UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
(Mark One)
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QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number
(Exact name of registrant as specified in its charter)
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(State of incorporation) |
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(I.R.S. Employer Identification No.) |
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(Address and telephone number of principal executive offices)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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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.
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 (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
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.
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Accelerated Filer |
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Non-Accelerated Filer |
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Smaller Reporting Company |
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Emerging Growth Company |
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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
The number of shares of the registrant’s common stock outstanding as of February 1, 2021 was
PART I. FINANCIAL INFORMATION
ITEM 1. |
FINANCIAL STATEMENTS |
Arrowhead Pharmaceuticals, Inc.
Consolidated Balance Sheets
(In thousands, except per share amounts)
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(unaudited) December 31, 2020 |
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September 30, 2020 |
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ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
$ |
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$ |
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Accounts receivable |
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Prepaid expenses |
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Other current assets |
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Marketable securities |
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Short term investments |
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TOTAL CURRENT ASSETS |
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Property and equipment, net |
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Intangible assets, net |
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Long term investments |
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Right-of-use assets |
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Other assets |
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TOTAL ASSETS |
$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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CURRENT LIABILITIES |
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Accounts payable |
$ |
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$ |
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Accrued expenses |
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Accrued payroll and benefits |
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Lease liabilities |
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Deferred revenue |
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Other current liabilities |
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TOTAL CURRENT LIABILITIES |
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LONG-TERM LIABILITIES |
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Lease liabilities, net of current portion |
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TOTAL LONG-TERM LIABILITIES |
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Commitments and contingencies (Note 7) |
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STOCKHOLDERS’ EQUITY |
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Arrowhead Pharmaceuticals, Inc. stockholders' equity: |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated other comprehensive income (loss) |
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Accumulated deficit |
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( |
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TOTAL STOCKHOLDERS’ EQUITY |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
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$ |
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The accompanying notes are an integral part of these unaudited consolidated financial statements.
1
Arrowhead Pharmaceuticals, Inc.
Consolidated Statements of Operations and Comprehensive Income (Loss)
(unaudited)
(In thousands, except per share amounts)
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Three Months Ended December 31, |
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2020 |
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2019 |
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REVENUE |
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$ |
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$ |
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OPERATING EXPENSES |
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Research and development |
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General and administrative expenses |
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TOTAL OPERATING EXPENSES |
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OPERATING INCOME (LOSS) |
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OTHER INCOME (EXPENSE) |
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Interest income (expense), net |
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Other income (expense) |
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- |
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TOTAL OTHER INCOME (EXPENSE) |
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INCOME (LOSS) BEFORE INCOME TAXES |
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( |
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Provision for income taxes |
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- |
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- |
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NET INCOME (LOSS) |
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NET INCOME (LOSS) PER SHARE - BASIC |
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$ |
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$ |
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NET INCOME (LOSS) PER SHARE - DILUTED |
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$ |
( |
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$ |
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Weighted average shares outstanding - basic |
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Weighted average shares outstanding - diluted |
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OTHER COMPREHENSIVE INCOME (LOSS), NET OF TAX: |
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Foreign currency translation adjustments |
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COMPREHENSIVE INCOME (LOSS) |
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$ |
( |
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$ |
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The accompanying notes are an integral part of these unaudited consolidated financial statements.
2
Arrowhead Pharmaceuticals, Inc.
Consolidated Statement of Stockholders’ Equity
(unaudited)
(In thousands, except per share amounts)
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Common Stock |
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Amount ($) |
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Additional Paid-In Capital |
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Accumulated Other Comprehensive Income (Loss) |
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Accumulated Deficit |
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Non-controlling Interest |
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Totals |
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Balance at September 30, 2019 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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$ |
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Stock-based compensation |
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- |
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- |
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- |
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- |
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- |
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Exercise of stock options |
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- |
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- |
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- |
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Common stock - restricted stock units vesting |
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( |
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- |
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- |
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- |
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- |
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Common stock - issued for cash |
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- |
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- |
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- |
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Foreign currency translation adjustments |
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- |
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- |
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- |
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- |
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- |
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Net income (loss) for the three months ended December 31, 2019 |
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- |
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- |
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- |
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- |
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( |
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- |
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Balance at December 31, 2019 |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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Common Stock |
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Amount ($) |
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Additional Paid-In Capital |
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Accumulated Other Comprehensive Income (Loss) |
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Accumulated Deficit |
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Totals |
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Balance at September 30, 2020 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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Stock-based compensation |
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- |
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- |
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- |
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- |
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Exercise of stock options |
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- |
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- |
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- |
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Common stock - restricted stock units vesting |
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- |
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- |
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- |
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- |
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- |
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Foreign currency translation adjustments |
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- |
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- |
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- |
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- |
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Net income (loss) for the three months ended December 31, 2020 |
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- |
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- |
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- |
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- |
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( |
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Balance at December 31, 2020 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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The accompanying notes are an integral part of these unaudited consolidated financial statements.
3
Arrowhead Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
(unaudited)
(In thousands, except per share amounts)
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Three Months Ended December 31, |
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2020 |
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2019 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net income (loss) |
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$ |
( |
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$ |
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Stock-based compensation |
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Depreciation and amortization |
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Amortization/(accretion) of note premiums |
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( |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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( |
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( |
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Prepaid expenses and other current assets |
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( |
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Deferred revenue |
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( |
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( |
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Accounts payable |
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( |
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Accrued expenses |
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( |
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( |
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Other |
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( |
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NET CASH PROVIDED BY (USED IN) OPERATING ACTIVITIES |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Purchases of property and equipment |
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( |
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Proceeds from sale of marketable securities |
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NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Proceeds from the exercises of stock options |
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Proceeds from the issuance of common stock |
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- |
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NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES |
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NET INCREASE (DECREASE) IN CASH |
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( |
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CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD |
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CASH AND CASH EQUIVALENTS AT END OF PERIOD |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited consolidated financial statements.
4
Arrowhead Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
(unaudited)
Unless otherwise noted, (1) the term “Arrowhead” refers to Arrowhead Pharmaceuticals, Inc., a Delaware corporation and its Subsidiaries, (2) the terms “Company,” “we,” “us,” and “our,” refer to the ongoing business operations of Arrowhead and its Subsidiaries, whether conducted through Arrowhead or a subsidiary of Arrowhead, (3) the term “Subsidiaries” refers to Arrowhead Madison Inc. (“Arrowhead Madison”) and Arrowhead Australia Pty Ltd (“Arrowhead Australia”), (4) the term “Common Stock” refers to Arrowhead’s Common Stock, (5) the term “Preferred Stock” refers to Arrowhead’s Preferred Stock and (6) the term “Stockholder(s)” refers to the holders of Arrowhead Common Stock.
NOTE 1. ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES
Nature of Business and Recent Developments
Arrowhead Pharmaceuticals, Inc. develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep and durable knockdown of target genes. RNA interference (“RNAi”) is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. The Company's pipeline includes ARO-APOC3 for hypertriglyceridemia, ARO-ANG3 for dyslipidemia, ARO-HSD for liver disease, ARO-ENaC for cystic fibrosis, ARO-HIF2 for renal cell carcinoma, ARO-LUNG2 as a candidate to treat chronic obstructive pulmonary disorder (“COPD”) and ARO-COV for treatment for the current novel coronavirus that causes COVID-19 and other possible future pulmonary-borne pathogens. ARO-JNJ1, ARO-JNJ2 and ARO-JNJ3 are being developed for undisclosed liver-expressed targets under a collaboration agreement with Janssen Pharmaceuticals, Inc. (“Janssen”). ARO-AAT for liver disease associated with alpha-1 antitrypsin deficiency (“AATD”) was out-licensed to Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) in October 2020. JNJ3989 (formerly referred to as ARO-HBV) for chronic hepatitis B virus was out-licensed to Janssen in October 2018. Olpasiran (formerly referred to as AMG 890 or ARO-LPA) for cardiovascular disease was out-licensed to Amgen Inc. (“Amgen”) in 2016.
Arrowhead operates lab facilities in Madison, Wisconsin and San Diego, California, where the Company’s research and development activities, including the development of RNAi therapeutics, are based. The Company’s principal executive offices are located in Pasadena, California.
During the first quarter of fiscal year 2021, the Company continued to develop its pipeline and partnered candidates. The Company hosted a key opinion leader webinar on its cardiometabolic candidates, ARO-APOC3 and ARO-ANG3. The Company presented positive interim clinical data from AROAAT2002, an open-label Phase 2 clinical study of ARO-AAT, the Company’s second-generation investigational RNAi therapeutic being developed as a treatment for the rare genetic liver disease associated with AATD. The Company also announced positive clinical data on its cardiometabolic candidates, ARO-APOC3 and ARO-ANG3, at the American Heart Association (“AHA”) Scientific Session 2020. Finally, the Company announced a collaboration with Takeda to co-develop and co-commercialize ARO-AAT for alpha-1 antitrypsin-associated liver disease. See Note 2 for more information regarding the collaboration with Takeda.
The Company’s partnered candidates under its collaboration agreements also continue to progress. Janssen began dosing patients in a Phase 2b triple combination study called REEF-1, designed to enroll up to 450 patients with chronic hepatitis B infection. In connection with the start of this study, Arrowhead earned a $
The Company’s collaboration agreement with Amgen for Olpasiran (previously referred to as AMG 890 or ARO-LPA), (the “Second Collaboration and License Agreement” or “Olpasiran Agreement”), continues to progress. In July 2020, Amgen initiated a Phase 2 clinical study, which resulted in a $
5
On October 7, 2020, the Company entered into an Exclusive License and Co-Funding Agreement with Takeda (the “Takeda License Agreement”). Under the Takeda License Agreement, Takeda and the Company will co-develop the Company’s ARO-AAT program. Within the United States, ARO-AAT, if approved, will be co-commercialized under a
The revenue recognition for these collaboration agreements is discussed further in Note 2 below.
The Company is actively monitoring the ongoing COVID-19 pandemic. The financial results for the three months ended December 31, 2020 were not significantly impacted by COVID-19. During fiscal year 2020, the Company had temporarily paused enrollment in its two ARO-AAT studies, SEQUOIA and the ARO-AAT 2002 study, but resumed the process of screening and enrolling patients. During the pause in enrollment, patients already enrolled in these studies continued to be dosed per protocol and continued to come in for their follow up visits. Additional delays have occurred in the Company’s earlier stage programs, but the Company does not expect a material impact to any program’s anticipated timelines. Additionally, the Company’s operations at its research and development facilities in Madison, Wisconsin and San Diego, California, and its corporate headquarters in Pasadena, California have continued to operate with limited impact, other than for enhanced safety measures, including work from home policies. However, the Company cannot predict the impact the progression of COVID-19 will have on future financial results due to a variety of factors including the ability of the Company’s clinical sites to continue to enroll subjects, the ability of the Company’s suppliers to continue to operate, the continued good health and safety of the Company’s employees, and ultimately the length of the COVID-19 pandemic.
Liquidity
The Consolidated Financial Statements have been prepared in conformity with the accounting principles generally accepted in the United States of America (“GAAP”), which contemplate the continuation of the Company as a going concern. Historically, the Company’s primary source of financing has been through the sale of its securities. Research and development activities have required significant capital investment since the Company’s inception. The Company expects its operations to continue to require cash investment to pursue its research and development goals, including clinical trials and related drug manufacturing.
At December 31, 2020, the Company had $
Summary of Significant Accounting Policies
There have been no changes to the significant accounting policies disclosed in the Company’s most recent Annual Report on Form 10-K.
Recent Accounting Pronouncements
In November 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2018-18 Collaborative Arrangements (Topic 808). This update provides clarification on the interaction between Revenue Recognition (Topic 606) and Collaborative Arrangements (Topic 808) including the alignment of unit of account guidance between the two topics. ASU 2018-18 became effective for the Company on
In August 2018, the FASB issued ASU No. 2018-15 Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. The new standard requires that certain implementation costs for cloud computing arrangements are capitalized and amortized over the term of the associated hosted cloud computing arrangement service. Capitalized implementation costs are classified in prepaid expenses and other assets. The amortization of the capitalized asset is presented in the same line on the statement of operations and comprehensive loss as the fees for the associated hosted cloud computing arrangement service and not included with depreciation or amortization expense related to property and equipment or intangible assets. Cash flows related to capitalized implementation costs are presented in cash flows used in operating activities. ASU 2018-15 became effective for the Company on
6
NOTE 2. COLLABORATION AND LICENSE AGREEMENTS
Amgen Inc.
On
The Company substantially completed its performance obligations under the Olpasiran Agreement and the ARO-AMG1 Agreement. Future milestones and royalties achieved will be recognized in their entirety when earned. In July 2020, Amgen initiated a Phase 2 clinical study, which resulted in a $
Janssen Pharmaceuticals, Inc.
On
The Company has evaluated these agreements in accordance with the new revenue recognition standard that became effective for the Company on October 1, 2018. The adoption of the new revenue standard did not have a material impact on the balances reported when evaluated under the superseded revenue standard. At the inception of these agreements, the Company has identified
7
The Company determined the transaction price totaled approximately $
The Company has begun to conduct its discovery, optimization and preclinical research and development of ARO-JNJ1, ARO-JNJ2 and ARO-JNJ3 under the Janssen Collaboration Agreement. All costs and labor hours spent by the Company will be entirely funded by Janssen. During the three months ended December 31, 2020 and 2019, the Company recognized $
Takeda Pharmaceuticals U.S.A., Inc.
On
The Company has evaluated the Takeda License Agreement in accordance with the new revenue recognition requirements that became effective for the Company on October 1, 2018. The adoption of the new revenue standard will not have a material impact on the balances reported when evaluated under the superseded revenue standard. At the inception of the Takeda License Agreement, the Company has identified
The Company determined the initial transaction price totaled approximately $
8
NOTE 3. PROPERTY AND EQUIPMENT
The following table summarizes the Company’s major classes of property and equipment:
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December 31, 2020 |
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September 30, 2020 |
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(In thousands) |
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Computers, office equipment and furniture |
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$ |
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$ |
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Research equipment |
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Software |
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Leasehold improvements |
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Total gross fixed assets |
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Less: Accumulated depreciation and amortization |
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( |
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( |
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Property and equipment, net |
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$ |
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$ |
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Depreciation and amortization expense for property and equipment for the three months ended December 31, 2020 and 2019 was $
NOTE 4. INVESTMENTS
Investments at December 31, 2020 primarily consisted of corporate bonds that have maturities of less than 36 months and marketable equity securities. The Company’s corporate bonds consist of both short-term and long-term bonds and are classified as “held-to-maturity” on the Company’s Consolidated Balance Sheets. The Company’s marketable equity securities consist of mutual funds that invest in U.S. government bonds, U.S. government agency bonds, corporate bonds and other asset backed debt securities. Dividends from these funds are automatically reinvested. The Company may also invest excess cash balances in certificates of deposits, money market accounts, government-sponsored enterprise securities, corporate bonds and/or commercial paper. The Company accounts for its held to maturity investments in accordance with FASB ASC 320, Investments – Debt and Equity Securities and its marketable equity securities in accordance with ASC 321, Investments – Equity Securities.
The following tables summarize the Company’s short-term and long-term investments and marketable securities as of December 31, 2020 and September 30, 2020 by measurement category.
Held to Maturity |
|
As of December 31, 2020 |
|
|
|
|||||||||||||
|
|
(In thousands) |
|
|
|
|||||||||||||
|
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
|
|
||||
Commercial notes (due within one year) |
|
$ |
|
|
|
$ |
|
|
|
$ |
- |
|
|
$ |
|
|
|
|
Commercial notes (due within one through three years) |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
|
Total |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2020 |
|
|
|
|||||||||||||
|
|
(In thousands) |
|
|
|
|||||||||||||
|
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
|
|
||||
Commercial notes (due within one year) |
|
$ |
|
|
|
$ |
|
|
|
$ |
- |
|
|
$ |
|
|
|
|
Commercial notes (due within one through three years) |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
|
Total |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
|
9
Fair Value |
|
As of December 31, 2020 |
|
|
|
|
|
|||||||||||||
|
|
(In thousands) |
|
|||||||||||||||||
|
|
Cost |
|
|
Realized Gains/(Losses) |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
|||||
Marketable securities |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
- |
|
|
$ |
|
|
Total |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
- |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2020 |
|
|
|
|
|
|||||||||||||
|
|
(In thousands) |
|
|||||||||||||||||
|
|
Cost |
|
|
Realized Gains/(Losses) |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
|||||
Marketable securities |
|
$ |
|
|
|
$ |
|
|
|
$ |
- |
|
|
$ |
( |
) |
|
$ |
|
|
Total |
|
$ |
|
|
|
$ |
|
|
|
$ |
- |
|
|
$ |
( |
) |
|
$ |
|
|
Realized gains for marketable securities recorded at fair value consist of dividends received and re-invested into the associated fund.
NOTE 5. INTANGIBLE ASSETS
Intangible assets subject to amortization include patents and a license agreement capitalized as part of the Novartis RNAi asset acquisition in March 2015. The license agreement associated with the Novartis RNAi asset acquisition is being amortized over the estimated life remaining at the time of acquisition, which was
The following table provides details on the Company’s intangible asset balances:
|
|
Intangible assets subject to amortization |
|
|
|
|
(in thousands) |
|
|
Balance at September 30, 2020 |
|
$ |
|
|
Impairment |
|
|
- |
|
Amortization |
|
|
( |
) |
Balance at December 31, 2020 |
|
$ |
|
|
NOTE 6. STOCKHOLDERS’ EQUITY
At December 31, 2020, the Company had a total of
At December 31, 2020,
10
NOTE 7. COMMITMENTS AND CONTINGENCIES
Litigation
From time to time, the Company may be subject to various claims and legal proceedings in the ordinary course of business. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount is reasonably estimable, the Company will accrue a liability for the estimated loss. There were
Purchase Commitments
In the normal course of business, the Company enters into various purchase commitments for the manufacture of drug components, for toxicology studies and for clinical studies. As of December 31, 2020, these future commitments were estimated at approximately $
Technology License Commitments
The Company has licensed from third parties the rights to use certain technologies for its research and development activities, as well as in any products the Company may develop using these licensed technologies. These agreements and other similar agreements often require milestone and royalty payments. Milestone payments, for example, may be required as the research and development process progresses through various stages of development, such as when clinical candidates enter or progress through clinical trials, upon a new drug application and upon certain sales level milestones. These milestone payments could amount to the mid to upper double-digit millions of dollars. During the three months ended December 31, 2020 and 2019, the Company did
NOTE 8. LEASES
Leases
In April 2019, the Company entered into a lease for its corporate headquarters in Pasadena, California. The
In January 2016, the Company entered into a lease for its research facility in Madison, Wisconsin. The lease was for approximately
In March 2020, the Company entered into a sublease agreement (the “Sublease”) with Halozyme, Inc. for additional research and development facility space in San Diego, California. The Sublease provides additional space needed to accommodate the recent growth of the Company’s personnel and discovery efforts. The sublease is for approximately
11
Operating lease cost during the three months ended December 31, 2020 and 2019 was $
The following table presents maturities of operating lease liabilities on an undiscounted basis as of December 31, 2020:
|
|
(in thousands) |
|
|
2021 (remainder of fiscal year) |
|
$ |
|
|
2022 |
|
|
|
|
2023 |
|
|
|
|
2024 |
|
|
|
|
2025 |
|
|
|
|
2026 and thereafter |
|
|
|
|
Total |
|
$ |
|
|
Less imputed interest |
|
$ |
( |
) |
Total operating lease liabilities (includes current portion) |
|
$ |
|
|
Cash paid for the amounts included in the measurement of the operating lease liabilities on the Company’s Consolidated Balance Sheet and included in Other changes in operating assets and liabilities within cash flows from operating activities on the Company’s Consolidated Statement of Cash Flow for the three months ended December 31, 2020 and 2019 was $
NOTE 9. STOCK-BASED COMPENSATION
Arrowhead has two plans that provide for equity-based compensation. Under the 2004 Equity Incentive Plan and the 2013 Incentive Plan, as of December 31, 2020,
The following table summarizes information about stock options:
|
|
Number of Options Outstanding |
|
|
Weighted- Average Exercise Price Per Share |
|
|
Weighted- Average Remaining Contractual Term |
|
Aggregate Intrinsic Value |
|
|||
Balance at September 30, 2020 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2020 |
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
Exercisable at December 31, 2020 |
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
Stock-based compensation expense related to stock options for the three months ended December 31, 2020 and 2019 was $
The grant date fair value of the options granted by the Company for the three months ended December 31, 2020 and 2019 was $
The intrinsic value of the options exercised during the three months ended December 31, 2020, and 2019 was $
12
As of December 31, 2020, the pre-tax compensation expense for all outstanding unvested stock options in the amount of $
The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options, which do not have vesting restrictions and are fully transferable. The determination of the fair value of each stock option is affected by the Company’s stock price on the date of grant, as well as assumptions regarding a number of highly complex and subjective variables. Because the Company’s employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in management’s opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its employee stock options.
The assumptions used to value stock options are as follows:
|
|
Three Months Ended December 31, |
|
|
|||||
|
|
2020 |
|
|
2019 |
|
|
||
Dividend yield |
|
|
- |
|
|
|
- |
|
|
Risk-free interest rate |
|
|
|
|
|
|
|
||
Volatility |
|
|
|
|
|
|
|
||
Expected life (in years) |
|
|
|
|
|
|
|
|
|
Weighted average grant date fair value per share of options granted |
|
$ |
|
|
|
$ |
|
|
|
The dividend yield is
The risk-free interest rate is based on that of the U.S. Treasury bond.
Volatility is estimated based on volatility average of the Company’s Common Stock price.
Restricted Stock Units
Restricted stock units (“RSUs”), including time-based and performance-based awards, were granted under the Company’s 2013 Incentive Plan and as inducements grants granted outside of the Plan. During the three months ended December 31, 2020, the Company issued
The following table summarizes the activity of the Company’s RSUs:
|
|
Number of RSUs |
|
|
Weighted- Average Grant Date Fair Value |
|
||
Unvested at September 30, 2020 |
|
|
|
|
|
$ |
|
|
Granted |
|
|
|
|
|
|
|
|
Vested |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
( |
) |
|
|
|
|
Unvested at December 31, 2020 |
|
|
|
|
|
$ |
|
|
During the three months ended December 31, 2020 and 2019, the Company recorded $
For RSUs, the grant date fair value of the award is based on the Company’s closing stock price at the grant date, with consideration given to the probability of achieving performance conditions for performance-based awards.
13
As of December 31, 2020, the pre-tax compensation expense for all unvested RSUs in the amount of $
NOTE 10. FAIR VALUE MEASUREMENTS
The Company measures its financial assets and liabilities at fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., exit price) in an orderly transaction between market participants at the measurement date. Additionally, the Company is required to provide disclosure and categorize assets and liabilities measured at fair value into one of three different levels depending on the assumptions (i.e., inputs) used in the valuation. Level 1 provides the most reliable measure of fair value while Level 3 generally requires significant management judgment. Financial assets and liabilities are classified in their entirety based on the lowest level of input significant to the fair value measurement. The fair value hierarchy is defined as follows:
Level 1—Valuations are based on unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2—Valuations are based on quoted prices for similar assets or liabilities in active markets, or quoted prices in markets that are not active for which significant inputs are observable, either directly or indirectly.
Level 3—Valuations are based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair value measurement. Inputs reflect management’s best estimate of what market participants would use in valuing the asset or liability at the measurement date.
The following table summarizes fair value measurements at December 31, 2020 and September 30, 2020 for assets and liabilities measured at fair value on a recurring basis.
