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Delaware
(State or other jurisdiction of
incorporation or organization)
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42-1560076
(I.R.S. Employer
Identification Number)
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1900 Powell Street, Suite 750
|
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Emeryville, CA
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94608
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(Address of Principal Executive Offices)
|
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(Zip Code)
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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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☐
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Emerging growth company
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☒
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Page
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September 30,
2017 |
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December 31,
2016 |
||||
Assets
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
22,121
|
|
|
$
|
23,735
|
|
Available-for-sale securities
|
101,605
|
|
|
89,917
|
|
||
Accounts receivable
|
3
|
|
|
794
|
|
||
Inventory
|
425
|
|
|
—
|
|
||
Prepaid expenses and other current assets
|
2,806
|
|
|
2,541
|
|
||
Total current assets
|
126,960
|
|
|
116,987
|
|
||
Property and equipment, net
|
3,110
|
|
|
3,156
|
|
||
Available-for-sale securities, non-current
|
7,004
|
|
|
22,292
|
|
||
Other assets
|
38
|
|
|
38
|
|
||
Total assets
|
$
|
137,112
|
|
|
$
|
142,473
|
|
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable
|
$
|
5,380
|
|
|
$
|
3,589
|
|
Accrued liabilities
|
9,539
|
|
|
5,867
|
|
||
Other current liabilities
|
292
|
|
|
287
|
|
||
Total current liabilities
|
15,211
|
|
|
9,743
|
|
||
Long-term debt
|
35,408
|
|
|
—
|
|
||
Other non-current liabilities
|
615
|
|
|
547
|
|
||
Total liabilities
|
51,234
|
|
|
10,290
|
|
||
Commitments and Contingencies (Note 7)
|
|
|
|
||||
Stockholders’ equity
|
|
|
|
||||
Preferred stock, $0.001 par value — 5,000,000 shares authorized, and zero shares issued and outstanding at September 30, 2017 and December 31, 2016
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value — 100,000,000 shares authorized, 22,716,277 and 22,013,644 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively
|
27
|
|
|
27
|
|
||
Additional paid-in capital
|
268,305
|
|
|
254,558
|
|
||
Accumulated other comprehensive loss
|
(112
|
)
|
|
(193
|
)
|
||
Accumulated deficit
|
(182,342
|
)
|
|
(122,209
|
)
|
||
Total stockholders’ equity
|
85,878
|
|
|
132,183
|
|
||
Total liabilities and stockholders’ equity
|
$
|
137,112
|
|
|
$
|
142,473
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
License and grant revenue
|
$
|
1
|
|
|
$
|
138
|
|
|
$
|
3
|
|
|
$
|
535
|
|
Operating expenses
|
|
|
|
|
|
|
|
||||||||
Research and development
|
6,459
|
|
|
7,437
|
|
|
20,723
|
|
|
24,183
|
|
||||
Selling, general and administrative, net
|
16,064
|
|
|
7,344
|
|
|
38,323
|
|
|
22,043
|
|
||||
Total operating expenses
|
22,523
|
|
|
14,781
|
|
|
59,046
|
|
|
46,226
|
|
||||
Loss from operations
|
(22,522
|
)
|
|
(14,643
|
)
|
|
(59,043
|
)
|
|
(45,691
|
)
|
||||
Interest and other income, net
|
839
|
|
|
249
|
|
|
1,265
|
|
|
593
|
|
||||
Interest expense
|
(1,677
|
)
|
|
—
|
|
|
(2,406
|
)
|
|
—
|
|
||||
Loss before income taxes
|
(23,360
|
)
|
|
(14,394
|
)
|
|
(60,184
|
)
|
|
(45,098
|
)
|
||||
Benefit for income taxes
|
—
|
|
|
—
|
|
|
(51
|
)
|
|
—
|
|
||||
Net loss
|
$
|
(23,360
|
)
|
|
$
|
(14,394
|
)
|
|
$
|
(60,133
|
)
|
|
$
|
(45,098
|
)
|
Net loss per share, basic and diluted
|
$
|
(1.04
|
)
|
|
$
|
(0.66
|
)
|
|
$
|
(2.69
|
)
|
|
$
|
(2.09
|
)
|
Weighted average shares used in computing net loss per share, basic and diluted
|
22,569
|
|
|
21,941
|
|
|
22,390
|
|
|
21,616
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Net loss
|
$
|
(23,360
|
)
|
|
$
|
(14,394
|
)
|
|
$
|
(60,133
|
)
|
|
$
|
(45,098
|
)
|
Unrealized gain (loss) on available-for-sale securities
|
71
|
|
|
(96
|
)
|
|
81
|
|
|
94
|
|
||||
Comprehensive loss
|
$
|
(23,289
|
)
|
|
$
|
(14,490
|
)
|
|
$
|
(60,052
|
)
|
|
$
|
(45,004
|
)
|
|
Nine Months Ended
September 30, |
||||||
|
2017
|
|
2016
|
||||
Cash flows from operating activities
|
|
|
|
||||
Net loss
|
$
|
(60,133
|
)
|
|
$
|
(45,098
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities
|
|
|
|
||||
Depreciation
|
884
|
|
|
562
|
|
||
Stock-based compensation
|
9,911
|
|
|
7,782
|
|
||
Non-cash interest expense
|
2,406
|
|
|
—
|
|
||
Change in fair value of embedded derivative liability
|
(531
|
)
|
|
—
|
|
||
Net accretion of discounts and amortization of premiums of available-for-sale securities
|
216
|
|
|
(332
|
)
|
||
Changes in assets and liabilities
|
|
|
|
|
|
||
Accrued interest of available-for-sale securities
|
(261
|
)
|
|
(119
|
)
|
||
Inventory
|
(75
|
)
|
|
—
|
|
||
