UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
|
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2021
or
|
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|
For the transition period from |
|
to |
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|
Commission File Number: 001-37718
F-STAR THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
|
Delaware |
52-2386345 |
|
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
|
|
|
|
Eddeva B920 Babraham Research Campus Cambridge, United Kingdom |
CB22 3AT |
|
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: +44-1223-497400
Securities registered pursuant to Section 12(b) of the Act:
|
Title of Each Class
|
Trading Symbol
|
Name of each exchange
|
|
Common Stock, $0.0001 par value per share |
FSTX |
The Nasdaq Stock Market (Nasdaq Capital Market) |
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ NO ☐
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes ☒ NO ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
|
Large accelerated filer |
☐ |
Accelerated filer |
☐ |
|
|
|
|
|
|
Non-accelerated filer |
☒ |
Smaller reporting company |
☒ |
|
|
|
|
|
|
|
|
Emerging growth company |
☒ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒
The number of shares of Registrant’s Common Stock outstanding as of November 8, 2021 was 20,624,494.
F-star Therapeutics, Inc.
INDEX
PART I. FINANCIAL INFORMATION
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Page
|
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Item 1. |
2 |
|
|
|
Condensed Consolidated Balance Sheets at September 30, 2021 and December 31, 2020 |
2 |
|
|
3 |
|
|
|
4 |
|
|
|
6 |
|
|
|
Notes to Unaudited Condensed Consolidated Financial Statements |
7 |
|
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
24 |
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Item 3. |
40 |
|
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Item 4. |
40 |
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|
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PART II. OTHER INFORMATION |
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|
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Item 1. |
42 |
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Item 1A. |
42 |
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Item 2 |
43 |
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Item 3 |
44 |
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Item 4 |
44 |
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Item 5 |
44 |
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Item 6. |
44 |
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|
45 |
||
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46 |
||
i
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
F-star Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(In Thousands, Except Share and Per Share Amounts)
|
|
|
September 30, |
|
|
December 31, |
|
||
|
|
|
2021 |
|
|
2020 |
|
||
|
|
|
Unaudited |
|
|
|
|
||
|
Assets |
|
|
|
|
|
|
||
|
Current Assets: |
|
|
|
|
|
|
||
|
Cash and cash equivalents |
|
$ |
71,050 |
|
|
$ |
18,526 |
|
|
Other receivables |
|
|
436 |
|
|
|
— |
|
|
Prepaid expenses and other current assets |
|
|
3,173 |
|
|
|
3,976 |
|
|
Tax incentive receivable |
|
|
1,502 |
|
|
|
3,563 |
|
|
Total current assets |
|
|
76,161 |
|
|
|
26,065 |
|
|
Property and equipment, net |
|
|
1,011 |
|
|
|
789 |
|
|
Right of use asset |
|
|
3,501 |
|
|
|
2,782 |
|
|
Goodwill |
|
|
14,885 |
|
|
|
14,926 |
|
|
In-process research and development and intangible assets, net |
|
|
18,790 |
|
|
|
18,986 |
|
|
Other long-term assets |
|
|
450 |
|
|
|
61 |
|
|
Total assets |
|
$ |
114,798 |
|
|
$ |
63,609 |
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
||
|
Current Liabilities: |
|
|
|
|
|
|
||
|
Accounts payable |
|
$ |
1,569 |
|
|
$ |
4,597 |
|
|
Accrued expenses and other current liabilities |
|
|
5,642 |
|
|
|
9,461 |
|
|
Contingent value rights |
|
|
648 |
|
|
|
2,080 |
|
|
Lease obligations, current |
|
|
976 |
|
|
|
539 |
|
|
Deferred revenue |
|
|
— |
|
|
|
300 |
|
|
Total current liabilities |
|
|
8,835 |
|
|
|
16,977 |
|
|
Long term Liabilities: |
|
|
|
|
|
|
||
|
Term debt |
|
|
9,535 |
|
|
|
— |
|
|
Lease obligations |
|
|
2,875 |
|
|
|
2,622 |
|
|
Contingent value rights |
|
|
2,899 |
|
|
|
440 |
|
|
Deferred tax liability |
|
|
576 |
|
|
|
576 |
|
|
Total liabilities |
|
|
24,720 |
|
|
|
20,615 |
|
|
Commitments and contingencies |
|
|
|
|
|
|
||
|
Stockholders’ equity: |
|
|
|
|
|
|
||
|
Preferred stock, $0.0001 par value; authorized, 10,000,000 shares at
|
|
|
— |
|
|
|
— |
|
|
Common Stock, $0.0001 par value; authorized 200,000,000 shares at
|
|
|
2 |
|
|
|
1 |
|
|
Additional paid-in capital |
|
|
174,410 |
|
|
|
91,238 |
|
|
Accumulated other comprehensive loss |
|
|
(1,142 |
) |
|
|
(1,077 |
) |
|
Accumulated deficit |
|
|
(83,192 |
) |
|
|
(47,168 |
) |
|
Total stockholders’ equity |
|
|
90,078 |
|
|
|
42,994 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
114,798 |
|
|
$ |
63,609 |
|
See accompanying notes to consolidated financial statements.
2
F-star Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In Thousands, Except Share and Per Share Amounts)
|
|
|
For the Three Months
|
|
|
For the Nine Months
|
|
||||||||||
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
|
License revenue |
|
$ |
751 |
|
|
$ |
9,195 |
|
|
$ |
3,668 |
|
|
$ |
11,093 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Research and development |
|
|
5,113 |
|
|
|
5,321 |
|
|
|
20,536 |
|
|
|
10,695 |
|
|
General and administrative |
|
|
5,239 |
|
|
|
7,261 |
|
|
|
18,169 |
|
|
|
13,805 |
|
|
Total operating expenses |
|
|
10,352 |
|
|
|
12,582 |
|
|
|
38,705 |
|
|
|
24,500 |
|
|
Loss from operations |
|
|
(9,601 |
) |
|
|
(3,387 |
) |
|
|
(35,037 |
) |
|
|
(13,407 |
) |
|
Other non-operating (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Other income (expense) |
|
|
(746 |
) |
|
|
506 |
|
|
|
230 |
|
|
|
(1,164 |
) |
|
Change in fair value of convertible debt |
|
|
— |
|
|
|
(446 |
) |
|
|
— |
|
|
|
(2,330 |
) |
|
Change in fair value of contingent value
|
|
|
(444 |
) |
|
|
— |
|
|
|
(1,027 |
) |
|
|
— |
|
|
Loss before income taxes |
|
|
(10,791 |
) |
|
|
(3,327 |
) |
|
|
(35,834 |
) |
|
|
(16,901 |
) |
|
Income tax expense |
|
|
— |
|
|
|
(124 |
) |
|
|
(190 |
) |
|
|
(171 |
) |
|
Net loss |
|
$ |
(10,791 |
) |
|
$ |
(3,451 |
) |
|
$ |
(36,024 |
) |
|
$ |
(17,072 |
) |
|
Net loss attributable to common stockholders |
|
$ |
(10,791 |
) |
|
$ |
(3,451 |
) |
|
$ |
(36,024 |
) |
|
$ |
(17,072 |
) |
|
Basic and diluted adjusted net loss per common
|
|
$ |
(0.52 |
) |
|
$ |
(1.88 |
) |
|
$ |
(2.35 |
) |
|
$ |
(9.34 |
) |
|
Weighted-average number of shares
|
|
|
20,617,822 |
|
|
|
1,832,194 |
|
|
|
15,300,433 |
|
|
|
1,828,597 |
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Net loss |
|
$ |
(10,791 |
) |
|
$ |
(3,451 |
) |
|
$ |
(36,024 |
) |
|
$ |
(17,072 |
) |
|
Other comprehensive (loss) gain : |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Foreign currency translation |
|
|
117 |
|
|
|
14 |
|
|
|
(65 |
) |
|
|
424 |
|
|
Total comprehensive loss |
|
$ |
(10,674 |
) |
|
$ |
(3,437 |
) |
|
$ |
(36,089 |
) |
|
$ |
(16,648 |
) |
See accompanying notes to consolidated financial statements.
3
F-star Therapeutics, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
For the three months ended September 30, 2021 and 2020
(Unaudited)
(In Thousands, Except Share Amounts)
|
|
|
Stockholders’ Equity |
|
|||||||||||||||||||||
|
|
|
Common Shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
For the Three Months Ended September 30, 2021 |
|
Number of
|
|
|
Value |
|
|
Capital in Excess
|
|
|
Accumulated Other
|
|
|
Accumulated
|
|
|
Total Stockholders’
|
|
||||||
|
Balance at June 30, 2021 as originally stated |
|
|
20,586,562 |
|
|
$ |
2 |
|
|
$ |
172,895 |
|
|
$ |
(1,218 |
) |
|
$ |
(72,686 |
) |
|
$ |
98,993 |
|
|
Adjustment (see note 1) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
$ |
(41 |
) |
|
$ |
285 |
|
|
$ |
244 |
|
|
Revised balance at June 30, 2021 |
|
|
20,586,562 |
|
|
$ |
2 |
|
|
$ |
172,895 |
|
|
$ |
(1,259 |
) |
|
$ |
(72,401 |
) |
|
$ |
99,237 |
|
|
Equity adjustment from foreign currency translation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
117 |
|
|
|
— |
|
|
|
117 |
|
|
RSU vesting and stock option exercises |
|
|
36,479 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
1,515 |
|
|
|
— |
|
|
|
— |
|
|
|
1,515 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(10,791 |
) |
|
|
(10,791 |
) |
|
Balance at September 30, 2021 |
|
|
20,623,041 |
|
|
$ |
2 |
|
|
$ |
174,410 |
|
|
$ |
(1,142 |
) |
|
$ |
(83,192 |
) |
|
$ |
90,078 |
|
|
|
|
Stockholders’ Equity |
|
|||||||||||||||||||||||||||||
|
|
|
Seed
|
|
|
Series A
|
|
|
Common Shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
For the Three Months Ended September 30, 2020 |
|
Number of
|
|
|
Number of
|
|
|
Number of
|
|
|
Value |
|
|
Capital in Excess
|
|
|
Accumulated Other
|
|
|
Accumulated
|
|
|
Total Stockholders’
|
|
||||||||
|
Balance at July 1, 2020 |
|
|
103,611 |
|
|
|
1,441,418 |
|
|
|
4,312,137 |
|
|
$ |
1 |
|
|
$ |
32,723 |
|
|
$ |
(1,224 |
) |
|
$ |
(35,170 |
) |
|
$ |
(3,670 |
) |
|
Equity adjustment from foreign
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
14 |
|
|
|
— |
|
|
|
14 |
|
|
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,194 |
|
|
|
— |
|
|
|
— |
|
|
|
1,194 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(3,451 |
) |
|
|
(3,451 |
) |
|
Balance at September 30, 2020 |
|
|
103,611 |
|
|
|
1,441,418 |
|
|
|
4,312,137 |
|
|
$ |
1 |
|
|
$ |
33,917 |
|
|
$ |
(1,210 |
) |
|
$ |
(38,621 |
) |
|
$ |
(5,913 |
) |
See accompanying notes to consolidated financial statements.
4
F-star Therapeutics, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
For the nine months ended September 30, 2021 and 2020
(Unaudited)
(In Thousands, Except Share Amounts)
|
|
|
Stockholders’ Equity |
|
|||||||||||||||||||||
|
|
|
Common Shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
For the Nine Months Ended September 30, 2021 |
|
Number of
|
|
|
Value |
|
|
Capital in Excess
|
|
|
Accumulated Other
|
|
|
Accumulated
|
|
|
Total Stockholders’
|
|
||||||
|
Balance at December 31, 2020 |
|
|
9,100,117 |
|
|
$ |
1 |
|
|
$ |
91,238 |
|
|
$ |
(1,077 |
) |
|
$ |
(47,168 |
) |
|
$ |
42,994 |
|
|
Issuance of warrants in connection with term loan |
|
|
— |
|
|
|
— |
|
|
|
326 |
|
|
|
— |
|
|
|
— |
|
|
|
326 |
|
|
Issuance of common stock in connection with
|
|
|
979,843 |
|
|
|
— |
|
|
|
9,115 |
|
|
|
— |
|
|
|
— |
|
|
|
9,115 |
|
|
Issuance of common stock in connection with
|
|
|
10,439,347 |
|
|
|
1 |
|
|
|
68,177 |
|
|
|
— |
|
|
|
— |
|
|
|
68,178 |
|
|
Equity adjustment from foreign currency translation |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
(65 |
) |
|
|
— |
|
|
|
(65 |
) |
|
|
RSU vesting and stock option exercises |
|
|
103,734 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
5,554 |
|
|
|
— |
|
|
|
— |
|
|
|
5,554 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(36,024 |
) |
|
|
(36,024 |
) |
|
Balance at September 30, 2021 |
|
|
20,623,041 |
|
|
$ |
2 |
|
|
$ |
174,410 |
|
|
$ |
(1,142 |
) |
|
$ |
(83,192 |
) |
|
$ |
90,078 |
|
|
|
|
Stockholders’ Equity |
|
|||||||||||||||||||||||||||||
|
|
|
Seed
|
|
|
Series A
|
|
|
Common Shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
For the Nine Months Ended September 30, 2020 |
|
Number of
|
|
|
Number of
|
|
|
Number of
|
|
|
Value |
|
|
Capital in Excess
|
|
|
Accumulated Other
|
|
|
Accumulated
|
|
|
Total Stockholders’
|
|
||||||||
|
Balance at December 31, 2019 |
|
|
103,611 |
|
|
|
1,441,418 |
|
|
|
4,128,441 |
|
|
$ |
1 |
|
|
$ |
31,718 |
|
|
$ |
(1,634 |
) |
|
$ |
(21,549 |
) |
|
$ |
8,536 |
|
|
Issuance of common stock for
|
|
|
— |
|
|
|
— |
|
|
|
10,972 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Issuance of common stock in connection
|
|
|
— |
|
|
|
— |
|
|
|
172,724 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Equity adjustment from foreign
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
424 |
|
|
|
— |
|
|
|
424 |
|
|
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,199 |
|
|
|
— |
|
|
|
— |
|
|
|
2,199 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(17,072 |
) |
|
|
(17,072 |
) |
|
Balance at September 30, 2020 |
|
|
103,611 |
|
|
|
1,441,418 |
|
|
|
4,312,137 |
|
|
$ |
1 |
|
|
$ |
33,917 |
|
|
$ |
(1,210 |
) |
|
$ |
(38,621 |
) |
|
$ |
(5,913 |
) |
See accompanying notes to consolidated financial statements.
5
F-star Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(In Thousands)
|
|
|
For the Nine Months Ended September 30, |
|
|||||
|
|
|
2021 |
|
|
2020 |
|
||
|
Cash flows from operating activities: |
|
|
|
|
|
|
||
|
Net loss |
|
$ |
(36,024 |
) |
|
$ |
(17,072 |
) |
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
||
|
Share based compensation expense |
|
|
5,554 |
|
|
|
2,199 |
|
|
Foreign currency (gain) loss |
|
|
(66 |
) |
|
|
968 |
|
|
(Gain) loss on disposal of property, plant and equipment |
|
|
(9 |
) |
|
|
7 |
|
|
Depreciation |
|
|
435 |
|
|
|
887 |
|
|
Amortization of intangible assets |
|
|
65 |
|
|
|
— |
|
|
Non-cash interest |
|
|
42 |
|
|
|
815 |
|
|
Interest expense |
|
|
69 |
|
|
|
— |
|
|
Fair value adjustments |
|
|
1,027 |
|
|
|
2,330 |
|
|
Operating right of use amortization |
|
|
749 |
|
|
|
— |
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
|
Other receivables |
|
|
(444 |
) |
|
|
— |
|
|
Prepaid expenses and other current assets |
|
|
800 |
|
|
|
1,254 |
|
|
Tax incentive receivable |
|
|
2,083 |
|
|
|
8,403 |
|
|
Accounts payable |
|
|
(3,050 |
) |
|
|
677 |
|
|
Accrued expenses and other current liabilities |
|
|
(3,796 |
) |
|
|
233 |
|
|
Deferred revenue |
|
|
(305 |
) |
|
|
(352 |
) |
|
Operating lease liability |
|
|
(400 |
) |
|
|
(467 |
) |
|
Other long term asset |
|
|
(778 |
) |
|
|
— |
|
|
Net cash used in operating activities |
|
|
(34,048 |
) |
|
|
(118 |
) |
|
Cash flows from investing activities: |
|
|
|
|
|
|
||
|
Purchase of property, plant and equipment |
|
|
(658 |
) |
|
|
— |
|
|
Proceeds from sale of property, plant and equipment |
|
|
15 |
|
|
|
— |
|
|
Purchase of intangible assets |
|
|
— |
|
|
|
(50 |
) |
|
Net cash used in investing activities |
|
|
(643 |
) |
|
|
(50 |
) |
|
Cash flows from financing activities: |
|
|
|
|
|
|
||
|
Proceeds from issuance of convertible notes |
|
|
— |
|
|
|
850 |
|
|
Net proceeds from issuance of common stock |
|
|
77,295 |
|
|
|
— |
|
|
Net proceeds from term debt |
|
|
9,845 |
|
|
|
— |
|
|
Payment of debt issuance costs |
|
|
(92 |
) |
|
|
— |
|
|
Net cash provided by financing activities |
|
|
87,048 |
|
|
|
850 |
|
|
Net increase in cash and cash equivalents |
|
|
52,357 |
|
|
|
682 |
|
|
Effect of exchange rate changes on cash |
|
|
167 |
|
|
|
(56 |
) |
|
Cash and cash equivalents at beginning of period |
|
|
18,526 |
|
|
|
4,901 |
|
|
Cash and cash equivalents at end of period |
|
$ |
71,050 |
|
|
$ |
5,527 |
|
|
Supplemental disclosure of cash flow information |
|
|
|
|
|
|
||
|
Cash paid for income taxes |
|
$ |
36 |
|
|
$ |
42 |
|
|
Cash paid for interest |
|
$ |
296 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
||
|
Non-cash investing and financing activities: |
|
|
|
|
|
|
||
|
Additions to ROU assets obtained from new operating lease liabilities |
|
$ |
1,468 |
|
|
$ |
— |
|
|
Issuance of warrants |
|
$ |
326 |
|
|
$ |
— |
|
See accompanying notes to consolidated financial statements.
6
F-star Therapeutics, Inc.
Notes to Condensed Consolidated Financial Statements
1. Nature of Business and Summary of Significant Accounting Policies
Nature of Business
F-star Therapeutics, Inc. (collectively with its subsidiaries, “F-star” or the “Company”) is a clinical-stage biopharmaceutical company dedicated to developing next generation immunotherapies to transform the lives of patients with cancer. F-star is pioneering the use of tetravalent (2+2) bispecific antibodies to create a paradigm shift in cancer therapy. The Company has four second-generation immuno-oncology ("IO") therapeutics in the clinic, each directed against some of the most promising IO targets in drug development, including LAG-3 and CD137. F-star’s proprietary antibody discovery platform is protected by a vast intellectual property portfolio, with 500 granted and pending patent applications relating to its platform technology and associated product pipeline. The Company has attracted multiple partnerships with biopharma targeting the significant unmet needs across several disease areas, including oncology, immunology, and CNS. F-star’s goal is to offer patients better and more durable benefits than currently available immuno-oncology treatments by developing medicines that seek to block tumor immune evasion. Through its proprietary tetravalent, bispecific natural antibody (mAb²™) format, F-star’s mission is to generate highly differentiated medicines with monoclonal antibody-like manufacturability, good safety and tolerability. With four distinct binding sites in a natural human antibody format, F-star believes its proprietary technology will overcome many of the challenges facing current immuno-oncology therapies, due to the strong pharmacology enabled by tetravalent bispecific binding.
Share Exchange Agreement
On November 20, 2020, F-star Therapeutics, Inc., formerly known as Spring Bank Pharmaceuticals, Inc., completed a business combination (the “Transaction”) with F-star Therapeutics Limited (“F-star Ltd”) in accordance with the terms of the Share Exchange Agreement, dated July 29, 2020 (the “Exchange Agreement”), by and among the Company, F-star Ltd and certain holders of capital stock and convertible notes of F-star Ltd (each a “Seller”, and collectively with holders of F-star Ltd securities who subsequently became parties to the Exchange Agreement, the “Sellers”). Pursuant to the Exchange Agreement, each ordinary share of F-star Ltd outstanding immediately prior to the closing of the Transaction (the “Closing”) was exchanged by the Sellers that owned such F-star Ltd shares for a number of duly authorized, validly issued, fully paid and non-assessable shares of Company common stock pursuant to the exchange ratio formula set forth in the Exchange Agreement (the “Exchange Ratio”), rounded to the nearest whole share of Company common stock (after aggregating all fractional shares of Company common stock issuable to such Seller). Also, on November 20, 2020, in connection with, and prior to completion of, the Transaction, Spring Bank effected a 1-for-4 reverse stock split of its common stock (the “Reverse Stock Split”) and, following the completion of the Transaction, changed its name to F-star Therapeutics, Inc. Following the completion of the Transaction, the business of the Company became the business conducted by F-star, which is a clinical-stage immuno-oncology company focused on cancer treatment through its proprietary tetravalent bispecific antibody programs. Unless otherwise noted, all references to share amounts in this report reflect the Reverse Stock Split.
Liquidity
On March 30, 2021, the Company entered into a Sales Agreement (the “Sales Agreement”) with SVB Leerink LLC (“SVB Leerink”) with respect to an “at-the-market” offering as defined in Rule 415 of the Securities Act of 1933, as amended, under which the Company could offer and sell, from time to time in its sole discretion, shares of its common stock, par value $0.0001 per share, having an aggregate offering price of up to $50.0 million through SVB Leerink as its sales agent. As of May 6, 2021, the Company had issued and sold 979,843 shares of common stock for gross proceeds of $9.5 million, resulting in net proceeds of $9.1 million after deducting sales commissions and offering expenses. On May 6, 2021, the Company terminated the Sales Agreement.
On August 13, 2021, the Company entered into a Sales Agreement (the “2021 Sales Agreement”) with SVB Leerink with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $50.0 million through
7
SVB Leerink as its sales agent. As of September 30, 2021 Company had not offered or sold any common stock under the 2021 Sales Agreement.
On May 6, 2021, the Company entered into an underwriting agreement with SVB Leerink, as representative of the underwriters, relating to an underwritten public offering (the “Underwritten Public Offering”) of 10.4 million shares of the Company’s common stock, par value $0.0001 per share. The underwritten public offering resulted in gross proceeds of $73.1 million. The Company incurred $4.4 million in issuance costs and $0.5 million of professional fees associated with the underwritten public offering, resulting in net proceeds to the Company of $68.2 million.
On April 1, 2021, the Company, as borrower, entered into a Venture Loan and Security Agreement (the “Loan and Security Agreement”) with Horizon Technology Finance Corporation (“Horizon”), as lender and collateral agent for itself. The Loan and Security Agreement provides for four separate and independent $2.5 million term loans (“Loan A”, “Loan B”, “Loan C”, and “Loan D”) (with each of Loan A, Loan B, Loan C and Loan D, individually a “Term Loan” and, collectively, the “Term Loans”), whereby, upon the satisfaction of all the conditions to the funding of the Term Loans, each Term Loan will be delivered by Horizon to the Company in the following manner: (i) Loan A was delivered by Horizon to the Company by April 1, 2021, (ii) Loan B was delivered by Horizon to the Company by April 1, 2021, (iii) Loan C was delivered by Horizon to the Company by June 30, 2021, and (iv) Loan D was delivered by Horizon to the Company by June 30, 2021. The Company may only use the proceeds of the Term Loans for working capital or general corporate purposes as contemplated by the Loan and Security Agreement. On April 1, 2021, the Company drew down $5 million. On June 22, 2021, the Company drew down another $5 million under this facility.
The Company has incurred significant losses and has an accumulated deficit of $83.2 million as of September 30, 2021. F-star expects to incur substantial losses in the foreseeable future as it conducts and expands its research and development activities and clinical trial activities. As of September 30, 2021, the Company had cash of $71.1 million and working capital of $67.3 million. As of November 10, 2021, the date of issuance of the condensed consolidated financial statements, the Company’s cash and cash equivalents on hand will be sufficient to fund its current operating plan and planned capital expenditures for at least the next 12 months.
The Company may continue to seek additional funding through public equity, private equity, debt financing, collaboration partnerships, or other sources. There are no assurances, however, that the Company will be successful in raising additional working capital, or if it is able to raise additional working capital, it may be unable to do so on commercially favorable terms. The Company’s failure to raise future capital or enter into other such arrangements if and when needed would have a negative impact on its business, results of operations and financial condition and its ability to develop its product candidates.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and the rules and regulations of the Securities Exchange Commission ("SEC") for interim financial statements.
The accompanying interim condensed consolidated financial statements as of September 30, 2021, and for the three and nine months ended September 30, 2021 and 2020, and information contained within the notes to these condensed consolidated financial statements, are unaudited. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s audited annual financial statements and in management's opinion contain all adjustrevisionments (including normal recurring adjustments) necessary for the fair presentation of the Company’s financial position as of September 30, 2021, results of operations for the three and nine months ended September 30, 2021 and 2020, statement of stockholders’ equity for the three and nine months ended September 30, 2021 and 2020 and its cash flows for the nine months ended September 30, 2021 and 2020. These interim condensed consolidated financial statements should be read in conjunction with the Company’s annual audited financial statements and notes thereto included in the Company’s Annual Report filed on SEC Form 10-K for the year ended December 31, 2020. The results for the three and nine months ended September 30, 2021, are not necessarily indicative of the results expected for the full fiscal year or any interim period.
8
Revision of Previously Issued Financial Statements
In September 2021, the Company identified an error in its accounting treatment for research and development expenses. This error resulted in an overstatement of research and development expenses for the first six months of 2021 and accrued expenses and other current liabilities as of March 31, 2021 and June 30, 2021. The Company assessed the materiality of this error on prior period financial statements in accordance with the SEC Staff Accounting Bulletin Number 99, Materiality, and ASC 250-10, Accounting Changes and Error Corrections. The Company determined that this error was not material to the financial statements of any prior interim period. To correct the immaterial misstatement, the Company decreased accumulated deficit by $0.3 million as of June 30, 2021.
Principles of Consolidation
The Company’s interim condensed consolidated financial statements have been prepared in conformity with U.S. GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the ASC and Accounting Standards Updates (“ASU”) of the FASB. The accompanying condensed consolidated financial statements include the accounts of F-star Therapeutics, Inc. and its wholly owned subsidiaries. All inter-company balances and transactions between the consolidated companies have been eliminated in consolidation.
Use of Estimates
The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting years. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the fair value of the assets and liabilities acquired in the transaction between Spring Bank and F-star Ltd fair value of the convertible loan containing embedded derivatives, the fair value of contingent value rights, the accrual for research and development expenses, revenue recognition, fair values of acquired intangible assets and impairment review of those assets, warrants, share based compensation expense, and income taxes. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Estimates are periodically reviewed in light of reasonable changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates or assumptions.
Concentrations of credit risk and of significant suppliers
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains its cash and cash equivalents in financial institutions in amounts that could exceed government-insured limits. The Company does not believe it is subject to additional credit risks beyond those normally associated with commercial banking relationships.
The Company is dependent on contract research organizations to provide its clinical trials and third-party manufacturers to supply products for research and development activities in its programs. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply its requirements for
9
supplies and raw materials related to these programs. These programs could be adversely affected by a significant interruption in these manufacturing services or the availability of raw materials.
Property, plant and equipment
Property, plant and equipment are stated at cost, less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the estimated useful lives of the respective assets as follows:
Leases
The Company determines if an arrangement is a lease at inception. Operating leases are included in right-of-use (“ROU”) assets, and lease obligations in the Company’s consolidated balance sheets.
ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The operating lease ROU asset also includes any lease payments made and excludes lease incentives. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term.
Impairment of Long-Lived Assets
Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If the undiscounted cash flows are insufficient to recover the carrying value, an impairment loss is recorded for the difference between the carrying value and fair value of the asset. As of September 30, 2021, no such impairment has been recorded.
License and collaboration arrangements and revenue recognition
The Company’s revenues are generated primarily through license and collaboration agreements with pharmaceutical and biotechnology companies. The terms of these arrangements may include (i) the grant of intellectual property rights (IP licenses) to therapeutic drug candidates against specified targets, developed using the Company’s proprietary mAb2 bispecific antibody platform, (ii) performing research and development services to optimize drug candidates, and (iii) the grant of options to obtain additional research and development services or licenses for additional targets, or to optimize product candidates, upon the payment of option fees.
The terms of these arrangements typically include payment to the Company of one or more of the following:
non-refundable, upfront license fees; payments for research and development services; fees upon the exercise of options to obtain additional services or licenses; payments based upon the achievement of defined collaboration objectives; future regulatory and sales-based milestone payments; and royalties on net sales of future products.
The Company has adopted FASB ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. To date, the Company has entered into License and Collaboration Agreements with Denali Therapeutics, Inc. (“Denali”), Ares Trading S.A. (“Ares,”)
10
an affiliate of Merck KGaA, Darmstadt, Germany) and in July 2021 with AstraZeneca AB ("AstraZeneca"), which were determined to be within the scope of ASC 606.
Research and development costs
Research and development costs are expensed as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including compensation expense, share-based compensation and benefits, facilities costs and laboratory supplies, depreciation, amortization and impairment expense, manufacturing expenses and external costs of outside vendors engaged to conduct preclinical development activities and clinical trials as well as the cost of licensing technology. Typically, upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred, except for payments relating to intellectual property rights with future alternative use which will be expensed when the intellectual property is in use. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
Warrants
The Company accounts for warrants within stockholders equity or as liabilities based on the characteristics and provisions of each instrument. The Company evaluates outstanding warrants in accordance with ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging. If none of the criteria in the evaluation in these standards are met, the warrants are classified as a component of stockholders’ equity and initially recorded at their grant date fair value without subsequent remeasurement. Warrants that meet the criteria are classified as liabilities and remeasured to their fair value at the end of each reporting period.
Stock-Based Compensation
The Company accounts for share-based compensation in accordance with ASC 718, “Compensation – Stock Compensation”(“ASC 718”). ASC 718 requires companies to estimate the fair value of equity-based payment awards on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service period in the Company’s consolidated statements of operations and comprehensive loss.
Fair value measurements of financial instruments
The Company’s financial instruments consist of cash, accounts payable, CVRs and liability classified warrants. The carrying amounts of cash and accounts payable approximate their fair value due to the short-term nature of those financial instruments. The fair value of CVRs and the liability classified warrants are remeasured to fair value each reporting period.
Net loss per share
The Company computes net loss per share in accordance with ASC Topic 260, Earnings Per Share (“ASC 260”) and related guidance, which requires two calculations of net (loss) income attributable to the Company’s shareholders per share to be disclosed: basic and diluted. Convertible preferred shares are considered participating securities and are included in the calculation of basic and diluted net (loss) income per share using the two-class method. In periods where the Company reports net losses, such losses are not allocated to the convertible preferred shares for the computation of basic or diluted net (loss) income.
Diluted net (loss) income per share is the same as basic net (loss) income per share for the periods in which the Company had a net loss because the inclusion of outstanding common stock equivalents would be anti-dilutive.
Income taxes
The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the
11
consolidated financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. The potential recovery of deferred tax assets is evaluated by estimating the potential for future taxable profits, if any.
Research and development tax credit
As the entities located in the United Kingdom carry out extensive research and development activities, they seek to benefit from the UK research and development tax credit cash rebate regime known as the Small and Medium-sized Enterprises R&D Tax Credit Program (the “SME Program”). Qualifying expenditures largely comprise employment costs for research staff, consumables expenses incurred under agreements with third parties that conduct research and development, preclinical activities, clinical activities and manufacturing on the Company’s behalf and certain internal overhead costs incurred as part of research projects. The tax credit received in the United Kingdom pursuant to the SME Program permits companies to deduct an extra 130% of their qualifying costs from their yearly profit or loss, as well as the normal 100% deduction, to make a total 230% deduction. If the company is incurring losses, it is entitled to claim a tax credit worth up to 14.5% of the surrenderable loss. To qualify for relief under the SME Program, companies are required to employ fewer than 500 staff and have a turnover of under €100.0 million or a balance sheet total of less than €86.0 million.
Research and development tax credits received in the United Kingdom are recorded as a reduction in research and development expenses. The UK research and development tax credit is payable to companies after surrendering tax losses and is not dependent on current or future taxable income. As a result, it is not reflected as part of the income tax provision.
During the nine months ended September 30, 2021 the Company received $3.4 million in research and development tax credits related to the year ended December 31, 2020.
Contingencies
Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential loss range is probable and reasonably estimable under the provisions of the authoritative guidelines that address accounting for contingencies. The Company expenses costs as incurred in relation to such legal proceedings as general and administrative expense within the consolidated statements of operations and comprehensive loss.
Recently Issued Accounting Pronouncements
In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 will change how companies account for credit losses for most financial assets and certain other instruments. For trade receivables, loans and held-to-maturity debt securities, companies will be required to recognize an allowance for credit losses rather than reducing the carrying value of the asset. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments — Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates to amend the effective date of ASU 2016-13, for entities eligible to be “smaller reporting companies,” as defined by the SEC, to be effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The Company has not elected to early adopt ASU No. 2016-13. The Company is currently evaluating the potential impact that the adoption of ASU 2016-13 will have on the Company’s financial position and results of operations.
12
2. Business Combination
As described in Note 1, on November 20, 2020, F-star Ltd completed a business combination with Spring Bank. For accounting purposes, the purchase price was based on (i) the fair value of Spring Bank common stock as of the Transaction date of $21.5 million, which was determined based on the number of shares of common stock issued in connection with the Transaction, and (ii) the portion of the fair value attributable to in-the-money fully and partially vested stock options and warrants.
