UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended June 30, 2020
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Transition Period from _____________ to _____________
Commission file number 001-37569
Strongbridge Biopharma plc
(Exact name of Registrant as specified in its charter)
|
|
|
Ireland |
|
98-1275166 |
(State or other jurisdiction of incorporation or organization) |
|
(I.R.S. Employer Identification Number) |
900 Northbrook Drive
Suite 200
Trevose, PA 19053
(Address of principal executive offices)
Registrant’s Telephone Number, Including Area Code: +1 610-254-9200
Securities Registered Pursuant to Section 12(b) of the Exchange Act:
Title of each class: |
|
Trading Symbol |
|
Name of each exchange on which registered: |
Ordinary shares, par value $0.01 per share |
|
SBBP |
|
The Nasdaq Global Select Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and emerging growth company in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer |
☐ |
Accelerated Filer |
☒ |
|
|
|
|
Non-Accelerated Filer |
☐ |
Smaller Reporting Company |
☒ |
|
|
|
|
|
|
Emerging Growth Company |
☒ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of July 28, 2020, there were 54,355,957 ordinary shares of the registrant issued and outstanding.
TABLE OF CONTENTS
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1 |
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1 |
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Consolidated Balance Sheets as of June 30, 2020 and December 31, 2019 |
1 |
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2 |
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3 |
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Consolidated Statements of Cash Flow for the Six Months Ended June 30, 2020 and 2019 |
4 |
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5 |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
15 |
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23 |
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23 |
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24 |
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24 |
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24 |
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27 |
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27 |
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27 |
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27 |
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28 |
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29 |
Solely for convenience, the trademarks and trade names in this Quarterly Report on Form 10-Q (this “Quarterly Report”) are referred to without the ® and ™ symbols, but absence of such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. The trademarks, trade names and service marks appearing in this Quarterly Report are the property of their respective owners.
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
STRONGBRIDGE BIOPHARMA plc
Consolidated Balance Sheets
(In thousands, except share and per share data)
(unaudited)
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
||
|
2020 |
|
2019 |
|
||
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
59,909 |
|
$ |
57,032 |
|
Marketable securities |
|
— |
|
|
21,072 |
|
Accounts receivable |
|
2,885 |
|
|
2,289 |
|
Inventory |
|
1,315 |
|
|
1,993 |
|
Prepaid expenses and other current assets |
|
1,914 |
|
|
1,157 |
|
Total current assets |
|
66,023 |
|
|
83,543 |
|
Property and equipment, net |
|
248 |
|
|
291 |
|
Right of use asset, net |
|
696 |
|
|
789 |
|
Intangible asset, net |
|
22,599 |
|
|
25,110 |
|
Goodwill |
|
7,256 |
|
|
7,256 |
|
Other assets |
|
812 |
|
|
649 |
|
Total assets |
$ |
97,634 |
|
$ |
117,638 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
$ |
1,957 |
|
$ |
3,331 |
|
Accrued and other current liabilities |
|
17,363 |
|
|
20,962 |
|
Current portion of long-term debt, net |
|
162 |
|
|
— |
|
Total current liabilities |
|
19,482 |
|
|
24,293 |
|
Long-term debt, net |
|
6,841 |
|
|
— |
|
Warrant liability |
|
10,914 |
|
|
4,127 |
|
Supply agreement liability, noncurrent |
|
11,556 |
|
|
15,947 |
|
Other long-term liabilities |
|
972 |
|
|
1,080 |
|
Total liabilities |
|
49,765 |
|
|
45,447 |
|
Commitments and contingencies (Note 8) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Deferred shares, $1.098 par value, 40,000 shares authorized, issued and outstanding at June 30, 2020 and December 31, 2019 |
|
44 |
|
|
44 |
|
Ordinary shares, $0.01 par value, 600,000,000 shares authorized; 54,355,957 and 54,205,852 shares issued and outstanding at June 30, 2020 and December 31, 2019 |
|
544 |
|
|
542 |
|
Additional paid-in capital |
|
337,734 |
|
|
332,085 |
|
Accumulated deficit |
|
(290,453) |
|
|
(260,483) |
|
Accumulated other comprehensive income |
|
— |
|
|
3 |
|
Total stockholders’ equity |
|
47,869 |
|
|
72,191 |
|
Total liabilities and stockholders’ equity |
$ |
97,634 |
|
$ |
117,638 |
|
The accompanying notes are an integral part of these unaudited consolidated financial statements.
1
STRONGBRIDGE BIOPHARMA plc
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|||||||||
|
|
June 30 |
|
June 30, |
|||||||||
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
7,752 |
|
$ |
6,073 |
|
$ |
14,415 |
|
$ |
10,406 |
|
Royalty revenue |
|
|
8 |
|
|
6 |
|
|
19 |
|
|
16 |
|
Total revenues |
|
|
7,760 |
|
|
6,079 |
|
|
14,434 |
|
|
10,422 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales (excluding amortization of intangible asset) |
|
$ |
393 |
|
$ |
1,022 |
|
$ |
1,362 |
|
$ |
1,835 |
|
Selling, general and administrative |
|
|
9,638 |
|
|
12,182 |
|
|
20,041 |
|
|
24,282 |
|
Research and development |
|
|
6,152 |
|
|
8,739 |
|
|
13,704 |
|
|
15,322 |
|
Amortization of intangible asset |
|
|
1,255 |
|
|
1,255 |
|
|
2,511 |
|
|
2,511 |
|
Total cost and expenses |
|
|
17,438 |
|
|
23,198 |
|
|
37,618 |
|
|
43,950 |
|
Operating loss |
|
|
(9,678) |
|
|
(17,119) |
|
|
(23,184) |
|
|
(33,528) |
|
Other (expense) income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on fair value of warrants |
|
|
(7,367) |
|
|
8,697 |
|
|
(6,787) |
|
|
6,877 |
|
Income from field services agreement |
|
|
— |
|
|
1,725 |
|
|
— |
|
|
3,741 |
|
Expense from field services agreement |
|
|
— |
|
|
(1,758) |
|
|
— |
|
|
(3,987) |
|
Interest expense |
|
|
(253) |
|
|
— |
|
|
(253) |
|
|
— |
|
Other income, net |
|
|
26 |
|
|
608 |
|
|
254 |
|
|
1,293 |
|
Total other (expense) income, net |
|
|
(7,594) |
|
|
9,272 |
|
|
(6,786) |
|
|
7,924 |
|
Loss before income taxes |
|
|
(17,272) |
|
|
(7,847) |
|
|
(29,970) |
|
|
(25,604) |
|
Income tax expense |
|
|
— |
|
|
(400) |
|
|
— |
|
|
(1,077) |
|
Net loss |
|
$ |
(17,272) |
|
$ |
(8,247) |
|
|
(29,970) |
|
|
(26,681) |
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on marketable securities |
|
|
(6) |
|
|
— |
|
|
(3) |
|
|
— |
|
Comprehensive loss |
|
$ |
(17,278) |
|
$ |
(8,247) |
|
$ |
(29,973) |
|
$ |
(26,681) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to ordinary shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(17,272) |
|
$ |
(8,247) |
|
$ |
(29,970) |
|
$ |
(26,681) |
|
Diluted |
|
$ |
(17,272) |
|
$ |
(16,944) |
|
$ |
(29,970) |
|
$ |
(33,558) |
|
Net loss per share attributable to ordinary shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.32) |
|
$ |
(0.15) |
|
$ |
(0.55) |
|
$ |
(0.49) |
|
Diluted |
|
$ |
(0.32) |
|
$ |
(0.30) |
|
$ |
(0.55) |
|
$ |
(0.60) |
|
Weighted-average shares used in computing net loss per share attributable to ordinary shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
54,302,325 |
|
|
54,175,731 |
|
|
54,266,675 |
|
|
54,165,439 |
|
Diluted |
|
|
54,302,325 |
|
|
55,781,078 |
|
|
54,266,675 |
|
|
56,262,936 |
|
The accompanying notes are an integral part of these unaudited consolidated financial statements.
2
STRONGBRIDGE BIOPHARMA plc
Consolidated Statement of Stockholders’ Equity
(In thousands, except share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
Accumulated Other |
|
Total |
|
||||||
|
|
Ordinary Shares |
|
Deferred Shares |
|
Paid-In |
|
Accumulated |
|
Comprehensive |
|
Shareholders’ |
|
||||||||||
|
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Capital |
|
Deficit |
|
Gain |
|
Equity |
|
||||||
Balance—March 31, 2019 |
|
54,167,948 |
|
$ |
542 |
|
40,000 |
|
$ |
44 |
|
$ |
325,863 |
|
$ |
(229,466) |
|
|
— |
|
$ |
96,983 |
|
Net loss |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
(8,247) |
|
|
— |
|
|
(8,247) |
|
Stock-based compensation |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
2,572 |
|
|
— |
|
|
— |
|
|
2,572 |
|
Exercise of stock options |
|
4,113 |
|
|
* |
|
— |
|
|
— |
|
|
12 |
|
|
— |
|
|
— |
|
|
12 |
|
Ordinary shares issued, net of shares withheld for employee taxes |
|
14,207 |
|
|
* |
|
— |
|
|
— |
|
|
(31) |
|
|
— |
|
|
— |
|
|
(31) |
|
Balance—June 30, 2019 |
|
54,186,268 |
|
$ |
542 |
|
40,000 |
|
$ |
44 |
|
$ |
328,416 |
|
$ |
(237,713) |
|
|
— |
|
$ |
91,289 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance—December 31, 2018 |
|
54,122,074 |
|
$ |
541 |
|
40,000 |
|
$ |
44 |
|
$ |
323,402 |
|
$ |
(211,032) |
|
|
— |
|
$ |
112,955 |
|
Net loss |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
(26,681) |
|
|
— |
|
|
(26,681) |
|
Stock-based compensation |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
4,895 |
|
|
— |
|
|
— |
|
|
4,895 |
|
Exercise of stock options |
|
43,841 |
|
|
1 |
|
— |
|
|
— |
|
|
178 |
|
|
— |
|
|
— |
|
|
179 |
|
Ordinary shares issued, net of shares withheld for employee taxes |
|
20,353 |
|
|
* |
|
— |
|
|
— |
|
|
(59) |
|
|
— |
|
|
— |
|
|
(59) |
|
Balance—June 30, 2019 |
|
54,186,268 |
|
$ |
542 |
|
40,000 |
|
$ |
44 |
|
$ |
328,416 |
|
$ |
(237,713) |
|
|
— |
|
$ |
91,289 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance—March 31, 2020 |
|
54,247,501 |
|
$ |
542 |
|
40,000 |
|
$ |
44 |
|
$ |
333,768 |
|
$ |
(273,181) |
|
|
6 |
|
$ |
61,179 |
|
Net loss |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
(17,272) |
|
|
— |
|
|
(17,272) |
|
Stock-based compensation |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
1,773 |
|
|
— |
|
|
— |
|
|
1,773 |
|
Issuance of warrants and beneficial conversion feature related to the Loan Agreement |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
2,457 |
|
|
— |
|
|
— |
|
|
2,457 |
|
Ordinary shares issued, net of shares withheld for employee taxes |
|
108,456 |
|
|
2 |
|
|
|
|
|
|
|
(264) |
|
|
|
|
|
|
|
|
(262) |
|
Unrealized loss on marketable securities |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
|
|
|
— |
|
|
(6) |
|
|
(6) |
|
Balance—June 30, 2020 |
|
54,355,957 |
|
$ |
544 |
|
40,000 |
|
$ |
44 |
|
$ |
337,734 |
|
$ |
(290,453) |
|
|
— |
|
$ |
47,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance—December 31, 2019 |
|
54,205,852 |
|
$ |
542 |
|
40,000 |
|
$ |
44 |
|
$ |
332,085 |
|
$ |
(260,483) |
|
|
3 |
|
$ |
72,191 |
|
Net loss |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
(29,970) |
|
|
— |
|
|
(29,970) |
|
Stock-based compensation |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
3,524 |
|
|
— |
|
|
— |
|
|
3,524 |
|
Issuance of warrants and beneficial conversion feature related to the Loan Agreement |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
2,457 |
|
|
— |
|
|
— |
|
|
2,457 |
|
Ordinary shares issued, net of shares withheld for employee taxes |
|
150,105 |
|
|
2 |
|
— |
|
|
— |
|
|
(332) |
|
|
— |
|
|
— |
|
|
(330) |
|
Unrealized loss on marketable securities |
|
|
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(3) |
|
|
(3) |
|
Balance—June 30, 2020 |
|
54,355,957 |
|
$ |
544 |
|
40,000 |
|
$ |
44 |
|
$ |
337,734 |
|
$ |
(290,453) |
|
|
— |
|
$ |
47,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Represents an amount less than $1.
3
The accompanying notes are an integral part of these unaudited consolidated financial statements.
STRONGBRIDGE BIOPHARMA plc
Consolidated Statements of Cash Flow
(In thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
||||
|
|
June 30, |
|
||||
|
|
2020 |
|
2019 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
|
Net loss |
|
$ |
(29,970) |
|
$ |
(26,681) |
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
Change in fair value of warrant liability |
|
|
6,787 |
|
|
(6,877) |
|
Stock-based compensation |
|
|
3,524 |
|
|
4,895 |
|
Amortization of intangible asset |
|
|
2,511 |
|
|
2,511 |
|
Accretion of discounts on marketable securities |
|
|
(53) |
|
|
(71) |
|
Depreciation |
|
|
43 |
|
|
36 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Accounts receivable |
|
|
(596) |
|
|
(4,717) |
|
Inventory |
|
|
294 |
|
|
393 |
|
Prepaid expenses and other current assets |
|
|
(757) |
|
|
1,782 |
|
Other assets |
|
|
314 |
|
|
(1,166) |
|
Accounts payable |
|
|
(1,374) |
|
|
285 |
|
Accrued and other liabilities |
|
|
(8,098) |
|
|
(6,873) |
|
Net cash used in operating activities |
|
|
(27,375) |
|
|
(36,483) |
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
— |
|
|
(33) |
|
Purchases of marketable securities |
|
|
— |
|
|
(27,939) |
|
Maturities of marketable securities |
|
|
21,122 |
|
|
— |
|
Net cash provided by (used in) investing activities |
|
|
21,122 |
|
|
(27,972) |
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
Proceeds from long-term debt, net |
|
|
9,460 |
|
|
— |
|
Proceeds from exercise of stock options |
|
|
— |
|
|
180 |
|
Payments related to tax withholding for net-share settled equity awards |
|
|
(330) |
|
|
(59) |
|
Net cash provided by financing activities |
|
|
9,130 |
|
|
121 |
|
Net increase (decrease) in cash and cash equivalents |
|
|
2,877 |
|
|
(64,334) |
|
Cash and cash equivalents—beginning of period |
|
|
57,032 |
|
|
122,490 |
|
Cash and cash equivalents—end of period |
|
$ |
59,909 |
|
$ |
58,156 |
|
Supplemental disclosures of cash flow information: |
|
|
|
|
|
|
|
Cash paid during the year for: |
|
|
|
|
|
|
|
Interest |
|
$ |
118 |
|
$ |
— |
|
Income taxes other, net of refunds |
|
$ |
531 |
|
$ |
— |
|
The accompanying notes are an integral part of these unaudited consolidated financial statements.
4
STRONGBRIDGE BIOPHARMA plc
Notes to Unaudited Consolidated Financial Statements
1. Organization
We are a global, commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs.
Our first commercial product is Keveyis (dichlorphenamide), the first and only treatment approved by the U.S. Food and Drug Administration (the “FDA”) for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis (“PPP”), a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis.
We have two clinical-stage product candidates for rare endocrine diseases, Recorlev and veldoreotide. Recorlev (levoketoconazole) is a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing's syndrome. Veldoreotide is a next-generation somatostatin analog being investigated for potential applications in conditions amenable to somatostatin receptor activation, such as acromegaly. Both levoketoconazole and veldoreotide have received orphan designation from the FDA and the European Medicines Agency (“EMA”).
In January 2018, Strongbridge Ireland Limited, one of our wholly-owned subsidiaries, acquired the U.S. and Canadian rights to Macrilen (macimorelin), the first and only oral drug approved by the FDA for the diagnosis of patients with adult growth hormone deficiency. We launched Macrilen in the United States in July 2018. In December 2018, we sold Strongbridge Ireland Limited to Novo Nordisk Healthcare AG (“Novo”) for $145 million plus the right to receive tiered royalties on net sales of Macrilen through 2027. In addition, Strongbridge U.S. Inc., another of our wholly-owned subsidiaries, entered into an agreement with Novo Nordisk Inc. (“NNI”), a subsidiary of Novo, pursuant to which NNI funded the costs of 23 of our field-based employees to provide full-time ongoing services to NNI, including the promotion of Macrilen in the United States, for a period of three years. Novo also purchased 5.2 million of our ordinary shares at a purchase price of $7.00 per share. In December 2019, we reached an agreement with Novo to terminate the services agreement. We received a $6 million payment in connection with such termination and we no longer provide services to Novo.
Liquidity
We believe that our cash and cash equivalents of $59.9 million at June 30, 2020, will be sufficient to allow us to fund planned operations for at least 12 months beyond the issuance date of these unaudited consolidated financial statements.
We may never achieve profitability, and unless and until we do, we will continue to need to raise additional capital. We plan to continue to fund our operations and capital funding needs through equity or debt financing along with revenues from Keveyis. There can be no assurances, however, that additional funding will be available on terms acceptable to us.
2. Summary of significant accounting policies and basis of presentation
Basis of presentation
These unaudited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”). The unaudited consolidated financial statements reflect all adjustments, which include only normal recurring adjustments that are, in the opinion of management, necessary to present a fair statement of the operating results and financial position for the periods presented.
The preparation of the unaudited consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and disclosures in the consolidated
5
financial statements. Actual results could differ from those estimates. Results for the six months ended June 30, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020.
These unaudited consolidated financial statements should be read in conjunction with the accounting policies and notes to the audited consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission on February 28, 2020 (the “2019 Annual Report”). Our significant accounting policies are described in Note 2 of the notes to the audited consolidated financial statements included in our 2019 Annual Report. Since the date of those financial statements, there have been no changes to our significant accounting policies.
Reclassifications
The consolidated financial statements contain certain reclassifications within our consolidated statements of cash flow for the six months ended June 30, 2019 due to an immaterial incorrect classification of investments in marketable securities and the related impact on investing activities.
Leases
We account for leases in accordance with Accounting Standards Codification Topic 842, Leases (“ASC 842”). We determine if an arrangement is a lease at contract inception. A lease exists when a contract conveys to us the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. The definition of a lease embodies two conditions: (1) there is an identified asset in the contract that is land or a depreciable asset (i.e., property, plant, and equipment), and (2) we have the right to control the use of the identified asset.
Operating leases where we are the lessee are included in Right of use (“ROU”) assets and Accrued and other current liabilities and Other long-term liabilities on our Consolidated Balance Sheets. The lease liabilities are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date.
Key estimates and judgments include how we determined (1) the discount rate we use to discount the unpaid lease payments to present value, (2) lease term and (3) lease payments.
ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. Because our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. Our incremental borrowing rate for a lease is the rate of interest we would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms.
The lease term for all of our leases includes the noncancellable period of the lease. Lease payments included in the measurement of the lease asset or liability are comprised of our fixed payments.
The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date less any lease incentives received.
For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term.
We monitor for events or changes in circumstances that require a reassessment of a lease. If a reassessment results in the remeasurement of a lease liability, a corresponding adjustment is made to the carrying amount of the corresponding ROU asset unless doing so would reduce the carrying amount of the ROU asset to an amount less than zero. In that case, the amount of the adjustment that would result in a negative ROU asset balance is recorded in profit or loss.
6
We have elected not to recognize ROU assets and lease liabilities for all short-term leases that have a lease term of 12 months or less. We recognize the lease payments associated with our short-term leases as an expense on a straight-line basis over the lease term. Variable lease payments associated with these leases are recognized and presented in the same manner as for all of our other leases.
Cash, cash equivalents and marketable securities
We consider all short-term highly liquid investments with an original maturity at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents consist of account balances at banks and money market accounts, respectively.
We occasionally invest our excess cash balances in marketable debt securities of highly rated financial institutions. We seek to diversify our investments and limit the amount of investment concentrations for individual institutions, maturities and investment types. We classify marketable debt securities as available-for-sale and, accordingly, record such securities at fair value. We classify these securities as current assets as these investments are intended to be available to us for use in funding current operations. There were no marketable securities as of June 30, 2020.
Unrealized gains and losses on marketable debt securities are recorded as a separate component of Accumulated other comprehensive income (loss) included in stockholders’ equity.
Segment information
Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions on how to allocate resources and assess performance. We view our operations and manage our business in one operating segment.
Net loss per share
Basic net loss per share is calculated by dividing the net loss attributable to shareholders by the weighted average number of ordinary shares outstanding during the period. Diluted net loss per share is calculated by dividing the net loss attributable to shareholders by the weighted-average number of ordinary shares outstanding for the period, including any dilutive effect from outstanding stock options or other equity-based awards. Shares used in the diluted net loss per share calculations exclude anti-dilutive ordinary share equivalents, which currently consist of outstanding stock options, unvested restricted stock units (“RSUs”) and equity-classified warrants.
The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of June 30, 2020 and 2019, as they would be anti-dilutive:
|
|
|
|
|
|
|
|
June 30, |
|||
|
|
2020 |
2019 |
||
Warrants |
|
|
7,100,643 |
|
1,803,253 |
Stock options issued and outstanding |
|
|
10,499,222 |
|
10,241,158 |
Unvested RSUs |
|
|
1,090,300 |
|
964,850 |
Recent accounting pronouncements – not yet adopted
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments. ASU 2016-13 requires an entity to measure and recognize expected credit losses for certain financial instruments, including trade receivables, as an allowance that reflects the entity's current estimate of credit losses expected to be incurred. For available-for-sale debt securities with unrealized losses, the standard requires allowances to be recorded through net income instead of directly reducing the amortized cost of the investment under the
7
current other-than-temporary impairment model. The standard is effective for smaller reporting companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2022. We do not expect the adoption of this standard to have a significant impact on our financial statements or internal controls.
3. Revenue recognition
Product sales, net
We sell Keveyis to one specialty pharmacy provider (the “Customer”), who is the exclusive distributor of Keveyis in the United States. The Customer subsequently resells Keveyis to patients, most of whom are covered by payors that may provide for government-mandated or privately negotiated rebates with respect to the purchase of Keveyis.
Revenues from sales of Keveyis are recognized when we satisfy a performance obligation by transferring control of the product to the Customer. Transfer of control occurs upon receipt of the product by the Customer. We expense incremental costs related to the set-up of contracts with the Customer when incurred, as these costs do not meet the criteria for capitalization.
Reserves for variable consideration
Revenues from sales of Keveyis are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and that result from rebates, co-pay assistance and other allowances that are offered between us and the patients’ payors. There is no variable consideration reserve for returns as we do not accept returns of Keveyis. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the Customer) or a current liability (if the amount is payable to a party other than the Customer). Where appropriate, these estimates may take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from our estimates. We reassess our estimates on an ongoing basis. If actual results in the future vary from our estimates, we will adjust our estimates. Any such adjustments would affect net product revenue and earnings in the period such variances become known.
Trade Discount: We provide the Customer with a discount that is explicitly stated in our contract and is recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, we receive sales order management, data and distribution services from the Customer. To the extent the services received are distinct from our sale of Keveyis to the Customer, these payments are classified in Selling, general and administrative expenses in our consolidated statement of operations and comprehensive loss.
Funded Co-pay Assistance Program: We contract with a third-party to manage the co-pay assistance program intended to provide financial assistance to qualified insured patients. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that we expect to receive associated with Keveyis that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. These payments are consideration payable to the Customer and the related reserve is recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses on the consolidated balance sheet.
Government Rebates: We are subject to discount obligations under state Medicaid programs and Medicare. We estimate our Medicaid and Medicare rebates for the estimated patient mix. These reserves are recorded in the same
8
period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses on the consolidated balance sheet. For Medicaid, accruals are based on estimates of future Medicaid beneficiary utilization applied to the Medicaid unit rebate formula established by the Center for Medicaid and Medicare Services. Manufacturers of pharmaceutical products are responsible for 70% of the patient’s cost of branded prescription drugs related to the Medicare Part D Coverage Gap. In order to estimate the cost to us of this Medicare coverage gap responsibility, we estimate the number of patients in the prescription drug coverage gap for whom we will owe an additional liability under the Medicare Part D program. Our liability for these rebates consists of estimates of claims for the current quarter and estimated future claims that will be made for Keveyis that have been recognized as revenue, but remains in the Customer’s inventory at the end of each reporting period.
Temporary Supply and Patient Assistance Programs: We provide free Keveyis to uninsured patients who satisfy pre-established criteria for either the Temporary Supply Program or the Patient Assistance Program. Patients who meet the Temporary Supply Program eligibility criteria may receive a temporary supply of free Keveyis for no more than sixty days while there is a determination of the patient’s third-party insurance, prescription drug benefit or other third-party coverage for Keveyis. The Patient Assistance Program provides free Keveyis for up to twelve months to uninsured patients who satisfy pre-established criteria for financial need. We do not recognize any revenue related to these free products and the associated costs are classified in selling, general and administrative expenses in our consolidated statements of operations and comprehensive loss.
4. Fair value measurement
We follow FASB accounting guidance on fair value measurements for financial assets and liabilities measured on a recurring basis. Because of their short-term nature, the amounts reported in the balance sheet for cash and accounts payable approximate fair value.
The guidance requires fair value measurements to maximize the use of “observable inputs.” The three-level hierarchy of inputs to measure fair value are as follows:
Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. Because of their short-term nature, the amounts reported in the balance sheet for cash and accounts payable approximate fair value.
Level 2: Significant observable inputs other than Level 1 prices such as quoted prices in markets that are not active, or inputs that are observable, either directly or indirectly, for substantially the full term of the asset or liability
Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). The fair values of the outstanding warrants were measured using the Black-Scholes option-pricing model. Inputs used to determine estimated fair value of the warrant liabilities include the estimated fair value of the underlying stock at the valuation date, the estimated term of the warrants, risk-free interest rates, and the expected volatility of the underlying stock. The significant unobservable inputs used in the fair value measurement of the warrant liabilities were the volatility rate and the estimated term of the warrants. Generally, increases and decreases in the fair value of the underlying stock and estimated term would result in a directionally similar impact to the fair value measurement.
We did not have any transfers between the different levels.
9
The following table presents our assets and liabilities that are measured at fair value on a recurring basis for the periods presented (in thousands):
The following table presents a reconciliation of our level 3 warrant liability (in thousands):
|
|
|
|
|
|
|
As of June 30, 2020 |
Balance as of December 31, 2019 |
|
$ |
4,127 |
Unrealized loss on fair value of warrants for six months ended June 30, 2020 |
|
|
6,787 |
Balance as of June 30, 2020 |
|
$ |
10,914 |
5. Intangible asset and goodwill
The following represents the balance of our intangible asset and goodwill as follows (in thousands):
Our finite-lived intangible asset consists of acquired developed product rights obtained from our acquisition of Keveyis (dichlorphenamide) from a subsidiary of Taro Pharmaceutical Industries Ltd. (“Taro”).
Pursuant to the terms of the Asset Purchase Agreement and Supply Agreement that we entered into with Taro in December 2016, we paid Taro an upfront payment in two installments of $1 million in December 2016 and $7.5 million in March 2017, and will pay an aggregate of $7.5 million in potential milestones upon the achievement of certain product sales targets. Taro has agreed to continue to manufacture Keveyis for us under an exclusive supply agreement through the orphan exclusivity period. We are obligated to purchase certain annual minimum amounts of product totaling approximately $29 million over a six-year period. We have concluded that the supply price payable by us exceeds fair value and, therefore, have used a discounted cash flow method with a probability assumption to value the payments in excess of fair value at $29.3 million, for which we have recorded an intangible asset and corresponding liability. This liability is being reduced as we purchase inventory over the term of the Supply Agreement that we entered into with Taro. In addition, we incurred transaction costs of $2.4 million. The transaction resulted in the recording of an intangible asset of $40.2 million. This asset is being amortized over an eight-year period using the straight-line method.
We recorded amortization expense of $1.3 million and $2.5 million for the three and six months ended June 30, 2020 and 2019, respectively.
10
6. Long-term debt
On May 19, 2020 (the “Closing Date”), Strongbridge Biopharma plc (“Strongbridge”), along with Strongbridge U.S. Inc., Cortendo AB (publ) and Strongbridge Dublin Limited, each a subsidiary of Strongbridge (the “Subsidiaries,” and together with Strongbridge, the “Company”), entered into a $30 million Term Loan Agreement (the “Loan Agreement”) with Avenue Venture Opportunities Fund L.P. (“Avenue”), as administrative agent and collateral agent, and the lenders named therein and from time to time a party thereto (the “Lenders”). Pursuant to the terms of the Loan Agreement, Strongbridge U.S. Inc. (the “Borrower”) borrowed $10 million (the “Initial Loan”) from the Lenders at closing.
