substantive in nature, and the achievement of the milestone was not reasonably assured at the inception of the agreement; (2) consideration earned relates to past performance, and (3) the milestone payment is nonrefundable. A milestone is considered substantive if the consideration earned from the achievement of the milestone is consistent with the Company’s performance required to achieve the milestone or consistent with the increase in value to the collaboration resulting from the Company’s performance, the consideration earned relates solely to past performance, and the consideration earned is reasonable relative to all of the other deliverables and payments within the arrangement. License, milestones and collaborative fee payments received in excess of amounts earned are classified as deferred revenue until earned.

 

Recently Issued Accounting Standards

 

In June 2011, the FASB issued guidance amending the presentation requirements for comprehensive income. Companies have the option to report total comprehensive income, including components of net income and components of other comprehensive income, as a single continuous statement or in two separate but consecutive statements. The Company adopted the presentation requirement effective January 1, 2012 and elected to report the components of comprehensive income in one single continuous statement as part of the Condensed Statement of Operations and Comprehensive Income. The adoption of this guidance did not have a material impact on the Company’s financial statements.

 

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NOTE 2. CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES

 

Securities classified as cash and cash equivalents and available-for-sale marketable securities as of March 31, 2012 and December 31, 2011 are summarized below (in thousands). Estimated fair value is based on quoted market prices for these investments.

 

March 31, 2012

 

Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Fair Value

 

Cash and cash equivalents:

 

 

 

 

 

 

 

 

 

Cash

 

$

9,080

 

$

 

$

 

$

9,080

 

Money market funds

 

6,731

 

 

 

6,731

 

Corporate debt securities

 

2,400

 

 

 

2,400

 

U.S. government agency debt securities

 

22,000

 

 

 

22,000

 

Total cash and cash equivalents

 

$

40,211

 

$

 

$

 

$

40,211

 

 

 

 

 

 

 

 

 

 

 

Available-for-sale securities:

 

 

 

 

 

 

 

 

 

Total maturing within 1 year and included in marketable securities:

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

31,328

 

14

 

(9

)

31,333

 

U.S. government agency debt securities

 

15,847

 

23

 

 

15,870

 

U.S. Treasury securities

 

5,518

 

5

 

 

5,523

 

Total maturing between 1 and 2 years and included in marketable securities:

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

16,890

 

43

 

(5

)

16,928

 

U.S. government agency debt securities

 

12,214

 

15

 

 

12,229

 

U.S. Treasury securities

 

6,483

 

 

(6

)

6,477

 

Total available-for-sale securities

 

$

88,280

 

$

100

 

$

(20

)

$

88,360

 

 

 

 

 

 

 

 

 

 

 

Total cash, cash equivalents and marketable securities

 

$

128,491

 

$

100

 

$

(20

)

$

128,571

 

 

December 31, 2011

 

Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Fair Value

 

Cash and cash equivalents:

 

 

 

 

 

 

 

 

 

Cash

 

$

5,629

 

$

 

$

 

$

5,629

 

Money market funds

 

12,467

 

 

 

12,467

 

Corporate debt securities

 

5,947

 

 

 

5,947

 

Total cash and cash equivalents

 

$

24,043

 

$

 

$

 

$

24,043

 

 

 

 

 

 

 

 

 

 

 

Available-for-sale securities:

 

 

 

 

 

 

 

 

 

Total maturing within 1 year and included in marketable securities:

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

49,717

 

10

 

(9

)

49.718

 

U.S. government agency debt securities

 

5,503

 

2

 

 

5,505

 

U.S. Treasury securities

 

6,870

 

13

 

 

6,883

 

Total maturing between 1 and 2 years and included in marketable securities:

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

17,767

 

7

 

(62

)

17,712

 

U.S. government agency debt securities

 

35,906

 

30

 

(4

)

35,932

 

Total available-for-sale securities

 

$

115,763

 

$

62

 

$

(75

)

$

115,750

 

 

 

 

 

 

 

 

 

 

 

Total cash, cash equivalents and marketable securities

 

$

139,806

 

$

62

 

$

(75

)

$

139,793

 

 

The Company considers all highly liquid investments with a maturity at date of purchase of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with banks, money market instruments and commercial paper. The Company places its cash, cash equivalents and marketable securities with U.S. Treasury and government agency securities, and high quality securities of U.S. and international financial and commercial institutions and, to date has not experienced material losses on

 

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any of its balances. All marketable securities are classified as available-for-sale since these instruments are readily marketable. These securities are carried at fair value, which is based on readily available market information, with unrealized gains and losses included in accumulated other comprehensive gain within shareholders’ equity. The Company uses the specific identification method to determine the amount of realized gains or losses on sales of marketable securities. Realized gains or losses have been insignificant and are included in “interest and other income” in the condensed statement of operations.

 

At March 31, 2012 the Company had seventeen securities in an unrealized loss position. The following table shows the gross unrealized losses and fair value of the Company’s investments with unrealized losses that are not deemed to be other-than-temporarily impaired, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position, at March 31, 2012 (in thousands):

 

 

 

Less than 12 months

 

12 months or greater

 

Total

 

 

 

Fair Value

 

Gross
Unrealized
Losses

 

Fair Value

 

Gross
Unrealized
Losses

 

Fair Value

 

Gross
Unrealized
Losses

 

Corporate debt securities

 

$

15,980

 

$

(14

)

 

 

$

15,980

 

$

(14

)

U.S. Treasury securities

 

7,485

 

(6

)

 

 

7,485

 

(6

)

Total available-for-sale

 

$

23,465

 

$

(20

)

$

 

$

 

$

23,465

 

$

(20

)

 

The gross unrealized losses above were caused by interest rate increases. No significant facts or circumstances have arisen to indicate that there has been any deterioration in the creditworthiness of the issuers of the Company’s securities. Based on the Company’s review of these securities, including the assessment of the duration and severity of the unrealized losses and the Company’s ability and intent to hold the investments until maturity, there were no material other-than-temporary impairments for these securities at March 31, 2012.

 

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.

 

The Company utilizes the following fair value hierarchy based on three levels of inputs:

 

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

·                   Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, 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.

·                   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.

 

The following table represents the Company’s fair value hierarchy for its financial assets measured at fair value on a recurring basis as of March 31, 2012 (in thousands):

 

 

 

Level 1

 

Level 2

 

Level 3

 

Total

 

Money market funds

 

$

6,731

 

$

 

$

 

$

6,731

 

Corporate debt securities

 

 

50,661

 

 

50,661

 

Government agency debt securities

 

 

50,099

 

 

50,099

 

U.S. Treasury securities

 

 

12,000

 

 

12,000

 

Total

 

$

6,731

 

$

112,760

 

$

 

$

119,491

 

 

The following table represents the Company’s fair value hierarchy for its financial assets measured at fair value on a recurring basis as of December 31, 2011 (in thousands):

 

 

 

Level 1

 

Level 2

 

Level 3

 

Total

 

Money market funds

 

$

12,467

 

$

 

$

 

$

12,467

 

U.S. corporate debt securities

 

 

73,378

 

 

73,378

 

U.S. government agency debt securities

 

 

41,437

 

 

41,437

 

U.S. Treasury securities

 

 

6,882

 

 

6,882

 

Total

 

$

12,467

 

$

121,697

 

$

 

$

134,164

 

 

There are no financial liabilities measured at fair value on a recurring basis as of March 31, 2012 and December 31, 2011.

 

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NOTE 3.  NET INCOME (LOSS) PER COMMON SHARE

 

Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share is calculated by dividing the net income (loss) by the weighted-average number of shares of common stock outstanding during the period, plus dilutive common shares for the period determined using the treasury-stock method. For purposes of this calculation, options to purchase stock are considered to be potential common shares and are only included in the calculation of diluted net income (loss) per share when their effect is dilutive. Basic and diluted earnings per share are calculated as follows:

 

 

 

Three Months Ended March 31,

 

(in thousands, except for per share amounts)

 

2012

 

2011

 

Numerator:

 

 

 

 

 

Net income (loss)

 

$

(8,804

)

$

98,817

 

 

 

 

 

 

 

Denominator for basic net income (loss) per share

 

55,555

 

53,353

 

Net effect of dilutive common stock equivalents

 

 

2,401

 

Denominator for diluted net income (loss) per share:

 

 

55,754

 

 

 

 

 

 

 

Basic net income (loss) per share

 

$

(0.16

)

$

1.85

 

Diluted net income (loss) per share

 

$

(0.16

)

$

1.77

 

 

For the three months ended March 31, 2012 and 2011, the total number of antidilutive outstanding common stock equivalents excluded from the net income per share computation was 5.7 million and 0.5 million, respectively.

 

NOTE 4. LICENSE AND COLLABORATIVE ARRANGEMENTS

 

Santarus, Inc.

 

In August 2011, the Company entered into a commercialization agreement with Santarus granting Santarus exclusive rights to manufacture and commercialize Glumetza in the United States. The commercialization agreement supersedes the previous promotion agreement between the parties originally entered into in July 2008.

 

Under the commercialization agreement, the Company transitioned to Santarus responsibility for manufacturing, distribution, pharmacovigilance and regulatory affairs. The Company ceased shipments of Glumetza in August 2011 and Santarus began distributing and recording product sales on shipments of Glumetza in September 2011. Santarus will continue to be responsible at its expense for advertising and promotional marketing activities for Glumetza.

 

Santarus is required to pay the Company royalties on net product sales of Glumetza in the United States of 26.5% in 2011; 29.5% in 2012; 32.0% in 2013 and 2014; and 34.5% in 2015 and beyond prior to generic entry of a Glumetza product. In the event of generic entry of a Glumetza product in the United States, the parties will equally share proceeds based on a gross margin split. Santarus has the exclusive right to commercialize authorized generic versions of the Glumetza products. Santarus will not pay additional sales milestones to the Company as was required under the prior promotion agreement. Royalty revenue from Santarus for the three months ended March 31, 2012 was $9.2 million.

 

In connection with its assumption of distribution and sales responsibility of Glumetza, Santarus purchased Depomed’s existing inventory of Glumetza and bulk metformin hydrochloride at cost.  Depomed is financially responsible for returns of Glumetza distributed by Depomed, up to the amount of the product returns reserve account for Glumetza product returns on the date immediately before Santarus began distributing Glumetza.  Depomed is financially responsible for Glumetza rebates and chargebacks up to the amount of its reserve accounts for those items. Santarus is responsible for all other Glumetza returns, rebates and chargebacks.

 

Under the commercialization agreement, Depomed is responsible for managing the patent infringement lawsuits against Sun Pharmaceutical Industries, Inc. (Sun) and Lupin Limited (Lupin), subject to certain consent rights in favor of Santarus, including with regard to any proposed settlements.  Santarus will reimburse Depomed for 70% of its out-of-pocket costs, and Depomed will reimburse Santarus for 30% of its out-of-pocket costs related to these two infringement cases.

 

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During 2011, Depomed distributed Glumetza for the first eight months of the year, recognized Glumetza product sales on those respective sales and paid Santarus a promotion fee equal to 75% of Glumetza gross margin. For the three months ended March 31, 2011, the Company recognized $10.3 million in promotion fee expense to Santarus related to sales of Glumetza by Depomed. In August 2011, the distribution and sales responsibility transitioned to Santarus, and Depomed no longer recorded sales of Glumetza and no longer was responsible for paying promotion fees to Santarus.  Accordingly, there was no promotion fee expense for the three months ended March 31, 2012.

 

Pursuant to the promotion agreement originally entered into in July 2008, Santarus paid the Company a $12.0 million upfront fee. The upfront payment received was originally being amortized as revenue ratably until October 2021, which represented the estimated length of time the Company’s obligations existed under the promotion agreement related to manufacturing Glumetza and paying Santarus promotion fees on gross margin of Glumetza. The commercialization agreement in August 2011 superseded the promotion agreement and removed the manufacturing and promotion fee obligations of the Company. The commercialization agreement includes obligations with respect to manufacturing and regulatory transition to Santarus and managing the ongoing patent infringement lawsuits against Sun and Lupin. These obligations are estimated to be completed in December 2013. Accordingly, on the effective date of the commercialization agreement, the amortization period related to remaining deferred revenue on the $12.0 million upfront fee has been adjusted, and the remaining deferred revenue will be recognized ratably until December 2013. The Company recognized approximately $1.0 million and $0.2 million of license revenue associated with this upfront license fee for the three months ended March 31, 2012 and 2011, respectively. The remaining deferred revenue balance related to this upfront payment is $6.8 million at March 31, 2012.

 

Ventiv Commercial Services, LLC

 

In June 2011, the Company entered into a service agreement with Ventiv Commercial Services, LLC (Ventiv), pursuant to which inVentiv Selling Solutions, Ventiv’s outsourced sales business, will provide sales force recruiting, training, deployment and ongoing operational support to the Company to promote Gralise. The agreement provides for a sales force of 164 full-time sales representatives dedicated to the Company, all of whom are employees of Ventiv.

 

Under the terms of the agreement, the Company paid Ventiv an upfront implementation fee and will pay an agreed upon fixed monthly management fee of approximately $1.8 million, which is subject to adjustment based on actual staffing levels. During the term of the agreement, a portion of Ventiv’s monthly management fee will be subject to payment by the Company only to the extent that specified performance objectives are met. The Company will also pay certain pass-through costs of Ventiv incurred in connection with the agreement, which primarily include bonuses, travel costs and certain administrative expenses. The Company incurred $6.8 million of expense related to Ventiv for the three months ended March 31, 2012.

 

The agreement will expire on the second anniversary of the date on which sales representatives hired by Ventiv were deployed. The agreement is subject to early termination under certain circumstances and may be terminated by either party upon advance notice beginning in October 2012. The agreement provides for conversion of sales representatives from Ventiv employees to Depomed employees beginning in October 2012 at an agreed-upon cost per employee converted.

 

Abbott Products Inc. (formerly Solvay Pharmaceuticals, Inc.)

 

In November 2008, the Company entered into an exclusive license agreement with Solvay Pharmaceuticals, Inc. (Solvay) granting Solvay exclusive rights to develop and commercialize Gralise for pain indications in the United States, Canada and Mexico. In February 2010, Abbott Laboratories acquired the pharmaceutical business of Solvay and Abbott Products (Abbott Products), a subsidiary of Abbott Laboratories, became responsible for the Gralise license agreement with the Company.

 

In January 2011, Abbott Products received FDA approval of Gralise for the management of postherpetic neuralgia. This triggered a $48.0 million development milestone from Abbott to the Company, which the Company received in February 2011. As the nonrefundable milestone was substantive in nature, achievement of the milestone was not reasonably assured at the inception of the agreement and the milestone was related to past performance, the Company recognized the entire $48.0 million as revenue in the first quarter of 2011.

 

In January 2011, Abbott Products notified the Company that Abbott Products did not intend to commercialize Gralise. In March 2011, the Company entered into a settlement agreement with Abbott Laboratories which provides for (i) the immediate termination of the Gralise license agreement, (ii) the transition of Gralise back to Depomed; and (iii) a $40.0 million payment to Depomed which the Company received in March 2011. The $40.0 million payment was recognized as a gain within operating income in the first quarter of 2011.

 

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Pursuant to the exclusive license agreement originally entered into in November 2008, Solvay paid the Company a $25.0 million upfront fee in February 2009. The upfront payment received was originally being amortized as revenue ratably until January 2013, which represented the estimated length of time the Company’s development and supply obligations existed under the agreement. In connection with the termination of the license agreement with Abbott Products, the Company no longer has continuing obligations to Abbott Products. Accordingly, all remaining deferred revenue related to the $25.0 million upfront license fee previously received from Abbott Products was fully recognized as revenue in March 2011, resulting in immediate recognition of approximately $11.3 million of license revenue in the first quarter of 2011.

 

Boehringer Ingelheim International GMBH

 

In March 2011, the Company entered into a license and service agreement with Boehringer Ingelheim International GMBH (Boehringer Ingelheim) granting Boehringer Ingelheim a license to certain patents related to the Company’s Acuform drug delivery technology to be used in developing fixed dose combinations of extended release metformin and proprietary Boehringer Ingelheim compounds in development for type 2 diabetes. Under the terms of the agreement, Boehringer Ingelheim was also granted a right of reference to the New Drug Application covering the Company’s Glumetza product and associated data for use in potential regulatory submission processes.

 

In connection with the license and service agreement, the Company received an upfront payment of $10.0 million less applicable withholding taxes of approximately $1.5 million, for a net receipt of approximately $8.5 million in April 2011. The Company received the remaining $1.5 million of taxes previously withheld directly from German tax authorities in June 2011.

 

The $10.0 million upfront was amortized ratably through November 2011, which was the estimated length of time Depomed was obligated to perform formulation work under the agreement. Accordingly, the Company recognized the entire $10.0 million upfront license fee during the year ended 2011.  The Company recognized zero and $1.0 million of revenue associated with this upfront license fee during the three months ended March 31, 2012 and 2011, respectively.

 

Under the terms of the agreement, the Company received an additional nonrefundable $2.5 million payment in March 2012 upon delivery of experimental batches of prototype formulations that met required specifications. As the milestone event was substantive in nature, achievement was not reasonably assured at the inception of the agreement and the milestone was related to past performance, the Company recognized the entire amount of this payment as revenue in the quarter ended March 31, 2012.  The Company is also eligible to receive additional milestone payments based on regulatory filing and approval events, as well as royalties on worldwide net sales of products.

 

Depomed is responsible for providing certain initial formulation work associated with the fixed dose combination products. Work performed by the Company under the service agreement will be reimbursed by Boehringer Ingelheim on an agreed-upon FTE rate per hour plus out-of-pocket expenses. The Company recognized approximately $0.1 million of revenue associated with the reimbursement of formulation work under the service agreement during the three months ended March 31, 2012 and 2011.

 

Ironwood Pharmaceuticals, Inc.

 

In July 2011, the Company entered into a collaboration and license agreement with Ironwood Pharmaceuticals, Inc. (Ironwood) granting Ironwood a license for worldwide rights to the Company’s Acuform drug delivery technology for an undisclosed Ironwood early stage development program.

 

In connection with the agreement, the Company received an upfront payment of $0.9 million which is being amortized ratably through June 2012, which is the estimated length of time Depomed is obligated to perform formulation work under the agreement. The Company recognized approximately $0.2 million of revenue associated with this upfront license fee during the three months ended March 31, 2012. The remaining deferred revenue balance related to this upfront payment is $0.2 million at March 31, 2012, all of which is expected to be recognized as revenue in the second quarter of 2012.

 

Under the terms of the agreement, the Company will assist with initial product formulation and Ironwood will be responsible for all development and commercialization of the product. The initial formulation work performed by the Company under the agreement will be reimbursed by Ironwood on an agreed-upon FTE rate per hour plus out-of-pocket expenses. The Company recognized approximately $0.1 million of revenue associated with the reimbursement of formulation work under the agreement during the three months ended March 31, 2012.

 

In March 2012, the Company achieved the first milestone under the agreement with respect to delivery of experimental batches of prototype formulations that meet required specifications. The associated $1.0 million milestone payment is nonrefundable and expected to be paid during the second quarter of 2012. As the nonrefundable milestone was substantive in nature, achievement of the

 

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milestone was not reasonably assured at the inception of the agreement, the milestone was related to past performance, and the collectability of the milestone is reasonably assured, the Company recognized the $1.0 million as revenue during the three months ended March 31, 2012. Under the terms of the agreement, the Company may receive additional payments pending achievement of certain development and regulatory milestones, as well as royalties on product sales.

 

NOTE 5.  LONG-TERM DEBT

 

In June 2008, the Company entered into a loan and security agreement with General Electric Capital Corporation, as agent (GECC), and Oxford Finance Corporation (Oxford) that provided the Company with a $15.0 million credit facility. The credit facility was available in up to three tranches.  The first tranche of $3.8 million was advanced to the Company upon the closing of the loan agreement.  The second tranche of $5.6 million was advanced to the Company in July 2008. The third tranche of $5.6 million was not drawn and is no longer available to the Company, and GECC and Oxford waived the 2% unused line fee related to the unused portion of the credit facility.

 

The Company paid interest only on the first tranche for the first six months at an interest rate of 11.59%.  Beginning in January 2009, the Company began principal payments on the first tranche, plus interest at such rate, which was paid in 30 equal monthly installments. The second tranche was interest-only through December 31, 2008, with principal and interest paid thereafter in 30 equal monthly installments at an interest rate of 11.59%. Interest expense, which includes amortization of debt issuance costs, was $0.1 million for the three months ended March 31, 2011.  As all obligations under the credit facility were paid in full in July 2011, the Company incurred no interest expense for the three months ended March 31, 2012.

 

NOTE 6.  STOCK-BASED COMPENSATION

 

The following table presents stock-based compensation expense recognized for stock options, stock awards, restricted stock units and the Company’s employee stock purchase program (ESPP) in the Company’s statements of operations (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2012

 

2011

 

 

 

 

 

 

 

Cost of sales

 

$

14

 

$

19

 

Research and development expense

 

197

 

155

 

Selling, general and administrative expense

 

1,147

 

528

 

Total

 

$

1,358

 

$

702

 

 

At March 31, 2012, the Company had $8.5 million of total unrecognized compensation expense, net of estimated forfeitures, related to stock option grants that will be recognized over an average vesting period of 2.7 years.

 

NOTE 7.  COMPREHENSIVE INCOME (LOSS)

 

The following table summarizes components of total comprehensive income (loss) (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2012

 

2011

 

Net income (loss)

 

$

(8,804

)

$

98,817

 

Change in unrealized gains (losses) on available-for-sale securities

 

93

 

(11

)

Total comprehensive income (loss)

 

$

(8,711

)

$

98,806

 

 

NOTE 8.  INVENTORIES

 

Inventories relate to the manufacture of the Company’s Gralise product at March 31, 2012 and December 31, 2011. Inventories are stated at the lower of cost or market and consist of the following (in thousands):

 

 

 

March 31, 2012

 

December 31, 2011

 

Raw materials

 

$

1,184

 

$

1,244

 

Work-in-process

 

1,437

 

643

 

Finished goods

 

3,430

 

2,831

 

Deferred costs

 

503

 

677

 

Total

 

$

6,554

 

$

5,395

 

 

Deferred costs at March 31, 2012 represent the costs of Gralise product shipped for which recognition of revenue has been deferred. Deferred costs at December 31, 2011 represent the costs of Gralise and Proquin XR products shipped for which recognition of revenue has been deferred.

 

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NOTE 9.  ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

 

Accounts payable and accrued liabilities consist of the following (in thousands):

 

 

 

March 31, 2012

 

December 31, 2011

 

Accounts payable

 

$

3,782

 

$

2,417

 

Accrued compensation

 

1,974

 

3,235

 

Accrued clinical trial expense

 

262

 

31

 

Accrued rebates and sales discounts

 

2,589

 

2,626

 

Allowance for product returns

 

9,553

 

9,843

 

Accrued contract sales organization fees

 

1,302

 

3,365

 

Other accrued liabilities

 

5,349

 

5,267

 

Total accounts payable and accrued liabilities

 

$

24,811

 

$

26,784

 

 

NOTE 10.  SHAREHOLDERS’ EQUITY

 

Option Exercises

 

For the three months ended March 31, 2012, employees and consultants exercised options to purchase 134,061 shares of the Company’s common stock with net proceeds to the Company of approximately $0.5 million.

 

NOTE 11.  RELATED PARTY TRANSACTIONS

 

Carl A. Pelzel

 

In April 2011, the Company entered into a separation agreement and release with Carl A. Pelzel, the Company’s former President and Chief Executive Officer. Pursuant to the separation agreement, Mr. Pelzel is being paid $520,000, which is equivalent to one year of his base salary.  Payments are being made over one year, and will be reduced dollar-for-dollar by any compensation Mr. Pelzel receives in connection with employment (or full-time consulting) by another employer (or third party).  The Company is also paying Mr. Pelzel’s health and dental insurance COBRA premiums for up to 18 months following his separation from the Company.  The separation agreement further provides for three months’ accelerated vesting of Mr. Pelzel’s options to purchase the Company’s common stock, and a release of claims in favor of the Company.  The Company incurred a one-time severance charge of approximately $1.0 million in the second quarter of 2011 with respect to this separation agreement, consisting of approximately $0.4 million in stock-based compensation related to the accelerated vesting of Mr. Pelzel’s awards and approximately $0.6 million of severance expense related to future payments and health care benefits.

 

NOTE 12.  INCOME TAXES

 

As of December 31, 2011 and March 31, 2012, the Company had $3.6 million of unrecognized tax benefits. All tax years since inception remain open to examination by the Internal Revenue Service and the California Franchise Tax Board until such time the Company’s net operating losses and credits are either utilized or expire. Interest and penalties, if any, related to unrecognized tax benefits, would be recognized as income tax expense by the Company. The Company does not have any accrued interest or penalties associated with unrecognized tax benefits.  The Company does not foresee any material changes to unrecognized tax benefits within the next twelve months except as related to any new items impacting the current year operations.

 

NOTE 13. SUBSEQUENT EVENTS

 

In April 2012, the Company entered into an office and laboratory lease agreement to lease approximately 52,500 rentable square feet in Newark, California commencing on December 1, 2012. The Company is obligated to lease approximately 8,000 additional rentable square feet commencing no later than December 1, 2015.  The Lease will expire on November 30, 2022.  However, the Company has the right to renew the lease for one additional five year term, provided that written notice is made to the landlord no later than 12 months prior to the lease expiration. The Company will have the one-time right to terminate the lease in its entirety effective as of November 30, 2017 by delivering written notice to the landlord on or before December 1, 2016.  In the event of such termination, the Company will pay the landlord the unamortized portion of the tenant improvement allowance, specified additional allowances made by the landlord, waived base rent and leasing commissions, in each case amortized at 8% interest.

 

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

 

FORWARD-LOOKING INFORMATION

 

Statements made in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report on Form 10-Q that are not statements of historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended.  We have based these forward-looking statements on our current expectations and projections about future events.  Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as “believe,” “anticipate,” “expect,” “intend,” “plan,” “will,” “may” and other similar expressions.  In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Forward-looking statements include, but are not necessarily limited to, those relating to:

 

·                   the commercial success and market acceptance of Gralise ®  (gabapentin), our once-daily product for the management of postherpetic neuralgia;

·                   the commercial success of Glumetza ®  (metformin hydrochloride extended-release tablets) in the United States, and the efforts of our Glumetza commercial partner, Santarus, Inc. (Santarus);

·                   the results of our ongoing litigation against filers of abbreviated New Drug Applications (each, an ANDA) to market generic Gralise in the United States;

·                   the outcome of our ongoing litigation against filers of ANDAs to market generic Glumetza in the United States;

·                   any additional patent infringement or other litigation that may be instituted related to Gralise, Glumetza or any other of our product candidates;

·                   our and our collaborative partners’ compliance or non-compliance with legal and regulatory requirements related to the promotion of pharmaceutical products in the United States;

·                   our plans to in-license, acquire or co-promote other products;

·                   our plans to file a New Drug Application in the United States for Serada ®  for the treatment of menopausal hot flashes;

·                   the commercial success and market acceptance of Serada if we receive approval to market Serada in the United States;

·                   the results and timing of our clinical trials;

·                   the results of our research and development efforts;

·                   submission, acceptance and approval of regulatory filings;

·                   our need for, and ability to raise, additional capital;

·                   our collaborative partners’ compliance or non-compliance with obligations under our collaboration agreements; and

·                   our plans to develop other product candidates.

 

Factors that could cause actual results or conditions to differ from those anticipated by these and other forward-looking statements include those more fully described in the “ RISK FACTORS ” section and elsewhere in this Quarterly Report on Form 10-Q. We disclaim any intent to update or revise these forward-looking statements to reflect new events or circumstances.

 

ABOUT DEPOMED

 

Depomed is a specialty pharmaceutical company initially focused on neurology, pain and other conditions and diseases of the central nervous system. The centerpiece of our specialty pharmaceutical business is Gralise (gabapentin), a once-daily product for the management of postherpetic neuralgia that we launched and made commercially available in October 2011. We also have a portfolio of royalty and milestone producing assets based on our proprietary drug delivery technologies. The cornerstone of that portion of our business is Glumetza, a once-daily treatment for adults with type 2 diabetes that we licensed to, and is currently being commercialized by Santarus in the United States. We have a number of other license and development arrangements associated with our Acuform gastroretentive drug delivery technology. In addition, we have two product candidates in clinical development, DM-1992 for Parkinson’s disease and Serada for menopausal hot flashes.

 

We are seeking to develop and commercialize a number of pharmaceutical products for neurology, pain and other central nervous system conditions and diseases that can be promoted together effectively. We are actively seeking to expand our product portfolio through in-licensing, acquiring or obtaining co-promotion rights to commercially available products or late-stage product candidates that could be marketed and sold through our existing sales and marketing capability.

 

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We also seek to realize value from our drug delivery technology and related intellectual property through licensing and collaborative development partnerships with other companies. Our license agreement with Santarus which we restructured in August 2011, our license and development arrangements with Covidien, Janssen Pharmaceutica N.V. (Janssen), Boehringer Ingelheim International GMBH (Boehringer Ingelheim), and Ironwood Pharmaceuticals, Inc. (Ironwood) and our license agreement with Merck & Co., Inc. (Merck) are examples of this element of our strategy.

 

The following table summarizes our marketed products and product pipeline.

 

Commercialized Products

 

Product

 

Indication

 

Status

 

 

 

 

 

Gralise ®

 

Postherpetic neuralgia

 

Currently sold in the United States.
Approved by the FDA in January 2011.
Launched in October 2011.

 

 

 

 

 

Glumetza ®

 

Type 2 diabetes

 

Currently sold in the United States and Canada.
United States rights held by Santarus.
Canadian rights held by Valeant.

 

Product Pipeline

 

Product

 

Indication

 

Status

 

 

 

 

 

Serada ®

 

Menopausal hot flashes

 

Three Phase 3 studies completed (Breeze 1, Breeze 2, and Breeze 3).

 

 

 

 

 

DM-1992

 

Parkinson’s disease

 

Phase 2 study commenced in January 2012.

 

Significant Developments and Highlights for the Quarter Ended March 31, 2012

 

·                   In January 2012, we initiated a Phase 2 clinical trial of DM-1992 for the treatment of motor symptoms associated with Parkinson’s diseases.

·                   In January 2012, Merck received FDA approval to market Janumet XR in the United States. We will receive very low single digit royalties on net product sales of Janumet XR through the expiration date of the licensed patents.

·                   In February 2012, we entered into a settlement and license agreement with Lupin to resolve our patent litigation with respect to Glumetza.

·                   In February 2012, we achieved the first milestone under our agreement with Boehringer related to delivery of experimental batches of prototype formulations that meet agreed upon specifications, which triggered a $2.5 million payment that was received in March 2012.

·                   In March 2012, we achieved the first milestone under our agreement with Ironwood related to delivery of experimental batches of prototype formulations that meet agreed upon specifications, which triggered a $1.0 million payment that is expected to be received during the second quarter of 2012.

 

PRODUCT DEVELOPMENTS AND TRANSACTIONS

 

Gralise ®   (gabapentin) tablets for the Management of Postherpetic Neuralgia

 

In October 2011, we launched and announced the commercial availability of Gralise. Gralise product sales for the first quarter of 2012 were $1.7 million.

 

Ventiv Commercial Services, LLC. In June 2011, we entered into a service agreement with Ventiv Commercial Services, LLC (Ventiv), pursuant to which Ventiv’s outsourced sales business, inVentiv Selling Solutions, provides us with sales force recruiting, training, deployment and ongoing operational support to promote Gralise. The agreement provides for a sales force of 164 full-time sales representatives dedicated to the Company, all of whom are employees of Ventiv. The sales representatives were hired in September 2011 and began promoting Gralise to physicians in October 2011. Members of sales management are our employees.

 

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Under the terms of the agreement, we incurred an upfront implementation fee, and we pay fixed monthly management fees. The monthly management fee is subject to adjustment for actual staffing levels. A portion of the monthly management fee is payable only on Ventiv’s achievement of specified performance objectives. We also pay certain pass-through costs of Ventiv. The agreement will expire in October 2013, two years after the date on which sales representatives hired by Ventiv are deployed, but may be terminated by either party upon advance notice after the first anniversary of the deployment date. The agreement is also subject to early termination under certain circumstances, such as a party’s uncured material breach.

 

Glumetza for Type 2 Diabetes

 

Santarus .  In August 2011, we entered into a commercialization agreement with Santarus granting Santarus exclusive rights to manufacture and commercialize Glumetza in the United States. The commercialization agreement supersedes the previous promotion agreement between the parties originally entered into in July 2008. Under the commercialization agreement, we granted Santarus exclusive rights to manufacture and commercialize Glumetza in the United States in return for a royalty on Glumetza net sales.

 

Pursuant to the commercialization agreement, we transitioned to Santarus responsibility for manufacturing, distribution, pharmacovigilance and regulatory affairs. We ceased shipments of Glumetza in August 2011, and Santarus began selling Glumetza in September 2011. Santarus is responsible for advertising and promotional marketing activities for Glumetza. In November 2011, we and Santarus entered into an assignment and assumption agreement pursuant to which Santarus assumed all of our rights and obligations under our commercial manufacturing agreement with Patheon, which provides that Patheon will serve as Santarus’ sole commercial supplier of the 500mg Glumetza in the United States. Santarus pays us royalties on net product sales of Glumetza in the United States of 29.5% in 2012; 32.0% in 2013 and 2014; and 34.5% in 2015 and beyond prior to generic entry of a Glumetza product.

 

In connection with its assumption of distribution and sales responsibility of Glumetza, Santarus purchased our existing inventory of Glumetza and bulk metformin hydrochloride at cost.  We will be financially responsible for returns of Glumetza distributed by us, up to the amount of our product returns reserve account for Glumetza product returns on the date immediately before Santarus began distributing Glumetza.  We will also be financially responsible for Glumetza rebates and chargebacks up to the amount of its reserve account for those items.  Santarus will be responsible for all other Glumetza returns, rebates and chargebacks.

 

Under the commercialization agreement, we will continue to manage the ongoing patent infringement lawsuits against Sun Pharmaceutical Industries, Inc. (Sun) and Lupin Limited (Lupin), subject to certain consent rights in favor of Santarus, including with regard to any proposed settlements.  Santarus will reimburse us for 70% of our out-of-pocket costs, and we will reimburse Santarus for 30% of its out-of-pocket costs related to these two infringement cases.

 

During 2011, we sold Glumetza for the first eight months of the year, recognized Glumetza product sales and paid Santarus a promotion fee equal to 75% of Glumetza gross margin. In August 2011, the distribution and sales responsibility transitioned to Santarus and Santarus started paying us a royalty on net sales of Glumetza. For the three months ended March 31, 2011, the Company recognized $10.3 million in promotion fee expense to Santarus related to sales of Glumetza by Depomed.

 

We recognized $9.2 million in royalty revenue for the three months ended March 31, 2012 under the commercialization agreement.

 

Litigation .

 

We are involved in patent litigation associated with Glumetza against Sun and Watson, as described below under “Legal Proceedings”. In February 2012, we and Santarus entered into a settlement and license agreement with Lupin to resolve patent litigation involving Glumetza.  The agreement grants Lupin the right to begin selling a generic version of Glumetza on February 1, 2016, or earlier under certain circumstances.

 

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Serada ®   for Menopausal Hot Flashes

 

Serada is our proprietary extended release formulation of gabapentin in development for the treatment of menopausal hot flashes. We have completed three Phase 3 clinical trials evaluating Serada for menopausal hot flashes.

 

Study Design.  Breeze 3 was a randomized, double-blind, placebo-controlled study of 600 patients. Patients were randomized into one of two treatment arms, with patients receiving either placebo or a total dose of 1800mg of Serada dosed 600mg in the morning and 1200mg in the evening. The co-primary efficacy endpoints in the study were reductions in the mean frequency of moderate-to-severe hot flashes, and the average severity of hot flashes, measured after four and 12 weeks of stable treatment. As in the prior Breeze 1 trial, the treatment duration of the study was 24 weeks, to address the FDA’s view that an effective drug should also show statistically significant persistence of efficacy at 24 weeks. The trial also included a responder analysis to assess the clinical meaningfulness of any reduction in the frequency of hot flashes in the active arm relative to the placebo arm.

 

In August 2010, we reached agreement with the FDA regarding a Special Protocol Assessment (SPA) on the design and analysis of Breeze 3. An SPA is an agreement with the FDA that a proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support a product candidate’s regulatory approval. We began enrollment in Breeze 3 in August 2010 and completed enrollment in March 2011.

 

Study Results.   Under the statistical analyses set forth in the SPA, certain primary endpoints did not meet statistical significance. The primary severity endpoints were achieved with statistical significance at four weeks (p < 0.001) and 12 weeks (p < 0.01). The frequency endpoint at four weeks was achieved with statistical significance (p < 0.001). The frequency endpoint at 12 weeks, as well as the key secondary frequency and severity endpoints at 24 weeks, were not met.

 

Serada was generally well tolerated in Breeze 3. The most common adverse events were dizziness and somnolence. The incidence of dizziness in the active arm was 12.7% compared to 3.4% for the placebo arm. Somnolence was 6.0% in the active arm compared to 2.7% in the placebo arm. Withdrawals due to adverse events in the active arm were 17%, compared to 12% in the placebo arm.

 

In April 2012, we completed a Type B Pre-NDA meeting with the FDA to discuss the results of our three completed Phase 3 clinical trials for Serada. Based on the results of the meeting with the FDA, we intend to prepare and file a New Drug Application with the FDA in the second half of 2012. However, we cannot be certain that the FDA will determine the product candidate is sufficiently safe and effective to allow a New Drug Application to be accepted for review and/or approved.

 

Merck & Co., Inc.

 

We have received $12.5 million in upfront and milestone payments and will receive very low single digit royalties on Merck’s net sales of Janumet XR in the United States and other licensed territories through the expiration of the licensed patents under a July 2009 license agreement with Merck & Co., Inc. (Merck). The non-exclusive license agreement grants Merck a license as well as other rights to certain of our patents directed to metformin extended release technology for Janumet XR, Merck’s fixed-dose combination product for type 2 diabetes containing sitagliptin and extended release metformin that was approved by the FDA in January 2012. Merck began selling Janumet XR during the first quarter of 2012.

 

Boehringer Ingelheim

 

In March 2011, we entered into a license and service agreement with Boehringer Ingelheim granting Boehringer Ingelheim a license to certain patents related our Acuform drug delivery technology to be used in developing fixed dose combinations of extended release metformin and proprietary Boehringer Ingelheim compounds in development for type 2 diabetes.

 

In connection with the license and service agreement, we received the upfront license payment of $10.0 million less applicable withholding taxes of approximately $1.5 million, for a net receipt of approximately $8.5 million in April 2011. We received the remaining $1.5 million of taxes previously withheld directly from German tax authorities in June 2011.

 

In March 2012, we received an additional $2.5 million upon delivery of experimental batches of prototype formulations that met agreed-upon specifications, and we may receive additional milestone payments based on regulatory filings and approval events, as well as royalties on worldwide net sales of products.

 

We were responsible for providing certain initial formulation work associated with the fixed dose combination products. Services performed by us under the agreement were reimbursed by Boehringer Ingelheim on an agreed-upon rate, and out-of-pocket expenses were reimbursed.  All formulation work required by Depomed has been completed.

 

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Ironwood Pharmaceuticals, Inc.

 

In July 2011, we entered into a collaboration and license agreement with Ironwood Pharmaceuticals, Inc. (Ironwood) granting Ironwood a license for worldwide rights to certain patents and other intellectual property rights to our Acuform drug delivery technology for an undisclosed Ironwood early stage development program. In connection with the research collaboration and license agreement, we received an upfront payment of $0.9 million.

 

In March 2012, we achieved the first milestone under the agreement upon delivery of experimental batches of prototype formulations that met agreed-upon specifications. This triggered a nonrefundable $1.0 million milestone payment that we expect to receive during the second quarter of 2012. We may also receive milestone payments based on achievement of certain development and regulatory milestones, as well as royalties on product sales.

 

Under the agreement, we are responsible for assisting with initial product formulation and Ironwood is responsible for all development and commercialization of the product. The initial formulation work we perform is reimbursed by Ironwood on an agreed-upon FTE rate per hour plus out-of-pocket expenses.

 

DM-1992 for Parkinson’s Disease

 

In January 2012, we initiated a Phase 2 study to evaluate DM-1992 for the treatment of motor symptoms associated with Parkinson’s disease. The trial will enroll up to 45 patients at 8 U.S. centers. The trial is a randomized, active-controlled, open-label, crossover study testing DM-1992 dosed twice daily against a generic version of immediate-release carbidopa-levodopa dosed as needed. The study will assess efficacy, safety and pharmacokinetic variables. The primary endpoint for the study is change in off time as measured by patient self-assessment and clinician assessment.

 

In September 2010, we initiated a second pharmacokinetic-pharmacodynamic Phase 1 study for the DM-1992 program. We completed the study in February 2011. The trial was a randomized, open-label crossover study that enrolled 16 patients with stable Parkinson’s disease at two leading neurology centers in Russia. The objective of the study was to compare the pharmacokinetics-pharmacodynamics of two distinct twice-daily formulations of DM-1992 and a generic version of Sinemet CR sustained release carbidopa-levodopa dosed three-times daily, as well as the safety and tolerability of the formulations. Patients in the trial received a full day’s dose of each of the three treatments being studied, two doses of each DM-1992 formulation (460mg levodopa and 150mg carbidopa per dose) twelve hours apart, and three doses of generic levodopa-carbidopa over a 12 hour period (200mg of levodopa and 50mg of carbidopa per dose). During the 2 hour period following administration of each treatment, blood samples were drawn and a standard finger tapping test was given to assess efficacy. In the study, both formulations of DM-1992 maintained therapeutic blood levels above the efficacious threshold of 300 ng/mL for 24 hours. DM-1992 was well tolerated in the study.

 

CRITICAL ACCOUNTING POLICIES

 

Critical accounting policies are those that require significant judgment and/or estimates by management at the time that the financial statements are prepared such that materially different results might have been reported if other assumptions had been made. We consider certain accounting policies related to revenue recognition, accrued liabilities and stock-based compensation to be critical policies. There have been no changes to our critical accounting policies since we filed our 2011 Annual Report on Form 10-K with the Securities and Exchange Commission on March 8, 2012. For a description of our critical accounting policies, please refer to our 2011 Annual Report on Form 10-K.

 

RESULTS OF OPERATIONS

 

Our results of operations in 2012 will differ significantly from our reported results for 2011. For example, in 2011 we recognized $48 million in milestone revenue and a $40 million gain on settlement with regard to termination of our agreement with Abbott relating to Gralise. These were one-time payments and will not recur in 2012. In 2011, we reflect eight months of Glumetza product revenue, cost of sales and corresponding promotion expense to Santarus and four months of Glumetza royalty revenue from Santarus. As a result of the restructuring of our agreement with Santarus in August 2011, we will recognize royalty revenue from Santarus in 2012, but no product revenue or promotion expense for Glumetza. In 2011, we recognized $0.5 million of revenue from sales of Gralise and a partial year of corresponding sales and marketing expense. We expect to recognize a full year of Gralise sales in 2012 and to incur a full year of sales and marketing expense in 2012. Accordingly, we expect Gralise product sales and selling, general and administrative expense to be substantially higher in 2012 than in 2011.

 

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Three Months Ended March 31, 2012 and 2011

 

Revenue

 

Total revenues are summarized in the following table (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2012

 

2011

 

Product sales:

 

 

 

 

 

Gralise

 

$

1,749

 

$

 

Glumetza

 

 

15,297

 

Proquin XR

 

360

 

14

 

Total product sales

 

2,109

 

15,311

 

 

 

 

 

 

 

Royalties:

 

 

 

 

 

Santarus

 

9,222

 

 

Others

 

199

 

165

 

Total royalty revenue

 

9,421

 

165

 

 

 

 

 

 

 

License and collaborative revenue:

 

 

 

 

 

Gralise

 

 

60,593

 

Glumetza

 

1,388

 

3,635

 

Boehringer Ingelheim

 

2,617

 

1,094

 

Janssen

 

 

2,250

 

Ironwood

 

1,300

 

 

DM-1992

 

 

53

 

Total license and collaborative revenue

 

5,305

 

67,625

 

 

 

 

 

 

 

Total revenues

 

$

16,835

 

$

83,101

 

 

Product sales

 

Gralise. In October 2011, we announced the commercial availability of Gralise and began distributing Gralise to wholesalers and retail pharmacies. We defer recognition of revenue on product shipments of Gralise until the right of return no longer exists, which occurs at the earlier of (a) the time Gralise units are dispensed through patient prescriptions or (b) expiration of the right of return. At March 31, 2012, we have a deferred revenue balance, which is classified as a liability on the balance sheet, of $5.0 million associated with the deferral of revenue on Gralise product shipments, which is net of estimated wholesaler fees, retail pharmacy discounts, stocking allowances and prompt payment discounts. We will recognize revenue upon the earlier of prescription units dispensed or expiration of the right of return until we can reliably estimate product returns, at which time we will record a one-time increase in net revenue related to the recognition of revenue previously deferred.  We expect Gralise product sales to increase significantly in 2012 as compared to 2011 as 2011 only represented the first three months of selling Gralise.

 

Glumetza . In August 2011, we restructured our agreement with Santarus and entered into a commercialization agreement that superseded the July 2008 promotion agreement.  Under the commercialization agreement, we granted Santarus exclusive rights to manufacture and commercialize Glumetza in the United States in return for a royalty on Glumetza net sales. We ceased shipments of Glumetza in August 2011, and Santarus began selling Glumetza in September 2011.

 

Proquin XR . We ceased shipments of Proquin XR in the fourth quarter of 2010 and because of estimated significant levels of inventory at wholesalers and pharmacies in comparison to prescription demand, we deferred revenue recognition on product shipments of Proquin XR until the right of return no longer existed, which occurred at the earlier of the time Proquin XR units were dispensed through patient prescriptions or expiration of the right of return.  At March 31, 2012, all rights of return have expired and the remaining deferred revenue balance for Proquin XR of $0.4 million was recognized as revenue during the first quarter of 2012.

 

Royalties

 

Santarus . Santarus royalties relate to royalties we received from Santarus based on net sales of Glumetza in the U.S. Royalty revenue from Santarus for the three months ended March 31, 2012 was $9.2 million and represents a 29.5% royalty on Santarus’ net sales of Glumetza. There were no royalty revenue amounts from Santarus for the same period in the prior year.  We currently expect royalty revenue to increase in future periods in 2012 based on our expectation of increasing net sales of Glumetza by Santarus.

 

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Other Royalties . In January 2012, Merck received FDA approval to market Janumet XR in the United States, and Merck began selling Janumet XR during the first quarter of 2012. We are entitled to receive very low single digit royalties on net product sales of Janumet XR through the expiration date of the licensed patents. As such, we began recognizing royalty revenue in the first quarter of 2012. Other royalties also include royalties we received from Valeant on net sales of Glumetza in Canada and from LG Life Sciences on net sales of LG’s version of Glumetza, Novamet GR, in Korea.

 

License and collaborative revenue

 

Gralise . In January 2011, Abbott Products received FDA approval of Gralise for the management of postherpetic neuralgia, which triggered a $48.0 million development milestone from Abbott to us, which we received in February 2011. Because the milestone was substantive in nature, achieved and based on past performance, the entire $48.0 million was recognized as license revenue in the first quarter of 2011.

 

Pursuant to the exclusive license agreement originally entered into in November 2008, Solvay paid us a $25.0 million upfront fee in February 2009. The upfront payment received was originally scheduled to be recognized as revenue ratably until January 2013, which represented the estimated length of time our development and supply obligations existed under the agreement. In connection with the termination of the license agreement with Abbott Products, we no longer have continuing obligations to Abbott Products. Accordingly, all remaining deferred revenue related to the $25.0 million upfront license fee previously received from Abbott Products was fully recognized as revenue in March 2011, resulting in immediate recognition of approximately $11.3 million of license revenue.

 

Glumetza . Glumetza license revenue for the three months ended March 31, 2012 and 2011 also consisted of license revenue recognized from the $25.0 million upfront license fee received from Biovail in July 2005 and the $12.0 million upfront fee received from Santarus in July 2008.

 

We are recognizing the $25.0 million upfront license fee payment from Biovail as revenue ratably until October 2021, which represents the estimated length of time our obligations exist under the arrangement related to royalties we are obligated to pay Biovail on net sales of Glumetza in the United States and for our obligation to use Biovail as our sole supplier of the 1000mg Glumetza.

 

Pursuant to the promotion agreement originally entered into in July 2008, Santarus paid us a $12.0 million upfront fee. The upfront payment received was originally being amortized as revenue ratably until October 2021, which represented the estimated length of time our obligations existed under the promotion agreement related to manufacturing Glumetza and paying Santarus promotion fees on gross margin of Glumetza. The commercialization agreement in August 2011 superseded the promotion agreement and removed our manufacturing and promotion fee obligations. The commercialization agreement includes obligations with respect to manufacturing and regulatory transition to Santarus and managing the patent infringement lawsuits against Sun and Lupin. These obligations are estimated to be completed in December 2013. Accordingly, on the effective date of the commercialization agreement, the amortization period related to remaining deferred revenue on the $12.0 million upfront fee has been adjusted, and the remaining deferred revenue will be recognized ratably until December 2013. We recognized approximately $1.0 million and $0.2 million of revenue associated with this upfront license fee during the three months ended March 31, 2012 and 2011, respectively. The remaining deferred revenue balance is $6.8 million at March 31, 2012.

 

In January 2011, we achieved the first sales milestone under the promotion agreement with Santarus related to net sales of Glumetza reaching $50.0 million for the 13 month period ending January 31, 2011, which triggered a milestone payment of $3.0 million, which we received in March 2011.  As the milestone was achieved and related to past performance the entire $3.0 million was recognized as milestone revenue in the first quarter of 2011.

 

Boehringer Ingelheim .  Under our license and services agreement with Boehringer Ingelheim entered into in March 2011, Boehringer Ingelheim paid us a $10.0 million upfront license fee which we received in April 2011, less applicable withholding taxes of approximately $1.5 million, for a net receipt of approximately $8.5 million. We received the remaining $1.5 million of taxes previously withheld directly from German tax authorities in June 2011.

 

The $10.0 million was amortized ratably through November 2011, which was the estimated length of time we were obligated to perform formulation work under the agreements. As such the entire amount was recognized as license revenue in 2011. We recognized approximately $1.0 million of revenue associated with this upfront license fee during the three months ended March 31, 2011.

 

Under the terms of the agreement, we received an additional nonrefundable $2.5 million payment in March 2012 upon delivery of experimental batches of prototype formulations that meet required specifications. As the milestone event was substantive in nature, achievement was not reasonably assured at the inception of the agreement and the milestone was related to past performance, we recognized the entire amount of this payment as revenue during the three months ended March 31, 2012.

 

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We also provided certain initial formulation work associated with the fixed dose combination products. Work performed by us under the service agreement was reimbursed by Boehringer Ingelheim on an agreed-upon FTE rate per hour plus out-of-pocket expenses. We recognized approximately $0.1 million of revenue associated with the reimbursement of formulation work under the service agreement for each of the three months ended March 31, 2012 and 2011.

 

Janssen .  In August 2010, we entered into a non-exclusive license agreement with Janssen granting Janssen a license to certain patents related to our Acuform drug delivery technology to be used in developing fixed dose combinations of canagliflozin and extended release metformin. Janssen paid us a $5.0 million upfront license fee associated with the license agreement. The $5.0 million was amortized ratably through March 2011, which is the estimated length of time we were obligated to perform formulation work under the agreements. We recognized approximately $1.9 million of revenue associated with this upfront license fee during the first quarter of 2011.

 

We also entered into a service agreement with Janssen under which we provide formulation work for Janssen and are reimbursed by Janssen on an agreed-upon FTE rate per hour plus out-of-pocket expenses. We recognized approximately $0.3 million of revenue associated with the reimbursement of formulation work under the service agreement during the first quarter of 2011.

 

All formulation work under the agreement was completed at March 31, 2011 and there is no remaining deferred revenue.

 

Ironwood Pharmaceuticals, Inc. In July 2011, we entered into a collaboration and license agreement with Ironwood granting Ironwood a license for worldwide rights to the Company’s Acuform drug delivery technology for an undisclosed Ironwood early stage development program. In connection with the research collaboration and license agreement, the Company received an upfront payment of $0.9 million which is being amortized ratably through June 2012, which is the estimated length of time Depomed is obligated to perform formulation work under the agreement. We recognized approximately $0.2 million of revenue associated with this upfront license fee for the three months ended March 31, 2012. The remaining deferred revenue balance is $0.2 million at March 31, 2012.

