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Bermuda
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98-1333697
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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Clarendon House - 2 Church Street
Hamilton HM 11
Bermuda
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Not Applicable
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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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o
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Accelerated filer
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o
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Non-accelerated filer
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x
(Do not check if a smaller reporting company)
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Smaller reporting company
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o
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Page
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December 31, 2016 |
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March 31, 2016
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||||
Assets
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Current assets:
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Cash
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$
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200,405
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|
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$
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276,251
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Prepaid expenses and other current assets
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4,234
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|
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4,865
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||
Income tax receivable
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938
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970
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||
Total current assets
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205,577
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|
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282,086
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||
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||||
Property and equipment, net
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159
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89
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Deferred tax assets
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323
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323
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Total assets
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$
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206,059
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$
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282,498
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||||
Liabilities and Shareholders’ Equity
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Current liabilities:
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Accounts payable
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$
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9,251
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$
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622
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Due to Roivant Sciences Ltd. and Roivant Sciences, Inc.
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4,947
|
|
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1,814
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Accrued expenses
|
25,397
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|
|
8,319
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||
Contingent payment liability
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—
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5,000
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Total current liabilities
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39,595
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15,755
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||||
Total liabilities
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39,595
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15,755
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||||
Commitments and contingencies (Note 8)
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||||
Shareholders’ equity:
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Common shares, par value $0.00001 per share, 1,000,000,000 shares authorized, 99,161,719 and 99,150,000 issued and outstanding at December 31, 2016 and March 31, 2016
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1
|
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|
1
|
|
||
Additional paid-in capital
|
448,773
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|
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420,934
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||
Accumulated deficit
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(282,310
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)
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(154,192
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)
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||||
Total shareholders’ equity
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166,464
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266,743
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||
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||||
Total liabilities and shareholders’ equity
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$
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206,059
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$
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282,498
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Three Months Ended December 31,
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Nine Months Ended December 31,
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||||||||||||
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2016
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2015
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2016
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2015
|
||||||||
Operating expenses:
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|
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|
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||||||||
Research and development expenses
|
|
|
|
|
|
|
|
||||||||
(includes share-based compensation expense of $4,592 and $14,599 for the three months ended December 31, 2016 and 2015 and $14,029 and $24,421 for the nine months ended December 31, 2016 and 2015, respectively)
|
$
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36,630
|
|
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$
|
34,324
|
|
|
$
|
93,980
|
|
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$
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53,209
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|
General and administrative expenses
|
|
|
|
|
|
|
|
||||||||
(includes share-based compensation expense of $3,739 and $24,457 for the three months ended December 31, 2016 and 2015 and $13,800 and $39,537 for the nine months ended December 31, 2016 and 2015, respectively)
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11,342
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28,230
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33,422
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|
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49,364
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|
||||
Total operating expenses
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47,972
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62,554
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127,402
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102,573
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||||
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|||||||
Loss before provision for income tax
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(47,972
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)
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(62,554
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)
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(127,402
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)
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(102,573
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)
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||||
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|||||||
Income tax (benefit) expense
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(161
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)
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|
802
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716
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901
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|||||||
Net loss and comprehensive loss
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$
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(47,811
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)
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$
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(63,356
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)
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$
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(128,118
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)
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$
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(103,474
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)
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|
|
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|||||||
Net loss per common share — basic and diluted
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$
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(0.48
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)
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$
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(0.64
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)
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$
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(1.29
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)
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$
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(1.11
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)
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Weighted average common shares outstanding — basic and diluted
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99,161,719
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99,150,000
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99,157,415
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92,914,909
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Common Shares
|
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Additional Paid
in Capital
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Accumulated
Deficit
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Total
Shareholders’
Equity
|
|||||||||||
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Shares
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Amount
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|||||||||||||||
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|||||||||
Balance at March 31, 2016
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99,150,000
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$
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1
|
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$
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420,934
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|
|
$
|
(154,192
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)
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$
|
266,743
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Exercise of stock options
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11,719
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|
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—
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10
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|
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—
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|
10
|
|
||||
Share-based compensation expense
|
—
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|
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—
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|
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19,718
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—
|
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19,718
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|
||||
Capital contribution —share-based compensation expense
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—
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—
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8,111
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—
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8,111
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|
||||
Net loss
|
—
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—
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|
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—
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(128,118
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)
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|
(128,118
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)
|
||||
Balance at December 31, 2016
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99,161,719
|
|
|
$
|
1
|
|
|
$
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448,773
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|
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$
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(282,310
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)
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$
|
166,464
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Nine Months Ended December 31,
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||||||
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2016
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2015
|
||||
Cash flows from operating activities:
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|
|
|
|
|||
Net loss
|
$
|
(128,118
|
)
|
|
$
|
(103,474
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)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
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|
|||
In-process research and development expenses
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—
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|
|
5,252
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|
||
Share-based compensation
|
27,829
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|
|
63,958
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|
||
Depreciation and amortization
|
35
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|
|
8
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|||
Prepaid expenses and other current assets
|
631
|
|
|
(3,814
|
)
|
||
Accounts payable
|
8,629
|
|
|
3,153
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|
||
Due to Roivant Sciences Ltd. and Roivant Sciences, Inc.
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3,133
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|
|
(781
|
)
|
||
Accrued liabilities
|
17,078
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|
|
5,469
|
|
||
Income tax receivable
|
32
|
|
|
98
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|
||
Net cash used in operating activities
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(70,751
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)
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(30,131
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)
|
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Cash flows from investing activities:
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|
|
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|
|||
Purchase of in-process research and development
|
—
|
|
|
(4,756
|
)
|
||
Purchase of furniture and equipment
|
(105
|
)
|
|
(59
|
)
|
||
Net cash used in investing activities
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(105
|
)
|
|
(4,815
|
)
|
||
Cash flows from financing activities:
|
|
|
|
|
|||
Cash proceeds from issuance of common shares in initial public offering, net of underwriting discount
|
—
|
|
|
336,893
|
|
||
Initial public offering costs paid
|
—
|
|
|
(2,351
|
)
|
||
Cash capital contribution from Roivant Sciences Ltd.
|
—
|
|
|
750
|
|
||
Repayment of amounts due to Roivant Sciences Ltd. and Roivant Sciences, Inc. for amounts paid on behalf of the Company
|
—
|
|
|
(627
|
)
|
||
Payment of contingent liability
|
(5,000
|
)
|
|
—
|
|
||
Exercise of stock options
|
10
|
|
|
—
|
|
||
Due to Roivant Sciences Ltd. and Roivant Sciences, Inc. for amounts paid on behalf of the Company
|
—
|
|
|
279
|
|
||
Net cash (used in) provided by financing activities
|
(4,990
|
)
|
|
334,944
|
|
||
Net change in cash
|
(75,846
|
)
|
|
299,998
|
|
||
Cash—beginning of period
|
276,251
|
|
|
—
|
|
||
Cash—end of period
|
$
|
200,405
|
|
|
$
|
299,998
|
|
Supplemental disclosure of cash paid:
|
|
|
|
|
|||
Income Taxes
|
$
|
684
|
|
|
$
|
804
|
|
|
December 31, 2016
|
|
March 31, 2016
|
||||
|
|
|
|
||||
Research and development expenses
|
$
|
20,532
|
|
|
$
|
5,659
|
|
Salaries, bonuses, and other compensation
|
2,246
|
|
|
1,893
|
|
||
Legal expenses
|
1,153
|
|
|
183
|
|
||
Other expenses
|
1,466
|
|
|
584
|
|
||
Total accrued expenses
|
$
|
25,397
|
|
|
$
|
8,319
|
|
Compound
|
Clinical Indication
|
Development Stage
|
Entity Holding Global Commercial Rights
|
Intepirdine
|
|
|
|
|
Mild-to-Moderate Alzheimer’s disease
|
Phase 3
(
MINDSET Study
)
|
Axovant Sciences GmbH
|
|
Dementia with Lewy Bodies (DLB)
|
Phase 2b
(
HEADWAY-DLB Study
)
|
Axovant Sciences GmbH
|
|
Gait and Balance in Alzheimer's disease, DLB and Parkinson's disease dementia
|
Phase 2
|
Axovant Sciences GmbH
|
Nelotanserin
|
|
|
|
|
Visual Hallucinations in LBD
|
Phase 2
|
Axovant Sciences GmbH
|
|
REM Behavior Disorder (RBD) in DLB
|
Phase 2
|
Axovant Sciences GmbH
|
RVT-103
|
|
|
|
|
Alzheimer's disease
|
Proof of Concept Study
|
Axovant Sciences GmbH
|
RVT-104
|
|
|
|
|
Alzheimer's disease and DLB
|
Preparation for Proof of Concept Study
|
Axovant Sciences GmbH
|
•
|
employee-related expenses, such as salaries, share-based compensation, benefits and travel expense for research and development personnel;
|
•
|
costs allocated to us under the Services Agreements;
|
•
|
expenses incurred under or in connection with agreements with contract research organizations, or CROs, as well as consultants who assist in the development of our product candidates;
|
•
|
manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies;
|
•
|
costs for planning and developing clinical studies for Alzheimer’s disease and other forms of dementia including evaluating intepirdine for patients with DLB and evaluating intepirdine for gait and balance in patients with Alzheimer's disease, DLB and PDD;
|
•
|
costs for planning and developing clinical studies for nelotanserin for patients with LBD;
|
•
|
costs for planning and developing clinical studies for product candidates that combine cholinesterase inhibitors with peripheral muscarinic receptor antagonists including RVT-103, a combination of a peripheral muscarinic receptor antagonist, donepezil and possibly intepirdine, and RVT-104, a combination of a peripheral muscarinic receptor antagonist and high-dose rivastigmine and possibly intepirdine;
|
•
|
milestone payments and other costs that we incur under the GSK Agreement, the Arena Development Agreement, and our license agreement with Qaam;
|
•
|
costs for sponsored research; and
|
•
|
depreciation expense for assets used in research and development activities.
|
•
|
the number of trials required for approval;
|
•
|
the per patient trial costs;
|
•
|
the number of patients who participate in the trials;
|
•
|
the number of sites included in the trials;
|
•
|
the countries in which the trials are conducted;
|
•
|
the length of time required to enroll eligible patients;
|
•
|
the number of doses that patients receive;
|
•
|
the drop-out or discontinuation rates of patients;
|
•
|
the potential additional safety monitoring or other studies requested by regulatory agencies;
|
•
|
the duration of patient follow-up;
|
•
|
the timing and receipt of regulatory approvals; and
|
•
|
the efficacy and safety profile of the product candidates.
