U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 

ý                                   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended December 31, 2005

 

or

 

o                                  TRANSITION REPORT UNDER SECTION 13 OR 15 (d) OF THE EXCHANGE ACT OF 1934

 

For the transition period from        to       

 


 

Commission File Number: 000-31979

 

Array BioPharma Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

 

84-1460811

(State or Other Jurisdiction of
Incorporation or Organization)

 

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

 

 

 

3200 Walnut Street, Boulder, CO

 

80301

(Address of Principal Executive Offices)

 

(Zip Code)

 

 

 

(303) 381-6600

(Registrant’s Telephone Number, Including Area Code)

 


 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ý   No o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.

(Check one): Large Accelerated Filer   o      Accelerated Filer   ý      Non-Accelerated Filer   o

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes   o  No   ý

 

As of January 31, 2006, the registrant had 38,819,242 shares of common stock, par value $.001 per share, outstanding.

 

 



 

ARRAY BIOPHARMA INC.

TABLE OF CONTENTS

 

 

 

PAGE

PART I - FINANCIAL INFORMATION

 

 

 

 

Item 1.

Condensed Financial Statements

 

 

 

 

 

Balance Sheets at December 31, 2005 and June 30, 2005 (unaudited)

3

 

 

 

 

Statements of Operations – Three and Six Months Ended
December 31, 2005 and 2004 (unaudited)

4

 

 

 

 

Statements of Cash Flows – Six Months Ended December 31, 2005 and 2004 (unaudited)

5

 

 

 

 

Notes to Condensed Financial Statements (unaudited)

6

 

 

 

Item 2.

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

15

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

23

 

 

 

Item 4.

Controls and Procedures

24

 

 

 

PART II - OTHER INFORMATION

 

 

 

 

Item 4.

Submission of Matters to a Vote of Security Holders

25

 

 

 

Item 6.

Exhibits

25

 

 

 

SIGNATURES

26

 

2



 

PART I

 

Item 1. Financial Statements

 

ARRAY BIOPHARMA INC.

CONDENSED BALANCE SHEETS

(Unaudited)

 

 

 

December 31,
2005

 

June 30,
2005

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

 

$

12,305,662

 

$

12,429,526

 

Marketable securities

 

65,358,388

 

78,296,782

 

Restricted cash

 

 

1,979,678

 

Accounts receivable, net

 

1,578,968

 

679,609

 

Inventories, net

 

2,006,624

 

2,153,486

 

Prepaid expenses and other

 

1,675,161

 

1,025,871

 

Total current assets

 

82,924,803

 

96,564,952

 

 

 

 

 

 

 

Property, plant and equipment

 

63,719,235

 

61,516,975

 

Less accumulated depreciation and amortization

 

(34,591,942

)

(30,210,523

)

Property, plant and equipment, net

 

29,127,293

 

31,306,452

 

 

 

 

 

 

 

Other assets

 

80,246

 

80,246

 

 

 

 

 

 

 

Total assets

 

$

112,132,342

 

$

127,951,650

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable

 

$

4,342,836

 

$

3,708,656

 

Advance payments from collaborators - current

 

2,854,126

 

6,698,292

 

Accrued compensation and benefits

 

3,052,161

 

4,320,755

 

Deferred rent - current

 

430,256

 

341,555

 

Other current liabilities

 

1,872,680

 

1,061,080

 

Total current liabilities

 

12,552,059

 

16,130,338

 

 

 

 

 

 

 

Long term liabilities

 

 

 

 

 

Advance payments from collaborators - long term

 

312,500

 

937,500

 

Deferred rent and other liabilities

 

1,324,277

 

1,354,533

 

Long term debt

 

12,553,232

 

10,000,000

 

Other long term liabilities

 

350,398

 

113,933

 

Total long term liabilities

 

14,540,407

 

12,405,966

 

 

 

 

 

 

 

Total liabilities

 

27,092,466

 

28,536,304

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

Preferred stock

 

 

 

Common stock

 

38,674

 

38,467

 

Additional paid-in capital

 

197,801,830

 

193,696,156

 

Accumulated other comprehensive loss

 

(377,212

)

(279,098

)

Accumulated deficit

 

(112,423,416

)

(94,040,179

)

Total stockholders’ equity

 

85,039,876

 

99,415,346

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

112,132,342

 

$

127,951,650

 

 

See notes to condensed financial statements

 

3



 

ARRAY BIOPHARMA INC.

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

 

Three Months Ended
December 31,

 

Six Months Ended
December 31,

 

 

 

2005

 

2004

 

2005

 

2004

 

Revenue

 

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

9,231,735

 

$

9,548,445

 

$

17,515,150

 

$

16,892,953

 

License and milestone revenue

 

2,708,337

 

2,500,000

 

5,666,669

 

5,012,499

 

Total revenue

 

11,940,072

 

12,048,445

 

23,181,819

 

21,905,452

 

 

 

 

 

 

 

 

 

 

 

Operating expenses (1)

 

 

 

 

 

 

 

 

 

Cost of revenue

 

10,012,941

 

9,464,030

 

19,402,586

 

18,257,157

 

Research and development for proprietary drug discovery

 

7,801,805

 

5,312,484

 

16,427,149

 

9,794,609

 

Selling, general and administrative expenses

 

3,379,212

 

2,340,814

 

6,833,515

 

4,676,005

 

Total operating expenses

 

21,193,958

 

17,117,328

 

42,663,250

 

32,727,771

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(9,253,886

)

(5,068,883

)

(19,481,431

)

(10,822,319

)

 

 

 

 

 

 

 

 

 

 

Interest expense

 

(153,090

)

 

(281,621

)

 

Interest income

 

695,782

 

191,866

 

1,379,815

 

329,974

 

Net loss

 

$

(8,711,194

)

$

(4,877,017

)

$

(18,383,237

)

$

(10,492,345

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.23

)

$

(0.16

)

$

(0.48

)

$

(0.35

)

 

 

 

 

 

 

 

 

 

 

Number of shares used to compute per share data

 

38,616,654

 

30,705,855

 

38,557,434

 

29,806,512

 

 


(1) Operating expenses include share-based compensation expense of $1.7 million and $3.4 million for the three and six months ended December 31, 2005, respectively. For the three and six months ended December 31, 2004, share-based compensation expense was $0 and $151,004, respectively. See Note 1, Accounting for Share-Based Compensation, to the Unaudited Notes to Condensed Financial Statements.

 

See notes to condensed financial statements

 

4



 

ARRAY BIOPHARMA INC.

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

 

Six Months Ended
December 31,

 

 

 

2005

 

2004

 

Operating activities

 

 

 

 

 

Net loss

 

$

(18,383,237

)

$

(10,492,345

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Depreciation and amortization

 

4,627,076

 

3,923,980

 

Share-based compensation expense

 

3,411,043

 

151,004

 

Changes in operating assets and liabilities

 

(5,432,612

)

1,154,116

 

Net cash used in operating activities

 

(15,777,730

)

(5,263,245

)

 

 

 

 

 

 

Investing activities

 

 

 

 

 

Purchases of property, plant and equipment

 

(2,414,162

)

(2,777,815

)

Purchases of marketable securities

 

(34,884,720

)

(76,745,554

)

Proceeds from sale and maturity of marketable securities

 

47,725,000

 

32,000,000

 

(Increase) decrease in restricted cash

 

1,979,678

 

(726,455

)

Net cash provided by (used in) investing activities

 

12,405,796

 

(48,249,824

)

 

 

 

 

 

 

Financing activities

 

 

 

 

 

Proceeds from sale of common stock, net of issuance costs

 

 

66,626,986

 

Proceeds from exercise of stock options and shares issued under the employee stock purchase plan

 

694,838

 

857,679

 

Proceeds from the issuance of long term debt

 

2,553,232

 

 

Net cash provided by financing activities

 

3,248,070

 

67,484,665

 

 

 

 

 

 

 

Net increase (decrease) in cash and cash equivalents

 

(123,864

)

13,971,596

 

Cash and cash equivalents, beginning of period

 

12,429,526

 

6,499,589

 

Cash and cash equivalents, end of period

 

$

12,305,662

 

$

20,471,185

 

 

Supplemental disclosure of cash flow information

Cash paid for interest was $226,858 and $0 for the six months ended December 31, 2005 and 2004, respectively.

 

See notes to condensed financial statements

 

5



 

ARRAY BIOPHARMA INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

December 31, 2005

(Unaudited)

 

Note 1: Basis of Presentation and Summary of Significant Accounting Policies

 

Interim Financial Statements

 

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States and with the instructions to Form 10-Q and Article 10 of Regulation S-X for interim financial information. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three and six months ended December 31, 2005 are not necessarily indicative of the results that may be expected for the year ending June 30, 2006. For further information, refer to the financial statements and footnotes thereto as of and for the year ended June 30, 2005, included in the Annual Report on Form 10-K of Array BioPharma Inc. (the “ Company ” or “ Array ”) filed on September 13, 2005, with the Securities and Exchange Commission.

 

Summary of Significant Accounting Policies

 

Cash Equivalents and Marketable Securities

 

Cash equivalents consist of short term, highly liquid financial instruments that are readily convertible to cash and have maturities of three months or less from the date of purchase and may consist of money market funds, taxable commercial paper, U.S. government agency obligations and corporate notes and bonds with high credit quality. Marketable securities consist of similar financial instruments with maturities of greater than three months.

 

At December 31, 2005 and June 30, 2005, management designated marketable securities held by the Company as available-for-sale securities for purposes of Statement of Financial Accounting Standards No. 115, Accounting for Certain Investments in Debt and Equity Securities. Securities available-for-sale are carried at fair value, with unrealized gains and losses reported as a component of stockholders’ equity until their disposition. The amortized cost of debt securities in this category is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization is included in investment income. Realized gains and losses, declines in value judged to be other-than-temporary on securities available-for-sale and interest on securities available-for-sale are included in investment income. The cost of securities sold is based on the specific identification method.

 

Inventories

 

Inventories consist of individual chemical compounds in the form of Optimer â building blocks available-for-sale and commercially available fine chemicals used in the Company’s proprietary drug discovery programs and research collaborations. Inventories are stated at the lower of cost or market, cost being determined under the first-in, first-out method. The Company designs and produces the chemical compounds comprising its Optimer building blocks and capitalizes costs into inventory only after technological feasibility has been established. The Company reviews its chemical inventories periodically and, when required, writes down the carrying cost for non-marketability to estimated net realizable value through an appropriate reserve.

 

6



 

Revenue Recognition

 

Most of the Company’s revenue is derived from designing, creating, optimizing, evaluating and developing drug candidates for its collaborators. The majority of collaboration revenue consists of fees received based on contracted annual rates for full time equivalent employees working on a project. The Company’s collaboration agreements also include license and up-front fees, milestone payments upon achievement of specified research or development goals and royalties on sales of resulting products. A small portion of the Company’s revenue comes from fixed fee agreements and from sales of compounds on a per-compound basis.

 

Collaboration agreements typically call for a specific level of resources as measured by the number of full time equivalent scientists working a defined number of hours per year at a stated price under the agreement. The Company recognizes revenue under its collaboration agreements on a monthly basis for fees paid to the Company based on hours worked. The Company recognizes revenue from sales of Lead Generation Library and Optimer building block compounds as the compounds are shipped, as these agreements are priced on a per-compound basis and title and risk of loss passes upon shipment to the Company’s customers.

 

Revenue from license fees and up-front fees is non-refundable and is recognized on a straight-line basis over the expected period of the related research program. Milestone payments are non-refundable and are recognized as revenue over the expected period of the related research program. A portion of each milestone payment is recognized when the milestone is achieved based on the applicable percentage of the research term that has elapsed. Any balance is recognized ratably over the remaining research term. Revenue recognition related to license fees, up-front payments and milestone payments could be accelerated in the event of early termination of programs.

 

In general, contract provisions include predetermined payment schedules or the submission of appropriate billing detail. Payments received in advance of performance are recorded as advance payments from collaborators until the revenue is earned.

 

The Company reports revenue for lead generation and lead optimization research, custom synthesis and process research, the development and sale of chemical compounds and the co-development of proprietary drug candidates it out-licenses, as collaboration revenue. License and milestone revenue is combined and reported separately from collaboration revenue.

 

Accounting for Share-Based Compensation

 

Effective July 1, 2005, the Company adopted the fair value method of accounting for share-based compensation arrangements in accordance with Financial Accounting Standards Board (“FASB”) Statement No. 123R, Share-Based Payment (“SFAS 123R”), using the modified prospective method of transition. Under the provisions of SFAS 123R, the estimated fair value of options granted under the Company’s Amended and Restated Stock Option and Incentive Plan (the “Option Plan”) is recognized as compensation expense over the option-vesting period. In addition, the Company’s Employee Stock Purchase Plan (the “ESPP”) is considered to be a compensatory plan under SFAS 123R as purchases are made at a discount to the market price of the Company’s common stock as reported on the first or last day of each quarterly offering period (whichever is lower). Compensation expense is recognized based on the estimated fair value of the common stock during each offering period and the percentage of the purchase discount. Using the modified prospective method, compensation expense is recognized beginning with the effective date of adoption of SFAS 123R for all share-based payments (i) granted after the effective date of adoption and (ii) granted prior to the effective date of adoption and that remain unvested on the date of adoption.

 

Prior to July 1, 2005, the Company accounted for share-based employee compensation plans using the intrinsic value method of accounting in accordance with Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (“APB 25”), and its related interpretations. Under the provisions of APB 25, no compensation expense was recognized with respect to purchases of the Company’s common stock under the ESPP or when stock options were granted with exercise prices equal to or greater than market value on the date of grant.

 

7



 

The Company recorded $1.7 million and $3.4 million, or $0.04 and $0.09 per share, respectively, of total share-based compensation expense for the three and six months ended December 31, 2005 as required by the provisions of SFAS 123R, substantially all of which was related to stock options. The share-based compensation expense associated with stock options is calculated on a straight-line basis over the vesting periods of the related options. Share-based compensation expense for purchases under the ESPP is recognized based on the estimated fair value of the common stock during each offering period and the percentage of the purchase discount. These charges had no impact on the Company’s reported cash flows. In addition, during the three-month period ended September 30, 2004, the Company recorded approximately $151,000 of stock compensation expense pursuant to APB 25 associated with the final amortization of deferred stock compensation related to the vesting of stock options that were granted prior to its initial public offering of common stock in November 2000. Share-based compensation expense is allocated among the following categories:

 

 

 

Three Months Ended
December 31,

 

Six Months Ended
December 31,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

$

545,744

 

$

 

$

1,071,015

 

$

113,251

 

Research and development for proprietary drug discovery

 

320,516

 

 

733,229

 

 

Selling, general and administrative expenses

 

798,355

 

 

1,606,799

 

37,753

 

Total

 

$

1,664,615

 

$

 

$

3,411,043

 

$

151,004

 

 

Under the modified prospective method of transition under SFAS 123R, the Company is not required to restate its prior period financial statements to reflect expensing of share-based compensation under SFAS 123R. Therefore, the results for the three and six months ended December 31, 2005 are not comparable to the same periods in the prior year. 

 

As required by SFAS 123R, the Company has presented pro forma disclosures of its net loss and net loss per share for the prior year periods assuming the estimated fair value of the options granted prior to July 1, 2005 is amortized to expense over the option-vesting period as presented below.

 

 

 

Three Months Ended
December 31, 2004

 

Six Months Ended December 31, 2004

 

 

 

 

 

 

 

Net loss, as reported

 

$

(4,877,017

)

$

(10,492,345

)

Add: Share-based employee compensation expense included in reported net loss

 

 

151,004

 

 

 

 

 

 

 

Less: Total share-based employee compensation expense determined under fair value based method for all options granted

 

(1,822,570

)

(3,595,278

)

Pro forma net loss

 

$

(6,699,587

)

$

(13,936,619

)

 

 

 

 

 

 

Net loss per share:

 

 

 

 

 

Basic and diluted - as reported

 

$

(0.16

)

$

(0.35

)

Basic and diluted - pro forma

 

$

(0.22

)

$

(0.47

)

 

For purposes of disclosure in the foregoing table and for purposes of determining estimated fair value under SFAS 123R, the Company has computed the estimated fair values of all share-based compensation using the Black-Scholes option pricing model and has applied the assumptions set forth in the following table. The Company increased the estimated life of stock options granted beginning in fiscal 2006 as a result of guidance from the SEC as contained in Staff Accounting Bulletin No. 107 permitting the initial application of a “simplified” method, which is based on the average of the vesting term and the term of the option. Previously, the Company calculated the estimated life based on the expectation that options would be exercised within five years on average. The Company based its estimate of expected volatility for options granted in fiscal year 2006 on daily historical trading data of its common stock from November 17, 2000, the date of the Company’s initial public offering, through the last day of the applicable period. For options granted in fiscal year 2005, the Company based its volatility estimate under the

 

8



 

same method as fiscal year 2006, using the period from November 1, 2001 through the last day of the applicable period.

 

 

 

Average
Risk-Free
Interest Rate

 

Dividend
Yield

 

Volatility
Factor

 

Weighted-
Average Option
Life (Years)

 

First six months of Fiscal Year 2006

 

4.30

%

0

%

76.4

%

6.38

 

First six months of Fiscal Year 2005

 

3.49

%

0

%

79.4

%

5

 

 

The Black-Scholes option pricing model requires the input of highly subjective assumptions. Because the Company’s employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in management’s opinion, the existing models may not provide a reliable single measure of the fair value of its employee stock options or common stock purchased under the ESPP. In addition, management will continue to assess the assumptions and methodologies used to calculate estimated fair value of share-based compensation. Circumstances may change and additional data may become available over time, which result in changes to these assumptions and methodologies, and which could materially impact the Company’s fair value determination.

 

A summary of option activity under the Option Plan as of December 31, 2005, and changes during the six months then ended is presented below.

 

Summary Details for Plan Share Options

 

 

 

Number of
Options

 

Weighted-
Average
Exercise
Price

 

Weighted-
Average
Remaining
Contractual
Life (Years)

 

Aggregate
Intrinsic
Value

 

 

 

 

 

 

 

 

 

(in millions)

 

Outstanding Balance, June 30, 2005

 

6,634,541

 

$

6.46

 

 

 

 

 

Granted

 

1,858,900

 

6.53

 

 

 

 

 

Exercised

 

(108,840

)

1.17

 

 

 

 

 

Forfeited or expired

 

(283,383

)

7.31

 

 

 

 

 

Outstanding Balance, December 31, 2005

 

8,101,218

 

6.51

 

7.0

 

$

12.3

 

Exercisable shares as of December 31, 2005

 

4,689,629

 

6.33

 

5.7

 

$

9.7

 

 

The weighted-average, grant-date fair value of options granted during the six-month period ended December 31, 2005 was $4.68 based on using the Black-Scholes option pricing model on the date of grant. The total intrinsic value of options exercised during the six-month period ended December 31, 2005 was approximately $618,000 and represents the difference between the exercise price of the option and the closing market price of the Company’s common stock on the dates exercised. The foregoing table corrects certain errors in the Company’s presentation of total intrinsic value of outstanding options and exercisable options reported in the Company’s Form 10-Q for the quarter ended September 30, 2005.

 

A summary of the status of the Company unvested shares as of December 31, 2005, and changes during the six-month period then ended is presented below.

 

Unvested Shares Issued Under the Plan

 

 

 

Nonvested
Shares

 

Weighted-
Average
Grant-Date
Fair Value

 

Unvested Balance, June 30, 2005

 

2,649,739

 

$

4.88

 

Granted

 

1,858,900

 

4.68

 

Vested

 

(872,034

)

5.16

 

Forfeited

 

(225,016

)

4.86

 

Unvested Balance, December 31, 2005

 

3,411,589

 

4.69

 

 

9



 

Unrecognized Share-Based Compensation Expense

 

As of December 31, 2005, there was $11.7 million of total unrecognized compensation expense related to unvested share-based compensation arrangements granted under the Plan. This expense is expected to be recognized over a weighted-average period of 2.0 years as follows:

 

 

 

(in thousands)

 

Fiscal Year 2006 - remaining periods

 

$

2,605

 

Fiscal Year 2007

 

3,616

 

Fiscal Year 2008

 

2,842

 

Fiscal Year 2009

 

1,791

 

Fiscal Year 2010

 

805

 

 

 

$

11,659

 

 

Comprehensive Loss

 

A reconciliation of net loss to comprehensive loss is as follows:

 

 

 

Three Months Ended
December 31,

 

Six Months Ended
December 31,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(8,711,194

)

$

(4,877,017

)

$

(18,383,237

)

$

(10,492,345

)

 

 

 

 

 

 

 

 

 

 

Change in unrealized gain (loss) on marketable securities

 

9,581

 

(20,275

)

(98,114

)

38,598

 

Total comprehensive loss

 

$

(8,701,613

)

$

(4,897,292

)

$

(18,481,351

)

$

(10,453,747

)

 

Net Loss Per Share

 

Basic and diluted net loss per share has been computed by dividing net loss for the period by the weighted average number of common shares outstanding during the period. The Company has excluded the effects of outstanding stock options from the calculation of diluted net loss per share because all such securities are anti-dilutive for all periods presented. The number of common share equivalents relating to these stock options excluded from the diluted loss per share calculations for the three and six months ended December 31, 2005 were 1,382,458 shares and 1,380,623 shares, respectively. For the three and six months ended December 31, 2004 the number of common share equivalents were 1,213,282 shares and 1,196,876 shares, respectively.

 

 Reclassifications

 

Certain reclassifications have been made to the prior year’s amounts to conform to the current year’s presentation. These reclassifications had no impact on the reported results of operations.