The purchase price is allocated to the fair value of assets and liabilities acquired as follows in the table below (in thousands, except shares of common stock and fair value per share):
|
Purchase Price Allocation |
|
|||
|
Number of full common shares |
|
|
4,449,559 |
|
|
Multiplied by fair value per share of common stock |
|
$ |
4.84 |
|
|
Purchase price |
|
$ |
21,536 |
|
|
Cash and cash equivalents |
|
$ |
9,779 |
|
|
Marketable securities |
|
|
5,000 |
|
|
Prepaid expenses and other assets |
|
|
935 |
|
|
Operating lease right of use asset |
|
|
2,784 |
|
|
Intangible assets |
|
|
4,720 |
|
|
Goodwill |
|
|
10,451 |
|
|
Accounts payable, accrued expenses and other
|
|
|
(5,453 |
) |
|
Contingent value rights |
|
|
(2,520 |
) |
|
Liability and equity based warrants |
|
|
(422 |
) |
|
Deferred tax liability |
|
|
(576 |
) |
|
Operating lease liability |
|
|
(3,162 |
) |
|
Fair value of net assets acquired |
|
$ |
21,536 |
|
3. Net Loss Per Share
The following table presents the calculation of basic and diluted net loss per share applicable to common stockholders of the Company (in thousands, except share and per share data):
|
Net Loss Per Share |
|
|||||||||||||||
|
|
|
For the Three Months
|
|
|
For the Nine Months
|
|
||||||||||
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
|
Net loss |
|
$ |
(10,791 |
) |
|
$ |
(3,451 |
) |
|
$ |
(36,024 |
) |
|
$ |
(17,072 |
) |
|
Weighted average number shares
|
|
|
20,617,822 |
|
|
|
1,832,194 |
|
|
|
15,300,433 |
|
|
|
1,828,597 |
|
|
Net loss income per common, basic
|
|
$ |
(0.52 |
) |
|
$ |
(1.88 |
) |
|
$ |
(2.35 |
) |
|
$ |
(9.34 |
) |
Diluted net loss per share of common stock is the same as basic net loss per share of common stock for all periods presented. The following shares were excluded from the calculation of diluted net loss per share, prior to the use of the treasury stock method or if-converted method, because their effect would have been anti-dilutive for the period presented:
4. In process R&D and intangible assets, net
|
|
|
September 30, 2021 |
|
|
December 31, 2020 |
|
||||||||||||||||||
|
|
|
In-process R&D |
|
|
Intangible assets |
|
|
Total |
|
|
In-process R&D |
|
|
Intangible assets |
|
|
Total |
|
||||||
|
Cost |
|
$ |
18,912 |
|
|
$ |
4,469 |
|
|
$ |
23,381 |
|
|
$ |
23,554 |
|
|
$ |
— |
|
|
$ |
23,554 |
|
|
Less: accumulated amortization |
|
|
— |
|
|
|
65 |
|
|
|
65 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Less: impairments |
|
|
4,526 |
|
|
|
— |
|
|
|
4,526 |
|
|
|
4,568 |
|
|
|
— |
|
|
|
4,568 |
|
|
|
|
$ |
14,386 |
|
|
$ |
4,404 |
|
|
$ |
18,790 |
|
|
$ |
18,986 |
|
|
$ |
— |
|
|
$ |
18,986 |
|
During the three months ended September 30, 2021, $4.5 million of in-process R&D assets were reclassified to intangible assets as management determined that these assets had been brought into use and were no longer in-process. The appropriate useful life of the intangible assets was determined in accordance with ASC 350, Goodwill and Other. Accordingly, the useful lives are based on the period during which 95% of the undiscounted cash flows of the assets will be realized. As a result $0.1 million of amortization was recorded for the three months ended September 30, 2021.
5. Property, Plant and Equipment, net
Property, plant and equipment, net consisted of the following (in thousands):
Depreciation expense for the nine months ended September 30, 2021 and 2020 was $0.4 million and $0.9 million, respectively.
6. Fair Value Measurements
The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
|
|
|
Fair Value Measurements as of September 30, 2021 Using: |
|
|||||||||||||
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Contingent value rights |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
3,547 |
|
|
$ |
3,547 |
|
|
Warrants |
|
|
— |
|
|
|
— |
|
|
|
11 |
|
|
|
11 |
|
|
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
3,558 |
|
|
$ |
3,558 |
|
|
|
|
Fair Value Measurements as of December 31, 2020 Using: |
|
|||||||||||||
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Contingent value rights |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
2,520 |
|
|
$ |
2,520 |
|
|
Warrants |
|
|
— |
|
|
|
— |
|
|
|
37 |
|
|
|
37 |
|
|
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
2,557 |
|
|
$ |
2,557 |
|
14
The following table reflects the change in the Company’s Level 3 liabilities, which consists of warrants, for the nine months ended September 30, 2021 (in thousands):
7. Accrued Expenses and other Current Liabilities
8. Term Debt
On April 1, 2021, the Company, as borrower, entered into the Loan and Security Agreement with Horizon, as lender and collateral agent for itself. The Loan and Security Agreement provides for four separate and independent $2.5 million term loans (Loan A, Loan B, Loan C, and Loan D), whereby, upon the satisfaction of all the conditions to the funding of the Term Loans, each Term Loan will be delivered by Horizon to the Company in the following manner: (i) Loan A was delivered by Horizon to the Company by April 1, 2021, (ii) Loan B was delivered by Horizon to the Company by April 1, 2021, (iii) Loan C was delivered by Horizon to the Company by June 30, 2021, and (iv) Loan D was delivered by Horizon to the Company by June 30, 2021. The Company may only use the proceeds of the Term Loans for working capital or general corporate purposes as contemplated by the Loan and Security Agreement. On April 1, 2021, the Company drew down $5 million. On June 22, 2021, the Company drew down another $5 million under this facility. The Company incurred $0.3 million of debt issuance costs and issued $0.3 million of warrants.
The term note matures on the 48-month anniversary following the funding date, therefore $5 million plus an additional fee of $0.2 million becomes due on April 1, 2025, and $5 million plus an additional fee of $0.2 million will become due on June 22, 2025. The principal balance the Term Loan bears a floating interest. The interest rate is calculated initially and, thereafter, each calendar month as the sum of (a) the per annum rate of interest from time to time published in The Wall Street Journal as contemplated by the Loan and Security Agreement, or any successor publication thereto, as the “prime rate” then in effect, plus (b) 6.25%; provided that, in the event such rate of interest is less than 3.25%, such rate shall be deemed to be 3.25% for purposes of calculating the interest rate. Interest is payable on a monthly basis based on each Term Loan principal amount outstanding the preceding month and at September 30, 2021 the rate applied was 9.5%.
The Company may, at its option upon at least five business days’ written notice to Horizon, prepay all or any portion of the outstanding Term Loan by simultaneously paying to Horizon an amount equal to (i) any accrued and unpaid interest on the outstanding principal balance of the Term Loan so prepaid; plus (ii) an amount equal to (A) if such Term Loan is prepaid on or before the Loan Amortization Date (as defined in the Loan and Security Agreement) applicable to such Term Loan, three percent of the then outstanding principal balance of such Term Loan, (B) if such Term Loan is prepaid after the Loan Amortization Date applicable to such Term Loan, but on or before the date
15
that is 12 months after such Loan Amortization Date, two percent of the then outstanding principal balance of such Term Loan, or (C) if such Term Loan is prepaid more than 12) months after the Loan Amortization Date applicable to such Term Loan, one percent of the then outstanding principal balance of such Term Loan; plus (iii) the outstanding principal balance of such Term Loan; plus (iv) all other sums, if any, that had become due and payable under the Loan and Security Agreement.
The Company’s debt obligation consisted of the following (in thousands)
|
Term Debt |
|
|||||||
|
|
|
September 30,
|
|
|
December 31,
|
|
||
|
Term Loan A and B due April 2025 |
|
$ |
5,000 |
|
|
$ |
— |
|
|
Term Loan C and D due June 2025 |
|
|
5,000 |
|
|
|
— |
|
|
Term debt |
|
|
10,000 |
|
|
|
— |
|
|
Less: Unamortized deferred issuance costs |
|
|
(216 |
) |
|
|
— |
|
|
Less: Warrant discount and interest |
|
|
(249 |
) |
|
|
— |
|
|
Total debt obligations- long term |
|
$ |
9,535 |
|
|
$ |
— |
|
9. Stockholders’ Equity
Common Stock
On March 30, 2021, the Company entered into a Sales Agreement with SVB Leerink with respect to an "at-the-market” (“ATM”) offering program under which the Company could offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.0001 per share, having an aggregate offering price of up to $50.0 million (the “Placement Shares”) through SVB Leerink as its sales agent.
Upon delivery of a placement notice in April 2021, and subject to the terms and conditions of the Sales Agreement, SVB Leerink began to sell the Placement Shares. Under the Sales Agreement, the Company agreed to pay SVB Leerink a commission equal to three percent of the gross sales proceeds of any Placement Shares, and also provided SVB Leerink with customary indemnification and contribution rights. For the three months ended June 30, 2021, the Company issued and sold 979,843 shares, for gross proceeds of $9.5 million, resulting in net proceeds of $9.2 million after deducting sales commissions. On May 6, 2021, the Company terminated the Sales Agreement.
On August 13, 2021, the Company entered into a new Sales Agreement (the “2021 Sales Agreement”) with SVB Leerink with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $50.0 million through SVB Leerink as its sales agent. As of September 30, 2021, Company had not offered or sold any common stock under the 2021 Sales Agreement.
On May 6, 2021, the Company entered into an underwriting agreement with SVB Leerink, as representative of the underwriters, relating to an underwritten public offering of 10.4 million shares of the Company’s common stock. The underwritten public offering resulted in gross proceeds of $73.1 million. The Company incurred $4.4 million in issuance costs and $0.5 million of professional fees associated with the underwritten public offering, resulting in net proceeds to the Company of $68.2 million.
Warrants
In connection with the entry into the Loan and Security Agreement (refer to Note 8), the Company has issued to Horizon warrants to purchase an aggregate number of shares of the Company’s common stock in an amount equal to $100,000 divided by the exercise price for each respective warrant. If at any time the Company files a registration statement relating to an offering for its own account, or the account of others, of any of its equity securities, the Company has agreed to include such number of shares underlying the warrants in such registration statement as requested by the holder. The warrants, which are exercisable for an aggregate of 42,236 shares, will be exercisable for a period of seven years at a per-share exercise price of $9.47, which is equal to the 10-day average closing price prior to January 15, 2021, the date on which the term sheet relating to the Loan and Security Agreement was entered
16
into, subject to certain adjustments as specified in the warrant. At September 30, 2021, there were 42,236 warrants outstanding.
10. Stock Option Plans
Incentive Plans
The Company maintains two equity incentive plans (the "Plans") that provide for the granting of stock options, share appreciation rights, restricted shares, restricted share units, performance share units and certain other share based awards as provided in the Plans to certain employees, members of the board of directors, consultants or other service providers of the Company, with a prescribed contractual term not to exceed ten years. As of September 30, 2021, there were 196,910 shares of common stock available for grant under the Plans. Awards granted under the Plans generally vest over a four-year period with 25% or 28% of the award vesting on the first anniversary of the commencement date and the balance vesting monthly over the remaining three years. Grants are generally awarded with a contractual terms of 10 years from the date of the grant. For certain senior members of management and directors, the board of directors approved an alternative vesting schedule. The share reserve under one of the Plans automatically increases on January 1st each year, in an amount equal to 4% of the total number of shares outstanding as of December 31 of the preceding year.
Stock option valuation
The fair value of stock option grants is estimated using the Black-Scholes option-pricing model with the following assumptions:
|
|
|
Black-Scholes Option-
|
|
|||||
|
|
|
September 30,
|
|
|
December 31,
|
|
||
|
Risk-free interest rate |
|
0.76%-0.86% |
|
|
0.17% – 0.42% |
|
||
|
Expected volatility |
|
|
92.9 |
% |
|
82.8%-98.3% |
|
|
|
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
|
Expected life (in years) |
|
|
5.1 |
|
|
|
5.1 |
|
The table below summarizes stock option activity under the Company’s stock option plans:
|
Stock Option Activity |
|
|||||||||||||||
|
|
|
Number of
|
|
|
Weighted
|
|
|
Weighted
|
|
|
Aggregate
|
|
||||
|
|
|
|
|
|
|
|
|
(in years) |
|
|
(in thousands) |
|
||||
|
Outstanding as of December 31, 2020 |
|
|
533,559 |
|
|
$ |
3.33 |
|
|
|
9.30 |
|
|
$ |
8,494 |
|
|
Granted |
|
|
624,986 |
|
|
|
7.76 |
|
|
|
8.99 |
|
|
|
(1,008 |
) |
|
Exercised |
|
|
(19,805 |
) |
|
|
0.12 |
|
|
|
8.15 |
|
|
|
500 |
|
|
Forfeited and expired |
|
|
(55,550 |
) |
|
|
5.98 |
|
|
|
9.38 |
|
|
|
157 |
|
|
Outstanding as of September 30, 2021 |
|
|
1,083,190 |
|
|
|
5.80 |
|
|
|
8.98 |
|
|
|
6,011 |
|
|
Options exercisable at September, 2021 |
|
|
232,626 |
|
|
|
5.86 |
|
|
|
8.26 |
|
|
|
2,801 |
|
17
The weighted average grant date fair value of options granted during the nine months ended September 30, 2021 and 2020 was $6.15 and $1.65 per share, respectively. The total fair value of options vested during the nine months ended September 30, 2021 and 2020 was $4.2 million and $4.4 million, respectively.
Restricted Stock Units
Time-Based Restricted Stock Units (RSU)
In February 2021, the Company issued 310,385 time-based RSUs to employees and directors under the Amended and Restated 2015 Plan. The weighted average grant date fair value of the time-based RSUs was $8.57 for the nine months ended September 30, 2021. The vesting for the time-based RSUs occurs either immediately, after one year or after four years. For the three and nine months ended September 30, 2021, the Company recognized approximately $0.4 million and $1.8 million in expenses related to the time-based RSUs.
The table below is a rollforward of all RSU activity under the Stock Incentive Plans The table below summarizes activity relating to RSUs for the nine months ended September 30, 2021:
|
RSU Activity |
|
|||||||
|
|
|
Restricted
|
|
|
Weighted-
|
|
||
|
Total nonvested units at December 31, 2020 |
|
|
69,749 |
|
|
$ |
11.73 |
|
|
Granted |
|
|
310,385 |
|
|
|
8.57 |
|
|
Vested |
|
|
(83,889 |
) |
|
|
9.34 |
|
|
Total nonvested units at September 30, 2021 |
|
|
296,245 |
|
|
$ |
9.10 |
|
Share-based Compensation
The Company recorded share-based compensation expense in the following expense categories for the three and nine months ended September 30, 2021 and 2020 of its consolidated statements of operations and comprehensive loss (in thousands):
|
Share-Based Compensation |
|
|||||||||||||||
|
|
|
For the Three Months
|
|
|
For the Nine Months
|
|
||||||||||
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
|
Research and development expenses |
|
$ |
1,115 |
|
|
$ |
1,135 |
|
|
$ |
4,197 |
|
|
$ |
1,682 |
|
|
General and administrative expenses |
|
|
400 |
|
|
|
59 |
|
|
|
1,357 |
|
|
|
517 |
|
|
|
|
$ |
1,515 |
|
|
$ |
1,194 |
|
|
$ |
5,554 |
|
|
$ |
2,199 |
|
At September 30, 2021, there was $4.4 million of unrecognized stock-based compensation expense relating to stock options granted pursuant to the Stock Incentive Plans, which will be recognized over the weighted-average remaining vesting period of 2.7 years.
At September 30, 2021, there was $1.5 million of unrecognized stock-based compensation expense relating to the time-based RSUs granted pursuant to the Stock Incentive Plans, which will be recognized over the weighted-average remaining vesting period of 3.0 years.
18
11. Significant Agreements
License and Collaboration agreements
For the nine months ended September 30, 2021 and 2020, the Company had License and Collaboration agreements (“LCAs”) with Denali, Ares and AstraZeneca. The following table summarizes the revenue recognized in the Company’s consolidated statements of operations and comprehensive loss from these arrangements (in thousands):
2019 License and collaboration agreement with Ares Trading S.A.
Summary
On May 13, 2019, the Company entered into a licensing and collaboration agreement ("2019 LCA") with Ares, pursuant to which the Company granted the option to enter into a worldwide, exclusive license to certain patents and know-how to develop, manufacture and commercialize two separate mAb2 antibody products that each contain a specific Fcab and a Fab target pair (each a licensed product).
For the exclusive rights granted in relation to the first molecule, an option fee of $11.1 million was paid by Ares to the Company. Following receipt of the option fee, Ares became responsible for the development of the molecule and development, regulatory and sales-based royalties become payable to Company upon achievement of specified events.
On July 15, 2020, a deed of amendment (the “2020 Amendment”) was entered into in respect of the 2019 LCA. The 2020 Amendment had two main purposes (i) to grant additional options to acquire intellectual property rights for a third and fourth molecule; and (ii) to allow Ares to exercise its option early to acquire intellectual property rights to the second molecule included in the 2019 LCA as well as to terminate the R&D services. An option fee of $8.5 million was paid by Ares to the Company on exercise of the option to acquire rights to the second molecule.
During March 2021 Ares paid an option fee of $2.7 million to acquire the rights to the third molecule.
As a result of the 2020 Amendment, the maximum amount payable by Ares on the achievement of certain development and regulatory milestones in the aggregate was increased to $473.9 million, and the maximum amount payable on the achievement of certain commercial milestones was increased to $292.3 million. In addition, to the extent that any product candidates covered by the exclusive licenses granted to Ares are commercialized, the Company will be entitled to receive a single digit royalty based on a percentage of net sales on a country-by-country basis.
Revenue recognition
Management has considered the performance obligations identified in the Ares LCA and concluded that the option for the grant of intellectual property rights is not distinct from the provision of R&D services, as the R&D services would significantly modify the early-stage intellectual property. As a result, the option for the grant of intellectual property rights and the provision of R&D services has been combined into a single performance obligation for each individual molecule included in the 2019 LCA. The Company recognized revenue using the cost-to-cost method, which it believes best depicted the transfer of control of the services to the customer. Under the cost-to-cost method, the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the identified performance obligation.
19
The total transaction price for the 2019 LCA, was initially determined to be $15.4 million, consisting of the upfront payment for the first molecule and research and development funding for the research term for the second molecule. Variable consideration to be paid to the company upon reaching certain milestones had been excluded from the calculation, as at the inception of the contract, it was not probable that a significant reversal of revenue recognized would not occur in a subsequent reporting period.
There were two components identified in the 2020 Amendment, each of which was accounted for as a separate performance obligation. The first component, the grant of the additional options to acquire intellectual property rights for the third and fourth molecule, was deemed to be distinct, as the customer can benefit from it on its own, and it is independent of the delivery of other performance obligations in the 2019 LCA. Additionally, as the amount of consideration reflects a standalone selling price, the Company determined that the second component is accounted for as a separate contract.
The second component, which allowed the customer to exercise its option to acquire intellectual property rights to the second molecule early, is considered to be a modification of the 2019 LCA. This is because the option is not independent of the R&D services provided under the 2019 LCA, and therefore the goods and services are not distinct. The Company updated the transaction price and measure of progress for the performance obligation relating to this molecule.
For the three and nine months ended September 30, 2020, $0.2 million and $1.5 million was recognized in relation to the first antibody included in the 2020 Amendment.
During the nine months ended September 30, 2021, Ares provided notice of its intention to exercise its option granted under the 2020 Amendment to acquire the intellectual property rights for an additional molecule and $2.7 million was recognized at a point in time in respect of the option exercise.
License and collaboration agreement with Denali Therapeutics, Inc.
Summary
In August 2016 the Company entered into an exclusive license and collaboration agreement (the “Denali LCA”) with Denali. Under the terms of the Denali LCA, Denali was granted the right to nominate up to three Fcab targets for approval (“Accepted Fcab Targets”), within the first three years of the date of the agreement. Upon entering into the Denali LCA, Denali had selected Transferrin receptor as the first Accepted Fcab Target and paid an upfront fee of $5.5 million to the Company. In May 2018, Denali exercised its right to nominate two additional Fcab targets and identified a second Accepted Fcab Target. Denali made a one-time payment to the F-star group for the two additional Accepted Fcab Targets of $6.0 million and extended the time period for its selection of the third Accepted Fcab Target until August 2020.
Under the terms of the agreement the Company is entitled to receive contingent payments that relate to certain defined preclinical, clinical, regulatory, and commercial milestones with a maximum value of $49.5 million.
Revenue recognition
The Company has considered the performance obligations identified in the contracts and concluded that the grant of intellectual property rights is not distinct from the provision of R&D services, as the R&D services are expected to significantly modify the early-stage intellectual property. As a result, the grant of intellectual property rights and the provision of R&D services has been combined into a single performance obligation for this contract.
The initial transaction price for first Accepted Fcab Target was deemed to be $7.1 million consisting of $5.0 million for the grant of intellectual property rights and $2.1 million for R&D services. The initial transaction price for the second Accepted Fcab target was $5.1 million, consisting of $3.0 million for the grant of intellectual property rights and $2.1 million for R&D services. During the year ended December 31, 2019, the transaction price for the first Accepted Fcab was increased to $6.6 million due to achievement of a $1.5 million milestone that on initial recognition of the Denali LCA was not included in the transaction price, as it was not deemed probable that a reversal would not occur in a future reporting period.
20
All performance obligations were deemed to have been fully satisfied during the year ended December 31, 2019 in respect of the first Accepted Fcab Target, and during the three months ended March 30, 2021 in respect of the second Accepted Fcab Target. As a result, no revenue was recognized in respect of these targets for the three months ended September 30, 2021. In respect of the second Accepted Fcab Target, for the nine months ended September 30, 2021 and 2020, the Company recognized $0.1 million and $1.1 million, respectively, and for the three months ended September 30, 2020, the Company recognized $0.5 million.
2021 Agreement with AstraZeneca
Summary
On July 7, 2021 the Company entered into a License Agreement with AstraZeneca AB. Under the terms of the agreement the Company has granted an exclusive license to certain patents and know-how to develop, manufacture and commercialize STING inhibitor compounds. AstraZeneca will be responsible for all future research, development and commercialization activities.
For the exclusive rights granted, an initial upfront fee of $0.5 million was paid by AstraZeneca to the Company during the three months ended September 2021. The Company is entitled to receive additional contingent near-term preclinical milestones of $11.5 million, plus maximum contingent payments that relate to certain defined development and regulatory milestones of $96.5 million and commercial milestones of $221.3 million, as well as royalty payments based upon a single digit percentage on net sales of products developed. Pursuant to the STING Antagonist CVR Agreement, 80% of net proceeds received the Company under the License Agreement with AstraZeneca will be payable, pursuant to the Exchange Agreement, to common stockholders of Spring Bank as of November 19, 2020, immediately prior to the Closing of the transaction.
Revenue recognition
Management has identified a single performance obligation in the contract, which is the grant of intellectual property rights.
The total transaction price was initially determined to be $0.5 million, consisting only of the upfront payment. Variable consideration to be paid to the company upon reaching certain milestones has been excluded from the calculation, as at the inception of the contract, it is not probable that a significant reversal of revenue recognized would not occur in a subsequent reporting period. The transaction price was allocated to the single performance obligation, which was deemed to be fully satisfied on the grant of intellectual property rights, and therefore the initial upfront fee was recognized at a point in time.
In the three and nine months ended September 30, 2021, the Company recorded revenue of $0.5 million in respect of this contract.
Summary of Contract Assets and Liabilities
Up-front payments and fees are recorded as deferred revenue upon receipt or when due until such time as the Company satisfies its performance obligations under these arrangements. A contract asset is a conditional right to consideration in exchange for goods or services that the Company has transferred to a customer. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional.
21
The following table presents changes in the balances of the Company’s contract liabilities (in thousands):
|
|
|
Deferred
|
|
|
Additions |
|
|
Revenue
|
|
|
Impact of
|
|
|
Deferred
|
|
|||||
|
Deferred revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
Ares collaboration |
|
$ |
37 |
|
|
$ |
— |
|
|
$ |
(37 |
) |
|
$ |
— |
|
|
$ |
— |
|
|
Denali collaboration |
|
|
263 |
|
|
|
— |
|
|
|
(117 |
) |
|
|
(146 |
) |
|
|
— |
|
|
Total deferred revenue |
|
$ |
300 |
|
|
$ |
— |
|
|
$ |
(154 |
) |
|
$ |
(146 |
) |
|
$ |
— |
|
During the nine months ended September 30, 2021, all revenue recognized by the Company as a result of changes in the contract liability balances in the respective periods was based on proportional performance.
12. Commitments and Contingencies
Lease Obligations
On January 27, 2021, the Company signed an operating lease for three years for its corporate headquarters in Cambridge, United Kingdom, which has approximately 2.3 years remaining. The Company also has leases for the former Spring Bank headquarters and laboratory space in Hopkinton, Massachusetts, which are being subleased. The Company’s leases have remaining lease terms of approximately 7.1 years for its former principal office and laboratory space, which includes an option to extend the lease for up to five years. The Company’s former locations are being subleased through the remainder of the lease term.
Operating lease costs under the leases for the nine months ended September 30, 2021, were approximately $0.8 million.
The following table summarizes the Company’s maturities of operating lease liabilities as of September 30, 2021 (in thousands):
|
Maturities of Operating Lease Liabilities |
|
|||
|
Periods |
|
|
|
|
|
For the period October 1, 2021 to December 31, 2021 |
|
$ |
242 |
|
|
2022 |
|
|
978 |
|
|
2023 |
|
|
990 |
|
|
2024 |
|
|
474 |
|
|
2025 |
|
|
486 |
|
|
Thereafter |
|
|
1,444 |
|
|
Total lease payments |
|
$ |
4,614 |
|
Sublease
The Company subleases the former Spring Bank offices in Hopkinton, Massachusetts. Operating sublease income under operating lease agreements for the nine months ended September 30, 2021, was $0.4 million. This sublease
22
has a remaining lease terms of 7.1 years. Future expected cash receipts from our sublease as of September 30, 2021, are as follows (in thousands):
|
Future Expected Cash Receipts From Sublease |
|
|||
|
Period |
|
|
|
|
|
For the period October 1, 2021 to December 31, 2021 |
|
$ |
56 |
|
|
2022 |
|
|
462 |
|
|
2023 |
|
|
474 |
|
|
2024 |
|
|
486 |
|
|
2025 |
|
|
498 |
|
|
Thereafter |
|
|
1,481 |
|
|
Total sublease receipts |
|
$ |
3,457 |
|
Service Agreements
As of September 30, 2021, the Company had contractual commitments of $2.6 million with a contract manufacturing organization (“CMO”) for activities that are ongoing or are scheduled to start between three and nine months of the date of the statement of financial position. Under the terms of the agreement with the CMO, the Company is committed to pay for some activities if those activities are cancelled up to three, six or nine months prior to the commencement date.
Contingent value rights
The acquisition-date fair value of the Contingent Value Rights ("CVR") liability represents the future payments that are contingent upon the achievement of sale or licensing for the STING product candidates. The fair value of the contingent value rights is based on the Company’s probability-weighted discounted cash flow assessment that considers probability and timing of future payments. The fair value measurement is based on significant Level 3 unobservable inputs such as the probability of achieving a sale or licensing agreement, anticipated timelines, and discount rate. The current liability of the CVR was $0.6 million and $2.1 million at September 30, 2021 and December 31, 2020, respectively. The long term liability of the CVR was $2.9 million and $0.4 million at September 30, 2021 and December 31, 2020, respectively. Changes in the fair value of the liability will be recognized in the consolidated statement of operations and comprehensive loss until settlement.
13. Subsequent Events
On October 19, 2021, the Company entered into a License and Collaboration Agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The agreement was facilitated by Johnson & Johnson Innovation. Under the terms of the agreement, F-star has granted Janssen a worldwide, exclusive royalty-bearing license to research, develop, and commercialize up to five novel bispecific antibodies directed to Janssen therapeutic targets using F-star’s proprietary Fcab™ and mAb2™ platforms. Janssen will be responsible for all research, development and commercialization activities under the agreement. Under the terms of the agreement F-star is entitled to receive upfront fees of $17.5 million with total potential income of up to $1.35 billion. F-star is also eligible to receive potential tiered mid-single digit royalties on annual net sales.
23
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following information should be read in conjunction with the unaudited financial information and the notes thereto included in this Quarterly Report on Form 10-Q and the consolidated financial statements and notes thereto for the year ended December 31, 2020, and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, contained in our Annual Report on Form 10-K filed with the SEC on March 30, 2021.
Our actual results and the timing of certain events may differ materially from the results discussed, projected, anticipated, or indicated in any forward-looking statements due to various important factors, risks and uncertainties, including, but not limited to, those set forth under “Forward-Looking Statements” included elsewhere in this Quarterly Report on Form 10-Q or under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 30, 2021, as may be updated by Part II, Item 1A, Risk Factors of our subsequently filed Quarterly Reports on Form 10-Q. We caution our readers that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from those expressed or implied by the forward-looking statements contained in this Quarterly Report on Form 10-Q.
We caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
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FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. In some cases, you can identify forward-looking statements by terms including, but not limited to, “may,” “likely,” “will,” “should,” “would,” “design,” “expect,” “seek,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions.
These forward-looking statements include, but are not limited to, statements about:
Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Factors that could cause actual results or events to differ materially from the forward-looking statements that we make include, but are not limited to, the following:
You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be
25
materially different from what we expect. You should also read carefully the factors described in “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the “SEC”) on March 30, 2021, to better understand the risks and uncertainties inherent in our business and underlying any forward-looking statements. You are advised, however, to consult any further disclosures we make on related subjects in our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, press releases, and our website. Any forward-looking statements that we make in this Quarterly Report on Form 10-Q speak only as of the date of this Quarterly Report on Form 10-Q, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect the occurrence of unanticipated events.
Overview
F-star Therapeutics, Inc. (collectively with its subsidiaries, “F-star” or the “Company”) is a clinical-stage biopharmaceutical company dedicated to developing next generation immunotherapies to transform the lives of patients with cancer. F-star is pioneering the use of tetravalent (2+2) bispecific antibodies to create a paradigm shift in cancer therapy. The Company has four second generation immuno-oncology ("IO") therapeutics in the clinic, each directed against some of the most promising IO targets in drug development, including LAG-3 and CD137. F-star’s proprietary antibody discovery platform is protected by an extensive IP estate. F-star has over 500 granted patents and pending patent applications relating to its platform technology and associated product pipeline. The Company has attracted multiple partnerships with biopharma targeting the significant unmet needs across several disease areas, including oncology, immunology, and CNS. F-star’s goal is to offer patients better and more durable benefits than currently available immuno-oncology treatments by developing medicines that seek to block tumor immune evasion. Through our proprietary tetravalent, bispecific natural antibody (mAb²™) format, our mission is to generate highly differentiated medicines with monoclonal antibody-like manufacturability, good safety and tolerability. With four distinct binding sites in a natural human antibody format, we believe that our proprietary technology will overcome many of the challenges facing current immuno-oncology therapies, due to the strong pharmacology enabled by tetravalent bispecific binding.
Our Programs
F-star’s most advanced product candidate, FS118, is currently being evaluated in a proof-of-concept Phase 2 trial in PD-1/PD-L1 acquired resistance head and neck cancer patients. FS118 is a tetravalent mAb2 bispecific antibody targeting two receptors, PD-L1 and LAG-3, both of which are validated targets in immuno-oncology. Phase 1 data from 43 heavily pre-treated patients with advanced cancer, who have failed PD-1/PD-L1 therapy, showed that administration of FS118 was well-tolerated with no dose limiting toxicities up to 20 mg/kg. In addition, a disease control rate (“DCR”), defined as either a complete response, partial response or stable disease, of 49% was observed in 39 evaluable patients receiving dose levels of FS118 of 1mg/kg or greater. In acquired resistance patients, DCR was 59% (16 out of 27 patients) and long-term (greater than six months) disease control was observed in six of these patients. We expect to provide an update from the proof-of-concept Phase 2 trial in PD-1/PD-L1 acquired resistance head and neck cancer patients in mid-2022. Recent data from an external randomized phase 3 trial in patients with previously untreated, locally advanced or metastatic melanoma provides clinical validation for the combination of LAG-3 and PD-1 inhibition. This clinical benefit in targeting PD-1 and LAG-3 gives us reason to believe that FS118 has potential to benefit patients not only with acquired resistance, but also in preventing resistance in patients receiving PD-1 monotherapy. We are initiating a clinical trial in checkpoint inhibitor (CPI) naïve patients in biomarker enriched non-small cell lung cancer (“NSCLC”) and diffuse large B cell lymphoma (“DLBCL”) populations in second half of 2021.
F-star’s second product candidate, FS120, aims to improve checkpoint inhibitor and chemotherapy outcomes and is a mAb2 bispecific antibody that is designed to bind to and stimulate OX40 and CD137, two proteins found on the surface of T cells that both function to enhance T cell activity. F-star is developing FS120 alone and in combination with PD-1/PD-L1 therapy for the treatment of tumors where PD-1/PD-L1 products are approved, and which have co-expression of OX40 and CD137 in the tumor microenvironment. F-star initiated a Phase 1 clinical trial in patients with advanced cancers in the fourth quarter of 2020 and has completed the accelerated dose titration phase during the fourth quarter of 2021. We are continuing further dose escalation to determine an optimal dosing regimen to initiate a combination of FS120 and the PD-1 inhibitor, pembrolizumab, in 2022. Pembrolizumab will be supplied under clinical trial collaboration and supply agreement with Merck & Co..
26
F-star’s third product candidate, FS222, aims to improve outcomes particularly in low PD-L1 expressing tumors and is a mAb2 bispecific antibody that is designed to target both the costimulatory CD137 and the inhibitory PD-L1 receptors, which are co-expressed in a number of tumor types. F-star initiated a Phase 1 clinical trial in patients with advanced cancers for FS222 in late 2020. We believe there is a strong rationale to combine FS222 with other anti-cancer agents, including targeted therapy and chemotherapy, and this can be done within the Phase 1 study. We expect to report an update on the current single agent dose escalation study in the fourth quarter of 2021.
SB 11285, which F-star acquired pursuant to a business combination with Spring Bank Pharmaceuticals, Inc. (“Spring Bank”), is a next generation cyclic dinucleotide STimulator of INterferon Gene (“STING”) agonist designed to improve checkpoint inhibition outcomes as an immunotherapeutic compound for the treatment of selected cancers. SB 11285 appeared to be well tolerated both alone and in combination with atezolizumab across all dose levels tested to-date, including five dose levels as monotherapy and three dose levels as a combination. Initial analysis showed that pharmacokinetics (PK) were in-line with the predicted profile for rapid cellular uptake, a characteristic of second generation STING agonists. F-star is continuing with further dose-escalation and in parallel pursuing strategic business development opportunities for SB 11285. We expect to report an update on this study in the second half of 2022.
Share Exchange Agreement
On November 20, 2020, the Company, formerly known as Spring Bank, completed a business combination (the “Transaction”) with F-star Therapeutics Limited (“F-star Ltd”) in accordance with the terms of the Share Exchange Agreement, dated July 29, 2020 (the “Exchange Agreement”), by and among the Company, F-star Ltd and certain holders of the capital stock and convertible notes of F-star Ltd (each a “Seller”, and collectively with holders of F-star Ltd securities who subsequently became parties to the Exchange Agreement, the “Sellers”). Pursuant to the Exchange Agreement, each ordinary share of F-star Ltd outstanding immediately prior to the closing of the Transaction (the “Closing”) was exchanged by the Sellers that owned such F-star Ltd shares for a number of duly authorized, validly issued, fully paid and non-assessable shares of Company common stock pursuant to an exchange ratio formula as set forth in the Exchange Agreement (the “Exchange Ratio”), rounded to the nearest whole share of Company common stock (after aggregating all fractional shares of Company common stock issuable to such Seller). Also, on November 20, 2020, in connection with, and prior to completion of, the Transaction, Spring Bank effected a 1-for-4 reverse stock split of its common stock (the “Reverse Stock Split”) and, following the completion of the Transaction, changed its name to F-star Therapeutics, Inc. Following the completion of the Transaction, the business of the Company became the business conducted by F-star, which is a clinical-stage immuno-oncology company focused on cancer treatment through its proprietary tetravalent bispecific antibody programs. Unless otherwise noted, all references to share amounts in this report reflect the Reverse Stock Split.