|
|
Three Months Ended December 31, |
Nine Months Ended December 31, |
|||||||||||||||||||||
|
2016
|
|
2015
|
|
Change
|
|
2016
|
|
2015
|
|
Change
|
||||||||||||
Operating expenses:
|
|
|
|
||||||||||||||||||||
Research and development expenses
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
(includes share-based compensation expense of $4,592 and $14,599 for the three months ended December 31, 2016 and 2015, and $14,029 and $24,421 for the nine months ended December 31, 2016 and 2015, respectively)
|
$
|
36,630
|
|
|
$
|
34,324
|
|
|
$
|
2,306
|
|
|
$
|
93,980
|
|
|
$
|
53,209
|
|
|
$
|
40,771
|
|
General and administrative expenses
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
(includes share-based compensation expense of $3,739 and $24,457 for the three months ended December 31, 2016 and 2015, and $13,800 and $39,537 for the nine months ended December 31, 2016 and 2015, respectively)
|
11,342
|
|
|
28,230
|
|
|
(16,888
|
)
|
|
33,422
|
|
|
49,364
|
|
|
(15,942
|
)
|
||||||
Total operating expenses
|
$
|
47,972
|
|
|
$
|
62,554
|
|
|
$
|
(14,582
|
)
|
|
$
|
127,402
|
|
|
$
|
102,573
|
|
|
$
|
24,829
|
|
•
|
continue our Phase 3 MINDSET trial of intepirdine for the treatment of mild-to-moderate Alzheimer’s disease designed to support regulatory approval in the United States and Europe, and initiate additional registrational studies to support regulatory approval in Japan;
|
•
|
continue our twelve month open-label extension study of intepirdine for patients completing the MINDSET study;
|
•
|
continue the intepirdine HEADWAY-DLB study for the development of intepirdine for DLB;
|
•
|
continue extension studies for patients completing the HEADWAY-DLB study;
|
•
|
continue studies of intepirdine for gait and balance in patients with Alzheimer's disease, DLB and PDD;
|
•
|
continue clinical studies for product candidates that combine cholinesterase inhibitors with peripheral muscarinic receptor antagonists including RVT-103, a combination of a peripheral muscarinic receptor antagonist and donepezil and potentially RVT-104, a combination of a peripheral muscarinic receptor antagonist and high-dose rivastigmine;
|
•
|
potentially commence future studies of intepirdine for the treatment of severe Alzheimer’s disease and other forms of dementia, such as PDD and vascular dementia;
|
•
|
continue the development of nelotanserin for LBD and other indications;
|
•
|
continue open-label extension studies for patients completing our nelotanserin phase 2 studies;
|
•
|
seek to identify, acquire, develop and commercialize additional product candidates;
|
•
|
integrate acquired technologies into a comprehensive regulatory and product development strategy;
|
•
|
achieve milestones under our agreements with third parties that will require us to make substantial payments to those parties;
|
•
|
maintain, expand and protect our intellectual property portfolio;
|
•
|
hire scientific, clinical, regulatory, manufacturing, quality control, commercial and administrative personnel;
|
•
|
add operational, financial and management information systems and personnel, including personnel to support our drug development efforts;
|
•
|
seek regulatory approvals for any product candidates that successfully complete clinical trials;
|
•
|
scale up external manufacturing capabilities to commercialize our product candidates;
|
•
|
establish a sales, marketing and distribution infrastructure for drug candidates for which we may obtain regulatory approval; and
|
•
|
operate as a public company.
|
|
Nine Months Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
Net cash used in operating activities
|
$
|
(70,751
|
)
|
|
$
|
(30,131
|
)
|
Net cash used in investing activities
|
(105
|
)
|
|
(4,815
|
)
|
||
Net cash (used in) provided by financing activities
|
(4,990
|
)
|
|
334,944
|
|
•
|
successfully complete clinical trials and obtain regulatory approval for the marketing of our product candidates;
|
•
|
set an acceptable price for our product candidates and obtain coverage and adequate reimbursement from third-party payors;
|
•
|
establish sales, marketing and distribution systems for our product candidates;
|
•
|
add operational, financial and management information systems and personnel, including personnel to support our clinical, manufacturing and planned future commercialization efforts and operations as a public company;
|
•
|
initiate and continue relationships with third-party manufacturers and have commercial quantities of our product candidates manufactured at acceptable cost levels;
|
•
|
attract and retain an experienced management and advisory team;
|
•
|
achieve broad market acceptance of our products in the medical community and with third party payors and consumers;
|
•
|
launch commercial sales of our products, whether alone or in collaboration with others; and
|
•
|
maintain, expand and protect our intellectual property portfolio.
|
•
|
we may not be able to demonstrate that a product candidate is safe and effective as a treatment for our targeted indications to the satisfaction of the applicable regulatory authorities;
|
•
|
the regulatory authorities may require additional nonclinical studies or registrational studies of the product candidate in mild-to-moderate Alzheimer’s disease, which would increase our costs and prolong our development;
|
•
|
the results of our clinical trials may not meet the level of statistical or clinical significance required for marketing approval;
|
•
|
the regulatory authorities may disagree with the number, design, size, conduct or implementation of our clinical trials;
|
•
|
the contract research organizations, or CROs, that we retain to conduct clinical trials may take actions outside of our control that materially adversely impact our clinical trials;
|
•
|
the regulatory authorities may not find the data from nonclinical studies and clinical trials sufficient to demonstrate that the clinical and other benefits of the product candidate outweigh its safety risks;
|
•
|
the regulatory authorities may disagree with our interpretation of data from our nonclinical studies and clinical trials or may require that we conduct additional studies;
|
•
|
the regulatory authorities may not accept data generated at our clinical trial sites;
|
•
|
the regulatory authorities may require, as a condition of approval, limitations on approved labeling or distribution and use restrictions;
|
•
|
in the United States, the FDA may require development of a risk evaluation and mitigation strategy, or REMS, as a condition of approval;
|
•
|
the regulatory authorities may identify deficiencies in the manufacturing processes or facilities of our third-party manufacturers; or
|
•
|
the regulatory authorities may change their approval policies or adopt new regulations.
|
•
|
the initiation, progress, timing, costs and results of our planned clinical trials for our product candidates;
|
•
|
the outcome, timing and cost of meeting regulatory requirements established by the FDA, the EMA, or the PMDA, and other comparable foreign regulatory authorities;
|
•
|
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
|
•
|
the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us or our product candidates or any future product candidates;
|
•
|
the effect of competing technological and market developments;
|
•
|
the cost and timing of completion of commercial-scale manufacturing activities;
|
•
|
the cost of establishing sales, marketing and distribution capabilities for our product candidates in regions where we choose to commercialize our products on our own; and
|
•
|
the initiation, progress, timing and results of our commercialization of our product candidates, if approved for commercial sale.
|
•
|
impairment of our business reputation and significant negative media attention;
|
•
|
withdrawal of participants from our clinical trials;
|
•
|
significant costs to defend related litigation;
|
•
|
distraction of management’s attention from our primary business;
|
•
|
substantial monetary awards to patients or other claimants;
|
•
|
inability to commercialize our product candidates or any future product candidate;
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•
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product recalls, withdrawals or labeling, marketing or promotional restrictions;
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•
|
decreased demand for our product candidates or any future product candidate, if approved for commercial sale; and
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•
|
loss of revenue.
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•
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failure to obtain regulatory approval to commence a trial;
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•
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unforeseen safety issues;
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•
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determination of dosing issues;
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•
|
lack of effectiveness during clinical trials;
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•
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inability to reach agreement on acceptable terms with prospective CROs and clinical trial sites;
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•
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slower than expected rates of patient recruitment or failure to recruit suitable patients to participate in a trial;
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•
|
failure to manufacture sufficient quantities of a drug candidate or placebo or failure to obtain sufficient quantities of concomitant medication for use in clinical trials;
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•
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inability to monitor patients adequately during or after treatment;
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•
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inability or unwillingness of medical investigators to follow our clinical protocols;
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•
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adding a sufficient number of clinical trial sites; or
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•
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develop and commercialize drugs that are superior to other products in the market;
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•
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demonstrate through our clinical trials that our product candidates are differentiated from existing and future therapies;
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•
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attract qualified scientific, product development and commercial personnel;
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•
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obtain patent or other proprietary protection for our medicines;
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•
|
obtain required regulatory approvals;
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•
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obtain coverage and adequate reimbursement from, and negotiate competitive pricing with, third-party payors; and
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•
|
successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines.
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•
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regulatory authorities may withdraw their approval of the product or require a REMS to impose restrictions on its distribution or other risk management measures;
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•
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regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;
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•
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we may be required to change the way the product is administered or to conduct additional clinical trials;
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•
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we could be sued and held liable for harm caused to patients;
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•
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we could elect to discontinue the sale of our product; and
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•
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our reputation may suffer.
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•
|
restrictions on manufacturing such products;
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•
|
restrictions on the labeling or marketing of such products;
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•
|
restrictions on product distribution or use;
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•
|
requirements to conduct post-marketing studies or clinical trials;
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•
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warning or untitled letters;
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•
|
withdrawal of the products from the market;
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•
|
recall of products;
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•
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fines, restitution or disgorgement of profits or revenues;
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•
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suspension or withdrawal of marketing approvals;
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•
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refusal to permit the import or export of such products;
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•
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product seizure; or
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•
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injunctions or the imposition of civil or criminal penalties.