 

In March 2012, we achieved a milestone under the agreement with respect to delivery of experimental batches of prototype formulations that meet required specifications. The associated $1.0 million milestone payment is nonrefundable and expected to be paid during the second quarter of 2012. As the nonrefundable milestone was substantive in nature, achievement of the milestone was not reasonably assured at the inception of the agreement, the milestone was related to past performance, and the collectability of the milestone is reasonably assured, we recognized the $1.0 million as revenue during the three months ended March 31, 2012.

 

Under the terms of the agreement, the Company will assist with initial product formulation and Ironwood will be responsible for all development and commercialization of the product. The initial formulation work performed by the Company under the agreement will be reimbursed by Ironwood on an agreed-upon FTE rate per hour plus out-of-pocket expenses. We recognized approximately $0.1  million of revenue associated with the reimbursement of formulation work under the agreement during the three months ended March 31, 2012.

 

Cost of Sales

 

Cost of sales consists of costs of the active pharmaceutical ingredient, contract manufacturing and packaging costs, inventory write-downs, product quality testing, internal employee costs related to the manufacturing process, distribution costs and shipping costs related to our product sales of Gralise, Glumetza and Proquin XR. Total cost of sales for the three months ended March 31, 2012, as compared to the prior year, was as follows (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2012

 

2011

 

Cost of sales

 

$

518

 

$

1,635

 

 

Cost of sales for the three months ended March 31, 2012 primarily relates to Gralise. Cost of sales for the three months ended March 31, 2011 primarily relates to Glumetza. We expect cost of sales to increase in 2012 as we expect product sales of Gralise to increase from current levels.

 

The costs of manufacturing associated with deferred revenue on Gralise product shipments are recorded as deferred costs, which are included in inventory, until such time the deferred revenue is recognized.

 

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Gain on Settlement with Abbott Products

 

In March 2011, we entered into a settlement agreement with Abbott Products which provided for (i) the immediate termination of the parties’ license agreement; (ii) the transition of Gralise back to Depomed; and (iii) a $40.0 million payment from Abbott to us which was paid in March 2011. The $40.0 million payment was recognized as a gain within operating income in the first quarter of 2011.

 

Research and Development Expense

 

Our research and development expenses currently include salaries, clinical trial costs, consultant fees, supplies, manufacturing costs for research and development programs and allocations of corporate costs. The scope and magnitude of future research and development expenses cannot be predicted at this time for our product candidates in research and development, as it is not possible to determine the nature, timing and extent of clinical trials and studies, the FDA’s requirements for a particular drug and the requirements and level of participation, if any, by potential partners. As potential products proceed through the development process, each step is typically more extensive, and therefore more expensive, than the previous step. Success in development therefore, generally results in increasing expenditures until actual product approval. Total research and development expense for the three months ended March 31, 2012 as compared to the prior year, was as follows (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2012

 

2011

 

Research and development expense

 

$

3,482

 

$

5,154

 

Dollar change from prior year

 

(1,672

)

 

 

Percentage change from prior year

 

(32

)%

 

 

 

The decrease in research and development expense for the three months ended March 31, 2012 as compared to the three months ended March 31, 2011 was primarily due to reduced clinical research organization costs associated with our Breeze 3 Phase 3 clinical trial for Serada, which was completed in October 2011.

 

We categorize our research and development expense by project. The table below shows research and development costs for our major clinical development programs, as well as other expenses associated with all other projects in our product pipeline.

 

 

 

Three Months Ended March 31,

 

(In thousands)

 

2012

 

2011

 

Serada

 

1,100

 

3,253

 

DM-1992

 

963

 

198

 

Other projects

 

1,419

 

1,703

 

Total research and development expense

 

$

3,482

 

$

5,154

 

 

We anticipate filing a New Drug Application for Serada in the second half of 2012. Accordingly, our research and development expense may increase from current levels to prepare for and submit the New Drug Application filing to the FDA.  We are obligated to pay PharmaNova under our sublicense agreement for Serada a $1 million milestone on submission of a New Drug Application filing to the FDA and a $2 million milestone on FDA approval.

 

Selling, General and Administrative Expense

 

Selling, general and administrative expenses primarily consist of personnel, contract personnel, marketing and promotion expenses associated with our commercial products, personnel expenses to support our administrative and operating activities, facility costs and professional expenses, such as legal fees. Total selling, general and administrative expense, as compared to the prior year, were as follows (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2012

 

2011

 

Selling, general and administrative expense:

 

 

 

 

 

Promotion fee expense

 

$

 

$

10,262

 

Other selling, general and administrative expense

 

21,773

 

7,241

 

Total selling, general and administrative expense

 

$

21,773

 

$

17,503

 

Dollar change from prior year

 

4,270

 

 

 

Percentage change from prior year

 

24

%

 

 

 

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The increase in selling, general and administrative expense was primarily due to increased sales and marketing costs related to the launch of Gralise including marketing activities and costs associated with our contract sales organization. In March 2011, we received back from Abbott the rights to market Gralise and commenced pre-launch commercial activities to support the launch of Gralise.  During 2011, we advanced our commercial infrastructure with the hiring of employees for our sales management and marketing organizations.  In June 2011, we entered into a service agreement with Ventiv as our contract sales organization, pursuant to which Ventiv will provide 164 full-time sales representatives dedicated to promoting Gralise.  The Ventiv sales representatives were hired and commenced training in September.  In October, we initiated commercial sales of Gralise.

 

As a result of the Santarus commercialization agreement entered into in August 2011, we no longer have promotion fee expense to Santarus. However, we expect selling, general and administrative expense to increase as we incur costs associated with our contract sales organization and other sales and marketing expenses related to Gralise.

 

Interest Income and Expense

 

 

 

Three Months Ended March 31,

 

(in thousands)

 

2012

 

2011

 

Interest and other income

 

$

143

 

$

79

 

Interest expense

 

 

(69

)

Net interest income (expense)

 

$

143

 

$

10

 

 

Interest and other income increased during the three months ended March 31, 2012 as compared to the corresponding period in 2011 as a result of higher investment balances.

 

Interest expense relates to interest on the credit facility we entered into in June 2008 with General Electric Capital Corporation and Oxford Finance Corporation. The credit facility was fully repaid in July 2011.

 

LIQUIDITY AND CAPITAL RESOURCES

 

(in thousands)

 

March 31,
2012

 

December 31,
2012

 

Cash, cash equivalents and marketable securities

 

$

128,571

 

$

139,793

 

 

Since inception through March 31, 2012, we have financed our product development efforts and operations primarily from private and public sales of equity securities, upfront license, milestone and termination fees from collaborative and license partners, and product sales.

 

As of March 31, 2012, we have accumulated net losses of $106.4 million. We may incur operating losses in future years. We anticipate that our existing capital resources will permit us to meet our capital and operational requirements for at least the next two years. We base this expectation on our current operating plan, which may change as a result of many factors.

 

Our cash needs may also vary materially from our current expectations because of numerous factors, including:

 

·                   sales of our marketed products;

·                   expenditures related to our commercialization of Gralise, including our contractual obligations to Ventiv and other arrangements we make for the commercialization of Gralise;

·                   milestone and royalty revenue we receive under our collaborative development and commercialization arrangements;

·                   acquisitions or licenses of complementary businesses, products or technologies.

·                   financial terms of definitive license agreements or other commercial agreements we may enter into;

·                   results of research and development efforts;

·                   changes in the focus and direction of our business strategy and/or research and development programs;

·                   results of clinical testing requirements of the FDA and comparable foreign regulatory agencies; and

·                   expenditures related to our commercialization and development efforts, including arrangements we make for the commercialization of Serada, if the product is approved for marketing;

 

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We will need substantial funds to:

 

·                   conduct research and development programs;

·                   commercialize any products we market;

·                   conduct preclinical and clinical testing; and

·                   manufacture (or have manufactured) and market (or have marketed) our marketed products and product candidates.

 

Our existing capital resources may not be sufficient to fund our operations until such time as we may be able to generate sufficient revenues to sustain support our operations. We currently do not have any other committed sources of capital. To the extent that our capital resources are insufficient to meet our future capital requirements, we will have to raise additional funds through the sale of our equity securities or from development and licensing arrangements to continue our development programs. We may be unable to raise such additional capital on favorable terms, or at all. If we raise additional capital by selling our equity or convertible debt securities, the issuance of such securities could result in dilution of our shareholders’ equity positions. If adequate funds are not available we may have to:

 

·                   significantly curtail commercialization of our marketed products or other operations

·                   obtain funds through entering into collaboration agreements on unattractive terms; and/or

·                   delay, postpone or terminate clinical trials;

 

The inability to raise any additional capital required to fund our operations could have a material adverse effect on our company.

 

Cash Flows from Operating Activities

 

Cash used in operating activities during the three months ended March 31, 2012 was approximately $11.5 million, compared to cash provided by operating activities of approximately $79.8 million during the three months ended March 31, 2011. Cash used in operating activities during the three months ended March 31, 2012 was primarily due to our net loss adjusted for movements in working capital, stock-based compensation and depreciation expense. Cash provided by operating activities during the three months ended March 31, 2012 was primarily as a result of the $48.0 million milestone payment and $40 million termination fee received from Abbott Products during the first quarter of 2011.

 

Cash Flows from Investing Activities

 

Net cash provided by investing activities during the three months ended March 31, 2012 was approximately $27.2 million and consisted of a decrease in marketable securities to fund our operations.  Net cash used in investing activities during the three months ended March 31, 2011 was approximately $19.8 million and consisted primarily of a net increase in marketable securities resulting from a partial investment of the milestone payment and settlement fee received from Abbott Products during the first quarter of 2011.

 

Cash Flows from Financing Activities

 

Cash provided by financing activities during the three months ended March 31, 2012 was approximately $0.5 million and consisted of proceeds from employee and consultant option exercises. Cash provided by financing activities during the three months ended March 31, 2011 was approximately $1.3 million and consisted of proceeds from employee and consultant option exercises offset by repayments of principal on our credit facility.

 

Contractual Obligations

 

As of March 31, 2012, our aggregate contractual obligations are as shown in the following table (in thousands):

 

 

 

Less than
1 year

 

1-3 years

 

Total

 

Operating leases

 

$

1,234

 

$

29

 

$

1,263

 

Related parties

 

43

 

 

43

 

Contract sales organization

 

8,028

 

 

8,028

 

Purchase commitments

 

642

 

 

642

 

 

 

$

9,947

 

$

29

 

$

9,976

 

 

At March 31, 2012, we had non-cancelable purchase orders and minimum purchase obligations of approximately $0.6 million under our manufacturing agreement with Patheon for the manufacture of Gralise. The amounts disclosed only represent minimum purchase requirements. Actual purchases are expected to exceed these amounts.

 

Pursuant to the separation agreement and release entered into with Carl A. Pelzel, our former President and Chief Executive Officer, we are obligated to pay Mr. Pelzel $43,333 per month through April 2012.

 

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In June 2011, we entered in to a service agreement with Ventiv.  Ventiv provides us with sales force recruiting, training, deployment and ongoing operational support to promote Gralise in the U.S. through 164 full-time sales representatives. Each month we are required to pay Ventiv a monthly fixed fee of $1.8 million during the term of the agreement. We may terminate the service agreement on the one year anniversary of the deployment date of the sales representatives. We have included an estimate of our expected contractual obligations to Ventiv based upon this fee and expected one year anniversary of deployment date of the sales representatives.

 

The contractual obligations reflected in this table exclude $3.0 million of contingent milestone payments we may be obligated to pay in the future under our sublicense agreement with PharmaNova related to the development of Serada. The payments relate to various milestones for the product candidate under the sublicense agreement, including submission to the FDA of an NDA, and FDA approval of an NDA. The above table also excludes any future royalty payments we may be required to pay on products we have licensed.

 

The contractual obligations reflected in the table above also exclude non-cancelable purchase orders and minimum purchase obligations of approximately $1.5 million under our supply agreement with Valeant for the supply of 1000mg Glumetza, which will be fully reimbursed by Santarus.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

There have been no significant changes in our market risk compared to the disclosures in Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2011.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

An evaluation was performed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this quarterly report. Based on that evaluation, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures were effective.

 

We review and evaluate the design and effectiveness of our disclosure controls and procedures on an ongoing basis to improve our controls and procedures over time and to correct any deficiencies that we may discover in the future. Our goal is to ensure that our senior management has timely access to all material financial and non-financial information concerning our business. While we believe the present design of our disclosure controls and procedures is effective to achieve our goal, future events affecting our business may cause us to significantly modify our disclosure controls and procedures.

 

Changes in Internal Controls

 

There were no changes in our internal controls over financial reporting during the quarter ended March 31, 2012 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II — OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

Depomed v. Sun Pharmaceuticals and Watson Laboratories (U.S. Generic Glumetza Litigation)

 

In June 2011, a lawsuit was filed in the United States District Court for the District of New Jersey against Sun Pharmaceutical Industries Inc., Sun Pharma Global FZE and Sun Pharmaceuticals Industries Ltd. (Sun), for infringement of five (5) U.S. patents listed in the Orange Book for the Glumetza product. The lawsuit is in response to an Abbreviated New Drug Application (ANDA) filed by Sun with the FDA regarding Sun’s intent to market generic versions of 500mg and 1000mg dosage strengths of Glumetza prior to the expiration of the Orange Book patents, which includes U.S. Patent Nos.: 6,340,475, 6,488,962, 6,635,280, 6,723,340 and 7,780,987. U.S. Patent No.7,736,667 is also being asserted against Sun in the lawsuit. The lawsuit commenced within the 45 days required to automatically stay, or bar, the FDA from approving Sun’s ANDA for 30 months or until a district court decision that is adverse to the patents, whichever occurs earlier.  Absent a court decision, the 30-month stay is expected to expire in November 2013.

 

In April 2012, we filed a lawsuit in the United States District Court for the District of Delaware against Watson Laboratories, Inc. — Florida, Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. (collectively, Watson ), for infringement of the six patents listed in the Orange Book for Glumetza 1000 mg (U.S. Patent Nos. 6,488,962 and 7,780,987).  The lawsuit is in response to an ANDA filed by Watson with the FDA regarding Watson’s intent to market a generic version of the 1000 mg dosage strength of Glumetza prior to the expiration of the asserted patents.  Valeant International (Barbados) SRL is joined in the lawsuit as a co-plaintiff as the owner of U.S. Patent No. 7,780,987.  We commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving Watson’s ANDA for 30 months or until a district court decision that is adverse to the patents, whichever may occur earlier.  Absent a court decision, the 30-month stay is expected to expire in September 2014.

 

Depomed v. Lupin (U.S. Generic Glumetza Litigation)

 

In November 2009, a lawsuit was filed in the United States District Court for the Northern District of California against Lupin Limited and its wholly-owned subsidiary, Lupin Pharmaceutical, Inc. (Lupin), for infringement of four (4) U.S. patents listed in the Orange Book for the Glumetza product. The lawsuit was filed in response to an ANDA filed by Lupin with the FDA regarding Lupin’s intent to market generic versions of 500mg and 1000mg dosage strengths of Glumetza prior to the expiration of the Orange Book, which includes U.S. Patent Nos.: 6,340,475; 6,488,962; 6,635,280; and 6,723,340. U.S. Patent No. 6,723,340 was subsequently removed from the litigation proceedings in an amended complaint.  In February 2012, we and Santarus entered into a settlement and license agreement with Lupin to resolve the litigation. The agreement grants Lupin the right to begin selling a generic version of Glumetza on February 1, 2016, or earlier under certain circumstances.  In March 2012, the litigation was dismissed in accordance with the settlement agreement.

 

Depomed vs. Gralise ANDA filers (U.S. Generic Gralise Litigation)

 

In March 2012, we filed lawsuit in the United States District Court for the District of New Jersey against Actavis Elizabeth LLC (Actavis), Watson Laboratories (Watson) and Incepta Pharmaceuticals (Incepta) for infringement of six (6) U.S. patents listed in the Orange Book for our Gralise product.  The lawsuit is in response to ANDAs filed by each of Actavis, Watson and Incepta with the FDA regarding the defendants’ intent to market generic versions of 300mg and 600mg dosage strengths of Gralise prior to the expiration of the Orange Book patents, which includes U.S. Patent Nos.: 6,340,475, 6,488,962, 6,635,280, 6,723,340, 7,438,927 and 7,731,989.  We commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving the ANDAs for 30 months or until a district court decision that is adverse to the asserted patents, whichever may occur earlier.  The 30-month stays expire in July 2014 and August 2014.

 

In April 2012, we filed lawsuit in the United States District Court for the District of New Jersey against Impax Laboratories (Impax) and Par Pharmaceuticals (Par) for infringement of six U.S. patents listed in the Orange Book for our Gralise product.  The lawsuit is in response to ANDAs filed by each of Impax and Par with the FDA regarding the defendants’ intent to market generic versions of 300mg and 600mg dosage strengths of Gralise prior to the expiration of the Orange Book patents, which includes U.S. Patent Nos.: 6,340,475, 6,488,962, 6,635,280, 6,723,340, 7,438,927 and 7,731,989.  We commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving the ANDAs for 30 months or until a district court decision that is adverse to the asserted patents, whichever may occur earlier.  The 30-month stays expire in August 2014.

 

ITEM 1A. RISK FACTORS

 

The risk factors presented below amend and restate the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2011.

 

The following factors, along with those described above under “MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS — LIQUIDITY AND CAPITAL RESOURCES” should be reviewed carefully, in conjunction with the other information contained in this Report and our financial statements. These factors, among others, could cause actual results to differ materially from those currently anticipated and contained in forward-looking statements made in this Form 10-Q and presented elsewhere by our management from time to time. See “Part I, Item 2—Forward-Looking Information.”

 

If we are not able to successfully commercialize Gralise, our business will suffer.

 

In October 2011, we began commercial sales of Gralise. Other than Ventiv, with whom we have contracted to provide sales force recruiting, training, deployment and operational support for this product, we do not currently have other partners assisting us with the commercialization of Gralise. We are a small organization with limited experience selling and marketing pharmaceutical products, and we have had limited time to build the capabilities necessary to commercialize the product. We may not be able to adequately or timely build, maintain or scale the necessary sales, marketing, manufacturing, managed markets or other capabilities on

 

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our own that are required to successfully commercialize Gralise, and we may not enter into arrangements with other collaborative partners or other third parties to perform those functions on terms that are acceptable to us, if at all. If we enter into a collaborative co-promotion or licensing arrangement related to Gralise, some of the revenues we receive will depend upon the efforts of one or more third parties, which may not be successful and over which we will have little or no control.

 

Ventiv and any other future third-party contractors and partners may not perform as required under their contracts with us or as expected. If our management of collaborative partners and third-party contractors is not effective or such partners or contractors do not perform as required or as expected, the commercial acceptance and success of Gralise may be limited and our business, financial condition and results of operations would be materially and adversely affected.

 

If Santarus does not successfully commercialize Glumetza in the United States, our business will suffer.

 

In August 2011, we entered into a commercialization agreement with Santarus pursuant to which Santarus assumed broad commercial, manufacturing and regulatory responsibility for the commercialization of Glumetza and we transferred the Glumetza NDA to Santarus. The commercialization agreement replaced the promotion agreement we entered into with Santarus in July 2008. Santarus pays us royalties on net sales of Glumetza and will not pay any additional sales milestones that were required under the promotion agreement. Although we have retained rights to promote Glumetza to physicians not targeted by Santarus, we do not have any immediate plans to exercise our Glumetza co-promotion rights. As a result, the commercial success of Glumetza depends almost entirely on Santarus’ commercialization efforts. Other factors that may affect the success of our commercialization arrangement with Santarus include the following:

 

·                   Santarus may acquire or develop alternative products;

·                   Santarus may pursue higher-priority programs, or change the focus of its marketing programs;

·                   Santarus may in the future choose to devote fewer resources to Glumetza;

·                   Glumetza may fail to achieve greater market acceptance;

·                   the outcome of our ongoing litigation against ANDA filers seeking to prevent the ANDA filers from marketing a generic version of Glumetza in the United States;

·                   Santarus may experience financial difficulties; and

·                   Santarus may fail to comply with its obligations under our commercialization agreement.

 

Any of the preceding factors could affect Santarus’ commitment to the commercialization agreement, which, in turn, could adversely affect the commercial success of Glumetza. Any failure by Santarus to successfully commercialize Glumetza would have a material adverse effect on our business, financial condition and results of operations.

 

If generic manufacturers use litigation and regulatory means to obtain approval for generic versions of our products, our business will suffer.

 

Under the Federal Food, Drug and Cosmetics Act (FDCA), the FDA can approve an Abbreviated New Drug Application (ANDA), for a generic version of a branded drug without the ANDA applicant undertaking the clinical testing necessary to obtain approval to market a new drug. In place of such clinical studies, an ANDA applicant usually needs only to submit data demonstrating that its product has the same active ingredient(s) and is bioequivalent to the branded product, in addition to any data necessary to establish that any difference in strength, dosage form, inactive ingredients, or delivery mechanism does not result in different safety or efficacy profiles, as compared to the reference drug.

 

The FDCA requires an applicant for a drug that relies, at least in part, on the patent of one of our branded drugs to notify us of their application and potential infringement of our patent rights. Upon receipt of this notice we have 45 days to bring a patent infringement suit in federal district court against the company seeking approval of a product covered by one of our patents. The discovery, trial and appeals process in such suits can take several years. If such a suit is commenced, the FDCA provides a 30-month stay on the FDA’s approval of the competitor’s application. Such litigation is often time-consuming and quite costly and may result in generic competition if the patents at issue are not upheld or if the generic competitor is found not to infringe such patents. If the litigation is resolved in favor of the applicant or the challenged patent expires during the 30-month stay period, the stay is lifted and the FDA may thereafter approve the application based on the standards for approval of ANDAs.

 

We are involved in patent infringement litigation against filers of two ANDAs to Glumetza.  In June 2011, we filed a lawsuit in the United States District Court for the District of New Jersey against Sun Pharmaceutical Industries Inc., Sun Pharma Global FZE and Sun Pharmaceuticals Industries Ltd. (Sun), for infringement of the patents listed in the Orange Book for Glumetza. The lawsuit is in response to an ANDA filed by Sun with the FDA regarding Sun’s intent to market generic versions of 500mg and 1000mg strengths

 

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of Glumetza prior to the expiration of the five listed U.S. patents (U.S. Patent Nos. 6,340,475; 6,488,962; 6,635,280; 6,723,340 and 7,780,987). We also are asserting U.S. Patent 7,736,667 in the lawsuit.  In April 2012, we filed a lawsuit in the United States District Court for the District of Delaware against Watson Laboratories, Inc. — Florida, Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. (collectively, Watson ) for infringement of U.S. Patent Nos. 6,488,962 and 7,780,987.  The lawsuit is in response to an ANDA filed by Watson with the FDA regarding Watson’s intent to market a generic version of the 1000 mg dosage strength of Glumetza prior to the expiration of the asserted patents.  We commenced both lawsuits within the 45 days required to automatically stay, or bar, the FDA from approving the ANDAs for 30 months or until a district court decision that is adverse to the patents, whichever may occur earlier.  Absent a court decision, the 30-month stay on the Sun ANDA is expected to expire in November 2013, and the 30-month stay on the Watson ANDA is expected to expire in September 2014.  In February 2012, we and Santarus entered into a settlement and license agreement with Lupin to resolve patent litigation involving Glumetza we initiated in November 2009. The agreement grants Lupin the right to begin selling a generic version of Glumetza on February 1, 2016, or earlier under certain circumstances.  The introduction of one or more products generic to Glumetza would harm our business, financial condition, results of operations and cash flows.

 

We are involved in patent infringement litigation against filers of five ANDAs to Gralise and have received notice of the filing of a sixth ANDA to Gralise.  In March 2012, we filed a lawsuit in the United States District Court for the District of New Jersey against Actavis Elizabeth LLC (Actavis), Watson Laboratories (Watson) and Incepta Pharmaceuticals (Incepta) for infringement of six (6) U.S. patents listed in the Orange Book for the Gralise product.  In April 2012, we filed a lawsuit in the same court against Impax Laboratories, Inc. (Impax), as well as Par Pharmaceutical, Inc. and Par Pharmaceutical Companies, Inc. (collectively, Par) for infringement of the same patents.  The lawsuits are in response to ANDAs filed by each of Actavis, Watson, Incepta, Par and Impax with the FDA regarding the defendants’ intent to market generic versions of 300mg and 600mg dosage strengths of Gralise prior to the expiration of the Orange Book patents, which includes U.S. Patent Nos.: 6,340,475, 6,488,962, 6,635,280, 6,723,340, 7,438,927 and 7,731,989. We commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving the ANDAs for 30 months or until a district court decision that is adverse to the asserted patents, whichever may occur earlier. The 30-month stays expire in July 2014 and August 2014. If the litigation is still ongoing after expiration of the applicable 30-month stay, the termination of the stay could result in the introduction of one or more products generic to Gralise prior to resolution of the litigation. Any introduction of one or more products generic to Gralise would harm our business, financial condition and results of operations.

 

In April 2012, we received a Paragraph IV certification notice that from Zydus Pharmaceuticals (USA), Inc. (Zydus) advising us of the filing by Zydus of an ANDA for a generic version of Gralise 300mg tablets.  We are currently evaluating the notice. The filing of the Zydus ANDA and the other ANDAs described above, or any other ANDA or similar application in respect to any of our products could have an adverse impact on our stock price. Moreover, if the patents covering our products were not upheld in litigation or if a generic competitor is found not to infringe these patents, the resulting generic competition would have a material adverse effect on our business, results of operations and financial condition.

 

We depend on third parties that are single source suppliers to manufacture Gralise and our product candidates. If these suppliers are unable to manufacture and supply Gralise or our product candidates, our business will suffer.

 

Patheon is our sole supplier for Gralise pursuant to a manufacturing and supply agreement we entered into with Patheon in September 2011 and our sole supplier of Serada. We do not have, and we do not intend to establish in the foreseeable future, internal commercial scale manufacturing capabilities. Rather, we intend to use the facilities of third parties to manufacture products for clinical trials and commercialization. Our dependence on third parties for the manufacture of our products and our product candidates adversely affect our ability to deliver such products on a timely or competitive basis, if at all. Any failure to obtain Gralise tablets from Patheon, active pharmaceutical ingredient from suppliers, or excipient suppliers, could adversely affect our business, results of operation and financial condition.

 

The manufacturing process for pharmaceutical products is highly regulated and regulators may shut down manufacturing facilities that they believe do not comply with regulations. We, our third-party manufacturers and our suppliers are subject to numerous regulations, including current FDA regulations governing manufacturing processes, stability testing, record keeping and quality standards. Similar regulations are in effect in other countries. Our third-party manufacturers and suppliers are independent entities who are subject to their own unique operational and financial risks which are out of our control. If we or any of these third-party manufacturers or suppliers fail to perform as required or fail to comply with the regulations of the FDA and other applicable governmental authorities, our ability to deliver our products on a timely basis or receive royalties or continue our clinical trials would be adversely affected. The manufacturing processes of our third party manufacturers and suppliers may also be found to violate the proprietary rights of others. To the extent these risks materialize and adversely affect their performance obligations to us, and we are unable to contract for a sufficient supply of required products on acceptable terms, or if we encounter delays and difficulties in our relationships with manufacturers or suppliers, our business, results of operation and financial condition would be adversely affected.

 

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Our collaborative arrangements may give rise to disputes over commercial terms, contract interpretation and ownership of our intellectual property and may adversely affect the commercial success of our products.

 

We currently have collaboration or license arrangements with Santarus, Covidien, Merck, Janssen, Boehringer Ingelheim, Ironwood and PharmaNova. In addition, we have in the past and may in the future enter into other collaborative arrangements, some of which have been based on less definitive agreements, such as memoranda of understanding, material transfer agreements, options or feasibility agreements. We may not execute definitive agreements formalizing these arrangements.

 

Collaborative relationships are generally complex and may give rise to disputes regarding the relative rights, obligations and revenues of the parties, including the ownership of intellectual property and associated rights and obligations, especially when the applicable collaborative provisions have not been fully negotiated and documented. Such disputes can delay collaborative research, development or commercialization of potential products, and can lead to lengthy, expensive litigation or arbitration. The terms of collaborative arrangements may also limit or preclude us from developing products or technologies developed pursuant to such collaborations. Additionally, the collaborators under these arrangements might breach the terms of their respective agreements or fail to prevent infringement of the licensed patents by third parties. Moreover, negotiating collaborative arrangements often takes considerably longer to conclude than the parties initially anticipate, which could cause us to enter into less favorable agreement terms that delay or defer recovery of our development costs and reduce the funding available to support key programs.

 

We may be unable to enter into future collaborative arrangements on acceptable terms, which could harm our ability to develop and commercialize our current and potential future products and technologies. Other factors relating to collaborations that may adversely affect the commercial success of our products include:

 

·                   any parallel development by a collaborative partner of competitive technologies or products;

·                   arrangements with collaborative partners that limit or preclude us from developing products or technologies;

·                   premature termination of a collaboration agreement; or

·                   failure by a collaborative partner to devote sufficient resources to the development and commercial sales of products using our current and potential future products and technologies.

 

Our collaborative arrangements do not necessarily restrict our collaborative partners from competing with us or restrict their ability to market or sell competitive products. Our current and any future collaborative partners may pursue existing or other development-stage products or alternative technologies in preference to those being developed in collaboration with us. Our collaborative partners may also terminate their collaborative relationships with us or otherwise decide not to proceed with development and commercialization of our products.

 

If we do not obtain orphan drug exclusivity for Gralise in PHN, our business could suffer.

 

The FDA has granted Gralise Orphan Drug designation for the management of PHN based on a plausible hypothesis that Gralise is “clinically superior” to immediate release gabapentin as contemplated by the FDA’s regulations related to Orphan drug designation and exclusivity. Generally, an Orphan-designated drug approved for marketing is eligible for seven years of regulatory exclusivity for the orphan-designated indication. If the FDA grants Orphan Drug exclusivity for Gralise, the FDA may not approve another application to market the same drug for the same indication until January 2018, except in very limited circumstances. However, the FDA has not yet granted Orphan Drug exclusivity for Gralise pending its determination whether Gralise meets applicable clinical superiority requirements.

 

We believe a showing of clinical superiority is not required under the statute and regulations related to Orphan Drugs in effect at the time of Gralise’s Orphan Drug designation and approval. We also believe amendments to the FDA’s Orphan Drug regulations proposed in October 2011 do not apply to our pending request to grant Orphan Drug exclusivity for Gralise. According to the FDA, the proposed amendments are intended to clarify certain provisions of the regulations and make minor improvements to address issues that have arisen since the regulations were issued. If adopted as proposed, it is possible the amendments will adversely affect our request for Orphan Drug exclusivity for Gralise.

 

The FDA may not grant Gralise orphan exclusivity in PHN. If we do not obtain orphan exclusivity for Gralise, the period of market exclusivity in the United States for Gralise may be reduced, which would adversely affect our business, results of operations and financial condition.

 

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Pharmaceutical marketing is subject to substantial regulation in the United States and any failure by us or our collaborative partners to comply with applicable statutes or regulations could adversely affect our business.

 

All marketing activities associated with Gralise and Glumetza, as well as marketing activities related to any other products for which we obtain regulatory approval, will be subject to numerous federal and state laws governing the marketing and promotion of pharmaceutical products. The FDA regulates post-approval promotional labeling and advertising to ensure that they conform to statutory and regulatory requirements. In addition to FDA restrictions, the marketing of prescription drugs is subject to laws and regulations prohibiting fraud and abuse under government healthcare programs. For example, the federal healthcare program anti-kickback statute prohibits giving things of value to induce the prescribing or purchase of products that are reimbursed by federal healthcare programs, such as Medicare and Medicaid. In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government. Under this law, the federal government in recent years has brought claims against drug manufacturers alleging that certain marketing activities caused false claims for prescription drugs to be submitted to federal programs. Many states have similar statutes or regulations, which apply to items and services reimbursed under Medicaid and other state programs, or, in some states, regardless of the payer. If we, or our collaborative partners, fail to comply with applicable FDA regulations or other laws or regulations relating to the marketing of our products, we could be subject to criminal prosecution, civil penalties, seizure of products, injunction, and exclusion of our products from reimbursement under government programs, as well as other regulatory actions against our product candidates, our collaborative partners or us.

 

We may incur significant liability if it is determined that we are promoting or have in the past promoted the “off-label” use of drugs.

 

Companies may not promote drugs for “off-label” uses—that is, uses that are not described in the product’s labeling and that differ from those approved by the FDA. Physicians may prescribe drug products for off-label uses, and such off-label uses are common across some medical specialties. Although the FDA and other regulatory agencies do not regulate a physician’s choice of treatments, the FDCA and FDA regulations restrict communications on the subject of off-label uses of drug products by pharmaceutical companies. The Office of Inspector General of the Department of Health and Human Services (OIG), the FDA, and the Department of Justice (DOJ) all actively enforce laws and regulations prohibiting promotion of off-label uses and the promotion of products for which marketing clearance has not been obtained. A company that is found to have improperly promoted off-label uses may be subject to significant liability, including civil and administrative remedies as well as criminal sanctions.

 

Notwithstanding the regulatory restrictions on off-label promotion, the OIG, the FDA, and DOJ allow companies to engage in truthful, non-misleading, and non-promotional speech concerning their products. If the OIG or the FDA takes the position that we are not in compliance with such requirements, and, if such non-compliance is proven, we may be subject to significant liability, including civil and administrative remedies, as well as criminal sanctions. In addition, management’s attention could be diverted from our business operations and our reputation could be damaged.

 

If we or our marketing partners are unable to obtain acceptable prices or adequate reimbursement for our products from third-party payers, our business will suffer.

 

In both domestic and foreign markets, sales of our products and product candidates will depend in part on the availability of adequate reimbursement from third-party payers such as:

 

·                   government health administration authorities;

·                   private health insurers;

·                   health maintenance organizations;

·                   pharmacy benefit management companies; and

·                   other healthcare-related organizations.

 

If reimbursement is not available for our products or product candidates, demand for these products may be limited. Further, any delay in receiving approval for reimbursement from third-party payers could have an adverse effect on our future revenues. Third-party payers are increasingly challenging the price and cost-effectiveness of medical products and services. Significant uncertainty exists as to the reimbursement status of newly approved healthcare products, including pharmaceuticals. Our products may not be considered cost effective, and adequate third-party reimbursement may be unavailable to enable us to maintain price levels sufficient to realize an acceptable return on our investment.

 

Federal and state governments in the United States and foreign governments continue to propose and pass new legislation designed to contain or reduce the cost of healthcare. Existing regulations affecting pricing may also change before many of our product candidates are approved for marketing. Cost control initiatives could decrease the price that we receive for our products and any product that we may develop.

 

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We may be unable to compete successfully in the pharmaceutical product and drug delivery technology industries.

 

Other companies that have oral drug delivery technologies competitive with our Acuform technology include Elan Corporation, Bristol-Myers Squibb, TEVA Pharmaceutical Industries, Ltd., Johnson & Johnson, SkyePharma plc, Flamel Technologies S.A., Ranbaxy Laboratories, Ltd. and Intec Pharma, all of which develop oral tablet products designed to release the incorporated drugs over time. Each of these companies has patented technologies with attributes different from ours, and in some cases with different sites of delivery to the gastrointestinal tract.

 

Bristol-Myers Squibb is currently marketing a sustained release formulation of metformin, Glucophage XR, with which Glumetza competes. The limited license that Bristol-Myers Squibb obtained from us under our November 2002 settlement agreement extends to certain current and internally-developed future compounds, which may increase the likelihood that we will face competition from Bristol-Myers Squibb in the future on products in addition to Glumetza. Several other companies, including Barr Pharmaceuticals, Inc., Mylan Laboratories, Inc. and Teva Pharmaceutical Industries, Ltd. have received FDA approval for and are selling an extended-release metformin product. There may be other companies developing products competitive with Glumetza of which we are unaware.

 

Gabapentin is currently marketed by Pfizer as Neurontin® for adjunctive therapy for epileptic seizures and for postherpetic pain. Pfizer’s basic U.S. patents relating to Neurontin have expired, and numerous companies have received approval to market generic versions of the immediate release product. Pfizer has also developed Lyrica® (pregabalin), which has been approved for marketing in the United States for postherpetic pain, fibromyalgia, diabetic nerve pain and for adjunctive therapy for epileptic seizures. In August 2011, GlaxoSmithKline and Xenoport, Inc. submitted a supplemental NDA for Horizant TM  (gabapentin enacarbil extended-release tablets) for the management of PHN. There may be other companies developing products competitive with Gralise of which we are unaware.

 

Competition in pharmaceutical products and drug delivery systems is intense. We expect competition to increase. Competing technologies or products developed in the future may prove superior to the Acuform technology or products using the Acuform technology, either generally or in particular market segments. These developments could make the Acuform technology or products using the Acuform technology noncompetitive or obsolete.

 

Most of our principal competitors have substantially greater financial, sales, marketing, personnel and research and development resources than we do. In addition, many of our potential collaborative partners have devoted, and continue to devote, significant resources to the development of their own drug products, drug candidates and drug delivery systems and technologies.

 

Our prior clinical trials evaluating Serada for menopausal hot flashes failed to meet all of their primary endpoints, and we cannot be certain that this product will be approved for marketing. The development of drug candidates is inherently difficult and uncertain and we cannot be certain that any of our product candidates will be approved for marketing or, if approved, will achieve market acceptance.

 

Each of our three Phase 3 trials evaluating Serada for menopausal hot flashes, including our Phase 3 trial known as Breeze 3, failed to meet all of their primary endpoints. Although we have discussed the results of our Serada trials with the FDA and intend to submit a New Drug Application for Serada in the second half of 2012, we cannot be certain that the FDA will accept the New Drug Application for filing. In the event the FDA accepts a New Drug Application for Serada for filing, we cannot be certain that the New Drug Application will be approved.

 

Clinical development is a long, expensive and uncertain process and is subject to delays and failures. Our own product candidates and those of our collaborative partners are subject to the risk that any or all of them may be found to be ineffective or unsafe, or otherwise may fail to receive necessary regulatory clearances. Positive or encouraging results of prior clinical trial are not necessarily indicative of the results obtained in later clinical trials, as was the case with the Phase 3 trial for Gralise for the management of PHN that we completed in 2007, and with the Phase 3 trials evaluating Serada for menopausal hot flashes, the last of which we completed in October 2011. In addition, data obtained from pivotal clinical trials are susceptible to varying interpretations, which could delay, limit or prevent regulatory approval.

 

Many other factors could delay or result in termination of our clinical trials, including:

 

·                   negative or inconclusive results;

·                   patient noncompliance with the protocol;

·                   adverse medical events or side effects among patients during the clinical trials;

·                   FDA inspections of our clinical operations; and

·                   actual or perceived lack of efficacy or safety of the product candidate.

 

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We are unable to predict whether any of our product candidates will receive regulatory clearances or be successfully manufactured or marketed. Further, due to the extended testing and regulatory review process required before marketing clearance can be obtained, the time frame for commercializing a product is long and uncertain. Even if these other product candidates receive regulatory clearance, our products may not achieve or maintain market acceptance. Also, substantially all of our product candidates use the Acuform technology. If it is discovered that the Acuform technology could have adverse effects or other characteristics that indicate it is unlikely to be effective as a delivery system for drugs or therapeutics, our product development efforts and our business could be significantly harmed.

 

Even when or if our products obtain regulatory approval, successful commercialization requires:

 

·                   market acceptance;

·                   cost-effective commercial scale production; and

·                   reimbursement under private or governmental health plans.

 

Any material delay or failure in the governmental approval process and/or the successful commercialization of our potential products could adversely impact our financial position and liquidity.

 

We may be unable to protect our intellectual property and may be liable for infringing the intellectual property of others.

 

Our success will depend in part on our ability to obtain and maintain patent protection for our products and technologies, and to preserve our trade secrets. Our policy is to seek to protect our proprietary rights, by, among other methods, filing patent applications in the United States and foreign jurisdictions to cover certain aspects of our technology. We hold issued United States patents, and have patent applications pending in the United States. In addition, we are preparing patent applications relating to our expanding technology for filing in the United States and abroad. We have also applied for patents in numerous foreign countries. Some of those countries have granted our applications and other applications are still pending. Our pending patent applications may lack priority over others’ applications or may not result in the issuance of patents. Even if issued, our patents may not be sufficiently broad to provide protection against competitors with similar technologies and may be challenged, invalidated or circumvented, which could limit our ability to stop competitors from marketing related products or may not provide us with competitive advantages against competing products. We also rely on trade secrets and proprietary know-how, which are difficult to protect. We seek to protect such information, in part, through entering into confidentiality agreements with employees, consultants, collaborative partners and others before such persons or entities have access to our proprietary trade secrets and know-how. These confidentiality agreements may not be effective in certain cases, due to, among other things, the lack of an adequate remedy for breach of an agreement or a finding that an agreement is unenforceable. In addition, our trade secrets may otherwise become known or be independently developed by competitors.

 

Our ability to develop our technologies and to make commercial sales of products using our technologies also depends on not infringing others’ patents or other intellectual property rights. We are not aware of any intellectual property claims against us. However, the pharmaceutical industry has experienced extensive litigation regarding patents and other intellectual property rights. Patents issued to third parties relating to sustained release drug formulations or particular pharmaceutical compounds could in the future be asserted against us, although we believe that we do not infringe any valid claim of any patents. If claims concerning any of our products were to arise and it was determined that these products infringe a third party’s proprietary rights, we could be subject to substantial damages for past infringement or be forced to stop or delay our activities with respect to any infringing product, unless we can obtain a license, or we may have to redesign our product so that it does not infringe upon others’ patent rights, which may not be possible or could require substantial funds or time. Such a license may not be available on acceptable terms, or at all. Even if we, our collaborators or our licensors were able to obtain a license, the rights may be nonexclusive, which could give our competitors access to the same intellectual property. In addition, any public announcements related to litigation or interference proceedings initiated or threatened against us, even if such claims are without merit, could cause our stock price to decline.

 

From time to time, we may become aware of activities by third parties that may infringe our patents. Infringement by others of our patents may reduce our market shares (if a related product is approved) and, consequently, our potential future revenues and adversely affect our patent rights if we do not take appropriate enforcement action. We may need to engage in litigation in the future to enforce any patents issued or licensed to us or to determine the scope and validity of third-party proprietary rights. Our issued or licensed patents may not be held valid by a court of competent jurisdiction. Whether or not the outcome of litigation is favorable to us, defending a lawsuit takes significant time, may be expensive and may divert management attention from other business concerns. We may also be required to participate in interference proceedings declared by the United States Patent and Trademark Office for the

 

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purpose of determining the priority of inventions in connection with our patent applications or other parties’ patent applications. Adverse determinations in litigation or interference proceedings could require us to seek licenses which may not be available on commercially reasonable terms, or at all, or subject us to significant liabilities to third parties. If we need but cannot obtain a license, we may be prevented from marketing the affected product.

 

If we are unable to obtain or maintain regulatory approval, we will be limited in our ability to commercialize our products, and our business will suffer.

 

The regulatory process is expensive and time consuming. Even after investing significant time and expenditures on clinical trials, we may not obtain regulatory approval of our product candidates. Data obtained from clinical trials are susceptible to varying interpretations, which could delay, limit or prevent regulatory approval, and the FDA may not agree with our methods of clinical data analysis or our conclusions regarding safety and/or efficacy. Significant clinical trial delays could impair our ability to commercialize our products and could allow our competitors to bring products to market before we do. In addition, changes in regulatory policy for product approval during the period of product development and regulatory agency review of each submitted new application may cause delays or rejections. Even if we receive regulatory approval, this approval may entail limitations on the indicated uses for which we can market a product.

 

For example, the active ingredients in the products utilizing our Acuform delivery technology that are being developed pursuant to our collaboration with Covidien include acetaminophen in combination with opiates. In connection with concerns that consumers may inadvertently take more than the recommended daily dose of acetaminophen, potentially causing liver damage, an FDA advisory committee has recommended that prescription products containing acetaminophen in combination with prescription analgesics (including opiates) should include black box warnings and/or be removed from the market. The FDA is evaluating the recommendations and has indicated that such an evaluation will take some time. The FDA is not required to accept advisory committee recommendations. Covidien’s ability or willingness to develop and market the products subject to our collaboration may be adversely affected by actions of the FDA in response to the advisory committee recommendations.

 

Further, with respect to our approved products, once regulatory approval is obtained, a marketed product and its manufacturer are subject to continual review. The discovery of previously unknown problems with a product or manufacturer may result in restrictions on the product, manufacturer or manufacturing facility, including withdrawal of the product from the market. Manufacturers of approved products are also subject to ongoing regulation and inspection, including compliance with FDA regulations governing current Good Manufacturing Practices (cGMP). The FDCA, the Controlled Substances Act and other federal and foreign statutes and regulations govern and influence the testing, manufacturing, packing, labeling, storing, record keeping, safety, approval, advertising, promotion, sale and distribution of our products. The failure to comply with these regulations can result in, among other things, warning letters, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, non-renewal of marketing applications or criminal prosecution.

 

We are also required to report adverse events associated with our products to the FDA and other regulatory authorities. Unexpected or serious health or safety concerns could result in labeling changes, recalls, market withdrawals or other regulatory actions. Recalls may be issued at our discretion or at the discretion of the FDA or other empowered regulatory agencies. For example, in June 2010, we instituted a voluntary class 2 recall of 52 lots of our 500mg Glumetza product after chemical traces of 2,4,6-tribromoanisole (TBA) were found in the product bottle. We cannot be certain that the FDA will determine that we adequately addressed the matters that led to this recall or that the FDA will not seek to impose fines or sanctions against us as a result of this recall.

 

We are subject to risks associated with NDAs submitted under Section 505(b)(2) of the Food, Drug and Cosmetic Act.

 

The products we develop generally are or will be submitted for approval under Section 505(b)(2) of the FDCA which was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984, otherwise known as the Hatch-Waxman Act. Section 505(b)(2) permits the submission of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. For instance, the NDA for Gralise relies on the FDA’s prior approval of Neurontin® (gabapentin), the immediate release formulation of gabapentin initially approved by the FDA. An NDA for Serada would also rely in part on the FDA’s prior approval of Neurontin.

 

For NDAs submitted under Section 505(b)(2) of the FDCA, the patent certification and related provisions of the Hatch-Waxman Act apply. In accordance with the Hatch-Waxman Act, such NDAs may be required to includes certifications, known as “Paragraph IV certifications,” that certify any patents listed in the FDA’s Orange Book publication in respect to any product referenced in the 505(b)(2) application, are invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale of the product that

 

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is the subject of the 505(b)(2) application. Under the Hatch-Waxman Act, the holder of the NDA which the 505(b)(2) application references may file a patent infringement lawsuit after receiving notice of the Paragraph IV certification. Filing of a patent infringement lawsuit triggers a one-time automatic 30-month stay of the FDA’s ability to approve the 505(b)(2) application. Accordingly, we may invest a significant amount of time and expense in the development of one or more products only to be subject to significant delay and patent litigation before such products may be commercialized, if at all. A Section 505(b)(2) application may also not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the referenced product has expired. The FDA may also require us to perform one or more additional clinical studies or measurements to support the change from the approved product. The FDA may then approve the new formulation for all or only some of the indications sought by us. The FDA may also reject our future Section 505(b)(2) submissions and require us to file such submissions under Section 501(b)(1) of the FDCA, which could be considerably more expensive and time consuming. These factors, among others, may limit our ability to successfully commercialize our product candidates.

 

If a product liability claim against us is successful, our business will suffer.

 

Our business involves exposure to potential product liability risks that are inherent in the development and production of pharmaceutical products. We have obtained product liability insurance for clinical trials currently underway and forecasted 2012 sales of our products, but:

 

·                   we may be unable to obtain product liability insurance for future trials;

·                   we may be unable to obtain product liability insurance for future products;

·                   we may be unable to maintain product liability insurance on acceptable terms;

·                   we may be unable to secure increased coverage as the commercialization of the Acuform technology proceeds; or

·                   our insurance may not provide adequate protection against potential liabilities.

 

Our inability to obtain adequate insurance coverage at an acceptable cost could prevent or inhibit the commercialization of our products. Defending a lawsuit could be costly and significantly divert management’s attention from conducting our business. If third parties were to bring a successful product liability claim or series of claims against us for uninsured liabilities or in excess of insured liability limits, our business, financial condition and results of operations could be materially and adversely affected.

 

We depend on clinical investigators and clinical sites to enroll patients in our clinical trials and other third parties to manage the trials and to perform related data collection and analysis, and, as a result, we may face costs and delays outside of our control.

 

We rely on clinical investigators and clinical sites to enroll patients and other third parties to manage our trials and to perform related data collection and analysis. However, we may be unable to control the amount and timing of resources that the clinical sites that conduct the clinical testing may devote to our clinical trials. If our clinical investigators and clinical sites fail to enroll a sufficient number of patients in our clinical trials or fail to enroll them on our planned schedule, we will be unable to complete these trials or to complete them as planned, which could delay or prevent us from obtaining regulatory approvals for our product candidates.

 

Our agreements with clinical investigators and clinical sites for clinical testing and for trial management services place substantial responsibilities on these parties, which could result in delays in, or termination of, our clinical trials if these parties fail to perform as expected. For example, if any of our clinical trial sites fail to comply with FDA-approved good clinical practices, we may be unable to use the data gathered at those sites. If these clinical investigators, clinical sites or other third parties do not carry out their contractual duties or obligations or fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to our clinical protocols or for other reasons, our clinical trials may be extended, delayed or terminated, and we may be unable to obtain regulatory approval for, or successfully commercialize, our product candidates.

 

Our licensed patent covering the use of gabapentin to treat hot flashes associated with menopause is a method-of-use patent, which increases the risk that prescriptions for gabapentin to treat hot flashes in menopausal women could be written for, or filled with, generic gabapentin.

 

We have an exclusive sublicense from PharmaNova, Inc. to a patent held by the University of Rochester to develop and commercialize in the United States a gabapentin product for the treatment of hot flashes associated with menopause. Because a method-of-use patent, such as the patent we have sublicensed from PharmaNova, covers only a specified use of a particular compound, not a particular composition of matter, we cannot prevent others from commercializing gabapentin for other indications for use. Accordingly, physicians can already prescribe another manufacturer’s gabapentin to treat hot flashes in menopausal women, or pharmacists could in the future seek to fill future prescriptions for Serada, if any, with another manufacturer’s gabapentin. Although any such “off-label” use could violate our licensed patent, effectively monitoring compliance with our licensed patent and enforcing our patent rights against individual physicians and pharmacies may be ineffective, impractical, difficult and costly.

 

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In the event the FDA allows us to file and subsequently approves a New Drug Application for Serada based on the results of our three completed Phase 3 clinical trials and we initiate commercial sales of Serada, such competition would reduce any revenues generated by such sales.

 

Our success is dependent in large part upon the continued services of our Chief Executive Officer and senior management with whom we do not have employment agreements.

 

Our success is dependent in large part upon the continued services of our President and Chief Executive Officer, James A. Schoeneck, and other members of our executive management team, and on our ability to attract and retain key management and operating personnel. We do not have agreements with Mr. Schoeneck or any of our other executive officers that provide for their continued employment with us. We may have difficulty filling open senior scientific, financial and commercial positions. Management, scientific and operating personnel are in high demand in our industry and are often subject to competing offers. The loss of the services of one or more members of management or key employees or the inability to hire additional personnel as needed could result in delays in the research, development and commercialization of our products and potential product candidates.

 

If we choose to acquire new and complementary businesses, products or technologies, we may be unable to complete these acquisitions or to successfully integrate them in a cost effective and non-disruptive manner.

 

Our success depends on our ability to continually enhance and broaden our product offerings in response to changing customer demands, competitive pressures and technologies. One element of our business strategy is to actively seek to acquire products or companies, and to in-license or seek co-promotion rights to products that could be sold by our sales force. We have no current commitments with respect to any acquisition, in-licensing or co-promotion. We do not know if we would be able to successfully complete any acquisitions, or whether we would be able to successfully integrate any acquired business, product or technology or retain any key employees. Integrating any business, product or technology we acquire could be expensive and time consuming, disrupt our ongoing business and distract our management. If we were to be unable to integrate any acquired businesses, products or technologies effectively, our business would suffer. In addition, any amortization or charges resulting from the costs of acquisitions could adversely affect our operating results.

