Delaware
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84-1460811
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(State or Other Jurisdiction of Incorporation or Organization)
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(I.R.S. Employer Identification No.)
|
|
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3200 Walnut Street, Boulder, CO
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80301
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(Address of Principal Executive Offices)
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(Zip Code)
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|
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(303) 381-6600
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(Registrant’s Telephone Number, Including Area Code)
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Large Accelerated Filer
¨
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Accelerated Filer
x
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Non-Accelerated Filer
¨
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Smaller Reporting Company
¨
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(do not check if smaller reporting company)
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|
|
|
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Page No.
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PART I
|
|
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Item 1.
|
|
|
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Balance Sheets as of
March 31, 2015 and June 30, 2014
|
|
|
Statements of Operations and Comprehensive Income (Loss) for the three
and nine months ended March 31, 2015 and 2014
|
|
|
Statement of Stockholders' Equity for the
nine months ended March 31, 2015
|
|
|
Statements of Cash Flows for the
nine months ended March 31, 2015 and 2014
|
|
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||
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Item 2.
|
||
Item 3.
|
||
Item 4.
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||
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PART II
|
|
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Item 1A.
|
||
Item 6.
|
||
|
|
|
|
|
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||
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|
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March 31,
|
|
June 30,
|
||||
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2015
|
|
2014
|
||||
Assets
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
141,470
|
|
|
$
|
68,591
|
|
Marketable securities
|
48,600
|
|
|
42,407
|
|
||
Accounts receivable
|
2,116
|
|
|
5,429
|
|
||
Prepaid expenses and other current assets
|
4,409
|
|
|
5,249
|
|
||
Total current assets
|
196,595
|
|
|
121,676
|
|
||
|
|
|
|
||||
Long-term assets
|
|
|
|
||||
Marketable securities
|
546
|
|
|
640
|
|
||
Property and equipment, net
|
7,455
|
|
|
8,157
|
|
||
Other long-term assets
|
3,849
|
|
|
8,580
|
|
||
Total long-term assets
|
11,850
|
|
|
17,377
|
|
||
Total assets
|
$
|
208,445
|
|
|
$
|
139,053
|
|
|
|
|
|
||||
Liabilities and Stockholders' Equity (Deficit)
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable
|
$
|
7,616
|
|
|
$
|
6,953
|
|
Accrued outsourcing costs
|
14,936
|
|
|
10,040
|
|
||
Accrued compensation and benefits
|
6,677
|
|
|
8,209
|
|
||
Other accrued expenses
|
2,034
|
|
|
1,444
|
|
||
Co-development liability
|
—
|
|
|
16,155
|
|
||
Deferred rent
|
3,856
|
|
|
3,739
|
|
||
Deferred revenue
|
9,798
|
|
|
6,193
|
|
||
Total current liabilities
|
44,917
|
|
|
52,733
|
|
||
|
|
|
|
||||
Long-term liabilities
|
|
|
|
||||
Deferred rent
|
1,184
|
|
|
4,096
|
|
||
Deferred revenue
|
3,662
|
|
|
3,353
|
|
||
Long-term debt, net
|
107,985
|
|
|
103,952
|
|
||
Other long-term liabilities
|
546
|
|
|
640
|
|
||
Total long-term liabilities
|
113,377
|
|
|
112,041
|
|
||
Total liabilities
|
158,294
|
|
|
164,774
|
|
||
|
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|
||||
Commitments and contingencies
|
|
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|
||||
|
|
|
|
||||
Stockholders' equity (deficit)
|
|
|
|
||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued and outstanding
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 220,000,000 shares authorized; 140,427,434 and 131,817,422 shares issued and outstanding as of March 31, 2015 and June 30, 2014, respectively
|
140
|
|
|
132
|
|
||
Additional paid-in capital
|
696,661
|
|
|
652,696
|
|
||
Warrants
|
39,385
|
|
|
39,385
|
|
||
Accumulated other comprehensive income
|
9,798
|
|
|
2
|
|
||
Accumulated deficit
|
(695,833
|
)
|
|
(717,936
|
)
|
||
Total stockholders' equity (deficit)
|
50,151
|
|
|
(25,721
|
)
|
||
Total liabilities and stockholders' equity (deficit)
|
$
|
208,445
|
|
|
$
|
139,053
|
|
|
|
|
|
||||
The accompanying notes are an integral part of these unaudited financial statements.
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
March 31,
|
|
March 31,
|
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Revenue
|
|
|
|
|
|
|
|
||||||||
License and milestone revenue
|
$
|
99
|
|
|
$
|
4,287
|
|
|
$
|
20,367
|
|
|
$
|
23,639
|
|
Collaboration and other revenue
|
6,502
|
|
|
3,486
|
|
|
19,222
|
|
|
12,428
|
|
||||
Total revenue
|
6,601
|
|
|
7,773
|
|
|
39,589
|
|
|
36,067
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Operating expenses
|
|
|
|
|
|
|
|
||||||||
Cost of partnered programs
|
12,140
|
|
|
10,756
|
|
|
37,415
|
|
|
34,524
|
|
||||
Research and development for proprietary programs
|
11,817
|
|
|
14,131
|
|
|
35,824
|
|
|
35,322
|
|
||||
General and administrative
|
8,187
|
|
|
5,405
|
|
|
23,064
|
|
|
16,056
|
|
||||
Total operating expenses
|
32,144
|
|
|
30,292
|
|
|
96,303
|
|
|
85,902
|
|
||||
Net gain on the Binimetinib and Encorafenib Agreements
|
80,010
|
|
|
—
|
|
|
80,010
|
|
|
—
|
|
||||
Income (loss) from operations
|
54,467
|
|
|
(22,519
|
)
|
|
23,296
|
|
|
(49,835
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Other income (expense)
|
|
|
|
|
|
|
|
||||||||
Realized gain from marketable securities, net
|
6,402
|
|
|
—
|
|
|
6,402
|
|
|
—
|
|
||||
Interest income
|
15
|
|
|
22
|
|
|
36
|
|
|
61
|
|
||||
Interest expense
|
(2,577
|
)
|
|
(2,435
|
)
|
|
(7,631
|
)
|
|
(7,246
|
)
|
||||
Total other income (expense), net
|
3,840
|
|
|
(2,413
|
)
|
|
(1,193
|
)
|
|
(7,185
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Net income (loss)
|
$
|
58,307
|
|
|
$
|
(24,932
|
)
|
|
$
|
22,103
|
|
|
$
|
(57,020
|
)
|
|
|
|
|
|
|
|
|
||||||||
Change in unrealized gains (losses) on marketable securities
|
(3,665
|
)
|
|
7
|
|
|
9,796
|
|
|
9
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Comprehensive income (loss)
|
$
|
54,642
|
|
|
$
|
(24,925
|
)
|
|
$
|
31,899
|
|
|
$
|
(57,011
|
)
|
|
|
|
|
|
|
|
|
||||||||
Net earnings (loss) per share – basic
|
$
|
0.42
|
|
|
$
|
(0.20
|
)
|
|
$
|
0.16
|
|
|
$
|
(0.47
|
)
|
Net earnings (loss) per share – diluted
|
$
|
0.37
|
|
|
$
|
(0.20
|
)
|
|
$
|
0.16
|
|
|
$
|
(0.47
|
)
|
|
|
|
|
|
|
|
|
||||||||
Weighted average shares outstanding – basic
|
139,769
|
|
|
125,471
|
|
|
135,113
|
|
|
122,277
|
|
||||
Weighted average shares outstanding – diluted
|
166,265
|
|
|
125,471
|
|
|
138,573
|
|
|
122,277
|
|
||||
|
|
|
|
|
|
|
|
||||||||
The accompanying notes are an integral part of these unaudited financial statements.
|
|
|
|
|
|
Additional Paid-in Capital
|
|
Warrants
|
|
Accumulated Other Comprehensive Income
|
|
Accumulated Deficit
|
|
Total
|
|||||||||||||
|
Common Stock
|
|
|
|
|
|
||||||||||||||||||||
|
Shares
|
|
Amounts
|
|
|
|
|
|
||||||||||||||||||
Balance as of June 30, 2014
|
131,817
|
|
|
$
|
132
|
|
|
$
|
652,696
|
|
|
$
|
39,385
|
|
|
$
|
2
|
|
|
$
|
(717,936
|
)
|
|
$
|
(25,721
|
)
|
Shares issued under employee share plans, net
|
1,149
|
|
|
1
|
|
|
3,516
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,517
|
|
||||||
Share-based compensation expense
|
—
|
|
|
—
|
|
|
5,126
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,126
|
|
||||||
Issuance of common stock, net of offering costs
|
7,461
|
|
|
7
|
|
|
35,323
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
35,330
|
|
||||||
Change in unrealized gain on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9,796
|
|
|
—
|
|
|
9,796
|
|
||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
22,103
|
|
|
22,103
|
|
||||||
Balance as of March 31, 2015
|
140,427
|
|
|
$
|
140
|
|
|
$
|
696,661
|
|
|
$
|
39,385
|
|
|
$
|
9,798
|
|
|
$
|
(695,833
|
)
|
|
$
|
50,151
|
|
|
||||||||||||||||||||||||||
The accompanying notes are an integral part of these unaudited financial statements.
|
|
Nine Months Ended March 31,
|
||||||
|
2015
|
|
2014
|
||||
Cash flows from operating activities
|
|
|
|
||||
Net income (loss)
|
$
|
22,103
|
|
|
$
|
(57,020
|
)
|
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
|
|
|
|
||||
Depreciation and amortization expense
|
2,776
|
|
|
3,576
|
|
||
Non-cash interest expense
|
4,295
|
|
|
3,899
|
|
||
Share-based compensation expense
|
5,126
|
|
|
3,080
|
|
||
Extinguishment of co-development liability, net
|
(21,610
|
)
|
|
—
|
|
||
Realized gain from marketable securities, net
|
(6,402
|
)
|
|
—
|
|
||
Non-cash license revenue
|
—
|
|
|
(4,500
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
(3,401
|
)
|
|
5,162
|
|
||
Prepaid expenses and other assets
|
809
|
|
|
(449
|
)
|
||
Accounts payable and other accrued expenses
|
1,253
|
|
|
2,659
|
|
||
Accrued outsourcing costs
|
4,896
|
|
|
2,460
|
|
||
Accrued compensation and benefits
|
(1,532
|
)
|
|
(2,260
|
)
|
||
Co-development liability
|
12,169
|
|
|
977
|
|
||
Deferred rent
|
(2,795
|
)
|
|
(2,731
|
)
|
||
Deferred revenue
|
3,914
|
|
|
(4,291
|
)
|
||
Other long-term liabilities
|
(129
|
)
|
|
(6
|
)
|
||
Net cash provided by (used in) operating activities
|
21,472
|
|
|
(49,444
|
)
|
||
|
|
|
|
||||
Cash flows from investing activities
|
|
|
|
||||
Purchases of property and equipment
|
(2,074
|
)
|
|
(1,365
|
)
|
||
Purchases of marketable securities
|
(94,420
|
)
|
|
(80,457
|
)
|
||
Proceeds from sales and maturities of marketable securities
|
109,054
|
|
|
70,262
|
|
||
Net cash provided by (used) in investing activities
|
12,560
|
|
|
(11,560
|
)
|
||
|
|
|
|
||||
Cash flows from financing activities
|
|
|
|
||||
Proceeds from the issuance of common stock
|
36,057
|
|
|
50,155
|
|
||
Proceeds from employee stock purchases and options exercised
|
3,517
|
|
|
3,417
|
|
||
Payment of debt issuance costs
|
—
|
|
|
(86
|
)
|
||
Payment of stock offering costs
|
(727
|
)
|
|
(1,040
|
)
|
||
Net cash provided by financing activities
|
38,847
|
|
|
52,446
|
|
||
|
|
|
|
||||
Net increase (decrease) in cash and cash equivalents
|
72,879
|
|
|
(8,558
|
)
|
||
Cash and cash equivalents at beginning of period
|
68,591
|
|
|
60,736
|
|
||
Cash and cash equivalents at end of period
|
$
|
141,470
|
|
|
$
|
52,178
|
|
|
|
|
|
||||
Supplemental disclosure of cash flow information
|
|
|
|
||||
Cash paid for interest
|
$
|
2,342
|
|
|
$
|
2,246
|
|
Unrealized gain on marketable securities available-for-sale
|
$
|
9,796
|
|
|
$
|
9
|
|
•
|
Level 1: Observable inputs such as unadjusted quoted prices in active markets for identical instruments.