The Borrower may borrow up to two additional tranches of $10 million under the Loan Agreement. The first $10 million tranche (the “Second Loan”) is available between October 1, 2020 and December 31, 2020 if Strongbridge achieves positive top-line data for RECORLEV in its Phase 3 LOGICS clinical trial. The second $10 million tranche (the “Third Loan” and, together with the Initial Loan and the Second Loan, the “Loans”) is available between October 1, 2021 and March 31, 2022 if Strongbridge achieves FDA approval of RECORLEV and subject to Avenue’s investment committee approval.
The Loan Agreement has a four-year term, no minimum revenue or cash balance financial covenants and an interest-only period of up to 36 months assuming the Company achieves positive top-line data for RECORLEV in its Phase 3 LOGICS clinical trial and the Company receives FDA approval of RECORLEV. The Borrower paid a commitment fee of $200,000 (1% of the amounts of the Initial Loan and the Second Loan).
Amounts borrowed under the Loan Agreement accrue interest at a floating rate per annum (based on a year of 365 days) equal to the sum of (a) the greater of (x) the Prime Rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, and (y) 3.25%, plus (b) 6.75%. Accrued interest is payable in advance on the first day of each month and on the maturity date; provided however that no principal payments are required for the first 12 months (which the period is extended for up to 36 months subject to the satisfaction of certain conditions under the Loan Agreement). The Borrower is also required to pay the Lenders a final payment fee upon repayment or prepayment of the Loans in accordance with the terms and conditions of the Loan Agreement. The interest rate as of June 30, 2020 was 10%.
The Borrower may prepay all or a portion of the outstanding principal amount of any Loans outstanding under the Loan Agreement at any time upon prior notice to the Lenders subject to a prepayment premium (which reduces after the first year) and the payment of the pro rata portion of the final payment fee (to the extent not already paid) based on the amount of Loans being prepaid. In certain circumstances, including a change of control and certain asset sales or licensing transactions, the Borrower may be required to prepay all or a portion of the Loans outstanding, and, to the extent required under the terms of the Loan Agreement, the applicable prepayment premium and final payment fee.
In connection with the execution of the Loan Agreement, Strongbridge issued warrants to the Lenders to purchase an aggregate of 267,390 ordinary shares at an exercise price (the “Exercise Price”) equal to the lower of (i) $1.87 (which is equal to the five-day volume weighted average price as of the trading day immediately prior to execution of the financing agreement) or (ii) the effective price of any bona fide equity financing prior to December 31, 2020 (subject to certain adjustments described in the Warrant). The Warrant will be exercisable, in full or in part, at any time prior to five years following the issue date and contains customary provisions for assumption or exchange upon a change of control or a sale of all or substantially all of the assets of the Company. We have accounted for these warrants as equity, and the fair value is recorded into Additional paid-in capital.
Avenue has the right to convert up to $3 million of the aggregate principal amount of any loans outstanding under the Loan Agreement into Strongbridge ordinary shares at a price per share of the lower of (a) $2.24, or (b) 20% above the effective price of any bona fide equity financing of Strongbridge prior to December 31, 2020, subject to the terms and conditions described in the Loan Agreement. We have accounted for this beneficial conversion feature, and the fair value is recorded into Additional paid-in capital.
11
Future principal payments due under the Loan Agreement, if the interest payment only period is not extended are as follows (in thousands):
|
|
|
|
|
|
|
Principal |
|
|
|
|
Payments |
|
|
|
|
|
|
|
2020 |
|
|
— |
|
2021 |
|
|
1,944 |
|
2022 |
|
|
3,333 |
|
2023 |
|
|
3,333 |
|
2024 |
|
|
1,390 |
|
Total future payments |
|
$ |
10,000 |
|
7. Accrued and other current liabilities
Accrued and other current liabilities consist of the following (in thousands):
8. Commitments and contingencies
(a) Commitments to Taro Pharmaceuticals Industries Ltd.
In December 2016, we acquired the U.S. marketing rights to Keveyis (dichlorphenamide) from Taro. Under the terms of the Asset Purchase Agreement, we paid Taro an upfront payment in two installments of $1 million in December 2016 and $7.5 million in March 2017, and will pay an aggregate of $7.5 million in potential milestones upon the achievement of certain product sales targets. Taro has agreed to continue to manufacture Keveyis for us under an exclusive supply agreement through the orphan exclusivity period. We are obligated to purchase certain annual minimum amounts of product totaling approximately $29 million over a six-year period. As of June 30, 2020, our remaining obligation was $19.0 million. Our Supply Agreement with Taro may extend beyond the orphan exclusivity period unless terminated by either party pursuant to the terms of the agreement. If terminated by Taro at the conclusion of the orphan exclusivity period, we have the right to manufacture the product on our own or have the product manufactured by a third party on our behalf. We are also required to reimburse Taro for its royalty obligation resulting from its sale of Keveyis to us.
(b) Indemnifications
In the ordinary course of business and in connection with the sale of assets and businesses and other transactions, we often indemnify our counterparties against certain liabilities that may arise in connection with the transaction or that are related to events and activities prior to or following a transaction, such as breaches of contracts, unfavorable tax consequences and employee liabilities. If the indemnified party were to make a successful claim pursuant to the terms of the indemnification, we may be required to reimburse the loss and such amount could be material to our consolidated financial statements. Where appropriate, the obligation for such indemnifications is recorded as a liability. Because the amount of these types of indemnifications generally is not specifically stated, the overall
12
maximum amount of the obligation under such indemnifications cannot be reasonably estimated. However, we believe that the likelihood of a material liability being triggered under these indemnification obligations is not probable at this time.
9. Taxes
Income Taxes
Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the carrying amounts and tax bases of assets and liabilities and operating loss carryforwards and other attributes using enacted rates expected to be in effect when those differences reverse. Valuation allowances are provided against deferred tax assets that are not more likely than not to be realized.
We assess our ability to realize deferred tax assets. Changes in future earnings projections, among other factors, may cause us to adjust our valuation allowance on deferred tax assets. Any such adjustments would impact our income tax expense in the period in which it is determined that these factors have changed.
We did not incur income any tax expense for the three and six months ended June 30, 2020.
CARES Act
The CARES Act allows companies to defer payments of employer Social Security payroll taxes that are otherwise owed for wage payments made after March 27, 2020 through December 31, 2020. Fifty percent of the taxes deferred are required to be paid by December 31, 2021 with the remaining fifty percent required to be paid by December 31, 2022. As of June 30, 2020, we have accrued $100,000 of Social Security payroll taxes that will be deferred under the CARES Act. We expect to continue to defer payroll taxes through the end of the year and pay them as described above.
10. Warrants
Warrants
Our outstanding warrants as of June 30, 2020 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding |
|
|
|
|
|
Exercise |
|
Expiration |
|
Warrants |
|
Warrants |
|
June 30, |
|
|
|
|
Classification |
|
Price |
|
Date |
|
Issued |
|
Exercised |
|
2020 |
|
|
Warrants in connection with private equity placement |
|
Liability |
|
$ |
2.50 |
|
6/28/2022 |
|
7,000,000 |
|
(1,970,000) |
|
5,030,000 |
|
Warrants in connection with Horizon and Oxford loan agreement |
|
Equity |
|
$ |
2.45 |
|
12/28/2026 |
|
428,571 |
|
(267,857) |
|
160,714 |
|
Warrants in connection with CRG loan agreement |
|
Equity |
|
$ |
7.37 |
|
7/14/2024 |
|
394,289 |
|
— |
|
394,289 |
|
Warrants in connection with CRG loan amendment in January 2018 |
|
Equity |
|
$ |
10.00 |
|
1/16/2025 |
|
1,248,250 |
|
— |
|
1,248,250 |
|
Warrants in connection with Avenue Capital loan agreement |
|
Equity |
|
$ |
1.87 |
(1) |
5/19/2025 |
|
267,390 |
|
— |
|
267,390 |
|
|
|
|
|
|
|
|
|
|
9,338,500 |
|
|
|
7,100,643 |
|
(1) | Exercise price is lower of (i) $1.87 per share or (ii) the effective price of any bona fide equity financing prior to December 31, 2020. |
11. Stock-based compensation
Our board of directors has adopted the 2017 Inducement Plan (the “Inducement Plan”). The Inducement Plan provides for the grant of equity-based awards to new employees. The purpose of the Inducement Plan is to attract valued
13
employees by offering them a greater stake in our success and a closer identity with us, and to encourage ownership of our ordinary shares by such employees. The Inducement Plan became effective on February 23, 2017. As of June 30, 2020, 1,373,903 shares are available for issuance pursuant to the Inducement Plan.
Our board of directors has adopted, and our shareholders have approved, the 2015 Equity Compensation Plan (the “2015 Plan”). The 2015 Plan provides for the grant of incentive stock options to our employees and any parent or subsidiary corporation’s employees, and for the grant of nonstatutory stock options, stock awards, and RSUs to our employees, directors and consultants and our parent or subsidiary corporations’ employees and consultants. The 2015 Plan became effective on September 3, 2015. As of June 30, 2020, 332,429 shares are available for issuance pursuant to the 2015 Plan.
Our board of directors has adopted, and our shareholders have approved, the Non-Employee Director Equity Compensation Plan (the “Non-Employee Director Plan”). The Non-Employee Director Plan provides for the grant of nonstatutory stock options, stock awards, and RSUs to our non-employee directors. The Non-Employee Director Plan became effective on September 3, 2015. As of June 30, 2020, 71,029 shares are available for issuance pursuant to the Non-Employee Director Plan.
A summary of our outstanding stock options as of June 30, 2020 is as follows:
Stock-based compensation expense
We recognized stock-based compensation expense for employees and directors for stock options and RSUs as follows (in thousands):
As of June 30, 2020, the total unrecognized compensation expense related to unvested stock options is $11.2 million, which we expect to recognize over an estimated weighted-average period of 2.70 years.
In determining the estimated fair value of our service-based awards, we use the Black-Scholes option-pricing model and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment.
14
The fair value of our service-based awards that were granted during the six months period ending June 30, 2020 and 2019 was estimated with the following assumptions:
Restricted stock units
We grant RSUs to employees and to members of our board of directors. RSUs that are granted to employees vest two years from the date of issuance, provided that the employee is employed by us on such vesting date. RSUs that are granted to directors, vest on the one-year anniversary of the grant date, provided that the director continues to serve as a member of the board of directors continuously from the grant date through such one-year anniversary. All RSUs will fully vest upon a change of control of our company. If and when the RSUs vest, we will issue one ordinary share for each whole RSU that has vested, subject to satisfaction of the employee’s or director’s tax withholding obligations. The RSUs will cease to be outstanding upon the issuance of ordinary shares upon vesting. We recorded expense related to RSUs, which is included in the stock-based compensation table above, of $498,000 and $533,000 for the three months ended June 30, 2020 and 2019, respectively, and $1 million and $771,000 for the six months ended June 30, 2020 and 2019, respectively. As of June 30, 2020, the total unrecognized compensation expense related to unvested RSUs is $2.0 million, which we expect to recognize over an estimated weighted-average period of 1.29 years.
A summary of our unvested RSUs as of June 30, 2020 is as follows:
|
|
|
|
|
|
Number of |
|
|
|
Shares |
|
Outstanding—January 1, 2020 |
|
791,350 |
|
Granted |
|
595,150 |
|
Forfeited |
|
(35,200) |
|
Vested |
|
(261,000) |
|
Unvested—June 30, 2020 |
|
1,090,300 |
|
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis should be read in conjunction with our interim unaudited consolidated financial statements and related notes included elsewhere in this Quarterly Report on 10-Q (this “Quarterly Report”) and the audited financial statements and related notes for the year ended December 31, 2019 and related Management’s Discussion and Analysis of Financial Condition and Results of Operations that are included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (the “2019 Annual Report”) filed with the Securities and Exchange Commission (“SEC”) on February 28, 2020. As used in this Quarterly Report, unless the context suggests otherwise, “we,” “us,” “our,” or “Strongbridge” refer to Strongbridge Biopharma plc.
Special Note Regarding Forward-Looking Statements
This Quarterly Report contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, prospective products, size of market or patient population, plans, objectives of management, expected market growth and the anticipated effects of the coronavirus (COVID-19) pandemic on our business, operating results and financial condition are forward-looking
15
statements. The words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report. Factors that might cause such differences include, but are not limited to, those discussed in Part I, Item 1A of our 2019 Annual Report on Form 10-K and Part II, Item 1A of this Quarterly Report, in each case under the heading “Risk Factors.” In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this Quarterly Report, they may not be predictive of results or developments in future periods.
Any forward-looking statement that we make in this Quarterly Report speaks only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this Quarterly Report except as required by law. You should also read carefully the factors described in the “Risk Factors” section of our 2019 Annual Report and this Quarterly Report to better understand the risks and uncertainties inherent in our business and underlying any forward-looking statements.
Overview
We are a global, commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs.
Our first commercial product is Keveyis (dichlorphenamide), the first and only treatment approved by the U.S. Food and Drug Administration (the “FDA”) for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis (“PPP”), a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis.
We have two clinical-stage product candidates for rare endocrine diseases, Recorlev and veldoreotide. Recorlev (levoketoconazole) is a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing's syndrome. Veldoreotide is a next-generation somatostatin analog being investigated for potential applications in conditions amenable to somatostatin receptor activation. Both levoketoconazole and veldoreotide have received orphan designation from the FDA and the European Medicines Agency (“EMA”).
In January 2018, Strongbridge Ireland Limited, one of our wholly-owned subsidiaries, acquired the U.S. and Canadian rights to Macrilen (macimorelin), the first and only oral drug approved by the FDA for the diagnosis of patients with adult growth hormone deficiency. We launched Macrilen in the United States in July 2018. In December 2018, we sold Strongbridge Ireland Limited to Novo Nordisk Healthcare AG (“Novo”) for $145 million plus the right to receive tiered royalties on net sales of Macrilen through 2027. In addition, Strongbridge U.S. Inc., another of our wholly-owned subsidiaries, entered into an agreement with Novo Nordisk Inc. (“NNI”), a subsidiary of Novo, pursuant to which NNI funded the costs of 23 of our field-based employees to provide full-time ongoing services to NNI, including the promotion of Macrilen in the United States, for a period of three years. Novo also purchased 5.2 million of our ordinary shares at a purchase price of $7.00 per share. In December 2019, we reached an agreement with Novo to terminate the services agreement. We received a $6 million payment in connection with such termination and we no longer provide services to Novo.
16
Recent Developments
On July 2, 2020, our board of directors appointed John H. Johnson to the position of Chief Executive Officer, effective immediately.
In June 2020, we conducted a pre-NDA meeting with the Division of General Endocrinology (DGE) of the FDA to review plans relating to our proposed NDA submission for Recorlev, with an anticipated submission date approximately 6 months following disclosure of topline results from the LOGICS study. Based on feedback received from DGE during this meeting, we believe that the LOGICS and SONICS study results together will provide a sufficient clinical-studies basis for a substantive review of an NDA and that it will be a review issue as to whether the data will be sufficient to support approval of the NDA. There can be no assurance that DGE will determine that the totality of data included in the NDA, including the results from our SONICS and LOGICS studies, will be sufficient to warrant approval of the NDA for Recorlev.
COVID-19
COVID-19 emerged in Asia at the end of calendar year 2019. On March 11, 2020, the World Health Organization declared COVID-19 a pandemic, and on March 13, 2020 the United States declared a national emergency with respect to COVID-19. The COVID-19 pandemic has negatively impacted the global economy, disrupted global supply chains and created significant volatility and disruption in the financial markets.
While the COVID-19 pandemic did not have a material impact on our business, financial condition or results of operations for the six months ended June 30, 2020, we have experienced business disruptions as a result of the outbreak. For example, most of our corporate employees are currently working remotely from home, we have suspended all commercial air and train travel for business, and any other employee travel is done in accordance with the state and local guidelines. In addition, our field teams have had limited access to visit physicians.
We continue to monitor the impacts of COVID-19 on the global economy and on our business operations. However, at this time, it is difficult to predict how long the potential operational impacts of COVID-19 will remain in effect or to what degree they will impact our operations and financial results. An extended period of global supply chain and economic disruption could materially affect our business, results of operations, access to sources of liquidity and financial condition, as well as our ability to execute our business strategies and initiatives in their respective expected time frames.
Financial Operations Overview
The following discussion sets forth certain components of our statements of operations as well as factors that impact those items.
Product Sales, net
Revenues from sales of our products are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and that result from rebates, co-pay assistance and other allowances that are offered by us and the patients’ payors. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to our customer) or a current liability (if the amount is payable to a party other than our customer). Where appropriate, these estimates may take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. For a complete discussion of accounting for net product revenue, see Note 3, "Revenue recognition" to our consolidated financial statements.
17
Cost of Sales
Cost of sales includes third-party acquisition costs, third-party warehousing and product distribution charges.
Selling, General and Administrative Expenses
Selling, general and administrative expenses include personnel costs, costs for outside professional services and other allocated expenses. Personnel costs consist of salaries, bonuses, benefits, travel and stock-based compensation. Outside professional services consist of legal, accounting and audit services, commercial evaluation and strategy services, sales, market access, marketing, investor relations, public relations, recruiting and other consulting services.
Research and Development Expenses
We expense all research and development costs as incurred. Our research and development expenses consist primarily of costs incurred in connection with the development of our product candidates, including:
● | personnel-related costs, such as salaries, bonuses, benefits, travel and other related expenses, including stock-based compensation; |
● | expenses incurred under our agreements with contract research organizations (CROs), clinical sites, contract laboratories, medical institutions and consultants that plan and conduct our preclinical studies and clinical trials. We recognize costs for each grant project, preclinical study or clinical trial that we conduct based on our evaluation of the progress to completion, including the use of information and data provided to us by our external research and development vendors and clinical sites; |
● | costs associated with regulatory filings; and |
● | costs of acquiring preclinical study and clinical trial materials, and costs associated with formulation, process development and statistical analysis. |
We do not allocate personnel-related research and development costs, including stock-based compensation or other indirect costs, to specific programs, as they are deployed across multiple projects under development.
Amortization of Intangible Asset
Amortization of intangible asset relates to the amortization of our product rights to Keveyis. This intangible asset is being amortized over an eight-year period using the straight-line method.
Other Income (Expense), Net
Other income (expense), net, consists of unrealized loss or gain on the remeasurement of the fair value of the warrant liability, interest income generated from our cash, cash equivalents and marketable securities, foreign exchange gains and losses and gains and losses on investments. In 2019, we recorded income and expenses relating to our service agreement with NNI to fund the costs of 23 of our field-based employees who provided full-time ongoing services to NNI, including the promotion of Macrilen in the United States.
Critical Accounting Policies and Significant Judgments and Estimates
This management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
18
We believe there have been no significant changes in our critical accounting policies and significant judgments and estimates as discussed in “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our 2019 Annual Report.
Results of Operations
Comparison of the Three and Six Months Ended June 30, 2020 and 2019.
The following table sets forth our results of operations for the three and six months ended June 30, 2020 and 2019.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||
|
|
June 30, |
|
Change |
|
June 30, |
|
Change |
|
||||||||||
|
|
2020 |
|
2019 |
|
$ |
|
2020 |
|
2019 |
|
$ |
|
||||||
|
|
(in thousands) |
|
(in thousands) |
|
||||||||||||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
7,752 |
|
$ |
6,073 |
|
$ |
1,679 |
|
$ |
14,415 |
|
$ |
10,406 |
|
$ |
4,009 |
|
Royalty revenues |
|
|
8 |
|
|
6 |
|
|
2 |
|
|
19 |
|
|
16 |
|
|
3 |
|
Total revenues |
|
|
7,760 |
|
|
6,079 |
|
|
1,681 |
|
|
14,434 |
|
|
10,422 |
|
|
4,012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales (excluding amortization of intangible asset) |
|
$ |
393 |
|
$ |
1,022 |
|
$ |
(629) |
|
$ |
1,362 |
|
$ |
1,835 |
|
$ |
(473) |
|
Selling, general and administrative |
|
|
9,638 |
|
|
12,182 |
|
|
(2,544) |
|
|
20,041 |
|
|
24,282 |
|
|
(4,241) |
|
Research and development |
|
|
6,152 |
|
|
8,739 |
|
|
(2,587) |
|
|
13,704 |
|
|
15,322 |
|
|
(1,618) |
|
Amortization of intangible asset |
|
|
1,255 |
|
|
1,255 |
|
|
— |
|
|
2,511 |
|
|
2,511 |
|
|
— |
|
Total cost and expenses |
|
|
17,438 |
|
|
23,198 |
|
|
(5,760) |
|
|
37,618 |
|
|
43,950 |
|
|
(6,332) |
|
Operating loss |
|
|
(9,678) |
|
|
(17,119) |
|
|
7,441 |
|
|
(23,184) |
|
|
(33,528) |
|
|
10,344 |
|
Other (expense) income, net |
|
|
(7,594) |
|
|
9,272 |
|
|
(16,866) |
|
|
(6,786) |
|
|
7,924 |
|
|
(14,710) |
|
Loss before income taxes |
|
|
(17,272) |
|
|
(7,847) |
|
|
(9,425) |
|
|
(29,970) |
|
|
(25,604) |
|
|
(4,366) |
|
Income tax expense |
|
|
— |
|
|
(400) |
|
|
400 |
|
|
— |
|
|
(1,077) |
|
|
1,077 |
|
Net loss |
|
$ |
(17,272) |
|
$ |
(8,247) |
|
$ |
(9,025) |
|
$ |
(29,970) |
|
$ |
(26,681) |
|
$ |
(3,289) |
|
Revenues
Net product sales were $7.8 million for the three months ended June 30, 2020, an increase of $1.7 million compared to the three months ended June 30, 2019. Product sales from Keveyis increased primarily due to the an increase the number of patients on Keveyis and an increase in price. Cost of sales decreased due to changes in the assumptions underlying the allocation between the purchase price of our inventory and the supply agreement.
Net product sales were $14.4 million for the six months ended June 30, 2020, an increase of $4.0 million compared to the six months ended June 30, 2019. Product sales from Keveyis increased primarily due to an increase in the number of patients on Keveyis and an increase in price. Cost of sales decreased due to changes in the assumptions underlying the allocation between the purchase price of our inventory and the supply agreement..
19
Selling, General and Administrative Expenses
The following table summarizes our selling, general and administrative expenses during the three and six months ended June 30, 2020 and 2019:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||
|
|
June 30, |
|
Change |
|
June 30, |
|
Change |
|
||||||||||
|
|
2020 |
|
2019 |
|
$ |
|
2020 |
|
2019 |
|
$ |
|
||||||
|
|
(in thousands) |
|
(in thousands) |
|
||||||||||||||
Compensation and other personnel costs |
|
$ |
3,669 |
|
$ |
6,133 |
|
$ |
(2,464) |
|
$ |
7,448 |
|
$ |
11,996 |
|
$ |
(4,548) |
|
Outside professional and consulting services |
|
|
4,516 |
|
|
3,841 |
|
|
675 |
|
|
9,701 |
|
|
8,001 |
|
|
1,700 |
|
Stock-based compensation expense |
|
|
1,280 |
|
|
1,981 |
|
|
(701) |
|
|
2,550 |
|
|
3,792 |
|
|
(1,242) |
|
Facility costs |
|
|
173 |
|
|
227 |
|
|
(54) |
|
|
342 |
|
|
493 |
|
|
(151) |
|
Total selling, general and administrative expenses |
|
$ |
9,638 |
|
$ |
12,182 |
|
$ |
(2,544) |
|
$ |
20,041 |
|
$ |
24,282 |
|
$ |
(4,241) |
|
Selling, general and administrative expenses were $9.6 million for the three months ended June 30, 2020, a decrease of $2.5 million compared to the three months ended June 30, 2019, mostly due to decreases in compensation and other personnel costs due to reduced headcount in 2020 and reduced spending due to COVID-19.
Selling, general and administrative expenses were $20.0 million for the six months ended June 30, 2020, a decrease of $4.2 million compared to the six months ended June 30, 2019, mostly due to decreases in compensation and other personnel costs due to reduced headcount in 2020 and reduced spending due to COVID-19.
Research and Development Expenses
The following table summarizes our research and development expenses during the three and six months ended June 30, 2020 and 2019:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||
|
|
June 30, |
|
Change |
|
June 30, |
|
Change |
|
||||||||||
|
|
2020 |
|
2019 |
|
$ |
|
2020 |
|
2019 |
|
$ |
|
||||||
|
|
(in thousands) |
|
(in thousands) |
|
||||||||||||||
Product development and supporting activities |
|
$ |
4,195 |
|
$ |
6,652 |
|
$ |
(2,457) |
|
$ |
9,732 |
|
$ |
11,387 |
|
$ |
(1,655) |
|
Compensation and other personnel costs |
|
|
1,464 |
|
|
1,495 |
|
|
(31) |
|
|
2,998 |
|
|
2,831 |
|
|
167 |
|
Stock-based compensation expense |
|
|
493 |
|
|
592 |
|
|
(99) |
|
|
974 |
|
|
1,104 |
|
|
(130) |
|
Total research and development expenses |
|
$ |
6,152 |
|
$ |
8,739 |
|
$ |
(2,587) |
|
$ |
13,704 |
|
$ |
15,322 |
|
$ |
(1,618) |
|
Research and development expenses were $6.2 million for the three months ended June 30, 2020, a decrease of $2.6 million compared to the three months ended June 30, 2019. The decrease was due to decreases in product development and supporting activities resulting from the completion of our SONICS trial in 2019 and higher costs related to our LOGICS trial in 2019, offset by an increase in costs from our OPTICS trial in 2020.
Research and development expenses were $13.7 million for the six months ended June 30, 2020, a decrease of $1.6 million compared to the six months ended June 30, 2019. The decrease was due to decreases in product development and supporting activities resulting from the completion of our SONICS trial in 2019 and higher costs related to our LOGICS trial in 2019, offset by an increase in costs from our OPTICS trial in 2020.
20
Amortization of Intangible Asset
Amortization of intangible asset was $1.3 million and $2.5 million for the three and six months ended June 30, 2020 and 2019, respectively.
Other (Expense) Income, Net
The following table summarizes our other income, net, during the three months ended March 31, 2020 and 2019:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||
|
|
June 30, |
|
Change |
|
June 30, |
|
Change |
|
||||||||||
|
|
2020 |
|
2019 |
|
$ |
|
2020 |
|
2019 |
|
$ |
|
||||||
|
|
(in thousands) |
|
(in thousands) |
|
||||||||||||||
Unrealized (loss) gain on fair value of warrants |
|
$ |
(7,367) |
|
$ |
8,697 |
|
$ |
(16,064) |
|
$ |
(6,787) |
|
$ |
6,877 |
|
$ |
(13,664) |
|
Income from field services agreement |
|
|
— |
|
|
1,725 |
|
|
(1,725) |
|
|
— |
|
|
3,741 |
|
|
(3,741) |
|
Expense from field services agreement |
|
|
— |
|
|
(1,758) |
|
|
1,758 |
|
|
— |
|
|
(3,987) |
|
|
3,987 |
|
Interest expense |
|
|
(253) |
|
|
— |
|
|
(253) |
|
|
(253) |
|
|
— |
|
|
(253) |
|
Other income, net |
|
|
26 |
|
|
608 |
|
|
(582) |
|
|
254 |
|
|
1,293 |
|
|
(1,039) |
|
Total other (expense) income, net |
|
$ |
(7,594) |
|
$ |
9,272 |
|
$ |
(16,866) |
|
$ |
(6,786) |
|
$ |
7,924 |
|
$ |
(14,710) |
|
Total other (expense) income, net, decreased by $16.9 million for the three months ended June 30, 2020 as compared to the three months ended June 30, 2019. The decrease was largely due to a net $16.1 million change in the revaluation of the fair value of our warrant liability for the three months ended June 30, 2020. The change in the warrant liability is primarily due to increases in our stock price.
Total other (expense) income, net, decreased by $14.7 million for the six months ended June 30, 2020 as compared to the six months ended June 30, 2019. The decrease was largely due to a net $13.7 million change in the revaluation of the fair value of our warrant liability for the six months ended June 30, 2020. The change in the warrant liability is primarily due to increases in our stock price.
Income Tax
We did not incur income any tax expense for the three and six months ended June 30, 2020.
Cash Flows
Comparison for the Six Months Ended June 30, 2020 and 2019:
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
||||
|
|
June 30 |
|
||||
|
|
2020 |
|
2019 |
|
||
|
|
(in thousands) |
|
||||
Net cash (used in) provided by: |
|
|
|
|
|
|
|
Operating activities |
|
$ |
(27,376) |
|
$ |
(36,483) |
|
Investing activities |
|
|
21,122 |
|
|
(27,972) |
|
Financing activities |
|
|
9,131 |
|
|
121 |
|
Net increase (decrease) in cash and cash equivalents |
|
$ |
2,877 |
|
$ |
(64,334) |
|
Operating Activities
Net cash used in operating activities was $27.4 million for the six months ended June 30, 2020 compared to $36.5 million for the six months ended June 30, 2019. The decrease in net cash used in operating activities resulted from an increase in total revenues of $4.0 million and reduced expenditures in our commercial activities for Keveyis.
21
Investing Activities
The increase in net cash provided by investing activities resulted from the maturities of our marketable securities.
Financing Activities
The increase in net cash provided by financing activities was due to the proceeds received under our Term Loan Agreement with Avenue Venture Opportunities Fund L.P.
Liquidity and Capital Resources
We are continuously and critically reviewing our liquidity and anticipated capital requirements in light of our clinical trial activities and the significant uncertainty created by the COVID-19 global pandemic.