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•
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the efficacy and potential advantages compared to alternative treatments;
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•
|
the effectiveness of sales and marketing efforts;
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•
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the cost of treatment in relation to alternative treatments, including any similar generic treatments;
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•
|
our ability to offer our products for sale at competitive prices;
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•
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the convenience and ease of administration compared to alternative treatments;
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•
|
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
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•
|
the strength of marketing and distribution support;
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•
|
the availability of third-party coverage and adequate reimbursement;
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•
|
the prevalence and severity of any side effects; and
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•
|
any restrictions on the use of our product together with other medications.
|
•
|
our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;
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•
|
the inability of sales personnel to obtain access to physicians or attain adequate numbers of physicians to prescribe any drugs; and
|
•
|
unforeseen costs and expenses associated with creating an independent sales and marketing organization.
|
•
|
different regulatory requirements for drug approvals and rules governing drug commercialization 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;
|
•
|
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
|
•
|
foreign reimbursement, pricing and insurance regimes;
|
•
|
foreign taxes;
|
•
|
foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, 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;
|
•
|
potential noncompliance with the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act 2010 and similar anti-bribery and anticorruption laws in other jurisdictions;
|
•
|
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, typhoons, floods and fires.
|
•
|
the federal Anti-Kickback Statute prohibits, among other things, persons and entities 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 of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation; in addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act;
|
•
|
the federal false claims laws, including the civil False Claims Act, impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;
|
•
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
•
|
the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics 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 government information related to payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and requires applicable manufacturers and group purchasing organizations to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members and payments or other “transfers of value” to such physician owners (covered manufacturers are required to submit reports to the government by the 90th day of each calendar year); and
|
•
|
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, 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 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; state 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 some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
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•
|
an annual, nondeductible fee payable by any entity that manufactures or imports specified branded prescription drugs and biologic agents;
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•
|
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 drugs that are inhaled, infused, instilled, implanted or injected;
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•
|
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 drugs to eligible beneficiaries under their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
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•
|
extension of manufacturers’ Medicaid rebate liability to individuals enrolled in Medicaid managed care organizations;
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•
|
expansion of eligibility criteria for Medicaid programs in certain states;
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•
|
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
|
•
|
a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
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•
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
|
•
|
inability to meet our product specifications and quality requirements consistently;
|
•
|
delay or inability to procure or expand sufficient manufacturing capacity;
|
•
|
manufacturing and product quality issues related to scale-up of manufacturing;
|
•
|
costs and validation of new equipment and facilities required for scale-up;
|
•
|
failure to comply with cGMP and similar foreign standards;
|
•
|
inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;
|
•
|
termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;
|
•
|
reliance on a limited number of sources, and in some cases, single sources for product components, such that if we are unable to secure a sufficient supply of these product components, we will be unable to manufacture and sell our product candidates or any future product candidate in a timely fashion, in sufficient quantities or under acceptable terms;
|
•
|
lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier;
|
•
|
operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier or regulatory sanctions related to the manufacture of our or other company’s products;
|
•
|
carrier disruptions or increased costs that are beyond our control; and
|
•
|
failure to deliver our products under specified storage conditions and in a timely manner.
|
•
|
any delay in the commencement, enrollment and ultimate completion of clinical trials;
|
•
|
results of clinical trials of our product candidates or those of our competitors;
|
•
|
any delay in filing applications for marketing approval and any adverse development or perceived adverse development with respect to applicable regulatory authorities’ review of those applications;
|
•
|
failure to successfully develop and commercialize our current product candidates or any future product candidate;
|
•
|
inability to obtain additional funding;
|
•
|
regulatory or legal developments in the United States and other countries applicable to our product candidates;
|
•
|
adverse regulatory decisions;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
inability to obtain adequate product supply for our current product candidates or any future product candidate, or the inability to do so at acceptable prices;
|
•
|
introduction of new products, services or technologies by our competitors;
|
•
|
failure to meet or exceed financial projections we provide to the public;
|
•
|
failure to meet or exceed the estimates and projections of the investment community;
|
•
|
changes in the market valuations of similar companies;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors, and the issuance of new or changed securities analysts’ reports or recommendations;
|
•
|
announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
|
•
|
significant lawsuits, including patent or shareholder litigation, and disputes or other developments relating to our proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
|
•
|
additions or departures of key scientific or management personnel;
|
•
|
sales of our common shares by us or our shareholders in the future;
|
•
|
trading volume of our common shares;
|
•
|
general economic, industry and market conditions; and
|
•
|
the other factors described in this “Risk Factors” section.
|
•
|
that a majority of its board of directors consists of independent directors;
|
•
|
for an annual performance evaluation of the nominating and corporate governance and compensation committees;
|
•
|
to have a nominating and corporate governance committee that is composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities; and
|
•
|
to have a compensation committee that is composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibility.
|
•
|
a classified Board of Directors with staggered three-year terms;
|
•
|
directors only to be removed for cause;
|
•
|
an affirmative vote of 66 2/3% of our voting shares for certain “business combination” transactions that have not been approved by our Board of Directors;
|
•
|
restrictions on the time period in which directors may be nominated; and
|
•
|
our Board of Directors to determine the powers, preferences and rights of our preference shares and to issue the preference shares without shareholder approval.
|
|
|
AXOVANT SCIENCES LTD.
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
/s/ Gregory Weinhoff
|
Date
|
February 14, 2017
|
|
Gregory Weinhoff
(Duly Authorized Officer and Principal Financial Officer)
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|
|
|
|
|
|
|
|
Exhibit
Number
|
|
Description of Document
|
|
|
|
3.1
|
|
Certificate of Incorporation. (1)
|
|
|
|
3.2
|
|
Memorandum of Association. (2)
|
|
|
|
3.3
|
|
Amended and Restated Bye-laws. (3)
|
|
|
|
4.1
|
|
Warrant Agreement, dated February 2, 2017, issued to Hercules Capital, Inc. (4)
|
|
|
|
10.1
|
|
Amended and Restated Services Agreement, dated February 14, 2017, by and among Roivant Sciences, Inc., Axovant Sciences Ltd., Axovant Sciences, Inc. and Axovant Sciences GmbH
|
|
|
|
10.2
|
|
Services Agreement, dated February 14, 2017, by and among Roivant Sciences GmbH and Axovant Sciences GmbH.
|
|
|
|
31.1
|
|
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2
|
|
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1*
|
|
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.2*
|
|
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
101.INS XBRL
|
|
Instance Document
|
|
|
|
101.SCH XBRL
|
|
Taxonomy Extension Schema
|
|
|
|
101.CAL XBRL
|
|
Taxonomy Extension Calculation Linkbase
|
|
|
|
101.DEF XBRL
|
|
Taxonomy Extension Definition Linkbase
|
|
|
|
101.LAB XBRL
|
|
Taxonomy Extension Label Linkbase
|
|
|
|
101.PRE XBRL
|
|
Taxonomy Extension Presentation Linkbase
|
1.
|
DEFINITIONS
|
1.1
|
Affiliate
. “Affiliate” shall mean any Person, whether de jure or de facto, other than a Party, that directly or indirectly owns, is owned by or is under common ownership with a Party to the extent of at least 50 percent of the equity having the power to vote on or direct the affairs of the entity, and any Person actually controlled by, controlling, or under common control with a Party.
|
1.2
|
Costs
. “Costs” shall mean the fully-burdened cost incurred by the Service Provider and its Affiliates during any applicable month to provide the Services. For purposes of this definition, the fully-burdened cost includes without limitation: (i) the costs of any materials used in providing the Services; (ii) the salary, benefits (if any) (including without limitation, medical plans and 401(k) or other retirement plans), and employment taxes (if any) of all the Service Provider’s employees involved in providing such services (excluding, however, any compensation that is provided to an employee or independent contractor in the form of equity instruments, options to acquire stock (stock options), rights with respect to (or determined by reference to) equity instruments or stock options, or any non-cash compensation provided by a third party to an employee or independent contractor); (iii) related overhead expenses (including, without limitation, cost of facilities and utilities costs, insurance, and the cost of all general support, operational and business services); (iv) any and all licensing fees paid or payable to Third Parties for any intellectual property incorporated into such services; and (v) any depreciation, amortization or other cost recovery for financial accounting purposes related to assets of the Service Provider to the extent such assets are used in providing the Services; provided, however, that the fully-burdened cost shall not include costs incurred by the Service Provider to engage a Third Party for the purpose of providing Services pursuant to Section 3.4 of the Agreement.
|
1.3
|
Marks
. “Marks” shall mean and include trademarks, service marks, trade names, domain names, trade dress, logos, and similar designations, whether registered or unregistered, and all applications and registrations therefor.
|
1.4
|
Party
. “Party” shall mean Service Provider or either Service Recipient, and “Parties” shall mean Service Provider and Service Recipients collectively.
|
1.5
|
Person
. “Person” shall mean and include any individual, corporation, trust, estate, partnership, joint venture, company, association, governmental bureau or agency, or any other entity regardless of the type or nature thereof.
|
1.6
|
Third Party
. “Third Party” shall mean any entity other than a Party or an Affiliate.
|
1.7
|
Works
. “Works” shall mean any work product, technical knowledge, creations, know-how, formulations, recipes, specifications, rights, devices, drawings, instructions, expertise, trade practices, customer lists, computer data, source codes, analytical and quality control data, Marks, copyrights, commercial information, inventions, works of authorship, designs, methods, processes, technology, patterns, techniques, data, , patents, trade secrets, copyrights, related contracts, licenses and agreements and the like, and all other intellectual property created, authored, composed, invented, discovered, performed, perfected, provided, acquired or learned by the Service Provider, whether solely or jointly with others, whether patented, patentable or not, whether in written form or otherwise, whether disclosed to Service Provider by either Service Recipient or otherwise, in performing its obligations under this Agreement, in each case, that (i) relates to intellectual property or potential intellectual property originating from research and development of any of Service Recipient or its affiliate’s drug products or portfolio candidates, and (ii) arises out of services provided directly or indirectly (e.g., through an employee, consultant clinical research organization, other vendor or other Third Party engaged by the Service Provider) in connection with such research and development.
|
1.8
|
Year
. “Year” shall mean the 12-month period ending on March 31.
|
2.
|
ENGAGEMENT.
|
3.
|
RELATIONSHIP OF THE PARTIES.
|
3.1
|
The Service Provider and the Service Recipients are each independent contractors and not joint venturers, partners, agents, or representatives of the other. The Service Provider shall perform the Services for the Service Recipients under this Agreement as an independent contractor and neither the Service Provider nor its employees, subcontractors or agents shall be deemed to be agents, servants or employees of either of the Service Recipients, nor shall the Service Provider and any of the Service Recipients be deemed or construed solely by this Agreement to be partners or joint venturers. The Service Provider shall have exclusive control over the direction and conduct of its employees in carrying out the activities required under this Agreement.
