MOLECULIN BIOTECH, INC.
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||||
(Exact name of registrant as specified in its charter)
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Delaware
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2834
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47-4671997
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(State or Other Jurisdiction of
Incorporation or Organization)
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(Primary Standard Industrial
Classification Code Number)
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(IRS Employer
Identification Number)
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2575 West Bellfort, Suite 333
Houston, TX
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77054
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(Address of principal executive offices)
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(Zip Code)
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713-300-5160
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(Registrant’s telephone number, including area code)
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Large accelerated filer
o
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Accelerated filer
o
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Smaller reporting company
x
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Non-accelerated filer
o
(Do not check if a smaller reporting company)
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Emerging growth company
x
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March 31, 2018
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December 31, 2017
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Assets
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(Unaudited)
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Current assets:
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|
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Cash and cash equivalents
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$
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13,114
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|
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$
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7,714
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Prepaid expenses and other
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634
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|
|
588
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||
Total current assets
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13,748
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8,302
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Furniture and equipment, net of accumulated depreciation of $32 and $21, respectively
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33
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33
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Intangible assets
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11,148
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11,148
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Total assets
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$
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24,929
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$
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19,483
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Liabilities and Stockholders’ Equity
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Current liabilities:
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Accounts payable
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$
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570
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$
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810
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Accrued expenses and current liabilities
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766
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|
|
902
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Warrant liability
|
463
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|
|
503
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Total current liabilities
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1,799
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2,215
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Long-term deferred compensation – related party
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150
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150
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Warrant liability - long term
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2,410
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—
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Total liabilities
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4,359
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|
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2,365
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Commitments and contingencies (Note 7)
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|
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Stockholders’ equity
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|
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Preferred stock, $0.001 par value; 5,000,000 shares authorized, no shares issued or outstanding
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—
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|
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—
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Common stock, $0.001 par value; 75,000,000 shares authorized, 25,768,861 issued outstanding at March 31, 2018 and 21,469,109 issued and outstanding at December 31, 2017
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26
|
|
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21
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Additional paid-in capital
|
36,951
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|
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31,577
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Accumulated deficit
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(16,407
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)
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|
(14,480
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)
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Total stockholders’ equity
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20,570
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17,118
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||||
Total liabilities and stockholders’ equity
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$
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24,929
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|
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$
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19,483
|
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Three Months Ended March 31,
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2018
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2017
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Revenues
|
$
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—
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$
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—
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Operating expenses:
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|
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Research and development
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1,237
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|
683
|
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General and administrative
|
1,392
|
|
|
848
|
|
||
Depreciation
|
8
|
|
|
4
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Total operating expenses
|
2,637
|
|
|
1,535
|
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Loss from operations
|
(2,637
|
)
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(1,535
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)
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||||
Other income (expense):
|
|
|
|
|
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||
Gain from change in fair value of warrant liability
|
709
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|
|
1,059
|
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||
Gain from settlement of liability
|
—
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|
|
149
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||
Other expense
|
—
|
|
|
(1
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)
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||
Interest income (expense), net
|
1
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(1
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)
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|
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||||
Net loss
|
$
|
(1,927
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)
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$
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(329
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)
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Net loss per common share – basic and diluted
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$
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(0.08
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)
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$
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(0.02
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)
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Weighted average common shares outstanding – basic and diluted
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23,331,685
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14,590,220
|
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Three Months Ended March 31,
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||||||
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2018
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2017
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||||
Cash Flows from Operating Activities:
|
|
|
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Net loss
|
$
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(1,927
|
)
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$
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(329
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)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
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|
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Depreciation
|
8
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|
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4
|
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Stock-based compensation
|
242
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|
|
110
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Deferred compensation - related party
|
—
|
|
|
38
|
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||
Change in fair value of warrant liability
|
(709
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)
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(1,059
|
)
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||
Gain in settlement of liability
|
—
|
|
|
(149
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)
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||
Changes in operating assets and liabilities:
|
|
|
|
|
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||
Prepaid expenses
|
(46
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)
|
|
(55
|
)
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||
Accounts payable
|
(239
|
)
|
|
287
|
|
||
Accrued expenses
|
(136
|
)
|
|
(238
|
)
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||
Net Cash Used in Operating Activities
|
(2,807
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)
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|
(1,391
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)
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||
Cash Flows from Investing Activities:
|
|
|
|
|
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Purchase of fixed assets
|
(8
|
)
|
|
—
|
|
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Net Cash Used in Investing Activities
|
(8
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)
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—
|
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Cash Flows from Financing Activities:
|
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Proceeds from exercise of warrants
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15
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805
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Proceeds from sale of common stock units, net of cash stock issuance costs
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8,200
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4,460
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Net Cash Provided by Financing Activities
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8,215
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5,265
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Net change in cash and cash equivalents
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5,400
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3,874
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Cash and cash equivalents, at beginning of period
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7,714
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5,007
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||
Cash and cash equivalents, at end of period
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$
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13,114
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$
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8,881
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Supplemental disclosures of cash flow information:
|
|
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Cash paid for interest
|
$
|
1
|
|
|
$
|
—
|
|
Cash paid for income taxes
|
$
|
5
|
|
|
$
|
—
|
|
Supplemental disclosure of non-cash investing and financing activities:
|
|
|
|
|
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Common stock issued for conversion of debt
|
$
|
—
|
|
|
$
|
190
|
|
Common stock issued for services provided
|
$
|
—
|
|
|
$
|
89
|
|
|
Common Stock
|
|
|
|
|
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|||||||||||
|
Number
|
|
Amount
|
|
Additional
Paid-In-Capital
|
|
Accumulated
Deficit
|
|
Stockholders'
Equity
|
|||||||||
Balance at December 31, 2017
|
21,469,109
|
|
|
$
|
21
|
|
|
$
|
31,577
|
|
|
$
|
(14,480
|
)
|
|
$
|
17,118
|
|
Warrants exercised
|
9,752
|
|
|
—
|
|
|
15
|
|
|
—
|
|
|
15
|
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||||
Issued for cash - sale of common stock, net of issuance costs of $809
|
4,290,000
|
|
|
5
|
|
|
5,117
|
|
|
—
|
|
|
5,122
|
|
||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
242
|
|
|
—
|
|
|
242
|
|
||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,927
|
)
|
|
(1,927
|
)
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||||
Balance at March 31, 2018
|
25,768,861
|
|
|
$
|
26
|
|
|
$
|
36,951
|
|
|
$
|
(16,407
|
)
|
|
$
|
20,570
|
|
•
|
WP1066 has an approved physician-sponsored IND for the treatment of brain tumors and is also being evaluated for potential treatment of AML and pancreatic cancer,
|
•
|
WP1220, an analog of WP1066 is being studied for the topical treatment of cutaneous T-cell lymphoma (CTCL),
|
•
|
WP1732, another analog of WP1066 that we believe is particularly well suited for intravenous administration is being evaluated for potential treatment of AML, pancreatic and other cancers, and
|
•
|
WP1122 and WP1234 are being evaluated for their potential to treat brain tumors and pancreatic cancer via their ability to inhibit glycolysis.