On May 19, 2020, we and our subsidiaries, Strongbridge U.S. Inc., Cortendo AB (publ) and Strongbridge Dublin Limited, entered into a $30 million Term Loan Agreement (the “Loan Agreement”) with Avenue Venture Opportunities Fund L.P. (“Avenue”), as administrative agent and collateral agent, and the lenders named therein and from time to time a party thereto (the “Lenders”). Pursuant to the terms of the Loan Agreement, Strongbridge U.S. Inc. (the “Borrower”) borrowed $10.0 million (the “Initial Loan”) from the Lenders at closing.
The Borrower may borrow up to two additional tranches of $10.0 million under the Loan Agreement. The first $10 million tranche is available between October 1, 2020 and December 31, 2020 if we achieve positive top-line data for RECORLEV in our Phase 3 LOGICS clinical trial. The second $10 million tranche is available between October 1, 2021 and March 31, 2022 if we achieve FDA approval of RECORLEV and subject to Avenue’s investment committee approval. See Note 6, "Long-term debt" to our consolidated financial statements for additional information regarding the Loan Agreement.
We believe that our cash and cash equivalents of $59.9 million at June 30, 2020 will be sufficient to allow us to fund planned operations for at least 12 months beyond the issuance date of these unaudited consolidated financial statements.
Cash used to fund operating expenses is affected by the timing of when we make payments to our vendors, as reflected in the change in our outstanding accounts payable and accrued expenses set forth in the consolidated financial statements, included in this Quarterly Report.
Our future funding requirements will depend on many factors, including the following:
● | the amount of revenue that we receive from sales of Keveyis; |
● | the cost and timing of establishing sales, marketing, distribution and administrative capabilities; |
● | the scope, rate of progress, results and cost of our clinical trials testing and other related activities for Recorlev and veldoreotide and our ability to prepare and file our NDA submissions on a timely basis and receive approval; |
● | the number and characteristics of product candidates that we pursue, including any additional product candidates we may in-license or acquire; |
● | the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights; |
22
● | the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us or our product candidates; |
● | the cost, timing and outcomes of regulatory approvals, including product labeling; |
● | adequate reimbursement from payors for Recorlev and Keveyis on a timely basis; |
● | the terms and timing of any collaborative, licensing and other arrangements that we may establish, including any required milestone and royalty payments thereunder; |
● | the emergence of competing technologies and their achieving commercial success before we do or other adverse market developments; and |
● | any extended impact of COVID-19. |
We may never achieve profitability, and unless and until we do, we will continue to need to raise additional capital. We plan to continue to fund our operations and capital funding needs through equity or debt financing along with revenues from Keveyis. There can be no assurances, however, that additional funding will be available on terms acceptable to us.
Off-Balance Sheet Arrangements
We do not have variable interests in variable interest entities or any off-balance sheet arrangements.
ITEM 3. Quantitative and Qualitative Disclosures about Market Risk
Except for the broad effects of COVID-19 including its negative impact on the global economy and major financial markets, there have been no material changes to our market risk exposures since December 31, 2019. In addition, as described in “Item 1A. Risk Factors,” there may be implications for our business with regard to the COVID-19 pandemic.
ITEM 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and the rules and regulations thereunder, is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Our management, under the supervision and with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2020, the end of the period covered by this Quarterly Report. Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures as of June 30, 2020 were effective to provide reasonable assurance that the information required to be disclosed by us in reports filed or submitted under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.
23
Changes in Internal Control over Financial Reporting
In response to the COVID-19 pandemic, most of our corporate employees, including all those involved in the operation of our internal controls over financial report, have been working remotely since mid-March 2020. Despite this change, there were no changes in our internal control over financial reporting that occurred during the fiscal quarter ended June 30, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. We are continuously monitoring and assessing the impact of COVID-19 on our internal controls to minimize any impact it may have on their design and operating effectiveness.
PART II – OTHER INFORMATION
ITEM 1. Legal Proceedings
The Company is not currently involved in any legal matters arising in the normal course of business. From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters.
ITEM 1A. Risk Factors
The risks described in Item 1A. Risk Factors of our 2019 Annual Report could materially and adversely affect our business, financial condition and results of operations. The risk factors discussed in our 2019 Annual Report do not identify all risks that we face because our business operations could also be affected by additional factors that are not presently known to us or that we currently consider to be immaterial to our operations. The following is an update to our risk factors.
The current outbreak of the novel coronavirus, or COVID-19, or the future outbreak of any other highly infectious or contagious diseases, could materially and adversely affect our results of operations, financial condition and cash flows. Further, the spread of the COVID-19 outbreak has caused severe disruptions in the U.S. and global economy and financial markets and could potentially create widespread business continuity issues of an as yet unknown magnitude and duration.
In December 2019, a novel strain of coronavirus (COVID-19) was reported to have surfaced in Wuhan, China. COVID-19 has since spread across the world, including every state in the United States. On March 11, 2020, the World Health Organization declared COVID-19 a pandemic, and on March 13, 2020 the United States declared a national emergency with respect to COVID-19.
The outbreak of COVID-19 has severely impacted global economic activity and caused significant volatility and negative pressure in the financial markets. The global impact of the outbreak has been rapidly evolving and many countries, including the United States, have reacted by instituting quarantines, mandating business and school closures and restricting travel, among other protective measures. While the COVID-19 pandemic has not had a material impact on our business operations to date, we have experienced business disruptions as a result of the outbreak and expect that the continued spread of COVID-19 could materially and adversely impact our operations due to, among other factors:
● | a general decline in business activity, |
● | the destabilization of the markets and negative impacts on the healthcare system globally could negatively impact our ability to market and sell Keveyis, including through the disruption of health care activities in general, the inability of our sales team to contact and/or visit doctors in person, patients’ interest in starting or |
24
staying on drugs, patients’ ability to obtain or maintain insurance coverage for Keveyis and our ability to support patients that presently use Keveyis; |
● | difficulty accessing the capital and credit markets on favorable terms, or at all, and a severe disruption and instability in the global financial markets, or deteriorations in credit and financing conditions which could affect our access to capital necessary to fund business operations; |
● | the potential negative impact on the health of our employees, especially if a significant number of them or any of their family members are impacted or if any of our senior leaders are impacted for an extended period of time; |
● | the potential negative impact on our ability to monitor the investigative sites participating in our LOGICs study in person or even remotely, which could result in a deviation from pre-pandemic protocols and/or site monitoring and data management plans, and delays in our ability to perform data-related tasks dependent on communications with personnel at the investigative sites, such as resolution of open data queries, the cumulative effects of which could lead to delayed or missed identification of non-compliance with good clinical practice (GCP), and/or unrecognized data errors. |
● | potential delays in the preparation and submission of applications for regulatory approval of our products, as well as potential delays in FDA’s ability to review applications in a timely manner consistent with past practices; |
● | the potential negative impact on our ability to manufacture and distribute our products, including as a result of disruptions to the businesses of third parties that manufacture and distribute our products; |
● | potential difficulty in adequately overseeing and/or evaluating the manufacturing process at the facilities that will manufacture future commercial supplies of Recorlev, if approved; |
● | a deterioration in our ability to ensure business continuity during a disruption. |
We continue to monitor the impacts of COVID-19 on the global economy and on our business operations. However, at this time, it is difficult to predict how long the potential operational impacts of COVID-19 will remain in effect or to what degree they will impact our operations and financial results in the future. An extended period of global supply chain and economic disruption could materially affect our business, results of operations, access to sources of liquidity and financial condition, as well as our ability to execute our business strategies and initiatives in their respective expected time frames.
The regulatory approval process of the FDA, EMA or any comparable foreign regulatory agency may be lengthy,
time consuming and unpredictable.
We cannot be certain that any of our product candidates will be successful in clinical trials or receive regulatory approval. The FDA, EMA and other comparable foreign regulatory agencies have substantial discretion in the approval process and in determining when or whether regulatory approval will be obtained for any of our product candidates. Even if we believe the data collected from clinical trials of our product candidates are promising, such data may not be sufficient to support approval by the FDA, EMA or any comparable foreign regulatory agency. Many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain regulatory approval for the product candidates.
Furthermore, while certain of our employees have prior experience with submitting marketing applications to the FDA, EMA and comparable foreign regulatory agencies, we, as a company, have not submitted such applications for our product candidates. Applications for any of our product candidates could fail to receive regulatory approval for many reasons, including, but not limited to, the following:
● | the FDA, EMA or any comparable foreign regulatory agency may disagree with the design or implementation of our clinical trials or our interpretation of data from nonclinical trials or clinical trials; |
25
● | the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which we seek approval, including reliance on foreign clinical data; |
● | the data collected from clinical trials of our product candidates may not be sufficient to support a finding that has statistical significance or clinical meaningfulness or support the submission of an NDA or other submission, or to obtain regulatory approval in the United States or elsewhere; |
● | we may be unable to demonstrate to the FDA, EMA or any comparable foreign regulatory agency that a product candidate’s risk-benefit ratio for its proposed indication is acceptable; |
● | the FDA, EMA or any comparable foreign regulatory agency may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and |
● | the approval policies or regulations of the FDA, EMA or any comparable foreign regulatory agency may significantly change in a manner rendering our clinical data insufficient for approval. |
In communications we had with the FDA, they recommended use of a concurrent control group in our SONICS Phase 3 clinical trial. However, SONICS utilizes an open-label, single-arm design because use of a placebo control in a parallel-arm monotherapy design was considered unethical or infeasible to enroll, depending on the specific country or clinical trial site under consideration. Studies lacking an active control group are more likely to be subject to unanticipated variability in study results that can potentially lead to flawed conclusions because they do not allow for discrimination of patient outcomes. In August 2018, we announced statistically significant positive top-line results from our SONICS Phase 3 clinical trial. However, even if we achieve the clinical trial’s endpoints for this clinical trial, the FDA or other regulatory authorities could view our study results as potentially biased due to our lack of an active control group.
Our LOGICS study, which is a second Phase 3 clinical trial of Recorlev for the treatment of endogenous Cushing’s syndrome, will supplement the long-term efficacy and safety data from the ongoing SONICS trial via a randomized, double-blind, placebo-controlled design that will randomize approximately 54 patients, in an attempt to address our lack of an active control group in our SONICS trial. There can be no assurances, however, that the FDA or other regulatory authorities will view the LOGICS study results as sufficient.
In March 2019, we conducted a Type C meeting with the Division of Metabolic and Endocrine Products (DMEP) of the FDA. DMEP stated in its meeting minutes that the FDA generally requests that a sponsor conduct two adequate and well-controlled clinical studies for the proposed indication of a drug candidate under 21 CFR 314.126(b)(2). DMEP also noted that the FDA recognizes situations when a single trial may be sufficient. DMEP reiterated that the characteristics of an “adequate and well-controlled” investigation under 21 CFR 314.126 include the use of a control group (e.g., placebo concurrent control, dose-comparison concurrent control), randomization and evaluation of primary endpoints that directly measure clinical benefits, or supported by evidence of clinical benefit. For this reason, while DMEP indicated that it would consider, as a review issue, the adequacy of an NDA submission with data from the SONICS trial as the sole Phase 3 evidence supporting the efficacy of RECORLEV, DMEP nonetheless recommended that we complete the LOGICS trial (which is double-blinded, randomized and placebo-controlled) and include the results from the LOGICS trial in addition to data from the SONICS trial in our NDA submission. We currently expect to receive LOGICS top-line data by the end of the first quarter of 2020 (compared to our prior projection of the end of 2019) and submit an NDA for Recorlev in the third quarter of 2020 that will include data from each of the SONICS and LOGICS trials. In addition, the DMEP stated in its meeting minutes that our clinical pharmacology program for Recorlev, as described to them, appears reasonable to support an NDA filing for Recorlev provided that the data generated are found to be suitable.
In June 2020, we conducted a pre-NDA meeting with the Division of General Endocrinology (DGE) of the FDA to review plans relating to our proposed NDA submission for Recorlev, with an anticipated submission date approximately 6 months following disclosure of topline results from the LOGICS study. Based on feedback received from DGE during this meeting, we believe that the LOGICS and SONICS study results together will provide a sufficient clinical-studies basis for a substantive review of an NDA and that it will be a review issue as to whether the data will be
26
sufficient to support approval of the NDA. There can be no assurance that DGE will determine that the totality of data included in the NDA, including the results from our SONICS and LOGICS studies, will be sufficient to warrant approval of the NDA for Recorlev.
In addition, following FDA consultation, we have determined that the 505(b)(2) approval pathway, which permits an NDA applicant to rely on data from studies that were not conducted by or for the applicant and for which the applicant has not obtained a right of reference, is the appropriate pathway for a Recorlev NDA. We intend to rely on published literature and the FDA’s prior findings concerning the safety and/or effectiveness of ketoconazole in our NDA for Recorlev and on similar processes in other jurisdictions. There can be no assurances, however, that the 505(b)(2) approval pathway in the United States, or similar approval pathways outside of the United States, will be available for Recorlev or that the FDA or other regulatory authorities will approve Recorlev through an application based on such pathways.
We generally plan to seek regulatory approval to commercialize our product candidates in the United States, the European Union and other key global markets. To obtain regulatory approval in other countries, we must comply with regulatory requirements of such other countries regarding safety, efficacy, chemistry, manufacturing and controls, clinical trials, commercial sales, pricing and distribution of our product candidates. Even if we are successful in obtaining approval in one jurisdiction, we cannot ensure that we will obtain approval in any other jurisdictions. Failure to obtain marketing authorization for our product candidates in any jurisdiction will result in our being unable to market and sell such products. Similarly, regulatory agencies may not approve the labeling claims that are necessary or desirable for the successful commercialization of our product candidates.
Any of our current or future product candidates could take a significantly longer time to gain regulatory approval than we expect or may never gain regulatory approval. This could delay or eliminate any potential product revenue by delaying or terminating the potential commercialization of our product candidates.
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds
None
ITEM 3. Defaults Upon Senior Securities
None.
ITEM 4. Mine Safety Disclosures
Not applicable.
ITEM 5. Other Information
None.
27
ITEM 6. Exhibits
EXHIBIT INDEX
|
|
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10.1 |
|
|
10.2 |
|
|
10.3 |
|
Warrant to Adventure Ventures Opportunities Fund, L.P., dated May 19, 2020 |
31.1 |
|
|
31.2 |
|
|
32.1 |
|
|
101.INS |
|
XBRL Instance Document |
101.SCH |
|
XBRL Taxonomy Extension Schema Document |
101.CAL |
|
XBRL Taxonomy Extension Calculation Linkbase Document |
101.LAB |
|
XBRL Taxonomy Extension Label Linkbase Document |
101.PRE |
|
XBRL Taxonomy Extension Presentation Linkbase Document |
101.DEF |
|
XBRL Taxonomy Extension Definitions Linkbase Document |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
28
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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|
STRONGBRIDGE BIOPHARMA PLC |
||
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|||
|
By: |
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/s/ Robert Lutz |
|
Name: |
|
Robert Lutz |
|
Title: |
|
Chief Financial Officer |
Date: August 4, 2020
29
Exhibit 10.1
EMPLOYMENT AGREEMENT
THIS EMPLOYMENT AGREEMENT (the “Agreement”) is made by and between Strongbridge U.S. Inc., a Delaware corporation (the “Company”), and John Johnson (“Executive”) as of July 2, 2020 (the "Effective Date").
W I T N E S S E T H:
WHEREAS, the Company and Executive are parties to that certain Executive Chairman Agreement, dated as of November 1, 2019 (such agreement, the “Prior Agreement”);
WHEREAS, the Company desires to continue to retain the services of Executive as set forth in this Agreement, and Executive desires to serve the Company in such capacity, subject to the terms and conditions of this Agreement; and
WHEREAS, the Company and Executive intend for this Agreement to replace the Prior Agreement except as otherwise set forth herein.
NOW, THEREFORE, for and in consideration of the mutual promises, covenants and obligations contained herein, Company and Executive agree as follows:
Page 1 of 16
Page 2 of 16
Page 3 of 16
A termination of employment by Executive for Good Reason shall be effectuated by giving the Company written notice (“Notice of Termination for Good Reason”), not later than thirty (30) days following the occurrence of the circumstance that constitutes Good Reason, setting forth in reasonable detail the specific conduct of the Company that constitutes Good Reason and the specific provision(s) of this Agreement on which Executive relied. The Company shall be entitled, during the forty-five (45) day period following receipt of a Notice of Termination for Good Reason, to cure the circumstances that gave rise to Good Reason, provided that the Company shall be entitled to waive its right to cure or reduce the cure period by delivery of written notice to that effect to Executive (such forty-five (45) day or shorter period, the “Cure Period”). If, during the Cure Period, such circumstance is remedied, Executive will not be permitted to terminate employment for Good Reason as a result of such circumstance. If, at the end of the Cure Period, the circumstance that constitutes Good Reason has not been remedied, Executive will be entitled to terminate employment for Good Reason during the thirty (30) day period that follows the end
Page 4 of 16
of the Cure Period. If Executive does not terminate employment during such thirty (30) day period, Executive will not be permitted to terminate employment for Good Reason as a result of such event.
Page 5 of 16
Page 6 of 16
Page 7 of 16
The Company hereby agrees that, for purposes of determining whether any payment and benefits set forth in Section 3.03 above would be subject to the Excise Tax, the non- compete set forth in in Section 4.02 above shall be treated as an agreement for the performance of personal services. The Company hereby agrees to indemnify, defend, and hold harmless Executive from and against any adverse impact, tax, penalty, or excise tax resulting from the Company or accountant’s attribution of a value to the non-compete set forth in in Section 4.02 above that is less than the total compensation amount that would be disclosed under Item 402(c) of Securities and Exchange Commission Regulation S-K if Executive had been a “named executive officer” of the Company in the year prior to year of the event that triggers the Excise Tax, to the extent the use of such lesser amount results in a larger Excise Tax than Executive would have been subject to had the Company or accountant attributed a value to the non-compete set forth in in Section 4.02 above that is at least equal to the total compensation amount disclosed under Item 402(c) of Securities and Exchange Commission Regulation S-K for such year..
Page 8 of 16
Page 9 of 16
Page 10 of 16
[signature page follows]
Page 11 of 16
IN WITNESS WHEREOF, this Agreement has been executed by the parties as of the date first written above.
STRONGBRIDGE U.S. INC.
By: ___________________________________
Name:
Title:
EXECUTIVE
_______________________________________
John Johnson
Page 12 of 16
ATTACHMENT A
GENERAL RELEASE
1.I, John H. Johnson (“Executive”), for and in consideration of the commitments of Strongbridge U.S. Inc. (the “Company”) as set forth in Article III of the Employment Agreement dated as of July 2, 2020 (the “Employment Agreement”), and intending to be legally bound, does hereby REMISE, RELEASE AND FOREVER DISCHARGE the Company and its present and former divisions, subsidiaries, parents, predecessor and successor corporations, officers, directors, and their respective successors, predecessors, assigns, heirs, executors, and administrators (collectively, “Releasees”) from all causes of action, suits, debts, claims and demands whatsoever in law or in equity, which Executive ever had, now has, or hereafter may have, whether known or unknown, or which Executive’s heirs, executors, or administrators may have, by reason of any matter, cause or thing whatsoever, up to the date of Executive’s execution of this General Release, particularly, but without limitation of the foregoing general terms, any claims arising from or relating in any way to Executive’s employment relationship with the Company and Releasees, the terms and conditions of that relationship, and the termination of that relationship, including, but not limited to, any claims arising under any applicable Company employee benefit plan(s), the Age Discrimination in Employment Act, the Older Workers’ Benefit Protection Act, Title VII of The Civil Rights Act of 1964, the Civil Rights Act of 1991, Sections 1981 through 1988 of Title 42 of the United States Code, the Americans with Disabilities Act, the Employee Retirement Income Security Act of 1974, the Family and Medical Leave Act, the Worker Adjustment and Retraining Notification Act, Pennsylvania employment laws, and any other federal, state and local employment laws, as amended, and any other claims under any federal, state or local common law, statutory, or regulatory provision, now or hereafter recognized, and any claims for attorneys’ fees and costs. This General Release is effective without regard to the legal nature of the claims raised and without regard to whether any such claims are based upon tort, equity, implied or express contract or discrimination of any sort.
2.To the fullest extent permitted by law, and subject to the provisions of Paragraph 3 below, Executive represents and affirms that (i) Executive has not filed or caused to be filed on Executive’s behalf any claim for relief against the Company or any Releasee and, to the best of Executive’s knowledge and belief, no outstanding claims for relief have been filed or asserted against the Company or any Releasee on Executive’s behalf; and (ii) Executive has no knowledge of any improper, unethical or illegal conduct or activities that Executive has not already reported to any supervisor, manager, department head, human resources representative, agent or other representative of the Company, to any member of the Company’s legal or compliance departments, or to the ethics hotline; and (iii) Executive will not file, commence, prosecute or participate in any judicial or arbitral action or proceeding against the Company or any Releasee based upon or arising out of any act, omission, transaction, occurrence, contract, claim or event existing or occurring on or before the date of execution of this General Release.
3.The release of claims described in Paragraph I of this General Release does not preclude Executive from filing a charge with the U.S. Equal Employment Opportunity Commission. However, Executive agrees and hereby waives any and all rights to any monetary relief or other personal recovery from any such charge, including costs and attorneys’ fees.
Page 13 of 16
4.Subject to the provisions of Paragraph 3 of this General Release, in further consideration of the commitments of the Company as described in the Employment Agreement, Executive agrees that Executive will not file, claim, sue or cause or permit to be filed, any civil action, suit or legal proceeding seeking equitable or monetary relief (including damages, injunctive, declaratory, monetary or other relief) for himself involving any matter released in Paragraph 1. In the event that suit is filed in breach of this release of claims, it is expressly understood and agreed that this release of claims shall constitute a complete defense to any such suit. In the event any Releasee is required to institute litigation to enforce the terms of this paragraph, Releasees shall be entitled to recover reasonable costs and attorneys’ fees incurred in such enforcement. Executive further agrees and covenants that should any person, organization, or other entity file, claim, sue, or cause or permit to be filed any civil action, suit or legal proceeding involving any matter occurring at any time in the past, Executive will not seek or accept personal equitable or monetary relief in such civil action, suit or legal proceeding. Nothing in this General Release shall prohibit or restrict Executive from: making any disclosure of information required by law; (ii) providing information to, or testifying or otherwise assisting in any investigation or proceeding brought by any federal regulatory or law enforcement agency or legislative body, any self-regulatory organization, or the Company’s designated legal, compliance or human resources officers; or (iii) filing, testifying, participating in or otherwise assisting in a proceeding relating to an alleged violation of any federal, state or municipal law relating to fraud, or any rule or regulation of the Securities and Exchange Commission or any self-regulatory organization.
5.Executive understands and agrees that the payments, benefits and agreements provided in the Employment Agreement are being provided to Executive in consideration for Executive’s acceptance and execution of, and in reliance upon Executive’s representations in, the Employment Agreement and this General Release, and that they are greater than the payments, benefits and agreements, if any, to which Executive would have received if Executive had not executed the Employment Agreement and this General Release. In addition, Executive acknowledges and agrees that Executive has been paid all amounts owed to Executive as of the date of Executive’s signing of this General Release.
6.Executive and the Company agree and acknowledge that the agreement by the Company described in the Employment Agreement, and the settlement and termination of any asserted or unasserted claims against the Releasees, are not and shall not be construed to be an admission of any violation of any federal, state or local statute or regulation, or of any duty owed by any of the Releasees to Executive.
7.This General Release and the obligations of the parties hereunder shall be construed, interpreted and enforced in accordance with and be governed by the laws of Pennsylvania without reference to its conflicts of laws principles.
a. | Executive certifies and acknowledges as follows: that Executive has read the terms of this General Release, and that Executive understands its terms and effects, including the fact that Executive has agreed to RELEASE AND FOREVER DISCHARGE the Company and each and every one of its affiliated entities from any legal action arising out of Executive’s relationship with the Company and the termination of that relationship; |
Page 14 of 16
b. | that Executive has signed this Release voluntarily and knowingly in exchange for the consideration described herein and in the Employment Agreement, which Executive acknowledges is adequate and satisfactory to Executive and to which Executive acknowledges that Executive would not otherwise be entitled; |
c. | that Executive has been and is hereby advised in writing to consult with an attorney prior to signing this General Release; |
d. | that Executive does not waive rights or claims that may arise after the date this General Release is executed; |
e. | that the Company has provided Executive with at least 21 (twenty-one) days within which to consider this General Release, that any modifications, material or otherwise, made to this General Release have not restarted or affected in any manner the original 21 (twenty-one) day consideration period, and that Executive has signed on the date indicated below after concluding that this General Release is satisfactory to Executive; |
f. | that Executive acknowledges that this General Release may be revoked by Executive within seven (7) days after Executive’s execution, and it shall not become effective until the expiration of such seven-day revocation period. If the last day of the revocation period is a Saturday, Sunday, or legal holiday in the state in which Executive resides, then the revocation period shall not expire until the next following day which is not a Saturday, Sunday, or legal holiday. In the event of a timely revocation by Executive, this General Release and the Employment Agreement will be deemed null and void and the Company will have no obligations hereunder; and |
g. | that this General Release may not be signed prior to the third calendar day before the last day of the Term of the Employment Agreement. If this General Release is signed prior to the last day of the Term of the Employment Agreement, the Company reserves the right to have Executive ratify the General Release on or after the last day of the Term. |
Page 15 of 16
Intending to be legally bound hereby, Executive executed the foregoing General Release on the date indicated below.
John Johnson
______________________________________
Signature
Date: _________________________________
Page 16 of 16
Exhibit 10.2
TERM LOAN AGREEMENT,
dated as of
May 19, 2020,
among
STRONGBRIDGE U.S. INC.,
as Borrower
STRONGBRIDGE BIOPHARMA PLC,
CORTENDO AB (PUBL),
STRONGBRIDGE DUBLIN LIMITED,
as Guarantors,
The other Subsidiary Guarantors from Time to Time Party Hereto,
The Lenders from Time to Time Party Hereto,
and
AVENUE VENTURE OPPORTUNITIES FUND, L.P.,
as Administrative Agent and Collateral Agent
U.S. $30,000,000
Table of Contents
1.02 Accounting Terms and Principles21
1.05 Swedish Trust Provision21
2.06 Substitution of Lenders23
-i-
SECTION 5 YIELD PROTECTION, ETC.30
SECTION 6 CONDITIONS PRECEDENT35
6.01 Conditions to First Borrowing35
6.02 Conditions to Second Borrowing37
6.03 Conditions to Third Borrowing39
6.05 Conditions to Each Borrowing40
SECTION 7 REPRESENTATIONS AND WARRANTIES40
7.02 Authorization; Enforceability41
7.03 Governmental and Other Approvals; No Conflicts41
7.04 Financial Statements; Material Adverse Change41
7.06 No Actions or Proceedings45
-ii-
7.15 Restrictive Agreements47
7.18 Collateral; Security Interest48
SECTION 8 AFFIRMATIVE COVENANTS48
8.01 Financial Statements and Other Information49
8.02 Notices of Material Events50
8.03 Existence; Conduct of Business52
8.04 Payment of Obligations52
8.06 Books and Records; Inspection Rights53
8.07 Compliance with Laws and Other Obligations53
8.08 Maintenance of Properties, Etc.53
8.10 Action under Environmental Laws54
8.12 Certain Obligations Respecting Subsidiaries; Further Assurances54
-iii-
SECTION 9 NEGATIVE COVENANTS57
9.03 Fundamental Changes and Acquisitions60
9.07 Payments of Indebtedness62
9.10 Transactions with Affiliates63
9.11 Restrictive Agreements63
9.12 Amendments to Material Agreements; Organizational Documents63
SECTION 10 RIGHT TO INVEST; CONVERSION OPTION64
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SECTION 12 ADMINISTRATIVE AGENT70
12.01 Appointment and Duties70
12.04 Delegation of Rights and Duties72
12.05 Reliance and Liability72
12.06 Administrative Agent Individually73
12.07 Lender Credit Decision73
12.08 Expenses; Indemnities74
12.09 Resignation of Administrative Agent74
12.10 Release of Collateral or Guarantors75
12.11 Release of Swedish Liens75
13.03 Expenses, Indemnification, Etc.76
13.05 Successors and Assigns78
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13.15 No Fiduciary Relationship82
13.18 Maximum Rate of Interest83
13.21 Original Issue Discount84
14.02 Obligations Unconditional; Subsidiary Guarantor Waivers84
14.06 Instrument for the Payment of Money86
14.08 Rights of Contribution86
14.09 General Limitation on Guaranteed Obligations87
14.10 Irish Companies Act Limitation on Guaranteed Obligations87
SECTION 15 INTERCOMPANY SUBORDINATION AGREEMENT87
15.01 Subordination of Intercompany Obligations87
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SCHEDULES AND EXHIBITS
Schedule 1 |
- |
Commitments |
Schedule 6.01 |
- |
Foreign Security Documents |
Schedule 7.05(b)(i) |
- |
Certain Intellectual Property |
Schedule 7.05(b)(ii) |
- |
Intellectual Property Exceptions |
Schedule 7.05(c) |
- |
Material Intellectual Property |
Schedule 7.06 |
- |
Certain Litigation |
Schedule 7.12 |
- |
Information Regarding Subsidiaries |
Schedule 7.13(a) |
- |
Existing Indebtedness of Parent Guarantor and its Subsidiaries |
Schedule 7.13(b) |
- |
Liens Granted by the Obligors |
Schedule 7.14 |
- |
Material Agreements of Obligors |
Schedule 7.15 |
- |
Restrictive Agreements |
Schedule 7.16 |
- |
Real Property Owned or Leased by Parent Guarantor or any Subsidiary |
Schedule 7.17 |
- |
Pension Matters |
Schedule 9.05 |
- |
Existing Investments |
Schedule 9.10 |
- |
Transactions with Affiliates |
Schedule 9.14 |
- |
Permitted Sales and Leasebacks |
|
|
|
Exhibit A |
- |
Form of Assumption Agreement |
Exhibit B |
- |
Form of Notice of Borrowing |
Exhibit C-l |
- |
Form of U.S. Tax Compliance Certificate |
Exhibit C-2 |
- |
Form of U.S. Tax Compliance Certificate |
Exhibit C-3 |
- |
Form of U.S. Tax Compliance Certificate |
Exhibit C-4 |
- |
Form of U.S. Tax Compliance Certificate |
Exhibit D |
- |
Form of Compliance Certificate |
Exhibit E |
- |
Reserved |
Exhibit F |
- |
Form of Landlord Consent |
Exhibit G |
- |
Form of Subordination Agreement |
Exhibit H |
- |
Reserved |
Exhibit I |
- |
Form of Warrant |
TERM LOAN AGREEMENT, dated as of May 19, 2020 (this “Agreement”), among STRONGBRIDGE U.S. INC., a Delaware corporation (“Borrower”), STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY, a public limited company incorporated under the laws of Ireland (“Parent Guarantor”), STRONGBRIDGE DUBLIN LIMITED, a private limited company incorporated under the laws of Ireland (“Irish Guarantor”), CORTENDO AB (PUBL), a public limited liability company incorporated under the laws of Sweden with registration number 556537-6554 (“Swedish Guarantor” and together with the Borrower, Parent Guarantor, Irish Guarantor and each other Person that becomes, or is required to become, a “Subsidiary Guarantor” after the date hereof pursuant to Section 8.12(a) or (b), each an “Obligor” and collectively, the “Obligors”), and AVENUE VENTURE OPPORTUNITIES FUND, L.P., a Delaware limited partnership (“Avenue”), as administrative agent and collateral agent for the Lenders (in such capacities, together with its successors and assigns, “Administrative Agent”).