|
•
|
Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the marketplace.
|
•
|
Level 3: Significant unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||
|
March 31,
|
|
March 31,
|
||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||
|
|
|
|
|
|
|
|
||||
Oncothyreon Inc.
|
4.1
|
%
|
|
10.8
|
%
|
|
55.2
|
%
|
|
7.4
|
%
|
Loxo Oncology, Inc.
|
31.9
|
|
|
16.4
|
|
|
16.2
|
|
|
22.2
|
|
Biogen Idec
|
17.5
|
|
|
—
|
|
|
8.8
|
|
|
—
|
|
Celgene
|
10.9
|
|
|
12.6
|
|
|
8.6
|
|
|
7.7
|
|
Novartis
|
24.8
|
|
|
48.2
|
|
|
4.1
|
|
|
31.2
|
|
AstraZeneca, PLC
|
0.4
|
|
|
0.2
|
|
|
0.2
|
|
|
14.1
|
|
|
89.6
|
%
|
|
88.2
|
%
|
|
93.1
|
%
|
|
82.6
|
%
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
March 31,
|
|
March 31,
|
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
|
|
|
|
|
|
|
|
||||||||
North America
|
$
|
4,937
|
|
|
$
|
4,007
|
|
|
$
|
37,810
|
|
|
$
|
19,713
|
|
Europe
|
1,664
|
|
|
3,765
|
|
|
1,710
|
|
|
16,318
|
|
||||
Asia Pacific
|
—
|
|
|
1
|
|
|
69
|
|
|
36
|
|
||||
Total revenue
|
$
|
6,601
|
|
|
$
|
7,773
|
|
|
$
|
39,589
|
|
|
$
|
36,067
|
|
|
March 31, 2015
|
||||||||||||||
|
|
|
Gross
|
|
Gross
|
|
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Short-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
U.S. treasury securities
|
$
|
35,604
|
|
|
$
|
2
|
|
|
$
|
(2
|
)
|
|
$
|
35,604
|
|
Equity securities
|
2,837
|
|
|
9,798
|
|
|
—
|
|
|
12,635
|
|
||||
Mutual fund securities
|
361
|
|
|
—
|
|
|
—
|
|
|
361
|
|
||||
|
38,802
|
|
|
9,800
|
|
|
(2
|
)
|
|
48,600
|
|
||||
Long-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
Mutual fund securities
|
546
|
|
|
—
|
|
|
—
|
|
|
546
|
|
||||
|
546
|
|
|
—
|
|
|
—
|
|
|
546
|
|
||||
Total
|
$
|
39,348
|
|
|
$
|
9,800
|
|
|
$
|
(2
|
)
|
|
$
|
49,146
|
|
|
June 30, 2014
|
||||||||||||||
|
|
|
Gross
|
|
Gross
|
|
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Short-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
U.S. treasury securities
|
$
|
42,184
|
|
|
$
|
2
|
|
|
$
|
(1
|
)
|
|
$
|
42,185
|
|
Mutual fund securities
|
222
|
|
|
—
|
|
|
—
|
|
|
222
|
|
||||
|
42,406
|
|
|
2
|
|
|
(1
|
)
|
|
42,407
|
|
||||
Long-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
Mutual fund securities
|
640
|
|
|
—
|
|
|
—
|
|
|
640
|
|
||||
|
640
|
|
|
—
|
|
|
—
|
|
|
640
|
|
||||
Total
|
$
|
43,046
|
|
|
$
|
2
|
|
|
$
|
(1
|
)
|
|
$
|
43,047
|
|
|
March 31,
|
|
June 30,
|
||||
|
2015
|
|
2014
|
||||
|
|
|
|
||||
Quoted prices in active markets for identical assets (Level 1)
|
$
|
49,146
|
|
|
$
|
43,047
|
|
Quoted prices for similar assets observable in the marketplace (Level 2)
|
—
|
|
|
—
|
|
||
Significant unobservable inputs (Level 3)
|
—
|
|
|
—
|
|
||
Total
|
$
|
49,146
|
|
|
$
|
43,047
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||
|
March 31, 2015
|
|
March 31, 2015
|
||||
Balance, beginning of period
|
$
|
17,967
|
|
|
$
|
—
|
|
Transfer into Level 3 due to restriction period on trading
|
—
|
|
|
4,500
|
|
||
Change in unrealized gains and losses included in comprehensive income (loss)
|
(262
|
)
|
|
13,205
|
|
||
Transfer out of Level 3 due to elimination of trading restrictions
|
(17,705
|
)
|
|
(17,705
|
)
|
||
Balance, end of period
|
$
|
—
|
|
|
$
|
—
|
|
|
Amortized
|
|
Fair
|
||||
|
Cost
|
|
Value
|
||||
|
|
|
|
||||
Due in one year or less
|
$
|
35,604
|
|
|
$
|
35,604
|
|
Total
|
$
|
35,604
|
|
|
$
|
35,604
|
|
•
|
NEMO trial: Novartis Pharma will conduct and solely fund the Phase 3 NEMO trial through June 30, 2016. For all NEMO activities required following that date, we are responsible for conducting the trial and Novartis Pharma will provide the financial support to us described above.
|
•
|
MILO trial: We will continue conduct and complete the Phase 3 MILO trial and Novartis Pharma will provide financial support to us as described above.
|
•
|
Novartis Pharma will conduct and fund, and transfer at designated times all other Novartis sponsored trials, including a series of planned clinical pharmacology and pediatric trials, through December 31, 2015. For all activities required following that date, we will be responsible for conducting those trials and Novartis Pharma would provide financial support to us as described above.
|
•
|
On the Effective Date, Novartis Pharma will transfer at designated times, and we will oversee the conduct and completion of, all ongoing and planned investigator sponsored clinical trials. Novartis Pharma will provide financial support to us as described above.
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
March 31,
|
|
March 31,
|
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
|
|
|
|
|
|
|
|
||||||||
Oncothyreon Inc. (1)
|
$
|
273
|
|
|
$
|
839
|
|
|
$
|
21,840
|
|
|
$
|
2,698
|
|
Loxo Oncology, Inc.
|
2,105
|
|
|
1,275
|
|
|
6,408
|
|
|
8,000
|
|
||||
Biogen Idec
|
1,153
|
|
|
—
|
|
|
3,468
|
|
|
—
|
|
||||
Celgene
|
721
|
|
|
976
|
|
|
3,411
|
|
|
2,766
|
|
||||
Novartis (2)
|
1,640
|
|
|
3,750
|
|
|
1,640
|
|
|
11,250
|
|
||||
Genentech, Inc.
|
99
|
|
|
537
|
|
|
367
|
|
|
2,764
|
|
||||
AstraZeneca, PLC
|
24
|
|
|
15
|
|
|
70
|
|
|
5,073
|
|
||||
Other partners
|
586
|
|
|
381
|
|
|
2,385
|
|
|
3,516
|
|
||||
Total revenue
|
$
|
6,601
|
|
|
$
|
7,773
|
|
|
$
|
39,589
|
|
|
$
|
36,067
|
|
|
March 31,
|
|
June 30,
|
||||
|
2015
|
|
2014
|
||||
|
|
|
|
||||
Comerica term loan
|
$
|
14,550
|
|
|
$
|
14,550
|
|
Convertible senior notes
|
132,250
|
|
|
132,250
|
|
||
Long-term debt, gross
|
146,800
|
|
|
146,800
|
|
||
Less: Unamortized debt discount
|
(38,815
|
)
|
|
(42,848
|
)
|
||
Long-term debt, net
|
$
|
107,985
|
|
|
$
|
103,952
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
March 31,
|
|
March 31,
|
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Comerica Term Loan
|
|
|
|
|
|
|
|
||||||||
Simple interest
|
$
|
117
|
|
|
$
|
118
|
|
|
$
|
360
|
|
|
$
|
360
|
|
Amortization of fees paid for letters of credit
|
11
|
|
|
9
|
|
|
34
|
|
|
38
|
|
||||
Total interest expense on the Comerica term loan
|
128
|
|
|
127
|
|
|
394
|
|
|
398
|
|
||||
Convertible Senior Notes
|
|
|
|
|
|
|
|
||||||||
Contractual interest
|
992
|
|
|
992
|
|
|
2,976
|
|
|
2,987
|
|
||||
Amortization of debt discount
|
1,379
|
|
|
1,245
|
|
|
4,033
|
|
|
3,655
|
|
||||
Amortization of debt issuance costs
|
78
|
|
|
71
|
|
|
228
|
|
|
206
|
|
||||
Total interest expense on the convertible senior notes
|
2,449
|
|
|
2,308
|
|
|
7,237
|
|
|
6,848
|
|
||||
Total interest expense
|
$
|
2,577
|
|
|
$
|
2,435
|
|
|
$
|
7,631
|
|
|
$
|
7,246
|
|
|
Nine Months Ended
|
||||||
|
March 31,
|
||||||
|
2015
|
|
2014
|
||||
|
|
|
|
||||
Total shares of common stock sold
|
7,461
|
|
|
8,046
|
|
||
Average price per share
|
$
|
4.83
|
|
|
$
|
6.23
|
|
Gross proceeds
|
$
|
36,058
|
|
|
$
|
50,155
|
|
Commissions earned by Cantor
|
$
|
721
|
|
|
$
|
1,015
|
|
•
|
Risk-free interest rate - We determine the risk-free interest rate by using a weighted average assumption equivalent to the expected term based on the U.S. Treasury constant maturity rate.
|
•
|
Expected term - We estimate the expected term of our options based upon historical exercises and post-vesting termination behavior.
|
•
|
Expected volatility - We estimate expected volatility using daily historical trading data of our common stock.
|
•
|
Dividend yield - We have never paid dividends and currently have no plans to do so; therefore, no dividend yield is applied.
