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, 2003

 

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)

 


 

Check 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

 

Check whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes   ý      No   o

 

As of January 29, 2004, the registrant had 28,561,964 shares of common stock, par value $.001 per share, outstanding.

 

 



 

ARRAY BIOPHARMA INC.

TABLE OF CONTENTS

 

 

PART I - FINANCIAL INFORMATION

 

 

 

Item 1.

Condensed Financial Statements

3

 

 

 

Balance Sheets at December 31, 2003 (unaudited) and June 30, 2003

3

 

 

 

Statements of Operations – Three and Six Months Ended December 31, 2003 and 2002 (unaudited)

4

 

 

 

Statements of Cash Flows – Six Months Ended December 31, 2003 and 2002 (unaudited)

5

 

 

 

Notes to Condensed Financial Statements (unaudited)

6

 

 

Item 2.

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

9

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

16

 

 

Item 4.

Controls and Procedures

17

 

 

 

 

PART II - OTHER INFORMATION

 

 

 

Item 4.

  Submission of Matters to a Vote of Security Holders

17

 

 

Item 6.

  Exhibits and Reports on Form 8-K

18

 

 

 

 

SIGNATURES

19

 

2



 

PART I.

 

Item 1 . Financial Statements

 

ARRAY BIOPHARMA INC.

CONDENSED BALANCE SHEETS

 

 

 

December 31,
2003

 

June 30,
2003

 

 

 

(Unaudited)

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

 

$

28,714,208

 

$

23,071,992

 

Marketable securities

 

6,190,876

 

11,058,458

 

Accounts receivable, net

 

7,699,493

 

1,643,746

 

Inventories, net

 

9,313,883

 

9,064,548

 

Prepaid expenses, advances and deposits

 

631,845

 

730,679

 

Total current assets

 

52,550,305

 

45,569,423

 

 

 

 

 

 

 

Property, plant and equipment

 

54,892,174

 

53,938,905

 

Less accumulated depreciation

 

(19,775,302

)

(15,758,221

)

Property, plant and equipment, net

 

35,116,872

 

38,180,684

 

 

 

 

 

 

 

Other assets

 

80,246

 

80,246

 

 

 

 

 

 

 

Total assets

 

$

87,747,423

 

$

83,830,353

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable trade

 

$

2,085,494

 

$

2,522,871

 

Advance payments from customers

 

17,147,359

 

2,102,346

 

Accrued compensation and benefits

 

954,591

 

1,054,779

 

Other current liabilities

 

522,341

 

436,840

 

Total current liabilities

 

20,709,785

 

6,116,836

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

Preferred stock

 

 

 

Common stock

 

28,516

 

28,221

 

Additional paid-in capital

 

124,512,388

 

124,050,659

 

Accumulated deficit

 

(56,353,894

)

(44,155,945

)

Accumulated other comprehensive income

 

3,640

 

21,856

 

Deferred compensation

 

(1,153,012

)

(2,231,274

)

Total stockholders’ equity

 

67,037,638

 

77,713,517

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

87,747,423

 

$

83,830,353

 

 

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,

 

 

 

2003

 

2002

 

2003

 

2002

 

Revenue

 

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

6,907,414

 

$

9,011,492

 

$

13,917,785

 

$

19,235,422

 

License, royalty and milestone revenue

 

687,499

 

490,947

 

872,600

 

770,763

 

Total revenue

 

7,594,913

 

9,502,439

 

14,790,385

 

20,006,185

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses

 

 

 

 

 

 

 

 

 

Cost of revenue*

 

5,009,306

 

5,670,321

 

10,031,047

 

11,669,970

 

Research and development expenses:

 

 

 

 

 

 

 

 

 

for collaborations*

 

2,220,166

 

2,343,706

 

4,450,863

 

4,182,505

 

for proprietary drug discovery

 

4,565,158

 

2,411,299

 

8,597,414

 

4,461,086

 

Selling, general and administrative expenses*

 

2,138,577

 

2,201,345

 

4,078,342

 

4,287,504

 

Total operating expenses

 

13,933,207

 

12,626,671

 

27,157,666

 

24,601,065

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(6,338,294

)

(3,124,232

)

(12,367,281

)

(4,594,880

)

 

 

 

 

 

 

 

 

 

 

Interest income

 

77,084

 

230,335

 

169,332

 

486,780

 

Net loss

 

$

(6,261,210

)

$

(2,893,897

)

$

(12,197,949

)

$

(4,108,100

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.22

)

$

(0.10

)

$

(0.43

)

$

(0.15

)

 

 

 

 

 

 

 

 

 

 

Number of shares used to compute per share data

 

28,388,261

 

27,720,183

 

28,324,384

 

27,639,234

 

 

 

 

 

 

 

 

 

 

 


* Includes compensation related to option grants

 

 

 

 

 

 

 

 

 

Cost of revenue

 

$

245,793

 

$

264,902

 

$

491,584

 

$

529,804

 

Research and development for collaborations

 

163,863

 

176,602

 

327,724

 

353,204

 

Selling, general and administrative expenses

 

129,477

 

134,061

 

258,954

 

268,122

 

Total

 

$

539,133

 

$

575,565

 

$

1,078,262

 

$

1,151,130

 

 

See notes to condensed financial statements

 

4



 

ARRAY BIOPHARMA INC.

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

 

Six Months Ended
December 31,

 

 

 

2003

 

2002

 

Operating activities

 

 

 

 

 

Net loss

 

$

(12,197,949

)

$

(4,108,100

)

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

 

 

 

 

 

Depreciation

 

4,026,489

 

3,169,491

 

Compensation related to stock option grants

 

1,078,262

 

1,151,130

 

Changes in operating assets and liabilities

 

8,386,701

 

(6,751,854

)

Net cash provided by (used in) operating activities

 

1,293,503

 

(6,539,333

)

 

 

 

 

 

 

Investing activities

 

 

 

 

 

Purchases of property, plant and equipment and long-term assets

 

(962,677

)

(7,571,377

)

Purchases of marketable securities

 

(6,175,634

)

(31,965,847

)

Proceeds from sale or maturity of marketable securities

 

11,025,000

 

32,000,000

 

Net cash provided by (used in) investing activities

 

3,886,689

 

(7,537,224

)

 

 

 

 

 

 

Financing activities

 

 

 

 

 

Proceeds from repayment of notes receivable for common stock

 

 

157,183

 

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

 

462,024

 

907,773

 

Net cash provided by financing activities

 

462,024

 

1,064,956

 

 

 

 

 

 

 

Net increase (decrease) in cash and cash equivalents

 

5,642,216

 

(13,011,601

)

Cash and cash equivalents, beginning of period

 

23,071,992

 

35,385,675

 

Cash and cash equivalents, end of period*

 

$

28,714,208

 

$

22,374,074

 

 


* Excludes marketable securities totaling $6,190,876 and $24,209,953 as of December 31, 2003 and 2002, respectively.

 

See notes to condensed financial statements

 

5



 

ARRAY BIOPHARMA INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

December 31, 2003

(Unaudited)

 

Note 1: Basis of Presentation

 

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-month month periods ended December 31, 2003, are not necessarily indicative of the results that may be expected for the year ending June 30, 2004. For further information, refer to the financial statements and footnotes thereto as of and for the year ended June 30, 2003, included in the Annual Report on Form 10-K of Array BioPharma Inc. (the “ Company ” or “ Array ”) filed on September 26, 2003, with the Securities and Exchange Commission.

 

Note 2: Inventory Components

 

 

 

December 31,
2003

 

June 30,
2003

 

Fine chemicals

 

$

3,853,656

 

$

3,463,230

 

Lead Generation Libraries, custom libraries and Optimer building blocks

 

10,087,354

 

11,252,962

 

Total inventories at cost

 

13,941,010

 

14,716,192

 

Less reserves

 

(4,627,127

)

(5,651,644

)

Total inventories, net

 

$

9,313,883

 

$

9,064,548

 

 

Note 3: Comprehensive Loss

 

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

 

 

 

Three Months Ended
December 31,

 

Six Months Ended
December 31,

 

 

 

2003

 

2002

 

2003

 

2002

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(6,261,210

)

$

(2,893,897

)

$

(12,197,949

)

$

(4,108,100

)

Change in unrealized gain (loss) on marketable securities

 

(440

)

36,200

 

(18,216

)

32,030

 

Total comprehensive loss

 

$

(6,261,650

)

$

(2,857,697

)

$

(12,216,165

)

$

(4,076,070

)

 

6



 

Note 4: Common Stock

 

In September 2002, the Company received $157,183 from a Company founder as full repayment of an outstanding note receivable balance, including accrued interest, payable in connection with the purchase by the founder of shares of the Company’s common stock in May 1998. All notes receivable for common stock have been fully repaid by the Company’s founders.

 

Note 5: Revenue Recognition

 

The Company recognizes revenue from fees under its collaboration agreements on a monthly basis as work is performed. Development and fixed-fee revenue is recognized on a percentage-of-completion basis. Per-compound revenue is recognized as compounds are shipped. Revenue from license fees and up-front fees is recognized over the expected period of the related research program. Royalty revenue is recorded when earned. Portions of milestone payments are recognized as revenue when the Company has met the contracted performance criterion of the related milestone, while the balance of the payment is recognized ratably over the remainder of the research program. Revenue recognition related to license fees, up-front payments and milestone payments could be accelerated in the event of early termination of programs, or extended over longer periods in the event of extensions to 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 advanced payments from customers until the revenue is earned. The Company reports revenue from collaboration agreements, which include lead generation and lead optimization research, custom synthesis and process research and the development and sale of chemical compounds, as collaboration revenue. License, royalty and milestone revenue are combined and reported separately from collaboration revenue.

 

Note 6: 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 applicable periods presented.

 

Note 7: Stock-Based Compensation

 

The Company accounts for its stock-based compensation arrangements under the provisions of Accounting Principle 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 is recognized when stock options are granted with exercise prices equal to or greater than market value on the date of grant.

 

The Company adopted the disclosure requirements of FASB Statement No. 148, Accounting for Stock-Based Compensation – Transition and Disclosure , which amends the disclosure provisions of FASB Statement No. 123, Accounting for Stock-Based Compensation (“SFAS 123”), and Accounting Principle Board Opinion No. 28, Interim Financial Reporting, to require disclosure of the method of accounting used for stock-based compensation and the effects of this method on reported net income and earnings per share for annual and interim financial statements. The following table illustrates the effect on net loss and net loss per share assuming the estimated fair value of the options granted is amortized to expense over the option-vesting period as required by SFAS 123.

 

7



 

 

 

Three Months Ended
December 31,

 

Six Months Ended
December 31,

 

 

 

2003

 

2002

 

2003

 

2002

 

 

 

 

 

 

 

 

 

 

 

Net loss applicable to common stockholders, as reported

 

$

(6,261,210

)

$

(2,893,897

)

$

(12,197,949

)

$

(4,108,100

)

 

 

 

 

 

 

 

 

 

 

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

 

539,133

 

575,565

 

1,078,262

 

1,151,130

 

 

 

 

 

 

 

 

 

 

 

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

 

(1,941,819

)

(2,215,740

)

(3,847,875

)

(4,410,598

)

 

 

 

 

 

 

 

 

 

 

Pro forma net loss applicable to common stockholders

 

$

(7,663,896

)

$

(4,534,072

)

$

(14,967,562

)

$

(7,367,568

)

 

 

 

 

 

 

 

 

 

 

Net loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted - as reported

 

$

(0.22

)

$

(0.10

)

$

(0.43

)

$

(0.15

)

Basic and diluted - pro forma

 

$

(0.27

)

$

(0.16

)

$

(0.53

)

$

(0.27

)

 

 

 

 

 

 

 

 

 

 

Number of shares used to compute per share data

 

28,388,261

 

27,720,183

 

28,324,384

 

27,639,234

 

 

Note 8: Financial Guarantees

 

At December 31, 2003 and June 30, 2003, the Company included in cash and cash equivalents restricted cash of $1.3 million and $1.1 million, respectively, as compensating balances to support outstanding standby letters of credit. The standby letters of credit were issued during the fiscal years of 2003 and 2002 to secure the Company’s obligations under its facilities leases.

 

8



 

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 and our future headcount 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 collaborate with and fund third parties on their drug discovery activities, the ability of our collaborators and of Array to meet drug discovery objectives tied to milestones and royalties, our ability to continue to fund and successfully progress internal research efforts and to create effective, commercially viable drugs, 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 on September 26, 2003. We are providing the information in this quarterly report filed on Form 10-Q as of the date of this report. We undertake no duty to update any forward-looking statements to reflect the effect on those statements of subsequent events or changes in our expectations or assumptions.

 

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 creating the next generation of orally active drugs by integrating the latest advances in chemistry, biology and informatics. Our drug development pipeline is focused primarily in cancer and inflammatory disease and includes many promising small molecule drugs that affect disease pathways with well-validated targets. Array also collaborates with leading pharmaceutical and biotechnology companies to invent and optimize drug candidates across a broad range of therapeutic areas.

 

We have incurred net losses since inception and expect to incur losses in the near future as we continue to expand our proprietary drug discovery programs. To date, we have funded our operations primarily through the issuance of equity securities and revenue from our collaborators. As of December 31, 2003, we had an accumulated deficit of $56.4 million.

 

We generate revenue by researching, designing, synthesizing and screening chemical compounds for the invention of drug candidates for our collaborators. We report revenue from collaboration agreements, which include lead generation and lead optimization services, custom synthesis and process research and the development and sale of chemical compounds, as collaboration revenue in our statement of operations. License, royalty and milestone revenue are combined and reported separately from collaboration revenue.

 

Our collaborations include lead generation, lead optimization, custom synthesis and process research and development. We provide lead generation services, including structural biology and screening compound libraries, to invent lead candidates for our collaborators and lead optimization services to refine and optimize potential drug candidates. We also design, synthesize and provide

 

9



 

libraries of chemical compounds or single compounds to our collaborators on a custom basis, with either an exclusive or non-exclusive license to use the compounds. We assist collaborators in process research and development, which involves developing the processes to make, and synthesizing for delivery, the larger quantities of chemical compounds required for preclinical and clinical testing. We also produce chemical compounds in our cGMP manufacturing facility that meet cGMP requirements for Phase I clinical testing. In fiscal 2003, we first used this facility to produce bulk material for clinical testing of ARRY-142886, our most advanced proprietary development program.

 

We license 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 internal research purposes. We retain all other rights to the compounds, which permits us to license the same compounds to other customers. Some of our agreements allow our collaborators to obtain exclusive rights to commercialize particular compounds upon the payment of additional fees. 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. We are also paid under our collaboration agreements based on the number of full-time equivalent employees contractually assigned to a project, plus certain expenses. Custom collections of chemical compounds we create and custom chemical syntheses we perform under our collaboration agreements are typically charged on a per-compound basis, plus a charge for research and development services. In addition, eight of our current, and six of our past, collaboration agreements provide for additional payments upon the achievement of certain drug development milestones, and seven of our collaboration agreements provide for royalty payments based on sales of products created as a result of these collaborations. Two of our current, and three of our past, collaboration agreements provided an up-front license or technology access fee. In general, our collaborators may terminate their collaboration agreement with us on 30 to 90 days’ prior notice. We earned our first milestone payment from ICOS Corporation in November 2001 with the commencement of a Phase I clinical trial on a jointly identified drug candidate. In August 2003, we received our first milestone payment from a major Japanese pharmaceutical company for Array’s successes in creating a series of small molecule drug leads against a proprietary target.

 

Although we have increased the number of our collaboration agreements, our top 20 collaborators contributed over 95% of our total revenue for the first six months of fiscal 2004, and our current top two collaborators, Merck & Co., Inc. and Eli Lilly and Company, accounted for 20% and 14%, respectively, of our total revenue. Future revenue from our newly announced collaborations with AstraZeneca AB and Genentech, Inc., is expected to position these companies as our top two collaborators for fiscal year 2004. During fiscal year 2003, ICOS Corporation, Merck and Eli Lilly accounted for 21%, 15% and 12%, respectively, of our total revenue.

 

We recognize revenue from fees under our collaboration agreements on a monthly basis as work is performed. Development and fixed-fee revenue is recognized on a percentage-of-completion basis. Per-compound revenue is recognized as compounds are shipped. Revenue from license fees and up-front fees is recognized over the expected period of the related research program. Royalty revenue is recorded when earned. Portions of milestone payments are recognized as revenue when we have met the contracted performance criterion of the related milestone, while the balance of the payment is recognized ratably over the remainder of the research program. Revenue recognition related to license fees, up-front payments and milestone payments could be accelerated in the event of early termination of programs, or extended over longer periods in the event of extensions to 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 advanced payments from customers until the revenue is earned. We report revenue from collaboration agreements, which include lead generation and lead optimization research, custom synthesis and process research and

 

10



 

the development and sale of chemical compounds, as collaboration revenue. License, royalty and milestone revenue are combined and reported separately from collaboration revenue.

 

Cost of revenue consists mainly of compensation, associated fringe benefits and other collaboration-related costs, including recruiting and relocation, fine chemicals, supplies, small tools, facilities, depreciation and other direct and indirect chemical handling and laboratory support costs, excluding any costs related to research and development. We review inventories periodically and reduce items considered to be slow moving or obsolete to estimated net realizable value through an appropriate reserve.

 

Research and development expenses consist of the same type of scientific expenditures that comprise cost of revenue, except that the expenses are related to the development of our early-stage intellectual property and compounds where we have not yet proven technological feasibility. Costs associated with activities where technological feasibility has been proven are charged directly to cost of revenue.

 

Selling, general and administrative expenses consist mainly of compensation and associated fringe benefits and other management, business development, accounting, information technology and administration costs, including recruiting and relocation, consulting and professional services, travel and meals, advertising, sales commissions, facilities, depreciation and other office expenses. In addition, termination related costs of approximately $541,000 associated with a reduction in workforce completed during the prior fiscal year in March 2003 were recorded as selling, general and administrative expenses.

 

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 26% of our total revenue during the first six months of fiscal year 2004, up from 14% for the full fiscal year of 2003. Our international revenue is attributed to European, Canadian and Japanese collaborations. All of our collaboration agreements and purchase orders are denominated in United States dollars.

 

We plan to continue to increase our investment in our proprietary research programs and to seek additional collaborations in which we participate in the success of our proprietary potential drug candidates through a combination of licensing fees, payments for continued research and down-stream payments that include milestone and/or royalty payments.  We also intend to continue to grow revenue with our existing collaborators and realize new revenue streams through collaborations with a diversified group of pharmaceutical and biotechnology companies. In addition, we expect to enter into additional agreements that allow us to participate in the success of potential drug candidates with our collaborators through milestone and/or royalty payments.

 

Deferred Stock Compensation

 

We recorded approximately $539,000 and $1.1 million of stock compensation expense for the three- and six-month periods ended December 31, 2003. This stock compensation is related to the vesting of stock options that were granted prior to our initial public offering in November 2000. The stock compensation expense is charged to cost of revenue, research and development expenses, and selling, general and administrative expenses, based on the functional responsibility of the associated employee. As of December 31, 2003, we had a total of $1.2 million of deferred stock compensation remaining to be amortized. We expect to amortize this deferred stock compensation through March 31, 2005, as follows: $1.0 million during the remainder of fiscal year 2004 and approximately $200,000 in fiscal year 2005.

 

11



 

Results of Operations

 

Three and Six Months Ended December 31, 2003 and 2002

 

 

 

Three Months Ended
December 31,

 

Six Months Ended
December 31,

 

 

 

2003

 

2002

 

2003

 

2002

 

 

 

(in thousands)

 

(in thousands)

 

Revenue:

 

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

6,907

 

$

9,011

 

$

13,918

 

$

19,235

 

 

 

 

 

 

 

 

 

 

 

License, royalty and milestone revenue

 

687

 

491

 

873

 

771

 

Total revenue

 

$

7,594

 

$

9,502

 

$

14,791

 

$

20,006

 

 

Revenue. Revenue from collaboration agreements for the three and six months ended December 31, 2003 decreased by $2.8 million and $4.8 million, respectively, compared with the same periods of the prior year primarily due to the expiration of four significant lead optimization programs during the last quarter of fiscal 2003 and the beginning of fiscal 2004. In addition, revenue from subscriptions and sales of chemical compounds from our Array Discovery Platform decreased by approximately $331,000 and $1.2 million for the three- and six-month periods ended December 31, 2003, respectively, compared with the same periods of the prior year. Partially offsetting these decreases were collaboration revenue generated from our new agreements with InterMune, Inc. and GenPath Pharmaceuticals, Inc., and our newly announced collaborations with AstraZeneca AB and Genentech, Inc.

 

During December 2003, we signed agreements containing up-front license fees related to the AstraZeneca and Genentech collaborations for a combined amount of $16.0 million. In December, we recorded approximately $667,000 in license fee revenue while the remaining $15.3 million was recorded as advance payments from customers. We anticipate license fee revenue to increase in future periods as three full months of the remaining license fee revenue is recognized each quarterly period through the expected term of each related research program.

 

Cost of revenue. Cost of revenue decreased by $0.7 million and $1.7 million for the three and six months ended December 31, 2003, respectively, primarily due to the decrease in lead optimization collaboration revenue over these same periods. Cost of revenue increased to 66% of revenue for the three months ended December 31, 2003, from 60% in the same period of the prior year. Cost of revenue increased to 68% of revenue for the six months ended December 31, 2003, from 58% in the same period of the prior year. The increased cost of revenue as a percentage of revenue for the three and six months ended December 31, 2003, was due primarily to a lower revenue base against which to apply certain fixed costs as well as lower revenue being generated from subscriptions and sales of chemical compounds from our Array Discovery Platform.

 

12



 

 

 

Three Months Ended
December 31,

 

Six Months Ended
December 31,

 

 

 

2003

 

2002

 

2003

 

2002

 

 

 

(in thousands)

 

(in thousands)

 

Research and development expenses:

 

 

 

 

 

 

 

 

 

for collaborations

 

$

2,220

 

$

2,344

 

$

4,451

 

$

4,183

 

for proprietary drug discovery

 

4,565

 

2,411

 

8,597

 

4,461

 

Total research and development

 

$

6,785

 

$

4,755

 

$

13,048

 

$

8,644

 

 

Research and development expenses. The increases in research and development expenses of 43% and 51% for the three and six months ended December 31, 2003, respectively, over the same periods of the prior year were directly the result of our expanded proprietary drug discovery efforts. These expanded research efforts required additional scientific staff and associated salaries and benefits, and included increased costs associated with pharmacology and drug metabolism testing. We plan to continue increasing our research and development efforts related to the discovery of additional intellectual property, which will result in increased research and development expenses in future periods.

 

Selling, general and administrative expenses. Selling, general and administrative expenses totaled $2.1 million for the three months ended December 31, 2003, compared with $2.2 million in the same period of the prior year. For the six-month period ended December 31, 2003, selling, general and administrative expenses decreased to $4.1 million from $4.3 million in the same period of the prior year. These decreases were attributed to cost savings associated with the elimination of certain administrative positions affected by our March 2003 reduction in workforce.

 

Compensation related to stock option grants. Compensation expense related to certain stock options that were granted prior to our November 2000 initial public offering, for the three- and six-month periods ended December 31, 2003 were approximately $539,000 and $1.1 million, respectively. During the comparable three- and six-month periods of the prior year this expense was approximately $576,000 and $1.1 million, respectively. This noncash charge is recognized on a straight-line basis over the vesting periods of the related options, which are generally four years, except for options with performance-based vesting provisions.

 

Interest income. Interest income decreased to approximately $77,000 and $169,000 for the three and six months ended December 31, 2003, respectively, from approximately $230,000 and $487,000, respectively, in the same periods of the prior year primarily due to lower investment interest rates earned on a lower average cash balance.

 

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, 2003, cash, cash equivalents and marketable securities totaled $34.9 million compared with $34.1 million at June 30, 2003. Net cash provided by operating activities was $1.3 million for the six months ended December 31, 2003, compared with net cash used of $6.5 million for the same period in fiscal 2003. During the first six months of fiscal year 2004, our net loss of $12.2 million was reduced by noncash charges of $5.1 million associated with depreciation and compensation related to stock option grants, and our working capital, excluding cash and marketable securities, decreased by $8.4 million. The decrease in working capital was primarily related to the $15.0 million increase in advance payments from customers, partially offset by the $6.1 million increase in

 

13



 

accounts receivable. These changes were largely the result of our executing agreements during the current quarter to receive up-front license fees from two collaborators for a combined amount of $16.0 million. As of December 31, 2003, $10.0 million of these up-front license fees had been received and the outstanding $6.0 million remained in accounts receivable. We recognized approximately $667,000 of these up-front license fees as revenue during December 2003, while the remaining $15.3 million was recorded as advance payments from customers.

 

During the six months ended December 31, 2003, we invested approximately $963,000 in capital equipment and leasehold improvements primarily associated with equipping and commencing operations in our new pharmacology and drug metabolism facilities. Financing activities provided approximately $462,000 of cash from the exercise of stock options under our stock option plan and the issuance of stock under our employee stock purchase plan.

 

Our future capital requirements will depend on a number of factors, including the rate at which we grow our business and our investment in proprietary research activities, the ability of our current and future collaborators to fund outside research and development activities, our success in increasing sales of both existing and new products and collaborations, expenses associated with unforeseen litigation, regulatory changes, competition, technological developments, general economic conditions and potential future merger and acquisition activity. 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;

our ability to enter into agreements to co-develop our proprietary drug candidates;

the number and scope of our research programs;

the progress of our preclinical and potential 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 costs and timing of regulatory approvals; and

the costs of establishing business development and distribution capabilities.

 

Future capital requirements will also depend upon the extent to which we acquire or invest in other businesses, products and technologies. 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 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 operate as an ongoing concern. If we raise additional funds by issuing equity securities, substantial dilution to existing stockholders may result.

 

14



 

Obligations and Commitments

 

There has been no material change in our obligations and commitments during the first six months of fiscal year 2004.

 

At December 31, 2003, we had restricted cash of $1.3 million as a compensating balance to support outstanding letters of credit we issued during prior fiscal years to secure our obligations under our facilities leases.

 

Critical Accounting Policies

 

We believe the policies identified below are critical 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 there is a great likelihood 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.

 

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. 101, 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.

 

We recognize revenue from fees under our collaboration agreements on a monthly basis as work is performed. Development and fixed-fee revenue is recognized on a percentage-of-completion basis. Per-compound revenue is recognized as compounds are shipped. Revenue from license fees and up-front fees is recognized over the expected period of the related research program. Royalty revenue is recorded when earned. Portions of milestone payments are recognized as revenue when we have met the contracted performance criterion of the related milestone, while the balance of the payment is recognized ratably over the remainder of the research program. Revenue recognition related to license fees, up-front payments and milestone payments could be accelerated in the event of early termination of programs, or extended over longer periods in the event of extensions to 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 advanced payments from customers until the revenue is earned. We report revenue from collaboration agreements, which include lead generation and lead optimization research, custom synthesis and process research and the development and sale of chemical compounds, as collaboration revenue. License, royalty and milestone revenue are combined and reported separately from collaboration revenue.

 

15



 

Inventory Valuation

 

Our inventories are a significant component of our total assets. In addition, the value at which we carry our inventory directly impacts our results of operations. Our inventories primarily consist of individual chemical compounds in the form of Optimer building blocks, our Lead Generation Libraries, custom libraries and commercially available fine chemicals. Our inventories are stated at the lower of cost or market, cost being determined under the first-in, first-out method. We design and produce chemical compounds comprising our Lead Generation Libraries, custom libraries and Optimer building blocks and for our proprietary research activities, and begin capitalizing costs into inventory only after technological feasibility has been established. We review inventories periodically and reduce items considered to be slow moving or obsolete to estimated net realizable value through an appropriate reserve.

 

Recent Accounting Pronouncements

 

In January 2003, the Emerging Issues Task Force (“EITF”) issued EITF Statement No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables (“EITF 00-21”). EITF 00-21 addresses how to determine whether a revenue arrangement involving multiple deliverables contains more than one unit of accounting for purposes of revenue recognition and how the revenue arrangement consideration should be measured and allocated to the separate units of accounting. EITF 00-21 applies to all revenue arrangements that are executed in fiscal periods beginning after June 15, 2003. Array adopted EITF 00-21 during the quarter ended September 30, 2003. The adoption of this statement is not expected to have a significant impact on our financial statements.

 

Item 3 . Quantitative and Qualitative Disclosures About Market Risk

 

Short-term investments . 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 maturity of our short-term investments, we have concluded that there is no material market risk exposure.

 

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.

 

16



 

Item 4 . Controls and Procedures.

 

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. Based on this evaluation, management concluded that, as of December 31, 2003, Array’s disclosure controls and procedures are 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.

 

There has been no change in our internal control for financial reporting that occurred during our second quarter ended December 31, 2003 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

 

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 30, 2003. At that meeting, two proposals were submitted to a vote of the Company’s stockholders. Proposal 1 was a proposal to elect two Class III directors to serve a three-year term of office expiring on the date of the 2006 annual meeting of stockholders. The two nominees for Class III director were Francis J. Bullock, Ph.D. and Kevin Koch, Ph.D.  Proposal 2 was a proposal to ratify the appointment of Ernst & Young LLP as the Company’s independent auditors for the fiscal year ending June 30, 2004. For further information regarding the annual meeting, please see the Company’s Proxy Statement on Schedule 14A filed with the Securities and Exchange Commission on October 1, 2003. The stockholders approved all proposals as follows:

 

 

 

Number of Votes

 

Proposal

 

For

 

Against

 

Abstain/ Withhold

 

 

 

 

 

 

 

 

 

Proposal 1 - Election of Class III directors

 

 

 

 

 

 

 

Francis J. Bullock, Ph.D.

 

25,075,267

 

 

340,198

 

Kevin Koch, Ph.D.

