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☒
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
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DELAWARE
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26-2025616
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
|
215 First Street, Suite 400
Cambridge, MA
|
02142
|
(Address of principal executive offices)
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(Zip code)
|
|
Large Accelerated filer
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☐
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Accelerated filer
|
☐
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Non-accelerated filer
|
☒
(Do not check if a smaller reporting company)
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Smaller reporting company
|
☐
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Page
|
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Item 1.
|
||
|
||
|
||
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||
|
||
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
|
|
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Item 1.
|
||
Item 1A.
|
||
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
Item 5.
|
||
Item 6.
|
•
|
the potential effectiveness of the License Agreement that we entered into with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. on June 10, 2016, and the impact of the transactions contemplated by the License Agreement, if it becomes effective;
|
•
|
the outcome of our process to review a range of strategic alternatives with a goal of maximizing stockholder value;
|
•
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our plans to research and develop our product candidates;
|
•
|
the initiation and conduct of clinical trials;
|
•
|
our ability to successfully develop our product candidates and complete clinical programs;
|
•
|
results of preclinical studies or other early stage studies and whether they will be indicative of the results of future studies;
|
•
|
expectations regarding regulatory approvals, the nature and timing of our future interactions with regulatory authorities and our ability to design, implement and complete registration trials acceptable to such regulatory authorities and sufficient to support applications for regulatory approvals;
|
•
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the timing of and our ability to obtain marketing approval of our product candidates, and the ability of our product candidates to meet existing or future regulatory standards;
|
•
|
the potential advantages of our product candidates;
|
•
|
our estimates regarding the potential market opportunity for our product candidates;
|
•
|
our sales, marketing and distribution capabilities and strategy;
|
•
|
our ability to establish and maintain arrangements for the manufacture of our product candidates;
|
•
|
our ability to enter into and successfully complete other collaborations or in-license or acquire rights to other products, product candidates or technologies;
|
•
|
our ability to obtain, maintain and protect our intellectual property for our technology and products;
|
•
|
the rate and degree of market acceptance and clinical utility of our products;
|
•
|
our estimates regarding expenses, future revenues, capital requirements and need for additional financing;
|
•
|
the impact of governmental laws and regulations; and
|
•
|
our competitive position.
|
|
June 30,
2016 |
|
December 31, 2015
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
8,484
|
|
|
$
|
36,079
|
|
Prepaid expenses and other current assets
|
350
|
|
|
232
|
|
||
Total current assets
|
8,834
|
|
|
36,311
|
|
||
Property and equipment, net
|
314
|
|
|
407
|
|
||
Restricted cash
|
119
|
|
|
94
|
|
||
Other assets
|
—
|
|
|
13
|
|
||
Total assets
|
$
|
9,267
|
|
|
$
|
36,825
|
|
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
1,855
|
|
|
$
|
1,246
|
|
Accrued expenses
|
1,153
|
|
|
1,794
|
|
||
Notes payable, current portion
|
—
|
|
|
4,134
|
|
||
Deferred revenue
|
—
|
|
|
406
|
|
||
Total current liabilities
|
3,008
|
|
|
7,580
|
|
||
Other liabilities
|
73
|
|
|
423
|
|
||
Notes payable, net of current portion
|
—
|
|
|
9,763
|
|
||
Warrant liability
|
13
|
|
|
115
|
|
||
Commitments and contingencies
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized at June 30, 2016 and December 31, 2015 and no shares issued and outstanding at June 30, 2016 and December 31, 2015
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value per share; 200,000,000 shares authorized at June 30, 2016 and December 31, 2015 and 20,005,771 and 19,619,124 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively
|
20
|
|
|
20
|
|
||
Additional paid-in capital
|
145,420
|
|
|
144,126
|
|
||
Accumulated deficit
|
(139,267
|
)
|
|
(125,202
|
)
|
||
Total stockholders’ equity
|
6,173
|
|
|
18,944
|
|
||
Total liabilities and stockholders’ equity
|
$
|
9,267
|
|
|
$
|
36,825
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Revenue
|
$
|
277
|
|
|
$
|
114
|
|
|
$
|
506
|
|
|
$
|
358
|
|
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
3,298
|
|
|
6,269
|
|
|
7,930
|
|
|
11,507
|
|
||||
General and administrative
|
3,471
|
|
|
2,247
|
|
|
5,618
|
|
|
4,850
|
|
||||
Total operating expenses
|
6,769
|
|
|
8,516
|
|
|
13,548
|
|
|
16,357
|
|
||||
Loss from operations
|
(6,492
|
)
|
|
(8,402
|
)
|
|
(13,042
|
)
|
|
(15,999
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
||||||||
Other income, net
|
1
|
|
|
1,826
|
|
|
139
|
|
|
3,134
|
|
||||
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
(915
|
)
|
|
—
|
|
||||
Interest expense
|
—
|
|
|
(330
|
)
|
|
(247
|
)
|
|
(565
|
)
|
||||
Total other income (expense), net
|
1
|
|
|
1,496
|
|
|
(1,023
|
)
|
|
2,569
|
|
||||
Net loss and comprehensive loss
|
$
|
(6,491
|
)
|
|
$
|
(6,906
|
)
|
|
$
|
(14,065
|
)
|
|
$
|
(13,430
|
)
|
Net loss per share applicable to common stockholders—basic and diluted
|
$
|
(0.33
|
)
|
|
$
|
(0.36
|
)
|
|
$
|
(0.71
|
)
|
|
$
|
(0.72
|
)
|
Weighted-average number of common shares used in net loss per share applicable to common stockholders—basic and diluted
|
19,874
|
|
|
19,087
|
|
|
19,756
|
|
|
18,532
|
|
|
Six Months Ended
June 30, |
||||||
|
2016
|
|
2015
|
||||
Operating activities
|
|
|
|
||||
Net loss
|
$
|
(14,065
|
)
|
|
$
|
(13,430
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
93
|
|
|
192
|
|
||
Non-cash interest expense
|
26
|
|
|
26
|
|
||
Stock-based compensation expense
|
1,207
|
|
|
1,266
|
|
||
Change in fair value of warrant liability
|
(102
|
)
|
|
(3,123
|
)
|
||
Loss on extinguishment of debt
|
221
|
|
|
—
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Prepaid expenses and other assets
|
(126
|
)
|
|
(596
|
)
|
||
Restricted cash
|
(25
|
)
|
|
—
|
|
||
Accounts payable
|
609
|
|
|
(578
|
)
|
||
Accrued expenses and other liabilities
|
(991
|
)
|
|
(1,209
|
)
|
||
Deferred revenue
|
(406
|
)
|
|
(55
|
)
|
||
Net cash used in operating activities
|
(13,559
|
)
|
|
(17,507
|
)
|
||
Investing activities
|
|
|
|
||||
Purchases of property and equipment
|
—
|
|
|
(286
|
)
|
||
Net cash used in investing activities
|
—
|
|
|
(286
|
)
|
||
Financing activities
|
|
|
|
||||
Proceeds from issuance of common stock and common stock warrants, net of offering costs
|
—
|
|
|
12,172
|
|
||
Payments on notes payable
|
(14,124
|
)
|
|
—
|
|
||
Proceeds from notes payable
|
—
|
|
|
5,000
|
|
||
Proceeds from exercise of common stock options and warrants
|
88
|
|
|
56
|
|
||
Net cash (used in) provided by financing activities
|
(14,036
|
)
|
|
17,228
|
|
||
Net decrease in cash and cash equivalents
|
(27,595
|
)
|
|
(565
|
)
|
||
Cash and cash equivalents at beginning of period
|
36,079
|
|
|
54,059
|
|
||
Cash and cash equivalents at end of period
|
$
|
8,484
|
|
|
$
|
53,494
|
|
Supplemental non-cash financing activities
|
|
|
|
||||
Issuance of warrants for common stock
|
—
|
|
|
$
|
328
|
|
|
Supplemental cash flow information
|
|
|
|
||||
Cash paid for interest
|
$
|
663
|
|
|
$
|
374
|
|
•
|
The Company entered into the License Agreement with Roche, which, subject to effectiveness, would provide meaningful cash resources to the Company.
|
•
|
The Company is engaged in a review of strategic alternatives with a goal of maximizing stockholder value.The Company cannot provide any commitment regarding precisely when or if this strategic review process will result in any type of additional transaction and no assurance can be given that the Company will determine to pursue a potential sale, strategic partnership, business combination or other arrangement.
|
•
|
The Company does not see an immediate path forward for isunakinra and has implemented a plan to wind down the development activities associated with isunakinra.
|
•
|
The Company has conducted a review of its operations and implemented a plan to reduce operating expenses to align with current operating conditions, including the workforce reduction described in Note 8 below.
|
•
|
On March 1, 2016, the Company prepaid all outstanding amounts owed to SVB under the Loan Agreement. The Company continues to evaluate other financing alternatives to provide additional working capital on terms that are consistent with the Company’s business plans.
|
|
As of June 30,
|
||||
|
2016
|
|
2015
|
||
Stock options
|
2,205,774
|
|
|
2,060,334
|
|
Unvested restricted stock
|
31,010
|
|
|
71,310
|
|
Restricted stock units
|
77,133
|
|
|
211,400
|
|
Common stock warrants
|
926,840
|
|
|
926,840
|
|
|
3,240,757
|
|
|
3,269,884
|
|
Description
|
Total
|
|
Active
Markets
(Level 1)
|
|
Observable
Inputs
(Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
8,484
|
|
|
$
|
8,484
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total
|
$
|
8,484
|
|
|
$
|
8,484
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Description
|
Total
|
|
Active
Markets
(Level 1)
|
|
Observable
Inputs
(Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrant liability
|
$
|
13
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
13
|
|
Total
|
$
|
13
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
13
|
|
Description
|
Total
|
|
Active
Markets
(Level 1)
|
|
Observable
Inputs
(Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
36,079
|
|
|
$
|
36,079
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total
|
$
|
36,079
|
|
|
$
|
36,079
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Description
|
Total
|
|
Active
Markets
(Level 1)
|
|
Observable
Inputs
(Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrant liability
|
$
|
115
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
115
|
|
Total
|
$
|
115
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
115
|
|
|
June 30,
2016 |
|
December 31, 2015
|
||
Risk-free interest rate
|
0.52
|
%
|
|
1.06
|
%
|
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
Expected term (in years)
|
1.42
|
|
|
1.92
|
|
Expected volatility
|
79.43
|
%
|
|
70.67
|
%
|
Beginning balance, January 1, 2016
|
$
|
115
|
|
Change in fair value
|
(102
|
)
|
|
Ending balance, June 30, 2016
|
$
|
13
|
|
|
June 30,
2016 |
|
December 31, 2015
|
||||
Development costs
|
$
|
160
|
|
|
$
|
931
|
|
Employee compensation
|
915
|
|
|
573
|
|
||
Professional fees
|
77
|
|
|
194
|
|
||
Interest
|
—
|
|
|
88
|
|
||
Other
|
1
|
|
|
8
|
|
||
|
$
|
1,153
|
|
|
$
|
1,794
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Stock options
|
$
|
444
|
|
|
$
|
598
|
|
|
$
|
879
|
|
|
$
|
1,234
|
|
Restricted stock
|
51
|
|
|
4
|
|
|
105
|
|
|
32
|
|
||||
Restricted stock units
|
106
|
|
|
—
|
|
|
198
|
|
|
—
|
|
||||
Performance stock options
|
14
|
|
|
—
|
|
|
14
|
|
|
—
|
|
||||
Employee stock purchase plan
|
6
|
|
|
—
|
|
|
11
|
|
|
—
|
|
||||
|
$
|
621
|
|
|
$
|
602
|
|
|
$
|
1,207
|
|
|
$
|
1,266
|
|
(1)
|
Represents the number of vested options, plus the number of unvested options expected to vest.