|
|
2015
|
|
|
|
|
Risk-free interest rate
|
1.6% - 2.0%
|
|
Expected option term in years
|
6.25
|
|
Expected volatility
|
63.2% - 67.1%
|
|
Dividend yield
|
0.0%
|
|
Weighted-average grant date fair value
|
$4.17
|
|
|
Number of
Options |
|
Weighted
Average Exercise Price |
|
Weighted Average Remaining Contractual Term (in years)
|
|
Aggregate Intrinsic Value (in thousands)
|
|||||
Outstanding at June 30, 2014
|
10,194,817
|
|
|
$
|
4.84
|
|
|
|
|
|
||
Granted
|
801,050
|
|
|
$
|
4.17
|
|
|
|
|
|
||
Exercised
|
(709,069
|
)
|
|
$
|
4.32
|
|
|
|
|
|
||
Forfeited
|
(1,231,244
|
)
|
|
$
|
4.85
|
|
|
|
|
|
||
Expired or canceled
|
(245,331
|
)
|
|
$
|
7.72
|
|
|
|
|
|
||
Outstanding balance at March 31, 2015
|
8,810,223
|
|
|
$
|
4.73
|
|
|
6.7
|
|
$
|
24,688
|
|
Vested and expected to vest at March 31, 2015
|
7,751,755
|
|
|
$
|
4.76
|
|
|
6.5
|
|
$
|
21,612
|
|
Exercisable at March 31, 2015
|
4,166,464
|
|
|
$
|
5.09
|
|
|
4.9
|
|
$
|
10,886
|
|
|
Number of RSUs
|
|
Weighted
Average Grant Date Fair Value |
|||
Non-vested at June 30, 2014
|
—
|
|
|
$
|
—
|
|
Granted
|
722,283
|
|
|
$
|
3.86
|
|
Vested
|
(261,030
|
)
|
|
$
|
3.97
|
|
Forfeited
|
(46,271
|
)
|
|
$
|
3.97
|
|
Non-vested at March 31, 2015
|
414,982
|
|
|
$
|
3.79
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
March 31,
|
|
March 31,
|
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
|
|
|
|
|
|
|
|
||||||||
Net earnings (loss) - basic
|
$
|
58,307
|
|
|
$
|
(24,932
|
)
|
|
$
|
22,103
|
|
|
$
|
(57,020
|
)
|
Interest on convertible senior notes
|
2,449
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Net earnings (loss) - diluted
|
$
|
60,756
|
|
|
$
|
(24,932
|
)
|
|
$
|
22,103
|
|
|
$
|
(57,020
|
)
|
|
|
|
|
|
|
|
|
||||||||
Weighted average shares outstanding - basic
|
139,769
|
|
|
125,471
|
|
|
135,113
|
|
|
122,277
|
|
||||
Convertible senior notes (1)
|
18,762
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Warrants
|
5,392
|
|
|
—
|
|
|
2,538
|
|
|
—
|
|
||||
Stock options
|
2,030
|
|
|
—
|
|
|
812
|
|
|
—
|
|
||||
RSUs
|
312
|
|
|
—
|
|
|
110
|
|
|
—
|
|
||||
Weighted average shares outstanding - diluted
|
166,265
|
|
|
125,471
|
|
|
138,573
|
|
|
122,277
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Per share data:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
0.42
|
|
|
$
|
(0.20
|
)
|
|
$
|
0.16
|
|
|
$
|
(0.47
|
)
|
Diluted
|
$
|
0.37
|
|
|
$
|
(0.20
|
)
|
|
$
|
0.16
|
|
|
$
|
(0.47
|
)
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||
|
March 31,
|
|
March 31,
|
||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||
Convertible senior notes
|
—
|
|
|
18,762
|
|
|
18,762
|
|
|
18,762
|
|
Warrants
|
—
|
|
|
12,000
|
|
|
—
|
|
|
12,000
|
|
Stock options
|
1,050
|
|
|
4,654
|
|
|
5,699
|
|
|
4,510
|
|
Total anti-dilutive common stock equivalents excluded from diluted earnings per share calculation
|
1,050
|
|
|
35,416
|
|
|
24,461
|
|
|
35,272
|
|
|
|
Proprietary Program
|
|
Indication
|
|
Clinical Status
|
1.
|
|
Binimetinib
|
|
MEK inhibitor for cancer
|
|
Phase 3
|
2.
|
|
Encorafenib
|
|
BRAF inhibitor for cancer
|
|
Phase 3
|
3.
|
|
Filanesib
|
|
Kinesin spindle protein, or KSP, inhibitor for multiple myeloma, or MM
|
|
Phase 2
|
4.
|
|
ARRY-797
|
|
p38 inhibitor for Lamin A/C-related dilated cardiomyopathy, or LMNA-DCM
|
|
Phase 2
|
|
|
Drug Candidate
|
|
Target/Indication
|
|
Partner
|
|
Clinical Status
|
1.
|
|
Selumetinib
|
|
MEK inhibitor for cancer
|
|
AstraZeneca, PLC
|
|
Phase 3
|
2.
|
|
ASLAN001/ARRY-543
|
|
HER2 / EGFR inhibitor for cancer
|
|
ASLAN Pharmaceuticals Pte Ltd.
|
|
Phase 2
|
3.
|
|
Ipatasertib/GDC-0068
|
|
AKT inhibitor for cancer
|
|
Genentech, Inc.
|
|
Phase 2
|
4.
|
|
Motolimod/VTX-2337
|
|
Toll-like receptor for cancer
|
|
VentiRx Pharmaceuticals, Inc.
|
|
Phase 2
|
5.
|
|
Danoprevir
|
|
Protease inhibitor for Hepatitis C virus
|
|
Roche Holding AG
|
|
Phase 2
|
6.
|
|
LY2606368
|
|
Chk-1 inhibitor for cancer
|
|
Eli Lilly and Company
|
|
Phase 2
|
7.
|
|
GDC-0575
|
|
Chk-1 inhibitor for cancer
|
|
Genentech, Inc.
|
|
Phase 1b
|
8.
|
|
ARRY-380/ONT-380
|
|
HER2 inhibitor for breast cancer
|
|
Oncothyreon Inc.
|
|
Phase 1b
|
9.
|
|
GDC-0994
|
|
ERK inhibitor for cancer
|
|
Genentech, Inc.
|
|
Phase 1
|
10.
|
|
LOXO-101
|
|
PanTrk inhibitor for cancer
|
|
Loxo Oncology, Inc.
|
|
Phase 1
|
|
Three Months Ended
|
|
Change
|
|
Nine Months Ended
|
|
Change
|
||||||||||||||||||||||
|
March 31,
|
|
2015 vs. 2014
|
|
March 31,
|
|
2015 vs. 2014
|
||||||||||||||||||||||
|
2015
|
|
2014
|
|
$
|
|
%
|
|
2015
|
|
2014
|
|
$
|
|
%
|
||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
License revenue
|
$
|
99
|
|
|
$
|
3,037
|
|
|
$
|
(2,938
|
)
|
|
(97
|
)%
|
|
$
|
20,367
|
|
|
$
|
13,764
|
|
|
$
|
6,603
|
|
|
48
|
%
|
Milestone revenue
|
—
|
|
|
1,250
|
|
|
(1,250
|
)
|
|
(100
|
)%
|
|
—
|
|
|
9,875
|
|
|
(9,875
|
)
|
|
(100
|
)%
|
||||||
Total license and milestone revenue
|
$
|
99
|
|
|
$
|
4,287
|
|
|
$
|
(4,188
|
)
|
|
(98
|
)%
|
|
$
|
20,367
|
|
|
$
|
23,639
|
|
|
$
|
(3,272
|
)
|
|
(14
|
)%
|
|
Three Months Ended
|
|
Change
|
|
Nine Months Ended
|
|
Change
|
||||||||||||||||||||||
|
March 31,
|
|
2015 vs. 2014
|
|
March 31,
|
|
2015 vs. 2014
|
||||||||||||||||||||||
|
2015
|
|
2014
|
|
$
|
|
%
|
|
2015
|
|
2014
|
|
$
|
|
%
|
||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Cost of partnered programs
|
$
|
12,140
|
|
|
$
|
10,756
|
|
|
$
|
1,384
|
|
|
13
|
%
|
|
$
|
37,415
|
|
|
$
|
34,524
|
|
|
$
|
2,891
|
|
|
8
|
%
|
|
Three Months Ended
|
|
Change
|
|
Nine Months Ended
|
|
Change
|
||||||||||||||||||||||
|
March 31,
|
|
2015 vs. 2014
|
|
March 31,
|
|
2015 vs. 2014
|
||||||||||||||||||||||
|
2015
|
|
2014
|
|
$
|
|
%
|
|
2015
|
|
2014
|
|
$
|
|
%
|
||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Salaries, benefits and share-based compensation
|
$
|
3,234
|
|
|
$
|
5,195
|
|
|
$
|
(1,961
|
)
|
|
(38
|
)%
|
|
$
|
9,994
|
|
|
$
|
14,495
|
|
|
$
|
(4,501
|
)
|
|
(31
|
)%
|
Outsourced services and consulting
|
6,010
|
|
|
5,484
|
|
|
526
|
|
|
10
|
%
|
|
17,942
|
|
|
10,880
|
|
|
7,062
|
|
|
65
|
%
|
||||||
Laboratory supplies
|
1,003
|
|
|
1,310
|
|
|
(307
|
)
|
|
(23
|
)%
|
|
3,147
|
|
|
4,198
|
|
|
(1,051
|
)
|
|
(25
|
)%
|
||||||
Facilities and depreciation
|
1,273
|
|
|
1,736
|
|
|
(463
|
)
|
|
(27
|
)%
|
|
3,704
|
|
|
4,716
|
|
|
(1,012
|
)
|
|
(21
|
)%
|
||||||
Other
|
297
|
|
|
406
|
|
|
(109
|
)
|
|
(27
|
)%
|
|
1,037
|
|
|
1,033
|
|
|
4
|
|
|
—
|
%
|
||||||
Total research and development expenses
|
$
|
11,817
|
|
|
$
|
14,131
|
|
|
$
|
(2,314
|
)
|
|
(16
|
)%
|
|
$
|
35,824
|
|
|
$
|
35,322
|
|
|
$
|
502
|
|
|
1
|
%
|
|
Three Months Ended
|
|
Change
|
|
Nine Months Ended
|
|
Change
|
||||||||||||||||||||||
|
March 31,
|
|
2015 vs. 2014
|
|
March 31,
|
|
2015 vs. 2014
|
||||||||||||||||||||||
|
2015
|
|
2014
|
|
$
|
|
%
|
|
2015
|
|
2014
|
|
$
|
|
%
|
||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
General and administrative expenses
|
$
|
8,187
|
|
|
$
|
5,405
|
|
|
$
|
2,782
|
|
|
51
|
%
|
|
$
|
23,064
|
|
|
$
|
16,056
|
|
|
$
|
7,008
|
|
|
44
|
%
|
|
Three Months Ended
|
|
Change
|
|
Nine Months Ended
|
|
Change
|
||||||||||||||||||||||
|
March 31,
|
|
2015 vs. 2014
|
|
March 31,
|
|
2015 vs. 2014
|
||||||||||||||||||||||
|
2015
|
|
2014
|
|
$
|
|
%
|
|
2015
|
|
2014
|
|
$
|
|
%
|
||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Realized gain from marketable securities, net
|
$
|
6,402
|
|
|
$
|
—
|
|
|
$
|
6,402
|
|
|
—
|
%
|
|
$
|
6,402
|
|
|
$
|
—
|
|
|
$
|
6,402
|
|
|
—
|
%
|
Interest income
|
15
|
|
|
22
|
|
|
(7
|
)
|
|
(32
|
)%
|
|
36
|
|
|
61
|
|
|
(25
|
)
|
|
(41
|
)%
|
||||||
Interest expense
|
(2,577
|
)
|
|
(2,435
|
)
|
|
(142
|
)
|
|
(6
|
)%
|
|
(7,631
|
)
|
|
(7,246
|
)
|
|
(385
|
)
|
|
(5
|
)%
|
||||||
Total other expense, net
|
$
|
3,840
|
|
|
$
|
(2,413
|
)
|
|
$
|
6,253
|
|
|
259
|
%
|
|
$
|
(1,193
|
)
|
|
$
|
(7,185
|
)
|
|
$
|
5,992
|
|
|
83
|
%
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
March 31,
|
|
March 31,
|
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Comerica Term Loan
|
|
|
|
|
|
|
|
||||||||
Simple interest
|
$
|
117
|
|
|
$
|
118
|
|
|
$
|
360
|
|
|
$
|
360
|
|
Amortization of fees paid for letters of credit
|
11
|
|
|
9
|
|
|
34
|
|
|
38
|
|
||||
Total interest expense on the Comerica term loan
|
128
|
|
|
127
|
|
|
394
|
|
|
398
|
|
||||
Convertible Senior Notes
|
|
|
|
|
|
|
|
||||||||
Contractual interest
|
992
|
|
|
992
|
|
|
2,976
|
|
|
2,987
|
|
||||
Amortization of debt discount
|
1,379
|
|
|
1,245
|
|
|
4,033
|
|
|
3,655
|
|
||||
Amortization of debt issuance costs
|
78
|
|
|
71
|
|
|
228
|
|
|
206
|
|
||||
Total interest expense on the convertible senior notes
|
2,449
|
|
|
2,308
|
|
|
7,237
|
|
|
6,848
|
|
||||
Total interest expense
|
$
|
2,577
|
|
|
$
|
2,435
|
|
|
$
|
7,631
|
|
|
$
|
7,246
|
|
•
|
In December 2009, we received a
$60 million
up-front payment from Amgen under a Collaboration and License Agreement.