December 31, 2020:
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
|
|
(in thousands) |
|
|||||||||||||
Cash and cash equivalents |
|
$ |
|
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
|
|
Marketable securities |
|
$ |
|
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
|
|
Short-term investments (held to maturity) |
|
$ |
- |
|
|
$ |
|
|
|
$ |
- |
|
|
$ |
|
|
Long-term investments (held to maturity) |
|
$ |
- |
|
|
$ |
|
|
|
$ |
- |
|
|
$ |
|
|
Contingent consideration |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
September 30, 2020:
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
|
|
(in thousands) |
|
|||||||||||||
Cash and cash equivalents |
|
$ |
|
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
|
|
Marketable securities |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
Short-term investments (held to maturity) |
|
$ |
- |
|
|
$ |
|
|
|
$ |
- |
|
|
$ |
|
|
Long-term investments (held to maturity) |
|
$ |
- |
|
|
$ |
|
|
|
$ |
- |
|
|
$ |
|
|
Contingent consideration |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
14
ITEM 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
This Quarterly Report on Form 10-Q contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and we intend that such forward-looking statements be subject to the safe harbors created thereby. For this purpose, any statements contained in this Quarterly Report on Form 10-Q except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “plan,” “project,” “could,” “estimate,” or “continue” or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our businesses, or other characterizations of future events or circumstances are forward-looking statements.
The forward-looking statements included herein are based on current expectations of our management based on available information and involve a number of risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond our control. In addition, many of these risks and uncertainties may be exacerbated by the COVID-19 pandemic and any worsening of the global business and economic environment as a result. As such, our actual results may differ materially from those expressed in any forward-looking statements. Readers should carefully review the factors identified in our most recent Annual Report on Form 10-K under the caption “Risk Factors” as well as the additional risks described in other documents we file from time to time with the Securities and Exchange Commission (“SEC”), including this Quarterly Report on Form 10-Q and subsequent quarterly reports on Form 10-Q. In light of the significant risks and uncertainties inherent in the forward-looking information included herein, the inclusion of such information should not be regarded as a representation by us or any other person that such results will be achieved, and readers are cautioned not to place undue reliance on such forward-looking information. Except as may be required by law, we disclaim any intent to revise the forward-looking statements contained herein to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Description of Business
Unless otherwise noted, (1) the term “Arrowhead” refers to Arrowhead Pharmaceuticals, Inc., a Delaware corporation and its Subsidiaries, (2) the terms “Company,” “we,” “us,” and “our,” refer to the ongoing business operations of Arrowhead and its Subsidiaries, whether conducted through Arrowhead or a subsidiary of Arrowhead, (3) the term “Subsidiaries” refers to Arrowhead Madison Inc. (“Arrowhead Madison”) and Arrowhead Australia Pty Ltd (“Arrowhead Australia”), (4) the term “Common Stock” refers to Arrowhead’s Common Stock, (5) the term “Preferred Stock” refers to Arrowhead’s Preferred Stock and (6) the term “Stockholder(s)” refers to the holders of Arrowhead Common Stock.
Overview
Arrowhead Pharmaceuticals, Inc. develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep and durable knockdown of target genes. RNA interference (“RNAi”) is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. The Company's pipeline includes ARO-APOC3 for hypertriglyceridemia, ARO-ANG3 for dyslipidemia, ARO-HSD for liver disease, ARO-ENaC for cystic fibrosis, ARO-HIF2 for renal cell carcinoma, ARO-LUNG2 as a candidate to treat chronic obstructive pulmonary disorder (“COPD”) and ARO-COV for treatment for the current novel coronavirus that causes COVID-19 and other possible future pulmonary-borne pathogens. ARO-JNJ1, ARO-JNJ2 and ARO-JNJ3 are being developed for undisclosed liver-expressed targets under a collaboration agreement with Janssen Pharmaceuticals, Inc. (“Janssen”). ARO-AAT for liver disease associated with alpha-1 antitrypsin deficiency (“AATD”) was out-licensed to Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) in October 2020. JNJ3989 (formerly referred to as ARO-HBV) for chronic hepatitis B virus was out-licensed to Janssen in October 2018. Olpasiran (formerly referred to as AMG 890 or ARO-LPA) for cardiovascular disease was out-licensed to Amgen Inc. (“Amgen”) in 2016.
Arrowhead operates lab facilities in Madison, Wisconsin and San Diego, California, where the Company’s research and development activities, including the development of RNAi therapeutics, are based. The Company’s principal executive offices are located in Pasadena, California.
Arrowhead has focused its resources on therapeutics that exclusively utilize the Company’s Targeted RNAi Molecule (TRiMTM) platform technology. Therapeutics built on the TRiMTM platform have demonstrated high levels of pharmacologic activity in multiple animal models spanning several therapeutic areas. TRiMTM enabled therapeutics offer several potential advantages over prior generation and competing technologies, including: simplified manufacturing and reduced costs; multiple routes of administration including subcutaneous injection and inhaled administration; the ability to target multiple tissue types including liver, lung and tumors; and the potential for improved safety and reduced risk of intracellular buildup, because there are less metabolites from smaller, simpler molecules.
15
During the first quarter of fiscal year 2021, the Company continued to develop its pipeline and partnered candidates. The Company hosted a key opinion leader webinar on its cardiometabolic candidates, ARO-APOC3 and ARO-ANG3. The Company presented positive interim clinical data from AROAAT2002, an open-label Phase 2 clinical study of ARO-AAT, the Company’s second-generation investigational RNAi therapeutic being developed as a treatment for the rare genetic liver disease associated with AATD. The Company also announced positive clinical data on its cardiometabolic candidates, ARO-APOC3 and ARO-ANG3, at the American Heart Association (“AHA”) Scientific Session 2020. Finally, the Company announced a collaboration with Takeda to co-develop and co-commercialize ARO-AAT for alpha-1 antitrypsin-associated liver disease. See Note 2 of the Notes to Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q for more information regarding the collaboration with Takeda.
The Company’s partnered candidates under its collaboration agreements also continue to progress. Janssen began dosing patients in a Phase 2b triple combination study called REEF-1, designed to enroll up to 450 patients with chronic hepatitis B infection. In connection with the start of this study, Arrowhead earned a $25.0 million milestone payment under the Company’s License Agreement with Janssen (“Janssen License Agreement”). The Company is currently performing discovery, optimization and preclinical research and development for ARO-JNJ1, ARO-JNJ2 and ARO-JNJ3 for Janssen as part of the Company’s Research Collaboration and Option Agreement with Janssen (“Janssen Collaboration Agreement”). Under the terms of the Janssen agreements taken together, the Company has received $175.0 million as an upfront payment, $75.0 million in the form of an equity investment by Johnson & Johnson Innovation-JJDC, Inc. (“JJDC”) in Arrowhead Common Stock, two $25.0 million milestone payments and may receive up to $1.6 billion in development and sales milestones payments for the Janssen License Agreement, and up to $1.9 billion in development and sales milestone payments for the three additional targets covered under the Janssen Collaboration Agreement. The Company is further eligible to receive tiered royalties on product sales up to mid-teens under the Janssen License Agreement and up to low teens under the Janssen Collaboration Agreement.
The Company’s collaboration agreement with Amgen for Olpasiran (previously referred to as AMG 890 or ARO-LPA), (the “Second Collaboration and License Agreement” or “Olpasiran Agreement”) continues to progress. In July 2020, Amgen initiated a Phase 2 clinical study, which resulted in a $20.0 million milestone payment to the Company. The Company has received $35.0 million in upfront payments, $21.5 million in the form of an equity investment by Amgen in the Company’s Common Stock, $30.0 million in milestone payments, and may receive up to an additional $400.0 million in remaining development, regulatory and sales milestone payments. The Company is eligible to receive up to low double-digit royalties for sales of products under the Olpasiran Agreement.
On October 7, 2020, the Company entered into an Exclusive License and Co-Funding Agreement with Takeda (the “Takeda License Agreement”). Under the Takeda License Agreement, Takeda and the Company will co-develop the Company’s ARO-AAT program. Within the United States, ARO-AAT, if approved, will be co-commercialized under a 50/50 profit sharing structure. Outside the United States, Takeda will lead the global commercialization strategy and receive an exclusive license to commercialize ARO-AAT with the Company eligible to receive tiered royalties of 20% to 25% on net sales. In January 2021, the Company received $300.0 million as an upfront payment and is eligible to receive potential development, regulatory and commercial milestones of up to $740.0 million.
The revenue recognition for these collaboration agreements is discussed further in Note 2 of the Notes to Consolidated Financial Statements of Part I, Item 1. Financial Statements of this Quarterly Report on Form 10-Q.
The Company continues to develop other clinical candidates for future clinical trials. Clinical candidates are tested internally and through GLP toxicology studies at outside laboratories. Drug materials for such studies and clinical trials are either contracted to third-party manufactures or manufactured internally. The Company engages third-party contract research organizations (“CROs”) to manage clinical trials and works cooperatively with such organizations on all aspects of clinical trial management, including plan design, patient recruiting, and follow up. These outside costs, relating to the preparation for and administration of clinical trials, are referred to as “candidate costs.” If the clinical candidates progress through human testing, candidate costs will increase.
The Company is actively monitoring the ongoing COVID-19 pandemic. The financial results for the three months ended December 31, 2020 were not significantly impacted by COVID-19. During fiscal year 2020, the Company had temporarily paused enrollment in its two ARO-AAT studies, SEQUOIA and the ARO-AAT 2002 study, but resumed the process of screening and enrolling patients. During the pause in enrollment, patients already enrolled in these studies continued to be dosed per protocol and continued to come in for their follow up visits. Additional delays have occurred in the Company’s earlier stage programs, but the Company does not expect a material impact to any program’s anticipated timelines. Additionally, the Company’s operations at its research and development facilities in Madison, Wisconsin and San Diego, California, and its corporate headquarters in Pasadena, California have continued to operate with limited impact, other than for enhanced safety measures, including work from home policies. However, the Company cannot predict the impact the progression of COVID-19 will have on future financial results due to a variety of factors including the ability of the Company’s clinical sites to continue to enroll subjects, the ability of the Company’s suppliers to continue to operate, the continued good health and safety of the Company’s employees, and ultimately the length of the COVID-19 pandemic.
16
Net losses were $20.7 million for the three months ended December 31, 2020 as compared to net losses of $2.7 million for the three months ended December 30, 2019. Net losses per share-diluted were $0.20 for the three months ended December 31, 2020 as compared to net losses per share-diluted of $0.03 for the three months ended December 31, 2019. An increase in research and development and general and administrative expenses coupled with a decrease in revenue from the license and collaboration agreements with Janssen were the drivers of the increase in net losses and net losses per share for the three months ended December 31, 2020, as discussed further below.
The Company has strengthened its liquidity and financial position through upfront and milestone payments received under its collaboration agreements, as well as equity financings. Under the terms of the Company’s agreements with Janssen taken together, the Company has received $175.0 million as an upfront payment, $75.0 million in the form of an equity investment by JJDC in Arrowhead Common Stock and two $25.0 million milestone payments. Under the terms of the Company’s agreements with Amgen, the Company has received $35.0 million in upfront payments, $21.5 million in the form of an equity investment by Amgen in the Company’s Common Stock and $30.0 million in milestone payments. The Company’s October 2020 licensing agreement with Takeda will result in a $300.0 million upfront payment, which has been collected in the beginning of the second quarter of 2021. Additionally, in December 2019, the Company completed a securities offering which generated approximately $250.5 million in net cash proceeds. These cash proceeds secure the funding needed to continue to advance our pipeline candidates. The Company had $139.9 million of cash and cash equivalents, $86.0 million of marketable securities, $79.4 million in short-term investments, $110.9 million of long term investments and $499.3 million of total assets as of December 31, 2020, as compared to $143.6 million, $85.0 million, $86.9 million, $137.5 million and $522.5 million as of September 30, 2020, respectively. Based upon the Company’s current cash and investment resources and operating plan, the Company expects to have sufficient liquidity to fund operations for at least the next twelve months.
Critical Accounting Policies and Estimates
There have been no changes to the significant accounting policies disclosed in the Company’s most recent Annual Report on Form 10-K.
Results of Operations
The following data summarizes our results of operations for the following periods indicated:
|
|
Three Months Ended December 31, |
|
|||||
|
|
2020 |
|
|
2019 |
|
||
|
|
(in thousands, except per share amounts) |
|
|||||
Revenues |
|
$ |
21,303 |
|
|
$ |
29,455 |
|
Operating Income (loss) |
|
$ |
(24,054 |
) |
|
$ |
(4,853 |
) |
Net Income (loss) |
|
$ |
(20,732 |
) |
|
$ |
(2,673 |
) |
Net Income (Loss) per Share- Diluted |
|
$ |
(0.20 |
) |
|
$ |
(0.03 |
) |
The decrease in revenue for the three months ended December 31, 2020 compared to the three months ended December 31, 2019 was driven by the timing of the recognition of the $252.6 million initial transaction price associated with our agreements with Janssen and JJDC as we achieved progress toward completing our performance obligation under those agreements; partially offset by the revenue recognized for the Takeda collaboration. The increase in Net Losses during the three months ended December 31, 2020 compared to the three months ended December 31, 2019 was driven by this decrease in Revenue and also increases in Research and Development Expenses as our pipeline of clinical candidates has continued to increase.
Revenue
Total revenue for the three months ended December 31, 2020 and 2019 was $21.3 million and $29.5 million, respectively. Revenue in the current period is primarily related to the recognition of a portion of the $252.6 million initial transaction price associated with our agreements with Janssen and JJDC as we achieved progress towards completing our performance obligation under those agreements. In addition, revenue in the current period consisted of $8.2 million of revenue associated with the Takeda collaboration. Revenue for the three months ended December 31, 2019, was primarily related to the recognition of a portion of the $252.6 million initial transaction price associated with our agreements with Janssen and JJDC. A higher proportion of performance activity was ongoing during the prior period than the current period, which resulted in the higher revenue recognized in the prior period.
17
Amgen Inc.
On September 28, 2016, the Company entered into two Collaboration and License Agreements and a Common Stock Purchase Agreement with Amgen. Under one of the collaboration and license agreements (the “Second Collaboration and License Agreement” or “Olpasiran Agreement”), Amgen has received a worldwide, exclusive license to Arrowhead’s novel, RNAi Olpasiran (previously referred to as AMG 890 or ARO-LPA) program. These RNAi molecules are designed to reduce elevated lipoprotein(a), which is a genetically validated, independent risk factor for atherosclerotic cardiovascular disease. Under the other collaboration and license agreement (the “First Collaboration and License Agreement” or the “ARO-AMG1 Agreement”), Amgen received an option to a worldwide, exclusive license for ARO-AMG1, an RNAi therapy for an undisclosed genetically validated cardiovascular target. In both agreements, Amgen is wholly responsible for clinical development and commercialization. Under the terms of the agreements taken together, the Company has received $35.0 million in upfront payments, $21.5 million in the form of an equity investment by Amgen in the Company’s Common Stock, and $30.0 million in milestone payments, and may receive up to an additional $400.0 million in remaining development, regulatory and sales milestone payments. The Company is further eligible to receive up to low double-digit royalties for sales of products under the Olpasiran Agreement. In July 2019, Amgen informed the Company that it would not be exercising its option for an exclusive license for ARO-AMG1, and as such, there will be no further milestone or royalty payments under the ARO-AMG1 Agreement.
The Company substantially completed its performance obligations under the Olpasiran Agreement and the ARO-AMG1 Agreement. Future milestones and royalties achieved will be recognized in their entirety when earned. In July 2020, Amgen initiated a Phase 2 clinical study, which resulted in a $20.0 million milestone payment to the Company. During the three months ended December 31, 2020 and 2019, the Company recognized $0 and $0, respectively. As of December 31, 2020, there were $0 in contract assets recorded as accounts receivable and $0 contract liabilities recorded as current deferred revenue on the Company’s Consolidated Balance Sheets.
Janssen Pharmaceuticals, Inc.
On October 3, 2018, the Company entered into the Janssen License Agreement and the Janssen Collaboration Agreement with Janssen, part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The Company also entered into a Stock Purchase Agreement (“JJDC Stock Purchase Agreement”) with JJDC. Under the Janssen License Agreement, Janssen has received a worldwide, exclusive license to the Company’s JNJ-3989 (ARO-HBV) program, the Company’s third-generation subcutaneously administered RNAi therapeutic candidate being developed as a potential therapy for patients with chronic hepatitis B virus infection. Beyond the Company’s Phase 1/2 study of JNJ-3989 (ARO-HBV), Janssen is also wholly responsible for clinical development and commercialization of JNJ-3989. Under the Janssen Collaboration Agreement, Janssen will be able to select three new targets against which Arrowhead will develop clinical candidates. These candidates are subject to certain restrictions and do not include candidates that already were in the Company’s pipeline. The Company will perform discovery, optimization and preclinical research and development, entirely funded by Janssen, which on its own or in combination with Janssen development work, is sufficient to allow the filing of a U.S. Investigational New Drug application or equivalent, at which time Janssen will have the option to take an exclusive license. If the option is exercised, Janssen will be wholly responsible for clinical development and commercialization of each optioned candidate. Under the terms of the agreements taken together, the Company has received $175.0 million as an upfront payment, $75.0 million in the form of an equity investment by JJDC in Arrowhead Common Stock under the JJDC Stock Purchase Agreement, and two $25.0 million milestone payments, and may receive up to $1.6 billion in development and sales milestones payments for the Janssen License Agreement, and up to $1.9 billion in development and sales milestone payments for the three additional targets covered under the Janssen Collaboration Agreement. The Company is further eligible to receive tiered royalties up to mid-teens under the Janssen License Agreement and up to low teens under the Janssen Collaboration Agreement on product sales.
The Company has evaluated these agreements in accordance with the new revenue recognition standard that became effective for the Company on October 1, 2018. The adoption of the new revenue standard did not have a material impact on the balances reported when evaluated under the superseded revenue standard. At the inception of these agreements, the Company has identified one distinct performance obligation. Regarding the Janssen License Agreement, the Company determined that the key deliverables included the license and certain R&D services including the Company’s responsibility to complete the Phase 1/2 study of JNJ-3989 (ARO-HBV) and the Company’s responsibility to ensure certain manufacturing of JNJ-3989 (ARO-HBV) drug product is completed and delivered to Janssen (the “Janssen R&D Services”). Due to the specialized and unique nature of these Janssen R&D Services, and their direct relationship with the license, the Company determined that these deliverables represent one distinct bundle and thus, one performance obligation. The Company also determined that Janssen’s option to require the Company to develop up to three new targets is not a material right, and thus, not a performance obligation at the onset of the agreement. The consideration for this option is accounted for separately.
18
The Company determined the transaction price totaled approximately $252.6 million which includes the upfront payment, the premium paid by JJDC for its equity investment in the Company, the two $25.0 million milestone payments earned and estimated payments for reimbursable Janssen R&D services to be performed. The Company has allocated the total $252.6 million initial transaction price to its one distinct performance obligation for the JNJ-3989 (ARO-HBV) license and the associated Janssen R&D Services. This revenue will be recognized using a proportional performance method (based on actual costs incurred versus total estimated costs incurred) beginning in October 2018 and ending as the Company’s efforts in overseeing the Phase 1/2 clinical trial are completed. During the three months ended December 31, 2020 and 2019, the Company recognized approximately $12.7 million and $28.8 million of Revenue associated with this performance obligation, respectively. As of December 31, 2020, there were $0 in contract assets recorded as accounts receivable, and $6.7 million of contract liabilities recorded as current deferred revenue on the Company’s Consolidated Balance Sheets. The $6.7 million of current deferred revenue is driven by the upfront payment, the premium paid by JJDC for its equity investment in the Company, and the two $25.0 million milestone payments earned, net of revenue recognized to date.
The Company has begun to conduct its discovery, optimization and preclinical research and development of ARO-JNJ1, ARO-JNJ2 and ARO-JNJ3 under the Janssen Collaboration Agreement. All costs and labor hours spent by the Company will be entirely funded by Janssen. During the three months ended December 31, 2020 and 2019, the Company recognized $0.3 million and $0.7 million of Revenue associated with these efforts, respectively. As of December 31, 2020, there were $0.8 million of contract assets recorded as accounts receivable and $0 of contract liabilities recorded as current deferred revenue on the Company’s Consolidated Balance Sheets.
Takeda Pharmaceuticals U.S.A., Inc.
On October 7, 2020, the Company entered into Takeda License Agreement with Takeda. Under the Takeda License Agreement, Takeda and the Company will co-develop the Company’s ARO-AAT program, the Company’s second-generation subcutaneously administered RNAi therapeutic candidate being developed as a treatment for liver disease associated with alpha-1 antitrypsin deficiency. Within the United States, ARO-AAT, if approved, will be co-commercialized under a 50/50 profit sharing structure. Outside the United States, Takeda will lead the global commercialization strategy and receive an exclusive license to commercialize ARO-AAT with the Company eligible to receive tiered royalties of 20% to 25% on net sales. In January 2021, the Company received $300.0 million as an upfront payment and is eligible to receive potential development, regulatory and commercial milestones of up to $740.0 million.
The Company has evaluated the Takeda License Agreement in accordance with the new revenue recognition requirements that became effective for the Company on October 1, 2018. The adoption of the new revenue standard will not have a material impact on the balances reported when evaluated under the superseded revenue standard. At the inception of the Takeda License Agreement, the Company has identified one distinct performance obligation. The Company determined that the key deliverables included the license and certain R&D services including the Company’s responsibilities to complete the initial portion of the SEQUOIA study, to complete the ongoing Phase 2 AROAAT2002 study and to ensure certain manufacturing of ARO-AAT drug product is completed and delivered to Takeda (the “Takeda R&D Services”). Due to the specialized and unique nature of these Takeda R&D services, and their direct relationship with the license, the Company determined that these deliverables represent one distinct bundle and thus, one performance obligation. Beyond the Takeda R&D Services, Takeda will be responsible for managing future clinical development and commercialization. The Company will co-fund certain of the development and commercialization costs that Takeda manages, and these co-funding amounts will be offset against amounts owed to Arrowhead, either from milestones or royalties earned, or profits earned under the 50/50 profit sharing structure for U.S. commercialization.
The Company determined the initial transaction price totaled approximately $300.0 million, which includes the upfront payment. The Company will exclude any future estimated milestones, royalties, or profit-sharing payments from this transaction price to date. The Company will allocate the total $300.0 million initial transaction price to its one distinct performance obligation for the ARO-AAT license and the associated Takeda R&D Services. Revenue will be recognized using a proportional performance method (based on actual costs incurred versus total estimated costs incurred for the Takeda R&D Services). Revenue for the three months ended December 31, 2020 and 2019 were $8.2 million and $0, respectively. As of December 31, 2020, there were $8.2 million in contract assets recorded as accounts receivable.
Operating Expenses
The analysis below details the operating expenses and discusses the expenditures of the Company within the major expense categories. Certain reclassifications have been made to prior-period operating expense categories to conform to the current period presentation. For purposes of comparison, the amounts for the three months ended December 31, 2020 and 2019 are shown in the tables below.