Under the terms of the Exchange Agreement, at the Closing, Spring Bank issued an aggregate of 4,620,618 shares of its common stock to F-star Ltd stockholders, based on an Exchange Ratio of 0.1125 shares of Spring Bank common stock for each F-star Ltd ordinary share, stock option and restricted stock unit (“RSU”) outstanding immediately prior to the Closing. The Exchange Ratio was determined through arms-length negotiations between Spring Bank and F-star Ltd pursuant to a formula set forth in the Exchange Agreement.
Pursuant to the Exchange Agreement, immediately prior to the Closing, certain investors in F-star Ltd purchased $15.0 million of F-star Ltd ordinary shares (the “Pre-Closing Financing”). These ordinary shares of F-star Ltd were then exchanged at the Closing for shares of the Company’s common stock in the Transaction at the Exchange Ratio.
Pursuant to the Exchange Agreement, all outstanding options to purchase Spring Bank common stock were accelerated immediately prior to the Closing and each outstanding option with an exercise price greater than the closing price of the stock on the Closing Date was exercised in full and all other outstanding options to purchase Company common stock were cancelled effective as of the Closing Date.
Immediately following the Reverse Stock Split and the Closing, there were approximately 4,449,559 shares of Spring Bank common stock outstanding. Following the Closing, the F-star Ltd stockholders beneficially owned approximately 53.7% of the combined company’s common stock, and the existing stockholders of Spring Bank beneficially owned approximately 46.3% of the combined company’s common stock. Concurrently with the execution of the Exchange Agreement, certain officers and directors of Spring Bank and F-star Ltd and certain
27
stockholders of F-star Ltd entered into lock-up agreements, pursuant to which they agreed to certain restrictions on transfers of any shares of the Company’s common stock for the 180-day period following the Closing, other than the shares of the Company’s common stock received in exchange for ordinary shares of F-star Ltd subscribed for in the Pre-Closing Financing and pursuant to certain other limited exceptions.
In addition, at the Closing, Spring Bank, F-star Ltd, a representative of Spring Bank stockholders prior to the Closing, and Computershare Trust Company N.A., as the Rights Agent, entered into a STING Agonist Contingent Value Rights Agreement (the “STING Agonist CVR Agreement”). Pursuant to the Exchange Agreement and the STING Agonist CVR Agreement, each pre-Reverse Stock Split share of Spring Bank common stock held by stockholders as of the record date on November 19, 2020, immediately prior to the Closing, received a dividend of one contingent value right (“CVR”) (“STING Agonist CVR”), payable on a pre-Reverse Stock Split basis, entitling such holders to receive, in connection with certain transactions involving proprietary STING agonist compound designated as SB 11285 occurring on or prior to the STING Agonist CVR Expiration Date (as defined below) that resulted in aggregate Net Proceeds (as defined in the STING Agonist CVR Agreement) at least equal to the Target Payment Amount (as defined below), an aggregate amount equal to the greater of (i) 25% of the Net Proceeds received from all CVR Transactions (as defined in the STING Agonist CVR Agreement) and (ii) an aggregate amount equal to the product of $1.00 and the total number of shares of Company common stock outstanding as of such record date (not to exceed an aggregate amount of $18.0 million) (the “Target Payment Amount”).
The CVR payment obligation expires on the later of 18 months following the Closing or the one-year anniversary of the date of the final database lock of the STING clinical trial (as defined in the STING Agonist CVR Agreement) (the “STING Agonist CVR Expiration Date”). The STING Agonist CVRs are not transferable, except in certain limited circumstances, are not certificated or evidenced by any instrument, do not accrue interest and are not registered with the SEC or listed for trading on any exchange. Until the STING Agonist CVR Expiration Date, subject to certain exceptions, the Company is required to use commercially reasonable efforts to (a) complete the STING Trial and (b) pursue a CVR Transaction. The STING Agonist CVR Agreement became effective upon the Closing and, unless terminated earlier in accordance with its terms, will continue in effect until the STING Agonist CVR Expiration Date the payment or all CVR payment amounts are paid pursuant to their terms.
At the Closing, Spring Bank, F-star Ltd, a representative of Spring Bank stockholders prior to the Closing, and Computershare Trust Company N.A., as the Rights Agent, also entered into a STING Antagonist Contingent Value Rights Agreement (the “STING Antagonist CVR Agreement”). Pursuant to the Exchange Agreement and the STING Antagonist CVR Agreement, each share of common stock held by Spring Bank stockholders as of November 19, 2020, immediately prior to the Closing, received a dividend of one CVR (“STING Antagonist CVR”) entitling such holders to receive, in connection with the execution of a potential development agreement (the “Approved Development Agreement”) and certain other transactions involving proprietary STING antagonist compound occurring on or prior to the STING Antagonist CVR Expiration Date (as defined below) equal to: 80% of all net proceeds (as defined in the STING Antagonist CVR Agreement) received by the Company after the Closing pursuant to (i) the Approved Development Agreement, if any, and (ii) all CVR Transactions (as defined in the STING Antagonist CVR Agreement) entered into prior to the STING Antagonist CVR Expiration Date.
The STING Antagonist CVRs are not transferable, except in certain limited circumstances, are not certificated or evidenced by any instrument, do not accrue interest, and are not registered with the SEC or listed for trading on any exchange. Until the STING Antagonist CVR Expiration Date, subject to certain exceptions, the Company is required to use commercially reasonable efforts to (a) consummate the Approved Development Agreement, (b) to perform the terms of the Approved Development Agreement and (c) pursue CVR Transactions. The STING Antagonist CVR Agreement became effective upon the Closing and, unless terminated earlier in accordance with its terms, will continue in effect until the STING Antagonist CVR Expiration Date or all CVR payment amounts are paid pursuant to their terms. On July 8, 2021, the Company entered into a License Agreement with AstraZeneca AB (“AstraZeneca”) under which AstraZeneca will receive global rights to research, develop and commercialize next generation STING inhibitor compounds. Under the terms of the agreement, AstraZeneca is granted exclusive access to and will be responsible for all future research, development and commercialization of the STING inhibitor compounds. F-star is eligible to receive upfront and near-term payments of up to $12 million upon meeting certain milestones. In addition, F-star will be eligible for development and sales milestone payments of over $300 million, as well as single digit percentage royalty payments. Payments received by F-star are subject to a contingent value
28
rights agreement (CVR 2), under which 80% will be payable to stockholders of F-star that were previously stockholders of Spring Bank prior to the business combination between F-star and Spring Bank.
The acquisition-date fair value of the CVR liability represents the future payments that are contingent upon the achievement of sale or licensing for the product candidates. The fair value of the contingent consideration acquired of $2.5 million as of December 31, 2020, and $3.5 million as of September 30, 2021, is based on the Company’s probability-weighted discounted cash flow assessment that considers probability and timing of future payments. The fair value measurement is based on significant Level 3 unobservable inputs such as the probability of achieving a sale or licensing agreement, anticipated timelines, and discount rate. Changes in the fair value of the liability will be recognized in the consolidated statement of operations and comprehensive loss until settlement. For the three months ended September 30, 2021, the estimated fair value increased to $3.5 million which resulted in a $0.4 million charge on the Consolidated Statements of Operations and Comprehensive Loss.
All issued and outstanding F-star Ltd share options granted under F-star’s three legacy equity incentive plans became exercisable in full immediately prior to the Closing. At the Closing, all issued share options and restricted stock units granted by F-star Ltd under the F-star Therapeutics Limited 2019 Equity Incentive Plan were replaced by options and awards on the same terms (including vesting), of the combined company’s common stock, based on the Exchange Ratio.
The Company’s common stock, which is listed on the Nasdaq Capital Market, traded through the close of business on Friday, November 20, 2020, under the ticker symbol “SBPH” and continued trading on the Nasdaq Capital Market, on a post-Reverse Stock Split adjusted basis, under the ticker symbol “FSTX” beginning on Monday, November 23, 2020. Commencing on November 23, 2020, the Company’s common stock was represented by a new CUSIP number, 30315R 107.
The Transaction was accounted for as a business combination using the acquisition method of accounting under the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 805, Business Combinations (“ASC 805”). The Transaction was accounted for as a reverse acquisition with F-star Ltd being deemed the acquiring company for accounting purposes. Under ASC 805, F-star Ltd as the accounting acquirer, recorded the assets acquired and liabilities assumed of Spring Bank in the Transaction at their fair values as of the acquisition date.
F-star Ltd was determined to be the accounting acquirer based on an analysis of the criteria outlined in ASC 805 and the facts and circumstances specific to the Transaction, including the fact that immediately following the Transaction: (1) F-star Ltd shareholders owned the majority of the voting rights of the combined company; (2) F-star Ltd designated a majority (five of eight) of the initial members of the board of directors of the combined company; and (3) F-star Ltd senior management held the key positions in senior management of the combined company. As a result, upon consummation of the Transaction, the historical financial statements of F-star Ltd became the historical financial statements of the combined organization.
Impact of COVID-19 on our Business
We continue to closely monitor the impact of the COVID-19 pandemic, including the emergence and spread of variants of COVID-19, on all aspects on our business, including how the pandemic continues to impact our employees, clinical trials, development programs, manufacturing supply, and other aspects of our operations. Overall, the global pandemic and consequent restrictions have resulted in a three to six-month delay in the operationalization of some aspects of our research and development operations. Specifically, by the way of example, patient enrollment in our FS118 Phase 2 trial has been somewhat slower than anticipated as a result of limited clinical trial staffing at certain study sites combined with some investigative sites inability to support remote site monitoring. While the COVID-19 pandemic did not have a material adverse effect on our reported results for the nine months ended September 30, 2021, we are unable to predict the ultimate impact that the pandemic may have on our business, future results of operations, financial position, or cash flows. The extent to which our operations may be impacted by the COVID-19 pandemic will depend largely on future developments, which are highly uncertain and cannot be accurately predicted, including new information which may emerge concerning the severity of the outbreak, including the emergence and spread of variants of COVID-19, such as the delta variant, and actions by government authorities to contain the outbreak.
29
Recent Developments
Subsequent Events
On October 19, 2021, the Company entered into a License and Collaboration Agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (“Janssen”). The agreement was facilitated by Johnson & Johnson Innovation. Under the terms of the agreement, F-star has granted Janssen a worldwide, exclusive royalty-bearing license to research, develop, and commercialize up to five novel bispecific antibodies directed to Janssen therapeutic targets using F-star’s proprietary Fcab™ and mAb2™ platforms. Janssen will be responsible for all research, development and commercialization activities under the agreement. Under the terms of the agreement, F-star is entitled to receive upfront fees of $17.5 million with total potential income of up to $1.35 billion. F-star is also eligible to receive potential tiered mid-single digit royalties on annual net sales.
Components of Operating Results
License revenue
To date, we have not generated any revenue from product sales, and we do not expect to generate any revenue from product sales for the foreseeable future. Our revenue consists of collaboration revenue under our license and collaboration agreements with Ares Trading S.A. (“Ares”), Denali Therapeutics, Inc. (“Denali”) and AstraZeneca, including amounts that are recognized related to upfront payments, milestone payments, option exercise payments, and amounts due to us for research and development services. In the future, revenue may include new collaboration agreements, additional milestone payments, option exercise payments, and royalties on any net product sales under our collaborations. We expect that any revenue we generate will fluctuate from period to period as a result of the timing and amount of license, research and development services, and milestone and other payments.
Operating Expenses
Research and development costs
Research and development costs are expensed as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries, share-based compensation and benefits, facilities costs and laboratory supplies, depreciation, amortization and impairment expense, manufacturing expenses and external costs of outside vendors engaged to conduct preclinical development activities and clinical trials as well as the cost of licensing technology. Typically, upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred, except for payments relating for intellectual property rights with future alternative use which will be expensed when the intellectual property is in use. Non-refundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
Those expenses associated with R&D and clinical costs primarily include:
30
The Company recognizes external R&D costs based on an evaluation of the progress to completion of specific tasks using information provided to it by its internal program managers and service providers.
Research and development activities are central to the Company’s business models. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later stage clinical trials. As a result, the Company expects that research and development expenses will increase over the next several years as the Company increases personnel costs, initiate and conduct additional clinical trials and prepare regulatory filings related to the various product candidates.
The successful development of our product candidates is highly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the remainder of the development of these product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from our product candidates. This is due to the numerous risks and uncertainties associated with developing products, including the uncertainty of:
A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, the U.S. Food and Drug Administration, European Medicines Agency or another regulatory authority may require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or we may experience significant trial delays due to patient enrolment or other reasons, in which case we would be required to expend significant additional financial resources and time on the completion of clinical development. In addition, we may obtain unexpected results from our clinical trials, and we may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and
31
uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success.
In September 2021, the Company identified an error in its accounting treatment for research and development expenses. This error resulted in an overstatement of research and development expenses for the first six months of 2021 and accrued expenses and other current liabilities as of March 31, 2021 and June 30, 2021. The Company assessed the materiality of this error on prior period financial statements in accordance with the SEC Staff Accounting Bulletin Number 99, Materiality, and ASC 250-10, Accounting Changes and Error Corrections. The Company determined that this error was not material to the financial statements of any prior interim period. To correct the immaterial misstatement, the Company decreased accumulated deficit by $0.3 million as of June 30, 2021.
General and administrative expenses
General and administrative expenses consist primarily of salaries, related benefits, travel, and share-based compensation expense for personnel in executive, finance, legal and administrative functions. General and administrative expenses also include facility-related costs, patent filing and prosecution costs, insurance and marketing costs and professional fees for legal, consulting, accounting, audit, tax services and costs associated with being a public company. Other expense also includes foreign currency transaction losses. The Company expects that general and administrative expenses will increase in the future as the Company expands its operating activities and incurs costs of being a US public company.
Other income and expenses, net
Other income and expenses, net, is primarily rent received from subletting an office in the United States and interest received on overdue trade receivable balances, bank interest received, and interest expense, which is primarily bank interest payable and similar charges, the interest liability on leased assets and convertible debt notes, changes in the fair value of CVR and foreign exchange losses incurred. Foreign exchange gain (loss) is foreign exchange gains or losses due to the fluctuation of the GBP, U.S. dollar and/or the Euro. Change in the fair value of convertible debt is the fair value adjustment of the convertible notes as measured using level 3 inputs which was converted on November 20, 2020, with the transaction with Spring Bank.
Income tax
The Company is subject to corporate taxation in the United States, United Kingdom and Austria.
Our UK established entities have generated losses and some profits in the United Kingdom since inception and have therefore not paid significant UK corporation tax. Our Austrian subsidiary has historical losses in Austria with more recent profits, which has resulted in payment of Austrian corporation tax in the years ended December 31, 2020, and 2019. The corporation tax benefit (tax) presented in the Company’s statements of comprehensive income (loss) represents the tax impact from its operating activities in the United States, United Kingdom and Austria, which have generated taxable income in certain periods. As the entities located in the United Kingdom carry out extensive research and development activities, they seek to benefit from the UK research and development tax credit cash rebate regime known as the Small and Medium-sized Enterprises R&D Tax Credit Program (the “SME Program”). Qualifying expenditures largely comprise employment costs for research staff, consumables expenses incurred under agreements with third parties that conduct research and development, preclinical activities, clinical activities and manufacturing on the Company’s behalf and certain internal overhead costs incurred as part of research projects.
The tax credit received in the United Kingdom pursuant to the SME Program permits companies to deduct an extra 130% of their qualifying costs from their yearly profit or loss, as well as the normal 100% deduction, to make a total 230% deduction. If the company is incurring losses, it is entitled to claim a tax credit worth up to 14.5% of the surrenderable loss. To qualify for relief under the SME Program, companies are required to employ fewer than 500 staff and have a turnover of under €100.0 million or a balance sheet total of less than €86.0 million.
32
Research and development tax credits received in the United Kingdom are recorded as a reduction in research and development expenses. The UK research and development tax credit is payable to companies after surrendering tax losses and is not dependent on current or future taxable income. As a result, it is not reflected as part of the income tax provision.
During the nine months ended September 30, 2021 the Company received $3.4 million in research and development tax credits related to the year ended December 31, 2020.
Income tax expense was not material for the three and nine months ended September 30, 2021.
Accrued Research and Development Expenses
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated costs incurred for the services when we have not yet been invoiced or otherwise notified of the actual costs. The majority of our service providers invoice us in arrears for services performed, on a predetermined schedule or when contractual milestones are met; however, some require advanced payments. We make estimates of our accrued expenses as of each balance sheet date in our consolidated financial statements based on facts and circumstances known to us at that time. Examples of estimated accrued research and development expenses include fees paid to:
We base our expenses related to preclinical studies and clinical trials on our estimates of the services received and efforts expended pursuant to quotes and contracts with multiple CROs that conduct and manage clinical trials on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, we estimate the time period over which services will be performed, enrollment of patients, number of sites activated and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or amount of prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low in any particular period. To date, we have not made any material adjustments to our prior estimates of accrued research and development expenses.
Contingent value rights
The acquisition-date fair value of the CVR liability represents the future payments that are contingent upon the achievement of sale or licensing for the STING product candidates. The fair value of the contingent value rights is based on the Company’s probability-weighted discounted cash flow assessment that considers probability and timing of future payments. The fair value measurement is based on significant Level 3 unobservable inputs such as the probability of achieving a sale or licensing agreement, anticipated timelines, and discount rate. Changes in the fair value of the liability will be recognized in the consolidated statement of operations and comprehensive loss until settlement.
33
Share-based compensation
The Company accounts for share-based compensation in accordance with ASC 718, “Compensation – Stock Compensation” (“ASC 718”). ASC 718 requires companies to estimate the fair value of equity-based payment awards on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service period in the Company’s consolidated statements of operations and comprehensive loss.
The Company records the expense for option awards using a graded vesting method. The Company accounts for forfeitures as they occur. For share-based awards granted to non-employee consultants, the measurement date is the date of grant. The compensation expense is then recognized over the requisite service period, which is the vesting period of the respective award.
The fair value of stock options (“options”) on the grant date is determined utilizing the Black-Scholes option-pricing model using the single-option approach. The Black-Scholes option pricing model requires the use of highly subjective and complex assumptions, including an option’s expected term and the price volatility of the underlying stock, to determine the fair value of the award.
The Company classifies share-based compensation expense in its consolidated statements of operations and comprehensive loss Income in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.
Results of Operations
Comparison of the three months ended September 30, 2021 and 2020
The table below summarizes our results of operations for the three months ended September 30, 2021 and 2020 :
|
|
|
Three Months Ended September 30, |
|
|||||||||
|
|
|
2021 |
|
|
2020 |
|
|
Change |
|
|||
|
|
|
(in thousands) |
|
|||||||||
|
Statements of Comprehensive Income |
|
|
|
|
|
|
|
|
|
|||
|
License revenue |
|
$ |
751 |
|
|
$ |
9,195 |
|
|
$ |
(8,444 |
) |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
|
Research and development |
|
|
5,113 |
|
|
|
5,321 |
|
|
|
(208 |
) |
|
General and administrative |
|
|
5,239 |
|
|
|
7,261 |
|
|
|
(2,022 |
) |
|
Total operating expenses |
|
$ |
10,352 |
|
|
$ |
12,582 |
|
|
$ |
(2,230 |
) |
|
Loss from operations |
|
|
(9,601 |
) |
|
|
(3,387 |
) |
|
|
(6,214 |
) |
|
Other non-operating income (expense): |
|
|
|
|
|
|
|
|
|
|||
|
Other income (expense) |
|
|
(746 |
) |
|
|
506 |
|
|
|
(1,252 |
) |
|
Change in fair value of convertible notes |
|
|
— |
|
|
|
(446 |
) |
|
|
446 |
|
|
Change in fair value of liability |
|
|
(444 |
) |
|
|
— |
|
|
|
(444 |
) |
|
Loss before income taxes |
|
|
(10,791 |
) |
|
|
(3,327 |
) |
|
|
(7,464 |
) |
|
(Loss) benefit for income taxes |
|
|
— |
|
|
|
(124 |
) |
|
|
124 |
|
|
Net loss |
|
$ |
(10,791 |
) |
|
$ |
(3,451 |
) |
|
$ |
(7,340 |
) |
Licensing and Research & Development Services Revenue
Revenue for the three months ended September 30, 2021 was $0.8 million compared to $9.2 million for the three months ended September 30, 2020, a decrease of approximately $8.4 million. This $8.4 million decrease is due primarily to a reduction of $7.7 million of licensing revenue and a $0.7 million reduction in R&D services revenue.
Research and development costs
Total Research and development expenses were $5.1 million for the three months ended September 30, 2021, as compared to $5.3 million for the prior year's third quarter. This $0.2 million decrease for the three months ended September 30, 2021, was due to an increase in clinical CRO costs of $1.6 million, due to a full quarter of Phase 1
34
clinical trial costs for FS120 and FS222 and SB11285 in 2021, a $0.9 million increase in R&D staff related costs, and $0.3 million in lab consumables, all offset by a $2.3 million reduction in the UK R&D tax credit, and decreases in manufacturing costs of $0.4 million and other allocated costs of $0.3 million.
General and administrative expense
General and administrative expense for the three months ended September 30, 2021, decreased by approximately $2.0 million over the prior comparable quarter, primarily due to a decrease in legal and professional costs of $2.6 million, due to costs incurred in the comparative period in preparation for the share exchange transaction with Spring Bank, and a decrease in staff costs of $0.6 million, offset by increases in insurance costs of $0.5 million, rent and repairs of $0.5 million, primarily due to the leased buildings acquired in the Spring Bank transaction, and other administrative costs of $0.2 million.
Other income (expenses)
Other income (expense) for the three months ended September 30, 2021, consisted primarily of rental income of $0.2 million offset by foreign exchange losses of $0.6 million and interest expense on the term debt of $0.3 million. In addition, there was a loss of $0.4 million for the change in fair value of the CVR liability.
For the three months ended September 30, 2020, the total expense of $0.5 million consisted of other income of $0.8 million of foreign currency gains offset by $0.3 million of interest related to the convertible notes.
A gain of $0.4 million was recorded in relation to a fair value adjustment for the convertible notes.
Comparison of the nine months ended September 30, 2021 and 2020
The table below summarizes our results of operations for the nine months ended September 30, 2021 and 2020 :
|
|
|
Nine Months Ended September 30, |
|
|||||||||
|
|
|
2021 |
|
|
2020 |
|
|
Change |
|
|||
|
|
|
(in thousands) |
|
|||||||||
|
Statements of Comprehensive Income |
|
|
|
|
|
|
|
|
|
|||
|
License revenue |
|
$ |
3,668 |
|
|
$ |
11,093 |
|
|
$ |
(7,425 |
) |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
|
Research and development |
|
|
20,536 |
|
|
|
10,695 |
|
|
|
9,841 |
|
|
General and administrative |
|
|
18,169 |
|
|
|
13,805 |
|
|
|
4,364 |
|
|
Total operating expenses |
|
$ |
38,705 |
|
|
$ |
24,500 |
|
|
$ |
14,205 |
|
|
Loss from operations |
|
|
(35,037 |
) |
|
|
(13,407 |
) |
|
|
(21,630 |
) |
|
Other non-operating income (expense): |
|
|
|
|
|
|
|
|
|
|||
|
Other income (expense) |
|
|
230 |
|
|
|
(1,164 |
) |
|
|
1,394 |
|
|
Change in fair value of convertible notes |
|
|
— |
|
|
|
(2,330 |
) |
|
|
2,330 |
|
|
Change in fair value of liability |
|
|
(1,027 |
) |
|
|
— |
|
|
|
(1,027 |
) |
|
Loss before income taxes |
|
|
(35,834 |
) |
|
|
(16,901 |
) |
|
|
(18,933 |
) |
|
(Loss) benefit for income taxes |
|
|
(190 |
) |
|
|
(171 |
) |
|
|
(19 |
) |
|
Net loss |
|
$ |
(36,024 |
) |
|
$ |
(17,072 |
) |
|
$ |
(18,952 |
) |
Licensing and Research & Development Services Revenue
Revenue for the nine months ended September 30, 2021, was $3.7 million compared with $11.1 million for the nine months ended September 30, 2020, a decrease of $7.4 million.
Revenue from contracts with Ares decreased by $7.1 million due to a reduction in licensing revenue and R&D services revenue.
35
In addition, there was a $1.0 million decrease relating to licensing and R&D services revenue with Denali. All performance obligations relating to this Denali contract were satisfied in February 2021.
These were offset by $0.5 million in revenue related to the license agreement with AstraZeneca executed in July 2021 and $0.2 million in other revenue.
Research and development costs
Costs related to research and development for the nine months ended September 30, 2021 was $20.5 million, an increase of approximately $9.8 million, compared to $10.7 million for the nine months ended September 30, 2020.
This $9.8 million increase for the nine months ended September 30, 2021, was primarily due to increases in clinical CRO and clinical assay costs of $4.7 million, due to a full nine months of Phase 1 clinical trial costs for FS120 and FS222 and SB11285, a $3.0 million increase in manufacturing costs, $0.9 million in R&D staff costs, $0.8 million in share-based compensation expense, $0.5 million in laboratory consumables, and a $0.4 million decrease in the UK R&D tax incentive credit (which is recorded as a credit against R&D expenditure), offset by a decrease of $0.3 million in allocated costs and a decrease in other R&D costs of $0.2 million, due to the timing of other project-related activities.
General and administrative expense
General and administrative expense for the nine months ended September 30, 2021 was $18.2 million, an increase of approximately $4.4 million, compared to $13.8 million for the nine months ended September 30, 2020.This increase was primarily due to $2.5 million in share-based compensation expense, $1.5 million in insurance and other costs of being a public company, $0.4 million in legal and professional fees, $0.3 million in IT costs and $0.6 million in rent and repairs, primarily related to the leased buildings acquired in the Spring Bank transaction. These increases were offset by a decrease in staff costs of $0.9 million.
Other income (expenses)
Other income for the nine months ended September 30, 2021 of $0.2 million consisted of $0.5 million of other income relating to sub-lease rental income, a foreign exchange gain of $0.2 million, offset by interest payable on the term debt facility of $0.5 million.
In addition, there was an expense of $1.0 million for the change in fair value of the CVR.
For the nine months ended September 30, 2020, other expense of $1.2 million consisted of foreign currency losses of $0.9 million, interest expense of $0.8 million in relation to the convertible debt, offset by other income of $0.5 million from the UK government Coronavirus Job Retention Scheme, for staff that were furloughed in the first half of 2020.
In addition, a fair value adjustment in respect of the convertible debt of $2.3 million was recorded.
Liquidity and Capital Resources
Sources of liquidity
From our inception through September 30, 2021, we have not generated any revenue from product sales, and we have incurred significant operating losses and negative cash flows from our operations. We do not expect to generate significant revenue from sales of any products for several years, if at all.
As of September 30, 2021, the Company had an accumulated deficit of $83.2 million, cash of $71.1 million and working capital of $67.3 million. The future success of the Company is dependent on its ability to successfully obtain additional working capital, obtain regulatory approval for and successfully launch and commercialize its product candidates and to ultimately attain profitable operations. As of November 10, 2021 the Company’s cash and
36
cash equivalents on hand will be sufficient to fund its current operating plan and planned capital expenditures for at least the next 12 months.
Historically, we have financed our operations with proceeds from the sale and issuance of equity securities, proceeds from the issuance of notes payable and proceeds received in connection with our collaboration arrangements and for providing research and development services. We expect this historical financing trend to continue if and until we are able obtain regulatory approval for and successfully commercialize one or more of our drug candidates, although there can be no assurance that we will obtain regulatory approval or successfully commercialize any of our current or planned future product candidates.
On March 30, 2021, the Company entered into a Sales Agreement with SVB Leerink LLC ("SVB Leerink") with respect to an at-the-market offering program under which the Company could offer and sell, from time to time in its sole discretion, shares of its common stock, par value $0.0001 per share, having an aggregate offering price of up to $50.0 million through SVB Leerink as its sales agent. As of May 6, 2021, the Company had issued and sold 979,843 shares, for gross proceeds of $9.5 million, resulting in net proceeds of $9.2 million after deducting sales commissions. On May 6, 2021, the Company terminated the Sales Agreement.
On August 13, 2021, the Company entered into a new Sales Agreement (the “2021 Sales Agreement”) with SVB Leerink with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $50.0 million through SVB Leerink as its sales agent. As of September 30, 2021 Company had not offered or sold any common stock under the 2021 Sales Agreement.
On May 6, 2021, the Company entered into an underwriting agreement with SVB Leerink, as representative of the underwriters, relating to an underwritten public offering of 10.4 million shares of the Company’s common stock, par value $0.0001 per share. The underwritten public offering resulted in gross proceeds of $73.1 million. The Company incurred $4.4 million in issuance costs and $0.5 million of professional fees associated with the underwritten public offering, resulting in net proceeds to the Company of $68.2 million.
On April 1, 2021, the Company, as borrower, entered into the Loan and Security Agreement with Horizon, as lender and collateral agent for itself. The Loan and Security Agreement provides for four (4) separate and independent $2.5 million term loans (Loan A, Loan B, Loan C, and Loan D), whereby, upon the satisfaction of all the conditions to the funding of the Term Loans, each Term Loan will be delivered by Horizon to the Company in the following manner: (i) Loan A was delivered by Horizon to the Company by April 1, 2021, (ii) Loan B was delivered by Horizon to the Company by April 1, 2021, (iii) Loan C was delivered by Horizon to the Company by June 30, 2021, and (iv) Loan D was delivered by Horizon to the Company by June 30, 2021. The Company may only use the proceeds of the Term Loans for working capital or general corporate purposes as contemplated by the Loan and Security Agreement. On April 1, 2021, the Company drew down $5 million. On June 22, 2021, the Company drew down another $5 million under this facility.
Cash Flows
The following table summarizes our cash flows for each of the periods presented:
|
Summarized cash flow information |
|
|||||||||||
|
|
|
Nine Months Ended September 30, |
|
|||||||||
|
|
|
2021 |
|
|
2020 |
|
|
Change |
|
|||
|
|
|
(in thousands) |
|
|||||||||
|
Net cash used in operating activities |
|
$ |
(34,048 |
) |
|
|
(118 |
) |
|
$ |
(33,930 |
) |
|
Net cash used in investing activities |
|
|
(643 |
) |
|
|
(50 |
) |
|
|
(593 |
) |
|
Net cash provided by financing activities |
|
|
87,048 |
|
|
|
850 |
|
|
|
86,198 |
|
|
Effect of exchange rate changes on cash |
|
|
167 |
|
|
|
(56 |
) |
|
|
223 |
|
|
Net increase in cash |
|
$ |
52,524 |
|
|
$ |
626 |
|
|
$ |
51,898 |
|
37
Operating activities
Net cash used of $34.0 million in operating activities for the nine months ended September 30, 2021, consisted of the net loss of $36.0 million adjusted for changes in operating assets and liabilities of $5.1 million and offset by non-cash charges of $7.1 million, primarily for share-based compensation expense of $5.6 million, fair value adjustment of the CVR liability of $1.0 million, depreciation and amortization of $0.5 million, non-cash interest expense of $0.1 million, offset by foreign exchange gains of $0.1 million.
Net cash used of $0.1 million in operating activities for the nine months ended September 30, 2020, was primarily due to a net loss of $17.1 million offset by changes in operating assets and liabilities of $9.8 million and non-cash charges of $7.2 million. The non-cash charges included share-based compensation of $2.2 million, foreign exchange losses of $1.0 million, depreciation of $0.9 million, non-cash interest expense of $0.8 million relating to the convertible notes and changes in fair value of convertible notes of $2.3 million.
Investing activities
For the nine months ended September 30, 2021 and 2020, net cash used in investing activities was $0.6 million and $0.1 million, respectively. In both periods this related to the purchase of capital equipment.
Financing activities
For the nine months ended September 30, 2021, net cash provided by financing activities was $87.0 million. This included $77.3 million raised on the issue of common stock, with $9.1 million of the total generated from the “at the market” offering and $68.2 million generated from the underwritten public offering, offset by $0.5 million legal fees in connection with the offering. In addition, we received net proceeds of $9.8 million from the Loan and Security Agreement with Horizon and third-party debt issuance costs of $0.1 million were paid.
For the nine months ended September 30, 2020, net cash provided by financing activities was $0.9 million, which was generated from the issuance of convertible notes.
Future Funding Requirements
The Company has incurred significant losses and has an accumulated deficit of $83.2 million as of September 30, 2021. F-star expects to incur substantial losses in the foreseeable future as it conducts and expands its clinical trial and research and development activities. As of November 10, 2021 the Company’s cash and cash equivalents on hand will be sufficient to fund its current operating plan and planned capital expenditures for at least the next 12 months.
The Company may continue to seek additional working capital through the sale and issuance of equity securities, debt financing, collaboration arrangements or other sources. There are no assurances, however, that the Company will be successful in raising additional working capital, or if it is able to raise additional working capital, it may be unable to do so on commercially favorable terms. The Company’s failure to raise additional capital or enter into other financing arrangements if and when needed would have an adverse impact on its business, results of operations and financial condition and its ability to develop its product candidates.
Our future capital requirements will depend on many factors, including:
38
Critical Accounting Policies and Significant Judgments and Estimates
Our condensed consolidated financial statements are prepared in accordance with U.S. GAAP and the rules and regulations of the SEC for interim financial statements. The preparation of our condensed consolidated financial statements and related disclosures requires our management to make estimates and assumptions that affect the reported amount of assets, liabilities, revenue, costs and expenses and related disclosures. We believe that the estimates and assumptions underlying the accounting policies described therein may have the greatest potential impact on our consolidated financial statements and, therefore, consider these to be our critical accounting policies. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these current estimates based on different assumptions and under different conditions. There have been no material changes to the Company’s critical accounting policies and estimates as disclosed in the Company’s Annual Report filed on SEC Form 10-K for the year ended December 31, 2020, filed with the SEC on March 30, 2021.
Contractual Obligations and Commitments
We enter into contracts in the normal course of business with third-party service providers for clinical trials, preclinical research studies and testing, manufacturing and other services and products for operating purposes. We have not included our payment obligations under these contracts as these contracts generally provide for termination upon notice, and therefore, we believe that our non-cancelable obligations under these agreements are not material, and we cannot reasonably estimate the timing of if and when they will occur. We could also enter into additional research, manufacturing, supplier and other agreements in the future, which may require up-front payments and even long-term commitments of cash.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Emerging Growth Company and Smaller Reporting Company Status
We are an emerging growth company, (“EGC”) as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). We will remain an EGC until the earlier of (1) the last day of the fiscal year following the fifth anniversary of the completion of our initial public offering (December 31, 2021), (2) the last day of the fiscal year in which we have total annual gross revenue of at least $1.07 billion, (3) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which would occur if the market value of our ordinary shares held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such fiscal year or (4) the date on
39
which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. The JOBS Act permits an EGC to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have irrevocably elected to “opt out” of this provision and, as a result, we will comply with new or revised accounting standards when they are required to be adopted by public companies that are not emerging growth companies. In addition, we intend to rely on the other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, we are entitled to rely on certain exemptions as an EGC we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b), (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that has or may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis), and (iv) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the chief executive officer’s compensation to median employee compensation. These exemptions will apply for a period of five years following the completion of Spring Bank’s initial public offering (December 31, 2021) or until we no longer meet the requirements of being an EGC, whichever is earlier.