Prepaid expenses and other assets
|
356
|
|
|
(2,325
|
)
|
||
Accounts receivable
|
791
|
|
|
515
|
|
||
Accounts payable
|
924
|
|
|
3,007
|
|
||
Accrued liabilities and other liabilities
|
3,509
|
|
|
(2,431
|
)
|
||
Net cash used in operating activities
|
(42,003
|
)
|
|
(38,439
|
)
|
||
Cash flows from investing activities
|
|
|
|
||||
Purchases of property and equipment
|
(936
|
)
|
|
(1,222
|
)
|
||
Purchases of available-for-sale securities
|
(56,524
|
)
|
|
(95,528
|
)
|
||
Maturities of available-for-sale securities
|
60,250
|
|
|
46,795
|
|
||
Net cash provided by (used in) investing activities
|
2,790
|
|
|
(49,955
|
)
|
||
Cash flows from financing activities
|
|
|
|
||||
Proceeds from issuance of long-term debt
|
34,600
|
|
|
—
|
|
||
Proceeds from public offerings, net of offering costs
|
—
|
|
|
61,822
|
|
||
Payment of debt issuance costs
|
(623
|
)
|
|
—
|
|
||
Proceeds from issuance of common stock upon exercise of stock options
|
3,192
|
|
|
2,918
|
|
||
Proceeds from employee stock purchase plan
|
430
|
|
|
326
|
|
||
Net cash provided by financing activities
|
37,599
|
|
|
65,066
|
|
||
Net decrease in cash and cash equivalents
|
(1,614
|
)
|
|
(23,328
|
)
|
||
Cash and cash equivalents at beginning of period
|
23,735
|
|
|
33,104
|
|
||
Cash and cash equivalents at end of period
|
$
|
22,121
|
|
|
$
|
9,776
|
|
Supplemental disclosure of noncash investing and financing activities
|
|
|
|
||||
Purchases of inventory in accounts payable and accrued expenses
|
$
|
337
|
|
|
$
|
—
|
|
Debt issuance costs in accounts payable and accrued expense
|
$
|
10
|
|
|
$
|
—
|
|
Purchases of property and equipment in accounts payable and accrued expense
|
$
|
51
|
|
|
$
|
227
|
|
Stock-based compensation capitalized in inventory
|
$
|
13
|
|
|
$
|
—
|
|
•
|
GOCOVRI
TM
(amantadine) extended release capsules, formerly referred to as ADS-5102, for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications;
|
•
|
ADS-5102 (amantadine) extended release capsules (GOCOVRI) in development for the treatment of walking impairment in patients with multiple sclerosis;
|
•
|
ADS-4101 (lacosamide) modified release capsules in development for the treatment of partial onset seizures in patients with epilepsy; and
|
•
|
Namzaric
®
(memantine hydrochloride extended release and donepezil hydrochloride) capsules and Namenda XR
®
(memantine hydrochloride) extended release capsules for the treatment of moderate to severe Alzheimer’s disease.
|
•
|
Level 1 inputs, which include quoted prices in active markets for identical assets or liabilities;
|
•
|
Level 2 inputs, which include observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the asset or liability. For available-for-sale securities, the Company reviews trading activity and pricing as of the measurement date. When sufficient quoted pricing for identical securities is not available, the Company uses market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs either represent quoted prices for similar assets in active markets or have been derived from observable market data; and
|
•
|
Level 3 inputs, which include unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the underlying asset or liability. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies, or similar valuation techniques, as well as significant management judgment or estimation.
|
|
September 30, 2017
|
||||||||||||||
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market
|
$
|
11,043
|
|
|
$
|
11,043
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Corporate debt
|
37,913
|
|
|
—
|
|
|
37,913
|
|
|
—
|
|
||||
U.S. Treasury notes
|
70,696
|
|
|
—
|
|
|
70,696
|
|
|
—
|
|
||||
Total assets measured at fair value
|
$
|
119,652
|
|
|
$
|
11,043
|
|
|
$
|
108,609
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Embedded derivative liability
|
$
|
233
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
233
|
|
Total liabilities measured at fair value
|
$
|
233
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
233
|
|
|
December 31, 2016
|
||||||||||||||
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market
|
$
|
192
|
|
|
$
|
192
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Corporate debt
|
51,233
|
|
|
—
|
|
|
51,233
|
|
|
—
|
|
||||
U.S. Treasury notes
|
60,976
|
|
|
—
|
|
|
60,976
|
|
|
—
|
|
||||
Total assets measured at fair value
|
$
|
112,401
|
|
|
$
|
192
|
|
|
$
|
112,209
|
|
|
$
|
—
|
|
Balance as of December 31, 2016
|
$
|
—
|
|
Issuance of long-term debt with embedded derivative
|
764
|
|
|
Change in fair value included in interest and other income, net
|
(531
|
)
|
|
Balance as of September 30, 2017
|
$
|
233
|
|
|
September 30, 2017
|
||||||||||||||
|
Amortized Cost
|
|
Gross Unrealized
Gains
|
|
Gross Unrealized
Losses
|
|
Estimated Fair Value
|
||||||||
Investments:
|
|
|
|
|
|
|
|
||||||||
Corporate debt
|
$
|
37,948
|
|
|
$
|
—
|
|
|
$
|
(35
|
)
|
|
$
|
37,913
|
|
U.S. Treasury notes
|
70,773
|
|
|
—
|
|
|
(77
|
)
|
|
70,696
|
|
||||
Total
|
$
|