 

Our operating results may fluctuate and affect our stock price.

 

The following factors will affect our operating results and may result in a material adverse effect on our stock price:

 

·                   the degree of commercial success of Gralise and Glumetza;

·                   announcements and results regarding clinical trial results and plans for our drug candidates;

·                   filings and other regulatory actions related to our product candidates;

·                   developments concerning proprietary rights, including patents, infringement allegations and litigation matters;

·                   decisions by collaborative partners to proceed or not to proceed with subsequent phases of a collaboration or program;

·                   adverse events related to our products, including recalls;

·                   interruptions of manufacturing or supply, or other manufacture or supply difficulties;

·                   the outcome of our patent infringement litigation against Sun for Glumetza;

·                   the outcome of our patent infringement litigation against filers of abbreviated new drug applications for Gralise;

·                   variations in revenues obtained from collaborative agreements, including milestone payments, royalties, license fees and other contract revenues;

·                   adoption of new technologies by us or our competitors;

·                   the introduction of new products by our competitors;

·                   the status of our compliance with laws and regulations applicable to the commercialization of pharmaceutical products;

·                   any limitations to access to physician prescription data, which may make our marketing efforts more effective;

·                   manufacturing costs;

·                   third-party reimbursement policies; and

·                   the status of our compliance with the provisions of the Sarbanes-Oxley Act of 2002.

 

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As a result of these factors, our stock price may continue to be volatile and investors may be unable to sell their shares at a price equal to, or above, the price paid. Additionally, any significant drops in our stock price, such as the ones we experienced following the announcement of our Serada Phase 3 trial results in October 2009 and October 2011, could give rise to shareholder lawsuits, which are costly and time consuming to defend against and which may adversely affect our ability to raise capital while the suits are pending, even if the suits are ultimately resolved in our favor.

 

We expect to incur operating losses this year and may incur operating losses in the future.

 

To date, we have recorded revenues from license fees, product sales, royalties, collaborative research and development arrangements and feasibility studies. For the three months ended March 31, 2012, we recorded total revenues of $16.8 million and for the three years ended 2011, 2010 and 2009 we recorded total revenues of $133.0 million, $80.8 million and $57.7 million, respectively. Collaborative milestones and settlement fees received from Abbott Products, Janssen and Merck resulted in our reaching profitability of $70.7 million and $3.9 million in 2011 and 2010, respectively. For the year ended December 31, 2009, we incurred a net loss of $22.0 million. We expect to incur operating losses in 2012, and we may incur operating losses in future years. Any such losses may have an adverse impact on our total assets, shareholders’ equity and working capital.

 

Our existing resources may not be sufficient to fund our operations until such time as we may be able to consistently generate sufficient revenues to support our operations.

 

Our existing capital resources may not be sufficient to fund our operations until such time as we may be able to generate sufficient revenues to consistently support our operations. We currently do not have any committed sources of capital. To the extent that our capital resources are insufficient to meet our future capital requirements, in order to continue our operations, we will have to raise additional funds through the sale of our equity securities, through debt financing, or from development and licensing arrangements. We may be unable to raise such additional capital on favorable terms, or at all. If we raise additional capital by selling our equity or convertible debt securities, the issuance of such securities could result in dilution of our shareholders’ equity positions. If adequate funds are not available we may have to:

 

·                   significantly curtail commercialization of our marketed products or other operations;

·                   delay, postpone or terminate clinical trials; and/or

·                   obtain funds through entering into collaboration agreements on unattractive terms.

 

We have implemented certain anti-takeover provisions.

 

Certain provisions of our articles of incorporation and the California General Corporation Law could discourage a third party from acquiring, or make it more difficult for a third party to acquire, control of our company without approval of our board of directors. These provisions could also limit the price that certain investors might be willing to pay in the future for shares of our common stock. Certain provisions allow the board of directors to authorize the issuance of preferred stock with rights superior to those of the common stock. We are also subject to the provisions of Section 1203 of the California General Corporation Law which requires a fairness opinion to be provided to our shareholders in connection with their consideration of any proposed “interested party” reorganization transaction.

 

We have adopted a shareholder rights plan, commonly known as a “poison pill”. The provisions described above, our poison pill and provisions of the California General Corporation Law may discourage, delay or prevent a third party from acquiring us.

 

Increased costs associated with corporate governance compliance may significantly impact our results of operations.

 

Changing laws, regulations and standards relating to corporate governance, public disclosure and compliance practices, including the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, the Sarbanes-Oxley Act of 2002, new SEC regulations and NASDAQ Global Market rules, are creating uncertainty for companies such as ours in understanding and complying with these laws, regulations and standards. As a result of this uncertainty and other factors, devoting the necessary resources to comply with evolving corporate governance and public disclosure standards has resulted in and may in the future result in increased general and administrative expenses and a diversion of management time and attention to compliance activities. We also expect these developments to increase our legal compliance and financial reporting costs. In addition, these developments may make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. Moreover, we may be unable to comply with these new rules and regulations on a timely basis.

 

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These developments could make it more difficult for us to attract and retain qualified members of our board of directors, or qualified executive officers. We are presently evaluating and monitoring regulatory developments and cannot estimate the timing or magnitude of additional costs we may incur as a result. In the event these costs are significant, our selling, general and administrative expenses are likely to increase.

 

If we are unable to satisfy regulatory requirements relating to internal controls, our stock price could suffer.

 

Section 404 of the Sarbanes-Oxley Act of 2002 requires companies to conduct a comprehensive evaluation of their internal control over financial reporting. At the end of each fiscal year, we must perform an evaluation of our internal control over financial reporting, include in our annual report the results of the evaluation, and have our external auditors publicly attest to such evaluation. If material weaknesses were found in our internal controls in the future, if we fail to complete future evaluations on time, or if our external auditors cannot attest to our future evaluations, we could fail to meet our regulatory reporting requirements and be subject to regulatory scrutiny and a loss of public confidence in our internal controls, which could have an adverse effect on our stock price.

 

Business interruptions could limit our ability to operate our business.

 

Our operations are vulnerable to damage or interruption from computer viruses, human error, natural disasters, telecommunications failures, intentional acts of vandalism and similar events. In particular, our corporate headquarters are located in the San Francisco Bay area, which has a history of seismic activity. We have not established a formal disaster recovery plan, and our back-up operations and our business interruption insurance may not be adequate to compensate us for losses that occur. A significant business interruption could result in losses or damages incurred by us and require us to cease or curtail our operations.

 

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

 

Not applicable.

 

ITEM 3.                              DEFAULTS UPON SENIOR SECURITIES

 

Not applicable.

 

ITEM 4.                              MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5.                              OTHER INFORMATION

 

Not applicable.

 

ITEM 6.                              EXHIBITS

 

(a)

Exhibits

 

 

 

10.1

 

Lease Agreement dated April 4, 2012 between the Company and BMR-Pacific Research Center LP

 

10.2*

 

Settlement and License Agreement dated February 22, 2012 between the Company, Santarus, Inc., and Lupin Pharmaceuticals, Inc.

 

31.1

 

Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of James A. Schoeneck

 

31.2

 

Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of August J. Moretti

 

32.1

 

Certification pursuant to 18 U.S.C. Section 1350 of James A. Schoeneck

 

32.2

 

Certification pursuant to 18 U.S.C. Section 1350 of August J. Moretti

 

101

 

Interactive Data Files pursuant to Rule 405 of Regulation S-T

 


*  Confidential Treatment Requested

 

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Table of Contents

 

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.

 

 

Date: May 8, 2012

DEPOMED, INC.

 

 

 

 

 

/s/ James A. Schoeneck

 

James A. Schoeneck

 

President and Chief Executive Officer

 

 

 

 

 

/s/ August J. Moretti

 

August J. Moretti

 

Chief Financial Officer

 

40


Exhibit 10.1

 

LEASE

 

by and between

 

BMR-PACIFIC RESEARCH CENTER LP,

a Delaware limited partnership

 

and

 

DEPOMED, INC.

a California corporation

 



 

TABLE OF CONTENTS

 

 

 

Page

 

 

 

1.

Lease of Premises

1

2.

Basic Lease Provisions

2

3.

Term

4

4.

Possession and Commencement Date

5

5.

Condition of Premises

7

6.

Rentable Area

8

7.

Rent

9

8.

Intentionally omitted

9

9.

Operating Expenses

9

10.

Taxes on Tenant’s Property

15

11.

Security Deposit

16

12.

Use

19

13.

Rules and Regulations, CC&Rs, Parking Facilities and Common Areas

21

14.

Project Control by Landlord

22

15.

Quiet Enjoyment

24

16.

Utilities and Services

24

17.

Alterations

27

18.

Repairs and Maintenance

29

19.

Liens

31

20.

Estoppel Certificate

31

21.

Hazardous Materials

32

22.

Odors and Exhaust

35

23.

Insurance; Waiver of Subrogation

36

24.

Damage or Destruction

38

25.

Eminent Domain

40

26.

Surrender

41

27.

Holding Over

42

28.

Indemnification and Exculpation

42

29.

Assignment or Subletting

43

30.

Subordination and Attornment

47

31.

Defaults and Remedies

48

32.

Bankruptcy

53

33.

Brokers

53

34.

Definition of Landlord

54

35.

Limitation of Landlord’s Liability

54

36.

Joint and Several Obligations

55

37.

Representations

55

38.

Confidentiality

55

39.

Notices

56

40.

Rooftop Installation Area

56

41.

Miscellaneous

58

42.

Option to Extend Term

60

43.

Expansion Premises

61

44.

Campus Amenities

63

 

i



 

LEASE

 

THIS LEASE (this “ Lease ”) is entered into as of this 4 th  day of April, 2012 (the “ Execution Date ”), by and between BMR-PACIFIC RESEARCH CENTER LP, a Delaware limited partnership (“ Landlord ”), and DEPOMED, INC., a California corporation (“ Tenant ”).

 

RECITALS

 

A.                                    WHEREAS, Landlord owns certain real property (“ Property ”) and the improvements on the Property located at 7999 Gateway Boulevard in Newark, California including the building known as Building No. 7 located thereon (the “ Building ”) in which the Premises (as defined below) are located; and

 

B.                                      WHEREAS, Landlord wishes to lease to Tenant, and Tenant desires to lease from Landlord, certain premises located in the Building, pursuant to the terms and conditions of this Lease, as detailed below.

 

AGREEMENT

 

NOW, THEREFORE, Landlord and Tenant, in consideration of the mutual promises contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, agree as follows:

 

1.                                        Lease of Premises .

 

1.1                                  Landlord hereby leases to Tenant, and Tenant hereby leases from Landlord, that certain portion of the third floor of the Building, as shown on Exhibit A attached hereto including exclusive shafts, cable runs and mechanical spaces (the “ Premises ”), for use by Tenant in accordance with the Permitted Use (as defined below) and no other uses.  The Property and all landscaping, parking facilities, private drives and other improvements and appurtenances related thereto, including, without limitation, the Building, the Amenities Building (as defined below), the nine (9) other buildings currently located on the Property and each additional building that is constructed on the Property (following substantial completion of such building), are hereinafter collectively referred to as the “ Project .”  All portions of the Building that are for the non-exclusive use of the tenants of the Building only, and not the tenants of the Project generally, such as service corridors, elevators, public restrooms, public lobbies and stairways (all to the extent located in the Building), are hereinafter referred to as the “ Building Common Area ”.  All portions of the Project that are for the non-exclusive use of tenants of the Project generally, including, without limitation, driveways, sidewalks, parking areas, landscaped areas, and the amenities building (“ Amenities Building ”) in which Landlord currently provides certain amenities, as more particularly described on Exhibit G attached hereto, including food services, a fitness center and a conference center (“Amenities Building Services”), but excluding the Building Common Area, are hereinafter referred to as the “ Project Common Area .”  The Building Common Area and the Project Common Area are collectively hereinafter referred to as the “ Common Areas .”  The Building is located on a portion of the Project commonly referred to as the “North Campus,” which is that part of the Project to the north of Gateway Boulevard and comprised of the Building and six other buildings commonly referred to as buildings 1, 2, 3, 4, 5 and 6, together with all appurtenances thereto (collectively, the “ North Campus ”).

 



 

2.                                        Basic Lease Provisions .  For convenience of the parties, certain basic provisions of this Lease are set forth herein.  The provisions set forth herein are subject to the remaining terms and conditions of this Lease and are to be interpreted in light of such remaining terms and conditions.

 

2.1                                  This Lease shall take effect upon the Execution Date and, except as specifically otherwise provided within this Lease, each of the provisions hereof shall be binding upon and inure to the benefit of Landlord and Tenant from the date of execution and delivery hereof by all parties hereto.

 

2.2                                  In the definitions below, each current Rentable Area (as defined below) is expressed in rentable square footage.  Rentable Area and “ Tenant’s Pro Rata Shares ” are all subject to adjustment as provided in this Lease.

 

Definition or Provision

 

Means the Following (As of the Term
Commencement Date)

 

Approximate Rentable Area of Premises

 

52,732 square feet

 

Approximate Rentable Area of Building

 

178,047 square feet

 

Approximate Rentable Area of North Campus

 

966,271

 

Approximate Rentable Area of Project

 

1,389,517 square feet

 

Tenant’s Pro Rata Share of Building

 

29.62%

 

Tenant’s Pro Rata Share of North Campus

 

5.46%

 

Tenant’s Pro Rata Share of Project

 

3.80%

 

 


* In the event the Rentable Area of the Premises changes prior to the Term Commencement Date, Landlord and Tenant shall enter into an amendment setting forth the correct Rentable Area and Tenant’s Pro Rata Shares.  In addition, Landlord and Tenant acknowledge that Landlord’s and Tenant’s space plans have not been completed as of the Execution Date, and the parties agree to adjust the Rentable Area of the initial Premises (and to make corresponding changes in the Rentable Area of the Expansion Premises) to the extent required upon finalization of such plans.

 

2.3                                  Initial monthly and annual installments of Base Rent for the Premises (“ Base Rent ”) as of the Term Commencement Date:

 

2



 

Dates

 

Square Feet of
Rentable Area

 

Monthly Base Rent
per Square Foot of
Rentable Area

 

Monthly Base
Rent

 

Annual Base
Rent

 

Months 1-5

 

52,732

 

$

0.00

 

$

0.00

 

N/A

 

Months 6-12

 

52,732

 

$

1.75

 

$

92,281.00

 

$

1,107,372.00

 

Months 13-24

 

52,732

 

$

1.80

 

$

94,917.60

 

$

1,139,011.20

 

Months 25-36

 

52,732

 

$

1.86

 

$

98,081.52

 

$

1,176,978.24

 

Months 37-48

 

52,732

 

$

1.91

 

$

100,718.12

 

$

1,208,617.44

 

Months 49-60

 

52,732

 

$

1.97

 

$

103,882.04

 

$

1,246,584.48

 

Months 61-72

 

52,732

 

$

2.03

 

$

107,045.96

 

$

1,284,551.52

 

Months 73-84

 

52,732

 

$

2.09

 

$

110,209.88

 

$

1,322,518.56

 

Months 85-96

 

52,732

 

$

2.15

 

$

113,373.80

 

$

1,360,485.60

 

Months 97-108

 

52,732

 

$

2.22

 

$

117,065.04

 

$

1,404,780.48

 

Months 108-120

 

52,732

 

$

2.28

 

$

120,228.96

 

$

1,442,747.52

 

 


* In the event the Rentable Area of the Premises changes prior to the Term Commencement Date, Landlord and Tenant shall enter into an amendment setting forth the correct Rentable Area and Base Rent.

 

2.4                                  Term Commencement Date:  December 1, 2012

 

2.5                                  Term Expiration Date:  November 30, 2022

 

2.6                                  Security Deposit:  $320,872.32, subject to adjustment based upon the final Rentable Area of the Premises (based upon the following formula: ([Rentable Area of Premises] x [$1.75] x [3]) + ([Rentable Area of Expansion Premises] x [$1.91] x [3])

 

2.7                                  Permitted Use:  Office and/or laboratory use, and uses ancillary or related to the foregoing, including, server rooms, lunch rooms and wellness rooms, and high density storage areas in each case in conformity with all federal, state, municipal and local laws, codes, ordinances, rules and regulations of Governmental Authorities (as defined below), committees, associations, or other regulatory committees, agencies or governing bodies having jurisdiction over the Premises, the Building, the Property, the Project, Landlord or Tenant, including both statutory and common law and hazardous waste rules and regulations (“ Applicable Laws ”)

 

2.8           Address for Rent Payment:

BMR-Pacific Research Center LP

 

P.O. Box 511231

 

Los Angeles, California 90051-2997

 

 

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2.9                                  Address for Notices to Landlord:                 BMR-Pacific Research Center LP

17190 Bernardo Center Drive

San Diego, California  92128

Attn: Vice President, Real Estate Counsel

 

2.10                            Address for Notices/Invoices to Tenant:                         Prior to Term Commencement:

 

Depomed, Inc.

1360 O’Brien Drive

Menlo Park, California  94025

Attn:  Chief Financial Officer

 

From and after Term Commencement:

 

Depomed, Inc.

7999 Gateway Boulevard, Suite 300

Newark, California  94560

Attn:  Chief Financial Officer

 

2.11                            The following Exhibits are attached hereto and incorporated herein by reference:

 

Exhibit A                                                Premises

Exhibit B                                                  Work Letter

Exhibit B-1                                        Approved Contractors

Exhibit C                                                  Acknowledgement of Term Commencement Date for Expansion Premises

Exhibit D                                                 Form of Additional TI Allowance Acceptance Letter

Exhibit E                                                   Form of Letter of Credit

Exhibit F                                                   Rules and Regulations

Exhibit G                                                  Amenities Building Services

Exhibit H                                                 Tenant’s Personal Property

Exhibit I                                                      Form of Estoppel Certificate

Exhibit J                                                     Expansion Premises

Exhibit K                                                 Hazardous Materials Shed Size and Location

Exhibit L                                                   Building Capacities/Base Building Systems

Exhibit M                                              Rooftop Installation Area

Exhibit N                                                 Landlord Repair Items

 

3.                                        Term .  The actual term of this Lease (as the same may be extended pursuant to Article 42 hereof, and as the same may be earlier terminated in accordance with this Lease, the “ Term ”) shall commence on the Term Commencement Date (as defined in Section 2.3 ) and end on November 30, 2022 (such date, the “ Term Expiration Date ”), subject to earlier termination of this Lease as provided herein.  Failure by Tenant to obtain validation by any medical review board or other similar governmental licensing of the Premises required for the Permitted Use by Tenant shall not serve to extend the Term Commencement Date.  TENANT HEREBY WAIVES THE REQUIREMENTS OF SECTION 1933 OF THE CALIFORNIA CIVIL CODE, AS THE SAME MAY BE AMENDED FROM TIME TO TIME.

 

4



 

3.1                                  Termination Option .  Notwithstanding any provision to the contrary contained in this Lease, Tenant shall have the one-time right to terminate the Lease in its entirety effective as of November 30, 2017 (the “ Termination Date ”) by delivering written notice (the “ Termination Notice ”) to Landlord on or before December 1, 2016.  On or before the Termination Date, Tenant shall deliver to Landlord the “Termination Fee” (as defined below) as consideration for and a condition precedent to such early termination.  The “ Termination Fee ” shall equal the unamortized (as of the Termination Date) amounts (calculated by amortizing the same at eight percent (8%) per annum commencing on the Term Commencement Date (or, in the case of the Expansion Premises, commencing as of the Expansion Premises Term Commencement Date), and continuing thereafter for a period of time equal to one hundred twenty (120) months (or, in the case of the Expansion Premises, the amount of months remaining in the Term)) of (a) in the case of the Premises, (i) the Base TI Allowance actually used by Tenant and (ii) the Additional TI Allowance actually used by Tenant in connection with the Premises, (b) in the case of the Expansion Premises, the Base Expansion TI Allowance actually used by Tenant, (c) any brokers’ commission payable in connection with this Lease, and (d) the five (5) months of abated Base Rent on the initial Premises (calculated at $1.75 per square foot per month).  Subject to Landlord’s timely receipt of the Termination Notice and the Termination Fee, this Lease shall automatically terminate and be of no further force or effect with respect to the Premises as of the Termination Date, and Landlord and Tenant shall be relieved of their respective obligations under this Lease with respect to the Premises from and after the Termination Date, except with respect to those obligations set forth in this Lease that expressly survive the expiration or earlier termination thereof, including the payment by Tenant of all amounts owed by Tenant under this Lease up to and including the Termination Date.  The termination right granted to Tenant under this Article shall automatically terminate and be of no further force or effect in the event that (w) Tenant fails to properly and timely exercise such termination right as set forth in this Article, (x) Tenant assigns, subleases or otherwise Transfers the Premises or any portion thereof by other entities or persons, other than in connection with a Permitted Transfer (or in connection with any sublease approved by Landlord pursuant to Article 29 ), or (y) Tenant’s right to possession of the Premises has previously been terminated.  The termination right granted to Tenant under this Article is personal to the Tenant and any Permitted Transferee, and may not be exercised by any assignee, sublessee or transferee of Tenant’s or a Permitted Transferee’s interest in this Lease.

 

4.                                        Possession and Commencement Date .

 

4.1                                  Landlord shall deliver possession of the Premises to Tenant on the later of (a) the Execution Date and (b) the date in which Landlord receives evidence of Tenant’s insurance (pursuant to Section 4.6 ) and the Security Deposit (such date, the “ Possession Date ”) for the purpose of constructing the work to be performed by Tenant and described in the Work Letter (the “ Tenant Improvements ”).  During the period beginning on the Possession Date and continuing through the Term Commencement Date, Tenant and its contractors, representatives and agents shall be entitled to enter the Premises, the Building and the Project for the sole purposes of (i) constructing the Tenant Improvements in the Premises and (ii) in Landlord’s sole and absolute discretion, placing personal property in the Premises.  Such access shall include the right to use the loading dock serving the Building and the Building’s parking facilities and elevators.

 

4.2                                  Tenant shall cause the Tenant Improvements to be constructed in the Premises

 

5



 

pursuant to the Work Letter attached hereto as Exhibit B (the “ Work Letter ”).  Tenant shall pay all of the costs and expenses in connection with the construction of the Tenant Improvements, except that Landlord shall make available to Tenant the following allowance amounts:  (a) Six Million Three Hundred Twenty-Seven Thousand Eight Hundred Forty Dollars ($6,327,840) (based upon One Hundred Twenty Dollars ($120.00) per square foot of Rentable Area (as defined below)) (the “ Base TI Allowance ”) plus (b) if properly requested by Tenant pursuant to this Section, Seven Hundred Ninety Thousand Nine Hundred Eighty Dollars ($790,980) (based upon Fifteen Dollars ($15.00) per square foot of Rentable Area) (the “ Additional TI Allowance ”), for a total of Seven Million One Hundred Eighteen Thousand Eight Hundred Twenty Dollars ($7,118,820) (based upon One Hundred Thirty-Five Dollars ($135.00) per square foot of Rentable Area).  The Base TI Allowance, together with the Additional TI Allowance (if properly requested by Tenant pursuant to this Article), shall be referred to herein as the “ TI Allowance .”  Notwithstanding the foregoing, the TI Allowance shall be adjusted based upon the final Rentable Area of the Premises.  The TI Allowance may be applied to the costs of (n) construction, (o) a construction manager reasonably approved by Landlord, (p) space planning, architect, engineering and other related services performed by third parties unaffiliated with Tenant, (q) building permits and other taxes, fees, charges and levies by Governmental Authorities (as defined below) for permits or for inspections of the Tenant Improvements, (r) costs and expenses for construction labor, material, equipment and fixtures, and (s) office/moveable lab furniture, fixtures and equipment (provided that the portion of the TI Allowance applied to costs described in this clause (s) shall not exceed a total of Seven Hundred Twenty-Four Thousand Nine Hundred Ninety-Two Dollars ($724,992) (based upon Twelve Dollars ($12.00) per square foot of Rentable Area of the initial Premises and Expansion Premises); provided , however, such amount shall be adjusted based upon the final Rentable Area of the initial Premises and the Expansion Premises).  In no event shall the TI Allowance be used for (v) the cost of work that is not authorized by the Approved Plans (as defined in the Work Letter) or otherwise approved in writing or deemed approved by Landlord, (w) payments to Tenant or any affiliates of Tenant (other than reimbursements to Tenant for costs incurred in connection with the items described in the immediately preceding sentence), (x) costs resulting from any default by Tenant of its obligations under this Lease or (y) costs that are recoverable by Tenant from a third party (e.g., insurers, warrantors, or tortfeasors).  Tenant shall not be obligated to pay any construction supervision or management fee to Landlord with respect to the Tenant Improvement work (including in connection with Landlord’s review of plans, specifications and drawings).

 

4.3                                  Base Rent shall be increased to include the amount of the Additional TI Allowance disbursed by Landlord in accordance with this Lease at a rate of $0.012 per square foot per month per Dollar of Additional TI Allowance per square foot used.  Tenant shall have until May 31, 2013 (the “ TI Deadline ”), to expend the unused portion of the TI Allowance, after which date Landlord’s obligation to fund such costs shall expire. The amount by which Base Rent shall be increased shall be determined (and Base Rent shall be increased accordingly) as of the Term Commencement Date and, if such determination does not reflect use by Tenant of all of the Additional TI Allowance, shall be determined again as of the TI Deadline, with Tenant paying (on the next succeeding day that Base Rent is due under this Lease (the “ TI True-Up Date ”)) any underpayment of the further adjusted Base Rent for the period beginning on the Term Commencement Date and ending on the TI True-Up Date.

 

6



 

4.4                                  Landlord shall not be obligated to expend any portion of the Additional TI Allowance until Tenant submits to Landlord a duly authorized and executed letter substantially in the form attached hereto as Exhibit D (an “ Additional TI Allowance Request Letter ”), specifying the portion of the Additional TI Allowance that Tenant desires to receive.   In no event shall any unused TI Allowance entitle Tenant to a credit against Rent payable under this Lease.  Tenant shall deliver to Landlord (i) a certificate of occupancy for the Premises suitable for the Permitted Use and (ii) a Certificate of Substantial Completion in the form of the American Institute of Architects document G704, executed by the project architect and the general contractor.

 

4.5                                  Architect/Test Fit Allowance.  Landlord shall pay for two (2) preliminary space plans at Landlord’s sole cost and expense, not to exceed a total of Five Thousand Dollars ($5,000.00) (the “ Test-Fit Allowance ”).  The Test-Fit Allowance shall be separate from and in addition to the TI Allowance.  Should architectural costs and expenses exceed the Test-Fit Allowance, any such architectural fees in excess of the Test-Fit Allowance may be paid out of the TI Allowance.

 

4.6                                  Prior to entering upon the Premises, Tenant shall furnish to Landlord evidence satisfactory to Landlord that insurance coverages required of Tenant under the provisions of Article 23 are in effect, and such entry shall be subject to all the terms and conditions of this Lease other than the payment of Base Rent (as defined below), Operating Expenses (as defined below) and the Property Management Fee (as defined below).

 

4.7                                  Intentionally Deleted.

 

4.8                                  Tenant shall pay for all water, gas, heat, light, power, telephone, internet service, cable television, other telecommunications and other utilities supplied to the Premises for use during Tenant’s construction of the Tenant Improvements and until the Term Commencement Date.  Tenant shall pay all such utility charges (as reasonably determined by Landlord) and the cost to purchase and install any temporary utility meters to measure such utilities, together with any fees, surcharges and taxes thereon for the period beginning on the date that Tenant first accesses the Premises for any reason after the Execution Date.

 

5.                                        Condition of Premises .  Tenant acknowledges that, except as set forth in this Section, neither Landlord nor any agent of Landlord has made any representation or warranty with respect to the condition of the Premises, the Building or the Project, or with respect to the suitability of the Premises, the Building or the Project for the conduct of Tenant’s business.  Tenant acknowledges that (a) it is fully familiar with the condition of the Premises and agrees to take the same in its condition “as is” as of the Execution Date and (b) Landlord shall have no obligation to alter, repair or otherwise prepare the Premises for Tenant’s occupancy or to pay for or construct any improvements to the Premises, except with respect to the Base TI Allowance and, if properly requested by Tenant pursuant to the terms of the Lease, the Additional TI Allowance and the performance of the Landlord Improvements (as defined in the Work Letter).  Tenant’s taking of possession of the Premises shall, except as otherwise agreed to in writing by Landlord and Tenant, and without limiting the obligations of Landlord described in Article 18 , and subject to the remaining provisions of this Section, conclusively establish that the Premises, the Building and the Project were at such time in good, sanitary and satisfactory condition and repair.

 

7



 

Notwithstanding the foregoing, Landlord shall, at its sole cost and expense and in accordance with Exhibit B , construct and deliver the following improvements consistent with improvements to other multi-tenant buildings in the Project, to the Building Common Area, in order to support multi-tenanting the Building: (m) a common lobby on the first (1 st ) floor of the Building, (n) lobby and suite directional signage, (o) utility meters for the Building Common Area and (p) a service elevator.  As of the Term Commencement Date, (y) the Building Common Area shall be compliance with all Applicable Laws, including the ADA, and (z) all base Building systems set forth on Exhibit L attached hereto shall be in good working order and condition.  In addition, Landlord shall, at its sole cost and expense (and not as an Operating Expense), perform the repairs identified in Exhibit N .  In the event any base Building systems set forth on Exhibit L require replacement (as reasonably determined by Landlord and for reasons other than those caused by Tenant) during the initial twelve (12) months of the Term, Landlord, at its sole cost and expense (and not as an Operating Expense), shall make such replacements ( provided , however, that any ordinary repair and maintenance costs of such base Building systems shall be included as an Operating Expense).

 

6.                                        Rentable Area.

 

6.1                                  The term “ Rentable Area ” shall reflect such areas as reasonably calculated by Landlord’s architect, as the same may be reasonably adjusted from time to time by Landlord in consultation with Landlord’s architect to reflect changes to the Premises, the Building or the Project, as applicable.

 

6.2                                  The Rentable Area of the Building is generally determined by making separate calculations of Rentable Area applicable to each floor within the Building and totaling the Rentable Area of all floors within the Building.  The Rentable Area of a floor is computed by measuring to the outside finished surface of the permanent outer Building walls.  The full area calculated as previously set forth is included as Rentable Area, without deduction for columns and projections or vertical penetrations, including stairs, elevator shafts, flues, pipe shafts, vertical ducts and the like, as well as such items’ enclosing walls.

 

6.3                                  The term “ Rentable Area ,” when applied to the Premises, is that area equal to the usable area of the Premises, plus an equitable allocation of Rentable Area within the Building that is not then utilized or expected to be utilized as usable area, including that portion of the Building devoted to corridors, equipment rooms, restrooms, elevator lobby, atrium and mailroom.

 

6.4                                  The Rentable Area of the Project is the total Rentable Area of all buildings within the Project.

 

6.5                                  Review of allocations of Rentable Areas as between tenants of the Building and the Project shall be made as frequently as Landlord deems appropriate, provided any reallocation shall represent an equitable apportionment as between tenants of the Building and the Project.  Landlord shall notify (verbal notification shall be acceptable) Tenant of any adjustments in the allocation of Rentable Areas affecting Tenant’s Pro Rata Share and, prior to implementing any such modifications with respect to Tenant, Landlord shall meet with Tenant (and Tenant shall not unreasonably withhold, condition or delay such meeting) in good faith to explain and discuss

 

8



 

such modifications.  If Tenant objects in good faith that any reallocation is inequitable, Landlord and Tenant shall endeavor in good faith to resolve such objection, but Tenant shall continue to pay Rent in accordance with such reallocation until Landlord and Tenant resolve such objection.  Tenant shall not have the right to object to the calculation of the Rentable Area if the calculations are certified by a licensed architect as being correct, but the foregoing shall not prevent Tenant from challenging, in good faith, any such allocations as inequitable as provided above.

 

 

7.                                        Rent .

 

7.1                                  Tenant shall pay to Landlord as Base Rent for the Premises, commencing on the Term Commencement Date, the sums set forth in Section 2.3 .  Base Rent shall be paid in equal monthly installments as set forth in Section 2.3 , each in advance on the first day of each and every calendar month during the Term.

 

7.2                                  In addition to Base Rent, but subject to Section 9.5 , Tenant shall pay to Landlord as additional rent (“ Additional Rent ”) at times hereinafter specified in this Lease (a) Tenant’s Share (as defined below) of Operating Expenses (as defined below), (b) the Property Management Fee (as defined below) and (c) any other amounts that Tenant assumes or agrees to pay under the provisions of this Lease that are owed to Landlord, including any and all other sums that may become due by reason of any default of Tenant or failure on Tenant’s part to comply with the agreements, terms, covenants and conditions of this Lease to be performed by Tenant, after notice and the lapse of any applicable cure periods.

 

7.3                                  Base Rent and Additional Rent shall together be denominated “ Rent .”  Rent shall be paid to Landlord, without abatement, deduction or offset, except as expressly provided otherwise in Sections 2.3 and 16.2 , in lawful money of the United States of America at the office of Landlord as set forth in Section 2.8 or to such other person or at such other place as Landlord may from time designate in writing.  In the event the Term commences or ends on a day other than the first day of a calendar month, then the Rent for such fraction of a month shall be prorated for such period on the basis of a thirty (30) day month and shall be paid at the then-current rate for such fractional month.

 

8.                                        Intentionally omitted .

 

9.                                        Operating Expenses .

 

9.1                                  As used herein, the term “ Operating Expenses ” shall include the following costs and expenses incurred by Landlord in connection with the ownership and operation of the Project:

 

(a)                                   Government impositions, including property tax costs consisting of real and personal property taxes and assessments (including amounts due under any improvement bond upon the Building or the Project (including the parcel or parcels of real property upon which the Building, the other buildings in the Project and areas serving the Building and the Project are located)) or assessments in lieu thereof imposed by any federal, state, regional, local or municipal governmental authority, agency or subdivision (each, a “Governmental Authority”); taxes on or measured by gross rentals received from the rental of space in the Project; taxes based on the square footage of the Premises, the Building or the Project, as well as any parking

 

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charges, utilities surcharges or any other costs levied, assessed or imposed by, or at the direction of, or resulting from Applicable Laws or interpretations thereof, promulgated by any Governmental Authority in connection with the use or occupancy of the Project or the parking facilities serving the Project; taxes on this transaction or any document to which Tenant is a party creating or transferring an interest in the Premises; any fee for a business license to operate an office building; and any expenses, including the reasonable cost of attorneys or experts, reasonably incurred by Landlord in seeking reduction by the taxing authority of the applicable taxes, less tax refunds obtained as a result of an application for review thereof.  Notwithstanding the foregoing, Operating Expenses shall not include (i) any federal or state income taxes, franchise taxes, capital stock, estate or inheritance taxes or taxes that are the personal obligation of Tenant or of another tenant of the Project, including taxes on the personal property of Tenant or other tenants of the Project or (ii) any transfer taxes imposed in connection with any transfer by Landlord of the ownership of the Project or any portion thereof or any interest therein; and

 

(b)                                  All other costs of any kind paid or incurred by Landlord in connection with the operation or maintenance of the Building and the Project (including, the Building Common Area and the Project Common Area (including the Amenities Building, which shall include (i) Project office rent (at market rates) for a commercially reasonably amount of space, to the extent an office used for Project operations is maintained at the Project, plus customary expenses for such office and (ii) fair market rent for the portion of the Amenities Building used in providing the Amenities Building Services)); costs of repairs and replacements to improvements within the Building, Building Common Area, Project Common Areas, North Campus or the Project as a whole as appropriate to maintain the such areas as required hereunder (but excluding the cost of alterations attributable solely to other tenants of the Project); costs of utilities furnished to the Common Areas; sewer fees; cable television; trash collection; cleaning, including windows; heating; ventilation; air-conditioning; maintenance of landscaping and grounds; maintenance of drives and parking areas; maintenance of the roof; security services and devices; building supplies; maintenance or replacement of equipment utilized for operation and maintenance of the Building, Building Common Area, Project Common Areas, North Campus or the Project as a whole; license, permit and inspection fees; sales, use and excise taxes on goods and services purchased by Landlord in connection with the operation, maintenance or repair of the systems and equipment of the Building, Building Common Area, Project Common Areas, North Campus or the Project as a whole; telephone, postage, stationery supplies and other expenses incurred in connection with the operation, maintenance or repair of the Building, Building Common Area, Project Common Areas, North Campus or the Project as a whole; accounting, legal and other professional fees and expenses incurred in connection with the Building, Building Common Area, Project Common Areas, North Campus or the Project as a whole; costs of furniture, draperies, carpeting, landscaping and other customary and ordinary items of personal property provided by Landlord for use in Common Areas or in the Project office; capital expenditures incurred (i) in replacing obsolete equipment, (ii) for the primary purpose of reducing Operating Expenses or (iii) required by any Governmental Authority to comply with changes in Applicable Laws that take effect after the Execution Date or to ensure continued compliance with Applicable Laws in effect as of the Execution Date (collectively, “ Permitted Capital Expenditures ”), in each case amortized over the useful life thereof, as reasonably determined by Landlord, in accordance with generally accepted accounting principles; costs of complying with Applicable Laws that are first enacted or first made applicable to the Project after the Term Commencement Date (and excluding such costs incurred

 

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to remedy non-compliance as of the Term Commencement Date with Applicable Laws); costs to keep the Project in compliance with, or fees otherwise required under, any CC&Rs (as defined below) (including the costs of funding reasonable reserves as may be permitted by the CC&Rs to provide for future repairs and replacements), but excluding costs incurred to remedy non-compliance as of the Term Commencement Date with the CC&Rs; insurance premiums, including premiums for public liability, property casualty, earthquake, terrorism and environmental coverages; the cost of any commercially reasonable deductible paid by Landlord with respect to any insured loss pursuant to the terms of insurance policies; service contracts; costs of services of independent contractors retained to do work of a nature referenced above; and costs of compensation (including employment taxes and fringe benefits) of all persons who perform regular and recurring duties connected with the day-to-day operation and maintenance of the Project, its equipment, the adjacent walks, landscaped areas, drives and parking areas, including janitors, floor waxers, window washers, watchmen, gardeners, sweepers and handymen (provided that such costs for personnel not exclusively engaged in the management of the Project but who work on the Project and other projects shall be equitably allocated among the Project and all such projects in proportion to their time spent in performing services for the Project and such other projects).

 

(c)                                   Notwithstanding the foregoing, Operating Expenses shall not include any leasing commissions; expenses that relate to preparation of rental space for a tenant, including completing, fixturing, furnishing, renovating or otherwise improving, decorating or redecorating space for a tenant, or vacant, leasable space in the Project, including space planning and interior design fees for same, “tap” fees allocated to a specific tenant, inspection costs incurred with respect to the installation of tenant improvements, tenant allowances and other tenant concessions; advertising, marketing, promotional and entertainment expenses (including vendor and tenant relation programs); construction clean-up and disposal costs; expenses in connection with services or benefits which are provided to another tenant or occupant of the Project but are not offered to Tenant (whether or not such other tenant or occupant is charged therefor); any gifts provided to any entity whatsoever (including Tenant); any entertainment expenses including “above-standard” cleaning associated with parties or events; expenses of initial development and construction (including the Landlord Improvements), including grading, paving, landscaping and decorating; legal expenses (including attorneys’ fees and court costs) relating to tenants of the Project (other than Tenant), including legal expenses incurred by Landlord or its agents in connection with the negotiation of leases with prospective tenants and occupants of the Project (other than Tenant), and legal expenses incurred in connection with disputes and enforcement of any leases with tenants of the Project (other than Tenant); costs of repairs to the extent reimbursed by payment of insurance proceeds received by Landlord (or proceeds that would have been received by Landlord if Landlord had maintained the insurance required under this Lease) or payment otherwise received from a tenant or other third party, including costs covered by and reimbursed under any contractor, manufacturer or supplier warranty or service contract; costs incurred to comply with Applicable Laws relating to the removal of Hazardous Materials (as defined in Article 21 below) or to remove, remedy, treat or contain any Hazardous Material to the extent such costs (w) result from Landlord’s gross negligence or willful misconduct, (x) resulted from Hazardous Materials that are placed on, or released into the Project by Tenant, or are otherwise made Tenant’s responsibility pursuant to Article 21 , (in which case Tenant shall be responsible for such costs in accordance with Article 21 ) or another tenant at the Project; (y) resulted from Hazardous Materials which existed in the Building or on the Property prior to the

 

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Execution Date and (z) as to any other Hazardous Materials-related costs not described in (w), (x) or (y), Landlord will first exhaust any available insurance proceeds and use good faith and commercially reasonable efforts (short of litigation) to pursue any third parties for reimbursement of any such costs prior to including such amounts in Operating Expenses; payments of principal, finance charges or interest upon loans to Landlord or secured by a mortgage or deed of trust covering the Project or a portion thereof or on any other debt of Landlord ( provided that interest upon a government assessment or improvement bond payable in installments shall constitute an Operating Expense under Subsection 9.1(a) ); payments under any ground lease; tax penalties incurred as a result of Landlord’s gross negligence or inability or unwillingness to make payments and/or to file any tax or informational returns when due; costs arising solely from the gross negligence or willful misconduct of Landlord, its employees or agents; costs or expenses (i.e., fines, penalties and legal fees) incurred due to Landlord’s default of this Lease or any other lease at the Project, or Landlord’s willful violation of any Applicable Law; costs of charitable or political contributions; costs for procurement, installation or removal of sculpture, paintings or other works of art; amounts with respect to the general corporate overhead and general administrative expenses (except as otherwise permitted in this Article) of Landlord or its affiliates, including salaries of executive officers of Landlord and any other employees of Landlord above the level of senior property manager; a property management fee other than the Property Management Fee (as defined below); costs associated with the operation of the business of the partnership as distinguished from the costs of operation of the Project; depreciation claimed by Landlord for tax purposes ( provided that this exclusion of depreciation is not intended to delete from Operating Expenses actual costs of repairs and replacements and reasonable reserves in regard thereto that are provided for in Subsection 9.1(b) ); capital expenditures other than Permitted Capital Expenditures; services, items and benefits for which Tenant or any other tenant or occupant of the Project is specifically obligated to (or does) reimburse Landlord (except such costs reimbursed as operating expenses pursuant to a lease provision similar to this Section 9.1 ); costs or fees relating to the defense of Landlord’s title to or interest in the Project, or any part thereof; and taxes that are excluded from Operating Expenses by the last sentence of Subsection 9.1(a) .  To the extent that Tenant uses more than Tenant’s Pro Rata Share of any item of Operating Expenses, Tenant shall pay Landlord for such excess in addition to Tenant’s obligation to pay Tenant’s Pro Rata Share of Operating Expenses (such excess, together with Tenant’s Pro Rata Share, “ Tenant’s Share ”).

 

9.2                                  From and after the Term Commencement Date, except as otherwise provided in Section 9.5, Tenant shall pay to Landlord on the first day of each calendar month of the Term, as Additional Rent, (a) the Property Management Fee (as defined below) and (b) Landlord’s estimate of Tenant’s Share of Operating Expenses with respect to the Building, the North Campus and the Project, as applicable, for such month.  For purposes of determining the estimated amount payable each month by Tenant pursuant to clause (b) above, Landlord shall endeavor to provide Tenant (within sixty (60) days after the commencement of each calendar year during the Term) a statement of Landlord’s estimate of Tenant’s Share of annual Operating Expenses for such calendar year.  Prior to receiving such estimate of annual Operating Expenses, Tenant shall continue to pay Operating Expenses based upon the previous estimate of annual Operating Expenses.

 

(a)                                   The “ Property Management Fee ” shall equal three percent (3%) of Base Rent due from Tenant.  Tenant shall pay the Property Management Fee in accordance with

 

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Section 9.2 with respect to the entire Term, including any extensions thereof or any holdover periods, regardless of whether Tenant is obligated to pay Base Rent, Operating Expenses or any other Rent with respect to any such period or portion thereof; provided , however, that Tenant shall not be required to pay the Property Management Fee for the first five (5) months of the Term.

 

(b)                                  Within ninety (90) days after the conclusion of each calendar year (or such longer period as may be reasonably required by Landlord), Landlord shall furnish to Tenant a statement showing in reasonable detail the actual Operating Expenses and Tenant’s Share of Operating Expenses for the previous calendar year.  Any additional sum due from Tenant to Landlord shall be due and payable within ten (10) days following written invoice from Landlord (subject to Tenant’s audit rights set forth in Section 9.4 ).  If the amounts paid by Tenant pursuant to this Section exceed Tenant’s Share of Operating Expenses for the previous calendar year, then Landlord shall credit the difference against the Rent next due and owing from Tenant; provided that, if the Lease term has expired, Landlord shall accompany said statement with payment for the amount of such difference.  Notwithstanding anything herein to the contrary, beginning with calendar year 2014, any annual increase in Tenant’s Share of Operating Expenses (excluding taxes and insurance) shall be limited to no greater than a four percent (4%) per annum increase over the amount charged as Tenant’s Share of Operating Expenses (excluding taxes and insurance) for the prior calendar year.

 

(c)                                   Any amount due under this Section for any period that is less than a full month shall be prorated (based on a thirty (30)-day month) for such fractional month.

 

9.3                                  Landlord may, from time to time, modify Landlord’s calculation and allocation procedures for Operating Expenses, so long as such modifications produce Dollar results substantially consistent with Landlord’s then-current practice at the Project and are consistently and uniformly (on a proportionate basis) applied to all tenants of the Project in a reasonable, non-discriminatory manner.  Since the Project consists of multiple buildings, certain Operating Expenses may pertain to a particular building(s), certain Operating Expenses may pertain to the North Campus and other Operating Expenses to the Project as a whole.  Landlord reserves the right in its reasonable discretion to allocate any such costs applicable to any particular building within the Project to such building, any such costs applicable to the North Campus to each building in the North Campus (including the Building) and other such costs applicable to the Project to each building in the Project (including the Building), with the tenants in each building being responsible for paying their respective proportionate shares of their buildings to the extent required under their leases; provided, Landlord shall allocate such costs to the buildings (including the Building) in a reasonable, non-discriminatory manner.  Such allocation shall be binding on Tenant.

 

9.4                                  Landlord’s annual statement shall be final and binding upon Tenant unless Tenant, within sixty (60) days after Tenant’s receipt thereof, shall elect to audit any item therein by giving written notice to Landlord, reasonably describing the items to be audited; provided that Tenant shall in all events pay the amount specified in Landlord’s annual statement, pending the results of the Independent Review and determination of the Accountant(s), as applicable and as each such term is defined below.  If, during such sixty (60) day period, Tenant reasonably and in good faith questions or contests the correctness of Landlord’s statement of Tenant’s Share of

 

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Operating Expenses, Landlord shall provide Tenant with reasonable access to Landlord’s books and records to the extent relevant to determination of Operating Expenses, and such information as Landlord reasonably determines to be responsive to Tenant’s written inquiries.  In the event that, after Tenant’s review of such information, Landlord and Tenant cannot agree upon the amount of Tenant’s Share of Operating Expenses, then Tenant shall have the right to have an independent public accounting firm hired by Tenant on an hourly basis and not on a contingent-fee basis (at Tenant’s sole cost and expense) and approved by Landlord (which approval Landlord shall not unreasonably withhold or delay) audit and review such of Landlord’s books and records for the year in question as directly relate to the determination of Operating Expenses for such year (the “ Independent Review ”).  Landlord shall make such books and records available at the location where Landlord maintains them in the ordinary course of its business.  Landlord need not provide copies of any books or records.  Tenant shall commence the Independent Review within fifteen (15) days after the date Landlord has given Tenant access to Landlord’s books and records for the Independent Review.  Tenant shall complete the Independent Review and notify Landlord in writing of Tenant’s specific objections to Landlord’s calculation of Operating Expenses (including Tenant’s accounting firm’s written statement of the basis, nature and amount of each proposed adjustment) no later than sixty (60) days after Landlord has first given Tenant access to Landlord’s books and records for the Independent Review.  Landlord shall review the results of any such Independent Review.  The parties shall endeavor to agree promptly and reasonably upon Operating Expenses taking into account the results of such Independent Review.  If, as of sixty (60) days after Tenant has submitted the Independent Review to Landlord, the parties have not agreed on the appropriate adjustments to Operating Expenses, then the parties shall engage a mutually agreeable independent third party accountant with at least ten (10) years’ experience in commercial real estate accounting in the Counties of Alameda or San Mateo who has not been retained or engaged by either party during the previous ten (10) years (the “ Accountant ”).  If the parties cannot agree on the Accountant, each shall within ten (10) days after such impasse appoint an Accountant (different from the accountant and accounting firm that conducted the Independent Review) and, within ten (10) days after the appointment of both such Accountants, those two Accountants shall select a third (which cannot be the accountant and accounting firm that conducted the Independent Review).  If either party fails to timely appoint an Accountant, then the Accountant the other party appoints shall be the sole Accountant.  Within ten (10) days after appointment of the Accountant(s), Landlord and Tenant shall each simultaneously give the Accountants (with a copy to the other party) its determination of Operating Expenses, with such supporting data or information as each submitting party determines appropriate.  Within ten (10) days after such submissions, the Accountants shall by majority vote select either Landlord’s or Tenant’s determination of Operating Expenses.  The Accountants may not select or designate any other determination of Operating Expenses.  The determination of the Accountant(s) shall bind the parties.  If the parties agree or the Accountant(s) determine that the Operating Expenses actually paid by Tenant for the calendar year in question exceeded Tenant’s obligations for such calendar year, then Landlord shall, at Tenant’s option, either (a) credit the excess to the next succeeding installments of estimated Additional Rent or (b) pay the excess to Tenant within thirty (30) days after delivery of such results.  If the parties agree or the Accountant(s) determine that Tenant’s payments of Operating Expenses for such calendar year were less than Tenant’s obligation for the calendar year, then Tenant shall pay the deficiency to Landlord within thirty (30) days after delivery of such results.  If the Independent Review reveals or the Accountant(s) determine that the

 

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Operating Expenses billed to Tenant by Landlord and paid by Tenant to Landlord for the applicable calendar year in question exceeded by more than five percent (5%) what Tenant should have been billed during such calendar year, then Landlord shall pay the reasonable cost of the Independent Review and the cost of the Accountant(s).  In all other cases Tenant shall pay the cost of the Independent Review and the Accountant(s).

 

9.5                                  Tenant shall not be responsible for Operating Expenses attributable to the time period prior to the Term Commencement Date; provided , however, that if Tenant substantially completes the Tenant Improvements and occupies the Premises for the conduct of its business prior to the Term Commencement Date, Tenant shall be responsible for Tenant’s Share of Operating Expenses from such earlier date of occupation.  Tenant’s responsibility for Tenant’s Share of Operating Expenses shall continue to the latest of (a) the date of termination of the Lease, (b) the date Tenant has fully vacated the Premises and (c) if termination of the Lease is due to a default by Tenant, the date of rental commencement of a replacement tenant.

 

9.6                                  Operating Expenses for the calendar year in which Tenant’s obligation to share therein commences and for the calendar year in which such obligation ceases shall be prorated on a basis reasonably determined by Landlord.  Expenses such as taxes, assessments and insurance premiums that are incurred for an extended time period shall be prorated based upon the time periods to which they apply so that the amounts attributed to the Premises relate in a reasonable manner to the time period wherein Tenant has an obligation to share in Operating Expenses.

 

9.7                                  Within sixty (60) business days after the end of each calendar month, Tenant shall submit to Landlord an invoice, or, in the event an invoice is not available, an itemized list, of all costs and expenses that (a) Tenant has incurred (either internally or by employing third parties) during the prior month and (b) for which Tenant reasonably believes it is entitled to reimbursements from Landlord pursuant to the terms of this Lease or that Tenant reasonably believes is the responsibility of Landlord pursuant to this Lease or the Work Letter.  The failure to submit such an invoice shall not, in and of itself, result in the waiver of Tenant’s right to reimbursement of such costs and expenses.

 

9.8                                  In the event that less than ninety-five percent (95%) of the Building, North Campus or Project is fully occupied, Tenant acknowledges that Landlord may extrapolate each component of Operating Expenses that vary depending on the occupancy of the Building, North Campus or Project, as applicable, by dividing (a) the total cost of such Operating Expenses by (b) the Rentable Area of the Building, North Campus or Project (as applicable) that is occupied, then multiplying (y) the resulting quotient by (z) ninety-five percent (95%) of the total Rentable Area of the Building, North Campus or Project (as applicable).  Tenant shall pay Tenant’s Share of the product of (y) and (z), subject to adjustment as reasonably determined by Landlord; provided , however, that Landlord shall not recover more than one hundred percent (100%) of Operating Expenses.