We are also a smaller reporting company as defined under the Exchange Act. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company, as defined in Rule 12b-2 under the Exchange Act for this reporting period and are not required to provide the information required under this item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
As of September 30, 2021, our management, under the supervision of our Chief Executive Officer and Chief Financial Officer, performed an evaluation of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified by the SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer determined the material weaknesses in our internal controls as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2020, as described below, our disclosure controls and procedures were not effective as of September 30, 2021.
Management’s Annual Report on Internal Control over Financial Reporting
We have performed an evaluation of the effectiveness of our internal control over financial reporting, based on criteria established by the Committee of Sponsoring Organizations of the Treadway Commission in its 2013 Internal Control-Integrated Framework. Based on that evaluation, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our internal control over financial reporting was not effective as of September 30, 2021, due to material weaknesses in internal control over financial reporting, associated with (i) the lack of formal policies and procedures and sufficient complement of personnel to implement effective segregation of duties and (ii) the lack of sufficient formality and evidence of controls over key reports, contracts and spreadsheets.
40
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be prevented or detected on a timely basis.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Projections of any evaluation of effectiveness to future years are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
As an EGC under the JOBS Act, we are exempt from the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002.
Remediation Plans
As discussed above, the material weaknesses over effective controls on the financial statement close and reporting process as well as lack of an effective control environment with formal processes and procedures and not having sufficient formality and evidence of controls as of December 31, 2020, were not fully remediated as of September 30, 2021. We have commenced measures to remediate these material weaknesses and have hired additional finance and accounting personnel with appropriate expertise to perform specific functions which we believe will allow for proper segregation of duties, design key controls and implement improved processes and internal controls. We will continue to assess our finance and accounting staffing needs to ensure remediation of these material weaknesses. The material weaknesses will not be considered remediated until the applicable remedial controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the three months ended September 30, 2021, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
41
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not presently a party to any material litigation.
Item 1A. Risk Factors.
In addition to the other information set forth in this report, you should carefully consider the risk factors discussed in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with the SEC on March 30, 2021, which could materially affect our business, financial condition, or results of operations. Except as disclosed below, there have been no material changes to the risk factors described in our Annual Report on Form 10-K filed with the SEC on March 30, 2021, as updated by “Part II, Item 1A, Risk Factors” of our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2021 and June 30, 2021, filed with the SEC on May 17, 2021 and August 13, 2021, respectively.
Intellectual property rights of third parties could adversely affect our ability to commercialize our product candidates, such that we could be required to litigate or obtain licenses from third parties in order to develop or market our product candidates. Such litigation is costly and any required licenses may not be available on commercially reasonable terms.
Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts. Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. However, our research, development and commercialization activities may be subject to claims that we infringe or otherwise violate patents or other intellectual property rights owned or controlled by third parties. There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, derivation proceedings, oppositions and inter partes reexamination proceedings before the USPTO, and corresponding foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are pursuing development candidates.
In particular, we are aware of a “method of use” patent issued in 2021 in the United States to E.R. Squibb & Sons, L.L.C. that expires in 2029, subject to the timely payment of maintenance fees and absent any patent term extension, and which includes claims directed to a method for treating cancer in a subject comprising administering to the subject an anti-LAG-3 antibody and an anti-PD-L1 antibody, which antibodies are specified in a subclaim as being in a bispecific molecule. We believe, based on our review of this U.S. patent, that the patent claims are impermissibly broad and that there would be strong arguments available to us should we decide to challenge its validity in court or USPTO post-grant proceedings, based on prior art and lack of written description and enablement for the entire scope of the claims. If we succeed in developing and obtaining regulatory approval to market our product candidate FS118 in the future, this patent, prior to its expiration, could impact our commercial plans for FS118 in the United States. We do not expect the patent to have any impact on commercialization of FS118 outside of the United States, and we do not expect the patent to impact our pre-commercial development of FS118 inside or outside of the United States. We are also aware of a “second medical use” patent issued in 2021 in Europe to Bristol-Myers Squibb Company, which includes claims protecting until 2036 (subject to the timely payment of annual renewal fees and absent any supplementary protection certificates based on the patent) an anti-PD-1 or anti-PD-L1 antibody that inhibits PD-1 activity for use in a method for treating a subject identified as HPV positive and afflicted with a tumor derived from a HPV positive squamous cell carcinoma head and neck cancer, the method comprising administering to the subject a therapeutically effective amount of the antibody. Multiple parties, including Regeneron Pharmaceuticals, Inc. and Merck Sharp and Dohme Corp, have filed oppositions at the European Patent Office challenging the validity of this European patent. We believe, based on our review of this European patent and the oppositions that have been filed, that there are strong grounds to argue that the patent is invalid due to lack of novelty and inventive step based on prior art as well as impermissible added matter and lack of sufficiency. If not revoked or amended to a form that poses no or a sufficiently reduced risk to our business, this patent, prior to its expiration, could impact our commercial plans for FS118 and FS222 in Europe, but we do not
42
expect the patent to impact our pre-commercial development efforts. Patent litigation is costly and time-consuming and there is no assurance that we would prevail, should we initiate or defend such litigation. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that we may be subject to claims of infringement of the patent rights of third parties.
Our competitive position may suffer if patents issued to third parties or other third-party intellectual property rights cover our products or product candidates or elements thereof, our manufacture or uses relevant to our development plans, the targets of our mAb2 product candidates, or other attributes of our mAb2 product candidates or our mAb2 technology. In such cases, we may not be in a position to develop or commercialize products or product candidates unless we successfully pursue litigation to nullify or invalidate the third-party intellectual property right concerned or enter into a license agreement with the intellectual property right holder, if available on commercially reasonable terms or at all.
It is also possible that we fail to identify relevant patents or patent applications. For example, certain U.S. applications filed after November 29, 2000 that will not be filed outside the United States may remain confidential until issuance of a patent. In general, patent applications in the United States and elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications relating to our products or platform technology could have been filed by others without our knowledge. Furthermore, we operate in a highly competitive field, and given our limited resources, it is unreasonable to monitor all patent applications purporting to gain broad coverage in the areas in which we are active. Additionally, pending patent applications which have been published can, subject to certain limitations, be later amended in a manner that could cover our platform technologies, our products or the use of our products.
Parties making claims of infringement against us or defending against our invalidity actions may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. If we fail in any such dispute, in addition to being forced to pay damages, we or our licensees may be temporarily or permanently prohibited from commercializing any of our product candidates that are held to be infringing. We might, if possible, also be forced to redesign product candidates so that we no longer infringe the third-party intellectual property rights. We may be required to seek a license to any such technology that we are found to infringe, which license may not be available on commercially reasonable terms, or at all. Even if we or our collaboration partners obtain a license, it may be non-exclusive; thereby giving our competitors access to the same technologies licensed to us or our licensors or collaboration partners. Moreover, such a license may require us to pay royalties to the licensor; thus, reducing our expected revenues. In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent in the United States. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.
In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, they could have a substantial adverse effect on our share price. Such litigation or proceedings could substantially increase our operating losses and reduce our resources available for development activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.
In addition, if the breadth or strength of protection provided by our or our collaboration partners’ patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
43
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures.
Not Applicable.
Item 5. Other Information.
None.
Item 6. Exhibits.
The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index set forth immediately prior to the signature page.
44
EXHIBIT INDEX
|
Exhibit Number
|
Description
|
|
|
|
|
10.1 |
|
|
|
|
|
10.2*± |
License Agreement between F-star Therapeutics, Inc. and Astrazeneca AB, dated as of July7, 2021. |
|
|
|
|
10.3*± |
|
|
|
|
|
31.1* |
|
|
|
99 |
|
31.2* |
|
|
|
;lk; |
|
32.1* |
|
|
|
|
|
32.2* |
|
|
|
|
|
101.INS |
Inline XBRL Instance Document |
|
|
|
|
101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
|
|
|
|
101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
|
|
101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
|
|
|
|
101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document |
|
|
|
|
101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
|
|
|
|
104 |
The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, has been formatted in Inline XBRL. |
|
* |
Filed herewith. |
|
± |
Certain confidential portions of this Exhibit were omitted by means of marking such portions with brackets (“[***]”) because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed. |
45
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
F-star Therapeutics, Inc. |
|||
|
|
|
|
|
||
|
Date: November 10 2021 |
|
By: |
/s/ Eliot R. Forster
|
||
|
|
|
|
Eliot R. Forster, Ph.D. |
||
|
|
|
|
President and Chief Executive Officer |
||
46
Exhibit 10.2
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
LICENSE AGREEMENT
between
F-STAR THERAPEUTICS, INC.
and
ASTRAZENECA AB
Dated as of 7 July 2021
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
TABLE OF CONTENTS
|
ARTICLE 1 DEFINITIONS |
3 |
|
ARTICLE 2 GRANT OF RIGHTS |
17 |
|
ARTICLE 3 DEVELOPMENT AND REGULATORY ACTIVITIES |
19 |
|
ARTICLE 4 COMMERCIALIZATION |
20 |
|
ARTICLE 5 PAYMENTS AND RECORDS |
21 |
|
ARTICLE 6 INTELLECTUAL PROPERTY |
29 |
|
ARTICLE 7 CONFIDENTIALITY AND NON-DISCLOSURE |
36 |
|
ARTICLE 8 REPRESENTATIONS AND WARRANTIES |
40 |
|
ARTICLE 9 INDEMNITY |
44 |
|
ARTICLE 10 TERM AND TERMINATION |
47 |
|
ARTICLE 11 MISCELLANEOUS |
51 |
SCHEDULES
Schedule 1.54 Licensed Compound
Schedule 1.56 Licensed Patents
Schedule 1.84 [***]
Schedule 2.5 Transition Plan
Schedule 3.1.2 Template Development Report
Schedule 7.5 Press Release
2
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
LICENSE AGREEMENT
This License Agreement (the “Agreement”) is made and entered into effective as of 7 July 2021 (the “Effective Date”) by and between F-STAR THERAPEUTICS, INC., a company incorporated under the laws of Delaware with registered number 4557165 and registered address at Eddeva B920, Babraham Research Campus, Cambridge CB22 3AT, United Kingdom (“Licensor”) and ASTRAZENECA AB, a company incorporated in Sweden under No. 556011-7482, whose registered office is registered at SE-151 85 Södertälje, Sweden and with offices at SE-431 83 Mölndal, Sweden (“AstraZeneca”). Licensor and AstraZeneca are sometimes referred to herein individually as a “Party” and, collectively, as the “Parties”.
RECITALS
WHEREAS, Licensor owns or controls certain intellectual property rights with respect to the Licensed Compounds (as defined herein) and Licensed Products (as defined herein) in the Territory (as defined herein); and
WHEREAS, Licensor wishes to grant to AstraZeneca, and AstraZeneca wishes to take, an exclusive license under such intellectual property rights to develop and commercialize Licensed Products in the Territory, in each case in accordance with the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
ARTICLE 1
DEFINITIONS
Unless otherwise specifically provided herein, the following terms shall have the following meanings:
1.1 “Affiliate” means, with respect to a Party, any Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” means: (i) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance or otherwise; or (ii) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).
1.2 “Agreement” has the meaning set forth in the preamble hereto.
3
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
1.3 “Anti-Corruption Laws” means the US Foreign Corrupt Practices Act, as amended, the UK Bribery Act 2010, as amended, and any other applicable anti-corruption laws and laws for the prevention of fraud, racketeering, money laundering or terrorism.
1.4 “Applicable Law” means applicable laws, rules and regulations, including any rules, regulations, guidelines or other requirements of the Regulatory Authorities, that may be in effect from time to time, which shall be deemed to include the applicable regulations and guidances of the FDA and the EMA (and national implementations thereof) that constitute good laboratory practices, good manufacturing practices and good clinical practices (and, if and as appropriate under the circumstances, International Conference on Harmonization (ICH) guidance or other comparable regulation and guidance of any applicable Regulatory Authority in the Territory).
1.5 “AstraZeneca” has the meaning set forth in the preamble hereto.
1.6 “AstraZeneca Know-How” means all Information Controlled by AstraZeneca or any of its Affiliates or its or their Sublicensees during the Term that is (a) developed by AstraZeneca or any of its Affiliates or its or their Sublicensees under this Agreement after the Effective Date and during the Term, (b) not generally known and (c) reasonably necessary for the Exploitation of a Licensed Compound, a Licensed Product or any Improvement with respect thereto, but excluding any Information to the extent covered or claimed by published AstraZeneca Patents.
1.7 “AstraZeneca Patents” means all of the Patents Controlled by AstraZeneca or any of its Affiliates or its or their Sublicensees during the Term (a) made or conceived by AstraZeneca or any its Affiliates or its or their Sublicensees under this Agreement after the Effective Date and during the Term and (b) that claim or cover or otherwise relate to a Licensed Compound, a Licensed Product, any Improvement with respect thereto or the Exploitation of any of the foregoing.
1.8 “Auditor” has the meaning set forth in Section 5.10.2.
1.9 “Authorized Generic Version” means, with respect to a pharmaceutical product, any other pharmaceutical product that (i) is sold under the Drug Approval Application for the first product or any supplement or amendment thereto; (ii) is sold under a different Trademark than the first product; and (iii) has a National Drug Code (NDC) number that differs from the NDC number for the first product (other than on a temporary basis as may be necessary to launch the second product in the Territory).
1.10 “Board of Directors” has the meaning set forth in Section 1.17.1.
1.11 “Breaching Party” has the meaning set forth in Section 10.2.1.
4
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
1.12 “Business Day” means a day other than a Saturday or Sunday or a day on which banking institutions in London, England, Stockholm, Sweden or New York, United States are permitted or required to be closed.
1.13 “Calendar Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 or October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date and the last Calendar Quarter shall end on the last day of the Term.
1.14 “Calendar Year” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.
1.15 [***].
1.16 “cGAS” means cyclic GMP-AMP synthase.
1.17 “Change of Control”, with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Effective Date:
1.17.1 any “person” or “group” (as such terms are defined below) (i) is or becomes the “beneficial owner” (as defined below, except that a “person” or “group” shall be deemed to have “beneficial ownership” of all shares of capital stock or other equity interests if such person or group has the right to acquire, whether such right is exercisable immediately or only after the passage of time), directly or indirectly, of shares of capital stock or other interests (including partnership interests) of such Party then outstanding and normally entitled (without regard to the occurrence of any contingency) to vote in the election of the directors, managers or similar supervisory positions (“Voting Stock”) of such Party representing fifty percent (50%) or more of the total voting power of all outstanding classes of Voting Stock of such Party or (ii) has the power, directly or indirectly, to elect a majority of the members of the Party’s board of directors or similar governing body (“Board of Directors”);
1.17.2 such Party enters into a merger, consolidation or similar transaction with another Person (whether or not such Party is the surviving entity) and as a result of such merger, consolidation or similar transaction (i) the members of the Board of Directors of such Party immediately prior to such transaction constitute less than a majority of the members of the Board of Directors of such Party or such surviving Person immediately following such transaction or (ii) the Persons that beneficially owned, directly or indirectly, the shares of Voting Stock of such Party immediately prior to such transaction cease to beneficially own, directly or indirectly, shares of Voting Stock of such Party representing at least a majority of the total voting power of all
5
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
outstanding classes of Voting Stock of the surviving Person in substantially the same proportions as their ownership of Voting Stock of such Party immediately prior to such transaction;
1.17.3 such Party sells or transfers to any Third Party, in one or more related transactions, properties or assets representing all or substantially all of such Party’s consolidated total assets to which this Agreement relates; or
1.17.4 the holders of capital stock of such Party approve a plan or proposal for the liquidation or dissolution of such Party.
For the purpose of this definition of Change of Control: (i) “person” and “group” have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934, as amended, and the term “group” includes any group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d-5(b)(1) under the aforesaid Act; (ii) a “beneficial owner” shall be determined in accordance with Rule 13d-3 under the aforesaid Act; and (iii) the terms “beneficially owned” and “beneficially own” shall have meanings correlative to that of “beneficial owner.”
1.18 “Combination Product” means a Licensed Product that is comprised of or contains a Licensed Compound as an active ingredient together with one (1) or more other active ingredients or Delivery Systems and is sold either as a fixed dose/unit or as separate doses/units in a single package.
1.19 “Commercialization” means any and all activities directed to the preparation for sale of, offering for sale of or sale of a Licensed Product, including activities related to marketing, promoting, distributing and importing such Licensed Product, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization and “Commercialized” has a corresponding meaning.
1.20 “Commercially Reasonable Efforts” means:
1.20.1 with respect to the Development and Commercialization activities in relation to [***], the carrying out of such activities using efforts and resources that AstraZeneca and its Affiliates would typically devote to carrying out such activities, acting in good faith, to compounds or products of similar market potential at a similar stage in development or product life, taking into account all scientific, commercial and other factors that AstraZeneca and its Affiliates would typically take into account, including [***];
1.20.2 with respect to the prosecution of Patents, the carrying out of such activities using efforts and resources that AstraZeneca and its Affiliates would typically devote to carrying out such activities, acting in good faith, as relate to compounds or products of similar market potential at a similar stage in development or product life, taking into account all scientific,
6
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
commercial and other factors that AstraZeneca and its Affiliates would typically take into account; and
1.20.3 with respect to an activity that is subcontracted by AstraZeneca or its Affiliates to a Third Party as permitted hereunder, the exercise of such care and the dedication of such efforts by AstraZeneca or its Affiliate with respect to [***].
1.21 “Confidential Information” has the meaning set forth in Section 7.1.
1.22 “Control” means, with respect to any item of Information, material, Patent or other intellectual property right, and subject to Section 11.3.2, possession of the right, whether directly or indirectly and whether by ownership, license or otherwise (other than by operation of the license and other grants in Section 2.1), to grant a license, sublicense or other right to or under such Information, material, Patent or other intellectual property right as provided for herein without violating the terms of any agreement with any Third Party.
1.23 “Delivery System” means any delivery system comprising equipment, instrumentation, one or more devices, or other components designed to assist in, or useful for, the administration of a Licensed Product.
1.24 “Development” means all activities related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, clinical studies, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, “Develop” means to engage in Development.
1.25 “Dispute” has the meaning set forth in Section 11.5.1.
1.26 “Distributor” means any Person(s) appointed by AstraZeneca or any of its Affiliates or its or their Sublicensees to distribute, market and sell Licensed Product(s), with or without packaging rights, in one or more countries in the Territory, in circumstances where the Person purchases its requirements of Licensed Product(s) from AstraZeneca or its Affiliates or its or their Sublicensees but does not otherwise make any royalty or other payment to AstraZeneca or its Affiliates or its or their Sublicensees with respect to its intellectual property rights with respect to such Licensed Product. For clarity, if AstraZeneca or any of its Affiliates or its or their Sublicensees appoints a Person (including an Affiliate or Sublicensee of AstraZeneca or its Affiliates, as applicable) to distribute an Authorized Generic Version of a Licensed Product, such Person shall be a Distributor for purposes of this Agreement.
7
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
1.27 “Dollars” or “$” means United States Dollars.
1.28 “Drug Approval Application” means a New Drug Application as defined in the FFDCA or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval.
1.29 “Effective Date” has the meaning set forth in the preamble hereto.
1.30 “EMA” means the European Medicines Agency and any successor agency thereto.
1.31 “European Union” means the economic, scientific and political organization of European Union member states as it may be constituted from time to time, specifically including any country that was a European Union member state as of the Effective Date, whether or not such country is a participating member as of the applicable time. For the purposes of this Agreement, United Kingdom shall not be considered as a part of the European Union.
1.32 “Exploit” means to make, have made, import, use, sell or offer for sale, including to research, Develop, Commercialize, register, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market or have sold or otherwise dispose of. “Exploitation” means the act of Exploiting a compound, product or process.
1.33 “FDA” means the United States Food and Drug Administration and any successor agency thereto.
1.34 “FFDCA” means the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).
1.35 “Field” means all human and non-human diagnostic, prophylactic, palliative, analgesic and therapeutic uses.
1.36 “First Commercial Sale” means, with respect to a Licensed Product and a country, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such country after Regulatory Approval for such Licensed Product has been obtained in such country. Sales prior to receipt of Regulatory Approval for such Licensed Product, such as so-called “treatment IND sales,” “named patient sales,” and “compassionate use sales,” shall not be construed as a First Commercial Sale but shall count towards Net Sales and therefore be subject to a royalty in accordance with Section 5.3.
8
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
1.37 “First Indication” means, with respect to the relevant milestone payment [***], the first Indication for which any Licensed Product achieves that particular milestone.
1.38 “Generic Product” means, with respect to a Licensed Product, any pharmaceutical or biological product that (i) is distributed by a Third Party under a Drug Approval Application approved by a Regulatory Authority in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Licensed Product, including any product authorized for sale (a) in the United States pursuant to Section 505(b)(2) or Section 505(j) of the Act (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively), (b) in the European Union pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision) or (c) in any other country or jurisdiction pursuant to all equivalents of such provisions; or (ii) is otherwise substitutable under Applicable Law for such Licensed Product when dispensed without the intervention of a physician or other health care provider with prescribing authority.
1.39 “Hatch-Waxman Act” means the U.S. “Drug Price Competition and Patent Term Restoration Act” of 1984, as set forth at 21 U.S.C. §355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV).
1.40 “Improvements” means any invention, discovery, development or modification with respect to a Licensed Compound or a Licensed Product or relating to the Exploitation thereof, whether or not patented or patentable, including any enhancement in the efficiency, operation, Manufacture, ingredients, preparation, presentation, formulation, means of delivery (including the development of any Delivery System or enhancement thereto) or dosage of such Licensed Compound or Licensed Product, any discovery or development of any new or expanded indications for such Licensed Compound or Licensed Product, or any discovery or development that improves the stability, safety or efficacy of such Licensed Compound or Licensed Product.
1.41 “IFRS” means International Financial Reporting Standards.
1.42 “IND” means (i) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions; and (ii) all supplements and amendments that may be filed with respect to the foregoing.
1.43 “Indemnification Claim Notice” has the meaning set forth in Section 11.4.1.
1.44 “Indemnified Party” has the meaning set forth in Section 9.3.1.
1.45 “Indication” means the use of a Licensed Product for the treatment of a particular disease, disorder or condition.
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
1.46 “Indirect Tax” means value added, sales, consumption, goods and services taxes or other similar taxes required by Applicable Law to be disclosed as a separate item on the relevant invoice including, for the avoidance of doubt, any tax imposed in compliance with the Council Directive of 28 November 2006 on the common system of value added tax (EC Directive 2006/112).
1.47 “Information” means all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including: biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, and biological methodology, in each case (whether or not confidential, proprietary, patented or patentable) in written or electronic form now known or hereafter developed.
1.48 “Infringement” has the meaning set forth in Section 6.4.1.
1.49 “Initiation” means, with respect to a clinical study, the first dosing of the first human subject in such clinical study.
1.50 “Invoiced Sales” has the meaning set forth in Section 1.63.
1.51 “Knowledge” means as the context requires as it relates to a Party (i) the actual knowledge of the Chief Executive Officer, Chief Scientific Officer, Chief Financial Officer, Chief Medical Officer, Director of Business Development and in-house IP counsel of Licensor or any personnel holding positions equivalent to such job titles (but only to the extent such positions exist at such Party, having (in each case) made reasonable enquiry), or (ii) the actual knowledge of the Director Marketing Applications, Regulatory Processes and Partnerships of AstraZeneca.
1.52 “Lead Asset” has the meaning set forth in Section 1.53.
1.53 “Licensed Compound” means (i) [***]; (ii) [***] (iii) [***]; and (iv) [***] (in each case, more specifically described in Schedule 1.53 attached hereto) or any other compound listed in or covered by the Licensed Patents or otherwise making use of the Licensed Know-How, together with any [***].
1.54 “Licensed Know-How” means that Information or materials Controlled by Licensor or any of its Affiliates as of the Effective Date that claim or cover or otherwise relate to the Licensed Compound or Licensed Product, but excluding any information and materials to the extent claimed by or covered by published Licensed Patents.
10
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
1.55 “Licensed Patents” means all of the Patents listed in Schedule 1.55, together with all Patents related thereto pursuant to Section 1.68, Controlled by Licensor or any of its Affiliates as of the Effective Date that claim or cover or otherwise relate to any Licensed Compound or Licensed Product with respect thereto or the Exploitation of any of the foregoing, together with all Patents deriving priority from the above mentioned Patents and all Patents that are re-filed in accordance with Section 6.3.1, and such Patents shall continue to be regarded as being Licensed Patents even after they are assigned (if at all) to AstraZeneca in accordance with Section 2.3.
1.56 “Licensed Product” means any pharmaceutical product that is comprised of or contains a Licensed Compound, alone or in combination with one (1) or more other active ingredients, in any and all forms, presentations, Delivery Systems, dosages and formulations.
1.57 “Licensor” has the meaning set forth in the preamble hereto.
1.58 “Losses” has the meaning set forth in Section 9.1.
1.59 “Major Market” means each of [***].
1.60 “Manufacture” and “Manufacturing” means all activities related to the production, manufacture, processing, filling, finishing, packaging, labelling, shipping and holding of a Licensed Compound, any Licensed Product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control.
1.61 “Manufacturing Process” has the meaning set forth in Section 2.5.3.
1.62 “Material Anti-Corruption Law Violation” means a violation of an Anti-Corruption Law relating to the subject matter of this Agreement that would, if it were publicly known, in the reasonable view of AstraZeneca, have a material adverse effect on AstraZeneca or on the reputation of AstraZeneca because of its relationship with Licensor.
1.63 “Net Sales” means, with respect to a Licensed Product for any period, the gross amount billed or invoiced by AstraZeneca, its Affiliates or its or their Sublicensees for the sale of a Licensed Product to Third Parties (including Distributors, but not including Distributors of Authorized Generic Versions of Licensed Product(s), for which Net Sales are defined as set forth in Section 5.3.5) (the “Invoiced Sales”), less deductions for:
1.63.1 normal and customary trade, quantity and prompt settlement discounts (including chargebacks and allowances) actually allowed;
1.63.2 amounts repaid or credited by reason of rejection, return or recall of goods, rebates or bona fide price reductions;
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
1.63.3 customs and excise duties and other taxes or duties related to the sales to the extent that such items are included in the gross amount invoiced;
1.63.4 rebates and similar payments made with respect to sales paid for by any governmental or regulatory authority such as, by way of illustration and not in limitation of the Parties’ rights hereunder, Federal or state Medicaid, Medicare or similar state program or equivalent foreign governmental program;
1.63.5 the portion of administrative fees paid during the relevant time period to group purchasing organizations or pharmaceutical benefit managers relating to such Licensed Product;
1.63.6 any consideration actually paid or payable for, or reasonably allocable to, any Delivery System related to a billed or invoiced sale of such Licensed Product;
1.63.7 any invoiced amounts that are not collected by AstraZeneca, its Affiliates or its or their Sublicensees, including bad debts;
1.63.8 that portion of the annual fee on prescription drug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended) that AstraZeneca, its Affiliate or its or their Sublicensee, as applicable, allocates to sales of the Licensed Products in accordance with AstraZeneca’s, its Affiliate’s or its or their Sublicensee’s standard policies and procedures consistently applied across its products, as applicable;
1.63.9 any other similar and customary deductions that are consistent with
IFRS; and
1.63.10 an allowance for transportation costs, distribution expenses, special packaging, freight, postage, shipping and insurance expenses at a rate not exceeding [***] percent ([***]%) of the amount arrived at after application of the deductions under Sections 1.63.1 to 1.63.9 above, provided that no costs included within the above categories of this Section 1.63.10 shall be deducted under Sections 1.63.1 to 1.63.9 above.
Any of the deductions listed above that involves a payment by AstraZeneca, its Affiliates or its or their Sublicensees shall be taken as a deduction in the Calendar Quarter in which the payment is accrued by such entity. For the purposes of determining Net Sales, a Licensed Product shall be deemed to be sold when invoiced and a “sale” shall not include transfers or dispositions of such Licensed Product for pre-clinical or clinical purposes or as samples, in each case, without charge. AstraZeneca’s, its Affiliates’ or its or their Sublicensees’ transfer of any Licensed Product to an Affiliate or Sublicensee shall not result in any Net Sales, unless such Licensed Product is consumed by such Affiliate or Sublicensee in the course of its commercial activities.
12
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
In the event that a Licensed Product is sold in any country in the form of a Combination Product, Net Sales of such Combination Product shall be adjusted by multiplying actual Net Sales of such Combination Product in such country calculated pursuant to the foregoing definition of “Net Sales” by the fraction A/(A+B), where A is the average invoice price in such country of any Licensed Product that contains the same Licensed Compound(s) as such Combination Product as its sole active ingredient(s), if sold separately in such country and B is the average invoice price in such country of each product that contains (i) active ingredient(s) other than the Licensed Compound(s) contained in such Combination Product as its sole active ingredient(s) and (ii) if applicable, Delivery Device(s), in each case ((i) and (ii)), if sold separately in such country; provided that the invoice price in a country for each Licensed Product that contains only the Licensed Compound(s) and each product that contains solely (x) active ingredient(s) other than the Licensed Compound(s) or (y) Delivery Device(s), as applicable, included in the Combination Product shall be for a quantity comparable to that used in such Combination Product and of substantially the same class, purity and potency or functionality, as applicable. If either such Licensed Product that contains the Licensed Compound(s) as its sole active ingredient or a product that contains the active ingredient(s) (other than the Licensed Product) or Delivery Device(s), as applicable, in the Combination Product as its sole active ingredient(s) is not sold separately in a particular country, the Parties shall negotiate in good faith a reasonable adjustment to Net Sales in such country that takes into account the medical contribution to the Combination Product of and all other factors reasonably relevant to the relative value of, the Licensed Compound(s), on the one hand and all of the other active ingredient(s) or Delivery Device(s), as applicable, collectively, on the other hand. In the case of pharmacy incentive programs, hospital performance incentive programs, chargebacks, disease management programs, similar programs or discounts on portfolio product offerings, all rebates, discounts and other forms of reimbursements shall be allocated among products on the basis on which such rebates, discounts and other forms of reimbursements were actually granted or, if such basis cannot be determined, in accordance with AstraZeneca’s, its Affiliates’ or its or their Sublicensees’ existing allocation method; provided that any such allocation shall be done in accordance with Applicable Law, including any price reporting laws, rules and regulations.
Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of AstraZeneca, its Affiliates or its or their Sublicensees, which must be in accordance with IFRS.
1.64 “Non-Breaching Party” has the meaning set forth in Section 10.2.1.
1.65 “Notice Period” has the meaning set forth in Section 10.2.1.
1.66 “Other Lead Compounds” means those compounds listed in Schedule 5.2.1.
1.67 “Party” and “Parties” have the meaning set forth in the preamble hereto.
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
1.68 “Patents” means: (i) all national, regional and international patents and patent applications, including provisional patent applications; (ii) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications; (iii) any and all patents that have issued or in the future issue from the foregoing patent applications ((i) and (ii)), including utility models, petty patents, innovation patents and design patents and certificates of invention; (iv) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((i), (ii) and (iii)); and (v) any similar rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents.
1.69 “Payment” has the meaning set forth in Section 5.8.1.
1.70 “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.
1.71 “Phase I Clinical Study” means a human clinical study of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(a) and that is designed or intended to explore its metabolism and pharmacologic actions in a target or healthy patient population to permit the design of a Phase II Clinical Study, or a similar clinical study prescribed by the relevant Regulatory Authorities or Applicable Law in a country other than the United States.
1.72 “Phase II Clinical Study” means a human clinical study of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and that is designed or intended to explore a variety of doses, dose response, and duration of effect and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities or Applicable Law in a country other than the United States.
1.73 “Phase III Clinical Study” means a human clinical study of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21I and that is designed or intended to (a) establish that the product is safe and efficacious for its intended use, (b) define warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (c) support Regulatory Approval for such product.
1.74 “Product Trademarks” means the Trademark(s) used or to be used by AstraZeneca or its Affiliates or its or their Sublicensees for the Commercialization of Licensed Products in the Territory and any registrations thereof or any pending applications relating thereto
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
in the Territory, including any unregistered Trademark rights related to the Licensed Products as may exist through use before, on or after the Effective Date (excluding, in any event, any trademarks, service marks, names or logos that include any corporate name or logo of the Parties or their Affiliates or its or their Sublicensees).
1.75 “Reference Rate” means the greater of (i) [***]; and (ii) [***].
1.76 “Regulatory Approval” means, with respect to a country in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations or authorizations of any Regulatory Authority necessary to commercially distribute, sell or market a Licensed Product in such country, including, where applicable, (i) pricing or reimbursement approval in such country; (ii) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto); and (iii) labeling approval.
1.77 “Regulatory Authority” means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of Licensed Compounds or Licensed Products in the Territory, including the FDA in the United States and the EMA in the European Union.
1.78 “Regulatory Exclusivity Period” means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that confers exclusive marketing rights with respect to such Licensed Product in such country or prevents another Person from using or otherwise relying on any data supporting the approval of the Drug Approval Application for such Licensed Product without the prior written consent of the owner of the Drug Approval Application, as applicable, such as new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, non-patent related pediatric exclusivity or any other applicable marketing or data exclusivity, including any such periods listed in the FDA’s Orange Book or any such periods under national implementations in the European Union of Article 10 of Directive 2001/83/ED, Article 14(11) of Parliament and Council Regulation (EC) No. 726/2004, Parliament and Council Regulation (ED) No. 141/2000 on orphan medicines, Parliament and Council Regulation (ED) No. 1901/2006 on medicinal products for pediatric use and all international equivalents of any of the foregoing.
1.79 “Representatives” has the meaning set forth in Section 8.4.
1.80 “Royalty Term” means, with respect to each Licensed Product and each country in the Territory, the period beginning on the Effective Date and ending on the later of (a) the expiration of the [***]; or (b) [***] following the date of the First Commercial Sale of such Licensed Product in such country.
15
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
1.81 “Second Indication” means, with respect to the relevant milestone payment set forth in [***], the second Indication for which a Licensed Product achieves that particular milestone. For clarity, the Second Indication can be the second Indication for the Licensed Product that received the First Indication or the first Indication of another Licensed Product.
1.82 “Senior Officer” means, with respect to Licensor, its Chief Executive Officer and with respect to AstraZeneca, its EVP and President Biopharmaceuticals R&D (or any position that subsequently replaces that position).
1.83 “Sublicensee” means a Person, other than an Affiliate or a Distributor, that is granted a sublicense by AstraZeneca or its Affiliate under the grants in Section 2.1, as provided in Section 2.2.