 

25,368,349

 

 

47,116

 

 

 

 

 

 

 

 

 

Proposal 2 - Ratification of the appointment of
Ernst & Young LLP

 

25,360,383

 

47,860

 

7,222

 

 

17



 

Item 6 . Exhibits and Reports on Form 8-K

 

(a)                                   Exhibits

 

10.1 (1)           Collaboration and License Agreement by and between the Company and AstraZeneca AB, dated December 18, 2003

 

10.2 (1)           Drug Discovery Collaboration Agreement by and between the Company and Genentech, Inc., dated December 22, 2003

 

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.

 


(1) Confidential treatment of redacted portions has been applied for

 

 

(b)                                  Reports on Form 8-K during the second quarter of Fiscal 2004

 

The Company filed a Current Report on Form 8-K dated November 3, 2003, to file a press release reporting financial results for the first quarter of fiscal 2004.

 

The Company filed a Current Report on Form 8-K dated December 18, 2003, to file a press release announcing a licensing and collaboration agreement between the Company and AstraZeneca AB.

 

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

 

18



 

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 2, 2004

By:

/s/ Robert E. Conway

 

 

 

Robert E. Conway

 

 

Chief Executive Officer

 

 

 

 

 

 

Dated:  February 2, 2004

By:

/s/ R. Michael Carruthers

 

 

 

R. Michael Carruthers

 

 

Chief Financial Officer

 

 

(Principal Financial Officer and

 

 

Principal Accounting Officer)

 

19


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.

 

COLLABORATION AND LICENSE AGREEMENT

 

THIS COLLABORATION AND LICENSE AGREEMENT (the “Agreement”) is made effective as of the 18 th day of December, 2003 (“Effective Date”) by and between Array BioPharma Inc., a Delaware corporation of 3200 Walnut Street, Boulder, Colorado 80301  (“Array”), and AstraZeneca AB, a company incorporated in Sweden under no. 556011-7482 with offices at S-151 85 Södertälje, Sweden  (“AZ”).  Array and AZ are each referred to herein by name or as a “Party” or, collectively, as “Parties”.

 

RECITALS

 

A.                                    Array owns certain intellectual property rights and know-how with respect to that certain chemical compound designated as ARRY-142886, and believes that ARRY-142886 has the potential to become an anti-cancer agent with significant worldwide sales.

 

B.                                      Array desires to collaborate with a pharmaceutical company with oncology research, development and commercialization expertise with the aim of developing and commercializing ARRY-142886 worldwide so as to realize its therapeutic and commercial potential.  AZ is a leader in the research and development of pharmaceutical compounds and possesses pharmaceutical research, development and commercialization capabilities, as well as proprietary compounds and technology in the field of cancer treatment.

 

C.                                      AZ desires to collaborate with Array in the development and commercialization of ARRY-142886 for the treatment of cancer.

 

D.                                     In addition, Array has an ongoing research program to identify and develop additional small molecule pharmaceutical products, the mechanism of action of which is the direct binding and inhibition of MEK, for the treatment of cancer, and has developed and continues to develop certain novel, proprietary compounds and technology in this field.  AZ is interested in collaborating with Array to develop the compounds identified by Array, and to develop and commercialize pharmaceutical products directed to MEK in the field of cancer treatment.

 

Now, therefore, in consideration of the premises and mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:

 

ARTICLE I - DEFINITIONS

 

The following terms shall have the following meanings as used in this Agreement:

 



 

1.1                                  Abandoned Product ” shall have the meaning ascribed to it in Section 11.3.2.

 

1.2                                  Affiliate ” shall mean any corporation or other entity which is directly or indirectly controlling, controlled by or under common control with a Party hereto for so long as such control exists.  For the purposes of this Section 1.2, “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 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.

 

1.3                                  Array Existing Technology ” shall mean Array Patents and Array Know-How, in each case Controlled by Array as of the Effective Date, that are reasonably necessary or useful for the Parties to conduct their respective activities under the Research Program and the Process Program and for AZ to develop, make, have made, use, import, offer to sell and sell, research, register, formulate, have used, export, transport, distribute, promote, market or have sold or otherwise dispose or offer to dispose of Candidate Drugs or Licensed Products in the Field.

 

1.4                                  Array Know-How ” shall mean Information which (a) Array discloses to AZ under this Agreement or specifically in anticipation of this Agreement and (b) is within the Control of Array.  Notwithstanding anything herein to the contrary, Array Know-How excludes published Array Patents.

 

1.5                                  Array Patents ” shall mean the Patents set out in Exhibit 1.5.

 

1.6                                  AZ Existing Technology ” shall mean AZ Patents and AZ Know-How, in each case Controlled by AZ or its Affiliates as of the Effective Date, that are reasonably necessary for the discovery, development, manufacture, use or sale of Candidate Drugs or Licensed Products.

 

1.7                                  AZ Know-How ” shall mean Information which (a) AZ discloses to Array under this Agreement or specifically in anticipation of this Agreement and (b) is within the Control of AZ or its Affiliates.  Notwithstanding anything herein to the contrary, AZ Know-How excludes published AZ Patents.

 

1.8                                  AZ Patents ” shall mean all Patents in the Territory owned or Controlled by AZ or its Affiliates.

 

1.9                                  “Calendar Quarter” means each successive period of three (3) calendar months commencing on 1st January, 1st April, 1st July and 1st October.

 

1.10                            “Calendar Year” means each successive period of twelve (12) calendar months commencing on 1st January.

 

1.11                            Candidate Drug ” shall mean a Compound selected for clinical development in accordance with Section 2.5 below.

 

2



 

1.12                            Candidate Drug Target Profile ” shall mean (i) those criteria set forth in Exhibit 1.12, and/or (ii) such other criteria as are approved by the JRC and agreed in writing by the Parties.  No criteria shall be deemed part of the Candidate Drug Target Profile under (ii) unless such criteria are formally approved by the JRC and agreed in writing by the Parties, regardless of whether such criteria are used informally or discussed by the Parties in the course of the Research Program.

 

1.13                            Chemical Patent ” shall have the meaning set out in Section 8.2.2.

 

1.14                            Collaboration Technology ” shall mean Joint Patents, Chemical Patents, Joint Chemical Patents and all inventions and Information, invented, conceived or created solely or jointly by employees, agents or consultants of AZ and/or Array in the course of performing their respective activities in connection with the Research Program or the Process Program and including any biological assays and test methods.

 

1.15                            Co-Funded Product “ shall have the meaning defined in Section 3.5.1.

 

1.16                            Co-Funding Option ” shall mean the option of Array to fund a portion of the Phase III Development Costs of a Licensed Product as provided in Section 3.5.

 

1.17                            Combination Product ” shall mean a Licensed Product that is a pharmaceutical preparation incorporating two or more therapeutically active ingredients, including a Candidate Drug, as its main active ingredients.  Notwithstanding the foregoing, drug delivery vehicles, adjuvants, and excipients shall not be deemed to be “therapeutically active ingredients,” and their presence shall not be deemed to create a Combination Product under this Section 1.17.

 

1.18                            Compound ” shall mean a small molecule modulator of MEK, the mechanism of which is direct binding and inhibition of MEK, wherein such chemical entity is identified by Array or AZ using Array Existing Technology, AZ Existing Technology or Collaboration Technology prior to the end of the Research Term.

 

1.19                            Contract Year ” shall mean a year of 365 days (or 366 days in a leap year) beginning on the Effective Date and ending one (1) year thereafter and so on year-by-year.  “ Contract Year One ” shall mean the first such year; “ Contract Year Two ” shall mean the second such year, and so on, year-by-year.

 

1.20                            Control, Controls, Controlled or Controlling ” shall mean possession of the ability to grant the licenses or sublicenses as provided herein without violating the terms of any agreement or other arrangements with any Third Party.

 

3



 

1.21                            Development Committee ” shall mean the team of AZ personnel and one (1) Array representative formed in accordance with Section 3.2 to discuss and report on the development of a Licensed Product.

 

1.22                            Development Criteria ” shall have the meaning described in Section 3.2 hereof.

 

1.23                            Development Milestone ” shall mean a milestone described in Section 6.4.

 

1.24                            Development Plan ” shall mean the workplan with respect to the development of a Licensed Product as set forth in Section 3.2.

 

1.25                            Exclusivity Period ” shall mean the period of time commencing with the Effective Date and ending upon the first anniversary of the end of the Research Term.

 

1.26                            Existing Technology ” shall mean either or both of Array Existing Technology and/or AZ Existing Technology.

 

1.27                            FDA ” shall mean, with respect to the United States, the U.S. Food and Drug Administration, any successor entity thereto, or any equivalent foreign regulatory authority(ies) in the particular country of the Territory.

 

1.28                            Field ” shall mean the diagnosis, treatment, palliation, and/or prevention of cancer in humans.

 

1.29                            FTE ” shall mean a full-time person dedicated to the Research Program or the Process Program, or in the case of less than a full-time dedicated person, a full-time, equivalent person year, based upon a total of one thousand eight hundred eighty (1,880) hours per year of work in connection with the Research Program or the Process Program.

 

1.30                            IND ” shall mean an investigational new drug application filed with the FDA as more fully defined in 21 C.F.R. § 312.3 or its equivalent in any country.

 

1.31                            Information ” shall mean information and materials relating to the subject matter of this Agreement and including (i) techniques and data, including, but not limited to, screens, models, inventions, methods, test data, including but not limited to, pharmacological, toxicological and clinical test data, analytical and quality control data, marketing, pricing, distribution, costs, and sales data, manufacturing information, and patent and legal data or descriptions (to the extent that disclosure thereof would not result in loss or waiver of privilege or similar protection) and (ii) compositions of matter, including but not limited to compounds, biological materials and assays.  As used herein, “clinical test data” shall be deemed to include all information related to the clinical or preclinical testing of a Candidate Drug or Licensed Product, including without limitation, patient report forms, investigators’ reports, biostatistical, pharmaco-economic and other related analyses, and the like.

 

4



 

1.32                            Joint Chemical Patent ” shall have the meaning set out in Section 8.2.2(k).

 

1.33                            Joint Intellectual Property shall have the meaning set out in Section 8.2.3.

 

1.34                            Joint Patent ” shall have the meaning set out in Section 8.2.3.

 

1.35                            Joint Research Committee (or JRC ”) shall mean the committee established under Section 2.2.

 

1.36                            Know How ” shall mean either or both of Array Know How and/or AZ Know How.

 

1.37                            Licensed Product ” shall mean a pharmaceutical preparation for human use incorporating ARRY-142886 or incorporating another Candidate Drug as an active ingredient.  For purposes of clarity, the term “Licensed Product” includes a pharmaceutical preparation formulated and first used in a clinical trial.

 

1.38                            Licensed Technology ” shall mean Array Existing Technology, AZ Existing Technology and Collaboration Technology.

 

1.39                            Major European Country ” shall mean France, Germany, Italy, Spain, or the United Kingdom.

 

1.40                            Marketing Approval ” shall mean 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 Licensed Products in a regulatory jurisdiction.  For countries where governmental approval is required for pricing or reimbursement for the Licensed Product to be reimbursed by national health insurance (i.e., other than the United States), “Marketing Approval” shall not be deemed to occur until such pricing or reimbursement approval is obtained;  provided, that if a Party has not accepted the pricing offered by the governmental authority of a particular country within eighteen (18) months after the date the first MAA is approved in such country, then Marketing Approval shall be deemed to have occurred in such country.

 

1.41                            Marketing Approval Application ” or “ MAA ” shall mean a New Drug Application (as defined in 21 C.F.R. § 314.50 et. seq .), or a comparable filing for Marketing Approval (not including pricing or reimbursement approval) in a country, in each case with respect to a Licensed Product in the Territory.

 

1.42                            “MEK” shall mean (mitogen activated protein kinase / extracellularly regulated protein kinase) kinase.

 

1.43                            Net Sales ” shall mean the gross invoiced amount on sales of the Licensed Products by AZ or its Affiliates (the “Selling Party”) to Third Parties (including distributors), less deductions allowed

 

5



 

to the Third Party customer by the Selling Party, and with respect only to (a) and (b) below to the extent actually taken by the Third Party customer, on such sales for:

 

(a)                                   trade, quantity, and cash discounts;

 

(b)                                  credits, rebates and chargebacks (including those to managed-care entities and government agencies), and allowances or credits to customers on account of rejection or returns (including, but not limited to, wholesaler and retailer returns) or on account of retroactive price reductions affecting such Licensed Product;

 

(c)                                   [ * ] of the gross invoiced amount as an allowance for freight, postage and duties, and transportation charges specifically relating to Licensed Product, including handling and insurance thereto;

 

(d)                                  sales (such as VAT or its equivalent) and excise taxes, other consumption taxes, customs duties and compulsory payments to governmental authorities and any other governmental charges imposed upon the sale of such Licensed Product to Third Parties; and

 

(e)                                   any other similar and customary deductions that are consistent with generally accepted accounting principles or other applicable accounting standards.

 

In addition, the Selling Party may exclude from Net Sales a reasonable provision for uncollectible accounts, to the extent such reserve is determined in accordance with the generally accepted accounting standards under which the Selling Party reports, consistently applied across all product lines of the particular Party, until such amounts are actually collected.

 

In the event a Licensed Product is sold which is a Combination Product under Section 1.17, for purposes of determining payments due to Array under Section 6.6, Net Sales of Combination Products shall be calculated by multiplying the Net Sales of the Combination Product by the fraction A over A+B, in which A is the Gross Selling Price of the Licensed Product when such Product is sold in substantial quantities comprising a Development Compound as the sole therapeutically active ingredient during the applicable accounting period in which the sales of the Licensed Product were made, and B is the Gross Selling Price of the other therapeutically active ingredients contained in the Combination Product sold separately in substantial quantities during the accounting period in question.  All Gross Selling Prices of the therapeutically active ingredients of the Licensed and Combination Products shall be calculated as the average Gross Selling Price of the therapeutically active ingredients in such Products during the applicable accounting period for which the Net Sales are being calculated.  In the event that no separate sale of either the Licensed Product comprising a single Development Compound as the sole therapeutically active ingredient or the other therapeutically active ingredients of the Combination Product are made during the accounting period in which the sale was made or if the Gross Selling Price for a particular therapeutically active ingredient cannot be determined for an accounting period, Net

 

6



 

Sales allocable to the Licensed Product and Combination Product shall be determined by mutual agreement reached in good faith by the Parties prior to the end of the accounting period in question based on an equitable method of determining same that takes into account, in the Territory, variations in potency, the relative contribution of each therapeutically active ingredient in the Combination Product, and relative value to the end user of each therapeutically active ingredient.  For purposes of this Section 1.41, “Gross Selling Price” shall mean the gross price at which an active ingredient is sold to a Third Party, before discounts, deductions, credits, taxes or allowances.

 

1.44                            Patent ” shall mean (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals, and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents and certificates of invention, (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b) and (c)), and (e) any similar rights, including so-called pipeline protection, or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any such foregoing patent applications and patents; which in each case has not been held, by a court or governmental agency of competent jurisdiction, to be invalid or unenforceable in a decision from which no appeal can be taken.

 

1.45                            “Payments” has the meaning set forth in Section 6.12.1.

 

1.46                            Phase I ,” “ Phase II ,” and “ Phase III ” shall have the following meanings:

 

1.46.1                   Phase I ” shall mean human clinical trials, the principal purpose of which is preliminary determination of safety in healthy individuals or patients as required in 21 C.F.R. §312, or similar clinical study in a country other than the United States.

 

1.46.2                   Phase II ” shall mean 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.

 

1.46.3                   Phase III ” shall mean human clinical trials, the principal purpose of which is to establish safety and efficacy of one or more particular doses in patients being studied as required in 21 C.F.R. §312, or similar clinical study in a country other than the United States.

 

1.47                            Phase III Development Costs ” shall have the meaning defined in Section 3.5.3.

 

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1.48                            Process Plan ” shall have the meaning described in Section 3.4.1(a) hereof.

 

1.49                            Process Program ” shall mean the research and development of processes, related assays and formulations for the manufacture of bulk quantities of Licensed Products.

 

1.50                            Recommendation Request ” shall have the meaning described in Section 2.5.1 hereof.

 

1.51                            Research Milestone ” shall mean the milestones set forth in Section 6.3.1.

 

1.52                            Research Plan ” shall have the meaning described in Section 2.3.1 hereof.

 

1.53                            Research Program ” shall mean the research, discovery, characterization, optimization and pre-clinical development of small molecule pharmaceutical products, the mechanism of action of which is the direct binding and inhibition of MEK, for the treatment of cancer, during the Research Term.

 

1.54                            Research Term ” shall mean the period commencing on the Effective Date and ending on the first to occur of (i) termination of this Agreement by either Party under Article 11 or Section 12.4.3 below; or (ii) two (2) years after the Effective Date, or if the Research Term is extended under Section 2.7 below, the end of such extension period.

 

1.55                            Sublicensee ” shall mean, with respect to a particular Licensed Product, a Third Party to whom AZ has granted a license or sublicense under any Licensed Technology to make, have made, use, sell, offer for sale and import, research, develop, register, manufacture, have manufactured, formulate, have used, export, transport, distribute, promote, market or have sold or otherwise dispose or offer to dispose of such Licensed Product.  As used in this Agreement, “Sublicensee” shall also include a Third Party to whom AZ has granted the right to distribute a Licensed Product, respectively, provided that such Third Party is responsible for marketing and promotion of such Licensed Product within its distribution territory.

 

1.56                            Territory ” shall mean the entire world.

 

1.57                            Third Party ” shall mean any entity other than Array or AZ, excepting Affiliates of either or Sublicensees of AZ.

 

1.58                            “Valid Claim” shall mean, with respect to a Licensed Product or a Candidate Drug in a particular country, any claim of a Patent within the Array Existing Technology or filed pursuant to Section 8.2 that claims i) the Compound included in such Licensed Product or Candidate Drug as a composition of matter or ii) the use of such Compound for one or more indications in the Field and either:

 

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(a)                                   with respect to a granted and unexpired Patent in such country, that (i) has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal, and (ii) has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise; or

 

(b)                                  with respect to a pending patent application, that was filed and is being prosecuted in good faith and has not been abandoned or finally disallowed without the possibility of appeal or re-filing of the application, provided that such claim has not been pending for more than ten (10) years.

 

ARTICLE II - RESEARCH PROGRAM

 

2.1                                  Research Program .  Array and AZ agree to conduct a research program on a collaborative basis with the principal goal of identifying other Candidate Drugs for use within the Field which AZ will develop and commercialise as set forth below.

 

2.2                                  The JRC .  Promptly after the Effective Date, the Parties shall establish a Joint Research Committee (“JRC”).  The JRC shall have responsibility to (i) oversee, review and coordinate the Research Program and Process Program and to expedite the progress of work being done under the Research Plan or Process Plan, and (ii) make such other decisions as are expressly allocated to the JRC under this Agreement.

 

(a)                                   Membership .  The JRC shall be comprised of an equal number of representatives from each of AZ and Array.  The exact number of such representatives shall be three (3) for each of AZ and Array, or such other number as the Parties may agree.  Either Party may replace its respective JRC representatives at any time, with prior written notice to the other Party.  Unless otherwise agreed, the JRC shall at all times include the Array officer overseeing all research and the AZ UK head of oncology research.  From time to time, the JRC may establish subcommittees to oversee particular projects or activities, and such subcommittees will be constituted as the JRC approves.

 

(b)                                  Meetings .  The JRC shall meet quarterly, or as more or less often as otherwise agreed by the Parties, at such locations as the Parties agree.

 

(c)                                   Decision Making .  Decisions of the JRC shall be made by majority vote of the members present in person or by other means ( e.g. , teleconference) at any meeting; provided that, if there is not an equal number of representatives of each Party present at such meeting, then only an equal number of representatives of each Party shall be entitled to vote at such meeting.  In the event that the votes required to approve a decision cannot be reached, then (i) AZ shall have the deciding vote on prioritization of Compounds in the Research Program, whether or not to initiate GLP toxicology studies

 

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with respect to a particular Compound and whether to nominate as a Candidate Drug in accordance with Section 2.5.1 a Compound which does not meet the Candidate Drug Target Profile and (ii) with respect to all other matters, either Party may, by written notice to the other, have such issue referred to the Chief Executive Officer of Array and the VP and Global Head of Oncology Research of AZ, for attempted resolution by good faith negotiations within thirty (30) days after such notice is received.  Minutes of the JRC meetings shall be taken, and shall, at a minimum, record all decisions made.  Such minutes shall be approved by both Parties.

 

2.3                                  Research Plan .

 

2.3.1                         Responsibilities .  The Research Program shall be carried out in accordance with a written workplan and budget (the “Research Plan”) approved by the JRC.  Each Party will be responsible for conducting those activities within the Research Program as are allocated to such Party under the Research Plan.  Each Party shall use commercially reasonable diligent efforts to (a) perform or cause to be performed its allocated activities under the Research Plan in good scientific manner and in compliance in all material respects with all applicable laws, including good laboratory practices and good clinical practices, and (b) achieve the objectives of the Research Plan efficiently and expeditiously by allocating sufficient time, effort, equipment and skilled personnel to complete such activities successfully and promptly.

 

2.3.2                         Establishment of Research Plan .  The initial Research Plan is attached hereto as Exhibit 2.3, which covers the period from the Effective Date through December 31, 2004 in detail and includes general plans for the following year.  The JRC shall review the Research Plan on an ongoing basis and may make changes thereto as the JRC approves.

 

2.4                                  Information and Reports .  AZ and Array will use commercially reasonable diligent efforts to make available and disclose to each other all Collaboration Technology, including all patent applications filed, and Information within such Technology regarding Compounds synthesized or discovered, and results of in vitro and in vivo studies, with significant discoveries or advances being communicated as soon as reasonably possible after such Information is obtained or its significance is appreciated; provided, however, that with respect to tangible research material, the Parties shall exchange such material as determined by the JRC.  The Parties will exchange, for the Research Term, at least once quarterly, a written summary of such research and results.  Each Party will provide the other with raw data for work carried out in the course of the Research Program to the extent reasonably requested by the other Party.  Each Party shall use commercially reasonable diligent efforts to inform the other Party of any of its respective Existing Technology used or evaluated in connection with the Research Program.

 

2.5                                  Recommendation and Selection of Candidate Drugs .

 

2.5.1                         Recommendation .  The Parties have established a Candidate Drug Target Profile, set forth in Exhibit 1.12,  to indicate the suitability of Compounds as Candidate Drugs. Such Candidate

 

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Drug Target Profile may be amended or subsequent Candidate Drug Target Profiles may be agreed and attached from time to time as appropriate to meet the relevant Compound requirements of AZ.  Based upon the results of the Research Program, either Party may from time to time request that the JRC recommend a particular Compound meeting the Candidate Drug Target Profile to AZ for selection as a Candidate Drug (a “Recommendation Request”).  Promptly after receipt of a Recommendation Request, the JRC shall confirm whether such Compound meets the Candidate Drug Target Profile and, following such confirmation, shall recommend such Compound for selection by AZ as a Candidate Drug.  In the event the JRC determines, in its discretion, that a particular Compound does not strictly meet the Candidate Drug Target Profile, but should be considered as a potential Candidate Drug, then the JRC may recommend such Compound to AZ for selection as a Candidate Drug.

 

2.5.2                         Selection .

 

(a)                                   AZ Decisions .  AZ may at its discretion:

 

(i)              select as a Candidate Drug a Compound recommended by the JRC in accordance with Section 2.5.1 above, whether or not such Compound meets the Candidate Drug Target Profile, and a Compound shall not be deemed a Candidate Drug unless so selected by AZ;
 
(ii)           reject a Compound recommended by the JRC in accordance with Section 2.5.1 above, whether or not such Compound meets the Candidate Drug Target Profile, and such Compound shall not be deemed a Candidate Drug; and
 
(iii)        defer its decision whether to select or reject a Compound recommended by the JRC in accordance with Section 2.5.1 above, whether or not such a Compound meets the Candidate Drug Target Profile during the term of the Research Program and for a period of [ * ] thereafter, and such Compound shall not be deemed a Candidate Drug unless so selected by AZ, provided that AZ may only defer its decision in accordance with this Section 2.5.2(a)(iii) for up to a maximum of [ * ] such JRC recommended Compounds at any one time.  At such time as AZ has deferred its decision under this Section 2.5.2(a)(iii) with respect to the maximum [ * ] JRC recommended Compounds, if the JRC then recommends an additional Compound in accordance with Section 2.5.1 above, AZ may substitute the newly recommended Compound for one of the Compounds for which it had deferred its decision; upon such substitution, the previously deferred Compound for which the newly recommended Compound is substituted shall be deemed rejected pursuant to Section 2.5.2(a)(ii) above.
 

(b)                                  Number of Candidate Drugs .  AZ may select up to [ * ] recommended Compounds as Candidate Drugs in addition to ARRY-142886, or such other number as the Parties may agree.  Unless the Parties otherwise agree, AZ shall not undertake clinical testing with respect to a particular Compound, including the preparation of an IND directed to such Compound, until (i) such Compound has been selected as a Candidate Drug in accordance with this Section 2.5.2 and (ii) AZ has [ * ].

 

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(c)                                   ARRY-142886 .  The Parties acknowledge that Array has identified and developed certain Compounds including ARRY-142886.  ARRY-142886 shall be deemed selected as a Candidate Drug under this Agreement.

 

(d)                                  Other Recommended Compounds .  Within ninety (90) days after the JRC recommends a particular Compound other than ARRY-142886 to AZ for selection as a Candidate Drug, AZ shall notify Array whether it selects, rejects or wishes to defer its decision as to whether it wishes to select or reject such Compound pursuant to Section 2.5.2(a).  If AZ rejects a recommended Compound as a Candidate Drug pursuant to Section 2.5.2(a)(ii) within the ninety (90) day selection period, or such other period as the Parties may agree, then (i) such Compound shall not be deemed a Candidate Drug under this Agreement, and (ii) subject to Section 4.1 below, Array shall be free to develop such Compound.

 

2.6                                  FTE Requirements and Funding . AZ agrees to fund the Array FTEs included in the Research Plan in accordance with Section 6.2 below.  Unless otherwise agreed by the Parties the Research Plan shall specify and Array shall provide [ * ] Array FTEs in Contract Year One and [ * ] Array FTEs in Contract Year Two.

 

2.7                                  Extension of Research Term .  AZ shall have the right to extend the Research Term on an annual basis for up to [ * ].  To exercise such option, AZ shall so notify Array in writing at least three (3) months prior to the expiration of the Research Term (including any extensions thereof in accordance with this Section 2.7) and the Parties shall enter into good faith discussions as to the required number of Array FTEs for such extension of the Research Term.  All such Array FTEs shall be funded by AZ at the FTE rate established under Section 6.2.1 below.

 

ARTICLE III - PRODUCT DEVELOPMENT

 

3.1                                  Licensed Product Development .

 

3.1.1                         AZ Responsibilities .  Following the selection of a Candidate Drug in accordance with Section 2.5.2 above, AZ shall be responsible for undertaking a development program to obtain regulatory approval in the Field for one or more Licensed Products incorporating such Candidate Drug in the Major European Countries, Japan and the USA and [ * ].  Such program shall include all preclinical, clinical, manufacturing and other activities, beyond those to be undertaken pursuant to the Research Program or Process Program, as are necessary or appropriate to bring such Licensed Products to market.  All MAAs and Marketing Approvals for the Licensed Products shall be owned by AZ, unless otherwise agreed.

 

3.1.2                         INDs .  It is understood that, prior to the Effective Date, Array has been proceeding with development activities with respect to ARRY-142886, including activities directed to the preparation and filing of an IND (the “Initial IND”).   To facilitate the development of ARRY-142886

 

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in the Field, Array shall complete preparation of and file the Initial IND to cover the agreed Phase I clinical trial activities as set out in Exhibit 3.1.2, subject to AZ prior written approval of the study design and study protocol for such trial.  Array shall be responsible, at its own cost, for the agreed Phase I clinical trial activities.  In addition:

 

(a)                                   Array shall only be entitled to use a clinical research organization for such Phase I clinical trial activities which has been assessed by and approved in advance in writing by AZ;

 

(b)                                  during the preparation and filing of the Initial IND Array shall inform AZ of and involve AZ in any interactions between Array and the FDA with respect to the Initial IND;

 

(c)                                   during the Phase I clinical trial Array shall provide AZ with all safety data arising from the Phase I clinical trial at the same time as it is provided to the FDA;

 

(d)                                  during the Phase I clinical trial Array shall provide AZ with all pharmacokinetic and pharmacodynamic data arising from the Phase I trial as soon as reasonably practicable; and

 

(e)                                   during the Phase I clinical trial Array shall inform AZ of and involve AZ in any interactions between Array and the FDA with respect to the Phase I clinical trial activities.

 

At the completion of the Phase I clinical trial Array shall close or inactivate the Initial IND, shall complete all relevant clinical trial and Initial IND administrative activities and shall share all clinical trial data with AZ.  AZ shall be responsible for the preparation and filing of all subsequent INDs with respect to any subsequent clinical development for ARRY-142886 and all INDs with respect to any clinical development of any other Candidate Drugs.  Array shall also provide to AZ in support of any AZ IND filings all relevant ARRY-142886 non-clinical data, including CMC, pharmacology and toxicology generated by Array.

 

3.2                                  Development Committee .  As soon as reasonably practicable after selection of the first Candidate Drug, AZ shall form a committee that will manage the conduct and progress of the further development and regulatory affairs with respect to that and each subsequent Candidate Drug (the “Development Committee”).  Day to day management of the development and regulatory activities for the Candidate Drugs shall be carried out by an AZ global product team which shall report to the Development Committee at quarterly meetings.  Development Committee Meetings shall be held face to face or by teleconference or videoconference.  Array shall be notified at least two weeks in advance of the date of each Development Committee meeting and shall have the opportunity to send one Array representative to such meeting, who shall have observer status.  AZ shall provide such Array representative with schedules for all Development Committee meetings and all other information distributed to AZ members of the Development Committee.  The Development Committee shall review the plan for the development of the subject Candidate Drug (each, a “Development Plan”), and in so

 

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doing shall consider all reasonable suggestions and comments of Array in formulating such Development Plan.  Such Development Plan shall be reasonably comprehensive and shall describe at least (i) the proposed activities related to clinical studies and regulatory plans, (ii) clinical goals and objectives as well as criteria for successful completion of clinical trials and other development activities (“Development Criteria”) and (iii) other activities and timelines directed to obtaining regulatory approval.  In any event, AZ agrees to keep Array informed as to the progress and activities relating to the further development and regulatory matters pertaining to each Candidate Drug and Licensed Product.  In addition, AZ shall provide Array with such information as Array may reasonably request from time to time.  It is understood that such information will include correspondence with regulatory authorities with respect to each Licensed Product.