 

Use of Management’s Estimates

 

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

 

10



 

Note 2: Cash, Cash Equivalents and Marketable Securities

 

Cash, cash equivalents and marketable securities classified as available-for-sale and restricted cash as of December 31, 2005 and June 30, 2005 consist of the following:

 

 

 

December 31,
2005

 

June 30,
2005

 

Cash and cash equivalents:

 

 

 

 

 

Cash

 

$

350,798

 

$

440,958

 

Money market fund

 

11,954,864

 

11,988,568

 

Total

 

$

12,305,662

 

$

12,429,526

 

 

 

 

 

 

 

Marketable securities:

 

 

 

 

 

Auction rate securities

 

$

5,759,852

 

$

28,553,313

 

Federal agency mortgage-backed securities

 

59,598,536

 

49,743,469

 

Total

 

$

65,358,388

 

$

78,296,782

 

 

 

 

 

 

 

Restricted cash:

 

 

 

 

 

Money market fund

 

$

 

$

1,979,678

 

 

On December 28, 2005, the Company entered into a First Amendment to its Loan and Security Agreement (“First Amendment”) with Comerica Bank (“Comerica” or “Bank”). The First Amendment decreased the required minimum cash balance that the Company must maintain at the Bank to zero, as long as the Company’s total cash, cash equivalents and marketable securities, including those invested at the Bank, is $40 million or higher. As of December 31, 2005, the Company’s total cash, cash equivalents and marketable securities exceeded $40 million; therefore none of the Company’s cash was restricted.

 

Debt securities at December 31, 2005 and June 30, 2005, are shown below by contractual maturity. Actual maturities may differ from contractual maturities because issuers of the securities may have the right to prepay obligations.

 

 

 

December 31,
2005

 

June 30,
2005

 

Marketable securities:

 

 

 

 

 

Due in one year or less

 

$

49,885,528

 

$

56,147,883

 

Due after one year through two years

 

15,472,860

 

22,148,899

 

Total

 

$

65,358,388

 

$

78,296,782

 

 

The Company has included marketable securities due after one year within current assets, as these investments are available for use in current operating activities.

 

Note 3: Inventory Components

 

 

 

December 31,
2005

 

June 30,
2005

 

 

 

 

 

 

 

Fine chemicals

 

$

3,125,911

 

$

2,884,541

 

Optimer building blocks

 

2,109,659

 

2,186,260

 

Total inventories at cost

 

5,235,570

 

5,070,801

 

Less reserves

 

(3,228,946

)

(2,917,315

)

Total inventories, net

 

$

2,006,624

 

$

2,153,486

 

 

11



 

Note 4: Long Term Debt

 

On June 28, 2005, the Company entered into a Loan and Security Agreement (“Loan and Security Agreement”) with Comerica Bank. The Loan and Security Agreement provides for a term loan, equipment advances and a revolving line of credit, all of which are secured by a security interest in the Company’s assets, other than its intellectual property. The full $10 million term loan was advanced to the Company on June 30, 2005, and currently has an interest rate of 5.5% per annum and a maturity date of June 28, 2010. Up to $5 million in equipment advances are available to the Company from time to time through December 28, 2006 to finance the purchase of equipment, capitalized software and tenant improvements. As of December 31, 2005, the Company has received $2.6 million of equipment advances, which currently have an interest rate of 5.5% per annum and a maturity date of June 28, 2010. A revolving line of credit, with a maturity date of June 28, 2008, in the amount of $2 million is available to support outstanding standby letters of credit that have been issued in relation to the Company’s facilities leases.

 

Interest on the loans is payable in monthly installments, with a balloon payment of $12.6 million due in June 2010, based on current amounts outstanding as of December 31, 2005. The agreement contains certain covenants that restrict the Company’s ability to, among other things, sell certain assets, engage in a merger or change in control transaction, incur debt, pay cash dividends and make investments. The agreement also requires the Company to maintain certain minimum balances in an interest earning Comerica money market account when the Company’s total cash, cash equivalents and marketable securities, including those invested at the Bank, is below $40 million.

 

Based on the outstanding debt balances and interest rates in effect as of December 31, 2005, the aggregate future minimum interest payments of the Loan and Security Agreement are $345,000 for the remainder of fiscal 2006, $690,000 in each of fiscal years 2007, 2008, 2009 and 2010 with $12.6 million of principal payable in 2010.

 

Note 5: Stock Compensation Plans

 

Stock Options

 

In September 2000, the Company’s Board of Directors approved the Amended and Restated Stock Option and Incentive Plan (the “Option Plan”), which is the successor equity incentive plan to the Company’s 1998 Stock Option Plan (the “1998 Plan”), initially adopted by the Board of Directors in July 1998. Upon the closing of the Company’s initial public offering, the Option Plan became effective and no additional grants were made under the 1998 Plan. A total of 14.2 million shares of common stock have been reserved for issuance under the Option Plan to eligible employees, consultants and directors of the Company. Of these shares, 4.8 million were authorized pursuant to the provision under the Option Plan which provides for the reservation of additional authorized shares on any given day in an amount equal to the difference between: (i) 25% of the Company’s issued and outstanding shares of common stock, on a fully diluted and as-converted basis and (ii) the number of outstanding shares relating to awards under the Option Plan plus the number of shares available for future grants of awards under the Option Plan on that date. As of December 31, 2005, there were 3.6 million shares available for future grant under the Option Plan.

 

The Option Plan provides for awards of both nonstatutory stock options and incentive stock options within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended, and other incentive awards and rights to purchase shares of the Company’s common stock. A total of 7.75 million shares of common stock may be issued as incentive stock options as of January 1, 2006. The Option Plan provides that the number of shares reserved for issuance as incentive stock options increased on January 1 of each year from 2003 through 2006 by 250,000 shares, provided that this number did not exceed the total number of shares reserved under the Option Plan.

 

The Option Plan is administered by the Compensation Committee of the Board of Directors, which has the authority to select the individuals to whom awards will be granted and to determine whether and to what extent stock options and other stock incentive awards are to be granted, the number of shares of common stock to be covered by each award, the vesting schedule of stock options, generally straight-line over a period of four years, and all other terms and conditions of each award.

 

12



 

Employee Stock Purchase Plan

 

During fiscal year 2001, the Company adopted an Employee Stock Purchase Plan (the “ESPP”), authorizing the issuance of 800,000 shares of its common stock pursuant to purchase rights granted to eligible employees of the Company. During fiscal 2003, stockholders approved an increase of 400,000 shares for a total of 1.2 million authorized shares for issuance under the ESPP. The ESPP provides a means by which employees purchase common stock of the Company through payroll deductions of up to 15% of their base compensation. The Compensation Committee determines the length and duration of the periods during which payroll deductions will be accumulated to purchase shares of common stock. This period is known as the offering period. Within a single offering period, the Company permits periodic purchases of stock, known as purchase periods. During the first six months of fiscal 2006, the offering periods were six-month periods and the purchase periods were three-month periods. Effective January 1, 2006, the purchase periods will be 12-month periods. The Compensation Committee may modify the duration of the offering periods and the purchase periods again in the future. At the end of each purchase period during a calendar year, the Company uses accumulated payroll deductions to purchase, on behalf of participating employees, shares of common stock at a price equal to the lower of 85% of the fair value of a share of common stock (i) at the beginning of the offering period or (ii) at the end of the purchase period. Generally, all employees, including executive officers, who work at least 20 hours per week and five months per year, may participate in the ESPP. Employees who are deemed to own greater than 5% of the combined voting power of all classes of stock of the Company are not eligible for participation in the ESPP. For the three and six months ended December 31, 2005 total shares issued under the ESPP were 54,660 and 108,588, respectively. As of December 31, 2005, there were 49,975 shares available for future issuance under the ESPP. On December 9, 2005, the Company’s Board of Directors approved an additional 450,000 shares of common stock for issuance under the ESPP, subject to shareholder approval.

 

Note 6: Operating Lease

 

Amendment to Lease Agreement. On August 5, 2005, the Company amended two existing Lease Agreements (the “Prior Lease Agreements”), for the two buildings totaling approximately 75,000 square feet that the Company occupies in Longmont, Colorado under the terms of an Addendum No.4 (the “Amendment”). Under the Amendment, the Company has the option to expand its leased space by up to an additional 80,000 square feet in three adjacent buildings. On December 2, 2005 and December 22, 2005, the Company entered into Addendum No.5 and Addendum No.6, respectively, representing the Company’s exercise of the option to occupy two of the three buildings. In addition, the Company has the right to purchase each of the leased buildings, including the expansion space. The Amendment provides for monthly lease payments along with 3% annual increases.

 

Addendum No. 5 also extended the lease terms under the Prior Lease Agreements for both buildings to May 31, 2013. The Company also has options to extend the term of the lease for three additional consecutive terms of five years each.

 

Note 7: Segment, Geographic and Concentration Information

 

All operations of the Company are considered to be in one operating segment and, accordingly, no segment disclosures have been presented. The physical location of the Company’s property, plant and equipment is within the United States. The following table details revenue from customers by geographic area based on the country in which collaborators are located or the destination where compounds from the Company’s inventories are shipped.

 

 

 

Three Months Ended
December 31,

 

Six Months Ended
December 31,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

 

 

 

 

 

 

 

 

North America

 

$

7,809,300

 

$

8,057,860

 

$

14,778,725

 

$

13,861,520

 

Europe

 

2,548,569

 

3,232,523

 

6,062,586

 

6,405,006

 

Japan and Asia-Pacific

 

1,582,203

 

758,062

 

2,340,508

 

1,638,926

 

Total revenue

 

$

11,940,072

 

$

12,048,445

 

$

23,181,819

 

$

21,905,452

 

 

13



 

Approximately 97% of the revenue generated from Europe during both the three months ended December 31, 2005, and 2004, is related to the Company’s collaboration and licensing agreement with AstraZeneca AB, located in Sweden. During the six months ended December 31, 2005 and 2004, revenue from AstraZeneca represented 95% and 97%, respectively, of the revenue generated from Europe. For the three and six months ended December 31, 2005, revenue generated primarily from two Japanese customers represented 13% and 10%, respectively, of total revenue. No other individual international country exceeded 10% of the Company’s revenue for any of the above periods.

 

During the three months ended December 31, 2005, revenue from three of the Company’s customers represented approximately 35%, 22%, and 21% of total revenue, while three of the Company’s customers represented approximately 34%, 26%, and 11% of total revenue for the comparative period in fiscal 2005. For the six-month period ended December 31, 2005, revenue from three of the Company’s customers represented approximately 33%, 25%, and 20% of total revenue, while three of the Company’s customers represented approximately 29%, 28%, and 11% of total revenue for the comparative period in fiscal 2005.

 

Note 8: Recent Accounting Pronouncement

 

In May 2005, the FASB issued Statement No. 154, Accounting Changes and Error Corrections (“SFAS 154”) , which replaces APB Opinion No. 20, Accounting Changes , and SFAS No. 3, Reporting Accounting Changes in Interim Financial Statements, and changes the requirements for the accounting for and reporting of a change in accounting principle. SFAS 154 applies to all voluntary changes in accounting principle and to changes required by an accounting pronouncement when the pronouncement does not include specific transition provisions. SFAS 154 requires retrospective application of changes in accounting principle to prior periods’ financial statements unless it is impracticable to determine either the period-specific effects or the cumulative effect of the change. APB Opinion No. 20 previously required that most voluntary changes in accounting principle be recognized by including the cumulative effect of the change in net income for the period of the change in accounting principle. SFAS 154 carries forward without change the guidance contained in APB Opinion No. 20 for reporting the correction of an error in previously issued financial statements and a change in accounting estimate. SFAS 154 also carries forward the guidance in APB Opinion No. 20 requiring justification of a change in accounting principle on the basis of preferability. SFAS 154 is effective for accounting changes and correction of errors made in fiscal years beginning after December 15, 2005 with early adoption permitted. The Company does not believe that the adoption of this statement will have a material impact on its financial condition or results of operations.

 

14



 

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

 

The Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about our expectations related to realizing new revenue streams and obtaining future collaboration agreements that include milestone and/or royalty payments, the success of our internal proprietary drug discovery activities, the expected level of our investment in proprietary research and our future headcount and capital expenditure requirements. These statements involve significant risks and uncertainties, including those discussed below and those described more fully in other reports filed by Array BioPharma with the Securities and Exchange Commission. Because these statements reflect our current expectations concerning future events, our actual results could differ materially from those anticipated in these forward-looking statements. The factors that could cause actual results to differ from our expectations include, but are not limited to, our ability to achieve and maintain profitability, the extent to which the pharmaceutical and biotechnology industries are willing to in-license drug candidates for their product pipelines and to collaborate with and fund third parties on their drug discovery activities, our ability to out-license our proprietary candidates on favorable terms, our ability to continue to fund and successfully progress internal research efforts and to create effective, commercially viable drugs, risks associated with our dependence on our collaborators for the clinical development and commercialization of our out-licensed drug candidates, the ability of our collaborators and of Array to meet objectives, including clinical trials, tied to milestones and royalties, our ability to attract and retain experienced scientists and management, and the risk factors contained in the Annual Report on Form 10-K filed by Array with the Securities and Exchange Commission (“SEC”) on September 13, 2005. We are providing this information as of the date of this report. We undertake no duty to update any forward-looking statements to reflect the occurrence of events or circumstances after the date of such statements or of anticipated or unanticipated events that alter any assumptions underlying such statements.

 

The following discussion of our financial condition and results of operations should be read in conjunction with the financial statements and notes to those statements included elsewhere in this report.

 

Overview

 

Array BioPharma is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat life threatening and debilitating diseases. Our proprietary drug development pipeline is primarily focused on the treatment of cancer and inflammatory disease and includes clinical candidates that are designed to regulate therapeutically important targets. In addition, leading pharmaceutical and biotechnology companies collaborate with Array to discover and develop drug candidates across a broad range of therapeutic areas.

 

We have identified multiple drug candidates in our own proprietary programs and in collaborations with other drug companies. We intend to progress our proprietary drug programs internally through clinical testing and continue to evaluate select programs for out-licensing opportunities with pharmaceutical and biotechnology partners.

 

We have built our drug development pipeline, and our discovery and development capabilities, primarily through cash flow from collaborations and through sales of our equity securities. Through December 31, 2005, we have recognized $173.1 million in collaboration revenue, and we have received $18.2 million in up-front payments and $7.7 million in milestone payments from our collaborators and out-licensing partners. Under our existing collaboration agreements, we have the potential to earn over $190.0 million in additional milestone payments if we achieve all of the drug discovery objectives under these agreements, as well as royalties on any resulting product sales from 14 different programs.

 

We have incurred net losses since inception and expect to incur losses in the near future as we continue to invest in our proprietary drug discovery programs. As of December 31, 2005, we had an accumulated deficit of $112.4 million.

 

15



 

Revenue . We generate revenue through the out-licensing of select proprietary drug discovery programs for license and up-front fees, research funding based on the number of full-time equivalents contractually assigned to the program, and research and development milestone payments. We also have the potential to generate revenue from royalties on future product sales. Four programs have been out-licensed to date to AstraZeneca, Genentech, Inc. and Amgen Inc., and we have received up-front license fees of $18.2 million in total for these programs.

 

We also generate revenue through collaborations aimed at inventing drug candidates for our collaborators. We receive research funding based on the number of full-time equivalent employees contractually assigned to a program, plus related research expenses. Under certain of these agreements, we are entitled to receive additional payments based on the achievement of research milestones, drug development milestones and/or royalty payments based on sales of products created as a result of these collaborations.

 

We sell our Optimer â building blocks, which are the starting materials used to create more complex chemical compounds in the drug discovery process, on a per-compound basis without any restrictions on use. In addition, we have licensed our Lead Generation Libraries, which are a collection of structurally related chemical compounds that may have the potential of becoming drug candidates, on a non-exclusive basis to our collaborators for their internal research purposes. We are no longer developing new Lead Generation Libraries other than for our proprietary research. Under our existing agreements, we retain all other rights to the compounds, which permits us to license the same compounds to other collaborators. Some of our existing Lead Generation Library agreements allow our collaborators to obtain exclusive rights to commercialize particular compounds upon the payment of additional fees. Lead Generation Library revenue represented less than 1% of total revenue for each of the three and six months ended December 31, 2005 and approximately 4% of revenue for the full 2005 fiscal year. Future revenue from any sales of compounds in our Lead Generation Library is not expected to be significant.

 

We report revenue for lead generation and lead optimization research, custom synthesis and process research, the development and sale of chemical compounds and the co-development of proprietary drug candidates we out-license, as collaboration revenue. License and milestone revenue is combined and reported separately from collaboration revenue.

 

Revenue recognition. We recognize revenue from fees under our collaboration agreements on a monthly basis as work is performed. Per-compound revenue is recognized as compounds are shipped. Revenue from license fees and up-front fees is recognized on a straight-line basis over the expected period of the related research program. Payments received in advance of performance are recorded as advance payments from collaborators until the revenue is earned. Milestone payments are non-refundable and are recognized as revenue over the expected period of the related research program. A portion of each milestone payment is recognized when the milestone is achieved based on the applicable percentage of the research term that has elapsed. Any balance is recognized ratably over the remaining research term. Revenue recognition related to license fees, up-front payments and milestone payments could be accelerated in the event of early termination of programs.

 

Customer concentration. Our top 20 collaborators contributed approximately 99% of our total revenue for the first six months of fiscal 2006, and our current top three collaborators, Genentech, AstraZeneca and InterMune, Inc, accounted for 33%, 25%, and 20%, respectively, of our total revenue. During the same period of fiscal year 2005, AstraZeneca, Genentech, and Eli Lilly and Company accounted for 29%, 28%, and 11%, respectively, of our total revenue. In general, our collaborators may terminate their collaboration agreements with us on 30 to 90 days’ prior notice.

 

Cost of revenue. Cost of revenue consists mainly of compensation, associated fringe benefits and other collaboration-related costs, including research and development conducted for our collaborators, supplies, small tools, facilities, depreciation, recruiting and relocation and other direct and indirect chemical handling and laboratory support costs. Fine chemicals consumed as well as any required inventory reserve adjustments are also recorded as cost of revenue. We review the levels and values of our chemical inventories periodically and, when required, write down the carrying cost of our inventories for non-marketability to estimated net realizable value through an appropriate reserve.

 

16



 

Research and development expenses for proprietary drug discovery. Research and development expenses for proprietary drug discovery consists of all costs associated with our proprietary drug development pipeline, including compensation and fringe benefits, consulting and outsourced services, laboratory supplies, and allocated facility costs and depreciation. When an internal proprietary program is out-licensed, all subsequent costs of the out-licensed program are reported as cost of revenue.

 

Selling, general and administrative expenses. Selling, general and administrative expenses consist mainly of compensation and associated fringe benefits not included in cost of revenue or research and development expenses and include other management, business development, accounting, information technology and administration costs, including patent prosecution, recruiting and relocation, consulting and professional services, travel and meals, advertising, sales commissions, facilities, depreciation and other office expenses.

 

Business development. We currently license or sell our compounds and enter into collaborations directly with pharmaceutical and biotechnology companies through opportunities identified by our business development group, senior management, scientists and customer referrals. In addition, we license or sell our compounds and collaborations in Japan through an agent. International revenue represented 36% of our total revenue during the first six months of fiscal year 2006, down slightly from 37% for the same period in the prior year. Our international revenue is primarily attributable to both European and Japanese collaborations. All of our collaboration agreements and purchase orders are denominated in United States dollars.

 

Future outlook . We plan to increase our investment in proprietary research to broaden our product pipeline and to further enhance our clinical and regulatory capabilities to allow us to advance drugs further in clinical development. We will consider commercializing select programs ourselves with appropriate market characteristics while continuing to evaluate out-licensing opportunities to maximize the risk-adjusted return of our proprietary programs. We also intend to evaluate opportunities to grow our product pipeline by acquiring or in-licensing later-stage clinical programs. As part of these efforts, we expect near term selling, general and administrative costs to rise in connection with increased patent and other intellectual property related costs incurred to protect and enforce our intellectual property rights in our proprietary programs. As we devote more scientists to our proprietary research, we expect fewer scientists will be assigned to revenue generating collaborations. In addition, as of November 2005, we have fully recognized all revenue from previously received up-front and milestone payments from out-licensed proprietary programs. Because of our strategy to retain other proprietary programs later in clinical development before out-licensing them or commercializing them ourselves, it is unlikely that this revenue will be replaced during the remainder of fiscal 2006. Our statements about future events in this paragraph are subject to many risks and uncertainties, including many that are beyond our control. These risks are described in the risk factors included in our annual report on Form 10-K filed with the SEC on September 13, 2005, and in other reports we file with the SEC.

 

Results of Operations

 

 

 

Three Months Ended
December 31,

 

Six Months Ended
December 31,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

(in thousands)

 

(in thousands)

 

Revenue

 

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

9,232

 

$

9,548

 

$

17,515

 

$

16,893

 

License and milestone revenue

 

2,708

 

2,500

 

5,667

 

5,012

 

Total revenue

 

$

11,940

 

$

12,048

 

$

23,182

 

$

21,905

 

 

Three and Six Months Ended December 31, 2005 and 2004

 

Revenue. Total revenue for the three months ended December 31, 2005 was $11.9 million, down slightly from $12.0 million in the same period of the prior year. For the six months ended December 31, 2005, total revenue was $23.2 million, up 6% from $21.9 million in the same period of the prior year. Collaboration revenue from research collaborations increased by $4.1 million and $7.0 million for the three and six months ended December 31, 2005, respectively, over the same periods in the prior year, as a result of expanded programs with Genentech and InterMune and a new research collaboration with Ono Pharmaceutical Co., Ltd. These increases were partially offset

 

17



 

by decreased collaboration revenue from research programs of $2.9 million and $4.4 million during the same time periods above, related to programs that expired in fiscal 2005 with QLT Inc., as well as the expiration of one of our two research programs with Eli Lilly. In addition, revenue from our programs with AstraZeneca declined over the first half of fiscal 2006 as the research-funding period expired in November 2005. Additionally, collaboration revenue from the sale of Lead Generation Libraries decreased during the three and six months ended December 31, 2005, by $1.5 million due to the sale of the remainder of our Lead Generation Library compounds to a single collaborator that occurred during December 2004.