|
Description
|
|
Liabilities
Measured at Fair
Value
|
|
Quoted Prices
in Active
Markets for
Identical
Assets (Level 1)
|
|
Significant Other
Observable Inputs
(Level 2)
|
|
Significant Other
Unobservable Inputs
(Level 3)
|
||||||||
Fair value of warrant liability:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
2018
|
|
$
|
2,873
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,873
|
|
|
Warrant
Liability –
Current
|
|
Warrant
Liability –
Long-Term
|
|
Warrant
Liability –
Total
|
||||||
Balance, December 31, 2017
|
$
|
503
|
|
|
$
|
—
|
|
|
$
|
503
|
|
Exercise of warrants
|
(13
|
)
|
|
—
|
|
|
(13
|
)
|
|||
Issuances of warrants
|
—
|
|
|
3,092
|
|
|
3,092
|
|
|||
Change in fair value - net
|
(27
|
)
|
|
(682
|
)
|
|
(709
|
)
|
|||
|
|
|
|
|
|
||||||
Balance, March 31, 2018
|
$
|
463
|
|
|
$
|
2,410
|
|
|
$
|
2,873
|
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
Accrued payroll
|
|
$
|
437
|
|
|
$
|
250
|
|
Accrued clinical testing
|
|
—
|
|
|
320
|
|
||
Accrued license fees and SRA
|
|
188
|
|
|
260
|
|
||
Accrued legal and professional fees
|
|
75
|
|
|
50
|
|
||
Accrued other
|
|
66
|
|
|
22
|
|
||
Total accrued expenses and other liabilities
|
|
$
|
766
|
|
|
$
|
902
|
|
|
|
Three Months Ended March 31, 2018
|
|
Year Ended December 31,
2017 |
Risk-free interest rate
|
|
2.58%-2.68%
|
|
N/A
|
Volatility
|
|
80%-85%
|
|
N/A
|
Expected life (years)
|
|
5.38-5.5
|
|
N/A
|
Dividend yield
|
|
—%
|
|
N/A
|
|
|
Three Months Ended March 31, 2018
|
|
Year Ended December 31,
2017 |
Risk-free interest rate
|
|
2.46%-2.55%
|
|
1.68%-1.86%
|
Volatility
|
|
80.0%
|
|
80.00%-160.11%
|
Expected life (years)
|
|
3.87-3.96
|
|
0.5-5.0
|
Dividend yield
|
|
—%
|
|
—%
|
Description
|
|
Number of
Shares Under
Warrant
|
|
Range of
Warrant Price
per Share
|
|
Weighted
Average
Exercise Price
|
|
Weighted Average
Remaining
Contractual Life (Years)
|
||||||
Balance at January 1, 2018
|
|
419,772
|
|
|
$1.35-$1.50
|
|
|
1.46
|
|
|
4.38
|
|
||
Granted
|
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
Exercised
|
|
(9,752
|
)
|
|
—
|
|
|
$
|
1.50
|
|
|
—
|
|
|
Expired
|
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
Balance at March 31, 2018
|
|
410,020
|
|
|
$
|
1.50
|
|
|
$
|
1.50
|
|
|
3.88
|
|
Vested and Exercisable at March 31, 2018
|
|
410,020
|
|
|
$
|
1.50
|
|
|
$
|
1.50
|
|
|
3.88
|
|
|
Three Months Ended March 31,
|
||||
|
2018
|
|
2017
|
||
Risk-free interest rate
|
1.3% - 2.24%
|
|
1.3% - 2.24%
|
||
Volatility
|
70.18% - 89.11%
|
|
70.18% - 89.11%
|
||
Expected life (years)
|
5 to 6.25
|
|
6 to 6.25
|
||
Expected dividend yield
|
—
|
|
|
—
|
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
General and administrative
|
$
|
209
|
|
|
$
|
108
|
|
Research and development
|
33
|
|
|
2
|
|
||
Total
|
$
|
242
|
|
|
$
|
110
|
|
•
|
Our ability to obtain additional funding to develop our product candidates;
|
•
|
The need to obtain regulatory approval of our product candidates, both in the United States and in Poland;
|
•
|
The success of our clinical trials through all phases of clinical development;
|
•
|
Our ability to complete our clinical trials in a timely fashion and within our expected budget;
|
•
|
Compliance with obligations under intellectual property licenses with third parties;
|
•
|
Any delays in regulatory review and approval of product candidates in clinical development;
|
•
|
Our ability to commercialize our product candidates;
|
•
|
Market acceptance of our product candidates;
|
•
|
Competition from existing products or new products that may emerge;
|
•
|
Potential product liability claims;
|
•
|
Our dependency on third-party manufacturers to supply or manufacture our product candidates;
|
•
|
Our ability to establish or maintain collaborations, licensing or other arrangements;
|
•
|
Our ability and third parties’ abilities to protect intellectual property rights;
|
•
|
Our ability to adequately support future growth; and
|
•
|
Our ability to attract and retain key personnel to manage our business effectively.
|
•
|
WP1066 has an approved physician-sponsored IND for the treatment of brain tumors and is also being evaluated for potential treatment of AML and pancreatic cancer,
|
•
|
WP1220, an analog of WP1066 is being studied for the topical treatment of cutaneous T-cell lymphoma (CTCL),
|
•
|
WP1732, another analog of WP1066 that we believe is particularly well suited for intravenous administration is being evaluated for potential treatment of AML, pancreatic and other cancers, and
|
•
|
WP1122 and WP1234 are being evaluated for their potential to treat brain tumors and pancreatic cancer via their ability to inhibit glycolysis.
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Revenues
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
||||
Operating Expenses:
|
|
|
|
|
|
||
Research and development
|
1,237
|
|
|
683
|
|
||
General and administrative
|
1,392
|
|
|
848
|
|
||
Depreciation
|
8
|
|
|
4
|
|
||
Total operating expenses
|
2,637
|
|
|
1,535
|
|
||
Loss from operations
|
(2,637
|
)
|
|
(1,535
|
)
|
||
Other income (expense):
|
|
|
|
|
|
||
Gain from change in fair value of warrant liability
|
709
|
|
|
1,059
|
|
||
Gain from settlement of liability
|
—
|
|
|
149
|
|
||
Other expense
|
—
|
|
|
(1
|
)
|
||
Interest income (expense), net
|
1
|
|
|
(1
|
)
|
||
Net loss
|
$
|
(1,927
|
)
|
|
$
|
(329
|
)
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
Net cash used in operating activities
|
|
$
|
(2,807
|
)
|
|
$
|
(1,391
|
)
|
Net cash used in investing activities
|
|
(8
|
)
|
|
—
|
|
||
Net cash provided by financing activities
|
|
8,215
|
|
|
5,265
|
|
||
Net increase in cash and cash equivalents
|
|
$
|
5,400
|
|
|
$
|
3,874
|
|
Exhibit
Number
|
|
Description
|
10.1*
|
|
|
|
|
|
10.2±
|
|
|
|
|
|
31.1*
|
|
|
|
|
|
31.2*
|
|
|
|
|
|
32.1*
|
|
|
|
|
|
32.2*
|
|
|
|
|
|
101.INS*
|
|
XBRL Instance Document
|
|
|
|
101.SCH*
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
101.CAL*
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
101.DEF*
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
101.LAB*
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
101.PRE*
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
MOLECULIN BIOTECH, INC.
|
|
|
|
|
Date: May 14, 2018
|
By:
|
/s/ Walter V. Klemp
|
|
|
Walter V. Klemp,
|
|
|
Chief Executive Officer and Chairman
(Principal Executive Officer)
|
|
|
|
Date: May 14, 2018
|
By:
|
/s/ Jonathan P. Foster
|
|
|
Jonathan P. Foster,
|
|
|
Executive Vice President & Chief Financial Officer
(Principal Financial and Accounting Officer)
|
(a)
|
“
Tenant’s Current Address
”: ____________________________________________.
|
(b)
|
“
Premises
”: Suite 950 on the ninth (9th) floor in the building (the “
Building
”) located on land with an address of 5300 Memorial Drive, Houston, TX 77007
(the “
Land
”)
|
(c)
|
“
Rentable Area of Premises
”: 2,333 rentable square feet (“
RSF
”)
|
(d)
|
“
Rentable Area of Building
”: 153,671 RSF
|
(e)
|
“
Pro-rata Share
”: Tenant’s pro-rata share is 1.518%, which is determined by dividing the Rentable Area of Premises by the Rentable Area of Building.
|
(f)
|
“
Term
”: a period of approximately sixty-six (66) months beginning on the Commencement Date and expiring at 6 o’clock PM local time on the Expiration Date.
|
(g)
|
“
Commencement Date
”: Subject to and upon the terms and conditions set forth herein, the Commencement Date of this Lease shall be the earlier of (i) ten (10) business days after Landlord’s delivery of written notice to Tenant advising Tenant that the Initial Improvements are substantially completed (as further set forth in
Exhibit D
); or (ii) the date Tenant takes possession of all or any portion of the Premises for the purpose of conducting Tenant’s business. Landlord shall use reasonable efforts to commence and diligently prosecute to completion the Initial Improvements such that the Premises are ready for occupancy by the expected Commencement Date of June 1, 2018, but Landlord shall not be in default if Landlord fails to substantially complete the Initial Improvements by such date, it being agreed that Tenant shall accept possession of the Premises at such time as Landlord delivers same. Notwithstanding the foregoing or anything to the contrary in this Lease, if the Premises have not been delivered to Tenant in the condition required by this Lease within one hundred eighty (180) days following the date the Final Plans are approved by Landlord and Tenant (the “
Outside Delivery Date
”), as such Outside Delivery Date may be extended one day for each day of force majeure events or Tenant Delay, then Tenant shall be entitled to an abatement of Base Rent in an amount equal to one (1) day of Base Rent for each one (1) day of delay from the day following the Outside Delivery Date (as the same may be adjusted) until the Commencement Date. The abatement of Base Rent provided in this subsection (g) shall be Tenant’s sole remedy for Landlord’s failure to timely deliver the Premises and shall be in addition to, and not in substitution of, the Base Rent abated during the Abatement Period.
|
(h)
|
“
Expiration Date
”: 6 o’clock PM local time on the last day of the sixty-sixth (66th) full calendar month after the Commencement Date.
|
(i)
|
“
Base Rent
”: the amounts specified in the chart below, to be paid by Tenant according to the provisions hereof:
|
(j)
|
“
Initial Payment
” means an amount equal to $6,689.88, which is the total of the first full month of Base Rent due and payable hereunder after the Abatement Period in the amount of $4,277.17, plus the first full month of Additional Rent due and payable hereunder after the Abatement Period in the amount of $2,412.71.
|
(k)
|
“
Payment Address
” means:
|
(l)
|
“
Initial Improvements
”: the improvements, if any, to be made to the Premises in accordance with the work letter attached hereto as
Exhibit D
(the “
Work Letter
”).
|
(m)
|
“
Security Deposit
”: The sum of $7,175.92 [which is the total of the last full month of Base Rent due and payable hereunder (in the amount of $4,763.21) plus the first full month of Additional Rent after the Abatement Period due and payable hereunder (in the amount of $2,412.71)], to be delivered to Landlord pursuant to the provisions of Section 8.
|
(n)
|
“
Guarantor
”: none.
|
(o)
|
“
Parking Spaces
”: Seven (7) unreserved parking spaces in the Building’s Parking Facility at a ratio of three (3) parking spaces per 1,000 RSF (the “
Parking Ratio
”). Tenant can
|
(p)
|
“
Tenant’s Broker
” is: Indermeuhle & Co., Inc., DBA ICO Commercial
|
(q)
|
“
Landlord’s Broker
” is: Jones Lang LaSalle Brokerage, Inc.
