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
|
|
(I.R.S. Employer Identification No.) |
|
|
|
3200 Walnut Street, Boulder, CO |
|
80301 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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|
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(303) 381-6600 |
||
(Registrants 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
2
Item 1 . Financial Statements
ARRAY BIOPHARMA INC.
CONDENSED BALANCE SHEETS
|
|
December 31,
|
|
June 30,
|
|
||
|
|
(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)
See notes to condensed financial statements
4
ARRAY BIOPHARMA INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
Six Months Ended
|
|
||||
|
|
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
|
|
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,
|
|
June 30,
|
|
||
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
|
|
Six Months Ended
|
|
||||||||
|
|
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 Companys common stock in May 1998. All notes receivable for common stock have been fully repaid by the Companys 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
|
|
Six Months Ended
|
|
||||||||
|
|
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
|
|
539,133 |
|
575,565 |
|
1,078,262 |
|
1,151,130 |
|
||||
|
|
|
|
|
|
|
|
|
|
||||
Less:
Total stock-based employee
|
|
(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 Companys obligations under its facilities leases.
8
Item 2 . Managements Discussion and Analysis of Financial Condition and Results of Operations
The Managements 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.
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 Arrays 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.
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
Three and Six Months Ended December 31, 2003 and 2002
|
|
Three Months Ended
|
|
Six Months Ended
|
|
||||||||
|
|
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
|
|
Six Months Ended
|
|
||||||||
|
|
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.
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
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.
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 Managements 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.
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.
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
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, Arrays 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.
The annual meeting of the Companys stockholders was held on October 30, 2003. At that meeting, two proposals were submitted to a vote of the Companys 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 Companys independent auditors for the fiscal year ending June 30, 2004. For further information regarding the annual meeting, please see the Companys 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
|
|
25,360,383 |
|
47,860 |
|
7,222 |
|
17
(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
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:
The following terms shall have the following meanings as used in this Agreement:
2
3
4
5
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.
7
8
(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.
9
10
11
12
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.
13
14
15
BANK ACCOUNT |
||
Bank Name: |
|
[ * ] |
Account Name: |
|
[ * ] |
Account No: |
|
[ * ] |
SWIFT code: |
|
[ * ] |
Corr Bank: |
|
[ * ] |
16
17
18
19
20
BANK ACCOUNT |
||
Bank Name: |
|
[ * ] |
Bank Address: |
|
[ * ] |
Account Name: |
|
[ * ] |
Account No: |
|
[ * ] |
ABA code: |
|
[ * ] |
SWIFT code: |
|
[ * ] |
MILESTONE |
|
CASH PAYMENT |
||
|
|
(in U.S. dollars) |
||
1. |
|
[ * ] |
|
[ * ] |
2. |
|
[ * ] |
|
[ * ] |
21
MILESTONE |
|
CASH
PAYMENT
|
|
|
|
|
|
1a. |
[ * ] |
|
[ * ] |
|
|
|
|
1b. |
[ * ] |
|
[ * ] |
|
|
|
|
2. |
[ * ] |
|
[ * ] |
|
|
|
|
3. |
[ * ] |
|
[ * ] |
|
|
|
|
4. |
[ * ] |
|
[ * ] |
|
|
|
|
5. |
[ * ] |
|
[ * ] |
|
|
|
|
6. |
[ * ] |
|
[ * ] |
|
|
|
|
7. |
[ * ] |
|
[ * ] |
|
|
|
|
8. |
[ * ] |
|
[ * ] |
|
|
|
|
9. |
[ * ] |
|
[ * ] |
|
|
|
|
10. |
[ * ] |
|
[ * ] |
22
23
Total Annual Net Sales |
|
Royalty |
|
Less than [ * ] |
|
[ * ] |
% |
Between [ * ] and [ * ] |
|
[ * ] |
% |
Greater than [ * ] |
|
[ * ] |
% |
Total Annual Net Sales |
|
Royalty |
|
Less than [ * ] |
|
[ * ] |
% |
Between [ * ] and [ * ] |
|
[ * ] |
% |
Greater than [ * ] |
|
[ * ] |
% |
Total Annual Net Sales |
|
Royalty |
|
Less than [ * ] |
|
[ * ] |
% |
Between [ * ] and [ * ] |
|
[ * ] |
% |
Greater than [ * ] |
|
[ * ] |
% |
24
Total Annual Net Sales |
|
Royalty |
|
Less than [ * ] |
|
[ * ] |
% |
Between [ * ] and [ * ] |
|
[ * ] |
% |
Greater than [ * ] |
|
[ * ] |
% |
Total Annual Net Sales |
|
Royalty |
|
Less than [ * ] |
|
[ * ] |
% |
Between [ * ] and [ * ] |
|
[ * ] |
% |
Greater than [ * ] |
|
[ * ] |
% |
Total Annual Net Sales |
|
Royalty |
|
Less than [ * ] |
|
[ * ] |
% |
Between [ * ] and [ * ] |
|
[ * ] |
% |
Greater than [ * ] |
|
[ * ] |
|
25
26
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.