 

License and milestone revenue increased by approximately $208,000 and $654,000 during the three and six months ended December 31, 2005, over the same periods of the prior year. This increase was due to the recognition of $1.5 million of milestone payments received from AstraZeneca during the first six months of fiscal 2006 for advancing our out-licensed compound, ARRY-142886, into Phase Ib clinical trials and the selection of a second clinical candidate. Partially offsetting this increase was one less month of recognized revenue from previously received up-front and milestone payments from out-licensed proprietary programs.

 

Cost of revenue. Cost of revenue increased by approximately 6% during each of the three and six months ended December 31, 2005 over the same periods of the prior year, primarily due to the recording of approximately $546,000 and $1.1 million, respectively, of share-based compensation expense in accordance with FASB Statement No. 123R, Share-Based Payment – an amendment of FASB Statement No. 123 and 95 (“SFAS 123R”). During the three and six months ended December 31, 2004, we expensed $0 and approximately $113,000, respectively, of share-based compensation expense, associated with the final amortization of deferred stock option compensation related to grants prior to our initial public offering of common stock in November 2000. In addition, during June 2005, we began amortizing the cost of leasehold improvements for our facility located in Boulder, Colorado over the remaining months of our initial lease term, which ends March 2008. Prior to that, all leasehold improvements were amortized over a period of 15 years, which included optional lease extension periods we were reasonably assured of exercising at that time. This change in useful life resulted in approximately $143,000 and $263,000, respectively, of additional leasehold improvement amortization to cost of revenue for the three and six months ended December 31, 2005 compared to the same periods of the prior year.

 

Research and development expenses for proprietary drug discovery. Research and development expenses for proprietary drug discovery increased by approximately 47% and 68% during the three and six months ended December 31, 2005, over the same periods of the prior year. This increase was primarily due to additional scientists and increased pharmacology studies supporting our expanded efforts to advance proprietary compounds into regulated safety testing and clinical trials. The most significant increase in costs came from outsourced pharmacology studies to support the advancement of our ErB2/EGFR, P38, Mek for inflammation, and other programs. We expect that proprietary research and development spending will continue to increase as we focus more resources on our proprietary drug discovery and development programs and advance our programs into and through clinical development. For the three and six months ended December 31, 2005, we expensed approximately $321,000 and $733,000, respectively, related to share-based compensation in accordance with SFAS 123R. In addition, as described in cost of revenue above, we recorded approximately $240,000 and $500,000, respectively, of additional leasehold improvement amortization to research and development expenses for proprietary drug discovery for the three and six months ended December 31, 2005 compared to the same periods of the prior year.

 

Selling, general and administrative expenses. Selling, general and administrative expenses increased 44% and 46%, respectively, during the three and six months ended December 31, 2005, over the same periods of the prior year. The increase was primarily the result of approximately $798,000 and $1.6 million, respectively, of share-based compensation in accordance with SFAS 123R. The remaining increase was primarily attributable to increases in compensation expense, as well as costs associated with the audit of our internal control over financial reporting in compliance with Section 404 of the Sarbanes Oxley Act for the end of fiscal year 2005 and the first half of fiscal 2006. For the three and six months ended December 31, 2005, compensation expense increased by approximately $98,000 and $212,000, respectively, over the same periods of the prior year, while consulting and audit fees related to Section 404 compliance increased by approximately $61,000 and $174,000 for the same comparable periods.

 

Interest expense. During the three and six months ended December 31, 2005, we incurred interest expense of approximately $153,000 and $282,000, respectively, associated with borrowings related to the Loan and Security Agreement that we entered into on June 28, 2005.

 

18



 

Interest income. Interest income increased to approximately $696,000 and $1.4 million for the three and six months ended December 31, 2005, from approximately $192,000 and $330,000, respectively, in the same periods of the prior year. This increase was primarily due to higher investment interest rates earned on higher average cash and investment balances with the increased balances primarily being attributable to the Company’s public common stock offering in December 2004.

 

Share-Based Compensation . Effective July 1, 2005, we adopted the fair value method of accounting for share-based compensation arrangements in accordance with SFAS 123R, using the modified prospective method of transition. Share-based compensation arrangements covered by SFAS 123R currently include stock options granted under our Amended and Restated Stock Option and Incentive Plan (the “Option Plan”) and purchases of common stock by our employees at a discount to the market price during each offering period under our Employee Stock Purchase Plan (the “ESPP”). Prior to July 1, 2005, we accounted for share-based employee compensation plans using the intrinsic value method of accounting in accordance with APB 25. Under the provisions of APB 25, no compensation expense was recognized with respect to purchases of our common stock under the ESPP or when stock options were granted with exercise prices equal to or greater than market value on the date of grant and no compensation expense was recognized for purchases of shares of our common stock by employees under our ESPP. Under the modified prospective method of transition, we are not required to restate our prior period financial statements to reflect expensing of share-based compensation under SFAS 123R. Therefore, the results as of the three and six months ended December 31, 2005 are not directly comparable to the same periods in the prior year.

 

As required by the provisions of SFAS 123R, we recorded $1.7 million and $3.4 million, or $0.04 and $0.09 per share, respectively, of share-based compensation expense for the three and six months ended December 31, 2005. These amounts are allocated among cost of revenue, research and development expenses for proprietary drug discovery and selling, general and administrative expenses based on the function of the applicable employee. This charge had no impact on our reported cash flows. We used the Black-Scholes option pricing model to determine the estimated fair value of our share-based compensation arrangements.

 

As of December 31, 2005, there was $11.7 million of total unrecognized compensation expense related to unvested share-based compensation arrangements granted under the Option Plan. See Note 1, Accounting for Share-Based Compensation, to the Unaudited Notes to Condensed Financial Statements and Critical Accounting Policies – Share-Based Compensation below for more information about the adoption of SFAS 123R.

 

Liquidity and Capital Resources

 

We have historically funded our operations through revenue from our collaborations and the issuance of equity securities. As of December 31, 2005, cash, cash equivalents, restricted cash and marketable securities totaled $77.7 million compared with $92.7 million at June 30, 2005.

 

Net cash used in operating activities was $15.8 million and $5.3 million for the six months ended December 31, 2005, and 2004 respectively. During the first six months of fiscal year 2006, our net loss of $18.4 million was reduced by noncash charges of $8.0 million, primarily associated with depreciation, share-based compensation, and an increase in our net operating assets and liabilities, excluding cash and marketable securities, of approximately $5.4 million. Net operating assets and liabilities increased due to decreases in advance payment balances from collaborators and decreased accrued compensation and benefits. Advance payments from collaborators decreased by $4.5 million due to the recognition of revenue from previously received up-front license and milestone payments. Accrued compensation and benefits decreased by $1.3 million primarily due to the payment of the fiscal year 2005 employee bonuses during August 2005, partially offset by the bonus accrual amounts recorded through December 31, 2005 for fiscal 2006.

 

During the six months ended December 31, 2005, we invested $2.4 million in laboratory equipment, primarily for biology and drug metabolism operations, as well as in various computer hardware and software. Purchases of marketable securities used $34.9 million of cash while proceeds from the sale and maturity of marketable securities provided $47.7 million of cash. During the six months ended December 31, 2005, p reviously restricted cash in the amount of $2.0 million became available for use in operations. Financing activities provided $3.2 million of cash consisting of $2.6 million from the issuance of long term debt used to finance purchases of capital equipment and approximately $695,000 of cash resulting from the exercise of stock options under our stock option plan and purchases of stock under our employee stock purchase plan.

 

19



 

As of December 31, 2005, we had a $10 million term loan and $2.6 million of equipment advances outstanding under our Loan and Security Agreement, which currently bear interest at the rate of 5.5% per annum. Interest on the loans is payable in monthly installments. A balloon payment of $12.6 million is due at maturity of the loan on June 28, 2010, based on current amounts outstanding as of December 31, 2005. We also have a revolving line of credit, with a maturity date of June 28, 2008, in the amount of $2 million to support outstanding standby letters of credit that have been issued in relation to our facilities leases.

 

Our future capital requirements will depend on a number of factors, including the rate at which we invest in proprietary research, the growth of our collaboration business and the amount of collaboration research funding we receive, the timing of milestone and royalty payments, if any, from our collaboration and out-licensed programs, our capital spending on new facilities and equipment, expenses associated with unforeseen litigation, regulatory changes, competition, technological developments, general economic conditions and the extent to which we acquire or invest in other businesses, products and technologies.

 

In addition, our future capital requirements may be impacted if we do not receive milestone or royalty payments under our existing or future collaboration agreements. Our ability to realize these payments is subject to a number of risks, many of which are beyond our control and include the following: the drug development process is risky and highly uncertain, and we or our collaborators may not be successful in commercializing drug candidates we create; our collaborators have substantial control and discretion over the timing and continued development and marketing of drug candidates we create; the sale and manufacture of drug candidates we develop may not obtain regulatory approval; and, if regulatory approval is received, drugs we develop will remain subject to regulation or may not gain market acceptance, which could delay or prevent us from generating milestone or royalty revenue from the commercialization of these drugs.

 

We believe that our existing cash, cash equivalents and marketable securities and anticipated cash flow from existing collaboration agreements will be sufficient to support our current operating plan for at least the next 12 months. This estimate of our future capital requirements is a forward-looking statement that is based on assumptions that may prove to be wrong and that involve substantial risks and uncertainties. Our actual future capital requirements could vary as a result of a number of factors, including:

 

                  the progress of our research activities;

                  the availability of resources for revenue generating collaborations as we devote more resources to our proprietary programs;

                  our ability to enter into agreements to out-license and co-develop our proprietary drug candidates, and the timing of those agreements in each candidate’s development stage;

                  the number and scope of our research programs;

                  the progress of our preclinical and clinical development activities;

                  the progress of the development efforts of our collaborators;

                  our ability to establish and maintain current and new collaboration agreements;

                  the ability of our collaborators to fund research and development programs;

                  the costs involved in enforcing patent claims and other intellectual property rights;

                  the decision to stay in our current facilities, or to consolidate operations in an existing or new location;

                  the costs and timing of regulatory approvals; and

                  the costs of establishing clinical development, business development and distribution or commercialization capabilities.

 

Until we can generate sufficient levels of cash from our operations, which we do not expect to achieve in the foreseeable future, we expect to continue to utilize our existing cash and marketable securities resources that were primarily generated from the proceeds of our equity offerings. In addition, we may finance future cash needs through the sale of equity securities, strategic collaboration agreements and debt financing. We cannot assure that we will be successful in obtaining new or in retaining existing out-license or collaboration agreements, in securing agreements for the co-development of our proprietary drug candidates, or in receiving milestone and/or royalty payments under those agreements, that our existing cash and marketable securities resources will be adequate or that additional financing will be available when needed or that, if available, this financing will be obtained on terms favorable to us or our stockholders. Insufficient funds may require us to delay, scale back or eliminate some or all of our research or development programs or to relinquish greater or all rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose, or may adversely affect our ability to

 

20



 

operate as a going concern. If we raise additional funds by issuing equity securities, substantial dilution to existing stockholders may result.

 

Obligations and Commitments

 

The following table shows our contractual obligations and commitments as of December 31, 2005.

 

 

 

Payments due by period

 

 

 

(in thousands)

 

 

 

Less than
1 year

 

1-3 years

 

4-5 years

 

After 5
years

 

Total

 

Operating lease obligations

 

$

5,005

 

$

7,026

 

$

1,626

 

$

6,935

 

$

20,592

 

Purchase obligations

 

5,012

 

890

 

100

 

 

6,002

 

Debt obligations (including interest)

 

690

 

1,381

 

13,589

 

 

15,660

 

Total obligations

 

$

10,707

 

$

9,297

 

$

15,315

 

$

6,935

 

$

42,254

 

 

We are obligated under noncancelable operating leases for our facilities and certain equipment. The original lease terms for our facilities range from seven to eight years with renewal options and generally require us to pay a proportionate share of real estate taxes, insurance, common area and other operating costs. Equipment leases generally range from three to five years.

 

Due to the high cost to replace and the limited availability of laboratory facilities, we concluded that the exercise of a portion of our lease term options for at least 15 years was reasonably assured. During the last quarter of fiscal 2005, we reassessed our facility requirements and began to consider the possibility of consolidating operations in one of our existing locations, or a new location. During the second quarter of fiscal 2006, we entered into an agreement to extend and expand our existing facility in Longmont, Colorado. Therefore it is no longer reasonably assured that we will remain in our Boulder, Colorado location beyond the initial lease term, which ends in March 2008. We have not changed our determination that it is reasonably assured that we will exercise certain of our lease extensions and lease our other facility, located in Longmont, Colorado, for at least another 13 years. Therefore, we have included in our operating lease obligations reflected in the table above the cash to be paid for our facility leases for the remaining reasonably assured lease terms of 2-1/4 years for our Boulder facility and 13 years for our Longmont facility. The portion of operating lease obligations that is related to optional extension periods for our Longmont facility is $4.8 million and is included within the “after 5 years” column above. 

 

Critical Accounting Policies

 

We believe critical accounting policies are essential to the understanding of our results of operations and require our management to make significant judgments in preparing the financial statements included in this report. Management has made estimates and assumptions based on these policies. We do not believe that materially different amounts would be reported if different assumptions were used. However, the application of these policies involves judgments and assumptions as to future events and, as a result, actual results could differ. The impact and any associated risks related to these policies on our business operations is discussed throughout Management’s Discussion and Analysis of Financial Condition and Results of Operations where such policies affect our reported and expected financial results.

 

21



 

Revenue Recognition

 

We believe our revenue recognition policy is significant because the amount and timing of revenue is a key component of our results of operations. We follow the guidance of Staff Accounting Bulletin No. 104, which requires that a series of criteria be met in order to recognize revenue related to the performance of services or the shipment of products. If these criteria are not met, the associated revenue is deferred until the criteria are met. We recognize revenue when (a) persuasive evidence of an arrangement exists, (b) products are delivered or services are rendered, (c) the sales price is fixed or determinable and (d) collectibility is assured.

 

Most of our revenue is derived from designing, creating, optimizing, evaluating and developing drug candidates for our collaborators. The majority of our collaboration revenue consists of fees received based on contracted annual rates for full time equivalent employees working on a project. Our collaboration agreements also include license and up-front fees, milestone payments upon achievement of specified research or development goals and royalties on sales of resulting products. A small portion of our revenue comes from fixed fee agreements and from sales of compounds on a per-compound basis.

 

Our collaboration agreements typically call for a specific level of resources as measured by the number of full time equivalent scientists working a defined number of hours per year at a stated price under the agreement. We recognize revenue under our collaboration agreements on a monthly basis for fees paid to us based on hours worked. We recognize revenue from sales of Lead Generation Library and Optimer building block compounds as the compounds are shipped, as these agreements are priced on a per-compound basis and title and risk of loss passes upon shipment to our customers.

 

Revenue from license fees and up-front fees is non-refundable and is recognized on a straight-line basis over the expected period of the related research program. Milestone payments are non-refundable and are recognized as revenue over the expected period of the related research program. A portion of any milestone payment is recognized at the date the milestone is achieved which is determined using the applicable percentage of the research term that has elapsed at the date the milestone is achieved. Any balance is recognized ratably over the remaining research term. Revenue recognition related to license fees, up-front payments and milestone payments could be accelerated in the event of early termination of programs.

 

In general, contract provisions include predetermined payment schedules or the submission of appropriate billing detail. Payments received in advance of performance are recorded as advance payments from collaborators until the revenue is earned.

 

We report revenue for lead generation and lead optimization research, custom synthesis and process research, the development and sale of chemical compounds and the co-development of proprietary drug candidates we out-license, as collaboration revenue. License and milestone revenue is combined and reported separately from collaboration revenue.

 

Share-Based Compensation

 

During the first quarter of fiscal 2006, we adopted the fair value method of accounting for share-based awards using the modified-prospective method of transition as outlined in Financial Accounting Standards Board Statement No. 123R, Share-Based Payment (“SFAS 123R”). Under SFAS 123R, the estimated fair value of share-based-compensation, including stock options granted under the Option Plan and purchases of common stock by employees at a discount to market price under the ESPP, is recognized as compensation expense. The estimated fair value of stock options is expensed on a straight-line basis over the expected term of the grant. Compensation expense for purchases under the ESPP is recognized based on the estimated fair value of the common stock during each offering period and the percentage of the purchase discount. Prior to July 1, 2005, we accounted for share-based employee compensation plans using the intrinsic value method of accounting in accordance with Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (“APB 25”), and its related interpretations. Under the provisions of APB 25, no compensation expense was recognized with respect to purchases of common stock under the ESPP or when stock options were granted with exercise prices equal to or greater than market value on the date of grant.

 

22



 

Under the modified prospective method of transition that we adopted, compensation expense is recognized beginning with the effective date of adoption for all share-based payments (i) granted after the effective date of adoption and (ii) granted prior to the effective date of adoption and that remain unvested on the date of adoption. Under the modified prospective method of transition, we are not required to restate our prior period financial statements to reflect expensing of share-based compensation under SFAS 123R. Therefore, the results for the periods ended September 30, 2005 and December 31, 2005 are not comparable to the same periods in the prior year.

 

Under SFAS 123R, we use the Black-Scholes option pricing model to estimate the fair value of the share-based awards as of the grant date. The Black-Scholes model, by its design, is highly complex, and dependent upon key data inputs estimated by management. The primary data inputs with the greatest degree of judgment are the estimated lives of the share-based awards and the estimated volatility of our stock price. The Black-Scholes model is highly sensitive to changes in these two data inputs. Beginning in fiscal year 2006, we calculated the estimated life of stock options granted using a “simplified” method, which is based on the average of the vesting term and the term of the option, as a result of guidance from the SEC as contained in Staff Accounting Bulletin No. 107 permitting the initial use of this method. Previously, we calculated the estimated life based on the expectation that options would be exercised on average five years after the date of grant. We determined expected volatility for fiscal year 2006 using the historical method, which is based on the daily historical trading data of our common stock from November 2000, the date of our initial public offering, through the last day of the applicable period. For fiscal year 2005, we determined expected volatility using the same method as fiscal year 2006, using the period from November 2001 though the last day of the applicable period. Management selected the historical method primarily because we have not identified a more reliable or appropriate method to predict future volatility. See Note 1, Accounting for Share-Based Compensation, to our financial statements for more information about the adoption of SFAS 123R.

 

Recent Accounting Pronouncements

 

For a summary description of a recent accounting pronouncement, see Note 8 to the Unaudited Notes to Condensed Financial Statements.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Interest Rate Risk . Our interest income is sensitive to changes in the general level of United States interest rates, particularly since a significant portion of our investments are and will be in short term marketable securities. Due to the nature and short term maturities of our short term investments, we have concluded that there is no material market risk exposure. Based on outstanding investment balances at December 31, 2005, a change of 100 basis points in interest rates would result in a change in our annual interest income of approximately $773,000.

 

We are also impacted by adverse changes in interest rates relating to variable-rate borrowings under our credit facility. We pay interest on advances under our loan agreement at one of three variable rates, which are adjusted periodically for changes in the underlying prevailing rate. Changes in prevailing interest rates will not affect the fair value of our debt, but would impact future results of operations and cash flows. At December 31, 2005, we had $12.6 million of long-term debt outstanding and the interest rate on our term loan and equipment advances was 5.5%. This rate is adjusted based on changes in the bank’s prime lending rate. Assuming constant debt levels, a change of 100 basis points in our interest rate would result in a change in our annual interest expense of approximately $126,000.

 

Foreign currency rate fluctuations. All of our collaboration agreements and purchase orders are denominated in United States dollars. Therefore, we are not exposed to changes in foreign currency exchange rates.

 

Inflation . We do not believe that inflation has had a material impact on our business or operating results during the periods presented.

 

23



 

Item 4. Controls and Procedures

 

In connection with the closing of the general ledger and the preparation of our Form 10-Q for the quarter ended September 30, 2005, errors were identified in the adoption of Financial Accounting Standards Board Statement No. 123R, Share-Based Payment (“SFAS 123R”) and in the calculation of compensation expense under the provisions of SFAS 123R. In addition, management discovered a miscalculation and error in the disclosure of the aggregate intrinsic values included in Footnote 1, Accounting for Share-Based Compensation in the quarterly report filed on Form 10-Q for the quarter ended September 30, 2005. Management concluded that the errors associated with the disclosure of aggregate intrinsic values were not material and the disclosure has been corrected in this quarterly report.

 

A material weakness is a significant deficiency, or a combination of significant deficiencies, that results in more than a remote likelihood that a material misstatement of our annual or interim financial statements would not be prevented or detected. Management and the Audit Committee concluded that ineffective controls relating to the adoption of this new accounting pronouncement, the entry of transactional data and the application of certain assumptions used in the calculation of estimated fair value of share-based compensation under SFAS 123R could result in a material misstatement in Array’s annual or interim financial statements that would not be prevented or detected. Consequently, management and the Audit Committee concluded that these control deficiencies constituted a material weakness. Management identified steps considered necessary to address these weaknesses, including additional training of finance personnel, additional review of transactional data, additional oversight of the entry of data relating to transactions, a comprehensive third party review of the processes used to gather and enter transactional data and the application of such data to critical accounting practices, and certain upgrades to our option tracking software. Management believes that the compensating internal controls and remediation efforts, taken as a whole, reduces the risk of error with respect to our preparation of this quarterly report on Form 10-Q for the period ended December 31, 2005. We began implementing the above improvements during the second quarter of fiscal 2006 and will continue to test these controls through the remainder of the fiscal year. Management believes that its controls and procedures will continue to improve as a result of further implementation of these measures.