|
•
|
During May and June 2010, we received a total of
$45 million
in up-front and milestone payments under a License Agreement with Novartis.
|
•
|
In December 2010, we received a
$10 million
milestone payment under a Drug Discovery and Development Agreement with Celgene.
|
•
|
In May 2011, we received a
$10 million
milestone payment under a License Agreement with Novartis.
|
•
|
In September 2011, we received a
$28 million
up-front payment under a Drug Discovery Collaboration Agreement with Genentech.
|
•
|
In June 2012, we received an
$8.5 million
milestone payment from Amgen under a Collaboration and License Agreement.
|
•
|
In June 2013, we received a
$10 million
up-front payment under a Development and Commercialization Agreement with Oncothyreon.
|
•
|
In July 2013, we received an
$11 million
up-front payment under a Drug Discovery and Development Option and License Agreement with Celgene.
|
•
|
In August 2013, we received a
$5 million
milestone payment under a License Agreement with Novartis.
|
•
|
In November 2013, we received a
$5 million
milestone payment under a Collaboration and License Agreement with AstraZeneca.
|
•
|
In December 2014, we received a
$20 million
up-front payment under a License Agreement with Oncothyreon.
|
|
March 31, 2015
|
|
June 30, 2014
|
|
$ Change
|
||||||
|
|
|
|
|
|
||||||
Cash and cash equivalents
|
$
|
141,470
|
|
|
$
|
68,591
|
|
|
$
|
72,879
|
|
Marketable securities – short-term
|
48,600
|
|
|
42,407
|
|
|
6,193
|
|
|||
Marketable securities – long-term
|
546
|
|
|
640
|
|
|
(94
|
)
|
|||
Total
|
$
|
190,616
|
|
|
$
|
111,638
|
|
|
$
|
78,978
|
|
|
Nine Months Ended March 31,
|
|
|
||||||||
|
2015
|
|
2014
|
|
$ Change
|
||||||
Cash flows provided by (used in):
|
|
|
|
|
|
||||||
Operating activities
|
$
|
21,472
|
|
|
$
|
(49,444
|
)
|
|
$
|
70,916
|
|
Investing activities
|
12,560
|
|
|
(11,560
|
)
|
|
24,120
|
|
|||
Financing activities
|
38,847
|
|
|
52,446
|
|
|
(13,599
|
)
|
|||
Total
|
$
|
72,879
|
|
|
$
|
(8,558
|
)
|
|
$
|
81,437
|
|
By:
|
/s/ RON SQUARER
|
|
Ron Squarer
|
|
Chief Executive Officer
|
|
|
|
|
By:
|
/s/ DAVID HORIN
|
|
David Horin
|
|
Chief Financial Officer
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
Incorporated by Reference
|
||||
Exhibit Number
|
|
Description of Exhibit
|
|
Form
|
|
File No.
|
|
Date Filed
|
3.1
|
|
Amended and Restated Certificate of Incorporation of Array BioPharma Inc.
|
|
S-1/A
|
|
333-45922
|
|
10/27/2000
|
3.2
|
|
Amendment to Amended and Restated Certificate of Incorporation of Array BioPharma Inc.
|
|
8-K
|
|
001-16633
|
|
11/6/2007
|
3.3
|
|
Amendment to Amended and Restated Certificate of Incorporation of Array BioPharma Inc.
|
|
8-K
|
|
001-16633
|
|
10/29/2012
|
3.4
|
|
Bylaws of Array BioPharma Inc., as amended and restated on October 30, 2008
|
|
8-K
|
|
001-16633
|
|
11/4/2008
|
4.1
|
|
Specimen certificate representing the common stock
|
|
S-1/A
|
|
333-45922
|
|
10/27/2000
|
4.2
|
|
Registration Rights Agreement, dated May 15, 2009, between the registrant and Deerfield Private Design Fund, L.P. and Deerfield Private Design International, L.P.
|
|
10-K
|
|
001-16633
|
|
8/18/2009
|
4.3
|
|
Form of Warrant to purchase shares of the registrant's Common Stock issued to Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P., Deerfield Partners, L.P., Deerfield International Limited
|
|
8-K/A
|
|
001-16633
|
|
9/24/2009
|
4.4
|
|
Form of Amendment No. 1 to Warrant to purchase shares of the registrant's Common Stock issued to Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P., Deerfield Partners, L.P., Deerfield International Limited
|
|
8-K
|
|
001-16633
|
|
5/3/2011
|
4.5
|
|
Indenture dated June 10, 2013 by and between Array BioPharma Inc. and Wells Fargo Bank, National Association, as Trustee
|
|
8-K
|
|
001-16633
|
|
6/10/2013
|
4.6
|
|
First Supplemental Indenture dated June 10, 2013 by and between Array BioPharma Inc. and Wells Fargo Bank, National Association, as Trustee
|
|
8-K
|
|
001-16633
|
|
6/10/2013
|
4.7
|
|
Form of global note for the 3.00% Convertible Senior Notes Due 2020
|
|
8-K
|
|
001-16633
|
|
6/10/2013
|
10.1
|
|
LGX818 Asset Transfer Agreement, dated January 19, 2015, between registrant and Novartis Pharma AG*
|
|
Filed herewith
|
||||
10.2
|
|
First Amendment to Termination and Asset Transfer Agreement, dated January 19, 2015, between registrant, Novartis Pharma AG and Novartis Pharmaceutical International Ltd.*
|
|
Filed herewith
|
||||
10.3
|
|
Seventh Amendment to Drug Discovery Collaboration Agreement, dated as of February 10, 2015, between the registrant and Genentech, Inc.*
|
|
Filed herewith
|
||||
10.4
|
|
Transition Agreement, dated March 2, 2015, between the registrant and Novartis Pharma AG (binimetinib)*
|
|
Filed herewith
|
||||
10.5
|
|
Transition Agreement, dated March 2, 2015, between the registrant and Novartis Pharma AG (encorafenib)*
|
|
Filed herewith
|
||||
31.1
|
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
|
Filed herewith
|
||||
31.2
|
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
|
Filed herewith
|
||||
32.1
|
|
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
Furnished
|
||||
101.INS
|
|
XBRL Instance Document
|
|
Filed herewith
|
||||
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
Filed herewith
|
||||
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
Filed herewith
|
||||
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
Filed herewith
|
||||
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
Filed herewith
|
||||
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
Filed herewith
|
|
|
|
|
Incorporated by Reference
|
||||
Exhibit Number
|
|
Description of Exhibit
|
|
Form
|
|
File No.
|
|
Date Filed
|
|
|
|
|
|
|
|
|
|
*
|
|
Confidential treatment of redacted portions of this exhibit has been applied for.