|
3.2
|
Neither the Service Provider nor its employees, subcontractors or agents shall have the authority to (i) negotiate the terms of or execute contracts and agreements of either of the Service Recipients (including letters of intent, even if non-binding), provided the Service Provider may suggest incorporating certain non-core agreement terms within the parameters and guidelines provided by the applicable Service Recipient; (ii) hire personnel for either of the Service Recipients; (iii) exercise binding authority with respect to the operations of either of the Service Recipients; (iv) make binding recommendations to either of the Service Recipients; (v) make decisions or have decision-making rights with respect to either of the Service Recipients; (vi) hold itself out as representing either of
|
3.3
|
The Service Provider and its employees, subcontractors or agents shall have the authority to (i) provide advice, assistance, direction and recommendations to the Service Recipients with respect to the operation of ASG; (ii) make recommendations on key points of contracts, without having the power to negotiate the terms of or conclude contracts or agreements on behalf of either of the Service Recipients; (iii) participate in discussions on contracts and agreements; (iv) arrange transactions between a Service Recipient and other parties, provided that the Service Provider does not make any actual decisions or participate in substantive activities, such as negotiations with respect to the terms of such transactions, provided the Service Provider may suggest incorporating certain non-core agreement terms within the parameters and guidelines provided by the applicable Service Recipient; and (v) contact banks in connection with raising capital for the Service Recipient, without having, in any circumstance, the power to negotiate the terms of or conclude contracts or agreements on behalf of either of the Service Recipients in connection with raising capital for ASG.
|
3.4
|
Engagement of Third Parties
. The Service Provider may, with the prior consent of the applicable Service Recipient, engage such persons, corporations, or other entities as it reasonably deems necessary for the purpose of performing Services under this Agreement; provided, however, that the Service Provider shall remain responsible for the performance of all such Services and shall be considered to engage with such persons, corporations, or other entities in its own name and on its own behalf.
|
4.
|
FEES AND EXPENSES.
|
4.1
|
Each Service Recipient shall pay the Service Provider a fee in accordance with Exhibit B attached hereto for the Services provided to such Service Recipient hereunder. The rates specified in Exhibit B attached hereto shall be reviewed and may be updated from time to time by the Parties. Fees for Services performed by the Service Provider will be billed by the Service Provider to the applicable Service Recipient on a monthly basis. All other costs for Third Party services shall be billed, by or on behalf of the Service Provider, to the applicable Service Recipient, in such manner and format and with such supporting information as the Parties may reasonably agree from time to time. Payment for undisputed invoices received by the applicable Service Recipient shall be due within sixty (60) days after the billing date. Any fees and expenses not paid by the due date thereof shall accrue interest at the safe harbor interest rate based on the applicable Federal rate as set forth in U.S. Treasury Regulations Section 1.482-2(a)(2)(iii)(B). All fees and expenses shall be invoiced and payable in U.S. dollars.
|
4.2
|
Yearly Reconciliation
. The Parties shall perform a yearly reconciliation for the compensation amounts paid as follows:
|
a.
|
Administrative Services Yearly Reconciliation
.
|
i.
|
As soon as reasonably practicable following the close of each Year during the Term of this Agreement, the Parties will calculate the total service fee with respect to the activities listed in Exhibit A, subsection 1 (“Administrative and Support Services”) owing under this Agreement by each Service Recipient for the Year (the “Exhibit B Administrative Services Fees”) by calculating the Service Provider’s Costs with respect to such services provided to the applicable Service Recipient and applying the mutually agreed mark-up percentage for such services determined in accordance with Exhibit B, and adding the amount of any third-party costs reimbursable under Exhibit B paragraph (c) that relate to such services. As soon as reasonably practicable following the close of each Year, the Parties shall also calculate the total amount of service fees actually paid by each Service Recipient for the Year under Section 4.1 with respect to the activities listed in Exhibit A, subsection 1 (“Administrative and Support Services”), adding the amount of any third-party costs reimbursable under Exhibit B paragraph (c) that relate to such services (the “Actual Administrative Services Fees”).
|
ii.
|
If, for any Year, the total Actual Administrative Services Fees paid by a Service Recipient is greater than the Exhibit B Administrative Services Fees for such Service Recipient, there shall be deemed to exist an excess of service fee in an amount equal to the difference between the total Actual Administrative Services Fees paid by such Service Recipient and the total Exhibit B Administrative Services Fees for such Service Recipient for the Year (hereinafter “Administrative Services Excess”).
|
iii.
|
If, for any Year, the total Actual Administrative Services Fees paid by a Service Recipient is less than the total Exhibit B Administrative Services Fees for such Service Recipient, there shall be deemed to exist a shortfall in an amount equal to the difference between the total Exhibit B Administrative Services Fees for such Service Recipient and the total Actual Administrative Services Fees paid by such Service Recipient (hereinafter “Administrative Services Shortfall”).
|
b.
|
Other Services Yearly Reconciliation
.
|
i.
|
As soon as reasonably practicable following the close of each Year during the Term of this Agreement, the Parties will calculate the total service fee with respect to the activities listed in Exhibit A, subsection 2 (“Other Services”) owing under this Agreement by each Service Recipient for the Year (the “Exhibit B Other Services Fees”) by calculating the Service Provider’s Costs with respect to such services provided to the applicable Service Recipient and applying the mutually agreed mark-up percentage for such services determined in accordance with Exhibit B, and adding the amount of any third-party costs reimbursable under Exhibit B paragraph (c) that
|
ii.
|
If, for any Year, the total Actual Other Services Fees paid by a Service Recipient is greater than the Exhibit B Other Services Fees for such Service Recipient, there shall be deemed to exist an excess of service fee in an amount equal to the difference between the total Actual Other Services Fees paid by such Service Recipient and the total Exhibit B Other Services Fees for such Service Recipient for the Year (hereinafter “Other Services Excess”).
|
iii.
|
If, for any Year, the total Actual Other Services Fees paid by a Service Recipient is less than the total Exhibit B Other Services Fees for such Service Recipient, there shall be deemed to exist a shortfall in an amount equal to the difference between the total Exhibit B Other Services Fees for such Service Recipient and the total Actual Other Services Fees paid by such Service Recipient (hereinafter “Other Services Shortfall”).
|
c.
|
Settlement of Excess or Shortfall Amounts
.
|
i.
|
If, for any Year, (1) the sum of the Administrative Services Shortfall for a Service Recipient and the Other Services Shortfall for such Service Recipient exceeds (2) the sum of the Administrative Services Excess for such Service Recipient and the Other Services Excess for such Service Recipient (such excess amount, the “Net Shortfall”), such Service Recipient shall pay such Net Shortfall to Service Provider within thirty (30) days after the Exhibit B Administrative Services Fees, Exhibit B Other Services Fees, Actual Administrative Services Fees, and Actual Other Services Fees have been calculated for such Year.
|
ii.
|
If, for any Year, (1) the sum of the Administrative Services Excess for a Service Recipient and the Other Services Excess for such Service Recipient exceeds (2) the sum of the Administrative Services Shortfall for such Service Recipient and the Other Services Shortfall for such Service Recipient (such excess amount, the “Net Excess”), the Service Provider may (x) treat such Net Excess, in whole or in part, as a contribution to the capital of the Service Provider; or (y) treat such Net Excess, in whole or in part, as an overpayment to the Service Provider that must be repaid to such Service Recipient within 30 days after the end of the Year.
|
4.3
|
Withholding
. The Service Recipients shall be entitled to deduct from any payments to Service Provider the amount of any withholding taxes with respect to such amounts payable, or any taxes in each case required to be withheld by the applicable Service Recipient to the extent that such Service Recipient pays to the appropriate governmental authority on behalf of Service Provider such
|
5.
|
ACCESS TO BOOKS AND RECORDS.
|
6.
|
CONFIDENTIAL INFORMATION
|
6.1
|
Obligations
. The Parties acknowledge that, from time to time, one Party (the “Disclosing Party”) may disclose to another Party (the “Receiving Party”) information that is marked as “proprietary,” or “confidential,” or which would, under the circumstances, be understood by a reasonable person to be proprietary and nonpublic (“Confidential Information”). The Receiving Party shall retain such Confidential Information in confidence. Each Party shall use at least the same procedures and degree of care that it uses to protect its own Confidential Information of like importance, including those procedures used when disclosing Confidential Information to Third Parties, and in no event less than reasonable care.
|
6.2
|
Exceptions
. Nothing in this Agreement shall prevent the disclosure by the Receiving Party or its employees of Confidential Information that:
|
a.
|
Prior to the transmittal thereof to Receiving Party was of general public knowledge;
|
b.
|
Becomes, subsequent to the time of transmittal to Receiving Party, a matter of general public knowledge otherwise than as a consequence of a breach by Receiving Party of any obligation under this Agreement;
|
c.
|
Is made public by Disclosing Party;
|
d.
|
Was in the possession of Receiving Party in documentary form prior to the time of disclosure thereof to Receiving Party by Disclosing Party, and is held by Receiving Party free of any obligation of confidence to Disclosing Party or any Third Party; or
|
e.
|
Is received in good faith from a Third Party having the right to disclose it, who, to the best of Receiving Party’s knowledge, did not obtain the same from Disclosing Party and who imposed no obligation of secrecy on Receiving Party with respect to such information.
|
6.3
|
No Unauthorized Use
. The Receiving Party shall refrain from using or exploiting any and all Confidential Information for any purposes or activities other than those contemplated in this Agreement or any other written agreement entered into by and between the Parties.
|
6.4
|
Survival
. The Parties’ obligations under this Article 6 shall survive the termination of this Agreement for any reason whatsoever.
|
7.
|
OWNERSHIP OF INTANGIBLE PROPERTY
|
8.
|
USE OF TRADEMARKS
|
9.
|
INDEMNIFICATION; LIMITATION OF LIABILITY
|
9.1
|
The Service Provider, to the maximum extent permitted by law, shall defend, protect, indemnify and hold the Service Recipients and their officers, employees and directors, as the case may be (“
Indemnified Parties
”), harmless from and against any and all losses, demands, damages (including, without limitation, special, consequential and punitive damages awarded to Third Parties), claims, liabilities, interest, awards, actions or causes of action, suits, judgments, settlements and compromises relating thereto, and all reasonable attorney’s fees and other fees and expenses in connection therewith (“
Losses
”) which may be incurred by an Indemnified Party, arising out of, due to, or in connection with, directly or indirectly, the provision of the Services or failure to provide the Services under this Agreement, except to the extent that such Losses are the result of the gross negligence or willful misconduct of an Indemnified Party.