 

10.                                  Taxes on Tenant’s Property .

 

10.1                            Tenant shall be responsible for paying (prior to delinquency) any and all taxes levied against any personal property or trade fixtures placed by Tenant in or about the Premises.

 

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For the avoidance of doubt, Tenant shall have the right to contest (by appropriate legal proceedings, diligently pursued and in Tenant’s name only) the imposition or amount of taxes imposed on any personal property or trade fixtures of Tenant placed in or about the Premises or the Project; provided that (a) Tenant shall first make all contested payments, under protest if it desires, (b) the Premises, Building or Project are not in any danger of being sold, forfeited, lost or interfered with, (c) all expenses incurred in connection with such proceedings shall be paid by Tenant and (d) such dispute does not result in a violation of Applicable Laws.

 

10.2                            If any such taxes on Tenant’s personal property or trade fixtures are levied against Landlord or Landlord’s property or, if the assessed valuation of the Building, the Property or the Project is expressly increased by inclusion therein of a value attributable to Tenant’s personal property or trade fixtures, and if Landlord, after written notice to Tenant, pays the taxes based upon any such increase in the assessed value of the Building, the Property or the Project, then Tenant shall, upon demand, repay to Landlord the taxes so paid by Landlord.

 

10.3                            If any improvements in or alterations to the Premises, whether owned by Landlord or Tenant and whether or not affixed to the real property so as to become a part thereof, are assessed for real property tax purposes at a valuation higher than the valuation at which improvements conforming to Landlord’s building standards (the “ Building Standard ”) in other spaces in the Building are assessed, then the real property taxes and assessments levied against Landlord or the Building, the Property or the Project by reason of such excess assessed valuation shall be deemed to be taxes levied against personal property of Tenant and shall be governed by the provisions of Section 10.2 , but only to the extent the applicable taxing authority has made a separate assessment therefor.  Any such excess assessed valuation due to improvements in or alterations to space in the Project leased by other tenants at the Project shall not be included in Operating Expenses.  If the records of the County Assessor are available and sufficiently detailed to serve as a basis for determining whether such Tenant improvements or alterations are assessed at a higher valuation than the Building Standard, then such records shall be binding on both Landlord and Tenant.

 

11.                                  Security Deposit .

 

11.1                            Tenant shall deposit with Landlord on or before the Execution Date the sum set forth in Section 2.6 (the “ Security Deposit ”), which sum shall be held by Landlord as security for the faithful performance by Tenant of all of the terms, covenants and conditions of this Lease to be kept and performed by Tenant during the period commencing on the Execution Date and ending upon the expiration or termination of Tenant’s obligations under this Lease.  If Tenant commits any Default, including any provision relating to the payment of Rent, then Landlord may (but shall not be required to) use, apply or retain all or any part of the Security Deposit for the payment of any Rent or any other sum in default, or to compensate Landlord for any other loss or damage that Landlord may suffer by reason of Tenant’s Default.  If any portion of the Security Deposit is so used or applied, then Tenant shall, within ten (10) days following demand therefor, deposit cash with Landlord in an amount sufficient to restore the Security Deposit to its original amount, and Tenant’s failure to do so shall be a material breach of this Lease.  The provisions of this Article shall survive the expiration or earlier termination of this Lease.  TENANT HEREBY WAIVES THE REQUIREMENTS OF SECTION 1950.7 OF THE CALIFORNIA CIVIL CODE, AS THE SAME MAY BE AMENDED FROM TIME TO TIME.

 

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11.2                            In the event of bankruptcy or other debtor-creditor proceedings against Tenant, the Security Deposit shall be deemed to be applied first to the payment of Rent and other charges due Landlord for all periods prior to the filing of such proceedings.

 

11.3                            Landlord shall deliver to any purchaser of Landlord’s interest in the Premises the funds deposited hereunder by Tenant, and thereupon Landlord shall be discharged from any further liability with respect to such deposit.  This provision shall also apply to any subsequent transfers.

 

11.4                            If Tenant shall fully and faithfully perform every provision of this Lease to be performed by it, then the Security Deposit, or any balance thereof, shall be returned to Tenant (or, at Landlord’s option, to the last assignee of Tenant’s interest hereunder) within thirty (30) days after the expiration or earlier termination of this Lease.

 

11.5                            Intentionally omitted.

 

11.6                            If the Security Deposit shall be in cash, Landlord shall hold the Security Deposit in an account at a banking organization selected by Landlord; provided , however, that Landlord shall not be required to maintain a separate account for the Security Deposit, but may intermingle it with other funds of Landlord.  Landlord shall be entitled to all interest and/or dividends, if any, accruing on the Security Deposit.  Landlord shall not be required to credit Tenant with any interest for any period during which Landlord does not receive interest on the Security Deposit.

 

11.7                            The Security Deposit may be in the form of cash, a letter of credit in the form required by this Section or any other security instrument acceptable to Landlord in its sole discretion.  Tenant may at any time, except when Tenant is in Default (as defined below), deliver a letter of credit (the “ L/C Security ”) as the entire Security Deposit, as follows:

 

(a)                                   If Tenant elects to deliver L/C Security, then Tenant shall provide Landlord, and maintain in full force and effect throughout the Term and until the date that is three (3) months after the then-current Term Expiration Date, a letter of credit in the form of Exhibit E issued by an issuer reasonably satisfactory to Landlord, in the amount of the Security Deposit, with an initial term of at least one year.  Landlord may require the L/C Security to be re-issued by a different issuer at any time during the Term if Landlord reasonably believes that the issuing bank of the L/C Security is or may soon become insolvent; provided, however, Landlord shall return the existing L/C Security to the existing issuer immediately upon receipt of the substitute L/C Security.  If any issuer of the L/C Security shall become insolvent or placed into FDIC receivership, then Tenant shall deliver to Landlord (promptly after becoming aware of such insolvency or receivership, but in no event, later than thirty (30) days after such insolvency or receivership) substitute L/C Security issued by an issuer reasonably satisfactory to Landlord, and otherwise conforming to the requirements set forth in this Article.  As used herein with respect to the issuer of the L/C Security, “insolvent” shall mean the determination of insolvency as made by such issuer’s primary bank regulator ( i.e ., the state bank supervisor for state chartered banks; the OCC or OTS, respectively, for federally chartered banks or thrifts; or the Federal Reserve for its member banks).  In addition, Tenant may, from time to time, replace any L/C Security with new L/C Security satisfying the requirements of this Section, and Landlord shall reasonably cooperate with Tenant’s efforts to do so, including by executing such

 

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instruments as may be reasonably required to evidence the Landlord’s consent to the termination of the replaced L/C Security; provided , however, that Landlord shall not be required execute any such instrument prior to receiving such replacement L/C Security satisfying the requirements of this Section.  If, at the Term Expiration Date, any Rent remains uncalculated or unpaid, then:  (i) Landlord shall with reasonable diligence complete any necessary calculations; (ii) Tenant shall extend the expiry date of such L/C Security from time to time as Landlord reasonably requires; and (iii) in such extended period, Landlord shall not unreasonably refuse to consent to an appropriate reduction of the L/C Security.  Tenant shall reimburse Landlord for its reasonable legal costs in handling Landlord’s acceptance of any replacement or extension L/C Security (not to exceed Two Thousand Dollars ($2,000) per replacement or extension).

 

(b)                                  If Tenant delivers to Landlord satisfactory L/C Security in place of any cash Security Deposit previously delivered, Landlord shall remit to Tenant the cash Security Deposit (or applicable portion thereof) Landlord previously held.

 

(c)                                   Landlord may draw upon the L/C Security, and hold and apply the proceeds in the same manner and for the same purposes as the Security Deposit, if:  (i) an uncured Default (as defined below) exists; (ii) as of the date that is thirty (30) days before any L/C Security expires (even if such scheduled expiry date is after the Term Expiration Date) Tenant has not delivered to Landlord an amendment or replacement for such L/C Security, satisfying the requirements in Subsection 11.7(a) , extending the expiry date to the earlier of (1) three (3) months after the then-current Term Expiration Date or (2) the date one year after the then-current expiry date of the L/C Security; (iii) the L/C Security provides for automatic renewals, Landlord asks the issuer to confirm the current L/C Security expiry date, and the issuer fails to do so within ten (10) business days; (iv) Tenant fails to pay (when and as Landlord reasonably requires) any bank charges for Landlord’s transfer of the L/C Security; or (v) the issuer of the L/C Security ceases, or announces that it will cease, to maintain an office in the city where Landlord may present drafts under the L/C Security (and fails to permit drawing upon the L/C Security by overnight courier or facsimile).  This Section does not limit any other provisions of this Lease allowing Landlord to draw the L/C Security under specified circumstances.

 

(d)                                  Tenant shall not seek to enjoin, prevent, or otherwise interfere with Landlord’s draw under L/C Security, even if it violates this Lease.  Tenant acknowledges that the only effect of a wrongful draw would be to substitute a cash Security Deposit for L/C Security, causing Tenant no legally recognizable damage.  Landlord shall hold the proceeds of any draw in the same manner and for the same purposes as a cash Security Deposit.  In the event of a wrongful draw, the parties shall cooperate to allow Tenant to post replacement L/C Security simultaneously with the return to Tenant of the wrongfully drawn sums, and Landlord shall upon request confirm in writing to the issuer of the L/C Security that Landlord’s draw was erroneous.

 

(e)                                   If Landlord transfers its interest in the Premises, then Landlord shall have the right to assign the benefits of the L/C Security to the transferee, and Landlord shall have no liability for any subsequent draws against the L/C Security; and Tenant agrees to look solely to the new landlord for the return of the Security Deposit; provided that such purchaser or lessee assumes all of the obligations of Landlord arising hereunder from and after the date of the transfer.  Tenant shall be responsible for the payment of all fees in connection with any such transfer of the L/C Security.  Tenant, at its sole cost and expense, shall reasonably cooperate with

 

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Landlord’s efforts to assign the L/C Security, including by executing and delivering (within five (5) business days after receiving a request from Landlord) such instruments as may be reasonably required to evidence Tenant’s consent thereto and delivering (within ten (10) business days after receiving a request from Landlord) an amendment to the L/C Security naming Landlord’s grantee as substitute beneficiary.  The provisions hereof shall apply to every transfer or assignment made of the L/C Security to a new landlord.  If the required Security Deposit changes while L/C Security is in force, then Tenant shall deliver (and, if the issuer requires, Landlord shall consent to) a corresponding amendment to the L/C Security.

 

12.                                  Use .

 

12.1                            Tenant shall use the Premises for the purpose set forth in Section 2.7 , and shall not use the Premises, or permit or suffer the Premises to be used, for any other purpose without Landlord’s prior written consent, which consent Landlord may withhold in its sole and absolute discretion.  Nothing in this Section is intended to prohibit Tenant from using the Premises to construct the Tenant Improvements.

 

12.2                            Tenant shall not use or occupy the Premises in violation of Applicable Laws; zoning ordinances; or the certificate of occupancy issued for the Building or the Project, and shall, upon five (5) days’ written notice from Landlord, discontinue any use of the Premises that is declared or claimed by any Governmental Authority having jurisdiction to be a violation of any of the above, or that in Landlord’s reasonable opinion violates any of the above.  Tenant shall comply with any direction of any Governmental Authority having jurisdiction that shall, by reason of the nature of Tenant’s use or occupancy of the Premises, impose any duty upon Tenant or Landlord with respect to the Premises or with respect to the use or occupation thereof.

 

12.3                            Tenant shall not do or permit to be done anything that will invalidate any fire, environmental, extended coverage or any other insurance policy covering the Building or the Project, and shall comply with all rules, orders, regulations and requirements of the insurers of the Building and the Project of which Tenant is aware or given prior written notice, and Tenant shall promptly, upon demand, reimburse Landlord for any additional premium charged for such policy by reason of Tenant’s failure to comply with the provisions of this Article.

 

12.4                            Tenant shall keep all doors opening onto public corridors closed, except when in use for ingress and egress.

 

12.5                            No additional locks, bolts or alarm or access control/monitoring systems of any kind shall be placed upon any of the doors or windows by Tenant, nor shall any changes be made to existing locks or the mechanisms thereof without Landlord’s prior written consent, such consent not to be unreasonably withheld, conditioned or delayed.  Notwithstanding the foregoing, Landlord acknowledges that Tenant intends to install certain security access controls in the Premises as part of the Tenant Improvements and Landlord shall review such controls as part of the Tenant Improvements in accordance with the provisions of the Work Letter.  Tenant shall, upon termination of this Lease, return to Landlord all keys to offices and restrooms either furnished to or otherwise procured by Tenant.  In the event any key so furnished to Tenant is lost, Tenant shall pay to Landlord the cost of replacing the same or of changing the lock or locks opened by such lost key if Landlord shall deem it necessary to make such change.

 

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12.6                            No awnings or other projections shall be attached to any outside wall of the Building.  No curtains, blinds, shades or screens shall be attached to or hung in, or used in connection with, any window or door of the Premises other than Landlord’s standard window coverings without Landlord’s prior written consent, such consent not to be withheld, conditioned or delayed as long as such proposed window coverings present an external appearance reasonably uniform with Landlord’s standard window coverings.  Neither the interior nor exterior of any windows shall be coated or otherwise sunscreened without Landlord’s prior written consent, such consent not to be unreasonably withheld, conditioned or delayed, nor shall any bottles, parcels or other articles be placed on the windowsills.  No equipment, furniture or other items of personal property shall be placed on any exterior balcony without Landlord’s prior written consent, such consent not to be unreasonably withheld, conditioned or delayed.

 

12.7                            No sign, advertisement or notice (“ Signage ”) shall be exhibited, painted or affixed by Tenant on any part of the Premises or the Building without Landlord’s prior written consent. Subject to the provisions of this Section, Tenant shall have the right to Building Standard monument, lobby, directory and suite Signage.  Signage shall conform to Landlord’s design criteria.  For any Signage, Tenant shall, at Tenant’s own cost and expense, (a) acquire all permits for such Signage in compliance with Applicable Laws and (b) design, fabricate, install and maintain such Signage in a first-class condition.  Tenant shall be responsible for reimbursing Landlord for costs incurred by Landlord in removing any of Tenant’s Signage upon the expiration or earlier termination of the Lease.  Interior signs on entry doors to the Premises and the directory tablet shall be inscribed, painted or affixed for Tenant by Landlord at Tenant’s sole cost and expense, and shall be of a size, color and type and be located in a place acceptable to Landlord.  The directory tablet shall be provided exclusively for the display of the name and location of tenants only.  Tenant shall not place anything on the exterior of the corridor walls or corridor doors other than Landlord’s standard lettering.  Subject to Landlord’s approval (which shall not be unreasonably withheld, conditioned or delayed) and consistent with Landlord’s standard building signage program, Tenant may place its logo on the door leading into the Premises.  At Landlord’s option, Landlord may install any Tenant Signage, and Tenant shall pay all costs associated with such installation within thirty (30) days after demand therefor.

 

12.8                            Tenant shall only place equipment within the Premises with floor loading consistent with the Building’s then-current structural design without Landlord’s prior written approval, and such equipment shall be placed in a location designed to carry the weight of such equipment.  Tenant shall be solely responsible for the cost of any structural upgrades needed to the Building as a result of Tenant’s high density storage equipment, or use thereof, (which structural upgrades shall be made in accordance with the provisions of this Lease and the Work Letter).  Any such high density storage equipment, or use thereof, shall in no way compromise the structural integrity of the Building (including the roof of the Building).

 

12.9                            Tenant shall cause any equipment or machinery to be installed in the Premises so as to reasonably prevent sounds or vibrations therefrom from extending into the Common Areas or other offices in the Project.

 

12.10                      Tenant shall not (a) do or permit anything to be done in or about the Premises that shall unreasonably interfere with the rights of other tenants or occupants of the Project, or injure them, (b) use or allow the Premises to be used for unlawful purposes, (c) cause, maintain or

 

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permit any nuisance or waste in, on or about the Project or (d) take any other action that would in Landlord’s reasonable determination in any manner adversely affect other tenants’ quiet use and enjoyment of their space other than in a de minimis manner or adversely impact their ability to conduct business in a professional and suitable work environment other than in a de minimis manner.

 

12.11                      Notwithstanding any other provision herein to the contrary, Tenant shall be responsible for all liabilities, costs and expenses arising out of or in connection with the compliance of the Premises with the Americans with Disabilities Act, 42 U.S.C. § 12101, et seq., and any state and local accessibility laws, codes, ordinances and rules (collectively, and together with regulations promulgated pursuant thereto, the “ ADA ”), and Tenant shall indemnify, save, defend and hold Landlord and its affiliates, employees, agents and contractors; and any lender, mortgagee or beneficiary (each, a “ Lender ” and, collectively with Landlord and its affiliates, employees, agents and contractors, the “ Landlord Indemnitees ”) harmless from and against any demands, claims, liabilities, losses, costs, expenses, actions, causes of action, damages or judgments, and all reasonable expenses (including reasonable attorneys’ fees, charges and disbursements) incurred in investigating or resisting the same (collectively, “ Claims ”) arising out of any such failure of the Premises to comply with the ADA.  Landlord shall be responsible for causing the Building Common Area and the parking facilities to comply with the ADA, and shall indemnify, save, defend (at Tenant’s option) and hold Tenant and its affiliates, employees, agents and contractors harmless from and against any Claims incurred arising out of such failure.  The provisions of this Section shall survive the expiration or earlier termination of this Lease.

 

13.                                  Rules and Regulations, CC&Rs, Parking Facilities and Common Areas .

 

13.1                            Tenant shall have the non-exclusive right, in common with others, to use the Common Areas in conjunction with Tenant’s use of the Premises for the Permitted Use, and such use of the Common Areas and Tenant’s use of the Premises shall be subject to the rules and regulations adopted by Landlord and attached hereto as Exhibit F , together with such other reasonable and nondiscriminatory rules and regulations as are hereafter promulgated by Landlord (in its sole and absolute discretion, provided that such sole and absolute discretion shall not reduce Landlord’s obligation to make such rules and regulations reasonable and nondiscriminatory), delivered in writing to Tenant from time to time (the “ Rules and Regulations ”).  Tenant shall faithfully observe and comply with the Rules and Regulations.  Landlord shall not be responsible to Tenant for the violation or non-performance by any other tenant or any agent, employee or invitee thereof of any of the Rules and Regulations but shall not enforce the Rules and Regulations in a discriminatory manner against Tenant.

 

13.2                            This Lease is subject to any recorded covenants, conditions or restrictions on the Project or Property (the “ CC&R s”), as the same may be amended, amended and restated, supplemented or otherwise modified from time to time; provided that any such amendments, restatements, supplements or modifications do not materially modify Tenant’s rights or obligations hereunder.  Tenant shall comply with the CC&Rs.

 

13.3                            Tenant, at no charge, shall have a non-exclusive, irrevocable license to use Tenant’s Pro Rata Share of parking facilities serving the Building in common on an unreserved basis with other tenants of the Building during the Term.  As of the Execution Date, the parking

 

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ratio for the Building is three and two-tenths (3.2) parking spaces in the parking facilities serving the Building for each one thousand (1,000) square feet of Rentable Area.  Subject only to the loss or destruction of parking facilities (or portion thereof) as a result of condemnation or casualty, Tenant’s Pro Rata Share of the parking facilities serving the Building shall not be reduced below three and two-tenths (3.2) parking spaces in the parking facilities serving the Building for each one thousand (1,000) square feet of Rentable Area.

 

13.4                            Tenant agrees to cooperate reasonably with Landlord and other tenants in the use of the parking facilities.  If Landlord reasonably determines that the parking facilities are becoming overcrowded, Landlord shall have the right (but subject to Section 13.3 ) to limit the use thereof by Tenant and other tenants of the Building in a non-discriminatory manner by reasonably allocating parking spaces among Tenant and other tenants of the Building or the Project.  Nothing in this Section, however, is intended to create an affirmative duty on Landlord’s part to monitor parking.

 

13.5                            Landlord reserves the right to modify the Common Areas, including the right to add or remove exterior and interior landscaping and to subdivide real property.  Tenant acknowledges that Landlord specifically reserves the right to allow the exclusive use of corridors and restroom facilities located on specific floors to one or more tenants occupying such floors; provided , however, that Tenant shall not be deprived of the use of the corridors reasonably required to serve the Premises or of restroom facilities serving the floor upon which the Premises are located.

 

13.6                            Subject to Article 21 of this Lease regarding Tenant’s obligations with respect to Hazardous Materials, Landlord hereby grants Tenant a license during the Term of this Lease to build and maintain, at Tenant’s sole cost and expense, a small storage shed (the “ Hazardous Materials Shed ”) within the Common Area near the Building’s loading dock to store combustibles and hazardous materials in accordance with all Applicable Laws.  The design, construction, size and location of the Hazardous Materials Shed shall be subject to Landlord’s approval, in its sole discretion, provided that Landlord hereby approves the size and location of the Hazardous Materials Shed as shown on Exhibit K attached hereto.  Tenant’s maintenance and use of the Hazardous Materials Shed shall be subject to all provisions of this Lease, provided that the Hazardous Materials Shed shall not be part of the Premises or included in the Rentable Area of the Premises and Tenant shall not be obligated to pay Base Rent or Operating Expenses with respect thereto.  The Hazardous Materials Shed shall remain in the Common Areas upon Tenant’s surrender of the Premises and shall be the property of Landlord.

 

14.                                  Project Control by Landlord .

 

14.1                            Landlord reserves full control over the Building and the Project to the extent not inconsistent with Tenant’s use and enjoyment of, and access to, the Premises and the parking areas as provided by this Lease.  This reservation includes Landlord’s right to subdivide the Project; convert the Building and other buildings within the Project to condominium units; change the size of the Project by selling all or a portion of the Project or adding real property and any improvements thereon to the Project; grant easements and licenses to third parties; maintain or establish ownership of the Building separate from fee title to the Property; make additions to or reconstruct portions of the Building and the Project; install, use, maintain, repair, replace and

 

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relocate for service to the Premises and other parts of the Building or the Project pipes, ducts, conduits, wires and appurtenant fixtures, wherever located in the Premises, the Building or elsewhere at the Project; and alter or relocate any other Common Area or facility, including private drives, lobbies and entrances; provided , however, that any such activities do not unreasonably impair Tenant’s access to or use of the Premises, parking areas and Common Areas adjacent to the Building.

 

14.2                            Possession of areas of the Premises necessary for utilities, services, safety and operation of the Building is reserved to Landlord.

 

14.3                            Tenant shall, at Landlord’s request, promptly execute such further documents as may be reasonably appropriate to assist Landlord in the performance of its obligations hereunder; provided that Tenant need not execute any document that creates additional liability for Tenant, materially reduces Tenant’s rights hereunder, that deprives Tenant of the quiet enjoyment or use of the Premises as provided for in this Lease or materially reduces the obligations of Landlord hereunder.

 

14.4                            Landlord may, at any and all reasonable times during non-business hours (or during business hours if Tenant so requests or if Landlord so requests with respect to Section 14.4(c) ), and upon not less than twenty-four (24) hours’ prior notice ( provided that no time restrictions shall apply or advance notice be required if an emergency necessitates immediate entry, but Landlord shall use reasonable efforts to provide such prior notice as may be practicable under the circumstances and shall provide notice and an explanation of the emergency within a reasonable time following such entry), enter the Premises to (a) inspect the same and to determine whether Tenant is in compliance with its obligations hereunder, (b) supply any service Landlord is required to provide hereunder, (c) show the Premises to prospective purchasers or tenants during the final year of the Term, (d) post notices of nonresponsibility, (e) access the telephone equipment, electrical substation and fire risers and (f) alter, improve or repair any portion of the Building other than the Premises for which access to the Premises is reasonably necessary.  Tenant, in its sole discretion, shall have the right to accompany Landlord in connection with any such entry (except for any entry as a result of or in response to an emergency); provided , however, that if Tenant is not present at the scheduled time of entry (as provided by Landlord’s notice requirement in this Section), Landlord may enter the Premises without the company of Tenant (except for the laboratory areas of the Premises (as described below), unless an emergency necessitates immediate entry).  Landlord shall coordinate with Tenant to schedule in advance any entry to the laboratory areas of the Premises or the Hazardous Materials Shed, which entry Tenant shall not unreasonably withhold, condition or delay, (except in the case of any emergency, as set forth below, in which case, no prior notice, coordination or scheduling shall be required), and except in the event of an emergency, Landlord shall not enter such laboratory areas or the Hazardous Materials Shed unless accompanied by a representative of Tenant.  Any entry to the laboratory areas of the Premises by Landlord shall be subject to the reasonable safety rules and procedures of Tenant (as provided to Landlord), except in the case of an emergency, in which case, no such safety rules and procedures shall apply.  In connection with any alteration, improvement or repair as described in Subsection 14.4(f)  (which shall include any excavation that may need to be made upon land adjacent to or under the Building), Landlord may erect in the Premises or elsewhere in the Project scaffolding and other structures reasonably required for the alteration, improvement or repair work to be performed

 

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(and, in the event of any excavation, Tenant shall afford to the person causing or authorized to cause such excavation, license to enter the Premises for the purpose of performing such work as shall be necessary to preserve and protect the Building from injury or damage and to support the same by proper foundations); provided , however, that except in the case of any emergency (as set forth below), Landlord shall use commercially reasonable efforts to coordinate with Tenant to schedule such alteration, improvement or repairs with Tenant in advance.  Without limiting Section 16.2 , in no event shall Tenant’s Rent abate as a result of Landlord’s activities pursuant to this Section (except in the case of any entry described in Section 14.4(f)  which substantially interferes with Tenant’s use of the Premises for the Permitted Use and continues for more than five (5) consecutive business days, in which event Base Rent shall abate commencing on the sixth (6 th ) business day with respect to the portion of the Premises so affected until Tenant’s use of such portion of the Premises for the Permitted Use is no longer being substantially interfered with); provided , however, that all such activities shall be conducted in such a manner so as to cause as little interference to Tenant as is reasonably possible.  Landlord shall at all times retain a key with which to unlock all of the doors in the Premises and the Hazardous Materials Shed.  If an emergency necessitates immediate access to the Premises, Landlord may use whatever force is necessary to enter the Premises, and any such entry to the Premises shall not constitute a forcible or unlawful entry to the Premises, a detainer of the Premises, or an eviction of Tenant from the Premises or any portion thereof.  Any notice or explanation required by this Section to be given to Tenant shall be permitted to be given verbally or by email.

 

15.                                  Quiet Enjoyment .  So long as Tenant is not in Default under this Lease, Landlord or anyone acting through or under Landlord shall not disturb Tenant’s occupancy of the Premises, except as permitted by this Lease.

 

16.                                  Utilities and Services .

 

16.1                            Tenant shall pay for all water (including the cost to service, repair and replace reverse osmosis, de-ionized and other treated water), gas, heat, light, power, telephone, internet service, cable television, other telecommunications and other utilities supplied to the Premises, together with any fees, surcharges and taxes thereon.  Tenant, as part of the Tenant Improvements, shall install meters to measure Tenant’s use of such utilities supplied to the Premises and Tenant shall pay the cost of such use (along with any monitoring costs) to Landlord as Additional Rent.  If any such utility is not separately metered to Tenant, Tenant shall pay Tenant’s Share (as defined in Section 9.1(c) ) of all charges of such utility jointly metered with other premises as Additional Rent.  In the event that the Building, the North Campus or Project is less than fully occupied, Tenant acknowledges that Landlord may extrapolate utility usage that vary depending on the occupancy of the Building, the North Campus or Project, as applicable, by dividing (a) the total cost of utility usage by (b) the Rentable Area of the Building, North Campus or Project (as applicable) that is occupied, then multiplying (y) the resulting quotient by (z) ninety-five percent (95%) of the total Rentable Area of the Building, North Campus or Project (as applicable).  Tenant shall pay Tenant’s Share of the product of (y) and (z), subject to adjustment based on actual usage as reasonably determined by Landlord.  In no event shall Landlord recover more than one hundred percent (100%) of such utility costs.

 

16.2                            Landlord shall not be liable for, nor shall any eviction of Tenant result from, the failure to furnish any utility or service, whether or not such failure is caused by accident;

 

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breakage; repair; strike, lockout or other labor disturbance or labor dispute of any character; act of terrorism; shortage of materials, which shortage is not unique to Landlord or Tenant, as the case may be; governmental regulation, moratorium or other governmental action, inaction or delay; or other causes beyond Landlord’s control (collectively, “ Force Majeure ”) or Landlord’s negligence.  In the event of such failure, Tenant shall not be entitled to termination of this Lease or any abatement or reduction of Rent, nor shall Tenant be relieved from the operation of any covenant or agreement of this Lease.  Notwithstanding anything to the contrary in this Lease, if, for more than five (5) consecutive business days following written notice to Landlord and either (a) as a direct result of Landlord’s gross negligence or willful misconduct or (b) as a direct result of an event that is insured against under Landlord’s business interruption insurance, the provision of HVAC or other utilities to all or a material portion of the Premises that Landlord must provide pursuant to this Lease is interrupted, then Tenant’s Base Rent and Operating Expenses (or, to the extent that less than all of the Premises are affected, a proportionate amount (based on the Rentable Area of the Premises that is rendered unusable) of Base Rent and Operating Expenses) shall thereafter be abated until the Premises are again usable by Tenant for the Permitted Use; provided , however, that, if Landlord is diligently pursuing the restoration of such HVAC and other utilities and Landlord provides substitute HVAC and other utilities reasonably suitable for Tenant’s continued use and occupancy of the Premises for the Permitted Use (e.g., supplying potable water or portable air conditioning equipment), then neither Base Rent nor Operating Expenses shall be abated.  In the event of any interruption of HVAC or other utilities that Landlord must provide pursuant to this Lease, regardless of the cause, Landlord shall diligently pursue the restoration of such HVAC and other utilities.  Notwithstanding anything in this Lease to the contrary, but subject to Article 24 (which shall govern in the event of a casualty), the provisions of this Section shall be Tenant’s sole recourse and remedy in the event of an interruption of HVAC or other utilities to the Premises.

 

16.3                            Tenant shall pay for, prior to delinquency of payment therefor, any utilities and services that may be furnished to the Premises during or, if Tenant occupies the Premises after the expiration or earlier termination of the Term, after the Term, beyond those utilities provided by Landlord, including telephone, internet service, cable television and other telecommunications, together with any fees, surcharges and taxes thereon.  Upon Landlord’s demand, utilities and services provided to the Premises that are separately metered shall be paid by Tenant directly to the supplier of such utilities or services.

 

16.4                            Tenant shall not, without Landlord’s prior written consent, use any device in the Premises (including data processing machines) that will in any way increase the amount of ventilation, air exchange, gas, steam, electricity or water beyond the existing capacity of the Building or Project as proportionately allocated to the Premises based upon Tenant’s Pro Rata Share of the Building or (b) exceed Tenant’s Pro Rata Share of the Building’s capacity to provide such utilities or services.  As of the Execution Date, the Building capacities are as set forth in Exhibit L attached hereto.   In the event Tenant shall require utilities or services in excess of its allocated amount (as described above), Tenant shall first procure Landlord’s consent for the use thereof, which consent Landlord may condition upon the availability of such excess utilities or services, and Tenant shall pay as Additional Rent an amount equal to the cost of providing such excess utilities and services.

 

16.5                            Intentionally omitted.

 

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16.6                            Landlord shall provide water in Common Areas for lavatory and landscaping purposes only, which water shall be from the local municipal or similar source; provided , however, that if Landlord determines that Tenant requires, uses or consumes water provided to the Common Areas for any purpose other than ordinary lavatory purposes, Landlord may install a water meter (“ Tenant Water Meter ”) and thereby measure Tenant’s water consumption for all purposes.  Tenant shall pay Landlord for the costs of any Tenant Water Meter and the installation and maintenance thereof during the Term.  If Landlord installs a Tenant Water Meter, Tenant shall pay for water consumed, as shown on such meter, as and when bills are rendered.  If Tenant fails to timely make such payments, Landlord may pay such charges and collect the same from Tenant.  Any such costs or expenses incurred or payments made by Landlord for any of the reasons or purposes stated in this Section shall be deemed to be Additional Rent payable by Tenant and collectible by Landlord as such.

 

16.7                            Landlord reserves the right to stop service of the elevator, plumbing, ventilation, air conditioning and utility systems, when Landlord reasonably deems necessary or desirable, due to accident, emergency or the need to make repairs, alterations or improvements, until such repairs, alterations or improvements shall have been completed; provided , that, except in the event of an emergency, Landlord shall use commercially reasonable efforts to coordinate with Tenant to schedule in advance and conduct such activities in such a manner so as to reasonably minimize interference to Tenant’s use of the Premises for the Permitted Use.  Except as provided in Section 16.2 , Landlord shall further have no responsibility or liability for failure to supply elevator facilities, plumbing, ventilation, air conditioning or utility service when prevented from doing so by Force Majeure or Landlord’s negligence; a failure by a third party to deliver gas, oil or another suitable fuel supply; or Landlord’s inability by exercise of reasonable diligence to obtain gas, oil or another suitable fuel.  Without limiting the foregoing, it is expressly understood and agreed that any covenants on Landlord’s part to furnish any service pursuant to any of the terms, covenants, conditions, provisions or agreements of this Lease, or to perform any act or thing for the benefit of Tenant, shall not be deemed breached if Landlord is unable to furnish or perform the same by virtue of Force Majeure or Landlord’s negligence.

 

16.8                            For the Premises, Landlord shall (a) maintain and operate the heating, ventilating and air conditioning systems used for the Permitted Use only (“ HVAC ”) and (b) subject to clause (a) above, furnish HVAC as reasonably required (except as this Lease otherwise provides) for reasonably comfortable occupancy of the Premises twenty-four (24) hours a day, every day during the Term, subject to casualty, eminent domain or as otherwise specified in this Article.  Except as provided in Section 16.2 , Landlord shall have no liability, and Tenant shall have no right or remedy, on account of any interruption or impairment in HVAC services; provided that Landlord diligently endeavors to cure any such interruption or impairment.

 

16.9                            For any utilities serving the Premises for which Tenant is billed directly by such utility provider, Tenant agrees to furnish to Landlord (a) any invoices or statements for such utilities within thirty (30) days after Tenant’s receipt thereof, and (b) within thirty (30) days after each calendar year during the Term, an ENERGY STAR® Statement of Performance (or similar comprehensive utility usage report (e.g., related to Labs 21), if requested by Landlord).  Tenant shall retain records of utility usage at the Premises, including invoices and statements from the utility provider, for at least twenty-four (24) months.  Tenant acknowledges that any utility information for the Premises, the Building and the Project may be shared with third parties,

 

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including Landlord’s consultants and Governmental Authorities.  In the event that Tenant fails to comply with this Section, Tenant hereby authorizes Landlord to collect utility usage information directly from the applicable utility providers.

 

17.                                  Alterations .

 

17.1                            Tenant shall make no alterations, additions or improvements in or to the Premises or engage in any construction, demolition, reconstruction, renovation, or other work (whether major or minor) of any kind in, at, or serving the Premises (“ Alterations ”) without Landlord’s prior written approval, which approval Landlord shall not unreasonably withhold, condition or delay; provided , however, that in the event any proposed Alteration affects (a) any structural portions of the Building, including exterior walls, roof, foundation, foundation systems (including barriers and subslab systems), or core of the Building, (b) the exterior of the Building or (c) any Building systems, including elevator, plumbing, air conditioning, heating, electrical, security, life safety and power, then Landlord may withhold its approval with respect thereto in its sole and absolute discretion.  Tenant shall, in making any such Alterations, use only those architects, contractors, suppliers and mechanics of which Landlord has given prior written approval, which approval shall not be unreasonably withheld, conditioned or delayed.  In no event shall Tenant use or Landlord be required to approve any architects, consultants, contractors, subcontractors or material suppliers that Landlord reasonably believes could cause labor disharmony.  In seeking Landlord’s approval, Tenant shall provide Landlord, at least fourteen (14) days in advance of any proposed construction, with plans, specifications, bid proposals, certified stamped engineering drawings and calculations by Tenant’s engineer of record or architect or record, (including connections to the Building’s structural system, modifications to the Building’s envelope, non-structural penetrations in slabs or walls, and modifications or tie-ins to life safety systems), requests for laydown areas and such other information concerning the nature and cost of the Alterations as Landlord may reasonably request.  Notwithstanding the foregoing, Tenant may make strictly cosmetic changes to the Premises (“ Cosmetic Alterations ”) without Landlord’s consent; provided that (y) the cost of any Cosmetic Alterations does not exceed Fifty Thousand Dollars ($50,000) in any one instance or One Hundred Thousand Dollars ($100,000) annually, (z) such Cosmetic Alterations do not (i) require any structural or other substantial modifications to the Premises, (ii) require any changes to, or adversely affect, the Building systems, (iii) affect the exterior of the Building or (iv) trigger any requirement under Applicable Laws that would require Landlord to make any alteration or improvement to the Premises, the Building or the Project.  Tenant shall give Landlord at least ten (10) days’ prior written notice of any Cosmetic Alterations.

 

17.2                            Tenant shall not construct or permit to be constructed partitions or other obstructions that might interfere with free access to mechanical installation or service facilities of the Building or with other tenants’ components located within the Building, or interfere with the moving of Landlord’s equipment to or from the enclosures containing such installations or facilities.

 

17.3                            Tenant shall accomplish any work performed on the Premises or the Building in such a manner as to permit any life safety systems to remain fully operable at all times, unless a temporary shutdown of such life safety systems has been approved in writing by Landlord, in which case, any such approved shutdown shall be administered as directed by Landlord.

 

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17.4                            Any work performed on the Premises, the Building or the Project by Tenant or Tenant’s contractors shall be done at such times and in such manner as Landlord may from time to time reasonably designate.  Tenant covenants and agrees that all work done by Tenant or Tenant’s contractors shall be performed in full compliance with Applicable Laws.  Within thirty (30) days after completion of any Alterations, Tenant shall provide Landlord with complete “as-built” drawing print sets and electronic CADD files on disc (or files in such other current format in common use as Landlord reasonably approves or requires) showing any changes in the Premises.

 

17.5                            Before commencing any Alterations or Tenant Improvements, Tenant shall give Landlord at least fourteen (14) days’ prior written notice of the proposed commencement of such work.  In addition, except with respect to the Tenant Improvements (including the Expansion Improvements) and any Cosmetic Alterations, Landlord may require that Tenant secure, at Tenant’s own cost and expense, a completion and lien indemnity bond reasonably satisfactory to Landlord for such work.

 

17.6                            Tenant shall repair any damage to the Premises caused by Tenant’s removal of any property from the Premises.  During any such restoration period, Tenant shall pay Rent to Landlord as provided herein as if such space were otherwise occupied by Tenant.  The provisions of this Section shall survive the expiration or earlier termination of this Lease.

 

17.7                            (a)            The Premises shall at all times remain the property of Landlord and shall be surrendered to Landlord upon the expiration or earlier termination of this Lease.

 

(b)                                  Except for those items listed on Exhibit H attached hereto (which Exhibit H may be updated by Tenant from and after the Term Commencement Date, subject to Landlord’s written consent) and subject to Section 17.7(c) , all Alterations, Signage, Tenant Improvements, attached equipment, decorations, fixtures, movable laboratory casework and related appliances, trade fixtures, additions and improvements attached to or built into the Premises, made by either of the Parties (including all floor and wall coverings, built-in furniture, built-in cabinet work and paneling, sinks and related plumbing fixtures, laboratory benches, exterior venting fume hoods and walk-in freezers and refrigerators, ductwork, conduits, electrical panels and circuits, together with all additions and accessories thereto), shall (unless, prior to such construction or installation, Landlord notifies Tenant in writing that such item must be removed by Tenant upon the expiration or earlier termination of the Term) (i) not be removed from the Premises by Tenant (without prior written consent from Landlord) at any time during the Term and (ii) become the property of Landlord upon the expiration or earlier termination of the Term, and shall remain upon and be surrendered with the Premises as a part thereof.

 

(c)                                   Notwithstanding anything to the contrary set forth in this Section 17.7 , any business and trade fixtures, machinery and equipment (whether or not affixed to the Premises) that Tenant purchases without the use of any funds provided by Landlord (including the TI Allowance, Base Expansion TI Allowance and any other allowance provided by Landlord) shall, at Tenant’s option, remain the property of Tenant and Tenant may remove such equipment at the end of the Term (subject to Tenant’s repair obligations in Section 17.6 ).

 

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(d)                                  Notwithstanding any other provision of this Article to the contrary, in no event shall Tenant remove any improvement from the Premises as to which Landlord contributed payment, including the Tenant Improvements, without Landlord’s prior written consent, which consent Landlord may withhold in its sole and absolute discretion.

 

(e)                                   If Tenant shall fail to remove any of its effects from the Premises prior to termination of this Lease, then Landlord may, at its option, remove the same in any manner that Landlord shall choose and store such effects without liability to Tenant for loss thereof or damage thereto, and Tenant shall pay Landlord, upon demand, any costs and expenses incurred due to such removal and storage or Landlord may, at its sole option and without notice to Tenant, sell such property or any portion thereof at private sale and without legal process for such price as Landlord may obtain and apply the proceeds of such sale against any (i) amounts due by Tenant to Landlord under this Lease and (ii) any expenses incident to the removal, storage and sale of such personal property.

 

17.8                            Tenant shall reimburse Landlord for any extra expenses actually incurred by Landlord by reason of faulty work done by Tenant or its contractors, or by reason of delays caused by such work, or by reason of inadequate clean-up.

 

17.9                            Within ninety (90) days after final completion of the Tenant Improvements or any other Alterations performed by Tenant with respect to the Premises, Tenant shall submit to Landlord documentation showing the amounts expended by Tenant with respect to such Tenant Improvements and Alterations, together with supporting documentation reasonably acceptable to Landlord.

 

17.10                      Tenant shall take, and shall cause its contractors to take, commercially reasonable steps to protect the Premises during the performance of any Alterations, including covering or temporarily removing any window coverings so as to guard against dust, debris or damage.

 

17.11                      Tenant shall require its contractors and subcontractors performing work on the Premises to name the parties specified in Section 23.4 as additional insureds on their respective insurance policies as their interests may appear.

 

18.                                  Repairs and Maintenance .

 

18.1                            Landlord shall repair and maintain in good condition and repair the structural and exterior portions and Common Areas of the Building and the Project, and the base Building systems set forth on Exhibit L attached hereto, including roofing and covering materials; foundations; exterior walls; plumbing; fire sprinkler systems and fire alarms (if any); heating, ventilating, air conditioning systems; elevators; and electrical systems installed or furnished by Landlord.

 

18.2                            Except for services of Landlord, if any, required by Section 18.1 , Tenant shall at Tenant’s sole cost and expense maintain and keep the Premises and every part thereof in good condition and repair, damage thereto from ordinary wear and tear and casualty and condemnation excepted.  Subject to Section 17.7 , Tenant shall, upon the expiration or sooner termination of the Term, surrender the Premises to Landlord in substantially as good a condition as when received

 

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(except that the improvements in the Premises shall be surrendered in substantially as good a condition as existed on the Term Commencement Date), ordinary wear and tear and casualty and condemnation excepted; and shall, at Landlord’s request and Tenant’s sole cost and expense, remove all telephone and data systems, wiring and equipment from the Premises, and repair any damage to the Premises caused thereby.  Landlord shall have no obligation to alter, remodel, improve, repair, decorate or paint the Premises or any part thereof.

 

18.3                            Except as provided Section 16.2 , Landlord shall not be liable for any failure to make any repairs or to perform any maintenance that is Landlord’s obligation pursuant to this Lease unless such failure shall persist for an unreasonable time after Tenant provides Landlord with written notice of the need of such repairs or maintenance.  In the event that Landlord timely fails to make a repair or perform maintenance that is Landlord’s obligation pursuant to this Lease, Tenant may notify Landlord of such failure and, if Landlord does not make the repair or perform the maintenance within thirty (30) days after Landlord’s receipt of such notice (or, if such repair or maintenance cannot reasonably be completed with such period, within the period of time reasonably required (so long as Landlord begins the repair or maintenance within such period and diligently prosecutes the same to completion)), Tenant may perform the repair or maintenance; provided , that before performing any such repairs or maintenance, Tenant shall notify Landlord of Tenant’s intent to do so and shall use commercially reasonable efforts to coordinate with Landlord, and any other tenants of the Project that may be affected, to schedule such repairs or maintenance.  Notwithstanding the foregoing, in the event of an emergency that poses an imminent threat of harm to the Premises or people or property within the Premises, Tenant may perform such repairs as is necessary to repair the portion of the Premises affected by such emergency; provided , however, that prior to taking any such action or performing such work, Tenant shall contact Landlord (via phone, if necessary) and shall not take such action or perform such work if Landlord promptly commits to perform the same in at least an expeditious manner as Tenant is able to take such action or perform such work and thereafter diligently prosecutes the same to completion.   Landlord agrees to reimburse Tenant for such portion of the reasonable out-of-pocket costs of such work performed by Tenant pursuant to this Section that is Landlord’s responsibility under this Lease within thirty (30) days after receipt of an invoice from Tenant therefor.  Tenant shall use commercially reasonable efforts to minimize interference with the rights of other tenants to use their respective premises in the Building.

 

18.4                            Intentionally omitted.

 

18.5                            This Article relates to repairs and maintenance arising in the ordinary course of operation of the Building and the Project.  In the event of a casualty described in Article 24 , Article 24 shall apply in lieu of this Article.  In the event of eminent domain, Article 25 shall apply in lieu of this Article.

 

18.6                            Costs incurred by Landlord pursuant to this Article shall constitute Operating Expenses, unless such costs are (i) excluded from Operating Expenses pursuant to the definition thereof or (ii) incurred due in whole or in part to any act, neglect, fault or omissions of Tenant or its employees, agents, contractors or invitees, in which case Tenant shall, subject to Section 23.7 , pay to Landlord the reasonable cost of such repairs and maintenance.

 

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19.                                  Liens .

 

19.1                            Subject to the immediately succeeding sentence, Tenant shall keep the Premises, the Building and the Project free from any liens arising out of work performed, materials furnished or obligations incurred by Tenant.  Tenant further covenants and agrees that any mechanic’s lien filed against the Premises, the Building or the Project for work claimed to have been done for, or materials claimed to have been furnished to, shall be discharged or bonded by Tenant within ten (10) business days after the earlier of (a) obtaining knowledge and (b) receiving written notice of the filing thereof, at Tenant’s sole cost and expense.

 

19.2                            Should Tenant fail to discharge or bond against any lien of the nature described in Section 19.1 within the time period therein provided, Landlord may, at Landlord’s election, pay such claim or post a bond or otherwise provide security to eliminate the lien as a claim against title, and Tenant shall immediately reimburse Landlord for the costs thereof as Additional Rent.  Tenant shall indemnify, save, defend and hold the Landlord Indemnitees harmless from and against any Claims arising from any such liens, including any administrative, court or other legal proceedings related to such liens.

 

19.3                            In the event that Tenant leases or finances the acquisition of office equipment, furnishings or other personal property of a removable nature utilized by Tenant in the operation of Tenant’s business, Tenant warrants that any Uniform Commercial Code financing statement shall, upon its face or by exhibit thereto, indicate that such financing statement is applicable only to removable personal property of Tenant located within the Premises.  In no event shall the address of the Premises, the Building or the Project be furnished on a financing statement without qualifying language as to applicability of the lien only to removable personal property located in an identified suite leased by Tenant.  Should any holder of a financing statement record or place of record a financing statement that appears to constitute a lien against any interest of Landlord or against equipment that may be located other than within an identified suite leased by Tenant, Tenant shall, (a) within ten (10) business days after earlier of (i) obtaining knowledge and (ii) receiving written notice of the filing such financing statement, cause a copy of the Lender security agreement or other documents to which the financing statement pertains to be furnished to Landlord to facilitate Landlord’s ability to demonstrate that the lien of such financing statement is not applicable to Landlord’s interest and (b) cause Tenant’s Lender to amend, as soon as reasonably practicable (but in no event longer than thirty (30) days after obtaining knowledge of the filing of such financing statement), such financing statement and any other documents of record to clarify that any liens imposed thereby are not applicable to any interest of Landlord in the Premises, the Building or the Project.

 

20.                                  Estoppel Certificate .  Tenant shall, within ten (10) days of receipt of written notice from Landlord, execute, acknowledge and deliver a statement in writing substantially in the form attached to this Lease as Exhibit I , or on any other form reasonably requested by a proposed Lender or purchaser, (a) certifying that this Lease is unmodified and in full force and effect (or, if modified, stating the nature of such modification and certifying that this Lease as so modified is in full force and effect) and the dates to which rental and other charges are paid in advance, if any, (b) acknowledging that there are not, to Tenant’s knowledge, any uncured defaults on the part of Landlord hereunder, or specifying such defaults if any are claimed, and (c) setting forth such further customary information with respect to this Lease or the Premises as may be reasonably requested thereon.  Any such statement may be relied upon by any prospective purchaser or encumbrancer of all or any portion of the real property of which the Premises are a

 

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part.  If Tenant fails to provide such statement within such ten (10) business day period, then Landlord shall provide Tenant with a reminder notice requesting that Tenant execute the certificate, and shall include a prominent, all capital legend that failure to respond to such notice may result in Default under this Lease.  Tenant’s failure to deliver such statement within five (5) business days following the receipt of the reminder notice shall, at Landlord’s option, constitute a Default (as defined below) under this Lease, and, in any event, shall be binding upon Tenant that the Lease is in full force and effect and without modification except as may be represented by Landlord in any certificate prepared by Landlord and delivered to Tenant for execution.  Landlord shall, within ten (10) business days after receipt of written notice from Tenant, execute and deliver to Tenant, an estoppel certificate in form and substance reasonably requested by Tenant certifying to such customary facts concerning the status of the Lease as Tenant may reasonably request, which certificate may be relied upon by Tenant and/or any lender, equity investor or partner, assignee or sublessee, potential purchaser of Tenant or its assets or its interest in and to the Lease, or other third party reasonably requested by Tenant.

 

21.                                  Hazardous Materials .

 

21.1                            Tenant shall not cause or permit any Hazardous Materials (as defined below) to be brought upon, kept or used in or about the Premises, the Building or the Project in violation of Applicable Laws by Tenant or its affiliates, employees, agents, contractors or invitees (Tenant and such parties are each referred to as a “ Tenant Party ” and collectively, the “ Tenant Parties ”).  If Tenant breaches such obligation, or if the presence of Hazardous Materials as a result of such a breach results in contamination of the Project, any portion thereof, or any adjacent property, or if contamination of the Premises otherwise occurs during the Term or any extension or renewal hereof or holding over hereunder (other than if such contamination results from (a) migration of Hazardous Materials from outside the Premises not caused by any Tenant Party or (b) to the extent such contamination is solely caused by Landlord’s negligence or willful misconduct), or if contamination of the Project occurs as a result of Hazardous Materials that are placed or released on, into, under or about the Project by a Tenant Party, then without limiting the indemnification obligations set forth in the next sentence, Tenant shall promptly take all actions at its sole cost and expense as are necessary to return the Project, any portion thereof or any adjacent property to substantially its respective condition existing prior to the time of such contamination or, if the foregoing is not reasonably possible, in compliance with Applicable Laws; provided that Landlord’s written approval of such action shall first be obtained, which approval Landlord shall not unreasonably withhold, condition or delay; and provided , further, that it shall be reasonable for Landlord to withhold its consent if such actions could have a material adverse long-term or short-term effect on the Project, any portion thereof or any adjacent property.  Tenant shall indemnify, save, defend and hold the Landlord Indemnitees harmless from and against any and all Claims that arise during or after the Term as a result of any breach of this Article or contamination that Tenant is responsible for pursuant to this Article.  This indemnification by Tenant includes costs incurred in connection with any investigation of site conditions or any clean-up, remedial, removal or restoration work required by any Governmental Authority because of Hazardous Materials present in the air, soil or groundwater above, on or under or about the Project that are the responsibility of Tenant as provided above.  Notwithstanding the foregoing, Landlord shall indemnify, save, defend (at Tenant’s option) and hold Tenant and its affiliates, employees, agents and contractors harmless from and against any and all Claims resulting from the presence of Hazardous Materials at the Project in violation of Applicable

 

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Laws as of the Execution Date, unless placed at the Project by a Tenant Party.  For the avoidance of doubt, Tenant shall not be in default under this Lease as a result of any breach of the first sentence of this paragraph or any release of Hazardous Materials as long as Tenant commences efforts to remedy the same within thirty (30) days after such breach or release and thereafter diligently prosecutes such remedy to completion.