 

Other than the above mentioned improvements to the controls for accounting for share-based compensation under SFAS 123R, there has been no change in our internal control for financial reporting that occurred during the quarter ended December 31, 2005 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

We evaluated, under the supervision and with the participation of our Chief Executive Officer, Chief Financial Officer and other senior management personnel, the effectiveness of the design and operation of our disclosure controls and procedures. Because of the existing control deficiencies described above, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2005, Array’s disclosure controls and procedures were not effective to ensure that information required to be disclosed in the reports we file with the SEC under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported as and when required.

 

24



 

PART II

 

Item 4. Submission of Matters to a Vote of Security Holders

 

The annual meeting of the Company’s stockholders was held on October 26, 2005. At that meeting, three proposals were submitted to a vote of the Company’s stockholders. Proposal 1 was a proposal to elect three Class II directors to serve a three-year term of office expiring on the date of the 2008 annual meeting of stockholders. The three nominees for Class II director were Marvin H. Caruthers, Ph.D., Robert E. Conway and Kyle A. Lefkoff. Proposal 2 was a proposal to approve the material terms of the performance criteria for payment of executive incentive compensation. Proposal 3 was a proposal to ratify the appointment of KPMG LLP as the Company’s independent auditors for the fiscal year ending June 30, 2006. For further information regarding the annual meeting, including the terms of office of the directors remaining in office following the meeting, please see the Company’s Proxy Statement on Schedule 14A filed with the Securities and Exchange Commission on September 27, 2005. The stockholders approved the proposals as follows:

 

 

 

Number of Votes

 

Proposal

 

For

 

Against

 

Abstain/
Withhold

 

 

 

 

 

 

 

 

 

Proposal 1 - Election of Class II directors

 

 

 

 

 

 

 

Marvin H. Caruthers, Ph.D.

 

35,671,324

 

 

36,815

 

Robert E. Conway

 

35,671,453

 

 

36,686

 

Kyle A. Lefkoff

 

35,671,474

 

 

36,665

 

 

 

 

 

 

 

 

 

Proposal 2 - Approval of the material terms of the performance criteria for executive incentive compensation

 

25,048,592

 

502,146

 

10,157,401

 

 

 

 

 

 

 

 

 

Proposal 3 - Ratification of the appointment of KPMG LLP

 

35,696,429

 

7,901

 

 

 

Item 6. Exhibits

 

(a)

 

Exhibits

 

 

 

10.1

 

Amendment No. 2, dated October 1, 2005, to the Collaboration and License Agreement by and between Registrant and Genentech, Inc. **

10.2

 

Drug Discovery Agreement by and between Registrant and Ono Pharmaceutical Co., Ltd., dated November 1, 2005. **

10.3

 

First Amendment to Loan and Security agreement by and between Registrant and Comerica Bank dated December 19, 2005.

10.4

 

Addendum No. 5, dated December 2, 2005 and Addendum No. 6, dated December 22, 2005, to Lease Agreement by and between Registrant, as Tenant, and Circle Capital Longmont LLC, as Landlord.

10.5

 

Amendment to the Array BioPharma Inc. Employee Stock Purchase Plan, as amended and restated September 12, 2002 and as amended on April 29,2004. *

10.6

 

First Amendment to the Amended and Restated Deferred Compensation Plan of Array BioPharma Inc. *

31.1

 

Certification of Robert E. Conway pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2

 

Certification of R. Michael Carruthers pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.0

 

Certifications of Robert E. Conway and R. Michael Carruthers pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 


*             Management contract or compensatory plan.

**      Confidential treatment of redacted portions has been applied for

 

Items 1, 2, 3 and 5 of Part II are not applicable and have been omitted.

 

25



 

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, in the City of Boulder, State of Colorado.

 

 

 

 

ARRAY BIOPHARMA INC.

 

 

 

 

 

 

Dated: February 6, 2006

By:

/s/ Robert E. Conway

 

 

 

Robert E. Conway

 

 

Chief Executive Officer

 

 

 

 

 

 

Dated: February 6, 2006

By:

/s/ R. Michael Carruthers

 

 

 

R. Michael Carruthers

 

 

Chief Financial Officer

 

 

(Principal Financial and

 

 

Accounting Officer)

 

26


EXHIBIT 10.1

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

SECOND AMENDMENT TO DRUG DISCOVERY COLLABORATION AGREEMENT

 

T HIS A MENDMENT N O . 2 (“Second Amendment”), effective as of October 1, 2005 (Amendment Date”), is entered into by and between Genentech, Inc., a Delaware corporation, having a principal place of business at 1 DNA Way, South San Francisco, California 94080 (“Genentech”) and Array BioPharma Inc., a Delaware corporation, having a principal place of business at 3200 Walnut Street, Boulder, Colorado 80301 (“Array”) (collectively, the “Parties” or individually, a “Party”).

 

W HEREAS , Genentech and Array entered into a Drug Discovery Collaboration Agreement, effective as of December 22, 2003, which was subsequently modified by a Letter Agreement, dated October 11, 2004, and amended by a First Amendment, dated May 20, 2005 (collectively, the “Agreement”).

 

W HEREAS , the Parties desire to amend the Agreement as set forth below.

 

N OW , THEREFORE , the Parties agree as follows:

 

1.                This Second Amendment hereby amends and revises the Agreement to incorporate the terms and conditions set forth in this Second Amendment.  The relationship of the Parties shall continue to be governed by the terms of the Agreement, as amended.

 

2.                All capitalized terms used in this Second Amendment shall have the meanings defined in the Agreement unless otherwise defined herein.

 

3.                Section 1.55 of the Agreement is hereby amended and replaced in its entirety as follows:

 

“              1.55        “Research Term” means the period commencing on January 30, 2004 (the date that the Research Plan was Approved by the JRC) and ending on the first to occur of (a) termination of this Agreement by either Party under Article 10; or (b)  [*] .  Genentech has the right to extend the foregoing Research Term, in its sole discretion, for [*] , upon written notice to Array at least six (6) months prior to the expiration of the Research Term.  Any such notice shall specify the number of [*] for which Genentech is extending the Research Term.”

 

4.                As of the Amendment Date, there are three (3) Collaboration Targets ( [*] , [*] and [*] ) and Array is currently devoting, and Genentech is paying for, [*] to perform activities under the Research Plan ( [*] for each Collaboration Target, pursuant to Section 2.7 of the Agreement, and an additional [*] that are [*] pursuant to the Letter Agreement, dated October 11, 2004).  As of the Amendment Date, pursuant to this Second Amendment, the number of [*] shall increase by an additional [*] ( i.e. , for a total of [*] ).  As of January 1, 2006, the number of [*] shall further increase by an additional [*] ( i.e. , for a total of [*] .  Beginning on January 1, 2006, and during the remainder of the Research Term, the JRC

 



 

shall have the right, with the agreement of Array, to further increase the number of [*] devoted to performing activities under the Research Plan by up to an additional [*] (i.e., for a total of [*] ).  Any of the [*] added pursuant to the provisions of this Second Amendment shall be [*] , and Genentech shall have the right, upon two (2) months written notice to Array, to reduce the number of such additional [*] .

 

5.                Section 6.2 of the Agreement is hereby amended and replaced in its entirety as follows:

 

 

6.2

[* ]; Outsourcing.

 

 

 

 

 

 

 

(a) [*] .

 

 

 

 

 

 

 

(b) [* ]

 

 

6.                This Second Amendment and the Agreement constitute the entire agreement between the Parties in connection with the subject matter of this Second Amendment.  The Agreement, as herein amended, is and remains in full force and effect.

 

IN WITNESS WHEREOF , the Parties have caused this Second Amendment to be executed by their respective duly authorized representatives as set forth below.

 

 

GENENTECH, INC.

ARRAY BIOPHARMA INC.

 

 

By:

 

 

By:

 

 

 

 

 

 

 

 

Name:

 

 

Name:

 

 

 

 

 

 

 

 

Title:

 

 

Title:

 

 

 

2


EXHIBIT 10.2

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

DRUG DISCOVERY AGREEMENT

 

THIS DRUG DISCOVERY AGREEMENT (the “Agreement”), is made and entered into, effective as of November 1, 2005 (the “Effective Date”), by and between Ono Pharmaceutical Co., Ltd., a Japanese corporation having a principal place of business at 8-2 Kyutaromachi 1-Chome, Chuo-Ku Osaka 541-8564, JAPAN  (“ ONO ”), and Array BioPharma Inc., a Delaware corporation having a principal place of business at 3200 Walnut Street, Boulder, Colorado 80301, USA (“ ARRAY ”).

 

RECITALS

 

A.                                                    ARRAY has skills, expertise and proprietary technology for the discovery, generation, optimization and preclinical testing of small molecule clinical candidates from drug discovery programs.  ONO is a pharmaceutical company involved in the research, development, manufacture and sale of pharmaceutical products.

 

B.                                                      ONO has identified multiple protein targets that have the potential to be used as the basis for drug discovery programs.

 

C.                                                      ONO and ARRAY desire to enter a collaboration wherein ARRAY will perform certain drug discovery research on protein targets requested by ONO with assistance from ONO, with the goal of delivering to ONO multiple preclinical candidates for selection as clinical lead compounds for clinical development and commercialization by ONO.

 

AGREEMENT

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual promises and covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, ONO and ARRAY, intending to be legally bound, hereby agree as follows:

 

ARTICLE 1
DEFINITIONS

 

Capitalized terms used in this Agreement, whether used in the singular or plural, shall have the meanings set forth below, unless otherwise specifically indicated herein.

 

1.1                                                          Active Claimed Compound ” means a Claimed Compound which demonstrates activity against a Collaboration Target in accordance with the activity criteria set forth in the definition of Active Compound, as confirmed by ONO or Array.

 



 

1.2                                                          Active Compound ” means any Compound, whether or not covered under claims of a Collaboration Patent, which has a level of activity against a Collaboration Target, expressed as [*] as measured in the applicable [*] set forth in the Research Plan.

 

1.3                                                          Affiliate ” means any corporation or other entity, whether de jure or de facto , which is directly or indirectly controlling, controlled by or under common control of a Party hereto for so long as such control exists.  For the purposes of this Section 1.3, “control” shall mean the direct or indirect ownership of at least fifty percent (50%) of the outstanding shares or other voting rights of the subject entity having the power to vote on or direct the affairs of the entity, or if not meeting the preceding, the maximum voting right that may be held by the particular Party under the laws of the country where such entity exists.

 

1.4                                                          Claimed Compound ” means a chemical entity which has not been synthesized by ARRAY during the Collaboration Term, the composition of matter of which is claimed in a Collaboration Patent.

 

1.5                                                          Collaboration ” shall mean the drug discovery research activities for each Collaboration Target undertaken by the Parties pursuant to Article 2 below.

 

1.6                                                          Collaboration Product ” means a product which contains any Active Compound, Active Claimed Compound or Derivative Compound for use in the Field in the Territory.

 

1.7                                                          Collaboration Know-How ” means Compounds not covered under the claims of the Collaboration Patent, any and all technologies including, but not limited to, trade secrets, know-how, inventions, information (including structure-activity data) and materials, whether patentable or not, directed to processes, formulations and/or methods discovered, developed, owned, licensed or acquired solely by ARRAY, solely by ONO or jointly by ARRAY and ONO, in the course of the Collaboration during the Collaboration Term.

 

1.8                                                          Collaboration Patent ” means (i) any and all patent applications and patents thereof the subject of which is an invention (a “ Collaboration Invention ”) conceived or reduced to practice solely by ARRAY, solely by ONO or jointly by ARRAY and ONO in the course of the Collaboration during the Collaboration Term, including without limitation any such inventions comprising any Active Compound, Inactive Compound and/or any Active Claimed Compound, or method of use or process for the synthesis thereof or composition-of-matter containing such Active Compound, Inactive Compound and/or Active Claimed Compound, and (ii) any divisions, continuations, continuations-in-part, reissues, reexaminations, extensions or other governmental actions which extend any of the subject matter of the patent applications and/or patents in (i) above, and any substitutions, confirmations, registrations or revalidations of any of the foregoing.

 

1.9                                                          Collaboration Target(s) ” means (i)  [*].

 

1.10                                                    Collaboration Term ” means the term of the Collaboration, as provided in Section 2.6 below.

 

2



 

1.11                                                    Compound ” means any chemical entity synthesized by ARRAY and made available to ONO during the Collaboration Term in accordance with the Research Plan mutually agreed upon by the Parties.

 

1.12                                                    Consumer Price Index ” or “ CPI ” means the Consumer Price Index, All Urban Consumers, as published by the U.S. Bureau of Labor Statistics.

 

1.13                                                    Derivative Compound ” means any chemical entity, other than a Compound or Claimed Compound, synthesized by or on behalf of ONO after the Collaboration Term that:

 

(i)                                      results from a chemical synthesis program based on one or more Compounds;

 

(ii)                                   is based on structure-activity data relating to a Compound; or

 

(iii)                                is covered by the claims of any ONO Patent, which patent application or patent discloses any compound in (i) or (ii) above.

 

ONO will not synthesize any chemical entities for use against a Collaboration Target during the Collaboration Term.

 

1.14                                                    Field ” means the discovery, development and commercialization of small molecules for the diagnosis or therapeutic or prophylactic treatment of diseases and conditions, wherein the primary mechanism of action of such small molecules is to modulate the activity of a Collaboration Target.

 

1.15                                                    FTE ” means a full-time employee of ARRAY dedicated to each Collaboration, or in the case of less than a full-time dedicated employee, a full-time, equivalent employee year, based upon a total of one thousand eight hundred eighty (1,880) hours per year of work in connection with each Collaboration.

 

1.16                                                    Inactive Compound ” means any Compound, whether or not covered under claims of a Collaboration Patent, which does not meet the level of activity specified in the definition of Active Compound.

 

1.17                                                    JMC ” or “ Joint Management Committee ” shall have the meaning set forth in Section 3.1.

 

1.18                                                    Marketing Approval ” means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport and sale of a Collaboration Product in a regulatory jurisdiction in the Territory.

 

1.19                                                    NDA ” means a New Drug Application, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder.

 

1.20                                                    Net Sales ” means the gross invoice price of Collaboration Products (such Collaboration Products being in final form intended for use by the end user) sold by ONO

 

3



 

or its Affiliates or Sublicensees, as the case may be (or Distributors on behalf of the foregoing parties) , in arms length transactions with Third Parties after deducting, if not previously deducted, from the amount invoiced or received:

 

(i)                                      trade, cash and quantity discounts or rebates actually allowed or taken;

 

(ii)                                   credits or allowances given or made for rejection or return of, and for uncollectible amounts on, previously sold Collaboration Products or for retroactive price reductions (including, without limitation, rebates similar to Medicare and/or Medicaid);

 

(iii)                                taxes, duties or other governmental charges levied on or measured by the billing amount, as adjusted for rebates or refunds, that are borne by the seller thereof and that are not refundable and to the extent non-creditable;

 

(iv)                               charges for freight and insurance directly related to the distribution of the Collaboration Products (to the extent not paid by the Third Party customer); and

 

(v)                                  credits or allowances given or made for wastage replacement, indigent patient and similar programs.

 

For purposes of this Section 1.20, “ Distributor ” means a Third Party that is employed by or otherwise under written contract with ONO or its Affiliates or Sublicensees to sell, promote, distribute, market, import, and/or export Collaboration Products on behalf of or in partnership with ONO or its Affiliates or Sublicensees.

 

1.21                                                    ONO Patent ” means (i) any and all patent applications and patents thereof the subject of which is an invention conceived or reduced to practice solely by ONO after the Collaboration Term, including without limitation any such inventions comprising any Derivative Compound, or method of use or process for the synthesis thereof or composition-of-matter containing such Derivative Compound, and (ii) any divisions, continuations, continuations-in-part, reissues, reexaminations, extensions or other governmental actions which extend any of the subject matter of the patent applications and/or patents in (i) above, and any substitutions, confirmations, registrations or revalidations of any of the foregoing.

 

1.22                                                    Party ” or “ Parties ” shall mean, respectively, ARRAY or ONO individually, or ARRAY and ONO collectively.

 

1.23                                                    Phase II ” means human clinical trials, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as required in 21 C.F.R. §312, or similar clinical study in a country other than the United States.

 

1.24                                                    Phase III ” means human clinical trials, the principal purpose of which is to establish safety and efficacy of one or more particular doses in patients being studied, and which will (or are intended to) satisfy the requirements of a pivotal trial for purposes of

 

4



 

obtaining approval of a product in a country by the health regulatory authority in such country to market such product.

 

1.25                                                    Pre-existing ARRAY Know-How ” means any ARRAY library compounds not covered under the claims of Pre-existing ARRAY Patent and all other technologies (i) including, but not limited to, trade secrets, know-how, inventions, information (including structure-activity data) and materials, whether patentable or not, directed to processes, formulations and/or methods discovered, developed, owned, licensed or acquired by ARRAY prior to the Effective Date, and (ii) which is useful in conducting the Collaboration under the Research Plan.

 

1.26                                                    Pre-existing ARRAY Patent ” means (i) any and all patent applications and patent thereof, existing as of the Effective Date, that claim any ARRAY library compound, or method of use or process for the synthesis thereof or composition-of-matter containing such ARRAY library compound for any target including the Collaboration Target, but activities to such Collaboration Target has not been demonstrated, and (ii) any divisions, continuations, reissues, reexaminations, or extensions to the extent the same have an earliest effective filing date prior to the Effective Date, and any substitutions, confirmations, or registrations of any of the foregoing, in each case, which is owned by ARRAY (solely or jointly), to the extent ARRAY has the right to license or sublicense the same.

 

1.27                                                    Pre-existing ONO Compound ” means any chemical entity which has been synthesized by ONO against the Collaboration Target prior to the Effective Date, whether or not covered under Pre-existing ONO Patent.

 

1.28                                                    Pre-existing ONO Know-How ” means any Pre-existing ONO Compound not covered under Pre-existing ONO Patent and all other technologies (i) including, but not limited to, trade secrets, know-how, inventions, information (including structure-activity data) and materials, whether patentable or not, directed to processes, formulations and/or methods discovered, developed, owned, licensed or acquired by ONOprior to the Effective Date, and (ii) which is useful in conducting the Collaboration under the Research Plan.

 

1.29                                                    Pre-existing ONO Patent ” means (i) any and all patent applications and patents thereof that claim any Pre-existing ONO Compound, or method of use or process for the synthesis thereof or composition-of-matter containing such chemical entity for the Collaboration Target, which exist as of the Effective Date, and (ii) any divisions, continuations, reissues, reexaminations, or extensions to the extent the same have an earliest effective filing date prior to the Effective Date, and any substitutions, confirmations, or registrations of any of the foregoing, in each case, which is owned by ONO.

 

1.30                                                    Product ” means a product which contains any Active Compound and Active Claimed Compound [*] .

 

1.31                                                    Research Plan ” means the written research plan governing the joint effort of the Parties in conducting the Collaboration, which may be amended from time to time by mutual agreement of the Parties.  The initial Research Plan is attached hereto as Exhibit 1.31.

 

5



 

1.32                                                    Sublicensee ” shall mean, with respect to a particular Collaboration Product, a Third Party to whom ONO has granted a sublicense of the right to make, use, sell, offer for sale, import and/or export such Collaboration Product.

 

1.33                                                    [* ] .

 

1.34                                                    Territory ” means worldwide.

 

1.35                                                    Third Party ” means any person or entity other than ARRAY and ONO, their respective Affiliates and Sublicensee.

 

ARTICLE 2
RESEARCH COLLABORATION

 

2.1                                                          Goals .  The goal of the Collaboration is the discovery and optimization of small molecule inhibitors against each Collaboration Target by ARRAY pursuant to a Research Plan, and the delivery of one or more preclinical candidates to ONO, during the Collaboration Term, for selection as clinical lead compounds for clinical development and commercialization by ONO.

 

2.2                                                          Conduct of the Collaboration .  Subject to the terms and conditions set forth herein, ARRAY and ONO will undertake research directed to (i) research and development of small molecule inhibitors of [*] which, if possible, will also inhibit [* ] , for the treatment of [*] , and (ii) research and development of small molecule inhibitors of [*] or, preferably, both for the treatment of [*] .  The Collaboration shall be funded as set forth in Article 5 below.  During the Collaboration Term for each Collaboration Target, ARRAY and ONO shall collaborate and use their commercially reasonable efforts to conduct the Collaboration for each Collaboration Target in accordance with the Research Plan within the time schedules contemplated therein and to keep the other Party informed as to the progress and results of the Collaboration hereunder.  Once per quarter during the Collaboration Term, ONO will have the right to send, to observe the progress of the Collaboration in accordance with the Research Plan, one (1) ONO scientist to ARRAY’s facilities, with such visit to last up to two (2) weeks in duration.

 

2.3                                                          Research Plan .  The Collaboration for each Collaboration Target shall be carried out in accordance with a mutually agreed upon the written Research Plan, which shall establish specific research objectives and the research tasks to be performed and resources to be provided by each Party.  The Research Plan shall, among other things, establish: (i) the scope of the research activities which will be performed; (ii) the research objectives and work plan activities with respect to the Collaboration for each Collaboration Target; and (iii) specific screening assays for identifying and testing the activity of Compounds against each Collaboration Target to determine when a Compound shall be deemed an Active Compound.  The Research Plan shall be reviewed on an ongoing basis and may be amended by the Joint Management Committee in accordance with Article 3.

 

2.4                                                          Additional Target (s ) .  In the event that ONO wishes to collaborate with ARRAY, and ARRAY accept to collaborate with ONO, with respect to drug discovery research on any other molecular target(s) than the Collaboration Target(s), the Parties shall enter

 

6



 

into the separate drug discovery agreement with substantially the same terms and conditions as applied under this Agreement.