1.84 “Successful Completion of [***]” means [***].
1.85 “Term” has the meaning set forth in Section 10.1.
1.86 “Termination Notice” has the meaning set forth in Section 10.2.1.
1.87 “Territory” means the entire world.
1.88 “Third Party” means any Person other than Licensor, AstraZeneca and their respective Affiliates.
1.89 “Third Party Claims” has the meaning set forth in Section 9.1.
1.90 “Third Party Infringement Claim” has the meaning set forth in Section 8.5.
1.91 “Third Party Right” has the meaning set forth in Section 6.7.
1.92 “Trademark” means any word, name, symbol, color, shape, designation or any combination thereof, including any trademark, service mark, trade name, brand name, sub-brand name, trade dress, product configuration, program name, delivery form name, certification mark, collective mark, logo, tagline, slogan, design or business symbol, that functions as an identifier of source or origin, whether or not registered and all statutory and common law rights therein and all registrations and applications therefor, together with all goodwill associated with, or symbolized by, any of the foregoing.
1.93 “United Kingdom” or the “UK” means the United Kingdom of Great Britain and Northern Ireland.
1.94 “United States” or “US” means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico).
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
1.95 “Valid Claim” means a claim of any issued and unexpired Patent whose validity, enforceability or patentability has not been extinguished in its entirety by (i) an irretrievable lapse, abandonment, revocation, dedication to the public or disclaimer or (ii) a holding, finding or decision of invalidity, unenforceability or non-patentability by a court, governmental agency, national or regional patent office or other appropriate body that has competent jurisdiction, such holding, finding or decision being final and unappealable or unappealed within the time allowed for appeal.
1.96 “Voting Stock” has the meaning set forth Section 1.17.1.
1.97 “Year” means each twelve (12) month period commencing on the Effective Date and each subsequent anniversary of the Effective Date.
ARTICLE 2
GRANT OF RIGHTS
2.1 Grants to AstraZeneca. Licensor hereby grants to AstraZeneca an exclusive (including with regard to Licensor and its Affiliates) license, with the right to grant sublicenses in accordance with Section 2.2, under the Licensed Patents and the Licensed Know-How, to Exploit the Licensed Compounds and Licensed Products in the Field and in the Territory.
2.2 Sublicenses. AstraZeneca shall have the right to grant sublicenses (or further rights of reference), through multiple tiers of sublicensees, under the licenses granted in Section 2.1, to its Affiliates and other Persons; provided that any such sublicenses shall be consistent with the terms and conditions of this Agreement and AstraZeneca shall be liable for any act or omission of such sublicensees that would amount to a breach of this Agreement if carried out by AstraZeneca.
2.3 Assignment.
2.3.1 As soon as reasonably practicable following payment in full and cleared funds to Licensor of the milestone payment becoming payable to Licensor for [***] in accordance with Section 5.2.1, Licensor shall assign and transfer to AstraZeneca (and AstraZeneca will accept from Licensor) all right, title and interest in and to the Licensed Patents and the Licensed Know-How to be held and enjoyed by AstraZeneca without restriction for its own use and for the use of its Affiliates, successors, licensees and assignees in the Territory. Such assignment by Licensor shall be subject to the remaining provisions of this Agreement which shall remain in full force and effect, including as they relate to the Development and Commercialization of the Licensed Products and the making of payments becoming due to Licensor under Article 5.
2.3.2 Licensor shall, at AstraZeneca’s request and cost, following the assignment of the Licensed Patents in accordance with Section 2.3.1, promptly execute and sign (or cause to be executed and signed) any further instruments, applications or documents and take (or cause to
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
be taken) any further actions necessary for AstraZeneca (i) to become the registered owner of the Licensed Patents and (ii) to otherwise enjoy the full benefit of the Licensed Patents provided always that Licensor shall not be required to provide any assistance in respect of Section 2.3.2(ii) beyond the expiry of the [***] period following the date of assignment of the Licensed Patents in accordance with Section 2.3.1.
2.4 Retention of Rights.
2.4.1 Except as expressly provided herein, Licensor grants no other right or license, including any rights or licenses to the Licensed Patents, the Licensed Know-How or any other Patent or intellectual property rights not otherwise expressly granted herein.
2.4.2 Except as expressly provided herein, AstraZeneca grants no other right or license, including any rights or licenses to the AstraZeneca Patents, the AstraZeneca Know-How or any other Patent or intellectual property rights not otherwise expressly granted herein.
2.5 Disclosure of Know-How; Transition.
2.5.1 Licensor shall, and shall cause its Affiliates to, without additional compensation, disclose and make available to AstraZeneca, the Licensed Know-How listed in Schedule 2.5, promptly after the Effective Date in accordance with the timeframe set out in Schedule 2.5.
2.5.2 Upon the Effective Date, the Parties will initiate the transition activities set forth in Schedule 2.5 (the “Transition Plan”) and shall use reasonable efforts to complete the Transition Plan activities as expeditiously as possible, but in any event, within the timelines set forth therein. Each Party shall bear its own expenses with respect to its obligations and activities under the Transition Plan.
2.5.3 Without prejudice to the foregoing, Licensor shall, where it becomes aware within the [***] period following the Effective Date of any other Information relating to its and its Affiliates’ Exploitation of any Licensed Product which was in existence as of the Effective Date, provide such Information to AstraZeneca within [***] of becoming aware of the same, in such form and format as the Parties may agree. Such Information may include, but is not limited to, (i) clinical and non-clinical data, research, analyses and other Information relating to the Licensed Compounds or Licensed Products; and (ii) copies of all correspondence, as of the Effective Date, to and from any Regulatory Authority that relates to the Licensed Compounds or Licensed Products, and all Information relating to the Manufacture of the Licensed Compound and the Licensed Products, including, for clarity, the then-current process for the Manufacture of the Licensed Compound and Licensed Products, as well as any improvements or enhancements to such processes (the “Manufacturing Process”) and Licensor provide such reasonable support, at AstraZeneca’s cost, as may be necessary or reasonably useful to AstraZeneca or its designee to
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
use and practice the Manufacturing Process. Any such Information provided to AstraZeneca under this Section 2.5.3 shall form part of the Licensed Know-How.
2.6 Confirmatory Patent License. Licensor shall if requested to do so by AstraZeneca, at AstraZeneca’s cost, promptly enter into confirmatory license agreements in such form as may be reasonably requested by AstraZeneca for purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as AstraZeneca considers appropriate. Until the execution of any such confirmatory licenses, so far as may be legally possible, Licensor and AstraZeneca shall have the same rights in respect of the Licensed Patents and be under the same obligations to each other in all respects as if the said confirmatory licenses had been executed.
2.7 Change of Control. Licensor (or its successor) shall provide AstraZeneca with written notice of any Change of Control of Licensor within [***] following the earlier of the first public announcement of the execution of any agreement with respect to such transaction and the closing date of such transaction.
ARTICLE 3
DEVELOPMENT AND REGULATORY ACTIVITIES
3.1 Development.
3.1.1 In General. As between the Parties, AstraZeneca (or its Affiliates) shall have the sole right and responsibility, at its sole expense, for all aspects of the Development of the Licensed Compounds and Licensed Products. Without limiting the generality of the foregoing, AstraZeneca shall have the sole right and responsibility, at its sole expense, to (i) file all Drug Approval Applications and make all other filings with the Regulatory Authorities, and to otherwise seek all Regulatory Approvals for Licensed Products, in the Territory, as well as to conduct all correspondence and communications with Regulatory Authorities regarding such matters and (ii) report all Adverse Events to Regulatory Authorities if and to the extent required by Applicable Law.
3.1.2 Diligence. AstraZeneca shall use Commercially Reasonable Efforts to Develop a Licensed Product for the First Indication for each of the Major Markets.
3.1.3 Subcontracting. AstraZeneca shall have the right to subcontract any of its other Development activities to a Third Party.
3.1.4 Development Reports. Until such time as the last Development milestone is paid, within [***] following the end of [***], AstraZeneca shall provide Licensor with a high level written summary of its material Development activities in process and those that it expects to initiate during the following [***] period, in the form appearing at Schedule 3.1.4. AstraZeneca shall also inform Licensor of any significant events in relation to the Development of Licensed
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
Products that are likely to occur, to enable Licensor to prepare to comply with its disclosure obligations under Applicable Law or the rules of any stock exchange on which its securities are listed (provided that any actual disclosure shall be subject to ARTICLE 7).
3.2 Regulatory Activities.
3.2.1 Regulatory Approvals.
(i) Following the successful completion by AstraZeneca of the Development activities, AstraZeneca shall use Commercially Reasonable Efforts to obtain Regulatory Approval for the First Indication of a Licensed Product in each of the Major Markets.
(ii) As between the Parties, AstraZeneca shall have the sole right to prepare, obtain and maintain Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions and to conduct communications with the Regulatory Authorities, for Licensed Products in the Territory. Licensor shall support AstraZeneca, as may be reasonably necessary and at AstraZeneca’s cost, in obtaining Regulatory Approvals for the Licensed Products and in the activities in support thereof, including providing all documents or other materials in the possession or control or Licensor or any of its Affiliates as may be necessary or useful for AstraZeneca or any of its Affiliates or its or their Sublicensees to obtain Regulatory Approvals for the Licensed Products.
(iii) Except to the extent prohibited by Applicable Law, all Regulatory Approvals relating to a Licensed Compound or a Licensed Product with respect to the Territory developed or granted pursuant to this Agreement after the Effective Date shall be owned by and shall be the sole property and held in the name of, AstraZeneca or its designated Affiliate, Sublicensee or designee. At AstraZeneca’s request and cost, Licensor shall duly execute and deliver or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary under or as AstraZeneca may reasonably request in connection with or to carry out more effectively the purpose of or to better assure and confirm unto AstraZeneca its rights under, this Section.
ARTICLE 4
COMMERCIALIZATION
4.1 In General. As between the Parties, AstraZeneca (itself or through its Affiliates or its or their Sublicensees) shall have the sole right to Commercialize Licensed Products in the Territory at its sole cost and expense.
4.2 Diligence. AstraZeneca shall use Commercially Reasonable Efforts to Commercialize a Licensed Product for the First Indication following receipt of Regulatory Approval therefor in each of the Major Markets; provided that AstraZeneca shall not be obligated
20
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
to use Commercially Reasonable Efforts to Commercialize [***] in each of the Major Markets. Licensor acknowledges and agrees that nothing in this Section is intended, or shall be construed, to require AstraZeneca to Develop or Commercialize a specific Licensed Product. Further, Licensor acknowledges and agrees that AstraZeneca is not required to Commercialize a Licensed Product in any Major Market where the carrying out by it of Commercially Reasonable Efforts would not require it to do so. In the event that AstraZeneca decides to discontinue the development or commercialization of a Licensed Product in favor of another Licensed Product, its obligations under this Section shall cease with respect to such initial Licensed Product in favor of such other Licensed Product. Licensor further acknowledges that AstraZeneca is in the business of Exploiting pharmaceutical products and nothing in this Agreement shall be construed as restricting such business.
4.3 Booking of Sales; Distribution. As between the Parties, AstraZeneca shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehouse and distribute the Licensed Products in the Territory and perform or cause to be performed all related services. As between the Parties, AstraZeneca shall handle all returns, recalls or withdrawals, order processing, invoicing, collection, distribution and inventory management with respect to the Licensed Products in the Territory.
4.4 Statements and Compliance with Applicable Law. Each Party shall and shall cause its Affiliates to, comply with all Applicable Law with respect to the Commercialization of Licensed Products hereunder.
4.5 Subcontracting; Distributors. Subject to Section 2.2, AstraZeneca shall have the right to subcontract any of its Commercialization activities to a Third Party (including by appointing one or more contract sales forces, co-promotion partners or Distributors); provided that (i) no such permitted subcontracting shall relieve AstraZeneca of any obligation (except to the extent AstraZeneca uses Commercially Reasonable Efforts with respect to selecting such subcontractor, entering into a subcontract therewith, and managing (and, if applicable enforcing) such subcontract) hereunder and (ii) if and to the extent AstraZeneca uses Commercially Reasonable Efforts with respect to selecting such subcontractor, entering into a subcontract therewith and managing (and, if applicable, enforcing) such subcontract. AstraZeneca shall be liable to Licensor for any act or omission of any such subcontractor that would amount to a breach of this Agreement if carried out by AstraZeneca.
ARTICLE 5
PAYMENTS AND RECORDS
5.1 Upfront Payment. In partial consideration of the rights granted by Licensor to AstraZeneca hereunder and subject to the terms and conditions of this Agreement, AstraZeneca shall pay Licensor an upfront amount equal to [***] Dollars ($[***]). On or after the Effective
21
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
Date, Licensor shall provide a valid invoice to AstraZeneca for the upfront payment due, which amount shall be payable by AstraZeneca [***] following receipt of the invoice.
5.2 Milestones.
5.2.1 [***]. In partial consideration of the rights granted by Licensor to AstraZeneca hereunder and subject to the terms and conditions of this Agreement, AstraZeneca shall pay to Licensor each of the following milestone payments, calculated as follows:
Each milestone payment in this Section 5.2.1 shall be payable only upon the first achievement of such milestone and no amounts shall be due for subsequent or repeated achievements of such milestone, whether for the same or a different Licensed Product.
Notwithstanding anything to the contrary in this Section 5.2.1, in the event that [***] is made in relation to a Licensed Compound:
(a) [***], or
(b) [***],
[***].
If, at any time, the achievement of the milestones described in this Section 5.2.1 has occurred with respect to which a payment is due hereunder and any of preceding milestones in this Section 5.2.1 have not been triggered, become due or been paid, then each such skipped milestone
22
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
payment shall become due and payable concurrently with such subsequent milestone in this Section 5.2.1.
5.2.2 [***]. In partial consideration of the rights granted by Licensor to AstraZeneca hereunder and subject to the terms and conditions of this Agreement, in the event that AstraZeneca Develops any Licensed Product for a Second Indication, AstraZeneca shall pay to Licensor additional milestone payments, calculated as follows:
|
i. [***] |
$[***] |
|
ii. [***] |
$[***] |
|
iii. [***] |
$[***] |
|
iv. [***] |
$[***] |
|
v. [***] |
$[***] |
In the event that AstraZeneca Develops more than one Licensed Product, for clarity, the milestone payments set forth in this Section 5.2.2 shall be payable [***]. If, at any time, the achievement of the milestones described in this Section 5.2.2 has occurred with respect to which a payment is due hereunder and any of preceding milestones in this Section 5.2.2 have not been triggered, become due or been paid, then each such skipped milestone payment shall become due and payable concurrently with such subsequent milestone in this Section 5.2.2 for such Indication.
5.2.3 Invoicing for Development and Regulatory Milestones. AstraZeneca shall give Licensor written notice of the achievement of each milestone event in Sections 5.2.1 and 5.2.2 no later than [***] after such achievement. Licensor shall submit an invoice to AstraZeneca promptly following receipt of such notice for the full amount of the corresponding milestone, which amount shall then be payable within [***] after the receipt of the invoice.
5.2.4 Sales-Related Milestones. In partial consideration of the license rights granted by Licensor to AstraZeneca hereunder and subject to the terms and conditions of this Agreement, AstraZeneca shall pay to Licensor milestone payments, calculated as follows:
23
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
|
i. In the event that the aggregate of all Net Sales of all Licensed Products made by AstraZeneca or any of its Affiliates or its or their Sublicensees in a given Calendar Year exceeds $[***] for such Calendar Year |
$[***] |
|
ii. In the event that the aggregate of all Net Sales of all Licensed Products made by AstraZeneca or any of its Affiliates or its or their Sublicensees in a given Calendar Year exceeds $[***] for such Calendar Year |
$[***] |
|
iii. In the event that the aggregate of all Net Sales of all Licensed Products made by AstraZeneca or any of its Affiliates or its or their Sublicensees in a given Calendar Year exceeds $[***] for such Calendar Year |
$[***] |
In the event that in a given Calendar Year more than one (1) of the foregoing thresholds set forth in this Section 5.2.4 is exceeded, AstraZeneca shall pay to Licensor a separate milestone payment with respect to each such threshold that is exceeded in such Calendar Year. Each milestone payment in this Section 5.2.4 shall be payable only upon the first achievement of such milestone in a given Calendar Year and no amounts shall be due for subsequent or repeated achievements of such milestone in subsequent Calendar Years.
5.2.5 Invoicing for Sales-Related Milestones. AstraZeneca shall give Licensor written notice of the achievement of each milestone event in Section 5.2.4 no later than [***] after the close of the [***] in which such achievement occurs. Following receipt of such notice, Licensor shall submit an invoice promptly following receipt of such notice to AstraZeneca for the full amount of the corresponding milestone payment. Each such milestone payment shall then be payable [***] after receipt of a valid invoice.
5.3 Royalties.
5.3.1 Royalty Rates. As further consideration for the rights granted to AstraZeneca hereunder and subject to the terms and conditions of this Agreement, including any right of AstraZeneca to offset amounts due from Licensor to AstraZeneca pursuant to ARTICLE 6, AstraZeneca shall pay to Licensor a royalty on Net Sales to Third Parties (including Distributors but excluding sales of Authorized Generic Versions) of each Licensed Product in the Territory (excluding Net Sales of each Licensed Product in any country for which the Royalty Term for such Licensed Product in such country has expired as set forth in Section 5.3.2) during each Calendar Year at the following rates:
(i) for that portion of aggregate Net Sales of all Licensed Products in the Territory during a Calendar Year less than [***], a royalty rate of [***] percent ([***]%);
24
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
(ii) for that portion of aggregate Net Sales of all Licensed Products in the Territory during a Calendar Year equal to or greater than [***] Dollars ($[***]), but less than [***] Dollars ($[***]), a royalty rate of [***] percent ([***]%); and
(iii) for that portion of aggregate Net Sales of all Licensed Products in the Territory during a Calendar Year equal to or greater than [***] Dollars ($[***]), a royalty rate of [***] percent ([***]%).
With respect to each Licensed Product in each country in the Territory, from and after the expiration of the Royalty Term for such Licensed Product in such country, Net Sales of such Licensed Product in such country shall be excluded for purposes of calculating the Net Sales thresholds and ceilings set forth in this Section 5.3.1.
5.3.2 Royalty Term. AstraZeneca shall have no obligation to pay any royalty with respect to Net Sales of any Licensed Product in any country after the last day of the month in which the Royalty Term for such Licensed Product in such country has expired.
5.3.3 Reductions. Notwithstanding the foregoing, in the event that:
(i) AstraZeneca enters into an agreement with a Third Party in order to obtain a license or other right to a Third Party Right with respect to a Licensed Compound in a country pursuant to Section 6.7, AstraZeneca shall be entitled to [***]; and
(ii) a court or a governmental agency of competent jurisdiction requires AstraZeneca or any of its Affiliates or its or their Sublicensees to grant a compulsory license to a Third Party permitting such Third Party to make and sell a Licensed Product in a country in the Territory, [***].
Any reductions set forth in this Section 5.3.3 shall be applied to the royalty rate payable to Licensor under Section 5.3.1 in the order in which the event triggering such reduction occurs.
5.3.4 Maximum Amount of Royalty Reduction. In no event shall the royalty rate payable to Licensor under this Section 5.3 in respect of any country or Licensed Product be reduced by more than [***] percent ([***]%) of what it would otherwise be by operation of Section 5.3.3 or 5.3.5. Credits not exhausted in any [***] may be carried into future [***], subject to the foregoing sentence.
5.3.5 Authorized Generics. If, in any country in the Territory during the Royalty Term for a Licensed Product, one or more Authorized Generic Versions of such Licensed Product are sold lawfully, then for the purposes of calculating the royalties due under Section 5.3.1, (a) sales from AstraZeneca or its Affiliates or its or their Sublicensees to the Distributor of such Authorized Generic Versions of the Licensed Product shall not be included in “Net Sales,” and (b) such Distributor’s sales of Authorized Generic Versions of Licensed Products to Third Parties shall
25
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
be included in “Net Sales,” except that such sales shall be (x) adjusted for deductions from such sales as are permitted to the Distributor in calculating its payments to AstraZeneca and its Affiliates and its and their Sublicensees and (y) reduced by that portion of such sales as are permitted to be retained by such Distributor.
5.4 Sublicense Revenue. No royalty or other payments shall be due with respect to any payments made to AstraZeneca or its Affiliates from Sublicensees or their Affiliates (i) in the form of upfront fees or milestone payments; (ii) under a credit facility; (iii) in connection with any Change of Control; (iv) in consideration of (x) any issuance of equity or debt securities by AstraZeneca or its Affiliates; or (y) any research, development or other activities relating to the Licensed Product that AstraZeneca or its Affiliates may perform on behalf of a Sublicensee; (v) as reimbursement of actual patent prosecution and maintenance costs and expenses; or (vi) in connection with awards or judgments in Patent or other intellectual or proprietary rights enforcement, which shall be allocated between the Parties in accordance with ARTICLE 6.
5.5 Estimated Sales Levels. Licensor acknowledges and agrees that the sales levels set forth in Sections 5.2 and 5.3 shall not be construed as representing an estimate or projection of anticipated sales of the Licensed Products or implying any level of diligence or Commercially Reasonable Efforts, in the Territory and that the sales levels set forth in those Sections are merely intended to define AstraZeneca’s royalty and other payment obligations, as applicable, in the event such sales levels are achieved.
5.6 Royalty Payments and Reports. AstraZeneca shall calculate all amounts payable to Licensor pursuant to Section 5.3 at the end of each [***], which amounts shall be converted to Dollars, in accordance with Section 5.7. AstraZeneca shall give to Licensor a written statement of the royalty amounts due with respect to a given [***] within [***] after the end of such [***], which statement shall include the Net Sales of all Licensed Products subject to royalty payments sold by AstraZeneca and its Affiliates and Sub-licensees in the Territory during the reporting period and the royalties payable under this Agreement. Following receipt of such statement, Licensor shall promptly submit an invoice to AstraZeneca for the full amount of the corresponding royalty payment, which amount shall be payable [***] after the date of invoice.
5.7 Mode of Payment. All payments to either Party under this Agreement shall be made by deposit of Dollars in the requisite amount to such bank account as the receiving Party may from time to time designate by notice to the paying Party. For the purpose of calculating any sums due under, or otherwise reimbursable pursuant to, this Agreement (including the calculation of Net Sales expressed in currencies other than Dollars), a Party shall convert any amount expressed in a foreign currency into Dollar equivalents using its, its Affiliate’s or Sublicensee’s standard conversion methodology consistent with IFRS.
5.8 Taxes.
26
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
5.8.1 General. The milestones, royalties and other amounts payable by AstraZeneca to Licensor pursuant to this Agreement (each, a “Payment”) shall be paid free and clear of any and all taxes, except for any withholding taxes required by Applicable Law. Except as provided in this Section 5.8, Licensor shall be solely responsible for paying any and all taxes (other than withholding taxes required by Applicable Law to be deducted from Payments and remitted by AstraZeneca) levied on account of, or measured in whole or in part by reference to, any Payments it receives. AstraZeneca shall deduct or withhold from the Payments any taxes that it is required by Applicable Law to deduct or withhold. Notwithstanding the foregoing, if Licensor is entitled under any applicable tax treaty to a reduction of rate of, or the elimination of, applicable withholding tax, it may deliver to AstraZeneca or the appropriate governmental authority (with the assistance of AstraZeneca to the extent that this is reasonably required and is expressly requested in writing) the prescribed forms necessary to reduce the applicable rate of withholding or to relieve AstraZeneca of its obligation to withhold such tax and AstraZeneca shall apply the reduced rate of withholding or dispense with withholding, as the case may be; provided that AstraZeneca has received evidence, in a form satisfactory to AstraZeneca, of Licensor’s delivery of all applicable forms (and, if necessary, its receipt of appropriate governmental authorization) at least [***] prior to the time that the Payments are due. If, in accordance with the foregoing, AstraZeneca withholds any amount, it shall pay to Licensor the balance when due, make timely payment to the proper taxing authority of the withheld amount and send to Licensor proof of such payment within [***] following such payment. Notwithstanding the foregoing, in the event a Party assigns its rights or obligations under this Agreement or otherwise makes Payments from a jurisdiction other than the jurisdiction in which such Party is tax resident at the time of this Agreement, and immediately after such assignment the amount of withholding tax deductions in respect of any payment it makes are greater than the amount of withholding tax deductions that would have been required by Applicable Law absent such assignment, then such increased tax shall be borne by the Party making such assignment.
5.8.2 Indirect Taxes. Notwithstanding anything to the contrary contained elsewhere in this Agreement, the following shall apply with respect to Indirect Taxes. All payments and consideration are stated exclusive of Indirect Taxes. If any Indirect Taxes are chargeable by the payee in respect of any payments or consideration due under any Transaction Document, the payer shall pay such Indirect Taxes at the applicable rate in respect of any such payments or consideration, following the receipt, where applicable, of a valid Indirect Taxes invoice issued in the appropriate form by the payee in respect of those payments or consideration to which such Indirect Taxes relate. The Parties shall issue valid invoices for all goods and services supplied under the Transaction Documents consistent with the law governing such Indirect Tax, and to the extent any invoice is not initially issued in an appropriate form, the parties shall cooperate to provide such information or assistance as may be necessary to enable the issuance of such invoice consistent with the law governing such Indirect Tax.
5.8.3 Tax Co-operation. AstraZeneca and Licensor shall procure that their group tax functions shall fully cooperate with each other in relation to any reasonable request in
27
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
connection with any tax liability arising from the payments due under this Agreement, including information required for the preparation and filing of any tax return or the conduct of any audit, investigation, dispute or appeal or any other communication with any tax authority, in each case if and to the extent: (i) legally permissible; and (ii) that such disclosure would not breach any duty of confidentiality or waive privilege. The requesting party shall be responsible for any third-party costs properly incurred by the other party in complying with this Section 5.8.3.
5.8.4 Prevention of Facilitation of Tax Evasion.
(i) Each Party represents, warrants and undertakes that neither it nor its Affiliates shall commit a tax evasion facilitation offence under Part 3 of the UK Criminal Finances Act 2017 in connection with or attributable to this Agreement or the transactions contemplated hereby.
(ii) Each Party shall promptly report to the other Party any apparent breach of Section 5.8.4(i) and shall (a) answer, in reasonable detail, any written or oral inquiry from the other Party related to its and its Affiliates compliance with Section 5.8.4(i), (b) facilitate the interview of employees of such Party by the other Party (or any agent of such Party) at any reasonable time specified by the inquiring Party related to such Party’s compliance with Section 5.8.4(i) and (c) co-operate with the inquiring Party or any governmental authority in relation to any investigation relating to the matters referred to in Section 5.8.4(i), in all cases, as reasonably required to enable that other Party to comply with its undertaking in Section 5.8.4(i).
5.9 Interest on Late Payments. If any payment due to either Party under this Agreement is not paid when due, then such paying Party shall pay interest thereon (before and after any judgment) at an annual rate equal to the lessor of (i) [***] per cent ([***]%) above the Reference Rate, and (ii) the maximum rate permitted under Applicable Law. Any interest will accrue from day to day and is calculated based on the actual number of days elapsed from the payment due date to the actual payment date and a year of 365 days. Interest is compounded daily.
5.10 Audit.
5.10.1 Procedures. At the request of the Licensor, AstraZeneca shall, and shall cause its Affiliates and its and their Sublicensees to, permit an independent auditor designated by Licensor and reasonably acceptable to AstraZeneca, at reasonable times and upon reasonable notice, to audit the books and records maintained pursuant to Section 5.10 to ensure the accuracy of all reports and payments made hereunder. Such examinations may not (i) be conducted for any Calendar Quarter more than [***] after the end of such quarter; (ii) be conducted more than once in any [***] period (unless a previous audit during such [***] period revealed an underpayment (or with respect to any reimbursement, an overpayment) with respect to such period); or (iii) be repeated for any Calendar Quarter. Except as provided below, the cost of this audit shall be borne by the auditing Party, unless the audit reveals a variance of more than [***] percent ([***]%) from the reported amounts, in which case the audited Party shall bear the cost of the audit. Unless
28
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
disputed pursuant to Section 5.10.2 below, if such audit concludes that (x) additional amounts were owed by the audited Party, the audited Party shall pay the additional amounts, with interest from the date originally due as provided in Section 5.8 or (y) excess payments were made by the audited Party, the auditing Party shall reimburse such excess payments, in either case ((x) or (y)), within [***] after the date on which such audit is completed by the auditing Party.
5.10.2 Audit Dispute. In the event of a dispute with respect to any audit under Section 5.10, Licensor and AstraZeneca shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***], the dispute shall be submitted for resolution to a certified public accounting firm jointly selected by each Party’s certified public accountants or to such other Person as the Parties shall mutually agree (the “Auditor”). The decision of the Auditor shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Auditor shall determine. Not later than [***] after such decision and in accordance with such decision, the audited Party shall pay the additional amounts, with interest from the date originally due as provided in Section 5.8 or the auditing Party shall reimburse the excess payments, as applicable.
5.10.3 Confidentiality. The receiving Party shall treat all information subject to review under this ARTICLE 5 in accordance with the confidentiality provisions of ARTICLE 7 and the Parties shall cause the Auditor to enter into a reasonably acceptable confidentiality agreement with the audited Party obligating such firm to retain all such financial information in confidence pursuant to such confidentiality agreement.
ARTICLE 6
INTELLECTUAL PROPERTY
6.1 Ownership of Intellectual Property.
6.1.1 Ownership. As between the Parties, AstraZeneca shall own and retain all right, title and interest in and to any and all: (i) Information, Improvements and other inventions that are conceived, discovered, developed or otherwise made by or on behalf of AstraZeneca (or its Affiliates or its or their Sublicensees) under or in connection with this Agreement, whether or not patented or patentable and any and all Patents and other intellectual property rights with respect thereto; and (ii) other Information, inventions, Patents and other intellectual property rights that are owned or otherwise controlled by AstraZeneca or any of its Affiliates or its or their sublicensees outside of this Agreement. As between the Parties, Licensor shall own and retain all right, title and interest in and to any and all Information, inventions, Patents and other intellectual property rights that are owned or otherwise controlled by Licensor or any of its Affiliates prior to the Effective Date.
6.1.2 United States Law. The determination of whether Information, Improvements and inventions are conceived, discovered, developed or otherwise made by a Party for the purpose of allocating proprietary rights (including Patent, copyright or other intellectual
29
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
property rights) therein, shall, for purposes of this Agreement, be made in accordance with Applicable Law in the United States as such law exists as of the Effective Date irrespective of where or when such conception, discovery, development or making occurs. In the event that United States law does not apply to the conception, discovery, development or making of any Information, Improvements or other inventions hereunder, each Party shall, and does hereby, assign, and shall cause its Affiliates and its and their licensees and Sublicensees to so assign, to the other Party, without additional compensation but at AstraZeneca’s cost, such right, title and interest in and to any Information, Improvements and other inventions as well as any intellectual property rights with respect thereto, as is necessary to fully effect, as applicable the sole ownership provided for in Section 6.1.1
6.1.3 Ownership of Product Trademarks. As between the Parties, AstraZeneca shall have the sole right to determine and shall own all right, title and interest in and to the Product Trademarks on a worldwide basis. Licensor shall not and shall not permit its Affiliates to, (i) use in their respective businesses, any Trademark that is confusingly similar to, misleading or deceptive with respect to or that dilutes any (or any part) of the Product Trademarks and (ii) do any act that endangers, destroys, or similarly affects, in any material respect, the value of the goodwill pertaining to the Product Trademarks. Licensor shall not and shall not permit its Affiliates to, attack, dispute or contest the validity of or ownership of any Product Trademark anywhere in the Territory or any registrations issued or issuing with respect thereto.
6.2 Control of Intellectual Property. Neither Party shall enter into or amend any agreement with a Third Party, or include in any such agreement or amendment any restrictive provisions, with an intent to limit its Control of, or to not Control, any Information, Patent or other intellectual property right that would be subject to the license grants in Section 2.1 in the absence of such agreement, amendment or restrictive provisions. Further, when entering into any agreement or amendment with a Third Party relating to any Information, Patents or other intellectual property rights that, if Controlled by a Party or its Affiliates, would be subject to the license grants in Section 2.1, each Party shall use good faith efforts to obtain Control of such Information, Patents and other intellectual property rights.
6.3 Maintenance and Prosecution of Patents.
6.3.1 Patent Prosecution and Maintenance of Licensed Patents.
(i) As between the Parties, AstraZeneca shall:
(a) subject to Section 6.3.1(b), have the sole right, but not the obligation, including by using counsel of its own choice to prepare, file, prosecute and maintain the Licensed Patents in the Territory and to be responsible for any related interference, re-issuance, re-examination and opposition proceedings, and
30
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
(b) use its Commercially Reasonable Efforts to prepare, file prosecute and (subject to Sections 6.3.1(ii) and (iv)) maintain the Licensed Patents in each of the Major Markets and be responsible for any related interference, re-issuance, re-examination and opposition proceedings, in each case (a) and (b), at AstraZeneca’s sole cost and expense.
(ii) Notwithstanding Section 6.3.1(i), if AstraZeneca, as between the Parties, decides not to prepare, file (or re-file in accordance with Section 6.3.1(iv)), prosecute or maintain a Licensed Patent, AstraZeneca shall provide Licensor with written notice at least [***] prior to lapse or abandonment (or withdrawal or expiry in accordance with Section 6.3.1(iv)) of the relevant Licensed Patent, as the case may be. Within [***] after receipt of such notice, the Licensor shall be entitled to require by written notice that AstraZeneca assigns, or assigns exclusive control of, such Licensed Patent to Licensor, at [***] (subject to Licensor paying AstraZeneca’s reasonable out-of-pocket costs incurred in effecting such assignment), and any such Licensed Patent shall be deemed to be excluded from the Licensed Patents. Should AstraZeneca not receive written notice of assignment within such [***] period, such Licensed Patent shall be allowed to lapse or become abandoned.
(iii) AstraZeneca shall regularly (and not less than once every [***]) inform Licensor of all material steps with regard to the preparation, filing, prosecution and maintenance of the Licensed Patents in the Territory.
(iv) If a Licensed Patent has not been published, AstraZeneca shall have the right, but not the obligation, to withdraw and re-file in Licensor’s name, or to let expire and then re-file in Licensor’s name, those Licensed Patents in order, and as required, to reset priority for such Licensed Patents and allow incorporation of Improvements, at AstraZeneca’s sole cost and expense, provided that, in the event that a Licensed Patent is, in accordance with this Section 6.3.1(iv), withdrawn or allowed to expire, then it shall be refiled promptly, but no later than within [***], to reset the priority date.
6.3.2 Patent Prosecution and Maintenance of AstraZeneca Patents. As between the Parties, AstraZeneca shall have the sole right, but not the obligation, to prepare, file, prosecute and maintain the AstraZeneca Patents worldwide, and to be responsible for any related interference, re-issuance, re-examination and opposition proceedings, in each case, at its sole cost and expense and using counsel of its own choice.