|
9.2
|
The Service Provider’s liability for aggregate Losses under this Agreement for any cause whatsoever, and regardless of the form of action, whether in contract or in tort, shall be limited to the payments made by the Service Recipients under this Agreement for the specific Service that allegedly caused or was related to the Losses during the period in which the alleged Losses were incurred. In no event shall the Service Provider be liable for any Losses caused by a Service Recipient’s failure to perform such Service Recipient’s obligations under this Agreement.
|
9.3
|
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT OR AT LAW OR IN EQUITY, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR PUNITIVE, SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES TO THE OTHER PARTY OR ANY OTHER PERSON (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF BUSINESS PROFITS, BUSINESS INTERRUPTION, ACTIONS OF THIRD PARTIES OR ANY OTHER LOSS) ARISING FROM OR RELATING TO ANY CLAIM MADE UNDER THIS AGREEMENT OR THE PROVISION OR THE FAILURE TO PROVIDE THE SERVICES.
|
10.
|
TERM AND TERMINATION
|
10.1
|
Term
. This Agreement shall commence on the Effective Date and continue until terminated by a Party in accordance with this Section 10.1. A Party may terminate this Agreement at its discretion by giving written notice to the other Parties at least sixty (60) days before the proposed termination date. Section 12.14 and Article 6 shall survive the termination of this Agreement. The Service Recipients hereby specifically agree and acknowledge that all obligations of the Service Provider to provide any and all Services shall immediately cease upon termination of this Agreement. The Service Provider hereby specifically agrees and acknowledges that all of its rights to use Marks pursuant to Article 8 of this Agreement shall immediately cease upon termination of this Agreement. To the extent permitted by applicable law, no Party shall be liable to another Party for, and each Party hereby expressly waives any right to, any termination compensation of any kind or character whatsoever, to which such Party may be entitled solely by virtue of termination of this Agreement.
|
10.2
|
Rights and Duties on Termination
. Upon termination of this Agreement for any reason, each Party shall cease all use of the other Party’s Confidential Information, and the Service Recipients shall pay Service Provider all accrued and unpaid fees for Services performed through the date of termination.
|
11.
|
COMPLIANCE WITH LAWS
|
11.1
|
General Compliance
. The Parties shall at all times strictly comply with all applicable laws, rules, regulations, and governmental orders, now or hereafter in effect, relating to their performance of this Agreement. Each Party further agrees to make, obtain, and maintain in force at all times during the term of this Agreement, all filings, registrations, reports, licenses, permits, and authorizations (collectively, “
Authorizations
”) required under applicable law, regulation, or order for such Party to perform its obligations under this Agreement. The Service Recipients shall provide Service Provider with such assistance as Service Provider may reasonably request in making or obtaining any such Authorizations.
|
12.
|
GENERAL PROVISIONS
|
12.1
|
Notices
. Any and all notices, elections, offers, acceptances, and demands permitted or required to be made under this Agreement shall be in writing, signed by the Party giving such notice, election, offer, acceptance, or demand and shall be delivered personally, by messenger, courier service, telecopy, first class mail or similar transmission, to the Party, at its address on file with the Party giving such notice, election, offer, acceptance or demand or at such other address as may be supplied in writing. The date of personal delivery or the date of mailing, as the case may be, shall be the date of such notice, election, offer, acceptance, or demand.
|
12.2
|
Force Majeure
. If the performance of any part of this Agreement by a Party, or of any obligation under this Agreement, is prevented, restricted, interfered with, or delayed by reason of any cause beyond the reasonable control of the Party liable to perform, unless conclusive evidence to the contrary is provided, the Party so affected shall, on giving written notice to the other Parties, be excused from such performance to the extent of such prevention, restriction, interference, or delay, provided that the affected Party shall use its reasonable best efforts to avoid or remove such causes of nonperformance and shall continue performance with the utmost dispatch whenever such causes are removed. When such circumstances arise, the Parties shall discuss what, if any, modification of the terms of this Agreement may be required in order to arrive at an equitable solution.
|
12.3
|
Successors and Assigns
. This Agreement may not be assigned or otherwise conveyed by any Party without the prior written consent of the other Parties; provided however that such prior written consent will not be required for an assignment to an Affiliate of a Party. This Agreement shall be binding on and inure to the benefit of the Parties hereto and their respective successors, successors in title and assigns to the extent that such assignment is permitted under this paragraph.
|
12.4
|
Entire Agreement, Amendments
. This Agreement constitutes the entire agreement between the Parties with respect to the subject matter hereof, and supersedes all prior agreements, understandings, and communications between the Parties, whether oral or written, relating to the same subject matter. No change, modification, or amendment of this Agreement shall be valid or binding on the Parties unless such change or modification shall be in writing signed by the Party or Parties against whom the same is sought to be enforced.
|
12.5
|
Remedies Cumulative
. The remedies of the Parties under this Agreement are cumulative and shall not exclude any other remedies to which the Party may be lawfully entitled.
|
12.6
|
Other Persons
. Nothing in this Agreement shall be construed to prevent or prohibit the Service Provider from providing services to any other Person or from engaging in any other business activity.
|
12.7
|
Not for the Benefit of Third Parties
. This Agreement is for the exclusive benefit of the Parties to this Agreement and not for the benefit of any Third Party.
|
12.8
|
Further Assurances
. Each Party hereby covenants and agrees that it shall execute and deliver such deeds and other documents as may be required to implement any of the provisions of this Agreement.
|
12.9
|
No Waiver
. The failure of any Party to insist on strict performance of a covenant hereunder or of any obligation hereunder shall not be a waiver of such Party’s right to demand strict compliance therewith in the future, nor shall the same be construed as a novation of this Agreement.
|
12.10
|
Integration
. This Agreement constitutes the full and complete agreement of the Parties.
|
12.11
|
Captions
. Titles or captions of articles and paragraphs contained in this Agreement are inserted only as a matter of convenience and for reference, and in no way define, limit, extend, or describe the scope of this Agreement or the intent of any provision hereof.
|
12.12
|
Number and Gender
. Whenever required by the context, the singular number shall include the plural, the plural number shall include the singular, and the gender of any pronoun shall include all genders.
|
12.13
|
Counterparts
. This Agreement may be executed in multiple copies, each one of which shall be an original and all of which shall constitute one and the same document, binding on the Parties, and each Party hereby covenants and agrees to execute all duplicates or replacement counterparts of this Agreement as may be required.
|
12.14
|
Governing Law and Jurisdiction
. THIS AGREEMENT AND THE LEGAL RELATIONS BETWEEN THE PARTIES HERETO SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK, WITHOUT REGARD TO ANY CONFLICT OF LAWS RULES. THE COURTS LOCATED WITHIN THE STATE OF NEW YORK SHALL HAVE EXCLUSIVE JURISDICTION OVER ANY AND ALL DISPUTES BETWEEN THE PARTIES HERETO, WHETHER IN LAW OR EQUITY, ARISING OUT OF OR RELATING TO THIS AGREEMENT AND THE AGREEMENTS, INSTRUMENTS AND DOCUMENTS CONTEMPLATED HEREBY AND THE PARTIES CONSENT TO AND AGREE TO SUBMIT TO THE EXCLUSIVE JURISDICTION OF SUCH COURTS. EACH OF THE PARTIES HEREBY WAIVES AND AGREES NOT TO ASSERT IN ANY SUCH DISPUTE, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY CLAIM THAT (A) SUCH PARTY IS NOT PERSONALLY SUBJECT TO THE JURISDICTION OF SUCH COURTS, (B) SUCH PARTY AND SUCH PARTY’S PROPERTY IS IMMUNE FROM ANY LEGAL PROCESS ISSUED BY SUCH COURTS OR (C) ANY LITIGATION OR OTHER PROCEEDING COMMENCED IN SUCH COURTS IS BROUGHT IN AN INCONVENIENT FORUM.
|
12.15
|
Computation of Time
. Whenever the last day for the exercise of any privilege or the discharge of any duty hereunder shall fall on a Saturday, Sunday, or any public or legal holiday, whether local or national, the Party having such privilege or duty shall have until 5:00 p.m. (EST or, if in effect in New York, EDT) on the next succeeding business day to exercise such privilege, or to discharge such duty.
|
12.16
|
Severability
. In the event any provision, clause, sentence, phrase, or word hereof, or the application thereof in any circumstances, is held to be invalid or unenforceable, such invalidity or unenforceability shall not affect the validity or enforceability of the remainder hereof, or of the application of any such provision, sentence, clause, phrase, or word in any other circumstances.
|
12.17
|
Costs and Expenses
. Unless otherwise provided in this Agreement, each Party shall bear all fees and expenses incurred in performing its obligations under this Agreement.
|
12.18
|
Provisions of Law
. A reference in this Agreement to a provision of law, regulation, rule, official directive, request, or guideline (whether or not having the force of law) of any governmental, intergovernmental or supranational body, agency, department or regulatory, self-regulatory, or other authority or organization is a reference to that provision as amended or re-enacted currently or in the future.
|
12.19
|
Meaning in Notices
. Unless a contrary indication appears, a term used in any notice given under or in connection with this Agreement has the same meaning in that notice as in this Agreement.
|
AXOVANT SCIENCES LTD.
|
|
ROIVANT SCIENCES, INC.
|
|
|
|
|
|
|
|
|
|
/s/ Marianne L. Romeo
|
|
/s/ Matthew Gline
|
By: Marianne L. Romeo
|
|
By: Matthew Gline
|
Title: Head, Global Transaction & Risk Management
|
|
Title: SVP, Finance and Business Operations
|
Date: 14 February 2017
|
|
Date: February 14, 2017
|
|
|
|
|
|
|
AXOVANT SCIENCES, INC.
|
|
AXOVANT SCIENCES GMBH
|
|
|
|
|
|
|
|
|
|
/s/ Gregory Weinhoff
|
|
/s/ Ruben Masar
|
By: Gregory Weinhoff
|
|
By: Ruben Masar
|
Title: Chief Financial Officer
|
|
Title: Secretary
|
Date: February 14, 2017
|
|
Date: 14 February 2017
|
|
|
|
1.