 

2.5                                                          Collaboration Staffing .  ONO will fund ARRAY’s activities under the Collaboration for each Collaboration Target in accordance with the applicable Research Plan.  During the Collaboration and subject to ONO funding FTEs for such Collaboration pursuant to Section 5.1, ARRAY shall devote that number of FTEs to the conduct of the Collaboration for each Collaboration Target specified in the initial Research Plan.  The number of ARRAY FTEs may be increased or decreased upon mutual agreement.

 

2.6                                                          Term and Termination of Collaboration .

 

2.6.1                         Term .  The Collaboration Term for the Collaboration Target set forth in Section 1.9 (i) shall commence on the Effective Date and shall end upon [*] after the Effective Date.  Further, the Collaboration Term for the Collaboration Target set forth in Section 1.9 (ii) shall commence on the Effective Date and shall end upon [*] after the Effective Date.  ONO shall have the right to extend the Collaboration Term for each Collaboration Target for [*] by providing written notice to ARRAY at least [*] before the end of the then-current Collaboration Term.

 

2.6.2                         [* ] .  ONO shall have the right [*] for each Collaboration Target, of this Agreement within [*] following the first anniversary of the Collaboration Term for each Collaboration Target, with [*] from ONO to ARRAY.  In such event, the provisions of [* ] shall apply.

 

2.7                                                          Third Party Licenses .  In the event that the Parties agree to acquire additional technologies from a Third Party specifically for use in the conduct of each Collaboration in the Field, ONO will be responsible for the payment of any amounts due to Third Parties for the licenses of intellectual property which directly applies to any Collaboration Target, and the costs of negotiating, preparing and executing any such license.  Such licenses are granted to ONO asa licensee, and ONO will grant the sublicense to ARRAY in order for ARRAY to conduct the Collaboration only.  Upon the termination of the Collaboration and/or this Agreement, ONO may, at the sole option of ONO, terminate such sublicense to ARRAY.

 

2.8                                                          Records; Inspection .

 

(a)                                   Records .  Each Party shall maintain records of the Collaboration for each Collaboration Target (or cause such records to be maintained) in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved in the performance of such Collaboration (including all data in the form required under any applicable governmental regulations and as directed by the JMC).

 

(b)                                  Reports and Information Exchange .  Each Party shall use commercially reasonable and diligent efforts to disclose to the other Party all material information (including any documents, data and electronic information related thereto) relating to the Collaboration, including without limitation any Active Compound, promptly after it is learned or its materiality is appreciated.  Each Party shall also keep the other Party, including the Joint Management Committee, informed as to its progress under the Research Plan. Within

 

7



 

[*] following the end of each calendar quarter during the Collaboration, each Party shall provide the other Party with a reasonably detailed written report describing the progress to date of all activities for which such Party was allocated responsibility during such quarter under the Research Plan.  Notwithstanding the foregoing, in no event shall ARRAY be required to disclose to ONO any Pre-existing ARRAY Know-How or Pre-existing ARRAY Patents; provided, however, that to the extent that such Pre-existing ARRAY Know-How and/or Pre-existing ARRAY Patents are specifically related to the Collaboration, ARRAY shall disclose them to ONO.

 

2.9                                                          Supply of Compounds .  In accordance with a schedule determined by the JMC, ARRAY will provide to ONO an agreed amount of each Compound, up to [* ] .

 

2.10                                                    Post Collaboration Activities .  For each Active Compound, Active Claimed Compound and Collaboration Product to which ONO retains exclusive rights under this Agreement, ONO shall be responsible, at its sole expense, for conducting all clinical development of such Active Compound, Active Claimed Compound or Collaboration Product following the Collaboration Term for each Collaboration Target, and all commercialization of such Active Compound, Active Claimed Compound or Collaboration Product.  In addition to the above monetary responsibility for clinical development by ONO, ONO shall be responsible for all costs and expenses for commercializing the Collaboration Product for use in the Field, including without limitation, preclinical development, pre-marketing and commercial activities

 

2.11                                                    Exclusivity .  Except as set forth herein, for each Collaboration Target, during (a) the Collaboration Term, and (b) thereafter for (i) so long as ONO is using commercially reasonable efforts to pursue research and/or development on the Collaboration Product directed to such Collaboration Target consistent with ONO’s usual practices for its own research and development, where such efforts could result in ARRAY accruing milestones and royalties, or (ii)  [*] from the end of the Collaboration Term, [*] , ARRAY will not conduct, participate in, or fund, directly or indirectly, either alone or with a Third Party, research or development activities directed to the discovery of small molecule chemical entities that modulate the activity of the Collaboration Target; [* ].   However, in the event of a Change of Control, the surviving entity shall be bound by all other terms and conditions of this Agreement as provided in Section 12.3.  It is understood and agreed that testing of a chemical entity against the Collaboration Target for the purpose of establishing selectivity of such chemical entity against a target other than the Collaboration Target shall not be deemed a violation of this Section 2.11.  For purposes of this Section 2.11, “ Change of Control ” means the merger, consolidation, sale of substantially all of its assets or similar transaction or series of transactions, as a result of which ARRAY’s shareholders before such transaction or series of transactions own less than fifty percent (50%) of the total number of voting securities of the surviving entity immediately after such transaction or series of transactions.  Notwithstanding the foregoing, if as a result of any such Change of Control, ARRAY exists as a wholly owned subsidiary of a parent, then the provisions of this Section 2.11 shall continue to apply to ARRAY but not to such parent.

 

8



 

ARTICLE 3
MANAGEMENT

 

3.1                                                          Joint Management Committee .  Promptly after the Effective Date, the Parties will establish a joint management committee (the “Joint Management Committee” or “JMC”), which shall be responsible for monitoring, planning and coordinating research activities under the Research Plan during the Collaboration Term.  The responsibilities of the Joint Management Committee shall include, among other things, establishing research objectives, reviewing data and allocating resources.

 

3.2                                                          Membership .  The JMC shall consist of three (3) representatives of each of ONO and ARRAY, each Party’s members selected by such Party.  ARRAY and ONO may each replace its JMC representatives at any time, upon written notice to the other Party.  From time to time, the JMC may establish subcommittees, to oversee particular projects or activities, and such subcommittees will be constituted as the JMC agrees.

 

3.3                                                          Meetings .  During the Collaboration Term, the JMC shall meet at least semi-annually, at each Party’s facilities alternately or at a mutually agreed location.  In addition to regular JMC meetings, either Party may request an ad-hoc meeting at a mutually agreeable date and location.  The JMC meetings do not necessarily have to be face-to-face meetings but, upon agreement of both Parties, can be via other methods of communication such as teleconferences and/or videoconferences.  With the consent of the Parties, other representatives than JMC members of ARRAY or ONO may attend JMC meetings as nonvoting observers.  Each Party shall be responsible for all of its own expenses associated with attendance of such meetings.  The first meeting of the JMC shall occur within thirty (30) days after the Effective Date.  In addition to such JMC meetings, the Parties will otherwise communicate from time to time by telephone, electronic mail, facsimile and/or video conference.

 

3.4                                                          Minutes .  The JMC shall keep accurate minutes of its deliberations which shall record all proposed decisions and all actions recommended or taken.  The host of the JMC meeting shall be responsible for the preparation of draft minutes.  Draft minutes shall be sent to all members of the JMC within five (5) working days after each meeting and shall be approved, if appropriate, at the next meeting.  All records of the JMC meetings shall at all times be available to both ARRAY and ONO.

 

3.5                                                          Decision Making .  Each Party shall have one (1) vote in all JMC decisions, and the Parties shall attempt to make decisions by consensus.  In the event the JMC cannot reach consensus, the dispute shall be referred to executive officers of each Party for resolution.  If the executives cannot resolve the dispute, then, other than with respect to (i) setting criteria for Active Compounds and (ii) any other matter that requires mutual consent under this Agreement, ONO shall have the deciding vote; provided, however, that ARRAY shall not be obligated, as a result of such a deciding vote by ONO, to violate any obligation or agreement it may have with any Third Party, or to incur any extraordinary costs.

 

ARTICLE 4
LICENSES

 

4.1                                                          Exclusive License .  Subject to the terms and conditions of this Agreement, ARRAY hereby grants to ONO an exclusive right and license in the Territory under ARRAY’s interest in the Collaboration Patent and the Collaboration Know-How, with a right to sublicense, to develop, make, have made, use, offer for sale and/or sell, import and export any Active Compound, Active Claimed Compound and/or Derivative Compound,and, also with a right to

 

9



 

sublicense, to develop, make, have made, use, import and export, offer for sale and/or sell any Collaboration Product or Product.

 

4.2                                                          Non-Exclusive Licenses .

 

4.2.1                         Collaboration Technology .  Subject to the terms and conditions of this Agreement, ARRAY hereby grants to ONO (i) a non-exclusive, sublicensable, royalty free license in the Territory under ARRAY’s interest in the Collaboration Patent and the Collaboration Know-How, to develop, make, have made, use, offer to sell, sell, import and export any Inactive Compound or Claimed Compound (other than Active Claimed Compounds, which are subject to the license in Section 4.1 above), and (ii) upon ONO’s discovery that a particular Inactive Compound or such Claimed Compound is active against a particular target, the right to negotiate to obtain the exclusive rights to such Inactive Compound or Claimed Compound, in each case in the Territory.

 

4.2.2                         Pre- existing A RRAY Patents .  In the event that the development, making, having made, use, offer for sale, sale, import and export by ONO of (i) any Active Compound, Inactive Compound, Active Claimed Compound, Claimed Compound or Derivative Compound, (ii) any Collaboration Product, Product or any product containing an Inactive Compound, a Claimed Compound or Derivative Compound would infringe during the term of the Agreement a claim of Pre-existing ARRAY Patent, ARRAY hereby grants to ONO, to the extent ARRAY is legally able to do so, a non-exclusive, sublicensable, royalty-free license in the Territory under such Pre-existing ARRAY Patent for those purposes.

 

4.3                                                          Inactive Compounds and Claimed Compounds .  With respect to an Inactive Compound or a Claimed Compound (other than an Active Claimed Compound, which is subject to the license in Section 4.1 above), at least [*] prior to ARRAY entering into material and substantial negotiations to grant to a Third Party any rights to such Inactive Compound or Claimed Compound, ARRAY agrees to notify ONO in writing, together with a description of the chemical entity that would be the subject of such negotiations.  Within thirty (30) days after receipt from ARRAY of such notice, ONO shall notify ARRAY whether or not it desires to discuss terms and conditions under which ARRAY would grant exclusive rights to such Inactive or Claimed Compound to ONO.  However, in the event that ONO reasonably determines that a sample evaluation of such Inactive Compound or Claimed Compound is crucial for ONO’s decision-making ONO shall immediately inform ARRAY, and ARRAY shall provide such sample(s) to ONO, and such thirty (30)-day period shall be extended for a certain period of time as mutually agreed by the Parties.  ARRAY and ONO will then negotiate in good faith for [*] to finalize the terms and conditions of such grant of rights.

 

4.4                                                          No Implied Licenses .  Only the licenses granted pursuant to the express terms of this Agreement shall be of any legal force or effect.  No other license or rights shall be created by implication, estoppel or otherwise.

 

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ARTICLE 5
PAYMENTS
; BOOKS AND RECORDS

 

5.1                                                          Collaboration Funding .

 

5.1.1                         Research Phase Payment Schedule .  ONO agrees to pay ARRAY research funding for the conduct of the Collaboration quarterly, in advance, in an amount equal to the number of ARRAY FTEs called for in the Research Plan for the applicable quarter multiplied by the ARRAY FTE Rate (as defined below).  Such payments shall be paid in quarterly installments, in advance.  The initial payment shall be made within thirty (30) days after the Effective Date, and subsequent payments shall be made before the first day of each quarter thereafter.  ARRAY shall submit to ONO an invoice for such payment calculated based on the Research Plan and the ARRAY FTE Rate at least thirty (30) days prior to the initiation of each quarter for relevant research, except for the invoice for initial payment which shall be submitted to ONO immediately after the Effective Date.

 

5.1.2                         FTE Rate .  The “ A RRAY FTE Rate ” shall be equal to [*] per FTE per year.  Beginning on the first anniversary of the Effective Date, the ARRAY FTE Rate shall increase no more than once annually by the percentage increase, if any, in the Consumer Price Index, since the Effective Date or the last adjustment hereunder, whichever is later.

 

5.1.3                         Non-FTE Costs .  Non-FTE costs and research requirements associated with the research activities specified in the Research Plan shall be borne by ARRAY, except that ARRAY shall not be required to incur any extraordinary chemical or screening costs without ARRAY’s prior written consent.  In the event that ONO agrees, in the course of the Collaboration during the Collaboration Term, to enter into one or more agreements with a Third Party for the performance of additional activities which are not covered under the Research Plan, ONO will be responsible for the payment of all additional amounts incurred as a result of any such agreement.

 

5.2                                                          Milestones .  Except as set forth below, ONO shall pay to ARRAY upon achievement by ONO or its Affiliates, Sublicensees or other designees, as the case may be, of the corresponding events set forth below (each, a “ Development Milestone ”) for each Collaboration Product, regardless of whether the development, promotion, or marketing of such Collaboration Product is discontinued at any time after the achievement of such milestone :

 

5.2.1                         Collaboration Products Containing Active Compounds.

 

(a)                                   [*] .   For each Collaboration Product containing an Active Compound, which Active Compound is demonstrated [*]:

 

 

Milestone

 

Cash Payment
(in U.S. Dollars)

 

 

 

 

 

 

 

1.

[*]

 

 

 

[*]

 

 

 

 

 

 

2.

[*]

 

 

 

[*]

 

 

 

 

 

 

3.

[*]

 

 

 

[*]

 

 

 

 

 

 

4.

[*]

 

 

 

[*]

 

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5.

[*]

 

 

 

[*]

 

 

 

 

 

 

6.

[*]

 

 

 

[*]

 

(b)                                  [*] .  For each Collaboration Product containing an Active Compound, which Active Compound is demonstrated [*] :

 

Milestone

 

Cash Payment
(in U.S. Dollars)

 

 

 

 

 

 

 

1.

[*]

 

 

 

[*]

 

 

 

 

 

 

2.

[*]

 

 

 

[*]

 

 

 

 

 

 

3.

[*]

 

 

 

[*]

 

 

 

 

 

 

4.

[*]

 

 

 

[*]

 

 

 

 

 

 

5.

[*]

 

 

 

[*]

 

 

 

 

 

 

6.

[*]

 

 

 

[*]

 

5.2.2                         Collaboration Products Containing Active Claimed Compounds .  For each Collaboration Product containing an Active Claimed Compound:

 

Milestone

 

Cash Payment
(in U.S. Dollars)

 

 

 

 

 

 

 

1.

[*]

 

 

 

[*]

 

 

 

 

 

 

2.

[*]

 

 

 

[*]

 

 

 

 

 

 

3.

[*]

 

 

 

[*]

 

 

 

 

 

 

4.

[*]

 

 

 

[*]

 

 

 

 

 

 

5.

[*]

 

 

 

[*]

 

 

 

 

 

 

6.

[*]

 

 

 

[*]

 

 

5.2.3                         Collaboration Products Containing Derivative Compounds .  For each Collaboration Product containing a Derivative Compound:

 

Milestone

 

Cash Payment
(in U.S. Dollars)

 

 

 

 

 

 

 

1.

[*]

 

 

 

[*]

 

 

 

 

 

 

2.

[*]

 

 

 

[*]

 

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3.

[*]

 

 

 

[*]

 

 

 

 

 

 

4.

[*]

 

 

 

[*]

 

 

 

 

 

 

5.

[*]

 

 

 

[*]

 

 

 

 

 

 

6.

[*]

 

 

 

[*]

 

ARRAY acknowledges and agrees that any Derivative Compound is covered under ONO Patent and ONO has rights to research, develop, use, make, have made and commercialize a product containing such Derivative Compound without any restriction or obligation hereof.  However, in case any [*] has been developed and commercialized as a [*] ONO shall pay to ARRAY [* ]

 

(a)                                                           The milestone payments set forth above shall be due with respect to each Collaboration Product (on a Collaboration Product-by-Collaboration Product basis).  For purposes of Section 5.2, and Section 5.3 below, all dosage forms, and all formulations, of the same active ingredient shall be deemed a single Collaboration Product.  Collaboration Products having different active ingredients shall be deemed separate Collaboration Products.

 

(b)                                                          Should all development of a particular Collaboration Product discontinue for any reason, and be replaced by an alternative Collaboration Product directed to the same Collaboration Target, then, when the alternative Collaboration Product achieves a milestone for which a corresponding milestone payment was made for the discontinued Collaboration Product, no payment shall be due with respect to such alternative Collaboration Product with respect to such milestone.

 

(c)                                                           If Development Milestone 5 or 6 is achieved with respect to a particular Collaboration Product without occurrence of Development Milestone 4, then such Development Milestone 4 shall be deemed achieved upon achievement of either Development Milestone 5 or 6, and Development Milestone 4 shall be paid together with such Development Milestone 5 or 6, whichever is earlier.

 

(d)                                                          For a [*], if it is later demonstrated that such [*] then the Development Milestones set forth in Section 5.2.1(a) above shall be paid with respect to such Collaboration Product.  ONO agrees to promptly notify ARRAY if [* ] is demonstrated to [*] .

 

(e)                                                           For purposes of this Section 5.2, a clinical trial shall be deemed initiated upon the first dosing of the first patient in such trial.

 

(f)                                                             It is understood that no milestone payments under this Section 5.2 and no royalty payments under Section 5.3 below shall be due for development and commercialization activities with respect to [*] .

 

5.2.5                                                 Milestone Payment Timing .  The payments set forth in Section 5.2 hereof shall each be due and payable by ONO to ARRAY within thirty (30) days of the occurrence of the milestone event set forth therein.  ONO agrees to promptly notify ARRAY of its achievement of any milestone.

 

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5.3                                                  Royalties .  In partial consideration for the licenses granted to ONO under Section 4.1, ONO shall pay ARRAY a royalty on the worldwide Net Sales of Collaboration Products by ONO, its Affiliates or Sublicensees.  Such royalty shall be paid based on the total annual worldwide Net Sales, on a Collaboration Product-by-Collaboration Product basis.

 

5.3.1                                                 Royalty Rate .  The royalty rate for a particular Collaboration Product shall be as follows:

 

 

Collaboration Product

 

Royalty rate

 

[*]

 

 

[*]

[*]

 

 

[*]

[*]

 

 

[*]

 

ARRAY acknowledges and agrees that any Derivative Compound is covered under ONO Patent and ONO has rights to research, develop, use, make, have made, import and export, and commercialize a product containing such Derivative Compound without any restriction or oblig ation hereof.  However, in case any [*] has been developed and commercialized as a [*] ONO shall pay to ARRAY [* ] .

 

5.3.2                                                 Royalty Term .  Royalties shall be paid on a country-by-country basis from the date of the first commercial sale of each Collaboration Product with respect to which royalty payments are due for a period which is the longer of:

 

(a)                                                           the expiration of the last to expire the Collaboration Patent in such country covering the composition of matter, a method of manufacture or the use of such Collaboration Product; or

 

(b)                                                          ten (10) years after the first commercial sale of such Collaboration Product in such country.

 

5.3.3                                                 Third Party Royalties .  ONO shall be responsible for all payments due to Third Parties for the manufacture, use, or sale of Collaboration Products by ONO, its Affiliates or Sublicensees.

 

5.4                                                          Reports .  Until first commercial sale of each royalty-bearing Collaboration Product, ONO shall keep ARRAY apprised of the status of the pre-clinical, clinical and commercial development of such Collaboration Product by semi-annually providing ARRAY with a written report reasonably detailing such activities with respect to each applicable Collaboration Product.

 

5.5                                                          Payment Method .  All payments due under this Agreement shall be made by bank wire transfer to a bank account designated by ARRAY.  All payments hereunder shall be made in U.S. dollars.  In the event that the due date of any payment subject to Article 5 hereof is a Saturday, Sunday or national holiday, such payment may be paid on the following

 

 

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business day.  Any payments that are not paid on the date such payments are due under this Agreement shall bear interest to the extent permitted by applicable law at the U.S. prime rate per annum quoted in the “Money Rates” column of The Wall Street Journal , Eastern Edition, on the first business day after such payment is due, plus an additional [*] calculated on the number of days such payment is delinquent.  This Section 5.5 shall in no way limit any other remedies available to ARRAY.

 

5.6                                                          Royalty Payments, Reports and Audits .

 

5.6.1                         Payments and Reports .  Royalty payments under this Agreement shall be made to ARRAY semi-annually within [*] following the end of March or September for which royalties are due.  Each royalty payment shall be accompanied by a report summarizing the Net Sales during the relevant six (6)-month period, setting forth all the information necessary for the calculation of such royalty payment.  Unless otherwise requested, or consented to in writing, by ARRAY, all royalty payments and reports related to the Net Sales by ONO’s Sublicensees shall be made to ARRAY by ONO together with (or as a part of) ONO’s payments and reports.

 

5.6.2                         Records .  ONO shall keep full, true and accurate books of account, in accordance with generally accepted accounting practices in Japan, relevant to payments under this Agreement and containing all particulars that may be necessary for the purpose of showing the Net Sales and demonstrating the calculation of royalty payments.  Such books of account and the supporting data and other records shall be kept by ONO.  ONO’s books and records shall be open at all reasonable times, for [* ] following the end of March or September to which they pertain, for examination in accordance with the provisions of Section 5.6.3 below.