 

3.3                                  Phase I Success Criteria .  At any time during or at the completion of the Phase I activities with respect to ARRY-142886, the Development Committee shall assess that Licensed Product against agreed Phase I success criteria set out in Exhibit 3.3 (the “Phase I Success Criteria”) and shall confirm whether the Phase I Success Criteria have been met.  If ARRY-142886 fails to meet the Phase I Success Criteria, AZ shall have the right to cease development of ARRY-142886 pursuant to this Agreement, and it shall be deemed an Abandoned Product pursuant to Section 11.3.2 below.

 

3.4                                  Process Development; Manufacturing .

 

3.4.1                         Process Program .  Array and AZ agree to conduct a program on a collaborative basis with the principal goal of further developing processes and related assays for the manufacture of bulk quantities of ARRY-142886, other Candidate Drugs and Licensed Products.

 

(a)                                   Process Plan .  The Process Program shall be carried out in accordance with a written workplan and budget (the “Process Plan”) agreed to by the Parties set out in Exhibit 3.4.1.  Each Party will be responsible for conducting those activities within the Process Program as are allocated to such Party under the Process Plan.  It is understood that Array will manufacture and supply bulk quantities of ARRY-142886 for formulation studies under the Process Program.

 

(b)                                  FTE Requirements and Funding . AZ agrees to fund the Array FTEs included in the Process Plan in accordance with Section 6.2 below.  Unless otherwise agreed by the Parties, the Process Plan shall specify and Array shall provide [ * ] Array FTEs in Contract Year One and [ * ] Array FTEs in Contract Year Two.   The Parties shall enter into good faith discussions as to the required number of Array FTEs for any extension of the term covered by the Process Plan.

 

(c)                                   Technology Transfer .  At the completion of the Process Program or in accordance with a mutually agreed schedule, the Parties shall cooperate to ensure a seamless and rapid transfer of the Collaboration Technology developed under the Process Program that is necessary or useful for the manufacture of bulk quantities of Licensed Products.

 

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(d)                                  Reports . Array shall provide to AZ, at least once quarterly, a written summary of the results of the Process Program.

 

3.4.2                         Supply for Clinical Trials .  Array shall use commercially reasonable efforts to manufacture and supply AZ’s requirements of Candidate Drugs (other than ARRY-142886) for use in Phase I clinical trials under the development program, at [ * ].  The Parties shall agree to terms for such supply prior to the first supply of each Candidate Drug, and such terms shall conform to the terms of this Agreement.  As used in this Section 3.4.2, with respect to a particular Candidate Drug, “[ * ]” shall mean [ * ] costs of manufacturing such Candidate Drug, plus [ * ] attributable to manufacture of such Candidate Drug, based on [ * ].

 

3.5                                  Co-Funding Option .  Array shall have the right, on a Licensed Product-by-Licensed Product basis, to elect to fund [ * ] of the Phase III Development Costs of such Licensed Product, all in accordance with this Section 3.5 (the “Co-Funding Option”).

 

3.5.1                         Election .  AZ shall notify Array at least [ * ], but not more than [ * ], prior to initiation of any and all Phase III trials for each Licensed Product (each, a “Phase III Notice”).  Such Phase III Notice shall include the date by which any such Phase III trial is projected to start (the “Projected Start Date”), and shall include a description of the indication for which such Phase III trial will be directed, together with a detailed draft plan and budget, for the conduct of the Phase III Clinical Trials intended to support Marketing Approval of such Licensed Product.  At least [ * ] prior to the Projected Start Date, Array may elect, by so notifying AZ in writing, to participate in the further development of such Licensed Product, to the extent described in this Section 3.5 below (such notice, the “Election Notice”).  Following the Phase III Notice, AZ shall cooperate fully with Array, and shall promptly provide Array with such information, as Array may reasonably request to enable Array to make an informed decision of whether to exercise its Co-Funding Option under this Section 3.5 with respect to such Licensed Product.  In the event Array exercises its Co-Funding Option with respect to a particular Licensed Product (such Licensed Product, a “Co-Funded Product”), the provisions of Sections 3.5.2 and  3.5.3 below shall apply with respect to such Co-Funded Product.

 

3.5.2                         Co-Funding Obligation .  In the event Array exercises its Co-Funding Option with respect to a Licensed Product, Array shall be obligated to [ * ] AZ for [ * ] of such Phase III Development Costs for such Licensed Product, subject to the provisions of this Section 3.5.

 

(a)                                   The draft plan and budget provided with the Phase III Notice, as modified in accordance with this Section 3.5.2 (a), is referred to as the “Co-Development Plan and Budget.”  By October 1 of each year during the Phase III Development for a particular Co-Funded Product, the Development Committee shall update and amend the Co-Development Plan and Budget for such Co-Funded Product for the next succeeding year.  Unless otherwise specified in the Co-Development Plan and Budget, any amounts projected for a full year shall be considered budgeted in four equal quarterly amounts.  Whether or not Array exercises its Co-Funding Option, AZ agrees to use commercially

 

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reasonable diligent efforts to carry out the Phase III Development of each Licensed Product in accordance with the budget specified in the Co-Development Plan and Budget.

 

(b)                                  Within [ * ], AZ shall provide to Array a statement reflecting the total Phase III Development Costs [ * ] such Calendar Quarter with respect to the particular Co-Funded Product.  Within [ * ] days after Array’s receipt of such statement, Array shall [ * ] AZ [ * ] of the Phase III Development Costs [ * ] such quarterly period in accordance with the statement for such Co-Funded Product; provided, however, that Array shall not be required to [ * ] AZ for [ * ].  AZ agrees to keep Array informed on an ongoing basis as to the actual Phase III Development Costs incurred to date as compared to the Phase III Development Costs reflected in the Co-Development Plan and Budget.

 

(c)                                   Upon [ * ] prior written notice to AZ, Array may terminate its Co-Funding Option for a particular Co-Funded Product.  In such event, Array’s funding obligation under Section 3.5.2(b) above shall apply only with respect to Phase III Development Costs of activities conducted with respect to such Co-Funded Product prior to such termination.  Such costs shall be [ * ] to Array in accordance with Section 6.6.2(d).  Should AZ have [ * ] Phase III Development Costs in the period prior to Array’s termination of its Co-Funding Option AZ shall invoice Array in respect of [ * ] of costs within [ * ] of such costs being [ * ] and such payments shall be due [ * ] of receipt of invoice by Array.

 

(d)                                  Bank Details .   All payments set forth in this Section 3.5.2 shall be remitted by wire transfer to the following bank account of AZ or such other account as AZ may designate in writing to Array:

 

BANK ACCOUNT

Bank Name:

 

[ * ]

Account Name:

 

[ * ]

Account No:

 

[ * ]

SWIFT code:

 

[ * ]

Corr Bank:

 

[ * ]

 

3.5.3                         Certain Terms .  As used in this Section 3.5, the following terms shall have the meaning set forth below:

 

(a)                                   “Phase III Development” shall mean those activities consisting of Phase III clinical trials intended to support regulatory approval of a Licensed Product, including the collection and analysis of data from those trials.

 

(b)                                  “Phase III Development Costs” with respect to a particular Co-Funded Product shall mean, to the extent incurred in accordance with the Co-Development Plan and Budget then

 

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in effect and to the extent not reimbursed by a Third Party, [ * ] of Phase III Development of the particular Co-Funded Product.

 

(c)                                   For purposes of this Section 3.5 only, a particular “Co-Funded Product” shall include all dosages of the same formulation of the same active ingredient for all indications within the Field; Licensed Products having a different formulation or active ingredient shall be deemed a separate Licensed Product (or a separate Co-Funded Product, as the case may be).

 

ARTICLE IV - EXCLUSIVITY

 

4.1                                  Exclusivity of Efforts .  During the term of the Research Program and for [ * ] from the final selection of a Candidate Drug pursuant to Section 2.5.2(a), Array and AZ will not [ * ], either alone or with a Third Party, [ * ] with respect to, or [ * ] of a product comprising [ * ] for use within the Field, other than in accordance with the Agreement nor will either Party licence [ * ] to any other party.  It is understood and agreed that this Section 4.1 shall not prevent a Party from collaborating with a Third Party academic entity in the Field or with any Third Party for the purpose of [ * ] to be used in support of any Candidate Drug or Licensed Product.

 

4.2                                  Candidate Drugs .  Following the selection of a Candidate Drug in accordance with Section 2.5 above (including AZ’s payment of the milestone set forth in Section 6.3.1 below), for so long as AZ is reasonably diligently developing and/or commercializing such particular Candidate Drug or Licensed Product, Array shall not [ * ], or license a Third Party to [ * ], such Candidate Drug or Licensed Product in any Field.  If such Candidate Drug, or any Licensed Product incorporating such Candidate Drug, becomes an Abandoned Product pursuant to Section 11.3.2 below, then Array’s obligations under this Section 4.2 shall terminate with respect to such Candidate Drug or Licensed Product. For the avoidance of doubt, provided that AZ is diligently developing ARRY-142886 or such other Candidate Drug as may have been selected in its place, AZ shall be under no obligation to concurrently [ * ] any other Candidate Drugs which have been selected.  Such [ * ] selected Candidate Drugs shall not form part of the Abandoned Products except as provided in Section 11.3.2 below.

 

4.3                                  Retention of Rights .  AZ acknowledges that Array has ongoing research programs related to the development of pharmaceutical products for use outside the Field, the mechanism of action of which is to modulate MEK, and that such programs include (i) Compounds that have been mutually determined not to meet the Candidate Drug Target Profile in the course of the Research Program, (ii) any Compound that has been determined to meet the Candidate Drug Target Profile in the course of the Research Program but that is rejected as a Candidate Drug pursuant to Section 2.5.2(a)(ii) above, and (iii) following AZ’s selection of [ * ] Candidate Drugs (or such other number as the Parties may agree) in addition to ARRY-142886 under Section 2.5 above, any other Compound that is the subject of the Research Program.  AZ further acknowledges that such ongoing research programs as well as similar future Array research programs related to MEK are outside the scope of this Agreement and, without limitation, such activities of Array are not prohibited by this Article IV.

 

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4.4                                  Inflammation Rights; Right of First Discussion .

 

4.4.1                         Notice .  During [ * ] from the Effective Date, at least [ * ] prior to Array [ * ] to grant to a Third Party the right to develop and/or commercialize one or more Compounds for use outside the Field, Array agrees to notify AZ in writing, together with a summary description of the Compound (including a general statement of its then-current stage of development) or field to be proposed, if any, that [ * ] (“Initial Notice”).  Within [ * ] following receipt of such Initial Notice, AZ shall notify Array of its decision whether or not it desires to discuss terms and conditions under which Array would grant such rights to AZ.  As soon as practicable following such notice the Parties shall enter into exclusive good faith negotiations to finalise the terms and conditions of such grant of rights.  If (i) AZ notifies Array that it does not desire to discuss such terms and conditions, or (ii) the Parties have not agreed upon such terms and conditions pursuant to which such rights and license would be granted to AZ within [ * ] after the date Array provided the Initial Notice to AZ(the “Negotiation Period”), then Array shall be free to grant to any Third Party the right to develop and/or commercialize one or more Compounds for use outside the Field, without further obligation to AZ, and on any terms that Array deems appropriate.  It is understood that, because Array will be providing the Initial Notice to AZ prior to [ * ] with a Third Party, Array may not be able to define the entire or exact scope of the product, field or rights to be granted, and accordingly, so long as the Initial Notice describes a product, field or rights that overlap with the product, field or rights discussed with, or granted to, a Third Party, Array shall be deemed to have satisfied its obligations, under this Section 4.4; also, it is understood that Array need only provide one such Initial Notice hereunder before engaging in such material and substantial negotiations with the first Third Party, and that Array is not obligated to provide any further notice if Array subsequently engages in discussion with more than one Third Party with respect to the subject matter described in the Initial Notice.

 

4.4.2                         No Implied Obligations .  The only obligations of Array and AZ under Section 4.4.1 above are as expressly stated therein, and there are no further implied obligations relating to the matters contemplated therein.  Without limiting the foregoing, it is further understood and agreed that the subject Compound(s) for use outside the Field may or may not be discovered or reduced to practice at all, may or may not be discovered or reduced to practice to any particular degree or at all at the time of the Initial Notice under Section 4.4.1, and that further modification and/or variations of a Compound or product may be developed after the date of such Initial Notice; accordingly, so long as Array includes within the Initial Notice a good faith summary of the Compound or product as it then exists, or a good faith summary of the field in which the rights would be granted, the requirements of Section 4.4.1 above shall be deemed satisfied with respect to any and all modifications, variants or derivatives of the Compound or product developed or reduced to practice after the date of the Initial Notice.  Without limiting the foregoing, it is further acknowledged and agreed that (i) this Section 4.4 shall not be deemed to apply to a transaction by which a Third Party acquires all or substantially all of the business assets of this Agreement in accordance with Section 12.4 below; and (ii) if Array enters into a transaction with a Third Party in accordance with this Section 4.4 that includes the grant by Array of [ * ] one or more Compounds for use outside the Field (each such [ * ] being referred to as a “[ * ]”), then the grant of rights by Array upon [ * ] shall not be subject to this Section 4.4 so long as the grant of

 

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[ * ] was made in a transaction entered into with the Third Party in compliance with Section 4.4.1; and (iii) Array is not obligated under this Section 4.4 to provide AZ any particular information other than as expressly stated in Section 4.4.1, and that Array may require a separate confidentiality agreement as a condition to any disclosure of information in connection with Section 4.4.

 

4.4.3                         Disputes .  If AZ disputes Array’s right to proceed to enter into any transaction with a Third Party with respect to one or more Compounds for use outside the Field, AZ shall submit such dispute to binding arbitration within [ * ] from the end of the Negotiation Period.  AZ shall provide Array a notice of such arbitration together with a written report setting forth the specific basis for the dispute and the specific actions AZ believes Array must take to resolve the dispute (“Arbitration Notice”).  Such arbitration shall be conducted in accordance with Section 12.2.  If an Arbitration Notice is not received within the [ * ] period then AZ shall have no further right to dispute Array’s right to grant any Third Party rights contemplated by this Section 4.4.

 

ARTICLE V - LICENSE GRANTS

 

5.1                                  Research Licenses .  AZ hereby grants Array a non-exclusive, non-sublicensable, worldwide license without royalty or charge during the Research Term solely to make and use subject matter within the AZ Existing Technology and its rights to Collaboration Technology, to conduct activities assigned to Array under the Research Plan or the Process Plan.  Array hereby grants AZ a non-exclusive, non-sublicensable, worldwide license without royalty or charge during the Research Term solely to make and use subject matter within the Array Existing Technology and its rights to Collaboration Technology, to conduct activities assigned to AZ under the Research Plan or the Process Plan, during the Research Term.  The licenses granted under this Section 5.1 shall not include the right to grant or authorize sublicenses other than to Affiliates in order to conduct the Research Program or Process Program.

 

5.2                                  Licenses to AZ .

 

5.2.1                         Candidate Drugs and Licensed Products .  Subject to the terms and conditions of this Agreement, Array hereby grants AZ an exclusive license, under Array’s interest in Compounds, Candidate Drugs and Licensed Technology, to make, have made, use, sell, offer for sale and import,  research, develop, register, manufacture, have manufactured, formulate, have used, export, transport, distribute, promote, market or have sold or otherwise dispose or offer to dispose of Candidate Drugs and Licensed Products for use in the Field and in the Territory.

 

5.2.2                         Sublicenses .  AZ may sublicense the rights granted under Section 5.2.1 above for a particular Candidate Drug or Licensed Product; provided that such sublicense (and any right to obtain such a sublicense) is granted no earlier than the date the Compound incorporated therein has been selected as a Candidate Drug in accordance with Section 2.5 above.

 

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5.3                                  Licenses to Array.

 

5.3.1                         Abandoned Products .  AZ hereby grants to Array an exclusive license [ * ] under AZ’s interest in the Collaboration Technology, to make, have made, use, sell, offer for sale and import, research, register, formulate, have used, export, transport, distribute, promote, market or have sold or otherwise dispose or offer to dispose of Abandoned Products for use in the Territory.  Such license shall include the right to grant and authorize sublicenses.  If Array requires a license under AZ Existing Technology to enable it to exercise its rights under this Section 5.3.1, then AZ shall grant such license to Array [ * ].

 

5.4                                  No Implied Licenses .  Each Party acknowledges that the licenses granted under this Article V are limited to the scope expressly granted, and all other rights to Licensed Technology are expressly reserved to the Party owning such Licensed Technology. Without limiting the foregoing, it is understood that where an exclusive license under Licensed Technology is granted to a Party under this Article V for a particular purpose, the Party granting such license retains all of its rights to such Licensed Technology for all purposes not expressly licensed.

 

ARTICLE VI - PAYMENTS

 

6.1                                  Initial Payment .  In consideration of [ * ] AZ shall pay to Array [ * ].  Such sum shall be due upon the Effective Date and shall be payable within [ * ].  Such amount shall be non-refundable and non-creditable against any other amounts due to Array under this Agreement.

 

6.2                                  Research and Process Payments - Funding .

 

6.2.1                         FTEs .  An FTE rate determined in accordance with this Section 6.2.1 shall be used for purposes of determining the costs incurred by Array with respect to Array personnel performing work on the Research Program and the Process Program.  The FTE rate shall be [ * ] per FTE.  The FTE rate includes but is not limited to all salary, employee benefits and other expenses including support staff and overhead for or associated with an FTE.

 

6.2.2                         Non-FTE Costs .  If the JRC specifically requests, as confirmed by AZ in writing or in the written Research Plan approved by the JRC, that Array conduct and fund a research activity at an external center, Array’s [ * ] costs incurred by Array in following such request shall be reimbursed by AZ at Array’s cost [ * ].  Such sums shall be payable [ * ] following receipt by AZ of a valid invoice from Array.

 

6.2.3                         Payment .  On or before the first day of each Calendar Quarter during the Research Term, AZ shall pay to Array [ * ] for each FTE for such quarter.  Such sums shall be payable [   *   ] following receipt by AZ of a valid invoice from Array.  Unless otherwise specified in the applicable

 

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Research Plan, amounts budgeted for the full year will be deemed budgeted in equal amounts for each Calendar Quarter during such year.

 

6.2.4                         Bank Details .   All payments set forth in this Article VI shall be remitted by wire transfer to the following bank account of Array or such other account as Array may designate in writing to AZ:

 

BANK ACCOUNT

Bank Name:

 

[ * ]

Bank Address:

 

[ * ]

Account Name:

 

[ * ]

Account No:

 

[ * ]

ABA code:

 

[ * ]

SWIFT code:

 

[ * ]

 

6.3                                  Research Milestones .

 

6.3.1                         Milestones .  AZ shall pay to Array the following amounts upon achievement of each occurrence of the following events (each a “ Research Milestone ”):

 

MILESTONE

 

CASH PAYMENT

 

 

(in U.S. dollars)

1.

 

[ * ]

 

[ * ]

2.

 

[ * ]

 

[ * ]

 

6.3.2                         Certain Terms .

 

Selection of Candidate Drugs shall be in accordance with Section 2.5.  It is understood that Research Milestone 2 shall be paid [ * ].

 

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6.4                                  Development Milestones .

 

6.4.1                         Milestones .  Except as set forth below, AZ shall pay to Array the following amounts upon achievement of the corresponding events set forth below (each, a “ Development Milestone ”) for each Licensed Product, regardless of whether thedevelopment, promotion, or marketing of such Licensed Product is discontinued at any time after theachievement of such milestone:

 

MILESTONE

 

CASH PAYMENT
(in U.S. dollars)

 

 

 

1a.

[ * ]

 

[ * ]

 

 

 

 

1b.

[ * ]

 

[ * ]

 

 

 

 

2.

[ * ]

 

[ * ]

 

 

 

 

3.

[ * ]

 

[ * ]

 

 

 

 

4.

[ * ]

 

[ * ]

 

 

 

 

5.

[ * ]

 

[ * ]

 

 

 

 

6.

[ * ]

 

[ * ]

 

 

 

 

7.

[ * ]

 

[ * ]

 

 

 

 

8.

[ * ]

 

[ * ]

 

 

 

 

9.

[ * ]

 

[ * ]

 

 

 

 

10.

[ * ]

 

[ * ]

 

6.4.2                         Certain Terms .  For purposes of the Development Milestones due under this Section 6.4:

 

(a)                                   Development Milestones 1a and 1b shall be paid [ * ].  Development Milestones 3 through 10 shall be paid [ * ].

 

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(b)                                  For purposes of this Section 6.4, and Section 6.6 below, all dosage forms, and all formulations, of the same active ingredient shall be deemed a single Licensed Product; Licensed Products having a different active ingredient shall be deemed separate Licensed Products.

 

(c)                                   “Initiation” of a particular clinical trial shall mean the first dosing of the first patient in such trial.

 

(d)                                  If a subsequent Development Milestone is achieved with respect to a particular Licensed Product before a prior Development Milestone (“prior” and “subsequent” referring to a lower and higher number respectively in the tables above, e.g. Development Milestone 2 being “prior” to Development Milestone 3), then prior Development Milestones 1 through 4 with respect to that Licensed Product shall be deemed achieved upon achievement of the subsequent Development Milestone.  In addition, where Development Milestone 8 is achieved Development Milestone 5 only shall be deemed to have been achieved, where Development Milestone 9 is achieved Development Milestone 6 only shall be deemed to have been achieved and where Development Milestone 10 is achieved Development Milestone 7 only shall be deemed to have been achieved.

 

(e)                                   “Acceptance” of an MAA shall mean the date of receipt by AZ of written notice of acceptance from the FDA (or its equivalent in a country outside the U.S.) of the first MAA for the Licensed Product for substantive review.

 

(f)                                     “Acceptance of an MAA in the European Union” shall mean the date that the first MAA has been accepted for a Licensed Product in at least one (1) of the Major European Countries or by the European Medicines Evaluation Agency (“EMEA”).

 

(g)                                  “First Commercial Sale” shall mean, with respect to a Licensed Product in a particular country, the first bona fide commercial sale of such Licensed Product following Marketing Approval in such country by or under authority of AZ, its Affiliates or Sublicensees.  It is understood that Development Milestone 9 shall be paid upon the First Commercial Sale of a Licensed Product in any country that is a Major European Country.

 

6.4.3                         Credits .  Should all development of a particular Licensed Product discontinue prior to MAA Approval in the first country, for any reason, and be replaced by an alternative Licensed Product, then, when the next Licensed Product achieves a milestone for which a corresponding milestone payment was made for the discontinued Licensed Product, no payment shall be due with respect to such alternative Licensed Product with respect to milestones 3 through 7.

 

6.5                                  Milestone Payment Timing .  AZ and Array each agree to notify the other of its achievement of any milestone promptly, but in any event within twenty (20) days of such achievement. For milestones accomplished by AZ, the relevant payments set forth in Sections 6.3 and 6.4 hereof shall each be due to Array upon notice by AZ to Array of the occurrence of the milestone event set forth

 

23



 

therein and shall be payable within thirty (30) days of receipt by AZ of a valid invoice from Array.  For milestones accomplished by Array, such payment shall be due thirty (30) days after notice thereof to AZ, subject to AZ’s verification during such thirty (30) day period that the milestone occurred and subject to receipt of a valid invoice from Array.

 

6.6                                  Earned Royalties For Licensed Products .  AZ shall pay Array a royalty on worldwide Net Sales of Licensed Products.  Such royalty shall be paid based on the total annual worldwide Net Sales for each Calendar Year, on a Licensed Product-by-Licensed Product basis.

 

6.6.1                         General .  Subject to Section 6.6.2 below, the annual royalty rate for a particular Licensed Product in a given year shall be determined by the total worldwide annual Net Sales of such Licensed Product for the particular Calendar Year, according to the following schedules.

 

(a)                                   For each Licensed Product that incorporates [ * ]:

 

Total Annual Net Sales

 

Royalty

 

Less than [ * ]

 

[ * ]

%

Between [ * ] and [ * ]

 

[ * ]

%

Greater than [ * ]

 

[ * ]

%

 

(b)                                  For each Licensed Product that incorporates [ * ] (i) for which [ * ] or (ii) which [ * ]:

 

Total Annual Net Sales

 

Royalty

 

Less than [ * ]

 

[ * ]

%

Between [ * ] and [ * ]

 

[ * ]

%

Greater than [ * ]

 

[ * ]

%

 

(c)                                   For each Licensed Product that incorporates [ * ]:

 

 

Total Annual Net Sales

 

Royalty

 

Less than [ * ]

 

[ * ]

%

Between [ * ] and [ * ]

 

[ * ]

%

Greater than [ * ]

 

[ * ]

%

 

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6.6.2                         Licensed Products Subject to Co-Funding Option .  With respect to Licensed Products for which Array has exercised its Co-Funding Option pursuant to Section 3.5, the annual royalty rate for a particular Co-Funded Product in a given Calendar Year shall be determined by the total annual worldwide Net Sales of such Licensed Product in that Calendar Year, according to the following schedules.

 

(a)                                   For each Co-Funded Product that incorporates [ * ]:

 

Total Annual Net Sales

 

Royalty

 

Less than [ * ]

 

[ * ]

%

Between [ * ] and [ * ]

 

[ * ]

%

Greater than [ * ]

 

[ * ]

%

 

(b)                                  For each Co-Funded Product that incorporates [   *   ] (i) for [   *   ] or (ii) which [   *   ] :

 

Total Annual Net Sales

 

Royalty

 

Less than [ * ]

 

[ * ]

%

Between [ * ] and [ * ]

 

[ * ]

%

Greater than [ * ]

 

[ * ]

%

 

(c)                                   For each Co-Funded Product that incorporates a [   *   ] :

 

Total Annual Net Sales

 

Royalty

 

Less than [ * ]

 

[ * ]

%

Between [ * ] and [ * ]

 

[ * ]

%

Greater than [ * ]

 

[ * ]

 

 

25



 

(d)                                  For any particular Co-Funded Product for which Array terminates its obligation to fund Phase III Development Costs under Section 3.5.2(c), AZ shall pay the royalty rate [ * ].

 

6.6.3                         Other .

 

(a)                                   For purposes of determining the royalty rates applicable hereunder, it is understood that “total annual Net Sales” shall be determined on a world-wide, Calendar Year basis, and shall be determined separately for each separate Licensed Product.

 

(b)                                  Further it is understood that if the total annual Net Sales for a particular Calendar Year are within a particular Net Sales range, as reflected in the tables in either 6.6.1 or 6.6.2 above, then the royalty corresponding to such range shall apply to Net Sales for the particular Calendar Year within such range only.  For convenience of example only and without limiting the above, for each Licensed Product that incorporates [ * ] without any right of reduction, the royalty rate of [ * ]% shall apply to the amount of annual Net Sales under [ * ], should annual Net Sales exceed [ * ] then the royalty rate of [ * ]% shall apply only to the amount of Net Sales exceeding [ * ] (and up to [ * ]) and should annual Net Sales exceed [ * ] then the royalty rate of [ * ]% shall apply only to the amount of Net Sales exceeding [ * ].

 

(c)                                   If AZ sells a Licensed Product to a Third Party that purchases other products or services from AZ, AZ agrees not to discount the purchase price of the Licensed Product to a greater degree than AZ generally discounts the prices of the other products and/or services sold to such Third Party

 

6.7                                  Sublicensees .  In the event that AZ grants a license or sublicense under any Licensed Technology to make, have made, use, sell, offer for sale and import, research, develop, register, manufacture, have manufactured, formulate, have used, export, transport, distribute, promote, market or have sold or otherwise dispose or offer to dispose of a Candidate Drug or Licensed Product to a Sublicensee, AZ shall pay to Array a royalty of [ * ] of all Net Proceeds.  AZ shall pay such amounts to Array [ * ] after the [ * ] with respect to all Net Proceeds received in [ * ].  For the purposes of this Section 6.7, “Net Proceeds” shall mean [ * ], including without limitation, (i) [ * ] payments, (ii) [ * ] payments, (iii) [ * ] and (iv) [ * ].    With respect to amounts received for (iv) above, Net Proceeds shall mean [ * ],

 

26



 

6.8                                  Sales Subject to Royalties .  Sales [ * ] shall not be subject to royalties hereunder.  Royalties shall be calculated on AZ’s or its Affiliates’ sale of the Licensed Products to a Third Party (including Distributors) and on Net Proceeds from Sublicencees in accordance with Section 6.7.  Royalties shall be payable only once for any given unit of Licensed Product.  For purposes of determining Net Sales, the Licensed Product shall be deemed to be sold when invoiced and a “sale” shall not include, and no royalties shall be payable on, transfers by AZ orits Affiliates of samples of Licensed Products or clinical trial materials containing Compound or other transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory or governmental purposes.

 

6.9                                  Term For Royalty Payment .  Royalties payable under Section 6.6 shall be paid on a country-by-country basis from the date of the First Commercial Sale (as defined in Section 6.4.2(g)) of each Licensed Product in such country.  The obligation shall expire, on a country-by-country basis, with respect to each separate Licensed Product, on the later to occur of (a) the [ * ] anniversary of the first commercial sale of such Licensed Product in such country and (b) the expiration date in such country of the last to expire of any issued licensed Patent that includes at least one Valid Claim [ * ] in such country.

 

Upon such expiry all applicable licences for such Licensed Product in such country shall be deemed fully paid up and perpetual and AZ shall have no further obligations under Article VI.

 

6.10                            No Valid Claim .  In the event that a Licensed Product is sold in a country and is not covered by a Valid Claim within the Licensed Technology in such country, the Net Sales of such Licensed Product for purposes of the royalty rate payable to Array by AZ with respect to such sales of such Licensed Product in such country shall be reduced by [ * ].  Net Sales of such Licensed Product shall be reduced for only so long as no Valid Claim within the Licensed Technology covering such Licensed Product exists.  For those countries in which patents on pharmaceutical compositions may not be obtained, this Section 6.10 shall not apply.