|
Administrative and Support Services
. Various administrative and supportive services, which may include, but are not limited to:
|
(a)
|
Payroll
|
(b)
|
Accounts Receivable
|
(c)
|
Accounts Payable
|
(d)
|
General Administrative
|
(e)
|
Corporate and Public Relations (including advertising, investor relations and/or financial marketing)
|
(f)
|
Meeting Coordination and Travel Planning
|
(g)
|
Accounting and Auditing
|
(h)
|
Tax
|
(i)
|
Budgeting
|
(j)
|
Treasury Activities
|
(k)
|
Staffing and Recruiting
|
(l)
|
Training and Employee Development
|
(m)
|
Benefits
|
(n)
|
Information and Technology Services
|
(o)
|
Legal Services
|
(p)
|
Insurance Claims Management
|
(q)
|
Purchasing
|
(a)
|
Preparatory assistance in respect of the identification/location of potential drug asset candidates
|
(b)
|
Perform/oversee due diligence to evaluate a drug candidate (including, but not limited to, studying the compound, market demand, potential opportunities and competitive landscape with respect to such drug candidate and probability of commercial success of such drug candidate)
|
(c)
|
Engage, manage and oversee external consultants, whether individuals or consulting companies, in connection with in-depth analyses of potential drug investment opportunities and other activities relating to drugs and drug candidates
|
(d)
|
Form recommendations regarding potential drug investment opportunities and deliver recommendations to the board of directors of either of the Service Recipients
|
(e)
|
Provide the board of directors of either of the Service Recipients with advice in connection with the acquisition of drug assets and, if necessary, assist in communications between the board of directors of the applicable Service Recipient and the sellers of the relevant drug asset in order for ASG to negotiate and conclude agreements to acquire drug assets and related intellectual property
|
(f)
|
Participate in meetings with regulatory authorities related to drug assets of ASG (within the parameters and guidelines provided by ASG)
|
(g)
|
Develop a plan for clinical testing with respect to a drug asset, identify appropriate contract research organizations to be used in connection with such clinical testing and contract with such contract research organizations (within the parameters and guidelines provided by ASG)
|
(h)
|
Select manufacturers to manufacture small batch sample of drug product for purposes of clinical trials and contract with such manufacturers (within the parameters and guidelines provided by ASG)
|
(i)
|
Manage and oversee clinical trials and drug manufacturing to the extent such clinical trials and drug manufacturing costs do not exceed established cost parameters set by ASG (j) Gather and analyze data obtained in connection with clinical trials and present such information to the board of directors of ASG
|
(k)
|
Conduct final filings to obtain regulatory approvals with respect to a drug asset
|
(a)
|
The applicable Service Recipient shall reimburse Service Provider for its Costs, excluding third-party costs as provided in (c), incurred in providing the
Administrative
and Support Services
described in Exhibit A to such Service Recipient or in making, obtaining, and maintaining in force the Authorizations as described in Section 11.1 for such Service Recipient and shall further pay Service Provider a mark-up on such costs. The mark-up shall be based on the mark-up percentage that the Parties mutually agree is consistent with the financial returns of independent companies performing similar services. The Parties shall review and (if necessary) update the mark-up percentage on an annual basis.
|
(b)
|
The applicable Service Recipient shall reimburse Service Provider for its Costs, excluding third-party costs as provided in (c), incurred in providing the
Other Services
described in Exhibit A to such Service Recipient, and shall further pay Service Provider a mark-up on such costs. The mark-up shall be based on the mark-up percentage that the Parties mutually agree is consistent with the financial returns of independent companies performing similar services. The Parties shall review and (if necessary) update the markup percentage on an annual basis.
|
(c)
|
If the Service Provider engages a third party pursuant to Section 3.4 hereof, the applicable Service Recipient shall reimburse the Service Provider for all reasonable and actual out-of-pocket costs incurred by the Service Provider in connection with such engagement to the extent such Service Recipient is the beneficiary of the services performed by such third party.
|
1.
|
DEFINITIONS
|
1.1
|
Affiliate
. “Affiliate” shall mean any Person, whether de jure or de facto, other than a Party, that directly or indirectly owns, is owned by or is under common ownership with a Party to the extent of at least 50 percent of the equity having the power to vote on or direct the affairs of the entity, and any Person actually controlled by, controlling, or under common control with a Party.
|
1.2
|
Costs
. “Costs” shall mean the fully-burdened cost incurred by the Service Provider and its Affiliates during any applicable month to provide the Services. For purposes of this definition, the fully-burdened cost includes without limitation: (i) the costs of any materials used in providing the Services; (ii) the salary, benefits (if any) (including without limitation, medical plans and 401(k) or other retirement plans), and employment taxes (if any) of all the Service Provider’s employees involved in providing such services (excluding, however, any compensation that is provided to an employee or independent contractor in the form of equity instruments, options to acquire stock (stock options), rights with respect to (or determined by reference to) equity instruments or stock options,
|
1.3
|
Marks
. “Marks” shall mean and include trademarks, service marks, trade names, domain names, trade dress, logos, and similar designations, whether registered or unregistered, and all applications and registrations therefor.
|
1.4
|
Party
. “Party” shall mean Service Provider or Service Recipient, and “Parties” shall mean Service Provider and Service Recipient collectively.
|
1.5
|
Person
. “Person” shall mean and include any individual, corporation, trust, estate, partnership, joint venture, company, association, governmental bureau or agency, or any other entity regardless of the type or nature thereof.
|
1.6
|
Third Party
. “Third Party” shall mean any entity other than a Party or an Affiliate.
|
1.7
|
Works
. “Works” shall mean any work product, technical knowledge, creations, know-how, formulations, recipes, specifications, rights, devices, drawings, instructions, expertise, trade practices, customer lists, computer data, source codes, analytical and quality control data, Marks, copyrights, commercial information, inventions, works of authorship, designs, methods, processes, technology, patterns, techniques, data, , patents, trade secrets, copyrights, related contracts, licenses and agreements and the like, and all other intellectual property created, authored, composed, invented, discovered, performed, perfected, provided, acquired or learned by the Service Provider, whether solely or jointly with others, whether patented, patentable or not, whether in written form or otherwise, whether disclosed to Service Provider by either Service Recipient or otherwise, in performing its obligations under this Agreement, in each case, that (i) relates to intellectual property or potential intellectual property originating from research and development of Service Recipient or its affiliate’s drug products or portfolio candidates, and (ii) arises out of services provided directly or indirectly (e.g., through an employee, consultant clinical research organization, other vendor or other Third Party engaged by the Service Provider) in connection with such research and development.
|
1.8
|
Year
. “Year” shall mean the 12-month period ending on March 31.
|
2.
|
ENGAGEMENT.
|
3.
|
RELATIONSHIP OF THE PARTIES.
|
3.1
|
The Parties are each independent contractors and not joint venturers, partners, agents, or representatives of the other. The Service Provider shall perform the Services for the Service Recipient under this Agreement as an independent contractor and neither the Service Provider nor its employees, subcontractors or agents shall be deemed to be agents, servants or employees of the Service Recipient, nor shall the Service Provider and the Service Recipient be deemed or construed solely by this Agreement to be partners or joint venturers. The Service Provider shall have exclusive control over the direction and conduct of its employees in carrying out the activities required under this Agreement.
|
3.2
|
Neither the Service Provider nor its employees, subcontractors or agents shall have the authority to (i) negotiate the terms of or execute contracts and agreements of the Service Recipient (including letters of intent, even if non-binding), provided the Service Provider may suggest incorporating certain non-core agreement terms within the parameters and guidelines provided by Service Recipient; (ii) hire personnel for the Service Recipient; (iii) exercise binding authority with respect to the operations of the Service Recipient; (iv) make binding recommendations to the Service Recipient; (v) make decisions or have decision-making rights with respect to the Service Recipient; (vi) hold itself out as representing the Service Recipient or as having the authority to negotiate the terms of or conclude contracts on behalf of the Service Recipient or (vii) perform services for the Service Recipient that are not covered by this Agreement.
|
3.3
|
The Service Provider and its employees, subcontractors or agents shall have the authority to (i) provide advice, assistance, direction and recommendations to the Service Recipient with respect to its operations; (ii) make recommendations on key points of contracts, without having the power to negotiate the terms of or conclude contracts or agreements on behalf of the Service Recipient; (iii) participate in discussions on contracts and agreements; (iv) arrange transactions between the Service Recipient and other parties, provided that the Service Provider does not make any actual decisions or participate in substantive activities, such as negotiations with respect to the terms of such transactions, provided the Service Provider may suggest incorporating certain non-core agreement terms within the parameters and guidelines provided by Service Recipient; and (v) contact banks in connection with raising capital for the Service Recipient, without having, in any circumstance, the power to negotiate the terms of or conclude contracts or agreements on behalf of the Service Recipient in connection with raising capital for the Service Recipient.
|
3.4
|
Engagement of Third Parties
. The Service Provider may, with the prior consent of the Service Recipient, engage such persons, corporations, or other entities as it reasonably deems necessary for the purpose of performing Services under this Agreement; provided, however, that the Service Provider shall remain responsible for the performance of all such Services and shall be considered to engage with such persons, corporations, or other entities in its own name and on its own behalf.
|
4.
|
FEES AND EXPENSES.
|
4.1
|
The Service Recipient shall pay the Service Provider a fee in accordance with Exhibit B attached hereto for the Services provided hereunder. The rates specified in Exhibit B attached hereto shall be reviewed and may be updated from time to time by the Parties. Fees for Services performed by the Service Provider will be billed by the Service Provider on a monthly basis. All other costs for Third Party services shall be billed, by or on behalf of the Service Provider, to the Service Recipient, in such manner and format and with such supporting information as the Parties may reasonably agree from time to time. Payment for undisputed invoices received by the Service Recipient shall be due within sixty (60) days after the billing date. Any fees and expenses not paid by the due date thereof shall accrue interest at the safe harbor interest rate based on the applicable Federal rate as set forth in U.S. Treasury Regulations Section 1.482-2(a)(2)(iii)(B). All fees and expenses shall be invoiced and payable in U.S. dollars.
|
4.2
|
Yearly Reconciliation
. The Parties shall perform a yearly reconciliation for the compensation amounts paid as follows:
|
a.
|
Administrative Services Yearly Reconciliation
.
|
i.