|
|
Restricted
Stock
|
|
Weighted-Average
Grant Date
Fair Value
|
|||
Unvested at December 31, 2015
|
41,657
|
|
|
$
|
11.05
|
|
Vested
|
(10,647
|
)
|
|
9.94
|
|
|
Unvested at June 30, 2016
|
31,010
|
|
|
$
|
11.43
|
|
|
Restricted
Stock Units
|
|
Weighted-Average
Grant Date
Fair Value
|
|||
Unvested at December 31, 2015
|
150,932
|
|
|
$
|
2.85
|
|
Vested
|
(73,799
|
)
|
|
2.82
|
|
|
Unvested at June 30, 2016
|
77,133
|
|
|
$
|
2.88
|
|
•
|
We entered into the License Agreement with Roche, which, subject to effectiveness, would provide meaningful cash resources to us.
|
•
|
We are engaged in a review of strategic alternatives with the goal of maximizing stockholder value. We cannot provide any commitment regarding precisely when or if this strategic review process will result in any type of additional transaction and no assurance can be given that we will determine to pursue a potential sale, strategic partnership, business combination or other arrangement.
|
•
|
We do not see an immediate path forward for isunakinra and have implemented a plan to wind down the development activities associated with isunakinra.
|
•
|
We have conducted a review of our operations and implemented a plan to reduce future operating expenses to align with current operating conditions, including the workforce reduction described in Note 8 to our Condensed Financial Statements included in this Quarterly Report on Form 10-Q.
|
•
|
On March 1, 2016, we prepaid all outstanding amounts owed to Silicon Valley Bank, or SVB, under our Loan and Security Agreement with SVB. We continue to evaluate other financing alternatives to provide additional operating funds on terms that are consistent with our business plans.
|
•
|
employee-related expenses, including salaries, benefits, travel and stock-based compensation expense;
|
•
|
expenses incurred under agreements with contract research organizations, or CROs, and investigative sites that conduct our clinical trials;
|
•
|
expenses associated with developing manufacturing capabilities and manufacturing clinical study materials;
|
•
|
facilities, depreciation, and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance, and other supplies; and
|
•
|
expenses associated with preclinical and regulatory activities.
|
•
|
the scope, progress, outcome and costs of our clinical trials and other research and development activities;
|
•
|
the efficacy and potential advantages of our product candidates compared to alternative treatments, including any standard of care;
|
•
|
the market acceptance of our product candidates;
|
•
|
obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
|
•
|
significant and changing government regulation; and
|
•
|
the timing, receipt and terms of any marketing approvals.
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
(in thousands)
|
||||||||||||||
Programs:
|
|
|
|
|
|
|
|
||||||||
Isunakinra
|
$
|
208
|
|
|
$
|
4,372
|
|
|
$
|
1,530
|
|
|
$
|
7,423
|
|
EBI-031
|
1,013
|
|
|
398
|
|
|
2,752
|
|
|
826
|
|
||||
Total program expenses
|
1,221
|
|
|
4,770
|
|
|
4,282
|
|
|
8,249
|
|
||||
Personnel and other expenses:
|
|
|
|
|
|
|
|
||||||||
Employee and contractor-related expenses
|
1,716
|
|
|
1,067
|
|
|
2,900
|
|
|
2,335
|
|
||||
Platform-related lab expenses
|
102
|
|
|
151
|
|
|
239
|
|
|
340
|
|
||||
Facility expenses
|
163
|
|
|
128
|
|
|
310
|
|
|
237
|
|
||||
Other expenses
|
96
|
|
|
153
|
|
|
199
|
|
|
346
|
|
||||
Total personnel and other expenses
|
2,077
|
|
|
1,499
|
|
|
3,648
|
|
|
3,258
|
|
||||
Total research and development expenses
|
$
|
3,298
|
|
|
$
|
6,269
|
|
|
$
|
7,930
|
|
|
$
|
11,507
|
|
|
Three Months Ended
June 30, |
|
|
||||||||
|
2016
|
|
2015
|
|
Change
|
||||||
|
(in thousands)
|
||||||||||
Revenue
|
$
|
277
|
|
|
$
|
114
|
|
|
$
|
163
|
|
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
3,298
|
|
|
6,269
|
|
|
(2,971
|
)
|
|||
General and administrative
|
3,471
|
|
|
2,247
|
|
|
1,224
|
|
|||
Total operating expenses
|
6,769
|
|
|
8,516
|
|
|
(1,747
|
)
|
|||
Loss from operations
|
(6,492
|
)
|
|
(8,402
|
)
|
|
1,910
|
|
|||
Other income, net
|
1
|
|
|
1,496
|
|
|
(1,495
|
)
|
|||
Net loss
|
$
|
(6,491
|
)
|
|
$
|
(6,906
|
)
|
|
$
|
415
|
|
|
Six Months Ended
June 30, |
|
|
||||||||
|
2016
|
|
2015
|
|
Change
|
||||||
|
(in thousands)
|
||||||||||
Revenue
|
$
|
506
|
|
|
$
|
358
|
|
|
$
|
148
|
|
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
7,930
|
|
|
11,507
|
|
|
(3,577
|
)
|
|||
General and administrative
|
5,618
|
|
|
4,850
|
|
|
768
|
|
|||
Total operating expenses
|
13,548
|
|
|
16,357
|
|
|
(2,809
|
)
|
|||
Loss from operations
|
(13,042
|
)
|
|
(15,999
|
)
|
|
2,957
|
|
|||
Other (expense) income, net
|
(1,023
|
)
|
|
2,569
|
|
|
(3,592
|
)
|
|||
Net loss
|
$
|
(14,065
|
)
|
|
$
|
(13,430
|
)
|
|
$
|
(635
|
)
|
|
Six Months Ended
June 30, |
||||||
|
2016
|
|
2015
|
||||
|
(in thousands)
|
||||||
Net cash (used in) provided by:
|
|
|
|
||||
Operating activities
|
$
|
(13,559
|
)
|
|
$
|
(17,507
|
)
|
Investing activities
|
—
|
|
|
(286
|
)
|
||
Financing activities
|
(14,036
|
)
|
|
17,228
|
|
||
Net decrease in cash and cash equivalents
|
$
|
(27,595
|
)
|
|
$
|
(565
|
)
|
•
|
continue the research and development of our preclinical product candidates;
|
•
|
seek to discover and develop additional product candidates;
|
•
|
in-license or acquire the rights to other products, product candidates or technologies;
|
•
|
seek marketing approvals for any product candidates that successfully complete clinical trials;
|
•
|
establish sales, marketing and distribution capabilities and scale up and validate external manufacturing capabilities to commercialize any products for which we may obtain marketing approval;
|
•
|
maintain, expand and protect our intellectual property portfolio;
|
•
|
hire additional clinical, quality control, scientific and management personnel; and
|
•
|
expand our operational, financial and management systems and personnel.
|
•
|
effectiveness of the License Agreement with Roche;
|
•
|
the outcome and timing of our review of a range of strategic alternatives with the goal of maximizing stockholder value;
|
•
|
the scope, progress, results and costs of preclinical development, laboratory testing and, if we determine to proceed into clinical development, clinical trials of our preclincal product candidates;
|
•
|
our ability to establish collaborations on favorable terms, if at all, particularly manufacturing, marketing and distribution arrangements for our product candidates;
|
•
|
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and
|
•
|
the extent to which we in-license or acquire rights to other products, product candidates or technologies.
|
|
Total
|
|
Less than 1 Year
|
|
1 to 3 Years
|
|
3 to 5 Years
|
|
More than 5 Years
|
||||||||||
|
(in thousands)
|
||||||||||||||||||
Operating lease obligations(1)
|
$
|
1,229
|
|
|
$
|
666
|
|
|
$
|
563
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total fixed contractual obligations
|
$
|
1,229
|
|
|
$
|
666
|
|
|
$
|
563
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Item 1A.
|
Risk Factors
|
•
|
continue the research and development of our preclinical product candidates;
|
•
|
seek to discover and develop additional product candidates;
|
•
|
in-license or acquire the rights to other products, product candidates or technologies;
|
•
|
seek marketing approvals for any product candidates that successfully complete clinical trials;
|
•
|
establish sales, marketing and distribution capabilities and scale up and validate external manufacturing capabilities to commercialize any products for which we may obtain marketing approval;
|
•
|
maintain, expand and protect our intellectual property portfolio;
|
•
|
hire additional clinical, quality control, scientific and management personnel; and
|
•
|
expand our operational, financial and management systems and personnel.
|
•
|
we are required by the United States Food and Drug Administration, or FDA, or the European Medicine Agency, or EMA, to perform studies in addition to those currently expected; or
|
•
|
if there are any delays in enrollment of patients in, or completing our clinical trials or the development of any product candidates that we may develop.
|
•
|
initiating and completing clinical development of EBI-031 in patients with DME, uveitis, or other indications;
|
•
|
subject to obtaining favorable results from clinical trials, applying for and obtaining marketing approvals for EBI-031;
|
•
|
establishing sales, marketing and distribution capabilities, either ourselves or through collaboration or other arrangements with third parties, to effectively market and sell EBI-031;
|
•
|
achieving an adequate level of market acceptance of EBI-031;
|
•
|
protecting our rights to our intellectual property portfolio related to EBI-031; and
|
•
|
ensuring the manufacture of commercial quantities of EBI-031.