|
(r)
|
“
Laws
” shall mean any and all laws, ordinances, rules, regulations and building and other codes of any governmental or quasi-governmental entity or authority (“
Governmental Authority
”) applicable to the subject matter hereof, including, without limitation, all Laws relating to disabilities, health, safety or the environment.
|
(s)
|
“
Project
”: shall mean the Building, Land, any areas designated by Landlord from time to time for the common use of all tenants and occupants of the Building (“
Common Areas
”), including, but not limited to, the parking facility for the Building designated by Landlord from time to time (the “
Parking Facility
”), walkways, greenspace, plaza and common areas, and related equipment, fixtures and improvements.
|
(t)
|
“
Building Standard
”: The quantity and quality of materials, finishes and workmanship from time to time specified by Landlord for use throughout the Building. “
Above Standard
” means all improvements, fixtures, materials, finishes and workmanship which exceed Building Standard in terms of quantity or quality (or both), including but not limited to Supplemental HVAC Equipment, defined below; water heaters, instant hot faucets, garbage disposals, dishwashers, stoves, microwaves, refrigerators, ice machines, coffee machines, washing machines, dryers or other appliances; and sinks, sink fixtures, sink drain lines, appliance drain lines, water source plumbing, ground fault interrupters, dedicated outlets or other similar plumbing and/or electrical fixtures or items.
|
(u)
|
“
Building Systems
”:
The mechanical, electrical, plumbing, sanitary, sprinkler, heating, ventilation and air conditioning (“
HVAC
”), security, life-safety, elevator and other service systems or facilities of the Building up to the point of connection of localized distribution to the Premises.
|
4.
|
All carpeted areas and rugs to be detailed vacuumed twice weekly and all carpeted traffic areas and other areas as needed to be vacuumed nightly.
|
GLASS
|
1. Clean inside of all perimeter windows as needed, but not more frequently than once every eighteen (18) months.
|
|
2. Clean outside of all perimeter windows as needed, but not more frequently than once every eighteen (18) months.
|
3.
|
Supply toilet tissue, soap and towels in men’s and ladies’ washrooms.
|
1.
|
Initial Improvements
|
a.
|
The design and construction of the improvements shown in the Final Plans defined below (the “
Initial Improvements
”) shall be at the expense of Tenant except to the extent of the Improvement Allowance defined below.
|
b.
|
The cost of the Initial Improvements shall include all “hard” construction costs (e.g., materials) and related “soft” costs (e.g., architectural fees, MEP construction management fees equal to 5%, permitting costs, and other indirect construction costs incurred by Landlord or its contractor in constructing the Initial Improvements). The total amount of the hard and soft construction costs, including the construction management fee, is referred to herein as the “
Improvement Costs.
”
|
c.
|
“
Improvement Allowance
” shall mean an allowance of $35.00 per square foot of Rentable Area of Premises, to be provided by Landlord as set forth in the Improvement Allowance Section below.
|
2.
|
Tenant Plans
|
a.
|
Landlord shall cause to be prepared at Tenant’s direction the following proposed drawings for the Initial Improvements (“
Tenant Plans
”):
|
1.
|
architectural drawings (consisting of floor construction plan, ceiling lighting and layout, power and telephone plan);
|
2.
|
mechanical drawings (consisting of HVAC, electrical, telephone, and plumbing); and
|
3.
|
finish schedule (consisting of wall finishes, floor finishes, and miscellaneous details).
|
b.
|
Within five (5) business days after Tenant receives the Tenant Plans, Tenant shall approve the Tenant Plans or provide Landlord with reasonable revisions to the Tenant Plans. After the Tenant Plans are finalized to the parties’ satisfaction, Landlord shall provide Tenant with a cost estimate and construction bid for the Initial Improvements, which, within five (5) business days of receipt, Tenant shall approve or direct Landlord to make certain changes, deletions, or additions and to rebid the same. Landlord shall cause the rebidding of the revised Tenant Plans in accordance with Tenant’s directives and shall submit the revised bid information to Tenant for Tenant’s review and approval, which shall not be unreasonably
|
c.
|
The Tenant Plans and Final Plans shall comply with all applicable Laws. Neither review nor approval by Landlord of the Tenant Plans or Final Plans shall constitute a representation or warranty by Landlord that such plans either (1) are complete or suitable for their intended purpose or (2) comply with applicable Laws, it being expressly agreed by Tenant that Landlord assumes no responsibility or liability whatsoever to Tenant or to any other person or entity for such completeness, suitability, or compliance. Tenant shall not without Landlord’s prior written approval make any changes to the Final Plans, except that immaterial changes may be made without Landlord’s prior approval, provided that Tenant provides Landlord with prior written notice of any such change.
|
3.
|
Construction of Initial Improvements
|
a.
|
Upon the full execution of the Lease and the approval by both parties of the Final Plans, Landlord shall proceed to construct the Initial Improvements in accordance with the Final Plans.
|
b.
|
If Tenant desires to change the Final Plans, Tenant shall, at its expense, provide to Landlord plans and specifications for such change(s). All such plans and specifications shall be subject to Landlord’s written approval, which will not be unreasonably withheld. Tenant shall be responsible for all costs related to such changes.
|
c.
|
If Tenant requests Landlord to perform additional work to the Premises outside the scope of the Final Plans, then such work, if approved by Landlord, shall be performed by Landlord at Tenant’s expense. Prior to commencing any such work requested by Tenant, Landlord will submit to Tenant written estimates of the cost of any such work. If Tenant fails to approve any such estimate within five (5) business days, then the same shall be deemed disapproved in all respects by Tenant, and Landlord shall not be authorized to proceed thereon.
|
d.
|
If Tenant fails to supply to Landlord any of the above-specified information within ten (10) days after the dates so specified, then Landlord may, at its option, declare a Default under the Lease and exercise any of Landlord’s remedies for Default thereunder, including terminating the Lease. If Landlord so terminates the Agreement, Tenant shall pay Landlord for all costs and expenses incurred by Landlord in designing and refurbishing the Premises for Tenant within ten (10) days after Tenant’s receipt of Landlord’s invoice for same.
|
e.
|
Upon Substantial Completion (defined below), Landlord will assign to Tenant, on a nonexclusive basis, all warranties available from the contractors, subcontractors, suppliers, manufacturers, and materialmen for construction of the Initial Improvements. “
Substantial Completion
” shall mean that the Premises are broom-clean and Initial Improvements have been completed (as reasonably determined by Landlord) in accordance with the Final Plans, except for such incomplete items as would not materially interfere with the use of the Premises for its intended uses, as described in the Lease (but excluding items not included in the Initial Improvements which are required for use of the Premises for such purposes).
|
f.
|
Landlord, at Landlord’s sole discretion, may permit Tenant and Tenant’s agents, suppliers, contractors, subcontractors and workmen (collectively, “
Tenant’s Contractors
”), who have been approved by Landlord, to enter the Premises fourteen (14) days prior to the Commencement Date to enable Tenant to install wiring/cabling and furniture in the Premises. Tenant shall notify Landlord of the identity of Tenant’s Contractors not less than two (2) business days prior to the initial entry into the Premises by any such Tenant’s Contractors, and Landlord shall have the right to approve or disapprove any of Tenant’s Contractors. Tenant agrees that if permission is granted Tenant for early entry under this Section, then (i) Tenant and Tenant’s Contractors and their activities in the Premises and Building will not interfere with or delay the completion of the Initial Improvements to be done by Landlord and will not interfere with other construction by Landlord, its contractors and subcontractors and their agents and employees or occupants of the Building and their contractors in or about the Premises or Building, and (ii) Landlord, its contractors and subcontractors and their agents and employees shall have priority over Tenant and Tenant’s Contractors in performing work within the Premises or Building, including, without limitation, the use of hoists and elevators. Landlord shall have the right to withdraw its early occupancy permission given under this subsection f. upon written or oral notice to Tenant if Landlord determines that any interference or delay has been or will be caused. Tenant agrees that any such entry into the Premises shall be at Tenant’s own risk and Landlord shall not be liable in any way for any injury, loss or damage which may occur to any of the Tenant’s property or installations made in the Premises. Tenant shall promptly pay to each of Tenant’s Contractors when due the cost of all work done by such Tenant’s Contractor and, if required by Landlord, shall deliver to Landlord evidence of payment to each such party, together with contractors’ affidavits, partial and full and final waivers of all liens for labor, service or materials and such other documents as Landlord may request. Any work performed by Tenant or Tenant’s Contractors shall be done in a first class workmanlike manner using only first class grades of materials and shall comply with all of Landlord’s rules and requirements and all applicable Laws. Any work done by Tenant or Tenant’s Contractors will be scheduled and coordinated through Landlord and shall be performed under the supervision and control of Landlord to the extent Landlord determines to be necessary. Tenant agrees to defend, indemnify and hold harmless Landlord and its officers, directors, partners, employees and agents from all liabilities, costs, damages, fees and expenses arising out of or connected with the activities of Tenant or Tenant’s Contractors in or about the Premises or Building, including, without limitation, the cost of any repairs to the Premises or Building necessitated by activities of Tenant or Tenant’s Contractors in performing the work pursuant to this Work Letter. In addition, prior to the initial entry into the Building or the Premises by Tenant or any of Tenant’s Contractors, Tenant shall furnish Landlord, at Tenant’s sole cost, with policies of insurance required by the Lease and with any additional insurance covering Landlord and
|
g.