19
Research and Development Expenses
R&D expenses are related to the Company’s research and development efforts, and related program costs which are comprised primarily of outsourced costs related to the manufacturing of clinical supplies, toxicity/efficacy studies and clinical trial expenses. Internal costs primarily relate to operations at our research facilities in Madison, Wisconsin and San Diego, California, including facility costs and laboratory-related expenses. Salaries and stock compensation expense consist of salary, bonuses, payroll taxes and related benefits and stock compensation for our R&D personnel. Depreciation and amortization expense relates to depreciation on lab equipment and leasehold improvements at our research facilities. The following table provides details of research and development expenses for the periods indicated:
(table below in thousands)
|
|
Three |
|
|
|
|
|
|
Three |
|
|
|
|
|
|
|
|
|||||||
|
|
Months Ended |
|
|
% of Expense |
|
|
Months Ended |
|
|
% of Expense |
|
|
Increase (Decrease) |
|
|||||||||
|
|
December 31, 2020 |
|
|
Category |
|
|
December 31, 2019 |
|
|
Category |
|
|
$ |
|
|
% |
|
||||||
Salaries |
|
$ |
8,173 |
|
|
|
22 |
% |
|
$ |
4,096 |
|
|
|
18 |
% |
|
$ |
4,077 |
|
|
|
100 |
% |
Facilities related |
|
|
1,478 |
|
|
|
4 |
% |
|
|
620 |
|
|
|
3 |
% |
|
|
858 |
|
|
|
138 |
% |
Candidate costs |
|
|
15,017 |
|
|
|
41 |
% |
|
|
13,430 |
|
|
|
58 |
% |
|
|
1,587 |
|
|
|
12 |
% |
R&D discovery costs |
|
|
4,711 |
|
|
|
13 |
% |
|
|
2,955 |
|
|
|
13 |
% |
|
|
1,756 |
|
|
|
59 |
% |
Total research and development expense, excluding non-cash expense |
|
|
29,379 |
|
|
|
80 |
% |
|
|
21,101 |
|
|
|
90 |
% |
|
|
8,278 |
|
|
|
39 |
% |
Stock compensation |
|
|
5,486 |
|
|
|
15 |
% |
|
|
1,162 |
|
|
|
5 |
% |
|
|
4,324 |
|
|
|
372 |
% |
Depreciation/amortization |
|
|
1,690 |
|
|
|
5 |
% |
|
|
1,111 |
|
|
|
5 |
% |
|
|
579 |
|
|
|
52 |
% |
Total research and development expense |
|
$ |
36,555 |
|
|
|
100 |
% |
|
$ |
23,374 |
|
|
|
100 |
% |
|
$ |
13,181 |
|
|
|
56 |
% |
Salaries expense increased by $4,077,000 from $4,096,000 during the three months ended December 31, 2019 to $8,173,000 during the current period. This increase is primarily due to an increase in R&D headcount that has occurred as the Company has expanded its pipeline of candidates.
Facilities expense increased by $858,000 from $620,000 during the three months ended December 31, 2019 to $1,478,000 during the current period. This category includes rental costs for our research and development facilities in Madison, Wisconsin and San Diego, California. This increase is primarily due the commencement of our sublease in San Diego, California in April 2020.
Candidate costs increased by $1,587,000 from $13,430,000 during the three months ended December 31, 2019 to $15,017,000 during the current period. This increase is primarily due to the progression of our pipeline candidates into and through clinical trials, which results in higher outsourced clinical trial, toxicity study and manufacturing costs. We anticipate these expenses to continue to increase as our pipeline of candidates grows and progresses to later phase clinical trials.
R&D discovery costs increased by $1,756,000 from $2,955,000 during the three months ended December 31, 2019 to $4,711,000 in the current period. This increase is due to the growth of our discovery efforts, including the addition of our research facility in San Diego. We anticipate this expense to continue to increase as we increase headcount to support our discovery efforts to identify new drug candidates.
Stock compensation expense, a non-cash expense, increased by $4,324,000 from $1,162,000 during the three months ended December 31, 2019 to $5,486,000 during the current period. Stock compensation expense is based upon the valuation of stock options and restricted stock units granted to employees, directors and certain consultants. Many variables affect the amount expensed, including the Company’s stock price on the date of the grant, as well as other assumptions. The increase in the expense in the current period is primarily due to the increased headcount discussed above and a mix of higher grant date fair values of awards amortizing during the current period due to the Company’s stock price at the time of the grants.
Depreciation and amortization expense, a non-cash expense, increased by $579,000 from $1,111,000 during the three months ended December 31, 2019 to $1,690,000 during the current period. The majority of depreciation and amortization expense relates to depreciation on lab equipment and leasehold improvements at our Madison research facility.
20
General & Administrative Expenses
The following table provides details of our general and administrative expenses for the periods indicated:
(table below in thousands)
|
|
Three |
|
|
|
|
|
|
Three |
|
|
|
|
|
|
|
|
|||||||
|
|
Months Ended |
|
|
% of Expense |
|
|
Months Ended |
|
|
% of Expense |
|
|
Increase (Decrease) |
|
|||||||||
|
|
December 31, 2020 |
|
|
Category |
|
|
December 31, 2019 |
|
|
Category |
|
|
$ |
|
|
% |
|
||||||
Salaries |
|
$ |
2,584 |
|
|
|
29 |
% |
|
$ |
4,081 |
|
|
|
37 |
% |
|
$ |
(1,497 |
) |
|
|
-37 |
% |
Professional/outside services |
|
|
1,982 |
|
|
|
23 |
% |
|
|
1,822 |
|
|
|
17 |
% |
|
|
160 |
|
|
|
9 |
% |
Facilities related |
|
|
730 |
|
|
|
8 |
% |
|
|
793 |
|
|
|
7 |
% |
|
|
(63 |
) |
|
|
-8 |
% |
Other G&A |
|
|
694 |
|
|
|
8 |
% |
|
|
760 |
|
|
|
7 |
% |
|
|
(66 |
) |
|
|
-9 |
% |
Total general & administrative expense, excluding non-cash expense |
|
|
5,990 |
|
|
|
68 |
% |
|
|
7,456 |
|
|
|
1 |
|
|
|
(1,466 |
) |
|
|
-45 |
% |
Stock compensation |
|
|
2,658 |
|
|
|
30 |
% |
|
|
3,330 |
|
|
|
31 |
% |
|
|
(672 |
) |
|
|
-20 |
% |
Depreciation/amortization |
|
|
154 |
|
|
|
2 |
% |
|
|
148 |
|
|
|
1 |
% |
|
|
6 |
|
|
|
4 |
% |
Total general & administrative expense |
|
$ |
8,802 |
|
|
|
100 |
% |
|
$ |
10,934 |
|
|
|
100 |
% |
|
$ |
(2,132 |
) |
|
|
-61 |
% |
Salaries expense decreased by $1,497,000 from $4,081,000 during the three months ended December 31, 2019 to $2,584,000 during the current period. The decrease is primarily due to higher annual performance bonuses awarded in December 2019. We expect salaries expense to increase as our headcount continues to increase to help support our expanding clinical pipeline.
Professional/outside services include legal, accounting, consulting, patent expenses, business insurance expenses and other outside services retained by the Company. Professional/outside services expense increased by $160,000 from $1,822,000 during the three months ended December 31, 2019 to $1,982,000 during the current period. The increase is primarily related to certain patent-related expenses.
Facilities-related expense decreased by $63,000 from $793,000 during the three months ended December 31, 2019 to $730,000 during the current period. This category primarily includes rental costs for our corporate headquarters in Pasadena, California. The decrease in the expense in the current period is primarily related to the moving costs we incurred in the three months ended December 31, 2019 to move to our new corporate headquarters.
Other G&A expense decreased by $66,000 from $760,000 during the three months ended December 31, 2019 to $694,000 during the current period. This category consists primarily of travel, communication and technology, office expenses, and franchise and property tax expenses. The decrease in the expense was due to decreased travel expenses.
Stock compensation expense, a non-cash expense, decreased by $672,000 from $3,330,000 during the three months ended December 31, 2019 to $2,658,000 during the current period. Stock compensation expense is based upon the valuation of stock options and restricted stock units granted to employees, directors and certain consultants. Many variables affect the amount expensed, including the Company’s stock price on the date of the grant, as well as other assumptions. We expect future stock compensation expense to increase as our headcount continues to increase to help support our clinical pipeline.
Depreciation and amortization expense, a noncash expense, increased by $6,000 from $148,000 during the three months ended December 31, 2019 to $154,000 during the current period. The increase is primarily related to amortization of leasehold improvements for our new corporate headquarters.
Other Income/Expense
Other income/expense was income of $2,180,000 during the three months ended December 31, 2019 compared to income of $3,322,000 during the current period. Other income is primarily related to interest income and gain/loss on our marketable securities. The increase in other income is consistent with the increase in our investment holdings.
21
Liquidity and Capital Resources
Arrowhead has historically financed its operations through the sale of its equity securities. Research and development activities have required significant capital investment since the Company’s inception and are expected to continue to require significant cash expenditure in the future.
At December 31, 2020, the Company had cash on hand of approximately $139.9 million as compared to $143.6 million at September 30, 2020. Cash invested in short-term fixed income securities and marketable securities was $165.4 million at December 31, 2020, compared to $171.9 million at September 30, 2020. Cash invested in long-term fixed income securities was $110.9 million at December 31, 2020, compared to $137.5 million at September 30, 2020. The Company also entered into an Open Market Sale Agreement (the “ATM agreement”), pursuant to which the Company may, from time to time, sell up to $250,000,000 in shares of the Company’s common stock through Jefferies LLC. As of December 31, 2020, no shares have been issued under the ATM agreement. The Company believes its current financial resources are sufficient to fund its operations through at least the next twelve months.
A summary of cash flows for the three months ended December 31, 2020 and 2019 is as follows:
|
|
Three Months Ended |
|
Three Months Ended |
|
||
|
|
December 31, 2020 |
|
December 31, 2019 |
|
||
|
|
(in thousands) |
|
||||
Cash Flow from: |
|
|
|
|
|
|
|
Operating Activities |
|
|
-38,922 |
|
|
-23,530 |
|
Investing Activities |
|
|
30,158 |
|
|
9,280 |
|
Financing Activities |
|
|
5,102 |
|
|
253,478 |
|
Net Increase (decrease) in cash and cash equivalents |
|
|
-3,662 |
|
|
239,228 |
|
Cash and cash equivalents at beginning of period |
|
|
143,583 |
|
|
221,804 |
|
Cash and cash equivalents at end of period |
|
|
139,921 |
|
|
461,032 |
|
During the three months ended December 31, 2020, the Company used $38.9 million in cash from operating activities, which was primarily related to the ongoing expenses of the Company’s research and development programs and general and administrative expenses. Cash provided in investing activities was $30.2 million, which was primarily related to the sale of marketable securities of $34.4 million, partially offset by the purchase of property and equipment of $4.3 million. Cash provided by financing activities of $5.1 million was related to cash received from stock option exercises.
During the three months ended December 31, 2019, the Company used $23.5 million in cash from operating activities, which was primarily related to the ongoing expenses of the Company’s research and development programs and general and administrative expenses. Cash provided by investing activities was $9.3 million, which was primarily related to maturities of fixed-income investments of $13.6 million, partially offset by capital expenditures of $4.3 million. Cash provided by financing activities of $253.5 million was driven by the securities financing in December 2019, which generated $250.5 million in net cash proceeds, as well as $3.0 million in cash received from stock option exercises.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
22
ITEM 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
There has been no material change in our exposure to market risk from that described in Item 7A of our Annual Report on Form 10-K for the year ended September 30, 2020.
ITEM 4. |
CONTROLS AND PROCEDURES |
Our Chief Executive Officer and our Chief Financial Officer, after evaluating our “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of the end of the period covered by this Quarterly Report on Form 10-Q (the “Evaluation Date”), have concluded that, as of the Evaluation Date, our disclosure controls and procedures are effective to ensure that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and to ensure that information required to be disclosed by us in such reports is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer where appropriate, to allow timely decisions regarding required disclosure.
No change in the Company’s internal controls over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) of the Exchange Act) occurred during the Company’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
23
PART II—OTHER INFORMATION
ITEM 1. |
LEGAL PROCEEDINGS |
From time to time, we may be involved in routine legal proceedings, as well as demands, claims and threatened litigation, which arise in the normal course of our business. Litigation can be expensive and disruptive to normal business operations. Moreover, the results of legal proceedings, particularly complex legal proceedings, cannot be predicted with any certainty. We disclosed information about certain of our legal proceedings in Part I, Item 3 of our Annual Report on Form 10-K for the year ended September 30, 2020.
ITEM 1A. |
Risk Factors |
There have been no material changes to the risk factors included in our Annual Report on Form 10-K for the year ended September 30, 2020. Please carefully consider the information set forth in this Quarterly Report on Form 10-Q and the risk factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended September 30, 2020, which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K, as well as other risks and uncertainties, could materially and adversely affect our business, results of operations and financial condition, which in turn could materially and adversely affect the trading price of shares of our Common Stock. Additional risks not currently known or currently material to us may also harm our business.
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.
24
ITEM 6. |
EXHIBITS |
Exhibit |
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Document Description |
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10.1 |
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10.2 |
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10.3 |
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10.4 |
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31.1 |
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31.2 |
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32.1 |
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32.2 |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema Document* |
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|
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101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document* |
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101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document* |
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|
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101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document* |
|
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101.DEF |
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Inline XBRL Taxonomy Extension Definition Linkbase Document* |
|
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104 |
|
The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2020, formatted in Inline XBRL (included as Exhibit 101)* |
* |
Filed herewith |
** |
Furnished herewith |
† |
Certain confidential portions of this exhibit were omitted by means of marking such portions with asterisks because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed. |
25
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Quarterly Report on Form 10-Q to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: February 4, 2021
|
ARROWHEAD PHARMACEUTICALS, INC. |
||
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By: |
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/s/ Kenneth A. Myszkowski |
|
|
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Kenneth A. Myszkowski Chief Financial Officer |
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(Principal Financial Officer and Duly Authorized Officer) |
26
Exhibit 10.1
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
EXECUTION VERSION
Exclusive License and Co-Funding Agreement
Arrowhead Pharmaceuticals Inc.
Takeda Pharmaceuticals U.S.A., Inc.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1. |
DEFINITIONS |
1 |
|
2. |
LICENSE GRANT |
21 |
|
|
2.1. |
License Grants to Takeda |
21 |
|
2.2. |
Sublicensing Terms |
21 |
|
2.3. |
Subcontractors |
22 |
|
2.4. |
In-Licenses |
22 |
|
2.5. |
Knowledge and Technology Transfer |
22 |
|
2.6. |
No Other Rights and Retained Rights |
23 |
|
2.7. |
License to Arrowhead |
23 |
|
2.8. |
Exclusivity and Restrictions |
23 |
3. |
DEVELOPMENT |
24 |
|
|
3.1. |
Development Responsibility |
24 |
|
3.2. |
Development Diligence Obligations |
25 |
|
3.3. |
Scientific Records |
27 |
4. |
REGULATORY MATTERS |
27 |
|
|
4.1. |
Regulatory Responsibilities |
27 |
|
4.2. |
Assignment of Regulatory Submissions |
27 |
|
4.3. |
Takeda Obligations |
28 |
|
4.4. |
Costs of Regulatory Affairs |
29 |
|
4.5. |
Pharmacovigilance Agreement |
29 |
5. |
OTHER OPERATING EXPENSES |
29 |
|
|
5.1. |
Other Operating Expenses |
29 |
6. |
MANUFACTURING |
29 |
|
|
6.1. |
Initial Manufacturing Period |
29 |
|
6.2. |
Supply After the Initial Manufacturing Period |
31 |
|
6.3. |
Observation by Takeda |
31 |
|
6.4. |
Manufacturing Technology Transfer |
31 |
|
6.5. |
Arrowhead Manufacturing Support |
32 |
7. |
COMMERCIALIZATION |
32 |
|
|
7.1. |
Commercialization of the Products |
32 |
|
7.2. |
Commercialization Expenses |
33 |
|
7.3. |
Recalls, Market Withdrawals, or Corrective Actions |
33 |
8. |
MEDICAL AFFAIRS |
33 |
i
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
8.1. |
Co-Funded Medical Affairs Plan |
33 |
|
8.2. |
Products Medical Affairs Expenses |
34 |
9. |
GOVERNANCE |
34 |
|
|
9.1. |
Alliance Manager |
34 |
|
9.2. |
Joint Steering Committee |
34 |
|
9.3. |
Decisions of the JSC |
37 |
|
9.4. |
Resolution of JSC Disputes |
37 |
10. |
PAYMENTS |
38 |
|
|
10.1. |
Upfront Payment |
38 |
|
10.2. |
Payments for the Compounds and Products |
38 |
|
10.3. |
Other Amounts Payable |
39 |
|
10.4. |
Payment Terms |
40 |
11. |
CONFIDENTIALITY AND PUBLICATION |
42 |
|
|
11.1. |
Nondisclosure and Non‑Use Obligations |
42 |
|
11.1.2. |
Non-Disclosure and Non-Use |
43 |
|
11.2. |
Publication and Publicity |
46 |
12. |
REPRESENTATIONS, WARRANTIES AND COVENANTS |
47 |
|
|
12.1. |
Mutual Representations and Warranties as of the Execution Date |
47 |
|
12.2. |
Representations and Warranties by Arrowhead |
48 |
|
12.3. |
Warranty Disclaimer |
51 |
|
12.4. |
Certain Covenants |
51 |
13. |
INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE |
52 |
|
|
13.1. |
Indemnification by Arrowhead |
52 |
|
13.2. |
Indemnification by Takeda |
53 |
|
13.3. |
Third Party Losses for Products |
53 |
|
13.4. |
Indemnification Procedure |
54 |
|
13.5. |
Limitation of Liability |
55 |
|
13.6. |
Insurance |
55 |
14. |
INTELLECTUAL PROPERTY |
55 |
|
|
14.1. |
Inventions |
55 |
|
14.2. |
Prosecution and Maintenance of Patent Rights |
56 |
|
14.3. |
Third Party Infringement and Defense |
59 |
|
14.4. |
Patent Right Extensions |
63 |
|
14.5. |
Third Party Rights |
63 |
ii
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
14.6. |
Orange Book Listing |
63 |
|
14.7. |
Trademarks |
63 |
|
14.8. |
Common Interest |
63 |
15. |
TERM AND TERMINATION |
64 |
|
|
15.1. |
Term |
64 |
|
15.2. |
Termination for Convenience |
64 |
|
15.3. |
Termination for Bankruptcy |
64 |
|
15.4. |
Termination for Material Breach |
65 |
|
15.5. |
Termination For Safety Reasons |
66 |
|
15.6. |
Effects of Termination |
67 |
|
15.7. |
Alternative Remedy in Lieu of Termination |
69 |
|
15.8. |
Survival |
70 |
16. |
EFFECTIVENESS |
70 |
|
|
16.1. |
Effective Date |
70 |
|
16.2. |
Filings |
70 |
|
16.3. |
Outside Date |
71 |
17. |
MISCELLANEOUS. |
71 |
|
|
17.1. |
Assignment |
71 |
|
17.2. |
Governing Law |
72 |
|
17.3. |
Dispute Resolution |
72 |
|
17.4. |
Entire Agreement; Amendments |
73 |
|
17.5. |
Severability |
73 |
|
17.6. |
Headings |
73 |
|
17.7. |
Waiver of Rule of Construction |
73 |
|
17.8. |
Interpretation |
73 |
|
17.9. |
No Implied Waivers; Rights Cumulative |
74 |
|
17.10. |
Notices |
74 |
|
17.11. |
Compliance with Export Regulations |
76 |
|
17.12. |
Force Majeure |
76 |
|
17.13. |
Independent Parties |
76 |
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17.14. |
Further Assurances |
76 |
|
17.15. |
Performance by Affiliates |
77 |
|
17.16. |
Binding Effect; No Third Party Beneficiaries |
77 |
|
17.17. |
Counterparts |
77 |
iii
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
SCHEDULE 2.5 |
Transition Plan |
SCHEDULE 3.1.3 |
Arrowhead Development Plan |
SCHEDULE 4.2.3 |
Regulatory Submissions Dates |
SCHEDULE 6.1.1 |
Forecasted CTM Supply Requirements |
SCHEDULE 6.1.4 |
CTM Supply Agreement Term Sheet |
SCHEDULE 12.2.1(a) |
Arrowhead AAT-Specific Patent Rights |
SCHEDULE 12.2.1(b) |
Arrowhead Platform Patent Rights |
iv
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Exclusive LICENSE AND CO-FUNDING AGREEMENT
THIS EXCLUSIVE LICENSE AND CO-FUNDING AGREEMENT (this “Agreement”), entered into as of October 7, 2020 (the “Execution Date”), is entered into by and between Takeda Pharmaceuticals U.S.A., Inc., a company incorporated under the laws of the State of Delaware (“Takeda”), and Arrowhead Pharmaceuticals Inc., a company organized and existing under the Laws of the State of Delaware (“Arrowhead”). Arrowhead and Takeda are referred to in this Agreement individually as a “Party” and collectively as the “Parties.”
WHEREAS, Takeda is a global pharmaceutical company engaged in the research, development, and commercialization of products useful in the amelioration, treatment, or prevention of human diseases and conditions;
WHEREAS, Arrowhead is a biopharmaceutical company focused on developing medicines that treat intractable diseases by silencing the genes that cause them, including advancing treatments for protein-based genetic disorders;
WHEREAS, Arrowhead Controls certain Patent Rights, Know-How, and other intellectual property rights related to the Compounds and Products; and
WHEREAS, Takeda wishes to obtain, and Arrowhead desires to grant, a license under certain Patent Rights, Know-How, and other intellectual property rights Controlled by Arrowhead to Exploit the Compounds and Products on the terms and conditions set forth herein.