6.3.3 Cooperation. The non-prosecuting Party shall, and shall cause its Affiliates to, assist and cooperate with the prosecuting Party, as the prosecuting Party may reasonably request from time to time, in the preparation, filing, prosecution and maintenance of the Licensed Patents and the AstraZeneca Patents worldwide under this Agreement, including that the non-prosecuting Party shall, and shall ensure that its Affiliates, (i) offer its comments, if any, promptly; and (ii) provide access to relevant documents and other evidence, to the extent that these are in the non-prosecuting Party’s control or possession, and make its employees available at reasonable business
31
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
hours; provided, that the prosecuting Party shall reimburse the non-prosecuting Party for its out-of-pocket costs and expenses incurred in connection therewith.
6.3.4 Patent Term Extension and Supplementary Protection Certificate. As between the Parties, AstraZeneca shall have the sole right to make decisions regarding, and to apply for, patent term extensions worldwide, including the United States with respect to extensions pursuant to 35 U.S.C. §156 et. seq. and in other jurisdictions pursuant to supplementary protection certificates, and in all jurisdictions with respect to any other extensions that are now or become available in the future, wherever applicable, for the Licensed Patents, the AstraZeneca Patents and with respect to the Licensed Compound and the Licensed Products, in each case including whether or not to do so. Licensor shall provide prompt and reasonable assistance, as requested by and at the cost of AstraZeneca, including by taking such action as patent holder as is required under any Applicable Law to obtain such extension or supplementary protection certificate.
6.3.5 Patent Listings. As between the Parties, AstraZeneca shall have the sole right to make all filings with Regulatory Authorities in the Territory with respect to the Licensed Patents and the AstraZeneca Patents, including as required or allowed (i) in the United
29
States, in the FDA’s Orange Book; and (ii) in the European Union, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents.
6.4 Enforcement of Patents.
6.4.1 Notice. Each Party shall promptly notify the other Party in writing of (i) any alleged or threatened infringement of the Licensed Patents or the AstraZeneca Patents in any jurisdiction in the Territory; or (ii) any certification filed under the Hatch-Waxman Act claiming that any Licensed Patent or AstraZeneca Patent is invalid or unenforceable or claiming that any Licensed Patent or AstraZeneca Patent would not be infringed by the making, use, offer for sale, sale or import of a product for which an application under the Hatch-Waxman Act is filed or any equivalent or similar certification or notice in any other jurisdiction in the Territory, in each case ((i) and (ii)) of which such Party becomes aware (an “Infringement”).
6.4.2 Enforcement of Licensed Patents. As between the Parties, AstraZeneca shall have the first right, but not the obligation, to prosecute any Infringement with respect to the Licensed Patents, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at AstraZeneca’s sole cost and expense, using counsel of its own choice. In the event AstraZeneca prosecutes any such Infringement, Licensor shall have the right to join as a party to such claim, suit or proceeding in the Territory and participate with its own counsel at its sole cost and expense; provided that AstraZeneca shall retain control of the prosecution of such claim, suit or proceeding, including the response to any defense or defense of any counterclaim
32
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
raised in connection therewith. If AstraZeneca or its designee does not take commercially reasonable steps to prosecute an Infringement (i) within [***] following the first notice provided above with respect to such Infringement; or (ii) provided such date occurs after the first such notice of such Infringement is provided, [***] before the time limit, if any, set forth in appropriate laws and regulations for filing of such actions, whichever comes first, then (x) AstraZeneca shall so notify Licensor and Licensor may prosecute such alleged or threatened infringement at its sole cost and expense.
6.4.3 Enforcement of AstraZeneca Patents. As between the Parties, AstraZeneca shall have the sole right, but not the obligation, to prosecute Infringement with respect to the AstraZeneca Patents, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at AstraZeneca’s sole cost and expense, using counsel of its own choice, and AstraZeneca shall retain control of the prosecution of such suit.
6.4.4 Cooperation. The Parties agree to cooperate fully in any Infringement action pursuant to this Section 6.4, including in the case of Licensor, by making the inventors, applicable records and documents (including laboratory notebooks) in respect of the relevant Patents available to AstraZeneca upon AstraZeneca’s request. Where a Party controls such an action, the other Party shall, and shall cause its Affiliates to, assist and cooperate with the controlling Party, as such controlling Party may reasonably request from time to time, in connection with its activities set forth in this Section 6.4, including where necessary, furnishing a power of attorney solely for such purpose or joining in, or being named as a necessary party to, such action, providing access to relevant documents and other evidence and making its employees available at reasonable business hours; provided that the controlling Party shall reimburse such other Party for its out-of-pocket costs and expenses incurred in connection therewith. Unless otherwise set forth herein, the Party entitled to bring any patent infringement litigation in accordance with this Section 6.4 shall have the right to settle such claim; provided that neither Party shall have the right to settle any Infringement litigation under this Section 6.4 in a manner that has a material adverse effect on the rights or interest of the other Party (including in its Patents) or in a manner that imposes any costs or liability on or involves any admission by, the other Party, without the express written consent of such other Party (which consent shall not be unreasonably withheld, conditioned or delayed); provided, further that the foregoing limitation shall not be deemed to preclude or require the consent of such other Party in connection with a settlement of Infringement that would or may result in reduced Payments hereunder, but would not otherwise fall within the scope of the foregoing limitation.
6.4.5 Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realized as a result of such litigation described above in this Section 6.4 (whether by way of settlement or otherwise) shall be first, allocated to reimburse the Parties for their costs and expenses in making such recovery (which amounts shall be allocated pro rata if insufficient to cover the totality of such expenses). Any remainder after such reimbursement is made shall be retained by the Party that has exercised its right to bring the
33
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
enforcement action; provided that to the extent that any award or settlement (whether by judgment or otherwise) with respect to a Licensed Patent is attributable to loss of sales or profits with respect to a Licensed Product, such amount shall be paid to or retained by AstraZeneca and treated as “Net Sales” in the Calendar Year in which the money is actually received and any royalties pursuant to Section 5.3.1 shall be payable by AstraZeneca to Licensor with respect thereto; provided that any such recovery shall not be considered for purposes of determining whether any milestones are payable pursuant to Section 5.2.
6.5 Infringement Claims by Third Parties. If the Exploitation of a Licensed Product in the Territory pursuant to this Agreement results in, or is reasonably expected to result in, any claim, suit or proceeding by a Third Party alleging infringement by AstraZeneca or any of its Affiliates or its or their Sublicensees, Distributors or customers (a “Third Party Infringement Claim”), including any defense or counterclaim in connection with an Infringement action initiated pursuant to Section 6.4, the Party first becoming aware of such alleged infringement shall promptly notify the other Party thereof in writing. As between the Parties, AstraZeneca shall have the first right, but not the obligation, to defend and control the defense of any such claim, suit or proceeding at its sole cost and expense (but subject to deduction as provided below), using counsel of its own choice. Licensor may participate in any such claim, suit or proceeding with counsel of its choice at its sole cost and expense; provided that AstraZeneca shall retain control of the defense of such claim, suit or proceeding. AstraZeneca shall be entitled to offset [***] percent ([***]%) of the reasonable out-of-pocket costs of defending or settling such claim, suit or proceeding under this Section 6.5, to the extent that the Third Party Infringement Claim arises from the exercise of a Licensed Patent, that are borne by AstraZeneca or its Affiliates and, with respect to any calculation pursuant to Section 5.4(i), its or their Sublicensees, in a given Calendar Quarter (including royalties, milestones and other consideration paid and any damages or other awards assessed in connection therewith) against any amounts owed to Licensor under this Agreement for such Calendar Quarter, with any balance then remaining to be carried over to amounts due with respect to subsequent Calendar Quarters, up to a maximum amount for each Calendar Quarter of [***] percent ([***]%) of the amounts owed with respect to such subsequent Calendar Quarter. Any recoveries awarded to a Party in connection with any Third Party Infringement Claim defended under this Section 6.5 shall be applied first to reimburse such Party for its reasonable out-of-pocket costs of defending such claim, suit or proceedings and then to reimburse the other Party for amounts deducted pursuant to the previous sentence, with the balance of any such recoveries being retained by or provided to such first Party and where retained by or provided to AstraZeneca or its Affiliates shall be regarded as being Net Sales against which royalties are due to Licensor.
6.6 Invalidity or Unenforceability Defenses or Actions. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity or unenforceability of any of the Licensed Patents or the AstraZeneca Patents by a Third Party of which such Party becomes aware. As between the Parties, AstraZeneca shall have (i) the first right, but not the obligation, to defend and control the defense of the validity and enforceability of
34
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
the Licensed Patents and (ii) the sole right, but not the obligation, to defend and control the defense of the validity and enforceability of the AstraZeneca Patents, in each case ((i) and (ii)), at its sole cost and expense in the Territory and using counsel of its own choice, including when such invalidity or unenforceability is raised as a defense or counterclaim in connection with an Infringement action initiated pursuant to Section 6.4. Licensor may participate in any such claim, suit or proceeding in the Territory with counsel of its choice at its sole cost and expense; provided that AstraZeneca shall retain control of the defense in such claim, suit or proceeding. AstraZeneca shall be entitled to offset [***] percent ([***]%) of the reasonable out-of-pocket costs of defending or settling such claim, suit or proceeding under this Section 6.6, to the extent that the claim, suit or proceeding relates to the Licensed Patents, that are borne by AstraZeneca or its Affiliates and, with respect to any calculation pursuant to Section 5.4(i), its or their Sublicensees, in a given Calendar Quarter (including royalties, milestones and other consideration paid and any damages or other awards assessed in connection therewith) against any amounts owed to Licensor under this Agreement for such Calendar Quarter, with any balance then remaining to be carried over to amounts due with respect to subsequent Calendar Quarters, up to a maximum amount for each Calendar Quarter of [***] percent ([***]%) of the amounts owed with respect to such subsequent Calendar Quarter.
6.7 Third Party Rights. If, in the reasonable opinion of AstraZeneca, the Exploitation of a Licensed Compound by AstraZeneca or any of its Affiliates or any of its or their Sublicensees, Distributors or customers infringes or misappropriates or is reasonably expected to infringe or misappropriate any Patent, trade secret or other intellectual property right of a Third Party in any country in the Territory (such right, a “Third Party Right”), then, as between the Parties, AstraZeneca shall notify Licensor and provide such information and reasoning as is available to AstraZeneca to support the basis for a Third Party Right and AstraZeneca shall have the right, but not the obligation, to negotiate and obtain a license or other rights from such Third Party to such Third Party Right as reasonably necessary for AstraZeneca or its Affiliates or its and their Sublicensees to Exploit Licensed Compound and Licensed Products in such country. In the event that AstraZeneca negotiates and obtains any such license from a Third Party, AstraZeneca shall be entitled to deduct amounts payable to such Third Party for such Third Party Right from royalties payable to Licensor hereunder in accordance with Section 5.3.3.
6.8 Product Trademarks.
6.8.1 Notice. Each Party shall provide to the other Party prompt written notice of any actual or threatened infringement of the Product Trademarks in the Territory and of any actual or threatened claim that the use of the Product Trademarks in the Territory violates the rights of any Third Party, in each case, of which such Party becomes aware.
6.8.2 Prosecution of Product Trademarks. AstraZeneca shall have the sole right to register, prosecute and maintain the Product Trademarks using counsel of its own choice. All
35
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
costs and expenses of registering, prosecuting and maintaining the Product Trademarks shall be borne solely by AstraZeneca.
6.8.3 Enforcement of Product Trademarks. AstraZeneca shall have the sole right to take such action as AstraZeneca deems necessary against a Third Party based on any alleged, threatened or actual infringement, dilution, misappropriation or other violation of or unfair trade practices or any other like offense relating to, the Product Trademarks by a Third Party in the Territory at its sole cost and expense and using counsel of its own choice. AstraZeneca shall retain any damages or other amounts collected in connection therewith.
6.8.4 Third Party Claims. AstraZeneca shall have the sole right to defend against and settle any alleged, threatened or actual claim by a Third Party that the use or registration of the Product Trademarks in the Territory infringes, dilutes, misappropriates or otherwise violates any Trademark or other right of that Third Party or constitutes unfair trade practices or any other like offense or any other claims as may be brought by a Third Party against a Party in connection with the use of the Product Trademarks with respect to a Licensed Product in the Territory at its sole cost and expense and using counsel of its own choice. AstraZeneca shall retain any damages or other amounts collected in connection therewith.
ARTICLE 7
CONFIDENTIALITY AND NON-DISCLOSURE
7.1 Confidentiality Obligations. At all times during the Term and for a period of [***] following termination or expiration hereof in its entirety, each Party shall and shall cause its officers, directors, employees and agents to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement. “Confidential Information” means any technical, business or other information provided by or on behalf of one Party to the other Party or its Affiliates in connection with this Agreement, whether prior to, on or after the Effective Date, including the terms of this Agreement (subject to Section 7.4), information relating to any Licensed Compound or any Licensed Product, any Development or Commercialization of any Licensed Compound or any Licensed Product, any know-how with respect thereto developed by or on behalf of the disclosing Party or its Affiliates or, in the case of AstraZeneca, its or their Sublicensees (including AstraZeneca Know-How and Licensed Know-How, as applicable) or the scientific, regulatory or business affairs or other activities of either Party. Notwithstanding the foregoing, Confidential Information constituting (i) the Licensed Know-How shall be deemed the Confidential Information of AstraZeneca and Licensor (and AstraZeneca and Licensor shall each be deemed to the disclosing Party and the receiving Party with respect thereto); and (ii) the terms of this Agreement shall be deemed to be the Confidential Information of both Parties (and both Parties shall be deemed to be the receiving Party and the disclosing Party with respect thereto). Notwithstanding the foregoing, the
36
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
confidentiality and non-use obligations under this Section 7.1 with respect to any Confidential Information shall not include any information that:
7.1.1 is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no breach of this Agreement by the receiving Party;
7.1.2 can be demonstrated by documentation or other competent proof to have been in the receiving Party’s possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; provided that the foregoing exception shall not apply with respect to Confidential Information described in the immediately preceding sentence;
7.1.3 is subsequently received by the receiving Party from a Third Party who is not bound by any obligation of confidentiality with respect to such information;
7.1.4 has been published by a Third Party or otherwise enters the public domain through no fault of the receiving Party in breach of this Agreement; or
7.1.5 can be demonstrated by documentation or other competent evidence to have been independently developed by or for the receiving Party without reference to the disclosing Party’s Confidential Information; provided that the foregoing exception shall not apply with respect to Confidential Information described in the immediately preceding sentence.
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.
7.2 Permitted Disclosures. Each Party may disclose Confidential Information to the extent that such disclosure is:
7.2.1 made in response to a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental or regulatory body of competent jurisdiction or, if in the reasonable opinion of the receiving Party’s legal counsel, such disclosure is otherwise required by law, including by reason of filing with securities regulators; provided that the receiving Party shall first have given notice to the disclosing Party and given the disclosing Party a reasonable opportunity to quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or agency or, if
37
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
disclosed, be used only for the purposes for which the order was issued; and provided, further, that the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order;
7.2.2 made by or on behalf of the receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining or enforcing a Patent; provided that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available; or
7.2.3 made by or on behalf of the receiving Party to potential or actual investors or acquirers as may be necessary in connection with their evaluation of such potential or actual investment or acquisition; provided that such persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this ARTICLE 7 (with a duration of confidentiality and non-use obligations as appropriate that is no less than [***] from the date of disclosure).
7.3 Additional Permitted Disclosures by AstraZeneca. AstraZeneca and its Affiliates and its and their Sublicensees may disclose Confidential Information of Licensor as may be necessary or useful in connection with the Exploitation of the Licensed Compound, the Licensed Products (including in connection with any filing, application or request for Regulatory Approval by or on behalf of AstraZeneca or any of its Affiliates or its or their Sublicensees) or otherwise in connection with the performance of its obligations or exercise of AstraZeneca’s rights as contemplated by this Agreement, including to existing or potential Distributors, Sublicensees, collaboration partners or acquirers, provided that it does so subject to contractual undertakings no less equivalent to those set out in this ARTICLE 7.
7.4 Use of Name. Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo or Trademark of the other Party or any of its Affiliates or any of its or their Sublicensees (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material or other form of publicity without the prior written approval of such other Party. The restrictions imposed by this Section 7.4 shall not prohibit (i) AstraZeneca from making any disclosure identifying Licensor to the extent required in connection with its exercise of its rights or obligations under this Agreement and (ii) either Party from making any disclosure identifying the other Party that is required by Applicable Law or the rules of a stock exchange on which the securities of the disclosing Party are listed (or to which an application for listing has been submitted).
7.5 Public Announcements. The Parties have agreed upon the content of one (1) or more press releases which shall be issued substantially in the form(s) attached hereto as Schedule 7.5, the release of which the Parties shall coordinate in order to accomplish such release promptly
38
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
upon execution of this Agreement. Neither Party shall issue any other public announcement, press release or other public disclosure regarding this Agreement or its subject matter without the other Party’s prior written consent, except for any such disclosure that is, in the opinion of the disclosing Party’s counsel, required by Applicable Law or the rules of a stock exchange on which the securities of the disclosing Party are listed (or to which an application for listing has been submitted). In the event a Party is, in the opinion of its counsel, required by Applicable Law or the rules of a stock exchange on which its securities are listed (or to which an application for listing has been submitted) to make such a public disclosure, such Party shall submit the proposed disclosure in writing to the other Party as far in advance as reasonably practicable (and in no event less than [***] prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon. Notwithstanding the foregoing, AstraZeneca and its Affiliates and its and their Sublicensees shall have the right to publicly disclose research, development and commercial information (including with respect to regulatory matters) regarding the Licensed Compound and Licensed Products; provided such disclosure is subject to the provisions of ARTICLE 7 with respect to Licensor’s Confidential Information. Neither Party shall be required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement or any amendment hereto that has already been publicly disclosed by such Party or by the other Party, in accordance with this Section 9.5, provided that such information remains accurate as of such time and provided the frequency and form of such disclosure are reasonable.
7.6 Publications. The Parties recognize the desirability of publishing and publicly disclosing the results of and information regarding, activities under this Agreement. Accordingly, AstraZeneca shall be free to publicly disclose the results of and information regarding, activities under this Agreement. Subject to Sections 7.2 and 7.5, Licensor shall not and shall cause each of its Affiliates and its and their licensees and sublicensees not to, make any publications or public disclosures regarding the Licensed Compounds or Licensed Products or any Confidential Information of AstraZeneca without AstraZeneca’s prior written consent.
7.7 Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, either Party may request in writing and the non-requesting Party shall either, with respect to Confidential Information to which such non-requesting Party does not retain rights under the surviving provisions of this Agreement:
(i) promptly destroy all copies of such Confidential Information in the possession or control of the non-requesting Party and confirm such destruction in writing to the requesting Party; or
(ii) promptly deliver to the requesting Party, at the non-requesting Party’s sole cost and expense, all copies of such Confidential Information in the possession or control of the non-requesting Party. Notwithstanding the foregoing, the non-requesting Party shall be permitted to retain such Confidential Information (x) to the extent necessary or useful for purposes of performing any continuing obligations or exercising any ongoing rights hereunder and,
39
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
in any event, a single copy of such Confidential Information for archival purposes and (y) any computer records or files containing such Confidential Information that have been created solely by such non-requesting Party’s automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such non-requesting Party’s standard archiving and back-up procedures, but not for any other uses or purposes. All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in Section 7.1.
7.8 Privileged Communications. In furtherance of this Agreement, it is expected that the Parties will, from time to time, disclose to one another privileged communications with counsel, including opinions, memoranda, letters and other written, electronic and verbal communications. Such disclosures are made with the understanding that they shall remain confidential in accordance with this ARTICLE 7, that they will not be deemed to waive any applicable attorney-client or attorney work product or other privilege and that they are made in connection with the shared community of legal interests existing between AstraZeneca and Licensor, including the community of legal interests in avoiding infringement of any valid, enforceable patents of Third Parties and maintaining the validity of the Licensed Patents or the AstraZeneca Patents. In the event of any litigation (or potential litigation) with a Third Party related to this Agreement or the subject matter hereof, the Parties shall, upon either Party’s request, enter into a reasonable and customary joint defense agreement. In any event, each Party shall consult in a timely manner with the other Party before engaging in any conduct (e.g., producing information or documents) in connection with litigation or other proceedings that could conceivably implicate privileges maintained by the other Party. Notwithstanding anything contained in this Section 7.8, nothing in this Agreement shall prejudice a Party’s ability to take discovery of the other Party in disputes between them relating to the Agreement and no information otherwise admissible or discoverable by a Party shall become inadmissible or immune from discovery solely by this Section 7.8.
ARTICLE 8
REPRESENTATIONS AND WARRANTIES
8.1 Mutual Representations and Warranties. Licensor and AstraZeneca each represents and warrants to the other, as of the Effective Date that:
8.1.1 it is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization and has all requisite power and authority, corporate or otherwise, to execute, deliver and perform this Agreement;
8.1.2 the execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action and do not violate: (i) such Party’s charter documents, bylaws or other organizational documents; (ii) in any material respect, any agreement, instrument or contractual obligation to which such Party is bound; (iii) any requirement of any Applicable Law; or (iv) any order, writ, judgment,
40
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
injunction, decree, determination or award of any court or governmental agency presently in effect applicable to such Party;
8.1.3 this Agreement is a legal, valid and binding obligation of such Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance and general principles of equity (whether enforceability is considered a proceeding at law or equity);
8.1.4 it is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement or that would impede the diligent and complete fulfillment of its obligations hereunder; and
8.1.5 neither it nor any of its Affiliates has been debarred or is subject to debarment and neither it nor any of its Affiliates will use in any capacity, in connection with the services to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA or who is the subject of a conviction described in such section. It agrees to inform the other Party in writing promptly if it or any such Person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of its or its Affiliates’ Knowledge, is threatened, relating to the debarment or conviction of it or any such Person performing services hereunder.
8.2 Additional Representations and Warranties of Licensor. Licensor further represents and warrants to AstraZeneca, as of the Effective Date, as follows:
8.2.1 Licensor (i) is entitled to grant the licenses specified herein and
(i) has the right to use all Licensed Know-How and Licensed Patents necessary for the Parties to Exploit the Licensed Compounds as contemplated under this Agreement;
8.2.2 All Licensed Patents are listed on Schedule 1.55 and are (i) subsisting and, to Licensor’s Knowledge are not invalid or unenforceable, in whole or in part; (ii) solely and exclusively owned by Licensor free of any encumbrance, lien or claim of ownership by any Third Party; (iii) the pending applications included in the Licensed Patents are being diligently prosecuted in the respective patent offices in the Territory in accordance with Applicable Law and, to Licensor’s Knowledge, Licensor and its Affiliates have presented all relevant references, documents and information of which it and the inventors are aware to the relevant patent examiner at the relevant patent office; and (iv) filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment;
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
8.2.3 True, complete and correct copies of (i) the file wrappers and other documents and materials relating to the prosecution, defense, maintenance, validity and enforceability of the Licensed Patents and (ii) all license agreements (if any) under which Licensor or its Affiliates are granted rights regarding any intellectual property rights licensed hereunder, including the Licensed Patents, as amended to the date hereof, in each case ((i) and (ii)) have been provided to AstraZeneca prior to the Effective Date or, in the case of (i) only, as soon as reasonably practicable, but no later than fourteen (14) Business Days, following the Effective Date;
8.2.4 To Licensor’s Knowledge, the Licensed Know-How listed in Schedule 2.5 describes all the Information in Licensor’s and its Affiliates’ possession as at the Effective Date relating to the Licensed Compounds, any Licensed Product or the Exploitation thereof. All intellectual property rights relating to the Licensed Compounds or the Exploitation thereof assigned to the Licensor or its Affiliates are Controlled by Licensor.
8.2.5 Neither Licensor nor any of its Affiliates has assigned, transferred, licensed, conveyed or otherwise encumbered its right, title or interest in or to (i) the Licensed Patents, or (ii) to the Licensor’s or its Affiliates Knowledge, Licensed Know-How, the Licensed Compounds or the Licensed Products (including by granting any covenant not to sue with respect thereto) or any Patent or other intellectual property or proprietary right or Information that would be Licensed Patents or Licensed Know-How and it will not enter into any such agreements, grant any such right, title or interest to any Person that is inconsistent with or otherwise diminish the rights and licenses granted to AstraZeneca under this Agreement;
8.2.6 No claim or litigation has been brought or asserted (and Licensor has no Knowledge of any claim, whether or not brought or asserted) by any Person alleging that (i) the Licensed Patents or the Licensed Know-How are invalid or unenforceable or (ii) the conception, development, reduction to practice, disclosing, copying, making, assigning or licensing of the Licensed Know-How existing as of the Effective Date or the Development or Commercialization of the Licensed Compound or Licensed Products as contemplated herein, violates, infringes, constitutes misappropriation or otherwise conflicts or interferes with or would violate, infringe or otherwise conflict or interfere with, any intellectual property or proprietary right of any Person;
8.2.7 Licensor has obtained from its Affiliates the licenses and other rights necessary for Licensor to grant to AstraZeneca the rights and licenses provided herein and for AstraZeneca to perform its obligations hereunder;
8.2.8 To Licensor’s Knowledge, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Licensed Patents or the Licensed Know-How;
8.2.9 To Licensor’s Knowledge, each Person who has or has had any rights in or to any Licensed Patents or any Licensed Know-How, has assigned and has executed an agreement assigning its entire right, title and interest in and to such Licensed Patents and Licensed
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
Know-How to Licensor. To Licensor’s Knowledge, no current officer, employee, agent or consultant of Licensor or any of its Affiliates is in violation of any term of any assignment or other agreement regarding the protection of Patents or other intellectual property or proprietary information of Licensor or such Affiliate or of any employment contract or any other contractual obligation relating to the relationship of any such Person with Licensor;
8.2.10 Licensor has made (and will make, subject to Section 2.5.3) available to AstraZeneca all Licensed Know-How and other Information in its possession or Control related to the Licensed Compound or the Licensed Products and all such Regulatory Documentation, Licensed Know-How and other Information are, to Licensor’s Knowledge, true, complete and correct;
8.2.11 Neither Licensor nor any of its Affiliates has (i) committed (or after the Effective Date, will commit) an act; (ii) made (or after the Effective Date, will make) a statement; or (iii) failed (or after the Effective Date, will fail) to act or make a statement that, in any case ((i), (ii) (iii)), that (x) 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 Exploitation of the Licensed Compound or the Licensed Products or (y) could reasonably be expected to provide a basis for the FDA 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 in the Territory, with respect the Exploitation of the Licensed Compound or the Licensed Products;
8.2.12 To Licensor’s Knowledge, the Licensed Know-How does not, taken as a whole, (i) contain any untrue statement of a material fact or (ii) contain any material omissions that would make the Licensed Know-How misleading.
8.3 DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
8.4 Anti-Bribery and Anti-Corruption Compliance. Both Parties agree, on behalf of itself, its officers, directors and employees and on behalf of its Affiliates, agents, representatives, consultants and subcontractors hired in connection with the subject matter of this Agreement (“Representatives”) that for the performance of its obligations hereunder:
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
8.4.1 Each Party and its Representatives shall comply with the Anti-Corruption Laws and shall not take any action that will, or would reasonably be expected to, cause the other Party or the other Party’s Affiliates to be in violation of any Anti-Corruption Laws; and
8.4.2 Each Party shall promptly provide the other Party with written notice of the following events: (a) upon becoming aware of any breach or violation by that Party or its Representative of any representation, warranty or undertaking set forth in Section 8.4.1, or (b) upon receiving a formal notification that it is the target of a formal investigation by a governmental authority for a Material Anti-Corruption Law Violation or upon receipt of information from any of its Representatives connected with this Agreement that any of them is the target of a formal investigation by a governmental authority for a Material Anti-Corruption Law Violation.
ARTICLE 9
INDEMNITY
9.1 Indemnification of Licensor. AstraZeneca shall indemnify Licensor, its Affiliates and its and their respective directors, officers, employees and agents and defend and save each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) (collectively, “Losses”) in connection with any and all suits, investigations, claims or demands of Third Parties (collectively, “Third Party Claims”) arising from or occurring as a result of: (i) the breach by AstraZeneca of this Agreement, including the enforcement of Licensor’s rights under this Section 9.1; (ii) the gross negligence or willful misconduct on the part of AstraZeneca or its Affiliates or its or their respective directors, officers, employees or agents in performing its or their obligations under this Agreement; or (iii) the Exploitation by AstraZeneca or any of its Affiliates of any Licensed Compound or any Licensed Product in or for the Territory, except, in each case ((i), (ii) and (iii)), for those Losses for which Licensor has an obligation to indemnify AstraZeneca pursuant to Section 9.2 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability; provided, however that AstraZeneca’s indemnification obligation hereunder with respect to any Loss arising from or occurring as a result of the acts or omissions of a permitted Third Party subcontractor hereunder shall be limited to the indemnification, if any, with respect to such Loss that AstraZeneca is entitled to under its agreement with such Third Party subcontractor.
9.2 Indemnification of AstraZeneca. Licensor shall indemnify AstraZeneca, its Affiliates, its or their Sublicensees and Distributors and its and their respective directors, officers, employees and agents and defend and save each of them harmless, from and against any and all Losses in connection with any and all Third Party Claims arising from or occurring as a result of: (i) the breach by Licensor of this Agreement; (ii) the gross negligence or willful misconduct on the part of Licensor or its Affiliates or its or their respective directors, officers, employees or agents in performing its obligations under this Agreement or (iii) the Exploitation of any Licensed Compound or any Licensed Product by the Licensor in the event this Agreement is terminated; except, in each case ((i), (ii) and (iii)), for those Losses for which AstraZeneca has an obligation
44
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
to indemnify Licensor pursuant to Section 9.1 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability.
9.3 Indemnification Procedures.
9.3.1 Notice of Claim. All indemnification claims in respect of a Party, its Affiliates or, in the case of AstraZeneca, its or their Sublicensees or its or their respective directors, officers, employees and agents shall be made solely by such Party to this Agreement (the “Indemnified Party”). The Indemnified Party shall give the indemnifying Party prompt written notice (an “Indemnification Claim Notice”) of any Losses or discovery of fact upon which such indemnified Party intends to base a request for indemnification under this ARTICLE 9, but in no event shall the indemnifying Party be liable for any Losses that result from any delay in providing such notice. Each Indemnification Claim Notice must contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss is known at such time). The Indemnified Party shall furnish promptly to the indemnifying Party copies of all papers and official documents received in respect of any Losses and Third Party Claims.
9.3.2 Control of Defense. At its option, the indemnifying Party may assume the defense of any Third Party Claim by giving written notice to the Indemnified Party within [***] after the indemnifying Party’s receipt of an Indemnification Claim Notice. The assumption of the defense of a Third Party Claim by the indemnifying Party shall not be construed as an acknowledgment that the indemnifying Party is liable to indemnify the Indemnified Party in respect of the Third Party Claim, nor shall it constitute a waiver by the indemnifying Party of any defenses it may assert against the Indemnified Party’s claim for indemnification. Upon assuming the defense of a Third Party Claim, the indemnifying Party may appoint as lead counsel in the defense of the Third Party Claim any legal counsel selected by the indemnifying Party; provided that it obtains the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld, conditioned or delayed). In the event the indemnifying Party assumes the defense of a Third Party Claim, the Indemnified Party shall immediately deliver to the indemnifying Party all original notices and documents (including court papers) received by the Indemnified Party in connection with the Third Party Claim. Should the indemnifying Party assume the defense of a Third Party Claim, except as provided in Section 9.3.3, the indemnifying Party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party in connection with the analysis, defense or settlement of the Third Party Claim unless specifically requested in writing by the indemnifying Party. In the event that it is ultimately determined that the indemnifying Party is not obligated to indemnify, defend or hold harmless the Indemnified Party from and against the Third Party Claim, the Indemnified Party shall reimburse the indemnifying Party for any and all costs and expenses (including attorneys’ fees and costs of suit) and any Losses incurred by the indemnifying Party in its defense of the Third Party Claim.
45
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
9.3.3 Right to Participate in Defense. Any Indemnified Party shall be entitled to participate in, but not control, the defense of such Third Party Claim and to employ counsel of its choice for such purpose; provided, however, that such employment shall be at the Indemnified Party’s sole cost and expense unless (i) the employment thereof has been specifically authorized in writing by the indemnifying Party; (ii) the indemnifying Party has failed to assume the defense and employ counsel in accordance with Section 9.3.2 (in which case the Indemnified Party shall control the defense); or (iii) the interests of the Indemnified Party and the indemnifying Party with respect to such Third Party Claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under Applicable Law, ethical rules or equitable principles.
9.3.4 Settlement. With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim and that shall not result in the applicable Indemnified Party’s becoming subject to injunctive or other relief and as to which the indemnifying Party shall have acknowledged in writing the obligation to indemnify the applicable Indemnified Party hereunder, the indemnifying Party shall have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such terms as the indemnifying Party, in its sole discretion, shall deem appropriate. With respect to all other Losses in connection with Third Party Claims, where the indemnifying Party has assumed the defense of the Third Party Claim in accordance with Section 9.3.2, the indemnifying Party shall have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss; provided it obtains the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld, conditioned or delayed). If the indemnifying Party does not assume and conduct the defense of a Third Party Claim as provided above, the Indemnified Party may defend against such Third Party Claim; provided that the Indemnified Party shall not settle any Third Party Claim without the prior written consent of the indemnifying Party (which consent shall not be unreasonably withheld, conditioned or delayed).
9.3.5 Cooperation. Regardless of whether the indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours afforded to the indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Third Party Claim and making Indemnified Parties and other employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder and the indemnifying Party shall reimburse the Indemnified Party for all its reasonable and verifiable out-of-pocket expenses in connection therewith.
9.3.6 Expenses. Except as provided above, the costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any claim shall be reimbursed on a Calendar Quarter basis by the indemnifying Party, without prejudice to
46
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
the indemnifying Party’s right to contest the Indemnified Party’s right to indemnification and subject to refund in the event the indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party.
9.4 Special, Indirect and Other Losses. EXCEPT (I) IN THE EVENT OF THE WILLFUL MISCONDUCT OR FRAUD OF A PARTY OR A PARTY’S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 7; (II) AS PROVIDED UNDER SECTION 11.10; AND (III) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE 9, NEITHER PARTY NOR ANY OF ITS AFFILIATES OR SUBLICENSEES SHALL BE LIABLE IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY SPECIAL OR PUNITIVE DAMAGES OR FOR LOSS OF PROFITS SUFFERED BY THE OTHER PARTY.
9.5 Licensor’s Liability. Save for Losses which cannot be limited by Applicable Law:
9.5.1 save as set out in Section 9.5.2, the aggregate liability of Licensor under or in connection with this Agreement (including for breach of contract and any tortious liability, but excluding any claim under an indemnity set forth in Section 9.2. (ii) and (iii)) in respect of each Year shall be limited to the greater of: (i) the [***], and (ii) $[***]; and
9.5.2 the aggregate liability of Licensor under the indemnity at Section 9.2 (i) in respect of each Year shall be limited to the greater of: (i) the [***], and (ii) $[***].