 

5.6.3                         Audits .  Upon the written request and at expense of ARRAY, ONO shall permit an independent certified public accounting firm of internationally recognized standing selected by ARRAY and reasonably acceptable to ONO, to examine, not more than once in each calendar year during the period in which ONO has an obligation to pay royalty payments under this Agreement, such books of account and records under Section 5.6.2 as may be necessary to determine the correctness of any report or payment related to royalty payments under this Agreement.  Such examination shall be made during regular business hours and upon reasonable prior written notice and prior to such examination, ARRAY shall cause its accounting firm to enter into an acceptable confidentiality agreement with ONO, obligating it to retain all such information in confidence pursuant to such confidentiality agreement.  The accounting firm shall disclose to ARRAY only whether the calculation of royalty is correct or incorrect and the amount of discrepancy.  No other information shall be provided to ARRAY.  The Parties agree that all information subject to review under this Section 5.6.3 is the Confidential Information of ONO.

 

If such accounting firm correctly identifies a discrepancy made during the period covered by such examination, the appropriate Party shall pay the other Party the amount of the discrepancy [*] of the date ARRAY delivers to ONO such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties.  If such examination establishes that royalty payments payable under this Agreement have been, for the

 

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period covered by such examination, understated by more than [*] , ONO shall pay the reasonable costs of the examination.

 

5.6.4                         Currency Conversion .  For the purpose of computing the Net Sales in a currency other than United States Dollars, such currency shall be converted into U.S. dollars using the buying exchange rate for conversion of the foreign currency with U.S. dollars, quoted for current transactions reported in The Wall Street Journal , Eastern Edition for the last business day of March or September to which such payment pertains.

 

5.7                                                          Taxes .   All payments due to ARRAY under this Agreement will be made after any deduction or withholding taxes or other similar governmental charge (the “Withholding Taxes”) (For example, if an amount of payment due from ONO to ARRAY is one million US dollar (US$1,000,000), supposing Withholding Taxes to be 10%, Ono will deduct one hundred thousand US dollar (US$100,000) as Withholding Taxes and remit nine hundred thousand US dollar (US$900,000) to Array).  ONO shall provide ARRAY with a certificate evidencing payment of any Withholding Taxes hereunder and shall reasonably assist ARRAY, at ARRAY’s expense, to obtain the benefit of any applicable tax treaty.  However, under the current CONVENTION BETWEEN THE GOVERNMENT OF JAPAN AND THE GOVERNMENT OF THE UNITED STATES OF AMERICA FOR THE AVOIDANCE OF DOUBLE TAXATION AND THE PREVENTION OF FISCAL EVASION WITH RESPECT TO TAXES ON INCOME issued on March 30, 2003 (the “Taxation Treaty”), all payments paid by ONO to ARRAY will be made without Withholding Taxes.  In the event the change of Taxation Treaty requires the Withholding Taxes become due in Japan, the Parties shall negotiate which Party shall have the obligation to pay such Withholding Taxes.

 

ARTICLE 6
DILIGENCE

 

ONO shall use diligent efforts to research, develop and commercialize Collaboration Products, and to perform its obligations under Section 2. 10 of this Agreement, and to obtain the optimum commercial return for each Collaboration Product in all major markets throughout the world, consistent with the practice of ONO in pursuing the research, development, commercialization, and marketing of pharmaceutical products of its own development and of similar commercial value potential .

 

ARTICLE 7
INTELLECTUAL PROPERTY

 

7.1                                                          Ownership of Inventions; Disclosure .

 

7.1.1                         Ownership .  Title to all inventions and other intellectual property made by ARRAY in the course of performing, or in connection with, the Collaboration during the Collaboration Term shall be owned by ARRAY; title to all inventions and other intellectual property made by ONO in the course of performing, or in connection with, the Collaboration during the Collaboration Term shall be owned by ONO; title to all inventions and other intellectual property made jointly by ONO and ARRAY in the course of performing, or in

 

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connection with, the Collaboration during the Collaboration Term shall be owned jointly by ONO and ARRAY.  Inventorship of inventions and other intellectual property made pursuant to this Agreement shall be determined in accordance with the patent laws of the United States.  Except as provided in Articles 4 and 5, neither Party shall have an obligation to account to the other, or obtain the consent of the other, with respect to the exploitation (directly or through licensees or third parties) of any jointly owned invention or intellectual property right, and each Party hereby waives any right it may have under the laws of any jurisdiction to require such an accounting or consent.

 

7.1.2                         [* ] .  Upon receipt by ARRAY of [*] , ARRAY shall [*] its right, title and interest in any Collaboration Patent claiming the Active Compound or Active Claimed Compound contained in such Collaboration Product or a method of using or a method of making such Active Compound, Active Claimed Compound or Collaboration Product.

 

7.1.3                         Disclosure of Inventions .  Each Party shall promptly disclose to the other Party any inventions made in connection with this Agreement.

 

7.2                                                          Patent Prosecution .

 

7.2.1                         Collaboration Technology .  ONO shall be responsible, at its expense, (i) for preparing, filing, prosecuting and maintaining the Collaboration Patent, and (ii) for conducting any interferences, re-examinations, reissues and oppositions relating thereto.  ONO may elect, upon ninety (90)-day prior notice, to discontinue prosecution of any such Collaboration Patent and/or not to file or conduct any further activities with respect to such Collaboration Patent.  In the event ONO declines to file, or having filed, fails to further prosecute or maintain any such Collaboration Patent, or conduct any proceedings including, but not limited to, interferences, re-examinations, reissues and oppositions relating thereto, then ARRAY shall have the right to prepare, file, prosecute and maintain such Collaboration Patent in such countries as it deems appropriate, and conduct such proceedings, at its sole expense.  In such case, ONO shall immediately execute all necessary documents that may be required in order to enable ARRAY to file, prosecute and maintain such Collaboration Patent and to conduct any such proceedings.

 

7.2.2                         Other Technology .  Except as provided in Section 7.2.1, each Party shall be responsible, at its own expense and in its sole discretion, for preparing, filing, prosecuting and maintaining, in such countries as it deems appropriate, any and all patent applications and patents directed to inventions owned or controlled by such Party outside the Collaboration and conducting any interferences, re-examinations, reissues and oppositions relating to such patent applications and patents.

 

7.2.3                         Cooperation .  Each Party shall keep the other Party fully informed as to the status of patent matters described in Section 7.2.1, including without limitation, by providing the other Party with the opportunity, as far in advance of filing dates as possible, to fully review and comment on any documents which will be filed in any patent office, and by providing the other Party with copies of any substantive documents received by such Party from such patent offices promptly after receipt by such Party, including notice of all interferences, reissues, re-examinations, oppositions or requests for patent term extensions and shall incorporate all reasonable comments of the other Party in documents which will be filed in

 

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any patent office.  Each Party shall reasonably cooperate with and assist the other Party in connection with such activities, at such other Party’s reasonable request and expense, including without limitation by making scientists and scientific records reasonably available to the prosecuting Party.

 

7.3                                                          Enforcement and Defense .

 

7.3.1                         Notice .  Each Party shall promptly notify the other Party of either (i) any infringement of any Collaboration Patent by any Third Party or (ii) any misappropriation or misuse of the Collaboration Know-How by a Third Party that may come to such Party’s attention.

 

7.3.2                         ONO .  ONO shall have (i) the initial right, but not the obligation, to take reasonable legal action to enforce against infringements of the Collaboration Patent or misappropriation or misuse of the Collaboration Know-how by any Third Party or defend any declaratory judgment action relating to the Collaboration Patent filed pursuant to Section 7.2.1, and (ii) the sole right, but not the obligation, to take reasonable legal action to enforce against patent infringement by any Third Party or defend any declaratory judgment action relating to any patent filed by ONO pursuant to Section 7.2.2, or the Collaboration Patent [* ] ONO pursuant to Section 7.1.2, at its sole cost and expense.  If, within six (6) months following receipt of such notice from ARRAY, ONO fails to take such action to halt a commercially significant infringement of the Collaboration Patent filed pursuant to Section 7.2.1 (but not [*] ONO), ARRAY shall, in its sole discretion, have the right, at its sole expense, to take such action.

 

7.3.3                         ARRAY .  ARRAY shall have the sole right, but not the obligation, to take reasonable legal action to enforce against patent infringement by Third Parties or defend any declaratory judgment action relating to any patent filed by ARRAY pursuant to Section 7.2.2, at its sole cost and expense.

 

7.3.4                         Cooperation; Costs and Recoveries .  Each Party agrees to render such reasonable assistance as the enforcing Party may request, at the enforcing Party’s expense, including but not limited to joining such actions and/or executing such documents as may be necessary to, for example, enable the enforcing Party to establish standing in any court or tribunal to enforce the Collaboration Patent or the Collaboration Know How.  Amounts recovered from enforcing the Collaboration Patent filed pursuant to Section 7.2.1 or [*] pursuant to Section 7.1.2, whether as payment in settlement or otherwise, shall belong to the Party bringing the action, provided, however, that amounts recovered by ONO shall first be used to reimburse ONO for its reasonable expenses in enforcing the patent (including attorneys’ and experts fees), with the remainder, and then the amount of any recovery remaining shall be allocated between the Parties on a pro rata basis taking into consideration the relative economic losses suffered by each Party.  For example, [*] .  A settlement, consent judgment or other voluntary final disposition of a suit under this Section 7.3 may be entered into by ONO without the consent of ARRAY, provided that such settlement, consent judgment or other disposition does not admit the invalidity or unenforceability of any Pre-existing ARRAY Patent or any Collaboration Patent and provided further, that any rights to make such settlement, consent judgment or other disposition shall be limited to those rights ONO (and/or its Sublicensees) otherwise has the right to grant.   The costs in bringing any action to enforce a patent filed

 

18



 

pursuant to Section  7.2.2 shall be paid by, and all recoveries therefrom belong to, the Party bringing such action.

 

7.4                                                          Patent Registration in Territory .  Upon ONO’s request, ARRAY agrees that ONO shall be entitled to register, at ONO’s sole expense, “Tsujo Jisshiken Tohroku” with respect to the Collaboration Patent in accordance with Patent Law of Japan, or other similar rights in accordance with patent law in any other country, if any.  ARRAY shall render reasonable assistance for such registration by ONO, including, but not limited to, providing ONO with any documents reasonably necessary for such registration provided, however, that ONO shall promptly cancel such registration of Tsujo Jisshiken Tohroku and/or other similar rights in the event of the return of licenses and rights by ONO to ARRAY pursuant to Article 11 of this Agreement or in the event ONO ceases to sell the Collaboration Product containing an Active Compound or Active Claimed Compound during the term of this Agreement.

 

ARTICLE 8
CONFIDENTIALITY

 

8.1                                                          Confidential Information .  Except as otherwise expressly provided herein, the Parties agree that, for the term of this Agreement, the receiving Party shall not disclose to any Third Party or use for any purpose any Confidential Information furnished to it by the disclosing Party hereto pursuant to this Agreement, or the Collaboration Know-How.  For purposes of this Article 8, “Confidential Information” shall mean any information, which if disclosed in tangible form is marked “confidential” or with other similar designation to indicate its confidential or proprietary nature, or, if disclosed orally, is indicated orally to be confidential or proprietary at the time of such disclosure and is confirmed in writing as confidential or proprietary within forty-five (45) days after such disclosure.  It is understood and agreed by the Parties that the Collaboration Know-How shall be the Confidential Information of both of the Parties, and neither Party shall disclose such Collaboration Know-How as confidential information to a Third Party without the written consent of the other Party; provided, however, that ONO may disclose such Collaboration Know-How to its potential licensee for seeking business relationship.  Notwithstanding the foregoing, the Confidential Information shall not include any information that:

 

(a)                                                   was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure;

 

(b)                                                  was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;

 

(c)                                                   became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;

 

(d)                                                  was independently developed by the receiving Party as demonstrated by documented evidence prepared contemporaneously with such independent development; or

 

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(e)                                   was disclosed to the receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the disclosing Party not to disclose such information to others.

 

8.2                                                          Permitted Use and Disclosures .  Each Party hereto may use or disclose the Confidential Information and the Collaboration Know-How disclosed to it by the other Party to the extent such use or disclosure is reasonably necessary and permitted in the exercise of the rights granted hereunder in filing or prosecuting patent applications, prosecuting or defending litigation, complying with applicable governmental laws, regulations or court order or otherwise submitting information to tax or other governmental authorities, conducting clinical trials, or making a permitted sublicense or otherwise exercising license rights expressly granted by the other Party to it pursuant to the terms of this Agreement, provided that if a Party is required to make any such disclosure, other than pursuant to a confidentiality agreement, it will give reasonable advance notice to the other Party of such disclosure and, save to the extent inappropriate in the case of patent applications, will use its reasonable efforts to secure confidential treatment of such information in consultation with the other Party prior to its disclosure (whether through protective orders or otherwise) and disclose only the minimum necessary to comply with such requirements.

 

8.3                                                          Termination of Prior Agreement .  This Agreement supersedes the Confidentiality Agreement between the Parties dated April 12, 2005.  All information exchanged between the Parties under the Confidentiality Agreement shall be deemed the Confidential Information and shall be subject to the terms of this Article 8.

 

8.4                                                          Publicity /Use of the Name .  Each Party agrees not to disclose to any Third Party the financial terms of this Agreement without the prior written consent of the other Party hereto, except to advisors, investors and others on a need-to-know basis under circumstances that reasonably ensure the confidentiality thereof, or to the extent required by law.  Notwithstanding the foregoing, the Parties shall discuss the timing and contents of a press release to announce the execution of this Agreement, the achievement of Development Milestone for a Collaboration Product or the progress of the Collaboration and make such press release if the Parties mutually agree upon the timing and contents; thereafter, ONO and ARRAY may each disclose to any Third Party the information contained in such press release outline without the need for further approval by the other Party.  During the term hereof, neither Party shall use the name, trademark, tradename or logo of the other Party’s, its Affiliates’ or their respective employees in any publicity, promotion, press releases or disclosure relating to this Agreement or its subject matter without the prior consent of the other Party.

 

8.5                                                          Publication .  Except for disclosures permitted pursuant to Section 8.1, in the event a Party wishes to publish or orally present information relating to the Collaboration Know-How and the Confidential Information, such Party shall submit to the other Party all materials related to the proposed publication or presentation (including, without limitation, posters, abstracts, manuscripts and written descriptions of oral presentations) at least ninety (90) days prior to the date of submission for the draft publication and presentation.  The other Party shall review such submitted materials and respond to the submitting Party as soon as reasonably possible, but in any case within ninety (90) days of receipt thereof.  The reviewing Party shall have the rights (a) to propose modifications to publication or presentation for patent reasons, trade secret reasons or business reasons or (b) to request a reasonable delay in publication or

 

20



 

presentation in order to protect patentable information.  If the reviewing Party requests a delay, the publishing Party shall delay submission or presentation for a period of ninety (90) days to enable patent applications protecting each Party’s rights in Collaboration Inventions to be filed in accordance with Section 7.2 above.  If the reviewing Party requests modifications to publication or presentation, then the publishing Party shall edit such publication or presentation to prevent disclosure of trade secret or proprietary business information prior to submission of the publication or presentation.  In the event the reviewing Party does not respond within such ninety (90) day-period, the submitting Party will be free to make such proposed publication or presentation.  Further, should the reviewing Party make an objection to the publication or presentation of any such Collaboration Know-How and Confidential Information, then the Parties shall discuss the advantages and disadvantages of publishing such Collaboration Know-How and Confidential Information.  If the Parties are unable to agree on whether to publish the same, the Chief Executive Officer of ARRAY and the Chief Executive Officer of ONO shall reasonably agree on the extent to which the publication or presentation of such Collaboration Know-How and Confidential Information shall be made.

 

Notwithstanding the above, ONO has the sole right, without any consent of ARRAY, to make any publication or presentation with respect to the development and sale by or on behalf of ONO of any Collaboration Product, Product or any product containing an Inactive Compound, a Claimed Compound or Derivative Compound after the Collaboration Term.  ONO shall provide ARRAY, for information purposes, with copies of publications by ONO’s or its Affiliates’ employees, Sublicensees, academic entity or consultants following such publication or presentation.

 

ARTICLE 9
REPRESENTATIONS AND WARRANTIES

 

9.1                                                          ONO .  ONO represents and warrants that: (i) it has the legal power, authority and right to enter into this Agreement and to perform all of its obligations hereunder; and (ii) this Agreement is a legal and valid obligation binding upon it and enforceable in accordance with its terms.

 

9.2                                                          ARRAY .  ARRAY represents and warrants that: (i) it has the full legal right and power to grant to ONO the licenses under Article 4 hereof, to enter into this Agreement, and to fully perform its obligations hereunder; (ii) this Agreement is a legal and valid obligation binding upon it and enforceable in accordance with its terms; (iii) the execution and performance of this Agreement does not conflict with any agreement or understanding to which ARRAY may be bound; (iv) it has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in Pre-existing ARRAY Know-How; and (v) it shall comply with all applicable laws, regulations and guidelines in connection with the performance of its obligations and rights pursuant to this Agreement, including the laws and regulations of the U.S., Japan and any other relevant nation concerning any export or other transfer of technology, services or product..

 

9.3                                                          Disclaimer .  ONO and ARRAY specifically disclaim any guarantee that the Collaboration will be successful, in whole or in part.  The failure of the Parties to successfully develop, Active Compounds, Inactive Compounds, Claimed Compounds and/or

 

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Collaboration Products will not constitute a breach of any representation or warranty or other obligation under this Agreement.  EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, ARRAY AND ONO MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OR CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE COLLABORATION PATENTS, COLLABORATION KNOW-HOW, PRE-EXISTING ARRAY KNOW-HOW, PRE-EXISTING ARRAY PATENTS, PRE-EXISTING ONO KNOW-HOW, PRE-EXISTING ONO PATENTS, PRE-EXISTING ONO COMPOUNDS, ACTIVE COMPOUNDS, CLAIMED COMPOUNDS, INACTIVE COMPOUNDS,  HEREUNDER OR COLLABORATION PRODUCTS INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF ANY COLLABORATION PATENT OR KNOW-HOW, PATENTED OR UNPATENTED, OR NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

 

ARTICLE 10
INDEMNIFICATION

 

10.1                                                    MUTUAL INDEMINFICATION .  Each Party (the “Indemnitor, as defined in Section 10.4) shall defend, indemnify and hold the other Party and its Affiliate, and their respective directors, officers, employees, and agents (the “Indemnitee”, as defined in Section 10.4) harmless from and against any losses, costs, claims, damages, liabilities or expense (including reasonable attorneys’ and professional fees and other expenses of litigation) (collectively, “Liabilities”) arising, directly or indirectly out of or in connection with Third Party claims, suits, actions, demands or judgments, relating to:

 

(i)                                      any breach by the Indemnitor of its representations, warranties, covenants or agreements under this Agreement; or

 

(ii)                                   any personal injury or proprietary damage occurring at a location owned, leased or under the control of the Indemnitor in connection with the transactions contemplated by this Agreement (except to the extent such Liabilities arose out of or resulted from the gross negligence, recklessness or willful misconduct of the other Party or its Affiliates, and their respective directors, officers, employees, and agents).

 

10.2                                                    Indemnification by ONO .  ONO agrees to indemnify, defend and hold Indemnitees of ARRAY harmless from and against any Liabilities arising, directly or indirectly out of or in connection with Third Party claims, suits, actions, demands or judgments, relating to:

 

(i)                                      any Active Compound, Inactive Compound, Claimed Compound, Derivative Compound, Product or Collaboration Product developed, manufactured, used, sold or otherwise distributed by or on behalf of ONO, its Affiliates or Sublicensees or other designees (including, without limitation, product liability); or

 

(ii)                                   the use of a Collaboration Target (including a nucleic acid encoding such Collaboration Target, a Collaboration Target protein or a derivative, modification or subunit of any of the foregoing) which is involved in the conduct of the Collaboration and the making or use of modulators of such Collaboration Target,

 

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except, in each case, to the extent such Liabilities arose out of or resulted from the gross negligence, recklessness or intentional misconduct of Array or its Affiliates, directors, officers, employees, and agents.

 

10.3                                                    Indemnification by ARRAY .  ARRAY agrees to indemnify, defend and hold Indemnitees of ONO harmless from and against any Liabilities arising, directly or indirectly out of or in connection with Third Party claims, suits, actions, demands or judgments, relating to any Active Compound, Inactive Compound and Claimed Compound developed, manufactured, used, sold or otherwise distributed by or on behalf of ARRAY, its Affiliates or licensees or other designees (including, without limitation, product liability), except to the extent such Liabilities arose out of or resulted from the gross negligence, recklessness or intentional misconduct of ONO or its Affiliates, directors, officers, employees, and agents..

 

10.4                                                    Indemnification Procedure .  A Party that intends to claim indemnification (the “Indemnitee”) under this Article 10 shall promptly notify the other Party (the “Indemnitor”) in writing of any claim, complaint, suit, proceeding or cause of action with respect to which the Indemnitee intends to claim such indemnification (for purposes of this Section 10.4, each a “Claim”), and the Indemnitor shall have sole control of the defense and/or settlement thereof; provided that the Indemnitee shall have the right to participate, at its own expense, with counsel of its own choosing in the defense and/or settlement of such Claim.  The indemnification obligations of the Indemnitor under this Article 10 shall not apply in settlement of any Claim if such settlement is effected without the consent of the Indemnitor.  The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any such Claim, if prejudicial to its ability to defend such action, shall relieve such Indemnitor of any liability to the Indemnitee under this Article 10, but the omission so to deliver written notice to the Indemnitor shall not relieve the Indemnitor of any liability to any Indemnitee otherwise than under this Article 10.  The Indemnitee under this Article 10, and its employees, at the Indemnitor’s request and expense, shall provide full information and reasonable assistance to Indemnitor and its legal representatives with respect to such Claims covered by this indemnification.  It is understood that only ONO may claim indemnity under this Article 10 (on its own behalf or on behalf of a ONO Indemnitee), and other ONO Indemnitees may not directly claim indemnity hereunder.  Likewise, it is understood that only ARRAY may claim indemnity under this Article 10 (on its own behalf or on behalf of an ARRAY Indemnitee), and other ARRAY Indemnitees may not directly claim indemnity hereunder.