NOW, THEREFORE, the Parties hereby agree as follows:
Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, will have the respective meanings set forth below:
1.2. |
“AAT Protein” means alpha-1 antitrypsin protein, including [***]. |
1.3. |
“AATD” means alpha-1 antitrypsin deficiency. |
1.4. |
“AATD Field” means all [***] for the treatment of AATD. |
1.5. |
“Accounting Standards” means International Financial Reporting Standards (IFRS) or U.S. Generally Accepted Accounting Principles (GAAP), as generally and consistently applied in compliance with applicable Laws throughout a Party’s organization at the relevant time. |
1.6. |
“Acquired Party” and “Acquiring Party” have the meanings set forth in Section 2.8.2(c) (Permitted Competitive Products). |
1.7. |
“Actual Additional Study Credit” has the meaning set forth in Section 3.2.3(d) (Reimbursement for Additional Studies). |
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.8. |
“Additional Studies” means, collectively, (a) a Phase III Clinical Trial for a Product that is focused on the treatment of cirrhotic patients (adult F4cc) and (b) any Phase III Clinical Trials for a Product that are focused on the treatment of pediatric patients. |
1.13. |
“Allowable Overruns” means any amount that is [***] above the total budgeted or approved amounts for a [***] on a [***] basis set forth in the Co-Funded Development Budget, Co-Funded Commercialization Budget, or Co-Funded Medical Affairs Budget, or Other Operating Expenses Budget for such [***]. |
1.14. |
“Annual Takeda Territory Net Sales” has the meaning set forth in Section 10.2.4 (Takeda Territory Royalties). |
1.15. |
“Antitrust Clearance Date” means the earliest date on which all applicable waiting periods and approvals required under Antitrust Laws with respect to the transactions contemplated under this Agreement have expired or have been terminated (in the case of waiting periods) or been received (in the case of approvals), in each case, without the imposition of any conditions. |
1.16. |
“Antitrust Filing” means any filing with the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice and any other applicable Governmental Authority in the Territory, as required under any Antitrust Laws with respect to the transactions contemplated under this Agreement, together with all required documentary attachments thereto. |
2
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.17. |
“Antitrust Laws” means any federal, state or foreign law, regulation, or decree, including the HSR Act, designed to prohibit, restrict, or regulate actions for the purpose or effect of monopolization or restraint of trade. |
1.18. |
“ARO-AAT” has the meaning set forth in Section 1.64 (Compound). |
1.19. |
“Arrowhead” has the meaning set forth in the preamble. |
1.22. |
“Arrowhead AAT-Specific Technology” means, collectively, the Arrowhead AAT-Specific Patent Rights and the Arrowhead AAT-Specific Know‑How. |
1.23. |
“Arrowhead Competitive Product” means any compound or product [***]. |
1.25. |
“Arrowhead Development Plan” has the meaning set forth in Section 3.1.3 (Arrowhead Development Plan). |
1.26. |
“Arrowhead Indemnitees” has the meaning set forth in Section 13.2 (Indemnification by Takeda). |
1.27. |
“Arrowhead Know-How” means Know-How, other than Joint Program Know-How, owned or Controlled by Arrowhead or its Affiliates as of the Effective Date or during the Term that is necessary or reasonably useful to Exploit a Compound or a Product in the Field in the Territory, including any Program Know-How owned solely by Arrowhead. The Arrowhead Know-How as of the Execution Date includes the Arrowhead AAT-Specific Know-How and the Arrowhead Platform Know-How. |
1.28. |
“Arrowhead Manufacturing Activities” has the meaning set forth in Section 6.1.1 (Arrowhead Manufacturing Activities). |
1.29. |
“Arrowhead Patent Rights” means any Patent Rights owned or Controlled by Arrowhead as of the Effective Date or during the Term that are necessary or reasonably useful to exploit a Compound or a Product in the Field in the Territory, including any Program Patent Rights owned solely by Arrowhead. The Arrowhead Patent Rights as of the Execution Date include the Arrowhead AAT-Specific Patent Rights and the Arrowhead Platform Patent Rights. |
1.30. |
“Arrowhead Platform Know-How” means all Arrowhead Know-How that is not Arrowhead AAT-Specific Know-How. |
3
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.31. |
“Arrowhead Platform Patent Right” means all Arrowhead Patent Rights that are not Arrowhead AAT-Specific Patent Rights. The Arrowhead Platform Patent Rights as of the Execution Date are set forth on Schedule 12.2.1(b). |
1.32. |
“Arrowhead Platform Technology” means, collectively, the Arrowhead Platform Patent Rights and the Arrowhead Platform Know‑How. |
1.33. |
“Arrowhead Technology” means, collectively, (a) the Arrowhead Patent Rights, (b) the Arrowhead Know‑How, and (c) Arrowhead’s interest in the Joint Program Technology. |
1.36. |
“Bankruptcy Laws” has the meaning set forth in Section 15.3.1 (Section 365(N)) |
1.37. |
“Breaching Party” has the meaning set forth in Section 15.4.1 (Material Breach). |
1.38. |
“Business Day” means a calendar day other than a Saturday, Sunday, or a bank or other public holiday in Boston, Massachusetts or Pasadena, California in the United States, or Tokyo in Japan. |
1.39. |
“Calendar Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30, and December 31 of each Calendar Year. |
1.40. |
“Calendar Year” means each successive period of twelve months commencing on January 1 and ending on December 31. |
4
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.45. |
“Clinical Trial Regulatory Submissions” means all INDs, MAAs, and other Regulatory Submissions in the Territory related to the Current Phase II/III Clinical Trial or the New Clinical Trial, as applicable. |
1.47. |
“Co-Funded Commercialization Activities” has the meaning set forth in Section 7.1.1 (Co-Funded Commercialization Plan). |
1.48. |
“Co-Funded Commercialization Budget” has the meaning set forth in Section 7.1.1 (Co-Funded Commercialization Plan). |
1.49. |
“Co-Funded Commercialization Plan” has the meaning set forth in Section 7.1.1 (Co-Funded Commercialization Plan). |
1.50. |
“Co-Funded Development Activities” means (a) the Additional Studies conducted in or for the Profit-Share Territory and (b) and any PMR/PMC Activities. |
1.51. |
“Co-Funded Development Budget” has the meaning set forth in Section 3.1.5 (Co-Funded Development Plan). |
1.52. |
“Co-Funded Development Plan” has the meaning set forth in Section 3.1.5 (Co-Funded Development Plan). |
1.53. |
“Co-Funded Medical Affairs Activities” has the meaning set forth in Section 8.1 (Co-Funded Medical Affairs Plan). |
1.54. |
“Co-Funded Medical Affairs Budget” has the meaning set forth in Section 8.1 (Co-Funded Medical Affairs Plan). |
5
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.55. |
“Co-Funded Medical Affairs Plan” has the meaning set forth in Section 8.1 (Co-Funded Medical Affairs Plan). |
1.58. |
“Commercial Milestone Event” has the meaning set forth in Section 10.2.2(b) (Commercial Milestones). |
1.59. |
“Commercial Milestone Payment” has the meaning set forth in Section 10.2.2(b) (Commercial Milestones). |
1.62. |
“Competitive Product” means, with respect to Arrowhead, an Arrowhead Competitive Product and, with respect to Takeda, a Takeda Competitive Product. |
1.63. |
“Competitive Infringement” means (a) the making, using, selling, offering for sale, importing, or exporting by a Third Party of a pharmaceutical or biologic product in a country that actually or potentially infringes a Valid Claim of an Arrowhead Patent Right or Joint Program Patent Right in such country or (b) the filing of an ANDA under Section 505(j) of the FD&C Act or an application under Section 505(b)(2) of the FD&C Act naming a Product as a reference listed drug and including a certification under Section 505(j)(2)(A)(vii)(IV) or 505(b)(2)(A)(IV), respectively. |
6
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.68. |
“CRO” means a contract research organization. |
1.69. |
“Current Phase II/III Clinical Trial” means the clinical study entitled “Placebo-Controlled, Multi-dose, Phase 2/ 3 Study to Determine the Safety, Tolerability and Effect on Liver Histologic Parameters in Response to ARO-AAT in Patients With Alpha-1 Antitrypsin Deficiency (AATD),” and as identified by the ClinicalTrials.gov Identifier: NCT03945292. |
7
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.70. |
“Current Product” means the Product containing ARO-AAT that is the subject of the New Clinical Trial. |
1.71. |
“Data Read-Out” means, with respect to a Clinical Trial, the date that the tables, figures, and listings for such Clinical Trial are provided to the Party that is the sponsor of such Clinical Trial. |
1.73. |
“Development Milestone Event” has the meaning set forth in Section 10.2.2(a) (Development Milestones). |
1.74. |
“Development Milestone Payment” has the meaning set forth in Section 10.2.2(a) (Development Milestones). |
1.75. |
“Development Report” has the meaning set forth in Section 3.2.4 (Products Development Reports). |
1.76. |
“Directed To” means, with respect to a compound contained in a product and its target(s), that the therapeutic mechanism of such compound is intended to activate, inhibit, agonize, antagonize, or otherwise modulate the expression or activity of such target(s). |
1.77. |
“Disclosing Party” has the meaning set forth in Section 1.65 (Confidential Information). |
1.78. |
“Disputes” has the meaning set forth in Section 17.3.1 (Exclusive Dispute Resolution Mechanism). |
8
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
(a) |
[***]; |
|
(b) |
[***] that is specifically allocated to sales of such Product; and |
|
(c) |
costs and expenses that are attributable to [***]; |
in each case, to the extent such costs are consistent with the applicable Co-Funded Commercialization Budget, plus applicable Allowable Overruns [***].
If any FTE Cost, Out-of-Pocket Cost, or other cost or expense is specifically identifiable or reasonably allocable to more than one Commercialization cost category set forth above, then such cost or expense will only be counted once (i.e., as an Eligible Commercialization Expense with respect to only one such category). No FTE Cost, Out-of-Pocket Cost, or other cost or expense included as an Eligible Commercialization Expense will also be included as an Eligible Development Expense or an Eligible Medical Affairs Expense. Costs attributable to sales personnel will be calculated in accordance with Section 1.81(c) and not as FTE Costs. Eligible Commercialization Expenses will be recognized and calculated in accordance with the applicable Accounting Standards.
1.82. |
“Eligible Development Costs Share Ratio” has the meaning set forth in Section 3.2.3(b) (PMR/PMC Activities). |
|
(a) |
[***]; |
|
(b) |
[***]; and |
in each case to the extent such costs are consistent with the applicable Co-Funded Development Budget, plus applicable Allowable Overruns [***]. If any FTE Cost, Out-of-Pocket Cost, or other cost or expense is specifically identifiable or reasonably allocable to more than one Development cost category above, then such cost or expense will only be counted once. No expense included as an Eligible Development Expense will also be included as an Eligible Commercialization Expense or an Eligible Medical Affairs Expense. Eligible Development Expenses will be recognized and calculated in accordance with the applicable Accounting Standards.
1.84. |
“Eligible Development Expenses Report” has the meaning set forth in Section 3.2.3(b) (PMR/PMC Activities). |
9
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.86. |
“Eligible Shared Expenses” means the Eligible Commercialization Expenses, Eligible Medical Affairs Expenses, and Other Operating Expenses. |
1.87. |
“EU” means the European Union, as its membership may be constituted from time to time, and any successor thereto. |
1.91. |
“FD&C Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended. |
1.92. |
“FDA” means the United States Food and Drug Administration or any successor Governmental Authority having substantially the same function. |
1.96. |
“FTE” means the equivalent of a full‑time person’s work time, carried out by an appropriately qualified employee of a Party or its Affiliates, on the performance of Development, Manufacturing, Commercialization, or Medical Affairs activities, based on [***] person‑hours per year, pro-rated as necessary. Overtime, and work on weekends, holidays, and the like [***]. |
10
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.97. |
“FTE Costs” means, for any period, the FTE Rate multiplied by the number of FTEs in such period. |
1.98. |
“FTE Rate” means [***] per one full FTE per full 12-month Calendar Year, which rate includes all direct and indirect costs of the performing Party’s FTE, including personnel and travel expenses. Such rate, [***]. |
1.99. |
“Forecasted Additional Study Credit” has the meaning set forth in Section 3.2.3(d) (Reimbursement for Additional Studies). |
1.101. |
“Generic Entry” has the meaning set forth in Section 10.2.5(b) (Reduction for Generic Competition). |
1.102. |
“Generic Product” means any pharmaceutical product sold by a Third Party (excluding Products sold by Sublicensees on behalf of Takeda or its Affiliates in accordance with the terms of this Agreement or any settlement agreement pertaining to patent litigation arising in connection with this Agreement) that: (a) contains the same active ingredient as the applicable Product, [***]; (b) is A/B Rated with respect to such Product or otherwise approved by the Regulatory Authority in such country as a substitutable generic for such Product; or (c) is approved in reliance, in whole or in part, on a prior Regulatory Approval of such Product. |
1.106. |
“Hatch-Waxman Act” means rights conferred in the U.S. under the Drug Price Competition and Patent Term Restoration Act, 21 U.S.C. §355, as amended (or any successor statute or regulation). |
1.107. |
“HSR Act” means the Hart‑Scott‑Rodino Antitrust Improvements Act of 1976, as amended, and the rules promulgated thereunder. |
11
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.111. |
“IND Transfer Date” has the meaning set forth in Section 4.2.1(a) (Clinical Trial Regulatory Submissions). |
1.114. |
“Initial Co-Funded Commercialization Budget” has the meaning set forth in Section 7.1.1 (Co-Funded Commercialization Plan). |
1.115. |
“Initial Co-Funded Development Budget” has the meaning set forth in Section 3.1.5 (Co-Funded Development Plan). |
1.116. |
“Initial Co-Funded Medical Affairs Budget” has the meaning set forth in Section 8.1 (Co-Funded Medical Affairs Plan). |
1.117. |
“Initial Manufacturing Period” has the meaning set forth in Section 6.1.1 (Arrowhead Manufacturing Activities). |
1.118. |
“Initiation” means, with respect to a Clinical Trial of a pharmaceutical or biologic product, the first dosing of the first human subject in such Clinical Trial. |
1.119. |
“IP Counsel” means the IP Head, Gastroenterology Therapeutic Area of Takeda the Vice President, IP and Associate General Counsel of Arrowhead or their designees. |
1.120. |
“Joint Program Know-How” means any and all Program Know-How developed or invented jointly by or on behalf of the Parties or their respective Affiliates. |
1.121. |
“Joint Program Patent Rights” means the Program Patent Rights Covering any Joint Program Know-How. |
1.123. |
“JSC” has the meaning set forth in Section 9.2.1 (Joint Steering Committee: Purpose; Formation). |
12
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.130. |
“Manufacturing Costs” means, with respect to the Products, the consolidated fully burdened Manufacturing costs in accordance with the applicable Accounting Standards, which will be the sum of: |
|
(b) |
[***]. |
1.131. |
“Manufacturing Technology Transfer” has the meaning set forth in Section 6.4 (Manufacturing Technology Transfer). |
13
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.133. |
“Material Shared In-License” means any Shared In-License under which Takeda reasonably anticipates owing average annual payment obligations in excess of [***]. |
|
(b) |
[***]; |
|
(c) |
[***]; |
|
(d) |
[***]; |
|
(e) |
[***]; and |
|
(f) |
[***]. |
[***]
14
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Notwithstanding the foregoing, [***].
In the case of any Combination Product sold in a given country in the Territory, Net Sales for the purpose of determining royalties and sales milestone events of the Combination Product in such country will be calculated by multiplying actual Net Sales of such Combination Product in such country by the fraction A/(A+B), where A is the invoice price of the Product included in such Combination Product if sold separately as a stand-alone Product in such country, and B is the total invoice price of the Other Components in the Combination Product, if sold separately in such country.
If, on a country-by-country basis, the Product included in such Combination Product is sold separately as a stand-alone Product in a country, but the Other Components in the Combination Product are not sold separately in such country, then Net Sales for the purpose of determining royalties and sales milestone events of the Combination Product for such country will be calculated by multiplying actual Net Sales of the Combination Product in such country by the fraction A/C, where A is the invoice price of the Product if sold separately as a stand-alone Product in such country, and C is the invoice price of the Combination Product in such country.
If, on a country-by-country basis, the Product included in the Combination Product is not sold separately as a stand-alone Product in such country, but the Other Components included in the Combination Product are sold separately in such country, then Net Sales for the purpose of determining royalties and sales milestone events of the Combination Product for such country will be calculated by multiplying actual Net Sales of the Combination Product in such country by the fraction (C-B)/C, where B is the invoice price of the Other Components included in such Combination Product if sold separately in such country, and C is the invoice price of the Combination Product in such country.
If neither the Product nor the Other Components included in the Combination Product are sold separately in a given country, then Net Sales for the purpose of determining royalties and sales milestone events in such country will be determined [***].
1.140. |
“Neutral Expert” has the meaning set forth in Section 6.1.5(a) (Arbitration for Failure to Agree). |
1.141. |
“New Clinical Trial” means, collectively, the New Phase II Trial and the New Phase III Trial. |
1.142. |
“New Phase II Trial” means the Current Phase II/III Clinical Trial as amended with endpoints acceptable to FDA and appropriate for a Phase II Clinical Trial. |
1.143. |
“New Phase III Trial” means the clinical study to be designed and implemented with endpoints appropriate for a Phase III Clinical Trial. |
15
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.147. |
“Operating Profits or Losses” means, for all Products in the Profit-Share Territory, the profits or losses calculated in accordance with Schedule 10.2.1 (Profit and Loss Share). |
|
(a) |
[***]; |
|
(b) |
[***]; |
|
(c) |
[***]; |
|
(d) |
[***]; |
|
(e) |
[***]; |
|
(f) |
[***]; and |
|
(g) |
[***]; |
No expense included as an Eligible Development Expense, an Eligible Commercialization Expense, or an Eligible Medical Affairs Expense will also be included as an Other Operating Expense. Other Operating Expenses will be recognized and calculated in accordance with the applicable Accounting Standards.
1.150. |
“Other Operating Expenses Budget” has the meaning set forth in Section 5.1 (Other Operating Expenses). |
16
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.158. |
“Permitted Competitive Products” has the meaning set forth in Section 2.8.2(c) (Permitted Competitive Products). |
1.160. |
“Pharmacovigilance Agreement” has the meaning set forth in Section 4.5 (Pharmacovigilance Agreement). |
1.161. |
“Phase II Clinical Trial” means a Clinical Trial (or any arm thereof) of an investigational product that satisfies the requirements of U.S. federal regulation 21 C.F.R. § 312.21(b) and its successor regulation, or an equivalent Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States. |
1.163. |
“PMR/PMC Activities” means any post-marketing requirements, post-marketing commitments, or other Clinical Trials undertaken as a condition to obtain or maintain Regulatory Approval for a Product in the Profit-Share Territory. |
1.165. |
“Pricing Approval” means, with respect to any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical or biologic products, receipt (or, if required to make such authorization, approval, or determination effective, |
17
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
publication) of such reimbursement authorization, pricing approval, or determination (as the case may be). |
1.166. |
“Product” means any pharmaceutical product comprised, in whole or in part, of the Compound, including all forms, presentations, strengths, doses, and formulations (including any method of delivery), either alone or as a Combination Product. |
1.167. |
“Profit-Share Territory” means the United States. |
1.168. |
“Program Know-How” means any Know-How developed or invented during the Term by or on behalf of a Party, any of its Affiliates or Sublicensees, either alone or jointly, in the performance of activities relating to the Exploitation of Products under this Agreement. |
1.169. |
“Program Patent Rights” means any Patent Right that (a) has a priority date after the Effective Date, and (b) Covers any Program Know-How. |
1.171. |
“Potential Material Shared In-License Term Sheet” has the meaning set forth in Section 2.4.2 (Shared In-License Process). |
1.172. |
“P&L Share” means the Parties’ equal sharing of the Operating Profits or Losses for Products pursuant to Section 10.2.1 (Profit and Loss Share). |
1.173. |
“Receiving Party” has the meaning set forth in Section 1.65 (Confidential Information). |
1.174. |
“Redacted Agreement” has the meaning set forth in Section 11.1.4(b) (Confidential Treatment). |
1.176. |
“Regulatory Authority” means any Governmental Authority responsible for granting Regulatory Approvals of pharmaceutical or biologic products. |
18
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.180. |
“Roche Agreement” means the Stock and Asset Purchase Agreement between Arrowhead (at the time known as Arrowhead Research Corporation), and Hoffmann-La Roche Inc. and F. Hoffmann-La Roche Ltd., dated October 21, 2011. |
1.181. |
“Royalties” has the meaning set forth in Section 10.2.4 (Takeda Territory Royalties). |
1.182. |
“Royalty Rates” means the applicable royalty rate set forth in Table 10.2.4 (Royalty Payments (Takeda Territory)). |
1.185. |
“Shared In-License” has the meaning set forth in Section 2.4.1 (Shared In-Licenses). |
1.186. |
“SEC” means the United States Securities and Exchange Commission or any successor Governmental Authority having substantially the same function. |
1.189. |
“Sublicense Revenue” means [***]. |
1.190. |
“Sublicensee” means a Third Party to which Takeda or its Affiliate has granted or grants a sublicense, option to sublicense or similar right under the Arrowhead Technology to Exploit any Product, or any further sublicensee of such rights (regardless of the number of tiers, layers or levels of sublicenses of such rights), beyond the mere right to purchase any Product from or to provide services on behalf of Takeda or its Affiliates. |
1.191. |
“Supply Arbitration Draft” has the meaning set forth in Section 6.1.5(b) (Arbitration for Failure to Agree). |
19
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.192. |
“Takeda Competitive Product” means [***]. |
1.193. |
“Takeda Prosecuted Patent Rights” has the meaning set forth in Section 14.2.1(a) (Takeda’s Right). |
1.194. |
“Takeda Program Patent Rights” means Program Patent Rights Covering inventions within the Program Know-How developed or invented solely by or on behalf of Takeda or its Affiliates. |
1.195. |
“Takeda Technology” means, to the extent that Takeda determines, in its sole discretion, to contribute (and provides notice thereof in writing) to any of the following for use by Arrowhead in the performance of Development or Manufacturing activities for the Product in the Territory in accordance with this Agreement, (a) Know-How Controlled by Takeda as of the Effective Date or during the Term that is necessary to Exploit a Compound or a Product in the Territory and (b) Patent Rights Controlled by Takeda as of the Effective Date or during the Term that are necessary to Develop or Manufacture a Compound or a Product under this Agreement in the Territory. |
1.196. |
“Takeda Territory” means worldwide, excluding the Profit-Share Territory. |
1.199. |
“Terminated Country” has the meaning set forth in Section 15.4.1 (Material Breach). |
1.205. |
“United States” or “U.S.” means the United States and its territories, possessions and commonwealths. |
20
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.208. |
“Withholding Tax” has the meaning set forth in Section 10.4.5(b) (Withholding Taxes). |
|
2.1.2. |
Platform License Grant. Subject to the terms and conditions of this Agreement, during the Term, Arrowhead hereby grants to Takeda and its Affiliates an exclusive (even as to Arrowhead and its Affiliates, except as set forth in Section 2.6 (No Other Rights and Retained Rights)), non‑transferable (except as provided in Section 17.1 (Assignment)), sublicensable (through multiple tiers, in accordance with Section 2.2 (Sublicensing Terms)) license under the Arrowhead Platform Technology to Exploit the Products in the AATD Field and in the Territory. The foregoing license grant will be royalty-bearing in the Takeda Territory. |
21
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
with all provisions of, this Agreement, and for the performance of all obligations of its Affiliates and Sublicensees as required under this Agreement. |
22
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
(i) |
divest, or cause its relevant Affiliates to divest, whether by license or otherwise, its interest (excluding a solely economic interest) in such Competitive Products; or |
|
(ii) |
terminate, or cause its relevant Affiliates to terminate, any further Competitive Activities with respect to such Competitive Products. |
23
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
Competitive Products as provided in Section 2.8.2(a) (Acquisitions of or by Third Parties; Options), then such Party or its relevant Affiliate will effect (i) the consummation of such divestiture within [***] or such other period as may be required to comply with applicable Law or (ii) effect such termination of the applicable Competitive Activities with respect to the Competitive Product within [***], in each case ((i) and (ii)), after the closing of the relevant acquisition transaction and will confirm to the other Party in writing when it completes such divestiture pursuant to clause (i) or termination pursuant to clause (ii). The acquired or acquiring Party will keep the other Party reasonably informed of its efforts and progress in effecting such divesture or termination until such Party completes the same. |
24
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
3.1.4. |
Takeda Responsibility. For each Product, except as set forth in Section 3.1.1 (Arrowhead Responsibility) with respect to the Ongoing Development Trials and associated Ongoing Development Activities, Takeda will have sole control over and decision-making authority for the Development of such Product, including [***]. For the avoidance of doubt, other than with respect to the New Phase II Trial, Takeda will have sole control over and decision-making authority with respect to the conduct of all Clinical Trials for the Product, including [***]. |
25
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
3.2.1. |
Arrowhead Development Diligence Obligations. Arrowhead will use Commercially Reasonable Efforts to [***]. |
|
(a) |
Co-Funded Expenses. (i) The Parties will share the Eligible Development Expenses incurred [***] and (ii) Arrowhead will [***]. |
26
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
27
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
(c) |
Clinical Trial Data. In connection with the transfer of Regulatory Submissions provided for in this Section 4.2.1 (Clinical Trial Regulatory Submissions), Arrowhead will provide to Takeda separate copies (in electronic or other format) of the study reports and underlying data (to the extent not previously provided to Takeda) from the Ongoing Development Activities. |
28
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
29
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
CMC activities and stability studies and the Manufacture and supply of the quantity of Clinical Trial Material required for the conduct of the Current Phase II/III Clinical Trial or New Clinical Trial, as applicable (the “Arrowhead Manufacturing Activities”). The “Initial Manufacturing Period” will commence on the Effective Date and continue until the earliest to occur of (a) the date on which Takeda confirms that the Manufacturing Technology Transfer for the Current Product is complete, such that Takeda’s (or its designee’s) facilities has been qualified and otherwise received all Regulatory Approvals required to Manufacture such Product, and (b) the delivery by Arrowhead of all of the quantities of Clinical Trial Material required for Takeda’s conduct of the New Phase III Trial or such other Phase III Clinical Trial as is required to obtain Regulatory Approval for a Product comprising ARO-AAT pursuant to Section 3.1.2 (Changes to Development Plans), and will allocate sufficient reserved capacity for the foregoing. During the Initial Manufacturing Period, Arrowhead may conduct the Arrowhead Manufacturing Activities itself or through [***] or any other CMO approved in writing by Takeda. Arrowhead will be solely responsible for all Manufacturing Costs that it incurs in performing the Arrowhead Manufacturing Activities, whether itself or through a Third Party, during the Initial Manufacturing Period. |
|
6.1.3. |
Manufacture by CMO. Unless otherwise agreed by the Parties, if Arrowhead is performing the Arrowhead Manufacturing Activities through one or more CMOs, then, in connection with the transition of Manufacturing responsibility to Takeda, the Parties will discuss in good faith the assignment or transfer to Takeda of the agreements between Arrowhead and one or more of such CMOs. Arrowhead will use reasonable efforts to ensure that any such agreement between Arrowhead and such a CMO that is specific to a Product under this Agreement permits Arrowhead to assign such agreement to Takeda. |
|
6.1.5. |
Arbitration for Failure to Agree. If the Parties cannot reach agreement and enter into the CTM Supply Agreement within the applicable period set forth in Section 6.1.4 (CTM |
30
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
Supply Agreement), then the final terms and conditions of such CTM Supply Agreement will be determined through binding arbitration as follows: |
|
(d) |
[***]. |
31
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
7.1.2. |
Commercialization Diligence Obligations. Takeda will use Commercially Reasonable Efforts to perform the Co-Funded Commercialization Activities under the Co-Funded |
32
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
7.1.3. |
Commercialization Responsibility. As between the Parties, Takeda will lead and have sole control over and decision-making authority with respect to all Commercialization activities in the Profit-Share Territory and in the Takeda Territory. |
33
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
review, discuss, and determine whether to approve the proposed Co-Funded Medical Affairs Plan, including the Initial Co-Funded Medical Affairs Budget, and each annual update thereto and any other such proposed material update in accordance with Section 9.2.3 (Responsibilities of JSC). |
34
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
(a) |
review, discuss, and determine whether to approve (i) the Co-Funded Development Plan, Co-Funded Development Budget, and any updates thereto (ii) [***], and (iii) [***]; |
|
(c) |
review, discuss, and determine whether to approve an amendment to the Current Phase II/III Trial to reflect the New Phase II Trial and New Phase III Trial, as described in Section 3.1.2 (Changes to Development Plan); |
|
(d) |
review, discuss, and determine whether to approve any proposed amendments to the Arrowhead Development Plan, as described in Section 3.1.3 (Arrowhead Development Plan); |
|
(e) |
review, discuss, and determine whether to approve any proposed material amendments to the Co-Funded Development Plan, as described in Section 3.1.5 (Co-Funded Development Plan); |
|
(g) |
review discuss, and determine whether to approve any proposed material amendments to the Co-Funded Commercialization Plan, as described in Section 7.1.1 (Co-Funded Commercialization Plan); |
|
(h) |
review discuss, and determine whether to approve any proposed material amendments to the Co-Funded Medical Affairs Plan, as described in Section 8.1 (Co-Funded Medical Affairs Plan); |
|
(i) |
[***]; |
35
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
|
(j) |
review and discuss any proposed publication by either Party, as described in Section 11.2 (Publication and Publicity); |
|
(k) |
review, discuss, and determine, if requested by either Party, an alternate timeframe for Takeda’s negotiation of an agreement with a qualified vendor for purposes of the transfer and storage of inventory of Product or for Arrowhead’s transfer to Takeda of inventory of one or more Compounds, as described on Schedule 2.5 (Transition Plan); |
|
(m) |
establish a MWG, as described in Section 6.1.2 (Manufacturing Working Group); |
|
(o) |
form such other committees or working groups under the JSC as may be necessary or desirable to facilitate the activities under this Agreement as the Parties may agree and oversee the activities of any such other committees or working groups; |
|
(q) |
perform such other functions expressly allocated to the JSC in this Agreement or by the written agreement of the Parties. |
36
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
(b) |
Takeda Final Decision-Making Authority. [***]. |
37
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|
[***]
|
|
[***] |
|
If (i): [***]
or
if (ii): [***] |
Table 10.2.2(a)(ii) –Development Milestones – Scenario B |
|
Development Milestone Event |
Development Milestone Payment |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
38
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
TABLE 10.2.4 –Royalty Payments (Takeda Territory) |
|
Annual Takeda Territory Net Sales |
Marginal Royalty Rate (% of Annual Takeda Territory Net Sales) |
The portion of Annual Takeda Territory Net Sales less than or equal to [***] |
20%
|
The portion of Annual Takeda Territory Net Sales greater [***] and less than or equal to [***] |
[***]
|
The portion of Annual Takeda Territory Net Sales greater than [***] and less than or equal to [***] |
[***]
|
The portion of Annual Takeda Territory Net Sales greater than [***] |
25%
|
39
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
owing Party will pay any undisputed amounts within [***] after receipt of the invoice, and will pay any disputed amounts owed by such Party within [***] of resolution of the Dispute. |
40
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due hereunder for the audited period, then the fees and expenses charged by the Auditor will be paid by Takeda. |
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11.1.1. |
Confidential Information. The existence and terms of this Agreement are the Confidential Information of each Party, and each Party will be deemed a receiving Party |
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Agreement. In addition, a Receiving Party may provide Confidential Information disclosed to it, and disclose the existence and terms of this Agreement to: |
If and whenever any Confidential Information is disclosed in accordance with this Section 11.1.3 (Permitted Disclosures), such disclosure will not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (other than by breach of this Agreement).