 

6.11                            Foreign Exchange .  The remittance of royalties payable on Net Sales will be payable in U.S. dollars to a bank and to an account designated by Array in accordance with Section 6.2.4 above.  For the purpose of computing the Net Sales of Licensed Products sold in a currency other than U.S. Dollars, such currency shall be converted from local currency to U.S. Dollars by AZ in accordance with the rates of exchange for the relevant Calendar Quarter for converting such other currency into U.S. Dollars used by AZ’s internal accounting systems, which are independently audited on an annual basis.

 

6.12                            Taxes .

 

6.12.1                   General .  The royalties, milestones and other amounts payable by AZ to Array pursuant to this Agreement (“ Payments ”) shall not be reduced on account of any taxes unless required by applicable law.  Array alone shall be responsible for paying any and all taxes (other than withholding taxes required by applicable law to be deducted and paid on Array’s behalf by AZ) levied on account of,

 

27



 

or measured in whole or in part by reference to, any Payments it receives.  AZ shall deduct or withhold from the Payments any taxes that it is required by applicable law to deduct or withhold.  Notwithstanding the foregoing, if Array is entitled under any applicable tax treaty to a reduction of rate of, or the elimination of, applicable withholding tax, it may deliver to AZ or the appropriate governmental authority (with the assistance of AZ to the extent that this is reasonably required and is expressly requested in writing) the prescribed forms necessary to reduce the applicable rate of withholding or to relieve AZ of its obligation to withhold tax, and AZ shall apply the reduced rate of withholding, or dispense with withholding, as the case may be, provided that AZ has received evidence, in a form satisfactory to AZ, of Array’s delivery of all applicable forms (and, if necessary, its receipt of appropriate governmental authorization) at least fifteen (15) days prior to the time that the Payments are due.  If, in accordance with the foregoing, AZ withholds any amount, it shall pay to Array the balance when due, make timely payment to the proper taxing authority of the withheld amount, and send to Array proof of such payment within sixty (60) days following that payment.

 

6.12.2                   Indirect Taxes .  All Payments are exclusive of Indirect Taxes.  If any Indirect Taxes are chargeable in respect of any Payments, the payer shall pay such Indirect Taxes at the applicable rate in respect of any such Payments following the receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by the recipient in respect of those Payments, such Indirect Taxes to be payable on due date of the payment of the Payments to which such Indirect Taxes relate.

 

6.13                            Royalty Payment Reports .  The royalties shall be calculated quarterly as of the last day of March, June, September and December respectively, for the Calendar Quarter ending on that date.  AZ shall pay the royalties in conjunction with the delivery of a written report to Array within [ * ] after the end of each Calendar Quarter that shows, with respect to each country and each Licensed Product, the sales volume and Net Sales of the Licensed Products during such Calendar Quarter.

 

6.14                            Accounting .  AZ shall maintain complete and accurate records, in accordance with the generally accepted accounting practices under which it reports, which are relevant to costs, expenses and payments under this Agreement.  Upon the written request of Array, AZ shall permit a certified public accountant or a person possessing similar professional status and associated with an independent accounting firm acceptable to the Parties to inspect during regular business hours and no more than [ * ] and going back no more than [ * ] preceding the current year, all or any part of AZ’s records and books necessary to check the accuracy of such costs, expenses or payments made under this Agreement.  The accounting firm shall enter into appropriate obligations with AZ to treat all information it receives during its inspection in confidence.  The accounting firm shall disclose to Array and AZ only whether the costs, expenses or payments under this Agreement are correct and details concerning any discrepancies, but no other information shall be disclosed to Array.  The Parties agree to settle any discrepancies promptly.  The charges of the accounting firm shall be paid by Array, except in the case of a discrepancy against Array of more than [ * ], the charges shall be paid by AZ.  Any failure by Array to exercise its right under this Section 6.14 with respect to a Calendar Year within the time period allotted therefor, shall

 

28



 

constitute a waiver by Array of its right to later object to any payments made by AZ under this Agreement during such Calendar Year.

 

6.15                            Credit For Payments for Third Party Licenses .

 

6.15.1                   Reduction of Royalties; Amount .  In the event that (i) it becomes reasonably necessary for AZ at its sole discretion to obtain a license under a valid, issued patent of a Third Party, where such patent [ * ] and such patent would necessarily be infringed by [ * ] of such Licensed Product or [ * ] of a Candidate Drug, and (ii) AZ must pay such Third Party for such license a royalty on Net Sales of such Licensed Product in a particular country, AZ may reduce the amount [ * ] on Net Sales of such Licensed Product in such country; provided that the royalties otherwise due to Array on such Net Sales shall not be so reduced [ * ].  AZ shall not be entitled to such credit in any country of the Territory in the event the patents of such Third Party for which such obligations have been incurred are held invalid or unenforceable in that country.  Notwithstanding the foregoing, if AZ is required to obtain a license as described in this Section 6.15.1 for [ * ] of a Candidate Drug, and AZ [ * ], then AZ may reduce the amount due to Array [ * ]; provided that [ * ] for any Candidate Drug shall not be so reduced [ * ].

 

6.15.2                   Complementary Technologies .  In addition to the foregoing royalty reduction, it is understood that on a case-by-case basis, AZ and Array may agree that it would be in their mutual best interests to in-license a complementary technology for use with a Licensed Product, and in such case may similarly agree that it would be in their mutual best interests to agree upon a further reduction calculated by reference to royalties paid with respect to such in-license; provided, however, that neither Party shall be obligated to agree to any such reduction, and no such reduction shall be made unless so agreed.

 

6.15.3                   Consultation; Disputes.   AZ shall consult with Array prior to entering into any license agreement with a Third Party for which AZ would seek to deduct royalties under this Section 6.15, and shall take into account reasonable suggestions of Array with respect to such proposed license.  Any dispute under this Section 6.15 including any dispute as to whether such a license is necessary, shall be resolved in accordance with Section 12.2 below.

 

ARTICLE VII - COMMERCIALIZATION

 

7.1                                  Commercialization Rights .  AZ shall be responsible for the establishment, control and implementation of the strategy, plans and budgets for marketing and promotion of the Licensed Products.

 

7.2                                  Commercialization Efforts .  AZ shall use commercially reasonable diligent efforts to develop and commercialize Licensed Products, and to perform its obligations under Sections 2.1, 3.1, 3.2, 3.4 and 7.1 of this Agreement, and to obtain the optimum commercial return for each Licensed Product in all major markets throughout the world, consistent with the practice of AZ in pursuing the

 

29



 

development and commercialization of pharmaceutical products of its own development and of similar commercial value potential.

 

ARTICLE VIII - OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS

 

8.1                                  Existing Technology Inventions .

 

8.1.1                         General .  Each Party shall retain all of its rights, title and interest in and to its Existing Technology, including the right to transfer or license such intellectual property to others for any purpose, subject only to its obligations under this Agreement.  Each Party shall promptly disclose to the other any inventions made in connection with the Existing Technology.  Each Party shall keep the other informed as to material developments with respect to the prosecution and maintenance of Patents claiming Existing Technology that pertain to Candidate Drugs or Licensed Products, including without limitation, by providing copies of any substantive documents.  Inventorship shall be determined in accordance with the patent laws of the United States.

 

8.1.2                         Array shall, during the term of this Agreement, be responsible for the filing, prosecution and maintenance of the Array Patents, at Array’s sole discretion.

 

8.1.3                         Array shall use reasonable endeavours to prosecute the Array Patents so that there will be claims [ * ], and other claims [ * ] which are of interest to Array such as, for example, by the filing of divisional Patents.

 

8.1.4                         AZ shall have the right to give comments and recommendations as to the overall strategy regarding the filing, prosecution and maintenance of the Array Patents including any activity pursuant to Section 8.1.3; and before taking any step in the filing, prosecution or maintenance of the Array Patents, Array shall allow AZ to comment on the action proposed to be taken and Array shall endeavour to take into account any comments and suggestions of AZ, provided that any such advice by AZ is given without any warranty or guarantee as to the results.  In addition to the foregoing, (i) if AZ requests in good faith that Array expand the scope of the claims of an Array Patent, Array shall claim such additional subject matter so requested, and (ii) if Array intends to narrow the scope of the claims of an Array Patent in a manner to which AZ in good faith disagrees or objects, then AZ shall have the right to pursue claims to the subject matter so excluded in accordance with Section 8.1.7 below.  At such time as AZ has made all of its Candidate Drug selections, Array’s obligations under this Section 8.1 shall be limited to those Array Patents containing a Valid Claim.

 

8.1.5                         Array shall for the purposes of this Section provide AZ with copies of all substantive documents that Array receives from any patent office, including notice of all interferences, reissues, re-examinations, oppositions or requests for patent term extensions and any other documents which may be of importance for any action(s) to be taken sufficiently in time prior to the deadline for, or the intended date for, the action to be taken, whichever is the earlier, but no later than sixty (60) days

 

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prior to such date, provided that such period is available to Array.  AZ shall communicate its comments on same on the earlier of:

 

(a)                                   thirty (30) days from the date on which Array provided such information to AZ; and

 

(b)                                  no less than thirty (30) days before the deadline for, or the intended date for, the action to be taken, provided that such period is available to AZ.

 

8.1.6                         Should any such comment as provided for under Section 8.1.4 refer to a matter which AZ in its reasonable judgment considers to be of significant importance for the maintenance of the protection which the Array Patents are intended to provide for the Candidate Drugs and/or the Licensed Products, AZ and Array shall discuss in good faith how to maintain such protection.

 

8.1.7                         In the event that Array should decide to permit any pending patent application or any patent included in the Array Patents containing a Valid Claim to lapse by any action, inaction or failure to take any action or to pay any fee when due, Array shall promptly inform AZ of such decision, but no later than two months prior to such action, inaction or failure to pay, provided that such period is available to Array, so that AZ might, at AZ’s expense, seek such patent protection or prevent any such lapse.  In such event, Array shall promptly, at the request and expense of AZ, execute and deliver any transfer or assignment or other relevant documents necessary and make all such rightful oaths as will aid or permit AZ to take such actions on its own behalf.  Upon such transfer and assignment becoming effective AZ shall immediately assume the responsibility for any costs connected therewith, and such patent application or patent shall immediately be deemed AZ Patents.

 

However, upon request by AZ in writing to Array, Array shall, for a period of three (3) months from the date of such notice continue at AZ’s cost to be responsible for seeking such patent protection or preventing any such lapse or failure to pay as mentioned in this Section 8.1.7 and contemplated in AZ’s notice.

 

Where Array wishes to allow a patent application to lapse, and it is not possible for Array to assign its rights to AZ, the patent or patent application will be maintained in the existing name at the expense of AZ and with an exclusive licence to AZ.

 

At such time as AZ has made all of its Candidate Drug selections, Array’s obligations under this Section shall be limited to those Array Patents containing a Valid Claim.

 

8.1.8                         Should AZ reasonably require Array, [ * ] to seek additional patent protection which AZ in its reasonable judgment considers to be of significant importance for the maintenance of the protection which the Array Patents are intended to provide for the Candidate Drugs and/or Licensed Products, by way of patent registration, patent of importation or revalidation or otherwise, then Array

 

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may do so.  Should Array notify AZ in writing that it does not intend to do so, then AZ may do so in its own name or in the name of Array, whichever AZ may elect.

 

8.1.9                         The Parties shall cooperate and shall take each other’s advice into reasonable account in any issue regarding the gaining of patent term extension, including, but not limited to, Supplementary Protection Certificates in the European Economic Area, relating to the Array Patents which AZ in its reasonable judgment considers to be of significant importance for the maintenance of the protection which the Array Patents are intended to provide for the Candidate Drugs and/or the Licensed Products.

 

8.1.10                   Array warrants that it shall not grant any Third Party any right under the Array Patents or otherwise which might contravene or conflict with AZ’s rights under Sections 8.1.2 through 8.1.9.  Array further warrants that it shall not grant to any Third Party any right under the Array Patents or otherwise which would mean or have as a consequence that Array would not be entitled to prosecute the Array Patents in a way which would otherwise contravene or conflict with AZ’s rights or Array’s obligations under this Section.

 

8.1.11                   At the commencement of Phase III in respect of ARRY-142886, any Array Patent [ * ] shall be assigned such that it shall be jointly owned by Array and AZ in equal undivided shares.  Under any such assignment:

 

(i)              AZ rights only extend to any Valid Claim and not to any other claims contained within any jointly owned patent property; and
 
(ii)           Array has a perpetual, irrevocable, sub-licensable exclusive licence without royalty or charge in the Territory for any purpose inside or outside the Field under all the claims contained within any jointly owned patent property, other than any Valid Claim.
 

Neither Party can encumber the rights of the other Party with respect to such jointly owned patent property without the consent of the other Party except that Array grants AZ and its Affiliates a perpetual, irrevocable, sub-licensable, exclusive licence, without royalty or charge other than as set forth in Article VI, under any Valid Claim in the Territory for any purpose in the Field, subject to Section 2.5.2(b) above, and AZ grants Array a perpetual, irrevocable, sub-licensable exclusive licence without royalty or charge under any Valid Claim in the Territory for any purpose outside the Field.

 

8.1.12                   Upon commencement of Phase I in respect of any Candidate Drug other than ARRY-142886, any Array Patent [ * ] shall be assigned such that it shall be jointly owned by Array and AZ in equal undivided shares.  Under any such assignment:

 

(i)              AZ rights only extend to any Valid Claim and not to any other claims contained within any jointly owned patent property; and

 

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(ii)           Array has a perpetual, irrevocable, sub-licensable exclusive licence without royalty or charge in the Territory for any purpose inside or outside the Field under all the claims contained within any jointly owned patent property, other than any Valid Claim
 

Neither Party can encumber the rights of the other Party with respect to such jointly owned patent property without the consent of the other Party except that Array grants AZ and its Affiliates a perpetual, irrevocable, sub-licensable, exclusive licence, without royalty or charge other than as set forth in Article VI, under any Valid Claim in the Territory for any purpose in the Field, subject to Section 2.5.2(b) above, and AZ grants Array a perpetual, irrevocable, sub-licensable exclusive licence without royalty or charge under any Valid Claim in the Territory for any purpose outside the Field.

 

8.2                                  Collaboration Technology .

 

8.2.1                         Inventions .   Each Party shall promptly disclose to the other any inventions made in connection with this Agreement.  Each Party shall keep the other informed as to material developments with respect to the prosecution and maintenance of Patents claiming Collaboration Technology, including without limitation, by providing upon request copies of any substantive documents.

 

8.2.2                         Chemical Inventions .

 

(a)                                   Notwithstanding Section 8.2.3, all inventions and other intellectual property made by personnel of Array or AZ in the course of and in connection with the Research Program, the Process Program comprising compositions of matter but excluding inventions relating to specific salts and polymorphs, shall be owned by Array (“Chemical Intellectual Property” and in relation to Patents “Chemical Patents”).

 

(b)                                  Array shall, during the term of this Agreement, be responsible for the filing, prosecution and maintenance of the Chemical Patents at its sole discretion.

 

(c)                                   Array shall use reasonable endeavours to prosecute the Chemical Patents so that there will be claims [ * ], and other claims [ * ] which are of interest to Array such as, for example, by the filing of divisional Patents.

 

(d)                                  AZ shall have the right to give comments and recommendations as to the overall strategy regarding the filing, prosecution and maintenance of the Chemical Patents including any activity pursuant to Section 8.2.2(c); and before taking any step in the filing, prosecution or maintenance of the Chemical Patents, Array shall allow AZ to comment on the action proposed to be taken and Array shall endeavour to take into account any comments and suggestions of AZ, provided that any such advice by AZ is given without any warranty or guarantee as to the results.  In addition to the foregoing, (i) if AZ requests in good faith that Array expand the scope of the claims of a Chemical Patent, Array shall claim

 

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such additional subject matter so requested, and (ii) if Array intends to narrow the scope of the claims of a Chemical Patent in a manner to which AZ in good faith disagrees or objects, then AZ shall have the right to pursue claims to the subject matter so excluded in accordance with Section 8.2.2(g) below.  At such time as AZ has made all of its Candidate Drug selections, Array’s obligations under this Section 8.2.2 shall be limited to those Chemical Patents containing a Valid Claim.

 

(e)                                   Array shall for the purposes of this Section provide AZ with copies of all substantive documents that Array receives from any patent office, including notice of all interferences, reissues, re-examinations, oppositions or requests for patent term extensions and any other documents which may be of importance for any action(s) to be taken sufficiently in time prior to the deadline for, or the intended date for, the action to be taken, whichever is the earlier, but no later than sixty (60) days prior to such date, provided that such period is available to Array.  AZ shall communicate its comments on same on the earlier of:

 

(i)              thirty (30) days from the date on which Array provided such information to AZ; and
 
(ii)           no less than thirty (30) days before the deadline for, or the intended date for, the action to be taken, provided that such period is available to AZ.
 

(f)                                     Should any such comment as provided for under Section 8.2.2(d) refer to a matter which AZ in its reasonable judgment considers to be of significant importance for the maintenance of the protection which the Chemical Patents are intended to provide for the Candidate Drugs and/or the Licensed Products, AZ and Array shall discuss in good faith how to maintain such protection.

 

(g)                                  In the event that Array should decide to permit any pending patent application or any patent included in the Chemical Patents containing a Valid Claim to lapse by any action, inaction or failure to take any action or to pay any fee when due, Array shall promptly inform AZ of such decision, but no later than two months prior to such action, inaction or failure to pay, provided that such period is available to Array, so that AZ might, at AZ’s expense, seek such patent protection or prevent any such lapse.  In such event, Array shall promptly, at the request and expense of AZ, execute and deliver any transfer or assignment or other relevant documents necessary and make all such rightful oaths as will aid or permit AZ to take such actions on its own behalf.  Upon such transfer and assignment becoming effective AZ shall immediately assume the responsibility for any costs connected therewith, and such patent application or patent shall immediately be deemed AZ Patents.

 

However, upon request by AZ in writing to Array, Array shall, for a period of three (3) months from the date of such notice continue at AZ’s cost to be responsible for seeking such patent protection or preventing any such lapse or failure to pay as mentioned in this Section 8.2.2(g) and contemplated in AZ’s notice.

 

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Where Array wishes to allow a patent application to lapse, and it is not possible for Array to assign its rights to AZ, the patent or patent application will be maintained in the existing name at the expense of AZ and with an exclusive licence to AZ.

 

(h)                                  Should AZ reasonably require Array, [ * ] to seek additional patent protection which AZ in its reasonable judgment considers to be of significant importance for the maintenance of the protection which the Chemical Patents are intended to provide for the Candidate Drugs and/or Licensed Products, by way of patent registration, patent of importation or revalidation or otherwise, then Array may do so.  Should Array notify AZ in writing that it does not intend to do so, then AZ may do so in its own name or in the name of Array, whichever AZ may elect.

 

(i)                                      The Parties shall cooperate and shall take each other’s advice into reasonable account in any issue regarding the gaining of patent term extension, including, but not limited to, Supplementary Protection Certificates in the European Economic Area, relating to the Chemical Patents which AZ in its reasonable judgment considers to be of significant importance for the maintenance of the protection which the Chemical Patents are intended to provide for the Candidate Drugs and/or the Licensed Products.  In the event the Parties are unable to agree concerning any decision in any country as to what product or claim or otherwise to apply for such patent term extension, then AZ’s opinion shall be decisive for the action to be taken by Array.

 

(j)                                      Array warrants that it shall not grant any Third Party any right under the Chemical Patents or otherwise which might contravene or conflict with AZ’s rights under Sections 8.2.2(b) through 8.2.2(i).  Array further warrants that it shall not grant to any Third Party any right under the Chemical Patents or otherwise which would mean or have as a consequence that Array would not be entitled to prosecute the Chemical Patents in a way which would otherwise contravene or conflict with AZ’s rights or Array’s obligations under this Section.

 

(k)                                   Upon selection of a Compound as a Candidate Drug pursuant to Section 2.5.2(a), any Chemical Patent [ * ] shall be assigned such that it shall be jointly owned by Array and AZ in equal undivided shares (“Joint Chemical Patents”).  Under any such assignment:

 

(i)              AZ rights only extend to any Valid Claim and not to any other claims contained within any Joint Chemical Patent; and
 
(ii)           Array has a perpetual, irrevocable, sub-licensable exclusive licence without royalty or charge in the Territory for any purpose inside or outside the Field under all the claims contained within any Joint Chemical Patent, other than any Valid Claim
 

Neither Party can encumber the rights of the other Party with respect to such Joint Chemical Patents without the consent of the other Party except that Array grants AZ and its Affiliates a perpetual, irrevocable, sub-licensable, exclusive licence, without royalty or charge other than as set forth in Article

 

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VI, under any Valid Claim contained in the Joint Chemical Patents in the Territory for any purpose in the Field, subject to Section 2.5.2(b) above, and AZ grants Array a perpetual, irrevocable, sub-licensable exclusive licence without royalty or charge under any Valid Claim in the Territory for any purpose outside the Field.

 

8.2.3                         Other Inventions.   Subject to Section 8.2.2(a), all inventions and other intellectual property made by personnel of Array or AZ in the course of and in connection with the Research Program, the Process Program comprising but not limited to biological assays and test methods, processes for making compositions of matter or intermediates of such compositions of matter, combinations of a composition of matter with other therapeutically active agents, use of compositions of matter for therapeutic purposes, specific salts and polymorphs and formulations of compositions of matter shall be jointly owned by Array and AZ in equal undivided shares (“Joint Intellectual Property” and in relation to Patents “Joint Patents”).  Neither Party can encumber the rights of the other Party with respect to such Joint Patents without the consent of the other Party except that Array grants AZ and its Affiliates a perpetual, irrevocable, sub-licensable, exclusive licence, without royalty or charge other than as set forth in Article VI, in the Territory for any purpose in the Field, subject to Section 2.5.2(b) above, and AZ grants Array a perpetual, irrevocable, sub-licensable exclusive licence without royalty or charge in the Territory for any purpose outside the Field.

 

8.2.4                         The relevant countries within which patent applications shall be filed for the Joint Patents and the Joint Chemical Patents shall be agreed by both Parties.

 

8.2.5                         The filing, prosecution and maintenance of the Joint Patents and the Joint Chemical Patents shall be carried out by patent counsel mutually acceptable to the Parties.  In such connections, the Parties agree to discuss in good faith and to use all reasonably diligent endeavours to prepare and prosecute Joint Patent applications and Joint Chemical Patent applications in a manner that ensures the optimum scope of protection for any inventions specifically directed to such subject matter and, in particular, for Compounds, Candidate Drugs and Licensed Products.  In the event that the Parties are unable to agree on the required actions AZ shall have the final decision with respect to Joint Patents and to Joint Chemical Patents.

 

8.2.6                         AZ and Array shall, and shall cause their respective Affiliates, as applicable, to assist and cooperate with one another in, [ * ], filing, prosecuting and maintaining the Joint Patents and Joint Chemical Patents.  Notwithstanding the above, either Party may decline to pay its share of the costs and expenses for filing, prosecuting and maintaining any Joint Patent or Joint Chemical Patent in a particular country or particular countries, in which case the declining Party shall assign, and shall cause its Affiliates to assign, to the other Party all of their rights, titles and interests in and to any such Joint Patent or Joint Chemical Patent in the relevant country or countries whereupon such Joint Patent or Joint Chemical Patent shall become an AZ Patent or an Array Patent in such country or countries, as the case may be.

 

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8.2.7                         To the extent that either Party is obtaining, prosecuting or maintaining a Joint Patent or Joint Chemical Patent or otherwise exercising its rights under this Article 8, neither Party nor any of their respective employees, agents or representatives shall be liable to the other Party in respect of any act, omission, default or neglect on the part of any such employee, agent or representative in connection with such activities.

 

8.3                                  Enforcement Rights .

 

8.3.1                         Defence and Settlement of Third Party Claims .  If a Third Party asserts that a Patent or other right owned by it is infringed by the manufacture, use, sale, importation, research, development, registration, manufacture, formulation, exportation, transportation, distribution, promotion, marketing disposal of any Candidate Drug or Licensed Product, AZ or its Affiliates shall have:

 

(a)                                   the right to defend or settle such claim in its own name and/or in the name of Array; together with

 

(b)                                  the right to enforce and collect any judgment thereon;

 

(c)                                   subject to Section 8.3.1(d), full control over the conduct of the litigation, including settlement of it; provided that any settlement, consent judgment or other disposition does not admit the invalidity or unenforceability of any Patent within the Licensed Technology Controlled by Array, without the prior written consent of Array.  If AZ or its Affiliate elects to exercise the right to defend against an action, then Array shall, at AZ´s request and at AZ’s or its Affiliate’s expense for Array´s costs and expenses, assist in the prosecution of such action.  AZ shall bear its own internal and external legal and other costs and expenses associated with the prosecution of the action.

 

(d)                                  Array may join the proceedings voluntarily, subject always to AZ’s right to decide the conduct over such litigation.  Any such joining of the proceedings shall be at Array’s cost and expense.

 

(e)                                   Array shall have the right to independently retain legal counsel and consultants, at its sole cost and expense, but such counsel or consultants shall not have the right to affect AZ or its Affiliate’s sole management of the prosecution of the action.

 

8.3.2                         Any monetary recovery (whether by settlement or judgment) in connection with an infringement action defended by AZ or its Affiliate shall be applied first to reimburse AZ or its Affiliate for their out-of-pocket expenses (including reasonable attorneys fees) incurred in prosecuting such action and the expenses of Array borne by AZ hereunder.

 

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8.3.3                         Infringement by Third Parties .

 

(a)                                   If a Third Party shall, in the reasonable opinion of either Party, infringe any Patent within the Licensed Technology controlled by Array or a Joint Patent or Joint Chemical Patent, then the Party having such opinion shall promptly notify the other Party.  Each Party shall within five (5) working days or as soon as reasonably practicable thereafter advise the other Party of receipt of any notice of:

 

(i)              any certification filed under the U.S. “Drug Price Competition and Patent Term Restoration Act of 1984” (“ANDA Act”), claiming that any Array Patent or Joint Patent or Joint Chemical Patent is invalid or claiming that the Array Patent or Joint Patent or Joint Chemical Patent will not be infringed by the manufacture, use or sale of a product for which an application under the ANDA Act is filed or;
 
(ii)           any equivalent or similar certification or notice in any other jurisdiction.
 

(b)                                  If any Patent within the Licensed Technology Controlled by Array or a Joint Patent or Joint Chemical Patent is infringed by a Third Party in any country in connection with the manufacture, use and sale of a product the same as or substantially similar to a Licensed Product in the Field in such country, AZ shall have the primary right, but not the obligation, to institute, prosecute, and control any action or proceeding with respect to such infringement of such Patent, by counsel of its own choice, and Array shall have the right, at its own expense, to be represented in that action by counsel of its own choice.  If AZ fails to bring an action or proceeding within a period of one hundred twenty (120) days after a request by Array to do so, Array shall have the right to bring and control any such action by counsel of its own choice, and AZ shall have the right to be represented in any such action by counsel of its own choice at its own expense.

 

(c)                                   If one Party brings any such action or proceeding in accordance with this Section 8.3.3, the second Party agrees to be joined as a party plaintiff if necessary and to give the first Party reasonable assistance and authority to file and prosecute the suit.  The costs and expenses of the Party bringing suit under this Section shall be borne by such Party, and any damages or other monetary awards recovered shall be shared as follows: The amount of such recovery actually received by the Party controlling such action shall first be applied to the out-of-pocket costs of such action, and then (i) if AZ is the Party that brings such action or proceeding, then Array shall be paid an amount equal to the royalties that would have been due upon sales of the infringing product as if such infringing sales had been Net Sales of a Product sold by AZ, and the remaining portion of such recovery shall be paid to AZ, or (ii) if Array is the Party that brings such action or proceeding, then the remaining portion of such recovery shall be retained by Array.  A settlement or consent judgment or other voluntary final disposition of a suit under this Section 8.3.3 may be entered into without the consent of the Party not bringing the suit.  Neither Party shall, however, have the right to enter into any settlement or consent to any claim to the effect that the patent protection offered under any part of the Array Patents, the Joint

 

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Patents, the Joint Chemical Patents or the Chemical Patents would be materially negatively affected, without the consent of the other Party, such consent not to be unreasonably withheld.

 

(d)                                  For any other infringement actions relating to Array Patents containing Valid Claims, Chemical Patents, Joint Patents or Joint Chemical Patents falling outside of the application of Section 8.3.3(a) or 8.3.3(b) Array shall have:

 

(i)              the right to defend or settle such claim or commence an action for infringement against the Third Party, whichever would be applicable, together with
 
(ii)           the right to enforce and collect any judgment thereon;
 
(iii)        subject to Section 8.3.3(d)(v), full control over the conduct of the litigation, including settlement of it.  If Array elect to exercise the right to commence an action, then AZ or its Affiliates shall, at Array´s request and at Array’s expense for AZ or its Affiliate’s costs and expenses, assist in the prosecution of such action.  Array shall bear its own internal and external legal and other costs and expenses associated with the prosecution of the action;
 
(iv)       AZ or its Affiliates may join the proceedings voluntarily, subject always to Array’s right to decide the conduct over such litigation.  Any such joining of the proceedings shall be at AZ’s or its Affiliates’ cost and expense. AZ or its Affiliates shall have the right to independently retain legal counsel and consultants, at its sole cost and expense, but such counsel or consultants shall not have the right to affect Array’s sole management of the prosecution of the action.
 
(v)          Array shall, however, not have the right to enter into any settlement or consent to any claim to the effect that the patent protection offered under any part of the Array Patents or Chemical Patents or Joint Patents or Joint Chemical Patents covering the Candidate Drugs and/or the Licensed Products would be materially negatively affected, without the consent of AZ, such consent not to be unreasonably withheld.
 