108,721
|
|
|
$
|
—
|
|
|
$
|
(112
|
)
|
|
$
|
108,609
|
|
Reported as:
|
|
|
|
|
|
|
|
|
|
|
|||||
Short-term investments
|
$
|
101,709
|
|
|
$
|
—
|
|
|
$
|
(104
|
)
|
|
$
|
101,605
|
|
Long-term investments
|
7,012
|
|
|
—
|
|
|
(8
|
)
|
|
7,004
|
|
||||
Total
|
$
|
108,721
|
|
|
$
|
—
|
|
|
$
|
(112
|
)
|
|
$
|
108,609
|
|
|
December 31, 2016
|
||||||||||||||
|
Amortized Cost
|
|
Gross Unrealized
Gains
|
|
Gross Unrealized
Losses
|
|
Estimated Fair Value
|
||||||||
Investments:
|
|
|
|
|
|
|
|
||||||||
Corporate debt
|
$
|
51,354
|
|
|
$
|
—
|
|
|
$
|
(121
|
)
|
|
$
|
51,233
|
|
U.S. Treasury notes
|
61,048
|
|
|
5
|
|
|
(77
|
)
|
|
60,976
|
|
||||
Total
|
$
|
112,402
|
|
|
$
|
5
|
|
|
$
|
(198
|
)
|
|
$
|
112,209
|
|
Reported as:
|
|
|
|
|
|
|
|
|
|
|
|||||
Short-term investments
|
$
|
90,050
|
|
|
$
|
1
|
|
|
$
|
(134
|
)
|
|
$
|
89,917
|
|
Long-term investments
|
22,352
|
|
|
4
|
|
|
(64
|
)
|
|
22,292
|
|
||||
Total
|
$
|
112,402
|
|
|
$
|
5
|
|
|
$
|
(198
|
)
|
|
$
|
112,209
|
|
|
September 30, 2017
|
|
December 31, 2016
|
||||
Raw materials
|
$
|
326
|
|
|
$
|
—
|
|
Work-in-process
|
72
|
|
|
—
|
|
||
Finished goods
|
27
|
|
|
—
|
|
||
Total inventory
|
$
|
425
|
|
|
$
|
—
|
|
|
September 30, 2017
|
||
2017 (remaining)
|
$
|
2,144
|
|
2018
|
1,918
|
|
|
2019
|
1,925
|
|
|
2020
|
592
|
|
|
2021
|
—
|
|
|
Thereafter
|
—
|
|
|
Total
|
$
|
6,579
|
|
|
September 30, 2017
|
||
Loans payable, gross
|
$
|
35,000
|
|
Less: Unamortized debt discount and issuance costs
|
(1,879
|
)
|
|
Plus: Unpaid portion of quarterly interest payment
|
2,287
|
|
|
Carrying value of loans payable
|
$
|
35,408
|
|
Less: Current portion of long-term debt
|
—
|
|
|
Non-current portion of long-term debt
|
$
|
35,408
|
|
|
September 30,
2017 |
|
December 31,
2016 |
||
Common stock awards issued and outstanding
|
5,926,814
|
|
|
5,483,557
|
|
Authorized for future issuance under 2014 Equity Incentive Plan
|
1,700,824
|
|
|
1,576,926
|
|
Authorized for future issuance under 2016 Inducement Plan
|
429,365
|
|
|
334,062
|
|
Employee stock purchase plan
|
718,210
|
|
|
532,849
|
|
Total
|
8,775,213
|
|
|
7,927,394
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Research and development
|
$
|
837
|
|
|
$
|
738
|
|
|
$
|
2,553
|
|
|
$
|
2,136
|
|
Selling, general and administrative
|
2,425
|
|
|
1,860
|
|
|
7,358
|
|
|
5,646
|
|
||||
Total stock-based compensation expense
|
$
|
3,262
|
|
|
$
|
2,598
|
|
|
$
|
9,911
|
|
|
$
|
7,782
|
|
•
|
GOCOVRI
TM
(amantadine) extended release capsules, formerly referred to as ADS-5102, for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications;
|
•
|
ADS-5102 (amantadine) extended release capsules (GOCOVRI) in development for the treatment of walking impairment in patients with multiple sclerosis;
|
•
|
ADS-4101 (lacosamide) modified release capsules in development for the treatment of partial onset seizures in patients with epilepsy; and
|
•
|
Namzaric
®
(memantine hydrochloride extended release and donepezil hydrochloride) capsules and Namenda XR
®
(memantine hydrochloride) extended release capsules for the treatment of moderate to severe Alzheimer’s disease.
|
•
|
fees paid to clinical investigators, clinical trial sites, consultants, and vendors, including contract research organizations, or CROs, in conjunction with implementing, conducting, and monitoring our clinical trials and acquiring and evaluating clinical trial data, including all related fees, such as for investigator grants, patient screening fees, laboratory work, and statistical compilation and analysis;
|
•
|
expenses related to production of clinical supplies, including fees paid to contract manufacturing organizations, or CMOs;
|
•
|
expenses related to establishment and validation of manufacturing capabilities for commercial supply,
|
•
|
expenses related to the buildup of commercial supply to support commercial launch, prior to FDA approval,
|
•
|
expenses related to compliance with regulatory requirements;
|
•
|
other consulting fees paid to third parties; and
|
•
|
employee-related expenses, which include salaries, benefits, and stock-based compensation.
|
|
Three Months Ended
September 30, |
|
Increase
(Decrease)
|
|
Nine Months Ended
September 30, |
|
Increase
(Decrease) |
||||||||||||||||
|
2017
|
|
2016
|
|
|
2017
|
|
2016
|
|
||||||||||||||
ADS-5102(1)
|
$
|
4,921
|
|
|
$
|
5,748
|
|
|
$
|
(827
|
)
|
|
$
|
15,467
|
|
|
$
|
19,985
|
|
|
$
|
(4,518
|
)
|
ADS-4101
|
1,080
|
|
|
—
|
|
|
1,080
|
|
|
4,056
|
|
|
—
|
|
|
4,056
|
|
||||||
Other research and development expenses
|
458
|
|
|
1,689
|
|
|
(1,231
|
)
|
|
1,200
|
|
|
4,198
|
|
|
(2,998
|
)
|
||||||
Total research and development expenses
|
$
|
6,459
|
|
|
$
|
7,437
|
|
|
$
|
(978
|
)
|
|
$
|
20,723
|
|
|
$
|
24,183
|
|
|
$
|
(3,460
|
)
|
(1)
|
Includes program costs we incurred for GOCOVRI (formerly referred to as ADS-5102) for the treatment of dyskinesia in patients with Parkinson’s disease, and ADS-5102 (GOCOVRI) for additional potential CNS indications.