 

ARTICLE 11
TERM AND TERMINATION

 

11.1                                                    Term .  The term of this Agreement shall commence on the Effective Date, and shall continue in full force and effect on a country-by-country and Collaboration Product-by-Collaboration Product basis until ONO and its Sublicensees have no remaining royalty payment obligations in a country, unless terminated earlier as provided in this Article 11.

 

11.2                                                    Termination Upon Notice .  During the Collaboration Term, ONO shall have the right to terminate this Agreement [*] to ARRAY, provided that such notice may not be given prior to the first anniversary of the Effective Date.  Further, after the Collaboration Term, ONO shall have the right to terminate this Agreement [* ] to ARRAY for scientific or

 

23



 

commercial reasons consistent with the usual practice followed by ONO in pursuing the development and commercialization of its other pharmaceutical products of similar commercial value and ONO shall timely provide ARRAY with such reason for termination.

 

11.3                                                    Termination for Breach .  Either Party to this Agreement may terminate the Collaboration and this Agreement in the event the other Party hereto shall have materially breached or defaulted in the performance of any of its material obligations hereunder, and such default shall have continued for ninety (90) days after written notice thereof was provided to the breaching Party by the non-breaching Party.  Any termination shall become effective at the end of such ninety (90) day period unless the breaching Party (or any Third Party on its behalf) has cured any such breach or default prior to the expiration of the ninety (90) day period; provided, however, in the case of a failure to pay any amount due hereunder, such default may be the basis of termination ten (10) business days following the date that notice of such default was received by the breaching Party unless the breaching Party shall pay any amount due within such ten (10) business days.

 

11.4                                                    Termination for Insolvency .  If voluntary or involuntary proceedings by or against a Party are instituted in bankruptcy under any insolvency law, or a receiver or custodian is appointed for such Party, or proceedings are instituted by or against such Party for corporate reorganization, dissolution, liquidation or winding-up of such Party, which proceedings, if involuntary, shall not have been dismissed within sixty (60) days after the date of filing, or if such Party makes an assignment for the benefit of creditors, or substantially all of the assets of such Party are seized or attached and not released within sixty (60) days thereafter, the other Party may immediately terminate the Collaboration and/or this Agreement, effecttive upon notice of such termination.

 

11.5                                                    Survival Sections .  Articles  [* ] and any other provisions, which by their meaning are intended to survive this Agreement, shall survive the expiration or termination of this Agreement for any reason.

 

11.6                                                    Effect of Termination .

 

11.6.1                   Termination Not Sole Remedy; Accrued Rights and Obligations .  Termination is not the sole remedy under this Agreement and, whether or not termination is effected, all other remedies will remain available except as agreed to otherwise herein.  Termination of this Agreement for any reason shall not release either Party hereto from any liability which, at the time of such termination, has already accrued to the other Party or which is attributable to a period prior to such termination nor preclude either Party from pursuing any rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement.

 

11.6.2                   Upon termination of this Agreement (i) by ONO pursuant to Section 11.2, or (ii) by ARRAY pursuant to 11.3 and 11.4. .  If this Agreement terminated (i) by ONO pursuant to Section 11.2, or (ii) by ARRAY pursuant to 11.3 and 11.4, all the licenses and rights granted to ONO by ARRAY under Article 4 shall be terminated and each Party shall promptly return to the other Party all Confidential Information (including, without limitation, all Know-How) received from such Party, except one copy of which may be retained for archival purposes.  Further, ONO shall promptly make payment of all amounts owing to ARRAY, and

 

24



 

ONO shall promptly [*] to ARRAY all of ONO’s right, title and interest in any Collaboration Patent [*] to ONO under Section 7.1.2.

 

11.6.3                   Upon termination by ONO of this Agreement pursuant to Section 11.3 .  If this Agreement is terminated by ONO pursuant to Section 11.3, all the licenses and rights granted to ONO by ARRAY under Article 4 shall survive subject to ONO’s obligation to pay milestone and royalty payments as set forth in Sections 5.2 and 5.3; [*] .   [*] .  Further, Article 7, Sections 2.11, 5.5, 5.6 and 5.7 shall also survive.  ARRAY shall promptly return to ONO all Confidential Information (including, without limitation, all Know-How) received from ONO.

 

11.6.4                   Upon termination by ONO of this Agreement pursuant to Section 11.4 .  If this Agreement is terminated by ONO pursuant to Section 11.4 due to the rejection of this Agreement by or on behalf of ARRAY under Section 365 of the United States Bankruptcy Code (the “Code”) or similar foreign laws, all licenses and rights to licenses granted under or pursuant to this Agreement, including but not limited to Article 4, by ARRAY to ONO are, and shall otherwise be deemed to be, if required for purposes of Section 365(n) of the Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Code or similar foreign laws.  The Parties agree that ONO, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Code or similar foreign laws, and that upon commencement of a bankruptcy proceeding by or against ARRAY under the Code or similar foreign laws, ONO shall be entitled to a complete duplicate of, or complete access to (as ONO deems appropriate), any such intellectual property and all embodiments of such intellectual property.  Such intellectual property and all embodiments thereof shall be promptly delivered to ONO (i) upon any such commencement of a bankruptcy proceeding upon written request therefor by ONO, unless ARRAY elects to continue to perform all of its obligations under this Agreement or (ii) if not delivered under (i) above, upon the rejection of this Agreement by or on behalf of ARRAY upon written request therefor by ONO.

 

11.7                                                    Effect of [*] .  In the event ONO [*] , for either Collaboration Target, [*], the following shall apply:

 

11.7.1                   ONO shall promptly assign to ARRAY all of ONO’s right, title and interest in any jointly owned Collaboration Patent [*] .

 

11.7.2                   With respect to [*] Sections 7.3, 2.11, 5.2.3, 7.1.2, 7.1.3 and 7.2.1 shall terminate.

 

11.7.3                   Section 4.1 shall be amended [*] .

 

11.7.4                   The amounts payable to ARRAY under Sections 5.2.1 and 5.2.2 upon achievement of Development Milestones shall be [*] provided that ONO shall be required to pay Development Milestone only for Collaboration Products [*] claimed in an unabandoned Collaboration Patent owned by ARRAY covering the composition of matter, a method of manufacture or the use of such Collaboration Product.  For the avoidance of doubt, ONO shall not be required to pay [* ] .

 

11.7.5                   Section 5.3 shall be amended [*] :

 

25



 

5. Royalties .  ONO shall pay ARRAY a royalty of [*] on the worldwide Net Sales by ONO, its Affiliates or Sublicensees of each Collaboration Product [*] .  Such royalties shall be paid on a country-by-country basis from the date of the first commercial sale of each such Collaboration Product with respect to which royalty payments are due until the expiration of the last to expire the Collaboration Patent owned by ARRAY in such country covering the composition of matter, a method of manufacture or the use of such [*] .  It is understood and agreed that no royalty shall be due on sales of [* ] .

 

11.7.6                   It is acknowledged and agreed by the Parties that each Party shall be relieved from [*] upon [*] of [*] pursuant to [*] and each Party shall have the right [*] .

 

ARTICLE 12
MISCELLANEOUS

 

12.1                                                    Governing Laws .  This Agreement shall be governed by and construed, and enforced in accordance with, the laws of the state of Colorado, without reference to conflicts of laws principles.

 

12.2                                                    Waiver .  It is agreed that no waiver by either Party hereto of any breach or default of any of the covenants or agreements herein set forth shall be deemed a waiver as to any subsequent and/or similar breach or default.

 

12.3                                                    Assignment .  This Agreement shall not be assignable by either Party to any Third Party hereto without the written consent of the other Party hereto.  Notwithstanding the foregoing, either Party may assign this Agreement, without such consent, to an entity that acquires all or substantially all of the business or assets of such Party to which this Agreement pertains, whether by merger, reorganization, acquisition, sale, or otherwise; provided, however, that within thirty (30) days of such an assignment, the assignee shall agree in writing to be bound by the terms and conditions of this Agreement.  This Agreement shall be binding upon and inure to the benefit of any permitted assignee, and any such assignee shall agree to perform the obligations of the assignor.

 

12.4                                                    Independent Contractors .  The relationship of the Parties hereto is that of independent contractors.  The Parties hereto are not deemed to be agents, partners or joint venturers of the others for any purpose as a result of this Agreement or the transactions contemplated thereby.

 

12.5                                                    Compliance with Laws .  In exercising their rights under this license, the Parties shall fully comply in all material respects with the requirements of any and all applicable laws, regulations, rules and orders of any governmental body having jurisdiction over the exercise of rights under this license including, without limitation, those applicable to the discovery, development, manufacture, distribution, import and export and sale of Collaboration Products pursuant to this Agreement.

 

12.6                                                    Patent Marking .  ONO agrees to mark and have its Affiliates and Sublicensees mark all Collaboration Products or packaging or labels where appropriate sold

 

26



 

pursuant to this Agreement in accordance with the applicable statute or regulations relating to patent marking in the country or countries of manufacture and sale thereof.

 

12.7                                                    Notices .  All notices, requests and other communications hereunder shall be in writing and shall be personally delivered or by registered or certified mail, return receipt requested, postage prepaid, in each case to the respective address specified below, or such other address as may be specified in writing to the other Party hereto and shall be deemed to have been given upon receipt:

 

If to ONO:

 

O no Pharmaceutical Co., Ltd.

 

 

8-2 Kyutaromachi 1-Chome, Chuo-Ku

 

 

Osaka 541-8564, JAPAN

 

 

Attention: Director, International Business

 

 

Facsimile: +81 (6) 6263-2958

 

 

 

With a copy to:

 

Ono Pharma USA, Inc.

 

 

2000 Lenox Drive

 

 

Lawrenceville, NJ 08648, USA

 

 

Attention: President

 

 

Facsimile: +1 (609) 219-9229

 

 

 

If to ARRAY:

 

A rray BioPharma Inc.

 

 

3200 Walnut Street

 

 

Boulder, CO 80301 , USA

 

 

Attention: Chief Operating Officer

 

 

Facsimile: +1 (303) 381-6697

 

 

 

With a copy to:

 

Array BioPharma Corporation

 

 

3200 Walnut Street

 

 

Boulder, CO 80301 , USA

 

 

Attention: General Counsel

 

 

Facsimile: +1 (303) 386-1290

 

12.8                                                    Severability .  Each Party hereby agrees that it does not intend to violate any public policy, statutory or common laws, rules, regulations, treaty or decision of any government agency or executive body thereof of any country or community or association of countries.  Should one or more provisions of this Agreement be or become invalid, the Parties hereto shall substitute, by mutual consent, valid provisions for such invalid provisions which valid provisions in their economic effect are sufficiently similar to the invalid provisions that it can be reasonably assumed that the Parties would have entered into this Agreement with such valid provisions.  In case such valid provisions cannot be agreed upon, the invalidity of one or several provisions of its Agreement shall not affect the validity of this Agreement as a whole, unless the invalid provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without the invalid provisions.  In the event a Party seeks to avoid a material provision of this Agreement upon an assertion that such provision is invalid, illegal or otherwise unenforceable, the other Party shall have the right to terminate this Agreement upon sixty (60) days prior written notice to

 

27



 

the asserting Party, unless such assertion is eliminated and cured within such sixty (60) day period.  Such a termination shall be deemed a termination by such Party for breach pursuant to Section 1 1.3.

 

12.9                                                    Advice of Counsel .  ARRAY and ONO have each consulted counsel of their choice regarding this Agreement, and each acknowledges and agrees that this Agreement shall not be deemed to have been drafted by one Party or another and will be construed accordingly.

 

12.10                                              Performance Warranty .  Each Party hereby warrants and guarantees the performance of any and all rights and obligations of this Agreement by its Affiliates and Sublicensees.

 

12.11                                              Dispute resolution .  Except for the dispute to be resolved in accordance with Section 3.5, the Parties agree that any dispute, controversy, or difference which may arise between the Parties, out of or in relation to or in connection with this Agreement shall be attempted in good faith to amicably be settled by the Parties before having recourse to the arbitration procedure.  In the event such dispute, controversy, or difference is not resolved by the Parties, then such unresolved dispute, controversy, or difference shall be resolved through binding arbitration in accordance with the Rules of Conciliation and Arbitration of the International Chamber of Commerce applying the substantive law specified in Section 12.1.  A Party may initiate an arbitration by written notice to the other Party of its intention to arbitrate, and such demand notice shall specify in reasonable detail the nature of the dispute.   Each Party shall select one (1) arbitrator, and the two (2) arbitrators so selected shall choose a third arbitrator, and all three (3) shall serve as neutrals.   If a Party fails to nominate its arbitrator, or if the Parties’ arbitrators cannot agree on the third arbitrator, the necessary appointments shall be made in accordance with the Rules of Conciliation and Arbitration of the International Chamber of Commerce.   Within three (3) months of the conclusion of an arbitration proceeding, the arbitration decision shall be rendered in writing and shall specify the basis on which the decision was made.  The award of the arbitration tribunal shall be final and judgment upon such an award may be entered in any competent court or application may be made to any competent court for judicial acceptance of such an award and order of enforcement.  Unless otherwise mutually agreed upon by the Parties, the arbitration proceedings shall be conducted in Osaka, Japan, in the event that ARRY requests arbitration, and in Denver, Colorado, in the event ONO requests arbitration.  The Parties agree that they shall share equally the cost of the arbitration filing and hearing fees, and the cost of the arbitrator.  Each Party shall bear its own attorneys’ fees and associated costs and expenses.

 

12.12                                              Force Majeure .  Neither Party shall lose any rights hereunder or be liable to the other Party for damages or losses (except for payment obligations) on account of failure of performance by the defaulting Party if the failure is occasioned by war, terrorism, strike, fire, Act of God, earthquake, flood, lockout, embargo, governmental acts or orders or restrictions, failure of suppliers, or any other reason where failure to perform is beyond the reasonable control and not caused by the negligence, intentional conduct or misconduct of the non-performing Party and such Party has exerted all reasonable efforts to avoid or remedy such force majeure; provided, however, that in no event shall a Party be required to settle any labor dispute or disturbance.

 

28



 

12.13                                              Complete Agreement .  This Agreement with its Exhibits, constitutes the entire agreement, both written and oral, between the Parties with respect to the subject matter hereof, and all prior agreements respecting the subject matter hereof, either written or oral, express or implied, shall be abrogated, canceled, and are null and void and of no effect.  No amendment or change hereof or addition hereto shall be effective or binding on either of the Parties hereto unless reduced to writing and executed by the respective duly authorized representatives of ARRAY and ONO.

 

12.14                                              Headings .  The captions to the several Sections hereof are not a part of this Agreement, but are included merely for convenience of reference and shall not affect its meaning or interpretation.

 

12.15                                              Language .  This Agreement is in the English language only, which language shall be controlling in all respects, and all versions hereof in any other language shall not be binding on the Parties hereto.  All communications and notices to be made or given pursuant to this Agreement shall be in the English language.

 

12.16                                              Counterparts .  This Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which together shall be deemed to be one and the same agreement.

 

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly executed by their authorized representatives and delivered in duplicate originals as of the Effective Date.

 

ONO PHARMACEUTICAL CO., LTD.

ARRAY BIOPHARMA INC.

 

 

 

 

 

 

 

By:

 

 

By:

 

 

 

 

 

 

Name:

Takashi Iwai

Name:

 David L. Snitman, Ph.D.

 

 

 

 

 

 

Title:

President, Representative Director

Title

Chief Operating Officer& Vice

 

 

and C hief Executive Officer

 

President, Business Development

 

 

 

 

 

Date:

 

 

Date:

 

 

 

29



 

EXHIBIT 1.31

 

RESEARCH PLAN

 

Appendix to Drug Discovery Agreement between ONO and ARRAY: Research Plan for [ * ] Projects

 

The following is the research plan on [ * ] mutually agreed by ONO and ARRAY.  It is derived from analysis of the targets by ARRAY and after several discussions with ONO.  This Research Plan is intended to be a plan and guide for the project team.  The goasl, strategy and resource distribution can and will be changed in response to ongoing results, competitive information and changing science.  Significant changes to the Research Plan must be ratified by the Joint Management Committee.

 

 

Topics:

 

 

[ * ]  …………………………………………………………….[ * ]

[ * ]  …………………………………………………………….[ * ]

[ * ]  …………………………………………………………….[ * ]

[ * ]  …………………………………………………………….[ * ]

[ * ]  …………………………………………………………….[ * ]

[ * ]  …………………………………………………………….[ * ]

[ * ]  …………………………………………………………….[ * ]

[ * ]  …………………………………………………………….[ * ]

[ * ]  …………………………………………………………….[ * ]

 

30



 

EXHIBIT 1.3 3

 

[*]

 

[* ]

 


Exhibit 10.3

FIRST AMENDMENT

TO

LOAN AND SECURITY AGREEMENT

 

This First Amendment to Loan and Security Agreement (the “Amendment”) is entered into as of December 19, 2005, by and between COMERICA BANK (“Bank”) and ARRAY BIOPHARMA, INC. (“Borrower”).

 

RECITALS

 

Borrower and Bank are parties to that certain Loan and Security Agreement dated as of June 28, 2005 (as amended from time to time, together with any related agreements, the “Agreement”).  Hereinafter, all indebtedness owing by Borrower to Bank shall be referred to as the “Indebtedness.”  The parties desire to amend the Agreement in accordance with the terms of this Amendment.

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

 

AGREEMENT

 

I.               Incorporation by Reference . The Recitals and the documents referred to therein are incorporated herein by this reference.  Except as otherwise noted, the terms not defined herein shall have the meaning set forth in the Agreement.

 

II.             Amendment to the Agreement .  Subject to the satisfaction of the conditions precedent as set forth in Article IV hereof, the Agreement is hereby amended as set forth below.

 

A.             The first sentence of Section 6.6 of the Agreement is hereby amended and restated in its entirety to read as follows:

 

“Borrower shall at all times, measured on a daily basis, (A) maintain a balance of Cash at Bank of not less than: (i) Zero Dollars ($0) if Borrower’s total Cash at Bank plus Cash covered by Account Control Agreements is not less than Forty Million Dollars ($40,000,000), (ii) Two Million Dollars ($2,000,000) if Borrower’s total Cash at Bank plus Cash covered by Account Control Agreements is at least Thirty Million Dollars ($30,000,000) but less than Forty Million Dollars ($40,000,000), (iii) Eight Million Five Hundred Thousand Dollars ($8,500,000) if Borrower’s total Cash at Bank plus Cash covered by Account Control Agreements is at least Twenty Five Million Dollars ($25,000,000) but less than Thirty Million Dollars ($30,000,000), (iv) Seventeen Million Dollars ($17,000,000) if Borrower’s total Cash at Bank plus Cash covered by Account Control Agreements is less than Twenty Five Million Dollars ($25,000,000) and (B) maintain a balance of Cash at Bank plus Cash covered by Account Control Agreements of not less than Twenty Million Dollars ($20,000,000).”

 

B.             Bank’s primary address for notices set forth in Section 10 of the Agreement is hereby amended in its entirety to read as follows:

 

“If to Bank:

 

Comerica Bank

 

 

m/c 4770

 

 

75 E Trimble Road

 

 

San Jose, CA 95131

 

 

Attn: Manager

 

 

FAX: (408) 556-5091”

 

1



 

C.             The fourth sentence of Section 11 of the Agreement is hereby amended and restated in its entirety to read as follows:

 

“TO THE EXTENT PERMITTED BY LAW, EACH PARTY, AFTER CONSULTING OR HAVING HAD THE OPPORTUNITY TO CONSULT, WITH COUNSEL OF THEIR CHOICE, KNOWINGLY, VOLUNTARILY AND INTENTIONALLY WAIVES ANY RIGHT ANY OF THEM MAY HAVE TO A TRIAL BY JURY IN ANY LITIGATION BASED UPON OR ARISING OUT OF THIS AGREEMENT OR ANY RELATED INSTRUMENT OR LOAN DOCUMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT OR ANY COURSE OF CONDUCT, DEALING, STATEMENTS (WHETHER ORAL OR WRITTEN), OR ACTION OF ANY OF THEM.”

 

D.             The dollar amount of “Eight Million Dollars ($8,000,000)” in Sections 2.a. and 2.b. of Exhibit D (LIBOR/Cost of Funds Addendum) to the Agreement is hereby changed to “Ten Million Dollars ($10,000,000)”.

 

III.            Legal Effect .

 

A.             The Agreement is hereby amended wherever necessary to reflect the changes described above. Borrower agrees that it has no defenses against the obligations to pay any amounts under the Indebtedness.

 

B.             Borrower understands and agrees that in modifying the existing Indebtedness, Bank is relying upon Borrower’s representations, warranties, and agreements, as set forth in the Agreement.  Except as expressly modified pursuant to this Amendment, the terms of the Agreement remain unchanged, and in full force and effect.   Bank’s agreement to modifications to the existing Indebtedness pursuant to this Amendment in no way shall obligate Bank to make any future modifications to the Indebtedness.  Nothing in this Amendment shall constitute a satisfaction of the Indebtedness.  It is the intention of Bank and Borrower to retain as liable parties, all makers and endorsers of Agreement, unless the party is expressly released by Bank in writing.  No maker, endorser, or guarantor will be released by virtue of this Amendment.  The terms of this paragraph apply not only to this Amendment, but also to all subsequent loan modification requests.

 

C.             This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one instrument.  This is an integrated Amendment and supersedes all prior negotiations and agreements regarding the subject matter hereof.  All modifications hereto must be in writing and signed by the parties.