|
•
|
effectiveness of the License Agreement with Roche;
|
•
|
the outcome and timing of our review of a range of strategic alternatives with the goal of maximizing stockholder value;
|
•
|
the scope, progress, results and costs of preclinical development, laboratory testing and, if we determine to proceed into clinical development, clinical trials of our preclinical product candidates;
|
•
|
our ability to establish collaborations on favorable terms, if at all, particularly manufacturing, marketing and distribution arrangements for our product candidates;
|
•
|
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and
|
•
|
the extent to which we in-license or acquire rights to other products, product candidates or technologies.
|
•
|
commencing clinical development of EBI-031;
|
•
|
completing clinical development of EBI-031 in patients with DME, uveitis or other indications;
|
•
|
manufacturing commercial quantities of EBI-031 and receiving regulatory approval of manufacturing processes and facilities from applicable regulatory authorities;
|
•
|
subject to obtaining favorable results from clinical trials, applying for and obtaining marketing approvals for EBI-031;
|
•
|
effectively marketing and selling EBI-031;
|
•
|
acceptance of EBI-031, if and when approved, by patients, the medical community and third-party payors;
|
•
|
effectively competing with other therapies, including the existing standard of care;
|
•
|
maintaining a continued acceptable safety profile of EBI-031 following approval;
|
•
|
obtaining and maintaining coverage and adequate reimbursement from third-party payors;
|
•
|
obtaining and maintaining patent and trade secret protection and regulatory exclusivity; and
|
•
|
protecting rights in our intellectual property portfolio related to EBI-031.
|
•
|
clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;
|
•
|
the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;
|
•
|
our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
|
•
|
regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
•
|
we may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;
|
•
|
we may decide, or regulators or institutional review boards may require us, to suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;
|
•
|
the cost of clinical trials of our product candidates may be greater than we anticipate;
|
•
|
the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; and
|
•
|
our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or institutional review boards to suspend or terminate the trials.
|
•
|
be delayed in obtaining marketing approval for our product candidates;
|
•
|
not obtain marketing approval at all;
|
•
|
obtain approval for indications or patient populations that are not as broad as intended or desired;
|
•
|
obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;
|
•
|
be subject to additional post-marketing testing requirements; or
|
•
|
have the product removed from the market after obtaining marketing approval.
|
•
|
the severity of the disease under investigation;
|
•
|
the eligibility criteria for the study in question;
|
•
|
the perceived risks and benefits of the product candidate under study;
|
•
|
the efforts to facilitate timely enrollment in clinical trials;
|
•
|
the patient referral practices of physicians;
|
•
|
any ongoing clinical trials conducted by competitors for the same indication;
|
•
|
the ability to monitor patients adequately during and after treatment; and
|
•
|
the proximity and availability of clinical trial sites for prospective patients.
|
•
|
the efficacy and potential advantages compared to alternative treatments, including the existing standard of care;
|
•
|
our ability to offer our products for sale at competitive prices, particularly in light of the lower cost of alternative treatments;
|
•
|
the convenience and ease of administration compared to alternative treatments;
|
•
|
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
|
•
|
the strength of our marketing and distribution support;
|
•
|
timing of market introduction of competitive products;
|
•
|
the availability of third-party coverage and adequate reimbursement;
|
•
|
the prevalence and severity of any side effects; and
|
•
|
any restrictions on the use of our products together with other medications.
|
•
|
our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;
|
•
|
the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe our products;
|
•
|
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
|
•
|
unforeseen costs and expenses associated with creating an independent sales and marketing organization.
|
•
|
decreased demand for any product candidates or products that we develop;
|
•
|
injury to our reputation and significant negative media attention;
|
•
|
withdrawal of clinical trial participants;
|
•
|
significant costs to defend the related litigation;
|
•
|
substantial monetary awards to trial participants or patients;
|
•
|
loss of revenue;
|
•
|
reduced time and attention of our management to pursue our business strategy; and
|
•
|
the inability to commercialize any products that we develop.
|
•
|
collaborators or licensees have significant discretion in determining the amount and timing of efforts and resources that they will apply to these collaborations or licenses;
|
•
|
collaborators or licensees may not perform their obligations as expected;
|
•
|
collaborators or licensees may not pursue development and commercialization of our product candidates that receive marketing approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ or licensees' strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;
|
•
|
collaborators or licensees may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
|
•
|
collaborators or licensees could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators or licensees believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;
|
•
|
product candidates discovered under the collaboration or license with us may be viewed by our collaborators or licensees as competitive with their own product candidates or products, which may cause collaborators or licensees to cease to devote resources to the commercialization of our product candidates;
|
•
|
a collaborator or licensee with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product or products;
|
•
|
disagreements with collaborators or licensees, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would divert management attention and resources, be time-consuming and expensive;
|
•
|
collaborators or licensees may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;
|
•
|
collaborators or licensees may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and
|
•
|
collaborations or licenses may be terminated for the convenience of the collaborator or licensee and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates.
|
•
|
any product candidates that we may develop may compete with other product candidates and products for access to a limited number of suitable manufacturing facilities that operate under current good manufacturing practices, or cGMP, regulations;
|
•
|
reliance on the third party for regulatory compliance and quality assurance;
|
•
|
the possible breach of the manufacturing agreement by the third party;
|
•
|
the possible misappropriation of our proprietary information, including our trade secrets and know-how; and
|
•
|
the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.
|
•
|
the United States Congress could amend the BPCIA to significantly shorten this exclusivity period as has been previously proposed; and
|
•
|
a potential competitor could seek and obtain approval of its own BLA during our exclusivity period instead of seeking approval of a biosimilar version.
|
•
|
litigation involving patients taking our products;
|
•
|
restrictions on such products, manufacturers or manufacturing processes;
|
•
|
restrictions on the labeling or marketing of a product;
|
•
|
restrictions on product distribution or use;
|
•
|
requirements to conduct post-marketing studies or clinical trials;
|
•
|
warning letters or untitled letters;
|
•
|
withdrawal of the products from the market;
|
•
|
refusal to approve pending applications or supplements to approved applications that we submit;
|
•
|
recall of products;
|
•
|
fines, restitution or disgorgement of profits or revenues;
|
•
|
suspension or withdrawal of marketing approvals;
|
•
|
damage to relationships with any potential collaborators;
|
•
|
unfavorable press coverage and damage to our reputation;
|
•
|
refusal to permit the import or export of our products;
|
•
|
product seizure or detention; or
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation or arranging of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid;
|
•
|
the federal False Claims Act imposes criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, false or fraudulent claims for payment by a federal healthcare program or making a false statement or record material to payment of a false claim or avoiding, decreasing or concealing an obligation
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
|
•
|
the federal Physician Payments Sunshine Act requires applicable manufacturers of covered products to report payments and other transfers of value to physicians and teaching hospitals, with data collection beginning in August 2013;
|
•
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and their respective implementing regulations, which imposes obligations, including mandatory contractual terms, on covered healthcare providers, health plans and healthcare clearinghouses, as well as their business associates, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; and
|
•
|
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws and transparency statutes, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
|
•
|
an annual, non-deductible fee on any entity that manufactures or imports specified branded prescription products and biologic agents;
|
•
|
an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;
|
•
|
a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for products that are inhaled, infused, instilled, implanted or injected;
|
•
|
expansion of healthcare fraud and abuse laws, including the civil False Claims Act and the federal Anti-Kickback Statute, new government investigative powers and enhanced penalties for noncompliance;
|
•
|
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand products to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient products to be covered under Medicare Part D;
|
•
|
extension of manufacturers’ Medicaid rebate liability to individuals enrolled in Medicaid managed care organizations;
|
•
|
expansion of eligibility criteria for Medicaid programs;
|
•
|
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
|
•
|
new requirements to report certain financial arrangements with physicians and teaching hospitals;
|
•
|
a new requirement to annually report product samples that manufacturers and distributors provide to physicians;
|
•
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
|
•
|
a new Independent Payment Advisory Board, or IPAB, which has authority to recommend certain changes to the Medicare program to reduce expenditures by the program that could result in reduced payments for prescription products; and
|
•
|
established the Center for Medicare and Medicaid Innovation within CMS to test innovative payment and service delivery models.
|
•
|
delay, defer or prevent a change in control;
|
•
|
entrench our management and the board of directors; or
|
•
|
delay or prevent a merger, consolidation, takeover or other business combination involving us on terms that other stockholders may desire.
|
•
|
establish a classified board of directors such that only one of three classes of directors is elected each year;
|
•
|
allow the authorized number of our directors to be changed only by resolution of our board of directors;
|
•
|
limit the manner in which stockholders can remove directors from our board of directors;
|
•
|
establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our board of directors;
|
•
|
require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent;
|
•
|
limit who may call stockholder meetings;
|
•
|
authorize our board of directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors; and
|
•
|
require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal specified provisions of our certificate of incorporation or bylaws.
|
•
|
the success of competitive products or technologies;
|
•
|
results of clinical trials of EBI-031 or any other product candidate that we may develop;
|
•
|
results of clinical trials of product candidates of our competitors;
|
•
|
regulatory or legal developments in the United States and other countries;
|
•
|
developments or disputes concerning patent applications, issued patents or other proprietary rights;
|
•
|
the recruitment or departure of key scientific or management personnel;
|
•
|
the level of expenses related to any of our product candidates or clinical development programs;
|
•
|
the results of our efforts to discover, develop, acquire or in-license additional products, product candidates or technologies for the treatment of ophthalmic diseases, the costs of commercializing any such products and the costs of development of any such product candidates or technologies;
|
•
|
actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
|
•
|
variations in our financial results or those of companies that are perceived to be similar to us;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors;
|
•
|
general economic, industry and market conditions; and
|
•
|
the other factors described in this “Risk Factors” section.
|
•
|
For the prior 30 consecutive business days, the bid price of our common stock on The NASDAQ Global Market closed below the minimum $1.00 per share required for continued inclusion under NASDAQ Marketplace Rule 5810(c)(3)(A), or the Minimum Bid Price Rule.
|
•
|
For the prior 30 consecutive business days, our stockholders’ equity did not comply with the minimum stockholders’ equity requirement of $5,000,000 for continued listing on The NASDAQ Global Market pursuant to NASDAQ Marketplace Rule 5810(c)(3)(D), or the Minimum Market Value Rule.
|
•
|
not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting;
|
•
|
not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;
|
•
|
reduced disclosure obligations regarding executive compensation; and
|
•
|
exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
|
ELEVEN BIOTHERAPEUTICS, INC.
|
||
|
|
|
By:
|
|
/s/ John J. McCabe
|
|
|
John J. McCabe
|
|
|
Chief Financial Officer (Principal Financial and Accounting Officer)
|
Exhibit
No.