|
|
|
Page
|
|
ARTICLE I DEFINITIONS
|
2
|
|
|
Section 1.1
|
Definitions
|
2
|
|
Section 1.2
|
Interpretation
|
11
|
|
Section 1.3
|
Currency
|
11
|
|
|
|
|
|
ARTICLE II TERMINATION
|
11
|
|
|
Section 2.1
|
Termination of the Existing License Agreement
|
11
|
|
|
|
|
|
ARTICLE III TRANSFER OF TRANSFERRED ASSETS
|
12
|
|
|
Section 3.1
|
Transfer
|
12
|
|
Section 3.2
|
Effective Date
|
12
|
|
Section 3.3
|
Transferred Assets
|
12
|
|
Section 3.4
|
Assumption of Certain Liabilities and Obligations
|
14
|
|
Section 3.5
|
Nonassignability of Assets; Shared Assets
|
15
|
|
Section 3.6
|
Delivery; Retained Rights
|
17
|
|
Section 3.7
|
Ancillary Agreements
|
17
|
|
Section 3.8
|
Transfer Taxes and Fees
|
18
|
|
Section 3.9
|
Transition Committee
|
18
|
|
|
|
|
|
ARTICLE IV REPRESENTATIONS AND WARRANTIES OF THE PARTIES
|
19
|
|
|
Section 4.1
|
Representations and Warranties by Novartis
|
19
|
|
Section 4.2
|
Representations and Warranties by Array
|
25
|
|
Section 4.3
|
Disclaimer of Representations and Warranties
|
26
|
|
Section 4.4
|
Survival
|
26
|
|
|
|
|
|
ARTICLE V CERTAIN COVENANTS AND AGREEMENTS OF NOVARTIS
|
26
|
|
|
Section 5.1
|
Conduct of Business
|
26
|
|
Section 5.2
|
Access to Key Employees
|
27
|
|
Section 5.3
|
Payments
|
27
|
|
Section 5.4
|
Certain Additional Information
|
27
|
|
Section 5.5
|
Time is of the Essence
|
27
|
|
|
|
|
|
ARTICLE VI CERTAIN COVENANTS AND AGREEMENTS OF ARRAY
|
27
|
|
|
Section 6.1
|
Novartis's Names and Marks
|
27
|
|
Section 6.2
|
Records
|
28
|
|
Section 6.3
|
Bulk Transfer Laws
|
28
|
|
Section 6.4
|
Encorafenib Drug Product
|
28
|
|
Section 6.5
|
Supply Arrangements
|
28
|
|
Section 6.6
|
BRAF Competitor
|
28
|
|
|
|
|
|
ARTICLE VII OTHER COVENANTS AND AGREEMENTS
|
28
|
|
|
Section 7.1
|
Efforts to Consummate; Antitrust Matters
|
28
|
|
Section 7.2
|
Notice of Certain Events
|
31
|
|
Section 7.3
|
Press Releases; Publicity
|
31
|
|
Section 7.4
|
Confidential Information
|
31
|
|
Section 7.5
|
Pharmacovigilance
|
34
|
|
Section 7.6
|
Change of Product and Service Recipient
|
34
|
|
Section 7.7
|
Certain Matters Relating to the FTC Decisions and Order and EC Remedy Decisions
|
34
|
|
|
|
|
|
ARTICLE VIII TERMINATION, AMENDMENT AND WAIVER
|
35
|
|
|
Section 8.1
|
Termination
|
35
|
|
Section 8.2
|
Amendments and Waivers
|
36
|
|
|
|
|
|
ARTICLE IX INDEMNIFICATION
|
36
|
|
|
Section 9.1
|
Indemnification by Array
|
36
|
|
Section 9.2
|
Indemnification by Novartis
|
36
|
|
Section 9.3
|
Indemnification Procedure
|
37
|
|
Section 9.4
|
Special, Indirect and Other Losses
|
38
|
|
Section 9.5
|
No Exclusion
|
39
|
|
|
|
|
|
ARTICLE X GENERAL PROVISIONS
|
39
|
|
|
Section 10.1
|
Expenses
|
39
|
|
Section 10.2
|
Further Assurances and Actions
|
39
|
|
Section 10.3
|
Notices
|
39
|
|
Section 10.4
|
Headings
|
40
|
|
Section 10.5
|
Severability
|
40
|
|
Section 10.6
|
Counterparts
|
40
|
|
Section 10.7
|
Entire Agreement
|
40
|
|
Section 10.8
|
Governing Law
|
40
|
|
Section 10.9
|
Dispute Resolution
|
40
|
|
Section 10.10
|
Specific Performance
|
41
|
|
Section 10.11
|
Bindining Effect; Assignment
|
41
|
|
|
|
|
(i)
|
the Transferred IP;
|
(ii)
|
all product market research, product marketing materials, product branding reports and analyses and product marketing plans to the extent specifically related to Encorafenib;
|
(iii)
|
all product development reports to the extent related to Encorafenib;
|
(iv)
|
all Regulatory Materials to the extent related to Encorafenib, in each case, that are in the possession and control of Novartis or its Affiliates (“
Transferred Regulatory Materials
”), except to the extent set forth in
Section 3.3(b)(iii)
;
|
(v)
|
the Transferred Third Party Agreements, including the clinical trial agreements with respect to the Ongoing Investigator Sponsored Clinical Trials;
|
(vi)
|
all clinical trial and safety data, databases and analyses to the extent related to Encorafenib;
|
(vii)
|
the domain names listed on
Schedule 3.3(a)(vii)
;
|
(ix)
|
all Inventory; and
|
(x)
|
all Documents to the extent related to Encorafenib.
|
(i)
|
the Novartis Names and Marks;
|
(ii)
|
any compounds (other than Encorafenib) (“
Novartis Compounds
”) and related Regulatory Materials, in each case, of Novartis and/or its Affiliates;
|
(iii)
|
any Regulatory Materials to the extent related to Encorafenib, in each case, that are in the possession and control of Novartis or its Affiliates, as are necessary for Novartis to perform its obligations under this Agreement and the Ancillary Agreements with respect to the clinical trials set forth on
Exhibit A
sponsored by Novartis as of the Effective Date, but solely to the extent necessary and until completion of such obligations by Novartis (upon which such Regulatory Materials shall (automatically and without any further action of the Parties) be deemed to constitute Transferred Assets transferred hereunder);
|
(iv)
|
Novartis’s rights under the Columbus Trial Agreement and the Three-Way Clinical Trial Agreement;
|
(v)
|
accounts receivable, pre-paid expenses and any cash or cash equivalents of Novartis or any of its Affiliates;
|
(vi)
|
any plant, tangible property, equipment or employees, subject to
Section 5.2
, of Novartis or any of its Affiliates; and
|
(vii)
|
the property, assets and rights listed on
Section 3.3(b)(vi)
.
|
(i)
|
to the extent Novartis or its Affiliates uses prior to the Effective Date any Transferred Third Party Agreement for purposes unrelated to Encorafenib and unrelated to Binimetinib, after the Effective Date, Array shall cooperate with Novartis to (i) provide to Novartis or its Affiliates the benefits of use of such Transferred Third Party Agreement, (ii) partially assign to Novartis or an Affiliate thereof or
|
(ii)
|
to the extent any Third Party Agreement that is not a Transferred Third Party Agreement relates to Encorafenib, Novartis shall cooperate with Array to (i) provide to Array the benefits of use of such Third Party Agreement, (ii) partially assign to Array or otherwise divide such Third Party Agreement into one agreement for Array and one agreement for Novartis, and/or (iii) enable Array to obtain alternative benefits independently.
|
(i)
|
To the Knowledge of Novartis, Encorafenib is being, and at all
|
(ii)
|
To the Knowledge of Novartis, the clinical trials conducted by
|
(iii)
|
Novartis is not subject to any investigation related to Encorafenib
|
(iv)
|
To the Knowledge of Novartis, Novartis has not submitted any claim
|
(v)
|
To the Knowledge of Novartis, Novartis has complied in all material
|
(vi)
|
To the Knowledge of Novartis, there have not been and are not now
|
(vii)
|
To the Knowledge of Novartis, neither Novartis nor any of its
|
(i)
|
[*]Each of (i) the material Third Party Agreements and (ii) the [*]
|
(ii)
|
Schedule 4.1(g)(ii)
contains a complete and accurate list of all
|
(i)
|
The definition of “Novartis Compounds” set forth in
Section 1.1
of
|
(ii)
|
The definition of “Sponsor Compounds” set forth in
Section 1.1
of the
|
(iii)
|
The definition of “Other Clinical Trial(s)” set forth in
Section 1.1
of
|
(iv)
|
The definition of “Other Novartis Sponsored Trials” set forth in
|
(v)
|
The definition of “Standalone Clinical Trial(s)” set forth in
Section
|
(i)
|
Schedule 1.1(c)
lists all Transferred Patents, in each case
|
(ii)
|
Novartis and its Affiliates do not own any right, title or interest in or
|
(iii)
|
Novartis and its Affiliates have taken reasonable actions to protect the
|
(iv)
|
Novartis or one of its Affiliates owns all right, title and interest in and
|
(v)
|
(A) To the Knowledge of Novartis, the Development, manufacture
|
(vi)
|
To the Knowledge of Novartis, except as provided by Third Party
|
(ix)
|
To the Knowledge of Novartis, no Transferred IP or any agreement
|
(x)
|
Neither Novartis nor any of its Affiliates has granted any Third Party
|
(xi)
|
The Transferred IP and the Licensed IP constitute all Intellectual
|
(i)
|
Array
shall use its best efforts to [*] on terms such that the consummation of the Contemplated Transactions and compliance with the terms hereof and the Ancillary Agreements will not result in any breach, violation of or default (or an event that, with notice or lapse of time or both, would constitute a default) of the Relevant Third Party Agreement (as amended or waived in connection with such settlement). [*]
|
(ii)
|
[*]
|
(iii)
|
[*]
|
(i)
|
any notice or other communication from any Person alleging that the consent of such Person is or may be required in connection with the Contemplated Transactions;
|
(ii)
|
any material notice or other material communication from any Governmental Entity related primarily to the Contemplated Transactions; and
|
(iii)
|
any event, fact, occurrence or development resulting in a material breach of any of the representations and warranties in Article IV above.
|
(i)
|
by mutual written consent of Novartis and Array; or
|
(ii)
|
by either Novartis or Array, if the GSK Transactions are terminated without the consummation thereof.
|
(i)
|
Array will return all documents and other material received from Novartis, its Affiliates or representatives relating to Encorafenib and the Transferred Assets and to the Contemplated Transactions, whether so obtained before or after the execution of this Agreement, to Novartis;
|
(ii)
|
all confidential information received by Array with respect to Novartis, its Affiliates, Encorafenib or the Transferred Assets will be treated in accordance with the Confidentiality Agreement, which subject to
Section 10.7
, which will remain in full force and effect notwithstanding the termination of this Agreement; and
|
(iii)
|
this Agreement shall terminate and there shall be no liability of any Party to any other Party;
provided
, that, (x) nothing herein will relieve or release either Party from liability arising from any breach by such Party of this Agreement prior to the date of termination and (y)
Section 6.1
,
Section 7.3
,
Article VIII
and
Article X
shall survive such termination.
|
(i)
|
the negligence or willful misconduct of Array or any of its Affiliates, contractors or agents;
|
(ii)
|
the Assumed Liabilities;
|
(iii)
|
the breach of any of the covenants or agreements made by Array to Novartis under this Agreement or the Ancillary Agreements; or
|
(iv)
|
the breach of any of the representations or warranties made by Array to Novartis under this Agreement or the Ancillary Agreements.
|
(i)
|
the negligence or willful misconduct of Novartis or any of its Affiliates, contractors or agents;
|
(ii)
|
the Excluded Liabilities;
|
(iii)
|
the breach of any of the covenants or agreements made by Novartis to Array under this Agreement or the Ancillary Agreements; or
|
(iv)
|
the breach of any of the representations or warranties made by Novartis to Array under this Agreement or the Ancillary Agreements.
|
NOVARTIS PHARMA AG
|
||
|
|
|
By:
|
/s/ ROY PAPATHEODOROU
|
|
|
Name: ROY PAPATHEODOROU
|
|
|
Title: AS ATTORNEY
|
|
|
|
|
By:
|
/s/ J H EMERY
|
|
|
Name: J H EMERY
|
|
|
Title: AS ATTORNEY
|
|
|
|
|
ARRAY BIOPHARMA INC.
|
||
|
|
|
By:
|
/s/ John Moore
|
|
|
Name: John Moore
|
|
|
Title: General Counsel
|
1.
|
[*]
|
a.
|
[*]
|
b.
|
[*]
|
c.
|
[*]
|
d.
|
[*]
|
e.
|
[*]
|
2.
|
[*]
|
3.
|
[*]
|
ARRAY BIOPHARMA INC.
|
|
NOVARTIS PHARMA AG
|
||
|
|
|
|
|
By:
|
/s/ John R. Moore
|
|
By:
|
/s/Roy Papatheodorou
|
Name:
|
John R. Moore
|
|
Name:
|
Roy Papatheodorou
|
Title:
|
General Counsel
|
|
Title:
|
As Attorney
|
|
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
/s/ J H Emery
|
|
|
|
Name:
|
J H Emery
|
|
|
|
Title:
|
As Attorney
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For purposes of
Article II,
Section 4.1
,
|
|
|
|
|
Section 5.1 (d)
and
Article X
only of the
|
|
|
|
|
Agreement:
|
|
|
|
|
|
|
|
|
|
NOVARTIS INTERNATIONAL
|
|
|
|
|
PHARMACEUTICAL LTD.
|
|
|
|
|
|
|
|
|
|
By:
|
/s/ H.S. Zivi
|
|
|
|
Name:
|
H.S. Zivi
|
|
|
|
Title:
|
Deputy Chairman
|
|
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
/s/ Alison Dyer-Fagundo
|
|
|
|
Name:
|
Alison Dyer-Fagundo
|
|
|
|
Title:
|
Director
|
1.