 

21.2                            Landlord acknowledges that it is not the intent of this Article to prohibit Tenant from operating its business for the Permitted Use.  Tenant may operate its business according to the custom of Tenant’s industry so long as the use or presence of Hazardous Materials is monitored in accordance with Applicable Laws.  As a material inducement to Landlord to allow Tenant to use Hazardous Materials in connection with its business, Tenant agrees to deliver to Landlord (a) a list identifying each type of Hazardous Material to be present at the Premises that is subject to regulation under any environmental Applicable Laws, (b) a list of any and all approvals or permits from Governmental Authorities required in connection with the presence of such Hazardous Material at the Premises and (c) correct and complete copies of (i) notices of violations of Applicable Laws related to Hazardous Materials and (ii) plans relating to the installation of any storage tanks to be installed in, on, under or about the Project ( provided that installation of storage tanks shall only be permitted after Landlord has given Tenant its written consent to do so, which consent Landlord may withhold in its sole and absolute discretion) and closure plans or any other documents required by any and all Governmental Authorities for any storage tanks installed in, on, under or about the Project for the closure of any such storage tanks (collectively, “ Hazardous Materials Documents ”).  Tenant shall deliver to Landlord the Hazardous Materials Documents no later than the initial occupancy of any portion of the Premises or the initial placement of equipment anywhere at the Project, and Tenant shall thereafter deliver to Landlord updated Hazardous Material Documents (m) if there are any changes to the Hazardous Materials Documents, annually thereafter no later than December 31 of each year, and (n) thirty (30) days prior to the initiation by Tenant of any Alterations or changes in Tenant’s business that involve any material increase in the types or amounts of Hazardous Materials.  For each type of Hazardous Material listed, the Hazardous Materials Documents shall include (t) the chemical name, (u) the material state (e.g., solid, liquid, gas or cryogen), (v) the concentration, (w) the storage amount and storage condition (e.g., in cabinets or not in cabinets), (x) the use amount and use condition (e.g, open use or closed use), (y) the location (e.g, room number or other identification) and (z) if known, the chemical abstract service number.  Notwithstanding anything in this Section to the contrary, Tenant shall not be required to provide Landlord with any Hazardous Materials Documents containing information of a proprietary nature, which Hazardous Materials Documents, in and of themselves, do not contain a reference to any Hazardous Materials or activities related to Hazardous Materials.  Landlord may, at Landlord’s expense, cause the Hazardous Materials Documents to be reviewed by a person or firm qualified to analyze Hazardous Materials to confirm compliance with the provisions of this Lease and with Applicable Laws.  In the event that a review of the Hazardous Materials Documents indicates non-compliance with this Lease or Applicable Laws, Tenant shall, at its expense, diligently take steps to bring its storage and use of Hazardous Materials into compliance.

 

21.3                            Notwithstanding the provisions of Sections 21.1 21.2 or 21.9 , if (a) any proposed transferee, assignee or sublessee of Tenant (other than a Permitted Transferee) has been required by any prior landlord, Lender or Governmental Authority to take material remedial action in

 

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connection with Hazardous Materials contaminating a property if the contamination resulted from such party’s action or omission or use of the property in question or (b) any proposed transferee, assignee or sublessee (other than a Permitted Transferee) is subject to a material enforcement order issued by any Governmental Authority in connection with the use, disposal or storage of Hazardous Materials, then it shall not be unreasonable for Landlord to withhold its consent to any proposed transfer, assignment or subletting (with respect to any such matter involving a proposed transferee, assignee or sublessee) to such proposed transferee, assignee or sublessee.

 

21.4                            At any time, and from time to time, prior to the expiration of the Term, Landlord shall have the right to cause a third party environmental consultant reasonably acceptable to Tenant (a duly qualified independent environmental consultant shall be deemed to be acceptable) to conduct appropriate tests of the Project or any portion thereof to demonstrate that Hazardous Materials are present or that contamination has occurred due to Tenant or Tenant’s employees, agents, contractors or invitees.  Tenant shall pay all reasonable costs of such tests if such tests reveal that Hazardous Materials exist at the Project in violation of this Lease.  Landlord shall notify Tenant when any such consultant will be performing such testing so that Tenant may, in its sole discretion, accompany such consultant during such testing (provided, however, that if Tenant is not present at the scheduled time, Tenant shall be deemed to have elected not to accompany such consultant; provided , further, that any entry to the Premises or the Hazardous Materials Shed shall be subject to Section 14.4 ).  Tenant, at its sole cost and expense, shall be entitled to receive copies of any reports or analyses prepared by such consultant in connection with such tests.  In addition, if such consultant takes any sample from the Project for testing or assessment, Landlord shall first notify Tenant thereof and, upon Tenant’s request and at its sole cost and expense, a portion of such sample shall be provided to Tenant, at its option, to allow Tenant, if it so chooses at its sole cost and expense, to perform its own testing.  Any notice required to be given to Tenant under this Section may be given verbally or by email in accordance with Section 14.4 .

 

21.5                            If underground or other storage tanks storing Hazardous Materials are located on the Premises or are hereafter placed on the Premises by or on behalf of Tenant, Tenant shall monitor the storage tanks, maintain appropriate records, implement reporting procedures, properly close any underground storage tanks, and take or cause to be taken all other steps necessary or required under the Applicable Laws.

 

21.6                            Tenant shall promptly report to Landlord any actual or suspected presence of mold or water intrusion at the Premises.

 

21.7                            Tenant’s obligations under this Article shall survive the expiration or earlier termination of the Lease.  During any period of time needed by Tenant or Landlord after the termination of this Lease to complete the removal from the Premises of any such Hazardous Materials that are the obligation of Tenant pursuant to Section 21.1 , Tenant shall be deemed a holdover tenant and subject to the provisions of Article 27 below.

 

21.8                            As used herein, the term “ Hazardous Material ” means any hazardous or toxic substance, material or waste that is or becomes regulated by any Governmental Authority.

 

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21.9                            Notwithstanding anything to the contrary in this Lease, Landlord shall have sole control over the equitable allocation of fire control areas (as defined in the Uniform Building Code as adopted by the city or municipality(ies) in which the Project is located (the “ UBC ”)) within the Project for the storage of Hazardous Materials.  Notwithstanding anything to the contrary in this Lease, the quantity of Hazardous Materials allowed by this Section 21.9 is specific to Tenant and shall not run with the Lease in the event of a Transfer (as defined in Article 29 ) other than a Permitted Transfer.  In the event of a Transfer other than a Permitted Transfer, if the use of Hazardous Materials by such new tenant (“ New Tenant ”) is such that New Tenant utilizes fire control areas in the Project in excess of New Tenant’s Pro Rata Share of the Building or the Project, as applicable, then New Tenant shall, at its sole cost and expense and upon Landlord’s written request, establish and maintain a separate area of the Premises classified by the UBC as an “H” occupancy area for the use and storage of Hazardous Materials, or take such other action as is necessary to ensure that its share of the fire control areas of the Building and the Project is not greater than New Tenant’s Pro Rata Share of the Building or the Project, as applicable.

 

22.                                  Odors and Exhaust .  Tenant acknowledges that Landlord would not enter into this Lease with Tenant unless Tenant gave Landlord reasonable assurances that other occupants of the Building or the Project (including persons legally present in any outdoor areas of the Project) will not be subjected to an Odor Nuisance (as defined below), and that the Building and the Project will not be damaged by any exhaust, in each case from Tenant’s operations in the Premises.  Landlord and Tenant therefore agree as follows:

 

22.1                            Tenant shall not cause or conduct any activities that would cause an Odor Nuisance.  For purposes of this Article, an “ Odor Nuisance ” means any release of any offensive or noxious odors or fumes from the Premises, which release (a) is in violation of any Applicable Law, (b) creates a nuisance or (c) materially and adversely impacts any portion of the Building, the Project or the use of any portion of the Building or Project by other tenants.

 

22.2                            If the Building has a ventilation system that, in Landlord’s reasonable judgment is adequate, suitable, and appropriate to vent the Premises in a manner that will prevent an Odor Nuisance, Tenant shall vent the Premises through such system.  If Landlord at any time reasonably determines that any existing ventilation system is inadequate to so vent the Premises, or if no ventilation system exists, Tenant shall in compliance with Applicable Laws vent all fumes and odors from the Premises (and remove odors from Tenant’s exhaust stream) as Landlord requires.  The design, placement and configuration of all ventilation exhaust pipes, louvers and other equipment shall be subject to Landlord’s approval.  Consistent with the foregoing requirements, Landlord acknowledges that Tenant’s intended use of the Premises will require the venting of certain materials and that Tenant intends to install a vent and fume hood in the roof during the construction of the Tenant Improvements (and in accordance with the Work Letter) to accommodate such venting. Tenant acknowledges Landlord’s legitimate desire to maintain the Project (indoor and outdoor areas) in a manner free of any Odor Nuisance and Landlord may require Tenant to abate any such Odor Nuisance in a manner that goes beyond the requirements of Applicable Laws.

 

22.3                            Tenant shall, at Tenant’s sole cost and expense, provide odor eliminators and other devices (such as filters, air cleaners, scrubbers and whatever other equipment may in

 

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Landlord’s judgment be necessary or appropriate from time to time) to completely remove, eliminate and abate any Odor Nuisance.  Any work Tenant performs under this Section shall constitute Alterations.

 

22.4                            Tenant’s responsibility to remove, eliminate and abate any Odor Nuisance shall continue throughout the Term.  Landlord’s approval of the Tenant Improvements shall not preclude Landlord from reasonably requiring additional measures to eliminate any Odor Nuisance.  Tenant shall install additional equipment as Landlord may reasonably require from time to time under the preceding sentence.  Such installations shall constitute Alterations (except that the fourteen (14) day notice periods set forth in Sections 17.1 and 17.5 shall not apply to Alterations pursuant to this Article).

 

22.5                            If, in response to any appropriate demand by Landlord for the installation of odor control equipment or other ventilation equipment, Tenant fails to install satisfactory odor control equipment or otherwise eliminate any Odor Nuisance within ten (10) business days after such demand (the “ Odor Cure Period ”), then Landlord may, without limiting Landlord’s other rights and remedies, require Tenant to cease and suspend any operations in the Premises that, in Landlord’s determination, cause such Odor Nuisance.  Notwithstanding the foregoing, if Tenant’s installation of requested odor control equipment cannot be completed within the Odor Cure Period as a result of Tenant having to order lead time items such as filters, air cleaners, scrubbers and similar equipment, then Landlord shall not require Tenant to cease and suspend operations in the Premises in accordance with this Section so long as Tenant has ordered the lead time items within the Odor Cure Period and thereafter diligently prosecutes the installation of such equipment to completion.

 

23.                                  Insurance; Waiver of Subrogation .

 

23.1                            Landlord shall maintain insurance for the Building and the Project in amounts equal to full replacement cost (exclusive of the costs of excavation, foundations and footings, and without reference to depreciation taken by Landlord upon its books or tax returns), providing protection against any peril generally included within the classification an “all risk” property insurance policy, together with insurance against sprinkler damage (if applicable), vandalism and malicious mischief.  Landlord, subject to availability thereof, shall further insure coverage against flood, environmental hazard, and earthquake, and if Landlord deems it appropriate, loss or failure of building equipment, rental loss during the period of repairs or rebuilding, workmen’s compensation insurance and fidelity bonds for employees employed to perform services.  Notwithstanding the foregoing, Landlord may, but shall not be deemed required to, provide insurance for any improvements installed by Tenant or that are in addition to the standard improvements customarily furnished by Landlord, without regard to whether or not such are made a part of or are affixed to the Building.

 

23.2                            In addition, Landlord shall carry commercial general liability insurance with a single limit of not less than Three Million Dollars ($3,000,000) for death or bodily injury, or property damage with respect to the Project.

 

23.3                            Tenant shall, at its own cost and expense, procure and maintain in effect, beginning on the Term Commencement Date or the date of occupancy, whichever occurs first,

 

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and continuing throughout the Term (and occupancy by Tenant, if any, after termination of this Lease) commercial general liability insurance with limits of not less than Three Million Dollars ($3,000,000) per occurrence for death or bodily injury and for property damage with respect to the Premises (including $100,000 fire legal liability (each loss)).  The foregoing liability coverage may be carried under a single policy or by a combination of underlying policies and excess or umbrella coverage.

 

23.4                            The insurance required to be purchased and maintained by Tenant pursuant to this Lease shall name Landlord, BioMed Realty, L.P., BioMed Realty Trust, Inc. and their respective officers, directors, employees, agents, general partners, members, and subsidiaries (“ Landlord Parties ”) as additional insureds.  Said insurance shall be with companies authorized to do business in the state in which the Project is located and having a rating of not less than policyholder rating of A and financial category rating of at least Class XII in “Best’s Insurance Guide.”  Tenant shall obtain for Landlord from the insurance companies or cause the insurance companies to furnish certificates of coverage to Landlord.  All such policies shall be written as primary policies, not contributing with and not in excess of the coverage that Landlord may carry.  Tenant’s policy may be a “blanket policy” that specifically provides that the amount of insurance shall not be prejudiced by other losses covered by the policy.  Tenant shall, at least five (5) days prior to the expiration of such policies, furnish Landlord with renewals or binders.  Tenant agrees that if Tenant does not take out and maintain such insurance, Landlord may (but shall not be required to) procure said insurance on Tenant’s behalf and at its cost to be paid by Tenant as Additional Rent.

 

23.5                            Intentionally Deleted.

 

23.6                            In each instance where insurance is to name Landlord Parties as additional insureds, Tenant shall, upon Landlord’s written request, also furnish certificates evidencing such Landlord Parties as additional insureds to (a) any Lender of Landlord holding a security interest in the Building, the Property or the Project, (b) the landlord under any ground lease whereunder Landlord is a tenant of the Property if the interest of Landlord is or shall become that of a tenant under a ground lease rather than that of a fee owner and (c) any management company retained by Landlord to manage the Project.

 

23.7                            Notwithstanding anything herein to the contrary, Landlord and Tenant each hereby waive any and all rights of recovery against the other or against the officers, directors, employees, agents, general partners, members, subsidiaries, affiliates and Lenders of the other on account of loss or damage occasioned by such waiving party or its property or the property of others under such waiving party’s control, in each case to the extent that such loss or damage is or is required to be insured against under any fire and extended coverage insurance policy to be obtained by such party under this Lease, regardless of cause or origin, including negligence of the other party hereto, its officers, directors, employees or agents.  Each party covenants that no insurer shall hold any right of subrogation against such other party.  Landlord and Tenant, upon obtaining the policies of insurance required or permitted under this Lease, shall give notice to the insurance carrier or carriers that the foregoing mutual waiver of subrogation is contained in this Lease.  If the release of either Landlord or Tenant, as set forth in the first sentence of this Section, shall contravene Applicable Laws, then the liability of the party in question shall be deemed not released but shall be secondary to the other party’s insurer.

 

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23.8         Landlord may, upon not less than ninety (90) days prior written notice to Tenant, require insurance policy limits required under this Lease to be raised to conform to reasonable coverage limits then being required of new tenants with comparable uses within the Project.

 

23.9         The premiums of any insurance policies obtained by Landlord pursuant to this Article shall be included in Operating Expenses.

 

24.          Damage or Destruction .

 

24.1         In the event of a partial destruction of (a) the Premises or (b) Common Areas of the Building or the Project ((a) and (b) together, the “ Affected Areas ”) by fire or other perils covered by extended coverage insurance not exceeding twenty-five percent (25%) of the full insurable value thereof, and provided that (x) the damage thereto is such that the Affected Areas may be repaired, reconstructed or restored within a period of six (6) months from the date of the Damage Repair Estimate (as determined by the Damage Repair Estimate), (y) Landlord shall receive insurance proceeds sufficient to cover the cost of such repairs, reconstruction and restoration (except for any deductible amount provided by Landlord’s policy, which deductible amount, if paid by Landlord, shall constitute an Operating Expense to the extent provided in Article 9 ) and (z) such casualty was not intentionally caused by Tenant or its employees, agents or contractors, then Landlord shall commence and proceed diligently with the work of repair, reconstruction and restoration of the Affected Areas and this Lease shall continue in full force and effect.

 

24.2         In the event of any damage to or destruction of the Building or the Project other than as described in Section 24.1 , Landlord may elect to repair, reconstruct and restore the Building or the Project, as applicable, in which case this Lease shall continue in full force and effect.  If Landlord elects not to repair, reconstruct and restore the Building or the Project, as applicable, then this Lease shall terminate as of the date of such damage or destruction.  In the event of any damage or destruction (regardless of whether such damage is governed by Section 24.1 or this Section), if (a) the Damage Repair Estimate (as defined below) indicates that the Affected Areas cannot be repaired, reconstructed or restored within twelve (12) months after the date of the Damage Repair Estimate, (b) subject to Section 24.6 , the Affected Areas are not actually repaired, reconstructed and restored within twelve (12) months after the date of the Damage Repair Estimate (the expiration of such twelve (12) month period (as may be extended pursuant to Section 24.6 ), the “ Restoration Deadline ”), or (c) the damage and destruction occurs within the last twelve (12) months of the then-current Term, then Tenant shall have the right to terminate this Lease, effective as of the date of such damage or destruction, by delivering to Landlord its written notice of termination (a “ Termination Notice ”) (y) with respect to Subsections 24.2(a)  and (c) , no later than fifteen (15) days after Landlord delivers to Tenant Landlord’s Damage Repair Estimate and (z) with respect to Subsection 24.2(b) , no later than fifteen (15) days after such twelve (12) month period (as the same may be extended pursuant to Section 24.6 ) expires.  If Tenant provides Landlord with a Termination Notice pursuant to Subsection 24.2(z) , Landlord shall have an additional thirty (30) days after receipt of such Termination Notice to complete the repair, reconstruction and restoration.  If Landlord does not complete such repair, reconstruction and restoration within such thirty (30) day period, then Tenant may terminate this Lease by giving Landlord written notice within two (2) business days after the expiration of such thirty (30) day period.  If Landlord does complete such repair,

 

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reconstruction and restoration within such thirty (30) day period, then this Lease shall continue in full force and effect.

 

24.3         As soon as reasonably practicable, but in any event within thirty (30) days following the date of damage or destruction, Landlord shall notify Tenant of Landlord’s good faith estimate of the period of time in which the repairs, reconstruction and restoration will be completed (the “ Damage Repair Estimate ”), which estimate shall be based upon the opinion of a contractor reasonably selected by Landlord and experienced in comparable repair, reconstruction and restoration of similar buildings.  Additionally, Landlord shall give written notice to Tenant within sixty (60) days following the date of damage or destruction of its election not to repair, reconstruct or restore the Building or the Project, as applicable.

 

24.4         Upon any termination of this Lease under any of the provisions of this Article, the parties shall be released thereby without further obligation to the other from the date that is the later of (a) the date of the damage or destruction and (b) if Tenant occupies the Premises for the conduct of its business after the date of such damage or destruction, the date possession of the Premises is surrendered to Landlord, in each case, except with regard to (y) items occurring prior to the damage or destruction and (z) provisions of this Lease that, by their express terms, survive the expiration or earlier termination hereof.

 

24.5         In the event of repair, reconstruction and restoration as provided in this Article, all Rent to be paid by Tenant under this Lease shall be abated proportionately based on the extent to which Tenant’s use of the Premises is impaired from and after the date of the damage or destruction and during the period of such repair, reconstruction or restoration, unless Landlord provides Tenant with other space during the period of repair, reconstruction or restoration that, in Tenant’s reasonable opinion, is suitable for the temporary conduct of Tenant’s business.

 

24.6         Notwithstanding anything to the contrary contained in this Article, should Landlord be delayed or prevented from completing the repair, reconstruction or restoration of the damage or destruction to the Premises after the occurrence of such damage or destruction by Force Majeure or actual delays caused by Tenant or its employees, agents, contractors or invitees, then the time for Landlord to commence or complete repairs shall be extended on a day-for-day basis; provided , however, that Landlord shall use commercially reasonable efforts to minimize the impact of such Force Majeure.  Notwithstanding anything herein to the contrary, either party, in its discretion, shall have the right to terminate this Lease by delivering written notice of such election to the other party if Force Majeure causes the Restoration Deadline to be extended by one hundred twenty (120) days or more.

 

24.7         If Landlord is obligated to or elects to repair, reconstruct or restore as herein provided, then Landlord shall be obligated to make such repairs, reconstruction or restoration only with regard to (a) those portions of the Premises that were originally provided at Landlord’s expense (including Building Standard improvements paid by the TI Allowance or the Base Expansion TI Allowance) and (b) the Common Area portion of the Affected Areas.  The repair, reconstruction or restoration of improvements not originally provided by Landlord or at Landlord’s expense shall be the obligation of Tenant.  In the event Tenant has elected to upgrade certain improvements from the Building Standard, Landlord shall, upon the need for replacement due to an insured loss, provide only the Building Standard, unless Tenant again elects to upgrade

 

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such improvements and pay any incremental costs related thereto, except to the extent that excess insurance proceeds, if received, are adequate to provide such upgrades, in addition to providing for basic repairs, reconstruction and restoration of the Premises, the Building and the Project.

 

24.8         Notwithstanding anything to the contrary contained in this Article, Landlord shall not have any obligation whatsoever to repair, reconstruct or restore the Premises (a) if damage resulting from any casualty covered under this Article damages or destroys the Affected Areas in whole or in part, and less than thirteen (13) months remains in the Term upon the date of such casualty (unless, with respect to the initial Term, Tenant timely and properly elects to exercise the Option (in accordance with Article 42 ) and, prior to Landlord being otherwise obligated (in accordance with this Article) to make any repairs, reconstruction or restoration, Tenant has agreed in writing that its exercise of the Option is irrevocable notwithstanding any right Tenant has to rescind such Option set forth in Article 42 ) or, with respect to any extension Term, Landlord and Tenant otherwise enter into a written amendment to extend the Term) or (b) to the extent that insurance proceeds are not available therefor.  Landlord shall notify Tenant in writing within thirty (30) days following any casualty described in clause (a) above of its election not to repair, reconstruct or restore the Premises pursuant to this Section.  Landlord shall promptly notify Tenant in writing if Landlord at any time determines that insurance proceeds are not available or are not sufficient for repair, reconstruction or restoration that Landlord is obligated or has elected to make in accordance with this Article and Landlord does not elect (which election shall be in writing and in Landlord’s sole discretion) to contribute any remaining shortfall with respect to such obligated repair, reconstruction or restoration (except for any deductible amount provided by Landlord’s policy, which deductible amount, if paid by Landlord, shall constitute an Operating Expense to the extent provided in Article 9 ) towards such repair, reconstruction or restoration, in which event, Tenant shall have the right to terminate this Lease upon written notice to Landlord.

 

24.9         Landlord’s obligation, should it elect or be obligated to repair, reconstruct or restore, shall be limited to the Affected Areas described in Section 24.7 .  Tenant shall, at its expense, replace or fully repair all of Tenant’s personal property and any Alterations installed by Tenant existing at the time of such damage or destruction.  If Affected Areas are to be repaired, reconstructed or restored in accordance with the foregoing, Landlord shall make available to Tenant any portion of insurance proceeds it receives that are allocable to the Alterations constructed by Tenant pursuant to this Lease; provided Tenant is not then in default under this Lease, and subject to the requirements of any Lender of Landlord.

 

25.          Eminent Domain .

 

25.1         In the event (a) the whole of all Affected Areas or (b) such part thereof as shall substantially interfere with Tenant’s use and occupancy of the Premises for the Permitted Use shall be taken for any public or quasi-public purpose by any lawful power or authority by exercise of the right of appropriation, condemnation or eminent domain, or sold to prevent such taking, Tenant or Landlord may terminate this Lease effective as of the date possession is required to be surrendered to such authority, except with regard to (y) items occurring prior to the taking and (z) provisions of this Lease that, by their express terms, survive the expiration or earlier termination hereof.  Either party shall notify the other party in writing of its election to

 

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terminate within thirty (30) days after the date possession is surrendered to said authority.

 

25.2         In the event of a partial taking of (a) the Building or the Project or (b) drives, walkways or parking areas serving the Building or the Project for any public or quasi-public purpose by any lawful power or authority by exercise of right of appropriation, condemnation, or eminent domain, or sold to prevent such taking, then, without regard to whether any portion of the Premises occupied by Tenant was so taken, Landlord may elect to terminate this Lease (except with regard to (y) items occurring prior to the taking and (z) provisions of this Lease that, by their express terms, survive the expiration or earlier termination hereof) as of such taking if such taking is, in Landlord’s sole opinion, of a material nature such as to make it uneconomical to continue use of the unappropriated portion for purposes of renting office or laboratory space.

 

25.3         Tenant shall be entitled to any award that is specifically awarded as compensation for (a) the taking of Tenant’s personal property that was installed at Tenant’s expense, (b) the costs of Tenant moving to a new location and (c) other leasehold damages suffered by Tenant and compensable by Applicable Law as set forth in the specific award.  Except as set forth in the previous sentence, any award for such taking shall be the property of Landlord.

 

25.4         If, upon any taking of the nature described in this Article, this Lease continues in effect, then Landlord shall promptly proceed to restore the Affected Areas to substantially their same condition prior to such partial taking, if feasible.  Rent shall be decreased proportionately to reflect the loss of any portion of the Premises no longer available to Tenant from the date such space is taken until such portion is restored.

 

26.          Surrender .

 

26.1         At least ten (10) days prior to Tenant’s surrender of possession of any part of the Premises, Tenant shall provide Landlord with (a) a facility decommissioning and Hazardous Materials closure plan for the Premises (“ Exit Survey ”) prepared by an independent third party reasonably acceptable to Landlord, (b) written evidence of all appropriate governmental releases obtained by Tenant in accordance with Applicable Laws, including laws pertaining to the surrender of the Premises, and (c) proof that the Premises have been decommissioned in accordance with American National Standards Institute (“ ANSI ”) Publication Z9.11-2008 (entitled “Laboratory Decommissioning”) or any successor standards published by ANSI or any successor organization (or, if ANSI and its successors no longer exist, a similar entity publishing similar standards).  In addition, Tenant agrees to remain responsible after the surrender of the Premises for the remediation of any recognized environmental conditions set forth in the Exit Survey and compliance with any recommendations set forth in the Exit Survey, in each case to the extent such condition is the responsibility of Tenant pursuant to this Lease.  Tenant’s obligations under this Section shall survive the expiration or earlier termination of the Lease.

 

26.2         No surrender of possession of any part of the Premises shall release Tenant from any of its obligations hereunder, unless (a) with respect to any surrender during the Term (other than pursuant to Section 3.1 ), such surrender is accepted in writing by Landlord or (b) with respect to any surrender upon the expiration or earlier termination of the Term (including pursuant to Section 3.1 ), such surrender complies with all applicable provisions of this Lease.  In no event shall Landlord be deemed to accept Tenant’s surrender of possession unless such

 

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surrender complies with all applicable provisions of this Lease.

 

26.3         The voluntary or other surrender of this Lease by Tenant shall not effect a merger with Landlord’s fee title or leasehold interest in the Premises, the Building, the Property or the Project, unless Landlord consents in writing, and shall, at Landlord’s option, operate as an assignment to Landlord of any or all subleases.

 

26.4         The voluntary or other surrender of any ground or other underlying lease that now exists or may hereafter be executed affecting the Building or the Project, or a mutual cancellation thereof or of Landlord’s interest therein by Landlord and its lessor shall not effect a merger with Landlord’s fee title or leasehold interest in the Premises, the Building or the Property and shall, at the option of the successor to Landlord’s interest in the Building or the Project, as applicable, operate as an assignment of this Lease.

 

27.          Holding Over .

 

27.1         If, with Landlord’s prior written consent, Tenant holds possession of all or any part of the Premises after the Term, Tenant shall become a tenant from month to month after the expiration or earlier termination of the Term, and in such case Tenant shall continue to pay (a) Base Rent in accordance with Article 7 , and (b) any amounts for which Tenant would otherwise be liable under this Lease if the Lease were still in effect, including payments for Tenant’s Share of Operating Expenses.  Any such month-to-month tenancy shall be subject to every other term, covenant and agreement contained herein.

 

27.2         Notwithstanding the foregoing, if Tenant remains in possession of the Premises after the expiration or earlier termination of the Term without Landlord’s prior written consent, (a) Tenant shall become a tenant at sufferance subject to the terms and conditions of this Lease, except that the monthly Base Rent shall be equal to one hundred fifty percent (150%) of the Base Rent in effect during the last thirty (30) days of the Term, and (b) Tenant shall be liable to Landlord for any and all damages suffered by Landlord as a result of any such holdover continuing for thirty (30) days (provided, that Landlord has provided thirty (30) days prior written notice to Tenant that any such damages may occur), including any lost rent or consequential, special and indirect damages.

 

27.3         Acceptance by Landlord of Rent after the expiration or earlier termination of the Term shall not result in an extension, renewal or reinstatement of this Lease.

 

27.4         The foregoing provisions of this Article are in addition to and do not affect Landlord’s right of reentry or any other rights of Landlord hereunder or as otherwise provided by Applicable Laws.

 

28.          Indemnification and Exculpation .

 

28.1         Tenant agrees to indemnify, save, defend and hold the Landlord Indemnitees harmless from and against any and all Claims arising from injury or death to any person or damage to any property occurring within or about the Premises, the Building, the Property or the Project arising out of Tenant’s or Tenant’s employees’, agents’, contractors’ or invitees’ use or occupancy of the Premises or a breach or default by Tenant in the performance of any of its

 

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obligations hereunder, except to the extent caused by Landlord’s negligence or willful misconduct.

 

28.2         Notwithstanding anything in this Lease to the contrary, but without limiting Sections 16.2 and 18.3 , Landlord shall not be liable to Tenant for and Tenant assumes all risk of (a) damage or losses caused by fire, electrical malfunction, gas explosion, water damage of any type (including broken water lines, malfunctioning fire sprinkler systems, roof leaks or stoppages of lines), unless any such loss is due to Landlord’s willful disregard of written notice by Tenant of need for a repair that Landlord is responsible to make for an unreasonable period of time, and (b) damage to personal property or scientific research, including loss of records kept by Tenant within the Premises.  Tenant further waives any claim for injury to Tenant’s business or loss of income relating to any such damage or destruction of personal property as described in this Section.

 

28.3         Without limiting the obligations of Landlord in Section 18.1 , Landlord shall not be liable for any damages arising from any act, omission or neglect of any other tenant in the Building or the Project, or of any other third party.

 

28.4         Tenant acknowledges that security devices and services, if any, while intended to deter crime, may not in given instances prevent theft or other criminal acts.  Landlord shall not be liable for injuries or losses caused by criminal acts of third parties, and Tenant assumes the risk that any security device or service may malfunction or otherwise be circumvented by a criminal.  If Tenant desires protection against such criminal acts, then Tenant shall, at Tenant’s sole cost and expense, obtain appropriate insurance coverage.

 

28.5         The provisions of this Article shall survive the expiration or earlier termination of this Lease.

 

29.          Assignment or Subletting .

 

29.1         Except as hereinafter expressly permitted, Tenant shall not, either voluntarily or by operation of Applicable Laws, directly or indirectly sell, hypothecate, assign, pledge, encumber or otherwise transfer this Lease, or sublet the Premises (each, a “ Transfer ”), without Landlord’s prior written consent.  In no event shall Tenant perform a Transfer to or with an entity that is a tenant at the Project or that is in discussions or negotiations with Landlord or an affiliate of Landlord to lease premises at the Project.  Notwithstanding the foregoing, Tenant may assign all of its interest in this Lease or sublet any or all of the Premises without the consent of Landlord to any of the following entities (each, a “ Permitted Transferee ” and such Transfer to a Permitted Transferee, a “ Permitted Transfer ”): (a) any entity controlling, controlled by or under common control with Tenant; (b) any successor entity resulting from a merger, acquisition or consolidation with or a conversion of Tenant; or (c) any entity which acquires all or substantially all of the assets of Tenant.  For purposes of Permitted Transfers, “control” requires both (y) owning (directly or indirectly) more than fifty percent (50%) of the stock or other equity interests of another person and (z) possessing, directly or indirectly, the power to direct or cause the direction of the management and policies of such person.  Tenant shall give Landlord prompt written notice of the occurrence of any Permitted Transfer and shall provide evidence reasonably satisfactory to Landlord that such Transfer qualifies as a Permitted Transfer.  Such notice shall

 

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be given in writing at least ten (10) days prior to the effectiveness of such Permitted Transfer; provided , however, that if prior notice is not (as reasonably determined by Tenant) permitted by Applicable Laws or an obligation of confidentiality, then Tenant shall notify Landlord promptly after the effectiveness of such Permitted Transfer, but in no event more than four (4) days after the effectiveness of such Permitted Transfer.

 

29.2         In the event Tenant desires to effect a Transfer (other than a Permitted Transfer), then, at least thirty (30) but not more than ninety (90) days prior to the date when Tenant desires the assignment or sublease to be effective (the “ Transfer Date ”), Tenant shall provide written notice to Landlord (the “ Transfer Notice ”) containing information (including references) concerning the character of the proposed transferee, assignee or sublessee; the Transfer Date; any ownership or commercial relationship between Tenant and the proposed transferee, assignee or sublessee; and the consideration and all other material terms and conditions of the proposed Transfer, all in such detail as Landlord shall reasonably require.

 

29.3         Landlord, in determining whether consent should be given to a proposed Transfer, may give consideration to (a) the financial strength of such transferee, assignee or sublessee (notwithstanding Tenant remaining liable for Tenant’s performance), (b) any change in use that such transferee, assignee or sublessee proposes to make in the use of the Premises and (c) Landlord’s desire to exercise its rights under Section 29.8 to cancel this Lease.  Landlord shall not unreasonably withhold or condition its consent to any assignment or subletting of the Premises, provided that in no event shall Landlord be deemed to be unreasonable for declining to consent to a Transfer (i) to a transferee or assignee that lacks the reputation or financial qualifications that satisfy the criteria Landlord uses to select tenants of the Project having similar leasehold obligations, or to a transferee, assignee or sublessee seeking a change in the Permitted Use, or (ii) jeopardizing directly or indirectly the status of Landlord or any of Landlord’s affiliates as a Real Estate Investment Trust under the Internal Revenue Code of 1986 (as the same may be amended from time to time, the “ Revenue Code ”).  Notwithstanding anything contained in this Lease to the contrary, (w) no Transfer shall be consummated on any basis such that the rental or other amounts to be paid by the occupant, assignee, manager or other transferee thereunder would be based, in whole or in part, on a percentage of the income or profits derived by the business activities of such occupant, assignee, manager or other transferee; (x) Tenant shall not furnish or render any services to an occupant, assignee, manager or other transferee with respect to whom transfer consideration is required to be paid, or manage or operate the Premises or any capital additions so transferred, with respect to which transfer consideration is being paid; (y) Tenant shall not consummate a Transfer with any person in which Landlord owns an interest, directly or indirectly (by applying constructive ownership rules set forth in Section 856(d)(5) of the Revenue Code); and (z) Tenant shall not consummate a Transfer with any person or in any manner that could cause any portion of the amounts received by Landlord pursuant to this Lease or any sublease, license or other arrangement for the right to use, occupy or possess any portion of the Premises to fail to qualify as “rents from real property” within the meaning of Section 856(d) of the Revenue Code, or any similar or successor provision thereto or which could cause any other income of Landlord to fail to qualify as income described in Section 856(c)(2) of the Revenue Code.

 

29.4         As conditions precedent to a Transfer or to Landlord considering a request by Tenant to a Transfer, Tenant shall provide Landlord with the following:

 

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(a)           Tenant shall remain fully liable under this Lease during the unexpired Term;

 

(b)           Tenant shall provide Landlord with evidence reasonably satisfactory to Landlord of the relevant business experience and financial responsibility and status of the proposed transferee, assignee or sublessee;

 

(c)           Tenant shall reimburse Landlord for Landlord’s actual costs and expenses (including reasonable attorneys’ fees, charges and disbursements incurred in connection with the review, processing and documentation of such request), not to exceed Two Thousand Five Hundred Dollars ($2,500) per proposed Transfer;

 

(d)           If Tenant’s transfer of rights or sharing of the Premises provides for the receipt by, on behalf of or on account of Tenant of any consideration of any kind whatsoever (including a premium rental for a sublease or lump sum payment for an assignment, but excluding Tenant’s reasonable costs in marketing and subleasing the Premises) in excess of the rental and other charges due to Landlord under this Lease, then after Tenant has recovered all reasonable marketing expenses, tenant improvement funds expended by Tenant, alterations, cash concessions, brokerage commissions, attorneys’ fees and free rent actually paid by Tenant, Tenant shall pay fifty percent (50%) of all of such excess to Landlord as and when Tenant receives such payments from the assignee, transferee or sublessee; provided, however, no such excess shall be payable to Landlord in connection with a Permitted Transfer.  If said consideration consists of cash paid to Tenant, payment to Landlord shall be made upon receipt by Tenant of such cash payment;

 

(e)           Any proposed transferee, assignee or sublessee shall agree that, in the event Landlord gives such proposed transferee, assignee or sublessee notice that Tenant is in default under this Lease, such proposed transferee, assignee or sublessee shall thereafter make all payments otherwise due Tenant directly to Landlord, which payments shall be received by Landlord without any liability being incurred by Landlord, except to credit such payment against those due by Tenant under this Lease, and any such proposed transferee, assignee or sublessee shall agree to attorn to Landlord or its successors and assigns should this Lease be terminated for any reason; provided , however, that in no event shall Landlord or its Lenders, successors or assigns be obligated to accept such attornment (and, if such attornment is rejected, then such sublessee shall be entitled to terminate its sublease);

 

(f)            Landlord’s consent to any such Transfer shall be effected on Landlord’s forms, with such reasonable and customary revisions thereto as Landlord, Tenant and such proposed transferee, assignee or sublessee may agree;

 

(g)           Tenant shall not then be in monetary default or any other Default under any provisions of this Lease;

 

(h)           Such proposed transferee, assignee or sublessee’s use of the Premises shall be the same as the Permitted Use, except as otherwise agreed by Landlord, in its sole and absolute discretion;

 

(i)            Landlord shall not be bound by any provision of any agreement pertaining

 

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to the Transfer, except for Landlord’s written consent to the same;

 

(j)            Tenant shall pay all transfer and other taxes (including interest and penalties) assessed or payable for any Transfer;

 

(k)           Landlord’s consent (or waiver of its rights) for any Transfer shall not waive Landlord’s right to consent to any later Transfer;

 

(l)            Tenant shall deliver to Landlord one executed copy of any and all written instruments evidencing the Transfer; and

 

(m)          A list of Hazardous Materials (as defined in Section 21.7 ), certified by the proposed transferee, assignee or sublessee to be true and correct, that the proposed transferee, assignee or sublessee intends to use or store in the Premises.  Additionally, Tenant shall deliver to Landlord, on or before the date any proposed transferee, assignee or sublessee takes occupancy of the Premises, all of the items relating to Hazardous Materials of such proposed transferee, assignee or sublessee as described in Section 21.2 .

 

29.5         Any Transfer that is not in compliance with the provisions of this Article shall be void and shall, at the option of Landlord, terminate this Lease.

 

29.6         The consent by Landlord to a Transfer shall not relieve Tenant or proposed transferee, assignee or sublessee from obtaining Landlord’s consent to any further Transfer, nor shall it release Tenant or any proposed transferee, assignee or sublessee of Tenant from full and primary liability under this Lease.

 

29.7         Notwithstanding any Transfer, Tenant shall remain fully and primarily liable for the payment of all Rent and other sums due or to become due hereunder, and for the full performance of all other terms, conditions and covenants to be kept and performed by Tenant.  The acceptance of Rent or any other sum due hereunder, or the acceptance of performance of any other term, covenant or condition thereof, from any person or entity other than Tenant shall not be deemed a waiver of any of the provisions of this Lease or a consent to any Transfer.

 

29.8         Except with respect to a Permitted Transfer, if Tenant delivers to Landlord a Transfer Notice indicating a desire to transfer fifty percent (50%) or more of the Premises in this Lease to a proposed transferee, assignee or sublessee other than as provided within Section 29.4 , then Landlord shall have the option, exercisable by giving notice to Tenant at any time within ten (10) days after Landlord’s receipt of such Transfer Notice, to terminate this Lease as of the date specified in the Transfer Notice as the Transfer Date, except for those provisions that, by their express terms, survive the expiration or earlier termination hereof.  If Landlord exercises such option, then Tenant shall have the right to withdraw such Transfer Notice by delivering to Landlord written notice of such election within five (5) days after Landlord’s delivery of notice electing to exercise Landlord’s option to terminate this Lease.  In the event Tenant withdraws the Transfer Notice as provided in this Section, this Lease shall continue in full force and effect.  No failure of Landlord to exercise its option to terminate this Lease shall be deemed to be Landlord’s consent to a proposed Transfer.

 

29.9         If Tenant sublets the Premises or any portion thereof, Tenant hereby immediately

 

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and irrevocably assigns to Landlord, as security for Tenant’s obligations under this Lease, all rent from any such subletting, and appoints Landlord as assignee and attorney-in-fact for Tenant, and Landlord (or a receiver for Tenant appointed on Landlord’s application) may collect such rent and apply it toward Tenant’s obligations under this Lease; provided that, until the occurrence of a Default (as defined below) by Tenant, Tenant shall have the right to collect such rent.

 

30.          Subordination and Attornment .

 

30.1         Subject to Section 30.5 , this Lease shall be subject and subordinate to the lien of any mortgage, deed of trust, or ground lease in which Landlord is tenant now or hereafter in force against the Building or the Project and to all advances made or hereafter to be made upon the security thereof without the necessity of the execution and delivery of any further instruments on the part of Tenant to effectuate such subordination.

 

30.2         Notwithstanding the foregoing, solely in confirmation of the foregoing subordination, Tenant shall execute and deliver upon demand such reasonable and customary further instrument or instruments evidencing such subordination of this Lease to the lien of any such mortgage or mortgages or deeds of trust or ground lease in which Landlord is tenant as may be required by Landlord.  If any such mortgagee, beneficiary or landlord under a lease wherein Landlord is tenant (each, a “ Mortgagee ”) so elects, however, this Lease shall be deemed prior in lien to any such lease, mortgage, or deed of trust upon or including the Premises regardless of date and Tenant shall execute a statement in writing to such effect at Landlord’s request.  If Tenant fails to execute any document described in the first sentence of this Section 30.2 within ten (10) days after written request therefor, Tenant hereby constitutes and appoints Landlord or its special attorney-in-fact to execute and deliver any such document or documents in the name of Tenant.  Such power is coupled with an interest and is irrevocable.

 

30.3         Upon written request of Landlord and opportunity for Tenant to review, Tenant agrees to execute any Lease amendments that do not materially alter the terms of this Lease or in any way materially adversely affect or impair the rights of Tenant or materially reduce the obligations of Landlord hereunder, if reasonably required by a mortgagee or beneficiary of a deed of trust encumbering real property of which the Premises constitute a part incident to the financing of the real property of which the Premises constitute a part.

 

30.4         In the event any proceedings are brought for foreclosure, or in the event of the exercise of the power of sale under any mortgage or deed of trust made by Landlord covering the Premises, Tenant shall at the election of the purchaser at such foreclosure or sale attorn to the purchaser upon any such foreclosure or sale and recognize such purchaser as Landlord under this Lease.

 

30.5         Notwithstanding the foregoing, Tenant shall not be obligated to subordinate this Lease (nor shall this Lease be subordinate) to any mortgage, deed of trust or ground lease, or to attorn to any successor landlord, unless Landlord and the lender, trustee or lessor under such mortgage, deed of trust, or ground lease, as the case may be, and Tenant execute a commercially reasonable subordination, non-disturbance and attornment agreement (“ SNDA ”) wherein Tenant’s occupancy under the terms of this Lease shall be undisturbed.

 

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31.                                  Defaults and Remedies .

 

31.1                            Late payment by Tenant to Landlord of Rent and other sums due shall cause Landlord to incur costs not contemplated by this Lease, the exact amount of which shall be extremely difficult and impracticable to ascertain.  Such costs include processing and accounting charges and late charges that may be imposed on Landlord by the terms of any mortgage or trust deed covering the Premises.  Therefore, if any installment of Rent due from Tenant is not received by Landlord within five (5) days after the date such payment is due (provided that, with respect to the first (1 st ) late payment in any twelve (12) month period, the following late charges shall not commence to accrue until ten (10) days after the date such payment is due), Tenant shall pay to Landlord (a) an additional sum of six percent (6%) of the overdue Rent as a late charge plus (b) interest (from and after the expiration of such five (5) day (or ten (10) day, if applicable) period) at an annual rate (the “ Default Rate ”) equal to the lesser of (a) twelve percent (12%) and (b) the highest rate permitted by Applicable Laws.  The parties agree that this late charge represents a fair and reasonable estimate of the costs that Landlord shall incur by reason of late payment by Tenant and shall be payable as Additional Rent to Landlord due with the next installment of Rent or within five (5) business days after Landlord’s demand, whichever is earlier.  Landlord’s acceptance of any Additional Rent (including a late charge or any other amount hereunder) shall not be deemed an extension of the date that Rent is due or prevent Landlord from pursuing any other rights or remedies under this Lease, at law or in equity.

 

31.2                            No payment by Tenant or receipt by Landlord of a lesser amount than the Rent payment herein stipulated shall be deemed to be other than on account of the Rent, nor shall any endorsement or statement on any check or any letter accompanying any check or payment as Rent 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 Rent or pursue any other remedy provided in this Lease or in equity or at law.  If a dispute shall arise as to any amount or sum of money to be paid by Tenant to Landlord hereunder, Tenant shall have the right to make payment “under protest,” such payment shall not be regarded as a voluntary payment, and there shall survive the right on the part of Tenant to institute suit for recovery of the payment paid under protest.

 

31.3                            If Tenant fails to pay any sum of money required to be paid by it hereunder, or shall fail to perform any other act on its part to be performed hereunder, in each case within the applicable cure period (if any) described in Section 31.4 , then Landlord may, without waiving or releasing Tenant from any obligations of Tenant, but shall not be obligated to, make such payment or perform such act (and prior to making such payment or performing such act may require Tenant to increase the Security Deposit to include Landlord’s estimate of the cost of such payment or performance by Landlord); provided that such failure by Tenant unreasonably interfered with the use of the Building or the Project by any other tenant or with the efficient operation of the Building or the Project, or resulted or was reasonably likely (in Landlord’s reasonable determination) to result in a violation of Applicable Laws or the cancellation of an insurance policy maintained by Landlord.  Notwithstanding the foregoing, in the event of an emergency, Landlord shall have the right to enter the Premises and act in accordance with its rights as provided elsewhere in this Lease.  In addition to the late charge described in Section 31.1 , Tenant shall pay to Landlord as Additional Rent all out-of-pocket sums so paid or reasonably incurred by Landlord, together with interest at the Default Rate, computed from the

 

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date such sums were paid or incurred.

 

31.4                            The occurrence of any one or more of the following events shall constitute a “ Default ” hereunder by Tenant:

 

(a)                                   Tenant abandons the Premises;

 

(b)                                  Tenant fails to make any payment of Rent, as and when due, or to satisfy its obligations under Article 19 , where such failure shall continue for a period of three (3) business days after written notice thereof from Landlord to Tenant;

 

(c)                                   Tenant fails to observe or perform any obligation or covenant contained herein (other than described in Subsections 31.4(a) and 31.4(b) ) to be performed by Tenant, where such failure continues for a period of thirty (30) days after written notice thereof from Landlord to Tenant; provided that, if the nature of Tenant’s default is such that it reasonably requires more than thirty (30) days to cure, Tenant shall not be deemed to be in Default if Tenant commences such cure within said thirty (30) day period and thereafter diligently prosecute the same to completion; and provided , further, that such cure is completed no later than ninety (90) days after Tenant’s receipt of written notice from Landlord;

 

(d)                                  Tenant makes an assignment for the benefit of creditors;

 

(e)                                   A receiver, trustee or custodian is appointed to or does take title, possession or control of all or substantially all of Tenant’s assets (a “ Receivership ”) (provided that if such Receivership is involuntary, Tenant shall not be in Default unless the Receivership is not dissolved within one hundred twenty (120) days);

 

(f)                                     Tenant files a voluntary petition under the United States Bankruptcy Code or any successor statute (as the same may be amended from time to time, the “ Bankruptcy Code ”) or an order for relief is entered against Tenant pursuant to a voluntary or involuntary proceeding commenced under any chapter of the Bankruptcy Code;

 

(g)                                  Any involuntary petition is filed against Tenant under any chapter of the Bankruptcy Code and is not dismissed within one hundred twenty (120) days;

 

(h)                                  Tenant fails to deliver an estoppel certificate within five (5) days after the reminder notice as set forth in Article 20 ; or

 

(i)                                      Tenant’s interest in this Lease is attached, executed upon or otherwise judicially seized and such action is not released within one hundred twenty (120) days of the action.

 

Notices given under this Section shall specify the alleged default and shall demand that Tenant perform the provisions of this Lease or pay the Rent that is in arrears, as the case may be, within the applicable period of time, or quit the Premises.  No such notice shall be deemed a forfeiture or a termination of this Lease unless Landlord elects otherwise in such notice.

 

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31.5                            In the event of a Default by Tenant, and at any time thereafter, with or without notice or demand and without limiting Landlord in the exercise of any right or remedy that Landlord may have, Landlord has the right to do any or all of the following:

 

(a)                                   Halt any Tenant Improvements and Alterations and order Tenant’s contractors, subcontractors, consultants, designers and material suppliers to stop work;

 

(b)                                  Terminate Tenant’s right to possession of the Premises by written notice to Tenant or by any lawful means, in which case Tenant shall immediately surrender possession of the Premises to Landlord.  In such event, Landlord shall have the immediate right to re-enter and remove all persons and property, and such property may be removed and stored in a public warehouse or elsewhere at the cost and for the account of Tenant, all without service of notice or resort to legal process and without being deemed guilty of trespass or becoming liable for any loss or damage that may be occasioned thereby; and

 

(c)                                   Terminate this Lease, in which event Tenant shall immediately surrender possession of the Premises to Landlord.  In such event, Landlord shall have the immediate right to re-enter and remove all persons and property, and such property may be removed and stored in a public warehouse or elsewhere at the cost and for the account of Tenant, all without service of notice or resort to legal process and without being deemed guilty of trespass or becoming liable for any loss or damage that may be occasioned thereby.  In the event that Landlord shall elect to so terminate this Lease, then Landlord shall be entitled to recover from Tenant all damages incurred by Landlord by reason of Tenant’s default, including the following:

 

(i)                                      The worth at the time of award of any unpaid Rent that had accrued at the time of such termination; plus

 

(ii)                                   The worth at the time of award of the amount by which the unpaid Rent that would have accrued during the period commencing with termination of the Lease and ending at the time of award exceeds that portion of the loss of Landlord’s rental income from the Premises that Tenant proves could have been reasonably avoided; plus

 

(iii)                                The worth at the time of award of the amount by which the unpaid Rent for the balance of the Term after the time of award exceeds that portion of the loss of Landlord’s rental income from the Premises that Tenant proves could have been reasonably avoided; plus

 

(iv)                               Any other amount necessary to compensate Landlord for all the detriment caused by Tenant’s failure to perform its obligations under this Lease or that in the ordinary course of things would be likely to result therefrom, including the cost of restoring the Premises to the condition required under the terms of this Lease; plus

 

(v)                                  At Landlord’s election, such other amounts in addition to or in lieu of the foregoing as may be permitted from time to time by Applicable Laws.

 

As used in Subsections 31.5(c)(i)  and 31.5(c)(ii) , “worth at the time of award” shall be computed by allowing interest at the Default Rate.  As used in Subsection 31.5(c)(iii) , the “worth at the time of the award” shall be computed by taking the present value of such amount, using the

 

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discount rate of the Federal Reserve Bank of San Francisco at the time of the award plus one (1) percentage point.