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disclosure and otherwise complies with Section 11.1.3 (Permitted Disclosures), or (b) as expressly permitted by the terms hereof. |
12.1. |
Mutual Representations and Warranties as of the Execution Date. Each Party represents and warrants to the other Party, as of the Execution Date, that: |
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12.1.1. |
such Party is a corporation duly organized, validly existing, and in good standing under the Laws of its jurisdiction of incorporation or formation; |
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12.1.2. |
such Party has all requisite corporate power and corporate authority to enter into this Agreement and to carry out its obligations under this Agreement; |
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(including any articles or memoranda of organization or association, charter, bylaws, or similar documents); and |
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12.1.5. |
such Party has not entered into any agreement with any Third Party that is in conflict with the rights granted to the other Party under this Agreement, and has not taken any action that would prevent it from granting the rights granted to the other Party under this Agreement, or that would otherwise conflict with or adversely affect the other Party’s rights under this Agreement. |
12.2. |
Representations and Warranties by Arrowhead. Arrowhead represents and warrants to Takeda, as of the Execution Date that: |
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12.2.7. |
Good Standing. All official fees, maintenance fees and annuities for any pending or issued Arrowhead Patent Rights have been paid when due, and all administrative procedures with Governmental Authorities have been completed for such Arrowhead Patent Rights such that such Patent Rights are subsisting and in good standing. |
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12.2.8. |
Duty of Disclosure. To Arrowhead’s knowledge, all Arrowhead Patent Rights have been duly and properly filed and maintained and the inventors thereof and parties prosecuting such applications have complied in all material respects with their duty of candor and disclosure to the U.S. Patent and Trademark Office and other foreign patent offices in connection with such applications. |
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12.2.9. |
Disclosure to Takeda. To Arrowhead’s knowledge, Arrowhead has disclosed to Takeda (a) all information that is (i) known to any individual associated with the filing or prosecution (as defined in 37 C.F.R. § 1.56(c)) of the Arrowhead Patent Rights and (ii) material to patentability of the Arrowhead Patent Rights (as defined in 37 C.F.R. § 1.56(b)), or that would be considered material to patentability as defined in 37 C.F.R. § 1.56(b) but for an exception under 35 U.S.C. § 102(b), and (b) an indication to which Arrowhead Patent Rights each piece of such information relates. |
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12.2.10. |
Prior Art. To Arrowhead’s knowledge, there is not any reference or prior art that would anticipate the issuance of any claim as pending as of the Execution Date in any Arrowhead Patent Rights. |
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12.2.11. |
Government Funding. No government funding, facilities of a university, college, or other educational institution or research center was used in the development of any Arrowhead Patent Rights. No Person who was involved in, or who contributed to, the creation or development of any Arrowhead Patent Rights has, performed services for the government, university, college, or other educational institution or research center in a manner that would affect Arrowhead’s rights in the Arrowhead Patent Rights. |
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12.2.12. |
No Claims. There are (a) no claims, judgments or settlements against or owed by Arrowhead or its Affiliates and (b) no pending or, to Arrowhead’s knowledge, threatened claims or litigation, in each case ((a) and (b)), related to the Arrowhead Technology or the Compounds. |
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12.2.15. |
Third Party Infringement. To Arrowhead’s knowledge, no Third Party is infringing, misappropriating, or otherwise violating, or threatening to infringe, misappropriate, or otherwise violate the Arrowhead Technology. |
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12.2.19. |
Regulatory Submissions and Study Reports. Arrowhead or its Affiliates Control all Regulatory Submissions in the Territory related to the Compounds, and to Arrowhead’s knowledge, Arrowhead or its Affiliates Control all study reports and underlying data from the Ongoing Development Activities or any other Clinical Trials of any Compound conducted before the Effective Date. |
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12.2.20. |
No Fraudulent Statements. Neither Arrowhead nor its Affiliates, nor, to Arrowhead’s knowledge, any of its or their respective directors, officers, employees or agents has (a) committed an act, (b) made a statement or (c) failed to act or make statement, in any case ((a), (b) or (c)), that (i) would be or create an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the Development and Manufacture of any Compound or Product or (y) could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any analogous laws or policies, with respect to the Development and Manufacture of any Compound or Product. |
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12.4.1. |
Compliance. Each Party, its Affiliates, and Sublicensees will conduct the Exploitation of the Products in a good scientific manner [***] in accordance with all applicable Laws, |
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12.4.3. |
Control. Arrowhead or its Affiliates will retain Control during the Term of all Patent Rights and Know-How owned by Arrowhead or its Affiliates as of the Effective Date that are (a) necessary to Exploit any Products (excluding any active pharmaceutical ingredient therein that is not a Compound) in the Field in the Territory or (b) reasonably useful to Exploit one or more Products in the Field in the Territory. |
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12.4.4. |
No Conflicts. Arrowhead will not enter into any agreement with any Third Party that is in conflict with the rights granted to Takeda under this Agreement and will not take any action that would prevent it from granting the rights granted to Takeda under this Agreement or that would otherwise materially conflict with or adversely affect the rights granted to Takeda under this Agreement. |
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12.4.5. |
Assignment. Upon Takeda’s request, Arrowhead or its Affiliates will use reasonable efforts to obtain from each employee and independent contractor who participated in the invention or authorship of any Arrowhead Technology, assignments of all ownership rights of such employees and independent contractors in such Arrowhead Technology pursuant to written agreement. |
13.1. |
Indemnification by Arrowhead. Arrowhead will indemnify, hold harmless, and defend Takeda, its Affiliates, and their respective directors, officers, employees, and agents (“Takeda |
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13.1.1. |
any breach of, or inaccuracy in, any representation or warranty made by Arrowhead in this Agreement, or any breach or violation of any covenant or agreement of Arrowhead in this Agreement, |
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13.1.3. |
the Exploitation of any Product, in each case, by or on behalf of Arrowhead or any of its Affiliates, or the conduct of the Ongoing Development Activities. |
Notwithstanding the foregoing, Arrowhead will have no obligation to indemnify the Takeda Indemnitees to the extent that the Losses arise out of or result from matters described under Section 13.2.1 or 13.2.2 (Indemnification by Takeda).
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13.2.1. |
any breach of, or inaccuracy in, any representation or warranty made by Takeda in this Agreement, or any breach or violation of any covenant or agreement of Takeda in this Agreement, |
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13.2.3. |
the Exploitation of any Product by or on behalf of Takeda or any of its Affiliates or Sublicensees, including the infringement of any Third Party Patent Right in the course of such Exploitation, but excluding the Exploitation of any Product in the Profit-Share Territory. |
Notwithstanding the foregoing, Takeda will have no obligation to indemnify the Arrowhead Indemnitees to the extent that the Losses arise out of or result from matters described under Section 13.1.1 or 13.1.2 (Indemnification by Arrowhead).
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Affiliates or (in the case of Takeda) Sublicensees or any of their respective directors, officers, employees, or agents in the performance of such Party’s obligations or exercise of its rights under this Agreement, provided that, with respect to all such Losses other than those arising out of the foregoing clauses (a) or (b), Arrowhead will reimburse its [***] share of such Losses within [***] after receipt of invoice therefor from Takeda. Each Party will notify the other Party in writing promptly upon being notified of or having knowledge of any claim by a Third Party arising from the Exploitation of any Product. Takeda will defend the Arrowhead Indemnitees from any Claims described in this Section 13.3 (Third Party Losses for Products) pursuant to Section 13.4 (Indemnification Procedure). |
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14.1.2. |
Disclosure. Each Party will promptly disclose to the other Party all invention disclosures or other similar documents relating to Program Know-How developed or invented by or on behalf of such Party hereunder during the Term, (a) in the case of Arrowhead as the disclosing Party, for all Program Know-How that is necessary or reasonably useful to Exploit the Compounds and Products in the Field in the Territory and (b) in the case of Takeda as the disclosing Party, only for Program Know-How that Arrowhead requires to perform its obligations under this Agreement, and, in each case, all invention disclosures |
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or other similar documents submitted to such Party by its or its Affiliates’ employees, agents or independent contractors relating to such Program Know-How, and shall also respond promptly to reasonable requests from the other Party for additional information relating to such disclosures, documents or applications. |
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14.1.3. |
Personnel Obligations. Each employee, agent, or independent contractor of a Party or its respective Affiliates performing work under this Agreement will, prior to commencing such work, be bound by written invention assignment obligations, including: (a) promptly reporting any invention, discovery, or other intellectual property right; (b) presently assigning to the applicable Party or Affiliate all of his or her right, title, and interest in and to any invention, discovery, or other intellectual property; (c) cooperating in the preparation, filing, prosecution, maintenance and enforcement of any patent and patent application; and (d) performing all acts and signing, executing, acknowledging, and delivering any and all documents required for effecting the obligations and purposes of this Agreement. It is understood and agreed that such invention assignment agreement need not reference or be specific to this Agreement. Each Party will be solely responsible for any payments to inventors with an obligation to assign, or who do assign, their rights, title, and interests in and to any Program Know-How and Program Patent Rights to such Party. Arrowhead will be solely responsible for payments to inventors of any other Arrowhead Patent Rights. |
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14.1.4. |
Joint Research Agreement. This Agreement is a joint research agreement within the meaning of pre-AIA 35 U.S.C. § 103(c) and AIA 35 U.S.C. § 102(c). |
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(i) |
Beginning on the Effective Date, as between the Parties, Takeda will have (i) the first right (but not the obligation) to Prosecute and Maintain all Arrowhead AAT-Specific Patent Rights and Joint Program Patent Rights in the Territory and (ii) the sole right (but not the obligation) to Prosecute and Maintain the Takeda Program Patent Rights (such Patent Rights in clauses (i) and (ii), collectively, the “Takeda Prosecuted Patent Rights”), using outside patent counsel of its choice. The Parties will share the applicable Patent Costs incurred by Takeda for the Prosecution and Maintenance of the Takeda Prosecuted Patent Rights in the Profit-Share Territory in accordance with Section 10.2.1 (Profit and Loss Share), and Takeda will bear all Patent Costs incurred by Takeda for the Prosecution and Maintenance of the Takeda Prosecuted Patent Rights in the Takeda Territory. Takeda will provide Arrowhead with material communications from any patent authority in the Territory regarding the Takeda Prosecuted Patent Rights, as well as a reasonable opportunity to review and comment on drafts of any material filings or responses to be made to such patent |
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authorities in advance of submitting such filings or responses. Takeda will consider Arrowhead’s comments regarding such communications and drafts in good faith. In addition, Takeda will provide Arrowhead with copies of all final material filings and responses made to any Patent Office with respect to the Takeda Prosecuted Patent Rights in a timely manner following submission thereof. Arrowhead will (1) promptly after the Effective Date provide to Takeda or counsel designated by Takeda the file histories for, and correspondence with foreign patent counsel related to, the Arrowhead AAT-Specific Patent Rights, (2) provide to Takeda promptly after the Effective Date a report detailing the status of the Arrowhead AAT-Specific Patent Rights, and (3) provide all assistance reasonably requested by Takeda in Takeda’s Prosecution and Maintenance of the Arrowhead AAT-Specific Patent Rights and Program Patent Rights (including by executing all requested documents and providing additional information with respect to the applicable Patent Rights). For the avoidance of doubt, other than with respect to the Takeda Program Patent Rights as detailed above, Takeda will control, at its sole cost and expense, and in its sole discretion, the Prosecution and Maintenance of all Patent Rights within the Takeda Technology. |
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(i) |
Beginning on the Effective Date, as between the Parties, Arrowhead will be responsible for and control the Prosecution and Maintenance of all Arrowhead Platform Patent Rights in the Territory using outside patent counsel of its choice. Arrowhead will bear all Patent Costs incurred for the Prosecution and Maintenance of the Arrowhead Platform Patent Rights. Arrowhead will keep Takeda reasonably informed of all substantive matters relating to the Prosecution and Maintenance of the Arrowhead Platform Patent Rights, including providing Takeda with all material communications from any patent authority in the Territory regarding the Arrowhead Platform Patent Rights, as well as a reasonable opportunity to review and comment on drafts of any material filings or responses to be made to such patent authorities in advance of submitting such filings or responses. Arrowhead will consider in good faith Takeda’s comments, requests, and suggestions with respect to strategies for Prosecution and Maintenance of the Arrowhead Platform Patent Rights. In addition, Arrowhead will provide Takeda with copies of all final material filings and responses made to any Patent Office with respect to the Arrowhead Platform Patent Rights in a timely manner following submission thereof. Arrowhead will (A) promptly after the Effective Date provide to Takeda or counsel designated by Takeda the file histories for, and correspondence with foreign patent counsel related to, the Arrowhead Platform Patent Rights, and (B) provide to Takeda promptly after the Effective Date a report detailing the status of the Arrowhead Platform Patent Rights. |
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(ii) |
If Takeda determines in its sole discretion to abandon or not to Prosecute and Maintain any Arrowhead AAT-Specific Patent Right or Joint Program Patent Right, then Takeda will provide Arrowhead with written notice promptly after such determination to allow Arrowhead a reasonable period of time to determine, on a country-by-country basis, in its sole discretion, its interest in Prosecuting and Maintaining such Patent Rights in the Territory (which notice by Takeda will be given no later than [***] prior to the final deadline for any pending action or response that may be due with respect to such Patent Right with the applicable Patent Office). If Arrowhead provides written notice to Takeda expressing its interest in Prosecuting and Maintaining such Patent Right, then, with respect to such Patent Right in such country in the Territory, (A) Arrowhead may, in its sole discretion and at Arrowhead’s cost and expense, Prosecute and Maintain or abandon such Patent Right, and (B) Takeda will promptly: (I) provide to Arrowhead or counsel designated by Arrowhead the file histories for, and correspondence with foreign patent counsel related to, such Patent Right, (II) provide to Arrowhead a report detailing the status of such Patent Right as of the applicable date of such notice by Takeda, and (III) provide all assistance reasonably requested by Arrowhead in Arrowhead’s Prosecution and Maintenance of the applicable Patent Rights (including by executing all requested documents and providing additional information with respect to the applicable Patent Rights). |
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(i) |
As between the Parties, Takeda will have (A) the first right, but not the obligation, to bring an appropriate suit or other action to abate any existing, alleged, or threatened Competitive Infringement involving the Arrowhead AAT-Specific Patent Rights or Joint Program Patent Rights, and (B) the sole right, but not the obligation, to bring an appropriate suit or other action to abate any existing, alleged, or threatened Competitive Infringement involving the Takeda Program Patent Rights. |
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(ii) |
Takeda will notify Arrowhead of its decision as to whether to take any action in accordance with Section 14.3.2(a)(i) at least [***] before any time limit set forth in an applicable Law or regulation, or within [***] after being notified of such Competitive Infringement, whichever is shorter. If Takeda decides not to take such action with respect to any Arrowhead AAT-Specific Patent Right or Joint Program Patent Right, then Takeda will so notify Arrowhead in writing, and following discussion with Takeda and consideration in good faith of any rationale provided by Takeda as to why Takeda elected not to take such action, and with Takeda’s written consent (not to be unreasonably withheld) following consideration in good faith of any rationale provided by Arrowhead, Arrowhead will have the right, but not the obligation, to commence a suit or take action to enforce the applicable Arrowhead AAT-Specific Patent Right or Joint Program Patent Right to abate such Competitive Infringement in the Territory, by counsel of its own choice and at its own expense. |
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(i) |
As between the Parties, Arrowhead will have the first right, but not the obligation, to bring an appropriate suit or other action to abate any |
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existing, alleged, or threatened Competitive Infringement involving the Arrowhead Platform Patent Rights, provided that Arrowhead will seek and reasonably consider Takeda’s comments before determining the strategy for enforcing any Arrowhead Platform Patent Right. |
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(ii) |
Arrowhead will notify Takeda of its decision as to whether to take any action in accordance with Section 14.3.2(a)(i) at least [***] before any time limit set forth in an applicable Law or regulation, or within [***] after being notified of such Competitive Infringement, whichever is shorter. If Arrowhead decides not to take such action with respect to any Arrowhead Platform Patent Right, then Arrowhead will so notify Takeda in writing, and following discussion with Arrowhead and consideration in good faith of any rationale provided by Arrowhead as to why Arrowhead elected not to take such action, and with Arrowhead’s written consent (not to be unreasonably withheld) following consideration in good faith of any rationale provided by Takeda, Takeda will have the right, but not the obligation, to commence a suit or take action to enforce the applicable Arrowhead Platform Patent Right to abate such Competitive Infringement in the Territory, by counsel of its own choice and at its own expense. |
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action, to join any such suit or action at such other Party’s own expense by counsel of its own choice, but such other Party will at all times reasonably cooperate with the Party bringing such action. |
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between the Parties as provided in 14.3.2(g) (Allocation of Proceeds). |
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(a) |
Notice. If any Product becomes the subject of a Third Party’s claim or assertion of infringement of a Patent Right within the Territory, the Party first having notice of the claim or assertion will promptly notify the other Party through the JSC. |
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14.3.5. |
Other Invalidity or Unenforceability Proceedings. If either Party desires to bring an opposition, action for declaratory judgment, nullity action, interference, declaration for non-infringement, reexamination, post-grant proceedings, or other attack upon the validity, title or enforceability of a Patent Right owned or controlled by a Third Party and having [***] or more claims that Cover a Product, or the use, sale, offer for sale or importation of a Product (except insofar as such action is a counterclaim to or defense of, or accompanies a defense of, a Third Party’s claim or assertion of infringement under Section 14.3.4 (Infringement of Third Party Rights), in which case the provisions of Section 14.3.4 (Infringement of Third Party Rights) shall govern), such Party shall so notify the other |
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Party and the Parties shall promptly confer to determine whether to bring such action or the manner in which to settle such action. |
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15.2.1. |
Prior to First Commercial Sale. Takeda may terminate this Agreement for convenience in its entirety or on a Product-by-Product basis in [***], upon [***] written notice to Arrowhead prior to the First Commercial Sale of the first Product for which First Commercial Sale occurs in the Territory or the applicable Major Market(s). |
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as provided for under the Bankruptcy Laws, and Takeda elects to retain its rights hereunder as provided for under the Bankruptcy Laws, then Arrowhead (in any capacity, including debtor-in-possession) and its successors and assigns (including a Title 11 trustee), will provide to Takeda copies of all Patent Rights and information necessary for Takeda to prosecute, maintain and enjoy its rights under the terms of this Agreement. All rights, powers, and remedies of Takeda as provided herein are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including the Bankruptcy Laws) in the event of the commencement of a case by or against Arrowhead under the Bankruptcy Laws. In particular, it is the intention and understanding of the Parties to this Agreement that the rights granted to Takeda under this Section 15.3 (Termination for Bankruptcy) are essential to Takeda’s respective businesses and the Parties acknowledge that damages are not an adequate remedy in the event of any termination described in this Section 15.3 (Termination for Bankruptcy). |
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expiration of such Cure Period or, if such material breach is not susceptible to cure within the Cure Period, then the Cure Period will be extended so long as (i) the Breaching Party has provided to the Non-Breaching Party a written plan that is reasonably calculated to effect a cure of such material breach within the original Cure Period, (ii) such plan is accepted by the Non-Breaching Party (such acceptance not to be unreasonably withheld, conditioned, or delayed), and (iii) the Breaching Party commits to and diligently carries out such plan as provided to the Non-Breaching Party, provided that in no event will the Cure Period be extended to more than a total of [***]. The right of either Party to terminate this Agreement as provided in this Section 15.4.2 (Process for Termination) will not be affected in any way by such Party’s waiver of or failure to take action with respect to any previous breach under this Agreement. |
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cannot be ameliorated. In connection with such termination, Takeda will provide reasonable documentation to Arrowhead of the rationale for making any such determination. |
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termination the following terms of this Section 15.6.2 (Effects of Certain Termination) will apply: |
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(ii) |
transfer to Arrowhead copies of all Program Know-How within the Takeda Reversion IP in Takeda’s or its Affiliates’ Control that is related to and necessary for the continued Exploitation of all such Product(s) in the Terminated Countries; |
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(iii) |
to the extent permissible under applicable Law, assign to Arrowhead any Regulatory Approvals or Regulatory Submissions Controlled by Takeda with regard to all such Product(s) in the Terminated Countries as of the effective date of termination; |
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(iv) |
if Arrowhead elects to complete any ongoing Clinical Trial in the Terminated Countries relating to such Product, Takeda will transfer such trials to Arrowhead to the extent possible and to the extent permissible under applicable Law and subject to the rights of any Third Party. After completion of transfer, all costs associated with the relevant Clinical Trial(s) shall be borne by Arrowhead; |
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(v) |
at Arrowhead’s request and, if relevant, at Arrowhead’s sole cost and expense, and to the extent feasible under applicable Law and the terms of the applicable contract, assign to Arrowhead any contracts between Takeda or its Affiliates and any Third Party that exclusively relates to the Product(s) in the Terminated Countries; and |
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(vi) |
work with Arrowhead in good faith to assist Arrowhead with entering into an agreement with Takeda’s existing CMO to be supplied Products by |
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such contract manufacturer to the extent feasible and agreed to by such existing CMO. |
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(i) |