27
28
29
30
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 AZs 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 AZs 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, Arrays obligations under this Section shall be limited to those Array Patents containing a Valid Claim.
31
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.
32
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.
33
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 AZs 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 AZs notice.
34
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.
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
35
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.
36
37
38
39
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.
40
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.
41
42
43
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.
44
45
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.
46
47
48
49
50
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 |
|
51
|
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 |
|
|
|
|
|
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|
With a copy to: |
|
Assistant General Counsel |
|
|
|
|
AstraZeneca UK Limited |
|
|
|
|
Alderley House |
|
|
|
|
Alderley Park |
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|
|
|
Macclesfield SK10 4TF |
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England |
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Telephone: (44) 1625 512379 |
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Fax: (44) 1625 585618 |
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52
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.
53
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. |
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AstraZeneca AB |
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Robert E. Conway |
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Chief Executive Officer |
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[ * ] = 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
|
|
TITLE/INVENTORS |
[ * ] |
|
N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
|
[ * ] |
|
N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
|
[ * ] |
|
Heterocyclic Inhibitors
of MEK and Methods of Use Thereof
|
[ * ] |
|
N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
|
[ * ] |
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N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
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[ * ] |
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MEK Inhibitors
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PCT
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N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
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PCT
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N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
|
[ * ] |
|
N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
|
[ * ] |
|
N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
|
[ * ] |
|
N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
|
[ * ] |
|
N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
|
[ * ] |
|
N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
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[ * ] |
|
N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
|
[ * ] |
|
N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
|
[ * ] |
|
N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
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55
APPLICATION OR
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TITLE/INVENTORS |
[ * ] |
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N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
|
[ * ] |
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N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
|
[ * ] |
|
N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
|
[ * ] |
|
N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
|
[ * ] |
|
N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
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[ * ] |
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N3 Alkylated
Bendimidazole Derivatives as MEK Inhibitors
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56
EXHIBIT 1.12
Candidate Drug Target Profile (CDTP) Criteria
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CDTP Criteria |
Enzyme IC 50 |
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[ * ] |
Cell IC 50 [ * ] |
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[ * ] |
Cell IC 50 [ * ] |
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[ * ] |
Selectivity |
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[ * ] |
MW |
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[ * ] |
Log D |
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[ * ] |
Solubility |
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[ * ] |
IP Position |
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[ * ] |
Synthetic Route |
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[ * ] |
Bioavailability |
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[ * ] |
[ * ] |
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[ * ] |
[ * ] |
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[ * ] |
[ * ] |
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[ * ] |
[ * ] |
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[ * ] |
In Vivo CL |
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[ * ] |
Hepatocyte Cl int |
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[ * ] |
P450 inhibition |
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[ * ] |
Pharmacology |
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[ * ] |
Efficacy |
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[ * ] |
Adverse Effects |
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[ * ] |
Biopharmaceutics |
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[ * ] |
Safety |
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[ * ] |
57
EXHIBIT 2.3
Initial Research Plan
[ * ]
Discipline |
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FTEs |
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Location |
Chemistry |
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[ * ] |
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[ * ] |
Biology In vitro enzyme/cell/selectivity In vivo PK-PD |
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[ * ] |
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[ * ] |
Crystallography/molecular modelling |
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[ * ] |
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[ * ] |
Protein Supply |
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[ * ] |
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[ * ] |
PAR&D |
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[ * ] |
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[ * ] |
Solubility/Absorption and Drug Metabolism in vitro |
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[ * ] |
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[ * ] |
Xenograft studies |
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[ * ] |
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[ * ] |
Process Chemistry |
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[ * ] |
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[ * ] |
Toxicology |
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[ * ] |
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[ * ] |
Total |
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[ * ] |
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[ * ] FTEs 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. FTEs 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 |
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Criteria |
[ * ] Go/No Go Decision |
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No Go: |
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[ * ] ; and/or |
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[ * ] ; and/or |
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[ * ] |
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[ * ] Go/No Go Decision |
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No Go: |
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[ * ]; |
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[ * ] |
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[ * ] |
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[ * ] |
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[ * ] |
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[ * ] Go/No Go Decision |
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Evidence of [ * ] must be demonstrated by either: |
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[ * ]; or |
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[ * ]** |
*
[ * ]
**[ * ]
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 |
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Who |
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Suggested Timelines |
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[ * ] |
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AZ/Array |
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[ * ] |
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[ * ] |
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AZ/Array |
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[ * ] |
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[ * ] |
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AZ [ * ] |
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[ * ] |
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[ * ] |
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Array |
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[ * ] |
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[ * ] |
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Array/AZ |
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[ * ] |
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[ * ] |
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AZ/Array |
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[ * ] |
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[ * ] |
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AZ or Array (TBC)* |
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[ * ] |
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[ * ] Development |
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AZ |
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[ * ] |
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[ * ] |
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AZ |
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[ * ] |
*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.