 

31.6                            In addition to any other remedies available to Landlord at law or in equity and under this Lease, Landlord shall have the remedy described in California Civil Code Section 1951.4 and may continue this Lease in effect after Tenant’s Default and abandonment and recover Rent as it becomes due, provided Tenant has the right to sublet or assign, subject only to reasonable limitations.  In addition, Landlord shall not be liable in any way whatsoever for its failure or refusal to relet the Premises.  For purposes of this Section, the following acts by Landlord will not constitute the termination of Tenant’s right to possession of the Premises:

 

(a)                                   Acts of maintenance or preservation or efforts to relet the Premises, including alterations, remodeling, redecorating, repairs, replacements or painting as Landlord shall consider advisable for the purpose of reletting the Premises or any part thereof; or

 

(b)                                  The appointment of a receiver upon the initiative of Landlord to protect Landlord’s interest under this Lease or in the Premises.

 

Notwithstanding the foregoing, in the event of a Default by Tenant, Landlord may elect at any time to terminate this Lease and to recover damages to which Landlord is entitled.

 

31.7                            If Landlord does not elect to terminate this Lease as provided in Section 31.5 , then Landlord may, from time to time, recover all Rent as it becomes due under this Lease.  At any time thereafter, Landlord may elect to terminate this Lease and to recover damages to which Landlord is entitled.

 

31.8                            In the event Landlord elects to terminate this Lease and relet the Premises, Landlord may execute any new lease in its own name.  Tenant hereunder shall have no right or authority whatsoever to collect any Rent from such tenant.  The proceeds of any such reletting shall be applied as follows:

 

(a)                                   First, to the payment of any indebtedness other than Rent due hereunder from Tenant to Landlord, including storage charges or brokerage commissions owing from Tenant to Landlord as the result of such reletting;

 

(b)                                  Second, to the payment of the costs and expenses of reletting the Premises, including (i) alterations and repairs that Landlord deems reasonably necessary and advisable and (ii) reasonable attorneys’ fees, charges and disbursements incurred by Landlord in connection with the retaking of the Premises and such reletting;

 

(c)                                   Third, to the payment of Rent and other charges due and unpaid hereunder; and

 

(d)                                  Fourth, to the payment of future Rent and other damages payable by Tenant under this Lease.

 

31.9                            All of Landlord’s rights, options and remedies hereunder shall be construed and held to be nonexclusive and cumulative.  Landlord shall have the right to pursue any one or all of

 

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such remedies, or any other remedy or relief that may be provided by Applicable Laws, whether or not stated in this Lease.  No waiver of any default of Tenant hereunder shall be implied from any acceptance by Landlord of any Rent or other payments due hereunder or any omission by Landlord to take any action on account of such default if such default persists or is repeated, and no express waiver shall affect defaults other than as specified in such waiver.  Notwithstanding any provision of this Lease to the contrary, in no event shall Landlord be required to mitigate its damages with respect to any default by Tenant except to the extent required by Applicable Law.

 

31.10                      Landlord’s termination of (a) this Lease or (b) Tenant’s right to possession of the Premises shall not relieve Tenant of any liability to Landlord that has previously accrued or that shall arise based upon events that occurred prior to the later to occur of (i) the date of Lease termination or (ii) the date Tenant surrenders possession of the Premises.

 

31.11                      To the extent permitted by Applicable Laws, Tenant waives any and all rights of redemption granted by or under any present or future Applicable Laws if Tenant is evicted or dispossessed for any cause, or if Landlord obtains possession of the Premises due to Tenant’s default hereunder or otherwise.

 

31.12                      Without limiting Section 16.2 , Landlord shall not be in default or liable for damages under this Lease unless Landlord fails to perform obligations required of Landlord within a reasonable time, but in no event shall such failure continue for more than thirty (30) days after written notice from Tenant specifying the nature of Landlord’s failure; provided , however, that if the nature of Landlord’s obligation is such that more than thirty (30) days are required for its performance, then Landlord shall not be in default if Landlord commences performance within such thirty (30) day period and thereafter diligently prosecutes the same to completion.  In no event shall Tenant have the right to terminate or cancel this Lease or to withhold or abate rent or to set off any Claims against Rent as a result of any default or breach by Landlord of any of its covenants, obligations, representations, warranties or promises hereunder, except as may otherwise be expressly set forth in this Lease.

 

31.13                      In the event of any default by Landlord, Tenant shall give notice by registered or certified mail to any (a) beneficiary of a deed of trust or (b) mortgagee under a mortgage covering the Premises, the Building or the Project and to any landlord of any lease of land upon or within which the Premises, the Building or the Project is located, and shall offer such beneficiary, mortgagee or landlord a reasonable opportunity to cure the default, including time to obtain possession of the Building or the Project by power of sale or a judicial action if such should prove necessary to effect a cure; provided that Tenant shall be obligated to provide the notices described in clauses (a) and (b) above only to the extent Landlord has furnished to Tenant in writing the names and addresses of the parties described in clauses (a) and (b) who are to receive such notices.  Notwithstanding the foregoing, to the extent of any conflict between this Section and the terms of an executed SNDA pursuant to Section 30.5 , the terms of such SNDA shall control (but only with respect to the parties of such SNDA).

 

31.14                      Notwithstanding anything in the foregoing or this Lease to the contrary, except (y) as otherwise provided in Article 27 or (z) in the event of Tenant’s breach of Article 21 , in no event shall Landlord or Tenant be liable to the other for any consequential, special or indirect damages arising out of this Lease.

 

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32.                                  Bankruptcy .  In the event a debtor, trustee or debtor in possession under the Bankruptcy Code, or another person with similar rights, duties and powers under any other Applicable Laws, proposes to cure any default under this Lease or to assume or assign this Lease and is obliged to provide adequate assurance to Landlord that (a) a default shall be cured, (b) Landlord shall be compensated for its damages arising from any breach of this Lease and (c) future performance of Tenant’s obligations under this Lease shall occur, then such adequate assurances shall include any or all of the following, as designated by Landlord in its sole and absolute discretion:

 

32.1                            Those acts specified in the Bankruptcy Code or other Applicable Laws as included within the meaning of “adequate assurance,” even if this Lease does not concern a shopping center or other facility described in such Applicable Laws;

 

32.2                            A prompt cash payment to compensate Landlord for any monetary defaults or actual damages arising directly from a breach of this Lease;

 

32.3                            A cash deposit in an amount at least equal to the then-current amount of the Security Deposit; or

 

32.4                            The assumption or assignment of all of Tenant’s interest and obligations under this Lease.

 

33.                                  Brokers .

 

33.1                            Tenant represents and warrants that it has had no dealings with any real estate broker or agent in connection with the negotiation of this Lease other than CBRE (“ Tenant Broker ”), who represents Tenant, and that it knows of no other real estate broker or agent other than Tenant Broker and Landlord Broker (as defined below) that is or might be entitled to a commission in connection with this Lease.  Landlord represents and warrants that it has had no dealings with any real estate broker or agent in connection with the negotiation of this Lease, other than Kidder Mathews (“ Landlord Broker ”), who represents Landlord, and that it knows of no other real estate broker or agent other than Landlord Broker and Tenant Broker that is or might be entitled to a commission in connection with this Lease.  Landlord shall compensate Tenant Broker and Landlord Broker in relation to this Lease pursuant to separate agreements between Landlord and Tenant Broker and Landlord and Landlord Broker.

 

33.2                            Tenant represents and warrants that no broker or agent has made any representation or warranty relied upon by Tenant in Tenant’s decision to enter into this Lease, other than as contained in this Lease.

 

33.3                            Tenant acknowledges and agrees that the employment of brokers by Landlord is for the purpose of solicitation of offers of leases from prospective tenants and that no authority is granted to any broker to furnish any representation (written or oral) or warranty from Landlord unless expressly contained within this Lease.  Landlord is executing this Lease in reliance upon Tenant’s representations, warranties and agreements contained within Sections 33.1 and 33.2 .

 

33.4                            Tenant agrees to indemnify, save, defend and hold the Landlord Indemnitees harmless from any and all cost or liability for compensation claimed by any broker or agent, other than Tenant Broker and Landlord Broker, employed or engaged by Tenant or claiming to

 

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have been employed or engaged by Tenant.  Landlord agrees to indemnify, save, defend (at Tenant’s option) and hold the Tenant harmless from any and all cost or liability for compensation claimed by any broker or agent employed or engaged by Landlord or claiming to have been employed or engaged by Landlord.

 

34.                                  Definition of Landlord .  With regard to obligations imposed upon Landlord pursuant to this Lease, the term “ Landlord ,” as used in this Lease, shall refer only to Landlord or Landlord’s then-current successor-in-interest.  In the event of any transfer, assignment or conveyance of Landlord’s interest in this Lease or in Landlord’s fee title to or leasehold interest in the Property, as applicable, Landlord herein named (and in case of any subsequent transfers or conveyances, the subsequent Landlord) shall be automatically freed and relieved, from and after the date of such transfer, assignment or conveyance, from all liability for the performance of any covenants or obligations contained in this Lease thereafter to be performed by Landlord and, without further agreement, the transferee, assignee or conveyee of Landlord’s in this Lease or in Landlord’s fee title to or leasehold interest in the Property, as applicable, shall be deemed to have assumed and agreed to observe and perform any and all covenants and obligations of Landlord hereunder during the tenure of its interest in the Lease or the Property.  Landlord or any subsequent Landlord may transfer its interest in the Premises or this Lease without Tenant’s consent.

 

35.                                  Limitation of Landlord’s Liability .

 

35.1                            If Landlord is in default under this Lease and, as a consequence, Tenant recovers a monetary judgment against Landlord, the judgment shall be satisfied only out of (a) the proceeds of sale received on execution of the judgment and levy against the right, title and interest of Landlord in the Building and the Project, (b) rent or other income from such real property receivable by Landlord or (c) the consideration received by Landlord from the sale, financing, refinancing or other disposition of all or any part of Landlord’s right, title or interest in the Building or the Project.

 

35.2                            Landlord shall not be personally liable for any deficiency under this Lease.  If Landlord is a partnership or joint venture, then the partners of such partnership shall not be personally liable for Landlord’s obligations under this Lease, and no partner of Landlord shall be sued or named as a party in any suit or action, and service of process shall not be made against any partner of Landlord except as may be necessary to secure jurisdiction of the partnership or joint venture.  If Landlord is a corporation, then the shareholders, directors, officers, employees and agents of such corporation shall not be personally liable for Landlord’s obligations under this Lease, and no shareholder, director, officer, employee or agent of Landlord shall be sued or named as a party in any suit or action, and service of process shall not be made against any shareholder, director, officer, employee or agent of Landlord.  If Landlord is a limited liability company, then the members of such limited liability company shall not be personally liable for Landlord’s obligations under this Lease, and no member of Landlord shall be sued or named as a party in any suit or action, and service of process shall not be made against any member of Landlord except as may be necessary to secure jurisdiction of the limited liability company.  No partner, shareholder, director, employee, member or agent of Landlord shall be required to answer or otherwise plead to any service of process, and no judgment shall be taken or writ of execution levied against any partner, shareholder, director, employee, member or agent of

 

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Landlord.

 

35.3                            Each of the covenants and agreements of this Article shall be applicable to any covenant or agreement either expressly contained in this Lease or imposed by Applicable Laws and shall survive the expiration or earlier termination of this Lease.

 

36.                                  Joint and Several Obligations .  If more than one person or entity executes this Lease as Tenant, then:

 

36.1                            Each of them is jointly and severally liable for the keeping, observing and performing of all of the terms, covenants, conditions, provisions and agreements of this Lease to be kept, observed or performed by Tenant; and

 

36.2                            The term “ Tenant ,” as used in this Lease shall mean and include each of them, jointly and severally.  The act of, notice from, notice to, refund to, or signature of any one or more of them with respect to the tenancy under this Lease, including any renewal, extension, expiration, termination or modification of this Lease, shall be binding upon each and all of the persons executing this Lease as Tenant with the same force and effect as if each and all of them had so acted, so given or received such notice or refund, or so signed.

 

37.                                  Representations .  Tenant guarantees, warrants and represents that (a) Tenant is duly incorporated or otherwise established or formed and validly existing under the laws of its state of incorporation, establishment or formation, (b) Tenant has and is duly qualified to do business in the state in which the Property is located, (c) Tenant has full corporate, partnership, trust, association or other appropriate power and authority to enter into this Lease and to perform all Tenant’s obligations hereunder, (d) each person (and all of the persons if more than one signs) signing this Lease on behalf of Tenant is duly and validly authorized to do so and (e) neither (i) the execution, delivery or performance of this Lease nor (ii) the consummation of the transactions contemplated hereby will violate or conflict with any provision of documents or instruments under which Tenant is constituted or to which Tenant is a party.  In addition, Tenant guarantees, warrants and represents that none of (x) it, or any of its officers or directors (or, to the best of its actual knowledge, without duty of investigation, its employees), (y) its affiliates nor (z) to the best of its actual knowledge (without duty of investigation), its members, shareholders or other equity owners, in each case, owning a ten percent (10%) or greater equity interest in Tenant, is a person or entity with whom U.S. persons or entities are restricted from doing business under regulations of the Office of Foreign Asset Control (“ OFAC ”) of the Department of the Treasury (including those named on OFAC’s Specially Designated and Blocked Persons List) or under any statute, executive order (including the September 24, 2001, Executive Order Blocking Property and Prohibiting Transactions with Persons Who Commit, Threaten to Commit, or Support Terrorism) or other similar governmental action.

 

38.                                  Confidentiality .  Tenant shall keep the terms and conditions of this Lease and any information provided to Tenant or its employees, agents or contractors pursuant to Article 9 confidential and shall not (a) disclose to any third party any terms or conditions of this Lease or any other Lease-related document (including subleases, assignments, work letters, construction contracts, letters of credit, subordination agreements, non-disturbance agreements, brokerage agreements or estoppels) or (b) provide to any third party an original or copy of this Lease (or

 

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any Lease-related document).  Landlord shall keep confidential and not disclose to any third party any non-public financial, ownership or business information regarding Tenant.  Notwithstanding the foregoing, confidential information under this Section may be released by Landlord or Tenant under the following circumstances:  (x) if required by Applicable Laws, the rules of any securities exchange or in any judicial proceeding; provided that the releasing party has given the other party reasonable notice of such requirement, if feasible, (y) to a party’s attorneys, accountants, brokers and other bona fide consultants or advisers (with respect to this Lease only); provided such third parties agree to be bound by this Section or (z) to bona fide prospective transferees, assignees or subtenants of this Lease; provided they agree in writing to be bound by this Section.

 

39.                                  Notices .  Any notice, consent, demand, bill, statement or other communication required or permitted to be given hereunder shall be in writing and shall be given by overnight delivery with a reputable nationwide overnight delivery service, or certified mail (return receipt requested), and if given by overnight delivery, shall be deemed delivered one (1) day after deposit with a reputable nationwide overnight delivery service; and, if given by certified mail (return receipt requested), shall be deemed delivered three (3) business days after the time the notifying party deposits the notice with the United States Postal Service.  Any notices given pursuant to this Lease shall be addressed to Tenant at the Premises, or to Landlord or Tenant at the addresses shown in Sections 2.9 and 2.10 , respectively.  Either party may, by notice to the other given pursuant to this Section, specify additional or different addresses for notice purposes.

 

40.                                  Rooftop Installation Area .

 

40.1                            Tenant may use those portions of the Building’s roof identified as a “Rooftop Installation Area” on Exhibit M attached hereto or such other portions as otherwise permitted (in Landlord’s sole discretion) in writing by Landlord (the “ Rooftop Installation Area ”) solely to operate, maintain, repair and replace rooftop antennae, mechanical equipment, communications antennas, air compressors, HVAC equipment, and other equipment, and related ductwork installed in connection with any of the foregoing, installed by Tenant in the Rooftop Installation Area in accordance with this Article (“ Tenant’s Rooftop Equipment ”).  In connection with the foregoing, but subject to Landlord’s reasonable approval, Tenant shall also have right to install, repair, maintain and replace necessary conduit and sleeving, ductwork, wiring, and cabling from the Rooftop Installation Area to points of connection within the Premises.  Tenant’s Rooftop Equipment shall be used only in connection with the use of the Premises for the Permitted Use.  For the avoidance of doubt, the Rooftop Installation Area shall not be included in the calculation of the Rentable Area of the Premises, and Tenant shall not be obligated to pay Rent with respect to the Rooftop Installation Area.

 

40.2                            Tenant shall install Tenant’s Rooftop Equipment at its sole cost and expense, at such times and in such manner as Landlord may reasonably designate, and in accordance with this Article and the applicable provisions of this Lease regarding Alterations.  Tenant’s Rooftop Equipment and the installation thereof shall be subject to Landlord’s prior written approval, which approval shall not be unreasonably withheld.  Among other reasons, Landlord may withhold approval if the installation or operation of Tenant’s Rooftop Equipment could reasonably be expected to damage the structural integrity of the Building or to transmit vibrations or noise or cause other adverse effects beyond the Premises to an extent not customary

 

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in first class laboratory Buildings, unless Tenant implements measures that are acceptable to Landlord in its reasonable discretion to avoid any such damage or transmission.

 

40.3                            Tenant shall comply with any roof or roof-related warranties.  Upon Tenant’s request for Landlord approval for any installation of Tenant’s Rooftop Equipment, Landlord shall, upon Tenant’s request, confirm the existence of any roof or roof-related warranties that must be complied with and shall provide Tenant with the necessary compliance information.  Landlord represents that there are no roof-related warranties with respect to the Building in effect as of the Execution Date.  Tenant shall obtain a letter from Landlord’s roofing contractor within thirty (30) days after completion of any Tenant work on the rooftop stating that such work did not affect any such warranties.  Tenant, at its sole cost and expense, shall inspect the Rooftop Installation Area at least annually, and correct any loose bolts, fittings or other appurtenances and repair any damage to the roof caused by the installation or operation of Tenant’s Rooftop Equipment.  Tenant shall not permit the installation, maintenance or operation of Tenant’s Rooftop Equipment to violate any Applicable Laws or constitute a nuisance.  Tenant shall pay Landlord within thirty (30) days after demand (a) all applicable taxes, charges, fees or impositions imposed on Landlord by Governmental Authorities as the result of Tenant’s use of the Rooftop Installation Areas in excess of those for which Landlord would otherwise be responsible for the use or installation of Tenant’s Rooftop Equipment and (b) the amount of any increase in Landlord’s insurance premiums expressly attributable to the installation of Tenant’s Rooftop Equipment.  Upon Tenant’s written request to Landlord, Landlord shall use commercially reasonable efforts to cause other tenants to remedy any interference in the operation of Tenant’s Rooftop Equipment caused by any such tenants’ equipment installed after the applicable piece of Tenant’s Rooftop Equipment; provided , however, that Landlord shall not be required to request that such tenants waive their rights under their respective leases.

 

40.4                            If Tenant’s Equipment (a) causes physical damage to the structural integrity of the Building, (b) interferes with any telecommunications, mechanical or other systems located at or near or servicing the Building or the Project that were installed prior to the installation of Tenant’s Rooftop Equipment, (c) interferes with any other service provided to other tenants in the Building or the Project by rooftop or penthouse installations that were installed prior to the installation of Tenant’s Rooftop Equipment or (d) interferes with any telecommunications, mechanical or other systems of another tenant that were installed prior to the installation of Tenant’s Rooftop Equipment, in each case in excess of that permissible under Federal Communications Commission regulations, then Tenant shall cooperate with Landlord and any affected tenant (and Landlord shall use commercially reasonable efforts to cause such tenant to cooperate with Tenant) to determine the source of the damage or interference and promptly repair such damage and eliminate such interference, in each case at Tenant’s sole cost and expense, within ten (10) days after receipt of notice of such damage or interference (which notice may be oral; provided that Landlord also delivers to Tenant written notice of such damage or interference within twenty-four (24) hours after providing oral notice).

 

40.5                            Landlord reserves the right to cause Tenant to relocate Tenant’s Rooftop Equipment (excluding equipment installed as part of the Tenant Improvements (or the Expansion Improvements)) to comparably functional space on the roof by giving Tenant prior written notice thereof.  Landlord agrees to pay the reasonable costs thereof.  Tenant shall arrange for the relocation of Tenant’s Rooftop Equipment within sixty (60) days after receipt of Landlord’s

 

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notification of such relocation.  In the event Tenant fails to arrange for relocation within such sixty (60)-day period, Landlord shall have the right to arrange for the relocation of Tenant’s Rooftop Equipment in a manner that does not unnecessarily interrupt or interfere with Tenant’s use of the Premises for the Permitted Use.

 

41.                                Miscellaneous.

 

41.1                         Landlord reserves the right to change the name of the Building or the Project in its sole discretion.

 

41.2                         To induce Landlord to enter into this Lease, Tenant agrees that it shall promptly furnish to Landlord, from time to time, upon Landlord’s written request, the most recent year-end financial statements reflecting Tenant’s current financial condition audited by a nationally recognized accounting firm.  Tenant shall, within ninety (90) days after the end of Tenant’s financial year, furnish Landlord with a certified copy of Tenant’s year-end financial statements for the previous year audited by a nationally recognized accounting firm.  Tenant represents and warrants that all financial statements, records and information furnished by Tenant to Landlord in connection with this Lease are correct and complete in all material respects.  Notwithstanding the foregoing, Tenant shall not be required to deliver the foregoing financial statements to Landlord for so long as Tenant is a publicly-traded company, it being understood and agreed that such financial statements are otherwise publicly available to Landlord.  If audited financials are not otherwise prepared, unaudited financials complying with generally accepted accounting principles and certified to the knowledge of the chief financial officer of Tenant to be true, correct and complete in all respects shall suffice for purposes of this Section.

 

41.3                         Where applicable in this Lease, the singular includes the plural and the masculine or neuter includes the masculine, feminine and neuter.  The words “include,” “includes,” “included” and “including” shall mean “‘include,’ etc., without limitation.” The section headings of this Lease are not a part of this Lease and shall have no effect upon the construction or interpretation of any part hereof.

 

41.4                         If either party commences an action against the other party arising out of or in connection with this Lease, then the substantially prevailing party shall be reimbursed by the other party for all reasonable costs and expenses, including reasonable attorneys’ fees and expenses, incurred by the substantially prevailing party in such action or proceeding and in any appeal in connection therewith.

 

41.5                         Submission of this instrument for examination or signature by Tenant does not constitute a reservation of or option for a lease, and shall not be effective as a lease or otherwise until execution by and delivery to both Landlord and Tenant.

 

41.6                         Time is of the essence with respect to the performance of every provision of this Lease in which time of performance is a factor.

 

41.7                         Each provision of this Lease performable by Tenant shall be deemed both a covenant and a condition.

 

41.8                         Whenever consent or approval of either party is required, that party shall not

 

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unreasonably withhold such consent or approval, except as may be expressly set forth to the contrary.

 

41.9                         The terms of this Lease are intended by the parties as a final expression of their agreement with respect to the terms as are included herein, and may not be contradicted by evidence of any prior or contemporaneous agreement.

 

41.10                  Any provision of this Lease that shall prove to be invalid, void or illegal shall in no way affect, impair or invalidate any other provision hereof, and all other provisions of this Lease shall remain in full force and effect and shall be interpreted as if the invalid, void or illegal provision did not exist.

 

41.11                  Either party (i) may request the other party to execute, upon twenty (20) days’ prior written notice, a customary, mutually acceptable, short form or memorandum hereof and (ii) upon receipt of the fully executed short form or memorandum of this Lease, record the same in the appropriate real property records.  If any such short form or memorandum of this Lease is recorded, then promptly upon the expiration or termination of this Lease, Tenant, at its sole cost and expense, shall execute and record a termination of any short form or memorandum of lease recorded with respect hereto.  Neither party shall record this Lease.  The party recording the short form or memorandum of this Lease shall be responsible for the cost of recording the same, including any transfer or other taxes incurred in connection with said recordation.  This Section shall survive the expiration or earlier termination of this Lease.

 

41.12                  The language in all parts of this Lease shall be in all cases construed as a whole according to its fair meaning and not strictly for or against either Landlord or Tenant.

 

41.13                  Each of the covenants, conditions and agreements herein contained shall inure to the benefit of and shall apply to and be binding upon the parties hereto and their respective heirs; legatees; devisees; executors; administrators; and permitted successors, assigns, sublessees.  Nothing in this Section shall in any way alter the provisions of this Lease restricting assignment or subletting.

 

41.14                  This Lease shall be governed by, construed and enforced in accordance with the laws of the state in which the Premises are located, without regard to such state’s conflict of law principles.

 

41.15                  Landlord and Tenant each guarantee, warrant and represent that the individual or individuals signing this Lease on its behalf have the power, authority and legal capacity to sign this Lease on behalf of and to bind all entities, corporations, partnerships, limited liability companies, joint venturers or other organizations and entities on whose behalf said individual or individuals have signed.

 

41.16                  This Lease may be executed in one or more counterparts, each of which, when taken together, shall constitute one and the same document.

 

41.17                  No provision of this Lease may be modified, amended or supplemented except by an agreement in writing signed by Landlord and Tenant.  The waiver by Landlord of any breach by Tenant of any term, covenant or condition herein contained shall not be deemed to be a

 

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waiver of any subsequent breach of the same or any other term, covenant or condition herein contained.

 

41.18                  To the extent permitted by Applicable Laws, the parties waive trial by jury in any action, proceeding or counterclaim brought by the other party hereto related to matters arising out of or in any way connected with this Lease; the relationship between Landlord and Tenant; Tenant’s use or occupancy of the Premises; or any claim of injury or damage related to this Lease or the Premises.

 

42.                                Option to Extend Term .  Tenant shall have the option (“ Option ”) to extend the Term by five (5) years as to the entire Premises (and no less than the entire Premises) upon the following terms and conditions.  Any extension of the Term pursuant to Option shall be on all the same terms and conditions as this Lease, except as follows:

 

42.1                         Base Rent at the commencement of the Option term shall equal the then-current fair market value for comparable office and laboratory space in the Alameda/San Mateo County market of comparable age, quality, level of finish and proximity to amenities and public transit (“ FMV ”), and shall be further increased on each annual anniversary of the Option term commencement date by three percent (3%).   Landlord shall, within fifteen (15) days after receipt of Tenant’s Option Notice (defined below), give Tenant a written proposal of Landlord’s estimate of the FMV for the Option Term.  Within fifteen (15) days after receipt of such estimate, Tenant shall notify Landlord whether Tenant accepts Landlord’s proposed estimate of FMV.  If Tenant does not accept the FMV, then the parties shall endeavor to agree upon the FMV, taking into account all relevant factors, including (a) the size of the Premises, (b) the length of the Option term, (c) rent in comparable buildings in the relevant market, including concessions offered to new tenants, such as free rent, tenant improvement allowances and moving allowances, (d) Tenant’s creditworthiness and (e) the quality and location of the Building and the Project.  In the event that the parties are unable to agree upon the FMV within thirty (30) days after Tenant notifies Landlord of its objection to Landlord’s estimate of the FMV, then Tenant may either (i) rescind its exercise of the Option or (ii) request that the FMV be determined using the following procedures:  a senior officer of a nationally recognized leasing brokerage firm with local knowledge of the Alameda/San Mateo County laboratory/research and development leasing market (the “ Baseball Arbitrator ”) shall be selected and paid for jointly by Landlord and Tenant.  If Landlord and Tenant are unable to agree upon the Baseball Arbitrator, then the same shall be designated by the local chapter of the American Arbitration Association or any successor organization thereto (the “ AAA ”).  The Baseball Arbitrator selected by the parties or designated by the AAA shall (y) have at least ten (10) years’ experience in the leasing of office and laboratory/research space in the Alameda/San Mateo County market and (z) not have been employed or retained by either Landlord or Tenant or any affiliate of either for a period of at least ten (10) years prior to appointment pursuant hereto.  Each of Landlord and Tenant shall submit to the Baseball Arbitrator and to the other party its determination of the FMV.  The Baseball Arbitrator shall grant to Landlord and Tenant a hearing and the right to submit evidence.  The Baseball Arbitrator shall determine which of the two (2) FMV determinations more closely represents the actual FMV.  The arbitrator may not select any other FMV for the Premises other than one submitted by Landlord or Tenant.  The FMV selected by the Baseball Arbitrator shall be binding upon Landlord and Tenant and shall serve as the basis for determination of Base Rent payable for the Option term.  If, as of the commencement date of the

 

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Option term, the amount of Base Rent payable during the Option term shall not have been determined, then, pending such determination, Tenant shall pay Base Rent equal to the Base Rent payable with respect to the last year of the then-current Term.  After the final determination of Base Rent payable for the Option term, the parties shall promptly execute a written amendment to this Lease specifying the amount of Base Rent to be paid during the Option term.  Any failure of the parties to execute such amendment shall not affect the validity of the FMV determined pursuant to this Section.

 

42.2                         The Option is not assignable separate and apart from this Lease.

 

42.3                         The Option is conditional upon Tenant giving Landlord written notice of its election to exercise the Option (the “ Option Notice ”) at least twelve (12) months prior to the end of the expiration of the then-current Term.  Time shall be of the essence as to Tenant’s exercise of the Option.  Tenant assumes full responsibility for maintaining a record of the deadline to exercise the Option.  Tenant acknowledges that it would be inequitable to require Landlord to accept any exercise of the Option after the date provided for in this Section.

 

42.4                         Notwithstanding anything contained in this Article to the contrary, Tenant shall not have the right to exercise the Option during the time that Tenant is in monetary default or any other Default (provided, however, that, for purposes of this Section, Landlord shall not be required to provide Tenant with notice of such Default except as otherwise required in Section 31.4 ) under any provisions of this Lease and continuing until Tenant has cured the default.

 

42.5                         The period of time within which Tenant may exercise the Option shall not be extended or enlarged by reason of Tenant’s inability to exercise such Option because of the provisions of Section 42.4 .

 

42.6                         All of Tenant’s rights under the provisions of the Option shall terminate and be of no further force or effect even after Tenant’s due and timely exercise of the Option if, after such exercise, but prior to the commencement date of the new term, (a) Tenant fails to pay to Landlord a monetary obligation of Tenant for a period of twenty (20) days after written notice from Landlord to Tenant, (b) Tenant fails to commence to cure a default (other than a monetary default) within thirty (30) days after the date Landlord gives notice to Tenant of such default or (c) Tenant has defaulted under this Lease two (2) or more times and a service or late charge under Section 31.1 has become payable for any such default, whether or not Tenant has cured such defaults.

 

43.                                Expansion Premises.

 

43.1                         Subject to the conditions set forth in this Article, Tenant shall have the obligation to expand the Premises to include approximately Seven Thousand Six Hundred Eighty-Four (7,684) square feet of Rentable Area of contiguous premises as more particularly shown on the floor plan attached hereto as Exhibit J (the “ Expansion Premises ”).

 

43.2                         Landlord and Tenant acknowledge that the Expansion Premises is, and prior to the Expansion Premises Term Commencement Date will remain, unoccupied space.  Accordingly, Landlord shall, upon Tenant’s written request at any time prior to December 1,

 

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2015, make the Expansion Premises available to Tenant for the purpose of constructing the Expansion Improvements.  The “ Expansion Premises Term Commencement Date ” shall be the earlier of (a) December 1, 2015 and (b) the day the work described on Exhibit B in connection with the Expansion Premises (the “ Expansion Improvements ”) is Substantially Complete.  Tenant shall execute and deliver to Landlord written acknowledgment of the actual Expansion Premises Term Commencement Date for the Expansion Premises within ten (10) days after Tenant takes occupancy of the Expansion Premises, or December 2, 2015, whichever occurs first, in the form attached as Exhibit C hereto.  Failure to execute and deliver such acknowledgment, however, shall not affect the Expansion Premises Term Commencement Date for the Expansion Premises or Landlord’s or Tenant’s liability hereunder.  Failure by Tenant to obtain validation by any medical review board or other similar governmental licensing of the Premises or the Expansion Premises required for the Permitted Use by Tenant shall not serve to extend the Expansion Premises Term Commencement Date.  The term “ Substantially Complete ” or “ Substantial Completion ” means that the Expansion Improvements are substantially complete in accordance with the Approved Plans (as defined in the Work Letter), except for minor punch list items that will not unreasonably interfere with Tenant’s use of the Expansion Premises for the Permitted Use and which can be corrected with reasonable diligence within thirty (30) days.

 

43.3                         Tenant shall cause any Expansion Improvements to be constructed in the Expansion Premises pursuant to the Work Letter.  Tenant shall pay all of the costs and expenses of constructing the Expansion Improvements (including all utilities supplied to the Expansion Premises), except that Landlord shall make available to Tenant the following amounts: Six Hundred Fourteen Thousand Seven Hundred Twenty Dollars ($614,720) (based upon Eighty Dollars ($80.00) per square foot of Rentable Area (the “ Base Expansion TI Allowance ”); provided , however, such amount shall be adjusted based upon the final Rentable Area of the Expansion Premises).  The provisions of Article 4 regarding use of the TI Allowance (as well as the Work Letter) shall apply with regard to such Base Expansion TI Allowance; provided , however, that no portion of the Base Expansion TI Allowance shall be applied to the cost of items described in Section 4.2(s) .  For purposes of Article 4 and for purposes of the provisions of the Work Letter, references to the “Base TI Allowance” shall be references to the Base Expansion TI Allowance, references to the “TI Allowance” shall be references to the Base Expansion TI Allowance, references to the “Premises” shall be references to the Expansion Premises, references to “Excess TI Costs” with respect to the Tenant Improvements shall be references to such costs and amounts in connection with the Expansion Improvements and references to the “Approved Budget” and “Approved Plans” with respect to the Tenant Improvements shall be references to such Approved Budget or Approved Plans delivered in connection with the Expansion Improvements.

 

43.4                         Tenant shall have until the date that is six (6) months after the Expansion Premises Term Commencement Date (the “ Expansion TI Deadline ”), to expend the unused portion of the Base Expansion TI Allowance, after which date Landlord’s obligation to fund such costs shall expire.

 

43.5                         In no event shall any unused Base Expansion TI Allowance entitle Tenant to a credit against Rent payable under this Lease.  Tenant shall deliver to Landlord (i) a certificate of occupancy for the Expansion Premises suitable for the Permitted Use and (ii) a Certificate of Substantial Completion in the form of the American Institute of Architects document G704,

 

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executed by the project architect and the general contractor.

 

43.6                         Within ten (10) days after the Expansion Premises Term Commencement Date, Tenant and Landlord shall enter into a written amendment to the Lease (the “ Amendment ”), which amendment shall provide, unless otherwise agreed in writing, (a) that the Premises under this Lease shall be increased to include the square feet of Rentable Area of the Expansion Premises, (b) the new Base Rent, with the Expansion Premises increasing Base Rent at the then-current rental rate per square foot under the Lease and (c) Tenant’s new Pro Rata Share of Operating Expenses based upon the addition of the Expansion Premises to the Premises.  In all other respects, this Lease shall remain in full force and effect, and shall (except with regard to the five (5) month free rent period for the Premises) apply to the Expansion Premises.

 

44.                                Campus Amenities .  Landlord shall use commercially reasonable efforts to maintain the availability of the Amenities Building Services during the Term for use on a non-exclusive basis by the occupants of the Project and any other individuals approved by Landlord.  Tenant and its employees (in such capacity, the “ Amenity Users ”) are hereby permitted to use the Amenities Building Services; provided that all Amenity Users execute Landlord’s standard waiver of liability and release form and otherwise satisfy the conditions identified below.  Landlord shall have the right at any time to require that a new standard waiver of liability and release form be signed by any of the Amenity Users as a condition to any further use of the Amenities Building Services by any of the Amenity Users.  The use of the Amenities Building Services shall be subject to the rules and regulations applicable to the Amenities Building Services and any supplements thereto, which rules and regulations shall be uniformly applied in a non-discriminatory manner.  Landlord and Tenant acknowledge that the use of the Amenities Building Services by the Amenity Users shall be at their own risk and that the terms and provisions of the first two sentences of Section 16.2 shall apply to the use of the Amenities Building Services by the Amenity Users, or the use of any equipment related thereto by the Amenity Users (whether or not authorized), whether or not such persons have properly executed Landlord’s standard form waiver of liability and release form.  Tenant shall be solely responsible for the proper use of the Amenities Building Services and the equipment located therein by the Amenity Users.  Tenant acknowledges and agrees that Landlord shall not be obligated to provide supervision of use of the Amenities Building Services made by the Amenity Users or others.  No expansion or reduction construction of the Amenities Building Services shall entitle Tenant to an abatement or reduction in Rent, constitute a constructive eviction, or result in a default by Landlord under this Lease.  Any and all fees, costs and expenses relating to operating, managing, owning and maintaining the Amenities Building and the Amenities Building Services (not paid by Amenity Users) shall be included as part of Operating Expenses.

 

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IN WITNESS WHEREOF, the parties hereto have executed this Lease as of the date first above written.

 

LANDLORD :

 

 

 

BMR-PACIFIC RESEARCH CENTER LP,

 

a Delaware limited partnership

 

 

 

 

 

By:

/s/ Alan D. Gold

 

Name:

Alan D. Gold

 

Title:

Chief Executive Officer

 

 

 

 

 

TENANT :

 

 

 

DEPOMED, INC.

 

a California corporation

 

 

 

 

 

By:

/s/ James Schoeneck

 

Name:

James Schoeneck

 

Title:

President & CEO

 

 



 

EXHIBIT A

 

PREMISES

 

A-1



 

 


 


 

EXHIBIT B

 

WORK LETTER

 

This Work Letter (this “ Work Letter ”) is made and entered into as of the 4 th  day of April, 2012, by and between BMR-PACIFIC RESEARCH CENTER LP, a Delaware limited partnership (“ Landlord ”), and DEPOMED, INC., a California corporation (“ Tenant ”), and is attached to and made a part of that certain Lease dated as of April 4, 2012 (as the same may be amended, amended and restated, supplemented or otherwise modified from time to time, the “ Lease ”), by and between Landlord and Tenant for the Premises located at 7999 Gateway Boulevard, Newark, California.  All capitalized terms used but not otherwise defined herein shall have the meanings given them in the Lease.

 

1.                                       General Requirements .

 

1.1.                             Authorized Representatives .

 

(a)                                  Landlord designates, as Landlord’s authorized representative (“ Landlord’s Authorized Representative ”), (i) Andrew Richard as the person authorized to initial plans, drawings, approvals and to sign change orders pursuant to this Work Letter and (ii) John Bonanno as the person authorized to sign any amendments to this Work Letter or the Lease.  Tenant shall not be obligated to respond to or act upon any such item until such item has been initialed or signed (as applicable) by the appropriate Landlord’s Authorized Representative.  Landlord may change either Landlord’s Authorized Representative upon one (1) business day’s prior written notice to Tenant.

 

(b)                                  Tenant designates August Moretti or Jeff Coon (“ Tenant’s Authorized Representative ”) as the person authorized to initial and sign all plans, drawings, change orders and approvals pursuant to this Work Letter.  Landlord shall not be obligated to respond to or act upon any such item until such item has been initialed or signed (as applicable) by Tenant’s Authorized Representative.  Tenant may change Tenant’s Authorized Representative upon one (1) business day’s prior written notice to Landlord.

 

1.2.                             Schedule .  The schedule for design and development of the Tenant Improvements, including the time periods for preparation and review of construction documents, approvals and performance, shall be in accordance with a schedule to be prepared by Tenant (the “ Schedule ”).  Tenant shall prepare the Schedule so that it is a reasonable schedule for the completion of the Tenant Improvements.  As soon as the Schedule is completed, Tenant shall deliver the same to Landlord for Landlord’s approval, which approval shall not be unreasonably withheld, conditioned or delayed.  Such Schedule shall be approved or disapproved by Landlord within five (5) business days after delivery to Landlord.  Landlord’s failure to respond within such five (5) business day period shall be deemed approval by Landlord.  If Landlord disapproves the Schedule, then Landlord shall notify Tenant in writing of its objections to such Schedule, and the parties shall confer and negotiate in good faith to reach agreement on the Schedule.  The Schedule shall be subject to adjustment as mutually agreed upon in writing by the parties, or as provided in this Work Letter.

 

B-1



 

1.3.                             Tenant’s Architects, Contractors and Consultants .  The architect, engineering consultants, and general contractor, and the mechanical, electrical, and plumbing subcontractors (collectively, the “ MEP Subcontractors ”), responsible for the construction of the Tenant Improvements shall be selected by Tenant and approved by Landlord, which approval Landlord shall not unreasonably withhold, condition or delay.  Landlord may refuse to use any architects, consultants, contractors, subcontractors or material suppliers that Landlord reasonably believes could cause labor disharmony.  Landlord and Tenant shall each participate in the review of the competitive bid process.  Landlord hereby approves the engagement by Tenant of the parties identified on Exhibit B-1 attached hereto in connection with the Tenant Improvement work.  All Tenant contracts related to the Tenant Improvements shall provide that Tenant may assign such contracts and any warranties with respect to the Tenant Improvements to Landlord at any time.

 

2.                                       Landlord Improvements .

 

2.1.                             Landlord Improvement Plans .  All work to be performed by Landlord pursuant to Section 5 of the Lease (the “ Landlord Improvements ”) shall be performed by Landlord’s contractor, at Landlord’s sole cost and expense (and, for the avoidance of doubt, shall not be charged to Tenant as Operating Expenses), in all respects (a) in conformance with the Approved LI Plans (subject only to LI Changes (as defined below) approved in accordance with Section 2.2 ), (b) otherwise in compliance with the Lease and this Work Letter and (c) in accordance with Applicable Laws.  All material and equipment furnished by Landlord as the Landlord Improvements shall be new or “like new,” and the Landlord Improvements shall be performed in a first-class, workmanlike manner.  Landlord shall prepare final plans and specifications for the Landlord Improvements that are consistent with Section 5 of the Lease.  As soon as such final plans and specifications (“ Construction LI Plans ”) are completed, Landlord shall deliver the same to Tenant for Tenant’s approval, which approval shall not be unreasonably withheld, conditioned or delayed.  Such Construction LI Plans shall be approved or disapproved by Tenant within five (5) business days after delivery to Tenant.  Tenant’s failure to respond within such five (5) business day period shall be deemed approval by Tenant.  If the Construction LI Plans are disapproved by Tenant, then Tenant shall notify Landlord in writing of its reasonable objections to such Construction LI Plans, and the parties shall confer and negotiate in good faith to reach agreement on the Construction LI Plans.  Promptly after the Construction LI Plans are approved by Landlord and Tenant, two (2) copies of such Construction LI Plans shall be initialed and dated by Landlord and Tenant, and Landlord shall promptly submit such Construction LI Plans to all appropriate Governmental Authorities for approval.  The Construction LI Plans so approved, and all change orders related thereto that are specifically permitted by this Work Letter, are referred to herein as the “ Approved LI Plans .”

 

2.2.                             Changes to Landlord Improvements .  Landlord may make changes to the Approved LI Plans (each, an “ LI Change ”) in accordance with the provisions of this Article 2 , which changes shall be subject to the written approval of Tenant in accordance with this Work Letter.

 

(a)                                  LI Change Order Request .  Tenant’s consent shall not be required in connection with LI Permitted Changes (as defined below) to the Landlord Improvements.  Other than LI Permitted Changes, Landlord may request LI Changes after Tenant approves the Approved LI Plans by notifying Tenant thereof in writing in substantially the same form as the

 

B-2



 

AIA standard change order form (an “ LI Change Request ”), which LI Change Request shall detail the nature and extent of any requested LI Changes, including (i) the LI Change, (ii) the party required to perform the LI Change and (iii) any modification of the Approved LI Plans necessitated by the LI Change.  If the nature of an LI Change requires revisions to the Approved LI Plans, then Landlord shall be solely responsible for the cost and expense of such revisions and any increases in the cost of the Landlord Improvements as a result of such LI Change.  LI Change Requests shall be signed by Landlord’s Authorized Representative.

 

(b)                                  Tenant’s Approval of LI Changes .  All Change Requests shall be subject to Tenant’s prior written approval, which approval shall not be unreasonably withheld, conditioned or delayed.  Tenant shall have five (5) business days after receipt of an LI Change Request to notify Landlord in writing of Tenant’s approval or rejection of the LI Change, which approval shall not be unreasonably withheld, conditioned or delayed.  Tenant’s failure to respond within such five (5) business day period shall be deemed approval by Tenant.

 

(c)                                   LI Permitted Changes .  For purposes of this Work Letter, an “ LI Permitted Change ” shall mean (i) minor field changes, (ii) changes required by a Governmental Authority, (iii) any other changes that (A) do not materially and adversely affect the quality of the Landlord Improvements or Tenant’s ability to operate its business in the Building for the Permitted Use or increase the cost of the Tenant Improvements other than to a de minimis extent and (B) will not extend the projected substantial completion date of the Landlord Improvements beyond December 1, 2012, and (iv) development in the ordinary course of the Approved LI Plans in a manner (A) not inconsistent with the Approved LI Plans or clause (iii) above, (B) that does not materially and adversely affect Tenant’s ability to use the Premises for the Permitted Use or (C) that does not increase the cost of the Tenant Improvements other than to a de minimis extent.

 

3.                                       Tenant Improvements .  All Tenant Improvements shall be performed by Tenant’s contractor, at Tenant’s sole cost and expense (subject to Landlord’s obligations with respect to any portion of the Base TI Allowance and, if properly requested by Tenant pursuant to the terms of the Lease, the Additional TI Allowance) and in accordance with the Approved Plans (as defined below), the Lease and this Work Letter.  To the extent that the total projected cost of the Tenant Improvements (as projected by Landlord) exceeds the TI Allowance (such excess, the “ Excess TI Costs ”), Tenant shall pay the costs of the Tenant Improvements on a pari passu basis with Landlord as such costs become due, in the proportion of Excess TI Costs payable by Tenant to the Base TI Allowance (and, if properly requested by Tenant pursuant to the Lease, the Additional TI Allowance) payable by Landlord.  If Tenant fails to pay, or is late in paying, any sum due to Landlord under this Work Letter, then Landlord shall have all of the rights and remedies set forth in the Lease for nonpayment of Rent (including the right to interest and the right to assess a late charge), and for purposes of any litigation instituted with regard to such amounts the same shall be considered Rent.  All material and equipment furnished by Tenant or its contractors as the Tenant Improvements shall be new or “like new;” the Tenant Improvements shall be performed in a first-class, workmanlike manner; and the quality of the Tenant Improvements shall be of a nature and character not less than the Building Standard.  Tenant shall take, and shall its contractors to take, commercially reasonable steps to protect the Premises during the performance of any Tenant Improvements, including covering or temporarily removing any window coverings so as to guard against dust, debris or damage.

 

B-3



 

3.1.                             Work Plans .  Tenant shall prepare and submit to Landlord for approval schematics covering the Tenant Improvements prepared in conformity with the applicable provisions of this Work Letter (the “ Draft Schematic TI Plans ”).  The Draft Schematic TI Plans shall contain sufficient information and detail to accurately describe the proposed design to Landlord and such other information as Landlord may reasonably request.  Landlord shall notify Tenant in writing within five (5) business days after receipt of the Draft Schematic TI Plans whether Landlord approves or objects to the Draft Schematic TI Plans and of the manner, if any, in which the Draft Schematic TI Plans are unacceptable.  Landlord’s failure to respond within such five (5) business day period shall be deemed approval by Landlord.  If Landlord reasonably objects to the Draft Schematic TI Plans, then Tenant shall revise the Draft Schematic TI Plans and cause Landlord’s objections to be remedied in the revised Draft Schematic TI Plans.  Tenant shall then resubmit the revised Draft Schematic TI Plans to Landlord for approval, such approval not to be unreasonably withheld, conditioned or delayed.  Landlord’s approval of or objection to revised Draft Schematic TI Plans and Tenant’s correction of the same shall be in accordance with this Section until Landlord has approved the Draft Schematic TI Plans in writing or been deemed to have approved them.  The iteration of the Draft Schematic TI Plans that is approved or deemed approved by Landlord without objection shall be referred to herein as the “ Approved Schematic TI Plans .”

 

3.2.                             Construction TI Plans .  Tenant shall prepare final plans and specifications for the Tenant Improvements that (a) are consistent with and are logical evolutions of the Approved Schematic TI Plans and (b) incorporate any other Tenant-requested (and Landlord-approved) TI Changes (as defined below).  As soon as such final plans and specifications (“ Construction TI Plans ”) are completed, Tenant shall deliver the same to Landlord for Landlord’s approval, which approval shall not be unreasonably withheld, conditioned or delayed.  Such Construction TI Plans shall be approved or disapproved by Landlord within five (5) business days after delivery to Landlord.  Landlord’s failure to respond within such five (5) business day period shall be deemed approval by Landlord.  If the Construction TI Plans are disapproved by Landlord, then Landlord shall notify Tenant in writing of its objections to such Construction TI Plans, and the parties shall confer and negotiate in good faith to reach agreement on the Construction TI Plans.  Promptly after the Construction TI Plans are approved by Landlord and Tenant, two (2) copies of such Construction TI Plans shall be initialed and dated by Landlord and Tenant.  Contemporaneously with the submission of the Construction TI plans to Landlord for approval, or, at Tenant’s option, promptly following Landlord’s approval thereof, Tenant shall submit such Construction TI Plans to all appropriate Governmental Authorities for approval.  The Construction TI Plans so approved, and all change orders specifically permitted by this Work Letter, are referred to herein as the “ Approved TI Plans .”

 

3.3.                             Changes to the Tenant Improvements .  Any changes to the Approved TI Plans (each, a “ TI Change ”) shall be requested and instituted in accordance with the provisions of this Article 3 and shall be subject to the written approval of the non-requesting party in accordance with this Work Letter.

 

(a)                                  TI Change Request .  Either Landlord or Tenant may request TI Changes after Landlord approves the Approved TI Plans by notifying the other party thereof in writing in substantially the same form as the AIA standard change order form (a “ TI Change Request ”), which TI Change Request shall detail the nature and extent of any requested TI Changes,

 

B-4



 

including (a) the TI Change, (b) the party required to perform the TI Change and (c) any modification of the Approved TI Plans and the Schedule, as applicable, necessitated by the TI Change.  If the nature of a TI Change requires revisions to the Approved TI Plans, then the requesting party shall be solely responsible for the cost and expense of such revisions and any increases in the cost of the Tenant Improvements as a result of such Change.  TI Change Requests shall be signed by the requesting party’s Authorized Representative.

 

(b)                                  Approval of TI Changes .  All TI Change Requests shall be subject to the other party’s prior written approval, which approval shall not be unreasonably withheld, conditioned or delayed.  The non-requesting party shall have three (3) business days after receipt of a TI Change Request to notify the requesting party in writing of the non-requesting party’s decision either to approve or object to the TI Change Request.  The non-requesting party’s failure to respond within such three (3) business day period shall be deemed approval by the non-requesting party.

 

3.4.                             Preparation of Estimates .  Tenant shall, before proceeding with any TI Change, using its best efforts, prepare as soon as is reasonably practicable (but in no event more than three (3) business days after delivering a TI Change Request to Landlord or receipt of a TI Change Request) an estimate of the increased costs or savings that would result from such TI Change, as well as an estimate on such TI Change’s effects on the Schedule.  Landlord shall have three (3) business days after receipt of such information from Tenant to (a) in the case of a TI Change Request, approve or reject such TI Change Request in writing, or (b) in the case of a Landlord initiated TI Change Request, notify Tenant in writing of Landlord’s decision either to proceed with or abandon the Landlord-initiated TI Change Request.

 

4.                                       Completion of Tenant Improvements .  Tenant, at its sole cost and expense (except for the Base TI Allowance and, if properly requested by Tenant pursuant to the terms of the Lease, the Additional TI Allowance), shall perform and complete the Tenant Improvements in all respects (a) in substantial conformance with the Approved TI Plans, (b) otherwise in compliance with provisions of the Lease and this Work Letter and (c) in accordance with Applicable Laws, the requirements of Tenant’s insurance carriers, the requirements of Landlord’s insurance carriers (to the extent Landlord provides its insurance carriers’ requirements to Tenant) and the board of fire underwriters having jurisdiction over the Premises.  The Tenant Improvements shall be deemed completed at such time as Tenant shall furnish to Landlord (v) evidence reasonably satisfactory to Landlord that (i) all Tenant Improvements have been completed and paid for in full (which shall be evidenced by the architect’s certificate of completion and final unconditional waivers and releases of liens from the general contractor, architect, each MEP Subcontractor and each subcontractor and material supplier performing work in excess of Fifty Thousand Dollars ($50,000) (each, a “ Major Subcontractor ”) (provided, that Tenant shall provide lien waivers from the general contractor with respect to any work by or from subcontractors and material suppliers that is equal to or less than Fifty Thousand Dollars ($50,000)) (provided, further, that each lien waiver and release shall be in a form reasonably acceptable to Landlord and complying with Applicable Laws), (ii) all Tenant Improvements have been accepted by Landlord, (iii) any and all liens related to the Tenant Improvements have either been discharged of record (by payment, bond, order of a court of competent jurisdiction or otherwise) or waived by the party filing such lien and (iv) no security interests relating to the Tenant Improvements are outstanding, (w) all certifications and approvals with respect to the Tenant Improvements that may be required from

 

B-5



 

any Governmental Authority and any board of fire underwriters or similar body for the use and occupancy of the Premises, (x) certificates of insurance required by the Lease to be purchased and maintained by Tenant, (y) an affidavit from Tenant’s architect certifying that all work performed in, on or about the Premises is in substantial accordance with the Approved TI Plans and (z) complete drawing print sets and electronic CADD files on disc of all contract documents for work performed by their architect and engineers in relation to the Tenant Improvements.