|
|
Description
|
10.1*†
|
|
License Agreement, dated as of June 10, 2016, by and among Eleven Biotherapeutics, Inc., F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc.
|
31.1
|
|
Rule 13a-14(a) Certification of Principal Executive Officer
|
31.2
|
|
Rule 13a-14(a) Certification of Principal Financial Officer
|
32.1
|
|
Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. §1350
|
101.INS*
|
|
XBRL Instance Document
|
101.SCH*
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL*
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF*
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB*
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE*
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
*
|
Filed herewith.
|
†
|
Confidential treatment requested as to portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
|
1.
|
Definitions
|
1
|
|
|
|
1.1
|
Affiliate
|
1
|
|
|
1.2
|
Agreement
|
1
|
|
|
1.3
|
Agreement Term
|
2
|
|
|
1.4
|
Alternative Transaction
|
2
|
|
|
1.5
|
Applicable Law
|
2
|
|
|
1.6
|
Base Returnable Product
|
2
|
|
|
1.7
|
Biosimilar Product
|
2
|
|
|
1.8
|
BLA
|
2
|
|
|
1.9
|
Business Day
|
2
|
|
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1.10
|
Calendar Quarter
|
3
|
|
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1.11
|
Calendar Year
|
3
|
|
|
1.12
|
Carve-Out Transaction
|
3
|
|
|
1.13
|
Change of Control
|
3
|
|
|
1.14
|
Change of Control Group
|
3
|
|
|
1.15
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Clinical Study
|
3
|
|
|
1.16
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Combination Product
|
3
|
|
|
1.17
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Commercially Reasonable Efforts
|
4
|
|
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1.18
|
Companion Diagnostic
|
4
|
|
|
1.19
|
Composition of Matter Claim
|
4
|
|
|
1.20
|
Compound
|
4
|
|
|
1.21
|
Compulsory Sublicense Compensation
|
4
|
|
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1.22
|
Confidential Information
|
5
|
|
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1.23
|
Continuation Election Evaluation Process
|
5
|
|
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1.24
|
Continuation Election Notice
|
5
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1.25
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Control
|
5
|
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1.26
|
Cover
|
6
|
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1.27
|
Core Compound Patent Rights
|
6
|
|
|
1.28
|
Early Returnable Product
|
6
|
|
|
1.29
|
Effective Date
|
6
|
|
|
1.30
|
Eleven Base Patent Rights
|
6
|
|
|
1.31
|
Eleven Cell Line Materials
|
6
|
|
|
1.32
|
Eleven Compounds
|
6
|
|
|
1.33
|
Eleven Know-How
|
7
|
|
|
1.34
|
Eleven Patent Rights
|
7
|
|
|
1.35
|
EU
|
7
|
|
|
1.36
|
Excluded Eleven Patent Right
|
7
|
|
|
1.37
|
Exclusivity Agreement
|
7
|
|
|
1.38
|
Expert
|
7
|
|
|
1.39
|
Expiration Date
|
8
|
|
|
1.40
|
Extended Roche GLP Tox Study
|
8
|
|
|
1.41
|
FDA
|
8
|
|
|
1.42
|
FDCA
|
8
|
|
|
1.43
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Field
|
8
|
|
|
1.44
|
Filing
|
8
|
|
|
1.45
|
First Commercial Sale
|
8
|
|
|
1.46
|
First Option Period
|
9
|
|
|
1.47
|
FujiFilm
|
9
|
|
|
1.48
|
Handle
|
9
|
|
|
1.49
|
ICD-10
|
9
|
|
|
1.50
|
IFRS
|
9
|
|
|
1.51
|
IND
|
9
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1.52
|
IND Clearance
|
9
|
|
|
1.53
|
IND Clearance Activities
|
9
|
|
|
1.54
|
Indication
|
10
|
|
|
1.55
|
Infringe
|
10
|
|
|
1.56
|
Initiation
|
10
|
|
|
1.57
|
Inventory
|
10
|
|
|
1.58
|
Know-How
|
10
|
|
|
1.59
|
Licensed Compound
|
10
|
|
|
1.60
|
Licensed Product
|
10
|
|
|
1.61
|
Major EU Country
|
11
|
|
|
1.62
|
Modified Returnable Product
|
11
|
|
|
1.63
|
Net Sales
|
11
|
|
|
1.64
|
Non-Prosecution Claim
|
11
|
|
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1.65
|
Non-Prosecution Patent Right
|
12
|
|
|
1.66
|
Party
|
12
|
|
|
1.67
|
Patent Rights
|
12
|
|
|
1.68
|
Phase I Study
|
12
|
|
|
1.69
|
Phase II Study
|
12
|
|
|
1.70
|
Phase III Study
|
12
|
|
|
1.71
|
Pre-Commercialized Returnable Product
|
12
|
|
|
1.72
|
Primary Composition of Matter Claim
|
12
|
|
|
1.73
|
Product
|
13
|
|
|
1.74
|
Proprietary Manufacturing IP
|
13
|
|
|
1.75
|
Qualified Person
|
13
|
|
|
1.76
|
Regulatory Approval
|
13
|
|
|
1.77
|
Regulatory Authority
|
13
|
|
|
1.78
|
Required Company Stockholder Vote
|
13
|
|
|
1.79
|
Responsibility Transfer Date
|
14
|
|
|
1.80
|
Returnable Product
|
14
|
|
|
1.81
|
Roche Activated Termination
|
14
|
|
|
1.82
|
Roche Group
|
14
|
|
|
1.83
|
Roche Group Third Party
|
14
|
|
|
1.84
|
Roche Know-How
|
14
|
|
|
1.85
|
Roche Patent Rights
|
14
|
|
|
1.86
|
Royalty Term
|
14
|
|
|
10.4
|
Currency Conversion
|
28
|
|
|
10.5
|
Reporting
|
|
|
11.
|
Taxes
|
29
|
|
|
12.
|
Auditing
|
29
|
|
|
|
12.1
|
Eleven Right to Audit
|
29
|
|
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12.2
|
Audit Reports
|
30
|
|
|
12.3
|
Over- or Underpayment
|
30
|
|
13.
|
Intellectual Property
|
30
|
|
|
|
13.1
|
Prosecution of Primary Eleven Patent Rights
|
30
|
|
|
13.2
|
Prosecution of Select Non-Prosecution Patent Rights
|
31
|
|
|
13.3
|
Patent Coordination Liaison
|
31
|
|
|
13.4
|
Infringement
|
31
|
|
|
13.5
|
Defense
|
33
|
|
|
13.6
|
Common Interest Disclosures
|
33
|
|
|
13.7
|
Biosimilar or interchangeable biological products
|
34
|
|
|
13.8
|
Patent Term Extensions
|
34
|
|
|
13.9
|
Consent to File Patent Applications
|
34
|
|
14.
|
Representations and Warranties
|
34
|
|
|
|
14.1
|
Eleven Representations and Warranties
|
34
|
|
|
14.2
|
Roche Representations and Warranties
|
36
|
|
|
14.3
|
No Other Representations
|
37
|
|
15.
|
Indemnification
|
37
|
|
|
16.
|
Liability
|
38
|
|
|
|
16.1
|
Limitation of Liability
|
38
|
|
|
16.2
|
Coordination
|
38
|
|
17.
|
Obligation Not to Disclose Confidential Information
|
38
|
|
|
|
17.1
|
Non-Use and Non-Disclosure
|
38
|
|
|
17.2
|
Permitted Disclosure
|
38
|
|
|
17.3
|
Press Releases
|
38
|
|
|
17.4
|
Commercial Considerations
|
39
|
|
18.
|
Agreement Expiration and Termination
|
40
|
|
|
|
18.1
|
Commencement and Expiration
|
40
|
|
|
18.2
|
Termination
|
41
|
|
|
18.3
|
Consequences of Termination
|
42
|
|
|
18.4
|
Royalty and Payment Obligations
|
48
|
|
|
18.5
|
Survival
|
48
|
|
19.
|
Solicitation
|
48
|
|
|
20.
|
Bankruptcy
|
49
|
|
|
21.
|
Miscellaneous
|
49
|
|
|
|
21.1
|
Governing Law
|
49
|
|
|
21.2
|
Disputes
|
49
|
|
|
21.3
|
Jurisdiction; Arbitration
|
49
|
|
|
21.4
|
Assignment and Change of Control
|
50
|
|
|
21.5
|
Debarment
|
51
|
|
1.
|
Definitions
|
1.1
|
Affiliate
|
1.2
|
Agreement
|
1.3
|
Agreement Term
|
1.4
|
Alternative Transaction
|
1.5
|
Applicable Law
|
1.6
|
Base Returnable Product
|
1.7
|
Biosimilar Product
|
1.8
|
BLA
|
1.9
|
Business Day
|
1.10
|
Calendar Quarter
|
1.11
|
Calendar Year
|
1.12
|
Carve-Out Transaction
|
1.13
|
Change of Control
|
1.14
|
Change of Control Group
|
1.15
|
Clinical Study
|
1.16
|
Combination Product
|
a)
|
a single pharmaceutical formulation containing as its active ingredients both
|
(i)
|
a Compound and
|
(ii)
|
one or more other therapeutically or prophylactically active ingredients that are not Compounds (each such therapeutically or prophylactically active ingredients, a “
Non-Compound Active Agent
”), or
|
b)
|
a combination therapy comprised of
|
(i)
|
a Compound and
|
(ii)
|
one or more other therapeutically or prophylactically active products containing at least one Non-Compound Active Agent but not containing any Compounds,
|
1.17
|
Commercially Reasonable Efforts
|
(i)
|
with respect to Eleven, the efforts that a company of comparable size and resources to and at the same stage of development as Eleven devotes, and
|
(ii)
|
with respect to Roche, the efforts that Roche devotes,
|
1.18
|
Companion Diagnostic
|
1.19
|
Composition of Matter Claim
|
1.20
|
Compound
|
1.21
|
Compulsory Sublicense Compensation
|
1.22
|
Confidential Information
|
(i)
|
was generally available to the public at the time of disclosure by the Disclosing Party to the Receiving Party, or becomes available to the public after disclosure by the Disclosing Party to the Receiving Party other than through fault (whether by action or inaction) of the Receiving Party or any of its Affiliates under circumstances permitting its use or disclosure,
|
(ii)
|
can be evidenced by written records to have been already known to the Receiving Party or any of its Affiliates prior to its receipt from the Disclosing Party,
|
(iii)
|
is obtained by the Receiving Party or any of its Affiliates at any time lawfully from a Third Party under circumstances permitting its use or disclosure,
|
(iv)
|
is developed independently by the Receiving Party or any of its Affiliates as evidenced by written records other than through knowledge of or reference to the Disclosing Party’s Confidential Information, or
|
(v)
|
is approved in writing by the Disclosing Party for release by the Receiving Party.