on a Product-by- Product basis and country-by-country basis within the Terminated Countries, for so long as Arrowhead or its Affiliates or licensees sell such Product, Arrowhead will pay Takeda royalties on the aggregate worldwide Net Sales resulting from the sale of each such Product during each [***] for each Product in each country within the Territory, at a reasonable royalty rate to be agreed by the Parties at the time of the applicable termination; and |
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(ii) |
for the purposes of this Section 15.6.2(b), the definition of “Net Sales” and Section 10.2.4 (Takeda Territory Royalties) and Section 10.4 (Payment Terms) will apply mutatis mutandis to the calculation, payment, recording and auditing of Arrowhead’s obligations to pay royalties under this Section 15.6.2(b) as they apply to Takeda and, solely for such purpose, each reference in each such Section (and any related definitions) to (A) Takeda will be deemed to be a reference of Arrowhead and (B) Arrowhead will be deemed to be a reference of Takeda. |
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15.7.1. |
Takeda may retain all of its licenses and other rights granted under this Agreement, subject to all of its payment and other obligations, except that (a) the then-unearned Milestone Payments and the Royalties payable thereafter under this Agreement, in each case will be reduced by [***] effective from and after the delivery of the applicable notice of breach and (b) Takeda’s obligations under Section 3.2.2 (Takeda Development Diligence Obligations) and Section 7.1.2 (Commercialization Diligence Obligations) will terminate; and |
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15.7.2. |
any Confidential Information of Takeda provided to Arrowhead pursuant to this Agreement will be promptly returned to Takeda or destroyed, and Takeda will be released from its ongoing disclosure and information exchange obligations with respect to Development activities following the date of such election. |
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15.7.3. |
For the avoidance of doubt, except as set forth in this Section 15.7 (Alternative Remedy in Lieu of Termination), if Takeda exercises the alternative remedy set forth above in this Section 15.7 (Alternate Remedy in Lieu of Termination), then all rights and obligations of both Parties under this Agreement will continue unaffected, unless and until this |
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Agreement is subsequently terminated by either Party pursuant to this Article 15 (Term and Termination). In addition, and notwithstanding anything to the contrary set forth in this Agreement, if Arrowhead disputes the allegation of a material breach pursuant to Section 15.4.3 (Disputes Regarding Material Breach), and it is determined, as a result of the dispute resolution process set forth in Section 17.3 (Dispute Resolution), that Takeda has the right to terminate this Agreement pursuant to Section 15.4 (Termination for Material Breach) based on the uncured material breach by Arrowhead or pursuant to S Section 15.3 (Termination for Bankruptcy), then the adjustments of royalty rates contemplated by this Section 15.7 (Alternative Remedy in Lieu of Termination) will be deemed effective since the date of notice of the applicable material breach, and Takeda will have the right to credit any overpayment that has been made during the dispute resolution process against future payments payable to Arrowhead. |
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16.2.1. |
Each Party will, within [***] following the Execution Date, file the notification and report forms required under all Antitrust Laws. The Parties will use reasonable efforts to cooperate with one another to the extent necessary in the preparation and execution of all such documents that are required to be filed pursuant to the Antitrust Laws. Each Party will be responsible for its own costs and expenses associated with any such filing pursuant to the Antitrust Laws. The Parties will each use reasonable efforts to ensure that any applicable waiting period under the Antitrust Laws expires or is terminated as soon as practicable and to obtain any necessary approvals or consents under any applicable Antitrust Laws, at the earliest possible date after the date of filing. Notwithstanding any provision to the contrary set forth in this Agreement, nothing in this Agreement (including |
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this Section 16.2 (Filings)) will require either Party or any of its Affiliates to (a) disclose to the other Party or any of its Affiliates any information that is subject to obligations of confidentiality or non-use owed to Third Parties (nor will either Party be required to conduct joint meetings with any Governmental Authority in which such information might be shared with the other Party) in connection with any Antitrust Filing, (b) commit to any consent decree or similar undertaking, or any divestiture, license (in whole or in part), or any arrangement to hold separate (or any similar arrangement) with respect to any of its products or assets, or (c) litigate. |
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16.2.2. |
In furtherance of the foregoing, each Party shall consult and cooperate with the other Party, including: (a) promptly notify the other of, and if in writing, furnish the other with copies of, any communications from or with any Governmental Authority with respect to this Agreement; (b) permit the other to review and discuss in advance, and consider in good faith the view of the other in connection with, any proposed substantive written or oral communication with any Governmental Authority; (c) not participate in any substantive meeting or have any substantive communication with any Governmental Authority unless it has given the other Party a reasonable opportunity to consult with it in advance and, to the extent permitted by such Governmental Authority, gives the other the opportunity to attend; (d) furnish the other Party’s outside legal counsel with copies of all filings and communications between it and any such Governmental Authority with respect to this Agreement; provided, however, that such material may be redacted as necessary to (i) comply with contractual arrangements, (ii) address legal privilege concerns and (iii) comply with applicable Law; and (e) furnish the other Party’s outside legal counsel with such necessary information and reasonable assistance as the other Party’s outside legal counsel may reasonably request in connection with its preparation of necessary submissions of information to any such Governmental Authority. The Parties may, as they deem advisable and necessary, designate any competitively sensitive materials provided to the other under this Section 15.2 (Filings) as “outside counsel only.” Such materials and the information contained therein shall be given only to outside counsel and outside economic consultants of the recipient and will not be disclosed by such outside counsel or outside economic consultants to employees, officers, or directors of the recipient without the advance written consent of the Party providing such materials. Notwithstanding anything to the contrary in this Section 15.2 (Filings), materials provided to the other Party or its outside legal counsel may be redacted to remove references concerning the valuation of the Compounds. |
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preliminary injunction from any court of competent jurisdiction in order to prevent immediate and irreparable injury, loss, or damage on a provisional basis. |
17.6. |
Headings. The captions to the Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the several Sections hereof. |
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or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice will be deemed to have been given: (a) when delivered if personally delivered on a Business Day (or if delivered or sent on a non‑Business Day, then on [***]); (b) [***] if sent by email on a Business Day (or if sent on a non‑Business Day, then on [***]); (c) on [***] if sent by overnight courier; or (d) on [***] if sent by mail.
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17.11. |
Compliance with Export Regulations. Neither Party will export any technology licensed to it by the other Party under this Agreement except in compliance with U.S. export Laws and regulations. |
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correct any clerical, typographical, or other similar errors in this Agreement), all as the other Party may reasonably request for the purpose of carrying out the intent of this Agreement. |
[THE REMAINDER OF THIS PAGE HAS BEEN LEFT INTENTIONALLY BLANK]
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IN WITNESS WHEREOF, the Parties have caused this Exclusive License Agreement to be executed by their duly authorized representatives as of the Execution Date.
TAKEDA PHARMACEUTICALS U.S.A., INC. |
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BY: |
/s/ Nenad Grmusa |
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NAME: |
Nenad Grmusa |
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TITLE: |
Head, Center for External Innovation |
ARROWHEAD PHARMACEUTICALS, INC. |
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BY: |
/s/ Christopher Anzalone |
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NAME: |
Christopher Anzalone |
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TITLE: |
Chief Executive Officer |
78
Exhibit 10.2
FIRST AMENDMENT TO OFFICE LEASE
This FIRST AMENMENT TO OFFICE LEASE (‘‘First Amendment’’) is made and entered into on the 23rd day of October, 2020 (the ‘‘Effective Date’’), by and between 177 COLORADO OWNER LLC, a Delaware limited liability company (‘‘Landlord’’), and ARROWHEAD PHARMACEUTICALS, INC., a Delaware corporation (‘‘Tenant’’).
R E C I T A L S :
A.Landlord and Tenant entered into that certain Office Lease dated as of April 17, 2019 (the ‘‘Office Lease’’), as amended by that certain Notice of Lease Term Dates dated as of October 22, 2019 (the ‘‘Commencement Memo’’, and together with the Office Lease, the ‘‘Lease’’), pursuant to which Landlord leases to Tenant and Tenant leases from Landlord 24,434 RSF of space located on the seventh (7th) floor, commonly known as Suite 700 (the ‘‘Existing Premises’’), in that certain building located at 177 E. Colorado Boulevard, Pasadena, California (the ‘‘Building’’).
B.Landlord and Tenant desire to (i) expand the Existing Premises to include that certain space consisting of 24,434 RSF of space, commonly known as Suite 600, on the sixth (6th) floor of the Building (the ‘‘Expansion Premises’’), as delineated on Exhibit A attached hereto and made a part hereof, and (ii) otherwise amend the Lease on the terms and conditions set forth in this First Amendment.
A G R E E M E N T :
NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:
1.Capitalized Terms. As of the Effective Date, all of the references to the ‘‘Lease’’ in the Lease and this First Amendment shall mean the Lease as modified by this First Amendment; and all capitalized terms used herein shall have the same respective meanings as are given such terms in the Lease, unless expressly provided otherwise in this First Amendment.
2.Modification of Premises. Effective as of the date (the ‘‘Expansion Commencement Date’’) that is the earlier to occur of (i) the date of Tenant's occupancy of the Expansion Premises for the conduct of business, (ii) the date of ‘‘Substantial Completion’’ of the ‘‘Tenant Improvements’’ (as those terms are defined in Sections 4.4 and 2.1, respectively, of the Tenant Work Letter attached hereto as Exhibit B (the ‘‘Tenant Work Letter’’)), and (iii) the date that is six (6) months following the ‘‘Possession Date’’ (as that term is defined in Section 5 below) [provided that the dates under clauses (ii) and (iii) above shall in no event be earlier than July 1, 2021, and such dates under clauses (ii) and (iii) above shall be subject to extension as set forth in Section 5.7 of the Tenant Work Letter], and continuing until the Lease Expiration Date (i.e., April 30,2027, but subject to extension as set forth in Section 5.7 of the Tenant Work Letter), Tenant shall lease from Landlord and Landlord shall lease to Tenant the Expansion Premises. Consequently, effective upon the Expansion Commencement Date, the Existing Premises shall be increased to include the Expansion Premises. (The dates described in clauses (ii) and (iii) above are collectively referred to as the ‘‘Dates Subject to Extension’’.) In the event that the Lease Expiration Date is extended pursuant to Section 5.7 of the Tenant Work Letter, then Tenant shall continue to pay Rent for the Existing Premises and the Expansion Premises in accordance with the terms of the Lease during such extended period of the Lease Term, and Base Rent shall be payable at the rate set forth in the Lease for the last month of the Lease Term for each of the Existing Premises and the Expansion Premises. The addition of the Expansion Premises to the Existing Premises shall, effective as of the Expansion Commencement Date, increase the size of the Premises to 48,868 RSF. The Existing Premises and the Expansion Premises shall, effective as of the Expansion Commencement Date, collectively be referred to as the ‘‘Premises’’. Landlord and Tenant hereby
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177 E COLORADO BOULEVARD [Arrowhead pharmaceuticals, Inc ] [First Amendment] |
stipulate and agree that the rentable area of the Expansion Premises is as set forth in Recital Section B above. At any time during the ‘‘Expansion Term’’ (as that term is defined in Section 3.2 below), Landlord may deliver to Tenant a notice in the form as set forth in Exhibit C attached to the Office Lease, as a confirmation only of the information set forth therein, which, if accurate, Tenant shall execute and return to Landlord within five (5) days of receipt thereof. If Tenant fails to respond to such notice within such 5-day period, Landlord may send a written ‘‘reminder notice’’. Tenant's failure to respond to such reminder notice within three (3) business days following Tenant's receipt thereof shall be deemed Tenant's agreement that the information set forth in such notice is as specified therein. For the avoidance of any doubt, Tenant shall not be deemed to have failed to respond to, and shall not be bound by the information set forth in, a proposed confirmation of commencement for the Expansion Premises if Tenant shall timely notify Landlord, in writing, that Tenant disputes any or all of the information set forth therein...
3.Base Rent.
3.1Existing Premises. Tenant shall continue to pay Base Rent for the Existing Premises in accordance with the terms of the Lease.
3.2Expansion Premises. Commencing on the Expansion Commencement Date, and continuing through and including the Lease Expiration Date, Tenant shall pay to Landlord monthly installments of Base Rent for the Expansion Premises in accordance with the terms of the Lease, as set forth below. The period commencing on the Expansion Commencement Date and ending on the Lease Expiration Date is the ‘‘Expansion Term’’.
Expansion Years*** |
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Annual Base Rent |
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Monthly Installment of Base Rent |
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Monthly Base Rent Rate per RSF* |
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1◊ |
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$879,624.00** |
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$73,302.00** |
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$4.00 |
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2 |
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$1,208,016.96 |
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$100,668.08 |
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$4.12 |
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3 |
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$1,244,257.44 |
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$103,688.12 |
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$4.24 |
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4 |
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$1,281,585.12 |
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$106,798.76 |
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$4.37 |
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5 |
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$1,320,032.64 |
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$110,002.72 |
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$4.50 |
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6 (until Lease |
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Expiration Date) |
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$1,359,633.60 |
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$113,302.80 |
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$4.64 |
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* |
The amounts identified in the column entitled ‘‘Monthly Base Rent Rate per RSF’’ are rounded amounts provided for informational purposes only. |
** |
Note that (i) Base Rent during the first Expansion Year has been calculated as if the Expansion Premises contained only 18,326 RSF. Such calculation shall not affect Tenant's Share for the Expansion Premises or any other of Tenant's obligations under the Lease. |
*** |
For purposes of this First Amendment, ‘‘Expansion Year’’ shall mean each consecutive twelve (12) month period during the Expansion Term. |
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Notwithstanding the foregoing Base Rent schedule or any contrary provision of the Lease, but subject to the terms of Section 3.3. below, Tenant shall not be obligated to pay the monthly installment of Base Rent for the Expansion Premises for the second (2nd) through seventh (7th) full calendar months of the Expansion Term. |
On or prior to the Expansion Commencement Date, Tenant shall pay to Landlord the monthly installment of Base Rent payable for the Expansion Premises for the first full calendar month of the Expansion Term (in addition to any partial calendar month at the beginning of the Expansion Term).
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177 E COLORADO BOULEVARD [Arrowhead pharmaceuticals, Inc ] [First Amendment] |
3.3Abated Base Rent for Expansion Premises. Provided that Tenant is not then in default of the Lease beyond all applicable notice and cure periods, then during the six (6) month period commencing on the first (lst) day of the second (2nd) full calendar month of the Expansion Term and continuing through and including the last day of the seventh (7th) full calendar month of the Expansion Term (the ‘‘Base Rent Abatement Period’’), Tenant shall not be obligated to pay any Base Rent otherwise attributable to the Expansion Premises during such Base Rent Abatement Period (the ‘‘Base Rent Abatement’’). Landlord and Tenant acknowledge that the aggregate amount of the Base Rent Abatement equals $439,812.00 (i.e., $73,302.00 per month). Tenant acknowledges and agrees that the foregoing Base Rent Abatement has been granted to Tenant as additional consideration for entering into this First Amendment, and for agreeing to pay the rent and performing the terms and conditions otherwise required under the Lease. If Tenant shall be in default under the Lease, and shall fail to cure such default within the notice and cure period, if any, permitted for cure pursuant to the terms and conditions of the Lease, or if the Lease is terminated for any reason other than Landlord's breach of the Lease, then the dollar amount of the unapplied portion of the Base Rent Abatement as of the date of such default or termination, as the case may be, shall be converted to a credit to be applied to the Base Rent applicable at the end of the Expansion Term and Tenant shall immediately be obligated to begin paying Base Rent for the Expansion Premises in full.
4.Tenant's Share of Direct Expenses.
4.1Existing Premises. Tenant shall continue to be obligated to pay Tenant's Share of Direct Expenses in connection with the Existing Premises in accordance with the terms of the Lease.
4.2Expansion Premises. Notwithstanding any contrary provision contained in the Lease, effective as of the Expansion Commencement Date, and continuing through and including the Lease Expiration Date, Tenant shall pay Tenant's Share of Direct Expenses in connection with the Expansion Premises which arise or accrue during such period in accordance with the terms of the Lease; provided that with respect to the calculation of Tenant's Share of Direct Expenses in connection with the Expansion Premises, the following shall apply: (i) Tenant's Share shall equal 7.84% of the Building, (ii) the Base Year shall be the calendar year 2021, (iii) Tenant shall have no obligation to pay Tenant's Share of Direct Expenses attributable to the first twelve (12) months of the Expansion Term, and (iv) Tenant shall receive Proposition 13 protection with respect to the Expansion Premises pursuant to Section 4.7 of the Office Lease, provided that (A) all references therein to the ‘‘Lease Term’’ shall be deemed to mean the ‘‘Expansion Term’’, (B) all references therein to the ‘‘Base Year’’ shall mean calendar year 2021, which is the Base Year applicable to the Expansion Premises, (C) all references therein to ‘‘Lease Year’’ shall be deemed to mean ‘‘Expansion Year’’, and (D) with respect to the Expansion Premises, Section4.7.2 of the Office Lease shall be inapplicable, and the following shall be substituted therefor:
‘‘4.7.2Protection. With respect to the Expansion Premises, during the initial Extension Term Tenant shall not be obligated to pay the applicable ‘Percentage of Protection’ as set forth below, of the Tax Increase.
Expansion Year |
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Percentage of Protection |
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1 |
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50% |
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2 |
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25% |
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3 Lease Expiration Date |
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0% |
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As an example only, with respect to the Expansion Premises only, in the event of a Reassessment on the first day of the P1 Expansion Year Tenant would be responsible for 50% of the resulting Tax Increase in Expansion Year 1, 75% of the resulting Tax Increase in Expansion Year 2, and 100% of the resulting Tax Increase in Expansion Years 3 through the Lease Expiration Date.’’
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177 E COLORADO BOULEVARD [Arrowhead pharmaceuticals, Inc ] [First Amendment] |
5.Condition of Premises; Possession Date. Tenant hereby acknowledges and agrees that, notwithstanding anything contained in the Lease and this First Amendment to the contrary, (a) Tenant has been and is in occupancy of the Existing Premises pursuant to the Lease as of the Effective Date, and is aware of the condition of the Existing Premises as of the Effective Date, and (b) Tenant shall continue to occupy the Existing Premises in their currently existing, ‘‘as is’’ condition following the Effective Date. Except as otherwise provided in the Tenant Work Letter, Landlord shall tender possession of the Expansion Premises to Tenant in its then existing, ‘‘as-is’’ condition, and Landlord shall not be obligated to provide or pay for any work or services related to the improvement of the Expansion Premises. Landlord shall be deemed to have tendered possession of the Expansion Premises to Tenant upon the date that Landlord provides Tenant with a key or access card to the Expansion Premises (the ‘‘Possession Date’’), and no action by Tenant shall be required therefor. Tenant acknowledges that the Expansion Premises are currently occupied by an existing tenant. If for any reason Landlord is delayed in tendering possession of the Expansion Premises to Tenant by any particular date, Landlord shall not be subject to any liability for such failure, and the validity of this First Amendment shall not be impaired. Notwithstanding the foregoing or anything to the contrary contained herein, in the event that the Possession Date has not occurred by March 1, 2022 (the ‘‘Outside Possession Date’’, which date shall be extended to the extent of any action or inaction by Tenant or any Tenant Parties which actually delays Landlord in performing its obligations under this Lease and are required to cause the Possession Date to occur), then Tenant shall be entitled to terminate Tenant's lease of the Expansion Premises (the ‘‘Possession Delay Termination Right’’) by delivering written notice thereof to Landlord within ten (10) days after such Outside Possession Date, and in such event the termination of Tenant's lease of the Expansion Premises shall be effective immediately, and this First Amendment shall automatically be null and void, and of no further force or effect. In the event the Possession Date actually occurs before Landlord's receipt of a termination notice from Tenant, then such termination notice shall be deemed null and void, and Tenant's lease of the Expansion Premises shall continue in full force and effect. The Possession Delay Termination Right shall be Tenant's sole and exclusive remedy under the Lease, and at law and in equity, with respect to Landlord's failure to cause the Possession Date to occur by any particular date. Neither Landlord nor any agent of Landlord has made any representation or warranty regarding the condition of the Existing Premises, the Expansion Premises, the Building, or the Project as of the Effective Date or with respect to the suitability of the same for the conduct of Tenant's business.
6.Right of First Offer. Notwithstanding anything in the Lease to the contrary, the right of first offer with respect to the sixth (6th) floor of the Building set forth in Section 1.3 of the Office Lease is hereby deleted in its entirety and of no further force or effect. Instead, Landlord hereby grants to the Original Tenant and any Permitted Assignee an ongoing right of first offer with respect to any one (1) full floor of the Building (excluding the sixth (6) and seventh (7th) floors) (each such full floor, individually ‘‘First Offer Space’’ and collectively, the ‘‘First Offer Spaces’’). Notwithstanding any provision to the contrary contained in this Section 6, such first offer right of Tenant shall commence only following the expiration or earlier termination of the existing leases (including renewals (and irrespective of whether any such renewal is pursuant to an express written provision in such tenant's lease or whether such renewal is effectuated by a lease amendment or a new lease)) of the applicable First Offer Space, if any, and such right of first offer shall be subordinate to all rights with respect to such First Offer Space which are set forth in leases of space in the Building as of the date hereof, including any expansion rights (including, but not limited to, must-take, rights of first offer, rights of first negotiation, rights of first refusal, expansion options and other similar rights), regardless of whether such rights are executed strictly in accordance with their terms, or pursuant to a lease amendment or a new lease (all such tenants under such leases are collectively referred to herein as the ‘‘Superior Right Holders’’). Tenant's right of first offer shall be on the terms and conditions set forth in this Section 6, and Tenant shall not have any right of first offer, right of first refusal, or other expansion rights, except as set forth in this Section 6.