|
As soon as reasonably practicable following the close of each Year during the Term of this Agreement, the Parties will calculate the total service fee with respect to the activities listed in Exhibit A, subsection 1 (“Administrative and Support Services”) owing under this Agreement for the Year (the “Exhibit B Administrative Services Fees”) by calculating the Service Provider’s Costs with respect to such services and applying the mutually agreed mark-up percentage for such services determined in accordance with Exhibit B, and adding the amount of any third-party costs reimbursable under Exhibit B paragraph (c) that relate to such services. As soon as reasonably practicable following the close of each Year, the Parties shall also calculate the total amount of service fees actually paid for the Year under Section 4.1 with respect to the activities listed in Exhibit A, subsection 1 (“Administrative and Support Services”), adding the amount of any third-party costs reimbursable under Exhibit B paragraph (c) that relate to such services (the “Actual Administrative Services Fees”).
|
ii.
|
If, for any Year, the total Actual Administrative Services Fees is greater than the Exhibit B Administrative Services Fees for such services, there shall be deemed to exist an excess of service fee in an amount equal to the difference between the total Actual Administrative Services Fees and the total Exhibit B Administrative Services Fees for the Year (hereinafter “Administrative Services Excess”).
|
iii.
|
If, for any Year, the total Actual Administrative Services Fees is less than the total Exhibit B Administrative Services Fees, there shall be deemed to exist a shortfall in an amount equal to the difference between the total Exhibit B Administrative Services Fees and the total Actual Administrative Services Fees (hereinafter “Administrative Services Shortfall”).
|
b.
|
Other Services Yearly Reconciliation
.
|
i.
|
As soon as reasonably practicable following the close of each Year during the Term of this Agreement, the Parties will calculate the total service fee with respect to the activities listed in Exhibit A, subsection 2 (“Other Services”) owing under this Agreement for the Year (the “Exhibit B Other Services Fees”) by calculating the Service Provider’s Costs with respect to such services and applying the mutually agreed mark-up percentage for such services determined in accordance with Exhibit B, and adding the amount of any third-party costs reimbursable under Exhibit B paragraph (c) that relate to such services. As soon as reasonably practicable following the close of each Year, the Parties shall also calculate the total amount of service fees actually paid for the Year under Section 4.1 with respect to the activities listed in Exhibit A, subsection 1 (“Other Services”), adding the amount of any third-party costs reimbursable under Exhibit B paragraph (c) that relate to such services (the “Actual Other Services Fees”).
|
ii.
|
If, for any Year, the total Actual Other Services Fees is greater than the Exhibit B Other Services Fees for such services, there shall be deemed to exist an excess of service fee in an amount equal to the difference between the total Actual Other Services Fees and the total Exhibit B Other Services Fees for the Year (hereinafter “Other Services Excess”).
|
iii.
|
If, for any Year, the total Actual Other Services Fees is less than the total Exhibit B Other Services Fees, there shall be deemed to exist a shortfall in an amount equal to the difference between the total Exhibit B Other Services Fees and the total Actual Other Services Fees (hereinafter “Other Services Shortfall”).
|
c.
|
Settlement of Excess or Shortfall Amounts
.
|
i.
|
If, for any Year, (1) the sum of the Administrative Services Shortfall and the Other Services Shortfall exceeds (2) the sum of the Administrative Services Excess and the Other Services Excess (such excess amount, the “Net Shortfall”), the Service Recipient shall pay such Net Shortfall to Service Provider within thirty (30) days after the Exhibit B Administrative Services Fees, Exhibit B Other Services Fees, Actual Administrative Services Fees, and Actual Other Services Fees have been calculated for such Year.
|
ii.
|
If, for any Year, (1) the sum of the Administrative Services Excess and the Other Services Excess exceeds (2) the sum of the Administrative Services Shortfall and the Other Services Shortfall (such excess amount, the “Net Excess”), the Service Provider may (x) treat such Net Excess, in whole or in part, as a contribution to the capital of the Service Provider; or (y) treat such Net Excess, in whole or in part, as an overpayment to the Service Provider that must be repaid to the Service Recipient within 30 days after the end of the Year.
|
4.3
|
Withholding
. Service Recipient shall be entitled to deduct from any payments to Service Provider the amount of any withholding taxes with respect to such amounts payable, or any taxes in each case required to be withheld by Service Recipient to the extent that Service Recipient pays to the appropriate governmental authority on behalf of Service Provider such taxes, levies, or charges. Service Recipient shall, upon the request of Service Provider, deliver to Service Provider proof of payment of all such taxes, levies, and other charges and the appropriate documentation that is necessary to obtain a tax credit, to the extent such tax credit can be obtained.
|
5.
|
ACCESS TO BOOKS AND RECORDS.
|
6.
|
CONFIDENTIAL INFORMATION
|
6.1
|
Obligations
. The Parties acknowledge that, from time to time, one Party (the “Disclosing Party”) may disclose to the other Party (the “Receiving Party”) information that is marked as “proprietary,” or “confidential,” or which would, under the circumstances, be understood by a reasonable person to be proprietary and nonpublic (“Confidential Information”). The Receiving Party shall retain such Confidential Information in confidence. Each Party shall use at least the same procedures and degree of care that it uses to protect its own Confidential Information of like importance, including those procedures used when disclosing Confidential Information to Third Parties, and in no event less than reasonable care.
|
6.2
|
Exceptions
. Nothing in this Agreement shall prevent the disclosure by the Receiving Party or its employees of Confidential Information that:
|
a.
|
Prior to the transmittal thereof to Receiving Party was of general public knowledge;
|
b.
|
Becomes, subsequent to the time of transmittal to Receiving Party, a matter of general public knowledge otherwise than as a consequence of a breach by Receiving Party of any obligation under this Agreement;
|
c.
|
Is made public by Disclosing Party;
|
d.
|
Was in the possession of Receiving Party in documentary form prior to the time of disclosure thereof to Receiving Party by Disclosing Party, and is held by Receiving Party free of any obligation of confidence to Disclosing Party or any Third Party; or
|
e.
|
Is received in good faith from a Third Party having the right to disclose it, who, to the best of Receiving Party’s knowledge, did not obtain the same from Disclosing Party and who imposed no obligation of secrecy on Receiving Party with respect to such information.
|
6.3
|
No Unauthorized Use
. The Receiving Party shall refrain from using or exploiting any and all Confidential Information for any purposes or activities other than those contemplated in this Agreement or any other written agreement entered into by and between the Parties.
|
6.4
|
Survival
. The Parties’ obligations under this Article 6 shall survive the termination of this Agreement for any reason whatsoever.
|
7.
|
OWNERSHIP OF INTANGIBLE PROPERTY
|
8.
|
USE OF TRADEMARKS
|
9.
|
INDEMNIFICATION; LIMITATION OF LIABILITY
|
9.1
|
The Service Provider, to the maximum extent permitted by law, shall defend, protect, indemnify and hold the Service Recipient and its officers, employees and directors, as the case may be (“
Indemnified Parties
”), harmless from and against any and all losses, demands, damages (including, without limitation, special, consequential and punitive damages awarded to Third Parties), claims, liabilities, interest, awards, actions or causes of action, suits, judgments, settlements and compromises relating thereto, and all reasonable attorney’s fees and other fees and expenses in connection therewith (“Losses”) which may be incurred by an Indemnified Party, arising out of, due to, or in connection with, directly or indirectly, the provision of the Services or failure to provide the Services under this Agreement, except to the extent that such Losses are the result of the gross negligence or willful misconduct of an Indemnified Party.
|
9.2
|
The Service Provider’s liability for aggregate Losses under this Agreement for any cause whatsoever, and regardless of the form of action, whether in contract or in tort, shall be limited to the payments made by the Service Recipient under this Agreement for the specific Service that allegedly caused or was related to the Losses during the period in which the alleged Losses were incurred. In no event shall the Service Provider be liable for any Losses caused by the Service Recipient’s failure to perform the Service Recipient’s obligations under this Agreement.
|
9.3
|
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT OR AT LAW OR IN EQUITY, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR PUNITIVE, SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES TO THE OTHER PARTY OR ANY OTHER PERSON (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF BUSINESS PROFITS, BUSINESS INTERRUPTION, ACTIONS OF THIRD PARTIES OR ANY OTHER LOSS) ARISING FROM OR RELATING TO ANY CLAIM MADE UNDER THIS AGREEMENT OR THE PROVISION OR THE FAILURE TO PROVIDE THE SERVICES.
|
10.
|
TERM AND TERMINATION
|
10.1
|
Term
. This Agreement shall commence on the Effective Date and continue until terminated by either Party in accordance with this Section 10.1. Either party may terminate this Agreement at its discretion by giving written notice to the other party at least sixty (60) days before the proposed termination date. Section 12.14 and Article 6 shall survive the termination of this Agreement. The Service Recipient hereby specifically agrees and acknowledges that all obligations of the Service Provider to provide any and all Services shall immediately cease upon termination of this Agreement. The Service Provider hereby specifically agrees and acknowledges that all of its rights to use Marks pursuant to Article 8 of this Agreement shall immediately cease upon termination of this Agreement. To the extent permitted by applicable law, neither Party shall be liable to the other Party for, and each Party hereby expressly waives any right to, any termination compensation of any kind or
|
10.2
|
Rights and Duties on Termination
. Upon termination of this Agreement for any reason, each Party shall cease all use of the other Party’s Confidential Information, and Service Recipient shall pay Service Provider all accrued and unpaid fees for Services performed through the date of termination.
|
11.
|
COMPLIANCE WITH LAWS
|
11.1
|
General Compliance
. The Parties shall at all times strictly comply with all applicable laws, rules, regulations, and governmental orders, now or hereafter in effect, relating to their performance of this Agreement. Each Party further agrees to make, obtain, and maintain in force at all times during the term of this Agreement, all filings, registrations, reports, licenses, permits, and authorizations (collectively, “
Authorizations
”) required under applicable law, regulation, or order for such Party to perform its obligations under this Agreement. Service Recipient shall provide Service Provider with such assistance as Service Provider may reasonably request in making or obtaining any such Authorizations.
|
12.
|
GENERAL PROVISIONS
|
12.1
|
Notices
. Any and all notices, elections, offers, acceptances, and demands permitted or required to be made under this Agreement shall be in writing, signed by the Party giving such notice, election, offer, acceptance, or demand and shall be delivered personally, by messenger, courier service, telecopy, first class mail or similar transmission, to the Party, at its address on file with the other Party or at such other address as may be supplied in writing. The date of personal delivery or the date of mailing, as the case may be, shall be the date of such notice, election, offer, acceptance, or demand.