 

IV.            Conditions Precedent .         Except as specifically set forth in this Amendment, all of the terms and conditions of the Agreement remain in full force and effect.  The effectiveness of this Agreement is conditioned upon receipt by Bank of this Amendment, and any other documents which Bank may require to carry out the terms hereof, including but not limited to the following:

 

A.            This Amendment, duly executed by Borrower;

 

B.             A legal fee from the Borrower in the amount of $250; and

 

C.             Such other documents, and completion of such other matters, as Bank may reasonably deem necessary or appropriate.

 

IN WITNESS WHEREOF, the undersigned have executed this Amendment as of the first date above written.

 

2



 

 

ARRAY BIOPHARMA, INC.

 

 

 

 

 

 

 

By:

 

 

 

 

 

Title:

 

 

 

 

 

 

 

 

COMERICA BANK

 

 

 

 

 

 

 

By:

 

 

 

 

 

Title:

 

 

 

3


Exhibit 10.4

 

ADDENDUM #5 TO LEASE AGREEMENT

 

THIS ADDENDUM #5 TO LEASE AGREEMENT, dated as of December 2, 2005, is entered into by and between CIRCLE CAPITAL LONGMONT LLC, a Delaware limited liability company (“Landlord”) and ARRAY BIOPHARMA, INC., a Delaware corporation (“Tenant”).

 

Recitals:

 

  A. Landlord’s predecessor in interest and Tenant entered into a written lease agreement, dated February 28, 2000, as amended by Addendum to Lease Agreement #1 dated May 24, 2001, Addendum to Lease Agreement #2, dated February 11, 2002, Addendum to Lease Agreement dated November 30, 2004 and Addendum #4 to Lease Agreement dated August 1, 2005 (“Addendum #4) (collectively, the “Lease”), pertaining to Suites A & B of the Building located at 2620 Trade Centre Avenue which Premises consist of approximately 43,200 rentable square feet of space (the “Premises”). (Initially capitalized terms not otherwise defined herein have the same meaning as in the Lease.)

 

  B. Under Addendum #4 to Lease Agreement, Tenant was granted an option, under certain terms, to lease additional space (as defined in Addendum #4, the “Expansion Option”) in the buildings located at 2500, 2420 and/or 2410 Trade Centre Avenue.  To exercise the Expansion Option, Tenant was required to give written notice to Landlord of its election to exercise the Expansion Option on or before the 120 th day after mutual execution of Addendum #4.

 

  C. Tenant desires to exercise the Expansion Option with respect to the buildings located at 2500 and 2420 Trade Centre Avenue.  Tenant and Landlord have engaged in discussions concerning Tenant’s interest in the possible expansion and improvement of the building located at 2410 Trade Centre Avenue.  Tenant remains interested in exercising the Expansion Option with respect to the building located at 2410 Trade Centre Avenue, particularly if such building can be appropriately expanded and improved.

 

  D. Landlord and Tenant desire to amend the Lease in the manner and form hereinafter set forth.

 

 NOW, THEREFORE, for good and valuable consideration, Landlord and Tenant hereby agree as follows:

 

 1. Tenant is not required to exercise the Expansion Option with respect to all the Option Space at once.  Rather, Tenant may submit more than one Tenant’s Expansion Notice, provided that Tenant complies with the provisions set forth in Section 10B(ii) of Addendum #4.

 

 2. Upon execution by both Landlord and Tenant, this Addendum shall be deemed Tenant’s Expansion Notice with respect to the buildings located at 2500 and 2420 Trade Centre Avenue. Following the mutual execution of this Addendum, the procedures provided in Sections 10.B through 10.F of Addendum #4 shall govern the leasing of such space.

 

 3. To exercise the Expansion Option with respect to the building located at 2410 Trade Centre Avenue, Tenant shall give Tenant’s Expansion Notice on or before December 31, 2005.  If Tenant exercises the 2410 Trade Centre Avenue Expansion Option by giving Tenant’s Expansion Notice, Landlord shall use reasonable efforts to notify Tenant whether 2410 Trade Centre Avenue is included within the Expansion Premises on or before the 90 th day after mutual execution of this Addendum, but in no event later than the 90 th day after receipt of Tenant’s Expansion Notice for 2410 Trade Centre Avenue.

 

 4. In connection with Tenant’s consideration of whether to exercise the Expansion Option pertaining to 2410 Trade Centre Avenue, Tenant has requested that Landlord consider addition of a partial second floor to 2410 Trade Centre Avenue of sufficient size such that the building would comprise 36,000-40,000 square feet and improvements to the entry and landscaping to be compatible for use as a corporate office headquarters.  Tenant has already provided Landlord with preliminary requirements and with drawings of the requested addition and improvements. Following the mutual execution of this Addendum, Landlord

 



 

shall review and approve or suggest revisions to the preliminary requirements and drawings submitted by Tenant and thereafter Landlord and Tenant shall reasonably cooperate to finalize preliminary plans, taking into account reasonable design suggestions by Tenant concerning the nature and scope of such expansion and improvements; when approved by Landlord and Tenant such plans shall be deemed the “2410 Preliminary Plans.”  Following mutual approval of the 2410 Preliminary Plans, (i) Landlord shall use commercially reasonable efforts to obtain preliminary approvals of the 2410 Preliminary Plans from all relevant local officials prior to December 31, 2005, and (ii) prior to December 31, 2005, Landlord shall provide Tenant a written offer (as an alternative to the terms that would otherwise be applicable under Section 10.D of Addendum #4), taking into account the estimated costs for completing work in accordance with the 2410 Preliminary Plans, which offer shall include the terms under which Landlord would rent 2410 Trade Centre Avenue to Tenant assuming completion of such expansion and improvements and delivery of such space by March 1, 2008 (which offer would be subject to Landlord obtaining final building permit approvals for construction in accordance with the 2410 Preliminary Plans and confirming its ability to reach agreement with the existing tenant as provided below) and the terms that would be applicable to a purchase of 2410 Trade Centre Avenue under Section 12 of Addendum #4 taking into account such work (collectively, “Landlord’s 2410 Offer”).

 

 5. If Tenant desires to exercise Tenant’s Expansion Option for the building at 2410 Trade Centre Avenue, Tenant shall give Landlord Tenant’s Expansion Notice on or before January 6, 2006.  The terms of Section 10.D of Addendum #4 (without regard to Landlord’s 2410 Offer) shall govern the leasing of such space.  In the event Tenant remains interested in expansion and improvement of the building at 2410 Trade Centre Avenue in accordance with the 2410 Preliminary Plans, Tenant shall so indicate in Tenant’s Expansion Notice and the parties shall thereafter negotiate in good faith, based on Landlord’s 2410 Offer and taking into account the then-current status of construction building permit approvals, the basis on which Landlord is able to reach agreement with the existing tenant, and inclusion of 2410 Trade Centre Avenue within the Expansion Premises, the terms under which Landlord would rent 2410 Trade Centre Avenue to Tenant assuming completion of such expansion and improvements and delivery of such space by March 1, 2008 and the terms that would be applicable to a purchase of 2410 Trade Centre Avenue under Section 12 of Addendum #4 taking into account such work.  All other provisions relating to the Option Space at 2410 Trade Centre Avenue shall be as set forth in the Lease.

 

 6. Non-Disclosure.  The terms of the Lease, including this Addendum are subject to Section 16 of Addendum 4.

 

 7. Conflicts. If there is any conflict between the terms of this Addendum and the terms of the Lease, the terms of this Addendum shall govern.  The Lease as hereby amended is in full force and effect, is hereby ratified and affirmed by the parties, and is binding upon the parties in accordance with its terms.

 

 8. Time of Essence.  Time is of the essence herein.

 

 IN WITNESS WHEREOF, the parties have executed this Addendum as of the day and year first above written and is effective upon delivery of a fully executed copy to Tenant; the last date signed is the date of mutual execution as referred to above.

 

LANDLORD:

CIRCLE CAPITAL LONGMONT LLC

 

 

 

 

By:

Circle Capital Property Management LLC, Authorized Agent

 

 

 

 

By

 

 

Date Signed

 

Terry Fitzpatrick, Manager

 

 

 

 

 

 

TENANT:

ARRAY BIOPHARMA, INC., a Delaware corporation

 

 

 

 

 

 

 

By

 

 

Date Signed

 

R. Michael Carruthers, CFO

 



 

ADDENDUM #6 TO LEASE AGREEMENT

 

THIS ADDENDUM #6 TO LEASE AGREEMENT, dated as of December 22, 2005 is entered into by and between CIRCLE CAPITAL LONGMONT LLC, a Delaware limited liability company (“Landlord”) and ARRAY BIOPHARMA, INC., a Delaware corporation  (“Tenant”).

 

Recitals :

 

A.            Landlord’s predecessor in interest and Tenant entered into a written lease agreement, dated February 28, 2000, as amended by Addendum to Lease Agreement #1 dated May 24, 2001, Addendum to Lease Agreement #2, dated February 11, 2002, Addendum to Lease Agreement dated November 30, 2004, Addendum #4 to Lease Agreement dated August 1, 2005 (“Addendum #4”), and Addendum #5 to Lease Agreement dated as of November 30, 2005 (“Addendum #5”) (collectively, the “Lease”), pertaining to Suites A & B of the Building located at 2620 Trade Centre Avenue which Premises consist of approximately 43,200 rentable square feet of space (the “Premises”). (Initially capitalized terms not otherwise defined herein have the same meaning as in the Lease.)

 

B.            Under Addendum #4 to Lease Agreement, Tenant was granted an option, under certain terms, to lease additional space (as defined in Addendum #4, the “Expansion Option”) in the buildings located at 2500, 2420 and/or 2410 Trade Centre Avenue.  To exercise the Expansion Option, Tenant was required to give written notice to Landlord of its election to exercise the Expansion Option on or before the 120 th day after mutual execution of Addendum #4.

 

C.            Under Addendum #5 to Lease Agreement, Tenant exercised the Expansion Option with respect to 2500 and 2420 Trade Centre Avenue and amended the terms of the Expansion Option with respect to the 2410 Trade Centre Avenue.

 

D.            Landlord and Tenant wish to further amend the terms of the Expansion Option with respect to 2410 Trade Centre Avenue.

 

E.             Landlord and Tenant desire to amend the Lease in the manner and form hereinafter set forth.

 

NOW, THEREFORE, for good and valuable consideration, Landlord and Tenant hereby agree as follows:

 

1.             Modification of Section 3.  The date, December 31, 2005, in Section 3 of Addendum #5 shall be amended to February 6, 2006.

 

2.             Modification of Section 4.  The date, December 31, 2005 wherever it appears in Section 4 of Addendum #5 shall be amended to January 31, 2006.

 

3.             Modification of Section 5.  The date, January 6, 2006, in Section 5 of Addendum #5 shall be amended to February 6, 2006.

 

4.             Conflicts. If there is any conflict between the terms of this Addendum and the terms of the Lease, the terms of this Addendum shall govern.  The Lease as hereby amended is in full force and effect, is hereby ratified and affirmed by the parties, and is binding upon the parties in accordance with its terms.

 

5.             Time of Essence.  Time is of the essence herein.

 



 

IN WITNESS WHEREOF, the parties have executed this Addendum as of the day and year first above written and is effective upon delivery of a fully executed copy to Tenant; the last date signed is the date of mutual execution as referred to above.

 

LANDLORD:

CIRCLE CAPITAL LONGMONT LLC

 

 

 

 

 

 

 

By:

Circle Capital Property Management LLC,
Authorized Agent

 

 

 

 

 

 

By

 

Date Signed

 

 

Terry Fitzpatrick, Manager

 

 

 

 

 

 

 

 

 

TENANT:

ARRAY BIOPHARMA, INC., a Delaware corporation

 

 

 

 

 

 

 

 

 

By

 

Date Signed

 

 

R. Michael Carruthers, CFO

 


Exhibit 10.5

 

AMENDMENT TO THE

ARRAY BIOPHARMA INC.

 

EMPLOYEE STOCK PURCHASE PLAN

(as amended and restated September 12, 2002,
and as amended on April 29, 2004)

 

Pursuant to the authority of the Board of Directors of Array BioPharma Inc (the “Company”) and Section 24 of the Array BioPharma Inc. Employee Stock Purchase Plan (as amended and restated September 12, 2002, and as amended on April 29, 2004) (the “Plan”), the Plan is hereby amended as set forth below:

 

1.                                        The first sentence of Section 1, “Shares Subject to the Plan”, is hereby amended and restated as follows:

 

“Subject to adjustment as provided in Section 26 below, the aggregate number of shares of Common Stock that may be made available for purchase by participating employees under the Plan is 1,650,000.”

 

2.                                        Section 4, “Eligible Employees”, is hereby amended to delete subparagraph (a) thereof.

 

3.                                        Section 14(a), “Changes in Election to Participate”, is hereby amended and restated as follows:

 

“(a)                        A participating employee may, at any time prior to the last trading day of the Offering Period, by written notice to the Company, direct the Company to cease payroll deductions (or, if the payment for shares is being made through periodic cash payments, notify the Company that such payments will be terminated), and the amount in the employee’s account will be distributed and the employee’s option to purchase will terminate, unless the employee elects, by written notice to the Company, not to have such amount distributed, in which event such amount shall remain in the employee’s account and available to exercise his or her option to purchase shares under the Plan during such Offering Period.”

 

4.                                        This Amendment to the Array BioPharma Inc. Employee Stock Purchase Plan (the “Amendment”) was approved by the Board of Directors of the Company on December 9, 2005 and shall be effective thereon; provided, however, that the amendments set forth in Sections 1 and 2 of this Amendment are contingent upon the approval of such amendments by a majority vote by the stockholders of the Company on or prior to December 9, 2006 (“Stockholder Approval”).  If Stockholder Approval is not attained, then the provisions of Sections 1 and 4 of the Plan as in effect immediately prior to the time the Board of Directors approved this Amendment shall remain in effect.

 



 

5.                                        This Amendment shall affect only those provisions of the Plan set forth herein, and all of the remaining terms and provisions of the Plan shall not be modified or amended hereby and shall continue in full force and effect.

 

*                                          *                                          *                                          *                                          *

 



 

This Amendment to the Plan was duly adopted and approved by the Board of Directors of the Corporation by unanimous written consent on December 9, 2005.

 

 

 

 

 

 

 

 

 

 

 

R. Michael Carruthers

 

 

 

 

 

Chief Financial Officer

 

 


Exhibit 10.6

 

First Amendment to the

Amended and Restated

Deferred Compensation Plan of Array BioPharma Inc.

 

WHEREAS , Array BioPharma Inc. (the “Company”) adopted the Amended and Restated Deferred Compensation Plan of Array BioPharma Inc. (the “Plan”) on August 1, 2004,

 

WHEREAS , Section 8.2 of the Plan provides for the amendment of the Plan, and

 

WHEREAS , pursuant to the guidance provided by the Proposed Treasury Regulations promulgated under Internal Revenue Code Section 409A and IRS Notice 2005-1, the Company desires to amend the Plan to provide that distributions may commence three (3) years from the year of deferral.

 

NOW, THEREFORE, BE IT RESOLVED , that, effective as of the date hereof, Section 4.1(b) is deleted in its entirety and restated to read as follows:

 

“(b)                            Either on January 1 of the third year following the calendar year in which contributions and deferrals were made or any January 1 thereafter.”

 

FURTHER RESOLVED , that, effective as of the date hereof, a new Section 4.5(g) is added to the end of Section 4.5 of the Plan to read as follows:

 

“(g)                            Notwithstanding any other provisions of the Plan, the Plan Administrator may permit a Participant to change the form or timing of his or her distribution elections as set forth on an Elective Deferral Form if (1) the change is consistent with Sections 4.1 and 4.2 and (2) the change is made prior to December 31, 2005; provided, however, that the distribution must be made following the first to occur of either separation from Service or a specified month and year in the future and that the form and timing of a distribution with respect to a Participant whose Service has terminated will be determined in a manner consistent with Sections 4.1, 4.2 , 4.3 and 4.4.”

 

FURTHER RESOLVED , that, in all other respects not amended, the Plan is ratified.

 



 

IN WITNESS WHEREOF , the Company has caused this First Amendment to the Amended and Restated Deferred Compensation Plan of Array BioPharma Inc. to be executed this 15 th day of November 2005, by its duly authorized officer.

 

 

 

ARRAY BIOPHARMA INC.

 

 

 

 

 

 

By: R. Michael Carruthers

 

Title: Chief Financial Officer

 



 

FIRST AMENDMENT TO THE

AMENDED AND RESTATED DEFERRED COMPENSATION PLAN

OF ARRAY BIOPHARMA INC.

 

WHEREAS, Array BioPharma Inc. (the “Corporation”) has adopted the Amended and Restated Deferred Compensation Plan of Array BioPharma Inc. (the “Plan”), which has been amended from time to time and which was most recently restated by the adoption of The CORPORATEplan for Retirement SM EXECUTIVE Plan, Fidelity Basic Plan Document (the “Basic Plan Document”), by executing an Adoption Agreement on January 30, 2006 (the “Adoption Agreement”);

 

WHEREAS, Section 9.01 of the Basic Plan Document, provides for the amendment of the Plan by the Corporation, and

 

WHEREAS, the Corporation desires to amend the Plan to provide (1) for the participation by members of the Corporation’s Board of Directors, (2) provide discretion of employer and matching contributions, (3) to alter the timing of certain distributions, and (4) to provide for the assumption of the Plan upon a Change of Control.

 

NOW, THEREFORE, BE IT RESOLVED, that, effective as of the date hereof, Section 2.01(a)(8) of the Basic Plan Document is hereby amended to add a new sentence at the end of such section to read as follows:

 

“Notwithstanding the preceding, for purposes of an Employee who is a Self-Employed Individual, Compensation means Earned Income.”

 

FURTHER RESOLVED , that, effective as of the date hereof, Section 1.05(b)(4)(E) of the Adoption Agreement is hereby deleted in its entirety and restated to read as follows:

 

“(E)                            No requirements; provided, however, that the Administrator may determine that certain Participants are not entitled to Matching Contributions.”

 



 

FURTHER RESOLVED, that, effective as of the date hereof, Section 1.05(c)(3)(E) of the Adoption Agreement is hereby deleted in its entirety and restated to read as follows:

 

“(E)                            No requirements; provided, however, that the Administrator may determine that certain Participants are not entitled to Employer Contributions.”

 

FURTHER RESOLVED, that, effective as of the date hereof, Section 1.06(b)(1)(B) of the Adoption Agreement is hereby deleted in its entirety and restated to read as follows:

 

“(B)                           The date elected by the Participant, pursuant to Plan Section 8.02, and subject to the restrictions imposed in Plan Section 8.02 with respect to future Deferral Contributions, in which event such date of distribution must be at least three years after the date such Deferral Contribution would have been paid to the Participant in cash in the absence of the election to make the Deferral Contributions.  Distributions shall commence on the first of the month following the date of the distributable event.”

 

FURTHER RESOLVED, that, effective as of the date hereof, Section 1.06(c) of the Adoption Agreement is hereby deleted in its entirety and restated to read as follows:

 

“(c)                             Upon a Change of Control in accordance with Plan Section 7.08; provided, however, that a distribution shall not begin upon a Change of Control if a provision for the assumption or continuation of the Plan is made in writing in connection with such Change of Control.”

 

FURTHER RESOLVED , that, effective as of the date hereof, Section 1.06(b)(1) of the Adoption Agreement is hereby deleted in its entirety and restated to read as follows:

 

“(1) Upon the earliest to occur of:”

 

FURTHER RESOLVED , that, effective as of the date hereof, a new Section 1.13 is added to the Adoption Agreement to read as follows:

 

“1.13                      Administrator may permit Participants to change their elections in a manner consistent with Internal Revenue Code Section 409A and the guidance promulgated thereunder.”

 



 

IN WITNESS WHEREOF, the Corporation has caused this First Amendment to the Amended and Restated Deferred Compensation Plan of Array BioPharma Inc. to be executed this 30 th day of January 2006, by its duly authorized officer.

 

 

ARRAY BIOPHARMA INC.

 

 

 

 

By: R. Michael Carruthers

 

 

 

Title: Chief Financial Officer

 

 

 

 

 

Attest:

 

 

 


Exhibit 31.1

 

CERTIFICATION UNDER SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Robert E. Conway, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Array BioPharma 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 and I am 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 is made known to us by others within this entity, particularly during the period in which this report is being prepared;

 

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

 

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

 

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

 

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

 

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

 

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

 

Date: February 6, 2006

/s/ Robert E. Conway

 

 

 

 

 

Robert E. Conway

 

Chief Executive Officer

 

1


Exhibit 31.2

 

CERTIFICATION UNDER SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, R. Michael Carruthers, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Array BioPharma 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 and I am 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 is made known to us by others within this entity, particularly during the period in which this report is being prepared;

 

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

 

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

 

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

 

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

 

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

 

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

 

Date: February 6, 2006

/s/ R. Michael Carruthers

 

 

 

 

 

R. Michael Carruthers

 

Chief Financial Officer

 

1


Exhibit 32.0

 

CERTIFICATES PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

The undersigned, Robert E. Conway, Chief Executive Officer of Array BioPharma Inc. (the “Company”) and R. Michael Carruthers, Chief Financial Officer of the Company, do each hereby certify that, to the best of his knowledge and except as corrected or supplemented in a subsequent periodic report filed pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of the date hereof:

 

(a) the Quarterly Report on Form 10-Q of the Company for the three-month period ended December 31, 2005, filed on the date hereof with the Securities and Exchange Commission (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and

 

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

 

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

The undersigned have executed this Certificate as of the 6 th day of February 2006.

 

 

 

 

 

 

/s/ Robert E. Conway

 

 

 

 

 

 

 

 

 

 

Robert E. Conway

 

 

 

 

 

Chief Executive Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

/s/ R. Michael Carruthers

 

 

 

 

 

 

 

 

 

 

R. Michael Carruthers

 

 

 

 

 

Chief Financial Officer

 

 

1