WITNESSETH:
Borrower have requested the Lenders to make term loans to Borrower, and the Lenders are prepared to make such loans on and subject to the terms and conditions hereof. Accordingly, the parties agree as follows:
“Accounting Change Notice” has the meaning set forth in Section 1.04(a).
“Acquisition” means any transaction, or any series of related transactions, by which any Person directly or indirectly, by means of a take-over bid, tender offer, amalgamation, merger, purchase or license of assets, or similar transaction having the same effect as any of the foregoing, (a) acquires any business or product, or any division, product or line of business or all or substantially all of the assets of any Person engaged in any business or any division, product or line of business, (b) acquires control of securities of a Person engaged in a business representing more than 50% of the ordinary voting power for the election of directors or other governing body if the business affairs of such Person are managed by a board of directors or other governing body, or (c) acquires control of more than 50% of the ownership interest in any Person engaged in any business that is not managed by a board of directors or other governing body.
“Act” has the meaning set forth in Section 13.17.
“Administrative Agent” has the meaning set forth in the introduction hereto.
“Affected Lender” has the meaning set forth in Section 2.06(a).
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DMS 17185250.10
“Affiliate” means, with respect to a specified Person, another Person that directly, or indirectly through one or more intermediaries, Controls or is Controlled by or is under common Control with the Person specified.
“Agreement” has the meaning set forth in the introduction hereto.
“Anti-Corruption Laws” means all laws, rules, and regulations of any jurisdiction applicable to any Obligor, its Subsidiaries or Affiliates from time to time concerning or relating to bribery or corruption, including the United States Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder.
“Anti-Money Laundering Laws” means any and all laws, statutes, regulations or obligatory government orders, decrees, ordinances or rules applicable to an Obligor, its Subsidiaries or Affiliates related to terrorism financing or money laundering, including any applicable provision of the Act and The Currency and Foreign Transaction Reporting Act (also known as the “Bank Secrecy Act,” 31 U.S.C. §§5311-5330 and 12 U.S.C. §§ 1818(s), 1820(b) and 1951-1959).
“Asset Sale” has the meaning set forth in Section 9.09.
“Asset Sale Net Proceeds” means the aggregate amount of the cash proceeds received from any Asset Sale, net of any bona fide costs incurred in connection with such Asset Sale, plus, with respect to any non-cash proceeds of an Asset Sale, the fair market value of such non-cash proceeds as determined by the Majority Lenders, acting reasonably.
“Assignment and Assumption” means an assignment and assumption entered into by a Lender and an assignee of such Lender.
“Assumption Agreement” means a Guarantee or Borrower Assumption Agreement substantially in the form of Exhibit A by an entity that, pursuant to Section 8.12(a), is required to become a “Subsidiary Guarantor” or “Borrower” hereunder.
“Avenue” has the meaning set forth in the introduction hereto.
“Bankruptcy Code” means Title 11 of the United States Code entitled “Bankruptcy.”
“Basic Rate” means the per annum rate of interest (based on a year of three hundred sixty-five (365) days) equal to the sum of (I) the greater of (a) the Prime Rate reported in The Wall Street Journal on the last Business Day of the month that immediately precedes the month in which the interest will accrue, and (b) 3.25%, plus (II) 6.75%. Notwithstanding the foregoing, the Basic Rate shall not be less than 10%.
“Beneficiary” has the meaning set forth in Section 1.05.
“Benefit Plan” means any employee benefit plan as defined in Section 3(3) of ERISA (whether governed by the laws of the United States or otherwise) to which any Obligor or Subsidiary thereof incurs or otherwise has any obligation or liability, contingent or otherwise.
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DMS 17185250.10
“Borrower” has the meaning set forth in the introduction hereto.
“Borrower Facility” means the premises located at 900 Northbrook Drive, Suite 200, Trevose, PA 19053, which are leased by Borrower pursuant to the Borrower Lease.
“Borrower Landlord” means Northbrook TC Equities, Northbrook 134 West 93 Equities LLC, Northbrook Lemad Equities LLC, Northbrook CH Equities LLC, Northbrook Clinton Equities LLC, Northbrook UK1 Equities LLC, Northbrook Loken LLC, Northbrook HS Development LLC, Northbrook HS RK LLC, Northbrook TEIDIF LLC, as tenants in common.
“Borrower Lease” means the Lease dated November 27, 2017 by and between Borrower and Borrower Landlord.
“Borrower Party” has the meaning set forth in Section 13.03(b).
“Borrowing” means a borrowing consisting of Loans made on the same day by the Lenders according to their respective Commitments.
“Borrowing Date” means the date of a Borrowing.
“Borrowing Notice Date” means, (a) in the case of the first Borrowing, a date that is at least two (2) Business Days prior to the Borrowing Date of such Borrowing, (b) in the case of the second Borrowing, a date that is at least ten (10) Business Day prior to the Borrowing Date of such Borrowing and, (c) in the case of a subsequent Borrowing (that is not the first Borrowing or the second Borrowing), a date that is at least ten (10) Business Days prior to the Borrowing Date of such Borrowing.
“Business Day” means a day (other than a Saturday or Sunday) on which commercial banks are not authorized or required to close in New York City, New York.
“Capital Lease Obligations” means, as to any Person, the obligations of such Person to pay rent or other amounts under a lease of (or other agreement conveying the right to use) real and/or personal Property which obligations are required to be classified and accounted for as a capital lease on a balance sheet of such Person under GAAP and, for purposes of this Agreement, the amount of such obligations shall be the capitalized amount thereof, determined in accordance with GAAP.
“Change of Control” means (a) the acquisition of ownership, directly or indirectly, beneficially or legally (or otherwise of record), by any Person or group of Persons acting jointly or otherwise in concert of capital stock representing more than 49% of the aggregate ordinary voting power represented by the issued and outstanding capital stock of Parent Guarantor, (b) during any period of twelve (12) consecutive calendar months, the occupation of a majority of the seats (other than vacant seats) on the board of directors of Parent Guarantor by Persons who were neither (i) nominated by the board of directors of Parent Guarantor, nor (ii) appointed by directors so nominated, (c) the acquisition of direct or indirect Control of Parent Guarantor by any Person or group of Persons acting jointly or otherwise in concert; in each case whether as a result of a tender or exchange offer, open market purchases, privately negotiated purchases or
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DMS 17185250.10
otherwise, or (d) Borrower ceases to be a wholly owned direct or indirect subsidiary of Parent Guarantor.
“Claims” means any claims, demands, complaints, grievances, actions, applications, suits, causes of action, orders, charges, indictments, prosecutions, informations (brought by a public prosecutor without grand jury indictment) or other similar processes, assessments or reassessments.
“Closing Date” means May 19, 2020.
“Code” means the Internal Revenue Code of 1986, as amended from time to time, and the rules and regulations promulgated thereunder from time to time.
“Collateral” means any Property in which a Lien is purported to be granted under any of the Security Documents (or all such Property, as the context may require).
“Commitment” means, with respect to each Lender, the obligation of such Lender to make Loans to Borrower in accordance with the terms and conditions of this Agreement, which commitment is in the amount set forth opposite such Lender’s name on Schedule 1 under the caption “Commitment”, as such Schedule may be amended from time to time. The aggregate Commitments on the Closing Date hereof equal $20,000,000. In the event that investment committee approval is obtained pursuant to Section 6.03(d), the “Commitment” shall mean $30,000,000 as of the date of such investment committee approval and Schedule 1 shall be amended by the Administrative Agent to reflect the increased Commitment amount.
“Commitment Period” means the period from and including the first date on which all of the conditions precedent set forth in Section 6 have been satisfied (or waived by the Lenders) and through and including March 31, 2022.
“Compliance Certificate” has the meaning given to such term in Section 8.01(d).
“Connection Income Taxes” means Other Connection Taxes that are imposed on or measured by net income (however denominated) or that are franchise Taxes or branch profits Taxes.
“Contracts” means contracts, licenses, leases, agreements, obligations, promises, undertakings, understandings, arrangements, documents, commitments, entitlements or engagements under which a Person has, or will have, any liability or contingent liability (in each case, whether written or oral, express or implied).
“Control” means, in respect of a particular Person, the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of such Person, whether through the ability to exercise voting power, by contract or otherwise. “Controlling” and “Controlled” have meanings correlative thereto.
“Controlled Foreign Corporation” means a “controlled foreign corporation” as defined in Section 957(a) of the Code.
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DMS 17185250.10
“Conversion Amount” has the meaning set forth in Section 10.02.
“Conversion Date” means the date immediately prior to the date any Lender exercises the Conversion Option by delivering a Conversion Notice in accordance with Section 10.02.
“Conversion Notice” has the meaning set forth in Section 10.02.
“Conversion Option” has the meaning set forth in Section 10.02.
“Conversion Price” means the Exercise Price multiplied by 120%.
“Copyright” has the meaning set forth in the Security Agreement.
“Default” means any Event of Default and any event that, upon the giving of notice, the lapse of time or both, would constitute an Event of Default.
“Default Rate” has the meaning set forth in Section 3.02(b).
“Defaulting Lender” means, subject to Section 2.05, any Lender that (a) has failed to perform any of its funding obligations hereunder, including in respect of its Loans, within three (3) Business Days of the date required to be funded by it hereunder, (b) has notified Borrower or any Lender that it does not intend to comply with its funding obligations or has made a public statement to that effect with respect to its funding obligations hereunder or under other agreements in which it commits to extend credit, (c) has failed, within three Business Days after written request by the Administrative Agent or the Borrower, to confirm in writing to the Administrative Agent and the Borrower that it will comply with its prospective funding obligations hereunder; provided that such Lender shall cease to be a Defaulting Lender pursuant to this clause (c) upon receipt of such written confirmation by the Administrative Agent and the Borrower), or (d) has, or has a direct or indirect parent company that has, (i) become the subject of an Insolvency Proceeding, (ii) had a receiver, conservator, trustee, administrator, assignee for the benefit of creditors or similar Person charged with reorganization or liquidation of its business or a custodian appointed for it, or (iii) taken any action in furtherance of, or indicated its consent to, approval of or acquiescence in any such proceeding or appointment; provided that a Lender shall not be a Defaulting Lender solely by virtue of the ownership or acquisition of any equity interest in that Lender or any direct or indirect parent company thereof by a Governmental Authority so long as such ownership interest does not result in or provide such Lender with immunity from the jurisdiction of courts within the United States or from the enforcement of judgments or writs of attachment on its assets or permit such Lender (or such Governmental Authority) to reject, repudiate, disavow or disaffirm any contracts or agreements made with such Lender. Any determination by the Administrative Agent that a Lender is a Defaulting Lender under any one or more of clauses (a) through (d) above shall be conclusive and binding absent manifest error, and such Lender shall be deemed to be a Defaulting Lender (subject to Section 2.05(b)) upon delivery of written notice of such determination to the Borrower and each Lender.
“Deposit Account” has the meaning set forth in the Security Agreement.
“Dollars” and “$” means lawful money of the United States of America.
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DMS 17185250.10
“Eligible Transferee” means and includes a commercial bank, an insurance company, a finance company, a financial institution, any investment fund that invests in loans or any other “accredited investor” (as defined in Regulation D of the Securities Act) that is principally in the business of managing investments or holding assets for investment purposes.
“Environmental Law” means any federal, state, provincial or local governmental law, rule, regulation, order, writ, judgment, injunction or decree relating to pollution or protection of the environment or the treatment, storage, disposal, release, threatened release or handling of hazardous materials, and all local laws and regulations related to environmental matters and any specific agreements entered into with any competent authorities which include commitments related to environmental matters.
“Equity Interest” means, with respect to any Person, any and all shares, interests, participations or other equivalents, including membership interests (however designated, whether voting or nonvoting), of equity of such Person, including, if such Person is a partnership, partnership interests (whether general or limited) and any other interest or participation that confers on a Person the right to receive a share of the profits and losses of, or distributions of property of, such partnership, but excluding debt securities convertible or exchangeable into such equity.
“Equivalent Amount” means, with respect to an amount denominated in one currency, the amount in another currency that could be purchased by the amount in the first currency determined by reference to the Exchange Rate at the time of determination.
“ERISA” means the United States Employee Retirement Income Security Act of 1974, as amended.
“ERISA Affiliate” means, collectively, any Obligor, Subsidiary thereof, and any Person under common control, or treated as a single employer, with any Obligor or Subsidiary thereof, within the meaning of Section 414(b), (c), (m) or (o) of the Code.
“ERISA Event” means (a) a reportable event as defined in Section 4043 of ERISA with respect to a Title IV Plan, excluding, however, such events as to which the PBGC by regulation has waived the requirement of Section 4043(a) of ERISA that it be notified within 30 days of the occurrence of such event; (b) the applicability of the requirements of Section 4043(b) of ERISA with respect to a contributing sponsor, as defined in Section 4001(a)(13) of ERISA, to any Title IV Plan where an event described in paragraph (9), (10), (11), (12) or (13) of Section 4043(c) of ERISA is reasonably expected to occur with respect to such plan within the following 30 days; (c) a withdrawal by any Obligor or any ERISA Affiliate thereof from a Title IV Plan or the termination of any Title IV Plan resulting in liability under Sections 4063 or 4064 of ERISA; (d) the withdrawal of any Obligor or any ERISA Affiliate thereof in a complete or partial withdrawal (within the meaning of Section 4203 and 4205 of ERISA) from any Multiemployer Plan if there is any potential liability therefore, or the receipt by any Obligor or any ERISA Affiliate thereof of notice from any Multiemployer Plan that it is in reorganization or insolvency pursuant to Section 4241 or 4245 of ERISA; (e) the filing of a notice of intent to terminate, the treatment of a plan amendment as a termination under Section 4041 or 4041A of ERISA, or the commencement of proceedings by the PBGC to terminate a Title IV Plan or Multiemployer Plan;
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DMS 17185250.10
(f) the imposition of liability on any Obligor or any ERISA Affiliate thereof pursuant to Sections 4062(e) or 4069 of ERISA or by reason of the application of Section 4212(c) of ERISA; (g) the failure by any Obligor or any ERISA Affiliate thereof to make any required contribution to a Plan, or the failure to meet the minimum funding standard of Section 412 of the Code with respect to any Title IV Plan (whether or not waived in accordance with Section 412(c) of the Code) or the failure to make by its due date a required installment under Section 430 of the Code with respect to any Title IV Plan or the failure to make any required contribution to a Multiemployer Plan; (h) the determination that any Title IV Plan is considered an at-risk plan or a plan in endangered to critical status within the meaning of Sections 430, 431 and 432 of the Code or Sections 303, 304 and 305 of ERISA; (i) an event or condition which might reasonably be expected to constitute grounds under Section 4042 of ERISA for the termination of, or the appointment of a trustee to administer, any Title IV Plan or Multiemployer Plan; (j) the imposition of any liability under Title I or Title IV of ERISA, other than PBGC premiums due but not delinquent under Section 4007 of ERISA, upon any Obligor or any ERISA Affiliate thereof; (k) an application for a funding waiver under Section 303 of ERISA or an extension of any amortization period pursuant to Section 412 of the Code with respect to any Title IV Plan; (1) the occurrence of a non-exempt prohibited transaction under Sections 406 or 407 of ERISA for which any Obligor or any Subsidiary thereof may be directly or indirectly liable; (m) the assertion of a material claim (other than routine claims for benefits) against any Plan or the assets thereof, or against any Obligor or any Subsidiary thereof in connection with any such plan; (n) receipt from the IRS of notice of the failure of any Qualified Plan to qualify under Section 401(a) of the Code, or the failure of any trust forming part of any Qualified Plan to fail to qualify for exemption from taxation under Section 501(a) of the Code; (o) the imposition of any lien (or the fulfillment of the conditions for the imposition of any lien) on any of the rights, properties or assets of any Obligor or any ERISA Affiliate thereof, in either case pursuant to Title I or IV, including Section 302(f) or 303(k) of ERISA or to Section 401(a)(29) or 430(k) of the Code; or (p) the establishment or amendment by any Obligor or any Subsidiary thereof of any “welfare plan”, as such term is defined in Section 3(1) of ERISA, that provides post-employment welfare benefits in a manner that would increase the liability of any Obligor.
“ERISA Funding Rules” means the rules regarding minimum required contributions (including any installment payment thereof) to Title IV Plans, as set forth in Sections 412, 430, 431, 432 and 436 of the Code and Sections 302, 303, 304 and 305 of ERISA.
“Event of Default” has the meaning set forth in Section 11.01.
“Exchange Rate” means the rate at which any currency (the “Pre-Exchange Currency”) may be exchanged into another currency (the “Post-Exchange Currency”), as set forth on such date on the relevant Reuters screen at or about 11:00 a.m. (Eastern time) on such date. In the event that such rate does not appear on the Reuters screen, the “Exchange Rate” with respect to exchanging such Pre-Exchange Currency into such Post-Exchange Currency shall be determined by reference to such other publicly available service for displaying exchange rates as may be agreed upon by Borrower and Administrative Agent or, in the absence of such agreement, such Exchange Rate shall instead be determined by Administrative Agent by any reasonable method as they deem applicable to determine such rate, and such determination shall be conclusive absent manifest error.
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DMS 17185250.10
“Excluded Foreign Subsidiary” means any Foreign Subsidiary that is (i) a Controlled Foreign Corporation or (ii) a Foreign Subsidiary owned by a Subsidiary described in clause (i).
“Excluded Taxes” means any of the following Taxes imposed on or with respect to a Recipient or required to be withheld or deducted from a payment to a Recipient: (a) Taxes imposed on or measured by net income (however denominated), franchise Taxes and branch profits Taxes, in each case (i) imposed as a result of such Recipient being organized under the laws of, or having its principal office or, in the case of any Lender, its applicable lending office located in, the jurisdiction imposing such Tax (or any political subdivision thereof), or (ii) that are Other Connection Taxes, (b) U.S. Federal withholding Taxes that are imposed on amounts payable to a Lender to the extent that the obligation to withhold amounts existed on the date that (i) such Lender became a “Lender” under this Agreement (other than pursuant to an assignment request by Borrower under Section 5.03(g)), or (ii) such Lender changes its applicable lending office, except in each case to the extent such Lender is a direct or indirect assignee of any other Lender that was entitled, at the time the assignment of such other Lender became effective or to such Lender immediately before it changed its applicable lending office, to receive additional amounts under Section 5.03, (c) any U.S. Federal withholding Taxes imposed under FATCA, and (d) Taxes attributable to such Recipient’s failure to comply with Section 5.03(e).
“Exercise Price” means the lower of (i) $1.87 or (ii) the effective price of any bona fide equity financing prior to December 31, 2020.
“FATCA” means Sections 1471 through 1474 of the Code, as of the date of this Agreement (or any amended or successor version that is substantively comparable and not more onerous to comply with), any regulations or official interpretations thereof and any agreements entered into pursuant to Section 1471(b)(1) of the Code.
“FDA” means the United States Food and Drug Administration.
“Federal Funds Effective Rate” means, for any day, the weighted average of the rates on overnight federal funds transactions with members of the Federal Reserve System arranged by federal funds brokers, as published on the next succeeding Business Day by the Federal Reserve Bank of New York, or, if such rate is not so published for any day that is a Business Day, the average of the quotations for the day of such transactions received by Administrative Agent from three federal funds brokers of recognized standing selected by it.
“Final Payment” means a payment (in addition to and not a substitution for the regular monthly payments of principal plus accrued interest), due upon the earliest to occur of (a) the Maturity Date, (b) the acceleration of any Loan, or (c) the prepayment of a Loan pursuant to, and payable in accordance with, Section 3.03(a), equal to (x) $800,000 or (y), if the third Borrowing is provided, the sum of $800,000 plus 4% of the amount of the third Borrowing.
“First-Tier Foreign Subsidiary” means an Excluded Foreign Subsidiary that is a direct Subsidiary of an Obligor.
“Foreign Lender” means a Lender that is not a U.S. Person.
“Foreign Subsidiary” means a Subsidiary of any Obligor that is not a U.S. Person.
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“GAAP” means generally accepted accounting principles in the United States of America, as in effect from time to time, set forth in the opinions and pronouncements of the Accounting Principles Board and the American Institute of Certified Public Accountants, in the statements and pronouncements of the Financial Accounting Standards Board and in such other statements by such other entity as may be in general use by significant segments of the accounting profession that are applicable to the circumstances as of the date of determination. Subject to Section 1.02, all references to “GAAP” shall be to GAAP applied consistently with the principles used in the preparation of the financial statements described in Section 7.04(a).
“Governmental Approval” means any consent, authorization, approval, order, license, franchise, permit, certificate, accreditation, registration, filing or notice, of, issued by, from or to, or other act by or in respect of, any Governmental Authority.
“Governmental Authority” means any nation, government, branch of power (whether executive, legislative or judicial), state, province or municipality or other political subdivision thereof and any entity exercising executive, legislative, judicial, monetary, regulatory or administrative functions of or pertaining to government, including regulatory authorities, governmental departments, agencies, commissions, bureaus, officials, ministers, courts, bodies, boards, tribunals and dispute settlement panels, and other law-, rule- or regulation-making organizations or entities of any State, territory, county, city or other political subdivision of the United States.
“Guarantee” of or by any Person (the “guarantor”) means any obligation, contingent or otherwise, of the guarantor guaranteeing or having the economic effect of guaranteeing any Indebtedness or other obligation of any other Person (the “primary obligor”) in any manner, whether directly or indirectly, and including any obligation of the guarantor, direct or indirect, (a) to purchase or pay (or advance or supply funds for the purchase or payment of) such Indebtedness or other obligation or to purchase (or to advance or supply funds for the purchase of) any security for the payment thereof, (b) to purchase or lease property, securities or services for the purpose of assuring the owner of such Indebtedness or other obligation of the payment thereof, (c) to maintain working capital, equity capital or any other financial statement condition or liquidity of the primary obligor so as to enable the primary obligor to pay such Indebtedness or other obligation or (d) as an account party in respect of any letter of credit or letter of guaranty issued to support such Indebtedness or obligation; provided that the term Guarantee shall not include endorsements for collection or deposit in the ordinary course of business.
“Guaranteed Obligations” has the meaning set forth in Section 14.01.
“Hazardous Material” means any substance, element, chemical, compound, product, solid, gas, liquid, waste, by-product, pollutant, contaminant or material which is hazardous or toxic, and includes (a) asbestos, polychlorinated biphenyls and petroleum (including crude oil or any fraction thereof) and (b) any material classified or regulated as “hazardous” or “toxic” or words of like import pursuant to an Environmental Law.
“Hedging Agreement” means any interest rate exchange agreement, foreign currency exchange agreement, commodity price protection agreement or other interest or currency exchange rate or commodity price hedging arrangement.
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“Indebtedness” of any Person means, without duplication, (a) (i) all obligations of such Person for borrowed money or (ii) obligations of such Person with respect to deposits or advances of any kind by third parties (other than an Obligor), (b) all obligations of such Person evidenced by bonds, debentures, notes or similar instruments, (c) all obligations of such Person upon which interest charges are customarily paid, (d) all obligations of such Person under conditional sale or other title retention agreements relating to property acquired by such Person, (e) all obligations of such Person in respect of the deferred purchase price of property or services (excluding current accounts payable incurred in the ordinary course of business), (f) all Indebtedness of others secured by (or for which the holder of such Indebtedness has an existing right, contingent or otherwise, to be secured by) any Lien on property owned or acquired by such Person, whether or not the Indebtedness secured thereby has been assumed, (g) all Guarantees by such Person of Indebtedness or other obligations of others, (h) all Capital Lease Obligations of such Person, (i) all obligations, contingent or otherwise, of such Person as an account party in respect of letters of credit and letters of guaranty, (j) obligations under any Hedging Agreement currency swaps, forwards, futures or derivatives transactions, (k) all obligations, contingent or otherwise, of such Person in respect of bankers’ acceptances, (1) all obligations of such Person under license or other agreements containing a guaranteed minimum payment or purchase by such Person, and (m) all Equity Interests of such Person subject to repurchase or redemption rights or obligations (excluding repurchases or redemptions at the sole option of such Person). The Indebtedness of any Person shall include the Indebtedness of any other entity (including any partnership in which such Person is a general partner) to the extent such Person is liable therefor as a result of such Person’s ownership interest in or other relationship with such entity, except to the extent the terms of such Indebtedness provide that such Person is not liable therefor.
“Indemnified Party” has the meaning set forth in Section 13.03(b).
“Indemnified Taxes” means (a) Taxes, other than Excluded Taxes, imposed on or with respect to any payment made by or on account of any Obligation and (b) to the extent not otherwise described in clause (a), Other Taxes.
“Insolvency Proceeding” means (a) any case, action or proceeding before any court or other Governmental Authority relating to bankruptcy, reorganization, insolvency, liquidation, receivership, dissolution, winding-up or relief of debtors, or (b) any general assignment for the benefit of creditors, composition, marshaling of assets for creditors, or other, similar arrangement in respect of any Person’s creditors generally or any substantial portion of such Person’s creditors, in each case undertaken under U.S. Federal, state or foreign law, including the Bankruptcy Code.
“Intellectual Property” means all Patents, Trademarks, Copyrights, and Technical Information, whether registered or not, domestic and foreign. Intellectual Property shall include all:
(a)applications or registrations relating to such Intellectual Property;
(b)rights and privileges arising under applicable Laws with respect to such Intellectual Property;
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(c)rights to sue for past, present or future infringements of such Intellectual Property; and
(d)rights of the same or similar effect or nature in any jurisdiction corresponding to such Intellectual Property throughout the world.
“Interest Period” means, with respect to each Borrowing, (a) initially, the period commencing on and including the Borrowing Date thereof and ending on and excluding the next Payment Date, and, (b) thereafter, each period beginning on and including the last day of the immediately preceding Interest Period and ending on and excluding the next succeeding Payment Date.
“Interest-Only Period” means the period from and including the first Borrowing Date and through and including (i) the twelfth (12th) Payment Date following the first Borrowing Date; (ii) if Borrower has achieved the LOGICS Positive Data Milestone, and so long as no Default or Event of Default has occurred and is continuing, the twenty-third (24th) Payment Date following the first Borrowing Date; and (iii) if Borrower has achieved the Recorlev NDA Approval Milestone and so long as no Default or Event of Default has occurred and is continuing, the thirty-sixth (36th) Payment Date following the first Borrowing Date.
“Invention” means any novel, inventive and useful art, apparatus, method, process, machine (including article or device), manufacture or composition of matter, or any novel, inventive and useful improvement in any art, method, process, machine (including article or device), manufacture or composition of matter.