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177 E COLORADO BOULEVARD [Arrowhead pharmaceuticals, Inc ] [First Amendment] |
6.1Procedure for Offer. Landlord shall notify Tenant in writing (the ‘‘First Offer Notice’’) prior to leasing any such First Offer Space to a third party (other than a Superior Right Holder or a tenant under an existing lease). Pursuant to such First Offer Notice, Landlord shall offer to lease to Tenant the then available First Offer Space. A First Offer Notice shall describe the full floor(s) of space so offered to Tenant, the Base Rent, concessions, allowances and other economic terms, on a net effective basis based on the lease term for the First Offer Space as set forth in Section 6.4 below, upon which Landlord is willing to lease such space to Tenant and at which Landlord intends in good faith to market the First Offer Space to third-parties (the ‘‘First Offer Rent’’). The rentable square footage of the space so offered to Tenant shall be as set forth in the First Offer Notice.
6.2Procedure for Acceptance. If Tenant wishes to exercise Tenant's right of first offer with respect to the space described in the First Offer Notice, then within ten (10) business days of delivery of such First Offer Notice to Tenant, Tenant shall deliver notice to Landlord (the ‘‘First Offer Exercise Notice’’) irrevocably exercising its right of first offer with respect to one (1) full floor of the Building as described in the First Offer Notice on the terms contained therein. If Tenant does not so notify Landlord within the ten (10) business day period, then Landlord shall be free to lease the space described in such First Offer Notice to anyone to whom Landlord desires on terms that are not ‘‘materially more favorable’’ (as defined below) than the terms set forth in the First Offer Notice. Notwithstanding anything to the contrary contained herein, Tenant must elect to exercise its right of first offer, if at all, with respect to one (1) entire full floor of the Building as offered by Landlord to Tenant at any particular time, and Tenant may not elect to lease only a portion thereof. If Tenant does not exercise its right of first offer with respect to any space described in a First Offer Notice or if Tenant fails to respond to a First Offer Notice within ten (10) business days of delivery thereof, then Tenant's right of first offer as set forth in this Section 6 shall terminate as to all of the space described in such First Offer Notice. If Landlord fails to enter into a lease with a third party for such First Offer Space within nine (9) months thereafter, or if Landlord wishes to enter into a lease on terms that are materially more favorable to the tenant than those set forth in the First Offer Notice, then Landlord shall again provide Tenant with a First Offer Notice and Tenant shall have the same rights with respect to such First Offer Notice as are provided in this Section 6. For the purposes hereof, ‘‘terms materially more favorable’’ shall mean terms that result in a change, on a net present value basis, of seven percent (7%) or more (using an eight percent (8%) discount rate) to the material economic terms set forth in Landlord's First Offer Notice.
6.3Construction In First Offer Space. Except as otherwise provided in the First Offer Notice, Tenant shall accept the First Offer Space in its then existing ‘‘as is’’ condition and the construction of improvements in the First Offer Space shall comply with the terms of Article 8 of the Office Lease.
6.4Amendment to Lease. If Tenant timely exercises Tenant's right to lease First Offer Space as set forth herein, then, within thirty (30) days thereafter, Landlord and Tenant shall execute a lease amendment (the ‘‘First Offer Amendment’’) adding such First Offer Space to the Premises upon the terms and conditions as set forth in the First Offer Notice therefor and this Section 6, provided, however, that an otherwise valid exercise of the such right of first offer shall be fully effective whether or not the First Offer Amendment is executed. Tenant shall commence payment of Rent for such First Offer Space, and the lease term for such First Offer Space shall commence, upon the date that is the earlier to occur of (i) the date that is six (6) months after the date that Landlord provides Tenant with a key or access card to the First Offer Space (and no action by Tenant shall be required therefor), and (ii) the date upon which Tenant first commences to conduct business in the First Offer Space, and terminate on the date set forth in the First Offer Notice therefor (which date shall be no later than the Lease Expiration Date).
6.5Termination of Right of First Offer. Tenant shall not have the right to lease First Offer Space, as provided in this Section 6, if, as of the date of the attempted exercise of the right of first offer by Tenant, as of the date Landlord and Tenant execute the First Offer Amendment, or as of the scheduled date of delivery of
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such First Offer Space to Tenant, Tenant is in default under the Lease beyond all applicable notice and cure periods or Tenant has previously been in default beyond all applicable notice and cure periods under the Lease more than once (the (‘‘Option Conditions’’); provided Landlord shall have the right to waive the Option Conditions in Landlord's sole discretion. The right of first offer granted herein shall terminate as to all First Offer Spaces and thereafter shall be of no further force or effect upon the earlier to occur of (i) Tenant's lease of any First Offer Space pursuant to the terms herein, and (ii) the date which is two (2) years prior to the Lease Expiration Date.
7.Letter of Credit. Landlord is currently in possession of Tenant's L-C in the amount of $1,000,000.00 (the ‘‘Existing L-C Amount’’). Notwithstanding any contrary provision of the Lease, the Existing L-C Amount is hereby increased by $600,000.00 (the ‘‘Expansion L-C Amount’’), so that the new L-C Amount under the Lease shall initially equal $1,600,000.00. Tenant shall deliver to Landlord, on or prior to December 31, 2020, an amendment to the L-C increasing the amount of the L-C to the L-C Amount (i.e., $1,600,000.00) in a form reasonably acceptable to Landlord. Further notwithstanding any contrary provision of the Lease, effective as of the Effective Date, the table in Section 21.3.2 of the Office Lease is hereby replaced with the following:
Date of Reduction |
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Amount of Reduction |
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Remaining L-C Amount |
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June 1, 2021 |
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$200.000.00 |
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$1,400,000.00 |
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June 1, 2022 |
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$200,000.00 |
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$1,200,000.00 |
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The day after the thirteenth (13th) full calendar month of the Expansion Term |
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$200,000.00 |
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$1,000,000.00 |
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June 1, 2023 |
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$300,000.00 |
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$700,000.00 |
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The day after the twenty- fifth (25th) full calendar month of the Expansion Term |
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$1 00,000.00 |
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$600,000.00 |
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The day after the thirty- seventh (37th) full calendar month of the Expansion Term |
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$100,000.00 |
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$500,000.00 |
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8.Parking. Commencing as of the Expansion Commencement Date, Tenant shall have the use of up to seventy-five (75) additional unreserved parking passes, of which, up to five (5) unreserved parking passes may be converted to the use of an equal number of reserved parking passes subject to availability at such time, as reasonably determined by Landlord, all at the prevailing rate charged from time to time at the location of such parking passes. Such additional parking passes shall otherwise be subject to the terms of Article 28 of the Office Lease. In addition. Tenant shall be responsible for the full amount of any taxes imposed by any governmental authority in connection with the renting of such parking passes by Tenant or the use of the Parking Structure by Tenant.
9.Signs. In addition to the Tenant's Signage set forth in Section 23.5 of the Office Lease, during the Expansion Term Tenant shall be entitled to install, at Tenant's sole cost and expense, the following signage in connection with Tenant's lease of the Expansion Premises (collectively, the ‘‘Tenant's Expansion Signage’’, and which shall constitute part of ‘‘Tenant's Signage’’ under the Lease): (i) the non-exclusive right to one (I) monument signage strip located on the Arroyo Parkway monument sign, the location of which is depicted in Exhibit C attached hereto, in the top position (the ‘‘Expansion Monument Signage’’), and (ii) subject to the existing rights of third parties, the exclusive right to one (1) illuminated sign (the ‘‘Expansion Building Top Signage’’) at the top of either the western or southern facing facade of the Building, as depicted in Exhibit D attached hereto), provided that Tenant shall be required to notify Landlord in writing of Tenant's election to install the Expansion Building Top Signage within thirty (30) days following Tenant's receipt of Landlord's notice
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(‘‘Landlord's Building Top Sign Notice’’) that either or both of such facade locations is/are becoming available for installation of the Expansion Building Top Signage, which Landlord's Building Top Sign Notice shall include the anticipated date of availability for installation of the Expansion Building Top Signage, and if Landlord's Building Top Sign Notice specifies that both of such facade locations are becoming available then Tenant shall also specify in Tenant's election notice its choice of the facade (i.e., either the western or southern facing facade) for installation of the Expansion Building Top Signage. Landlord shall only be obligated to deliver Landlord's Building Top Sign Notice once for each of the facades for the Expansion Building Top Signage (i.e., one such notice for the western facing facade and one such notice for the southern facing facade ).
For illustration purposes only, if the western facing facade is the first of the two (2) facades to become available for installation of the Expansion Building Top Signage, then Landlord shall deliver Landlord's Building Top Sign Notice for the western facing facade, and if Tenant timely elects to install the Expansion Building Top Signage on the western facing facade then Tenant will not be entitled to any additional Landlord's Building Top Sign Notices thereafter. However, if Tenant fails to timely make such election, then at such time as the southern facing facade is becoming available, Landlord shall deliver Landlord's Building Top Sign Notice for the southern facing facade and Tenant shall have the right to elect to install the Expansion Building Top Signage on the southern facing facade, but Tenant will no longer have a right to elect to use the western facing facade regardless of whether the western facing facade is available or becoming available at such time, and if Tenant fails to timely elect to use the southern facing facade then Tenant shall have no further rights to Expansion Building Top Signage.
Notwithstanding any contrary provision of this Section 9, the exact position for the Expansion Building Top Signage on the applicable Building facade shall by designated by Landlord, in Landlord's reasonable discretion. Landlord hereby agrees that the Expansion Building Top Signage on the applicable Building facade shall be the only sign that Landlord will permit to be constructed on such applicable facade during the period that Tenant's right to Expansion Building Top Signage for the applicable Building facade is in effect. Exhibit H attached to the Office Lease shall be inapplicable to the Expansion Building Top Signage. Notwithstanding any contrary provision of Section 23.5.1 of the Office Lease, the Sign Specifications for the Expansion Building Top Signage shall be subject to the prior written approval of Landlord.
Except as expressly set forth in this Section 9, Tenant's Expansion Signage shall be subject to the terms of Section 23.5 of the Office Lease, as amended hereinbelow. Notwithstanding any provision to the contrary in the Lease, Tenant's rights to the respective Tenant's Expansion Signage shall terminate and be of no further force or effect (i) if Tenant fails to timely notify Landlord of the elections provided to Tenant under this Section 9, (ii) if Tenant fails to install Tenant's Expansion Monument Signage (as previously timely elected by Tenant) within six (6) months following the Expansion Commencement Date (subject to any documented delays caused by applicable governmental authorities in approving or granting permits for the applicable Tenant's Expansion Signage, provided that Tenant diligently and promptly applies for and pursues receipt of such governmental approvals and permits following the Effective Date), or (iii) if Tenant fails to install Tenant's Expansion Building Top Signage (as previously timely elected by Tenant) within the time period reasonably determined by Landlord at the time of Tenant's election therefor in order to ensure that the existing governmental permit for Building top signage on the applicable Building facade will not be jeopardized or subject to termination or expiration (subject to any documented delays caused by applicable governmental authorities in approving or granting permits for Tenant's Expansion Building Top Signage, provided that Tenant diligently and promptly applies for and pursues receipt of such governmental approvals and permits following the date of Tenant's election to install such signage). Additionally, Tenant's rights to Tenant's Expansion Signage shall terminate if the Original Tenant does not lease and occupy one hundred percent (1 00%) of the entire Premises (i.e., the Existing Premises and the Expansion Premises). In the event that the Original Tenant fails to lease and occupy the entire Expansion Premises, but the Original Tenant continues to lease and occupy the entire Existing Premises, then Tenant's Signage shall thereafter consist of only the Tenant's Signage set forth in Section 23.5 of the Office Lease and Tenant's Expansion Signage rights shall automatically terminate and be of no further force or effect.
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In connection with the Expansion Building Top Signage, Tenant shall pay to Landlord a monthly signage fee, as Additional Rent, commencing on the date (the ‘‘Signage Fee Commencement Date’’) that is the earlier to occur of (i) the date of Tenant's installation of the applicable Tenant's Expansion Building Top Signage, and (ii) the date that is ninety (90) days following the later to occur of (a) the date that the previous tenant with Building top signage in the applicable location removes its signage therefrom, and (b) the date of Tenant's receipt of Landlord's Building Top Sign Notice. The monthly signage fee shall thereafter be payable on or before the first (P1) day of each calendar month throughout the period of the Expansion Term during which Tenant continues to have the right to install and maintain such signage. The monthly signage fee shall be in the amount of$2,500.00 per month if Tenant elects to install such Expansion Building Top Signage on the western facing facade or in the amount of $7,500.00 per month if Tenant elects to install such Expansion Building Top Signage on the southern facing facade (each, the ‘‘Signage Fee’’). If Tenant fails to timely pay the Signage Fee and such failure continues beyond any applicable notice and cure period under the Lease then Landlord shall have the right, at Landlord's election, to terminate Tenant's right to maintain the Expansion Building Top Signage.
Notwithstanding any contrary provision of this Section 9, Tenant's right to the Expansion Monument Signage shall continue for so long as the applicable monument sign continues to exist, Tenant hereby acknowledging that Landlord may remove such monument sign at any time in Landlord's sole discretion; provided that if Landlord thereafter installs a new Building monument sign or new comparable alternative signage of similar scope and scale, then Tenant's rights with respect to the Expansion Monument Signage shall be applicable to such new Building monument sign.
Tenant hereby acknowledges that, notwithstanding Landlord's approval of Tenant's Expansion Signage, Landlord has made no representation or warranty to Tenant with respect to the probability of obtaining all necessary governmental approvals and permits for Tenant's Expansion Signage. In the event Tenant does not receive the necessary governmental approvals and permits for Tenant's Expansion Signage, Tenant's and Landlord's rights and obligations under the remaining terms and conditions of the Lease shall be unaffected.
Notwithstanding any contrary provision of Section 23.1 of the Office Lease, the identification signage installed by Tenant in the Premises (i.e., in the Existing Premises and the Expansion Premises) at Landlord's cost shall be Building standard identification signage. Further notwithstanding any contrary provision of Section 23.4 of the Office Lease, at the present time there is no Building directory in the Building lobby. The fourth (4th) sentence of Section 23.5.4 of the Office Lease is hereby deleted and the following is substituted in its place: ‘‘. Upon the expiration or earlier termination of this Lease, or upon the termination of any of Tenant's Signage rights, Tenant shall, at Tenant's sole cost and expense, cause the applicable Tenant's Signage to be removed and shall cause the areas in which such Tenant's Signage was located to be restored to the condition existing immediately prior to the placement of such Tenant's Signage (excepting normal wear and tear and casualty).’’
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177 E COLORADO BOULEVARD [Arrowhead pharmaceuticals, Inc ] [First Amendment] |
10.Landlord Parties Definition. Notwithstanding any contrary provision of Section 10.1 of the Office Lease, the term ‘‘Landlord Parties’’ shall mean Landlord, Landlord's managing agent and their respective affiliates, partners, subpartners, members, directors, trustees officers, agents, servants, employees, independent contractors of Landlord and any mortgagee of Landlord.
11.Brokers. Landlord and Tenant hereby warrant to each other that they have had no dealings with any real estate broker or agent in connection with the negotiation of this First Amendment other than CBRE, representing Landlord, and Cresa, representing Tenant (collectively, the ‘‘Brokers’’), and that they know of no other real estate broker or agent who is entitled to a commission in connection with this First Amendment other than the Brokers. Each party agrees to indemnify and defend the other party against and hold the other party harmless from any and all claims, demands, losses, liabilities, lawsuits, judgments, costs and expenses (including without limitation reasonable attorneys' fees) with respect to any leasing commission or equivalent compensation alleged to be owing on account of any dealings with any real estate broker or agent other than the Brokers occurring by, through, or under the indemnifying party. The terms of this Section 11 shall survive the expiration or earlier termination of the Lease Term.
12.CASp. For purposes of Section 1938 of the California Civil Code, Landlord hereby discloses to Tenant, and Tenant hereby acknowledges, that the Expansion Premises have not undergone inspection by a Certified Access Specialists (CASp). As required by Section 1938(e) of the California Civil Code, Landlord hereby states as follows: ‘‘A Cettified Access Specialist (CASp) can inspect the subject premises and determine whether the subject premises comply with all of the applicable construction-related accessibility standards under state law. Although state Jaw does not require a CASp inspection of the subject premises, the commercial property owner or lessor may not prohibit the lessee or tenant from obtaining a CASp inspection of the subject premises for the occupancy or potential occupancy of the lessee or tenant, if requested by the lessee or tenant. The parties shall mutually agree on the arrangements for the time and manner of the CASp inspection, the payment of the fee for the CASp inspection, and the cost of making any repairs necessary to correct violations of construction-related accessibility standards within the premises.’’ In furtherance of the foregoing, Landlord and Tenant hereby agree as follows: (a) any CASp inspection requested by Tenant shall be conducted, at Tenant's sole cost and expense, by a CASp designated by Landlord, subject to Landlord's reasonable rules and requirements; (b) Tenant, at its sole cost and expense, shall be responsible for making any improvements or repairs within the Expansion Premises to correct violations of construction-related accessibility standards relating to the Tenant Improvements or any Alterations; and (c) if anything done by of for Tenant in its use or occupancy of the Expansion Premises shall require any improvements or repairs to the Building or Project (outside the Expansion Premises) to correct violations of construction-related accessibility standards, then Tenant shall reimburse Landlord upon demand, as Additional Rent, for the cost to Landlord of performing such improvements or repairs.
13.Special Provision Relating to Bicycles. Notwithstanding anything to the contrary in the Office Lease or this First Amendment, but subject to additional reasonable rules, regulations, and restrictions Landlord may make from time to time, Landlord shall permit up to ten (1 0) of Tenant's designated employees to use the freight elevator of the Building to transport their bicycles between the lobby of the Building and the Premises. In no event shall Tenant or Tenant's employees use the passenger elevators of the Building to transport any bicycles. Tenant shall promptly reimburse Landlord for the cost of any repairs necessitated due to any damage caused to the Building as a result of Tenant's (or Tenant's employees') transporting of bicycles to and from the Premises and Tenant shall be responsible for any reasonable janitorial expenses incurred by Landlord as a result of Tenant's or its employees' bicycles being brought into the Building and the Premises, which expenses shall be payable by Tenant within thirty (30) days following Landlord's billing thereof. Landlord shall have no liability for any damage to any bicycles or contents thereof, and the transportation and storage of any bicycles throughout the Building by Tenant or Tenant's employees shall be at the sole risk of Tenant and Tenant's employees.
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14.Counterparts. This First Amendment may be executed in counterparts with the same effect as if both parties hereto had executed the same document. Both counterparts shall be construed together and shall constitute a single First Amendment.
15.Signatures. The parties hereto consent and agree that this First Amendment may be signed and/or transmitted by e-mail of a .pdf document or using electronic signature technology (e.g., via DocuSign or similar electronic signature technology), and that such signed electronic record shall be valid and as effective to bind the party so signing as a paper copy bearing such party's handwritten signature. The parties further consent and agree that (1) to the extent a party signs this First Amendment using electronic signature technology, by clicking ‘‘SIGN’’, such party is signing this First Amendment electronically, and (2) the electronic signatures appearing on this First Amendment shall be treated, for purposes of validity, enforceability and admissibility, the same as handwritten signatures.
16.No Further Modification. Except as specifically set forth in this First Amendment, all of the terms and provisions of the Lease shall remain unmodified and in full force and effect. In the event of any conflict between the terms and conditions of the Lease, and the terms and conditions of this First Amendment, the terms and conditions of this First Amendment shall prevail.
[signatures follow on next page]
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IN WITNESS WHEREOF, Landlord and Tenant have caused this First Amendment to be executed the day and date first above written.
‘‘LANDLORD’’ |
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177 COLORADO OWNER LLC, |
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a Delaware limited liability company |
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By: |
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/s/ Ron J. Hoyl |
Name: |
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Ron J. Hoyl |
Its: |
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Vice President |
‘‘TENANT’’ |
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ARROWHEAL PHARMACEUTICALS, INC, |
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a Delaware corporation |
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By: |
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/s/ Kenneth A Myszkowaki |
Name: |
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Kenneth A Myszkowaki |
Its: |
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CFO |
By: |
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Name: |
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Its: |
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177 E COLORADO BOULEVARD [Arrowhead pharmaceuticals, Inc ] [First Amendment] |
Exhibit 10.3
SIXTH AMENDMENT TO LEASE AGREEMENT
This Sixth Amendment to Lease Agreement (this “Amendment”) is between University Research Park, Incorporated, a Wisconsin nonstock corporation (“Landlord”) and Arrowhead Madison Inc., a Delaware corporation (“Tenant”) and is dated as of November 23, 2020.
RECITALS
A.Landlord and Tenant are parties to that certain Lease Agreement dated as of January 8, 2016, as amended by that certain First Amendment to Lease Agreement dated October 22, 2018, that certain Second Amendment to Lease Agreement dated January 10, 2019, that certain Third Amendment to Lease Agreement dated January 11, 2019, that certain Fourth Amendment to Lease Agreement dated September 19, 2019 and that certain Fifth Amendment to Lease Agreement dated as of May 14, 2020 (collectively, the “Original Lease”). The Original Lease and this Amendment are together referred to herein as the “Lease.”
B.Pursuant to the Original Lease, Tenant leases from Landlord approximately 63,662 rentable square feet located at 502 South Rosa Road, Madison, Wisconsin (the “502 Building”), an additional 2,971 rentable square feet in the 502 Building, approximately 7,558 rentable square feet located at 504 South Rosa Road, Madison, Wisconsin (the “504 Building”) and approximately 25,965 rentable square feet located at 500 South Rosa Road, Madison, Wisconsin (the “500 Building,” and together with the 502 Building and 504 Building, the “Buildings”), each as more particularly defined in the Original Lease (the “Leased Premises”).
C.Landlord and Tenant wish to amend the Lease to allow Tenant, to further expand the Leased Premises as more particularly set forth in this Amendment.
AGREEMENTS
NOW THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Landlord and Tenant hereby agree as follows:
1.Defined Terms. Terms that are not defined in this Amendment (including the attached exhibits) but are defined in the Original Lease have the meanings given in the Original Lease.