|
|
Three Months Ended
September 30, |
|
Increase
(Decrease)
|
|
% Increase
(Decrease)
|
|
Nine Months Ended
September 30, |
|
Increase
(Decrease) |
|
% Increase
(Decrease) |
||||||||||||||||||
|
2017
|
|
2016
|
|
|
|
2017
|
|
2016
|
|
|
||||||||||||||||||
Revenue
|
$
|
1
|
|
|
$
|
138
|
|
|
$
|
(137
|
)
|
|
(99
|
)%
|
|
$
|
3
|
|
|
$
|
535
|
|
|
$
|
(532
|
)
|
|
(99
|
)%
|
Research and development expenses
|
6,459
|
|
|
7,437
|
|
|
(978
|
)
|
|
(13
|
)%
|
|
20,723
|
|
|
24,183
|
|
|
(3,460
|
)
|
|
(14
|
)%
|
||||||
Selling, general and administrative expenses, net
|
16,064
|
|
|
7,344
|
|
|
8,720
|
|
|
119
|
%
|
|
38,323
|
|
|
22,043
|
|
|
16,280
|
|
|
74
|
%
|
||||||
Interest and other income, net
|
839
|
|
|
249
|
|
|
590
|
|
|
237
|
%
|
|
1,265
|
|
|
593
|
|
|
672
|
|
|
113
|
%
|
||||||
Interest expense
|
1,677
|
|
|
—
|
|
|
1,677
|
|
|
100
|
%
|
|
2,406
|
|
|
—
|
|
|
2,406
|
|
|
100
|
%
|
|
Nine Months Ended
September 30, |
||||||
|
2017
|
|
2016
|
||||
Net cash (used in) provided by:
|
|
|
|
||||
Operating activities
|
$
|
(42,003
|
)
|
|
$
|
(38,439
|
)
|
Investing activities
|
2,790
|
|
|
(49,955
|
)
|
||
Financing activities
|
37,599
|
|
|
65,066
|
|
||
Net decrease in cash and cash equivalents
|
$
|
(1,614
|
)
|
|
$
|
(23,328
|
)
|
•
|
our success in commercializing GOCOVRI, including the marketing, sales, and distribution of the product;
|
•
|
successfully establishing and maintaining commercial manufacturing with third parties;
|
•
|
acceptance of GOCOVRI by the physicians, patients and the healthcare community;
|
•
|
the acceptance of pricing and placement of GOCOVRI on payers’ formulary tiers and the reimbursement rates established for GOCOVRI;
|
•
|
effectively competing with other approved or used medicines and future compounds in development;
|
•
|
continued demonstration of an acceptable safety profile of GOCOVRI following approval; and
|
•
|
obtaining, maintaining, enforcing, and defending intellectual property rights and claims.
|
•
|
the prevalence and severity of any side effects;
|
•
|
efficacy, duration of response, and potential advantages compared to alternative treatments;
|
•
|
the price;
|
•
|
the willingness of physicians to change their current treatment practices;
|
•
|
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 effectiveness of marketing, promotion, selling, and distribution support; and
|
•
|
the availability of third-party insurance coverage or reimbursement.
|
•
|
have the product removed from the market;
|
•
|
be subject to additional post-marketing testing requirements; or
|
•
|
be subject to restrictions on how the product is distributed, marketed, or used.
|
•
|
regulatory authorities may require the addition of labeling statements, specific warnings, contraindications, or field alerts to physicians and pharmacies;
|
•
|
regulatory authorities may withdraw their approval of the product and require us to take our approved drugs off the market;
|
•
|
we may be required to change the way the product is administered, conduct additional clinical trials, change the labeling of the product, or implement a Risk Evaluation and Mitigation Strategy (REMS);
|
•
|
we may have limitations on how we promote our drugs;
|
•
|
third-party payers may limit coverage or reimbursement for GOCOVRI;
|
•
|
sales of GOCOVRI may decrease significantly;
|
•
|
we may be subject to litigation or product liability claims; and
|
•
|
our reputation may suffer.
|
•
|
decreased demand for any product candidates or products that we may develop;
|
•
|
the inability to commercialize any products that we may develop;
|
•
|
injury to our reputation and significant negative media attention;
|
•
|
withdrawal of patients from clinical studies or cancellation of studies;
|
•
|
significant costs to defend the related litigation;
|
•
|
substantial monetary awards to patients; and
|
•
|
loss of revenue.
|
•
|
clinical studies may produce negative or inconclusive results or raise significant safety concerns, and we may decide, or regulators may require us, to conduct additional clinical studies or abandon product development programs;
|
•
|
even if clinical studies demonstrate statistically significant efficacy and acceptable safety, the FDA or similar authorities outside the United States may not consider the results of our studies to be sufficient for approval;
|
•
|
our clinical sites and clinical investigators may fail to comply with, or inconsistently apply, the trial protocols, regulatory requirements including Good Clinical Practices, contractual obligations, and the rating assessments;
|
•
|
our third-party vendors, including our Contract Research Organizations (“CROs”) may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
|
•
|
we might have to suspend or terminate clinical studies for various reasons, including a finding that our product candidates have unanticipated serious side effects or other unexpected characteristics or that the patients are being exposed to unacceptable health risks;
|
•
|
regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements; and
|
•
|
the supply or quality of ADS-5102 or other materials necessary to conduct clinical studies may be insufficient or inadequate.
|
•
|
successfully completing the development program for our product candidates in a timely manner;
|
•
|
receiving marketing approval for our product candidates from the FDA in a timely manner;
|
•
|
successfully establishing and maintaining commercial manufacturing with third parties;
|
•
|
commercializing our product candidates, if approved, including marketing, sales, and distribution of the product independently or in partnership with another company;
|
•
|
acceptance by the medical community and patients of the approved product;
|
•
|
the pricing and placement of our product candidates on payers’ formulary tiers and the reimbursement rates established for the approved products;
|
•
|
effectively competing with other approved or used medicines and future compounds in development;
|
•
|
continued demonstration of an acceptable safety profile of the approved products following approval; and
|
•
|
obtaining, maintaining, enforcing, and defending intellectual property rights and claims.