|
1.23
|
Continuation Election Evaluation Process
|
1.24
|
Continuation Election Notice
|
1.25
|
Control
|
1.26
|
Cover
|
1.27
|
Core Compound Patent Rights
|
1.28
|
Early Returnable Product
|
1.30
|
Eleven Base Patent Rights
|
(a)
|
are Controlled by Eleven on the Signature Date or
|
(b)
|
are Controlled by Eleven and claim first priority to an application filed after the Signature Date and claim an invention conceived or reduced to practice before the Signature Date by an employee of Eleven or an individual with an obligation to assign all rights in such invention and related Patent Rights to Eleven,
|
1.31
|
Eleven Cell Line Materials
|
1.32
|
Eleven Compounds
|
(i)
|
EBI-031 (“
EBI-031
”),
|
(ii)
|
EBI-028,
|
(iii)
|
EBI-029, and
|
(iv)
|
EBI-030.
|
1.33
|
Eleven Know-How
|
(i)
|
on the Signature Date or
|
(ii)
|
during the Agreement Term but prior to a Change of Control (however for clarity, even in the event of a Change of Control, Eleven Know-How includes the Know-How relating to Licensed Compounds and Licensed Products to be transferred to Roche in connection with Articles 4, 5 and 6).
|
1.34
|
Eleven Patent Rights
|
(a)
|
the Eleven Base Patent Rights and
|
(b)
|
to the extent not included in Eleven Base Patent Rights, the Patent Rights that Eleven Controls on the period commencing the day after the Signature Date and ending at the end of the Agreement Term; provided, however, that
|
(i)
|
if Roche has exercised a Buy-Out Option, such period shall end on the second (2nd) anniversary of the Expiration Date, and
|
(ii)
|
in any event, such period shall end on the occurrence of a Change of Control,
|
1.35
|
EU
|
1.36
|
Excluded Eleven Patent Right
|
1.37
|
Exclusivity Agreement
|
1.38
|
Expert
|
1.39
|
Expiration Date
|
(a)
|
the date Roche provides timely written notice of exercise of a Buy-out Option, or
|
(b)
|
if Roche does not provide timely written notice of exercise of a Buy-out Option, then on the date after the First Commercial Sale of any Licensed Product when (i) Roche is not conducting any
|
1.40
|
Extended Roche GLP Tox Study
|
(a)
|
an FDA-Required GLP Tox Study or
|
(b)
|
a GLP toxicity study that (i) is not required by the FDA for IND Clearance but still satisfies the FDA’s requirements for IND Clearance and (ii) is not run in parallel with or after an FDA-Required GLP Tox Study designed such that the last dose is administered to subjects fifteen (15) or fewer weeks after the administration of the first dose.
|
1.41
|
FDA
|
1.42
|
FDCA
|
1.43
|
Field
|
1.44
|
Filing
|
1.45
|
First Commercial Sale
|
1.46
|
First Option Period
|
1.47
|
FujiFilm
|
1.48
|
Handle
|
1.49
|
ICD-10
|
1.50
|
IFRS
|
1.51
|
IND
|
1.52
|
IND Clearance
|
1.53
|
IND Clearance Activities
|
(a)
|
new GLP toxicology stud(y)(ies) required by the FDA to achieve IND Clearance for EBI-031 (each an “
FDA-Required GLP Tox Study
”),
|
(b)
|
IND Clearance Activities that the Parties mutually agree should be conducted by Roche; and
|
(c)
|
on or after September 16, 2016, any IND Clearance Activities that Roche requests to either conduct or take over from Eleven.
|
1.54
|
Indication
|
1.55
|
Infringe
|
1.56
|
Initiation
|
1.57
|
Inventory
|
1.58
|
Know-How
|
1.59
|
Licensed Compound
|
(a)
|
any Eleven Compound or
|
(b)
|
any other Compound that (i) is Covered by a Core Compound Patent Right in the US or EU or (ii) was Covered by an issued Core Compound Patent Right in the US or EU that has expired less than ten (10) years from the applicable date.
|
1.60
|
Licensed Product
|
1.61
|
Major EU Country
|
1.62
|
Modified Returnable Product
|
1.63
|
Net Sales
|
1.64
|
Non-Prosecution Claim
|
1.65
|
Non-Prosecution Patent Right
|
1.66
|
Party
|
1.67
|
Patent Rights
|
1.68
|
Phase I Study
|
1.69
|
Phase II Study
|
(i)
|
a control arm (placebo or standard of care),
|
(ii)
|
a minimum of one hundred (100) patients per indication (except (x) if the indication is an orphan indication as determined under Applicable Law, in which case there shall be no such minimum, or (y) if the clinical trial is intended to explore multiple indications in the same arm or arms of
|
(iii)
|
a minimum duration of dosing for each patient of five (5) months from the initial dose until the last dose, regardless of how frequently any such patients are dosed,
|
1.70
|
Phase III Study
|
1.71
|
Pre-Commercialized Returnable Product
|
1.72
|
Primary Composition of Matter Claim
|
1.73
|
Product
|
1.74
|
Proprietary Manufacturing IP
|
1.75
|
Qualified Person
|
1.76
|
Regulatory Approval
|
1.77
|
Regulatory Authority
|
1.78
|
Required Company Stockholder Vote
|
1.79
|
Responsibility Transfer Date
|
(a)
|
the date of the IND Clearance for a Licensed Product containing EBI-031 or
|
(b)
|
in the case of on-going Roche IND Clearance Activities, the conclusion of Eleven IND Clearance Activities (with the Parties to work in good faith to agree upon the appropriate date for conclusion of Eleven IND Clearance Activities).
|
1.80
|
Returnable Product
|
1.81
|
Roche Activated Termination
|
1.82
|
Roche Group
|
1.83
|
Roche Group Third Party
|
1.84
|
Roche Know-How
|
1.85
|
Roche Patent Rights
|
1.86
|
Royalty Term
|
1.87
|
Sales
|
(i)
|
the amount stated in the Roche Holding AG “Sales” line of its externally published audited consolidated financial statements with respect to such Licensed Product for such period (excluding sales for resale to any Sublicensees that are not Affiliates of Roche). This amount reflects the gross invoice price at which such Licensed Product was sold or otherwise disposed of (other than for use as clinical supplies or free samples) by Roche and its Affiliates to such Third Parties (excluding sales to any Sublicensees that are not Affiliates of Roche) in such period reduced by gross-to-net deductions, if not previously deducted from such invoiced amount, taken in accordance with the then currently used IFRS.
|
(a)
|
credits, reserves or allowances granted for (i) damaged, outdated, returned, rejected, withdrawn or recalled Licensed Product, (ii) wastage replacement and short-shipments; (iii) billing errors and (iv) indigent patient and similar programs (
e.g.
, price capitation);
|
(b)
|
governmental price reductions and government mandated rebates;
|
(c)
|
chargebacks, including those granted to wholesalers, buying groups and retailers;
|
(d)
|
customer rebates, including cash sales incentives for prompt payment, cash and volume discounts; and
|
(e)
|
taxes, duties and any other governmental charges or levies imposed upon or measured by the import, export, use, manufacture or sale of a Licensed Product (excluding income or franchise taxes).
|
(ii)
|
for Sublicensees that are not Roche Affiliates (and excluding Compulsory Sublicensees), the sales amounts reported to Roche and its Affiliates in accordance with the sublicensee contractual terms and their then-currently used accounting standards. For the purpose of clarity, any such Sublicensee sales as reported to Roche in accordance with Compulsory Sublicense agreements shall be excluded from the sales amount.
|
1.88
|
Secondary Composition of Matter Claim
|
1.89
|
Second Option Period
|
1.90
|
Signature Date
|
1.91
|
Stockholder Voting Proposal
|
1.92
|
Sublicensee
|
1.93
|
Symbiosis
|
1.94
|
Territory
|
1.95
|
Third Party
|
1.96
|
Third Party Eleven IP
|
1.97
|
US
|
1.98
|
US$
|
1.99
|
Valid Claim
|
1.100
|
Additional Definitions
|
Definition
|
Section
|
Accounting Period
|
10.1
|
Alliance Director
|
8.1
|
Bankruptcy Code
|
20
|
Breaching Party
|
18.2.1
|
Buy-out Notice
|
9.4
|
Buy-out Option
|
9.4
|
CEEP Start Date
|
18.3.2
|
Chugai
|
1.1
|
Company Meeting
|
1.78
|
Compound-Free Product
|
1.64
|
Compulsory Profit Share Percentage
|
9.3.8
|
Compulsory Sublicense
|
1.21
|
Compulsory Sublicensee
|
1.21
|
Core Patent Rights
|
1.30
|
Decision Period
|
13.4
|
EBI-031
|
1.32
|
Eleven Assigned Patent Rights
|
13.1.2
|
Eleven IND Clearance Activities
|
1.53
|
Eleven MTA Information
|
21.10
|
Eleven NDA Information
|
21.10
|
Eleven-Originated Transfer Activities
|
18.3.4.3
|
Excluded Roche Patent Rights
|
1.85
|
Expert Committee
|
9.3.3
|
Extended Roche GLP Tox Study Event
|
9.2
|
FDA-Required GLP Tox Study
|
1.53(a)
|
First Buy-out Option
|
9.4
|
FMI
|
1.1
|
Definition
|
Section
|
HSR Act
|
14.1.5
|
Indemnified Party
|
15.3
|
Indemnifying Party
|
15.3
|
Initiating Party
|
13.4
|
Involuntary Termination
|
1.81
|
Minimum Transfer Payment
|
18.3.4.3
|
MTA
|
13.9
|
NDA
|
21.10
|
Non-Breaching Party
|
18.2.1
|
Non-Compound Active Agent
|
1.16
|
Patent Term Extensions
|
13.8
|
Payment Currency
|
10.3
|
Peremptory Notice Period
|
18.2.1
|
Primary Eleven Patent Rights
|
13.1.1
|
Redacted Agreement
|
17.4
|
Reference Product Sponsor
|
13.7
|
Relative Commercial Value
|
9.3.3
|
Representatives
|
19
|
Roche IND Clearance Activities
|
1.53
|
Roche Indemnitees
|
15.2
|
Roche Transfer Activities
|
18.3.4.3
|
Samples and PI Information
|
18.3.4.3
|
Second Buy-out Option
|
9.4
|
Select Non-Prosecution Patent Rights
|
13.2
|
Sensitive Information
|
21.4(c)
|
Settlement
|
13.4
|
SPCs
|
13.8
|
Suit Notice
|
13.4
|
Voluntary Termination
|
1.81
|
2.