|
Upon Substantial Completion, Tenant shall provide Landlord with a punch list of items requiring completion and/or correction with regard to the Initial Improvements (“
Punch List
”). Landlord shall complete the Punch List as soon as reasonably practicable. Landlord shall own all Building Standard Initial Improvements as part of the Building. Upon Substantial Completion, the Initial Improvements shall be deemed by Tenant to be satisfactorily completed except to the extent noted in the Punch List.
|
h.
|
All Above Standard Initial Improvements shall be and remain the property of Tenant, until the expiration or earlier termination of the Lease or Tenant’s right to possession of the Premises under this Lease, at which time such Above Standard Initial Improvements shall become the property of Landlord and shall be surrendered to Landlord with the Premises, unless Landlord specifies, at the time of the approval of the installation of such Above Standard Initial Improvements, that Landlord will require Tenant to remove same upon the expiration or earlier termination of the Lease or Tenant’s right to possession of the Premises under the Lease. Any required removal of Above Standard Initial Improvements shall be at Tenant’s expense, and upon such removal, Tenant shall repair any damage to the Premises resulting from such removal. Tenant shall, at Tenant’s expense, be responsible for cleaning and maintaining any Above Standard Initial Improvements in good condition and repair throughout the Term of this Lease, and Tenant shall insure same as provided in Section 20 of the Lease.
|
4.
|
Selection of Contractor
|
5.
|
Improvement Allowance
|
a.
|
Landlord shall contribute the Improvement Allowance towards the Improvement Costs in accordance with the terms of this Section. All Improvement Costs incurred by Landlord shall be deducted from the Improvement Allowance, and applied by Landlord to pay the Improvement Costs, as such costs are incurred. The Improvement Allowance shall remain available to be used by Tenant through December 31, 2018 (the “
Allowance Expiration Date
”). Any portion of the Improvement Allowance remaining unused after the Allowance Expiration Date shall be retained by Landlord. In the event the Improvement Costs exceed the amount of the Improvement Allowance, Tenant shall pay Landlord, as additional rent under the Lease, any excess of the Improvement Costs over the amount of the Improvement
|
b.
|
After the Improvement Allowance has been expended by Landlord, the principal amount of the Improvement Allowance, shall be amortized evenly over the Term, and so long as Tenant does not Default in its monetary obligations under the Lease, and fail to cure such Default within the applicable period of cure, if any, provided under this Lease, then the balance of the Improvement Allowance shall be reduced each month by the principal amount amortized each month, and upon Landlord’s receipt of the final payment of Rent due during the initial Term of this Lease, Tenant shall have no liability to Landlord for the repayment of any portion of the Improvement Allowance or the interest that accrued and was amortized over the initial Term of this Lease. In the event of an uncured Default by Tenant under this Lease, then in addition to all of Landlord’s other remedies available under this Lease, Tenant shall also be liable to Landlord for the unamortized principal balance of the Improvement Allowance remaining as of the date of Default, and interest on such balance shall accrue at the Default Rate. Provided, however, that if Landlord elects to exercise its rights under Section 32 of this Lease to accelerate the entire amount of all Rent and other charges due from Tenant for the balance of the Term (in accordance with the terms of such Section), and Landlord obtains a judgment for, or is paid by Tenant, the entire amount of such accelerated sum, then such judgment for or payment of such accelerated sum shall preclude a separate recovery by Landlord under the foregoing terms of this Section of the unreduced balance of the Improvement Allowance and any interest thereon.
|
6.
|
Commencement Date
|
7.
|
Tenant Delay
|
a.
|
Tenant’s failure to respond within the time periods specified in this Work Letter, and if no applicable time period is specified in this Work Letter, then within reasonable time periods prescribed in writing by Landlord, to a request for information necessary for the completion of the Tenant Plans or the Final Plans; or
|
b.
|
Failure of Tenant to approve or disapprove the Tenant Plans within the time prescribed herein, or Tenant unreasonably withholding its approval of the Tenant Plans; or
|
c.
|
Tenant’s failure to pay the Security Deposit, if any, or any other sum, as required in the Lease; or
|
e.
|
Requirements by Tenant for materials, finishes or installations which are not Building Standard; or
|
j.
|
Any other cause defined under the Lease or this Work Letter as a Tenant Delay.
|
Months
|
Base Rent per RSF
|
Monthly Amount
|
Months 1-6*
_______, 20__ - ________, 20__
|
$22.00
|
$4,277.17
|
Months 7-12
_______, 20__ - ________, 20__
|
$22.00
|
$4,277.17
|
Months 13-24
_______, 20__ - ________, 20__
|
$22.50
|
$4,374.38
|
Months 25-36
_______, 20__ - ________, 20__
|
$23.00
|
$4,471.58
|
Months 37-48
_______, 20__ - ________, 20__
|
$23.50
|
$4,568.79
|
Months 49-60
_______, 20__ - ________, 20__
|
$24.00
|
$4,666.00
|
Months 61-66
_______, 20__ - ________, 20__
|
$24.50
|
$4,763.21
|
A.
|
BOARD owns certain PATENT RIGHTS and TECHNOLOGY RIGHTS related to LICENSED SUBJECT MATTER developed at UTMDACC.
|
B.
|
BOARD, through UTMDACC, desires to have the LICENSED SUBJECT MATTER developed in the LICENSED FIELD and used for the benefit of LICENSEE, BOARD, SYSTEM, UTMDACC, the inventor(s), and the public as outlined in BOARD’s Intellectual Property Policy.
|
C.
|
LICENSEE wishes to obtain a license from BOARD to practice LICENSED SUBJECT MATTER.
|
1.1
|
This AGREEMENT is effective as of the date written above ("EFFECTIVE DATE").
|
2.1
|
AFFILIATE
means any business entity more than fifty percent (50%) owned by LICENSEE, any business entity which owns more than fifty percent (50%) of LICENSEE, or any business entity that is more than fifty percent (50%) owned by a business entity that owns more than fifty percent (50%) of LICENSEE.
|
2.2
|
AMENDMENT
means
any agreement that: (a) identifies at least one IMPROVEMENT to be included within LICENSED SUBJECT MATTER and (b) is executed by an authorized representative of each of LICENSEE and BOARD, on behalf of UTMDACC; with the proviso that any one such agreement can include only such IMPROVEMENTS that have identity of creatorship and third-party encumbrances.
|
2.3
|
GENERIC PRODUCT
means any pharmaceutical product that: (a) competes directly with a LICENSED PRODUCT in the country of SALE; (b) contains an active ingredient that is covered by the TECHNOLOGY RIGHTS and/or PATENT RIGHTS and such active ingredient in the pharmaceutical product is the same active ingredient contained in the LICENSED PRODUCT; (c) has obtained marketing approval on an expedited or abbreviated basis in connection with the MARKETING APPROVAL of the LICENSED PRODUCT; and (d) is SOLD in the same country as the LICENSED PRODUCT by a third party that is not a sublicensee of LICENSEE or its AFFILIATES and who did not purchase such pharmaceutical product in a chain of distribution that included any of LICENSEE, its AFFILIATES or sublicensees.
|
2.4
|
IMPROVEMENT
means [*****]
|
2.5
|
IND
means the application submitted to the United States Food and Drug Administration (“FDA”) for approval to conduct a clinical investigation with an investigational new drug, as more specifically defined by 21 C.F.R. §312 et seq., or any future revisions or substitutes thereof, or an equivalent foreign filing in any jurisdiction other than the United States.
|
2.6
|
LICENSED FIELD
means all fields of use.
|
2.7
|
LICENSED PRODUCT
means any product or service sold by LICENSEE or its AFFILIATES or sublicensees comprising, using or made through the use of LICENSED SUBJECT MATTER pursuant to this AGREEMENT.
|
2.8
|
LICENSED SUBJECT MATTER
means PATENT RIGHTS and/or TECHNOLOGY RIGHTS within LICENSED FIELD.
|
2.9
|
LICENSED TERRITORY
means worldwide.
|
2.10
|
MARKETING APPROVAL means the regulatory approval necessary to market and sell a LICENSED PRODUCT in a country.
|
2.11
|
NDA
means the application submitted to the FDA for approval to market a new drug, as more specifically defined in 21 C.F.R. § 314 et seq., or any future revisions or substitutes thereof, or an equivalent foreign filing in any jurisdiction other than the United States.