|
•
|
enhance operational, financial, and information management systems and hire more personnel, including personnel to support development of our product candidates and, our commercial operations;
|
•
|
commercialize GOCOVRI, including establishing distribution, marketing, and sales capabilities;
|
•
|
manufacture GOCOVRI for commercial use;
|
•
|
investigate ADS-5102 (GOCOVRI) in preclinical and clinical trials for the treatment of walking impairment in patients with MS, and potentially other indications;
|
•
|
conduct preclinical and clinical trials of ADS-4101 for the treatment of epilepsy (partial onset seizures);
|
•
|
seek regulatory approvals for our product candidates that successfully complete clinical studies;
|
•
|
continue the research, development, and manufacture of our current product candidates; and
|
•
|
seek to discover or in-license additional product candidates.
|
•
|
the level of demand for our products, which may vary significantly as they are launched and compete for position in the marketplace;
|
•
|
pricing and reimbursement policies with respect to GOCOVRI and product candidates, if approved, and the competitive response from existing and potential future therapeutic approaches that compete with our product candidates;
|
•
|
the cost of manufacturing our product candidates, which may vary due to a number of factors, including the terms of our agreements with contract manufacturing organizations, or CMOs;
|
•
|
the timing, cost, level of investment, and success or failure of research and development activities relating to our preclinical and clinical-stage product candidates, which may change from time to time;
|
•
|
expenditures that we may incur to acquire and develop additional product candidates and technologies;
|
•
|
the timing and success or failure of clinical studies for competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners;
|
•
|
the timing and magnitude of upfront and milestone payments under any potential future collaboration and licensing agreements;
|
•
|
future accounting pronouncements or changes in our accounting policies; and
|
•
|
changing or volatile U.S., European, and global economic environments.
|
•
|
partners have significant discretion in determining the efforts and resources that they will apply to collaborations;
|
•
|
partners may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical study results, changes in their strategic focus due to the acquisition of competitive products, availability of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities;
|
•
|
partners may delay clinical studies, provide insufficient funding for a clinical study program, stop a clinical study, abandon a product candidate, repeat or conduct new clinical studies, or require a new formulation of a product candidate for clinical testing;
|
•
|
partners could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;
|
•
|
a partner with marketing, manufacturing, and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities;
|
•
|
we could grant exclusive rights to our partners that would prevent us from collaborating with others;
|
•
|
Allergan and future partners may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;
|
•
|
Allergan and future partners may not aggressively or adequately pursue litigation against ANDA filers or may settle such litigation on unfavorable terms, and as Allergan substantially controls the current ANDA litigation and terms of settlement and has different economic interests than ours, Allergan may grant licenses to generic manufacturers that permit them to make and sell generic versions of Namenda XR
®
and Namzaric
®
, which would negatively impact the royalties we receive under our license with Allergan;
|
•
|
disputes may arise between us and a partner that causes the delay or termination of the research, development, or commercialization of our current or future products or that results in costly litigation or arbitration that diverts management attention and resources;
|
•
|
agreements may be terminated, sometimes at-will, without penalty, and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future products;
|
•
|
partners may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to commercialize such intellectual property; and
|
•
|
a partner’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.
|
•
|
determine the efforts and resources that they apply towards commercialization;
|
•
|
market, manufacture, and distribute the licensed products or to otherwise not perform satisfactorily in carrying out these activities; and
|
•
|
to terminate the agreement without penalty and, such termination, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future products.
|
•
|
maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; and
|
•
|
not adequately pursue litigation against ANDA filers or settle such litigation on unfavorable terms, and as Allergan substantially controls the current ANDA litigation and terms of settlement and has different economic interests than ours, Allergan may grant licenses to generic manufacturers that permit them to make and sell generic versions of Namenda XR
®
and Namzaric
®
, which would negatively impact the royalties we receive under our license with Allergan.
|
•
|
disagreement with the design or implementation of our clinical trials;
|
•
|
failure of clinical trials to show the level of statistical significance or clinical meaningfulness needed for approval;
|
•
|
failure to demonstrate that a product candidate is safe or effective;
|
•
|
insufficient data from preclinical and clinical studies to support an application;
|
•
|
a finding by an institutional review board (IRB), Data Safety Monitoring Board (DSMB), Data Monitoring Committee (DMC), or the FDA that the clinical trial exposes subjects or patients to an unacceptable health risk;
|
•
|
disapproval of our or our third-party manufacturer’s processes or facilities; or
|
•
|
changes to FDA’s approval policies or regulations.
|
•
|
warning letters or untitled letters;
|
•
|
civil or criminal penalties and fines;
|
•
|
injunctions;
|
•
|
suspension, variation, or withdrawal of regulatory approval;
|
•
|
suspension of ongoing clinical studies;
|
•
|
voluntary or mandatory product recalls;
|
•
|
requirements for dissemination of corrective information or modifications to promotional materials;
|
•
|
refusal to approve pending applications for marketing approval of new drugs or supplements to approved applications filed by us;
|
•
|
refusal to permit import or export of our products;
|
•
|
restrictions on operations, including costly new manufacturing requirements; or
|
•
|
seizure or detention of our products.
|
•
|
our ability to set a price we believe is fair for our products;
|
•
|
the reputation of our company;
|
•
|
our ability to generate revenue and achieve or maintain profitability; and
|
•
|
the availability of capital.
|
•
|
the federal healthcare program Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully offering, paying, soliciting, or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order, lease, arrangement or recommendation of, any good, facility, item, or service for which payment may be made, in whole or in part, under federal healthcare programs, such as the Medicare and Medicaid programs. Liability under the Anti-Kickback Statute may be established without a person or entity having actual knowledge of the statute or specific intent to violate it. In addition, the government may assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act;
|
•
|
the federal civil False Claims Act, which prohibits individuals or entities from, among other things, knowingly presenting, or causing to be presented, false or fraudulent claims for payment of government funds, or knowingly using false records or statements, to obtain payment from the federal government. In recent years, several pharmaceutical and other health care companies have faced enforcement actions under the False Claims Act for, among other things, allegedly submitting false or misleading pricing information to government healthcare programs, providing free product to customers with the expectation that the customers would bill federal programs, product and patient assistance programs, including reimbursement services, and marketing products for off-label or unapproved uses;
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which prohibits, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private) and knowingly and willfully falsifying, concealing, or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items, or services relating to healthcare matters. HIPAA also imposes obligations on certain entities, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and their respective implementing regulations, also governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;
|
•
|
the federal Physician Payment Sunshine Act, being implemented as the Open Payments Program, which requires manufacturers of drugs, devices, biologicals, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually to the federal government information related to payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and teaching hospitals, as well as certain ownership and investment interests held by physicians and their immediate family members; and
|
•
|
analogous state laws and regulations, such as anti-kickback, and false claims laws, which may be broader in scope and apply to items or services reimbursed by any third-party payer, including commercial insurers. Several states also require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products in those states and to report gifts and payments to individual health care providers in those states. Some of these states also prohibit certain marketing-relating activities, including the provision of gifts, meals, or other items to certain health care providers. In addition, several states require pharmaceutical companies to implement compliance programs or marketing codes.