(e)                                   Should Array not take appropriate and diligent action with respect to any infringement by a Third Party as mentioned under Section 8.3.3(d) within one hundred and twenty (120) days after receiving notice of any infringement or possible infringement, or in the case of an ANDA any certificate filed under the ANDA Act within thirty (30) days, then AZ or its Affiliates shall have the right, but not the obligation, to take such action, at its own expense, in its own name, and the right to enforce and collect any judgment thereon.

 

8.4                                  Rights in Bankruptcy .  All rights and licenses granted under or pursuant to this Agreement by Array or AZ are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101 of the United States Bankruptcy Code.  The Parties agree that the Parties, as licensees of such rights

 

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under this Agreement, shall retain and may fully exercise all of their rights and elections under the United States Bankruptcy Code.  The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party under the United States Bankruptcy Code, the Party that is not a party to such proceeding shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property commensurate with the scope of the license thereunder, which, if not already in the non subject Party’s possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon the non subject Party’s written request therefor, unless the Party subject to such proceeding continues to perform all of its obligations under this Agreement or (b) if not delivered under clause (a) above, following the rejection of this Agreement by or on behalf of the Party subject to such proceeding upon written request therefor by the non subject Party.

 

ARTICLE IX - CONFIDENTIALITY

 

9.1                                  Confidentiality; Exceptions .   Except to the extent expressly authorized by this Agreement or otherwise agreed in writing, the Parties agree that the receiving Party shall keep confidential and shall not publish or otherwise disclose or use for any purpose other than as provided for in this Agreement any Information and other confidential and proprietary information and materials furnished to it by the other Party pursuant to this Agreement or any Information developed during the term of this Agreement (collectively, “Confidential Information”), except to the extent that it can be established by the receiving Party that such Confidential Information:

 

(i)              was in the lawful knowledge and possession of the receiving Party or its Affiliates prior to the time it was disclosed to, or learned by, the receiving Party, or was otherwise developed independently by the receiving Party, as evidenced by written records kept in the ordinary course of business, or other documentary proof of actual use by the receiving Party;
 
(ii)           was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;
 
(iii)        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; or
 
(iv)       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.
 

Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party.

 

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Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.

 

9.2                                  Authorized Disclosure .  Except as expressly provided otherwise in this Agreement, each Party may use and disclose Confidential Information of the other Party as follows:  (i) under appropriate confidentiality provisions substantially equivalent to those in this Agreement, in connection with the exercise of rights granted or reserved in this Agreement (including the rights to develop and commercialize Candidate Drugs and/or Licensed Products and to grant licenses and sublicenses hereunder), or (ii) to its Affiliates, or (iii) to the extent such disclosure is reasonably necessary in filing or prosecuting patent, copyright and trademark applications, prosecuting or defending litigation, complying with applicable governmental regulations, obtaining regulatory approval, conducting preclinical or clinical trials, marketing Licensed Products, or otherwise required by law, provided, however, that if a Party is required by law or regulation to make any such disclosure of the other Party’s Confidential Information it will, except where impracticable for necessary disclosures, for example in the event of medical emergency, give reasonable advance notice to the other Party of such disclosure requirement and, except to the extent inappropriate in the case of patent applications, will use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed or (iv) to the extent mutually agreed to by the Parties.

 

9.3                                  Termination of Prior Agreements .   This Agreement supersedes the Confidentiality Agreement between the Parties (or their Affiliates) dated [ * ] and the Materials Transfer Agreement between the Parties dated [ * ], including all modifications in so far as they relate to the Parties’ activities in the Field.  All information exchanged between the Parties under those Agreements shall be deemed Confidential Information and shall be subject to the terms of this Article IX.  All other provisions intended to survive termination of those Agreements shall survive according to their terms.

 

9.4                                  Publications .  The publication strategy of the Parties with respect to the Research Program during the Research Term shall be directed by the JRC.  After the end of the Research Term the publication strategy shall be directed by the Development Committee.  Any publication relating to the results of the Research Program or a Phase I or Phase II clinical trial of a Candidate Drug or Licensed Product shall describe such Candidate Drug or Licensed Product by Array compound number (e.g. ARRY-142866) as well as the applicable AZ designation.    Each Party shall submit or shall as far as reasonably possible procure that any Third Party carrying out research activities shall submit any proposed publication containing Confidential Information to the other Party at least [ * ] in advance to allow that Party to review such planned public disclosure.  The reviewing Party will promptly review such proposed publication and make any objections that it may have to the publication of Confidential Information of the reviewing Party contained therein.  Should the reviewing Party make an objection to the publication of any such Confidential Information, then the Parties shall discuss the advantages and disadvantages of publishing such Confidential Information.  If the Parties are unable to agree on whether

 

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to publish the same, the Chief Executive Officer of Array and the VP and Global Head of Oncology Research of AZ shall reasonably agree on the extent to which the publication of such Confidential Information shall be made.

 

ARTICLE X - REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION

 

10.1                            Representations and Warranties .  Each of the Parties hereby represents and warrants and covenants as follows:

 

(a)                                   This Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms.  The execution, delivery and performance of the Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a Party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.

 

(b)                                  Each Party has not, and during the term of the Agreement will not, grant any right to any Third Party relating to its respective technology in the Field which conflicts with the rights granted to the other Party hereunder.

 

(c)                                   Each Party owns or otherwise Controls all of the rights, title and interest in and to its Patents and Know-How within the Licensed Technology and is entitled to grant the licenses specified in this Agreement and during the term of this Agreement shall not encumber or diminish the rights granted hereunder.

 

(d)                                  To the best of the Parties’ and their Affiliates’ knowledge as of the Effective Date, each Party’s Patents have been and are being diligently procured from the respective patent offices in accordance with all applicable laws and regulations.  Each Party’s Patents have been and will continue to be filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment.

 

(e)                                   As of the Effective Date, to the best of each Party’s and its Affiliates’ Knowledge, there is no actual infringement or threatened infringement of that Party’s Patents or Know-How by any Person.

 

(f)                                     As of the Effective Date, to the best of each Party’s and its Affiliates’ knowledge, [ * ].

 

(g)                                  As of the Effective Date, to the best of each Party’s and its Affiliates’ knowledge, each Party’s Existing Technology Patents and Know-How existing as of the Effective Date are subsisting and [ * ], in whole or in part.  There are no claims, judgments or settlements against or amounts with respect thereto owed by either Party or any of its Affiliates relating to the Existing

 

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Technology Patents or the Know-How Controlled by such Party at that date.  No claim or litigation has been brought or threatened by any person alleging, and neither Party is aware of any possible claim, whether or not asserted, that (a) the Existing Technology Patents or the Know-How Controlled by such Party at that date are invalid or unenforceable or (b) the Existing Technology Patents or the Know-How Controlled by such Party at that date or the disclosing, copying, making, assigning, licensing or exploiting of such Existing Technology Patents or Know-How, or products and services embodying the Compounds, Candidate Drugs or Licensed Products violates, infringes or otherwise conflicts or interferes with any intellectual property or proprietary right of any Third Party.  For the purposes of this Section 10.1(g) “Existing Technology Patents or Know-How” shall mean with respect to Array the Array Existing Technology, the Array Patents and the Array Know-How and with respect to AZ the AZ Existing Technology, the AZ Patents and the AZ Know-How.

 

(h)                                  In respect of any pending United States patent applications included in the Existing Patents, the owning Party has presented or will present, as appropriate, all relevant prior art of which it and the inventors are aware to the relevant patent examiner at the United States Patent and Trademark Office.

 

(i)                                      The performance of any and all rights and obligations by a Party’s Affiliate(s) shall be guaranteed by that Party.

 

10.2                            Array hereby represents and warrants and covenants that as at the Effective Date it is not aware of any prior art or failure to disclose prior art that might result in the Array Patents being held invalid or unenforceable.

 

10.3                            Disclaimer .  Array and AZ specifically disclaim any guarantee that the Research Program or Process Program will be successful, in whole or in part.  The failure of the Parties to successfully develop Candidate Drugs or Licensed 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 AZ MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OR CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE ARRAY EXISTING TECHNOLOGY, AZ EXISTING TECHNOLOGY, COLLABORATION TECHNOLOGY, COMPOUNDS, CANDIDATE DRUGS, INFORMATION DISCLOSED HEREUNDER OR LICENSED PRODUCTS INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF ANY TECHNOLOGY LICENSED HEREUNDER, PATENTED OR UNPATENTED, OR NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

 

10.4                            Indemnification .

 

10.4.1                   Indemnification by AZ .  In addition to any other remedy available to Array AZ hereby agrees to indemnify, defend and hold Array and its agents, directors, employees and Affiliates

 

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harmless from and against any and all suits, claims, actions, demands, liabilities, expenses and/or loss, including reasonable legal expense and attorney’s fees (“Losses”) resulting directly from a breach of Section 10.1 or the development, manufacture, use, handling, storage, sale or other disposition of Candidate Drugs or Licensed Products but expressly excluding Abandoned Products, by AZ, its Affiliates, agents or Sublicensees, except to the extent that such Losses arise due to the negligence, fraud, misconduct or wrongful act of Array.

 

10.4.2                   Indemnification by Array .  In addition to any other remedy available to AZ Array hereby agrees to indemnify, defend and hold AZ and its agents, directors, employees and Affiliates harmless from and against any and all Losses resulting directly from a breach of Section 10.1 or the development, manufacture, use, handling, storage, sale or other disposition of Abandoned Products or Compounds but expressly excluding Candidate Drugs or Licensed Products, by Array, its Affiliates, agents or Sublicensees except to the extent that such Losses arise due to the negligence, fraud, misconduct or wrongful act of AZ.

 

10.4.3                   Procedure .  In the event a Party is seeking indemnification (the “Indemnified Party”) under Sections 10.4.1 or 10.4.2, it shall inform the other Party (the “Indemnifying Party”) in writing of any Losses in respect of which the Indemnified Party intends to claim such indemnification and the Indemnifying Party shall be entitled, but not obligated, to assume the defence of any Third Party claim thereof with counsel selected by it.  The Indemnified Party, including its Affiliates, directors, officers and employees, shall co-operate fully, at the Indemnifying Party’s expense, with the Indemnifying Party and its legal representatives in the investigation and defence of any Third Party claim covered by this indemnification.  The indemnification shall not apply to amounts paid in settlement of any third party claim if such settlement is effected without the consent of the Indemnifying Party.

 

10.3.4                    Limitation of Liability EXCEPT IN CIRCUMSTANCES OF GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT BY A PARTY OR ITS AFFILIATES, OR WITH RESPECT TO THIRD PARTY CLAIMS, NO PARTY OR ANY OF ITS AFFILIATES SHALL BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, OR FOR LOST PROFITS, MILESTONES OR ROYALTIES, WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF (a) THE DEVELOPMENT, MANUFACTURE, USE OR SALE OF ANY LICENSED PRODUCT, CANDIDATE DRUG OR COMPOUND DEVELOPED, MANUFACTURED OR MARKETED HEREUNDER, OR (b) ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS OF THIS AGREEMENT.

 

ARTICLE XI - TERM AND TERMINATION

 

11.1                            Term .  Unless earlier terminated, the Agreement will continue in full force and effect, on a product-by-product and country-by-country basis until the date no further payments are due under Article VI above.

 

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11.2                            Termination For Breach .  Either Party may terminate this Agreement in the event the other Party shall have materially breached or defaulted in the performance of any of its material obligations hereunder, and such default shall have continued for [ * ] after written notice thereof was provided to the breaching Party by the non-breaching Party provided always that the termination shall not become effective if the breaching Party cures the breach complained about during the [ * ] period (or, if such default cannot be cured within such [ * ] period, if the breaching Party commences actions to cure such default within the notice period and thereafter diligently continues such actions).

 

11.3                            Termination Upon Notice .

 

11.3.1                   AZ’s Notice .  AZ may terminate this Agreement upon [ * ] written notice to Array, provided that such notice is given after the end of the Research Term.

 

11.3.2                   Candidate Drug-by-Candidate Drug or Licensed Product-by-Licensed Product .  If AZ determines, in its sole discretion, that it is not feasible for AZ to pursue the development, launch or sale of a particular Candidate Drug or Licensed Product in the Territory because [ * ] or due to [ * ], then AZ shall, within [ * ] after such determination is made, notify the Development Committee that it does not intend to continue development or commercialization activities with respect to such Candidate Drug or Licensed Product.  If AZ notifies the Development Committee that it does not intend to continue development and/or commercialization activities with respect to a Candidate Drug or Licensed Product, termination of its development and/or commercialization activities with respect to that Candidate Drug or Licensed Product shall be effective:

 

(a)                                   [ * ] after the date of such notice for a Candidate Drug or Licensed Product which is not being sold in the Territory as at the date of notice, or such shorter period as the Parties may agree; or

 

(b)                                  [ * ] after the date of such notice for a Licensed Product which is being sold in the Territory as at the date of notice, or such shorter period as the Parties may agree.

 

In the event AZ decides to terminate development and/or commercialization activities with respect to such Candidate Drug or Licensed Product, such Candidate Drug or Licensed Product shall thereafter be deemed an “Abandoned Product”; provided, however, if the Research Term has ended and as a result of such termination, AZ is not actively performing or planning to perform GLP toxicology studies, or human clinical trials, with respect to any Candidate Drug or Licensed Product, and AZ has notified Array that it does not wish to select any other Candidate Drugs in accordance with Section 2.5.2 or it has no further right to select Candidate Drugs in accordance with Section 2.5.2, and there is no Candidate Drug or Licensed Product being sold in any country within the Territory, then the termination of such Candidate Drug or Licensed Product shall be deemed a termination of this Agreement in its entirety under Section 11.3.1 above.

 

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For the avoidance of doubt, provided that AZ is diligently developing and/or commercializing ARRY-142886 or such other Candidate Drug or Licensed Product as may have been selected in its place, AZ shall be under no obligation to concurrently develop and/or commercialize any other Candidate Drug or Licensed Product.  Such undeveloped or un-commercialized Candidate Drug or Licensed Product shall not be deemed an Abandoned Product until AZ has provided formal notice that it intends to terminate development and/or commercialization activities with respect to such Candidate Drug in accordance with this Section 11.3.2.

 

11.3.3                   For each Abandoned Product for which rights revert to Array under this Section 11.3, AZ shall, at Array’s request and cost, take all steps reasonably necessary to enable Array to develop and commercialize the subject Abandoned Product in the Territory, including transferring to Array any MAA or Marketing Approval for such Abandoned Product or other commercially reasonable arrangements as the Parties may agree.

 

11.3.4                   Array Notice .  If at any time after the Research Term Array has reasonable grounds to consider that the conditions in Section 11.3.2 above are met (i.e. regardless of whether AZ has formally terminated a particular Licensed Product or Candidate Drug under Section 11.3.2), Array shall notify AZ of such grounds in writing.  If AZ fails to remedy such grounds within [ * ] after receipt of written notice Array shall have the right to terminate this Agreement with respect to that particular Licensed Product or Candidate Drug only upon [ * ] written notice to AZ.  Any dispute under this Section 11.3.4 shall be subject to resolution under Section 12.2.

 

11.4                            Termination on Bankruptcy .  Either Party may terminate this Agreement if, at any time, the other Party shall file in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of the Party or of substantially all of its assets, or if the other Party proposes a written agreement of composition or extension of substantially all of its debts, or if the other Party shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed within sixty (60) days after the filing thereof, or if the other Party shall propose or be a party to any dissolution or liquidation, unless in connection with such dissolution or liquidation this Agreement is assigned under Section 12.4, or if the other Party shall make an assignment of substantially all of its assets for the benefit of creditors.

 

11.5                            Certain Payment Terms .

 

11.5.1                   Wind-Down Payments .  In the event of a termination of this Agreement under Section 11.2 by reason of breach by AZ or under Section 11.3, AZ shall meet its own costs of winding down any clinical trials and shall pay to Array an amount of compensation, calculated with reference to: (i) the amount [ * ], if any, over the [ * ] period after the notice of termination under Section 11.3, or over the [ * ] period after the effective date of termination under Section 11.2 (in each case the “Termination Period”) related to matters under the Research Program; (ii) [ * ] in accordance with

 

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Section 3.5; (iii) any non-cancelable commitments incurred by Array hereunder, to the extent such commitments pertained to activities that have been approved by the JRC or Development Committee (excluding any such commitments to the extent reimbursed in clauses (i) or (ii) above).  AZ shall make the payments to Array under (i), (ii) and (iii) above [ * ] after the notice of termination is given hereunder and upon receipt of a valid invoice from Array, and upon such payment, AZ shall have no further obligation under Section 6.2 above.  In the event there are less than [ * ] remaining under the Research Plan and/or Process Plan in effect on the date the notice of termination is given, such Research Plan and/or Process Plan shall be deemed extended for the remaining months of the Termination Period at the same average monthly amounts as were in effect for the last Research Plan and/or Process Plan approved by the JRC.    The Parties shall negotiate in good faith whether to transfer to Array or wind-down the conduct of any ongoing clinical trials.  For purposes of this Section 11.5.1, a clinical trial shall be deemed to be an “ongoing clinical trial” if the first patient has been dosed in such clinical trial but such clinical trial was not completed as of the beginning of the Termination Period.

 

11.5.2                   [ * ] Payments .  If (i) a termination notice is properly given by AZ pursuant to Section 11.3.1 or 11.3.2, or (ii) a termination has occurred pursuant to Section 11.2 by reason of a breach by Array or pursuant to Section 11.3.4, then AZ [ * ] if the [ * ] or [ * ] occurs after such notice or termination.

 

11.6                            Effect of Termination .

 

11.6.1                   Accrued Rights, Surviving Obligations .  Termination, relinquishment or expiration of the Agreement for any reason shall be without prejudice to any obligations which shall have accrued prior to such termination, relinquishment or expiration, including, without limitation, the payment obligations under Article VI hereof and any and all damages arising from any breach hereunder.

 

11.6.2                   Survival .  Articles [ * ] shall survive the expiration and any termination of this Agreement; and [ * ] shall survive the expiration but not an earlier termination (except as provided below) of this Agreement.

 

11.6.3                   In addition to Section 11.6.2, the following provisions shall survive termination of this Agreement in the events set forth below:

 

(a)                                   Certain Terminations .  In the event of a termination of this Agreement by AZ pursuant to Section 11.3.1, or termination by Array pursuant to Section 11.2: (i) all Licensed Products and Candidate Drugs then being developed or commercialized by AZ shall be deemed Abandoned Products and (ii) Section 5.3.1 shall survive, and in addition with respect to Licensed Products being sold in the Territory only, Array shall have an irrevocable, exclusive, worldwide license, with the right to grant and authorize sublicenses, under any trademarks owned by AZ and used specifically by AZ to identify the Licensed Products (excluding the AstraZeneca trade name and trade dress) to make, use, sell, import and otherwise exploit the corresponding Abandoned Products.  From and after the date of a notice

 

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of termination in the events described in this Section 11.6.3(a), neither Party shall have any further obligations under this Agreement beyond those obligations that survive termination in such events as specified in this Section 11.6.3.

 

(b)                                  Breach by Array .  In the event of a termination of this Agreement by AZ pursuant to Section 11.2:

 

(i)              Array’s obligations under Article VIII and Section 4.2 above shall continue indefinitely and Array’s obligations under Section 4.1 above shall continue for the Exclusivity Period as if the Agreement had not been terminated.  In addition, Sections [ * ] shall survive; and
 
(ii)           If such termination occurs prior to the end of the Research Term, AZ shall also have the option to continue the Research and/or the Process Programs with AZ personnel or the personnel of its Affiliates or subcontractors until the earlier of (i) the end of the then-current Research Term plus a period of [ * ], or (ii) selection by AZ of [ * ] Candidate Drugs in addition to ARRY-142886.  In the event AZ exercises such option, AZ shall amend the Research Plan to reflect such transfer and the activities to be conducted by AZ thereafter, and Array shall cooperate fully with AZ to provide AZ with all such Collaboration Technology and Array Existing Technology and existing material as is necessary for AZ to identify and select Candidate Drugs.  In addition, AZ’s obligation to meet any future FTE payments under Section 6.2.1 shall terminate and AZ shall reimburse Array’s reasonable out-of-pocket costs for such cooperation and provision of technology and material.  In addition, during the term set forth in this Section 11.6.3(b)(ii), Array shall develop for use outside the Field only those Compounds (y) that Array has demonstrated do not meet the Candidate Drug Target Profile, and (z) that were determined to meet the Candidate Drug Target Profile in the course of the Research Program prior to the termination, but that were rejected as Candidate Drugs pursuant to Section 2.5.2(a)(ii) above.  AZ shall inform Array promptly after it has selected [ * ] Candidate Drugs in addition to ARRY-142886.  In addition, licences granted to AZ under Section 5.1 shall survive termination for the duration of the Research Term plus a period of [ * ] thereafter.  From and after the date of a notice of termination in the events described in this Section 11.6.3(b), AZ shall have no further obligations under this Agreement (including any AZ payment obligations pursuant to Sections 6.2, 6.3 and 6.4) beyond those obligations that survive termination in such events as specified in this Section 11.6.3(b).
 

11.7                            Termination Not Sole Remedy .  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.

 

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ARTICLE XII - MISCELLANEOUS

 

12.1                            Publicity .

 

12.1.1                   Financial Terms .  Each of the Parties hereto 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 and subject always to Article IX, or to the extent required by law.  Notwithstanding the foregoing, the Parties shall agree upon a press release to announce the execution of this Agreement and the achievement of a milestone together with a corresponding Question & Answer outline for use in responding to inquiries about the Agreement; thereafter, AZ and Array may each disclose to Third Parties the information contained in such press release and Question & Answer outline without the need for further approval by the other.

 

12.1.2                   Development Progress .  In addition, each Party may not, without the prior written consent of the other Party disclose publicly any information, including information disclosed to it by the other Party, which pertains to the development and regulatory progress of any Licensed Product.  Such disclosure may include, without limitation, the achievement of a Development Milestone for a Licensed Product and any payments received in respect of such Development Milestone, as well as periodic updates regarding the status of the development and/or regulatory affairs pertaining to such Licensed Product.

 

12.2                            Short-Form Arbitration .  If the Parties do not agree upon (i) a matter to be decided by the JRC, for which AZ does not have the right to cast a deciding vote, or (ii) a dispute under Section 4.4 or 6.15 or 11.3.4 or 12.8 , then such matters in issue shall be determined by binding arbitration conducted pursuant to this Section 12.2 by one (1) arbitrator.  In such arbitration, the arbitrator shall be an independent expert (including in the area of the dispute) in the pharmaceutical industry mutually acceptable to the Parties.  If the Parties are unable to agree on an arbitrator, the arbitrator shall be an independent expert as described in the preceding sentence selected by the chief executive of the Denver office of the American Arbitration Association.  Each Party shall prepare a written report setting forth its position with respect to the substance of the dispute.  The arbitrator shall select one of the Party’s positions as his decision, and shall not have authority to render any substantive decision other than to so select the position of either AZ or Array.  The costs of such arbitration shall be shared equally by the Parties, and each Party shall bear its own expenses in connection with such arbitration.  Any such arbitration shall be commenced within thirty (30) days following a request by either Party for such arbitration.

 

12.3                            Jurisdiction and Governing Law .  Subject to Section 12.2, this Agreement and any dispute arising from the performance or breach hereof shall be governed by and construed and enforced in accordance with the laws of the State of New York, U.S.A. without reference to conflicts of laws principles and the Parties hereby submit to the exclusive jurisdiction of the courts of the State of New York.

 

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12.4                            Assignment .

 

12.4.1                   General .  This Agreement shall not be assignable by either Party to any Third Party hereto without the written consent of the other Party hereto; except either Party may assign this Agreement, without such consent, to an Affiliate or 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), and agrees in writing to be bound by the terms and conditions of this Agreement.  It is understood that the provisions of Sections 12.4.2 and 12.4.3 shall apply in the event of assignment of this Agreement under the circumstances described therein.  Notwithstanding the foregoing, if any permitted assignment to an Affiliate of AZ would result in additional withholding taxes becoming due on payments to Array under this Agreement, then the Parties shall negotiate in good faith terms and conditions under which such assignment would occur.  No assignment and transfer shall be valid and effective unless and until the assignee/transferee shall agree in writing to be bound by the provisions of this Agreement.  The terms and conditions shall be binding on and inure to the benefit of the permitted successors and assigns of the Parties.

 

12.4.2                   Certain Additional Matters on Change of Control of AZ .  In the event (i) AZ assigns this Agreement to an entity that acquires all or substantially all of the business or assets of AZ, or (ii) AZ merges or consolidates or enters into a similar transaction with an entity in which such entity becomes an Affiliate of AZ (each such event, a “Subject Transaction”), and, as a result of the Subject Transaction, AZ (or its successor) is thereafter required to [ * ] one or more Licensed Products to a Third Party, AZ (or its successor) shall so notify Array and [ * ].  Array shall confirm in writing to AZ whether or not it wishes to [ * ] within [ * ]of notification [ * ] by AZ.

 

12.4.3                   Certain Additional Matters on Change of Control of Array .  In the event (i) Array assigns this Agreement to an entity that acquires all or substantially all of the business or assets of Array, and such entity is a [ * ], or (ii) Array merges or consolidates or enters into a similar transaction with such a [ * ] entity in which such entity becomes an Affiliate of Array (each such event, a “Change of Control”), then the following shall apply:

 

(a)                                   Subject to Section 11.6.1 and 11.6.2, AZ may terminate this Agreement, upon [ * ] notice, provided that AZ so terminates within [ * ] after the occurrence of or AZ’s receipt of notice of such Change of Control, whichever is later.  Array shall provide notice to AZ within [ * ] after the event of any Change of Control.

 

(b)                                  If AZ does not terminate this Agreement upon a Change of Control of Array, then Sections 3.2, 4.1 and AZ’s obligations under Section 2.4 shall terminate and one of the following shall apply:

 

(i)              If the Change of Control occurs prior to the end of the Research Term, AZ shall have the option to continue the Research Program and/or the Process Program with AZ personnel or the personnel of its Affiliates or subcontractors until the earlier of (i) the end of the then-current Research Term plus a period of [ * ], or (ii) selection by AZ of [ * ] Candidate Drugs in addition

 

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to ARRY-142886.  In the event AZ exercises such option, AZ shall amend the Research Plan to reflect such transfer and the activities to be conducted by AZ thereafter, and Array shall cooperate fully with AZ to provide AZ with all such Collaboration Technology and Array Existing Technology and existing material as is necessary for AZ to identify and select Candidate Drugs.    In addition, AZ’s obligation to [ * ] for Candidate Drugs selected after the Change of Control shall terminate as shall its obligations to meet any future FTE payments under Section 6.2.1, and AZ shall reimburse Array’s reasonable out-of-pocket costs for such cooperation and provision of technology and material.  In addition, during the term set forth in this Section 12.4.3(b)(i), Array shall develop for use outside the Field only those Compounds (y) that Array has demonstrated do not meet the Candidate Drug Target Profile, and (z) that were determined to meet the Candidate Drug Target Profile in the course of the Research Program prior to the Change of Control, but that were rejected pursuant to Section 2.5.2(a)(ii) above.  AZ shall inform Array promptly after it has selected [ * ] Candidate Drugs in addition to ARRY-142886.
 
(ii)           If the Change of Control occurs prior to the end of the Research Term, AZ may continue the Research Program and/or the Process Program with Array as if the Change of Control had not occurred and this Agreement shall continue to be binding upon the Parties.
 

Upon request by AZ, the Parties will each use their respective commercially reasonable diligent efforts to put procedures into place to protect the secrecy of AZ or Array Confidential Information disclosed under any of Section 2.2, 2.3, 2.4, 3.2 or 3.4 above, including, without limitation, requiring each Party’s representatives on the JRC, Development Committee and any employees performing research or process development in connection with this Agreement to sign individual confidentiality agreements agreeing to comply with the confidentiality provisions of this Agreement.

 

12.5                            Notices .  All notices, requests and communications hereunder shall be in writing and shall be personally delivered or sent by facsimile transmission (confirmed by prepaid registered or certified mail, return receipt requested or by international express delivery service) (e.g. Federal Express), mailed by registered or certified mail (return receipt requested), postage prepaid, or sent by international express courier service, and shall be deemed to have been properly served to the addressee upon receipt of such written communication, to the following addresses of the Parties, or such other address as may be specified in writing to the other Party hereto:

 

If to Array,

 

 

 

 

 

 

addressed to:

 

Array BioPharma Inc.

 

 

3200 Walnut Street

 

 

Boulder, Colorado 80301

 

 

Attention: Chief Operating Officer

 

 

Telephone: (303) 381-6699

 

 

Telecopy: (303) 381-6697

 

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With copy to:

 

Array BioPharma Inc.

 

 

3200 Walnut Street

 

 

Boulder, Colorado 80301

 

 

Attention: General Counsel

 

 

Telephone: (303) 381-6679

 

 

Telecopy: (303) 386-1290

 

 

 

If to AZ,

 

 

 

 

 

 

addressed to:

 

AstraZeneca UK Limited

 

 

 

Mereside

 

 

 

Alderley Park

 

 

 

Macclesfield SK10 4TG

 

 

 

England

 

 

 

 

 

 

 

Attention: Director of Discovery Alliances, Cancer and Infection

 

 

 

Telephone: (44) 1625 513238

 

 

 

Fax: (44) 1625 513910

 

 

 

 

 

With a copy to:

 

Assistant General Counsel

 

 

 

AstraZeneca UK Limited

 

 

 

Alderley House

 

 

 

Alderley Park

 

 

 

Macclesfield SK10 4TF

 

 

 

England

 

 

 

 

 

 

 

Telephone: (44) 1625 512379

 

 

 

Fax: (44) 1625 585618

 

12.6                            Waiver .  Neither Party may waive or release any of its rights or interests in this Agreement except in writing.  The failure of either Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition.  No waiver by either Party of any condition or term in any one or more instances shall be construed as a continuing waiver of such condition or term or of another condition or term.

 

12.7                            Severability .  If any provision hereof should be held invalid, illegal or unenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be liberally construed in order to carry out the intentions of the Parties hereto as nearly as may be possible.  Such invalidity, illegality or

 

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unenforceability shall not affect the validity, legality or enforceability of such provision in any other jurisdiction.