|
2.12
|
NET SALES
means the gross revenues received by LICENSEE or its AFFILIATES or sublicensees from a SALE less: (a) [*****]; (b) [*****]; (c) [*****]; (d) [*****]; (e) [*****]; (f) [*****]; (g) [*****]; and (h) [*****], all as recorded by LICENSEE or its AFFILIATES or sublicensees in their official books and records in accordance
|
2.13
|
OTHER SUBLICENSEE CONSIDERATION
shall mean any and all consideration, other than royalties for NET SALES (provided that UTMDACC has been paid the royalty specified in Section 4.1(d) for such NET SALES), debt, research and development funds, and EXCLUDED AMOUNTS, as defined below, received by LICENSEE from any sublicensee pursuant to Sections 3.3 and 3.4 as consideration for the sublicense, including, but not limited to, up-front, marketing, distribution, franchise, and option payments, license and documentation fees, and bonus and milestone payments. Notwithstanding the foregoing, if LICENSEE receives a bona fide milestone payment from a sublicensee for achieving one of the milestones specified in Section 4.1(f), then for purposes of calculating OTHER SUBLICENSEE CONSIDERATION, LICENSEE may deduct the amount actually paid to UTMDACC by LICENSEE for achieving such milestone from the amount received by LICENSEE from the sublicensee for achieving the milestone. In addition, if LICENSEE receives a payment from a sublicense as a bona fide reimbursement for patent prosecution expenses for PATENT RIGHTS, then for purposes of calculating OTHER SUBLICENSEE CONSIDERATION, LICENSEE may deduct the amount actually paid to UTMDACC by LICENSEE as reimbursement for patent prosecution expenses from the amounts received by LICENSEE from the sublicensee as reimbursement of patent prosecution expenses. For purposes of clarification, consideration received by LICENSEE from a sublicensee for equity securities of LICENSEE shall not be considered OTHER
|
2.14
|
PATENT RIGHTS
means BOARD's rights in (i) the information and discoveries described in invention disclosures, or claimed in any patents and/or patent applications, whether domestic or foreign, as identified in Exhibit I attached hereto and as Exhibit I may be augmented from time to time subject to execution by the parties of an AMENDMENT and LICENEE’S timely payment of the AMENDMENT FEE, and all divisionals, continuations, continuations-in-part (to the extent the claims of such continuations-in-part are entitled to claim priority to the aforesaid patents and/or patent applications identified in Exhibit I), reissues, reexaminations, or extensions of the
|
2.15
|
PHASE I STUDY
means: (a) that portion of the FDA submission and approval process which provides for the first introduction into humans of a product with the purpose of determining human toxicity, metabolism, absorption, elimination and other pharmacological action as more specifically defined in 21 C.F.R. § 312.21(a) or any future revisions or substitutes thereof; or (b) a similar clinical study in any national jurisdiction other than the United States.
|
2.16
|
PHASE II STUDY
means: (a) that portion of the FDA submission and approval process which provides for early controlled clinical studies conducted to obtain preliminary data on the effectiveness of a product for a particular indication, as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(b) or any future revisions or substitutes thereof; or (b) a similar clinical study in any national jurisdiction other than the United States.
|
2.17
|
PHASE III STUDY
means: (a) that portion of the FDA submission and approval process in which expanded clinical studies are conducted to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of a product, as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(c) or any future revisions or substitutes thereof; or (b) a similar clinical study in any national jurisdiction other than the United States.
|
2.18
|
SALE or SOLD
means the transfer or disposition of a LICENSED PRODUCT for value to a party other than LICENSEE, an AFFILIATE, or a sublicensee (provided that
|
2.19
|
TECHNOLOGY RIGHTS
means BOARD's rights in any and all technical information, know-how, processes, procedures, compositions, devices, methods, formulae, protocols, techniques, software, designs, drawings or data (i) that were created by the inventor(s) listed in Exhibit I at UTMDACC before the EFFECTIVE DATE, which are not claimed in PATENT RIGHTS but that are necessary for practicing PATENT RIGHTS, as may be augmented from time to time subject to execution by the parties of an AMENDMENT and LICENSEE’S timely payment of the AMENDMENT FEE.
|
2.20
|
VALID CLAIM
means a claim of: (i) an issued and unexpired patent included within the PATENT RIGHTS, unless: the claim has been held unenforceable or invalid by the final, un-reversed decision of a court or other government body of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal; the claim has been irretrievably abandoned or disclaimed; or the claim has been otherwise finally admitted or determined to be invalid, un-patentable or unenforceable, whether through reissue, reexamination, disclaimer or otherwise; or (ii) a pending patent application within the PATENT RIGHTS to the extent the claim continues to be prosecuted in good faith and has not been pending for more than seven (7) years from its priority date.
|
3.1
|
BOARD, through UTMDACC, hereby grants to LICENSEE a royalty-bearing, exclusive license under LICENSED SUBJECT MATTER to research, develop,
|
(a)
|
Publish the general scientific findings from research related to LICENSED SUBJECT MATTER, subject to the terms of ARTICLE XI–Confidential Information and Publication; and
|
(b)
|
Use LICENSED SUBJECT MATTER for patient care at UTMDACC facilities, and for non-commercial research, teaching and other academically-related purposes. For purposes of clarification, and not by way of limitation, the rights retained by the BOARD and UTMDACC pursuant to this Section 3.1 do not include the right to engage in research sponsored by a commercial, for-profit entity.
|
3.2
|
LICENSEE may extend the license granted herein to any AFFILIATE provided that the AFFILIATE consents in writing to be bound by this AGREEMENT to the same extent as LICENSEE. LICENSEE agrees to deliver such written consent to UTMDACC within thirty (30) calendar days following execution thereof.
|
3.3
|
LICENSEE may grant sublicenses under LICENSED SUBJECT MATTER consistent with the terms of this AGREEMENT provided that LICENSEE is responsible for its sublicensees relevant to this AGREEMENT, and for diligently collecting all amounts due LICENSEE from sublicensees. If a sublicensee pursuant hereto becomes bankrupt, insolvent or is placed in the hands of a receiver or trustee, LICENSEE, to the extent allowed under applicable law and in a timely manner, agrees to use commercially reasonable efforts to collect all consideration owed to LICENSEE and to have the sublicense agreement confirmed or rejected by a court of proper jurisdiction.
|
3.4
|
LICENSEE must deliver to UTMDACC a true and correct copy of each sublicense granted by LICENSEE, and any modification or termination thereof, within thirty (30) calendar days after execution, modification, or termination.
|
3.5
|
LICENSEE shall have a right to amend the AGREEMENT to add IMPROVEMENTS as in the following manner: During the term of the AGREEMENT, UTMDACC shall promptly disclose each IMPROVEMENT in writing to LICENSEE. LICENSEE shall have thirty (30) calendar days from the disclosure of said IMPROVEMENT to notify UTMDACC in writing of its desire to amend the AGREEMENT to include such IMPROVEMENT. [*****] In the event that LICENSEE does not send written notice to UTMDACC of its desire to add the IMPROVEMENT to the AGREEMENT during the thirty (30) calendar day period, then BOARD shall have the right to freely license its rights to the IMPROVEMENT to third parties, with no further obligation or consideration due to LICENSEE.
|
3.6
|
If this AGREEMENT is terminated pursuant to ARTICLE XIII - Term and Termination, BOARD and UTMDACC agree to accept as successors to LICENSEE, existing sublicensees in good standing at the date of termination provided that each such sublicensee consents in writing to be bound by all applicable terms and conditions of this AGREEMENT.
|
4.1
|
In consideration of rights granted by BOARD to LICENSEE under this AGREEMENT, LICENSEE agrees to pay UTMDACC the following:
|
(a)
|
All out-of-pocket expenses incurred by UTMDACC in filing, prosecuting, and maintaining PATENT RIGHTS, and all such future expenses incurred by UTMDACC, for so long as, and in such countries as this AGREEMENT remains in effect. UTMDACC will invoice LICENSEE after the AGREEMENT has been fully executed by all parties for expenses incurred as of the EFFECTIVE DATE, which amount shall not exceed $[*****], and on a quarterly basis thereafter for expenses incurred on or after the EFFECTIVE DATE. Together with each such invoice, UTMDACC will provide reasonable documentation of such expenses, including copies of the original invoices from the corresponding law firm. The invoiced amounts will be due and payable by LICENSEE within thirty (30) calendar days of the receipt of the invoice; and
|
(b)
|
A nonrefundable license documentation fee in the amount of $[*****]. This fee will not reduce the amount of any other payment provided for in this ARTICLE IV, and is due and payable within sixty (60) calendar days after the AGREEMENT has been fully executed by all parties. This license
|
(c)
|
The following nonrefundable annual maintenance fees (“Annual Maintenance Fee(s)”) due and payable (without invoice) within thirty (30) calendar days of the applicable anniversary of the EFFECTIVE DATE until the first SALE following MARKETING APPROVAL in any country of any LICENSED PRODUCT as follows:
|
(d)
|
A running royalty due and payable quarterly as set forth in Section 4.4, calculated as follows:
|
(i)
|
FOR LICENSED PRODUCTS APPROVED FOR DERMATOLOGICAL USE: a running royalty of [*****] percent ([*****]%) of NET SALES, whether made by LICENSEE, a sublicensee or AFFILIATE; and
|
(ii)
|
FOR ALL OTHER LICENSED PRODUCTS: a running royalty of [*****] percent ([*****]%) of NET SALES whether made by LICENSEE, a sublicensee or AFFILIATE.