|
This Seventh Amendment hereby amends and revises the Agreement to incorporate the terms and conditions set forth in this Seventh Amendment. The relationship of the Parties shall continue to be governed by the terms of the Agreement, as amended hereby.
|
2.
|
The following capitalized terms shall have the meanings given to them in this paragraph 2. All other capitalized terms used in this Seventh Amendment shall have the meanings defined in the Agreement unless otherwise defined herein.
|
3.
|
Effective as of the Amendment Date, and notwithstanding anything to the contrary in the Agreement prior to the Amendment Date:
|
(a)
|
[*] shall not constitute a “Collaboration Target” (as such term is defined in the Agreement) under the Agreement or this Seventh Amendment.
|
(b)
|
No [*] Compound shall constitute a “Compound” (as such term is defined in the Agreement) under the Agreement or this Seventh Amendment.
|
(c)
|
No product incorporating a [*] Compound shall constitute a “Licensed Product” (as such term is defined in the Agreement) under the Agreement or this Seventh Amendment.
|
(d)
|
Nothing in the Agreement shall prohibit or otherwise restrict Array from conducting, participating in or funding, directly or indirectly, either alone or with a Third Party, research or development with respect to, or commercialization of, a [*] Compound or a product incorporating a [*] Compound.
|
(e)
|
Neither Party shall have any obligation under the Agreement to pay any payments, milestones, royalties or other amounts to the other Party with respect to [*], any [*] Compound and/or products incorporating a [*] Compound including, without limitation, pursuant to Articles 6 or 7 of the Agreement.
|
4.
|
Effective as of the Amendment Date, and notwithstanding anything to the contrary in the Agreement or this Seventh Amendment:
|
(a)
|
Nothing in the Agreement or this Seventh Amendment shall prohibit or otherwise restrict Genentech from exercising all of its rights to research, develop and/or commercialize [*] and any other [*]
Compound
or product incorporating a [*] Compound, in either case, other than [*].
|
(b)
|
Array hereby grants to Genentech a non‑exclusive, sublicensable license under (i) the Array Existing Technology, Array Collaboration Technology and Array’s interest in Joint Collaboration Technology, to make, use, offer for sale, sell and import [*] Compounds and products incorporating [*] Compounds in the Field in the Territory; and (ii) the Array Future Technology existing as of one (1) day prior to the Amendment Date, to make, use, offer for sale, sell and import [*] Compounds and products incorporating [*] Compounds in the Field in the Territory. Genentech shall have the right to grant sublicenses to any Third Parties, and any sublicensee may grant further sublicenses to one or more additional Third Parties.
|
(c)
|
For the avoidance of doubt, Array Future Technology does not include any Patents, Know‑How or other technology received by Array under the [*] by and between [*] and Array, dated as of [*].
|
(d)
|
Array hereby grants to Genentech the right to use all data, materials and Array’s Confidential Information, in all cases, transferred by Array to Genentech prior to the
|
(e)
|
The licenses and rights granted to Genentech under this Amendment may be exercised by a Third Party on Genentech’s behalf including, without limitation, by a Third Party performing contract manufacturing on behalf of Genentech or performing work under a material transfer agreement on behalf of Genentech.
|
(f)
|
All of Genentech’s Confidential Information existing as of the Amendment Date that relates to [*] and/or [*] Compounds (including, without limitation, chemical entities known by Array to be [*] Compounds and any information specifically related to [*] and/or [*] Compounds) continues to be the Confidential Information of Genentech, and Array has no rights to use such
Confidential Information,
including with respect to [*], subject to the confidentiality provisions of Article 9 of the Agreement.
|
(g)
|
Array, on behalf of itself and its Affiliates, and on behalf of their respective successors and assigns (of this Agreement or the applicable intellectual property), covenants, during the term of the Agreement and perpetually thereafter, not to enforce directly, or to prompt or cooperate with or impose an obligation on a Third Party to enforce, against Genentech, its Affiliates or Roche, or any of their respective successors, assigns, licensees, sublicensees and agents, any Patent acquired by Array under the [*] by and between [*] and Array, dated as of [*], based on the manufacture, use, offer for sale, sale or import of any [*] Compound, or any product incorporating a [*] Compound, in each case, excluding [*].
|
(h)
|
Genentech, on behalf of itself and its Affiliates, and on behalf of their respective successors and assigns (of this Agreement or the applicable intellectual property), covenants, during the term of the Agreement and perpetually thereafter, not to enforce directly, or to prompt or cooperate with or impose an obligation on a Third Party to enforce, against Array, or any of its successors, assigns, licensees, sublicensees and agents, any Genentech Patents existing as of the Amendment Date, based on the manufacture, use, offer for sale, sale or import of [*].
|
5.
|
Array hereby represents to Genentech that, prior to the Amendment Date, Array fulfilled its obligations under Section 2.4 of the Agreement. Genentech agrees that a breach of this representation does not entitle Genentech to termination or rescission of the Settlement and Release Agreement or this Seventh Amendment.
|
6.
|
Except as otherwise expressly provided, this Seventh Amendment does not grant any right or license to either Party under any of the other Party’s Patents or other intellectual property rights, and no other right or license is to be implied or inferred from any provision of this Seventh Amendment or by the conduct of the Parties. For clarity, but without limitation, no
|
7.
|
Within [*] days of the Amendment Date, and in partial consideration for the rights and releases granted under this Amendment and the Settlement and Release Agreement, Array shall make a one‑time, non‑refundable settlement payment to Genentech of [*] in accordance with the wiring instructions set forth on Attachment A hereto.
|
8.
|
This Seventh Amendment, the Agreement and the Settlement and Release Agreement constitute the entire agreement between the Parties in connection with the subject matter of this Seventh Amendment. The Agreement, as herein amended, is and remains in full force and effect.
|
GENENTECH, INC.
|
ARRAY BIOPHARMA INC.
|
By: /s/ Robert Andreatta
|
By: /s/ John Moore
|
Name: Robert Andreatta
|
Name: John Moore
|
Title: VP, Controller and CAO
|
Title: General Counsel
|
NOVARTIS PHARMA AG
|
|
|
|
|
|
|
|
|
By:
|
/s/ David P. Tolman
|
|
|
Name: David P. Tolman attorney-in-fact
|
|
|
Title: Vice President, General Counsel
|
|
|
Global Head Legal
|
|
|
Novartis Oncology
|
|
|
|
|
|
|
|
By:
|
/s/ Bruce Shapiro
|
|
|
Name: Bruce Shapiro attorney-in-fact
|
|
|
Title: Vice President
|
|
|
Global Head Legal Transactions
|
|
|
Novartis Oncology
|
|
|
|
|
|
|
|
ARRAY BIOPHARMA INC.
|
|
|
|
|
|
By:
|
/s/ Ron Squarer
|
|
|
Name: Ron Squarer
|
|
|
Title: CEO
|
|
|
|
|
|
|
|
1.
|
Regulatory Assistance and Support
. Upon reasonable notice and request from Array to Novartis, Novartis will provide to Array, in a timely manner and [*], the following assistance, cooperation or advice:
|
•
|
With respect to the initial regulatory filings for Marketing Approval of Binimetinib (either alone or in combination) for the first indication in the [*] and, until [*] after receipt by Array, its Affiliates or licensees of the first such Marketing Approval, with respect to regulatory filings in any of such countries, Novartis (i) will make its employees available to answer questions with respect to documentation, referencing and generation of tables and statistics necessary for such filings and (ii) provide access to any information, Know-How, data or supporting documentation in Novartis’s possession necessary or useful for such filings (if any). Array will be primarily responsible for, and the applicant of, any such filings.
|
2.
|
Tech Transfer
. Novartis will reimburse Array [*] incurred by Array pursuant to Section 7.5 of the Supply Agreement.
|
3.
|
Certain Manufacturing Items
. Novartis will transition to Array, at Novartis’s expense and on a mutually agreed timeline, which in no event will be completed later than [*], such plans and activities, if any, regarding the following projects, in each case, as have been approved by the JDC, and, until such transition is complete will continue these projects in the ordinary course of business as currently contemplated:
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*] and
|
•
|
[*].
|
4.
|
Conduct of Clinical Trials
.
|
a.
|
Phase 3 Clinical Trials
.
|
i.
|
Nemo
. Novartis will conduct, at its sole expense, the NEMO Trial,
provided, however
, that Array or its CRO will assume responsibility to conduct and Complete the NEMO Trial upon the applicable transition date set forth on
Exhibit A
, and, Novartis will reimburse Array the Out-of-Pocket costs and fifty percent (50%) of FTE Costs associated with such conduct and Completion of the NEMO Trial within the parameters of the current study protocol for such trial and such other costs resulting from changes to such protocol in accordance with
Section 4(e)(i)
of this Schedule I after the transition date.
For the NEMO trial, [*].
|
ii.
|
Milo
. Array will conduct and complete the MILO Trial, and Novartis will reimburse Array the Out-of-Pocket Costs and fifty percent (50%) of FTE Costs associated with such conduct and Completion of the MILO Trial within the parameters of the current study protocol for such trial and such other costs resulting from changes to such protocol in accordance with
Section 4(e)(i)
of this Schedule I.
|
iii.
|
Columbus
. Novartis or, to the extent assigned to the LGX818 Buyer, the LGX818 Buyer will conduct and complete, in accordance with the terms of the COLUMBUS Trial Agreement, the COLUMBUS Trial. Responsibility for costs associated with such conduct and Completion of the COLUMBUS Trial are set forth in the Columbus Trial Agreement.
|
b.
|
Other Novartis Sponsored Trials
. Novartis will conduct, at its sole expense, the Other Novartis Sponsored Trials,
provided
,
however
, that Array or its CRO will assume responsibility to conduct and Complete each such Other Novartis Sponsored Trial upon the applicable transition date set forth on
Exhibit A
, or, with respect to Other Novartis Sponsored Trials being conducted by Clinical Research Organizations, upon the assignment of the applicable agreement by Novartis to Array, and Novartis will reimburse Array the Out-of-Pocket Costs and fifty percent (50%) of FTE Costs associated with such conduct and Completion of the Other Novartis Sponsored Trials within the parameters of the current study protocols for such trials and such other costs resulting from changes to such protocol in accordance with
Section 4(e)(i)
of this Schedule I after the applicable transition date.
|
c.
|
Other Array Sponsored Trial
. Array will conduct the Other Array Sponsored Trial, and Novartis will reimburse Array the Out-of-Pocket Costs and fifty percent (50%) of FTE Costs associated with the Completion of the Other Array Sponsored Trial within the parameters of the current study protocol for such trial and such other costs resulting from changes to such protocol in accordance with
Section 4(e)(i)
of this Schedule I.
|
d.
|
Investigator Sponsored Clinical Trials
. Pursuant to the Termination Agreement, Novartis will transfer (by assigning applicable clinical trial agreements, as Third Party Agreements, to Array), and Array will oversee the conduct and Completion of, the Ongoing Investigator Sponsored Clinical Trials, and Novartis will evaluate, and make determinations to proceed with respect to, the Proposed Investigator Sponsored Clinical Trials in accordance with Section 5.1(c) of the Termination Agreement. Novartis will reimburse Array the Out-of-Pocket costs and fifty percent (50%) of FTE Costs associated with the conduct and Completion of the Investigator Sponsored Clinical Trials within the parameters of the current study protocols for such trials and such other costs resulting from changes to such protocol in accordance with
Section 4(e)(i)
of this Schedule.