“Investment” means, for any Person: (a) the acquisition (whether for cash, property, services or securities or otherwise) of capital stock, bonds, notes, debentures, partnership or other ownership interests or other securities of any other Person or any agreement to make any such acquisition (including any “short sale” or any sale of any securities at a time when such securities are not owned by the Person entering into such sale); (b) the making of any deposit with, or advance, loan or other extension of credit to, any other Person (including the purchase of property from another Person subject to an understanding or agreement, contingent or otherwise, to resell such property to such Person), but excluding any such advance, loan or extension of credit having a term not exceeding 90 days arising in connection with the sale of inventory or supplies by such Person in the ordinary course of business; (c) the entering into of any Guarantee of, or other contingent obligation with respect to, Indebtedness or other liability of any other Person and (without duplication) any amount committed to be advanced, lent or extended to such Person; or (d) the entering into of any Hedging Agreement.
“Irish Companies Act” means the Companies Act 2014 of Ireland.
“Irish Guarantor” has the meaning set forth in the introduction hereto.
“Irish Security Documents” means each Irish Debenture described on Schedule 6.01.
“IRS” means the U.S. Internal Revenue Service or any successor agency, and to the extent relevant, the U.S. Department of the Treasury.
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“Knowledge” means, with respect to any Person, the actual knowledge of the chief executive officer, executive chairman, chief financial officer or chief legal officer of Borrower, so long as such Person is an officer of Borrower.
“Landlord Consent” means a Landlord Consent substantially in the form of Exhibit F or such other form as reasonably acceptable to the Administrative Agent.
“Laws” means, collectively, all international, foreign, federal, state, provincial, territorial, municipal and local statutes, treaties, rules, guidelines, regulations, ordinances, codes and administrative or judicial precedents or authorities, including the interpretation or administration thereof by any Governmental Authority charged with the enforcement, interpretation or administration thereof, and all applicable administrative orders, directed duties, requests, licenses, authorizations and permits of, and agreements with, any Governmental Authority, in each case whether or not having the force of law.
“Lender” means each Person listed as a “Lender” on a signature page hereto, together with its successors, and each assignee of a Lender pursuant to Section 13.05(b).
“Lien” means any mortgage, lien, pledge, charge or other security interest, or any lease, title retention agreement, mortgage, restriction, easement, right-of-way or other encumbrance of any kind or character whatsoever or any preferential arrangement that has the practical effect of creating a security interest.
“Loan” means each loan advanced by a Lender pursuant to Section 2.01.
“Loan Documents” means, collectively, this Agreement, the Security Documents, each Warrant, the Perfection Certificates, any subordination agreement or any intercreditor agreement entered into by Administrative Agent (on behalf of the Lenders) with any other creditors of Obligors or any agent acting on behalf of such creditors, and any other present or future document, instrument, agreement or certificate executed by Obligors and delivered to Administrative Agent or any Secured Party in connection with or pursuant to this Agreement or any of the other Loan Documents, all as amended, amended and restated, supplemented or otherwise modified.
“LOGICS Positive Data Milestone” means Borrower has achieved positive Phase 3 data in its LOGICS clinical trial, sufficient to submit a New Drug Application to the FDA.
“Loss” means judgments, debts, liabilities, expenses, costs, damages or losses, contingent or otherwise, whether liquidated or unliquidated, matured or unmatured, disputed or undisputed, contractual, legal or equitable, including loss of value, professional fees, including fees and disbursements of legal counsel on a full indemnity basis, and all costs incurred in investigating or pursuing any Claim or any proceeding relating to any Claim.
“Majority Lenders” means, at any time, Lenders having at such time in excess of 50% of the aggregate Commitments (or, if such Commitments are terminated, the outstanding principal amount of the Loans) then in effect, ignoring, in such calculation, the Commitments of and outstanding Loans owing to any Defaulting Lender.
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“Margin Stock” means “margin stock” within the meaning of Regulation U and Regulation X.
“Material Adverse Change” and “Material Adverse Effect” mean a material adverse change in or effect on (a) the business, condition (financial or otherwise), operations, performance or Property of Parent Guarantor and its Subsidiaries taken as a whole, (b) the ability of any Obligor to perform its obligations under the Loan Documents, or (c) the legality, validity, binding effect or enforceability of the Loan Documents or the rights and remedies of Administrative Agent or any Lender under any of the Loan Documents.
“Material Agreements” means (a) the agreements which are listed in Schedule 7.14 on the Closing Date, (b) material inbound and outbound license agreements and (c) all other agreements held by the Obligors from time to time, the absence or termination of any of which would reasonably be expected to result in a Material Adverse Effect; provided, however, that “Material Agreements” exclude all: (i) licenses implied by the sale of a product; and (ii) paid-up licenses for commonly available software programs under which an Obligor is the licensee. “Material Agreement” means any one such agreement.
“Material Indebtedness” means, at any time, any Indebtedness of any Obligor, the outstanding principal amount of which, individually or in the aggregate, exceeds $300,000 (or the Equivalent Amount in other currencies).
“Material Intellectual Property” means, the Obligor Intellectual Property described in Schedule 7.05(c) and any other Obligor Intellectual Property acquired after the Closing Date, the loss of which would reasonably be expected to have a Material Adverse Effect.
“Maturity Date” means the earlier to occur of (a) the Stated Maturity Date, and (b) the date on which the Loans are accelerated pursuant to Section 11.02.
“Maximum Rate” has the meaning set forth in Section 13.18.
“Multiemployer Plan” means any multiemployer plan, as defined in Section 4001(a)(3) of ERISA, to which any ERISA Affiliate incurs or otherwise has any obligation or liability, contingent or otherwise.
“Non-Consenting Lender” has the meaning set forth in Section 2.06(a).
“Notice of Borrowing” has the meaning set forth in Section 2.02.
“Obligations” means, with respect to any Obligor, all amounts, obligations, liabilities, covenants and duties of every type and description owing by such Obligor to Administrative Agent, any Lender or any other indemnitee hereunder, arising out of, under, or in connection with, any Loan Document (other than the Warrant), whether direct or indirect (regardless of whether acquired by assignment), absolute or contingent, due or to become due, whether liquidated or not, now existing or hereafter arising and however acquired, and whether or not evidenced by any instrument or for the payment of money, including, without duplication, (a) all Loans, (b) all interest, whether or not accruing after the filing of any petition in bankruptcy or after the commencement of any insolvency, reorganization or similar proceeding, and whether or
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not a claim for post-filing or post-petition interest is allowed in any such proceeding, and (c) all other fees, expenses (including fees, charges and disbursement of counsel), interest, commissions, charges, costs, disbursements, indemnities and reimbursement of amounts paid and other sums chargeable to such Obligor under any Loan Document (other than the Warrant).
“Obligor Intellectual Property” means Intellectual Property owned by or licensed to any of the Obligors.
“Obligors” has the meaning set forth in the introduction hereto.
“OFAC” means the Office of Foreign Assets Control of the United States Department of the Treasury.
“Option Shares” has the meaning set forth in Section 10.02(c).
“Other Connection Taxes” means, with respect to any Recipient, Taxes imposed as a result of a present or former connection between such Recipient and the jurisdiction imposing such Tax (other than connections arising from such Recipient having executed, delivered, become a party to, performed its obligations under, received payments under, received or perfected a security interest under, engaged in any other transaction pursuant to or enforced any Loan Document, or sold or assigned an interest in any Loan or Loan Document).
“Other Taxes” means all present or future stamp, court or documentary, intangible, recording, filing or similar Taxes that arise from any payment made under, from the execution, delivery, performance, enforcement or registration of, from the receipt or perfection of a security interest under, or otherwise with respect to, any Loan Document, except any such Taxes that are Other Connection Taxes imposed with respect to an assignment (other than an assignment made pursuant to Section 5.03(g)).
“Parent Guarantor” has the meaning set forth in the introduction hereto.
“Participant” has the meaning set forth in Section 13.05(e).
“Participant Register” has the meaning set forth in Section 13.05(f).
“Patents” has the meaning set forth in the Security Agreement.
“Payment Date” means the first day of each month during the term hereof, and the Maturity Date, commencing on the first such date to occur following the first Borrowing Date; provided that, if any such date shall occur on a day that is not a Business Day, the applicable Payment Date shall be the immediately preceding Business Day.
“PBGC” means the United States Pension Benefit Guaranty Corporation referred to and defined in ERISA and any successor entity performing similar functions.
“Perfection Certificates” means each perfection certificate dated as of the Closing Date delivered by each Obligor to Administrative Agent.
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“Permitted Acquisition” means any acquisition by any Obligor, whether by purchase, merger, license or otherwise, of all or substantially all of the assets of, all of the Equity Interests of, or a business line or unit or a division or a product of, any Person; provided that:
(a)immediately prior to, and after giving effect thereto, no Default or Event of Default shall have occurred and be continuing or would result therefrom;
(b)all transactions in connection therewith shall be consummated, in all material respects, in accordance with all applicable Laws and in conformity in all material respects with all applicable Governmental Approvals;
(c)in the case of the acquisition of all of the Equity Interests of such Person, all of the Equity Interests (except for any such securities in the nature of directors’ qualifying shares required pursuant to applicable Law) acquired, or otherwise issued by such Person or any newly formed Subsidiary of Parent Guarantor in connection with such acquisition, shall be owned 100% by an Obligor or any other Subsidiary, and Parent Guarantor shall have taken, or caused to be taken, each of the actions set forth in Section 8.12, if applicable;
(d)[Reserved];
(e)such Person (in the case of an acquisition of Equity Interests) or assets (in the case of an acquisition of assets or a division) (i) shall be engaged or used, as the case may be, in the same business or lines of business in which Parent Guarantor and/or its Subsidiaries are engaged or (ii) shall have a similar customer base as Parent Guarantor and/or its Subsidiaries; and
(f)concurrent with the earlier of the execution of the applicable acquisition agreement or the consummation of such acquisition, Borrower shall have provided Administrative Agent copies of the acquisition agreement and other material documents relative to the proposed acquisition.
“Permitted Cash Equivalent Investments” means (a) marketable direct obligations issued or unconditionally guaranteed by the United States or any agency or any State thereof having maturities of not more than two (2) years from the date of acquisition thereof, (b) commercial paper maturing no more than one (1) year after its creation and having the highest rating from either Standard & Poor’s Ratings Group or Moody’s Investors Service, Inc., and (c) Investments permitted by Parent Guarantor’s investment policy in effect on the Closing Date hereof, as amended from time to time, provided that such amendment thereto has been approved in writing by the Administrative Agent.
“Permitted Indebtedness” means any Indebtedness permitted under Section 9.01.
“Permitted Liens” means any Liens permitted under Section 9.02.
“Permitted Priority Liens” means (a) Liens permitted under Section 9.02(c), (d), (e), (f), (g), and (j), and (b) Liens permitted under Section 9.02(b); provided that such Liens are also of the type described in Section 9.02(c), (d), (e), (f), (g), and (j).
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“Permitted Refinancing” means, with respect to any Indebtedness, any extensions, renewals and replacements of such Indebtedness; provided that such extension, renewal or replacement (a) shall not increase the outstanding principal amount of such Indebtedness, (b) contains terms relating to outstanding principal amount, amortization, maturity, collateral (if any) and subordination (if any), and other material terms taken as a whole no less favorable in any material respect to Parent Guarantor and its Subsidiaries or the Secured Parties than the terms of any agreement or instrument governing such existing Indebtedness, (c) shall have an applicable interest rate which does not exceed the rate of interest of the Indebtedness being replaced, and (d) shall not contain any new requirement to grant any lien or security or to give any guarantee that was not an existing requirement of such Indebtedness.
“Permitted Subordinated Debt” means Indebtedness (a) that is governed by documentation containing representations, warranties, covenants and events of default no more burdensome or restrictive than those contained in the Loan Documents, (b) that has a maturity date later than the Stated Maturity Date, (c) in respect of which no cash payments of principal or interest are required prior to the Stated Maturity Date, (d) that converts into equity immediately upon the occurrence of an Event of Default, and (e) in respect of which the holders have agreed in favor of Borrower and Secured Parties (i) that prior to the date on which the Commitments have expired or been terminated and all Obligations have been paid in full indefeasibly in cash, such holders will not exercise any remedies available to them in respect of such Indebtedness, (ii) that such Indebtedness is and shall remain unsecured, and (iii) to terms of subordination in substantially the form attached hereto as Exhibit G and with such changes (if any) as are reasonably satisfactory to Administrative Agent, or such other form as reasonably acceptable to the Majority Lenders.
“Person” means any individual, corporation, company, voluntary association, partnership, limited liability company, joint venture, trust, unincorporated organization or Governmental Authority or other entity of whatever nature.
“Plan” means any employee pension benefit plan (other than a Multiemployer Plan) subject to the provisions of Title IV of ERISA or Section 412 of the Code or Section 302 of ERISA, and in respect of which Parent Guarantor or any ERISA Affiliate is (or, if such plan were terminated, would under Section 4069 of ERISA be deemed to be) an “employer” as defined in Section 3(5) of ERISA.
“Prepayment Premium” has the meaning set forth in Section 3.03(a).
“Pro Rata Final Payment” means the percentage of the Final Payment obtained by dividing (a) the principal amount of any Loan being prepaid pursuant to Section 3.03(a) by (b) the total amount of Loans made hereunder.
“Product” means KEVEYIS®, Recorlev, Veldoreotide and such other products as may be acquired or in-licensed by any Obligor, and each of their respective successors.
“Property” of any Person means any property or assets, or interest therein, of such Person.
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“Proportionate Share” means, with respect to any Lender, the percentage obtained by dividing (a) the Commitment (or, if the Commitments are terminated, the outstanding principal amount of the Loans) of such Lender then in effect by (b) the sum of the Commitments (or, if the Commitments are terminated, the outstanding principal amount of the Loans) of all Lenders then in effect.
“Qualified Plan” means an employee benefit plan (as defined in Section 3(3) of ERISA) other than a Multiemployer Plan (a) that is or was at any time maintained or sponsored by any Obligor or any ERISA Affiliate thereof or to which any Obligor or any ERISA Affiliate thereof has ever made, or was ever obligated to make, contributions, and (b) that is intended to be tax qualified under Section 401(a) of the Code.
“Qualified Securities” means fully paid, non-assessable and unrestricted ordinary shares of Parent Guarantor allotted and issued in accordance with Section 10.02.
“Recipient” means Administrative Agent, any Lender or any other recipient of any payment to be made by or on account of any Obligation.
“Recorlev NDA Approval Milestone” means Borrower obtains approval of the New Drug Application for Recorlev for the treatment of Endogenous Cushing’s syndrome from the FDA.
“Redemption Date” has the meaning set forth in Section 3.03(a).
“Redemption Price” has the meaning set forth in Section 3.03(a).
“Register” has the meaning set forth in Section 13.05(d).
“Regulation T” means Regulation T of the Board of Governors of the Federal Reserve System, as amended.
“Regulation U” means Regulation U of the Board of Governors of the Federal Reserve System, as amended.
“Regulation X” means Regulation X of the Board of Governors of the Federal Reserve System, as amended.
“Regulatory Approvals” means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.
“Related Person” means, with respect to any Person, such Person’s Affiliates and the partners, directors, officers, employees, agents, trustees, administrators, managers, advisors and representatives of such Person and of such Person’s Affiliates.
“Requirement of Law” means, as to any Person, any statute, law, treaty, rule or regulation or determination, order, injunction or judgment of an arbitrator or a court or other
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Governmental Authority, in each case applicable to or binding upon such Person or any of its Properties or revenues.
“Responsible Officer” of any Person means each of the president, chief operating officer, chief financial officer, chief executive officer, chief legal officer, and chief medical officer or controller of such Person.
“Restricted Payment” means any dividend or other distribution (whether in cash, securities or other property) with respect to any Equity Interest of Parent Guarantor or any of its Subsidiaries, or any payment (whether in cash, securities or other property), including any sinking fund or similar deposit, on account of the purchase, redemption, retirement, acquisition, cancellation or termination of any such shares of capital stock, share capital or other Equity Interest of Parent Guarantor or any of its Subsidiaries or any option, warrant or other right to acquire any such shares of capital stock, share capital or other Equity Interest of Parent Guarantor or any of its Subsidiaries.
“Restrictive Agreement” has the meaning set forth in Section 7.15.
“Restructured Debt Securities” has the meaning set forth in Section 15.01.
“Revenue” of a Person means all revenue properly recognized under GAAP, consistently applied, less all rebates, discounts and other price allowances.
“Sanctioned Jurisdiction” means any country or territory to the extent that such country or territory is the subject of any Sanction.
“Sanctioned Person” means, at any time, (a) any Person listed in any Sanctions-related list of designated Persons maintained by OFAC, the U.S. Department of State, the United Nations Security Council, the European Union, Her Majesty’s Treasury, or other relevant sanctions authority, (b) any Person operating, organized or resident in a Sanctioned Jurisdiction or (c) any Person owned or Controlled by any such person or Persons described in clauses (a) and (b).
“Sanctions” means any international economic sanction administered or enforced by the United States (including OFAC), the United Nations Security Council, the European Union, Her Majesty’s Treasury or other relevant sanctions authority.
“SEC” means the Securities and Exchange Commission, or any other Governmental Authority succeeding to any of its principal functions.
“Secured Parties” means the Lenders, Administrative Agent, each other Indemnified Party and any other holder of any Obligation.
“Securities Account” has the meaning set forth in the Security Agreement.
“Security Agreement” means the Security Agreement, dated as of the Closing Date, among the Obligors and Administrative Agent, granting a security interest in the Obligors’ personal Property in favor of the Secured Parties.
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“Security Documents” means, collectively, the Security Agreement, each Short-Form IP Security Agreement, the Swedish Security Document, the Irish Security Documents and each other security document, control agreement or financing statement required or recommended to perfect Liens in favor of the Secured Parties.
“Senior Indebtedness” has the meaning set forth in Section 15.01.
“Short-Form IP Security Agreements” means New York law short-form copyright, patent or trademark (as the case may be) security agreements, dated as of the Closing Date, entered into by one or more Obligors in favor of Administrative Agent, for the benefit of the Secured Parties, in respect of the Obligors’ United States Intellectual Property, each in form and substance reasonably satisfactory to Administrative Agent (and as amended, modified or replaced from time to time).
“Solvent” means, with respect to any Person at any time, that (a) the present fair saleable value of the Property of such Person is greater than the total amount of liabilities (including contingent liabilities) of such Person, (b) the present fair saleable value of the Property of such Person is not less than the amount that will be required to pay the probable liability of such Person on its debts as they become absolute and matured, and (c) such Person has not incurred and does not intend to, and does not believe that it will, incur debts or liabilities beyond such Person’s ability to pay as such debts and liabilities mature.
“Stated Maturity Date” means May 19, 2024.
“Subordinated Intercompany Indebtedness” has the meaning set for in Section 15.01.
“Subsequent Financing” has the meaning set forth in Section 10.01.
“Subsidiary” means, with respect to any Person (the “parent”) at any date, any corporation, limited liability company, partnership, association or other entity the accounts of which would be consolidated with those of the parent in the parent’s consolidated financial statements if such financial statements were prepared in accordance with GAAP as of such date, as well as any other corporation, limited liability company, partnership, association or other entity (a) of which securities or other ownership interests representing more than 50% of the equity or more than 50% of the ordinary voting power or, in the case of a partnership, more than 50% of the general partnership interests are, as of such date, owned, controlled or held by the parent or one or more subsidiaries of the parent or by the parent and one or more subsidiaries of the parent or (b) that is, as of such date, otherwise Controlled by the parent or one or more subsidiaries of the parent or by the parent and one or more subsidiaries of the parent. Unless the context requires otherwise, “Subsidiary” refers to a Subsidiary of Parent Guarantor.
“Subsidiary Guarantors” means Parent Guarantor and each Subsidiary of Parent Guarantor that becomes, or is required to become, a “Subsidiary Guarantor” after the Closing Date pursuant to Section 8.12(a) or (b); provided that, as of the Closing Date, Irish Guarantor and Swedish Guarantor are “Subsidiary Guarantors”.
“Substitute Lender” has the meaning set forth in Section 2.06(a).
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“Swedish Guarantor” has the meaning set forth in the introduction hereto.
“Swedish Obligor” means an Obligor incorporated under the laws of Sweden.
“Swedish Security Document” means the Swedish share pledge agreement described on Schedule 6.01.
“Tax Affiliate” means (a) Parent Guarantor and its Subsidiaries, (b) each other Obligor and (c) any Affiliate of an Obligor with which such Obligor files or is eligible to file consolidated, combined or unitary Tax returns.
“Tax Returns” has the meaning set forth in Section 7.08.
“Taxes” means all present or future taxes, levies, imposts, duties, deductions, withholdings (including backup withholding), assessments, fees or other charges imposed by any Governmental Authority, including any interest, additions to tax or penalties applicable thereto.
“Technical Information” means all trade secrets and other proprietary or confidential information, public information, non-proprietary know-how, any information of a scientific, technical, or business nature in any form or medium, standards and specifications, conceptions, ideas, innovations, discoveries, Invention disclosures, all documented research, developmental, demonstration or engineering work and all other information, data, plans, specifications, reports, summaries, experimental data, manuals, models, samples, know-how, technical information, systems, methodologies, computer programs, information technology and any other information.
“Title IV Plan” means an employee benefit plan (as defined in Section 3(3) of ERISA) other than a Multiemployer Plan (i) that is or was at any time maintained or sponsored by any Obligor or any ERISA Affiliate thereof or to which any Obligor or any ERISA Affiliate thereof has ever made, or was obligated to make, contributions, and (ii) that is or was subject to Section 412 of the Code, Section 302 of ERISA or Title IV of ERISA.
“Trademarks” is defined in the Security Agreement.
“Transactions” means the execution, delivery and performance by each Obligor of this Agreement and the other Loan Documents to which such Obligor is intended to be a party and the Borrowings (and the use of the proceeds of the Loans).
“U.S. Person” means a “United States Person” within the meaning of Section 7701(a)(30) of the Code.
“U.S. Tax Compliance Certificate” has the meaning set forth in Section 5.03(e)(ii)(B)(3).
“United States” or “U.S.” means the United States of America.
“VWAP” means, for each trading day, the total amount of dollars traded for every transaction (price multiplied by the number of shares traded) involving Parent Guarantor’s ordinary shares, divided by the total number of Parent Guarantor’s ordinary shares traded.
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“Warrant” means each warrant to purchase Equity Interests of Parent Guarantor, issued by Parent Guarantor to the Lenders in connection with the Transactions substantially in the form of Exhibit I.
“Withdrawal Liability” means, at any time, any liability incurred (whether or not assessed) by any ERISA Affiliate and not yet satisfied or paid in full at such time with respect to any Multiemployer Plan pursuant to Section 4201 of ERISA.
“Withholding Agent” means any Obligor and Administrative Agent.
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agent for the Beneficiary in a separate account and shall promptly pay or transfer the same to the Beneficiary or as the Beneficiary may direct.
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Each Borrowing shall constitute a certification by Borrower to the effect that the conditions set forth in this Section 6.05 have been fulfilled as of the applicable Borrowing Date.
Each Obligor represents and warrants to Administrative Agent and the Lenders that:
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and other Requirements of Law, (x) there are no existing or pending (or to the Knowledge of any Obligor or Subsidiary thereof, threatened) claims (other than routine claims for benefits in the normal course), sanctions, actions, lawsuits or other proceedings or investigation involving any Benefit Plan to which any Obligor or Subsidiary thereof incurs or otherwise has or could have an obligation or any liability or Claim, (y) no ERISA Event is reasonably expected to occur and, as of the Closing Date, no ERISA Event has occurred in connection with which obligations and liabilities (contingent or otherwise) remain outstanding, and (z) no ERISA Affiliate would have any Withdrawal Liability as a result of a complete withdrawal from any Multiemployer Plan on the date this representation is made. Parent Guarantor and each of its ERISA Affiliates has met all applicable requirements under the ERISA Funding Rules with respect to each Title IV Plan, and no waiver of the minimum funding standards under the ERISA Funding Rules has been applied for or obtained. As of the most recent valuation date for any Title IV Plan, the funding target attainment percentage (as defined in Section 430(d)(2) of the Code) is at least 60%, and neither Parent Guarantor nor any of its ERISA Affiliates knows of any facts or circumstances that could reasonably be expected to cause the funding target attainment percentage to fall below 60% as of the most recent valuation date.
48
DMS 17185250.10
Each Obligor covenants and agrees with Administrative Agent and the Lenders that, until the Commitments have expired or been terminated and all Obligations have been paid in full indefeasibly in cash:
49
DMS 17185250.10
Notwithstanding the foregoing, documents required to be delivered pursuant to the terms of this Section 8.01 (to the extent any such documents are included in materials otherwise filed with the SEC) may be delivered electronically and, if so delivered, shall be deemed to have been delivered on the date on which the Parent Guarantor posts such documents, or provides a link thereto, on the Parent Guarantor’s website on the internet at the Parent Guarantor’s website address. For purposes of clarity, to the extent documents are posted electronically in accordance with SEC requirements, any requirement for prompt delivery under this Section 8.01 shall be deemed satisfied.
50
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51
DMS 17185250.10
Each notice delivered under this Section 8.02 shall be accompanied by a statement of a financial officer or other executive officer of Borrower setting forth the details of the event or development requiring such notice and any action taken or proposed to be taken with respect thereto.
Notwithstanding the foregoing, documents required to be delivered pursuant to the terms of clauses (d), (e), (g), (i) and (j) of this Section 8.02 (to the extent any such documents are included in materials otherwise filed with the SEC) may be delivered electronically and, if so delivered, shall be deemed to have been delivered on the date on which the Parent Guarantor posts such documents, or provides a link thereto, on the Parent Guarantor’s website on the internet at the Parent Guarantor’s website address. For purposes of clarity, to the extent documents required to be delivered pursuant to the terms of clauses (d), (e), (g), (i) and (j) of this Section 8.02 are posted electronically in accordance with SEC requirements, any requirement for prompt delivery under this Section 8.02 shall be deemed satisfied.
52
DMS 17185250.10
others to ensure, that all insurance policies required under this Section 8.05 shall provide that they shall not be terminated or cancelled nor shall any such policy be materially changed in a manner adverse to such Obligor without at least 30 days’ prior written notice to such Obligor and Administrative Agent. Receipt of notice of termination or cancellation of any such insurance policies or reduction of coverages or amounts thereunder and, unless the Borrower have delivered evidence that it has obtained replacement insurance that satisfies the requirements of this Section, shall entitle the Administrative Agent to renew any such policies, cause the coverages and amounts thereof to be maintained at levels required pursuant to the first sentence of this Section 8.05 or otherwise to obtain similar insurance in place of such policies, in each case at the expense of such Obligor (payable on demand). The amount of any such expenses shall accrue interest at the Default Rate if not paid on demand, and shall constitute “Obligations.”
53
DMS 17185250.10
54
DMS 17185250.10
Without limiting the generality of the foregoing, each Obligor will, and will cause each Person that is required to be a Subsidiary Guarantor to, take such action from time to time (including executing and delivering such assignments, security agreements, control agreements,
55
DMS 17185250.10
applications and other instruments prepared by the Administrative Agent or its counsel) as shall be reasonably requested by Administrative Agent or the Majority Lenders to create, in favor of the Secured Parties, perfected security interests and Liens in substantially all of the property of such Obligor as collateral security for the Obligations; provided that any such security interest or Lien shall be subject to the relevant requirements of, and limitations set forth in, the Security Documents.
Notwithstanding any provision under this Agreement or other Loan Documents to the contrary, (i) the Obligors shall not be required to take any actions in any jurisdiction outside the United States to grant or perfect a security interest in any asset to the extent the Administrative Agent determines that the costs or burdens thereof are disproportionate to the practical benefit obtained by the Secured Parties by reference to the costs or burdens of creating or perfecting the lien versus the value of the assets being secured, (ii) [reserved]; (iii) unless an Event of Default has occurred and is continuing under Sections 11.01(a), (b), (d) (solely in respect of Sections 9 and 10), (h), (i), (j), (m), (n), or (p), the Swedish Guarantor shall not be required to take any actions in Sweden except as required pursuant to the Swedish Security Document (if any); (iv) no Obligor shall be responsible for the reimbursement of legal and filing costs, duties, fees, expenses, stamp taxes, any other Taxes, and other amounts incurred or payable in respect of actions required to perfect the Liens on Intellectual Property in jurisdictions outside of the United States in excess of $15,000 in respect for each foreign jurisdiction, or $50,000 in the aggregate for all foreign jurisdictions; and (v) other than in respect of executing and delivering assignments, security agreements, control agreements, applications and other instruments prepared by the Administrative Agent or its counsel relating to Intellectual Property, no Subsidiary Guarantor or Borrower shall be obligated to take, or cause to be taken, any further steps to perfect any security interest or Lien granted in favor of the Secured Parties in the Intellectual Property (other than Material Intellectual Property) owned by the Obligors as of the Closing Date.
56
DMS 17185250.10
after the date, if any, subsequent to such acquisition that such representations and warranties are brought down or made anew as provided herein).
Each Obligor covenants and agrees with Administrative Agent and the Lenders that, until the Commitments have expired or been terminated and all Obligations have been paid in full indefeasibly in cash:
57
DMS 17185250.10
58
DMS 17185250.10
it, or assign or sell any income or revenues (including accounts receivable) or rights in respect of any thereof, except:
59
DMS 17185250.10
provided that no Lien otherwise permitted under any of the foregoing Sections 9.02(b) through (l) shall apply to any Material Intellectual Property.