|
•
|
different regulatory requirements for drug approvals in foreign countries;
|
•
|
reduced protection for intellectual property rights;
|
•
|
unexpected changes in tariffs, trade barriers, and regulatory requirements;
|
•
|
economic weakness, including inflation or political instability in particular foreign economies and markets;
|
•
|
difficulties in assuring compliance with foreign corrupt practices laws;
|
•
|
compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad;
|
•
|
foreign taxes, including withholding of payroll taxes;
|
•
|
foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
|
•
|
workforce uncertainty in countries where labor unrest is more common than in the United States;
|
•
|
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
|
•
|
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, including earthquakes, hurricanes or typhoons, floods, and fires.
|
•
|
our success in commercializing GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease;
|
•
|
the availability of reimbursement by payers at acceptable levels, or at all, for GOCOVRI;
|
•
|
the success of competitive products or technologies;
|
•
|
results of clinical studies of our product candidates or those of our competitors;
|
•
|
introductions and announcements of new products and product candidates by us, our commercialization partners, or our competitors, and the timing of these introductions or announcements;
|
•
|
actions taken by regulatory agencies with respect to our or our competitors’ products, product candidates, clinical studies, manufacturing process, or sales and marketing terms;
|
•
|
variations in our financial results or those of companies that are perceived to be comparable to us;
|
•
|
our revenue performance, both in absolute terms and relative to analyst and shareholder expectations;
|
•
|
the success of our efforts to acquire or in-license additional products or product candidates;
|
•
|
developments concerning our collaborations, including but not limited to those with our sources of manufacturing and our commercialization partners;
|
•
|
announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, or capital commitments;
|
•
|
developments or disputes concerning patents or other proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our current or future products;
|
•
|
our ability or inability to raise additional capital and the terms on which we raise it;
|
•
|
the recruitment or departure of key personnel;
|
•
|
changes in the structure of healthcare reimbursement systems;
|
•
|
regulatory or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our current or future products;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors;
|
•
|
actual or anticipated changes in revenue forecasts, earnings estimates or changes in stock market analyst recommendations regarding our common stock, other comparable companies or our industry generally;
|
•
|
trading volume of our common stock;
|
•
|
sales of our common stock by us or our stockholders;
|
•
|
general economic, industry, and market conditions; and
|
•
|
the other risks described in this “Risk Factors” section.
|
•
|
our board of directors is divided into three classes with staggered three-year terms, which may delay or prevent a change of our management or a change in control;
|
•
|
our board of directors has the right to change the size of our board of directors and to elect directors to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors;
|
•
|
our stockholders may not act by written consent or call special stockholders’ meetings; as a result, a holder, or holders, controlling a majority of our capital stock would not be able to take certain actions other than at annual stockholders’ meetings or special stockholders’ meetings called by the board of directors or the chairman of the board and chief executive officer;
|
•
|
our certificate of incorporation prohibits cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;
|
•
|
stockholders must provide advance notice and additional disclosures in order to nominate individuals for election to the board of directors or to propose matters that can be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquiror from conducting a solicitation of proxies to elect the acquiror’s own slate of directors or otherwise attempting to obtain control of our company; and
|
•
|
our board of directors may issue, without stockholder approval, shares of undesignated preferred stock, and the ability to issue undesignated preferred stock makes it possible for our board of directors to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to acquire us.
|
Exhibit Number
|
|
|
|
Incorporation By Reference
|
|
Filed/Furnished Herewith
|
||||||
|
Exhibit Description
|
|
Form
|
|
SEC File No.
|
|
Exhibit
|
|
Filing Date
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amended and Restated Certificate of Incorporation of Adamas Pharmaceuticals, Inc.
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8-K
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001-36399
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3.1
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4/15/2014
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Amended and Restated Bylaws of Adamas Pharmaceuticals, Inc.
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S-1
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333-194342
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3.4
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3/5/2014
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4.1
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Reference is made to Exhibits 3.1 through 3.2.
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Form of Common Stock Certificate of Adamas Pharmaceuticals, Inc.
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S-1
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333-194342
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4.1
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3/26/2014
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Fourth Amended and Restated Investor Rights Agreement, dated as of June 30, 2011, by and among the registrant and certain of its stockholders.
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S-1
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333-194342
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10.5
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3/5/2014
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Amended and Restated Commercial Supply Agreement by and between Adamas Pharmaceuticals, Inc. and Catalent Pharma Solutions, LLC.
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X
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Amended and Restated API Supply Agreement by and between Adamas Pharma, LLC and Moehs Ibérica, S.L.
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X
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Change in Compensation for Christopher B. Prentiss, Chief Accounting Officer.
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8-K
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001-36399
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Item 5.02
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9/21/2017
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Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
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X
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Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
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X
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Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.(1)
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X
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101.INS
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XBRL Instance Document
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101.SCH
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XBRL Taxonomy Extension Schema Document
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101.CAL
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XBRL Taxonomy Extension Calculation Linkbase Document
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101.DEF
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XBRL Taxonomy Extension Definition Linkbase Document
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101.LAB
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XBRL Taxonomy Extension Label Linkbase Document
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101.PRE
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XBRL Taxonomy Extension Presentation Linkbase Document
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Adamas Pharmaceuticals, Inc.