|
Grant of License
|
2.1
|
Grant of Rights
|
2.2
|
License
|
2.3
|
Sublicense
|
2.3.1
|
Right to Sublicense to its Affiliates
|
2.3.2
|
Right to Sublicense to Third Parties
|
2.3.3
|
Right to Subcontract
|
2.4
|
Retained Rights
|
3.
|
Diligence
|
4.
|
Development
|
4.1
|
Development for IND Clearance
|
4.2
|
Development Other Than IND Clearance Activities
|
5.
|
Regulatory
|
5.1
|
Responsibility
|
5.2
|
Disclosure Covenant
|
6.
|
Manufacture and Supply of Product
|
6.1
|
Product Inventory
|
6.2
|
Responsibility and Transfer
|
6.3
|
GMP Quality Agreements and Auditing
|
(a)
|
promptly enter into a GMP quality agreement with Eleven’s CMOs (including Eurofins Lancaster Laboratories, Inc.), and
|
(b)
|
in good faith facilitate a joint GMP audit of such CMOs by Eleven with Roche, in each case at Roche’s expense.
|
7.
|
Commercialization
|
8.
|
Information Exchange and Reports
|
8.1
|
Alliance Director
|
8.2
|
Updates to Eleven
|
9.
|
Payment
|
9.1
|
License Fee
|
9.2
|
Event Payments
|
Event
|
US Dollars (in millions)
|
|
IND Clearance-Related Events
|
(a) IND Clearance (if IND Clearance is achieved on or before September 15, 2016)
|
$22.5*
|
(b) IND Clearance (if IND Clearance is achieved after September 15, 2016 and no Extended Roche GLP Tox Study)
|
$20*
|
|
(c) Initiation of the first Extended Roche GLP Tox Study (the “
Extended Roche GLP Tox Study Event
”)
|
$5*
|
|
(d) IND Clearance (if IND Clearance is achieved after September 15, 2016 and subsequent to completion of an Extended Roche GLP Tox Study)
|
$15
|
|
Initiation of the first Phase II Study
|
$20
|
|
Initiation of the first Phase III Study
|
$30
|
|
BLA Filing in US
|
$25
|
|
BLA Filing anywhere in the EU**
|
$15
|
|
BLA Filing in Japan
|
$10
|
|
First Commercial Sale in US
|
$40
|
|
First Commercial Sale anywhere in the EU**
|
$25
|
|
First Commercial Sale in Japan
|
$10
|
|
BLA Filing for a second Indication in US
|
$10
|
|
BLA Filing for a second Indication anywhere in the EU**
|
$5
|
|
Regulatory Approval in a second Indication in US
|
$30
|
|
Regulatory Approval in a second Indication anywhere in the EU**
|
$20
|
9.3
|
Royalty Payments
|
9.3.1
|
Royalty Term
|
9.3.2
|
Royalty Rates
|
Tier of Calendar Year
Net Sales in billion US$
|
Percent (%) of Net Sales of Licensed Products containing EBI-031*
|
0 – 1
|
7.5%
|
> 1 – 2
|
9%
|
> 2 – 4
|
11%
|
> 4
|
15%
|
9.3.3
|
Combination Product
|
9.3.4
|
No Primary Composition of Matter Claim
|
(a)
|
If, after the ten year anniversary of the First Commercial Sale of such Licensed Product in such country, there is a Secondary Composition of Matter Claim Covering such Licensed Product in such country and a Biosimilar Product has entered the market in such country then no royalty payments shall be due to Eleven for such Licensed Product in such country; otherwise
|
(b)
|
the royalty payments due to Eleven for such Licensed Product in such country shall be reduced by fifty percent (50%).
|
9.3.5
|
Biosimilar Product
|
(a)
|
If a Product that is a Biosimilar Product to a given Licensed Product enters the market in a given country prior to the end of the Royalty Term and Net Sales of such Licensed Product in such country subsequently decrease for two consecutive Calendar Quarters by more than twenty-five percent (25%) of the level of the Net Sales of such Licensed Product in such country achieved in the Calendar Year immediately prior to such entry divided by four, then the royalty rate owed to Eleven for such Licensed Product shall be reduced by fifty percent (50%) in such country.
|
(b)
|
If subsequent to such a Biosimilar Product entry, the Net Sales of such Licensed Product in such country decrease by more than fifty percent (50%) of the level of the Net Sales of such Licensed Product in such country achieved in the Calendar Year immediately prior to such entry divided by four, then the royalty rate owed to Eleven in such country for such Licensed Product shall be reduced by seventy-five percent (75%) in such country.
|
9.3.6
|
Third Party Payments
|
(a)
|
The Roche Group shall not have the right to deduct any amounts paid by the Roche Group for any Patent Right that claims (i) any pharmaceutically-active compound other than a Licensed Compound, (ii) any use claims (except those claiming one or more approved Indications for the Licensed Product in the given country) or (iii) any manufacturing claims.
|
(b)
|
For all other Patent Rights that the Roche Group otherwise would have Infringed by selling the relevant Licensed Product in the relevant country, the Roche Group shall have the right to deduct from royalties otherwise due and payable by the Roche Group to Eleven for such Licensed Product in such country under the Agreement (i) a maximum of fifty percent (50%) of the royalties actually paid by the Roche Group to a Roche Group Third Party with respect to such arrangement except for Patent Rights that claim any delivery device and (i) a maximum of twenty-five percent (25%) of the royalties actually paid by the Roche Group to a Roche Group Third Party with respect to such arrangement for Patent Rights that claim any delivery device. Roche may not otherwise deduct the amounts paid to any such Roche Group Third Party, including any amounts for the development of any Licensed Product.
|
9.3.7
|
Maximum Deductions
|
9.3.8
|
Apportionment of Compulsory Sublicensee Consideration
|
1.5
x
|
(royalties payable to Eleven for the Licensed Product in the Territory)
|
(Net Sales related to the royalties payable for the Licensed Product in the Territory)
|
9.4
|
Buy-out Options
|
(i)
|
Two Hundred Sixty-Five Million US Dollars (US$ 265,000,000) in the event a Patent Right containing a Primary Composition of Matter Claim Covering any Licensed Compound or Licensed Product has issued anywhere in the EU, or
|
(ii)
|
Two Hundred Twenty Million US Dollars (US$ 220,000,000) in the event no Patent Right containing a Primary Composition of Matter Claim Covering any Licensed Compound or Licensed Product has issued anywhere in the EU,
|
9.5
|
Disclosure of Payments
|
10.
|
Accounting and Reporting
|
10.1
|
Timing of Payments
|
10.2
|
Late Payment
|
10.3
|
Method of Payment
|
10.4
|
Currency Conversion
|
10.5
|
Reporting
|
(a)
|
Sales in Swiss Francs;
|
(b)
|
Net Sales in Swiss Francs;
|
(c)
|
adjustments made pursuant to Section 9.3.3;
|
(d)
|
Net Sales in Swiss Francs after adjustments made pursuant to Section 9.3.3 in Swiss Francs;
|
(e)
|
exchange rate used for the conversion of Net Sales from Swiss Francs to the Payment Currency pursuant to Section 10.4;
|
(f)
|
Net Sales after adjustments made pursuant to Section 9.3.3 in the Payment Currency;
|
(g)
|
royalty rate pursuant to Section 9.3.2;
|
(h)
|
adjustments under Sections 9.3.4 - 9.3.7; and
|
(i)
|
total royalty payable in the Payment Currency after adjustments made pursuant to Sections 9.3.4 - 9.3.7.
|
11.
|
Taxes
|
12.
|
Auditing
|
12.1
|
Eleven Right to Audit
|
12.2
|
Audit Reports
|
12.3
|
Over- or Underpayment
|
13.
|
Intellectual Property
|
13.1
|
Prosecution of Primary Eleven Patent Rights
|
13.1.1
|
Prior to Exercising Buy-out Option
|
(i)
|
Core Patent Rights and
|
(ii)
|
other Eleven Patent Rights (excluding Non-Prosecution Patent Rights) claiming Products or any Compound therein (or any uses thereof) for a Product that has reached at least Initiation of a Phase I Study in development by or on behalf of a member of the Roche Group,
|
(a)
|
Roche shall use Commercially Reasonable Efforts to Handle Primary Eleven Patent Rights, without Roche taking into account the payment reductions under this Agreement that would occur if any such Patent Rights were not to exist or if any applicable Composition of Matter Claim were not to exist.
|
(b)
|
Should Roche decide that it does not desire to Handle a Primary Eleven Patent Right, it shall promptly advise Eleven thereof in writing in sufficient time as is reasonably needed for Eleven to not lose any rights with respect to such Primary Eleven Patent Right. Eleven may thereafter Handle the same at Eleven’s own cost, to the extent that Eleven desires to do so.
|
13.1.2
|
After Exercising Buy-out Option
|
13.2
|
Prosecution of Select Non-Prosecution Patent Rights
|
13.3
|
Patent Coordination Liaison
|
13.4
|
Infringement
|
(i)
|
known infringement or suspected infringement by a Roche Group Third Party of any Valid Claim of the Primary Eleven Patent Rights through the unauthorized manufacture, use, sale or importation of a Licensed Compound or Licensed Product, or
|
(ii)
|
known or suspected unauthorized use or misappropriation by a Roche Group Third Party of any Eleven Know-How in the unauthorized manufacture, use, sale or importation of a Licensed Compound or Licensed Product by such Roche Group Third Party,
|
(i)
|
if a member of the Roche Group is the Initiating Party,
|
(A)
|
any remaining amount that represents compensation for lost sales, a reasonable royalty or lost profits, shall be retained by or paid to the Initiating Party; provided, however, any such amount (after relevant adjustment to convert to Net Sales of Products) shall be subject to the royalty obligations set forth in Section 9.3; and
|
(B)
|
any remaining amount that represents additional damages (e.g., enhanced or punitive damages) shall be allocated to Roche; and
|
(ii)
|
if Eleven is the Initiating Party, the balance, if any, shall be allocated seventy five percent (75%) to the Initiating Party, and twenty five percent (25%) to the other Party.
|
13.5
|
Defense
|
13.6
|
Common Interest Disclosures
|
13.7
|
Biosimilar or interchangeable biological products
|
13.8
|
Patent Term Extensions
|
13.9
|
Consent to File Patent Applications
|
14.
|
Representations and Warranties
|
14.1
|
Eleven Representations and Warranties
|
14.1.1
|
Safety Data
|
(a)
|
Eleven has disclosed to Roche and, to the extent set forth in Section 5.2, will promptly disclose to Roche the results of all preclinical testing of Licensed Product in its Control.