60
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61
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62
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63
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64
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through the date 18 months thereafter (any such sale, a “Subsequent Financing”), in an amount of up to $1,000,000 on the same terms, conditions and pricing afforded to others participating in any such Subsequent Financing; provided, however, that such terms shall exclude any seat on the board of directors of Parent Guarantor that may be offered to other investors participating in a Subsequent Financing.
65
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66
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67
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provided that if an order, decree or judgment is granted or entered (whether or not entered or subject to appeal) against Parent Guarantor or such Subsidiary thereunder in the interim, such grace period will cease to apply; provided further that if Parent Guarantor or such Subsidiary files an answer admitting the material allegations of a petition filed against it in any such proceeding, such grace period will cease to apply;
68
DMS 17185250.10
69
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70
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71
DMS 17185250.10
greater proportion) and (iii) the exercise by Administrative Agent or the Majority Lenders (or, where so required, such greater proportion) of the powers set forth herein or therein, together with such other powers as are reasonably incidental thereto, shall be authorized and binding upon all of the Secured Parties.
72
DMS 17185250.10
and, for each of the items set forth in clauses (i) through (iv) above, each Lender and each Obligor hereby waives and agrees not to assert any right, claim or cause of action it might have against Administrative Agent based thereon.
73
DMS 17185250.10
connection with entering into, and taking or not taking any action under, any Loan Document or with respect to any transaction contemplated in any Loan Document, in each case based on such documents and information as it shall deem appropriate.
74
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75
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76
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77
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Notwithstanding anything to the contrary herein, (a) [reserved]; and (b) a Defaulting Lender shall not have any right to approve or disapprove any amendment, waiver or consent hereunder (and any amendment, waiver or consent which by its terms requires the consent of all Lenders or each affected Lender may be effected with the consent of the applicable Lenders other than Defaulting Lenders), except that (x) the Commitment of any Defaulting Lender may not be increased or extended without the consent of such Lender and (y) any waiver, amendment or modification requiring the consent of all Lenders or each affected Lender that by its terms affects any Defaulting Lender more adversely than other affected Lenders shall require the consent of such Defaulting Lender.
78
DMS 17185250.10
Any agreement or instrument pursuant to which a Lender sells such a participation shall provide that such Lender shall retain the sole right to enforce this Agreement and to approve any amendment, modification or waiver of any provision of this Agreement; provided that such agreement or instrument may provide that such Lender will not, without the consent of the Participant, agree to any amendment, modification or waiver that would (i) increase or extend the term of such Lender’s Commitment, (ii) extend the date fixed for the payment of principal of or interest on the Loans or any portion of any fee hereunder payable to the Participant, (iii) reduce the amount of any such payment of principal, or (iv) reduce the rate at which interest is payable thereon to a level below the rate at which the Participant is entitled to receive such interest. Subject to Section 13.05(f), Borrower agrees that each Participant shall be entitled to the benefits of Section 5 to the same extent as if it were a Lender and had acquired its interest by assignment pursuant to Section 13.05(b). To the extent permitted by law, each Participant also shall be entitled to the benefits of Section 4.04(a) as though it were the Lender.
79
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80
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81
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For purposes of this Section, “Information” means all information furnished by Parent Guarantor or any of its Subsidiaries relating to Parent Guarantor or any of its Subsidiaries or any of their respective businesses, other than any such information that is available to Administrative Agent or any Lender on a nonconfidential basis prior to disclosure by Parent Guarantor or any of its Subsidiaries; provided that the source was not, to the knowledge of the Administrative Agent or such Lender, prohibited from disclosing such Information by a legal, contractual or fiduciary
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DMS 17185250.10
obligation. Any Person required to maintain the confidentiality of Information as provided in this Section 13.16 shall be considered to have complied with its obligation to do so if such Person has exercised the same degree of care to maintain the confidentiality of such Information as such Person would accord to its own confidential information.
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a legal or equitable discharge or defense of a surety or guarantor. The liability of each Subsidiary Guarantor is irrevocable, continuing, absolute and unconditional. Without limiting the generality of the foregoing, it is agreed that the occurrence of any one or more of the following shall not discharge, alter, impair or otherwise affect the liability of the Subsidiary Guarantors hereunder, which shall remain absolute and unconditional as described above, and each Subsidiary Guarantor hereby irrevocably waives any defenses to enforcement it may have (now or in the future) by reason of:
The Subsidiary Guarantors hereby expressly waive diligence, presentment, demand of payment, protest and all notices whatsoever, and any requirement that any Secured Party exhaust any right, power or remedy or proceed against any Obligor under this Agreement or any other agreement or instrument referred to herein, or against any other Person under any other guarantee of, or security for, any of the Guaranteed Obligations.
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rescission or restoration, including any such costs and expenses incurred in defending against any claim alleging that such payment constituted a preference, fraudulent transfer or similar payment under any bankruptcy, insolvency or similar law.
86
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For purposes of this Section 14.08, (i) “Excess Funding Guarantor” means, in respect of any Guaranteed Obligations, a Subsidiary Guarantor that has paid an amount in excess of its Pro rata Share of such Guaranteed Obligations, (ii) “Excess Payment” means, in respect of any Guaranteed Obligations, the amount paid by an Excess Funding Guarantor in excess of its Pro rata Share of such Guaranteed Obligations and (iii) “Pro rata Share” means, for any Subsidiary Guarantor, the ratio (expressed as a percentage) of (x) the amount by which the aggregate present fair saleable value of all properties of such Subsidiary Guarantor (excluding any shares of stock or share capital, as applicable, of any other Subsidiary Guarantor) exceeds the amount of all the debts and liabilities of such Subsidiary Guarantor (including contingent, subordinated, unmatured and unliquidated liabilities, but excluding the obligations of such Subsidiary Guarantor hereunder and any obligations of any other Subsidiary Guarantor that have been Guaranteed by such Subsidiary Guarantor) to (y) the amount by which the aggregate fair saleable value of all properties of all of the Subsidiary Guarantors exceeds the amount of all the debts and liabilities (including contingent, subordinated, unmatured and unliquidated liabilities, but excluding the obligations of Borrower and the Subsidiary Guarantors hereunder and under the other Loan Documents) of all of the Subsidiary Guarantors, determined (A) with respect to any Subsidiary Guarantor that is a party hereto on the first Borrowing Date, as of such Borrowing Date, and (B) with respect to any other Subsidiary Guarantor, as of the date such Subsidiary Guarantor becomes a Subsidiary Guarantor hereunder.
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88
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[Signature Pages Follow]
89
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed and delivered as of the day and year first above written.
BORROWER:
STRONGBRIDGE U.S. INC.
By/s/ Robert Lutz
Name:Robert Lutz
Title: Chief Financial Officer
Address for Notices:
900 Northbrook Drive
Suite 200
Trevose, PA 19053
Attn:Chief Legal Officer
Tel.:610-254-9225
Fax:215-355-7389
Email:s.long@strongbridgebio.com
[Signature Page to Term Loan Agreement]
[Signatures Continued, Next Page]
DMS 17185250.10
SUBSIDIARY GUARANTORS:
STRONGBRIDGE BIOPHARMA PLC
By:/s/ Robert Lutz
Name:Robert Lutz
Title:Chief Financial Officer
Address for Notices:
900 Northbrook Drive
Suite 200
Trevose, PA 19053
Attn:Chief Legal Officer
Tel.:610-254-9225
Fax:215-355-7389
Email:s.long@strongbridgebio.com
[Signature Page to Term Loan Agreement]
[Signatures Continued, Next Page]
DMS 17185250.10
CORTENDO AB (PUBL)
By:/s/ Stephen Long
Name:Stephen J. Long
Title:Authorized Signatory
Address for Notices:
900 Northbrook Drive
Suite 200
Trevose, PA 19053
Attn:Chief Legal Officer
Tel.:610-254-9225
Fax:215-355-7389
Email:s.long@strongbridgebio.com
STRONGBRIDGE DUBLIN LIMITED
By: /s/ Stephen Long
Name:Stephen J. Long
Title:Authorized Signatory
Address for Notices:
900 Northbrook Drive
Suite 200
Trevose, PA 19053
Attn:Chief Legal Officer
Tel.:610-254-9225
Fax:215-355-7389
Email:s.long@strongbridgebio.com
[Signature Page to Term Loan Agreement]
[Signatures Continued, Next Page]
DMS 17185250.10
ADMINISTRATIVE AGENT:
AVENUE VENTURE OPPORTUNITIES FUND, L.P.
By/s/ Sonia Gardner
Name:
Title:
Address for Notices:
11 W. 42nd St., 9th Floor
New York, NY 10036
Attn:
Tel:
Fax:
Email:
LENDER:
AVENUE VENTURE OPPORTUNITIES FUND, L.P.
By/s/ Sonia Gardner
Name:
Title:
Address for Notices:
11 W. 42nd St., 9th Floor
New York, NY 10036
Attn:
Tel:
Fax:
Email:
[Signature Page to Term Loan Agreement]
DMS 17185250.10
Schedule 1
To Term Loan Agreement
COMMITMENTS
Lender |
Commitment |
Proportionate Share |
Avenue Venture Opportunities Fund, L.P. |
$20,000,000.00 |
100.00% |
TOTAL |
$20,000,000.00 |
100.00% |
DMS 17185250.10
Schedule 6.01
To Term Loan Agreement
FOREIGN SECURITY DOCUMENTS
1. |
Swedish law share pledge agreement entered into by Strongbridge Biopharma plc with respect to the shares of Cortendo AB (publ) |
2. |
Irish law Debenture entered into by Strongbridge Biopharma plc |
3. |
Irish law Debenture entered into by Strongbridge Dublin Limited |
DMS 17185250.10
Schedule 7.05(b)(i)
To Term Loan Agreement
Certain Intellectual Property1
COR-003 |
||
---|---|---|
Title / Owner / Inventor |
Country/Number |
Status |
Methods And Compositions For Treating Diabetes, Metabolic Syndrome And Other Conditions
|
Australia - 2006204334 |
Issued |
Canada - 2594433 |
Issued |
|
China - 101141964 |
Issued |
|
Hong Kong - 1118449 |
Issued |
|
Indonesia - 32847 |
Issued |
|
Israel - 184459 |
Issued |
|
Japan - 5358095 |
Issued |
|
South Korea - 1013879100000 |
Issued |
|
Mexico - 294589 |
Issued |
|
New Zealand - 560481 |
Issued |
|
Norway 339007 |
Issued |
|
Singapore - 133978 |
Issued |
|
South Africa - 2007/06020 |
Issued |
|
Europe - 1853266 |
Issued |
|
*countries designated (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IT, LT, LU, LV, NL, PL, PT, RO, SE, SI, SK, TR) |
Issued |
|
US 9,918,984 |
Issued |
|
US 10,098,877 |
Issued |
|
US 10,517,868 |
Issued |
|
US 16/715,690 |
Filed 12/16/2019 |
1 Intellectual property previously owned by Cortendo AB (publ) has been transferred to Strongbridge Dublin Limited in connection with an internal reorganization in 2018. Re-registrations of the transferred intellectual property in local patent office has not been undertaken in cases of patents that are not Material Intellectual Property.
DMS 17185250.10
DMS 17185250.10
COR-005 |
||
---|---|---|
Title / Owner / Inventor |
Country/Number |
Status |
Pharmaceutical Compositions Of Water Soluble Peptides With Poor Solubility In Isotonic Conditions And Methods For Their Use
|
PCT/IB17/00194 |
Pending - countries designated: EP, JP, CA, CN, AU, BR, RU |
Australia App # 2017220728 |
||
Brazil App # BR1120180167746** |
||
Canada App #3,014,406 |
||
China App # 2017800238416 |
||
Europe App # 177142668 |
||
Japan App # 2018561098 |
||
Russia App # 2018132631 |
||
US 10,039,801 |
Issued |
|
US 10,398,751 |
Issued |
|
US 16/512,536 |
Pending - Filed 7/16/2019 |
KEVEYIS |
|
|
|
|
---|---|---|---|---|
Owner |
Case Number |
Application No. |
Filing Date |
Title |
STRONGBRIDGE DUBLIN LIMITED |
STRG0001-201T-US |
16/201,410 |
11/27/2018 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0001-201TC1-US |
16/780,057 |
2/3/2020 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0001-201TD1-US |
16/535,704 |
8/8/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-201T-US |
16/205,602 |
11/30/2018 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-201TD1-US |
16/540,447 |
8/14/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-201TD2-US |
16/540,450 |
8/14/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
DMS 17185250.10
KEVEYIS |
|
|
|
|
---|---|---|---|---|
Owner |
Case Number |
Application No. |
Filing Date |
Title |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-201TD3-US |
16/540,456 |
8/14/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-201TD4-US |
16/540,461 |
8/14/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-201TD5-US |
16/540,464 |
8/14/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-201TD6-US |
16/540,468 |
8/14/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0003-201T-US |
16/253,505 |
1/22/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0004-201T-US |
16/253,515 |
1/22/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0004-201TC1-US |
16/535,692 |
8/8/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0007-101-US |
62/863,125 |
6/18/2019 |
DICHLORPHENAMIDE COMPOSITIONS AND METHODS OF USE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0008-101-US |
62/908,078 |
9/30/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0001-401-PC |
PCT/US19/63505 |
11/27/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-401-PC |
PCT/US19/63507 |
1/29/2020 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0004-401-PC |
PCT/US20/14250 |
1/20/2020 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
DMS 17185250.10
NEXT GENERATION |
||
Title / Owner / Inventor |
Country/Number |
Status |
Novel Cytochrome P450 Inhibitors And Their Method Of Use
|
US 9,725,436 |
Issued |
DMS 17185250.10
DMS 17185250.10
Schedule 7.05(b)(ii)
To Term Loan Agreement
Intellectual Property EXCEPTIONS
None.
DMS 17185250.10
Schedule 7.05(c)
to Term Loan Agreement
Material Intellectual Property
DMS 17185250.10
COR-005 |
||
---|---|---|
Title / Owner / Inventor |
Country/Number |
Status |
Pharmaceutical Compositions Of Water Soluble Peptides With Poor Solubility In Isotonic Conditions And Methods For Their Use
|
PCT/IB17/00194 |
Pending - countries designated: EP, JP, CA, CN, AU, BR, RU |
Australia App # 2017220728 |
||
Brazil App # BR1120180167746** |
||
Canada App #3,014,406 |
||
China App # 2017800238416 |
||
Europe App # 177142668 |
||
Japan App # 2018561098 |
||
Russia App # 2018132631 |
||
US 10,039,801 |
Issued |
|
US 10,398,751 |
Issued |
|
US 16/512,536 |
Pending - Filed 7/16/2019 |
KEVEYIS |
|
|||
---|---|---|---|---|
Owner |
Case Number |
Application No. |
Filing Date |
Title |
STRONGBRIDGE DUBLIN LIMITED |
STRG0001-201T-US |
16/201,410 |
11/27/2018 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0001-201TC1-US |
16/780,057 |
2/3/2020 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0001-201TD1-US |
16/535,704 |
8/8/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-201T-US |
16/205,602 |
11/30/2018 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-201TD1-US |
16/540,447 |
8/14/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
DMS 17185250.10
KEVEYIS |
|
|||
---|---|---|---|---|
Owner |
Case Number |
Application No. |
Filing Date |
Title |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-201TD2-US |
16/540,450 |
8/14/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-201TD3-US |
16/540,456 |
8/14/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-201TD4-US |
16/540,461 |
8/14/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-201TD5-US |
16/540,464 |
8/14/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-201TD6-US |
16/540,468 |
8/14/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0003-201T-US |
16/253,505 |
1/22/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0004-201T-US |
16/253,515 |
1/22/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0004-201TC1-US |
16/535,692 |
8/8/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0007-101-US |
62/863,125 |
6/18/2019 |
DICHLORPHENAMIDE COMPOSITIONS AND METHODS OF USE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0008-101-US |
62/908,078 |
9/30/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0001-401-PC |
PCT/US19/63505 |
11/27/2019 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0002-401-PC |
PCT/US19/63507 |
1/29/2020 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
STRONGBRIDGE DUBLIN LIMITED |
STRG0004-401-PC |
PCT/US20/14250 |
1/20/2020 |
METHODS OF TREATING DISEASE WITH DICHLORPHENAMIDE |
DMS 17185250.10
DMS 17185250.10
Schedule 7.06
To Term Loan Agreement
CERTAIN LITIGATION
None.
DMS 17185250.10
Schedule 7.12
To Term Loan Agreement
INFORMATION REGARDING SUBSIDIARIES
Subsidiary |
Jurisdiction of Organization |
Direct Equity Holder |
Percentage of Subsidiary held by Direct Equity Holder |
Cortendo AB (Publ) |
Sweden |
Strongbridge Biopharma PLC |
100% |
Strongbridge U.S. Inc. |
Delaware |
Cortendo AB (publ) |
100% |
Strongbridge Dublin Limited |
Ireland |
Strongbridge Biopharma PLC |
100% |
DMS 17185250.10
Schedule 7.13(a)
To Term Loan Agreement
EXISTING INDEBTEDNESS OF PARENT GUARANTOR AND ITS SUBSIDIARIES
Part I
1. | Intra-group loan agreement dated 10 July 2019 pursuant to which the Company granted Strongbridge Dublin Limited a loan of USD 200,000,000 in four tranches. |
Part II
1. | Intra-group loan agreement dated 10 July 2019 pursuant to which the Company granted Strongbridge Dublin Limited a loan of USD 200,000,000 in four tranches. |
DMS 17185250.10
Schedule 7.13(b)
To Term Loan Agreement
LIENS GRANTED BY THE OBLIGORS
Part I
None.
Part II
None.
DMS 17185250.10
Schedule 7.14
To Term Loan Agreement
MATERIAL AGREEMENTS OF OBLIGORS
Refer to the contracts listed in the Exhibit Index to our 2019 10-K filed with the SEC on February 28th, 2020.
DMS 17185250.10
Schedule 7.15
To Term Loan Agreement
RESTRICTIVE AGREEMENTS
None.
DMS 17185250.10
Schedule 7.16
To Term Loan Agreement
Real Property Owned or Leased by PARENT guarantor OR ANY SUBSIDiARY
None.
Name |
Address/City/State/Zip Code (County) |
Description of Assets and Value |
---|---|---|
Strongbridge U.S. Inc. |
900 Northbrook Dr., Trevose PA |
Leased office |
Strongbridge Biopharma plc |
Fitzwilliam Hall, Suite 206, Fitzwilliam Place, Dublin 2, Ireland |
Leased office |
DMS 17185250.10
Schedule 7.17
To Term Loan Agreement
PENSION MATTERS
None.
DMS 17185250.10
Schedule 9.05
To Term Loan Agreement
EXISTING INVESTMENTS
None.
DMS 17185250.10
Schedule 9.10
To Term Loan Agreement
TRANSACTIONS WITH AFFILIATES
None.
DMS 17185250.10
Schedule 9.14
To Term Loan Agreement
PERMITTED SALES AND LEASEBACKS
None.
DMS 17185250.10
Exhibit A
To Term Loan Agreement
FORM OF GUARANTEE ASSUMPTION AGREEMENT
GUARANTEE ASSUMPTION AGREEMENT dated as of [DATE] by [NAME OF ADDITIONAL SUBSIDIARY GUARANTOR, a ___________ [corporation] [limited liability company] [other type of business entity] (the “Additional Obligor”), in favor of AVENUE VENTURE OPPORTUNITIES FUND, L.P., as administrative agent and collateral agent (the “Administrative Agent”) for the benefit of the Secured Parties under that certain Term Loan Agreement, dated as of May 19, 2020 (as amended, amended and restated, supplemented or otherwise modified from time to time, the “Loan Agreement”), among STRONGBRIDGE U.S. INC., a Delaware corporation (“Borrower”), STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY, a public limited company incorporated under the laws of Ireland (“Parent Guarantor”), STRONGBRIDGE DUBLIN LIMITED, a private limited company incorporated under the laws of Ireland (“Irish Guarantor”), CORTENDO AB (PUBL), a public limited liability company incorporated under the laws of Sweden with registration number 556537-6554 (“Swedish Guarantor” and together with the Borrower, Parent Guarantor, Irish Guarantor and each other Person that becomes, or is required to become, a “Subsidiary Guarantor” after the date hereof pursuant to Section 8.12(a) or (b) thereof, each an “Obligor” and collectively, the “Obligors”), Administrative Agent, the lenders from time to time party thereto and the Subsidiary Guarantors from time to time party thereto. The terms defined in the Loan Agreement are herein used as therein defined.
Pursuant to Section 8.12(a) of the Loan Agreement, the Additional Obligor hereby agrees to become a “Subsidiary Guarantor” for all purposes of the Loan Agreement, and a “Grantor” for all purposes of the Security Agreement. Without limiting the foregoing, the Additional Obligor hereby, jointly and severally with the other Guarantors, guarantees to the Lenders and their successors and assigns the prompt payment in full when due (whether at stated maturity, by acceleration or otherwise) of all Guaranteed Obligations (as defined in Section 14.01 of the Loan Agreement) in the same manner and to the same extent as is provided in Section 14 of the Loan Agreement. In addition, as of the date hereof, the Additional Obligor hereby makes the representations and warranties set forth in Sections 7.01, 7.02, 7.03, 7.05(a), 7.06, 7.07, 7.08 and 7.18 of the Loan Agreement, and in Section 2 of the Security Agreement, with respect to itself and its obligations under this Agreement and the other Loan Documents, as if each reference in such Sections to the Loan Documents included reference to this Agreement, such representations and warranties to be made as of the date hereof.
The Additional Obligor hereby instructs its counsel to deliver the opinions referred to in Section 8.12(a) of the Loan Agreement to Administrative Agent.
IN WITNESS WHEREOF, the Additional Obligor has caused this Guarantee Assumption Agreement to be duly executed and delivered as of the day and year first above written.
Exhibit A-1
[ADDITIONAL SUBSIDIARY GUARANTOR]
By
Name:
Title:
Exhibit A-2
Exhibit B
To Term Loan Agreement
FORM OF NOTICE OF BORROWING
Avenue Venture Opportunities Fund, L.P.
11 West 42nd Street, 9th Floor
New York, New York 10036
Reference is made to the Term Loan Agreement, dated as of May 19, 2020 (as the same may be amended, amended and restated, supplemented or otherwise modified from time to time, the “Loan Agreement”; the capitalized terms used herein as defined therein), among, among others, Avenue Venture Opportunities Fund, L.P., as administrative agent and collateral agent (in such capacities, the “Administrative Agent”), the lenders party thereto (each a “Lender” and collectively, the “Lenders”), and STRONGBRIDGE U.S. INC. (“Borrower”).
The undersigned is the [Chief Financial Officer] of Borrower and hereby requests on behalf of Borrower a Loan under the Loan Agreement, and in that connection certifies as follows:
1.The amount of the proposed Loan is _______________________ Dollars ($_________________). The date of the proposed Loan is ___________________ (the “Borrowing Date”).
(a)On the Borrowing Date, the Lenders will wire $[__________], less fees and expenses to be deducted on the Borrowing Date of $[_________] [with respect to the first Borrowing, only: [less $125,000 in respect of the commitment fee which has been paid to the Lenders prior to the date hereof,]] for net proceeds of $[___________] to Borrower pursuant to the following wire instructions:
Institution Name: |
Silicon Valley Bank |
Address: |
|
ABA No.: |
|
Contact Name: |
|
B-1
DMS 17185250.10
Phone No.: |
|
E-mail: |
|
Account Title: |
|
Account No.: |
|
(b)On the Borrowing Date, the Lenders will wire the following amounts for fees and expenses in accordance with the respective following wire instructions:2
Amount: |
$ |
Institution Name: |
Fifth Third Bank |
Address: |
251 North Illinois Ave, Indianapolis, IN 46204 |
ABA No.: |
042000314 |
E-mail: |
Please send remittance information to: wireconfirmations@btlaw.com |
Account Title: |
Barnes & Thornburg LLP Attorney Operating Account |
Account No.: |
7653510706 |
Amount: |
$ |
Institution Name: |
|
Address: |
|
ABA No.: |
|
Contact Name: |
|
Phone No.: |
|
E-mail: |
|
Account Title: |
|
Account No.: |
|
2.As of the date of this request and as of the Borrowing Date:
(a)Borrower (on behalf of itself and the other Credit Parties) hereby represents and warrants that no Default has occurred and is continuing, or will result from the making of the proposed Loan or the application of the proceeds thereof;
2 The executed Borrowing Request must be delivered 2 Business Days prior to the Closing Date.
B-2
DMS 17185250.10
(b)Borrower (on behalf of itself and the other Credit Parties) hereby represents and warrants that the representations and warranties contained in Section 7 of the Loan Agreement are true and correct on and as of the Borrowing Date, and immediately after giving effect to the application of the proceeds of the proposed Loan, with the same force and effect as if made on and as of such date (except that the representations and warranties that refer to a specific earlier date were true and correct on such earlier date);
(c)Borrower (on behalf of itself and the other Credit Parties) hereby represents and warrants that no Material Adverse Effect has occurred since the end of the period covered by the financial statements most recently delivered pursuant to Section 8.01(b) or is reasonably likely to occur after giving effect the proposed Loan; and
(d)Borrower hereby represents and warrants that the conditions precedent described in Section 6, with respect to the relevant Borrowing, and Section 6.05 of the Loan Agreement, with respect to each Borrowing, have been met.
Remainder of this page intentionally left blank; signature page follows
B-3
DMS 17185250.10
Borrower shall notify you promptly before the funding of the Loan if any of the matters to which I have certified above shall not be true and correct on the Borrowing Date.
Very truly yours,
STRONGBRIDGE U.S. INC.
Title:*
[Signature Page to Notice of Borrowing]
* Must be executed by Borrower’s Chief Financial Officer or other Responsible Officer.
B-4
DMS 17185250.10
Exhibit C-1
To Term Loan Agreement
FORM OF U.S. TAX COMPLIANCE CERTIFICATE
(For Foreign Lenders That Are Not Partnerships For U.S. Federal Income Tax Purposes)
Reference is hereby made to the Term Loan Agreement dated as of May 19, 2020 (as amended, amended and restated, supplemented or otherwise modified from time to time, the “Loan Agreement”), among STRONGBRIDGE U.S. INC., a Delaware corporation (the “Borrower"), STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY, a public limited company incorporated under the laws of Ireland (“Parent Guarantor”), STRONGBRIDGE DUBLIN LIMITED, a private limited company incorporated under the laws of Ireland (“Irish Guarantor”), CORTENDO AB (PUBL), a public limited liability company incorporated under the laws of Sweden with registration number 556537-6554 (“Swedish Guarantor” and together with the Borrower, Parent Guarantor, Irish Guarantor and each other Person that becomes, or is required to become, a “Subsidiary Guarantor” after the date thereof pursuant to Section 8.12(a) or (b) thereof, each an “Obligor” and collectively, the “Obligors”), Avenue Venture Opportunities Fund, L.P., as administrative agent and collateral agent (in such capacities, the “Administrative Agent”), and each lender from time to time party thereto.
Pursuant to the provisions of Section 5.03 of the Term Loan Agreement, the undersigned hereby certifies that (i) it is the sole record and beneficial owner of the Loan(s) in respect of which it is providing this certificate, (ii) it is not a bank within the meaning of Section 881(c)(3)(A) of the Code, (iii) it is not a ten percent shareholder of the Borrower within the meaning of Section 871(h)(3)(B) of the Code and (iv) it is not a controlled foreign corporation related to the Borrower as described in Section 881(c)(3)(C) of the Code.
The undersigned has furnished the Administrative Agent and the Borrower with a certificate of its non-U. S. Person status on IRS Form W-8BEN or W-8BEN-E, as applicable. By executing this certificate, the undersigned agrees that (1) if the information provided on this certificate changes, the undersigned shall promptly so inform the Borrower and the Administrative Agent, and (2) the undersigned shall have at all times furnished the Borrower and the Administrative Agent with a properly completed and currently effective certificate in either the calendar year in which each payment is to be made to the undersigned, or in either of the two calendar years preceding such payments.
Unless otherwise defined herein, terms defined in the Loan Agreement and used herein shall have the meanings given to them in the Loan Agreement.
[Signature follows]
Exhibit C-1-1
IN WITNESS WHEREOF, the undersigned has caused this certificate to be duly executed and delivered as of the date indicated below.
[NAME OF NON-U. S. LENDER]
By
Name:
Title:
Date:
Exhibit C-1-2
Exhibit C-2
To Term Loan Agreement
FORM OF U.S. TAX COMPLIANCE CERTIFICATE
(For Foreign Lenders That Are Not Partnerships For U.S. Federal Income Tax Purposes)
Reference is hereby made to the Term Loan Agreement dated as of May 19, 2020 (as amended, amended and restated, supplemented or otherwise modified from time to time, the “Loan Agreement”), among STRONGBRIDGE U.S. INC., a Delaware corporation (“Borrower”), STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY, a public limited company incorporated under the laws of Ireland “Parent Guarantor”), STRONGBRIDGE DUBLIN LIMITED, a private limited company incorporated under the laws of Ireland (“Irish Guarantor”), CORTENDO AB (PUBL), a public limited liability company incorporated under the laws of Sweden with registration number 556537-6554 (“Swedish Guarantor” and together with the Borrower, Parent Guarantor, Irish Guarantor and each other Person that becomes, or is required to become, a “Subsidiary Guarantor” after the date thereof pursuant to Section 8.12(a) or (b) thereof, each an “Obligor” and collectively, the “Obligors”), Avenue Venture Opportunities Fund, L.P., as administrative agent and collateral agent (in such capacities, the “Administrative Agent”), and each lender from time to time party thereto.