 

12.8                            Force Majeure .  In this Agreement, “Force Majeure” means an event which is beyond a non-performing Party’s reasonable control, including an act of God, act of the other Party, strike, lock-out or other industrial/labour disputes (whether involving the workforce of the Party so prevented or of any Third Party), war, riot, civil commotion, terrorist act, malicious damage, epidemic, quarantine, fire, flood, storm, natural disaster or compliance with any law or governmental order, rule, regulation or direction (including changes in the requirements of the Health Authorities), whether or not it is later held to be invalid.

 

The non-performing party (the “Force Majeure Party”) shall, within thirty (30) days of the occurrence of a Force Majeure event, give notice in writing to the other Party specifying the nature and extent of the event of Force Majeure, its anticipated duration and any action being taken to avoid or minimize its effect.  Subject to providing such notice the Force Majeure Party shall not be liable for delay in performance or for non-performance of those obligations under this Agreement affected by the event of Force Majeure, in whole or in part, nor shall the other Party have the right to terminate this Agreement, except as otherwise provided in this Agreement, where non-performance or delay in performance has resulted from an event of Force Majeure.  The suspension of performance allowed hereunder shall be of no greater scope and no longer duration than is reasonably required.

 

The Force Majeure Party shall use reasonable endeavours, without being obligated to incur any expenditure or cost, to (a) bring the Force Majeure event to a close or (b) find a solution by which the Agreement may be performed despite the continuation of the event of Force Majeure.

 

12.9                            Counterparts .  This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

12.10                      Entire Agreement .  This Agreement set forth all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto and supersedes and terminates all prior agreements and understanding between the Parties.  There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as set forth herein.  No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties hereto unless reduced to writing and signed by the respective authorized officers of the Parties.

 

12.11                      Independent Contractors .  Nothing herein shall be construed to create any relationship of employer and employee, agent and principal, partnership or joint venture between the Parties.  Each Party is an independent contractor.  Neither Party shall assume, either directly or indirectly, any liability of or for the other Party.  Neither Party shall have the authority to bind or obligate the other Party and neither Party shall represent that it has such authority.

 

53



 

12.12                      Non-Importation .  For the avoidance of doubt, the Parties agree that none of the milestones or royalties payable are related directly to the import of Candidate Drugs or other goods supplied by either Party pursuant to this Agreement.

 

12.13                      Patent Marking .  To the greatest extent practicable but in any case for each Licensed Product sold in the United States, AZ agrees to mark and have its Affiliates and Sublicensees mark all Licensed Products sold 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.

 

12.14                      Headings .  Headings used herein are for convenience only and shall not in any way affect the construction of or be taken into consideration in interpreting this Agreement.

 

IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate originals by their duly authorized representatives as of the date and year first above written.

 

 

Array BioPharma Inc.

 

AstraZeneca AB

 

 

 

By:

 

 

By:

 

 

 

 

Name:

Robert E. Conway

 

Name:

 

 

 

 

Title:

Chief Executive Officer

 

Title:

 

 

 

 

Date:

 

 

Date:

 

 

[ * ] = 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.

 

54



 

EXHIBIT 1.5

 

Array Patents

 

APPLICATION OR
PATENT NUMBER

 

TITLE/INVENTORS

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

Heterocyclic Inhibitors of MEK and Methods of Use Thereof
Hurley et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

MEK Inhibitors
Wallace

PCT
US03/07864

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

PCT
US03/07565

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

 

55



 

APPLICATION OR
PATENT NUMBER

 

TITLE/INVENTORS

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

[ * ]

 

N3 Alkylated Bendimidazole Derivatives as MEK Inhibitors
Wallace et al.

 

56



 

EXHIBIT 1.12

 

Candidate Drug Target Profile (CDTP) Criteria

 

 

 

CDTP Criteria

Enzyme IC 50

 

[ * ]

Cell IC 50 – [ * ]

 

[ * ]

Cell IC 50 – [ * ]

 

[ * ]

Selectivity

 

[ * ]

MW

 

[ * ]

Log D

 

[ * ]

Solubility

 

[ * ]

IP Position

 

[ * ]

Synthetic Route

 

[ * ]

Bioavailability

 

[ * ]

[ * ]

 

[ * ]

[ * ]

 

[ * ]

[ * ]

 

[ * ]

[ * ]

 

[ * ]

In Vivo CL

 

[ * ]

Hepatocyte Cl int

 

[ * ]

P450 inhibition

 

[ * ]

Pharmacology

 

[ * ]

Efficacy

 

[ * ]

Adverse Effects

 

[ * ]

Biopharmaceutics

 

[ * ]

Safety

 

[ * ]

 

57



 

EXHIBIT 2.3

 

Initial Research Plan

 

[ * ]

 

Discipline

 

FTE’s

 

Location

Chemistry

 

[ * ]

 

[ * ]

Biology In vitro enzyme/cell/selectivity In vivo PK-PD

 

[ * ]

 

[ * ]

Crystallography/molecular modelling

 

[ * ]

 

[ * ]

Protein Supply

 

[ * ]

 

[ * ]

PAR&D

 

[ * ]

 

[ * ]

Solubility/Absorption and Drug Metabolism in vitro

 

[ * ]

 

[ * ]

Xenograft studies

 

[ * ]

 

[ * ]

Process Chemistry

 

[ * ]

 

[ * ]

Toxicology

 

[ * ]

 

[ * ]

Total

 

[ * ]

 

 

 

[ * ] FTE’s will be required for synthesis and progression of compounds within the project to the point when [ * ] will be required. These should be located within Array although AstraZeneca may contribute.  Research Support Laboratory back-up will initially be required to [ * ] but as the project develops there will be an increased need for [ * ]. These resources would be provided at Array but there is a case when AstraZeneca may need to be involved.

 

[ * ] is best placed within Array but could be located within the [ * ] in AstraZeneca.   FTE’s to support [ * ] could either be located at Array or AstraZeneca. While AstraZeneca runs these many of these [ * ] routinely, these again may be best placed within Array.

 

[ * ] could be located within Array but since Astrazeneca has such facilities it provides an alternative option.  [ * ] are probably best supported from within AstraZeneca as are [ * ] on [ * ] compounds.

 

58



 

Funding of Array FTEs is described in section 2.6.  Array and AstraZeneca will ensure appropriate respective allocation of resources between Year One and Year Two in line with the agreed FTE funding and research programme requirements.

 

59



 

EXHIBIT 3.1.2

 

Phase I Clinical Trial Activities

 

 

[ * ]

 

Part A  [ * ] :

 

                                                  [ * ]

 

Part B [ * ]

 

[ * ]

 

60



 

EXHIBIT 3.3

 

Phase I Success Criteria

 

Attribute

 

Criteria

[ * ] Go/No Go Decision

 

No Go:  

 

 

    [ * ] ; and/or

 

 

 

 

 

     [ * ] ; and/or

 

 

 

 

 

      [ * ]

 

 

 

 

 

 

[ * ] Go/No Go Decision

 

No Go:

 

 

 

 

 

    [ * ];

 

 

 

 

 

    [ * ]

 

 

 

 

 

    [ * ]

 

 

 

 

 

   [ * ]

 

 

 

 

 

[ * ]

 

 

 

[ * ] Go/No Go Decision

 

Evidence of [ * ] must be demonstrated by either:

 

 

 

 

 

    [ * ]; or

 

 

 

 

 

    [ * ]**

 


* [ * ]
**[ * ]

 

Note:

 

61



 

In order to achieve an [ * ], ARRY-142886 must demonstrate [ * ].

 

[ * ] shall mean any or all of the following:

 

 

                                          [ * ];

 

                                          [ * ];

 

                                          [ * ];

 

                                          [ * ].

 

62



 

EXHIBIT 3.4.1

 

Process Plan

 

Current Status of the ARRY-142886 Processes

 

The current processes are suitable for [ * ].  It is a [ * ] but the [ * ] for each [ * ] is [ * ].  The overall [ * ] for the synthesis is [ * ].  The processes are [ * ].  [ * ] has been limited to date and a formal study will be carried out with AZ [ * ] on start up of the project.

 

Process Research and Development Goals and Plans for the Collaboration

 

[ * ]

 

There should be sufficient [ * ] available to support [ * ].  Current [ * ] estimates are in the region of [ * ].  As a contingency, further material should be produced [ * ]. This ought to be done at Array, at a time to be agreed [ * ].  Based on current estimates, [ * ], a further [ * ] can be made.

 

Some [ * ] work will be required to be done in support of [ * ]. This could [ * ] which would need to be [ * ].   As such, subsequent [ * ].  When a decision [ * ] is made, further [ * ] will be carried out by Array.

 

[ * ]

 

There is no advantage [ * ]. Laboratory evaluation of [ * ] will be divided between Array and AZ.

 

Once a [ * ] has been agreed, the [ * ] will need to be [ * ]. This will be done at Array or AZ, depending on [ * ]. Based on [ * ], it is likely that [ * ].  Subsequent to demonstrating [ * ], [ * ] will transfer to AZ.

 

Timings

 

Assuming [ * ] it should be possible to [ * ].  Given that [ * ].  The timing of subsequent activities will be dictated by the material requirements of the development plan.

 

Suggested timelines linked with activities:

 

63



 

Activity

 

Who

 

Suggested Timelines

 

 

 

 

 

[ * ]

 

AZ/Array

 

[ * ]

 

 

 

 

 

[ * ]

 

AZ/Array

 

[ * ]

 

 

 

 

 

[ * ]

 

AZ [ * ]

 

[ * ]

 

 

 

 

 

[ * ]

 

Array

 

[ * ]

 

 

 

 

 

[ * ]

 

Array/AZ

 

[ * ]

 

 

 

 

 

[ * ]

 

AZ/Array

 

[ * ]

 

 

 

 

 

[ * ]

 

AZ or Array (TBC)*

 

[ * ]

 

 

 

 

 

[ * ] Development

 

AZ

 

[ * ]

 

 

 

 

 

[ * ]

 

AZ

 

[ * ]

 

                  *Dependent on facility availability

 

                  ^Dependent on need [ * ]

 

Work on the back-up program and communication with AZ [ * ]

 

The licensing agreement also covers back ups to ARRY-142886 and therefore [ * ] could [ * ] of the back up compounds.  [ * ] would be involved in this [ * ] with subsequent [ * ] following a similar track to the lead compound.  Based on [ * ] activities would start in [ * ].  Detailed agreement of logistics of communication for this and the collaboration as a whole will be agreed in [ * ].

 

FTE Requirements

 

See Section 3.4.1(b).

 

64


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 COLLABORATION AGREEMENT

 

 

BETWEEN

 

GENENTECH, INC.

 

AND

 

ARRAY BIOPHARMA INC.

 



 

[*] = 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 of 1934, as amended.

 

Table of Contents

 

 

 

Page

Article 1 Definitions

 

2

 

 

 

Article 2 Research Program

 

9

 

 

 

 

2.1

Research Program Overview

 

9

 

2.2

Joint Research Committee

 

9

 

2.3

Responsibilities Under the Research Plan

 

10

 

2.4

Information and Reports

 

11

 

2.5

Materials and Confidential Information Transferred

 

11

 

2.6

Collaboration Targets

 

12

 

2.7

[ * ]; Costs

 

12

 

 

 

 

 

Article 3 Development and Commercialization of Licensed Products

 

13

 

 

 

 

3.1

Genentech Responsibilities

 

13

 

3.2

[ * ]

 

13

 

 

 

 

 

Article 4 Exclusivity

 

13

 

 

 

 

4.1

During the Research Term

 

13

 

4.2

After the Research Term

 

13

 

 

 

 

 

Article 5 Licenses

 

14

 

 

 

 

5.1

Research Licenses

 

14

 

5.2

Commercial License

 

14

 

5.3

No Implied Licenses

 

14

 

5.4

Exercise of License Rights by Third Party

 

15

 

5.5

Third Party Agreements

 

15

 

 

 

 

 

Article 6 License Fees; [ * ] and Milestone Payments

 

15

 

 

 

 

6.1

License Fee

 

15

 

6.2

[ * ]; Outsourcing

 

15

 

6.3

Development Milestones

 

15

 

 

 

 

 

Article 7 Royalties

 

16

 

 

 

 

7.1

Royalty Rate

 

16

 

7.2

Single Royalty

 

17

 

7.3

Royalty Term; Fully Paid Licenses

 

17

 

7.4

Royalty Offsets

 

17

 

7.5

Payments, Reports and Audits

 

18

 

i



 

Article 8 Materials; Intellectual Property

 

19

 

 

 

 

8.1

Materials

 

19

 

8.2

Ownership of Technology

 

20

 

8.3

[ * ]

 

20

 

8.4

Inventorship

 

21

 

8.5

Assignment; Cooperation

 

21

 

8.6

Patent Prosecution

 

21

 

8.7

Patent Interferences

 

23

 

8.8

Third Party Claims

 

23

 

8.9

Infringement by Third Parties

 

23

 

 

 

 

 

Article 9 Confidentiality

 

24

 

 

 

 

9.1

Confidentiality

 

24

 

9.2

Authorized Disclosures

 

24

 

9.3

Patent Applications

 

26

 

9.4

Continuing Obligation

 

26

 

9.5

Termination of Prior Agreements

 

26

 

 

 

 

 

Article 10 Term; Termination

 

26

 

 

 

 

10.1

Term

 

26

 

10.2

Termination by Genentech

 

26

 

10.3

Material Breach

 

27

 

10.4

Insolvency or Bankruptcy

 

27

 

10.5

Effects of Termination; Survival

 

28

 

 

 

 

 

Article 11 Representations and Warranties

 

30

 

 

 

 

11.1

Mutual Representations and Warranties

 

30

 

11.2

Array Representations and Warranties

 

30

 

11.3

Disclaimers

 

30

 

 

 

 

 

Article 12 Indemnification; Limitation on Liability

 

31

 

 

 

 

12.1

Losses Defined

 

31

 

12.2

Indemnification by Genentech

 

31

 

12.3

Indemnification by Array

 

31

 

12.4

Limitation on Liability

 

32

 

 

 

 

 

Article 13 Insurance

 

32

 

 

 

 

13.1

Coverages

 

32

 

13.2

Additional Requirements

 

33

 

ii



 

Article 14 Dispute Resolution

 

33

 

 

 

 

14.1

Internal Resolution

 

33

 

14.2

Arbitration

 

33

 

14.3

Patent Validity

 

34

 

 

 

 

 

Article 15 Miscellaneous

 

34

 

 

 

 

15.1

Assignment

 

34

 

15.2

Publicity and Disclosure Relating to this Agreement

 

34

 

15.3

No Right to Use Names

 

35

 

15.4

Notices

 

35

 

15.5

Relationship of the Parties

 

36

 

15.6

Entire Agreement

 

36

 

15.7

Amendment; Waiver

 

36

 

15.8

Governing Law

 

36

 

15.9

Construction

 

36

 

15.10

Captions

 

37

 

15.11

Legal Compliance; Severability

 

37

 

15.12

Force Majeure

 

37

 

15.13

Counterparts; Facsimiles

 

37

 

Exhibits

 

 

Exhibit A

Materials, Data and Information that Will be Transferred to Genentech

 

 

 

Exhibit B

Materials, Data and Information that Will NOT be Transferred to Genentech

 

 

 

Exhibit C

[ * ]

 

 

 

iii



 

DRUG DISCOVERY COLLABORATION AGREEMENT

 

This Drug Discovery Collaboration Agreement (“Agreement”) is made and entered into, effective as of December 22, 2003 (“Effective Date”), 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”).

 

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.  Genentech possesses pharmaceutical research, development and commercialization capabilities.

 

B.            Array and Genentech have each identified multiple protein targets that have the potential to be used as the basis for drug discovery programs.  As of the Effective Date, Array has developed assays, lead compounds and other proprietary technology directed to certain of such targets.

 

C.            Genentech and Array desire to enter a collaboration wherein Array will perform certain research on several of such protein targets with assistance from Genentech, with the goal of developing small molecule inhibitors of such targets for clinical and commercial development by Genentech.

 

AGREEMENT

 

Now, therefore , for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Genentech and Array agree as follows:

 

1



 

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.  [* Certain definitions have been deleted from Article 1.]

 

“Affiliate” means, with respect to a Party, any entity, that controls, is controlled by, or is under common control with, such Party.  For purposes of this definition, “control” shall refer to:  (a) the possession, directly or indirectly, of the power to direct the management or policies of an entity, whether through ownership of voting securities, by contract or otherwise; or (b) the ownership, directly or indirectly, of at least fifty percent (50%) of the voting securities or other ownership interest of an entity.  Notwithstanding the foregoing, unless expressly specified otherwise, for the purposes of this Agreement, F. Hoffman-La Roche Ltd and all entities controlled by, controlling, or under common control with F. Hoffman-La Roche Ltd, except for any entity controlled by Genentech, shall not be considered an Affiliate of Genentech.

 

“Approved by the JRC” or “ Approval by the JRC, ” “ JRC Approval, ” or the like, means, that the Joint Research Committee has made a particular decision (in the context of the reference), and that such decision is reflected in minutes of a JRC meeting that have been formally approved by both Array and Genentech.

 

“Array Collaboration Technology” is defined in Section 8.2.

 

 “Array Contributed Technology” means Array Existing Technology and Array Future Technology.

 

“Array Existing Technology” means Array’s inventions (whether patentable or not), Patents and Know-How existing as of the Effective Date, in each case, that is Controlled by Array or Controlled by an Array Affiliate that is controlled by Array (where “control” is as defined in the definition of Affiliate in this Agreement).

 

“Array Future Technology” means Array’s inventions (whether patentable or not), Patents and Know-How, other than Collaboration Technology and Array Existing Technology, in each case, (a) that is Controlled by Array or Controlled by an Array Affiliate that is controlled by Array (where “control” is as defined in the definition of Affiliate in this Agreement); and (b) is/are necessary to make, use, sell, offer for sale or import Compounds in the Field in the Territory.

 

2



 

 “Array IP Rights” means Array’s intellectual property rights in the Array Contributed Technology, the Array Collaboration Technology and Array’s interest in the Joint Collaboration Technology.

 

 “Array Patents” means Patents covering Array Contributed Technology or Array Collaboration Technology.

 

“Collaboration Target” means a [ * ], for which Array shall develop small molecule inhibitors under the Research Program, in accordance with the provisions of this Agreement; provided, however, inclusion of [ * ] shall be subject to the consent of both Parties, which consent shall not be unreasonably withheld.  The specific Collaboration Targets that are included in the Research Plan at any given time may be changed in accordance with Section 2.6(a), but once a Collaboration Target has been included in the Research Plan, it shall continue to be a Collaboration Target, even if no further research with respect to such Collaboration Target is performed under the Research Plan; provided, however, if a Collaboration Target is abandoned in accordance with Section 2.6(b), it shall thereafter cease to be a Collaboration Target.

 

“Collaboration Technology” means inventions (whether patentable or not), Patent Rights and Know-How that are discovered, conceived or reduced to practice in the course of the activities performed by (or on behalf of) either or both Parties in connection with the Research Program.  Collaboration Technology means Genentech Collaboration Technology and/or Array Collaboration Technology, as determined by the context of the reference.

 

“Combination Product” means a Licensed Product that is a pharmaceutical preparation that incorporates a Compound and one or more therapeutically active ingredients other than a Compound as its main active ingredients.  Notwithstanding the foregoing, drug delivery vehicles, adjuvants, and excipients shall not be deemed to be “therapeutically active ingredients,” and their presence shall not be deemed to create a Combination Product.

 

“Commercial License” means the license granted to Genentech in Section 5.2.

 

“Commercially Reasonable Efforts” means, with respect to development and commercialization of a product, a Party’s use of those efforts and resources, consistent with the exercise of prudent scientific and business judgment, as are applied by such Party to other pharmaceutical products of comparable commercial potential, stage of medical/scientific development, technical and regulatory profile, and patent protection, in a particular geographic locale.

 

“Compound” means a small molecule [ * ] of a Collaboration Target, [ * ], or as otherwise agreed with the consent of both Parties, which consent shall not be unreasonably withheld.

 

3



 

“Compound Criteria” means, on a Collaboration Target-by-Collaboration Target basis, the desired characteristics of Compounds that modulate such Collaboration Target for the purposes of the research, development and commercialization of such Compound under this Agreement.

 

“Confidential Information” means a Party’s nonpublic information and materials, whether or not patentable, that are disclosed or provided by such Party to the other Party in connection with this Agreement, to the extent that such information and materials do not fall within the exceptions set forth in Section 9.1.  “Confidential Information” includes, without limitation, information regarding such Party’s research, technology, products, business information or objectives and other information of the type that is customarily considered to be confidential information by parties engaged in activities that are substantially similar to the activities being engaged in by the Parties pursuant to this Agreement.  Notwithstanding the foregoing, whether or not disclosed by Genentech to Array, Genentech’s Confidential Information shall include, without limitation, the identities of all Collaboration Targets (whether or not subsequently dropped from the Research Program by Genentech) and chemical entities known by Array to be Compounds, and any information specifically related to the Collaboration Targets and such Compounds.

 

“Contributed Technology” means Genentech Contributed Technology and/or Array Contributed Technology, as determined by the context of the reference.

 

“Controlled by” means the rightful possession by a party, as of the Effective Date or throughout the term of this Agreement, of the ability to grant a license, sublicense or other right to exploit, as provided herein, without violating the terms of any agreement with any third party.

 

“Covers” or “ Covered by, ” or the like, means that the manufacture, use, sale, offer for sale or importation of a Licensed Product would infringe a Valid Claim of a patent licensed to Genentech under this Agreement in the absence of a grant of rights under such patent, as determined on a country-by-country basis.

 

“Development Milestone Payment” is defined in Section 6.3(a).

 

“Disclosing Party” is defined in Section 9.1.

 

“Distributor” means a Third Party that is employed by or otherwise under written contract with Genentech or its Sublicensees to sell, promote, distribute, market, import, and/or export Licensed Products on behalf of or in partnership with Genentech or its Sublicensees.

 

“Executive” means, in the case of Array, the Chief Executive Officer of Array and, in the case of Genentech, a Senior or Executive Vice President of Research.

 

4



 

“FDA” means the United States Food and Drug Administration, or any successor entity thereto performing similar functions.

 

“Field” means any use.

 

“First Commercial Sale” means, with respect to a particular Licensed Product in a given country, the first bona fide commercial sale of such Licensed Product following Marketing Approval in such country by or under authority of Genentech or its Sublicensees.

 

“GAAP” means United States generally accepted accounting principles, consistently applied by a Party.

 

“Genentech Collaboration Technology” is defined in Section 8.2.

 

“Genentech Contributed Technology” means Genentech’s inventions (whether patentable or not), Patents and Know-How, other than Collaboration Technology, in each case, that is Controlled by Genentech.

 

“Genentech IP Rights” means Genentech’s intellectual property rights in the Genentech Contributed Technology, the Genentech Collaboration Technology and Genentech’s interest in the Joint Collaboration Technology.

 

“Genentech Patents” means Patents covering Genentech Contributed Technology or Genentech Collaboration Technology.

 

“GLP” means the then current FDA regulations and guidelines for “Good Laboratory Practice,” as promulgated by the FDA under 21 CFR Part 58, as amended from time to time, or any foreign equivalents thereto in the country in which such studies or clinical trials are conducted.

 

“IND” means an investigational new drug application filed with the FDA pursuant to 21 CFR Part 312 before the commencement of clinical trials of a product, or any comparable filing with any relevant regulatory authority in any other jurisdiction.

 

“IP Rights” means Genentech IP Rights and/or Array IP Rights, as determined by the context of the reference.

 

“Joint Collaboration Technology” is defined in Section 8.2(a).

 

“Joint Research Committee” or “JRC” is defined in Section 2.2.

 

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“Know-How” means information or materials including, without limitation, data, assays, protocols, methods, processes, techniques, models, designs, libraries and trade secrets.

 

“Licensed Product” means any product incorporating a Compound as an active ingredient.

 

“Losses” is defined in Section 12.1.

 

“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 Licensed Products in a regulatory jurisdiction.  For countries where governmental approval is required for pricing or reimbursement for the Licensed Product to be reimbursed by national health insurance, “Marketing Approval” shall not be deemed to occur until such pricing or reimbursement approval is obtained.

 

“Marketing Approval Application” or “MAA”  means a new drug application (as defined in 21 C.F.R. § 314.50 et. seq .), or a comparable filing for Marketing Approval (not including pricing or reimbursement approval) in a country, in each case with respect to a Licensed Product in the Territory.

 

“Net Sales” means, with respect to a particular time period, the gross amount invoiced by Genentech and its Sublicensees (or Distributors on behalf of the foregoing parties) for sales of Licensed Products (such Licensed Products being in final form intended for use by the end user) in arms length transactions with Third Parties during such time period, less the following estimated and/or incurred charges or expenses, to the extent each is actually incurred and included in the invoiced gross sales price:

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

 

(b)           credits or allowances given or made for rejection or return of, and for uncollectible amounts on, previously sold Licensed Products or for retroactive price reductions (including rebates similar to Medicare and/or Medicaid);

 

(c)           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;

 

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

 

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

 

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The specific deductions taken under, and the general provisions of, (a) through (e) above shall be adjusted periodically as necessary to reflect amounts actually incurred.  Sales between Genentech and its Sublicensees (or Distributors of the foregoing parties) shall be disregarded for purposes of calculating Net Sales.  Notwithstanding anything herein to the contrary, in all cases Net Sales shall be determined in accordance with GAAP.

 

In the event a Licensed Product is sold in the form of a Combination Product containing one or more active ingredients, devices or components in addition to the Licensed Product, Net Sales for such Combination Product will be adjusted by multiplying actual Net Sales of such Combination Product by the fraction A/(A + B), where A is the weighted (by sale volume) average invoice price of the Licensed Product, if sold separately, and B is the weighted (by sale volume) average invoice price of any other active ingredient, device or component in the combination, if sold separately.  If, on a country-by-country basis, the other active ingredient, device or component in the combination is not sold separately, Net Sales shall be calculated by multiplying actual Net Sales of such Combination Product in such country by the fraction A/C, where A is the invoice price of the Licensed Product, if sold separately, in such country and C is the invoice price of the Combination Product in such country.  If, on a country-by-country basis, neither the Licensed Product nor the other active ingredient, device or component of the Combination Product is sold separately, Net Sales shall be determined by the Parties in good faith.

 

“Patent Disclosure Data” is defined in Section 9.3.

 

“Patents” means all U.S. and foreign patents and patent applications and any patents issuing therefrom, and any reissues, extensions, registrations, continuations, divisions, continuations-in-part, reexaminations, substitutions or renewals thereof, and supplementary protection certificates based thereon.

 

“Phase I” means human clinical trials, the principal purpose of which is preliminary determination of safety in healthy individuals or patients as described in 21 C.F.R. §312.21, or similar clinical study in a country other than the United States.

 

“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 described in 21 C.F.R. §312.21, or similar clinical study in a country other than the United States.

 

“Phase III” means human clinical trials, that are prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition

 

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being studied as described in 21 C.F.R. §312.21, or similar clinical study in a country other than the United States.

 

“Receiving Party” is defined in Section 9.1.

 

“Research Plan” means a written research plan for the Research Program covering the Research Term, as may be amended from time to time by the Joint Research Committee.  The initial Research Plan, which shall be agreed upon by the JRC as soon as practicable after the Effective Date, shall cover the period through December 31, 2004 in detail, and shall include general plans for the remainder of the Research Term.

 

“Research Program” is defined in Section 2.1.

 

“Research Term” means the [ * ] period commencing on the date that the Research Plan is 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) if the Research Term is extended by the written agreement of both Parties, for an additional [ * ] period (or such other additional period agreed to by both Parties), the end of such extension period.

 

“Royalty Offsets” is defined in Section 7.4(a).

 

“Royalty Payment” is defined in Section 7.1.

 

“Sublicensee” means, with respect to a particular Licensed Product, a Third Party to whom Genentech has granted a sublicense, under the Commercial License, of the right to make, use, sell, offer for sale and/or import such Licensed Product.

 

“Territory” means worldwide.

 

“Third Party” means any entity other than Array or Genentech.

 

“United States” or “U.S.” means the United States of America, its territories and possessions as of the Effective Date, and the Commonwealth of Puerto Rico.

 

“Valid Claim” means a claim of an issued and unexpired patent (a) that is within the Array IP Rights; and (b) that is [ * ] ; and (c) that has not been found to be unpatentable, invalid or unenforceable by a decision of a court or other authority in the country of the patent, from which decision no appeal is taken or can be taken.

 

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Article 2

Research Program

 

2.1 Research Program Overview.   The Parties agree, pursuant and subject to the terms and conditions of this Agreement, to establish a research program under which Array shall perform certain research on Collaboration Targets, with assistance from Genentech, with the goal of developing Compounds that meet the Compound Criteria for each Collaboration Target, in accordance with the Research Plan (“Research Program”).  Each Party shall use diligent efforts to perform its respective responsibilities under the Research Plan, and shall cooperate with and provide reasonable support to the other Party in such other Party’s performance of its responsibilities thereunder.  Other than as specified in this Agreement, or as agreed in writing by the Parties, any subsequent research, development and/or commercialization related to such Compounds, and Licensed Products incorporating such Compounds, shall be solely Genentech’s responsibility, in accordance with the terms and conditions of this Agreement.

 

2.2 Joint Research Committee.

 

(a)  The JRC.   Promptly after the Effective Date, the Parties shall establish a Joint Research Committee (“Joint Research Committee” or “JRC”), which shall be responsible for monitoring the Research Program and planning and coordinating activities under the Research Plan.  The JRC shall be composed of three (3) representatives designated by each Party (or such other number as the Parties may agree).  One representative from each Party shall be designated as that Party’s “Team Leader” to act as the primary JRC contact for that Party.  Either Party may replace any or all of its representatives at any time upon prior written notice to the other Party; provided, however, if a Party’s representative is unable to attend a meeting, such Party may designate an alternate to attend such meeting and perform the functions of such representative.  From time to time, the JRC may establish subcommittees to oversee particular projects or activities, and such subcommittees will be constituted as the JRC approves.