|
(e)
|
Following the first SALE after MARKETING APPROVAL has been obtained in any country for any LICENSED PRODUCT, minimum annual royalties ("Minimum Annual Royalties") of $[*****], due and payable (without invoice) within thirty (30) calendar days of the first and subsequent anniversaries of the EFFECTIVE DATE which follow the first SALE to occur after MARKETING APPROVAL has been obtained in any country for any LICENSED PRODUCT. Running royalties accrued under Section 4.1(d) and actually paid to UTMDACC for NET SALES made during the twelve month period preceding an anniversary of the EFFECTIVE DATE may be credited against the Minimum Annual Royalties due on that anniversary date. Notwithstanding the foregoing, beginning on the fifteenth anniversary of the EFFECTIVE DATE, LICENSEE’s obligation to pay a Minimum Annual Royalty pursuant to this Section 4.1(e) shall cease if there are no VALID CLAIMS in any country covering any
|
(f)
|
The following one-time milestone payments, regardless of whether the milestone is achieved by LICENSEE, a sublicensee or AFFILIATE:
|
(g)
|
The following percentages of OTHER SUBLICENSEE CONSIDERATION, as defined above:
|
(1)
|
[*****] percent ([*****]%) of all OTHER SUBLICENSEE CONSIDERATION received prior to the Commencement of the first PHASE II STUDY of a LICENSED PRODUCT; and
|
(2)
|
[*****] percent ([*****]%) of all OTHER SUBLICENSEE CONSIDERATION received on or after the Commencement of the first PHASE II STUDY of a LICENSED PRODUCT; and
|
(h)
|
An Assignment Fee of $[*****] (in consideration for UTMDACC allowing the assignment), due and payable prior to any assignment of this AGREEMENT that requires UTMDACC’s consent pursuant to Section 12.1 below; and
|
(i)
|
In the event of a liquidation event that is above $[*****] in value, a payment of $[*****] due within thirty (30) calendar days of such liquidation event. This Section 4.1(i) shall not reduce the amount of any other payment provided for in this ARTICLE IV, except that no Assignment Fee shall be due under Section 4.1(h) if the $[*****] payment provided in this Section 4.1(i) is timely paid to UTMDACC; and
|
(j)
|
A nonrefundable AMENDMENT FEE in the amount of $[*****] for each AMENDMENT. The AMENDMENT FEE will not reduce the amount of any other payment provided for in this ARTICLE IV, and is due and payable within sixty (60) calendar days after any AMENDMENT is fully executed by both parties.
|
4.2
|
If LICENSEE or its AFFILIATE or sublicensee is obligated to pay running royalties to a third party in order to SELL a LICENSED PRODUCT to avoid infringing such third party’s rights which dominate BOARD’S PATENT RIGHTS (the basis for such
|
4.3
|
In the event that a LICENSED PRODUCT is sold in combination with one or more other functional components for which no royalty would be due hereunder if sold separately (“Combination Product(s)”) and no deduction is being made pursuant to Section 4.2, then the running royalty due for NET SALES of the Combination Product will be calculated by multiplying the royalty rate set forth in Section 4.1(d)(i) or 4.1(d)(ii) above (whichever is applicable) by the total NET SALES received for the Combination Product, and then multiplying the resulting product by the fraction, A/(A+B), where A is the average sale price of the LICENSED PRODUCT when sold by LICENSEE separately, and B is the average sale price of all other functional component(s) included in the Combination Product when sold by LICENSEE separately. In the event either the component that is a LICENSED PRODUCT or the other functional component(s) included in the Combination Product are not sold separately, then the running royalty due for NET SALES of the LICENSED PRODUCT sold as part of a Combination Product will be calculated by multiplying the royalty rate set forth in 4.1(d)(i) or 4.1(d)(ii) above (whichever is applicable) by the NET
|
4.4
|
Unless otherwise provided, all such payments are payable within sixty (60) calendar days after March 31, June 30, September 30, and December 31 of each year during the term of this AGREEMENT, at which time LICENSEE will also deliver to UTMDACC a true and accurate report, giving such particulars of the business conducted by LICENSEE, its AFFILIATES and its sublicensees, if any exist, during the preceding three (3) calendar months under this AGREEMENT as necessary for UTMDACC to account for LICENSEE's payments hereunder. This report will include pertinent data, including, but not limited to:
|
(a)
|
the accounting methodologies used to account for and calculate the items included in the report and any differences in such accounting methodologies used by LICENSEE since the previous report; and
|
(b)
|
a list of LICENSED PRODUCTS SOLD in the three (3) preceding calendar months categorized by (i) the technology it relates to under PATENT RIGHTS;
|
(c)
|
the total quantities of LICENSED PRODUCTS SOLD by the categories listed in Section 4.4(b); and
|
(d)
|
the total SALES by the categories listed in Section 4.4(b); and
|
(e)
|
the calculation of NET SALES by the categories listed in Section 4.4(b); and
|
(f)
|
the royalties so computed and due UTMDACC by the categories listed in Section 4.4(b) and/or minimum royalties;
and
|
(g)
|
all consideration received from each sublicensee and a calculation of the payments due UTMDACC; and
|
4.5
|
During the term of this AGREEMENT and for one (1) year thereafter, LICENSEE agrees to keep complete and accurate records of its and its AFFILIATES' and sublicensees' SALES and NET SALES and amounts received from its sublicensees hereunder, each in sufficient detail to enable the royalties and other payments due hereunder to be determined. LICENSEE agrees to permit UTMDACC or its representatives, at UTMDACC's expense, to periodically examine, no more than once
|
4.6
|
Within thirty (30) calendar days following each anniversary of the EFFECTIVE DATE, LICENSEE will deliver to UTMDACC a true and accurate, signed, written progress report that summarizes: (i) LICENSEE’s efforts and accomplishments during the prior year to diligently commercialize LICENSED PRODUCTS; and (ii) LICENSEE’s development and commercialization plans with respect to LICENSED PRODUCTS for the next year. The report shall also cover such activities by AFFILIATES and sublicensees. The report shall contain the following information to the extent relevant to the activities under the AGREEMENT:
|
(a)
|
The name of the LICENSEE, the names of any AFFILIATES and sublicensees, and the products and services being developed and/or commercialized;
|
(b)
|
The progress toward completing and the plans for completing the applicable milestone events specified in Section 4.1(f) and 13.2(b); and
|
(c)
|
The research and development activities, including status and plans for obtaining any necessary MARKETING APPROVALS, performed during the past year, and the plans for research and development activities for the next year.
|
4.7
|
All amounts payable hereunder by LICENSEE will be paid in United States funds without deductions for taxes, assessments, fees, or charges of any kind; provided, however, that if LICENSEE has used good faith, diligent efforts to seek all available exemptions from or reductions in withholding taxes to which BOARD and/or UTMDACC are entitled, then LICENSEE may deduct those withholding taxes LICENSEE is required by law to withhold from the amounts payable to UTMDACC. Checks are to be made payable to “The University of Texas M. D. Anderson Cancer Center,” and sent by United States mail to Box 4390, Houston, Texas, 77210-4390, or by wire transfer to:
|
4.8
|
No payments due or royalty rates owed under this AGREEMENT will be reduced as the result of co-ownership of LICENSED SUBJECT MATTER by BOARD and another party, including, but not limited to, LICENSEE.
|
5.1
|
If LICENSEE desires to sponsor research for or related to the LICENSED SUBJECT MATTER, LICENSEE will notify UTMDACC, and the parties will negotiate in good faith the terms of such sponsored research.
|
6.1
|
(a) If after consultation with LICENSEE both parties agree that a new patent application should be filed for LICENSED SUBJECT MATTER, UTMDACC will prepare and file appropriate patent applications, and LICENSEE will pay the cost of searching, preparing, filing, prosecuting and maintaining same. If LICENSEE notifies UTMDACC that it does not intend to pay the cost of a patent application in a specific country, or if LICENSEE does not respond or make an effort to agree with UTMDACC on the disposition of rights of the subject invention in such country, then UTMDACC may, but is not obligated to, file such patent application at its own expense and such patent application in such country shall cease to be included in the PATENT RIGHTS under this AGREEMENT. UTMDACC will consult with and keep LICENSEE fully informed of the status of any patent application or patent directed to the PATENT RIGHTS, and will provide LICENSEE with a copy of any patent applications for which LICENSEE has paid the cost of filing, as well as copies of any material documents received or filed during prosecution thereof, such as patent applications, office actions,
|
(i)
|
UTMDACC and LICENSEE shall confer in good faith regarding the filing of new applications, the prosecution of pending applications, and the maintenance and post-grant activities of issued patents;
|
(ii)
|
UTMDACC shall not abandon a patent application or patent under PATENT RIGHTS that is timely funded by LICENSEE so long as there is a bona fide basis, consistent with applicable laws, rules, and regulations, for continuing prosecution of the respective patent application or maintaining the respective patent, but the foregoing shall not prohibit UTMDACC from abandoning a patent application in favor of further prosecution via a related continuation or continuation in part application claiming priority to such abandoned application or from seeking reissue of a patent via a reissue proceeding for an issued patent; and
|
(iii)
|
UTMDACC shall not refuse to file a patent application under PATENT RIGHTS that is timely funded and timely requested in writing by LICENSEE so long as there is a bona fide basis, consistent with applicable laws, rules, and regulations, for such filing.
|
7.1
|
LICENSEE, at its expense, shall have the first right to enforce any patent exclusively licensed hereunder against infringement by third parties and is entitled to retain recovery from such enforcement, which right may be granted by LICENSEE to its AFFILIATE or sublicensee. After reimbursement of reasonable legal costs and expenses related to such recovery incurred by LICENSEE, its AFFILIATE or sublicensee, LICENSEE agrees to pay UTMDACC either: (a) the applicable royalty detailed in Section 4.1(d) for any monetary recovery that is for sales of LICENSED PRODUCTS lost due to the
|
7.2
|
In any suit or dispute involving an infringer, the parties agree to cooperate fully with each other. At the request and expense of the party bringing suit, the other party will permit access during regular business hours, to all relevant personnel, records, papers, information, samples, specimens, and the like in its possession.