|
(b)
|
Eleven has not conducted human clinical testing of any Licensed Product. In accordance with Section 5.2, Eleven will disclose to Roche all information in its Control concerning side effects, injury, toxicity or sensitivity reaction and incidents or severity thereof in humans with respect to Licensed Product.
|
14.1.2
|
Ownership of Patent Rights
|
14.1.3
|
Third Party Eleven IP
|
14.1.4
|
Inventors
|
14.1.5
|
Grants
|
14.1.6
|
Authorization
|
14.1.7
|
Validity of Patent Rights
|
14.1.8
|
Ownership and Validity of Know-How
|
14.1.9
|
No Claims
|
14.1.10
|
Scope of License
|
14.2
|
Roche Representations and Warranties
|
14.2.1
|
Authorization
|
14.2.2
|
No Claims
|
14.3
|
No Other Representations
|
15.
|
Indemnification
|
15.1
|
Indemnification by Roche
|
15.2
|
Indemnification by Eleven
|
15.3
|
Procedure
|
16.
|
Liability
|
16.1
|
Limitation of Liability
|
(a)
|
Subject to Article 3, neither Party shall be liable to the other Party as a result of failure or delay to develop or commercialize the Licensed Compound or the Licensed Product, as applicable, including but not limited to, a) a delay in timelines, or b) delay or failure to recruit patients, or c) a change in its respective study protocols, or d) failure of the other Party to obtain Regulatory Approval for the Licensed Compound or the Licensed Product, as applicable.
|
(b)
|
EXCEPT FOR INDEMNIFICATION UNDER ARTICLE 15, NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, INDIRECT OR PUNITIVE DAMAGES, OR LOST PROFITS, IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER REGARDLESS OF THE FORM OF ACTION THROUGH WHICH ANY OF THE FOREGOING ARE SOUGHT.
|
16.2
|
Coordination
|
17.
|
Obligation Not to Disclose Confidential Information
|
17.1
|
Non-Use and Non-Disclosure
|
17.2
|
Permitted Disclosure
|
17.3
|
Press Releases
|
(a)
|
The Parties may issue solely or jointly the press releases announcing the existence and selected key terms of this Agreement, in a form substantially similar to the templates attached as Appendix 17.3.
|
(b)
|
Eleven shall only issue other press releases related to the activities contemplated by this Agreement that either (i) have been approved by Roche or (ii) are required to be issued by Eleven as a matter of law based on advice of legal counsel. In all such circumstances, Eleven shall provide Roche with a draft press release at least two (2) weeks prior to its intended publication for Roche's review. During such period, Roche shall (i) approve the draft press release and permit Eleven to issue the press release, (ii) contact Eleven to discuss modification to the draft press release, or (iii) contact Eleven and disapprove the press release. If Roche asks for modification, then Eleven shall either make such modification or work with Roche to arrive at a press release that Roche approves.
|
(c)
|
Notwithstanding anything else to the contrary in this Agreement, Eleven may issue press releases or announcements, make filings or submissions or otherwise publicly disclose information regarding this Agreement and the transactions contemplated hereby without the prior written consent of Roche to the extent required by Applicable Law or the rules or regulations of any applicable U.S. or non-U.S. securities exchange or regulatory governmental body to which it is subject to or submits to, including any disclosures contained in proxy or other similar materials issued in connection with the Stockholder Voting Proposal; provided, however, the issuance by Eleven of any such press release without following the procedures of Section 17.3(b) must be based on advice of legal counsel that the release was required to be issued by Eleven as a matter of law. Notwithstanding the foregoing, in all such cases Eleven shall use Commercially Reasonable
|
(d)
|
To the extent the content of any press release or other announcement has been made in accordance with this Section 17.3 or with Section 17.4, no separate approval shall be required in respect of such content to the extent replicated in whole or in part in any subsequent press release or other announcement.
|
(e)
|
To ensure communication alignment, responses (if any) to inquiries by media or other Third Parties (other than inquiries by any governmental authority, body, agency or other instrumentality) after issuance of a permitted press release by Eleven (solely or jointly with Roche) shall consist solely of the press release language or shall follow the response guidelines that may be mutually developed by the Parties.
|
17.4
|
Commercial Considerations
|
(a)
|
After the Effective Date, nothing in this Agreement shall prevent Roche or its Affiliates from disclosing Confidential Information of Eleven to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture or sale of Product in the Territory, (ii) Third Parties acting on behalf of Roche, to the extent reasonably necessary for the development, manufacture or sale of Product in the Territory, or (iii) Third Parties to the extent reasonably necessary to market the Product in the Territory.
|
(b)
|
Either Party may disclose this Agreement to actual or potential licensees, sublicensees, acquirers or investors under terms of confidentiality no less stringent than in this Agreement.
|
(c)
|
The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with Applicable Law, to defend or prosecute litigation or to comply with governmental regulations, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party, if possible, and, to the extent practicable, takes reasonable and lawful actions to minimize the degree of such disclosure.
|
(d)
|
The Parties acknowledge that either or both Parties may be obligated to make one or more filings (including to file a copy of this Agreement) with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority. Each Party will be entitled to make such a required filing, provided that it will (i) submit in connection with such filing a copy of this Agreement in a form mutually agreed by the Parties in advance or, if despite the commercially reasonable efforts of Eleven a form mutually agreed by the Parties cannot be agreed in advance, redacted to the extent permitted by Applicable Law (the “
Redacted Agreement
”), (ii) request, and use commercially reasonable efforts consistent with Applicable Laws to obtain, confidential treatment of all terms redacted from this Agreement, as reflected in
|
18.
|
Agreement Expiration and Termination
|
18.1
|
Commencement and Expiration
|
18.2
|
Termination
|
18.2.1
|
Termination for Material Breach After the Effective Date
|
18.2.2
|
Termination by Roche without Cause After the Effective Date
|
18.2.3
|
Termination by Eleven for Development Discontinuation After the Effective Date
|
18.2.4
|
Termination for Eleven Debarment
|
18.2.5
|
Termination by a Party Prior to the Effective Date
|
(a)
|
Eleven will inform Roche of the date of the Company Meeting at which a vote of the Stockholder Voting Proposal is to be taken. Eleven will inform Roche of the results of the Company Meeting at which a vote on the Stockholder Voting Proposal was taken within one (1) Business Day of such meeting. Eleven will inform Roche within one (1) Business Day of a decision by the Board of Directors of Eleven to approve or recommend to the stockholders any Alternative Transaction from a Qualified Person.
|
(b)
|
Prior to the Effective Date, if, at the Company Meeting at which a vote on the Stockholder Voting Proposal is taken, the Required Company Stockholder Vote in favor of the Stockholder Voting Proposal is not obtained, this Agreement shall automatically terminate as of the date of such Company Meeting at which such vote on the Stockholder Voting Proposal was taken.
|
(c)
|
Prior to the Effective Date, Roche shall have the right to terminate this Agreement upon written notice if the Company Meeting at which a vote on the Stockholder Voting Proposal is taken does not occur on or prior to the seventy-fifth (75
th
) day following the Signature Date.
|
(d)
|
Prior to the Effective Date, either Party shall have the right to terminate this Agreement upon written notice if the Board of Directors of Eleven shall have approved or recommended to the stockholders any Alternative Transaction from a Qualified Person.
|
18.3
|
Consequences of Termination
|
18.3.1
|
Termination for Eleven Breach or Debarment
|
18.3.2
|
Roche Activated Termination
|
a)
|
Roche shall, and shall ensure that its Affiliates shall, (and, to the extent Roche or any of its Affiliates has the right to do so and to the extent such sublicensees do not take a direct license in accordance with Section 18.3.3, shall require the other members of the Roche Group to,) promptly transfer to Eleven all regulatory filings and approvals, all final pre-clinical and clinical study reports and clinical study protocols, and all data, including clinical data, in their possession and control related to Returnable Product(s) necessary for Eleven to continue to develop and commercialize the Returnable Product(s). All data shall be transferred in the form and format in which it is maintained by the relevant member of the Roche Group. Original paper copies shall only be transferred, if legally required. Roche shall not be required to prepare or finalize any new data, reports or information solely for purposes of transfer to Eleven.
|
b)
|
Roche shall, and shall ensure that its Affiliates shall, (and, to the extent Roche or any of its Affiliates has the right to do so and to the extent such sublicensees do not take a direct license in accordance with Section 18.3.3, shall require the other members of the Roche Group to,) make reasonable efforts to promptly assign all clinical trial agreements, to the extent such agreements have not been cancelled, are assignable without subjecting Roche to any material liability and are assignable without Roche paying any consideration (unless Eleven agrees to pay such consideration) or commencing litigation in order to effect an assignment of any such agreement.
|
c)
|
Eleven shall, upon such transfer, have the right to disclose such filings, approvals and data to (i) governmental agencies of the country to the extent required or desirable to secure government
|
d)
|
In exchange for Roche’s transfer of such items that were not originally provided from Eleven to Roche under this Agreement (i.e., created or developed by or on behalf of Roche), Eleven shall pay Roche a royalty on all net sales (as determined by reasonable accounting methods) of such Returnable Product(s) by Eleven, its Affiliates or licensees or sublicensees to which Eleven has licensed or sublicensed rights other than through a Compulsory Sublicense,
mutatis mutandis
, for such Returnable Product(s) (other than licensees that have a direct license in accordance with Section 18.3.3), with the royalty rate as follows:
|
e)
|
In connection with such transfer, and in all cases subject to Section 18.3.4.3, Eleven shall have a non-exclusive license, sublicensable through multiple tiers, under the Roche Patent Rights and Roche Know-How, solely to the extent necessary to allow Eleven, its Affiliates or licensees or sublicensees to register, have registered, develop, manufacture, have manufactured, use, offer to sell, sell, promote, export and import the Base Returnable Product associated with each applicable Returnable Product specified in such Continuation Election Notice and all associated applicable Modified Returnable Product(s) for such Base Returnable Product in the applicable country(ies),
with the proviso
that
|
(i)
|
with respect to Early Returnable Products, unless Roche specifically agrees to the contrary, such license shall not extend to Proprietary Manufacturing IP for Early Returnable Products;
|
(ii)
|
with respect to Returnable Products other than Early Returnable Products, such license does not apply to Proprietary Manufacturing IP for so long as Roche elects to manufacture and supply such Returnable Product under Section 18.3.4.2(c), and if Roche transfers the process to one or more Third Party CMOs acceptable to Roche under conditions of confidentiality and non-use acceptable to Roche in accordance with Section 18.3.4.2(c), such license of
|
f)
|
If requested by Eleven in writing, and solely to the extent Roche is able to do so truthfully, Roche will represent and warrant to Eleven that, as of the effective date of the termination, Roche and its Affiliates have not been debarred under 21 U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal Health Care Program (as defined in 42 U.S.C. §1320 a-7b(f)), including without limitation the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar Federal or state agency or program in a manner that would materially impact the Returnable Products.