9.6 Insurance. Each Party shall have and maintain such types and amounts of insurance covering its activities as is (i) normal and customary in the pharmaceutical industry generally for parties similarly situated and (ii) otherwise required by Applicable Law. Notwithstanding the foregoing, AstraZeneca may self-insure in whole or in party the insurance requirements described above.
ARTICLE 10
TERM AND TERMINATION
10.1 Term and Expiration. This Agreement shall commence on the Effective Date and, unless earlier terminated in accordance herewith, shall continue in force and effect until the date of expiration of the last Royalty Term for the last Licensed Product (such period, the “Term”). Following the expiration of the Royalty Term for a Licensed Product in any country, the grants in Section 2.1 shall become fully-paid, royalty-free, perpetual and irrevocable for such Licensed Product in such country. For clarity, upon the expiration of the Term, the grants in Section 2.1 shall become fully-paid, royalty-free, perpetual and irrevocable in their entirety.
10.2 Termination.
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
10.2.1 Material Breach. In the event that either Party (the “Breaching Party”) shall be in material breach of the performance of any of its material obligations under this Agreement, in addition to any other right and remedy the other Party (the “Non-Breaching Party”) may have, the Non-Breaching Party may terminate this Agreement in its entirety by providing [***] (the “Notice Period”) prior written notice (the “Termination Notice”) to the Breaching Party and specifying the breach and its claim of right to terminate; provided that:
(i) the termination shall not become effective at the end of the Notice Period if the Breaching Party cures the breach specified in the Termination Notice during the Notice Period (or, if such default cannot be cured within the Notice Period, if the Breaching Party commences actions to cure such breach within the Notice Period and thereafter diligently continues such actions);
(ii) with respect to any alleged breach by AstraZeneca of its diligence obligations set forth in Sections 3.2.1(i) or 4.2, Licensor shall first provide written notice thereof to AstraZeneca and the Parties shall meet within [***] after delivery of such notice to AstraZeneca to discuss in good faith such alleged breach and AstraZeneca’s Development or Commercialization plans, as applicable, with respect to the applicable Licensed Product, before Licensor may issue any Termination Notice with respect to such alleged breach (for clarity, the Notice Period shall not commence prior to the conclusion of such good faith discussions and the subsequent issuance of a Termination Notice by Licensor); and
(iii) if either Party initiates a dispute resolution procedure under Section 11.5.1 as permitted under this Agreement within [***] following the end of the Notice Period to resolve the dispute for which termination is being sought and is diligently pursuing such procedure, the cure period set forth in this Section 10.2.1 shall be tolled and the termination shall become effective only if such breach remains uncured for [***] after the final resolution of the dispute through such dispute resolution procedure (or, if the breach cannot be cured within such [***] period, if the Breaching Party commences actions to cure such breach within such period and thereafter diligently continues such actions).
10.2.2 Termination by AstraZeneca. AstraZeneca may terminate this Agreement (i) in its entirety; or (ii) on a Licensed Product-by-Licensed Product basis, for any or no reason, upon [***] prior written notice to Licensor.
10.2.3 Termination for Insolvency. In the event that either Party (i) files for protection under bankruptcy or insolvency laws; (ii) makes an assignment for the benefit of creditors; (iii) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is not discharged within [***] after such filing; (iv) proposes a written agreement of composition or extension of its debts; (v) proposes or is a party to any dissolution or liquidation; (vi) files a petition under any bankruptcy or insolvency act or has any such petition filed against that is not discharged within [***] of the filing thereof; or (vii) admits in writing its inability
48
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
generally to meet its obligations as they fall due in the general course, then the other Party may terminate this Agreement in its entirety effective immediately upon written notice to such Party.
10.3 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by AstraZeneca or Licensor are and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that the Parties, as licensees of such rights under this Agreement, shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against either Party under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, the Party hereto that is not a Party to such proceeding shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, which, if not already in the non-subject Party’s possession, shall be promptly delivered to it (i) upon any such commencement of a bankruptcy proceeding upon the non-subject Party’s written request therefor, unless the Party subject to such proceeding elects to continue to perform all of its obligations under this Agreement; or (ii) if not delivered under clause (i) above, following the rejection of this Agreement by or on behalf of the Party subject to such proceeding upon written request therefor by the non-subject Party. The Parties acknowledge and agree that payments made under Sections 5.2 shall not (x) constitute royalties within the meaning of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction or (y) relate to licenses of intellectual property hereunder.
10.4 Consequences of Termination.
10.4.1 Termination in its Entirety. In the event of a termination of this Agreement in its entirety for any reason:
(i) prior to AstraZeneca’s [***] all rights and licenses granted by either Party hereunder shall immediately terminate and AstraZeneca shall: (a) return to Licensor the Licensed Patents and Licensed Know-How, and (b) grant to Licensor, with effect from the date of termination, an exclusive, fully paid-up, perpetual, irrevocable, sub-licensable and transferable license to the AstraZeneca Patents and AstraZeneca Know-How for the purposes of Exploiting Licensed Products, in the Field and in the Territory;
(ii) following AstraZeneca’s [***], but prior to an assignment pursuant to Section 2.3, all rights and licenses granted by either Party hereunder shall immediately terminate and AstraZeneca shall return to Licensor the Licensed Patents and Licensed Know-How;
(iii) following an assignment pursuant to Section 2.3, AstraZeneca grants to Licensor, with effect from the date of termination, an exclusive, fully paid-up, perpetual,
49
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
irrevocable, sub-licensable and transferable license to the Licensed Patents and the Licensed Know-How for the purposes of Exploiting Licensed Products, in the Field and in the Territory;
(iv) in the event of termination in the case of either (ii) or (iii), at Licensor’s written request, the Parties shall as soon as reasonably practicable negotiate in good faith, upon reasonable commercial terms, a license from AstraZeneca to Licensor under the AstraZeneca Patents, AstraZeneca Know-How and the Product Trademarks, then Controlled by AstraZeneca that, in each case, are reasonably necessary for Licensor to Develop or Commercialize the Licensed Compound or Licensed Products that are or have been the subject of Development or Commercialization hereunder as of the effective date of termination; and
(v) except in connection with a termination pursuant to Section 10.2.2 (i) and unless expressly prohibited by any Regulatory Authority, at Licensor’s written request, AstraZeneca shall transfer control to Licensor of all clinical studies involving Licensed Products being conducted by AstraZeneca as of the effective date of termination and continue to conduct such clinical studies, at Licensor’s cost, for up to [***] to enable such transfer to be completed without interruption of any such clinical study; provided that Licensor has the resources to adequately conduct such clinical studies and to fully indemnify AstraZeneca and its Affiliates and its and their Sublicensees for any Losses incurred in connection therewith.
10.5 Remedies. Except as otherwise expressly provided herein, termination of this Agreement in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity.
10.6 Accrued Rights; Surviving Obligations.
10.6.1 Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration; provided that in no event shall Licensor accrue any rights to, and AstraZeneca shall have no obligation to make, any milestone payment under Section 5.2 based on any milestone event with respect to a Licensed Product that occurs on or after the date of delivery by either Party of any termination notice with respect to such Licensed Product pursuant to Section 10.2. Termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement. Without limiting the foregoing, Sections 5.10.2 and 10.4 and this Section 10.6 and Articles 1, 7, 9 and 11 of this Agreement shall survive the termination or expiration of this Agreement for any reason.
10.6.2 Notwithstanding the termination of AstraZeneca’s licenses and other rights under this Agreement, AstraZeneca shall have the right for [***] after the effective date of such termination to sell or otherwise dispose of all Licensed Product then in its inventory, as though this Agreement had not terminated and such sale or disposition shall not constitute infringement of Licensor’s or its Affiliates’ Patent or other intellectual property or other
50
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
proprietary rights. For the avoidance of doubt, AstraZeneca shall continue to make payments thereon as provided in Section 5.3 (as if this Agreement had not terminated).
ARTICLE 11
MISCELLANEOUS
11.1 Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, shortages, epidemics, pandemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts or other labor disturbances (whether involving the workforce of the nonperforming Party or of any other Person), acts of God or acts, orders, omissions or delays in acting by any governmental authority (except to the extent such delay results from the breach by the nonperforming Party or any of its Affiliates of any term or condition of this Agreement). The nonperforming Party shall notify the other Party of such force majeure within [***] after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the nonperforming Party shall use commercially reasonable efforts to remedy its inability to perform.
11.2 Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United Kingdom, United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other governmental entity in accordance with Applicable Law.
11.3 Assignment.
11.3.1 Neither Party may assign its rights or, except as provided in Sections 2.3, 3.1.3 and 4.5 and ARTICLE 6, delegate its obligations under this Agreement, whether by operation of law or otherwise, in whole or in part without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed, except (a) AstraZeneca shall have the right, without such consent, (i) to perform any or all of its obligations and exercise any or all of its rights under this Agreement through any of its Affiliates or, where applicable its, Sublicensees, and (ii) assign any or all of its rights and delegate any or all of its obligations hereunder to any of its Affiliates or its or their Sublicensees or to any successor in interest (whether by merger, acquisition, asset purchase or otherwise) to all or substantially all of the business to
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
which this Agreement relates; provided that the AstraZeneca shall provide written notice to Licensor within [***] after such assignment or delegation; and (b) Licensor shall have the right, without such consent, to assign any or all of its rights and delegate any or all of its obligations hereunder to any of its Affiliates; provided that Licensor shall provide written notice to AstraZeneca within [***] after such assignment or delegation. Any permitted successor of a Party or any permitted assignee of all of a Party’s rights under this Agreement that has also assumed all of such Party’s obligations hereunder in writing shall, upon any such succession or assignment and assumption, be deemed to be a party to this Agreement as though named herein in substitution for the assigning Party, whereupon the assigning Party shall cease to be a party to this Agreement and shall cease to have any rights or obligations under this Agreement. All such validly assigned rights of a Party shall inure to the benefit of and be enforceable by, and all such validly delegated obligations of such Party shall be binding on and be enforceable against, the permitted successors and assigns of such Party. Any attempted assignment or delegation in violation of this Section 11.3.1 shall be void and of no effect. Notwithstanding any other provision of this Section 11.3.1, the terms of this Agreement may be varied, amended or modified or this Agreement may be suspended, canceled or terminated without the consent of any assignee or delegate that is not deemed pursuant to the provisions of this Section 11.3.1 to have become a party to this Agreement.
11.3.2 The rights to Information, materials and intellectual property: (i) controlled by a Third Party permitted assignee of a Party that were controlled by such assignee (and not such Party) immediately prior to such assignment (other than as a result of a license or other grant of rights, covenant or assignment by such Party or its Affiliates to, or for the benefit of, such Third Party); or (ii) controlled by an Affiliate of a Party that becomes an Affiliate through any Change of Control of such Party, that were controlled by such Affiliate (and not such Party) immediately prior to such Change of Control (other than as a result of a license or other grant of rights, covenant or assignment by such Party or its other Affiliates to, or for the benefit of, such Affiliate), in each case ((i) and (ii)), shall be automatically excluded from the rights licensed or granted to the other Party under this Agreement.
11.4 Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future law and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (i) such provision shall be fully severable, (ii) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (iii) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (iv) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties. To the fullest extent permitted by Applicable Law, each Party hereby waives any provision of law that would render any provision hereof illegal, invalid or unenforceable in any respect.
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
11.5 Dispute Resolution.
11.5.1 Except as provided in Section 1.63.9, 5.10.2 or 11.10, if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a “Dispute”), then either Party shall have the right to refer such Dispute to the Senior Officers for attempted resolution by good faith negotiations during a period of [***]. Any final decision mutually agreed to by the Executive Officers shall be conclusive and binding on the Parties. If such Executive Officers are unable to resolve any such Dispute within such [***] period, either Party shall be free to institute litigation in accordance with Section 11.6 and seek such remedies as may be available. Notwithstanding anything in this Agreement to the contrary, either Party shall be entitled to institute litigation in accordance with Section 11.6 immediately if litigation is necessary to prevent irreparable harm to that Party.
11.6 Governing Law, Jurisdiction and Service.
11.6.1 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of England, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.
11.6.2 Jurisdiction. Subject to Sections 11.5 and 11.10, the Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of England for any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement and agree not to commence any action, suit or proceeding (other than appeals therefrom) related thereto except in such courts.
11.6.3 Venue. The Parties further hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement in the courts of England and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.
11.6.4 Service. Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 11.7.2 shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any such court.
11.7 Notices.
11.7.1 Notice Requirements. Any notice or other communication required or permitted to be given by either Party under this Agreement shall be in writing and shall be deemed
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
given as of (i) the date delivered if delivered by hand, or reputable courier service; (ii) the date sent if sent by email (with transmission confirmed); (iii) the second Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service; or (iv) the fifth (5th) Business day after mailing if mailed by registered or certified mail, postage prepaid and return receipt requested, addressed to the other Party at the addresses specified below, or to such other addresses of which notice shall have been given in accordance with this Section. This Section 11.7.1 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement.
11.7.2 Address for Notice.
|
Licensor |
To: F-star Therapeutics, Inc., Eddeva B920, Babraham Research Campus, Cambridge CB22 3AT, United Kingdom Attention: [***] |
With a copy to:
Email: [***] Attention: [***] |
|
AstraZeneca |
To: AstraZeneca AB (publ) Pepparedsleden 1 SE-431 83 Mölndal, Sweden Attention: [***] Email: [***] |
With a copy to (which shall not constitute effective notice): Email: [***] Attention: [***] |
11.8 Entire Agreement; Amendments. This Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises and representations, whether written or oral, with respect thereto are superseded hereby. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement. No amendment, modification, release or discharge shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties. In the event of any inconsistencies between this Agreement and any schedules or other attachments hereto, the terms of this Agreement shall control.
11.9 English Language. This Agreement shall be written and executed in and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
11.10 Equitable Relief. Each Party acknowledges and agrees that the restrictions set forth in ARTICLE 7 are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into this Agreement in the absence of such restrictions and that any breach or threatened breach of any provision of such Articles may result in irreparable injury to such other Party for which there will be no adequate remedy at law. In the event of a breach or threatened breach of any provision of such Articles, the non-breaching Party shall be authorized and entitled to seek from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, specific performance and an equitable accounting of all earnings, profits and other benefits arising from such breach, which rights shall be cumulative and in addition to any other rights or remedies to which such non-breaching Party may be entitled in law or equity. Both Parties agree to waive any requirement that the other (i) post a bond or other security as a condition for obtaining any such relief and (ii) show irreparable harm, balancing of harms, consideration of the public interest or inadequacy of monetary damages as a remedy. Nothing in this Section 11.10 is intended or should be construed, to limit either Party’s right to equitable relief or any other remedy for a breach of any other provision of this Agreement.
11.11 Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein.
11.12 No Benefit to Third Parties. Except for any rights and immunities granted in this Agreement to any Affiliates, the Contracts (Rights of Third Parties) Act 1999 shall not apply to this Agreement. Except as expressly provided in ARTICLE 11, no Person who is not a party to this Agreement (including any employee, officer, agent, representative or subcontractor of either Party) shall have the right (whether under the Contracts (Rights of Third Parties) Act 1999 or otherwise) to enforce any provision of this Agreement which expressly or by implication confers a benefit on that Person without the express prior agreement in writing of the Parties, which agreement must refer to this Section 11.12.
11.13 Further Assurance. Each Party shall duly execute and deliver or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof or to better assure and confirm unto such other Party its rights and remedies under this Agreement.
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
11.14 Relationship of the Parties. It is expressly agreed that Licensor, on the one hand, and AstraZeneca, on the other hand, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Licensor, on the one hand, nor AstraZeneca, on the other hand, shall have the authority to make any statements, representations or commitments of any kind, or to take any action that will be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such first Party.
11.15 References. Unless otherwise specified, (i) references in this Agreement to any Article, Section or Schedule shall mean references to such Article, Section or Schedule of this Agreement; (ii) references in any Section to any clause are references to such clause of such Section; and (iii) references to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently amended, replaced or supplemented from time to time, as so amended, replaced or supplemented and in effect at the relevant time of reference thereto.
11.16 Construction. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is used in the inclusive sense (and/or). Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term “including”, “include” or “includes” as used herein shall mean including, without limiting the generality of any description preceding such term. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against either Party hereto.
11.17 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may be executed by facsimile, PDF format via email or other electronically transmitted signatures and such signatures shall be deemed to bind each Party hereto as if they were original signatures.
[SIGNATURE PAGE FOLLOWS.]
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the date first written above.
ASTRAZENECA AB (PUBL) F-STAR THERAPEUTICS, INC.
BioPharmaceuticals R&D
By: [***] By: [***]
Name: [***] Name: [***]
Title: [***] Title: [***]
Jul 7, 2021 Jul 7, 2021
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
Schedule 1.53
Licensed Compound
[***]
|
[***] |
[***] |
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
Schedule 1.55
Licensed Patents
[***]
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
Schedule 1.84
[***]
[***]
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
Schedule 2.5
Transition Plan
Stage 1
Compound transfer: The following materials to be transferred to AstraZeneca (delivery details below) within [***] of the Effective Date:
[***]
Contact name and delivery address:
[***]
Licensed Know-How transfer: Where available, the following Licensed Know-How will be transferred to AstraZeneca within [***] of the Effective Date:
[***]
Stage 2
Compound transfer. The following materials to be transferred to AstraZeneca (address provided above) within [***] of the Effective Date:
[***]
Licensed Know-How transfer: Where available, the following Licensed Know-How will be transferred to AstraZeneca within [***] of the Effective Date:
[***]
61
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
Stage 3:
Licensed Know-How transfer: The following Licensed Know-How to be transferred to AstraZeneca within [***] of the Effective Date:
[***]
62
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
Schedule 3.1.2
Template Development Report
Development Report AZDxxx/alternative name
(pursuant to section x.x.x. of the Agreement)
Date
Non-Clinical
Activities Conducted between insert date and insert date
xxxxx
o Summary results: xxx
xxxxx
o Summary results: xxx
Ongoing Activities
xxx
xxx
Activities planned to be initiated within the next [***]
xxx
xxx
Clinical
Activities Conducted between insert date and insert date
xxxxx
o Summary results: xxxxx
Ongoing Activities
xxx
63
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
Activities planned to be initiated within the next [***]
xxx
Regulatory
Activities Conducted between insert date and insert date
xxx
Ongoing Activities
xxx
Activities planned to be initiated within the next [***]
Chemistry Manufacturing and Controls (CMC)
Activities Conducted between insert date and insert date
xxx
Ongoing Activities
xxx
Activities planned to be initiated within the next [***]
xxx
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
Schedule 5.2.1
Other Lead Compounds
The Other Lead Compounds are the following:
[***]
65
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
Schedule 7.5
Press Release
F-star Therapeutics Enters Into Exclusive Licensing Agreement with AstraZeneca for Novel
STING Inhibitors
CAMBRIDGE, United Kingdom and CAMBRIDGE, Mass.- July XX, 2021—(Globe Newswire) F-star Therapeutics, Inc. (NASDAQ: FSTX) (“F-star” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing next generation bispecific immunotherapies to transform the lives of patients with cancer, today announced that it has entered into an exclusive license agreement with AstraZeneca plc (NASDAQ: AZN) (“AstraZeneca”), under which AstraZeneca will receive global rights to research, develop and commercialize next generation Stimulator of Interferon Genes (“STING”) inhibitor compounds.
Under the terms of the agreement, AstraZeneca is granted exclusive access to novel preclinical STING inhibitors. AstraZeneca will be responsible for all future research, development and commercialization of the STING inhibitor compounds, and F-star will retain rights to all STING agonists, currently in clinical development for patients with cancer.
Neil Brewis, Chief Scientific Officer of F-star, said, “We are excited to announce this agreement with AstraZeneca to develop these promising drug candidates. STING inhibitors offer enormous potential for new treatments, as STING is known to play a role in activating the innate immune system across a range of inflammatory and autoimmune diseases. We are confident that AstraZeneca can maximize the value of these discovery stage compounds to benefit patients.”
Maria Belvisi, Senior Vice President and Head of Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&D of AstraZeneca, said, “As part of our bold ambition to develop therapeutic options for patients across immune mediated diseases I am delighted to announce this agreement with F-star to explore novel STING inhibitors. We look forward to advancing our discovery efforts in these areas of high unmet medical need.”
F-star is eligible to receive upfront and near-term payments of up to $12 million. In addition, F-star will be eligible for development and sales milestone payments of over $300 million, as well as single digit percentage royalty payments. Payments received by F-star are subject to a contingent value rights agreement (CVR 2), under which a percentage will be payable to stockholders of F-star that were previously stockholders of Spring Bank Pharmaceuticals, Inc. (“Spring Bank”) prior to the business combination between F-star and Spring Bank.
About F-star Therapeutics, Inc.
F-star is a clinical-stage biopharmaceutical company developing tetravalent bispecific antibodies for a paradigm shift in cancer therapy. By developing medicines that seek to block tumor immune
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Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
evasion, the Company’s goal is to offer patients greater and more durable benefits than current immuno-oncology treatments. Through its proprietary tetravalent, bispecific natural antibody (mAb2TM) format, F-star’s mission is to generate highly differentiated best-in-class drug candidates with monoclonal antibody-like manufacturability. For more information visit www.f-star.com and follow us on LinkedIn and Twitter.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” or the negative of these terms or other comparable terminology, which are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, the therapeutic potential of F-star’s product candidates, the potential success of the collaboration between F-star and AstraZeneca and F-star’s potential receipt of milestone and sales-based payments from AstraZeneca. You are cautioned not to place undue reliance on these statements. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected.
Such forward-looking statements are based on F-star’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, risks relating to F-star’s status as a clinical stage immuno-oncology company and its need for substantial additional funding in order to complete the development and commercialization of its product candidates, that it may experience delays in completing, or ultimately be unable to complete, the development and commercialization of its product candidates, that its clinical trials may fail to adequately demonstrate the safety and efficacy of its product candidates, that results of preclinical studies and early stage clinical trials may not be predictive of the results of later state clinical trials, that F-star faces significant competition in its drug discovery and development efforts, risks from global pandemics including COVID-19, legislative, regulatory, political and economic developments, references to novel technologies and methods and F-star’s business and product development plans, including the advancement of F-star’s proprietary and co-development programs, and inherent uncertainties associated with developing new products or technologies.
New factors emerge from time to time and it is not possible for F-star to predict all such factors, nor can it assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed in F-star’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed from time to time with
67
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
the Securities and Exchange Commission. Forward-looking statements included in this press release are based on information available to us as of the date of this press release. F-star does not undertake any obligation to update such forward-looking statements to reflect new information, events or circumstances after the date of this press release, except to the extent required by law.
For further information, please contact:
For investor inquiries
Lindsey Trickett
VP Investor Relations & Communications
+1 240 543 7970
lindsey.trickett@f-star.com
For media inquiries
Helen Shik
Shik Communications LLC
+1 617-510-4373
IF " DOCVARIABLE "SWDocIDLocation" 3" = "3" " DOCPROPERTY "SWDocID" 117262163v.9" "" 117262163v.9Shik.Helen10@gmail.com
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Exhibit 10.3
Confidential Treatment Requested by F-star Therapeutics, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
LICENSE AND COLLABORATION AGREEMENT
between
F-Star Therapeutics Limited,
and
JANSSEN BIOTECH, INC.
Dated as of October 19, 2021
TABLE OF CONTENTS
|
ARTICLE 1 DEFINITIONS AND INTERPRETATION |
3 |
|
ARTICLE 2 RESEARCH PROGRAM |
19 |
|
ARTICLE 3 TARGETS |
21 |
|
ARTICLE 4 DEVELOPMENT AND CommercialiZation |
26 |
|
ARTICLE 5 ADDITIONAL LICENSING PROVISIONS AND TECHNOLOGY TRANSFER |
28 |
|
ARTICLE 6 EXCLUSIVITY |
29 |
|
ARTICLE 7 Regulatory matters |
30 |
|
ARTICLE 8 Alliance MANAGEMENT |
30 |
|
ARTICLE 9 MILESTONE PAYMENTS |
31 |
|
ARTICLE 10 Royalties |
35 |
|
ARTICLE 11 ADDITIONAL Payment TERMS |
41 |
|
ARTICLE 12 INTELLECTUAL PROPERTY |
44 |
|
ARTICLE 13 Confidentiality and Non-Disclosure |
51 |
|
ARTICLE 14 representations and warranties |
57 |
|
ARTICLE 15 Indemnity |
60 |
|
ARTICLE 16 TERM AND TERMINATION |
65 |
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ARTICLE 17 Miscellaneous |
74 |
|
Schedule 1 |
84 |
|
Schedule 2 |
85 |
|
Schedule 3 |
86 |
|
Schedule 4 |
87 |
|
Schedule 5 |
88 |
|
Schedule 6 |
89 |
|
Schedule 7 |
90 |
|
Schedule 8 |
91 |
|
Schedule 9 |
92 |
|
Schedule 10 |
93 |
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THIS LICENSE AND COLLABORATION AGREEMENT (the “Agreement”) is made and entered into on October 19, 2021 (the “Effective Date”) by and between:
(1) F-star THERAPEUTICS Limited, a limited company incorporated under the laws of England and Wales with company number 11532458, whose registered office is at Eddeva B920 Babraham Research Campus, Cambridge, CB22 3AT, United Kingdom (“F-star”) for itself and on behalf of its Affiliates, and
(2) JANSSEN BIOTECH, INC., a Pennsylvania corporation with offices at 800 Ridgeview Road, Horsham, PA 19044, USA (“Janssen”),
(each of F-star and Janssen being a “Party” and together the “Parties”).
RECITALS
(A) F-star Controls certain intellectual property rights with respect to mAb2.
(B) The Parties have agreed that, pursuant to the Agreement, Janssen shall undertake the Research Program in respect of up to five (5) Research mAb2 and have the option to thereafter Exploit up to five (5) Subject mAb2, in each case in accordance with the terms and conditions set out in the Agreement.
OPERATIVE PROVISIONS
NOW, THEREFORE, for and in consideration of the covenants and obligations contained herein, the Parties hereby agree as follows:
ARTICLE 1
DEFINITIONS AND INTERPRETATION
As used in the Agreement and the Schedules to the Agreement the following capitalised terms, whether used in the singular or plural, shall have the meanings set out below:
1.1 “Acquiror Group Companies” has the meaning set forth in Section 6.3.1.
1.2 “Action” means any claim, action, cause of action or suit (whether in contract or tort or otherwise), litigation (whether at law or in equity, whether civil or criminal), controversy, assessment, arbitration, investigation, hearing, charge, complaint, demand, notice or proceeding of, to, from, by or before any Governmental Authority.
1.3 “Active Program” means a clinical or pre-clinical research program being conducted by F-star, any of its Affiliates or any Third-Party (under license from F-star or any of its Affiliates), or for which financial or FTE resources have been committed or are being expended by F-star or any of its Affiliates, for the research and/or Development of mAb2 having [***]. An Active Program for a given mAb2 shall be deemed to include [***].
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1.4 “Affiliate” means, with respect to a Party, any Person that, at the relevant time, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party. For the purposes of this definition, “control” and, with correlative meanings, the terms “controlling”, “controlled by” and “under common control with” means (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a Person (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).
1.5 “Agreement” has the meaning set forth in the preamble hereto.
1.6 “Alliance Manager” has the meaning set forth in Section 8.1.
1.7 “Antibody” means an immunoglobulin (Ig) molecule or fragment thereof that binds to at least one antigen, or a nucleic acid-containing molecule that encodes such an immunoglobulin molecule or fragment thereof.
1.8 “API” means an active pharmaceutical ingredient.
1.9 “Applicable Law” means all applicable provisions of any and all federal, national, supranational, provincial and local laws, rules and regulations (including any rules, regulations, guidelines or other requirements of any Government Authority or Regulatory Authority within the applicable jurisdiction that may be in effect from time to time including, General Data Protection Regulation (EU) 2016/679 and equivalent legislation in the applicable jurisdiction; good laboratory and manufacturing practices; the Clinical Trials Regulation (EU) 536/2014, Clinical Trials Directive 2001/20/EC and Good Clinical Practice Directive 2005/28/EC and all applicable implementing or amending legislation and guidelines for countries within the EU; the current version of the Declaration of Helsinki in force; the current International Conference on Harmonization Guidelines for Good Clinical Practice in force and the United States Federal Food, Drug, and Cosmetic Act), all as amended or replaced from time to time, together with any rules, regulations, and compliance guidance promulgated thereunder.
1.10 “Available Target” means individually each of, and collectively all of, the five (5) [***], provided that a Target shall no longer be an Available Target if it has been replaced in accordance with Section 3.5.
1.11 “Available to be Licensed” has the meaning set forth in Section 3.2.1.
1.12 “Available for Reference Use” has the meaning set forth in Section 3.2.2.
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1.13 “Availability Notice” has the meaning set forth in Section 3.4.
1.14 “Average Net Selling Price” has the meaning set forth in Section 10.5.4.
1.15 “Bankruptcy Code” means Title 11 of the United States Code, as may be amended or superseded from time to time.
1.16 “Breaching Party” has the meaning set forth in Section 16.3.1.
1.17 “Business Day” means a day, other than a Saturday or Sunday or a public holiday day in the United States or in the United Kingdom.
1.18 “Calendar Quarter” means a financial quarter based on the Calendar Year (as defined in Section 1.19); provided, however, that the first Calendar Quarter for the first Calendar Year extends from the Effective Date to the end of the then-current Calendar Quarter and the last Calendar Quarter extends from the first day of such Calendar Quarter until the effective date of the termination or expiration of the Agreement.
1.19 “Calendar Year” means a year based on the Johnson & Johnson Universal Calendar for that year used by Janssen or its Affiliates for internal and external reporting purposes (a copy of which for 2021 and 2022 is attached hereto as Schedule 1 and for additional years shall be provided upon request). The last Calendar Year of the Term begins on the first day of the Johnson & Johnson Universal Calendar Year for the year during which termination or expiration of the Agreement will occur, and the last day of such Calendar Year will be the effective date of such termination or expiration. The first Calendar Year will begin on the Effective Date and end on the last day of the first full Calendar Year thereafter.
1.20 [***]
1.21 “Change in Control” means a change of control (as defined in the definition of Affiliate) of a Party by way of share acquisition, merger, or other agreement with a Third-Party, or the sale of all or substantially all of the assets to which the Agreement relates to such person.
1.22 “Claim” has the meaning set forth in Section 15.1.
1.23 “Clinical Studies” means individually and collectively, any Phase I Clinical Studies, Phase II Clinical Studies, Phase III Clinical Studies, and any other investigational research study in which human subjects are dosed with a Product, whether approved or investigational.
1.24 “Clinical Study Purposes” has the meaning set forth in Section 13.2.
1.25 “Combination Product” has the meaning set forth in Section 10.5.3.
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1.26 “Commercialization” means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Product, including activities related to marketing, promoting, distributing, importing and exporting such Product, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialisation, and “Commercialized” has a corresponding meaning.
1.27 “Commercially Reasonable Efforts” means, with respect to the Development or Commercialization of a Product by Janssen or its Affiliates, [***], taking into account all relevant factors.
1.28 “Competing Product” means: [***]. For clarity, a Competing Product shall cease to be a Competing Product as of [***].
1.29 “Confidential Information” means any non-public, confidential or proprietary Know-How provided orally, visually, in writing or other form by or on behalf of a Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with the Agreement, whether prior to, on, or after the Effective Date, including Know-How relating to the terms of the Agreement, any Fcab, any Fab, any mAb2 or any Product, any Exploitation of any Fcab, any Fab, any mAb2 or any Product, any Know-How with respect thereto developed by or on behalf of the disclosing Party or its Affiliates, or the scientific, financial, operational, regulatory or business affairs or other activities of the disclosing Party. Know-How identified as being confidential that was disclosed between the Parties under the [***] shall be considered Confidential Information under the Agreement and may be used for the purposes permitted hereunder. Notwithstanding the foregoing, F-star IP shall be considered Confidential Information of F-star, and Product IP and Janssen Fab IP shall be considered Confidential Information of Janssen.
1.30 “Control” or “Controlled”, other than for purposes of Section 1.4, means the ability of a Party to grant to the other Party access or a license or sublicense without violating the terms of any agreement or other arrangement with a Third-Party and without misappropriating or infringing the proprietary or trade secret information of a Third-Party.
1.31 “Controlling Party” has the meaning set forth in Section 12.4.4.
1.32 “Cover,” “Covering” or “Covered” means, in reference to a claim of a Patent Right in a particular country or other jurisdiction with respect to particular subject matter (such as a composition of matter, product, manufacturing or other process, or method of use), that the claim (as interpreted under principles of patent law in such jurisdiction) reads on or encompasses such subject matter.
1.33 “Cure Period” has the meaning set forth in Section 16.3.1.
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1.34 “Currency Hedge Rate” means the rate that is calculated as a weighted average hedge rate of the outstanding external foreign currency forward hedge contracts of Johnson & Johnson with Third-Party banks.
1.35 “Default Notice” “has the meaning set forth in Section 16.3.1.
1.36 “Development” means all activities related to pre-clinical and other non-clinical research, testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of drug or medicine approval applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval; and Development shall include, for the avoidance of doubt, any submissions and activities required in support thereof, required by Applicable Laws or a Regulatory Authority as a condition or in support of obtaining a Price and Reimbursement Approval for an approved molecule or product. When used as a verb, “Develop” means to engage in Development.
1.37 “Development and Commercialization Term” means, on a Subject mAb2-by-Subject mAb2 basis, the term commencing as of [***] for a Subject mAb2 and expiring on the earlier of [***].
1.38 “Development Milestone” has the meaning set forth in Section 9.3.1
1.39 “Development Milestone Payment” has the meaning set forth in Section 9.3.1.
1.40 “Dispute” means any dispute, claim, or controversy arising from or regarding the Agreement, including the interpretation, application, breach, termination, or validity of any provision hereof. For the avoidance of doubt, any matter within the decision-making authority of the Parties or subject to the agreement of the Parties shall not be deemed a Dispute merely if a unanimous decision cannot be reached or if one of the Parties has the final decision making authority on such matter; however, if a controversy between the Parties arises regarding the interpretation of any provisions hereunder pertaining to any decision within the Agreement that cannot be made due to such controversy, such controversy shall be deemed a Dispute to the extent of such controversy.
1.41 “Distributors” has the meaning set forth in Section 4.7.
1.42 “Dollars”/“$” means US dollars.
1.43 “Effective Date” has the meaning set forth in the preamble hereto.
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1.44 “EMA” means the European Medicines Agency and any successor agency that is responsible for reviewing applications seeking approval for the sale of pharmaceuticals in the EU.
1.45 “Enforcement Action” has the meaning set forth in Section 12.4.4.
1.46 “Engagement Letter” has the meaning set forth in Section 3.8.1.
1.47 “European Union” or “EU” means the countries of the European Union, as the European Union is constituted as of the Effective Date and as it may be modified from time to time.