 

(b)  Responsibilities of JRC.   The Joint Research Committee shall perform the following functions:

 

(i)          draft, review and amend the Research Plan in writing, as needed, taking into account the activities for which each Party is responsible as set forth in Section 2.3;

 

(ii)         define Compound Criteria for each Collaboration Target;

 

(iii)        review and approve the allocation of resources and efforts for the Research Program;

 

(iv)         evaluate the progress of the Research Program, as compared to the objectives set forth in this Agreement and the Research Plan;

 

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(v)          subject to Section 2.5, coordinate, and be the primary conduit for, the transfer of materials and Confidential Information between the Parties; and

 

(vi)         perform such other functions referred to in the Research Plan, and as appropriate to further the purposes of the Research Program, or as otherwise specified in this Agreement or agreed to by the Parties.

 

(c)  Decision Making Authority.   With respect to the responsibilities of the Joint Research Committee, each Party shall have collectively one (1) vote in all decisions, and the Parties shall attempt to make decisions by consensus.  If the JRC cannot reach consensus, then the dispute shall be referred to the Executives for resolution in accordance with Section 14.1.  If the Executives cannot resolve the dispute, then, notwithstanding the arbitration provisions of Section 14.2, Genentech shall have final decision making authority; provided, however, Array shall not be obligated, as a result of a deciding vote by Genentech, to violate any obligation or agreement it may have with any Third Party, or to incur any extraordinary costs.

 

(d)  Meetings; Minutes.   The Joint Research Committee shall meet quarterly, or as more or less often as otherwise agreed by the Parties, at such locations as the Parties agree.  The JRC may meet in person, by teleconference, videoconference or as otherwise agreed.  Minutes of the JRC meetings shall be taken, and shall, at a minimum, record all decisions made.  Such minutes shall be approved by both Parties.  A Party may, with the prior consent of the other Party, invite a reasonable number of non-voting employees, consultants or scientific advisors to attend the meetings of the JRC, provided that such invitees are bound by appropriate confidentiality obligations.

 

(e)  Other Communications.  In addition to formal meetings, the Joint Research Committee representatives shall communicate as necessary to ensure the appropriate direction of the Research Program.  Genentech shall have reasonable access to Array’s facilities and personnel to achieve this goal, including visits by Genentech personnel ( e.g. , up to two (2) business days a month), upon reasonable notice, and regular phone or electronic mail communications ( e.g. , up to several times a week when needed).  Array shall use reasonable efforts to accommodate such requests.

 

(f)  Term of JRC Operations.   The Joint Research Committee shall meet during the Research Term.  Thereafter, the JRC shall cease operations and have no further functions hereunder.

 

2.3 Responsibilities Under the Research Plan.

 

(a)  Array.   During the Research Term, Array shall be primarily responsible for the following activities, among others, as specified in the Research Plan:

 

(i)    [ * ];

 

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(ii)   [ * ];

 

(iii) [ * ];

 

(iv)  [ * ];

 

(v)    [ * ]; and

 

(vi)  [ * ].

 

(b)  Array and/or Genentech.   During the Research Term, Array and/or Genentech shall be responsible for the following activities, among others, as specified in the Research Plan:

 

(i)    [ * ];

 

(ii)   [ * ];

 

(iii) [ * ];

 

(iv)  [ * ]; and

 

(v)    [ * ].

 

2.4 Information and Reports.  Subject to the second sentence of Section 2.5, during the Research Term, (a) at least once quarterly, each Party shall provide to the other a written summary of the research carried out by such Party under the Research Plan and the results of such research including, without limitation, Compounds synthesized or discovered, and results of in vitro and in vivo studies, with significant discoveries or advances being communicated promptly after such results are obtained or their significance is appreciated; and (b) each Party shall also promptly provide the other with raw data for work carried out by such Party under the Research Plan, to the extent reasonably requested by the other Party.  Subject to the second sentence of Section 2.5, during the term of the Agreement, Array shall also transfer to Genentech all data Controlled by Array related to Collaboration Targets or chemical entities known by Array to be Compounds, in each case that Array knows or has reason to know would assist Genentech in the development or commercialization of Compounds.

 

2.5 Materials and Confidential Information Transferred.   Array agrees to transfer to Genentech, [ * ], the materials and Confidential Information set forth in Exhibit A, to the extent such materials and Confidential Information exist; Array shall transfer [ * ] to Genentech on or before December 31, 2003.  Array agrees that it shall not transfer to Genentech any of the materials and Confidential Information set forth in Exhibit B, unless requested by Genentech in writing, subject to Array’s consent, which consent is in its sole discretion.  Array further agrees that, unless requested by Genentech in accordance with the following sentence, it shall not transfer any other materials or Confidential Information of Array to Genentech without Genentech’s prior written consent, and any such other materials or Confidential Information of Array transferred without such consent shall not be subject to any limitations on use, transfer or

 

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disclosure by Genentech, notwithstanding anything to the contrary herein.  Genentech may request in writing that Array transfer to Genentech such other materials or Confidential Information of Array, subject to Array’s consent, which consent is in its sole discretion.  Any materials and Confidential Information that a Party receives from the other Party hereunder may only be used and/or further transferred or disclosed to a Third Party in accordance with the applicable provisions of this Agreement including, without limitation, Section 8.1(b) and Article 9.

 

2.6 Collaboration Targets.

 

(a)  In the Research Plan .  As of the Effective Date, [ * ] and [ * ] have been selected by the Parties as Collaboration Targets.  At any time after [ * ] following the Effective Date, the Joint Research Committee may choose to include additional Collaboration Targets in, or remove Collaboration Targets from, the Research Plan; provided, however, any such change shall not (i) violate any agreement that Array has with a Third Party; (ii) add a Collaboration Target that is the target of Array’s own research or drugs in Array’s clinical development pipeline or marketed product portfolio; or (iii) result in less than [ * ] or more than [ * ] Collaboration Targets being included in the Research Plan at any given time.

 

(b)  Abandonment.   With respect to a particular Collaboration Target, in the event that (i) the Joint Research Committee determines that the Research Program has not yielded sufficient progress and that work on such Collaboration Target should be discontinued; or (ii) Genentech, in its sole discretion, elects that all work on such Collaboration Target be discontinued ( i.e. , under the Research Program and by Genentech internally), regardless of the progress made on such Collaboration Target; in either event, such Collaboration Target shall be deemed abandoned and shall cease to be a Collaboration Target under this Agreement.

 

2.7 [ * ]; Costs.  During the Research Term, for each Collaboration Target, Array shall have [ * ] skilled in small molecule drug discovery and/or preclinical development, and possessing a bachelor’s degree or higher in a relevant scientific discipline, devoted exclusively to performing activities under the Research Plan for such Collaboration Target.  At Genentech’s request, Array shall provide resumes or curriculum vitae for such [ * ].  Except as otherwise expressly provided herein (including, without limitation, for [ * ] support under Section 6.2), or agreed to by the Parties, each Party shall be responsible for [ * ] in performing its obligations related to the Research Program, or otherwise under this Agreement, including, without limitation, [ * ].

 

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Article 3

Development and Commercialization of Licensed Products

 

3.1 Genentech Responsibilities.

 

(a)  Development.   Genentech shall be responsible, at its expense, for undertaking a development program to obtain regulatory approval for Licensed Products for Collaboration Targets in the Field in the Territory.  Such program shall include all preclinical, clinical, manufacturing and other activities, beyond those to be undertaken pursuant to the Research Program, or as otherwise expressly specified or agreed, as are necessary or appropriate to bring such Licensed Products to market.

 

(b)  Commercialization.  Genentech shall be responsible for establishing, controlling and implementing strategies, plans and budgets for the marketing and promotion of Licensed Products in the Field in the Territory.

 

(c)  Diligence.  Genentech shall use Commercially Reasonable Efforts to develop and commercialize [ * ] in the Field in the Territory.

 

3.2  [ * ].   If Genentech decides to use a Third Party to (a) [ * ]; and/or (b) [ * ], Genentech shall notify Array in writing of Genentech’s requirements and Array may, in its discretion, elect to submit a written bid for such work.  If Genentech receives such bid from Array within [ * ] of Array receiving Genentech’s notice, the Parties shall negotiate in good faith for [ * ].  If after such [ * ] period the Parties have not reached agreement on the terms under which Array will perform such work, or if after [ * ] the Parties have not executed a definitive agreement for such work, Genentech shall be free to initiate such work with a Third Party.  Other than as set forth in this Section 3.2, Genentech has no other obligations to Array with respect to [ * ].

 

Article 4

Exclusivity

 

4.1 During the Research Term .   During the Research Term, with respect to each Collaboration Target, Array shall not conduct, participate in, or fund, directly or indirectly, either alone or with a Third Party, research or development with respect to, or commercialize a product comprising a chemical entity, a mechanism of action of which is to modulate the activity of such Collaboration Target, other than in accordance with this Agreement.

 

4.2 After the Research Term.   After the Research Term, with respect to each Collaboration Target, for as long as Genentech (or a Sublicensee or other Third Party on Genentech’s behalf) (a) has an active research and/or development program for such Collaboration Target, where such program could result in Array accruing Development

 

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Milestones and Royalties; or (b) is commercializing a Licensed Product for such Collaboration Target; or (c) is providing [ * ] support to Array with respect to such Collaboration Target (if at all); then, in each case, Array shall not conduct, participate in, or fund, directly or indirectly, either alone or with a Third Party, research or development with respect to, or commercialize a product comprising a chemical entity, a mechanism of action of which is to modulate the activity of such Collaboration Target, other than in accordance with this Agreement.

 

Article 5

Licenses

 

5.1 Research Licenses.

 

(a)  To Genentech.   Array hereby grants to Genentech, during the Research Term, a royalty-free, non-exclusive, non-sublicensable license under the Array IP Rights solely for the purpose of performing Genentech’s responsibilities under the Research Program.

 

(b)  To Array.   Genentech hereby grants to Array, during the Research Term, a royalty-free, non-exclusive, non-sublicensable license under the Genentech IP Rights solely for the purpose of performing Array’s responsibilities under the Research Program.

 

5.2 Commercial License.

 

(a)  Commercial License Grant.   Subject to the terms and conditions of this Agreement, Array hereby grants to Genentech a royalty-bearing, exclusive, sublicensable license (in accordance with Section 5.2(b)) under (i) the Array Existing Technology, Array Collaboration Technology and Array’s interest in Joint Collaboration Technology, to make, use, offer for sale, sell and import Compounds and Licensed Products in the Field in the Territory; and (ii) the Array Future Technology to make, use, offer for sale, sell and import Compounds in the Field in the Territory.

 

(b)  Sublicenses.   Genentech may sublicense the rights granted under the Commercial License for a particular Compound and/or Licensed Product, and such sublicense may be further sublicensed by a Sublicensee to multiple tiers of sublicensees.

 

5.3 No Implied Licenses.   Each Party acknowledges that the licenses granted under this Article 5 are limited to the scope expressly granted, and all other rights under a Party’s IP Rights are expressly reserved to the granting Party.  Without limiting the foregoing, it is understood that where a license under a Party’s IP Rights is granted to the other Party under this Article 5 for a particular purpose, the granting Party retains all of its rights under its IP Rights for all purposes not expressly licensed under this Agreement.

 

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5.4 Exercise of License Rights by Third Party.   Unless otherwise expressly provided in this Agreement, the rights granted to a Party under the licenses granted hereunder may be exercised by a Third Party on such Party’s behalf ( e.g. , on Genentech’s behalf as set forth in Section 8.1(b) or to have Licensed Products made by a contract manufacturer), whether or not such license is non-sublicensable, including, without limitation, by a Third Party performing work under a material transfer agreement on behalf of such Party.

 

5.5 Third Party Agreements.   If any IP Rights of one Party that are licensed to the other Party hereunder are Controlled by the licensing Party by virtue of an agreement with a Third Party, such licensing Party shall not intentionally commit any acts or omissions that could cause a material breach of any agreement pursuant to which such licensing Party has rights that it has sublicensed to such other Party hereunder, such that its Third Party licensor would be entitled to terminate such agreement or amend it in any way that would adversely affect a license or other rights granted to such other Party under this Agreement.  In addition, without the prior written consent of such other Party, such licensing Party shall not exercise any rights it may have with respect to any such agreement or amend, or waive any of its rights under, such agreement in any way that would adversely affect a license or other rights granted to such other Party under this Agreement.

 

Article 6

License Fees; [ * ] and Milestone Payments

 

6.1 License Fee.   In consideration [ * ], Genentech shall pay to Array [ * ] after the Effective Date, which amount shall be non-refundable and non-creditable against any other amounts due Array under this Agreement.

 

6.2 [ * ]; Outsourcing [ * ] .

 

6.3 Development Milestones.

 

(a)  Milestone Schedule.   Within [ * ] following the first occurrence of each milestone event (set forth in this Section 6.3(a)) with respect to a particular Collaboration Target, Genentech shall pay to Array the following milestone payments (each payment, a “Development Milestone Payment”), regardless of whether the development or commercialization of such Licensed Product is discontinued at any time after the occurrence of such milestone event.  By way of example only, if a particular milestone event is achieved by more than one Licensed Product for the [ * ] Collaboration Target, the corresponding Development Milestone Payment shall only be due for the first such Licensed Product for [ * ].

 

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Milestone Event

 

Milestone Payment

(with respect to each Collaboration Target)

 

(in U.S. dollars)

(1)

[ * ]

 

[ * ]

(2)

[ * ]

 

[ * ]

(3)

[ * ]

 

[ * ]

(4)

[ * ]

 

[ * ]

(5)

[ * ]

 

[ * ]

(6)

[ * ]

 

[ * ]

(7)

[ * ]

 

[ * ]

(8)

[ * ]

 

[ * ]

(9)

[ * ]

 

[ * ]

(10)

[ * ]

 

[ * ]

 

(b)  Definitions.  The following definitions shall be used for the purposes of the Development Milestone Payments due under this Section 6.3:

 

(i)    “Acceptance” of an MAA shall mean the date of receipt by Genentech or its Sublicensees of written notice of acceptance from the FDA (or the equivalent regulatory authority in a country outside the U.S.) of an MAA for a Licensed Product for substantive review.

 

(ii)   “[ * ]” is defined in Section 0.

 

(iii) “[ * ]” is defined in Section 0.

 

(iv)  “Major European Country” means France, Germany, Italy, Spain or the United Kingdom.

 

Article 7

Royalties

 

7.1 Royalty Rate.   Genentech shall pay, or cause to be paid, to Array a royalty of [ * ] of Net Sales of each Licensed Product (“Royalty Payment”), subject to Royalty Offsets and other provisions of this Article 7 including, without limitation, Section 7.3(a).

 

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7.2 Single Royalty.   In no event shall more than one Royalty Payment be due to Array hereunder with respect to the sale of a particular Licensed Product, even if such Licensed Product contains more than one Compound, or such Licensed Product or its manufacture or use is Covered by more than one Valid Claim.

 

7.3 Royalty Term; Fully Paid Licenses.

 

(a)  Royalty Term.   Genentech’s obligation to make Royalty Payments shall pertain only to a Licensed Product that is Covered by a Valid Claim in the country of sale on the date of sale by Genentech or its Sublicensees to Third Parties.  Such Royalty Payment obligation shall expire on a Licensed Product-by-Licensed Product and country-by-country basis upon the expiration of the last-to-expire Valid Claim that Covers such Licensed Product in such country.  For purposes of this Section 7.3(a), the date of sale of a Licensed Product shall be deemed to occur on the later of (i) the date such Licensed Product is shipped; or (ii) the date of the invoice to the purchaser of such Licensed Product.

 

(b)  Fully Paid Licenses.   Upon expiration of the Royalty Payment obligation for a particular Licensed Product in a given country, the Commercial License granted to Genentech under this Agreement with respect to such Licensed Product in such country shall become fully paid and irrevocable.

 

7.4 Royalty Offsets.

 

(a)  Royalty Offsets.  Reductions of Royalty Payments made under this Section 7.4(a) shall be referred to collectively as “Royalty Offsets.”  In the event that (i) it becomes necessary for Genentech, or its Sublicensee, to [ * ] of a Third Party, where such [ * ], and such [ * ] would be [ * ] by [ * ] of such Licensed Product [ * ] in a given country; then (ii) the amount of the Royalty Payments due for such Licensed Product in such country shall be [ * ] of the amount of the royalties [ * ] to such Third Party for such license.  Notwithstanding the preceding sentence, in no event shall the applicable royalty rate be [ * ], other than as expressly provided in this Agreement including, without limitation, in accordance with Section 10.5(a)(ii).

 

(b)  Complementary Technologies.  Without limiting Royalty Offsets under Section 7.4(a), it is understood that on a case-by-case basis, Genentech and Array may agree that it would be in their mutual best interests to in-license a complementary technology for use with a Licensed Product, and in such case may similarly agree that it would be in their mutual best interests to agree upon an offset for royalties paid with respect to such in-license; provided, however, neither Party shall be obligated to agree to any such in-license or offset, and no such offset shall be made unless so agreed.

 

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7.5 Payments, Reports and Audits.  The following terms and conditions shall apply to Royalty Payments under this Agreement:

 

(a)  Payments and Reports.   Genentech shall make Royalty Payments to Array or its designee [ * ] in which Royalty Payments are due.  Each Royalty Payment shall be accompanied by a written report, setting forth all the information necessary for the calculation of such payment.  Unless otherwise requested, or consented to in writing, by Array, all Royalty Payments and reports related to Net Sales by Genentech’s Sublicensees shall be made to Array by Genentech together with (or as a part of) Genentech’s payments and reports.

 

(b)  Records.   Genentech shall keep full, true and accurate books of account containing all particulars that may be necessary for the purpose of showing Net Sales and demonstrating the calculation of Royalty Payments.  Such books of account and the supporting data and other records shall be kept at the principal place of business of Genentech.  Genentech’s books and records shall be open at all reasonable times, for [ * ] following the end of the [ * ] to which they pertain, for examination in accordance with the provisions of Section 7.5(c); provided, however, any given set of books and records may only be examined once.

 

(c)  Audits.   At the request and expense of Array, Genentech shall permit a nationally recognized independent certified public accountant, selected by Array and reasonably acceptable to Genentech, to examine, not more than once [ * ] during the period in which Genentech has an obligation to pay Royalty Payments under this Agreement, such books of account and records under Section 7.5(b) 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 [ * ] prior written notice.  After review of the accountant’s examination report, Genentech shall promptly pay any uncontested, understated Royalty Payments.  Any overpayment of Royalty Payments shall be promptly refunded or fully creditable against amounts payable in subsequent payment periods, at Genentech’s election.  Genentech shall pay contested, understated Royalty Payments, if any, that are due promptly after the dispute is resolved, in accordance with the provisions of Article 14.  If such accountant reasonably determines that Royalty Payments payable under this Agreement have been, for any [ * ], understated by [ * ], Genentech shall pay the reasonable costs of the examination.  The Parties agree that all information subject to review under this Section 7.5(c) is Confidential Information of Genentech and may only be used for purposes germane to this Section 7.5(c), and that Array shall retain and cause its accountant to retain all such information in confidence.

 

(d)  Mode of Payment; Foreign Exchange.   All payments due under this Agreement shall be made in United States dollars via wire transfer of immediately available funds, or by check if requested by Array, and shall be made where directed by Array from time to time.  For the purpose of computing Net Sales in a currency other than United States Dollars,

 

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such currency shall be converted into United States Dollars using the ending conversion rate for the relevant period as reported by Reuters Ltd.

 

(e)  Taxes.   Each Party shall comply with applicable United States Internal Revenue Service guidelines regarding filing and reporting for income tax purposes.  Neither Party shall treat their relationship under this Agreement as a partnership or as a pass through entity for tax purposes.

 

(f)  Blocked Currency.   In each country where the local currency is blocked and cannot be removed from such country, Royalty Payments related to Net Sales of Licensed Products sold in such country shall continue to be accrued without interest in such country, and shall continue to be reported, but such Royalty Payments will not be paid until they may be removed from such country.  At such time as Genentech or its Sublicensee, as the case may be, is able to remove currency from such country, it shall also remove and pay such accrued Royalty Payments.

 

Article 8

Materials; Intellectual Property

 

8.1 Materials.

 

(a)  Ownership.   Each Party may transfer certain materials to the other Party pursuant to the Research Plan, Approval by the Joint Research Committee or other provisions of this Agreement.  Except as otherwise expressly provided herein, as between the Parties, all right, title and interest in and to all such transferred materials (and any IP Rights relating thereto) shall remain in the Party transferring such materials to the other Party.

 

(b)  Use; Transfer.   Each Party agrees that, except as otherwise expressly provided herein, it shall use the other Party’s materials only in connection with activities contemplated by this Agreement or in order to further the purposes of this Agreement, and shall not transfer such materials of the other Party to any Third Party without such other Party’s prior written consent.  Array hereby consents that Genentech may transfer any or all of the Compounds to Third Parties that perform activities on behalf of Genentech for the purposes of this Agreement; provided, however, such Third Parties shall be contractually bound to Genentech (including, without limitation, being bound by confidentiality obligations at least as restrictive as those set forth in Article 9, and agreeing to use such transferred Compounds only for the purposes of this Agreement and to not further transfer such Compounds without Array’s prior written consent).

 

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8.2 Ownership of Technology.

 

(a)  General.   As between the Parties, each Party shall solely own its Contributed Technology.  Except as otherwise expressly provided in this Agreement (including, without limitation, Section 8.3), as between the Parties, (i) Collaboration Technology that is discovered, conceived or reduced to practice by employees of Array solely (or jointly with a Third Party collaborator/agent of Array) (“Array Collaboration Technology”) shall be solely owned by Array; (ii) Collaboration Technology that is discovered, conceived or reduced to practice by employees of Genentech solely (or jointly with a Third Party collaborator/agent of Genentech) (“Genentech Collaboration Technology”) shall be solely owned by Genentech; and (iii) Collaboration Technology that is discovered, conceived or reduced to practice by an employee of Genentech (or a Third Party collaborator/agent of Genentech) and an employee of Array (or a Third Party collaborator/agent of Array) jointly (“Joint Collaboration Technology”) shall be jointly owned by Genentech and Array.

 

(b)  Restrictions on Joint Collaboration Technology.   During the term of the Agreement, with respect to any Collaboration Target that is included in the scope of the Commercial License, Array shall not, in the Territory, license (except by Array to Genentech pursuant to the licenses granted hereunder), assign, dispose of, encumber or otherwise impair any portion of its interest in the Joint Collaboration Technology that relates to any such Collaboration Target or Compounds thereto, without the prior written consent of Genentech.  Except as provided in Article 6, and subject to the licenses granted hereunder, 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 Joint Collaboration Technology, and each Party hereby waives any right it may have under the laws of any jurisdiction to require such an accounting or consent.

 

8.3 [ * ].

 

(a)  [ * ] Patentability.   Solely to the extent [ * ], as reasonably determined by Genentech and Array, inventions within Genentech Collaboration Technology or Joint Collaboration Technology shall be subject to an [ * ].  Provided further, whether or not Genentech has requested [ * ], Array shall promptly [ * ] (i) [ * ], upon termination of the Agreement; (ii) [ * ], upon abandonment of such Collaboration Target pursuant to Section 2.6(b); and (iii) [ * ], upon such exclusion.

 

(b)  [ * ] Patent Term Extensions.   With respect to any Compound for which Genentech has filed an IND, at the time of such filing, or at any time thereafter, Genentech may request that Array [ * ], to Genentech such [ * ], so as to provide Genentech [ * ], and Array shall undertake [ * ] that are reasonably necessary to facilitate Genentech procuring a patent term extension with respect to such Compound.

 

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8.4 Inventorship.   The determination of inventorship for Collaboration Technology shall be made in accordance with applicable laws relating to inventorship set forth in the patent laws of the United States.  All such determinations shall be documented to ensure that any divisional or continuation patent applications reflect appropriate inventorship and that inventions and patent rights are assigned to the appropriate Party.  If either Party identifies Joint Collaboration Technology, the Parties’ patent counsel shall determine inventorship and, in the event of a disagreement, the Parties shall refer such determination to mutually acceptable outside counsel.

 

8.5 Assignment; Cooperation .   Each Party shall require all of its employees and any Third Parties working pursuant to this Agreement on its behalf, to assign to such Party any Collaboration Technology discovered, conceived or reduced to practice by such employee or Third Party, and to cooperate with such Party in connection with obtaining patent protection therefor.  The Parties agree to reasonably cooperate with each other to effectuate ownership of Collaboration Technology as set forth herein, including, but not limited to, by executing and recording documents.

 

8.6 Patent Prosecution.

 

(a)  Definitions.  The following definitions shall be used only for the purposes of this Section 8.6 (or as otherwise expressly referenced in this Agreement):

 

(i)    “Prosecuting Party” is defined in Section 8.6(d)(ii).

 

(ii)   “Prosecution and Maintenance” or “Prosecute and Maintain,” with regard to a particular Patent, means the preparation, filing, prosecution and maintenance of such Patent, as well as re-examinations, reissues, requests for patent term extensions and the like with respect to such Patent, together with the conduct of interferences, the defense of oppositions and other similar proceedings with respect to such Patent.

 

(b)  Disclosure of Technology.   During the Research Term, each Party shall promptly disclose to the other any Collaboration Technology discovered, conceived or reduced to practice by such Party.  During the term of the Agreement, Array shall promptly disclose to Genentech all Array Contributed Technology (including, without limitation, any Array Contributed Technology of which it acquires Control after the Effective Date) that Array knows or has reason to know is within the scope of the licenses granted to Genentech hereunder.

 

(c)  Contributed Technology.  Each Party, in its sole discretion and expense, may Prosecute and Maintain Patents covering its Contributed Technology.  Array shall use diligent efforts to obtain Valid Claims that Cover Licensed Products.

 

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(d)  Collaboration Technology.

 

(i)          Sole Control.   Genentech, in its sole discretion and expense, may Prosecute and Maintain Patents covering Genentech Collaboration Technology.

 

(ii)         Joint Control.   The Parties shall jointly decide on a strategy for the Prosecution and Maintenance of Patents covering Joint Collaboration Technology, which strategy may include retention of mutually acceptable outside counsel to conduct such Maintenance and Prosecution, and the Parties shall equally share the expenses therefor, regardless of which Party is responsible for such Prosecution and Maintenance.  The Parties shall jointly decide on a strategy for, and shall collaborate and cooperate with each other in the Prosecution and Maintenance of Patents covering Array Collaboration Technology, which strategy may include retention of mutually acceptable outside counsel to conduct such Maintenance and Prosecution, and Array shall be responsible for such Prosecution and Maintenance, at its expense.  The Party that is responsible for the Prosecution and Maintenance of a Patent under this Section 8.6(d)(ii) shall be referred to as the “Prosecuting Party.”  The Prosecuting Party shall use diligent efforts to obtain a reasonable scope of protection for such Collaboration Technology inventions, and will consider in good faith reasonable comments provided by the other Party.

 

(iii)        Cooperation.   Each Party shall, at its own expense, reasonably cooperate with and assist the other Party, at such other Party’s request, in connection with the Prosecution and Maintenance Patents covering any Collaboration Technology, including without limitation by making scientists and scientific records reasonably available to such other Party.

 

(e)  Disclosure of Developments.   Each Party shall keep the other informed as to material developments with respect to the Prosecution and Maintenance of Patents covering any Collaboration Technology (other than Genentech Collaboration Technology) or of Patents covering Array Contributed Technology that pertain to chemical entities that Array knows or has reason to know are Compounds or Licensed Products including, without limitation, by promptly providing to the other Party, upon request, copies of any substantive documents that such Party receives from any patent office (including notice of interferences, reissues, re-examinations, oppositions or requests for patent term extensions), and by providing such other Party the opportunity to have reasonable input into the strategic aspects of such Prosecution and Maintenance.

 

(f)  Transfer of Prosecution and Maintenance.   If a Prosecuting Party elects not to Prosecute and Maintain Patents covering Collaboration Technology in a country in which the Parties had agreed to Prosecute and Maintain such Patents, such Prosecuting Party shall provide at least sixty (60) days written notice to the other Party.  Thereafter, such other Party shall have the right, but not the obligation, to pursue, at its sole expense and in its sole discretion, the Prosecution and Maintenance of such Patents in such country.  The ownership of such Patents

 

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shall not be affected, notwithstanding any transfer of Prosecution and Maintenance of such Patents to such other Party in accordance with this Section 8.6(f).

 

8.7 Patent Interferences .   In the event that an interference is declared by the U.S. Patent and Trademark Office (a) between (i) a claim in one or more patents or patent applications within the Array Patents and (ii) a claim in one or more patents or patent applications within the Genentech Patents, where at least one of such claims would be infringed by the making, using, offering for sale, selling or importing of Licensed Products but for the licenses granted hereunder; or (b) between either of (i) or (ii) above and a claim in one or more patents or patent applications within the Joint Collaboration Technology, where at least one of such claims would be infringed by the making, using, offering for sale, selling or importing of Licensed Products, but for the licenses granted hereunder; then the Parties shall in good faith establish within thirty (30) days of the declaration of such interference, or such other time as agreed upon, a mutually agreeable process to resolve such interference in a reasonable manner (including, without limitation, control and cost sharing), in conformance with all applicable legal standards.

 

8.8 Third Party Claims .   If a claim of infringement is brought by a Third Party against Genentech on account of the manufacture, use, offer for sale, sale or import of any Licensed Product, Genentech shall be solely responsible for defending such Third Party claim, at its sole discretion and sole expense.  At Genentech’s request and expense, Array shall cooperate reasonably with Genentech in connection with any such defense.

 

8.9 Infringement by Third Parties.

 

(a)  Actions.  If any Patent within the Array Contributed Technology or the Collaboration Technology is infringed by a Third Party in any country in connection with the manufacture, use, offer for sale, sale or import of a product substantially similar to a Licensed Product in the Field in such country, Genentech (and its Sublicensees) shall have the primary right, but not the obligation to institute, prosecute, and control any action or proceeding with respect to such infringement of such Patent, by counsel of its own choice, and Array shall have the right, at its own expense, to be represented in that action by counsel of its own choice.