|
e.
|
General
.
|
i.
|
Novartis (or a Third Party, as applicable) will use its best efforts to conduct and, with respect to trials with then-current timelines that contemplate Completion prior to the applicable transition date set forth on
Exhibit A
, Complete all the clinical trials assigned to it in accordance with the then-current protocol and timeline, including taking into account any changes made thereto by the JDC or Transition Committee, as applicable, or in accordance with this
Section 4(e)(i)
. Novartis will not make any changes to any of the protocols therefor that would reasonably be expected
to delay or halt any trial, except as approved by the Transition Committee. Without limiting the foregoing:
|
(1)
|
each Party agrees that it will consent to and implement any changes to the protocols for the NEMO Trial or the MILO Trial, in each case, that are reasonably necessary in order for such clinical trial to achieve the intended objectives of such clinical trial as set forth in the clinical protocol in place subsequent to such change and [*];
|
(2)
|
each Party agrees that it will consent to and implement any changes to the protocols for any clinical trials involving Binimetinib (but not any Novartis Compound) other than the NEMO Trial or the MILO Trial, in each case, that are reasonably necessary in order for the applicable clinical trial to achieve the intended objectives of such clinical trial as set forth in the clinical protocol in place subsequent to such change and [*]; and
|
(3)
|
the Parties agree that any proposed changes to the protocols for any clinical trials involving a Novartis Compound shall be mutually agreed upon by the Parties and [*].
|
ii.
|
Array (or a Third Party, as applicable) will use its best efforts to conduct and complete all the clinical trials assigned to it that involve a Novartis Compound in accordance with the then-current protocol and timeline, including taking into account any changes made thereto by the Transition Committee.
|
iii.
|
Novartis will provide all other information, data, technical assistance, support and other materials as may be requested by Array that is reasonably necessary for carrying out the foregoing clinical trial activities.
|
iv.
|
For the avoidance of doubt, and notwithstanding any other provision of the Termination Agreement or the Ancillary Agreements (including this Agreement), Novartis will have the right to suspend any clinical trial involving a Novartis Compound immediately if (a) Novartis concludes in its reasonable judgment, which conclusion shall be subject to confirmation by a dispute resolution committee (“
DRC
”) in the event that Array in its reasonable judgment disagrees with the conclusion of Novartis, (b) a Regulatory Authority concludes, or (c) if applicable, the data safety monitoring board recommends, that the Study Data show that the continuation of such trial would pose adverse risks to
|
5.
|
NRAS Melanoma Companion Diagnostic Product
. Novartis will (i) remain responsible for conducting and completing development of the NRAS Melanoma Companion Diagnostic Product (the “
NRAS Companion Diagnostic
”) until Post Marketing Approval from the FDA (the “
PMA
”) and (ii) until such PMA approval by the FDA and [*], support submission and approval in such other countries where approval of the NRAS Companion Diagnostic is required for the approval of Binimetinib or products containing Binimetinib. Novartis will transfer the PMA for the NRAS Companion Diagnostic after approval of the PMA by the FDA, or earlier if agreed by the Parties, to Array or to a Third Party agreed by both Parties to the extent such transfer is permitted under Applicable Laws. Novartis and Array will mutually agree on a GMP manufacturer of the NRAS Companion Diagnostic [*]. With respect to the NRAS Companion Diagnostic, such manufacturer [*].
|
6.
|
Novartis Pipeline Agents
. Novartis will provide continued clinical supply for and permit continuation of the combination studies of Binimetinib that include a Novartis Pipeline Agent within the parameters of the current study protocols for the clinical trials referenced in
Exhibit A
. On or before each subsequent clinical trial of Binimetinib in combination with a particular Novartis Pipeline Agent (the “
Combination Trial
”), the Parties shall enter into a clinical trial agreement governing each such trial on commercially reasonable terms. For each Combination Trial that is a Phase 3 trial, Novartis will notify Array by [*] whether or not it intends to register and Commercialize the Novartis Pipeline Agent for the indication(s) specified in such Combination Trial; provided, that if Novartis notifies Array of its intent to register and Commercialize but thereafter makes a determination not to Commercialize such Novartis Pipeline Agent for such indication, then it will provide at least [*] prior notice to Array of cessation of Development activities for that Novartis Pipeline Agent. Subject to any license agreement obligations that Novartis may have with Third Parties for return to any such Third Party of Novartis Pipeline Agents that are licensed by Novartis from such Third Party, if Novartis determines that it (or any licensee of Novartis) will not Commercialize such Novartis Pipeline Agent (or, if after launch of any Novartis Pipeline Agent, Novartis determines to no longer Commercialize such Novartis Pipeline Agent) for any indication, then it will enter into a license agreement with Array on mutually agreed upon commercially reasonable terms, including with respect to financial terms taking into account a discount to the market value reflecting Novartis’s decision not to commercialize the product, with an exclusive, irrevocable, worldwide license, with the right to sublicense, to the rights to
|
7.
|
Audits
. Novartis shall permit its books and records pertaining to the clinical trials to be conducted by or on its behalf pursuant to this Agreement to be examined no more than [*] per calendar year, upon reasonable notice during normal business hours, provided such examination is requested in writing at least ten (10) business days in advance; provided, further, that any Array representative signs a confidentiality agreement in form and substance reasonably acceptable to Novartis (and its CRO, as applicable). Such examination is to be made at the expense of Array.
|
8.
|
Participation in Regulatory Communications
.
|
a.
|
With respect to any clinical trials conducted by Novartis: Prior to transition of any such clinical trial to Array (as applicable), (i) Novartis shall be primarily responsible for interfacing, corresponding and meeting with Regulatory Authorities with respect to the conduct of any clinical trial involving Binimetinib, and shall keep Array fully informed of all regulatory communications and developments relating to such clinical trial,
provided, however
, that (A) Array shall have the right, at its option, to participate in any preparation for meetings with Regulatory Authorities and/or to attend and participate in all such meetings and (B) Array shall have primary control over all such interfaces, correspondence and meetings to the extent related solely to Binimetinib; and (ii) Novartis shall provide Array with all draft filings with any Regulatory Authorities related to each clinical trial involving Binimetinib (other than non-substantial, routine correspondence) for review and comment at least [*] in advance of the intended date of submission (or, to the extent necessary, such shorter period to meet such intended date of submission), and shall incorporate all reasonable comments of Array thereto. For the sake of clarity, after transition of any such clinical trial to Array, Array shall be primarily responsible and shall have primary control over all such interfaces, correspondence and meetings.
|
b.
|
With respect to any clinical trials conducted by Array: Array shall be primarily responsible for interfacing, corresponding and meeting with Regulatory Authorities with respect to the conduct of such clinical trial, and shall keep Novartis fully informed of all regulatory communications and developments to the extent relating to a Novartis Pipeline Agent,
provided, however
, that (a) Novartis shall have the right, at its option, to participate in any preparation for meetings with Regulatory Authorities and/or to attend and participate in all such meetings to the extent related solely to any clinical trial involving a Novartis Pipeline Agent and (b) Novartis shall have primary control over all such interfaces, correspondence and meetings to the extent related solely to a Novartis Pipeline Agent. Array shall provide Novartis with all draft filings with any Regulatory Authorities related to each clinical trial involving a Novartis Pipeline Agent (other than
|
c.
|
Each Party shall provide the other Party with copies of all correspondence with the applicable Regulatory Authorities relating to its compound that affects the conduct of a clinical trial, and respond within a reasonable time frame to all reasonable inquiries by the other Party with respect thereto.
|
Trials
|
Transition Date*
|
Phase III Trials:
|
|
COLUMBUS Trial
|
N/A
|
NEMO Trial
|
Availability of Conclusions from First Interpretable Results (but in no event later than the end of Q3 2016)
|
[*]
|
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
|
[*]
|
[*]
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[*]
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[*]
|
[*]
|
[*]
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[*]
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[*]
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[*]
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[*]
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[*]
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[*]
|
[*]
|
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[*]
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[*]
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[*]
|
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[*]
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[*]
|
NOVARTIS PHARMA AG
|
|
|
|
|
|
|
|
|
By:
|
/s/ David P. Tolman
|
|
|
Name: David P. Tolman attorney-in-fact
|
|
|
Title: Vice President, General Counsel
|
|
|
Global Head Legal
|
|
|
Novartis Oncology
|
|
|
|
|
|
|
|
By:
|
/s/ Bruce Shapiro
|
|
|
Name: Bruce Shapiro attorney-in-fact
|
|
|
Title: Vice President
|
|
|
Global Head Legal Transactions
|
|
|
Novartis Oncology
|
|
|
|
|
|
|
|
ARRAY BIOPHARMA INC.
|
|
|
|
|
|
By:
|
/s/ Ron Squarer
|
|
|
Name: Ron Squarer
|
|
|
Title: CEO
|
|
|
|
|
|
|
|
1.
|
Regulatory Assistance and Support
. Upon reasonable notice and request from Array to Novartis, Novartis will provide to Array, in a timely manner and [*], the following assistance, cooperation or advice:
|
•
|
With respect to the initial regulatory filings for Marketing Approval of Encorafenib (either alone or in combination) for the first indication in the [*] and, until [*] after receipt by Array, its Affiliates or licensees of the first such Marketing Approval, with respect to regulatory filings in any of such countries, Novartis (i) will make its employees available to answer questions with respect to documentation, referencing and generation of tables and statistics necessary for such filings and (ii) provide access to any information, Know-How, data or supporting documentation in Novartis’s possession necessary or useful for such filings (if any). Array will be primarily responsible for, and the applicant of, any such filings.
|
2.
|
Manufacturing Technology Transfer
.
|
a)
|
In connection with the transfer and assignment of the Manufacturing Technology pursuant to the Asset Transfer Agreement, Novartis will provide to Array, in a timely manner and [*], cooperation and support with respect to: (i) transferring the Manufacturing Technology for the Drug Substance and Product, as applicable, to the Tech Transfer CMOs (the “
Product Tech Transfer
”); and (ii) qualifying and gaining regulatory approval for the Tech Transfer CMOs as a manufacturing site (“
Qualification Support Services
,” and together with the Product Tech Transfer, the “
Technical Transfer Services
”). Novartis will reimburse Array for [*] associated with the Technical Transfer Services (including all costs associated with registration stability batch runs, data validation and qualification batch runs and successful pre-approval inspections) [*].
|
b)
|
Novartis and Array, in consultation with the Tech Transfer CMOs, shall discuss and agree on a plan that sets out the timelines and respective obligations of each of the Parties in relation to the Technical Transfer Services to be provided hereunder (the “
Technical Transfer Plan
”), which shall be attached hereto as Exhibit C to this
Schedule I
. The Parties shall endeavor to agree on a Technical Transfer Plan within [*].
|
c)
|
Novartis’s obligations to perform the Technical Transfer Services will continue until (a) [*] or (b) [*] (the “
Tech Transfer Period
”).
|
d)
|
The Technical Transfer Services provided by Novartis shall be [*].