|
12.2
|
Force Majeure
. If the performance of any part of this Agreement by either Party, or of any obligation under this Agreement, is prevented, restricted, interfered with, or delayed by reason of any cause beyond the reasonable control of the Party liable to perform, unless conclusive evidence to the contrary is provided, the Party so affected shall, on giving written notice to the other Party, be excused from such performance to the extent of such prevention, restriction, interference, or delay, provided that the affected Party shall use its reasonable best efforts to avoid or remove such causes of nonperformance and shall continue performance with the utmost dispatch whenever such causes are removed. When such circumstances arise, the Parties shall discuss what, if any, modification of the terms of this Agreement may be required in order to arrive at an equitable solution.
|
12.3
|
Successors and Assigns
. This Agreement may not be assigned or otherwise conveyed by any Party without the prior written consent of the other Party; provided however that such prior written consent will not be required for an assignment to an Affiliate of either Party. This Agreement shall be binding on and inure to the benefit of the Parties hereto and their respective successors, successors in title and assigns to the extent that such assignment is permitted under this paragraph.
|
12.4
|
Entire Agreement, Amendments
. This Agreement constitutes the entire agreement between the Parties with respect to the subject matter hereof, and supersedes all prior agreements, understandings, and communications between the Parties, whether oral or written, relating to the same subject matter. No change, modification, or amendment of this Agreement shall be valid or binding on the Parties unless such change or modification shall be in writing signed by the Party or Parties against whom the same is sought to be enforced.
|
12.5
|
Remedies Cumulative
. The remedies of the Parties under this Agreement are cumulative and shall not exclude any other remedies to which the Party may be lawfully entitled.
|
12.6
|
Other Persons
. Nothing in this Agreement shall be construed to prevent or prohibit the Service Provider from providing services to any other Person or from engaging in any other business activity.
|
12.7
|
Not for the Benefit of Third Parties
. This Agreement is for the exclusive benefit of the Parties to this Agreement and not for the benefit of any Third Party.
|
12.8
|
Further Assurances
. Each Party hereby covenants and agrees that it shall execute and deliver such deeds and other documents as may be required to implement any of the provisions of this Agreement.
|
12.9
|
No Waiver
. The failure of any Party to insist on strict performance of a covenant hereunder or of any obligation hereunder shall not be a waiver of such Party’s right to demand strict compliance therewith in the future, nor shall the same be construed as a novation of this Agreement.
|
12.10
|
Integration
. This Agreement constitutes the full and complete agreement of the Parties.
|
12.11
|
Captions
. Titles or captions of articles and paragraphs contained in this Agreement are inserted only as a matter of convenience and for reference, and in no way define, limit, extend, or describe the scope of this Agreement or the intent of any provision hereof.
|
12.12
|
Number and Gender
. Whenever required by the context, the singular number shall include the plural, the plural number shall include the singular, and the gender of any pronoun shall include all genders.
|
12.13
|
Counterparts
. This Agreement may be executed in multiple copies, each one of which shall be an original and all of which shall constitute one and the same document, binding on the Parties, and each Party hereby covenants and agrees to execute all duplicates or replacement counterparts of this Agreement as may be required.
|
12.14
|
Governing Law and Jurisdiction
. THIS AGREEMENT AND THE LEGAL RELATIONS BETWEEN THE PARTIES HERETO SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK, WITHOUT REGARD TO ANY CONFLICT OF LAWS RULES. THE COURTS LOCATED WITHIN THE STATE OF NEW YORK SHALL HAVE EXCLUSIVE JURISDICTION OVER ANY AND ALL DISPUTES BETWEEN THE PARTIES HERETO, WHETHER IN LAW OR EQUITY, ARISING OUT OF OR RELATING TO THIS AGREEMENT AND THE AGREEMENTS, INSTRUMENTS AND DOCUMENTS CONTEMPLATED HEREBY AND THE PARTIES CONSENT TO AND AGREE TO SUBMIT TO THE EXCLUSIVE JURISDICTION OF SUCH COURTS. EACH OF THE PARTIES HEREBY WAIVES AND AGREES NOT TO ASSERT IN ANY SUCH DISPUTE, TO
|
12.15
|
Computation of Time
. Whenever the last day for the exercise of any privilege or the discharge of any duty hereunder shall fall on a Saturday, Sunday, or any public or legal holiday, whether local or national, the Party having such privilege or duty shall have until 5:00 p.m. (EST or, if in effect in New York, EDT) on the next succeeding business day to exercise such privilege, or to discharge such duty.
|
12.16
|
Severability
. In the event any provision, clause, sentence, phrase, or word hereof, or the application thereof in any circumstances, is held to be invalid or unenforceable, such invalidity or unenforceability shall not affect the validity or enforceability of the remainder hereof, or of the application of any such provision, sentence, clause, phrase, or word in any other circumstances.
|
12.17
|
Costs and Expenses
. Unless otherwise provided in this Agreement, each Party shall bear all fees and expenses incurred in performing its obligations under this Agreement.
|
12.18
|
Provisions of Law
. A reference in this Agreement to a provision of law, regulation, rule, official directive, request, or guideline (whether or not having the force of law) of any governmental, intergovernmental or supranational body, agency, department or regulatory, self-regulatory, or other authority or organization is a reference to that provision as amended or re-enacted currently or in the future.
|
12.19
|
Meaning in Notices
. Unless a contrary indication appears, a term used in any notice given under or in connection with this Agreement has the same meaning in that notice as in this Agreement.
|
ROIVANT SCIENCES GMBH
|
|
AXOVANT SCIENCES GMBH
|
|
|
|
|
|
|
|
|
|
/s/ Marianne Romeo Dinsmore
|
|
/s/ Ruben Masar
|
By: Marianne Romeo Dinsmore
|
|
By: Ruben Masar
|
Title: Managing Director
|
|
Title: Secretary
|
Date: 14 February 2017
|
|
Date: 14 February 2017
|
1.
|
Administrative and Support Services
. Various administrative and supportive services, which may include, but are not limited to:
|
(a)
|
Payroll
|
(b)
|
Accounts Receivable
|
(c)
|
Accounts Payable
|
(d)
|
General Administrative
|
(e)
|
Corporate and Public Relations (including advertising, investor relations and/or financial marketing)
|
(f)
|
Meeting Coordination and Travel Planning
|
(g)
|
Accounting and Auditing
|
(h)
|
Tax
|
(i)
|
Budgeting
|
(j)
|
Treasury Activities (k) Staffing and Recruiting (l) Training and Employee Development (m) Benefits
|
(n)
|
Information and Technology Services
|
(o)
|
Legal Services (p) Insurance Claims Management (q) Purchasing
|
2.
|
Other Services
|
(a)
|
Preparatory assistance in respect of the identification/location of potential drug asset candidates
|
(b)
|
Perform/oversee due diligence to evaluate a drug candidate (including, but not limited to, studying the compound, market demand, potential opportunities and competitive landscape with respect to such drug candidate and probability of commercial success of such drug candidate)
|
(c)
|
Engage, manage and oversee external consultants, whether individuals or consulting companies, in connection with in-depth analyses of potential drug investment opportunities and other activities relating to drugs and drug candidates
|
(d)
|
Form recommendations regarding potential drug investment opportunities and deliver recommendations to the board of directors of the Service Recipient
|
(e)
|
Provide the board of directors of the Service Recipient with advice in connection with the acquisition of drug assets and, if necessary, assist in communications between the board of directors of the Service Recipient and the sellers of the relevant drug asset in order for the Service Recipient to negotiate and conclude agreements to acquire drug assets and related intellectual property
|
(f)
|
Participate in meetings with regulatory authorities related to drug assets of Service Recipient (within the parameters and guidelines provided by Service Recipient)
|
(g)
|
Develop a plan for clinical testing with respect to a drug asset, identify appropriate contract research organizations to be used in connection with such clinical testing and contract with such contract research organizations (within the parameters and guidelines provided by Service Recipient)
|
(h)
|
Select manufacturers to manufacture small batch sample of drug product for purposes of clinical trials and contract with such manufacturers (within the parameters and guidelines provided by Service Recipient)
|
(i)
|
Manage and oversee clinical trials and drug manufacturing to the extent such clinical trials and drug manufacturing costs do not exceed established cost parameters set by Service Recipient
|
(j)
|
Gather and analyze data obtained in connection with clinical trials and present such information to the board of directors of the Service Recipient
|
(k)
|
Conduct final filings to obtain regulatory approvals with respect to a drug asset
|
(a)
|
Service Recipient shall reimburse Service Provider for its Costs, excluding third-party costs as provided in (c), incurred in providing the
Administrative and Support Services
described in Exhibit A or in making, obtaining, and maintaining in force the Authorizations as described in Section 11.1, and shall further pay Service Provider a mark-up on such costs. The mark-up shall be based on the mark-up percentage that the Parties mutually agree is consistent with the financial returns of independent companies performing similar services. The Parties shall review and (if necessary) update the markup percentage on an annual basis.
|
(b)
|
Service Recipient shall reimburse Service Provider for its Costs, excluding third-party costs as provided in (c), incurred in providing the
Other Services
described in Exhibit A, and shall further pay Service Provider a mark-up on such costs. The mark-up shall be based on the mark-up percentage that the Parties mutually agree is consistent with the financial returns of independent companies performing similar services. The Parties shall review and (if necessary) update the mark-up percentage on an annual basis.
|
(c)
|
If the Service Provider engages a third party pursuant to Section 3.4 hereof, the Service Recipient shall reimburse the Service Provider for all reasonable and actual out-of-pocket costs incurred by the Service Provider in connection with such engagement.
|
Date: February 14, 2017
|
By:
|
/s/ Vivek Ramaswamy
|
|
|
Vivek Ramaswamy
|
|
|
Principal Executive Officer
|
Date: February 14, 2017
|
By:
|
/s/ Gregory Weinhoff
|
|
|
Gregory Weinhoff
|
|
|
Principal Financial Officer
|
Date: February 14, 2017
|
By:
|
/s/ Vivek Ramaswamy
|
|
|
Vivek Ramaswamy
|
|
|
Principal Executive Officer
|
Date: February 14, 2017
|
By:
|
/s/ Gregory Weinhoff
|
|
|
Gregory Weinhoff
|
|
|
Principal Financial Officer
|