Pursuant to the provisions of Section 5.03 of the Loan Agreement, the undersigned hereby certifies that (i) it is the sole record and beneficial owner of the participation in respect of which it is providing this certificate, (ii) it is not a bank within the meaning of Section 881(c)(3)(A) of the Code, (iii) it is not a ten percent shareholder of the Borrower within the meaning of Section 871(h)(3)(B) of the Code, and (iv) it is not a controlled foreign corporation related to the Borrower as described in Section 881(c)(3)(C) of the Code.
The undersigned has furnished its participating Lender with a certificate of its non-U.S. Person status on IRS Form W-8BEN or W-8BEN-E, as applicable. By executing this certificate, the undersigned agrees that (1) if the information provided on this certificate changes, the undersigned shall promptly so inform such Lender in writing, and (2) the undersigned shall have at all times furnished such Lender with a properly completed and currently effective certificate in either the calendar year in which each payment is to be made to the undersigned, or in either of the two calendar years preceding such payments.
Unless otherwise defined herein, terms defined in the Loan Agreement and used herein shall have the meanings given to them in the Loan Agreement.
[Signature follows]
Exhibit C-2-1
IN WITNESS WHEREOF, the undersigned has caused this certificate to be duly executed and delivered as of the date indicated below.
[NAME OF NON-U.S. LENDER]
By
Name:
Title:
Date:
Exhibit C-2-2
Exhibit C-3
To Term Loan Agreement
FORM OF U.S. TAX COMPLIANCE CERTIFICATE
(For Foreign Lenders That Are Not Partnerships For U.S. Federal Income Tax Purposes)
Reference is hereby made to the Term Loan Agreement dated as of May 19, 2020 (as amended, amended and restated, supplemented or otherwise modified from time to time, the “Loan Agreement”), among STRONGBRIDGE U.S. INC., a Delaware corporation (“Borrower”), STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY, a public limited company incorporated under the laws of Ireland “Parent Guarantor”), STRONGBRIDGE DUBLIN LIMITED, a private limited company incorporated under the laws of Ireland (“Irish Guarantor”), CORTENDO AB (PUBL), a public limited liability company incorporated under the laws of Sweden with registration number 556537-6554 (“Swedish Guarantor” and together with the Borrower, Parent Guarantor, Irish Guarantor and each other Person that becomes, or is required to become, a “Subsidiary Guarantor” after the date thereof pursuant to Section 8.12(a) or (b) thereof, each an “Obligor” and collectively, the “Obligors”), Avenue Venture Opportunities Fund, L.P., as administrative agent and collateral agent (in such capacities, the “Administrative Agent”), and each lender from time to time party thereto.
Pursuant to the provisions of Section 5.03 of the Loan Agreement, the undersigned hereby certifies that (i) it is the sole record owner of the participation in respect of which it is providing this certificate, (ii) its direct or indirect partners/members are the sole beneficial owners of such participation, (iii) with respect such participation, neither the undersigned nor any of its direct or indirect partners/members is a bank extending credit pursuant to a loan agreement entered into in the ordinary course of its trade or business within the meaning of Section 881(c)(3)(A) of the Code, (iv) none of its direct or indirect partners/members is a ten percent shareholder of the Borrower within the meaning of Section 871(h)(3)(B) of the Code and (v) none of its direct or indirect partners/members is a controlled foreign corporation related to the Borrower as described in Section 881(c)(3)(C) of the Code.
The undersigned has furnished its participating Lender with IRS Form W-8IMY accompanied by one of the following forms from each of its partners/members that is claiming the portfolio interest exemption: (i) an IRS Form W-8BEN or W-8BEN-E, as applicable, or (ii) an IRS Form W-8IMY accompanied by an IRS Form W-8BEN or W-8BEN-E, as applicable, from each of such partner’s/member’s beneficial owners that is claiming the portfolio interest exemption. By executing this certificate, the undersigned agrees that (1) if the information provided on this certificate changes, the undersigned shall promptly so inform such Lender and (2) the undersigned shall have at all times furnished such Lender with a properly completed and currently effective certificate in either the calendar year in which each payment is to be made to the undersigned, or in either of the two calendar years preceding such payments.
Unless otherwise defined herein, terms defined in the Loan Agreement and used herein shall have the meanings given to them in the Loan Agreement.
[Signature follows]
Exhibit C-3-1
IN WITNESS WHEREOF, the undersigned has caused this certificate to be duly executed and delivered as of the date indicated below.
[NAME OF NON-U.S. LENDER]
By
Name:
Title:
Date:
Exhibit C-3-2
Exhibit C-4
To Term Loan Agreement
FORM OF U.S. TAX COMPLIANCE CERTIFICATE
(For Foreign Lenders That Are Partnerships For U.S. Federal Income Tax Purposes)
Reference is hereby made to the Term Loan Agreement dated as of May 19, 2020 (as amended, amended and restated, supplemented or otherwise modified from time to time, the “Loan Agreement”), among STRONGBRIDGE U.S. INC., a Delaware corporation (“Borrower”), STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY, a public limited company incorporated under the laws of Ireland “Parent Guarantor”), STRONGBRIDGE DUBLIN LIMITED, a private limited company incorporated under the laws of Ireland (“Irish Guarantor”), CORTENDO AB (PUBL), a public limited liability company incorporated under the laws of Sweden with registration number 556537-6554 (“Swedish Guarantor” and together with the Borrower, Parent Guarantor, Irish Guarantor and each other Person that becomes, or is required to become, a “Subsidiary Guarantor” after the date thereof pursuant to Section 8.12(a) or (b) thereof, each an “Obligor” and collectively, the “Obligors”), Avenue Venture Opportunities Fund, L.P., as administrative agent and collateral agent (in such capacities, the “Administrative Agent”), and each lender from time to time party thereto.
Pursuant to the provisions of Section 5.03 of the Loan Agreement, the undersigned hereby certifies that (i) it is the sole record owner of the Loan(s) in respect of which it is providing this certificate, (ii) its direct or indirect partners/members are the sole beneficial owners of such Loan(s), (iii) with respect to the extension of credit pursuant to this Loan Agreement or any other Loan Document, neither the undersigned nor any of its direct or indirect partners/members is a bank extending credit pursuant to a loan agreement entered into in the ordinary course of its trade or business within the meaning of Section 881(c)(3)(A) of the Code, (iv) none of its direct or indirect partners/members is a ten percent shareholder of the Borrower within the meaning of Section 871(h)(3)(B) of the Code and (v) none of its direct or indirect partners/members is a controlled foreign corporation related to the Borrower as described in Section 881(c)(3)(C) of the Code.
The undersigned has furnished the Administrative Agent and the Borrower with IRS Form W-8IMY accompanied by one of the following forms from each of its partners/members that is claiming the portfolio interest exemption: (i) an IRS Form W-8BEN or W-8BEN-E, as applicable, or (ii) an IRS Form W-8IMY accompanied by an IRS Form W-8BEN or W-8BEN-E, as applicable, from each of such partner’s/member’s beneficial owners that is claiming the portfolio interest exemption. By executing this certificate, the undersigned agrees that (1) if the information provided on this certificate changes, the undersigned shall promptly so inform the Borrower and the Administrative Agent, and (2) the undersigned shall have at all times furnished the Borrower and the Administrative Agent with a properly completed and currently effective certificate in either the calendar year in which each payment is to be made to the undersigned, or in either of the two calendar years preceding such payments.
Unless otherwise defined herein, terms defined in the Loan Agreement and used herein shall have the meanings given to them in the Loan Agreement.
[Signature follows]
Exhibit C-4-1
IN WITNESS WHEREOF, the undersigned has caused this certificate to be duly executed and delivered as of the date indicated below.
[NAME OF NON-U.S. LENDER]
By
Name:
Title:
Date:
Exhibit C-4-2
Exhibit D
To Term Loan Agreement
FORM OF COMPLIANCE CERTIFICATE
Avenue Venture Opportunities Fund, L.P.
11 West 42nd Street, 9th Floor
New York, New York 10036
Re:STRONGBRIDGE U.S. INC. (for itself and on behalf of the other Obligors party to the Loan Agreement (as defined below))
Ladies and Gentlemen:
Reference is made to the Term Loan Agreement, dated as of May 19, 2020 (as the same may be amended, amended and restated, supplemented or otherwise modified from time to time, the “Loan Agreement”; the capitalized terms used herein as defined therein), among, among others, Avenue Venture Opportunities Fund, L.P., as administrative agent and collateral agent (in such capacities, the “Administrative Agent”), and the lenders party thereto (each a “Lender” and collectively, the “Lenders”), and STRONGBRIDGE U.S. INC. (for itself and on behalf of all other Credit Parties (under and as defined in the Loan Agreement), “Borrower”).
The undersigned Responsible Officer of Borrower hereby certifies in such capacity that in accordance with the terms and conditions of the Loan Agreement, (i) no Event of Default has occurred and is continuing, except as noted below, and (ii) Borrower is in compliance for the financial reporting period ending ____________________________ with all required financial reporting under Section 8.01 of the Loan Agreement, except as noted below. Attached herewith are the required documents supporting the foregoing certification. The undersigned Responsible Officer of Borrower further certifies in such capacity that: (a) the accompanying financial statements have been prepared in accordance with GAAP consistently applied for such period; and (b) the financial statements fairly present in all material respects the financial condition and operating results of Parent Guarantor and its Subsidiaries as of the dates, and for the periods, indicated therein, subject to the absence of footnotes and normal year-end audit adjustments (in the case of interim monthly financial statements), except as explained below.
Please provide the following requested information and indicate compliance status by circling (or otherwise indicating) Yes/No under “Included/Complies”:
3) |
Annual Financial Projections/Budget (prepared on a monthly basis) |
Annually (within 10 days of FYE), and when revised |
|
Yes |
No |
N/A |
4) |
8-K, 10-K and 10-Q Filings |
Within 5 days of filing |
|
Yes |
No |
N/A |
5) |
Compliance Certificate |
Monthly within 30 days; Annually within 90 days |
|
Yes |
No |
N/A |
6) |
IP Report |
Quarterly within 45 days |
|
Yes |
No |
N/A |
7) |
Total amount of Borrower’s cash and cash equivalents at the last day of the measurement period |
|
$_______ |
Yes |
No |
N/A |
8) |
Total amount of Borrower’s Subsidiaries’ cash and cash equivalents at the last day of the measurement period |
|
$_______ |
Yes |
No |
N/A |
Deposit and Securities Accounts
(Please list all accounts; attach separate sheet if additional space needed)
|
Credit Party /
|
Account Number |
New Account? |
Account Control Agreement in place? |
||
1) |
|
|
Yes |
No |
Yes |
No |
2) |
|
|
Yes |
No |
Yes |
No |
3) |
|
|
Yes |
No |
Yes |
No |
4) |
|
|
Yes |
No |
Yes |
No |
Other Matters
1) |
Have there been any changes in management since the last Compliance Certificate? |
Yes |
No |
|
|
|
|
2) |
Have there been any Asset Sales or any transfers/sales/disposals/retirement of Collateral or IP prohibited by the Loan Agreement? |
Yes |
No |
|
|
|
|
3) |
Have there been any new or pending claims or causes of action against any Credit Party that involve more than One Hundred Thousand Dollars ($100,000.00)? |
Yes |
No |
|
|
|
|
4) |
Have there been any amendments of or other changes to Operating Documents of any Credit Party or any of its Subsidiaries? If yes, provide |
Yes |
No |
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copies of any such amendments or changes with this Compliance Certificate. |
|||
5) |
Has any Credit Party directly or indirectly acquired or created, or does any Credit Party intend, directly or indirectly, to acquire or create, any Subsidiary or other Person other than any Excluded Foreign Subsidiary not required to be a Subsidiary Guarantor or Borrower under Section 8.12(b)(i) of the Loan Agreement? If yes, has such Subsidiary or Person been made a guarantor of the Obligations? Please complete the table below. |
Yes |
No |
|
Name: |
Jurisdiction of formation or organization:3 |
Co-borrower or guarantor ? |
Complies? |
New Subsidiary or Person? |
1.) |
_______________________ |
______________________ |
YES / NO |
YES / NO |
YES / NO |
2.) |
_______________________ |
_______________________ |
YES / NO |
YES / NO |
YES / NO |
3.) |
_______________________ |
_______________________ |
YES / NO |
YES / NO |
YES / NO |
4.) |
________________________ |
_______________________ |
YES / NO |
YES / NO |
YES / NO |
Exceptions
Please explain any exceptions with respect to the certification above: (If no exceptions exist, state “No exceptions.” Attach separate sheet if additional space needed.)
[Remainder of this page intentionally left blank; signature page follows]
3 Under the “Explanations” heading (see below) please include a description of such Subsidiary’s or Person’s fully diluted capitalization and Borrower’s purpose for its acquisition or creation of such Subsidiary if such information has not been previously furnished to Lender.
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IN WITNESS WHEREOF, the undersigned has executed this certificate on the date first written above.
STRONGBRIDGE U.S. INC.,
for itself and on behalf of all Credit Parties party to the Loan Agreement
By:
Name:
Title:*
[Signature page to Compliance Certificate]
* Must be executed by Borrower’s Chief Financial Officer or other executive officer.
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Annex A to Compliance Certificate
FINANCIAL STATEMENTS
[see attached]
D-5
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Exhibit E
To Term Loan Agreement
[RESERVED]
Exhibit E
Exhibit F
To Term Loan Agreement
FORM OF LANDLORD CONSENT
RECORDING REQUESTED BY
AND WHEN RECORDED RETURN TO:
AVENUE VENTURE OPPORTUNITIES FUND, L.P.
11 W. 42nd St., 9th Floor
New York, NY 10036
Attn:
CONSENT TO REMOVAL OF PERSONAL PROPERTY
KNOW ALL PERSONS BY THESE PRESENTS:
(a)This Consent to Removal of Personal Property is dated as of May 19, 2020.
(b)The undersigned has an interest in the real property at the location described on Attachment 1 (the “Real Property”).
(c)STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY, a public limited company incorporated under the laws of Ireland with company number 562659 and having its registered office at Fitzwilliam Hall, Suite 206, Fitzwilliam Place, Dublin 2, Ireland (“Parent Guarantor”), STRONGBRIDGE DUBLIN LIMITED, a private limited company incorporated under the laws of Ireland (“Irish Guarantor”), CORTENDO AB (PUBL), a public limited liability company incorporated under the laws of Sweden with corporate identity number 556537-6554 (“Swedish Guarantor”) and STRONGBRIDGE U.S. INC., a Delaware corporation with an office located at 900 Northbrook Drive, Suite 200, Trevose, Pennsylvania 19053 (“Borrower” and together with Parent Guarantor, Irish Guarantor and Swedish Guarantor, individually and collectively, jointly and severally, “Obligor”), has entered into or will enter into a Term Loan Agreement with AVENUE VENTURE OPPORTUNITIES FUND, L.P. as Administrative Agent and Collateral Agent (“Avenue” and in such capacity, “Collateral Agent”), the lenders that become a party thereto from time to time (each a “Lender” and collectively, the “Lenders”), (as amended, amended and restated, supplemented or otherwise modified from time to time, the “Loan Agreement”). As a condition to entering into the Loan Agreement, Collateral Agent and Lenders require that the undersigned consent to the removal by Collateral Agent of Obligor’s personal property assets serving as collateral for Obligor’s obligations to Collateral Agent and Lenders under the Loan Agreement (hereinafter called “Collateral”) from the Real Property.
NOW, THEREFORE, the undersigned consents to the placing of the Collateral on the Real Property, and agrees with Collateral Agent as follows:
1.The undersigned waives and releases each and every right which undersigned now has under applicable law or by virtue of the lease for the Real Property now in effect, to
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levy or distrain upon for rent, in arrears, in advance or both, or to claim or assert title to the Collateral that is located on the Real Property.
2.The Collateral shall be considered to be personal property and shall not be considered part of the Real Property regardless of whether or by what means it is or may become attached or affixed to the Real Property. The undersigned shall (a) provide written notice to Collateral Agent of any termination or expiration of the lease (a “Termination Notice”), and (b) will not dispose of any of the Collateral nor assert any right or interest therein unless it has first sent such Termination Notice to Collateral Agent and has given Collateral Agent a reasonable period of time (in any case, not less than thirty (30) days after Collateral Agent’s receipt of such Termination Notice) to exercise Collateral Agent’s rights in and to the Collateral.
3.The undersigned will permit Collateral Agent, or its agent or representative, to enter upon the Real Property for the purpose of exercising any right Collateral Agent may have under the terms of the Loan Agreement, at law, or in equity, including, without limitation, the right to remove the Collateral; provided, however, that if Collateral Agent, in removing the Collateral, causes any physical damage to the Real Property, Collateral Agent, will, at its expense, cause the same to be repaired to the condition such Real Property was in prior to said damage; provided, further, Collateral Agent shall not be liable for any diminution in value of the Real Property caused by the absence of any item Collateral so removed. If Obligor abandons the Collateral located on the Real Property upon termination or expiration of the Lease, Collateral Agent shall have the option to remove the Collateral from the Real Property within thirty (30) days after receipt of written notice thereof from the undersigned or Collateral Agent’s right to such Collateral shall be deemed forfeited. Notwithstanding the foregoing, Collateral Agent shall not have any duty or obligation to remove or dispose of any Collateral or any other property left on the Real Property by the Obligor.
4.This agreement shall be binding upon the successors and assigns of the undersigned and shall inure to the benefit of Collateral Agent and its successors and assigns.
[Balance of Page Intentionally Left Blank]
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NORTHBROOK
TC EQUITIES LLC
NORTHBROOK 134 WEST 93
EQUITIES LLC
NORTHBROOK LEMAD EQUITIES
LLC
NORTHBROOK CH EQUITIES LLC
NORTHBROOK CLINTON EQUITIES
LLC
NORTHBROOK UK1 EQUITIES LLC
NORTHBROOK LOKEN LLC
NORTHBROOK HS DEVELOPMENT
LLC
NORTHBROOK HS RK LLC
NORTHBROOK TEIDIF LLC
As Tenants in Common, as
Landlord
By:
Name:
Title:
AVENUE VENTURE OPPORTUNITIES FUND, L.P., as Administrative
Agent and Collateral Agent
By:
Name:
Title:
Acknowledged and agreed:
OBLIGORS:
Given under the common seal of STRONGBRIDGE
BIOPHARMA PUBLIC LIMITED COMPANY and
delivered as a deed
By:
Name:
Title: _________________________
Exhibit F-3
[SIGNATURE PATE TO LANDLORD CONSENT]
By:
Name:
Title: _________________________
CORTENDO AB (PUBL)
By:
Name:
Title:
Exhibit F-3
[SIGNATURE PATE TO LANDLORD CONSENT]
STRONGBRIDGE U.S. INC.
By:
Name:
Title:
STRONGBRIDGE DUBLIN LIMITED
By:
Name:
Title:
Exhibit F-4
[SIGNATURE PATE TO LANDLORD CONSENT]
Attachment 1
Approximately 22,069 rentable square feet of space located in Suites 200 and 250 of that certain building located at 900 Northbrook Drive, Trevose, Pennsylvania 19053.
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Exhibit G
To Term Loan Agreement
FORM OF SUBORDINATION AGREEMENT
This Subordination Agreement is made as of [ ] (this “Agreement”) among AVENUE VENTURE OPPORTUNITIES FUND, L.P., a Delaware limited partnership “Senior Agent”), and [ ], a [ ] [corporation] (“Subordinated Creditor”).
A.[APPLICABLE CREDIT PARTY], a [ ] (“Credit Party”), will, as of the date hereof, issue in favor of Subordinated Creditor the Subordinated Note (as defined below).
B.Senior Creditors, Credit Party and certain of its subsidiaries and affiliates have entered into the Senior Loan Agreement (as defined below), and Senior Agent, Credit Party and certain of its subsidiaries and affiliates have entered into the Senior Security Agreement (as defined below) under which Credit Party and such subsidiaries and affiliates have granted a security interest in the Collateral (as defined below) in favor of the Senior Creditors as security for the payment of Credit Party’s obligations under the Senior Loan Agreement.
C.To induce Lenders under and as defined in the Senior Loan Agreement referred to below to make and maintain the credit extensions to the Credit Party and the other borrowers under the Senior Loan Agreement, Subordinated Creditor is willing to subordinate the Subordinated Debt (as defined below) to the Senior Debt (as defined below) on the terms and conditions herein set forth.
NOW, THEREFORE, THE PARTIES AGREE AS FOLLOWS:
“Bankruptcy Code” means title 11 of the United States Code, 11 U.S.C. §§ 101 et seq.
“Collateral’ has the meaning set forth in the Senior Security Agreement.
“Enforcement Action” means, with respect to any indebtedness, obligation (contingent or otherwise) or Collateral at any time held by any lender or noteholder, (i) commencing, by judicial or non-judicial means, the enforcement of, or otherwise attempting to enforce, such indebtedness, obligation or Collateral of any of the default remedies under any of the applicable agreements or documents of such lender or noteholder, the UCC or other applicable law (other than the mere issuance of a notice of default or notice of the right by such lender or noteholder to seek specific performance with respect to any covenants in favor of such lender or noteholder), (ii) repossessing, selling, leasing or otherwise disposing of all or any part of such Collateral, including without limitation causing any attachment of, levy upon, execution against, foreclosure upon or the taking of other action against or institution of other proceedings with respect to any Collateral, or exercising account debtor or obligor notification or collection rights with respect to all or any portion thereof, or attempting or agreeing to do so, (iii) appropriating, setting off or applying to such lender or noteholder’s claim any part or all of such Collateral or other property
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in the possession of, or coming into the possession of, such lender or noteholder or its agent, trustee or bailee, (iv) asserting any claim or interest in any insurance with respect to such indebtedness, obligation or Collateral, (v) instituting or commencing, or joining with any Person in commencing, any action or proceeding with respect to any of the foregoing rights or remedies (including any action of foreclosure, enforcement, collection or execution and any Insolvency Event involving any Obligor), (vi) exercising any rights under any lockbox agreement, account control agreement, landlord waiver or bailee’s letter or similar agreement or arrangement to which the Subordinated Creditor is a party or (vii) otherwise enforcing, or attempting to enforce, any other rights or remedies under or with respect to any such indebtedness, obligation or Collateral.
“Insolvency Event” means that any Obligor or any of its subsidiaries shall have (i) applied for, consented to or acquiesced in the appointment of a trustee, receiver or other custodian for it or any of its property, or (ii) made a general assignment for the benefit of creditors or similar arrangement in respect of such Obligor’s or subsidiary’s creditors generally or any substantial portion thereof, or (iii) permitted, consented to, or suffered to exist the appointment of a trustee, receiver or other custodian for it or for a substantial part of its property, or (iv) commenced any case, action or proceeding before any court or other governmental agency or authority relating to bankruptcy, reorganization, insolvency, debt arrangement or relief or other case, action or proceeding under any bankruptcy or insolvency law, or any dissolution, winding up or liquidation case, action or proceeding, including without limitation any case under the Bankruptcy Code, in respect of it, or (v) (A) permitted, consented to, or suffered to exist the commencement of any case, action or proceeding before any court or other governmental agency or authority relating to bankruptcy, reorganization, insolvency, debt arrangement or relief or other case, action or proceeding under any bankruptcy or insolvency law, or any dissolution, winding up or liquidation case, action or proceeding, including without limitation any case under the Bankruptcy Code, in respect of it, or (B) any such case, action or proceeding shall have resulted in the entry of an order for relief or shall have remained for sixty (60) days undismissed.
“Obligor” has the meaning set forth in the Senior Loan Agreement.
“Person” has the meaning set forth in the Senior Loan Agreement.
“Senior Creditors” means Senior Agent and the Lenders under and as defined in the Senior Loan Agreement.
“Senior Debt” means the Obligations (as defined in the Senior Loan Agreement).
“Senior Discharge Date” means the first date on which all of the Senior Debt (other than contingent indemnification obligations has been paid indefeasibly in full in cash and all commitments of Senior Lenders under the Senior Loan Documents have been terminated.
“Senior Loan Agreement” means that certain Term Loan Agreement, dated as of May 19, 2020, by and among Strongbridge U.S. Inc., as borrower, Strongbridge Biopharma Public Limited Company, as guarantor, Strongbridge Dublin Limited, as guarantor, and Cortendo AB (publ), as guarantor, the other subsidiary guarantors from time to time party thereto, and the
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Senior Creditors, as amended, amended and restated, supplemented or otherwise modified from time to time.
“Senior Loan Documents” means, collectively, the Loan Documents (as defined in the Senior Loan Agreement), in each case as amended, amended and restated, supplemented or otherwise modified from time to time.
“Senior Security Agreement” means that certain Security Agreement, dated as of May 19, 2020, among each Obligor party thereto, and Senior Agent, as amended, amended and restated, supplemented or otherwise modified from time to time.
“Subordinated Debt” means and includes all obligations, liabilities and indebtedness of APPLICABLE CREDIT PARTY] owed to Subordinated Creditor, whether direct or indirect, absolute or contingent, due or to become due, or now existing or hereafter incurred, including without limitation, principal, premium (if any), interest, fees, charges, expenses, costs, professional fees and expenses, and reimbursement obligations.
“Subordinated Debt Documents’“ means, collectively, the Subordinated Note and each other loan document or agreement entered into by [APPLICABLE CREDIT PARTY] in connection with the Subordinated Note, as amended, amended and restated, supplemented or otherwise modified from time to time.
“Subordinated Note” means that certain $[ ] subordinated promissory note, dated [_______], issued by [APPLICABLE CREDIT PARTY] to Subordinated Creditor, as amended, amended and restated, supplemented or otherwise modified from time to time.
“UCC’ means the Uniform Commercial Code of any applicable jurisdiction and, if the applicable jurisdiction shall not have any Uniform Commercial Code, the Uniform Commercial Code as in effect in the State of New York.
(b)Subordinated Creditor acknowledges that the Senior Creditors have been granted liens upon the Collateral, and Subordinated Creditor hereby consents thereto and to the incurrence of the Senior Debt.
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(c)Until the Senior Discharge Date, in the event of any private or public sale or other disposition of all or any portion of the Collateral, Subordinated Creditor agrees that such Collateral shall be sold or otherwise disposed of free and clear of any liens in favor of Subordinated Creditor. Subordinated Creditor agrees that any such sale or disposition of Collateral shall not require any consent from Subordinated Creditor, and Subordinated Creditor hereby waives any right it may have to object to such sale or disposition.
(b)Subordinated Creditor must deliver to the Senior Agent in the form received (except for endorsement or assignment by Subordinated Creditor) any payment, distribution, security or proceeds it receives on the Subordinated Debt other than according to this Agreement.
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(b)Without limiting the generality of the other provisions of this Agreement, until the Senior Discharge Date, without the express written consent of the Senior Agent, Subordinated Creditor shall not institute or commence (nor shall it join with or support any third party instituting, commencing, opposing, objecting or contesting, as the case may be, or otherwise suffer to exist), any Insolvency Event involving Credit Party or any other Obligor.
(c)The Senior Creditors shall have the right to enforce rights, exercise remedies (including set-off and the right to credit bid its debt) and make determinations regarding the release, disposition, or restrictions with respect to the Collateral without any consultation with or consent of Subordinated Creditor.
(d)Subordinated Creditor will not, and hereby waives any right to bring, join in, or otherwise support or take any action to (i) contest the validity, legality, enforceability, perfection, priority or avoidability of any of the Senior Debt, any of the Senior Loan Documents or any security interests and/or liens of the Senior Creditors on or in any property or assets of Credit Party or any other Obligor, including without limitation, the Collateral; (ii) interfere with or in any manner oppose or support any other Person in opposing any foreclosure on or other disposition of any Collateral by the Senior Creditors in accordance with applicable law, or otherwise to contest, protest, object to or interfere with the manner in which the Senior Creditors may seek to enforce the Liens on any Collateral; (iii) provide a debtor-in-possession facility (including on a priming basis) to Credit Party or any other Obligor, under Section 362, 363 or 364 of the Bankruptcy Code or any other applicable law, without the consent, in their sole discretion, of the Senior Creditors; or (iv) exercise any rights against the Senior Creditors or the Collateral under Section 506(c) of the Bankruptcy Code.