|
8.1
|
LICENSEE agrees that all packaging containing individual LICENSED PRODUCT(S), documentation therefor, and, when possible, actual LICENSED
|
9.1
|
LICENSEE agrees to hold harmless, defend and indemnify BOARD, SYSTEM, UTMDACC, their Regents, officers, employees, students and agents (“Indemnified Parties”) from and against any liabilities, damages, causes of action, suits, judgments, liens, penalties, fines, losses, costs and expenses (including, without limitation, reasonable attorneys’ fees and other expenses of litigation) (collectively “Liabilities”) resulting from claims or demands brought by third parties against an Indemnified Party on account of any injury or death of persons, damage to property, or any other damage or loss arising out of or in connection with this AGREEMENT or the exercise or practice of the rights granted hereunder by or under authority of LICENSEE, its AFFILIATES, or their sublicensees, or third party wholesalers or distributors, or physicians, hospitals or other healthcare providers who purchase a LICENSED PRODUCT, provided however, that the following is excluded from LICENSEE’s obligation to indemnify and hold harmless:
|
(a)
|
the negligent failure of UTMDACC or SYSTEM to substantially comply with any applicable governmental requirements; and
|
(b)
|
the negligence or willful malfeasance by a Regent, officer, agent or employee of UTMDACC or SYSTEM.
|
9.2
|
In no event shall BOARD, SYSTEM or UTMDACC be liable for any indirect, special, consequential, incidental, exemplary, or punitive damages (including, without limitation, damages for loss of profits or revenue) arising out of or in connection with the AGREEMENT or its subject matter, regardless of whether any such party knows or should know of the possibility of such damages. Other than for claims against LICENSEE for indemnification (Section 9.1) or for misuse or misappropriation or infringement of BOARD and/or UTMDACC’s intellectual property rights, LICENSEE will not be liable to BOARD and/or UTMDACC for any indirect, special, consequential or punitive damages (including, without limitation, damages for loss of profits or revenue) arising out of or in connection with the AGREEMENT or its subject matter, regardless of whether LICENSEE knows or should have known of the possibility of such damages.
|
9.3
|
Beginning at the time when any LICENSED PRODUCT is being distributed or sold (including for the purpose of obtaining regulatory approvals) by LICENSEE, an AFFILIATE, or by a sublicensee, LICENSEE shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts not less than [*****] per incident and [*****] annual aggregate, and LICENSEE shall use reasonable efforts to have the BOARD, SYSTEM, UTMDACC, their Regents, officers, employees, students and agents named as additional insureds. Such commercial general liability insurance shall provide: (i) product liability coverage; (ii) broad form contractual liability coverage for LICENSEE's indemnification under this AGREEMENT; and (iii) coverage for litigation costs. The minimum amounts of insurance coverage required
|
9.4
|
LICENSEE shall provide UTMDACC with written evidence of such insurance within thirty (30) calendar days of its procurement. Additionally, LICENSEE shall provide UTMDACC with written notice of at least fifteen (15) calendar days prior to the cancellation, non-renewal or material change in such insurance.
|
9.5
|
LICENSEE shall maintain such commercial general liability insurance beyond the expiration or termination of this AGREEMENT during: (i) the period that any LICENSED PRODUCT developed pursuant to this AGREEMENT is being commercially distributed or sold by LICENSEE, an AFFILIATE or by a sublicensee or agent of LICENSEE; and (ii) the five (5) year period immediately after such period.
|
X.
|
USE OF BOARD AND UTMDACC’S NAME
|
10.1
|
LICENSEE will not use the name of (or the name of any employee of) UTMDACC, SYSTEM or BOARD in any advertising, promotional or sales literature, on its Web site, or for the purpose of raising capital without the advance express written consent of BOARD secured through:
|
11.1
|
UTMDACC and LICENSEE each agree that Confidential Information of the other party, as defined below in this Section 11.1, which is disclosed to it by the other party pursuant to this AGREEMENT: (i) shall be received in strict confidence, (ii) shall be used only for the purposes of this AGREEMENT, and (iii) will not be disclosed by the recipient party (except as required by law, court order or regulation), its agents or employees without the prior written consent of the disclosing party, except to the extent that the recipient party can establish by competent written proof that such information:
|
(a)
|
was in the public domain at the time of disclosure; or
|
(b)
|
later became part of the public domain through no act or omission of the recipient party, its employees, agents, successors or assigns; or
|
(c)
|
was lawfully disclosed to the recipient party by a third party having the right to disclose it; or
|
(d)
|
was already known by the recipient party at the time of disclosure; or
|
(e)
|
was independently developed by the recipient party without use of the disclosing party’s Confidential Information; or
|
(f)
|
is required by law, court order or regulation to be disclosed, provided that such party shall promptly notify the other party of such requirement and provide the other party an opportunity to challenge or limit the disclosure requirement and to seek confidential treatment or protection order, and that the Confidential Information so disclosed shall remain otherwise subject to the confidentiality and non-use obligations set forth above in this Section 11.1.
|
11.2
|
Subject to full compliance with Section 11.3, LICENSEE may disclose UTMDACC’s Confidential Information
in confidence
to its employees, consultants, AFFILIATES and potential or actual sublicensees, investors or other commercial partners, and in connection with the procurement of MARKETING APPROVAL for LICENSED PRODUCTS.
|
11.3
|
Each party’s obligation of confidence hereunder will be fulfilled by using at least the same degree of care with the disclosing party's Confidential Information as it uses to protect its own confidential information, but always at least a reasonable degree of care. This obligation will exist while this AGREEMENT is in force and for a period of three (3) years thereafter.
|
11.4
|
UTMDACC reserves the right to publish the general scientific findings from research related to LICENSED SUBJECT MATTER, with due regard to the protection of LICENSEE’s Confidential Information. UTMDACC will submit the manuscript of any proposed publication to LICENSEE at least thirty (30) calendar days before publication, and LICENSEE shall have the right to review and comment upon the publication in order to protect LICENSEE’s Confidential Information. Upon LICENSEE’s request, publication may be delayed up to sixty (60) additional calendar days to enable
|
12.1
|
Except to an AFFILIATE or in connection with the merger or acquisition of LICENSEE by a third party, or the sale of all or substantially all of LICENSEE's assets to which this AGREEMENT relates to a third party, this AGREEMENT may not be assigned by LICENSEE without the prior written consent of UTMDACC, which will not be unreasonably withheld. For any assignment to be effective: (a) the LICENSEE must timely pay UTMDACC the Assignment Fee specified in Section 4.1(h), if applicable; and (b) the assignee must assume in writing (a copy of which writing will be provided to UTMDACC) all of LICENSEE's interests, rights, duties, and obligations under the AGREEMENT and agree to comply with all terms and conditions of the AGREEMENT as if the assignee were the original party (i.e., the LICENSEE) to the AGREEMENT.
|
13.1
|
Subject to Sections 13.3 and 13.4 hereinbelow, the term of this AGREEMENT is from the EFFECTIVE DATE until the later of: (1) full end of the term or terms for which PATENT RIGHTS have not expired; or (2) if only TECHNOLOGY RIGHTS are licensed and no PATENT RIGHTS are applicable, for a term of [*****] years. Beginning on the fifteenth anniversary of the EFFECTIVE DATE, LICENSEE’s obligation to pay running royalties for NET SALES and Minimum Annual Royalties shall be governed by Section 4.1.
|
13.2
|
(a) LICENSEE, directly or through its AFFILIATES and sublicensees, will use diligent efforts to make LICENSED PRODUCTS commercially available in the LICENSED
|
13.3
|
Subject to any rights herein which survive termination, this AGREEMENT will earlier terminate in its entirety:
|
(a)
|
automatically, if LICENSEE becomes bankrupt or insolvent and/or if the business of LICENSEE shall be placed in the hands of a receiver or trustee, whether by voluntary act of LICENSEE or otherwise; or
|
(b)
|
upon thirty (30) calendar days written notice from UTMDACC, if LICENSEE materially breaches or defaults on the payment or report obligations of ARTICLE IV (excluding the license documentation fee specified in Section 4.1(b)), or use of name obligations of ARTICLE X, or any obligation set forth in Section 13.2(b), unless, before the end of the such thirty (30) calendar day notice period, LICENSEE has cured the material default or breach to UTMDACC’s reasonable satisfaction, and so notifies UTMDACC, stating the manner of the cure; or
|
(c)
|
upon ninety (90) calendar days written notice from UTMDACC if LICENSEE materially breaches or defaults on any other obligation under this AGREEMENT, unless, before the end of the such ninety (90) calendar-day notice period, LICENSEE has cured the material default or breach to UTMDACC’s reasonable satisfaction and so notifies UTMDACC, stating the manner of the cure; or
|
(d)
|
at any time by mutual written agreement between LICENSEE and UTMDACC upon one hundred eighty (180) calendar days written notice to all parties and subject to any terms herein which survive termination; or
|
(e)
|
immediately, upon written notice from UTMDACC, if Section 15.9 is invoked; or
|
(f)
|
immediately, upon written notice from UTMDACC, if LICENSEE fails to timely pay the license documentation fee specified in Section 4.1(b); or
|
(g)
|
If LICENSEE has defaulted or been late on its payment obligations pursuant to this AGREEMENT on any two (2) occasions in a twelve (12)-month period. Notwithstanding the foregoing, LICENSEE may avoid termination under this Section 13.3(g), if LICENSEE pays all past due amounts and a default waiver fee of $[*****] within thirty (30) calendar days following the receipt of written notice from UTMDACC identifying the second payment default in the twelve (12) month period. LICENSEE may avoid termination as provided in the foregoing sentence (by payment of all past due amounts and default waiver fee) a maximum of three (3) times during the term of this AGREEMENT. For purposes of clarification, a separate default waiver fee of $[*****] shall be due each time LICENSEE seeks to avoid termination under this provision. It is understood that time is of the essence with respect to the default waiver fees, and these fees are not subject to the thirty (30) day cure period specified in Section 13.3(b); or
|
(h)
|
for any reason upon thirty (30) calendar days written notice from LICENSEE to UTMDACC, provided that LICENSEE is not in default on or in breach of any of its obligations under this AGREEMENT.