 

(b)  Assistance, Costs and Recoveries.   If Genentech (and/or its Sublicensees) brings any such action or proceeding in accordance with this Section 8.9, Array agrees, at Genentech’s request and expense, to be joined as a party plaintiff and to give Genentech (and/or its Sublicensees) reasonable assistance and authority to file and prosecute the suit.  The costs and expenses of Genentech (and/or its Sublicensees) under this Section 8.9 shall be borne by Genentech (and/or its Sublicensees), and any damages, amounts received in settlement or other monetary awards recovered shall be shared as follows: [ * ].  A settlement, consent judgment or other voluntary final disposition of a suit under this Section 8.9 may be entered into without the consent of Array, provided that such settlement, consent judgment or other disposition does not admit the invalidity or unenforceability of any Patent within the Array Contributed Technology

 

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or the Collaboration Technology (other than Genentech Collaboration Technology) and provided further, that any rights to continue the infringing activity in such settlement, consent judgment or other disposition shall be limited to those rights Genentech (and/or its Sublicensees) otherwise has the right to grant.

 

Article 9

Confidentiality

 

9.1 Confidentiality .   Except to the extent expressly authorized by this Agreement, or otherwise agreed in writing, each Party (as a “Receiving Party”) in possession of the Confidential Information of the other Party (as a “Disclosing Party”) agrees: (a) to hold the Disclosing Party’s Confidential Information in confidence; and (b) to only use such Disclosing Party’s Confidential Information in connection with activities contemplated by this Agreement or in order to further the purposes of this Agreement.  The foregoing confidentiality and use restrictions shall not apply to a Disclosing Party’s Confidential Information to the extent that the Receiving Party establishes by written evidence that such Confidential Information:

 

(i)          was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the Disclosing Party;

 

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

 

(iii)        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;

 

(iv)         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; or

 

(v)          was subsequently developed by or on behalf of the Receiving Party without use of the Disclosing Party’s Confidential Information.

 

9.2 Authorized Disclosures.

 

(a)  Legal Compliance.   A Party may disclose the other Party’s Confidential Information only to the extent such disclosure is reasonably necessary to comply with the order of a court, applicable laws or governmental regulations; provided, however, that, except for disclosures otherwise permitted under this Section 9.2, or as otherwise required or necessitated by law, such Party shall provide prompt notice of such disclosure requirement to such other Party and provide reasonable assistance to enable such other Party to seek a protective order or otherwise prevent such disclosure.

 

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(b)  Regulatory Authorities.   A Party may disclose the other Party’s Confidential Information to the extent such disclosure is required to comply with applicable governmental regulations or to conduct pre-clinical or clinical trials related to Licensed Products.

 

(c)  Patent Prosecution.   A Party may disclose the other Party’s Confidential Information to the extent such disclosure occurs in the filing or publication of any patent application or patent on inventions, subject to the provisions of Section 8.6.  Array agrees that the provisions of Section 9.3 shall apply to disclosures by Array of Array Confidential Information in patent applications.

 

(d)  Publications.   Except as otherwise expressly provided, Array shall not disclose by any means (including electronically) any information related to Compounds discovered under the Research Plan or Collaboration Targets, or the identity or properties of other chemical entities known by Array to be Compounds, without Genentech’s prior written consent, which consent is in its sole discretion.  Subject to the preceding sentence, in the event a Party wishes to publish or orally present information relating to or arising from the Research Program, 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 thirty (30) days prior to the date of submission for publication or the date of presentation, whichever is earlier, of any of such submitted materials.  The other Party shall review such submitted materials and respond to the submitting Party as soon as reasonably possible, but in any case within thirty (30) days of receipt thereof.  At the request of the reviewing Party, the submitting Party shall modify or delete from such proposed publication or presentation any Confidential Information of the reviewing Party.  In the event the reviewing Party does not respond within the period specified above, the submitting Party will be free to make such proposed publication or presentation.

 

(e)  Other Permitted Disclosure.   A Receiving Party may disclose and grant use of particular Confidential Information of the Disclosing Party to such Receiving Party’s permitted sublicensees, agents, consultants, clinical investigators, collaborators or contractors as such Receiving Party reasonably determines is necessary to receive the benefits of or fulfill its obligations pursuant to this Agreement; provided, however, any such permitted sublicensees, agents, consultants, clinical investigators, collaborators or contractors must be obligated to substantially the same extent as set forth in Section 9.1 to hold in confidence and not make use of such Confidential Information for any purpose other than those permitted by this Agreement.  Nothing in this Article 9 shall restrict either Party from using or disclosing any of its own Confidential Information for any purpose whatsoever.  Further, a Receiving Party may disclose Confidential Information received under this Agreement to existing or potential investors, acquirers, merger partners, collaborators or licensees, or to professional advisors ( e.g. ,  attorneys, accountants and prospective investment bankers) involved in such activities, for the limited purpose of evaluating such investment, transaction, or license and under appropriate conditions

 

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of confidentiality, only to the extent necessary and with the agreement by these permitted individuals to maintain such Confidential Information in strict confidence.

 

9.3 Patent Applications .   Array agrees that, prior to filing a patent application that discloses any data or information that was generated or obtained by Array under the Research Program including, without limitation, Array Confidential Information, (“Patent Disclosure Data”), Array shall provide to Genentech, prior to filing and with sufficient time to allow Genentech to comment thereon, a copy of any such patent application that Array proposes to file with any patent office in the Territory.  The Parties acknowledge that Array may file such patent applications to protect Collaboration Technology in accordance with Section 8.6(d), and that it is in the interests of both Genentech and Array to disclose only Patent Disclosure Data that are necessary for successful prosecution of such filed patent applications in countries of interest.  In particular, the Parties will discuss in good faith Array’s proposed inclusion of any of the following types of data and information in the Patent Disclosure Data: [ * ].  Array agrees to fully and reasonably consider any of Genentech’s suggestions or proposed deletions prior to filing such Array patent applications, and further agrees to consider postponing publication of such patent applications containing Patent Disclosure Data as long as feasible, in Array’s sole discretion (for example, by filing provisional applications or by foregoing international filings, if Array deems such action appropriate).

 

9.4 Continuing Obligation .   This Article 9 shall survive the termination or expiration of this Agreement for a period of [ * ].

 

9.5 Termination of Prior Agreements .   As of the Effective Date, this Agreement supersedes the Mutual Confidentiality Agreement between the Parties effective as of July 9, 2003, but only insofar as it relates to the subject matter of this Agreement.  All “Information” (as defined in such confidentiality agreement) exchanged between the Parties thereunder relating to the subject matter of this Agreement shall be deemed Confidential Information hereunder and shall be subject to the provisions of this Article 9.

 

Article 10

Term; Termination

 

10.1        Term .   This Agreement shall be effective as of the Effective Date.  Unless sooner terminated as provided in this Article 10, this Agreement shall remain in effect until Array is no longer entitled (in fact or potentially) to receive Royalty Payments from Genentech, other than Royalties Payments pursuant to Section 10.5(c).

 

10.2        Termination by Genentech .   Genentech shall have the right to terminate this Agreement in its entirety, in its sole discretion, upon [ * ] written notice to Array.

 

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10.3        Material Breach.

 

(a)  Generally.   Subject to Section 10.3(b), either Party may terminate this Agreement, by written notice to the other Party, for any material breach of this Agreement by the other Party, if such breach is not cured within [ * ] after the breaching Party receives written notice of such breach from the non-breaching Party; provided, however, if such breach is not capable of being cured within such [ * ] period, the cure period shall be extended for such amount of time that the Parties agree to in writing is reasonably necessary to cure such breach, so long as the breaching Party is making diligent efforts to do so.  Such termination shall be effective upon expiration of the cure period.  Any dispute as to whether a notice of termination pursuant to this Section 10.3(a) is proper, or whether a breach is material or has been cured, shall be resolved as provided pursuant to Article 14.

 

(b)  Related to a Licensed Product or Collaboration Target.   If Array has the right to terminate this Agreement due to a material breach by Genentech, and (i) if such breach relates solely to a particular Collaboration Target, then Array may only exclude Compounds and Licensed Products for such Collaboration Target from the scope of the Commercial License; or (ii) if such breach relates solely to a particular Licensed Product, then Array may only exclude such Licensed Product from the scope of the Commercial License; and in either event, Array may not terminate the entire Agreement.

 

10.4        Insolvency or Bankruptcy.

 

(a)  Right to Terminate.   In the event that a Party becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a Third Party’s intention to file an involuntary petition in bankruptcy, such Party shall immediately notify the other Party in writing.  In addition to any other remedies available to such other Party by law or in equity, such other Party shall have the right to immediately terminate this Agreement, in whole or in part as the terminating Party may determine, upon learning of any of the foregoing events.

 

(b)  Retention of Rights.   In the event Array seeks or is involuntarily placed under the protection of the “Bankruptcy Code” ( i.e. , Title 11, U.S. Code), and the trustee in bankruptcy, or Array as a debtor-in-possession, rejects this Agreement, Genentech hereby elects, pursuant to Section 365(n) of such Bankruptcy Code, to retain all licenses of rights to “intellectual property” (as defined under such Bankruptcy Code) granted to it under this Agreement to the extent permitted by law.

 

(c)  Embodiments of IP.   The Parties agree that, in the event of the commencement of a bankruptcy proceeding by or against Array under such Bankruptcy Code, Genentech shall be entitled to a complete duplicate of all embodiments of such intellectual property, and such embodiments, if not already in its possession, shall be promptly delivered to

 

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Genentech (i) upon any such commencement of a bankruptcy proceeding, unless Array elects to continue to perform all of its obligations under this Agreement, or (ii) if not delivered under (i), immediately upon the rejection of this Agreement by or on behalf of Array.

 

(d)  Patent Prosecution.   Genentech acknowledges that certain Array Patents may contain subject matter that is licensed to Third Parties or may also include subject matter that is outside the scope of the Commercial License.  The Parties agree that, in the event of the commencement of a bankruptcy proceeding by or against Array under such Bankruptcy Code, to the extent consistent with the Bankruptcy Code and Array’s existing obligations to Third Parties, and to the extent permitted by Array’s trustee, Genentech shall have the right to Prosecute and Maintain (as defined in Section 8.6(a)) Array Patents, to the extent included within the scope of the Commercial License, at its expense.

 

10.5        Effects of Termination; Survival.

 

(a)  Termination by Genentech.

 

(i)    In the event that Genentech terminates this Agreement pursuant to Section 10.2, and subject to Sections 10.5(c) and (d), all rights and licenses granted by Array hereunder with respect to Compounds and Licensed Products shall immediately terminate.

 

(ii)   In the event that Genentech terminates this Agreement pursuant to Section 10.3(a), after the effective date of such termination, the Commercial License granted to Genentech hereunder shall become irrevocable and Genentech shall pay [ * ]; provided, however, that if such termination is due to a breach by Array of Article 4, the Commercial License shall [ * ].

 

(b)  Termination by Array.   In the event that Array terminates this Agreement pursuant to Section 10.3(a), and subject to Sections 10.5(c) and (d), all rights and licenses granted by Array hereunder with respect to Compounds and Licensed Products shall immediately terminate.

 

(c)  Inventory at Termination.   In the event this Agreement is terminated by a Party for any reason (or a Licensed Product is excluded from the scope of the Commercial License), Genentech shall have the right to sell or otherwise dispose of Licensed Products then in stock, subject to Royalty Payments and any other applicable provisions of this Agreement, and Array covenants not to sue Genentech for infringement under any Array IP Rights with respect to such activities conducted by Genentech pursuant to this Section 10.5(c).

 

(d)  Continuation of Sublicenses.   Upon termination of this Agreement (or if a Licensed Product is excluded from the scope of the Commercial License), an existing sublicense granted by Genentech under its Commercial License, if any, shall continue in full force and effect, provided that the Sublicensee agrees to be bound by all the terms and conditions of this

 

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Agreement that are applicable to such Sublicensee including, without limitation, rendering directly to Array all payments and other obligations due to Array related to such sublicense (including, without limitation, all Development Milestone Payments and Royalty Payments).

 

(e)  Return of Confidential Information.   Upon termination of this Agreement by Genentech pursuant to Section 10.2 or Array pursuant to Section 10.3, Genentech shall return to Array (or destroy at Array’s written request) all Confidential Information of Array directly related to this Agreement in the possession of Genentech as of the effective date of termination (with the exception of one copy of such Confidential Information, which may be retained by Genentech’s legal department to confirm compliance with the non-use and non-disclosure provisions of this Agreement).  Upon any termination of this Agreement by either Party, Array shall return to Genentech (or destroy at Genentech’s written request) all Confidential Information of Genentech directly related to this Agreement in the possession of Array as of the effective date of termination (with the exception of one copy of such Confidential Information, which may be retained by Genentech’s legal department to confirm compliance with the non-use and non-disclosure provisions of this Agreement).

 

(f)  Other.   Except as otherwise expressly provided herein, termination of this Agreement shall not affect the rights and obligations of the Parties that accrued prior to the effective date of such termination.  Any right that a Party has to terminate this Agreement, and any rights that such Party has under this Section 10.5, shall be in addition to and not in lieu of all other rights or remedies that such Party may have at law or in equity or otherwise, including without limitation rights under the United States Bankruptcy Code.

 

(g)  Survival.   Except as otherwise expressly provided herein, the provisions of Sections 5.4, 5.5 and 7.5 and Article 9, Article 10, Article 11, Article 12, Article 13, Article 14 and Article 15 (as applicable) shall survive any termination or expiration of this Agreement in perpetuity.  In addition, except as otherwise expressly provided herein, the provisions of Section 7.3(b) shall survive expiration, early termination by Genentech pursuant to Section 10.3(a) or early termination pursuant to Section 10.4, of this Agreement.  Further, Article 8 shall survive any termination or expiration of this Agreement in perpetuity except as follows:  Sections 8.3(b), 8.6(b) and 8.9 only survive early termination by Genentech pursuant to Section 10.3(a); Sections 8.6(e) and 8.6(f) only survive with respect to Joint Collaboration Technology; and Section 8.7 does not survive any termination or expiration of this Agreement.

 

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Article 11

Representations and Warranties

 

11.1        Mutual Representations and Warranties .   Each of the Parties hereby represents, warrants and covenants as follows:

 

(a)  This Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms.  The execution, delivery and performance of the Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a Party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.

 

(b)  Each Party has not, and during the term of the Agreement will not, grant or otherwise dispose of any right to any Third Party relating to its respective technology in the Field that conflicts with, or adversely affects, the rights granted to the other Party hereunder.

 

(c)  Each Party Controls all of the rights, title and interest in and to its inventions (whether patentable or not), Patents and Know-How within its respective Contributed Technology, in each case, that exist as of the Effective Date.

 

(d)  After the Effective Date, each Party shall disclose to the other Party any Third Party intellectual property of which it becomes aware that would be infringed by the discovery, development and/or commercialization of Compounds pursuant to this Agreement.  Genentech’s obligations under this Section 11.1(d) shall terminate at the end of the Research Term, and Array’s obligations under this Section 11.1(d) shall continue for the term of this Agreement.

 

11.2        Array Representations and Warranties .   Array hereby further represents, warrants and covenants to Genentech that:

 

(a)  As of the Effective Date, there are no material adverse proceedings, claims or actions pending, or to the best of Array’s knowledge, threatened, relating to the Array Contributed Technology that would materially interfere with Array’s performance of its obligations, or Genentech’s exercise of its rights, under this Agreement; after the Effective Date, Array shall disclose to Genentech any such material adverse proceedings, claims or actions that arise.

 

(b)  As of the Effective Date, to the best of Array’s knowledge, [ * ].

 

11.3        Disclaimers .   EXCEPT AS OTHERWISE EXPRESSLY STATED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO MATERIALS OR INFORMATION SUPPLIED BY IT TO THE OTHER PARTY HEREUNDER, AND EXPRESSLY DISCLAIMS ALL WARRANTIES,

 

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EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.

 

Article 12

Indemnification; Limitation on Liability

 

12.1        Losses Defined .   Solely for purposes of this Article 12, the term “Losses” means any and all third party suits, claims, actions, demands, losses, damages, liabilities, settlements, penalties, fines, costs and expenses (including, without limitation, reasonable attorneys’ fees and expenses).

 

12.2        Indemnification by Genentech.

 

(a)  Indemnification Scope.   Genentech hereby agrees to indemnify, defend and hold Array and its officers, directors, employees and agents harmless from and against Losses resulting directly from the discovery, development, manufacture, use, handling, storage, sale or other disposition of Compounds or Licensed Products by Genentech, its agents or Sublicensees, except to the extent that such Losses are attributable to (i) Array’s breach of its representations, warranties and/or covenants under Article 11; (ii) Array’s material breach of its obligations under this Agreement; and/or (iii) the negligence or willful misconduct of the indemnified Party(ies) in the course of performing activities under this Agreement.

 

(b)  Indemnification Procedures.   In the event that Array seeks indemnification under this Section 12.2, it shall (i) notify Genentech of any Losses for which it claims such indemnification within fifteen (15) business days after it receives notice of the claim; (ii) permit Genentech to assume the sole control of the defense thereof including, without limitation, the right to settle or conclude such defense; (iii) cooperate as reasonably requested (at the expense of Genentech) in the defense of the claim; and (iv) not settle the claim without the express, prior written consent of Genentech.  The indemnity agreement under this Section 12.2 shall not apply to amounts paid in settlement of any Losses if such settlement is effected without the consent of Genentech.

 

12.3        Indemnification by Array.

 

(a)  Indemnification Scope.   Array hereby agrees to indemnify, defend (if requested by Genentech) and hold Genentech and its officers, directors, employees and agents harmless from and against Losses to the extent that such Losses are attributable to (i) Array’s breach of its representations, warranties and/or covenants under Article 11; (ii) Array’s material breach of its obligations under this Agreement; and/or (iii) the negligence or willful misconduct of Array and its officers, directors, employees and agents in the course of performing activities

 

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under this Agreement, except to the extent that such Losses are attributable to (i) Genentech’s breach of its representations, warranties and/or covenants under Article 11; (ii) Genentech’s material breach of its obligations under this Agreement; and/or (iii) the negligence or willful misconduct of the indemnified Party(ies) in the course of performing activities under this Agreement.

 

(b)  Indemnification Procedures.   In the event that Genentech seeks indemnification under this Section 12.3, it shall (i) notify Array of any Losses for which it claims such indemnification within fifteen (15) business days after it receives notice of the claim; and (ii) if requested by Genentech, assume control of the defense thereof, with counsel mutually satisfactory to the Parties.  In the event Genentech requests that Array assume such control, Genentech shall (i) cooperate as reasonably requested (at the expense of Array) in the defense of the claim; and (ii) Array shall not settle the claim without the express, prior written consent of Genentech.

 

12.4        Limitation on Liability.   IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL OR PUNITIVE DAMAGES, HOWEVER CAUSED.  NOTHING IN THIS SECTION IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY.

 

Article 13

Insurance

 

13.1        Coverages.

 

(a)  General.   Each Party shall maintain, at its own cost, and provide evidence of the insurance coverages as set forth in this Article 13.  All insurance coverages shall be primary insurance with respect to each Party’s own participation under this Agreement, and shall be maintained with an insurance company or companies having an A.M. Best’s rating (or its equivalent) of A-XII or better, in the case of Genentech, and A-VII or better, in the case of Array.

 

(b)  Commercial General Liability.   For as long as a Party is performing obligations under the Agreement, and thereafter for the period of time required under this Section 13.1(b), each Party shall obtain and maintain, Commercial General Liability (CGL) insurance, including contractual liability, in the minimum amount of [ * ].  The CGL insurance policies shall be an occurrence form, but if only a claims-made form is available to a Party, then in such a case, such Party shall maintain the insurance coverage for at least [ * ] following such

 

32



 

Party’s completing performance of its obligations under this Agreement.  Each Party’s aggregate deductibles under its CGL insurance policies shall be satisfactory to the other Party.

 

13.2        Additional Requirements.

 

(a)  Additional Insured.   With respect to the insurance coverages set forth in Section 13.1, each Party shall name the other Party as an additional insured by endorsement under its Commercial General Liability insurance policy.

 

(b)  Certificates of Insurance.   Promptly following the Effective Date, each Party shall provide to the other Party its respective certificates of insurance evidencing the insurance coverages set forth in Section 13.1.  Each Party shall provide to the other Party at least [ * ] prior written notice of any cancellation, nonrenewal or material change in any of the insurance coverages.  Each Party shall continue to provide renewal certificates to the other Party for as long as such Party is required to maintain insurance coverages hereunder.

 

Article 14

Dispute Resolution

 

14.1        Internal Resolution .   Except as otherwise expressly provided herein, in the event of any controversy, claim or other dispute arising out of or relating to any provision of this Agreement or the interpretation, enforceability, performance, breach, termination or validity hereof, such dispute shall be first referred to the Executives of each Party for resolution, prior to proceeding under the following provisions of this Article 14.  A dispute shall be referred to the Executives upon one Party providing the other Party with written notice that such dispute exists, and the Executives shall attempt to resolve such dispute through good faith discussions.  In the event that the Executives cannot resolve such dispute within thirty (30) days of such other Party’s receipt of such written notice, except as otherwise provided in Section 2.2(c), either Party may initiate the dispute resolution procedures set forth in Section 14.2.

 

14.2        Arbitration .   Except as otherwise expressly provided in this Agreement, the Parties agree that any dispute not resolved internally by the Parties pursuant to Section 14.1, shall be resolved through binding arbitration in accordance with the then prevailing Commercial Arbitration Rules of the American Arbitration Association, except as modified in this Agreement, applying the substantive law specified in Section 15.8.  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

 

33



 

the then prevailing Commercial Arbitration Rules.  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 San Francisco, California, in the event that Array requests arbitration, and in Denver, Colorado, in the event Genentech 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.

 

14.3        Patent Validity .   Notwithstanding the other provisions of this Article 14, any dispute that involves the validity, infringement or claim interpretation of a patent (i) that is issued in the United States shall be subject to actions before the United States Patent and Trademark Office and/or submitted exclusively to the federal court located in the jurisdiction of the district where any of the defendants resides; and (ii) that is issued in any other country shall be brought before an appropriate regulatory or administrative body or court in that country, and the Parties hereby consent to the jurisdiction and venue of such courts and bodies.  For the sake of clarity, such patent disputes shall not be subject to the provisions of Section 14.2.

 

Article 15

Miscellaneous

 

15.1        Assignment .   Neither Party may assign, in whole or in part, this Agreement without the prior written consent of the non-assigning Party, such approval not to be unreasonably withheld.  Notwithstanding the foregoing, either Party may assign this Agreement to any purchaser of all or substantially all of the assets of such Party, or of all of its capital stock, or to any successor corporation or entity resulting from any merger or consolidation of such Party with or into such corporation or entity, provided that the party to which this Agreement is assigned expressly agrees in writing to assume and be bound by all obligations of the assigning Party under this Agreement.  A copy of such written agreement by such assignee shall be provided to the non-assigning Party within ten (10) days of execution of such written agreement.  Subject to the foregoing, this Agreement will benefit and bind the Parties’ successors and assigns.

 

15.2        Publicity and Disclosure Relating to this Agreement .   Neither Party shall issue press releases nor make any public announcements relating to this Agreement for any purpose whatsoever without the other Party’s prior written approval.  Except as otherwise set forth in Article 9, neither Party shall disclose the activities being performed by the Parties hereunder or the terms and conditions of this Agreement (including, without limitation, the financial terms) to

 

34



 

any Third Party without the other Party’s prior written consent; provided, however, such approval shall not be unreasonably withheld if required pursuant to the disclosure requirements of the U.S. Securities and Exchange Commission or the national securities exchange or other stock market on which such Party’s securities are traded.

 

15.3        No Right to Use Names .   Except as expressly provided herein, no right, express or implied, is granted by the Agreement to use in any manner the name “Array,” “Genentech” or any other trade name or trademark of the other Party in connection with the performance of this Agreement.

 

15.4        Notices.   Any notice required or permitted to be given by either Party under this Agreement shall be in writing and shall be personally delivered or sent by a nationally-recognized private express courier, or by first class mail (registered or certified), or by facsimile (confirmed by first class mail (registered or certified) or by express courier), to the respective Parties as set forth below.  Notices will be deemed effective (a) the next day if sent by express courier; (b) three (3) business days after deposit, postage prepaid, if mailed; or (c) the same day if sent by facsimile and confirmed as set forth above.  Either Party may change its address for purposes hereof by written notice to the other in accordance with the provisions of this Section 15.4.

 

If to Array:

Array BioPharma Inc.

3200 Walnut Street

Boulder, Colorado 80301

Attn:  Chief Operating Officer

Telephone:  (303) 381-6699

Facsimile:  (303) 381-6697

 

with a required copy to:

 

Array BioPharma Inc.

3200 Walnut Street

Boulder, Colorado 80301

Attn:  General Counsel

Telephone:  (303) 381-6679

Facsimile:  (303) 386-1290

 

35



 

If to Genentech:

 

Genentech, Inc.

1 DNA Way,

South San Francisco, CA 94080

Attn:  Corporate Secretary

Telephone:  (650) 225-1000

Facsimile:  (650) 952-9881

 

with a required copy to:

 

Genentech, Inc.

1 DNA Way,

South San Francisco, CA 94080

Attn:  Vice President, Business Development

Telephone:  (650) 225-1000

Facsimile:  (650) 225-3009

 

15.5        Relationship of the Parties .   The Parties hereto are independent contractors and nothing contained in this Agreement shall be deemed or construed to create a partnership, joint venture, employment, franchise, agency or fiduciary relationship between the Parties.

 

15.6        Entire Agreement .   This Agreement, including all Exhibits attached hereto, which are hereby incorporated by reference, contains the entire understanding between the Parties hereto with respect to the subject matter hereof and supersedes and terminates all prior agreements, understandings and arrangements between the Parties, whether written or oral, subject to Section 9.5 with respect to prior confidentiality agreements.

 

15.7        Amendment; Waiver .   Except as otherwise expressly provided herein, no alteration of or modification to this Agreement shall be effective unless made in writing and executed by an authorized representative of both Parties.  No course of dealing or failing of either Party to strictly enforce any term, right or condition of this Agreement in any instance shall be construed as a general waiver or relinquishment of such term, right or condition.  The observance of any provision of this Agreement may be waived (either generally or any given instance and either retroactively or prospectively) only with the written consent of the Party granting such waiver.

 

15.8        Governing Law.  This Agreement shall be governed by and construed under the laws of the State of New York, without regard to the conflict of laws provisions thereof.

 

15.9        Construction.  The Parties mutually acknowledge that they and their attorneys have participated in the negotiation and preparation of this Agreement.  Ambiguities, if any, in

 

36



 

this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have drafted the Agreement or authorized the ambiguous provision.

 

15.10      Captions.  Titles, headings and other captions are for convenience only and are not to be used for interpreting this Agreement.

 

15.11      Legal Compliance; Severability .   Both Parties hereby expressly state that it is the intention of neither Party to violate any rule, law and regulation.  If any of the provisions of this Agreement are held to be void or unenforceable, then such void or unenforceable provisions shall be replaced by valid and enforceable provisions that will achieve as far as possible the economic business intentions of the Parties.

 

15.12      Force Majeure .   Neither Party shall be held liable or responsible to the other Party or be deemed to have breached or defaulted under this Agreement for failure or delay in performing its obligations hereunder to the extent, and as long as, such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, such causes including, without limitation, earthquakes, fires, floods, embargoes, wars, acts of terrorism, insurrections, riots, civil commotions, acts of God, omissions or delays in action by any governmental authority, acts of a government or agency thereof and judicial orders or decrees.  In the event of occurrence of a force majeure event, each Party shall use commercially reasonable efforts to mitigate the adverse consequence thereof.

 

15.13      Counterparts; Facsimiles .   This Agreement may be executed in two (2) or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument.  For purposes hereof, a facsimile copy of this Agreement, including the signature pages hereto will be deemed to be an original.  Notwithstanding the foregoing, the Parties shall deliver original execution copies of this Agreement to one another as soon as practicable following execution thereof.

 

[Signature page follows]

 

37



 

In witness whereof , the Parties have caused this Agreement to be executed by their respective duly authorized representatives as set forth below.

 

Genentech, Inc.

Array BioPharma Inc .

 

 

 

 

By:

 

 

By:

 

 

 

 

 

 

 

 

Name:

 

 

Name:

 

 

 

 

 

 

 

 

Title:

 

 

Title:

 

 

 

[ * ] = 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.

 

38



 

EXHIBIT A

 

MATERIALS, DATA AND INFORMATION THAT WILL BE TRANSFERRED TO GENENTECH

 

1.                                        [ * ].

 

2.                                        [ * ].

 

3.                                        [ * ].

 

4.                                        [ * ].

 

5.                                        [ * ].

 

6.                                        [ * ].

 

7.                                        [ * ].

 

A – 1



 

EXHIBIT B

 

MATERIALS, DATA AND INFORMATION THAT WILL NOT BE TRANSFERRED TO GENENTECH

 

1.                                        [ * ].

 

2.                                        [ * ].

 

B – 1



 

EXHIBIT C

 

[ * ]

 

For [ * ] :

 

                [ * ]

 

For [ * ] :

 

                [ * ]

 

 

C – 1


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 officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) 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

 

c) 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 officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of 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 2, 2004

/s/ Robert E. Conway

 

 

 

 

Robert E. Conway

 

Chief Executive Officer

 


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 officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) 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

 

c) 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 officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of 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 2, 2004

/s/ R. Michael Carruthers

 

 

 

 

R. Michael Carruthers

 

Chief Financial Officer

 


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, 2003, 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 2 nd day of February 2004.

 

 

/s/ Robert E. Conway

 

 

 

 

Robert E. Conway

 

Chief Executive Officer

 

 

 

/s/ R. Michael Carruthers

 

 

 

 

R. Michael Carruthers

 

Chief Financial Officer