 

5.                                       Insurance .

 

5.1.                             Property Insurance .  At all times during the period beginning with commencement of construction of the Tenant Improvements and ending with final completion of the Tenant Improvements, Tenant shall maintain, or cause to be maintained (in addition to the insurance required of Tenant pursuant to the Lease), builder’s risk property insurance naming Landlord and the Landlord Parties, as their interests may appear, as loss payees or additional insureds (for purposes of clarity, whether Landlord and the Landlord Parties are named as loss payees or additional insureds shall depend on the nature of the insurance policy).  Such policy shall, on a completed values basis for the full insurable value at all times, insure against loss or damage by fire, vandalism and malicious mischief and other such risks as are customarily covered by the so-called “broad form extended coverage endorsement” upon all Tenant Improvements and the general contractor’s and any subcontractors’ machinery, tools and equipment, all while each forms a part of, or is contained in, the Tenant Improvements or any temporary structures on the Premises, or is adjacent thereto; provided that, for the avoidance of doubt, insurance coverage with respect to the general contractor’s and any subcontractors’ machinery, tools and equipment shall be carried on a primary basis by such general contractor or the applicable subcontractor(s).  Tenant agrees to pay any deductible, and Landlord is not responsible for any deductible, for a claim under such insurance.  Said property insurance shall contain an express waiver of any right of subrogation by the insurer against Landlord and the Landlord Parties, and shall name Landlord and its affiliates as loss payees as their interests may appear.

 

5.2.                             Workers’ Compensation Insurance .  At all times during the period of construction of the Tenant Improvements, Tenant shall cause its contractors or subcontractors to maintain statutory workers’ compensation insurance as required by Applicable Laws.

 

6.                                       Liability .  Tenant assumes sole responsibility and liability for any and all injuries or the death of any persons, including Tenant’s contractors and subcontractors and their respective employees, agents and invitees, and for any and all damages to property caused by, resulting from or arising out of any act or omission on the part of Tenant, Tenant’s contractors or subcontractors, or their respective employees, agents and invitees in the prosecution of the Tenant Improvements.  Tenant agrees to indemnify, save, defend, and hold the Landlord Indemnitees harmless from and against all Claims due to, because of or arising out of any and all such injuries, death or damage, whether real or alleged, and Tenant and Tenant’s contractors and subcontractors shall assume and defend at their sole cost and expense all such Claims; provided , however , that nothing contained in this Work Letter shall be deemed to indemnify or otherwise hold Landlord harmless from or against liability caused by Landlord’s negligence or willful misconduct.  Any deficiency in design or construction of the Tenant Improvements shall be solely the responsibility of Tenant, notwithstanding the fact that Landlord may have approved of the same in writing.

 

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7.                                       TI Allowance .

 

7.1.                             Application of TI Allowance .  Landlord shall contribute, in the following order, the Base TI Allowance and, if properly requested by Tenant pursuant to the terms of the Lease, the Additional TI Allowance, toward the costs and expenses incurred in connection with the performance of the Tenant Improvements, in accordance with Article 4 of the Lease.  If the entire TI Allowance is not applied toward or reserved for the costs of the Tenant Improvements or as otherwise set forth in Section 4.2 of the Lease, then Tenant shall not be entitled to a credit of such unused portion of the TI Allowance.  If the entire Excess TI Costs advanced by Tenant to Landlord are not applied toward the costs of the Tenant Improvements, then Landlord shall promptly return such excess to Tenant following completion of the Tenant Improvements.  Tenant may apply the Base TI Allowance and, if properly requested by Tenant pursuant to the terms of the Lease, the Additional TI Allowance for the payment of construction and other costs in accordance with the terms and provisions of the Lease.

 

7.2.                             Approval of Budget for the Tenant Improvements .  Notwithstanding anything to the contrary set forth elsewhere in this Work Letter or the Lease, Landlord shall not have any obligation to expend any portion of the TI Allowance until Landlord and Tenant shall have approved in writing the budget for the Tenant Improvements (the “ Approved TI Budget ”).  Prior to Landlord’s approval (or deemed approval) of the Approved TI Budget, Tenant shall pay all of the costs and expenses incurred in connection with the Tenant Improvements as they become due.  Landlord shall not be obligated to reimburse Tenant for costs or expenses relating to the Tenant Improvements that exceed the amount of the TI Allowance.  Landlord shall not unreasonably withhold, condition or delay its approval of any budget for Tenant Improvements that is proposed by Tenant.  Landlord’s failure to approve or disapprove a proposed budget within five (5) business days after receipt from Tenant shall be deemed Landlord’s approval of such budget.

 

7.3.                             Fund Requests .  Upon submission by Tenant to Landlord of (a) a statement (a “ Fund Request ”) setting forth the total amount of the TI Allowance requested, (b) a summary of the Tenant Improvements performed using AIA standard form Application for Payment (G 702) executed by the general contractor and by the architect, (c) invoices from the general contractor, the architect, each MEP Subcontractor and any subcontractors, material suppliers and other parties requesting payment with respect to the amount of the TI Allowance then being requested, (d) unconditional lien releases from the general contractor, architect, each MEP Subcontractor and any other Major Subcontractor with respect to previous payments made by either Landlord or Tenant for the Tenant Improvements in a form reasonably acceptable to Landlord and complying with Applicable Laws (provided, that Tenant shall provide lien waivers from the general contractor with respect to any work by or from subcontractors and material suppliers that is equal to or less than Fifty Thousand Dollars ($50,000)) and (e) conditional lien releases from the general contractor, architect, each MEP Subcontractor and any other Major Subcontractor with respect to the Tenant Improvements performed that correspond to the Fund Request in a form reasonably acceptable to Landlord and complying with Applicable Laws (provided, that Tenant shall provide lien waivers from the general contractor with respect to any work by or from subcontractors and material suppliers that is equal to or less than Fifty Thousand Dollars ($50,000)), then Landlord shall, within thirty (30) days following receipt by Landlord of a Fund Request and the accompanying materials required by this Section, pay to Tenant (for

 

B-7



 

reimbursement for payments made by Tenant to such contractors, subcontractors or material suppliers either prior to Landlord’s approval of the Approved TI Budget or as a result of Tenant’s decision to pay for the Tenant Improvements itself and later seek reimbursement from Landlord in the form of one lump sum payment in accordance with the Lease and this Work Letter) or directly to the applicable contractors, architect, subcontractors and material suppliers, as elected by Tenant, the amount of Tenant Improvement costs, or Landlord’s pari passu share thereof if Excess TI Costs exist based on the Approved Budget, set forth in such Fund Request; provided , however, that Landlord shall not be obligated to make any payments under this Section until the budget for the Tenant Improvements is approved in accordance with Section 7.2 above, and any Fund Request under this Section shall be subject to the payment limits set forth in Section 7.2 above and Article 4 of the Lease.

 

8.                                       Requests for Consent .  Except as otherwise provided in this Work Letter, each of Landlord and Tenant shall respond to all requests for consents, approvals or directions made by the other pursuant to this Work Letter within five (5) business days following the approving party’s receipt of such request.  Except as otherwise provided in this Work Letter, the approving party’s failure to respond within such five (5) business day period shall be deemed approval by such party.

 

9.                                       Miscellaneous .

 

9.1.                             Number; Headings .  Where applicable in this Work Letter, the singular includes the plural and the masculine or neuter includes the masculine, feminine and neuter.  The section headings of this Work Letter are not a part of this Work Letter and shall have no effect upon the construction or interpretation of any part hereof.

 

9.2.                             Attorneys’ Fees .  If either party commences an action against the other party arising out of or in connection with this Work Letter, then the substantially prevailing party shall be entitled to have and recover from the other party reasonable attorneys’ fees, charges and disbursements and costs of suit.

 

9.3.                             Time of Essence .  Time is of the essence with respect to the performance of every provision of this Work Letter in which time of performance is a factor.

 

9.4.                             Covenant and Condition .  Each provision of this Work Letter performable by Tenant shall be deemed both a covenant and a condition.

 

9.5.                             Withholding of Consent .  Whenever consent or approval of either party is required, that party shall not unreasonably withhold, condition or delay such consent or approval, except as may be expressly set forth to the contrary.

 

9.6.                             Invalidity .  Any provision of this Work Letter that shall prove to be invalid, void or illegal shall in no way affect, impair or invalidate any other provision hereof, and all other provisions of this Work Letter shall remain in full force and effect and shall be interpreted as if the invalid, void or illegal provision did not exist.

 

B-8



 

9.7.                             Interpretation .  The language in all parts of this Work Letter shall be in all cases construed as a whole according to its fair meaning and not strictly for or against either Landlord or Tenant.

 

9.8.                             Successors .  Each of the covenants, conditions and agreements herein contained shall inure to the benefit of and shall apply to and be binding upon the parties hereto and their respective heirs; legatees; devisees; executors; administrators; and permitted successors, assigns, sublessees.  Nothing in this Section shall in any way alter the provisions of the Lease restricting assignment or subletting.

 

9.9.                             Governing Law .  This Work Letter shall be governed by, construed and enforced in accordance with the laws of the state in which the Premises are located, without regard to such state’s conflict of law principles.

 

9.10.                      Power and Authority .  Tenant guarantees, warrants and represents that the individual or individuals signing this Work Letter have the power, authority and legal capacity to sign this Work Letter on behalf of and to bind all entities, corporations, partnerships, limited liability companies, joint venturers or other organizations and entities on whose behalf said individual or individuals have signed.

 

9.11.                      Counterparts .  This Work Letter may be executed in one or more counterparts, each of which, when taken together, shall constitute one and the same document.

 

9.12.                      Amendments; Waiver .  No provision of this Work Letter may be modified, amended or supplemented except by an agreement in writing signed by Landlord and Tenant.  The waiver by Landlord of any breach by Tenant of any term, covenant or condition herein contained shall not be deemed to be a waiver of any subsequent breach of the same or any other term, covenant or condition herein contained.

 

9.13.                      Waiver of Jury Trial .  To the extent permitted by Applicable Laws, the parties waive trial by jury in any action, proceeding or counterclaim brought by the other party hereto related to matters arising out of or in any way connected with this Work Letter; the relationship between Landlord and Tenant; Tenant’s use or occupancy of the Premises; or any claim of injury or damage related to this Work Letter or the Premises.

 

[REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]

 

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IN WITNESS WHEREOF, Landlord and Tenant have executed this Work Letter to be effective on the date first above written.

 

LANDLORD :

 

BMR-PACIFIC RESEARCH CENTER LP,

 

a Delaware limited partnership

 

 

 

 

 

By:

/s/ Alan D. Gold

 

Name:

Alan D. Gold

 

Title:

Chief Executive Officer

 

 

 

 

TENANT :

 

DEPOMED, INC.,

 

a California corporation

 

 

 

 

 

 

 

By:

/s/ James Schoeneck

 

Name:

James Schoeneck

 

Title:

President & CEO

 

 

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EXHIBIT B-1

 

APPROVED ARCHITECTS, ENGINEERS AND CONTRACTORS

 

Architects:

 

DGA, CAS, DES, WHL, Perkins+Will

 

 

 

Engineers:

 

AEI, Greene Engineers, Randall Lamb Associates

 

 

 

Contractors:

 

Novo, MAI, Dome, DPR, BN Builders, The Core Group

 

 

 

Mechanical/Utilities Contractors:

 

Therma, Southland, Hellwig Mechanical & Plumbing, Western Allied, Western Roundtree

 

 

 

Electrical Contractors:

 

Rosendin, Redwood City Electric, Howell Electric, Mission Electric, Corporate Electric, TDN Electric

 

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EXHIBIT C

 

ACKNOWLEDGEMENT OF
EXPANSION PREMISES TERM COMMENCEMENT DATE

 

THIS ACKNOWLEDGEMENT OF EXPANSION PREMISES TERM COMMENCEMENT DATE is entered into as of [              ], 20[    ], with reference to that certain Lease (the “ Lease ”) dated as of April 4, 2012, by Depomed, Inc., a California corporation (“ Tenant ”), in favor of BMR-Pacific Research Center LP, a Delaware limited partnership (“ Landlord ”).  All capitalized terms used herein without definition shall have the meanings ascribed to them in the Lease.

 

Tenant hereby confirms the following:

 

1.             Tenant accepted possession of the Expansion Premises on [              ], 20[    ].

 

2.             The Expansion Premises are in good order, condition and repair.

 

3.             The Tenant Improvements to the Expansion Premises are Substantially Complete.

 

4.             In accordance with the provisions of Article 43 of the Lease, the Expansion Premises Term Commencement Date is [              ], 20[    ], and, unless the Lease is terminated prior to the Term Expiration Date pursuant to its terms, the Term Expiration Date shall be [              ], 20[    ].

 

5.             Tenant commenced occupancy of the Expansion Premises for the Permitted Use on [              ], 20[    ].

 

6.             The Lease is in full force and effect, and the same represents the entire agreement between Landlord and Tenant concerning the Premises[, except [              ]].

 

7.             The obligation to pay Rent is presently in effect and all Rent obligations on the part of Tenant under the Lease commenced to accrue on [              ], 20[    ], with Base Rent payable on the dates and amounts set forth in the chart below:

 

Dates

 

Approximate
Square Feet of
Rentable Area

 

Base Rent per Square
Foot of Rentable Area

 

Monthly
Base Rent

 

Annual
Base Rent

 

[    ]/[    ]/[    ]-
[    ]/[    ]/[    ]

 

[    ]

 

$[              ]

[monthly][OR][annually]

 

[    ]

 

[    ]

 

 

8.             The undersigned Tenant has not made any prior assignment, transfer, hypothecation or pledge of the Lease or of the rents thereunder or sublease of the Premises or any portion thereof.

 

[REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]

 

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IN WITNESS WHEREOF, Tenant has executed this Acknowledgment of Term Commencement Date and Term Expiration Date as of the date first written above.

 

TENANT:

 

DEPOMED, INC.,

a California corporation

 

 

By:

 

 

Name:

 

 

Title:

 

 

 

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EXHIBIT D

 

FORM OF ADDITIONAL TI ALLOWANCE ACCEPTANCE LETTER

 

[TENANT LETTERHEAD]

 

BMR-Pacific Research Center LP

17190 Bernardo Center Drive

San Diego, California  92128

Attn:  Vice President, Real Estate Counsel

 

[Date]

 

Re:                                Additional TI Allowance

 

To Whom It May Concern:

 

This letter concerns that certain Lease dated as of April 4, 2012 (the “ Lease ”), between BMR-Pacific Research Center LP (“ Landlord ”) and Depomed, Inc. (“ Tenant ”).  Capitalized terms not otherwise defined herein shall have the meanings given them in the Lease.

 

Tenant hereby notifies Landlord that it wishes to exercise its right to utilize the Additional TI Allowance [consisting of $                      ] pursuant to Article 4 of the Lease.

 

If you have any questions, please do not hesitate to call [              ] at ([      ]) [      ]-[        ].

 

 

Sincerely,

 

 

 

 

 

[Name]

 

[Title of Authorized Signatory]

 

 

 

 

cc:

Greg Lubushkin

 

 

Karen Sztraicher

 

 

John Bonanno

 

 

Kevin Simonsen

 

 

D-1



 

EXHIBIT E

 

FORM OF LETTER OF CREDIT

 

[On letterhead or L/C letterhead of Issuer.]

 

LETTER OF CREDIT

 

Date:               , 200

 

(the “ Beneficiary ”)

 

Attention:

L/C. No.:

Loan No. :

 

Ladies and Gentlemen:

 

We establish in favor of Beneficiary our irrevocable and unconditional Letter of Credit numbered as identified above (the “ L/C ”) for an aggregate amount of $              , expiring at     :00 p.m. on                or, if such day is not a Banking Day, then the next succeeding Banking Day (such date, as extended from time to time, the “ Expiry Date ”). “ Banking Day ” means a weekday except a weekday when commercial banks in                            are authorized or required to close.

 

We authorize Beneficiary to draw on us (the “ Issuer ”) for the account of                (the “ Account Party ”), under the terms and conditions of this L/C.

 

Funds under this L/C are available by presenting the following documentation (the “ Drawing Documentation ”): (a) the original L/C and (b) a sight draft substantially in the form of Attachment 1 , with blanks filled in and bracketed items provided as appropriate. No other evidence of authority, certificate, or documentation is required.

 

Drawing Documentation must be presented at Issuer’s office at                          on or before the Expiry Date by personal presentation, courier (i.e., Federal Express or other nationally recognized overnight delivery service) or messenger service. Issuer will on request issue a receipt for Drawing Documentation.

 

We agree, irrevocably, and irrespective of any claim by any other person, to honor drafts drawn under and in conformity with this L/C, within the maximum amount of this L/C, presented to us on or before the Expiry Date, provided we also receive (on or before the Expiry Date) any other Drawing Documentation this L/C requires.

 

We shall pay this L/C only from our own funds by check or wire transfer, in compliance with the Drawing Documentation.

 

E-1



 

If Beneficiary presents proper Drawing Documentation to us on or before the Expiry Date, then we shall pay under this L/C at or before the following time (the “ Payment Deadline ”): (a) if presentment is made at or before noon of any Banking Day, then the close of such Banking Day; and (b) otherwise, the close of the next Banking Day.  We waive any right to delay payment beyond the Payment Deadline. If we determine that Drawing Documentation is not proper, then we shall so advise Beneficiary in writing, specifying all grounds for our determination, within one Banking Day after the Payment Deadline.

 

Partial drawings are permitted. This L/C shall, except to the extent reduced thereby, survive any partial drawings.

 

We shall have no duty or right to inquire into the validity of or basis for any draw under this L/C or any Drawing Documentation.  We waive any defense based on fraud or any claim of fraud.

 

The Expiry Date shall automatically be extended by one year (but never beyond            (the “ Outside Date ”)) unless, on or before the date 90 days before any Expiry Date, we have given Beneficiary notice that the Expiry Date shall not be so extended (a “ Nonrenewal Notice ”). We shall promptly upon request confirm any extension of the Expiry Date under the preceding sentence by issuing an amendment to this L/C, but such an amendment is not required for the extension to be effective. We need not give any notice of the Outside Date.

 

Beneficiary may from time to time without charge transfer this L/C, in whole but not in part, to any transferee (the “ Transferee ”).  Issuer shall look solely to Account Party for payment of any fee for any transfer of this L/C.  Such payment is not a condition to any such transfer. Beneficiary or Transferee shall consummate such transfer by delivering to Issuer the original of this L/C and a Transfer Notice substantially in the form of Attachment 2 , purportedly signed by Beneficiary, and designating Transferee.  Issuer shall promptly reissue or amend this L/C in favor of Transferee as Beneficiary.  Upon any transfer, all references to Beneficiary shall automatically refer to Transferee, who may then exercise all rights of Beneficiary.  Issuer expressly consents to any transfers made from time to time in compliance with this paragraph.

 

Any notice to Beneficiary shall be in writing and delivered by hand with receipt acknowledged or by overnight delivery service such as FedEx (with proof of delivery) at the above address, or such other address as Beneficiary may specify by written notice to Issuer. A copy of any such notice shall also be delivered, as a condition to the effectiveness of such notice, to:                        (or such replacement as Beneficiary designates from time to time by written notice).

 

No amendment that adversely affects Beneficiary shall be effective without Beneficiary’s written consent.

 

This L/C is subject to and incorporates by reference: (a) the International Standby Practices 98 (“ ISP 98 ”); and (b) to the extent not inconsistent with ISP 98, Article 5 of the Uniform Commercial Code of the State of New York.

 

 

Very truly yours,

 

E-2



 

 

[Issuer Signature]

 

E-3



 

ATTACHMENT 1 TO EXHIBIT E

 

FORM OF SIGHT DRAFT

 

[BENEFICIARY LETTERHEAD]

 

TO:

 

[Name and Address of Issuer]

 

SIGHT DRAFT

 

AT SIGHT, pay to the Order of                             , the sum of                              United States Dollars ($                            ). Drawn under [Issuer] Letter of Credit No.                              dated                             .

 

[Issuer is hereby directed to pay the proceeds of this Sight Draft solely to the following account:                                                   .]

 

[Name and signature block, with signature or purported signature of Beneficiary]

 

Date:

 

 

 

E-1-1



 

ATTACHMENT 2 TO EXHIBIT E

 

FORM OF TRANSFER NOTICE

 

[BENEFICIARY LETTERHEAD]

 

TO:

 

[Name and Address of Issuer] (the “ Issuer ”)

 

TRANSFER NOTICE

 

By signing below, the undersigned, Beneficiary (the “ Beneficiary ”) under Issuer’s Letter of Credit No.                              dated                              (the “ L/C ”), transfers the L/C to the following transferee (the “ Transferee ”):

 

[Transferee Name and Address]

 

The original L/C is enclosed. Beneficiary directs Issuer to reissue or amend the L/C in favor of Transferee as Beneficiary. Beneficiary represents and warrants that Beneficiary has not transferred, assigned, or encumbered the L/C or any interest in the L/C, which transfer, assignment, or encumbrance remains in effect.

 

[Name and signature block, with signature or purported signature of Beneficiary]

 

Date:

 

 

 

E-2-1



 

EXHIBIT F

 

RULES AND REGULATIONS

 

NOTHING IN THESE RULES AND REGULATIONS (“ RULES AND REGULATIONS ”) SHALL SUPPLANT ANY PROVISION OF THE LEASE.  IN THE EVENT OF A CONFLICT OR INCONSISTENCY BETWEEN THESE RULES AND REGULATIONS AND THE LEASE, THE LEASE SHALL PREVAIL.

 

1.             Neither Tenant nor Tenant’s employees, agents, contractors or invitees shall encumber or obstruct the common entrances, lobbies, elevators, sidewalks and stairways of the Building(s) or the Project or use them for any purposes other than ingress or egress to and from the Building(s) or the Project.

 

2.             Except as specifically provided in the Lease, no sign, placard, picture, advertisement, name or notice shall be installed or displayed on any part of the outside of the Premises or the Building(s) without Landlord’s prior written consent.  Landlord shall have the right to remove, at Tenant’s sole cost and expense and without notice, any sign installed or displayed in violation of this rule.

 

3.             If Landlord objects in writing to any curtains, blinds, shades, screens, hanging plants or other similar objects attached to or used in connection with any window or door of the Premises or placed on any windowsill, and (a) such window, door or windowsill is visible from the exterior of the Premises and (b) such curtain, blind, shade, screen, hanging plant or other object is not included in plans approved by Landlord, then Tenant shall promptly remove said curtains, blinds, shades, screens, hanging plants or other similar objects at its sole cost and expense.

 

4.             No deliveries shall be made that impede or interfere with other tenants in or the operation of the Project.

 

5.             Tenant shall not place a load upon any floor of the Premises that exceeds the load per square foot that (a) such floor was designed (including through any Landlord approved structural upgrades) to carry or (b) is allowed by Applicable Laws.  Fixtures and equipment that cause noises or vibrations that may be transmitted to the structure of the Building(s) to such a degree as to be objectionable to other tenants shall be placed and maintained by Tenant, at Tenant’s sole cost and expense, on vibration eliminators or other devices sufficient to eliminate such noises and vibrations to levels reasonably acceptable to Landlord and the affected tenants of the Project.

 

6.             Tenant shall not use any method of heating or air conditioning other than that shown in the Tenant Improvement plans.

 

7.             Tenant shall not install any radio, television or other antennae; cell or other communications equipment; or other devices on the roof or exterior walls of the Premises except in accordance with the Lease.   Tenant shall not interfere with radio, television or other digital or electronic communications at the Project or elsewhere.

 

8.             Canvassing, peddling, soliciting and distributing handbills or any other written material within, on or around the Project (other than within the Premises) are prohibited.  Tenant shall

 

F-1



 

cooperate with Landlord to prevent such activities by Tenant or its employees, agents, contractors and invitees.

 

9.             Except as provided in Section 13.6 of the Lease, Tenant shall store all of its trash, garbage and Hazardous Materials in receptacles within its Premises or in receptacles designated by Landlord outside of the Premises.  Tenant shall not place in any such receptacle any material that cannot be disposed of in the ordinary and customary manner of trash, garbage and Hazardous Materials disposal.  Any Hazardous Materials transported through Common Areas shall be held in secondary containment devices.  Tenant shall be responsible, at its sole cost and expense, for Tenant’s removal of its trash, garbage and Hazardous Materials; provided, however, that Tenant is encouraged to participate in the waste removal and recycling program in place at the Project.

 

10.           The Premises shall not be used for lodging or for any illegal purpose.  No cooking shall be done or permitted in the Premises; provided , however, that Tenant may use (a) equipment approved in accordance with the requirements of insurance policies that Landlord or Tenant is required to purchase and maintain pursuant to the Lease for brewing coffee, tea, hot chocolate and similar beverages, (b) microwave ovens for employees’ use and (c) equipment shown on Tenant Improvement plans approved by Landlord; provided , further, that any such equipment and microwave ovens are used in accordance with Applicable Laws.

 

11.           Tenant shall not, without Landlord’s prior written consent, use the name of the Project, if any, in connection with or in promoting or advertising Tenant’s business except as Tenant’s address.

 

12.           Tenant shall comply with all safety, fire protection and evacuation procedures and regulations established by Landlord or any Governmental Authority.

 

13.           Tenant assumes any and all responsibility for protecting the Premises from theft, robbery and pilferage, which responsibility includes keeping doors locked and other means of entry to the Premises closed.

 

14.           Tenant shall furnish Landlord with copies of keys, pass cards or similar devices for locks to the Premises.

 

15.           Tenant shall cooperate and participate in all reasonable security programs affecting the Premises.

 

16.           Tenant shall not permit any animals in the Project, other than for guide animals or for use in laboratory experiments.

 

17.           Bicycles shall not be taken into the Building(s) except into areas designated by Landlord.

 

18.           The water and wash closets and other plumbing fixtures shall not be used for any purposes other than those for which they were constructed, and no sweepings, rubbish, rags or other substances shall be deposited therein.

 

F-2



 

19.                                Discharge of industrial sewage shall only be permitted if Tenant, at its sole expense, first obtains all necessary permits and licenses therefor from all applicable Governmental Authorities.

 

20.                                Smoking is prohibited at the Project.

 

21.                                The Project’s hours of operation are currently 24 hours a day seven days a week.

 

22.                                Tenant shall comply with all orders, requirements and conditions now or hereafter imposed by Applicable Laws or Landlord (“ Waste Regulations ”) regarding the collection, sorting, separation and recycling of waste products, garbage, refuse and trash generated by Tenant (collectively, “ Waste Products ”), including (without limitation) the separation of Waste Products into receptacles reasonably approved by Landlord and the removal of such receptacles in accordance with any collection schedules prescribed by Waste Regulations.

 

23.                                Tenant, at Tenant’s sole cost and expense, shall cause the Premises to be exterminated as necessary or appropriate from time to time and shall cause all portions of the Premises used for the storage, preparation, service or consumption of food or beverages to be cleaned daily in a manner reasonably satisfactory to Landlord, and to be treated against infestation by insects, rodents and other vermin and pests whenever there is evidence of any infestation.  Tenant shall not permit any person to enter the Premises or the Project for the purpose of providing such extermination services, unless such persons have been approved by Landlord.  If requested by Landlord, Tenant shall, at Tenant’s sole cost and expense, store any refuse generated in the Premises by the consumption of food or beverages in a cold box or similar facility.

 

Landlord may waive any one or more of these Rules and Regulations for the benefit of Tenant or any other tenant, but no such waiver by Landlord shall be construed as a waiver of such Rules and Regulations in favor of Tenant or any other tenant, nor prevent Landlord from thereafter enforcing any such Rules and Regulations against any or all of the tenants of the Project, including Tenant.  These Rules and Regulations are in addition to, and shall not be construed to in any way modify or amend, in whole or in part, the terms covenants, agreements and conditions of the Lease.  Landlord reserves the right to make such other and reasonable rules and regulations as, in its judgment, may from time to time be needed for safety and security, the care and cleanliness of the Project, or the preservation of good order therein; provided , however, that Tenant shall not be obligated to adhere to such additional rules or regulations until Landlord has provided Tenant with written notice thereof.  Tenant agrees to abide by these Rules and Regulations and any additional rules and regulations issued or adopted by Landlord.  Tenant shall be responsible for the observance of these Rules and Regulations by Tenant’s employees, agents, contractors and invitees.

 

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EXHIBIT G

 

AMENITIES BUILDING SERVICES

 

F.I.T. @ PRC

 

A Full Service Workout Facility Operated by Fitness 101
Top-of-the-Line Star Trac Gym Equipment
Personal Training
50 Person Men’s and Women’s Shower & Locker Facility

 

CAFETERIA

 

Coffee/Barista Bar
Multiple hot and cold food stations
Open Booth, Table and Outdoor Patio Seating
Private Catering for Corporate Events
Service Provided by Guckenheimer

 

CONFERENCE CENTER

 

5 Conference Rooms
10-200 Person Capacity
Multimedia Capabilities
24/7 Availability

 

MISC AMENITIES

 

Purple Tie Laundry Service
Basketball Court
Volleyball Court
Game Room

 

G-1



 

EXHIBIT H

 

TENANT’S PERSONAL PROPERTY

 

Notwithstanding anything to the contrary, the items set forth on this Exhibit H are only Tenant’s personal property to the extent that such items were purchased without the use of any funds provided by Landlord (including the TI Allowance, Base Expansion TI Allowance and any other allowance provided by Landlord).  Any items to which Landlord contributed payment are Landlord’s property in accordance with Article 17 of the Lease.

 

Manufacturing and Lab equipment, including:

 

 

 

Coating Equipment

 

Balances

Chromotography skids

 

Centrifuges

Dry Boxes

 

Chemical Imagers

Equipment washers

 

Conductivity meters

Fillers

 

Corrosive storage cabinets

High-Shear Granulator

 

Dry ice chests

Fluid Bed Dryers

 

Electrophoresis

Powder Mills

 

ELISA apparatus

Blenders

 

Fast Protein Liquid Chromatography

 

 

 

 

 

Film developers

Gown room furniture

 

Flammable Storage cabinets

Inspection stations

 

Fourier transform infrared spectroscopy

Isolators

 

Freezers

Light boxes

 

 

Lockers

 

Gas chromatographs

Lyophilizers

 

Gel stations

Packaging stations

 

Heat blocks

Pallet racks

 

High pressure liquid chromatography

Pumps

 

Karl Fisher

Scales

 

Dissolution and Disintegration Apparatus

Shakers

 

Ion Chromatograph

Shelving, Wire Shelving, Metro Rack

 

Particle Size Analyzer

Sonicator, Ultrasonic Cleaner

 

Hood, capture hood, Flow

Tanks

 

Hot plates

Vacuum Pump

 

Ice machines

Washers

 

Incubators

Synthesizers

 

Lab coat racks

Tables and lab chairs

 

Laminar Flow Hoods

Thermocyclers

 

Mass Spectrophotometer

Waterbaths

 

Microfuges

Waterpolishers

 

Microscopes

 

H-1



 

Washers

 

Microwaves

Eye Washes

 

Ovens

Speed vacs

 

Ph meters

Stir plates

 

Refrigerators

Purified Water system

 

Rotovaps

Safety Showers

 

Spectrophotometer, UV Vis

Carts and cage racks

 

Tablet Press

 

Office furniture and equipment, including:

 

Closed office furniture

Conference room furniture

Breakroom furniture and equipment

Lobby furniture

Patio furniture

Chairs

PC workstations

Fork lifts

Servers

Server Racks

High Density Storage Shelving

 

H-2



 

EXHIBIT I

 

FORM OF ESTOPPEL CERTIFICATE

 

To:                              BMR-Pacific Research Center LP

17190 Bernardo Center Drive

San Diego, California  92128

Attention: Vice President, Real Estate Counsel

 

BioMed Realty, L.P.

17190 Bernardo Center Drive

San Diego, California  92128

 

Re:                              [PREMISES ADDRESS] (the “ Premises ”) at [STREET ADDRESS], [CITY AND STATE] (the “ Property ”)

 

The undersigned tenant (“ Tenant ”) hereby certifies to you as follows:

 

1.                                       Tenant is a tenant at the Property under a lease (the “ Lease ”) for the Premises dated as of April 4, 2012.  The Lease has not been cancelled, modified, assigned, extended or amended [except as follows:  [              ]], and there are no other agreements, written or oral, affecting or relating to Tenant’s lease of the Premises or any other space at the Property.  The lease term expires on [              ], 20[    ].

 

2.                                       Tenant took possession of the Premises, currently consisting of [              ] square feet, on [              ], 20[    ], and commenced to pay rent on [              ], 20[    ].  Tenant has full possession of the Premises, has not assigned the Lease or sublet any part of the Premises, and does not hold the Premises under an assignment or sublease[, except as follows:  [              ]].

 

3.                                       All Rent under the Lease have been paid through [              ], 20[    ].  There is no prepaid rent[, except $[              ]][, and the amount of security deposit is $[              ] [in cash][OR][in the form of a letter of credit]].  Tenant currently has no right to any future rent abatement under the Lease.

 

4.                                       Base Rent is currently payable in the amount of $[              ] per month.

 

5.                                       Tenant is currently paying estimated payments of Tenant’s Share of Operating Expenses) of $[              ] per month and a monthly Property Management Fee of $[                  ].

 

6.                                       All work to be performed for Tenant under the Lease has been performed as required under the Lease and has been accepted by Tenant[, except [              ]], and allowances to be paid to Tenant, including allowances for tenant improvements, moving expenses or other items, have been paid [except                         ].

 

7.                                       The Lease is in full force and effect.  To Tenant’s actual knowledge, without inquiry or investigation, the Lease is free from default by Tenant and Tenant knows of no event that could, with the passage of time or the giving of notice, become a default by Tenant under the Lease.  To Tenant’s actual knowledge, without inquiry or investigation, Tenant has no current

 

I-1



 

claims against Landlord or offsets or defenses against Rent, and there are no disputes with Landlord. Tenant has received no notice of prior sale, transfer, assignment, hypothecation or pledge of the Lease or of the rents payable thereunder[, except [              ]].

 

8.                                       [Tenant has the following expansion rights or options for the Property:  [              ].][OR][Tenant has no rights or options to purchase the Property.]

 

9.                                       To Tenant’s knowledge, no Hazardous Materials have been generated, treated, stored or disposed of by or on behalf of Tenant in, on or around the Premises or the Project in violation of the requirements of the Lease.

 

10.                                The undersigned has executed this Estoppel Certificate with the knowledge and understanding that [INSERT NAME OF LANDLORD, PURCHASER OR LENDER, AS APPROPRIATE] or its assignee is acquiring the Property in reliance on this certificate and that the undersigned shall be bound by this certificate.  The statements contained herein may be relied upon by [INSERT NAME OF PURCHASER OR LENDER, AS APPROPRIATE], [LANDLORD], BioMed Realty, L.P., BioMed Realty Trust, Inc., and any [other] mortgagee of the Property and their respective successors and assigns.

 

Any capitalized terms not defined herein shall have the respective meanings given in the Lease.

 

Dated this [        ] day of [              ], 20[    ].

 

[              ],

a [              ]

 

By:

 

 

Name:

 

 

Title:

 

 

 

I-2



 

EXHIBIT J

 

EXPANSION PREMISES

 

J-1



 

 



 

EXHIBIT K

 

HAZARDOUS MATERIALS SHED SIZE AND LOCATION

 

K-1



 

 



 

EXHIBIT L

 

BUILDING CAPACITIES/BASE BUILDING SYSTEMS

 

L-1



 

 

Building 7 - 7999 Gateway Blvd

 

Elevator

 

MFG

 

Use

 

Type

 

Capacity

 

Elev 1

 

Otis

 

Passenger

 

Hydraulic

 

2,500 lbs.

 

Elev 2

 

Otis

 

Passenger

 

Hydraulic

 

2,500 lbs.

 

 

BMS System

 

Existing

 

Provider

 

 

 

 

 

 

 

Yes

 

ALC

 

 

 

 

 

 

STRUCTURAL SYSTEM

 

Structural System

 

Concentric Braced Steel Frame

 

Floor 3

 

3” Metal Deck with 4-1/2” Concrete Fill

 

Roof

 

1-1/2” Metal Deck

 

 

Design Load

 

 

 

Floor 3

 

100 PSF Live, 30 PSF Dead

 

Roof

 

20 PSF

 

 

MECHANICAL SYSTEMS

 

Rooftop

 

Boilers

 

Location

 

Serving

 

MFG

 

Model #

 

Serial #

 

BMR Tag

 

Size

 

Comments

 

B 6-1

 

West Wing

 

 

 

Raypak

 

H3-1083

 

0008173246

 

200520

 

1.08 M

 

 

 

B 6-2

 

West Wing

 

 

 

Raypak

 

H3-1083

 

0008173245

 

200519

 

1.08 M

 

 

 

B 6-3

 

East Wing

 

 

 

Raypak

 

H3-1758

 

0008173247

 

200525

 

1.7 M

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Packaged Air Handlers

 

Location

 

Serving

 

MFG

 

Model #

 

Serial #

 

BMR Tag

 

Size

 

Comments

 

AC 6-3

 

West Wing

 

 

 

TRANE

 

SXHGD1240QJ8CF9D600

 

C00E16078

 

200507

 

115 tons

 

 

 

AC 6-5

 

East Wing

 

 

 

TRANE

 

SXHGC9040Q97CD8D600

 

C00E16086

 

200528

 

90 tons

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exhaust

 

Location

 

Serving

 

MFG

 

Model #

 

Serial #

 

BMR Tag

 

Size

 

Comments

 

EF 6-1

 

West

 

West Toilets & JCs

 

Penn

 

DX18B

 

 

 

 

 

 

EF 6-2

 

East

 

East Toilets & JCs

 

Penn

 

DX18B

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pumps

 

Location

 

Serving

 

MFG

 

Model #

 

Serial #

 

BMR Tag

 

Size

 

Comments

 

HWP-1 (HWP 6-1)

 

West Wing

 

B 6-1

 

B&G

 

Series 80 1.5x9.5 8BF

 

201564

 

200517

 

45 GPM / 60FT

 

 

 

HWP-2 (HWP 6-2)

 

West Wing

 

B 6-2

 

B&G

 

Series 80 1.5x9.5 8BF

 

201563

 

200518

 

45 GPM / 60FT

 

 

 

HWP-3 (HWP 6-3)

 

East Wing

 

B 6-3

 

B&G

 

Series 80 1.5x9.5 8BF

 

201565

 

200524

 

72 GPM / 60FT

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Piped Water Systems

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hot Water (HW)

 

Closed loop system

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ELECTRICAL SYSTEMS

 

Note: Tenant entitled to Pro-rata share of Power.

 

East Wing

 

480 V Power

 

Location

 

Label

 

Serving

 

Volts

 

Amps

 

Sub Divided

 

 

 

 

 

Main Electrical

 

South East Wing

 

MSB6E

 

East Wing

 

480v

 

4000a

 

No

 

 

 

 

 

Meter

 

North Façade

 

PG&E 2 of 2

 

East Wing

 

480v

 

4000a

 

No

 

 

 

 

 

 

208 V Power

 

XFRM at each floor steps power down from 480v.

 

 

 

 

 

 

 

 

 

Site & Building Emergency Generators

 

None

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Uninterrupted Power Supply (UPS)

 

None

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

West Wing

 

480 V Power

 

Location

 

Label

 

Serving

 

Volts

 

Amps

 

Sub Divided

 

 

 

 

 

Main Electrical

 

North West Wing

 

MSB6W

 

West Wing

 

480v

 

4000a

 

No

 

 

 

 

 

Meter

 

West Façade

 

PG&E 1 of 2

 

West Wing

 

480v

 

4000a

 

No

 

 

 

 

 

 

208 V Power

 

XFRM at each floor steps power down from 480v.

 

 

 

 

 

 

 

 

 

Site & Building Emergency Generators

 

None

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Uninterrupted Power Supply (UPS)

 

None

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PLUMBING SYSTEM

 

East Wing

 

Water

 

Size

 

Location

 

Above Grade Material

 

Below Grade Material

 

Sub Divided

 

 

 

 

 

 

 

Water Main

 

2.5”

 

East Façade

 

Type L Copper

 

Type L Copper

 

No

 

 

 

 

 

 

 

Meter

 

2.5”

 

East Façade

 

 

 

No

 

 

 

 

 

 

 

 

Waste

 

Size

 

Location

 

Above Grade Material

 

Below Grade Material

 

Sub Divided

 

 

 

 

 

 

 

Waste Main

 

4”

 

East Façade

 

Cast Iron

 

ABS Pipe

 

No

 

 

 

 

 

 

 

 

West Wing

 

Water

 

Size

 

Location

 

Above Grade Material

 

Below Grade Material

 

Sub Divided

 

 

 

 

 

 

 

Water Main

 

2.5”

 

North Façade

 

Type L Copper

 

Type L Copper

 

No

 

 

 

 

 

 

 

Meter

 

2.5”

 

North Façade

 

 

 

No

 

 

 

 

 

 

 

 

Gas

 

Size

 

Location

 

Above Grade Material

 

Below Grade Material

 

Sub Divided

 

 

 

 

 

 

 

Gas Main

 

6”

 

West Façade

 

Black Steel

 

Black Steel

 

No

 

 

 

 

 

 

 

Meter

 

2.5”

 

West Façade

 

 

 

No

 

 

 

 

 

 

 

 

Waste

 

Size

 

Location

 

Above Grade Material

 

Below Grade Material

 

Sub Divided

 

 

 

 

 

 

 

Waste Main

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FIRE PROTECTION SYSTEMS

 

East Wing

 

Existing

 

Size

 

Location

 

Sub Divided

 

Serves

 

 

 

 

 

 

 

Sprinklers

 

Yes

 

 

 

 

 

 

 

 

 

 

 

Fire Main

 

Yes

 

6”

 

Stair 1

 

No

 

East Wing

 

 

 

 

 

 

 

Specialty System

 

None

 

 

 

 

 

 

 

 

 

 

 

 

West Wing

 

Existing

 

Size

 

Location

 

Sub Divided

 

Serves

 

 

 

 

 

 

 

Sprinklers

 

Yes

 

 

 

 

 

 

 

 

 

 

 

Fire Main

 

Yes

 

6”

 

Stair 3

 

No

 

West Wing & Knuckle

 

 

 

 

 

 

 

Specialty System

 

None

 

 

 

 

 

 

 

 

 

 

 

 

FIRE ALARM SYSTEMS

 

East Wing

 

Panel Location

 

Audible

 

Strobes

 

Smoke Detectors

 

Fire/Smoke Dampers

 

 

 

 

 

 

 

Fire Alarm System

 

1st Flr Elec

 

Yes

 

Yes

 

Yes

 

Yes

 

 

 

 

 

 

 

 

West Wing

 

Panel Location

 

Audible

 

Strobes

 

Smoke Detectors

 

Fire/Smoke Dampers

 

 

 

 

 

 

 

Fire Alarm System

 

1st Flr Elec

 

Yes

 

Yes

 

Yes

 

Yes

 

 

 

 

 

 

 

 



 

EXHIBIT M

 

ROOFTOP INSTALLATION AREA

 

L-2



 

 



 

EXHIBIT N

 

LANDLORD REPAIR ITEMS

 

L-3



 

1.                                       Inspect all membrane flashings. Make repairs at damaged areas using roofing cement, reinforcing fabric and mineral granules or other approved materials, as necessary. Provide reflective coating at base flashings with surface cracking.

 

2.                                       Inspect all coping and counterflashing assemblies; and provide the following repairs:

 

·                                           Re-secure partially disengaged counterflashings and add fasteners with weathertight washers.

 

·                                           Provide sheet metal counterflashing extension at locations where the reglet vertical leg is not properly counterflashed by the overlying coping vertical leg or wall cladding.

 

·                                           Renew sealant applications as necessary to maintain a watertight, water shedding condition. Make adjustments using sheet metal components or flexible membrane components as necessary to ensure water shedding conditions at minor discontinuities in the counterflashing assemblies.

 

·                                           Replace backed-out screws at copings with larger sized screws with watertight washers.

 

·                                           Cover slots at coping inside vertical legs with flashing tape or other approved materials.

 

3.                                       Provide sheet metal counterflashing extensions at the seismic joint curb counterflashing, to improve resistance to wind driven water intrusion.

 

4.                                       Maintain sealant treatments at roof access metal stairway attachments at roof and wall locations. Upgrade detail treatments at the time of roofing replacement.

 

5.                                       inspect the roofing membrane. Make permanent repairs at temporarily repaired areas, damaged areas, loose cap sheet laps, and areas of missing cap sheet granules. Use roof cement with fabric reinforcement and granules, acrylics with fabric reinforcement, modified bitumen or other approved material as necessary.

 

6.                                       Improve roof drainage at the ponding water location located at the west wing roof between two HVAC curbs that are near a roof drain/overflow drain sump, by adding a roof drain or providing additional roofing materials.

 

7.                                       Inspect all penetration flashings, including service line penetrations, sight screen supports and equipment platform supports. Renew deteriorated sealant applications to maintain a watertight, water shedding flashing.

 

8.                                       Replace existing single penetration flashings at the multiple pipe penetrations; with appropriate multiple pipe penetration flashings.

 

APPLIED MATERIALS & ENGINEERING, INC.

 



 

9.                                       Provide permanent penetration flashing treatments at the roof hatch safety railing post penetrations.

 

10.                                Provide permanent caps at the top of abandoned pipe penetrations that currently have temporary cap seals. Remove abandoned equipment and penetrations at the time or roofing replacement.

 

11.                                Inspect all roof drains and overflow drains. Clear debris from the drains. Repair roofing if necessary. Heat the membrane and tighten loose clamping rings. Replace missing or broken debris guards.

 

12.                                Monitor the roofing membrane at locations where exposed wood blocks for pipe supports are adhered to the roofing membrane.

 

13.                                Clear roofs of all debris.

 

14.                                Provide minimum 4 inch wide sheet metal counterflashing extensions at equipment curb counterflashings that are less than 4 inches wide.

 

APPLIED MATERIALS & ENGINEERING, INC.

 



 

EIFS Wall System

 

1.                                       Inspect all EIFS system surfaces for damage. Repair damage found to EIFS system and paint to match existing finish.

 

Window Systems

 

1.                                       Inspect glazing gaskets at all windows. Replace all missing, loose and shrinking gaskets with new gaskets. New gaskets should be slightly longer than the window opening to allow for natural shrinkage of the gasket. The corners of the gaskets should be sealed to form a continuous, joint-free glazing material around all sides of the glazing rabbet.

 

2.                                       Inspect glazing panels for signs of lateral movement or “walking”. Where lateral movement in the glazing panes has occurred, reposition the glazing, install edge blocking of the proper size to prevent excessive movement and install new gaskets.

 

3.                                       Inspect weep holes at window sill locations. Clear weep holes that have become clogged. Where weep are not installed, provide weeps in like fashion to similar window system.

 

Sealant Joints

 

1.                                       Inspect sealant joints at EIFS walls, metal panel walls and window systems. Where sealant is found to be damaged or have loss of bond, cut out the sealant up to and including an area of good sealant, clean and prime the substrate and apply new sealant to match the existing sealant.

 

APPLIED MATERIALS & ENGINEERING, INC.

 



 

AH 6-3 TRANE M#SXHGD1240Q

·                                           Install twenty five Hi-E 40% air filters. (Filters missing)

·                                           Replace the condenser coils of pigeon droppings and vacuum out.

·                                           Replace the No.2 supply fan motor bearings.

·                                           Replace the bearings on the exhaust fan motor.

·                                           Replace the exhaust fan belts.

·                                           Replace the failed crankcase heaters on two smaller compressors.

·                                           Replace two VFD display key pads.

·                                           Replace the “3U13” economizer actuator motor.

·                                           Replace the faulty outside air temperature sensor.

·                                           Replace the faulty humidity sensor.

·                                           Adjust the power exhaust actuator.

 

AC 6-5 TRANE M#SXHCC9040Q

·                                           Install twenty five Hi-E 40% air filters. (Filters missing)

·                                           Replace the both supply motor sheaves and bushings.

·                                           Replace the bearings on both supply motors.

·                                           Replace the bearings on the power exhaust motor.

·                                           Perform a leak check and repair on the No.1 refrigerant circuit, cut out the suction shell was installed on the liquid line, install a liquid line shell, filter cores and add up to 120 lbs of refrigerant R-22.

·                                           Install a permanent core in the suction shell on suction line.

·                                           Replace missing power exhaust linkages and check for proper operations.

·                                           Secure loose wiring in the fan compartment by motor.

·                                           Replace two VFD display key pads.

·                                           Replace failed crankcase heaters on two compressors.

·                                           Replace the outside air temperature sensor.

·                                           Replace the humidity sensor.

 

1



 

EF 6-1 PENN DX18B

·                                           Replace the blower shaft bearings.

·                                           Install a new 1.5Hp Hi Efficient blower motor, adjustable motor sheave and fan belt.

                                                [ILLEGIBLE]

 

EF 6-2 PENN DX18B

·                                           Install a new l.5Hp Hi Efficient blower motor, adjustable motor sheave and fan belt.

                                                [ILLEGIBLE]

 

BOILER 6-1 RAYPAK M#H3-1083

PERFORM BOILER ANNUAL SERVICE

·                                           Replace the pilot assembly.

·                                           Pull and clean the burners and heat exchanger.

·                                           Replace the temperature and pressure gauge.

·                                           Replace the McDonnell-Miller FS4-3 flow switch.

·                                           Add five gallons of C453 closed loop chemicals.

 

BOILER 6-2 RAYPAK M#H3-1083

PERFORM BOILER ANNUAL SERVICE

·                                           Replace the pilot assembly.

·                                           Pull and clean the burners and heat exchanger.

·                                           Replace the temperature and pressure gauge.

·                                           Replace the McDonnell-Miller FS4-3 flow switch.

·                                           Replace the pump bearings head assembly.

 

BOILER 6-3 RAYPAK M#H3-1758

PERFORM BOILER ANNUAL SERVICE

·                                           Replace the pilot assembly.

·                                           Pull and clean the burners and heat exchanger.

·                                           Replace the temperature and pressure gauge.

·                                           Replace the pump bearings head assembly.

 

Sincerely,

 

2


Exhibit 10.2

 

CERTAIN MATERIAL (INDICATED BY [***]) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.  THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

SETTLEMENT AND LICENSE AGREEMENT

 

This SETTLEMENT AND LICENSE AGREEMENT (this “ Agreement ”) is made as of February 22, 2012, by and between Depomed, Inc. (“ Depomed ”), a California corporation having its principal place of business at 1360 O’Brien Drive, Menlo Park, CA 94025, and Santarus, Inc. (“ Santarus ”), a Delaware corporation having its principal place of business at 3721 Valley Centre Drive, Suite 400, San Diego, CA 92130, on the one hand, and each of Lupin Pharmaceuticals, Inc., a Virginia corporation having its principal place of business at 111 South Calvert Street 21st floor, Harborplace Tower, Baltimore, MD 21202, and Lupin Limited, an Indian corporation having its principal place of business at B/4 Laxmi Towers, Bandra Kurla Complex, Bandra (E), Mumbai 400 051 India (collectively, “ Lupin ”), on the other hand (each a “ Party ” and collectively, the “ Parties ”).