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Exhibits
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Materials, Data and Information that Will be Transferred to Genentech |
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Materials, Data and Information that Will NOT be Transferred to Genentech |
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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
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 Arrays 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 Arrays 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 Arrays intellectual property rights in the Array Contributed Technology, the Array Collaboration Technology and Arrays 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 Partys 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 Partys 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 Partys 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, Genentechs 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 Genentechs 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 Genentechs intellectual property rights in the Genentech Contributed Technology, the Genentech Collaboration Technology and Genentechs 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.
5
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:
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
7
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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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 Partys 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 Genentechs responsibility, in accordance with the terms and conditions of this Agreement.
2.3 Responsibilities Under the Research Plan.
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 Arrays 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 Genentechs 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 Arrays 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.
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 bachelors degree or higher in a relevant scientific discipline, devoted exclusively to performing activities under the Research Plan for such Collaboration Target. At Genentechs 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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3.1 Genentech Responsibilities.
3.2 [ * ]. If Genentech decides to use a Third Party to (a) [ * ]; and/or (b) [ * ], Genentech shall notify Array in writing of Genentechs 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 Genentechs 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 [ * ].
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 Genentechs 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.
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 Partys IP Rights are expressly reserved to the granting Party. Without limiting the foregoing, it is understood that where a license under a Partys 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 Partys behalf ( e.g. , on Genentechs 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.
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 . [ * ] .
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(2) |
[ * ] |
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(3) |
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[ * ] |
(4) |
[ * ] |
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[ * ] |
(5) |
[ * ] |
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[ * ] |
(6) |
[ * ] |
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[ * ] |
(7) |
[ * ] |
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(8) |
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[ * ] |
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.
7.4 Royalty Offsets.
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7.5 Payments, Reports and Audits. The following terms and conditions shall apply to Royalty Payments under this Agreement:
8.1 Materials.
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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.
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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 Genentechs request and expense, Array shall cooperate reasonably with Genentech in connection with any such defense.
8.9 Infringement by Third Parties.
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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 Partys Confidential Information in confidence; and (b) to only use such Disclosing Partys 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 Partys Confidential Information to the extent that the Receiving Party establishes by written evidence that such Confidential Information:
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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 Arrays 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 Genentechs 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 Arrays 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.
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.
10.4 Insolvency or Bankruptcy.
10.5 Effects of Termination; Survival.
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11.1 Mutual Representations and Warranties . Each of the Parties hereby represents, warrants and covenants as follows:
11.2 Array Representations and Warranties . Array hereby further represents, warrants and covenants to Genentech that:
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.
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.
12.3 Indemnification by Array.
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13.1 Coverages.
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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 Partys 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
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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.
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 Partys 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
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any Third Party without the other Partys 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 Partys 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
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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
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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]
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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 . |
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[ * ] = 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.
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MATERIALS, DATA AND INFORMATION THAT WILL BE TRANSFERRED TO GENENTECH
1. [ * ].
2. [ * ].
3. [ * ].
4. [ * ].
5. [ * ].
6. [ * ].
7. [ * ].
A 1
MATERIALS, DATA AND INFORMATION THAT WILL NOT BE TRANSFERRED TO GENENTECH
1. [ * ].
2. [ * ].
B 1
[ * ]
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 registrants 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 registrants 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 registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of registrants 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 registrants 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 registrants internal control over financial reporting.
Date: February 2, 2004 |
/s/ Robert E. Conway |
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Robert E. Conway |
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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 registrants 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 registrants 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 registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of registrants 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 registrants 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 registrants internal control over financial reporting.
Date: February 2, 2004 |
/s/ R. Michael Carruthers |
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R. Michael Carruthers |
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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.
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/s/ Robert E. Conway |
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Robert E. Conway |
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Chief Executive Officer |
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/s/ R. Michael Carruthers |
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R. Michael Carruthers |
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Chief Financial Officer |
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