|
e)
|
To the extent any Manufacturing Technology is currently used, or is contemplated to be used, by Novartis for use other than in connection with Encorafenib, the Parties
|
f)
|
The supply agreements for Materials used in Drug Substance and other Product presentations and the final formulation of Product and the contracts and purchase orders for laboratories and consultants related thereto included in the Manufacturing Technology may also be used by Novartis for use other than in connection with Encorafenib. To the extent that any such agreements, contracts and purchase orders are not transferred from Novartis to Array as Third Party Agreements pursuant to the Asset Transfer Agreement, either because it is not permitted under the terms of such Third Party Agreement or it is impractical, Novartis will work with Array, [*], to qualify and put in place appropriate supply and consulting agreements with relevant vendors, laboratories and consultants.
|
g)
|
During the Tech Transfer Period, Novartis shall make its relevant scientific and technical personnel reasonably available to Array at Novartis’s offices, at reasonable times during Novartis’s normal business hours and upon reasonable prior notice, to answer any questions or provide instruction as reasonably requested by Array concerning the Manufacturing Technology and shall facilitate visits to the Facility by Array personnel during regular business hours at a time and frequency to be determined by Novartis. In addition, Novartis agrees that Array may have a limited number of personnel at the portion of the Facility used in connection with the manufacture of the Product during regular business hours during a manufacturing campaign for the Product and as set forth in the Quality Agreement (as defined in the Supply Agreement). Such personnel may either be technical or quality personnel. Array’s personnel shall comply with Novartis’s procedures concerning cGMP (as defined in the Supply Agreement), training, safety, hygiene, confidentiality and
|
3.
|
Certain Manufacturing Items
. Novartis will transition to Array, at Novartis’s expense and on a mutually agreed timeline, which in no event will be completed later than [*], such plans and activities, if any, regarding the following projects, in each case, planned and approved by Novartis in the ordinary course, and until such transition is complete will continue these projects in the ordinary course of business as currently contemplated:
|
•
|
[*]
|
•
|
[*] and
|
•
|
[*]
|
4.
|
Conduct of Clinical Trials
.
|
a.
|
COLUMBUS Clinical Trial
. Novartis will conduct, at its sole expense (subject to
Section 4.1(b)
of the Agreement), the COLUMBUS Trial,
provided
,
however
, that Array or its CRO will assume responsibility to conduct and Complete the COLUMBUS Trial upon the applicable transition date set forth on
Exhibit A
, and, Novartis will reimburse Array the Out-of-Pocket costs and fifty percent (50%) of FTE Costs associated with such conduct and Completion of the COLUMBUS Trial, in each case, within the parameters of the current study protocol for such trial and such other costs resulting from changes to such protocol in accordance with
paragraph 4(e)(i)
of this Schedule I after the transition date.
|
b.
|
Other Novartis Sponsored Trials
. Novartis will conduct, at its sole expense, the Other Novartis Sponsored Trials,
provided
,
however
, that Array or its CRO will assume responsibility to conduct and Complete each such Other Novartis Sponsored Trial upon the applicable transition date set forth on
Exhibit A
, or, with respect to Other Novartis Sponsored Trials being conducted by Clinical Research Organizations, upon the assignment of the applicable agreement by Novartis to Array, and Novartis will reimburse Array the Out-of-Pocket Costs and fifty percent (50%) of FTE Costs associated with such conduct and Completion of the Other Novartis Sponsored Trials, in each case, within the parameters of the current study protocols for such trials and such other costs resulting from changes to such protocol in accordance with
paragraph 4(e)(i)
of this Schedule I after the applicable transition date.
|
c.
|
Intentionally left blank.
|
d.
|
Investigator Sponsored Clinical Trials
. Pursuant to the Asset Transfer Agreement, Novartis will transfer (by assigning applicable clinical trial agreements, as Third Party Agreements, to Array), and Array will oversee the conduct and Completion of, the Ongoing Investigator Sponsored Clinical Trials, and Novartis will evaluate, and make determinations to proceed with respect to, the Proposed Investigator Sponsored Clinical
|
e.
|
General
.
|
i.
|
Novartis (or a Third Party, as applicable) will use its best efforts to conduct and, with respect to trials with then-current timelines that contemplate Completion prior to the applicable transition date set forth on
Exhibit A
, Complete all the clinical trials assigned to it in accordance with the then-current protocol and timeline, including taking into account any changes made thereto by the Transition Committee, or in accordance with this
paragraph 4(e)(i)
. Novartis will not make any changes to any of the protocols therefor that would reasonably be expected
to delay or halt any trial, except as approved by the Transition Committee. Without limiting the foregoing:
|
(1)
|
each Party agrees that it will consent to and implement any changes to the protocols for any clinical trials involving Encorafenib (but not any Novartis Compound), in each case, that are reasonably necessary in order for the applicable clinical trial to achieve the intended objectives of such clinical trial as set forth in the clinical protocol in place subsequent to such change and [*]; and
|
(2)
|
the Parties agree that any proposed changes to the protocols for any clinical trials involving a Novartis Compound shall be mutually agreed upon by the Parties and that [*].
|
ii.
|
Array (or a Third Party, as applicable) will use its best efforts to conduct and complete all the clinical trials assigned to it that involve a Novartis Compound in accordance with the then-current protocol and timeline, including taking into account any changes made thereto by the Transition Committee.
|
iii.
|
Novartis will provide all other information, data, technical assistance, support and other materials as may be requested by Array that is reasonably necessary for carrying out the foregoing clinical trial activities.
|
iv.
|
For the avoidance of doubt, and notwithstanding any other provision of the Asset Transfer Agreement or the Ancillary Agreements (including this Agreement), Novartis will have the right to suspend any clinical trial involving a Novartis Compound immediately if (a) Novartis concludes in its reasonable judgment, which conclusion shall be subject to confirmation by a dispute resolution committee (“
DRC
”) in the event that Array in its reasonable judgment disagrees with the conclusion of Novartis, (b) a Regulatory Authority concludes, or (c) if applicable, the
|
5.
|
Intentionally left blank.
|
6.
|
Novartis Pipeline Agents
. Novartis will provide continued clinical supply for and permit continuation of the combination studies of Encorafenib that include a Novartis Pipeline Agent within the parameters of the current study protocols for the clinical trials referenced in
Exhibit A
. On or before each subsequent clinical trial of Encorafenib in combination with a particular Novartis Pipeline Agent (the “
Combination Trial
”), the Parties shall enter into a clinical trial agreement governing each such trial on commercially reasonable terms. For each Combination Trial that is a Phase 3 trial, Novartis will notify Array by [*] whether or not it intends to register and Commercialize the Novartis Pipeline Agent for the indication(s) specified in such Combination Trial; provided, that if Novartis notifies Array of its intent to register and Commercialize but thereafter makes a determination not to Commercialize such Novartis Pipeline Agent for such indication, then it will provide at least [*] prior notice to Array of cessation of Development activities for that Novartis Pipeline Agent. Subject to any license agreement obligations that Novartis may have with Third Parties for return to any such Third Party of Novartis Pipeline Agents that are licensed by Novartis from such Third Party, if Novartis determines that it (or any licensee of Novartis) will not Commercialize such Novartis Pipeline Agent (or, if after launch of any Novartis Pipeline Agent, Novartis determines to no longer Commercialize such Novartis Pipeline Agent) for any indication, then it will enter into a license agreement with Array on mutually agreed upon commercially reasonable terms, including with respect to financial terms taking into account a discount to the market value reflecting Novartis’s decision not to commercialize the product, with an exclusive, irrevocable, worldwide license, with the right to sublicense, to the rights to Develop and Commercialize such Novartis Pipeline Agents in the field of oncology in combination with Encorafenib. For the avoidance of doubt, Array shall not have any rights hereunder to pursue, and Novartis shall not have any obligations to permit, clinical trials of Encorafenib in combination with any Novartis compound other than the Novartis Pipeline Agents.
|
7.
|
Audits
. Novartis shall permit its books and records pertaining to the clinical trials to be conducted by or on its behalf pursuant to this Agreement to be examined no more than [*]
|
8.
|
Participation in Regulatory Communications
.
|
a.
|
With respect to any clinical trials conducted by Novartis: Prior to transition of any such clinical trial to Array (as applicable), (i) Novartis shall be primarily responsible for interfacing, corresponding and meeting with Regulatory Authorities with respect to the conduct of any clinical trial involving Encorafenib, and shall keep Array fully informed of all regulatory communications and developments relating to such clinical trial,
provided, however
, that (A) Array shall have the right, at its option, to participate in any preparation for meetings with Regulatory Authorities and/or to attend and participate in all such meetings and (B) Array shall have primary control over all such interfaces, correspondence and meetings to the extent related solely to Encorafenib; and (ii) Novartis shall provide Array with all draft filings with any Regulatory Authorities related to each clinical trial involving Encorafenib (other than non-substantial, routine correspondence) for review and comment at least [*] days in advance of the intended date of submission (or, to the extent necessary, such shorter period to meet such intended date of submission), and shall incorporate all reasonable comments of Array thereto. For the sake of clarity, after transition of any such clinical trial to Array, Array shall be primarily responsible and shall have primary control over all such interfaces, correspondence and meetings.
|
b.
|
With respect to any clinical trials conducted by Array: Array shall be primarily responsible for interfacing, corresponding and meeting with Regulatory Authorities with respect to the conduct of such clinical trial, and shall keep Novartis fully informed of all regulatory communications and developments to the extent relating to a Novartis Pipeline Agent,
provided, however
, that (a) Novartis shall have the right, at its option, to participate in any preparation for meetings with Regulatory Authorities and/or to attend and participate in all such meetings to the extent related solely to any clinical trial involving a Novartis Pipeline Agent and (b) Novartis shall have primary control over all such interfaces, correspondence and meetings to the extent related solely to a Novartis Pipeline Agent. Array shall provide Novartis with all draft filings with any Regulatory Authorities related to each clinical trial involving a Novartis Pipeline Agent (other than non-substantial, routine correspondence) for review and comment at least [*] days in advance of the intended date of submission (or, to the extent necessary, such shorter period to meet such intended date of submission), and shall incorporate all reasonable comments of Novartis thereto.
|
c.
|
Each Party shall provide the other Party with copies of all correspondence with the applicable Regulatory Authorities relating to its compound that affects the conduct of a
|
Trials
|
Transition Date*
|
Encorafenib Phase III Trials:
|
|
COLUMBUS Trial
|
The date upon which the last patient first visit occurs (but in no event later than end of Q2 2016)
|
[*]
|
|
[*]
|
[*]
|
[*]
|
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
1
|
Key Contacts
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
2
|
Drug Substance
|
A.
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
B.
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
C.
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
3
|
Drug Product
|
A.
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
B.
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
•
|
[*]
|
4
|
Reference Standard(s)
|
•
|
[*]
|
5
|
Regulatory
|
•
|
[*]
|
•
|
[*]
|
6
|
Environmental Health and Safety
|
•
|
[*]
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Array BioPharma Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within this entity, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date:
|
May 6, 2015
|
By:
|
/s/ RON SQUARER
|
|
|
|
Ron Squarer
|
|
|
|
Chief Executive Officer
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Array BioPharma Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within this entity, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date:
|
May 6, 2015
|
By:
|
/s/ DAVID HORIN
|
|
|
|
David Horin
|
|
|
|
Chief Financial Officer
|
(a)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
(b)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.
|
Date:
|
May 6, 2015
|
/s/ RON SQUARER
|
|
|
Ron Squarer
|
|
|
Chief Executive Officer
|
|
|
|
|
|
|
|
|
/s/ DAVID HORIN
|
|
|
David Horin
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial and Accounting Officer)
|