|
(a)
|
nothing herein will be construed to release either party of any obligation maturing prior to the effective date of the termination; and
|
(b)
|
The parties agree that the provisions of ARTICLES IX (Indemnification and Insurance), X (Use of Board and UTMDACC’s Name) and XI (Confidential Information and Publication) of this AGREEMENT shall survive termination of this AGREEMENT; and
|
(c)
|
LICENSEE, its AFFILIATES and sublicensees may, for a period of one year after the effective date of the termination, sell all LICENSED PRODUCTS and parts therefor that it has on hand at the date of termination, if LICENSEE pays the earned royalty thereon and any other amounts due pursuant to ARTICLE IV of this AGREEMENT; and
|
(d)
|
Subject to Section 13.4(c),
LICENSEE agrees to cease and desist any use and all SALE of the LICENSED SUBJECT MATTER and LICENSED PRODUCTS upon termination of this AGREEMENT.; and
|
(e)
|
LICENSEE grants to BOARD and UTMDACC a nonexclusive royalty bearing license with the right to sublicense others with respect to improvements made by LICENSEE (including improvements licensed by LICENSEE from third parties) in the LICENSED SUBJECT MATTER, but only to the extent licensable or sublicensable by LICENSEE. LICENSEE and UTMDACC agree
|
14.1
|
Except for the rights, if any, of the Government of the United States of America as set forth below, BOARD represents and warrants its belief that (a) it is the owner of the entire right, title, and interest in and to LICENSED SUBJECT MATTER, (b) it has the sole right to grant licenses thereunder, and (c) it has not knowingly granted licenses thereunder to any other entity that would restrict rights granted hereunder except as stated herein.
|
14.2
|
LICENSEE understands that the LICENSED SUBJECT MATTER may have been developed under a funding agreement with the Government of the United States of America ("Government") and, if so, that the Government may have certain rights relative thereto. This AGREEMENT is explicitly made subject to the Government's rights under any such agreement and any applicable law or regulation. To the extent that there is a conflict between any such agreement, applicable law or regulation and this AGREEMENT, the terms of such Government agreement, applicable law or regulation shall prevail. LICENSEE agrees that LICENSED PRODUCTS used or SOLD in the United States, to the extent such LICENSED PRODUCTS were developed under a funding agreement with the Government, will be manufactured substantially in the United States, unless a written waiver is obtained in advance from the GOVERNMENT. LICENSEE will promptly advise UTMDACC if such a written
|
14.3
|
LICENSEE understands and agrees that BOARD and UTMDACC, by this AGREEMENT, make no representation as to the operability or fitness for any use, safety, efficacy, approvability by regulatory authorities, time and cost of development, patentability, and/or breadth of the LICENSED SUBJECT MATTER. BOARD and UTMDACC, by this AGREEMENT, also make no representation as to whether any patent covered by PATENT RIGHTS is valid or as to whether there are any patents now held, or which will be held, by others or by BOARD or UTMDACC in the LICENSED FIELD, nor do BOARD and UTMDACC make any representation that the inventions contained in PATENT RIGHTS do not infringe any other patents now held or that will be held by others or by BOARD.
|
14.4
|
LICENSEE, by execution hereof, acknowledges, covenants and agrees that LICENSEE has not been induced in any way by BOARD, SYSTEM, UTMDACC or employees thereof to enter into this AGREEMENT, and further warrants and represents that (a) LICENSEE is entering into this AGREEMENT voluntarily; (b) LICENSEE has conducted sufficient due diligence with respect to all items and issues pertaining to this AGREEMENT; and (c) LICENSEE has adequate knowledge and expertise, or has used knowledgeable and expert consultants, to adequately conduct such due diligence, and agrees to accept all risks inherent herein.
|
15.1
|
This AGREEMENT constitutes the entire and only agreement between the parties for LICENSED SUBJECT MATTER and, as of the EFFECTIVE DATE, all other prior negotiations, representations, agreements and understandings are superseded hereby. No agreements altering or supplementing the terms hereof will be made except by a written document signed by both parties.
|
15.2
|
Any notice required by this AGREEMENT must be given by prepaid, first class, certified mail, return receipt requested, and addressed in the case of UTMDACC to:
|
15.3
|
LICENSEE must comply with all applicable federal, state and local laws and regulations in connection with its activities pursuant to this AGREEMENT. LICENSEE acknowledges that the LICENSED SUBJECT MATTER is subject to U. S. export control jurisdiction. LICENSEE agrees to comply with all applicable international and national laws that apply to the LICENSED SUBJECT MATTER, including U.S. Export Administration Regulations, as well as end-user, end-use, and destination restrictions applied by the United States.
|
15.4
|
This AGREEMENT will be construed and enforced in accordance with the laws of the United States of America and of the State of Texas, without regard to its conflict of law
|
15.5
|
Any dispute or controversy arising out of or relating to this AGREEMENT, its construction or its actual or alleged breach will be decided by mediation. If the mediation does not result in a resolution of such dispute or controversy, it will be finally decided by an appropriate method of alternate dispute resolution, including without limitation, arbitration, conducted in the city of Houston, Harris County, Texas, in accordance with the applicable, then-current procedures of the American Arbitration Association. The arbitration panel will include members knowledgeable in the evaluation of the LICENSED SUBJECT MATTER. Judgment upon the award rendered may be entered in the highest court or forum having jurisdiction, state or federal. The provisions of this Section 15.5 will not apply to decisions on the validity of patent claims or to any dispute or controversy as to which any treaty or law prohibits such arbitration. The decision of the arbitration must be sanctioned by a court of law having jurisdiction to be binding upon and enforceable by the parties.
|
15.6
|
Failure of BOARD, UTMDACC or LICENSEE to enforce a right under this AGREEMENT will not act as a waiver of right or the ability to later assert that right relative to the particular situation involved.
|
15.7
|
Headings included herein are for convenience only and will not be used to construe this AGREEMENT.
|
15.8
|
If any part of this AGREEMENT is for any reason found to be unenforceable, all other parts nevertheless will remain enforceable.
|
15.9
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In the event that LICENSEE brings an action before any court, agency or tribunal seeking to invalidate or otherwise challenge the enforceability of or BOARD’s ownership of any patent included in the PATENT RIGHTS, then UTMDACC may immediately terminate this AGREEMENT upon written notice to LICENSEE. Any dispute regarding the validity, enforceability or ownership of any patent included in the PATENT RIGHTS shall be litigated in the courts located in Houston, Texas, and LICENSEE agrees not to challenge personal jurisdiction in that forum. To the extent that LICENSEE unsuccessfully challenges the validity or enforceability of any patent included in the PATENT RIGHTS, LICENSEE agrees to reimburse UTMDACC and BOARD for all costs and fees (including attorney’s fees) paid by UTMDACC and BOARD in defending against such challenge. LICENSEE understands and agrees that, in the event LICENSEE successfully challenges the validity or enforceability of any patent included in the PATENT RIGHTS, all payments or other consideration made or otherwise provided by LICENSEE to UTMDACC prior to a final, non-appealable adjudication of invalidity and/or unenforceability shall be non-refundable. The obligations of this Section shall survive the expiration or termination of this AGREEMENT.
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Creators
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UTMDACC Reference No. and IDR Title
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U.S. and foreign patent application/patent numbers
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Waldemar Priebe, PhD,
Stanislaw Skora,
Izabela Fokt,
Rafal Zielinski,
Arumugam Jayakumar, and
Radjendirane Venugopal
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MDA18-010: Novel Anticancer Drugs Structurally Related To WP1066
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U.S. Prov. Appl. No. 62/584,591
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1.
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I have reviewed this Quarterly Report on Form 10-Q of Moleculin Biotech, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c)
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Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d)
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
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a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
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b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
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By: /s/ Walter V. Klemp
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Walter Klemp
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Chief Executive Officer
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(Principal Executive Officer)
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1.
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I have reviewed this Quarterly Report on Form 10-Q of Moleculin Biotech, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c)
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Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d)
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
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a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
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b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
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By: /s/ Jonathan P. Foster
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Jonathan P. Foster
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Executive Vice President and Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
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•
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The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C 78m or 78o(d)); and
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•
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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By: /s/ Walter V. Klemp
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Walter Klemp
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Chief Executive Officer
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(Principal Executive Officer)
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•
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The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C 78m or 78o(d)); and
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•
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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By: /s/ Jonathan P. Foster
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Jonathan P. Foster
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Executive Vice President and Chief Financial Officer
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(Principal Financial Officer and Principal Accounting Officer)
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