2.Amendment of Lease. The Lease is hereby amended as follows:
a.Fourth Expansion Premises. Subject to the provisions of this Amendment, effective as of the date hereof, the Leased Premises shall be expanded to include the approximately 4,162 rentable square feet of ground floor space (the “First Floor Space”) plus approximately 2,372 rentable square feet of enclosed mechanical penthouse space (the “Penthouse Space”; together with the First Floor Space, the “Fourth Expansion Premises”) for a total of approximately 6,534 rentable square feet to be constructed by Tenant in the area generally depicted on Exhibit A. The Fourth Expansion Premises will be constructed by Tenant in accordance with the “Work Letter” set forth at Exhibit C as an addition to the 500 Building as generally depicted on Exhibit A attached hereto, and partially funded by the Landlord Contribution, as defined and more particularly described in Section 10 of the Work Letter.
b.Base Rent. The “Fourth Expansion Rent Commencement Date” shall be the date of Substantial Completion of the Fourth Expansion Premises (as defined in the Work Letter attached at Exhibit C), but no later than September 30, 2021, provided, however, such date shall be subject to extension for Landlord Delays and force majeure events as defined and more fully described in the Work Letter. Tenant shall begin paying Base Rent on the Fourth Expansion Premises on the Fourth Expansion Rent Commencement Date in the
amounts set forth in a Base Rent matrix attached hereto as Exhibit B, together with all other amounts required by the Lease, as amended by this Amendment. For the avoidance of doubt, with respect to the Fourth Expansion Premises, the Base Rent amounts set forth in Exhibit B shall not be subject to adjustment regardless of the actual final square footage of the Fourth Expansion Premises.
c.Tenant’s Proportionate Share. Commencing upon the Fourth Expansion Rent Commencement Date, Tenant’s Proportionate Share shall be increased to reflect the addition of the rentable square footage of the Fourth Expansion Premises to the entire Leased Premises, currently estimated to be 71.48% based on the addition of an estimated 6,534 rentable square feet (106,690 rentable square feet of Leased Premises divided by 149,248 square feet in the Buildings within which the Leased Premises are located). Tenant shall thereafter in accordance with Section 2.2 of the Original Lease pay, as additional rent, Tenant’s Proportionate Share of all amounts set forth in the Original Lease, including, without limitation, Real Estate Taxes, Common Area/Operating Expenses and Landlord’s insurance and utilities based thereon. For the avoidance of doubt, Tenant’s Proportionate Share shall be increased to include the actual rentable square footage of both the First Floor Space and Penthouse Space (as well as the remainder of the Leased Premises), to be confirmed by the mutual agreement of the parties and their advisors upon Substantial Completion.
d.Fourth Expansion Premises Condition; Tenant Fourth Expansion Improvements. Tenant acknowledges that the area in which the Fourth Expansion Premises will be constructed by Tenant is currently vacant land immediately adjacent to the 500 Building. Tenant accepts the Fourth Expansion Premises in as-is, where-is condition and acknowledges that Landlord has not made any representation or warranty related thereto, and Landlord shall not be required to construct, modify or otherwise improve the Fourth Expansion Premises in any manner (the foregoing, however, shall not be deemed to relieve Landlord of its ongoing maintenance, repair and replacement obligations to the extent explicitly set forth in the Lease or this Amendment; provided, however, that Landlord will have no such obligations related to the Tenant Fourth Expansion Improvements, defined below, prior to Substantial Completion, including the completion of any punchlist items by Tenant, as defined in the Work Letter or as otherwise set forth in Section 2.e. below). Promptly following the date hereof, Tenant shall in a diligent, good and workmanlike manner and in compliance with all applicable federal, state and local laws, rules, regulations and ordinances, finalize plans and specifications for and construct the Fourth Expansion Premises pursuant to the Work Letter (collectively, “Tenant Fourth Expansion Improvements” or “Expansion Improvements”). For the avoidance of doubt: (a) Tenant’s obligations with respect to construction of the Expansion Improvements shall include all work to the 500 Building required to integrate the Expansion Improvements with the existing structure (including the removal of two facades in the course of construction) and the restoration of any surrounding land or improvements damaged or disturbed in connection with completing the Expansion Improvements; provided, however, nothing herein shall relieve Landlord from its maintenance, repair and replacement obligations with respect to the 500 Building pursuant to the Lease prior to Substantial Completion to the extent such obligations would have arisen independently of the Tenant Fourth Expansion Improvements or excuse Tenant for its failure to construct the Expansion Improvements in accordance with the Work Letter; and (b) except for the Landlord’s Contribution, Tenant shall otherwise be responsible for all costs and additional work or Change Orders arising from the Tenant Fourth Expansion Improvements, including but not limited to, those arising from unforeseen conditions. Section 1.6 in the Original Lease shall not apply to construction of the Tenant Fourth Expansion Improvements, which shall be governed solely by this Amendment.
e.Maintenance and Repair of Fourth Expansion Premises. All applicable provisions of the Original Lease regarding the Parties’ maintenance, repair and replacement obligations shall apply to the Fourth Expansion Premises including, but not limited to, Sections 3.1 and 3.2 of the Original Lease, as amended and restated in the Fifth Amendment to Lease Agreement, dated May 14, 2020 (the “Fifth Amendment”). Notwithstanding the foregoing, to the extent that Landlord would be responsible for any such maintenance, repairs
2
or replacements related to the Tenant Fourth Expansion Improvements: (i) Tenant shall first exhaust all of Tenant's remedies, at Tenant's expense, which may be available to Tenant in connection with such maintenance, repair and replacement, including, without limitation, pursuant to the Construction Contract and any manufacturer, supplier or subcontractor warranties or otherwise; (ii) notwithstanding any exclusion in the Original Lease for “costs of correcting defects in such original construction or renovation” or similar exclusion, Landlord may include the expenses actually incurred by Landlord related to the maintenance, repair and replacement of the Tenant Fourth Expansion Improvements pursuant to Section 3.2 of the Original Lease (as amended by the Fifth Amendment) in Common Area costs so long as such expenses are not otherwise expressly excluded from being included in Common Area costs by other provisions of the Lease; and (iii) the eighteen (18) month limitation regarding the exclusion of certain capital expenditures from Common Area costs as set forth in Section 2.f. of the Fifth Amendment shall not apply to the Tenant Fourth Expansion Improvements.
f.Insurance of Fourth Expansion Premises. Tenant shall be responsible for obtaining, or shall cause its general contractor to obtain, Builder’s Risk Insurance with industry standard coverage during construction of the Tenant Fourth Expansion Improvements with commercially reasonable limits insuring the interests of both Landlord and Tenant. Following Substantial Completion (as defined in the Work Letter), Landlord shall be deemed to be the owner of the Tenant Fourth Expansion Improvements and shall thereafter add that portion of the Tenant Fourth Expansion Improvements, including the building structure and building systems (excluding only Tenant trade fixtures, furniture and equipment) to the property insurance policy maintained by Landlord pursuant to Section 6.1 of the Original Lease. Tenant shall provide to Landlord with its cost of construction of the Tenant Fourth Expansion Improvements, including reasonable supporting information, so that Landlord can adjust its insurance policy appropriately.
g.Construction Liens. Nothing contained herein shall imply any consent or agreement on the part of Landlord or any ground or underlying lessors or mortgagees having an interest in the Property to subject their respective estates or interests to liability under any mechanic's or other lien law and, to the extent a lien arises out of any work performed by or at the direction of Tenant, such lien shall be limited to Tenant’s interest in this Lease. Nothing in this Section 2.g. shall be interpreted to limit Tenant’s indemnity and other obligations set forth in Section 3.6 of the Original Lease provided, however, any indemnification or other obligations of Tenant related to claims for liens or liens filed shall be subject to, and Tenant shall not have responsibility for such claims to the extent arising from Landlord’s default under the Lease as a result of its failure to make timely and full payment of the Landlord Contribution, or timely approval of payments for properly performed Work, as set forth in the Work Letter (and the schedules thereto).
h.Utilities. Tenant shall be responsible for the payment of all utilities supplied to the Fourth Expansion Premises beginning on the date hereof.
3.502 Building Sidewalk Replacement. In addition to the Landlord Contribution, Landlord will provide Tenant an allowance of up to $26,325.00 to reimburse Tenant for the cost of paving the existing pedestrian sidewalk now adjacent to the Fourth Expansion Premises on the west side of South Rosa Road between Research Park Boulevard and the horse farm pursuant to plans that are mutually acceptable to the parties. Landlord may deposit such funds and disburse the same in the same manner as the Landlord Contribution.
4.Effect. Except as amended by this Amendment, all of the terms, covenants, conditions, provisions, and agreements of the Original Lease remain in full force and effect. The provisions of this Amendment supersede and control over any conflicting provisions in the Original Lease.
3
5.Estoppel. Tenant and Landlord hereby represent and warrant that, as of the date hereof (to the best of their actual knowledge with respect to items (b) and (c)), (a) the Lease is in full force and effect and has not been modified or amended, except as set forth herein, (b) neither Tenant nor Landlord is in default under the Lease nor does Tenant or Landlord have any knowledge of any event which with the giving of notice and passage of time would result in a default, and (c) Landlord and Tenant have performed all obligations on each of their respective parts under the Lease, and neither Party has any claims against the other Party, including any claims of offset against any rent or other sums payable by Tenant under the Lease.
6.Miscellaneous. This Amendment and the Lease embodies the entire agreement between the parties as to its subject matter and supersedes any prior discussions with respect thereto. There are no agreements or understandings between the parties with respect to the subject matter of this Amendment not set forth in this Amendment or the Lease. This Amendment cannot be modified except by a writing signed by both parties.
7.Signing and Delivery. This Amendment will be effective only when both Landlord and Tenant have signed and delivered it. Landlord’s submission of an unsigned copy of this Amendment to Tenant for evaluation, negotiation, or signature by Tenant will not constitute signature of this Amendment by Landlord or otherwise bind Landlord, regardless of whether the cover letter or email transmitting that copy of this Amendment is signed or contains words of approval. This Amendment may be signed in counterparts and, when counterparts of this Amendment have been signed and delivered by the required parties as provided in this section, this Amendment will be fully binding and effective, just as if both of the parties had signed and delivered a single counterpart of this Amendment. Any counterpart transmitted by facsimile or email shall, in all cases, be deemed an original signature.
[Signature page follows]
4
IN WITNESS WHEREOF, this Sixth Amendment to Lease is signed by the parties as of the date set forth above.
Landlord: |
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UNIVERSITY RESEARCH PARK, INCORPORATED |
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By: |
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/s/ Aaron olver |
Aaron Olver, Assistant Secretary/Treasurer |
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Tenant: |
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ARROWHEAD MADISON INC. |
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By: |
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/s/ Kenneth A. Myszkowski |
Kenneth A. Myszkowski, CFO |
The undersigned Guarantor consents to the terms of this Sixth Amendment to Lease Agreement and agrees that, except as limited by the First Amendment to Lease Agreement dated October 22, 2018 with respect to that portion of the guaranty related to the Note (as defined in the First Amendment), the Guaranty Agreement dated January 8, 2016 remains in full force and effect (and to the extent previously terminated, is hereby reinstated) with respect to the full, and prompt payment and performance of all obligations of Tenant under the Lease, including, without limitation, as amended pursuant to this Sixth Amendment to Lease Agreement.
ARROWHEAD PHARMACEUTICALS, INC. (f/k/a ARROWHEAD RESEARCH |
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CORPORATION) |
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By: |
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/s/ Kenneth A. Myszkowski |
Kenneth A. Myszkowski, CFO |
5
EXHIBIT B
BASE RENT MATRIX
|
Lease Period |
Total Base Rent/Monthly Fourth Expansion Premises (“Notch”)** |
|
|
|||
|
|||
|
FERCD* – |
9/30/21 |
$7,543.63 |
|
10/1/21 – |
9/30/22 |
$7,732.22 |
|
10/1/22 – |
9/30/23 |
$7,925.52 |
|
10/1/23 – |
9/30/24 |
$8,123.66 |
|
10/1/24 – |
9/30/25 |
$8,326.75 |
|
10/1/25 – |
9/30/26 |
$8,534.92 |
|
10/1/26 – |
9/30/27 |
$8,748.29 |
|
10/1/27 – |
9/30/28 |
$8,967.00 |
|
10/1/28 – |
9/30/29 |
$9,191.17 |
|
10/1/29 – |
9/30/30 |
$9,420.95 |
|
10/1/30 – |
9/30/31 |
$9,656.48 |
Optional Extension # 1 (5 years) |
10/1/31 – |
9/30/32 |
$9,897.89 |
10/1/32 – |
9/30/33 |
$10,145.34 |
|
10/1/33 – |
9/30/34 |
$10,398.97 |
|
10/1/34 – |
9/30/35 |
$10,658.94 |
|
10/1/35 – |
9/30/36 |
$10,925.42 |
|
Optional Extension # 2 (5 years) |
10/1/36 – |
9/30/37 |
$11,198.55 |
10/1/37 – |
9/30/38 |
$11,478.52 |
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10/1/38 – |
9/30/39 |
$11,765.48 |
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10/1/39 – |
9/30/40 |
$12,059.62 |
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10/1/40 – |
9/30/41 |
$12,361.11 |
* |
FERCD = Fourth Expansion Rent Commencement Date. |
** |
Base Rent amount is fixed regardless of the final rentable square footage of the Fourth Expansion Premises, as approved in accordance with the Work Letter. |
EXHIBIT B
Exhibit 10.4
SEVENTH AMENDMENT TO LEASE AGREEMENT
This Seventh Amendment to Lease Agreement (this “Amendment”) is between University Research Park, Incorporated, a Wisconsin nonstock corporation (“Landlord”) and Arrowhead Madison Inc., a Delaware corporation (“Tenant”) and is dated as of December 9th, 2020.
RECITALS
A. Landlord and Tenant are parties to that certain Lease Agreement dated as of January 8, 2016, as amended by that certain First Amendment to Lease Agreement dated October 22, 2018, that certain Second Amendment to Lease Agreement dated January 10, 2019, that certain Third Amendment to Lease Agreement dated January 11, 2019, that certain Fourth Amendment to Lease Agreement dated September 19, 2019, that certain Fifth Amendment to Lease Agreement dated as of May 14, 2020 and that certain Sixth Amendment to Lease Agreement dated as of November 23, 2020 (collectively, the “Original Lease”). The Original Lease and this Amendment are together referred to herein as the “Lease.”
B.Pursuant to the Original Lease, Tenant leases from Landlord approximately 63,662 rentable square feet located at 502 South Rosa Road, Madison, Wisconsin (the “502 Building”), an additional 2,971 rentable square feet in the 502 Building, approximately 7,558 rentable square feet located at 504 South Rosa Road, Madison, Wisconsin (the “504 Building”) and approximately 32,499 rentable square feet located at (or to be constructed as an addition to) 500 South Rosa Road, Madison, Wisconsin (the “500 Building,” and together with the 502 Building and 504 Building, the “Buildings”), each as more particularly defined in the Original Lease (the “Leased Premises”).
C.Landlord and Tenant wish to amend the Lease to further expand the Leased Premises to include Suite 201 in the 504 Building as more particularly set forth in this Amendment.
AGREEMENTS
NOW THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Landlord and Tenant hereby agree as follows:
1.Defined Terms. Terms that are not defined in this Amendment (including the attached exhibits) but are defined in the Original Lease have the meanings given in the Original Lease.
2.Amendment of Lease. The Lease is hereby amended as follows:
a.Fifth Expansion Premises. Subject to the provisions of this Amendment, effective as of January 1, 2021 (the “Effective Date”), the Leased Premises shall be expanded to include the approximately 4,109 rentable square feet of space in the 504 Building commonly known as Suite 201 (the “Fifth Expansion Premises”) as generally depicted on Exhibit A. Subject to all of the terms and conditions of the Original Lease except for the payment of Rent, Landlord shall provide Tenant with early access to the Fifth Expansion Premises following the date in which such space is vacated by the existing tenant, anticipated to be approximately December 19, 2020. If Landlord is unable to deliver possession of the Fifth Expansion Premises to Tenant in accordance with the foregoing provisions, then Landlord shall not be in default hereunder or be liable for damages therefor and Tenant shall accept possession on the date when Landlord delivers possession thereof to Tenant (which date will then be the Effective Date). The term, with respect to the Fifth Expansion Premises only, shall expire on August 31, 2023 (for the avoidance of doubt, no options to renew shall be applicable to the Fifth Expansion Premises).
b.Base Rent. Tenant shall begin paying Base Rent related to the Fifth Expansion Premises on the Effective Date in the amounts set forth in the Base Rent matrix attached hereto as Exhibit B, together with all other amounts required by the Lease, as amended by this Amendment.
c.Tenant’s Proportionate Share. Commencing on the Effective Date, Tenant’s Proportionate Share shall be increased to reflect the addition of the rentable square footage of the Fifth Expansion Premises to the entire Leased Premises, currently estimated to be 74.24% based on the addition of an estimated 4,109 rentable square feet (110,799 rentable square feet of Leased Premises divided by 149,248 square feet in the Buildings within which the Leased Premises are located). Tenant shall thereafter in accordance with Section 2.2 of the Original Lease pay, as additional rent, Tenant’s Proportionate Share of all amounts set forth in the Original Lease, including, without limitation, Real Estate Taxes, Common Area/Operating Expenses and Landlord’s insurance and utilities based thereon.
d.Fifth Expansion Premises Condition. Tenant accepts the Fifth Expansion Premises in as-is, where-is condition and acknowledges that Landlord has not made any representation or warranty related thereto, and Landlord shall not be required to construct, modify or otherwise improve the Fifth Expansion Premises in any manner (the foregoing, however, shall not be deemed to relieve Landlord of its ongoing maintenance, repair and replacement obligations to the extent explicitly set forth in the Lease or this Amendment).
e.Maintenance and Repair of Fifth Expansion Premises. All applicable provisions of the Original Lease regarding the Parties’ maintenance, repair and replacement obligations shall apply to the Fifth Expansion Premises including, but not limited to, Sections 3.1 and 3.2 of the Original Lease, as amended and restated in the Fifth Amendment to Lease Agreement, dated May 14, 2020.
f.Utilities. Tenant shall be responsible for the payment of all utilities supplied to the Fifth Expansion Premises beginning on the date Tenant takes occupancy thereof.
g.Access to Data Closet. In addition to providing Landlord access to the Leased Premises as set forth in the Original Lease, Tenant shall permit access to the data closet identified on Exhibit A by Stemina Biomarker Discovery, Inc. (“Stemina”) and its employees, agents, successor or assigns upon reasonable prior notice to Tenant (except in the event of an emergency no notice shall be required but Landlord or Stemina shall use reasonable efforts to contact Tenant by phone as soon as possible). Except in the event of an emergency, a representative of Landlord, the property manager or Tenant shall accompany Stemina (or its agents) upon any such entry to the Fifth Expansion Premises.
h.Security Deposit. On the date hereof, Tenant shall deposit an additional $8,500 with Landlord bringing the total Security Deposit to $207,683.62.
3.Effect. Except as amended by this Amendment, all of the terms, covenants, conditions, provisions, and agreements of the Original Lease remain in full force and effect. The provisions of this Amendment supersede and control over any conflicting provisions in the Original Lease.
4.Estoppel. Tenant and Landlord hereby represent and warrant that, as of the date hereof (to the best of their actual knowledge with respect to items (b) and (c)), (a) the Lease is in full force and effect and has not been modified or amended, except as set forth herein, (b) neither Tenant nor Landlord is in default under the Lease nor does Tenant or Landlord have any knowledge of any event which with the giving of notice and passage of time would result in a default, and (c) Landlord and Tenant have performed all obligations on each of their respective parts under the Lease, and neither Party has any claims against the other Party, including any claims of offset against any rent or other sums payable by Tenant under the Lease.
2
5.Miscellaneous. This Amendment and the Lease embodies the entire agreement between the parties as to its subject matter and supersedes any prior discussions with respect thereto. There are no agreements or understandings between the parties with respect to the subject matter of this Amendment not set forth in this Amendment or the Lease. This Amendment cannot be modified except by a writing signed by both parties.
6.Signing and Delivery. This Amendment will be effective only when both Landlord and Tenant have signed and delivered it. Landlord’s submission of an unsigned copy of this Amendment to Tenant for evaluation, negotiation, or signature by Tenant will not constitute signature of this Amendment by Landlord or otherwise bind Landlord, regardless of whether the cover letter or email transmitting that copy of this Amendment is signed or contains words of approval. This Amendment may be signed in counterparts and, when counterparts of this Amendment have been signed and delivered by the required parties as provided in this section, this Amendment will be fully binding and effective, just as if both of the parties had signed and delivered a single counterpart of this Amendment. Any counterpart transmitted by facsimile or email shall, in all cases, be deemed an original signature.
7.Contingency. Landlord’s obligations under this Amendment are conditioned and contingent upon Landlord, no later than December ____, 2020, entering into an early termination agreement with Elephas Bio Corporation (“Existing Tenant”) to terminate Existing Tenant’s lease of the Fifth Expansion Premises on terms acceptable to Landlord, in Landlord’s sole discretion. In the event that Landlord is unable to enter into an acceptable termination agreement with Existing Tenant prior to the date set forth above, Landlord may unilaterally terminate this Amendment upon written notice to Tenant following which neither party shall have any further rights or obligations pursuant to this Amendment.
[Signature page follows]
3
IN WITNESS WHEREOF, this Seventh Amendment to Lease is signed by the parties as of the date set forth above.
Landlord: |
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UNIVERSITY RESEARCH PARK ,INCORPRATED |
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By: |
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/s/ Aaron Olver |
Aaron Olver, Assistant Secretary/Treasurer |
Tenant: |
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ARROWHEAD MADISON INC. |
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By: |
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/s/ Kenneth A. Myszkowski |
Kenneth A. Myszkowski, CFO |
The undersigned Guarantor consents to the terms of this Seventh Amendment to Lease Agreement and agrees that, except as limited by the First Amendment to Lease Agreement dated October 22, 2018 with respect to that portion of the guaranty related to the Note (as defined in the First Amendment), the Guaranty Agreement dated January 8, 2016 remains in full force and effect (and to the extent previously terminated, is hereby reinstated) with respect to the full, and prompt payment and performance of all obligations of Tenant under the Lease, including, without limitation, as amended pursuant to this Seventh Amendment to Lease Agreement.
ARROWHEAD PHARMACEUTICALS,INC. |
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(f/k/a ARROWHEAD RESEARCH CORPORATION) |
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By: |
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/s/ Kenneth A. Myszkowski |
Kenneth A. Myszkowski, CFO |
EXHIBIT B
BASE RENT MATRIX (FIFTH EXPANSION PREMISES ONLY)
Term |
Monthly Amount |
Annual Amount |
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Effective Date – Aug. 31, 2021 |
$ |
5,821.08 |
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N/A |
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(partial year contemplated: |
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|
$ |
46,568.64) |
Sep. 1, 2021 – Aug. 31, 2022 |
$ |
5,968.32 |
$ |
71,619.84 |
Sep. 1, 2022 – Aug. 31, 2023 |
$ |
6,118.99 |
$ |
73,427.88 |
Monthly amount to be prorated on a daily basis if the Effective Date is other than the first day of a calendar month.
EXHIBIT B
Exhibit 31.1
CERTIFICATION PURSUANT SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Christopher Anzalone, Chief Executive Officer of Arrowhead Pharmaceuticals, Inc., certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Arrowhead Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: February 4, 2021 |
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/s/ CHRISTOPHER ANZALONE |
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Christopher Anzalone |
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Chief Executive Officer
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Exhibit 31.2
CERTIFICATION PURSUANT SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Kenneth A. Myszkowski, Chief Financial Officer of Arrowhead Pharmaceuticals, Inc., certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Arrowhead Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: February 4, 2021 |
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/s/ Kenneth A. Myszkowski |
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Kenneth A. Myszkowski, |
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Chief Financial Officer |
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Exhibit 32.1
CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I, Christopher Anzalone, Chief Executive Officer of Arrowhead Pharmaceuticals, Inc. (the “Company”), certify, pursuant to Rule 13(a)-14(b) or Rule 15(d)-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, that (i) the Quarterly Report on Form 10-Q of the Company for the quarterly period ended December 31, 2020, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and (ii) the information contained in such Quarterly Report on Form 10-Q fairly presents in all material respects the financial condition and results of operations of the Company.
Date: February 4, 2021 |
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/s/ CHRISTOPHER ANZALONE |
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Christopher Anzalone |
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Chief Executive Officer
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A signed original of these written statements required by 18 U.S.C. Section 1350 has been provided to Arrowhead Pharmaceuticals, Inc. and will be retained by Arrowhead Pharmaceuticals, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.
Exhibit 32.2
CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I, Kenneth A. Myszkowski, Chief Financial Officer of Arrowhead Pharmaceuticals, Inc. (the “Company”), certify, pursuant to Rule 13(a)-14(b) or Rule 15(d)-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, that (i) the Quarterly Report on Form 10-Q of the Company for the quarterly period ended December 31, 2020, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and (ii) the information contained in such Quarterly Report on Form 10-Q fairly presents in all material respects the financial condition and results of operations of the Company.
Date: February 4, 2021 |
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/s/ Kenneth A. Myszkowski |
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Kenneth A. Myszkowski |
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Chief Financial Officer |
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A signed original of these written statements required by 18 U.S.C. Section 1350 has been provided to Arrowhead Pharmaceuticals, Inc. and will be retained by Arrowhead Pharmaceuticals, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.