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(Registrant)
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Date:
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November 2, 2017
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/s/ Gregory T. Went, Ph.D.
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Gregory T. Went, Ph.D.
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Chief Executive Officer
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(Principal Executive Officer)
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Date:
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November 2, 2017
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/s/ Alfred G. Merriweather
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Alfred G. Merriweather
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Chief Financial Officer
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(Principal Financial Officer)
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2.2.1
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Catalent shall Process Product in accordance with the Specifications, Applicable Laws and the terms and conditions of this Agreement.
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2.2.2
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Personnel
: Catalent shall provide an adequate number of properly trained operators and technicians to conduct all Product Processing, and such training shall be documented and promptly available to Client for review upon request. Catalent Quality Assurance personnel shall document and maintain a routine manufacturing room presence during all Product Processing activities, observing Product Processing at least one time per Catalent work shift. Quality Assurance documentation shall be promptly available to Client for review, upon request.
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2.2.3
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Equipment
: Catalent shall ensure that all equipment required for Product Processing is validated and calibrated, as necessary, and available prior to Product Processing. Catalent shall ensure equipment redundancies, as requested by Client, in the event that equipment malfunctions prior to or during Product Processing, for example, [*]. To the extent that [*] such equipment in order to [*], Client agrees to [*] such equipment [*], and Catalent agrees to [*] such equipment [*], and to [*] such equipment [*] determined by the parties.
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2.2.4
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Catalent shall provide to Client a detailed Processing plan and schedule at least [*] prior to start of Product Processing for each Client Product Batch or Campaign, specifying and confirming all preparatory and Processing steps, the equipment to be utilized in Product Processing, the raw materials to be utilized, and the raw material release dates, which dates shall be at least [*] prior to start of Product Processing,
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2.2.5
|
Client and its Affiliates shall purchase from Catalent their requirements of Product, subject to Section 4.1, and in accordance with the terms and conditions of this Agreement; provided, however, that nothing herein shall be construed to preclude Client from purchasing Product from one or more other manufacturers. Catalent shall provide an adequate number of properly trained operators and technicians to conduct all Product Processing, and such training shall be documented and promptly available to Client for review upon request.
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A.
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Subject to Section 4.8 (Failure to Supply) and Section 4.1.B and after the Commencement Date, Client shall purchase and accept delivery of Product in a Contract Year such that the sum of all purchases of such Product, in aggregate, is equal to or greater than the minimum requirement for such Contract Year set forth in Section II of Attachment C (the “
Minimum Requirement
”). For clarity, any Product purchased by Client in the entirety of Contract Year 1, regardless of whether before the Commencement Date, shall be credited towards Client’s obligation to purchase the Minimum Requirements for Contract Year 1.
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B.
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Shortfall Payment
. If Client does not purchase such Minimum Requirement during a Contract Year, then within [*] after the end of such Contract Year, Client shall pay Catalent the amount calculated as follows (the “
Shortfall Payment
”):
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(a)
|
notify Client in writing as agreed in the Quality Agreement;
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(b)
|
shall within [*] such failure, commence the Processing of replacement product for the failed Batches [*]; and
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(c)
|
shall pay all manufacturing costs necessary for Client to replace such Batch(es).
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4.9.1
|
In addition to Client’s audit right pursuant to Section 9.4, Client may (i) send up to [*] Representatives to the Facility to observe Processing of Client’s Product during any period in which Client’s Product is being Processed until and unless the Client and Catalent agree otherwise, and (ii) send up to [*] Representatives to the Facility to audit Client’s inventory of API, Client-supplied Materials, or Product, upon at least [*] prior notice, at reasonable times during regular business hours. Such Representatives shall abide by all Catalent safety rules and other applicable employee policies and procedures, and Client shall be responsible for such compliance. Client shall indemnify and hold harmless Catalent for any action, omission or other activity of such Representatives while on Catalent’s premises. Client’s Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility. Client observation of Processing does not relieve Catalent of any obligation, responsibility, representation or warranty under this Agreement.
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To Client:
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Adamas Pharmaceuticals, Inc.
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1900 Powell St., Suite 750
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Emeryville, CA 94608
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Attn: Chief Executive Officer
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Facsimile: 510-428-0519
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With a copy to:
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Address and Facsimile same as above
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Attn: General Counsel (Legal Department)
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To Catalent:
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Catalent Pharma Solutions, LLC
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14 Schoolhouse Road
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Somerset, NJ 08873
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Attn: General Manager
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Facsimile: (732) 537-6491
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With a copy to:
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Address and Facsimile same as above
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Attn: General Counsel (Legal Department)
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CATALENT PHARMA SOLUTIONS, LLC
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ADAMAS PHARMACEUTICALS, INC.
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||
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By:
/s/ Jonathan Arnold
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By:
/s/ Rajesh Mahey
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Name: Jonathan Arnold
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Name: Rajesh Mahey
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Title: Vice President & General Manager
Drug Delivery Solutions |
|
Title: Vice President
Manufacturing Operations |
|
I.
|
Client-supplied Materials (and associated specifications)
|
II.
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Raw Materials (and associated specifications) and Qualified Vendor List
|
III.
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Product Specifications (including Batch size)
|
Section 1.
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DEFINITIONS
|
Section 2.
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MANUFACTURE AND SALE
|
Section 3.
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REJECTED GOODS; CHANGES AND DEVIATIONS.
|
Section 4.
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RECORDS; INSPECTIONS
|
Section 5.
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REGULATORY MATTERS
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Section 6.
|
COMPENSATION
|
Section 8.
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REPRESENTATIONS AND WARRANTIES
|
Section 9.
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TERM AND TERMINATION
|
Section 10.
|
CONFIDENTIALITY
|
Section 11.
|
INDEMNIFICATION AND INSURANCE
|
Section 12.
|
FORCE MAJEURE
|
Section 13.
|
NOTICES
|
If to Company:
|
Adamas Pharma, LLC
1900 Powell St., Suite 750 Emeryville, CA 94608 Attn: Vice President, Manufacturing Operations Fax No.: (510) 428-0519 |
If to Manufacturer:
|
Moehs Iberica S.L.