(e)Subordinated Creditor will not, and hereby waives any right to, oppose, contest, object to, join in, or otherwise support any opposition to or objection with respect to, (i) any request or motion of the Senior Creditors seeking, pursuant to Section 362(d) of the Bankruptcy Code or otherwise, the modification, lifting or vacating of the automatic stay of Section 362(a) of the Bankruptcy Code or from any other stay in connection with any Insolvency Event or seeking adequate protection of the Senior Creditors’ interests in the Collateral or with respect to the Senior Debt (whether under Sections 362, 363, and/or 364 of the Bankruptcy Code or other applicable law), and, until Senior Discharge Date, Subordinated Creditor agrees that it shall not seek relief from such automatic stay without the prior written consent of the Senior Agent; (ii) any debtor-in-possession financing (including on a priming basis) or use of cash collateral (as
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defined in Section 363(a) of the Bankruptcy Code or other applicable law) arrangement by Credit Party or any other Obligor, whether from the Senior Creditors or any other third party under Section 362, 363 or 364 of the Bankruptcy Code or any other applicable law, if the Senior Creditors, in their sole discretion, consent to such debtor-in-possession financing or cash collateral arrangement, and Subordinated Creditor shall not request adequate protection (whether under Sections 362, 363, and/or 364 of the Bankruptcy Code or other applicable law) or any other relief in connection therewith; (iii) any sale or other disposition of the Collateral or substantially all of the assets of Credit Party or any other Obligor (include any such sale free and clear of liens or other claims) under Section 363 of the Bankruptcy Code or other applicable law if the Senior Creditors, in their sole discretion, consent to such sale or disposition; (vii) the Senior Creditors’ exercise or enforcement of its right to make an election under Section 1111(b) of the Bankruptcy Code, and Subordinated Creditor hereby waives any claim it may hereafter have against the Senior Creditors arising out of such election; (viii) the Senior Creditors’ exercise or enforcement of its right to credit bid any or all of its debt claims against Credit Party or any other Obligor, including, without limitation, the Senior Debt; or (ix) any plan of reorganization or liquidation if the Senior Creditors, in their sole discretion, consent to, vote in favor of, or otherwise do not oppose such plan of reorganization or liquidation, and, in furtherance thereof, Subordinated Creditor hereby grants to the Senior Creditors the right to vote Subordinated Creditor’s claim or claims (as such term is defined in the Bankruptcy Code) arising on account of or in connection with the Subordinated Debt, as Subordinated Creditor’s agent, with respect to any plan of reorganization or liquidation to which Subordinated Creditor may be entitled to vote in any bankruptcy or liquidation proceeding or in connection with any other Insolvency Event of Credit Party or any other Obligor.
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(a)file any claims in respect of the Subordinated Debt on behalf of Subordinated Creditor if Subordinated Creditor does not do so at least 30 days before the time to file claims expires; and
(b)vote Subordinated Creditor’s claim or claims (as such term is defined in the Bankruptcy Code) arising on account of or in connection with the Subordinated Debt, as Subordinated Creditor’s agent, with respect to any plan of reorganization or liquidation to which Subordinated Creditor may be entitled to vote in any bankruptcy or liquidation proceeding or in connection with any other Insolvency Event of Credit Party or any other Obligor.
Such power of attorney is irrevocable and coupled with an interest.
(b)Until the Senior Discharge Date, Subordinated Creditor shall not, without prior written consent of the Senior Agent, agree to any amendment, modification or waiver of any provision of the Subordinated Debt Documents, if the effect of such amendment, modification or waiver is to: (i) terminate or impair the subordination of the Subordinated Debt in favor of the Senior Creditors; (ii) increase the interest rate on the Subordinated Debt or change (to earlier dates) the dates upon which principal, interest and other sums are due under the Subordinated Note; (iii) alter the redemption, prepayment or subordination provisions of the Subordinated Debt; (iv) impose on Credit Party or any other Obligor any new or additional prepayment charges, premiums, reimbursement obligations, reimbursable costs or expenses, fees or other payment obligations; (v) alter the representations, warranties, covenants, events of default, remedies and other provisions in a manner which would make such provisions materially more onerous, restrictive or burdensome to Credit Party or any other Obligor; (vi) grant a lien or security interest in favor of any holder of the Subordinated Debt on any asset or Collateral to secure all or any portion of the Subordinated Debt; or (vii) otherwise increase the obligations, liabilities and indebtedness in respect of the Subordinated Debt or confer additional rights upon Subordinated Creditor, which individually or in the aggregate would be materially adverse to Credit Party, any other Obligor or the Senior Creditors. Any such amendment, modification or waiver made in violation of this Section 10(b) shall be void.
(c)At any time without notice to Subordinated Creditor, the Senior Creditors may take such action with respect to the Senior Debt as the Senior Creditors, in their sole discretion, may deem appropriate, including, without limitation, terminating advances, increasing the principal, extending the time of payment, increasing interest rates, renewing, compromising or otherwise amending any documents affecting the Senior Debt and any Collateral securing the Senior Debt, and enforcing or failing to enforce any rights against Credit Party or any other
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person. No action or inaction will impair or otherwise affect any Senior Creditor’s rights under this Agreement.
(b) Subordinated Creditor confirms that this Agreement shall govern as between the Senior Creditors and the Subordinated Creditor irrespective of: (i) any lack of validity or enforceability of any Senior Loan Document or any Subordinated Debt Document; (ii) the occurrence of any Insolvency Event in respect of any Obligor; (iii) whether the Senior Debt, or the liens or security interests securing the Senior Debt, shall be held to be unperfected, deficient, invalid, void, voidable, voided, unenforceable, subordinated, reduced, discharged or are set aside by a court of competent jurisdiction, including pursuant or in connection with any Insolvency Event; (iv) any change in the time, manner or place of payment of, or in any other terms of, all or any of the Senior Debt or the Subordinated Debt, or any amendment or waiver or other modification, including any increase in the amount thereof, whether by course of conduct or otherwise, of the terms of any Senior Loan Document or any Subordinated Debt Document or any guarantee thereof; or (v) any other circumstances which otherwise might constitute a defense available to, or a discharge of, any Obligor in respect of the Senior Debt or the Subordinated Debt.
(a)all action on the part of Subordinated Creditor, its officers, directors, partners, members and shareholders, as applicable, necessary for the authorization of this Agreement and the performance of all obligations of Subordinated Creditor hereunder has been taken;
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(b)this Agreement constitutes the legal, valid and binding obligation of Subordinated Creditor, enforceable against Subordinated Creditor in accordance with its terms;
(c)the execution, delivery and performance of and compliance with this Agreement by Subordinated Creditor will not (i) result in any material violation or default of any term of any of Subordinated Creditor’s charter, formation or other organizational documents (such as Articles or Certificate of Incorporation, bylaws, partnership agreement, operating agreement, etc.) or (ii) violate any material applicable law, rule or regulation; and
(d)Subordinated Creditor has not previously assigned any interest in the Subordinated Debt, and no Person other than the Subordinated Creditor owns an interest in the Subordinated Debt.
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(b)EACH PARTY HERETO WAIVES ITS RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION BASED UPON OR ARISING OUT OF THIS AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREIN.
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[Signature pages follow]
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IN WITNESS WHEREOF, the undersigned have executed this Agreement as of the date first above written.
SUBORDINATED CREDITOR:
[__________]
By____________________________
Name:
Title:
Address for Notices:
[__________]
[__________]
[__________]
Attn: [__________]
Tel.: [__________]
Fax: [__________]
Email: [__________]
SENIOR AGENT (on behalf of the SENIOR CREDITORS):
AVENUE VENTURE OPPORTUNITIES FUND, L.P.
By
Name:
Title:
Address for Notices:
11 W. 42nd St., 9th Floor
New York, NY 10036
Attn:
Tel:
Fax:
Email:
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[INSERT NAME OF APPLICABLE
CREDIT PARTY]
By____________________________
Name:
Title:
Address for Notices:
[__________]
[__________]
[__________]
Attn: [__________]
Tel.: [__________]
Fax: [__________]
Email: [__________]
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Exhibit H
To Term Loan Agreement
[RESERVED]
H
Exhibit I
To Term Loan Agreement
FORM OF WARRANT
THIS WARRANT AND THE UNDERLYING SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE. THESE SECURITIES MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED EXCEPT AS PERMITTED UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS IN ACCORDANCE WITH APPLICABLE REGISTRATION REQUIREMENTS OR AN EXEMPTION THEREFROM. THE ISSUER OF THESE SECURITIES MAY REQUIRE AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE ISSUER THAT SUCH OFFER, SALE, TRANSFER, PLEDGE OR HYPOTHECATION OTHERWISE COMPLIES WITH THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS. THIS WARRANT MUST BE SURRENDERED TO THE COMPANY OR ITS TRANSFER AGENT AS A CONDITION PRECEDENT TO THE SALE, TRANSFER, PLEDGE OR HYPOTHECATION OF ANY INTEREST IN ANY OF THE SECURITIES REPRESENTED HEREBY.
WARRANT TO PURCHASE ORDINARY SHARES
OF
STRONGBRIDGE BIOPHARMA PLC
Dated as of [ ], [ ] (the “Issue Date”)
Void after the date specified in Section 8
Warrant to Purchase
[__] Ordinary Shares
(subject to adjustment)
THIS CERTIFIES THAT, for value received, [ ], or its registered assigns (the “Holder”), is entitled, subject to the provisions and upon the terms and conditions set forth herein, to purchase from STRONGBRIDGE BIOPHARMA PLC, a public limited company incorporated under the laws of Ireland (the “Company”) that number of shares (the “Shares”) of the Company’s ordinary shares, of nominal value $0.01 per share (the “Ordinary Shares”), at such times and at the price per Share, set forth in Section 1. The term “Warrant” as used herein shall include this Warrant and any warrants delivered in substitution or exchange therefor as provided herein. This Warrant is issued in connection with the transactions described in the Term Loan Agreement, dated as of May 19, 2020, by and between the Company, the Borrower and Subsidiary Guarantors (each as defined therein) from time to time party thereto, the Lenders from time to time party thereto and Avenue Venture Opportunities Fund, L.P.
The following is a statement of the rights of the Holder and the conditions to which this Warrant is subject, and to which Holder, by acceptance of this Warrant, agrees:
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X = Y(A-B)
A
Where:
X = |
The number of Shares to be issued to the Holder |
Y = |
The number of Shares to be purchased (as specified in paragraph 1 of the applicable Notice of Exercise) |
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A = |
The fair market value of one Ordinary Share (at the date of such calculation) |
B = |
The Exercise Price (as adjusted to the date of such calculation) less the nominal value of one Ordinary Share |
For purposes of the calculation above, the fair market value of one Share shall be determined as follows:
For purposes hereof, the date of calculation shall be the date the Holder sends to the Company a Notice of Exercise. “Trading Day” means a day in which trading in the Ordinary Shares generally occurs on The Nasdaq Global Select Market or if the Ordinary Shares are not then listed on The Nasdaq Global Select Market, on the principal other U.S. national or regional securities exchange on which the Ordinary Shares are then listed, or if the Ordinary Shares are not then listed on a U.S. national or regional securities exchange, on the principal other market on which the Ordinary Shares are then traded. If the Ordinary Shares are not so listed or traded. “Trading Day” means any Business Day. “Business Day” means any day other than a Saturday, a Sunday or a day on which the Federal Reserve Bank of New York is authorized or required by law or executive order to close or be closed.
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I-4
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THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR UNDER THE SECURITIES LAWS OF CERTAIN STATES. THESE SECURITIES MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR
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HYPOTHECATED EXCEPT AS PERMITTED UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS IN ACCORDANCE WITH APPLICABLE REGISTRATION REQUIREMENTS OR AN EXEMPTION THEREFROM. THE ISSUER OF THESE SECURITIES MAY REQUIRE AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE ISSUER THAT SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION OTHERWISE COMPLIES WITH THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS. THIS CERTIFICATE MUST BE SURRENDERED TO THE COMPANY OR ITS TRANSFER AGENT AS A CONDITION PRECEDENT TO THE SALE, TRANSFER, PLEDGE OR HYPOTHECATION OF ANY INTEREST IN ANY OF THE SECURITIES REPRESENTED HEREBY.
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the Company shall send to the Holder of this Warrant at least ten (10) calendar days prior written notice of the date on which a record shall be taken for any such dividend or distribution specified in clause (a) or the expected effective date of any such other event specified in clause (b) or (c), as applicable. The notice provisions set forth in this section may be shortened or waived prospectively or retrospectively by the consent of the Holder of this Warrant.
4 Five years from Issue Date.
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dividends or subscription rights or any other rights of a shareholder of the Company until this Warrant shall have been exercised.
I-10
Each such notice or other communication shall for all purposes of this Warrant be treated as effective or having been given (it if delivered by hand, messenger or courier service, when
I-11
delivered (or if sent via a nationally-recognized overnight courier service, freight prepaid, specifying next-business-day delivery, one business day after deposit with the courier), or (ii) if sent via mail, at the earlier of its receipt or five days after the same has been deposited in a regularly-maintained receptacle for the deposit of the United States mail, addressed and mailed as aforesaid, or (iii) if sent via facsimile, upon confirmation of facsimile transfer or, if sent via electronic mail, upon confirmation of delivery when directed to the relevant electronic mail address, if sent during normal business hours of the recipient, or if not sent during normal business hours of the recipient, then on the recipient’s next business day. In the event of any conflict between the Company’s books and records and this Warrant or any notice delivered hereunder, the Company’s books and records will control absent fraud or error.
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(signature page follows)
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The Company and the Holder sign this Warrant as of the date stated on the first page.
COMPANY:
STRONGBRIDGE BIOPHARMA PLC
By
Name:
Title:
Address for Notices:
900 Northbrook Drive
Suite 200
Trevose, PA 19053
Attn:
Tel:
Fax:
Email:
With a copy (which shall not constitute notice) to:
Reed Smith LLP
599 Lexington Avenue
New York, New York 10022
Attention: Aron Izower
Tel:(212 549-0393
Fax:(212) 521-5450
Email:aizower@reedsmith.com
AGREED AND ACKNOWLEDGED,
HOLDER:
[ ]
By:
Name:
Title:
Address for Notices:
[ ]
Attn:[ ]
Tel:[ ]
Fax:[ ]
Email:[ ]
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SCHEDULE A
Capitalization
Class & Number of Shares |
Par Value |
Authorized |
Issued |
Outstanding |
Preferred Shares |
$0.01 |
100,000,000 |
[ ] |
[ ] |
Ordinary Shares |
$0.01 |
600,000,000 |
[ ] |
[ ] |
Deferred Ordinary Shares |
€1.00 |
40,000 |
[ ] |
[ ] |
Outstanding Options: [ ] with weighted average exercise price of $[ ].
Outstanding Warrants -
•[ ] Warrants with exercise price of $[ ]
•[ ] Warrants with exercise price of $[ ]
Outstanding Restricted Stock Units: [ ]
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EXHIBIT A
NOTICE OF EXERCISE
TO:[ ] (the “Company”)
Attention:CHIEF FINANCIAL OFFICER
(1) |
Exercise. The undersigned elects to purchase the following pursuant to the terms of the attached warrant: |
Number of shares:
Type of security:
(2)Method of Exercise. The undersigned elects to exercise the attached warrant pursuant to:
[ ] |
A cash payment, and tenders herewith payment of the purchase price for such shares in full, together with all applicable transfer taxes, if any. |
[ ] |
The net issue exercise provisions of Section 2(b) of the attached warrant. |
(3)Conditional Exercise. Is this a conditional exercise pursuant to Section 2(f):
[ ] Yes [ ] No
If “Yes,” indicate the applicable condition:
(4)Unexercised Portion of the Warrant. Please issue a new warrant for the unexercised portion of the attached warrant in the name of:
[ ] |
The undersigned |
[ ] |
Other—Name: |
[ ] |
Address: |
[ ] |
Not applicable |
(6) |
[Investment Intent. The undersigned represents and warrants that the aforesaid shares are being acquired for investment for its own account and not with a view to, or for resale in connection with, the distribution thereof, and that the undersigned has no present intention of selling, granting any participation in, or otherwise distributing the shares, nor does it have any contract, undertaking, agreement or arrangement for the same, and all |
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representations and warranties of the undersigned set forth in Section 10 of the attached warrant are true and correct as of the date hereof.]5
(Print name of the warrant holder)
(Signature)
(Name and title of signatory, if applicable)
(Date)
(Fax number)
(Email address)
5 Include if exercised pursuant to Section 2(a).
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EXHIBIT B
ASSIGNMENT FORM
ASSIGNOR:
COMPANY:
WARRANT: |
THE WARRANT TO PURCHASE SHARES OF ORDINARY SHARES ISSUED ON [ ], [ ] (THE “WARRANT”) |
DATE:
(1) |
Assignment. The undersigned registered holder of the Warrant (“Assignor”) assigns and transfers to the assignee named below (“Assignee”) all of the rights of Assignor under the Warrant, with respect to the number of shares set forth below: |
Name of Assignee:
Address of Assignee:
Number of Shares Assigned:
and does irrevocably constitute and appointas attorney to make such transfer on the books of Strongbridge Biopharma plc, maintained for the purpose, with full power of substitution in the premises.
(2) |
Obligations of Assignee. Assignee agrees to take and hold the Warrant and any shares to be issued upon exercise of the rights thereunder (the “Securities”) subject to, and to be bound by, the terms and conditions set forth in the Warrant to the same extent as if Assignee were the original holder thereof. |
(3) |
[Investment Intent. Assignee represents and warrants that the Securities are being acquired for investment for its own account, not as a nominee or agent, and not with a view to, or for resale in connection with, the distribution thereof, and that Assignee has no present intention of selling, granting any participation in, or otherwise distributing the shares, nor does it have any contract, undertaking, agreement or arrangement for the same, and all representations and warranties set forth in Section 10 of the Warrant are true and correct as to Assignee as of the date hereof.]6 |
Assignor and Assignee are signing this Assignment Form on the date first set forth above.
6 Include to the extent required pursuant to Section 5(a).
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Exhibit 10.3
WARRANT
THIS WARRANT AND THE UNDERLYING SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE. THESE SECURITIES MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED EXCEPT AS PERMITTED UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS IN ACCORDANCE WITH APPLICABLE REGISTRATION REQUIREMENTS OR AN EXEMPTION THEREFROM. THE ISSUER OF THESE SECURITIES MAY REQUIRE AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE ISSUER THAT SUCH OFFER, SALE, TRANSFER, PLEDGE OR HYPOTHECATION OTHERWISE COMPLIES WITH THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS. THIS WARRANT MUST BE SURRENDERED TO THE COMPANY OR ITS TRANSFER AGENT AS A CONDITION PRECEDENT TO THE SALE, TRANSFER, PLEDGE OR HYPOTHECATION OF ANY INTEREST IN ANY OF THE SECURITIES REPRESENTED HEREBY.
WARRANT TO PURCHASE ORDINARY SHARES
OF
STRONGBRIDGE BIOPHARMA PLC
Dated as of May 19, 2020 (the “Issue Date”)
Void after the date specified in Section 8
Warrant to Purchase
267,390 Ordinary Shares
(subject to adjustment)
THIS CERTIFIES THAT, for value received, AVENUE VENTURE OPPORTUNITIES FUND, L.P., or its registered assigns (the “Holder”), is entitled, subject to the provisions and upon the terms and conditions set forth herein, to purchase from STRONGBRIDGE BIOPHARMA PLC, a public limited company incorporated under the laws of Ireland (the “Company”) that number of shares (the “Shares”) of the Company’s ordinary shares, of nominal value $0.01 per share (the “Ordinary Shares”), at such times and at the price per Share, set forth in Section 1. The term “Warrant” as used herein shall include this Warrant and any warrants delivered in substitution or exchange therefor as provided herein. This Warrant is issued in connection with the transactions described in the Term Loan Agreement, dated as of May 19, 2020, by and between the Company, the Borrower and Subsidiary Guarantors (each as defined therein) from time to time party thereto, the Lenders from time to time party thereto and Avenue Venture Opportunities Fund, L.P.
The following is a statement of the rights of the Holder and the conditions to which this Warrant is subject, and to which Holder, by acceptance of this Warrant, agrees:
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X = Y(A-B)
A
Where:
X = |
The number of Shares to be issued to the Holder |
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Y = |
The number of Shares to be purchased (as specified in paragraph 1 of the applicable Notice of Exercise) |
A = |
The fair market value of one Ordinary Share (at the date of such calculation) |
B = |
The Exercise Price (as adjusted to the date of such calculation) less the nominal value of one Ordinary Share |
For purposes of the calculation above, the fair market value of one Share shall be determined as follows:
For purposes hereof, the date of calculation shall be the date the Holder sends to the Company a Notice of Exercise. “Trading Day” means a day in which trading in the Ordinary Shares generally occurs on The Nasdaq Global Select Market or if the Ordinary Shares are not then listed on The Nasdaq Global Select Market, on the principal other U.S. national or regional securities exchange on which the Ordinary Shares are then listed, or if the Ordinary Shares are not then listed on a U.S. national or regional securities exchange, on the principal other market on which the Ordinary Shares are then traded. If the Ordinary Shares are not so listed or traded. “Trading Day” means any Business Day. “Business Day” means any day other than a Saturday, a Sunday or a day on which the Federal Reserve Bank of New York is authorized or required by law or executive order to close or be closed.
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THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR UNDER THE SECURITIES LAWS OF CERTAIN STATES. THESE SECURITIES MAY NOT BE OFFERED, SOLD OR OTHERWISE
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TRANSFERRED, PLEDGED OR HYPOTHECATED EXCEPT AS PERMITTED UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS IN ACCORDANCE WITH APPLICABLE REGISTRATION REQUIREMENTS OR AN EXEMPTION THEREFROM. THE ISSUER OF THESE SECURITIES MAY REQUIRE AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE ISSUER THAT SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION OTHERWISE COMPLIES WITH THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS. THIS CERTIFICATE MUST BE SURRENDERED TO THE COMPANY OR ITS TRANSFER AGENT AS A CONDITION PRECEDENT TO THE SALE, TRANSFER, PLEDGE OR HYPOTHECATION OF ANY INTEREST IN ANY OF THE SECURITIES REPRESENTED HEREBY.
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the Company shall send to the Holder of this Warrant at least ten (10) calendar days prior written notice of the date on which a record shall be taken for any such dividend or distribution specified in clause (a) or the expected effective date of any such other event specified in clause (b) or (c), as applicable. The notice provisions set forth in this section may be shortened or waived prospectively or retrospectively by the consent of the Holder of this Warrant.
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Each such notice or other communication shall for all purposes of this Warrant be treated as effective or having been given (it if delivered by hand, messenger or courier service, when delivered (or if sent via a nationally-recognized overnight courier service, freight prepaid, specifying next-business-day delivery, one business day after deposit with the courier), or (ii) if
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sent via mail, at the earlier of its receipt or five days after the same has been deposited in a regularly-maintained receptacle for the deposit of the United States mail, addressed and mailed as aforesaid, or (iii) if sent via facsimile, upon confirmation of facsimile transfer or, if sent via electronic mail, upon confirmation of delivery when directed to the relevant electronic mail address, if sent during normal business hours of the recipient, or if not sent during normal business hours of the recipient, then on the recipient’s next business day. In the event of any conflict between the Company’s books and records and this Warrant or any notice delivered hereunder, the Company’s books and records will control absent fraud or error.
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(signature page follows)
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The Company and the Holder sign this Warrant as of the date stated on the first page.
COMPANY:
STRONGBRIDGE BIOPHARMA PLC
By /s/ Robert Lutz
Name:
Title:
Address for Notices:
900 Northbrook Drive
Suite 200
Trevose, PA 19053
Attn:
Tel:
Fax:
Email:
With a copy (which shall not constitute notice) to:
Reed Smith LLP
599 Lexington Avenue
New York, New York 10022
Attention: Aron Izower
Tel:(212 549-0393
Fax:(212) 521-5450
Email:aizower@reedsmith.com
AGREED AND ACKNOWLEDGED,
HOLDER:
[ ]
By:/s/ Sonia Gardner
Name:
Title:
Address for Notices:
[ ]
Attn:[ ]
Tel:[ ]
Fax:[ ]
Email:[ ]
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SCHEDULE A
Capitalization
Class & Number of Shares |
Par Value |
Authorized |
Issued |
Outstanding |
Preferred Shares |
$0.01 |
100,000,000 |
- |
- |
Ordinary Shares |
$0.01 |
600,000,000 |
54,355,957 |
54,355,957 |
Deferred Ordinary Shares |
€1.00 |
40,000 |
40,000 |
40,000 |
Outstanding Options: 10,518,999 with weighted average exercise price of $5.29.
Outstanding Warrants -
•5,030,000 Warrants with exercise price of $2.50
•160,714 Warrants with exercise price of $2.45
•394,289 Warrants with exercise price of $7.37
•1,248,250 Warrants with exercise price of $10.00
Outstanding Restricted Stock Units: 1,097,800
I-15
EXHIBIT A
NOTICE OF EXERCISE
TO:STRONGBRIDGE BIOPHARMA PLC (the “Company”)
Attention:CHIEF FINANCIAL OFFICER
(1) |
Exercise. The undersigned elects to purchase the following pursuant to the terms of the attached warrant: |
Number of shares:
Type of security:
(2)Method of Exercise. The undersigned elects to exercise the attached warrant pursuant to:
[ ] |
A cash payment, and tenders herewith payment of the purchase price for such shares in full, together with all applicable transfer taxes, if any. |
[ ] |
The net issue exercise provisions of Section 2(b) of the attached warrant. |
(3)Conditional Exercise. Is this a conditional exercise pursuant to Section 2(f):
[ ] Yes [ ] No
If “Yes,” indicate the applicable condition:
(4)Unexercised Portion of the Warrant. Please issue a new warrant for the unexercised portion of the attached warrant in the name of:
[ ] |
The undersigned |
[ ] |
Other—Name: |
[ ] |
Address: |
[ ] |
Not applicable |
(6) |
[Investment Intent. The undersigned represents and warrants that the aforesaid shares are being acquired for investment for its own account and not with a view to, or for resale in connection with, the distribution thereof, and that the undersigned has no present intention of selling, granting any participation in, or otherwise distributing the shares, nor does it have any contract, undertaking, agreement or arrangement for the same, and all |
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representations and warranties of the undersigned set forth in Section 10 of the attached warrant are true and correct as of the date hereof.]1
(Print name of the warrant holder)
(Signature)
(Name and title of signatory, if applicable)
(Date)
(Fax number)
(Email address)
1 Include if exercised pursuant to Section 2(a).
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EXHIBIT B
ASSIGNMENT FORM
ASSIGNOR:
COMPANY:
WARRANT: |
THE WARRANT TO PURCHASE SHARES OF ORDINARY SHARES ISSUED ON MAY 19, 2020 (THE “WARRANT”) |
DATE:
(1) |
Assignment. The undersigned registered holder of the Warrant (“Assignor”) assigns and transfers to the assignee named below (“Assignee”) all of the rights of Assignor under the Warrant, with respect to the number of shares set forth below: |
Name of Assignee:
Address of Assignee:
Number of Shares Assigned:
and does irrevocably constitute and appointas attorney to make such transfer on the books of Strongbridge Biopharma plc, maintained for the purpose, with full power of substitution in the premises.
(2) |
Obligations of Assignee. Assignee agrees to take and hold the Warrant and any shares to be issued upon exercise of the rights thereunder (the “Securities”) subject to, and to be bound by, the terms and conditions set forth in the Warrant to the same extent as if Assignee were the original holder thereof. |
(3) |
[Investment Intent. Assignee represents and warrants that the Securities are being acquired for investment for its own account, not as a nominee or agent, and not with a view to, or for resale in connection with, the distribution thereof, and that Assignee has no present intention of selling, granting any participation in, or otherwise distributing the shares, nor does it have any contract, undertaking, agreement or arrangement for the same, and all representations and warranties set forth in Section 10 of the Warrant are true and correct as to Assignee as of the date hereof.]2 |
Assignor and Assignee are signing this Assignment Form on the date first set forth above.
2 Include to the extent required pursuant to Section 5(a).
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Exhibit 31.1
CERTIFICATIONS
I, John Johnson, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Strongbridge Biopharma plc;
2. Based on my knowledge, this Quarterly Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this Quarterly Report;
4. I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
|
Date: August 4, 2020 |
|
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|
|
|
|
By: |
/s/ John Johnson |
|
|
John Johnson |
|
|
Chief Executive Officer |
|
|
(Principal Executive Officer) |
Exhibit 31.2
CERTIFICATIONS
I, Robert Lutz, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Strongbridge Biopharma plc;
2. Based on my knowledge, this Quarterly Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this Quarterly Report;
4. I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: August 4, 2020 |
|
|
|
|
|
|
By: |
/s/ Robert Lutz |
|
|
Robert Lutz |
|
|
Chief Financial Officer |
|
|
(Principal Financial Officer) |
Exhibit 32.1
CERTIFICATIONS PURSUANT TO 18 U.S.C. 1350
Pursuant to the requirement set forth in Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934, as amended, and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, John Johnson, the Chief Executive Officer (principal executive officer) of Strongbridge Biopharma plc (the “Company”), and Robert Lutz, the Chief Financial Officer (principal financial officer) of the Company, each hereby certifies that, to his knowledge on the date hereof:
(a) The Quarterly Report on Form 10-Q of the Company for the period ended June 30, 2020 filed on the date hereof with the Securities and Exchange Commission (the “Quarterly Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(b) The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the period covered by the Quarterly Report.
This certification shall not be deemed to be filed with the Securities and Exchange Commission and shall not be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Quarterly Report), irrespective of any general incorporation language contained in such filing. A signed original of this written statement required by Section 906 has been provided to the Company and will be retained and furnished to the Securities and Exchange Commission or its staff upon request.
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By: |
/s/ John Johnson |
|
|
John Johnson |
|
|
Chief Executive Officer (Principal Executive Officer) |
|
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August 4, 2020 |
|
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|
|
By: |
/s/ Robert Lutz |
|
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Robert Lutz |
|
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Chief Financial Officer (Principal Financial Officer) |
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August 4, 2020 |