 

RECITALS

 

WHEREAS, Depomed and Lupin are parties to a good faith patent infringement litigation captioned, Depomed, Inc., v. Lupin Pharmaceuticals, Inc. et al. (Case 4:09-cv-05587-PJH) pending in the United States District Court for the Northern District of California before the Honorable Phyllis J. Hamilton (the “ Litigation ”);

 

WHEREAS, Glumetza® brand metformin tablets (500 mg and 1000 mg dosages) are manufactured and marketed under Santarus’ New Drug Application (“ NDA ”) No. 021748, as amended, supplemented or replaced (the “ Depomed Products ”);

 

WHEREAS, Depomed has obtained patents issued by the U.S. Patent and Trademark Office containing claims covering the Depomed Products;

 

WHEREAS, on July 27, 2009, Lupin filed Abbreviated New Drug Application No. 91-664 with the Food and Drug Administration (the “ FDA ”), which contained a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“ Lupin’s p(IV) certification ”), seeking approval to market generic versions of 500 mg and 1000 mg tablets of metformin products before the expiration of the Depomed Patents (as hereinafter defined);

 

WHEREAS, in response to Lupin’s p(IV) certification, Depomed lawfully commenced the Litigation and asserted infringement of the Depomed Patents in good faith;

 

WHEREAS, the Parties wish to fully and finally settle the Litigation upon the terms and subject to the conditions set forth below;

 

WHEREAS, settlement of the Litigation will permit the Parties to avoid the substantial costs, uncertainty and risk involved with prolonged patent-infringement litigation, trial and appeal; and

 

WHEREAS, settlement of the Litigation will permit the management of the Parties to refocus on running their respective companies rather than devoting substantial time and resources to the Litigation;

 

1



 

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

ARTICLE 1
DEFINITIONS

 

Section 1.1.           Certain Defined Terms .  The following terms, when used with initial capital letters, shall have the meanings set forth below:

 

‘280 Patent ” means United States Patent No. 6,635,280.

 

‘475 Patent ” means United States Patent No. 6,340,475.

 

‘962 Patent ” means United States Patent No. 6,488,962.

 

[***]

 

Affiliate ” means any entity controlling, controlled by or under common control with a Party, but only as long as such control continues, where “ control ” means: (i) the ownership of at least fifty percent (50%) of the equity or beneficial interest of such entity, or the right to vote for or appoint a majority of the board of directors or other governing body of such entity; or (ii) the power to directly or indirectly direct or cause the direction of the management and policies of such entity by any means whatsoever.

 

Authorized Generic ” means a metformin product that is sold in the Territory pursuant to NDA No. 021748 (including any supplements or amendments thereto), but not under the Glumetza® trademark.

 

Depomed Patents ” means, collectively, the ‘280 Patent, the ‘475 Patent, and the ‘962 Patent, together with all reissues, reexaminations, continuations, continuations-in-part, divisionals, and patent and regulatory extensions thereof.

 

[***]

 

Effective Date ” has the meaning set forth in Section 6.8(e).

 

Execution Date ” shall be the date representatives from all the Parties execute and deliver this Agreement.

 

Final Court Decision ” means a decision of a United States Court from which no appeal has been or can be taken, other than a petition to the Supreme Court for a review of certiorari .

 

Generic Equivalent ” means a pharmaceutical product that has received FDA approval for marketing in the Territory pursuant to an abbreviated new drug application (“ ANDA ”) (or equivalent regulatory mechanism) as a generic, therapeutic equivalent to the Depomed Products.

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

2



 

[***]

 

License Effective Date ” means February 1, 2016.

 

Licensed Products ” means Lupin’s ANDA Products.

 

Losses ” means all pending and potential claims, demands, all manner of actions, causes of action, suits, debts, liabilities, losses, damages, attorneys’ fees, costs, expenses, judgments, settlements, interest, punitive damages and other damages or costs of whatever nature, whether known or unknown, pending or future, certain or contingent.

 

Lupin’s ANDA Products ” means the products that are the subject of Lupin’s ANDA, as amended, supplemented or replaced.

 

Lupin’s ANDA ” means ANDA No. 91-664, filed with the FDA on July 27, 2009, as amended, supplemented or replaced.

 

Market ”,  “ Marketed ” and “ Marketing ” mean to offer to sell or sell a pharmaceutical product; provided, however, “Market”, “Marketed” and “Marketing” do not include:  (a) engaging in discussions with potential customers to make them aware of the upcoming availability of products any earlier than [***] prior to availability of the products; or (b) importing products into the Territory starting any earlier than [***] prior to their availability so as to have sufficient quantities of inventory of product.

 

Orange Book ” means the FDA’s publication Approved Drug Products with Therapeutic Equivalence Evaluations (or any successor publication thereto).

 

[***]

 

Person ” means any individual, firm, corporation, partnership, limited liability company, trust, joint venture, governmental authority, or other entity or organization.

 

Proceeding ” means any administrative, judicial or legislative action, audit, litigation, investigation, suit or other proceeding in any tribunal.

 

Territory ” means the United States of America and its territories and possessions, including the Commonwealth of Puerto Rico.

 

Third Party ” means any Person other than Depomed, Santarus, Lupin, their Affiliates, and their subsidiaries.

 

ARTICLE 2
SETTLEMENT AND RELEASE

 

Section 2.1.           Mutual Release .  Upon the terms and subject to the conditions of this Agreement and the Consent Injunction and Dismissal Order (attached as Exhibit A), each Party, on behalf of itself and its Affiliates and subsidiaries hereby releases, acquits and forever discharges the other Party and its Affiliates and subsidiaries, and their respective directors,

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

3



 

officers, employees, agents, representatives, suppliers, customers, distributors, marketing partners, heirs, assigns, predecessors and successors (“ Related Parties ”) from any and all Losses arising out of, derived from, predicated upon or relating to infringement of the Depomed Patents or any other patent that Depomed or Santarus or any of their Affiliates or subsidiaries owns, or will own, or controls or licenses, or will control or license, in whole or in part, that is, or could be alleged to be, infringed by the Licensed Products, and the actions underlying the Litigation, or otherwise related to the Lupin ANDA or Lupin’s ANDA Products.  Notwithstanding the foregoing, nothing in this Agreement shall prevent or impair the right of either Party to bring a Proceeding in court or any other forum for breach of this Agreement (including, without limitation, any claim for infringement of any intellectual property based upon activities that are not the subject of the license granted hereunder) or any representation, warranty or covenant herein.  Notwithstanding the foregoing, the releases provided herein shall not apply to products other than Lupin’s ANDA Products that are the subject of the Lupin ANDA, and nothing in this Agreement shall prevent or impair the right of Lupin to challenge the infringement, validity and/or enforceability of the Depomed Patents in any Proceeding involving future Lupin products other than Lupin’s ANDA Products that are the subject of the Lupin ANDA.

 

Section 2.2.           Final Dismissal of Patent Litigation .  The Parties agree to the entry of the Consent Injunction and Dismissal Order attached hereto as Exhibit A.  To effectuate this final settlement, by no later than the first (1 st ) business day following the Effective Date, the Parties shall cause the Consent Injunction and Dismissal Order attached hereto as Exhibit A (each Party acknowledging that the approval of the court is required in order to make such Consent Injunction and Dismissal Order effective) to be filed with the United States District Court for the Northern District of California and shall take all other necessary actions to obtain the settlement and dismissal of the Litigation.

 

Section 2.3.           Patent Validity and No Challenge .

 

(a)           Lupin acknowledges and agrees for itself and its Affiliates that [***].

 

(b)           Lupin for itself and its Affiliates, agrees:  (i) not to challenge and not to assist others, whether directly or indirectly, in challenging the validity, enforceability, or patentability of the Depomed Patents in conjunction with the Lupin ANDA Products or any other Generic Equivalent; and (ii) not to assert that the Lupin ANDA Products or any other Generic Equivalent would not infringe the Depomed Patents, in any court or administrative agency having jurisdiction to consider the issue.  Nothing herein will prevent Lupin or its Affiliates from responding to subpoenas from courts or administrative agencies.  Notwithstanding the foregoing, nothing herein shall prevent or impair the right of Lupin to challenge the infringement, validity and/or enforceability of the Depomed Patents in any Proceeding involving future Lupin products other than Lupin’s ANDA Products that are the subject of the Lupin ANDA and any Generic Equivalent.

 

(c)           Nothing herein shall be construed as an admission or waiver as to any factual or legal matter by any Party or their Affiliates with respect to any jurisdiction outside of the Territory.

 

Section 2.4.           Mutual Agreements .  Each Party acknowledges and agrees that:

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

4



 

It may have sustained Losses that are presently unknown and unsuspected, and that such Losses might give rise to Losses in the future.  Nevertheless, each Party acknowledges and agrees that this Agreement has been negotiated and agreed upon, notwithstanding the existence of such possible Losses, all of which have been hereby released under Section 2.1 hereof.

 

If any fact relating to this Agreement or the Litigation now believed to be true is found hereafter to be other than, or different from, that which is now believed, each Party expressly assumes the risk of such difference in fact and agrees that this Agreement shall be, and will remain, effective notwithstanding any such difference in fact, subject to each Party’s right to bring a Proceeding for a breach of any representation, warranty or covenant herein.

 

This Agreement may be pleaded as a full and complete defense to, and used as a basis for injunction against, any Proceeding that may be instituted, prosecuted or attempted in breach hereof.

 

Section 2.5.           [***]

 

ARTICLE 3
LICENSE

 

Section 3.1.           License Grant .  Effective upon the License Effective Date, Depomed hereby grants to Lupin, and Santarus hereby consents to and authorizes the grant to Lupin of, a fully paid up, royalty free, non-exclusive (except as otherwise provided herein) license with respect to the Depomed Patents, with the right to grant sublicenses to Affiliates, (i) to make, have made, use, promote, offer to sell, sell, import, or otherwise dispose of Licensed Products in or for the Territory, and (ii) to make and have made the Licensed Products outside the Territory only for use, sale and importation in or for the Territory.   Further, in connection with the Depomed Products, Santarus and Depomed agree to waive and hereby waive, for themselves and their Affiliates, any and all regulatory exclusivities (including, without limitation, pediatric exclusivity) vis-à-vis the Licensed Products only that may prevent the approval of the Licensed Products in the Territory under the Lupin ANDA on or after the License Effective Date, as may be accelerated pursuant to the terms herein.  At Lupin’s request, Santarus and Depomed shall confirm to the FDA (in a form acceptable to all the Parties) the licenses and waivers granted by Santarus and Depomed hereunder, and shall do so within [***] Lupin’s request.

 

Section 3.2.           Covenant Not To Sue .   With respect to the Licensed Products, and effective on the Effective Date (subject to Lupin’s compliance with this Agreement, including Section 3.3) , Depomed, Santarus and their Affiliates covenant not to sue Lupin and its/or their Affiliates, Related Parties, and their manufacturers, importers, suppliers, distributors, marketing partners and customers, or support or encourage any Third Party to sue, for infringement of any Depomed Patents, or any United States or foreign patent application or any other issued United States or foreign patent owned, licensed or controlled by Depomed, Santarus or their Affiliates now or in the future purporting to cover the Licensed Products, based on Lupin’s and/or any Affiliate’s making, using, importing, selling, or offering for sale in or for the Territory, or making or having made outside the Territory only for importation, use, sale or offering for sale into or for the Territory, the Licensed Products (“ Covenant Not To Sue ”).  Depomed, Santarus and their Affiliates will impose the foregoing Covenant Not To Sue on any Third Party to whom

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

5



 

Depomed, Santarus or their Affiliates may assign, exclusively license, or otherwise transfer any of the Depomed Patents or any other United States or foreign patents purporting to cover the Licensed Products.  Depomed, Santarus and their Affiliates further covenant that for any patent owned, licensed or controlled by Depomed, Santarus or their Affiliates listed in the future in the Orange Book for the Depomed Products, the foregoing Covenant Not To Sue shall hereby be treated to also be in the form of a non-exclusive license limited to the Licensed Products, for the sole purpose of permitting Lupin and its Affiliates to file a “Paragraph IV Certification” against such patents under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced).   Lupin shall have the right to maintain its existing “Paragraph IV Certification” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) against the Depomed Patents and as to any other patent listed in the FDA’s Orange Book in connection with the Depomed Products.  Lupin also shall have the right to file a new Paragraph IV Certification against any patents listed in the future in the FDA’s Orange Book for the Depomed Products and still be covered by the Covenant Not To Sue provided for in this Section 3.2.

 

Section 3.3.           Restrictions Prior to License Effective Date .  Except as permitted by this Section 3.3, Lupin and their Affiliates and Related Parties shall not make, have made, import into, distribute, offer to sell, or sell in the Territory any Licensed Products prior to the License Effective Date.  Lupin agrees that any breach by either or both of them, or their Affiliates and/or Related Parties, of this Section 3.3 shall cause irreparable harm to Depomed and Santarus, and Lupin and their Affiliates, and their Related Parties consent irrevocably and unconditionally to specific performance, or immediate entry of a temporary restraining order, preliminary injunction, and permanent injunction, to enforce this Section 3.3.  Notwithstanding anything to the contrary, Lupin, their Affiliates and their Related Parties consent irrevocably and unconditionally to personal jurisdiction and venue in the United States District Court for the Northern District of California for the purpose of enforcing this provision.  Notwithstanding the foregoing, Lupin shall have the right and license under this Agreement to engage in the following activities:

 

(a)           [***] and

 

(b)           [***]

 

Section 3.4.           Impact of Granting Certain Licenses To Third Parties .  In the event that Depomed or Santarus or any of their Affiliates enters into an agreement with any Third Party or an Affiliate granting such party a license, sublicense, covenant or other agreement or authorization, as applicable, to Market in the Territory a Generic Equivalent of the Depomed Products prior to [***] after [***], then the License Effective Date in this Agreement shall automatically be amended to be the date that is [***] prior to the date such Third Party or Affiliate is permitted to Market such Generic Equivalent of the Depomed Products in the Territory under the license, sublicense, covenant or other agreement or authorization from Depomed, Santarus and/or their Affiliates.  For avoidance of doubt, Depomed, Santarus and their Affiliates shall not enter into any agreement with any Third Party or Affiliate granting such party a license, sublicense, covenant or other agreement or authorization, as applicable, to Market in the Territory a Generic Equivalent of the Depomed Products any earlier than [***] after the License Effective Date (as such License Effective Date may be accelerated pursuant to this Agreement).  Depomed and Santarus shall provide Lupin with reasonable advance notice of any

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

6



 

Third Party or Affiliate permitted a Marketing date that is earlier than [***] after [***], and in no event less than [***] prior to such Third Party or Affiliate permitted Marketing date.

 

Section 3.5.           [***].

 

Section 3.6.           [***]  Notwithstanding the provisions of Sections 3.4 and 3.5, Depomed and Santarus shall have the right to:  [***]

 

Section 3.7.           Impact Of Final Court Decision .  In the event of a Final Court Decision in a proceeding involving a Third Party proposing to market a Generic Equivalent prior to the License Effective Date of invalidity and/or unenforceability and/or non-infringement of each of the unexpired claims of the Depomed Patents asserted and adjudicated in such proceeding, then the License Effective Date shall automatically be accelerated and amended to the date of such Final Court Decision.

 

Section 3.8.           No Interference But No Consent for FDA Approval .  Depomed and Santarus shall not, and shall not cause any Affiliate or Third Party to: (a) initiate any activity (including but not limited to the filing of any citizen petitions or litigation against the FDA) to interfere with or obstruct Lupin’s efforts to (i) obtain FDA approval of the Lupin ANDA, or (ii) launch Lupin’s ANDA Products as of the date and under the terms provided by this Agreement; and/or (b) unless required by law, (i) delist or cancel the Depomed Products or NDA No. 21-748 with the FDA, (ii) delist or remove any Depomed Patents, or the Depomed Products or NDA 21-748, from the FDA’s Orange Book, (iii) seek or otherwise undertake any action with the FDA to withdraw the Depomed Products from the market, or (iv) delete, remove, designate as “obsolete” or cancel any National Drug Code(s) or any other relevant code(s) for the Depomed Products from the applicable National Drug Data File maintained by First Databank (or any successor or equivalent organization), or from any other pricing database.  Neither this Agreement nor this Section shall be interpreted as Depomed’s or Santarus’ consent to approval from the FDA or any other applicable regulatory authority for Lupin to market a product containing metformin in the Territory.  As Lupin may reasonably request, Depomed and Santarus will submit, or will cause their Affiliates to submit, appropriate and reasonable documentation to the FDA evidencing this Agreement.  Notwithstanding the above, this Section does not preclude Depomed, Santarus and/or their Affiliates from taking any action necessary or commencing a Proceeding to secure or maintain their statutory rights under 21 U.S.C. §355a.

 

Section 3.9.           Limited Use of Agreement Outside Territory . Depomed, Santarus and Lupin agree that neither will use this Agreement or the Consent Injunction and Dismissal Order outside of the Territory for any purpose except to enforce the Agreement.

 

Section 3.10.         Effect of Third Party Launch After Trial Court Decision .  If, prior to the License Effective Date, any Third Party launches any Generic Equivalent after a trial court enters a final judgment holding that each of the unexpired asserted and adjudicated claims of the Depomed Patents is invalid or unenforceable or not infringed (a “ Third Party At-Risk Launch ”), Lupin has the option of launching Lupin’s ANDA Products at that time (“ Lupin At-Risk Launch ”) only under the following conditions:

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

7



 

(a)           Lupin agrees that during such Lupin At-Risk Launch, if Depomed and/or Santarus obtains a court order from any court requiring, or if Depomed and/or Santarus and any Third Party enter into an agreement that requires, the cessation of sales of the Generic Equivalent that is the subject of the Third Party At-Risk Launch, Lupin will cease further shipping and At-Risk sales of Lupin’s ANDA Products and any other infringing activities until the occurrence of the License Effective Date (including any acceleration of the License Effective Date under the terms of this Agreement) or until the occurrence of another Third-Party At-Risk Launch.

 

(b)           Notwithstanding Section 2.1 above, in the event of a Final Court Decision as to the foregoing Third Party launching the Generic Equivalent that any claims of the Depomed Patents asserted in the Third Party proceeding are not invalid and not unenforceable and that such claims are infringed, [***] , and Lupin reserves all rights to contest and defend against, and to assert any and all defenses to, such a claim except that Lupin may not contest and may not raise as a defense the invalidity or unenforceability of any asserted Depomed Patent claim that such Final Court Decision affirms as valid and/or enforceable.

 

Section 3.11.         Effect of Third Party Launch Before Trial Court Decision .  If, prior to the License Effective Date, any Third Party launches any Generic Equivalent prior to a trial court entering a final judgment holding that each of the unexpired asserted and adjudicated claims of the Depomed Patents is invalid or unenforceable or not infringed (a “ Third Party True At-Risk Launch ”), Lupin has the option of launching Lupin’s ANDA Products (“ Lupin True At-Risk Launch ”) only under the following conditions:

 

(a)           Lupin may commence Lupin True At-Risk Launch no earlier than [ ***] after the Third Party True At-Risk Launch, and only after providing Depomed and Santarus written notice [ ***] before any intended True At-Risk Launch.

 

(b)           Lupin agrees that during any such Lupin True At-Risk Launch, if (i) Depomed obtains a court order from any court requiring, or Depomed and/or Santarus and any Third Party enter into an agreement that requires, the cessation of sales of the Generic Equivalent that is the subject of the Third Party True At-Risk Launch or (ii) the Third Party ceases sales of the Generic Equivalent that is the subject of the Third Party True At-Risk Launch, by agreement or otherwise, before the expiration of the [ ***] period in Section 3.11(a), Lupin will cease any shipping and True At-Risk sales of Lupin’s ANDA Products and any other infringing activity until the occurrence of the License Effective Date (including any acceleration of the License Effective Date under the terms of this Agreement), or until the occurrence of another Third-Party True At-Risk Launch.  For the avoidance of doubt, this paragraph does not terminate Lupin’s right to invoke the provisions of Sections 3.7 and/or 3.10 if they become applicable before the License Effective Date.

 

(c)           Notwithstanding Section 2.1 above, in the event there is a Final Court Decision with the Third Party launching the Generic Equivalent under this Section 3.11 that any claims of the Depomed Patents asserted in the Third Party proceeding are not invalid and not unenforceable and that such claims are infringed, [***] and before any reliance by Lupin on the provisions of Sections 3.7 and/or 3.10, and Lupin reserves all rights to contest and defend against, and to assert any and all defenses to, such a claim except that Lupin may not contest and

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

8



 

may not raise as a defense the invalidity or unenforceability of any asserted Depomed Patent claim that such Final Court Decision affirms as valid and/or enforceable.

 

Section 3.12.         Reservation of Rights .  All rights not expressly granted to Lupin hereunder are expressly reserved to Depomed and Santarus, and neither Depomed nor Santarus has any obligation to make available any intellectual property rights or to take any other actions other than as expressly set forth herein.  Except as expressly provided herein, nothing in this Agreement shall be construed as granting Lupin or their Affiliates, subsidiaries or Related Parties any rights: (a) with respect to any Licensed Products outside the Territory; (b) with respect to any product other than Licensed Products; or (c) to make, have made, use, offer to sell, sell, import, or otherwise dispose of any generic version of any Depomed Products covered by Depomed Patents at any time prior to the License Effective Date.

 

Section 3.13.         [***]

 

(a)           [***]   During each calendar quarter, commencing on the Effective Date and terminating on the date that is three (3) months prior to the License Effective Date, [***]

 

(b)           [***]   During each calendar year (and prorated for any partial calendar years), commencing on the Effective Date and terminating on the date that is three (3) months prior to the License Effective Date, [***]

 

(c)           Reporting .  Commencing on the Effective Date and terminating on the date that is three (3) months prior to the License Effective Date (the “ Reporting Period ”), Santarus or Depomed shall provide Lupin with the following periodic reports:  (i) within [***] following the end of each calendar quarter during the Reporting Period, a report of the [***] and (ii) within [***] following the end of each calendar year during the Reporting Period, a report of the [***].

 

(d)           [***]   In the event that Santarus and/or Depomed:  (i) fail to perform the aggregate [***] obligations set forth in Section 3.13(a) during any calendar quarter during the Reporting Period; or (ii) fail to perform the aggregate [***] obligations set forth in Section 3.13(b) during any calendar year period during the Reporting Period (each, a “ Failure Event ”), then Lupin shall provide each of Depomed and Santarus with written notice specifying the alleged Failure Event (the “ Lupin Notice ”).  Santarus and/or Depomed shall have an opportunity to dispute the facts underlying the alleged Failure Event (or provide evidence of a cure, as described below) by providing written notice to Lupin within [***] following the date of the Lupin Notice (the “ Response Notice ”).  In the event that Santarus and/or Depomed does not provide a Response Notice, the License Effective Date shall be accelerated to the date that is [***] following the date of the Lupin Notice.  In the event that Santarus and/or Depomed does provide a Response Notice, then, notwithstanding the provisions of Section 6.2, Lupin may commence arbitration proceedings in accordance with Section 3.13(e) to determine whether a Failure Event has occurred by delivering a written notice to Depomed and Santarus within [***]   after delivery of such Response Notice.  If a Failure Event is determined to have occurred pursuant to Section 3.13(e) below or by agreement among the Parties, the License Effective Date will be accelerated to the date of such determination.  Notwithstanding the foregoing, in the event Santarus and/or Depomed decide [***] , Santarus and/or Depomed shall notify Lupin of such decision within [***] thereof [***] , and the License Effective Date will be accelerated to

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

9



 

the date of such [***] .  Also notwithstanding the foregoing, a Failure Event shall not be deemed to have occurred in the event that Santarus and/or Depomed specifies its intent to cure the alleged breach in the Response Notice and provides written evidence to Lupin that the applicable [***] obligations were reinitiated at the rates required by Sections 3.13(a) and 3.13(b) as of the date of the Response Notice.

 

(e)           Failure Event Arbitration Proceedings .  Any dispute regarding whether a Failure Event has occurred pursuant to Section 3.13(d) shall be resolved by arbitration before a single arbitrator in accordance with the Commercial Arbitration Rules of the American Arbitration Association (“ AAA ”) then pertaining (available at http://www.adr.org), except where those rules conflict with this provision, in which case this provision controls.  Any court with jurisdiction shall enforce this clause and enter judgment on any final determination.  The AAA shall select the arbitrator within [***] from commencement of the arbitration from the AAA’s National Roster of Arbitrators pursuant to agreement or through selection procedures administered.  Within [***] of initiation of arbitration, the Parties shall reach agreement upon and thereafter follow procedures, including without limitation limits on discovery, assuring that the arbitration will be concluded and the final determination rendered within no more than [***]   from selection of the arbitrator or, failing agreement, procedures meeting such time limits will be designed by the AAA and adhered to by the Parties.  The arbitration shall be held in San Francisco, California and the arbitrator shall apply the substantive law of California, except that the Federal Arbitration Act shall govern the interpretation and enforcement of this arbitration provision.  Prior to appointment of the arbitrator or thereafter if he is unavailable, emergency relief is available from any court to avoid irreparable harm.

 

(f)            [ ***]

 

ARTICLE 4
REPRESENTATIONS, WARRANTIES AND COVENANTS

 

Section 4.1.           Mutual Representations .  Each Party hereby represents and warrants to the other Party as of the Effective Date as follows:

 

(a)           Due Authorization .  Such Party is an entity duly organized and in good standing as of the Effective Date, and the execution, delivery and performance of this Agreement by such Party have been duly authorized by all necessary action on the part of such Party.

 

(b)           Due Execution .  This Agreement has been duly executed and delivered by such Party and, with due authorization, execution and delivery by the other Party, constitutes a legal, valid and binding obligation of such Party, enforceable against such Party in accordance with its terms.

 

(c)           No Conflict .  Such Party’s execution, delivery and performance of this Agreement do not: (i) violate, conflict with or result in the breach of any provision of the charter or by-laws (or similar organizational documents) of the Party; (ii) conflict with or violate any law or governmental order applicable to the Party or any of its assets, properties or businesses; or (iii) conflict with, result in any breach of, constitute a default (or event which with the giving of notice or lapse of time, or both, would become a default) under, require any consent under, or

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

10



 

give to others any rights of termination, amendment, acceleration, suspension, revocation or cancellation of any note, bond, mortgage or indenture, contract, agreement, lease, sublease, license, permit, franchise or other instrument or arrangement to which it is a party.

 

Section 4.2.                                  Depomed and Santarus Representations and Warranties .  Depomed and Santarus represent and warrant to Lupin that, as of the Effective Date, Depomed and Santarus:  (i) have the right to grant to Lupin the licenses granted hereunder with respect to the Depomed Patents; (ii) have the right to grant the Covenant Not To Sue; and (iii) have the right to settle the Litigation under and pursuant to the terms in this Agreement.  Depomed and Santarus further warrant, represent and agree that, if Depomed, Santarus or their Affiliates enter into any agreement, license, sublicense, settlement, covenant, waiver or other authorization of any kind with any Third Party or an Affiliate involving a Generic Equivalent Product or Authorized Generic (“ Third Party Agreement ”), and such Third Party Agreement contains any more favorable terms regarding [***], then the applicable terms in the Agreement shall be automatically amended to provide such more favorable terms to Lupin, as amended to conform to any additional rights granted to Lupin under, without limitation, Sections 3.4 and 3.5 hereof.  Depomed and Santarus shall inform Lupin within ten (10) days of any amendment to the applicable terms in the Agreement, as applicable.

 

Section 4.3.                                  Lupin Representations and Warranties .  Lupin represents and warrants to Depomed that, as of the Effective Date:  (i) Lupin or its Affiliates own all right, title and interest in, to and under the Lupin ANDA, and Lupin and its Affiliates have not granted or assigned to any Third Party, directly or indirectly, any rights under or to the Lupin ANDA or Lupin’s ANDA Products; (ii) Lupin and its Affiliates will not transfer ownership, in whole or in part, of said Lupin ANDA, except to an Affiliate of Lupin or to a successor to all or substantially all of the business to which this Agreement pertains ( i.e ., Lupin’s ANDA and Lupin’s ANDA Products), until the expiration of the license granted herein; and (iii) Lupin has the right to settle the Litigation under and pursuant to the terms in this Agreement.  Lupin holds, and shall use all reasonable efforts to maintain, the first-filer 180-day exclusivity with regard to the Lupin ANDA and the Lupin ANDA Products.

 

Section 4.4.                                  Lupin’s Covenant Not to Sue Depomed Products .  With respect to Depomed Products, Lupin covenants not to sue Depomed and/or Santarus and their respective Affiliates, Related Parties, and their importers, suppliers, distributors, and customers, or support or encourage any Third Party to sue, for infringement of any patent owned, licensed, or controlled by Lupin, their Affiliates, and their Related Parties.

 

Section 4.5.                                  Disclaimer .  EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NO PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF APPLICABLE LAW, AND EACH PARTY HEREBY EXPRESSLY DISCLAIMS SUCH WARRANTIES.

 

ARTICLE 5
INDEMNIFICATION

 

Section 5.1.                                  Depomed and Santarus Indemnification .  Depomed and Santarus shall indemnify and hold harmless Lupin, their Affiliates, and their Related Parties (“ Lupin

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

11



 

Indemnitees ”) from and against any liabilities, damages, costs, or expenses, including reasonable attorneys’ fees and expert fees, incurred by any Lupin Indemnitee that arise from any claims, actions, demands, suits, or other cause of action by a Third Party arising out of or related to any breach of Depomed’s or Santarus’ representations, warranties and covenants set forth in this Agreement.

 

 

Section 5.2.                                  Lupin Indemnification .  Lupin shall indemnify and hold harmless each of Depomed and Santarus, and their respective Affiliates and Related Parties (“ Depomed/Santarus Indemnitees ”) from and against any liabilities, damages, costs, or expenses, including reasonable attorneys’ fees and expert fees, incurred by any Depomed/Santarus Indemnitee that arise from any claims, actions, demands, suits or other cause of action by a Third Party arising out of or related to any breach of Lupin’s, as applicable, representations, warranties and covenants set forth in this Agreement.

 

Section 5.3.                                  Indemnification Procedures .  The obligations to indemnify, defend, and hold harmless set forth in Section 5.1 and Section 5.2 shall be contingent upon the Party seeking indemnification (the “ Indemnitee ”): (i) notifying the indemnifying Party of a claim, demand or suit within fifteen (15) calendar days of receipt thereof; provided , however , that the Indemnitee’s failure or delay in providing such notice shall not relieve the indemnifying Party of its indemnification obligation except to the extent the indemnifying Party is prejudiced thereby; (ii) allowing the indemnifying Party and/or its insurers the right to assume direction and control of the defense of any such claim, demand or suit; (iii) cooperating with the indemnifying Party and/or its insurers in the defense of such claim, demand or suit at the indemnifying Party’s expense; and (iv) agreeing not to settle or compromise any claim, demand or suit without prior written authorization of and a release from the indemnifying Party.  The Indemnitee shall have the right to participate in the defense of any such claim, demand or suit referred to in this Article utilizing attorneys of its choice, at its own expense, provided , however , that the indemnifying Party shall have full authority and control to handle any such claim, demand or suit.

 

ARTICLE 6
MISCELLANEOUS

 

Section 6.1.                                  Assignment .  None of the Parties hereto may assign any of its rights or obligations under this Agreement, except to an Affiliate or successor to all or substantially all of the business of the Party to which this Agreement pertains ( i.e ., Santarus’ New Drug Application NDA No. 021748 and the Depomed Products or Lupin’s ANDA and Lupin’s ANDA Products, as the case may be), without the prior written consent of the other Parties.  Any Party may assign this Agreement without the prior written consent of the other Parties to an Affiliate or in connection with a merger, reorganization, change of control or sale of all or substantially all of the applicable business of such Party, in each case, on written notice to the other Parties, provided that the successor Person agrees in writing to adhere to all of the terms and conditions of this Agreement.  Any purported assignment in violation of the foregoing shall be null and void and of no force or effect.  No assignment of this Agreement will relieve the assigning Party from any of its obligations hereunder.  In the event of a permitted assignment, this Agreement shall be binding upon and inure solely to the benefit of the Parties and their respective successors and permitted assigns.

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

12



 

Section 6.2.                                  Dispute Resolution .  Except for Failure Event Arbitration Proceedings under Sections 3.13(d) and (e), any dispute, controversy or claim arising out of or relating to this Agreement (a “ Dispute ”) shall be attempted to be settled by the Parties, in good faith, by submitting each such Dispute to the Chief Executive Officers of each Party by written notice from one Party to the other Parties specifying the terms of such Dispute in reasonable detail.  Within ten (10) calendar days of receipt of such notice, the Chief Executive Officers of each Party involved in the Dispute or a member of management designated by the respective Chief Executive Officer, shall meet in person (at a mutually agreed upon time and location) or by telephone for the purpose of resolving such Dispute.  They will discuss the problems and/or negotiate for a period of up to twenty (20) calendar days in an effort to resolve the Dispute or negotiate an acceptable interpretation or revision of the applicable portion of this Agreement mutually agreeable to all Parties, without the necessity of formal procedures relating thereto.  If the problem is not resolved within the period set forth above, each Party shall be free to pursue all available remedies, at law or in equity, consistent with the terms of this Agreement.  Notwithstanding the foregoing, any Party may apply to a court of competent jurisdiction for a temporary restraining order, preliminary injunction, or other equitable relief, where such relief is necessary to protect its interests.

 

Section 6.3.                                  Governing Law and Venue .  This Agreement shall be governed by and construed in accordance with the laws of the State of California, without giving effect to its conflict of laws principles.  The Parties hereby consent to the exclusive jurisdiction of the federal courts located in the State of California, and expressly waive any objections or defenses based on lack of personal jurisdiction or venue in connection with any dispute arising out of or relating to this Agreement.

 

Section 6.4.                                  Bankruptcy .  All rights and licenses granted under or pursuant to any Section of this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code (the “ Bankruptcy Code ”), licenses of “intellectual property” as defined under the Bankruptcy Code.  The Parties shall retain and may fully exercise all of their respective rights and elections under the Bankruptcy Code.

 

Section 6.5.                                  Confidentiality .  Depomed, Santarus, Lupin, their Affiliates and Related Parties shall not use or disclose to Third Parties any information received from any other Party or otherwise developed or obtained by any Party in the performance of activities under this Agreement without first obtaining the written consent of the disclosing Party, except as may be otherwise provided in, or required in order for a Party to exercise its rights or fulfill its obligations under, this Agreement.  This confidentiality obligation shall not apply to information that:  (i) is or becomes a matter of public knowledge (other than by breach of this Agreement by the receiving Party); (ii) is required by law, regulation or order of a court or administrative agency of competent jurisdiction, to be disclosed; (iii) the receiving Party can establish was already known to it or was in its possession at the time of disclosure; (iv) the receiving Party can establish was independently developed by Persons in its employ who had no contact with and were not aware of the content of the confidential information; (v) is disclosed to the receiving Party by a Third Party having no obligation of confidentiality to the disclosing Party with respect to such information; or (vi) is necessary for Lupin to disclose to the FDA in order to secure and/or maintain approval of the Lupin ANDA and Lupin’s ANDA Products.  The Parties shall

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

13



 

take reasonable measures to assure that no unauthorized use or disclosure is made by others to whom access to such information is granted.

 

Section 6.6.                                  Publicity .  Except as consistent with a press release mutually agreed by all the Parties prior to the execution and delivery of this Agreement, no public announcement or other disclosure to Third Parties concerning the existence of or terms of this Agreement shall be made, either directly or indirectly, by any Party without first obtaining the written approval of each member of the other Parties to this Agreement and agreement upon the nature, text and timing of such announcement or disclosure; provided , however , any Party shall have the right to make any such public announcement or other disclosure required by law after such Party has provided to the other Parties a copy of such announcement or disclosure and an opportunity to comment thereon.  Each Party agrees that it shall cooperate fully with the others with respect to all disclosures regarding this Agreement to the Securities and Exchange Commission (“ SEC ”) and any other governmental or regulatory agencies, including requests for confidential treatment of proprietary information of any member of the Parties included in any such disclosure.  None of the Parties shall be required to provide to any other Party any advance notice of any public announcements or other disclosures related to periodic, routine financial reporting unless such announcement or other disclosure will include non-routine information relating to the Licensed Products and this Agreement.  The Parties are aware that each of Depomed and Santarus are obligated to generally describe the terms of this Agreement and to file a redacted version of this Agreement with its periodic reports pursuant to applicable regulations of the SEC, and each of Depomed and Santarus agrees to seek confidential treatment of the terms of the Agreement to the extent permitted under applicable laws and to provide Lupin with a reasonable opportunity to review and comment on the confidential treatment request prior to submission to the SEC.

 

Section 6.7.                                  Cooperation .  Subject to confidentiality restrictions that may be reasonably requested, the Parties shall use their respective commercially reasonable efforts to:

 

(a)                                  Make all required filings with all governmental authorities and obtain all necessary approvals in connection with this Agreement to the extent required under applicable laws.  Subject to confidentiality restrictions that may be reasonably requested and to the extent permissible by law, the Parties shall coordinate and exchange all filings and documents submitted to all government authorities regarding this Agreement;

 

(b)                                  Cooperate with each other in any review, investigation, inquiry or proceeding regarding the Agreement by any government authority.  Subject to such confidentiality restrictions as may be reasonably requested and to the extent permissible by law, the Parties will render reasonable assistance as the others may request in connection with this Agreement and coordinate and cooperate with one another in exchanging information, permitting reasonable access to each Party’s and their Affiliates documents, officials, and data in connection with any such review, investigation, inquiry or proceeding by any governmental authority;

 

(c)                                   Promptly inform the others of any material communication made to, or received by a Party from any governmental authority regarding this Agreement;

 

(d)                                  Without limiting any other provision of this Agreement, take all actions and do all things reasonably necessary or proper (at its own cost and expense), including under

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

14



 

applicable law to make effective and further the intent and purposes of the transactions contemplated by this Agreement, including executing any further instruments reasonably requested by any other Party, and to resist and to contest any proposals or efforts to materially alter the terms of the Agreement so as to permit the Parties to fulfill their obligations under and to obtain the full benefits contemplated by the Agreement; and

 

(e)                                   The Parties agree that the entering into of this Agreement and the performance of their respective obligations hereunder shall be in compliance with all applicable federal, state and local laws, rules, guidelines and regulations.

 

Section 6.8.                                  Government Proceedings .

 

(a)                                  Upon execution of this Agreement, the Parties shall promptly inform the District Court that an agreement settling the Litigation has been executed and request that proceedings be stayed to permit the review provided for in this Section prior to termination of the Litigation.

 

(b)                                  By no later than the [***] following the Execution Date, the Parties shall each file or cause to be filed with the U.S. Federal Trade Commission, Bureau of Competition (“FTC”) and the Antitrust Division of the U.S. Department of Justice (“DOJ”) this Agreement and any notifications to be filed pursuant to Title XI of the Medicare Prescription Drug Improvement and Modernization Act (Subtitle B — Federal Trade Commission Review) and any other applicable law, and shall request confidential treatment of any such submissions under all applicable law, rules and regulations.

 

(c)                                   The Parties shall use all commercially reasonable efforts to coordinate the foregoing filings and any responses thereto, to make such filings promptly and in good faith and to respond promptly and in good faith to any requests for additional information made by either of such agencies, and to coordinate any necessary or desirable joint presentations.  Each Party reserves the right to communicate with the FTC or DOJ regarding such filings as it believes appropriate.  Each Party shall keep the other Parties informed of such communications and shall not disclose any confidential information of the other Parties without such other Parties’ consent, which will not be unreasonably withheld or delayed.

 

(d)                                  If, within the [***] period after the Parties have submitted this Agreement to the FTC and DOJ (the “FTC Review Period”), the FTC (or its staff) or the DOJ raises an objection or expresses a concern as to the provisions of this Agreement and if the FTC (or its staff) or DOJ indicates that the objections or concerns are likely to result in an investigation or a judicial or administrative proceeding against any of the Parties in relation to this Agreement that will continue beyond the FTC Review Period (a “Negative Response”), unless the Parties agree otherwise following review of the Negative Response, the Parties shall use their commercially reasonable efforts to overcome such Negative Response within the FTC Review Period (or such extended period as the Parties may agree), including using their commercially reasonable efforts to promptly meet in good faith to modify this Agreement and resubmit it for approval pursuant to subsection 6.8(b) above (a “Resubmission”); provided , however , that the License Effective Date shall not be subject to modification, and in no event shall any Party be required to agree to any

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

15



 

modification of this Agreement that materially affects the economic value of the transactions contemplated hereby.

 

(e)                                   The effective date of this Agreement (the “ Effective Date ”) shall be the earlier of the date of expiration of the FTC Review Period in which no Negative Response was received or the date of the expiration, if applicable, of an additional FTC Review Period following a Resubmission with regard to which no Negative Response was received.  In no event will Lupin launch the Lupin ANDA Products prior to completion of the review provided for in this Section 6.8.

 

Section 6.9.                                  Notices .  All notices required or permitted under this Agreement must be in writing and must be given by addressing the notice to the address for the recipient set forth below or at such other address as the recipient may specify in writing under this procedure.  Notices will be deemed to have been given (a):  three (3) business days after deposit in the mail with proper postage for first class registered or certified mail prepaid, return receipt requested; or (b) one (1) business day after sending by nationally recognized overnight delivery service.

 

If to Depomed:

 

If to Lupin:

 

 

 

Depomed, Inc.

Attention: Legal Department

1360 O’Brien Drive

Menlo Park, CA 94025

Facsimile: (650) 462-9993

 

Lupin Limited

Attention: Managing Director

B/4 Laxmi Towers

Bandra Kurla Complex

Bandra (E)

Mumbai 400 051

India

 

 

 

 

 

Lupin Pharmaceuticals, Inc.

Attention: Vinita Gupta, Chief Executive Officer

Harborplace Tower

111 South Calvert Street 21st floor

Baltimore, MD 21202

 

 

 

With a copy (which shall not constitute notice hereunder) to:

 

With a copy (which shall not constitute notice hereunder) to:

 

 

 

William Gaede

McDermott, Will & Emery LLP

275 Middlefield Rd., Suite 100

Menlo Park, CA 94025

Facsimile: (650) 815-7401

 

William A. Rakoczy

Rakoczy Molino Mazzochi Siwik LLP

6 West Hubbard Street, Suite 500

Chicago, Illinois, 60654

Facsimile: (312) 222-6321

 

If to Santarus:

 

 

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

16



 

 

Santarus, Inc.

 

 

Attention:  Chief Executive Officer

 

 

3721 Valley Centre Dr., Suite 400

 

 

San Diego, CA 92130

 

 

Facsimile:  (858) 314-5701

 

 

 

 

 

With a copy (which shall not constitute notice hereunder) to:

 

 

 

 

 

Santarus, Inc.

 

 

Attention:  Legal Department

 

 

3721 Valley Centre Dr., Suite 400

 

 

San Diego, CA 92130

 

 

Facsimile:  (858) 314-5702

 

 

 

Section 6.10.                           Amendment .  This Agreement may not be amended or modified except by an instrument in writing signed by authorized representatives of each of Depomed, Santarus and Lupin.

 

Section 6.11.                           No Waiver .  The failure of any Party to enforce at any time for any period the provisions of or any rights deriving from this Agreement shall not be construed to be a waiver of such provisions or rights or the right of such Party thereafter to enforce such provisions.

 

Section 6.12.                           Severability .  If any term or other provision of this Agreement is invalid, illegal or incapable of being enforced by any law or public policy, all other terms and provisions of this Agreement shall nevertheless remain in full force and effect so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to any Party.

 

Section 6.13.                           Headings .  The descriptive headings contained in this Agreement are for convenience of reference only and shall not affect in any way the meaning or interpretation of the Agreement.

 

Section 6.14.                           Counterparts .  This Agreement may be executed in one or more counterparts, and by the respective Parties in separate counterparts, each of which when executed shall be deemed to be an original but all of which taken together shall constitute one and the same Agreement.

 

Section 6.15.                           Entire Agreement .  This Agreement constitutes the entire agreement between the Parties with respect to the subject matter hereof, and no oral or written statement that is not expressly set forth in this Agreement may be used to interpret or vary the meaning of the terms and conditions hereof.  This Agreement supersedes any prior or contemporaneous agreements and understandings, whether written or oral, between the Parties with respect to the subject matter hereof.

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

17



 

Section 6.16.                           Third Party Beneficiaries .  Except as expressly provided herein, nothing in this Agreement, either express or implied, is intended to or shall confer upon any Third Party any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

 

Section 6.17.                           Scope of Agreement . The mutual releases and licenses set forth in this Agreement shall be limited to the Lupin ANDA and Lupin’s ANDA Products, and shall be without prejudice to, shall have no preclusive effect as to, and shall not be admissible in any proceedings pertaining to any future or different product(s) or ANDA(s).

 

Section 6.18.                           Force Majeure .  In the event of any failure or delay in the performance by a Party of any provision of this Agreement due to acts beyond the reasonable control of such Party (such as, for example, fire, explosion, strike or other difficulty with workmen, shortage of transportation equipment, supply disruption, accident, act of God, declared or undeclared wars, acts of terrorism), then such Party shall have such additional time to perform as shall be reasonably necessary under the circumstances.  In the event of such failure or delay, the affected Party will use its diligent efforts, consistent with sound business judgment and to the extent permitted by law, to correct such failure or delay as expeditiously as possible.  In the event that a Party is unable to perform by a reason described in this Section 6.18, its obligation to perform under the affected provision of this Agreement shall be suspended during such time of nonperformance.

 

Section 6.19.                           Right to Seek Injunctive Relief .  Notwithstanding anything in this Agreement to the contrary, a Party may seek a temporary restraining order or a preliminary injunction from any court of competent jurisdiction in order to prevent immediate and irreparable injury, loss, or damage on a provisional basis, pending the decision of the arbitrator(s) on the ultimate merits of any dispute, controversy, or claim.

 

[Remainder of Page Intentionally Left Blank; Signature Page Follows]

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

18



 

IN WITNESS WHEREOF, this Agreement has been executed by the Parties as of the date first written above.

 

DEPOMED, INC.

LUPIN PHARMACEUTICALS, INC.

 

 

By:

/s/ James A. Schoeneck

 

By:

/s/ Vinita Gupta

 

 

 

 

 

Name:

James A. Schoeneck

 

Name:

Vinita Gupta

 

 

 

 

 

Title:

President & CEO

 

Title:

CEO

 

 

 

 

 

 

 

 

 

 

SANTARUS, INC.

 

LUPIN LIMITED

 

 

 

 

 

By:

/s/ Gerald T. Proehl

 

By:

/s/ Nilesh Gupta

 

 

 

 

 

Name:

Gerald T. Proehl

 

Name:

Nilesh Gupta

 

 

 

 

 

Title:

President & CEO

 

Title:

Group President

 

 

Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

19



 

EXHIBIT A

 

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF CALIFORNIA

 

DEPOMED, INC.,

Plaintiff,

v.

 

LUPIN PHARMACEUTICALS, INC.,

 

Civil Action No. C 09-5587 PJH

 

Defendants.

 

CONSENT INJUNCTION AND DISMISSAL ORDER

 

This action for alleged patent infringement (the “Litigation”) has been brought by Plaintiff Depomed, Inc. (“Depomed”) against Defendants Lupin Pharmaceuticals, Inc. and Lupin Limited (collectively, “Lupin”) for alleged infringement of United States Patent Nos. 6,635,280, 6,340,475, and 6,488,962 (collectively the “Depomed Patents”).  Depomed’s commencement of the Litigation was based on its receipt of notice from Lupin Limited that Lupin Limited had filed Abbreviated New Drug Application (“ANDA”) No. 91-664 with the United States Food and Drug Administration containing a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) directed to the Depomed Patents and seeking approval to market 500 mg and 1000 mg metformin tablets as a generic version of Glumetza®.

 

Depomed and Lupin have agreed to enter into a good faith final settlement agreement (the “ Settlement and License Agreement”) regarding this Litigation on the expectation and belief that this would eliminate the substantial litigation costs that would otherwise be incurred by both Depomed and Lupin during the Litigation, while also serving the public interest by saving judicial resources and avoiding the risks to each of the parties associated with infringement.  The

 

1



 

Settlement and License Agreement will afford Depomed and Lupin the procompetitive opportunity to more productively use money and other resources that would have been spent in the continued prosecution and defense of this Litigation, to the benefit of the parties and consumers alike, such as by investing more money in pharmaceutical research and development.

 

Each of Depomed and Lupin acknowledge there is significant risk to each of them associated with the continued prosecution of this Litigation and have consented to entry of this order through a final settlement as reflected herein.  The Court, upon the consent and request of Depomed and Lupin, hereby issues the following Order.

 

Depomed and Lupin now consent to this Consent Injunction and Dismissal Order and

 

IT IS HEREBY ORDERED that:

 

1.             Subject matter jurisdiction, personal jurisdiction, and venue are all proper in this Court.

 

2.             In this Litigation, Depomed has charged Lupin with infringement of the Depomed Patents in connection with Lupin Limited’s submission of ANDA No. 91-664 directed to generic tablets containing 500 mg or 1000 mg of metformin per tablet to the U.S. Food and Drug Administration (“FDA”).

 

3.             In response to Depomed’s charges of patent infringement, Lupin has alleged certain defenses and counterclaims, including that the Depomed Patents are invalid or not infringed.  The Court has not adjudicated Depomed’s charges of patent infringement or Lupin’s defenses and counterclaims.

 

4.             Lupin has agreed that each of the defenses and counterclaims set forth in its Answer, Affirmative Defenses and Counterclaims, including the allegations and averments contained therein, should be dismissed, without prejudice.

 

2



 

5.             Lupin, their officers, agents, servants, employees and attorneys, and those persons in active concert or participation with them who receive actual notice of this Order by personal service or otherwise, are hereby enjoined from manufacturing, using, offering to sell or selling within the United States and its territories and possessions, including the Commonwealth of Puerto Rico (the “Territory”), or importing into the Territory, any generic tablet product containing 500 mg or 1000 mg of metformin per tablet that is the subject of ANDA No. 91-664 until:

 

(a)   February 1, 2016; or

 

(b)   at such earlier date as may be permitted by the Settlement and License Agreement that the Parties have entered into.

 

6.             Depomed and Lupin each expressly waives any right to appeal or otherwise move for relief from this Consent Injunction and Dismissal Order.

 

7.             All claims and defenses as between Depomed and Lupin are hereby dismissed without prejudice.

 

8.             This Court retains jurisdiction over Depomed and Lupin for purposes of enforcing this Consent Injunction and Dismissal Order.

 

9.             The Clerk of the Court is directed to enter this Consent Injunction and Dismissal Order forthwith.

 

3



 

IT IS SO STIPULATED :

 

 

 

 

Attorneys for Plaintiff
Depomed

 

Attorneys for Defendants
Lupin

 

 

 

 

 

 

Of Counsel :

 

Of Counsel :

 

 

SO ORDERED :

 

This                  day of                  , 2012

 

 

 

 

HONORABLE PHYLLIS J. HAMILTON

 

UNITED STATES DISTRICT JUDGE

 

4


Exhibit 31.1

 

CERTIFICATION PURSUANT TO RULE 13a-14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, James A. Schoeneck, certify that:

 

1.               I have reviewed this Quarterly Report of Depomed, Inc.;

 

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

 

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

 

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

 

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

 

(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; and

 

(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;

 

5.               The registrant’s other certifying officers 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 function):

 

(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.

 

May 8, 2012

 

 

 

 

 

 

By:

/s/ James A. Schoeneck

 

 

James A. Schoeneck

 

 

Chief Executive Officer

 


Exhibit 31.2

 

CERTIFICATION PURSUANT TO RULE 13a-14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, August J. Moretti, certify that:

 

1.               I have reviewed this Quarterly Report of Depomed, Inc.;

 

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

 

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

 

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

 

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

 

(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; and

 

(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;

 

5.               The registrant’s other certifying officers 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 function):

 

(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.

 

May 8, 2012

 

 

 

 

 

 

 

 

 

By:

/s/ August J. Moretti

 

 

August J. Moretti

 

 

Chief Financial Officer

 


Exhibit 32.1

 

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

 

In connection with the Quarterly Report of Depomed, Inc. (the “Company”) on Form 10-Q for the period ending March 31, 2012 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, James A. Schoeneck, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:

 

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

 

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

 

 

Date: May 8, 2012

 

 

 

 

 

/s/ James A. Schoeneck

 

James A. Schoeneck

 

President and Chief Executive Officer

 


Exhibit 32.2

 

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

 

In connection with the Quarterly Report of Depomed, Inc. (the “Company”) on Form 10-Q for the period ending March 31, 2012 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, August J. Moretti, Principal Accounting and Financial Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:

 

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

 

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

 

 

Date: May 8, 2012

 

 

 

 

 

/s/ August J. Moretti

 

August J. Moretti

 

Chief Financial Officer