Poligono Industrial Rubi Sud, c/Cesar Martinell i Brunet 12A, |
Section 14.
|
MISCELLANEOUS
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ADAMAS PHARMA, LLC
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By:
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/s/ Rajesh Mahey
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Rajesh Mahey
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Vice President, Manufacturing Operations
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Adamas Pharmaceuticals, Inc.
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By:
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/s/ Jennifer Rhodes
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Jennifer Rhodes
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Secretary
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Adamas Pharma, LLC
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MOEHS IBERICA, S.L.
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By:
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/s/ Javier del Rio
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Javier del Rio
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Commercial Director
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|
Synonyms:
(Tricyclo[3,3,1,1
3,7
]decyl-1-ammonium) hydrochloride
(1-Aminoadamantane) hydrochloride 1-Adamantanamine hydrochloride 1-Adamantylamine hydrochloride 1-Aminoadamantane hydrochloride 1-Adamantanamine hydrochloride
Summary formula:
C
10
H
17
N • HCl
CAS No.:
665-66-7
|
API
|
Sum of Orders Placed [*]
|
Price / kg for Current Order
|
Amantadine HCl
|
[*]
|
[*]
|
A.
|
In the event that as a result of an increase or decrease in the cost of any key raw materials included in the API, the direct manufacturing costs incurred by Manufacturer to produce the API for Company increases or decreases by [*] or more and such increase or decrease in such manufacturing costs persists for at least [*], Manufacturer will issue a written notice to Company outlining such cost increase or decrease. Upon Company’s receipt of such request, the Parties shall promptly meet, negotiate in good faith and determine whether an adjustment to the prices of the API per kilogram set forth in the table above are appropriate to take into account such increase or decrease in the direct manufacturing costs as a result of an increase or decrease in the cost of such key raw materials.
|
B.
|
In addition, during the term of this Agreement, but not more than [*], the Parties agree to adjust the then current prices listed in the table set forth in this Exhibit 6.1 to address fluctuations in the U.S. dollar to Euro currency exchange rate according to the following procedures. For purposes of this Exhibit 6.1, “Base Rate” shall be initially defined as USD 1.1734 = € 1.00 (the currency exchange rate as of Oct 2, 2017) and going forward the Base Rate will always be defined as the value of the U.S. dollar compared to one (1) Euro (€ 1.00) as described below.
|
1.
|
If the average of the currency exchange rate between the U.S. Dollar and the Euro, as published in the Wall Street Journal (Eastern Edition) for the first five business days on or after January 1 or July 1 differs from the then current Base Rate in either direction by more than [*] (such new exchange rate, the “Triggering Rate”), then effective on the first business day following such publication, the Base Rate will thereafter be revised to equal the average of the Base Rate and the Triggering Rate, until the occurrence of a subsequent Triggering Rate according to this Section B(1) of this Exhibit 6.1.
1
|
|
|
2.
|
Upon revising the Base Rate above, the then current prices for the table above will be adjusted by multiplying each price set forth therein by the ratio of the newly revised Base Rate to the previously effective Base Rate.
2
|
3.
|
In the event either Party believes the prices set forth in the table above should be adjusted according to the terms set forth herein, the Manufacturer or Company, as applicable, will provide written documentation evidencing the Triggering Rate to the other Party together with written notice setting forth (a) the revised Base Rate and the calculation supporting such revision, (b) the new pricing for Products in comparison to the current prices set forth in the table above, and (c) the effective date for such change (which for clarity shall be no earlier than the date the foregoing information is provided to the other Party), provided that changes to the prices for Product in accordance with the terms set forth in this Exhibit 6.1 shall be modified no more than [*]. Any purchase order placed and accepted prior to the effective date for such change in pricing shall not be subject to the pricing adjustment described in Sections B(1) and B(2) of this Exhibit 6.1.
|
4.
|
The processes described in Sections B(1) through B(3) above shall be repeated in which a Triggering Rate occurs at the beginning of January or July as described in Section B(1) above.
|
|
|
If to Company:
|
Adamas Pharma, LLC
1900 Powell St., Suite 750 Emeryville, CA 94608 Attn: Vice President, Manufacturing Operations |
If to Manufacturer:
|
Moehs Iberica S.L.
Poligono Industrial Rubi Sud, c/Cesar Martinell I Brunet 12A, |
MOEHS IBÉRICA, S.L.
|
|
ADAMAS PHARMA, LLC
|
|
By:
|
|
By:
|
|
|
|
|
|
Name:
|
|
Name:
|
|
|
|
Rajesh Mahey
|
|
Title:
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|
Title:
|
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|
VP, Manufacturing Operations
|
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Adamas Pharmaceuticals, Inc.
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By:
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Name:
|
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Jennifer Rhodes
|
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Title:
|
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|
Secretary
|
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|
|
Adamas Pharma, LLC
|
|
[ * ]
|
|
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|
By:
|
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|
Name:
|
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|
[ * ]
|
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|
Title:
|
|
|
|
Senior Vice President
|
|
|
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Adamas Pharmaceuticals, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, 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 registrant’s most recent fiscal quarter (the registrant’s fourth 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.
|
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 registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
all significant deficiencies and material weakness in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date:
|
November 2, 2017
|
/s/ Gregory T. Went, Ph.D.
|
|
|
Gregory T. Went, Ph.D.
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Adamas Pharmaceuticals, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, 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 registrant’s most recent fiscal quarter (the registrant’s fourth 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.
|
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 registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
all significant deficiencies and material weakness in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date:
|
November 2, 2017
|
/s/ Alfred G. Merriweather
|
|
|
Alfred G. Merriweather
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial Officer)
|
1.
|
The Company’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2017
, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
|
2.
|
The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Gregory T. Went, Ph.D.
|
|
/s/ Alfred G. Merriweather
|
Gregory T. Went, Ph.D.
|
|
Alfred G. Merriweather
|
Chief Executive Officer
|
|
Chief Financial Officer
|
(Principal Executive Officer)
|
|
(Principal Financial Officer)
|