|
18.3.3
|
Direct License
|
18.3.4
|
Other Obligations Applicable for Roche Activated Terminations
|
18.3.4.1
|
Obligations Related to Ongoing Activities
|
(a)
|
If Eleven does not provide timely a Continuation Election Notice, then Roche (i) shall have the right to cancel all ongoing obligations with Third Parties with respect to any terminated Returnable Product under this Agreement and (ii) shall be permitted to complete, and be solely responsibility for, all non-cancellable obligations with Third Parties with respect to any terminated Returnable Product, but only at its own expense.
|
(b)
|
If Eleven provides such timely Continuation Election Notice, then from the date of notice of termination until (i) the effective date of termination (in the event of a Voluntary Termination) and (ii) four (4) months after the effective date of termination (in the event of an Involuntary Termination), Roche shall continue activities, including preparatory activities, ongoing as of the date of notice of termination with respect to the relevant Returnable Products, at Roche’s expense. However, Roche shall not be obliged to initiate any new activities not ongoing at the date of notice of termination except as expressly set forth herein.
|
(c)
|
After the effective date of termination, Roche shall have no obligation to perform or complete any activities or to make any payments for performing or completing any activities under this Agreement, except as expressly stated herein.
|
(i)
|
both Eleven and Roche in their reasonable judgment have concluded that completing any such Clinical Studies does not present an unreasonable risk to patient safety;
|
(ii)
|
Roche shall have no obligation to recruit or enroll any additional patients after the effective date of termination; and
|
(iii)
|
Subject to Section 18.3.4.1(b), Eleven agrees to reimburse Roche for all of its reasonable development costs that arise after the effective date of termination in completing or transitioning such Clinical Studies.
|
18.3.4.2
|
Obligations Related to Manufacturing
|
a)
|
Clinical Supplies
|
b)
|
Commercial Supplies
|
c)
|
Option of Roche
|
18.3.4.3
|
Limitations on Grant-Backs; Transfer Expenses
|
a)
|
All transfers and licenses from Roche to Eleven or other obligations of Roche under Section 18.3 are solely with respect to Returnable Product(s) that are not Combination Product(s). Such transfers, licenses and obligations do not extend to
|
(i)
|
other therapeutically active ingredients or therapeutically active products, even if physically mixed, combined or packaged together with a Returnable Product, or
|
(ii)
|
with respect to Pre-Commercialized Returnable Products, delivery technologies that are proprietary to Roche (through ownership or license) (
with the proviso
that if Eleven would be unable to use any alternative delivery technology to commercialize such Pre-Commercialized Returnable Product, Roche will in good faith consider making such delivery technologies available to Eleven),
|
b)
|
In connection with research studies, clinical trials or other activities associated with the development and commercialization of Returnable Products, Roche or other members of the Roche Group may have collected human samples and patient information that may contain personal identifiable information (“
Samples and PI Information
”). Legal and contractual restrictions may apply to such Samples and PI Information. Eleven acknowledges and accepts that, where Roche in good faith has reasonable concerns that Applicable Law or insufficient patient consent would prohibit the transfer of such Samples and PI Information or subject Roche to liability because of such transfer and subsequent use by Eleven, then Roche shall not be obliged to transfer such Samples and PI Information to Eleven.
|
c)
|
Nothing in this Agreement shall be construed as granting Eleven any license under the Excluded Roche Patent Rights.
|
d)
|
If Eleven issues a Continuation Election Notice, then Eleven shall reimburse Roche for all reasonable out-of-pocket costs and expenses (including FTE charges) incurred by or on behalf of Roche for transfer activities from Roche to Eleven under Section 18.3.2 (including costs associated with locating, assembling and populating information into the data room) (“
Roche Transfer Activities
”) within thirty (30) days after receipt of an invoice, with an invoice to be provided no more than once per Calendar Quarter; however transfer activities corresponding to the return of material remains, data, reports, records, documents, regulatory filings and Regulatory Approvals originally provided by Eleven to Roche no less than three (3) years prior to the effective date of termination (“
Eleven-Originated Transfer Activities
”) shall be returned to Eleven free of charge. If the Agreement was terminated due to a Voluntary Termination and Eleven desires Roche Transfer Activities other than Eleven-Originated Transfer Activities, Eleven shall make a payment to Roche of Two Hundred Fifty Thousand US Dollars (US$ 250,000) (“
Minimum Transfer Payment
”) within thirty (30) days after receipt of an invoice. The Minimum Transfer Payment shall be non-refundable, but shall be fully creditable against Eleven’s reimbursement for the Roche Transfer Activities and payments under Section 18.3.2(d). Roche shall be under no obligation to provide Roche Transfer Activities (beyond the Eleven-Originated Transfer Activities) prior to receipt of the Minimum Transfer Payment, if applicable.
|
18.4
|
Royalty and Payment Obligations
|
18.5
|
Survival
|
19.
|
Solicitation
|
(a)
|
solicit, initiate or knowingly facilitate or knowingly encourage the submission of any proposal or offer from any Third Party for an Alternative Transaction;
|
(b)
|
enter into or participate in any discussions or negotiations with, furnish any non-public information relating to the IL-6 program to, or afford access to the business, properties, assets, books or records of the IL-6 program to, any Third Party that, to Eleven’s knowledge, is seeking to make, or has made, any proposal or offer for an Alternative Transaction, in each case relating to or in connection with an Alternative Transaction; or
|
(c)
|
enter into any agreement with any person or entity (other than Roche) for an Alternative Transaction.
|
20.
|
Bankruptcy
|
21.
|
Miscellaneous
|
21.1
|
Governing Law
|
21.2
|
Disputes
|
21.3
|
Jurisdiction; Arbitration
|
21.4
|
Assignment and Change of Control
|
(a)
|
Eleven shall provide written notice to Roche within fifteen (15) days after completion of such Change of Control.
|
(b)
|
The acquirer of or the successor to in connection with such Change of Control shall acknowledge in writing to Roche that the Eleven Know-How and the Primary Eleven Patent Rights are subject to the exclusive licenses to Roche for the research, development or commercialization of Compounds or Products, subject to the terms and conditions of this Agreement.
|
(c)
|
If either Eleven or the Change of Control Group are engaged in the conduct of clinical studies or commercialization of competing ophthalmic products either at the time of the Change of Control or thereafter, then Roche may upon written request require Eleven and the Change of Control Group to institute a firewall to limit access of information and reports provided to Eleven by the Roche Group under Article 8 and Article 13 (collectively “
Sensitive Information
”) to (1) such Eleven and Change of Control Group personnel, attorneys, agents and advisors that reasonably need access to and knowledge of such Sensitive Information to perform Eleven’s obligations and exercise Eleven’s rights under the Agreement and (2) C-level personnel of Eleven or the Change of Control Group, with the objective to prohibit the use of such Sensitive Information by Eleven or the Change of Control Group for competitive reasons that would be detrimental to Roche’s interests under the Agreement or Licensed Compounds or Licensed Products without foreclosing the ability of Eleven or the Change of Control Group to perform Eleven’s obligations and exercise Eleven’s rights under the Agreement. For clarity, (i) information about payments made by Roche under this Agreement shall not be deemed as Sensitive Information that is subject to the firewall of this Section 21.4(c), and (ii) the exceptions under Sections 1.21(i)-(v), 17.3 and 17.4 to Eleven’s obligations to protect Roche’s Confidential Information shall also apply to Sensitive Information.
|
21.5
|
Debarment
|
21.6
|
Independent Contractor
|
21.7
|
Unenforceable Provisions and Severability
|
21.8
|
Waiver
|
21.9
|
Appendices
|
21.10
|
Entire Understanding
|
21.11
|
Amendments
|
21.12
|
Invoices
|
21.13
|
Notice
|
21.14
|
Interpretation
|
a)
|
Each Party acknowledges that it has been advised by counsel during the course of negotiation of this Agreement, and, therefore, that this Agreement shall be interpreted without regard to any presumption or rule requiring construction against the Party causing this Agreement to be drafted.
|
b)
|
The headings, captions and table of contents in this Agreement are for convenience of reference only and shall not be considered in construing this Agreement.
|
c)
|
In construing this Agreement, except where the context acquires otherwise, (i) use of the singular includes the plural and vice versa; (ii) the words “include” “including”, “includes” and “e.g.” means “including without limitation”; (iii) the word “or” is used in the inclusive sense that is typically associated with the phrase “and/or”; (iv) the words “herein,” “hereof” and “hereunder,” and words of similar import, refer to this Agreement in its entirety and not to any particular provision hereof; (v) the verb “will” shall be construed to have the same meaning and effect as the word “shall”; (vi) use of any gender includes any other gender; (vii) any reference to any law or regulation includes any amendment or modification to such law or regulation and shall be deemed also to refer to all rules and regulations promulgated thereunder; (viii) references to a particular person or entity include such person’s or entity’s successors and assigns to the extent not prohibited by this Agreement; and (ix) a capitalized term not defined herein but reflecting a different part of speech than a capitalized term which is defined herein shall be interpreted in a correlative manner.
|
Eleven Biotherapeutics, Inc.
___
/s/ Abbie Celniker
___________
Name: Abbie Celniker
Title: Chief Executive Officer
|
|
F. Hoffmann-La Roche Ltd
/s/ Stefan Arnold
______________
Name: Stefan Arnold
Title: Head Legal Pharma
|
/s/ Vikas Kabra
________________
Name: Vikas Kabra
Title: Head of Transaction Excellence
|
Hoffmann-La Roche Inc.
___
/s/ John P. Parise
_________________
Name: John P. Parise
Title: Authorized Signatory
|
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|
Amounts, format and storage place
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1.
|
I have reviewed this Quarterly Report on Form 10-Q of Eleven Biotherapeutics, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ Abbie C. Celniker
|
Abbie C. Celniker
|
President and Chief Executive Officer
|
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Eleven Biotherapeutics, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ John J. McCabe
|
John J. McCabe
|
Chief Financial Officer
|
(Principal Financial Officer)
|
(1)
|
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
(2)
|
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Abbie C. Celniker
|
Abbie C. Celniker
|
President and Chief Executive Officer
|
(Principal Executive Officer)
|
/s/ John J. McCabe
|
John J. McCabe
|
Chief Financial Officer
|
(Principal Financial Officer)
|