1.48 “Exploit”, “Exploiting” or “Exploitation” means to make, have made, import, have imported, use, have used, sell, offer for sale, research, Develop, Commercialize, register, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), export, transport, distribute, promote, market or have sold or otherwise dispose of.
1.49 “F-star Fab IP” means Fab IP Controlled by F-star or its Affiliates on the Effective Date or during the Term.
1.50 “F-star IP” means any and all Know-How and Patent Rights Controlled by F-star or its Affiliates on the Effective Date or during the Term that are necessary or useful for [***]. F-star IP includes the [***] but excludes any [***].
1.51 “F-star Product IP” means the F-star Product Know-How and F-star Product Patent Rights.
1.52 “F-star Product Know-How” means Product Know-How generated or otherwise Controlled by F-star or its Affiliates.
1.53 “F-star Product Patent Rights” means Product Patent Rights that are assigned to Janssen pursuant to Section 12.1.4(a) of the Agreement.
1.54 “Fab” means the region on an Antibody that binds to a Fab Target which comprises at least one variable domain.
1.55 “Fab IP” means any and all Know-How and Patent Rights relating to the composition of matter, method of use or method of manufacturing of any Fab comprised within a Subject mAb2.
1.56 “Fab Target” means the Target to which the Fab region of a mAb2 binds.
1.57 “Fcab” means the antigen binding loops in the CH3 domain of the Fc region of an Antibody that confers specific binding of the Fc region to the Fcab Target.
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1.58 “Fcab Platform Improvement Patent Rights” means any and all Patent Rights Covering Fcab Platform Improvements.
1.59 “Fcab Platform Improvements” means any adaptation, change, or modification to Fcab Platform Technology generated by or on behalf of Janssen or its Affiliates during the Term using the Fcab Platform Technology but excluding both (a) Janssen Fab IP and (b) Product IP.
1.60 “Fcab Platform IP” means the Fcab Platform Technology, the Fcab Platform Improvements, the Fcab Platform Technology Patent Rights, and the Fcab Platform Improvement Patent Rights.
1.61 “Fcab Platform Patent Rights” means, collectively, the Fcab Platform Technology Patent Rights and Fcab Platform Improvement Patent Rights.
1.62 “Fcab Platform Technology Patent Rights” means any and all Patent Rights Covering Fcab Platform Technology. F-star Platform Technology Patent Rights existing as of the Effective Date are set out in Schedule 2. Fcab Platform Technology Patent Rights exclude Fcab Platform Improvement Patent Rights.
1.63 “Fcab Platform Technology” means any and all Know-How relating to [***], that is (i) owned or Controlled by F-star or its Affiliates at the Effective Date or during the Term (but excluding Fcab Platform Improvements) or (ii) generated by or on behalf of F-star or its Affiliates during the Term.
1.64 “Fcab Target” means a Target to which the Fcab domain of a mAb2 binds.
1.65 “FDA” means the U.S. Food and Drug Administration, and any successor government agency that is responsible for approving the sale of pharmaceuticals in the United States.
1.66 “Field” means therapeutic, prophylactic, and diagnostic use in humans and animals.
1.67 “First Commercial Sale” means, with respect to a Product in any country in the Territory, the first sale by Janssen or its Affiliates or Sublicensees to a Third-Party (other than a Sublicensee) for use or consumption by an end-user of that Product in that country after all required Regulatory Approvals and Price and Reimbursement Approval for commercial sale of that Product have been obtained in such country. Product provided for: (a) research and Clinical Study purposes; (b) compassionate use, named patient sales, patient assistance programs; (c) similar uses in a limited number to support Regulatory Approvals, such as test marketing programs or other similar programs or studies (provided that the Product is not otherwise generally available for purchase in such country); and (d) early access programs, in each case ((a) – (d)), shall not constitute a First Commercial Sale of such Product. In addition, sales of a Product between (a)
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Janssen and its Affiliates, or (b) Janssen and its Affiliates, on the one hand, and Sublicensees, on the other hand, shall not constitute a First Commercial Sale.
1.68 “First Technology Access Fee” has the meaning set forth in Section 9.1.
1.69 “Gatekeeper” means a Third-Party independent legal counsel engaged by the Parties for the purpose of handling determinations regarding Unavailable Targets, Reference Targets and Available Targets in accordance with ARTICLE 3.
1.70 “Gatekeeper Agreement” has the meaning set forth in Section 3.8.1.
1.71 “Gatekeeper Services” has the meaning set forth in Section 3.8.1.
1.72 “Generic” means, in a particular country with respect to a particular Product, any biopharmaceutical product that: (a) has received all necessary approvals by the applicable Regulatory Authority in such country to market and sell such product as a biopharmaceutical product in such country; (b) is marketed or sold by a Third-Party who is not a licensee or Sublicensee of Janssen or its Affiliates regarding such biopharmaceutical product in such country; and (c) is approved as (i) a “biosimilar” (in the United States) of such Product, (ii) a “similar biological medicinal product” (in the EU) with respect to which such Product is the “reference medicinal product,” or (iii) if not in the US or EU, the local equivalent of a “biosimilar” or “similar biological medicinal product” of such Product, in each case, for use in such country pursuant to a regulatory approval process governing approval of generic biologics based on the then-current standards for regulatory approval in such country (e.g., the United States Biologics Price Competition and Innovation Act of 2009 or a similar or equivalent legislation under local law).
1.73 “Government Authority” means any national, federal, state or local government, or political subdivision thereof, or any multinational organization or authority or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof) or any government arbitrator or arbitral body.
1.74 “Government Order” means any order, writ, judgment, injunction, decree, stipulation, ruling, determination or award entered by or with any Governmental Authority.
1.75 “Identified Target(s)” has the meaning set forth in Section 3.1.
1.76 “Identified Target Notice” has the meaning set forth in Section 3.1.
1.77 “Income Taxes” shall have the meaning set forth in Section 11.5.5.
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1.78 “IND” means (a) an Investigational New Drug Application as defined in the United States Federal Food, Drug and Cosmetic Act, as amended, and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the applicable Regulatory Authority in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a drug or medicine in humans in such jurisdiction, and all supplements, amendments, variations, extensions and renewals thereof that may be filed.
1.79 “Indirect Taxes” shall have the meaning set forth in Section 11.5.5.
1.80 “Indemnified Party” has the meaning set forth in Section 15.1.
1.81 “Indemnified Persons” means, with respect to a Party, such Party and its Affiliates, and their respective officers, directors, employees, and agents.
1.82 “Indemnifying Party” has the meaning set forth in Section 15.1.
1.83 “Indirect Taxes” shall have the meaning set forth in Section 11.5.5.
1.84 [***] means the initial research objectives applying to each Research mAb2 being researched under the Research Program, as the same are described in Error! Reference source not found..
1.85 “Initial Research Term” has the meaning set forth in Section 1.143.
1.86 “Inventions” means inventions, patentable or not, conceived and/or reduced to practice during the course of the performance of activities pursuant to the Agreement.
1.87 “Janssen Fab Construct” means [***].
1.88 “Janssen Fab IP” means Fab IP Controlled by Janssen or its Affiliates on the Effective Date or during the Term.
1.89 “Janssen Product Patent Rights” means Product Patent Rights Controlled by Janssen or its Affiliates but excluding Product Patent Right(s) that are assigned to Janssen pursuant to Section 12.1.4(a) of the Agreement.
1.90 “Know-How” means any information not generally known to the public, whether patentable or not, including ideas, concepts, formulas, methods, procedures, designs, compositions, plans, documents, data, inventions, discoveries, works of authorship, compounds and biological materials. Know-How excludes information contained in a published patent application.
1.91 “Licenses” means the licenses granted under Section 2.2 and Section 4.2.
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1.92 “Licensed F-star [***] Patent Rights” shall have the meaning set forth in Section 12.2.1(b).
1.93 “Licensed F-star Patent Rights” shall have the meaning set forth in Section 12.2.1(a).
1.94 “Losses” means damages, losses, liabilities, costs (including costs of investigation and defense), fines, penalties, Government Orders, taxes, expenses or amounts paid in settlement (in each case, including reasonable attorneys’ and experts fees and expenses), resulting from a Claim in an Action of a Third-Party or Governmental Authority, and incurred by a Party (or other Indemnified Person as provided in ARTICLE 15) as a result of such Action.
1.95 “mAb2” means an Antibody which comprises (a) an Fcab and (b) a Fab.
1.96 “mAb2 Construct” means [***].
1.97 “Major [***] Countries” means [***], and “Major [***] Country” means any one of them.
1.98 “Major Market Countries” means [***], and “Major Market Country” means any one of them.
1.99 “Manufacture”, “Manufactured” and “Manufacturing” means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labelling, shipping, and holding of any molecule, product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial production and analytic development, product characterisation, supply chain, stability testing, quality assurance testing and release, and quality control.
1.100 “Milestone” means an individual Development Milestone or a Sales Milestone, and “Milestones” means, collectively, the Development Milestones and Sales Milestones.
1.101 “Milestone Payment” means an individual Development Milestone Payment or Sales Milestone Payment, and “Milestone Payments” means, collectively, the Development Milestone Payments and Sales Milestone Payments.
1.102 “Net Sales” has the meaning set forth in Section 10.2.1.
1.103 “NME Selection” means the selection by Janssen’s NME Selection committee (or such committee that is equivalent or a replacement to such committee) and endorsed by the Global Therapeutic Area Head for Janssen Oncology (or such role holder equivalent or a replacement to such role holder), or his/her designee, of a [***], which decision shall
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be based in part on Janssen’s review of a research package containing at least the criteria described in Schedule 3.
1.104 “Non-Breaching Party” has the meaning set forth in Section 16.3.1.
1.105 “Notice of NME Selection” has the meaning set forth in Section 4.1.1.
1.106 “Ongoing Clinical Study” means a Clinical Study of a Product for which the Agreement is terminated that is ongoing as of the effective date of termination.
1.107 “Original Product” has the meaning set forth in Section 9.3.2.
1.108 “Out-of-Pocket Costs” means expenses actually paid (with no mark-up) to any Third-Party that is either: (i) not an Affiliate of a Party claiming such expenses, or (ii) is an Affiliate of that Party where such payment is limited to reimbursing such Affiliate for expenses actually paid by such Affiliate to a Third-Party that is not an Affiliate of the Party claiming such expenses.
1.109 “Party” and “Parties” have the meaning set forth in the preamble hereto.
1.110 “Patent Controversy” means any Dispute between the Parties to the extent that it involves an issue relating to the inventorship, claim scope or interpretation, infringement, enforceability, patentability, or validity of any Patent Right hereunder, and including any such issues relevant to any Prosecution activities hereunder.
1.111 “Patent Representative” has the meaning set forth in Section 12.9.
1.112 “Patent Rights” means any and all national, regional, and international patents and patent applications, including any continuations, divisionals, national-stage applications, provisionals, continued prosecution applications, continuations-in-part, additions, substitutions, extensions (including any supplementary protection certificates and the like) and term restorations, registrations, confirmations, re-examinations, renewals, or reissues thereof, and any foreign counterpart of any of the foregoing.
1.113 “Patent Working Group” has the meaning set forth in Section 12.9.
1.114 “Patent Office” means the United States Patent and Trademark Office, European Patent Office, or other Governmental Authority responsible for the examination of patent applications or granting of patents in a country, region, or supra-national jurisdiction.
1.115 “Payee” shall have the meaning set forth in Section 11.5.2.
1.116 “Payor” shall have the meaning set forth in Section 11.5.2.
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1.117 “Person” means any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government, or any agency or political subdivisions thereof.
1.118 “Phase I Clinical Study” means any study in any country in humans the principal purpose of which is preliminary determination of safety of a Product in healthy individuals or patients as described under 21 C.F.R. §312.21(a) with respect to the United States, or, with respect to a jurisdiction other than the United States, a similar clinical study.
1.119 “Phase II Clinical Study” means a preliminary efficacy, dose-focusing (to provide initial information on exposure-response or dose-response relationships and help determine appropriate dose-range) or safety human clinical study in any country of a Product in the target patient population, as described under 21 C.F.R. §312.21(b) with respect to the United States, or, with respect to a jurisdiction other than the United States, a similar clinical study.
1.120 “Phase III Clinical Study” means a clinical study in any country designed as a pivotal confirmatory study to demonstrate the efficacy and safety of a Product with respect to a given indication, which study is performed for purposes of filing an application to obtain Regulatory Approval (e.g., NDA, BLA, or MAA) for such Product for such indication in any country (regardless of whether such Clinical Study is identified as a phase III clinical study on ClinicalTrials.gov), including a clinical study as described under 21 C.F.R. §312.21(c) with respect to the United States, or, with respect to a jurisdiction other than the United States, a similar clinical study.
1.121 “Price and Reimbursement Approval” means any approvals, licenses, registrations or authorisations of any supranational, national, regional, state or local Regulatory Authority or other regulatory agency, department, bureau or Government Authority, required by Applicable Law to determine or set the pricing of a Product, and/or its reimbursement level by the relevant health authorities, providers or other funding institutions, at supranational, national, regional, state or local level.
1.122 “Prior CDA” means the Confidentiality Agreement entered into between F-star’s Affiliate, F-star Therapeutics, Inc., and Janssen’s Affiliate, Johnson and Johnson Innovation Limited, dated [***], as amended thereafter.
1.123 “Prior MTA” means the Material Transfer Agreement, dated [***], entered into between F-star’s Affiliate, F-star Therapeutics, Inc., and Janssen.
1.124 “Product” means any pharmaceutical product in any form [***], in any dosage form, formulation or method of delivery alone or in combination with one or more other API. Products in any and all forms, in current and future formulations, dosage forms and
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strengths, and delivery modes, including any improvements thereto shall be deemed to be the same Product.
1.125 “Product IP” means, individually and collectively, Product Know-How and Product Patent Rights, including for clarity, the F-star Product IP.
1.126 “Product Know-How” means any and all Know-How, including Inventions, relating to a Subject mAb2 and/or a Product that is generated or otherwise Controlled (i) by or on behalf of Janssen or its Affiliates or (ii) by or on behalf of F-star or its Affiliates, either (i) and (ii), as a result of the Parties’ respective activities under this Agreement. Product IP shall not include Fcab Platform IP or Fab IP.
1.127 “Product Patent Rights” means Patent Rights Covering Product Know-How, including for clarity, the Product Patent Rights within the F-star Product IP.
1.128 “Product Royalty Term” shall have the meaning set forth in Section 10.6.
1.129 “Prosecution and Maintenance” or “Prosecute and Maintain” with regard to a Patent Right means the preparing, filing, prosecuting and maintenance of such Patent Right, as well as re-examinations, reissues, requests for patent term extensions and the like with respect to such Patent Right, together with the conduct of interferences, the defense of oppositions and other similar proceedings with respect to the particular Patent Right.
1.130 “Reference mAb2” means a mAb² where [***].
1.131 “Reference Target” means individually each of, and collectively all of, the [***] in accordance with the process set out in ARTICLE 3 provided that a Target shall no longer be a Reference Target upon [***].
1.132 “Regulatory Approval” means the approval of the applicable Regulatory Authority necessary for the marketing and sale of a Product in the Field in a country. “Regulatory Approval” shall not include Price and Reimbursement Approvals.
1.133 “Regulatory Authority” means any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other Government Authority with authority over the marketing and sale of a pharmaceutical product in a country, including the FDA and the EMA.
1.134 “Regulatory Filings” means filings and applications with any Regulatory Authority with respect to a Product, or its use or potential use in humans.
1.135 “Relevant Transaction” has the meaning set forth in Section 6.3.
1.136 “Relevant Terminated Subject mAb2” has the meaning set forth in Section 16.7.8.
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1.137 “Replacement Product” has the meaning set forth in Section 9.3.2.
1.138 “Replacement Target” has the meaning set forth in Section 3.5.
1.139 “Research mAb²” means a mAb² where [***]. For clarity, all [***] must be Available Targets.
1.140 “Research Program” has the meaning set forth in Section 2.1.
1.141 “Reverse Orientation mAb2” means, with regard to a particular mAb2, a corresponding mAb2 in which the Fcab Target and the Fab Target are reversed. For example, if the Fcab and the Fab of a mAb2 binds ‘Target A’ and ‘Target B’, respectively, then the Fcab and the Fab of the corresponding Reverse Orientation mAb2 would bind ‘Target B’ and ‘Target A’, respectively.
1.142 “[***] Patent” has the meaning set forth in Section 16.4.3.
1.143 “Research Term” means the [***] period following the Effective Date (the “Initial Research Term”), as such term may be extended in accordance with Section 2.3.
1.144 “Safety Reasons” means a determination by Janssen, in its good-faith judgment, that continued Development or Commercialization of a Product would be unethical or unreasonable due to a significant safety-related reason, such as if Janssen believes, based on its good-faith assessment of relevant data, that continuation of human use of a Product has resulted in, or has a significant risk of resulting in, the occurrence of a safety or tolerability finding that would raise material concerns regarding the clinical benefit of the Product for its target population (for example, harm significantly in excess of an acceptable side-effect profile).
1.145 “Sales Milestone” has the meaning set forth in Section 9.4.
1.146 “Sales Milestone Payments” has the meaning set forth in Section 9.4.
1.147 “Second Technology Access Fee” has the meaning set forth in Section 9.2.
1.148 “Selected Target” means an Available Target selected as the [***] by Janssen during the Research Term, provided that a Target shall no longer be a Selected Target if [***].
1.149 “Senior Officer” means, with respect to F-star, its Chief Executive Officer or his/her designee, and with respect to Janssen, the Global Therapeutic Area Head for Janssen Oncology, or his/her designee.
1.150 “Skipped Milestone Event” has the meaning set forth in Section 9.6.
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1.151 “Subject mAb²” means a mAb² in respect of which Janssen has exercised an option to license under Section 2.2.2 where (a) the [***] and (b) the [***]. For clarity, all [***] must be Selected Targets.
1.152 “Sublicensee” means a Person, other than an Affiliate of Janssen, to which Janssen (or its Affiliate) has, pursuant to Section 5.1, granted sublicense rights under any of the rights licensed under the Agreement, provided that “Sublicensee” shall exclude Distributors.
1.153 “Target” means a [***].
1.154 “Target ID Number” shall have the meaning set forth in Section 3.4.
1.155 “Tax” or “Taxes” shall have the meaning set forth in Section 11.5.4.
1.156 "Tax Authority” means a Government Authority (whether in the United States, United Kingdom or elsewhere) competent to assess, demand, impose, administer or collect Tax or make any decision or ruling on any matter relating to Tax.
1.157 “Term” has the meaning set forth in Section 16.1.
1.158 “Territory” means all countries and territories worldwide.
1.159 “Third-Party” means any Person other than F-star, Janssen and their respective Affiliates.
1.160 “Third-Party Agreement” means an agreement between F-star or any of its Affiliates with a Third-Party.
1.161 “Third-Party Infringement” has the meaning set forth in Section 12.4.1.
1.162 “Third-Party Patent” means a Patent Right owned or otherwise controlled by a Third-Party.
1.163 “Trade Secrets” has the meaning set forth in Section 13.2.
1.164 “Triggering Milestone Event” has the meaning set forth in Section 9.6.
1.165 “United States” or “U.S.” means the United States of America and its territories and possessions.
1.166 “Unavailable Target” has the meaning set forth in Section 3.3.1
1.167 “Unavailable Target List” has the meaning set forth in Section 3.3.4.
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1.168 “Valid Claim” means a claim (i) of any issued, unexpired Patent Right that has not been revoked or held unenforceable or invalid by a decision of a court or Government Authority of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, and that has not been disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise or (ii) of any patent application that has not been cancelled, withdrawn or abandoned or been pending or filed more than seven (7) years from the earliest possible priority date for said application (provided that if after such seven (7) year period a Patent Right issues from such application, the same would be deemed a Valid Claim).
1.169 In the Agreement, unless the context otherwise requires:
1.169.1 all references to a particular Article, Section, or Schedule shall, unless stated otherwise, be a reference to such Article, Section, or Schedule of the Agreement;
1.169.2 all headings are inserted for convenience only and do not affect the interpretation of the Agreement;
1.169.3 the use of any gender shall be applicable to all genders;
1.169.4 words denoting persons shall include any natural person, corporate or unincorporated body (whether or not having separate legal personality) and that person's personal representatives, successors or permitted assigns;
1.169.5 the words “include”, “included” and “including” are to be construed without conveying any limitation to the generality of the preceding words;
1.169.6 a reference to a particular statute, statutory provision or subordinate legislation is a reference to it as it is in force from time to time taking account of any amendment or re-enactment and includes any statute, statutory provision or subordinate legislation and any modification or re-enactment of that statute or regulation or any successor or materially equivalent legislation enacted or adopted from time to time in the relevant market;
1.169.7 the Schedules form part of the Agreement and a reference to “the Agreement” includes its Schedules, provided that, in the event of any inconsistency or conflict between the operative provisions of the Agreement and any of the Schedules, the operative provisions of the Agreement shall prevail;
1.169.8 references to time are to New York, New York time; and
1.169.9 the word “or” has the inclusive meaning represented by the phrase “and/or”.
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ARTICLE 2
RESEARCH PROGRAM
2.1 “Research Program” means the conduct by or on behalf of Janssen and its Affiliates during the Research Term of non-clinical discovery research directed towards enabling NME Selection for up to five (5) Research mAb2. The Research Program shall include the [***]. The research license granted under Section 2.2 shall not include the right to file an IND for any Research mAb2 or Product.
2.2 Grant to Janssen – Research License. Subject to the terms and conditions of the Agreement, including Section 5.4 and Section 6.4, F-star hereby grants, on behalf of itself and its Affiliates, to Janssen:
2.2.1 a worldwide exclusive license under the F-star IP to make, have made, use, have used, import, and have imported Research mAb2 during the Research Term for the conduct of the Research Program;
2.2.2 an exclusive right during the Research Term to make an NME Selection for up to five (5) of the Available Targets as a Selected Target for use in one or more Subject mAb2 and for such Subject mAb2 to be Developed, Manufactured, Commercialized, and otherwise Exploited by Janssen pursuant to Section 4.2 and in accordance with the Agreement (for clarity, where an NME Selection is made in respect of any Available Target, then any mAb2 having the [***] shall become a Subject mAb2); and
2.2.3 subject to Section 2.5 below, a worldwide non-exclusive license under the F-star IP to make, have made, use, have used, import, and have imported [***] in the conduct of the Research Program, for each [***] for a period of [***] commencing as of the date of the Availability Notice for the Reference Target therein (as of the Effective Date for Identified Targets confirmed as Reference Targets prior to the Effective Date).
2.3 Extension of Research Term. The Research Term may be extended beyond the Initial Research Term on [***], provided that during the Initial Research Term:
2.3.1 F-star receives written notice from Janssen that [***]; or
2.3.2 F-star receives written notice from Janssen that Janssen wishes to extend the Research Term (which shall require [***].
For clarity, if the Research Term is extended in accordance with this Section 2.3, the extended Research Term shall continue until [***] from the Effective Date.
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2.4 Notification. Janssen shall promptly notify F-star in writing (and in any event within [***] of the first [***] in the Research Program to achieve the [***].
2.5 Limitations on Use of Reference mAb2. The following shall apply to the use by Janssen and its Affiliates of Reference mAb2 pursuant to the license under Section 2.2.3:
2.5.1 Janssen and its Affiliates shall not file any Patent Rights Covering any Reference mAb2 (unless and until such Reference Target becomes an Available Target, if at all).
2.5.2 Janssen and its Affiliates shall not publish or otherwise publicly disclose any Reference mAb2 (unless and until such Reference Target becomes an Available Target, if at all).
2.5.3 Janssen and its Affiliates may include data generated using a Reference mAb2 in Regulatory Filings related to a Subject mAb2 as necessary or useful in the Development of such Subject mAb2 in accordance with any license granted under Section 4.2.1.
2.6 Compliance. Janssen shall conduct the Research Program in compliance with all Applicable Laws.
2.7 Janssen Licensed Patent Rights. In the event that Janssen or any of its Affiliates files any Patent Rights Covering any Research mAb2 that as of the expiry of the Research Term is not designated as a Subject mAb2, F-star shall be granted a royalty-free, non-exclusive, worldwide, irrevocable and perpetual license, with a right to sublicense through multiple tiers, to any such Patent Right (but excluding any rights to Janssen Fab IP contained therein) for the purposes of Exploiting [***]. For clarity, the license granted under this Section 2.7 does not include a right to Exploit any [***].
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ARTICLE 3
TARGETS
3.1 Identified Targets. Janssen may at any time during the Research Term, submit a written notice in the form set out in 0 (an “Identified Target Notice”) to the Gatekeeper in substantially the form agreed upon by the Parties in the Gatekeeper Agreement identifying one or more Target(s) (“Identified Target(s)”) that Janssen is interested in researching under the Research Program as a Fab Target for a Research mAb2 or for use in a Reference mAb2. The Identified Target Notice shall include the Entrez Gene ID, HUGO or official symbol and common synonyms (if available) of each Identified Target. Each Identified Target Notice shall be provided simultaneously to F-star with the name and identifying details of the Identified Target redacted.
3.2 Determination of Availability.
3.2.1 For use as a Fab Target for a Research mAb2. An Identified Target shall be available to be licensed to Janssen as an Available Target for use as a Fab Target for a Research mAb2 (“Available to be Licensed”) and thus available for licensing pursuant to Sections 2.2.1, 2.2.2, and 4.2), if all of Sections 3.2.1(a), 3.2.1(b) and 3.2.1(c) below apply to the Identified Target:
(a) The Identified Target is not part of an Active Program; and
(b) F-star is free to grant the exclusive licenses in respect of such Identified Target to Janssen as set forth in the Agreement without breaching the terms of any Third-Party Agreement; and
(c) The Identified Target is not the subject of ongoing and active negotiations for the grant of license rights by F-star or any of its Affiliates to a Third-Party.
3.2.2 For use as a Fab Target for a Reference mAb2. An Identified Target shall be available to be licensed to Janssen as a Reference Target for use as a Fab Target for a Reference mAb2 (“Available for Reference Use”) and thus available for licensing pursuant to Section 2.2.3, if:
(a) F-star is free to grant the non-exclusive license of Section 2.2.3 in respect of such Identified Target to Janssen as set forth in the Agreement without breaching the terms of any Third-Party Agreement.
3.3 Unavailable Targets.
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3.3.1 F-star shall identify to the Gatekeeper any Target which F-star reasonably believes is not “Available to be Licensed” (because it does not meet the criteria set forth in Sections 3.2.1(a), 3.2.1(b), and/or 3.2.1(c)) or is not Available for Reference Use (because it does not meet the criteria of Section 3.2.2(a)) (each such Target an “Unavailable Target”). F-star shall provide the Gatekeeper with such information that, in F-star’s reasonable opinion, it is able to provide without breaching or infringing the terms of any Third-Party Agreement or the rights of any Third-Party, to support F-star’s identification of any Target as an Unavailable Target. Notwithstanding the above and any other provision of the Agreement, F-star shall always act in good faith in identifying Targets to the Gatekeeper as Unavailable Targets.
3.3.2 The following shall apply to each Target identified by F-star to the Gatekeeper as an Unavailable Target:
(a) The Target shall be identified by the Entrez Gene ID, HUGO or official symbol and by common synonyms (if available); and
(b) F-star shall specify which of Sections 3.2.1(a), 3.2.1(b), and/or 3.2.1(c), or Section 3.2.2(a), is applicable to the Target, as the case may be.
3.3.3 Prior to the execution of the Agreement, F-star has identified to the Gatekeeper all Targets that it believes to be Unavailable Targets in accordance with Section 3.3.1. F-star shall during the Research Term promptly submit to the Gatekeeper the names of any additional Targets that qualify as Unavailable Targets.
3.3.4 Unavailable Target List.
(a) In accordance with the terms of the Engagement Letter, the Gatekeeper shall maintain a list of Unavailable Targets (the “Unavailable Target List”) and supporting information provided by F-star in confidence and shall not be entitled to disclose the same, in whole or in part, to Janssen or any other Person.
(b) In accordance with the terms of the Engagement Letter, the Gatekeeper shall add Available Targets and Reference Targets to the Unavailable Target List, and the Gatekeeper shall not disclose to F-star, its Affiliates or third party (sub)licensees or collaborators, or their respective affiliates, the identification of a Target that has been added to the Unavailable Target List as a result of being designated an Available Target or Reference Target.
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(c) Notwithstanding Section 3.3.4(b) above, for the limited purpose of allowing F-star and its Affiliates to ensure their compliance with the exclusivity provisions of ARTICLE 6, the following shall apply:
(i) In the event that, F-star wishes to license, authorize or otherwise assist or enable a Third-Party to Exploit, any [***], F-star (a) shall arrange for such Third-Party to clear the availability of the other Targets of interest for such mAb2 directly with the Gatekeeper, or (b) shall itself clear the availability of those other Targets where the relevant Third-Party requires F-star to do so, in a manner that (1) does not disclose to F-star, the identification of a Target that has been added to the Unavailable Target List by the Gatekeeper as a result of being designated an Available Target or Reference Target, and (2) maintains the confidentiality obligations owed by the Gatekeeper to Janssen under the Engagement Letter.
(ii) In the event that F-star or any of its Affiliates wishes to Exploit any mAb2 that [***], F-star shall have the right to clear the availability of the other Targets of interest for such mAb2 directly with the Gatekeeper, provided that F-star shall always act in good faith in identifying Targets to the Gatekeeper for clearance for Exploitation by it or its Affiliates.
3.4 Availability Notice. Within [***] of receipt of an Identified Target Notice in respect of an Identified Target(s), in accordance with the terms of the Engagement Letter, the Gatekeeper is required to confirm by written notice to Janssen whether or not the Identified Target in question is Available to be Licensed or Available for Reference Use, as requested (such notice being an “Availability Notice”) Where an Identified Target is either Available to be Licensed, or Available for Reference Use, as applicable, then the Identified Target in question shall become an Available Target or Reference Target, as applicable, as of the date of the Availability Notice. In accordance with the terms of the Engagement Letter, each Available Target and Reference Target shall be assigned a sequential identification number by the Gatekeeper (the “Target ID Number”). Each Availability Notice is required to be provided simultaneously to F-star with the name and identifying details of the Identified Targets and Available Targets and/or Reference Targets (as applicable) redacted.
3.5 Replacement Targets.
3.5.1 Subject to Section 3.7, Janssen may at any time during the Research Term, upon written notice in the form set out in Schedule 3 (a “Replacement Target
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Notice”) to the Gatekeeper, identify an Available Target or Reference Target by Target ID Number that it wishes to replace with a new Identified Target(s) (a “Replacement Target(s)”) if Available to be Licensed or Available for Reference Use, as requested. Any such notice shall be copied to F-star with the name and identifying details of the Available Target or Reference Target to be replaced and the Identified Target redacted. In accordance with the terms of the Engagement Letter, the Gatekeeper shall determine if the Identified Target is Available to be Licensed or Available for Reference Use, as applicable, in accordance with Section 3.2 and then shall provide notice to Janssen in accordance with Section 3.4, provided, however, that Janssen shall in any event be limited to:
(a) the replacement of [***] Available Targets with Replacement Targets, and
(b) the replacement of [***] Reference Targets with Replacement Targets,
during the Research Term.
3.5.2 An Available Target or Reference Target that is replaced by a Replacement Target shall no longer be regarded as being an Available Target or Reference Target for the purposes of the Agreement.
3.5.3 For clarity, Janssen may identify a Reference Target as an Identified Target or Replacement Target for licensing as an Available Target, in which case, if such Target is Available to be Licensed, it shall become an Available Target and, to the extent that it replaces an Available Target, shall be counted as a Replacement Target for the purpose of Section 3.5.1(a).
3.5.4 In the event that Janssen converts a Reference Target to an Available Target, Janssen shall not be entitled to an additional Reference Target for use in addition to the [***] Replacement Targets for Reference Targets provided for in Section 3.5.1(b).
3.6 Gatekeeper Obligations of Confidentiality.
3.6.1 All notifications sent by a Party to the Gatekeeper pursuant to this ARTICLE 3 shall be considered the Confidential Information of the sending Party and notices or other communications received from the Gatekeeper by a Party shall be considered the Confidential Information of the receiving Party.
3.6.2 In accordance with the terms of the Engagement Letter, the Gatekeeper shall maintain all Identified Targets, including Identified Target Notices,
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Replacement Target Notices, and unredacted Availability Notices in confidence and shall not be entitled to disclose it, in whole or in part, to F-star or any other Person.
3.6.3 In accordance with the terms of the Engagement Letter, the Gatekeeper is bound in writing and on terms agreed by the Parties to terms of confidentiality and non-use substantially similar to those imposed under this Agreement.
3.6.4 Upon the completion of the Gatekeeper Services, or in the event that the Gatekeeper is no longer able to perform the Gatekeeper Services, the Gatekeeper is in accordance with the terms of the Engagement Letter required to promptly return or destroy all tangible items containing or consisting of the Confidential Information of the Parties, provided that the Gatekeeper may retain a single copy of Confidential Information in a secured location (to which the terms and conditions of confidentiality shall continue to apply), solely to the extent necessary to allow the Gatekeeper to ensure its continued compliance with the Engagement Letter and applicable law and professional obligations.
3.7 Maximum number of Targets. At any given time, and notwithstanding any other provision of the Agreement, there shall be no more than:
3.7.1 [***] Reference Targets used in the conduct of the Research Program, and
3.7.2 in aggregate [***] Targets that are either Available Targets or Selected Targets,
being licensed for the purposes of the Agreement, and no more than [***] exchanges of an Available Target for a Replacement Target and, subject to Section 3.5.4, no more than [***] exchanges of a Reference Target for a Replacement Target
3.8 Gatekeeper; Initial Available Targets.
3.8.1 Prior to the execution of the Agreement, (a) F-star has entered into a written agreement (the “Engagement Letter”) approved in advance by Janssen with the Gatekeeper, on behalf of the Parties, for the conduct by the Gatekeeper of the activities designated for the Gatekeeper in accordance with this ARTICLE 3 (the “Gatekeeper Services”); and (b) F-star and Janssen have entered into an agreement (the “Gatekeeper Agreement”) for purposes of allowing the Gatekeeper to confirm certain Identified Targets as Available Targets and/or as Reference Targets in accordance with this ARTICLE 3.
3.8.2 The fees, costs and expenses of the Gatekeeper in performing the Gatekeeper Services shall be shared equally by the Parties. Such fees, costs and expenses shall be paid by F-star with [***] of the same then being reimbursed by Janssen
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to F-star. The Engagement Letter, along with the Gatekeeper Agreement, are attached as 0.
3.8.3 F-star shall promptly notify Janssen in the event that the Gatekeeper terminates its appointment under the Engagement Letter or is otherwise no longer able to perform the Gatekeeper Services in accordance with this ARTICLE 3 and the Gatekeeper Agreement. Janssen shall have the right to approve any new Gatekeeper designated by F-star and the terms of its engagement by F-star in advance provided always that Janssen shall not unreasonably withhold or delay such approval. Such new Gatekeeper shall be appointed on terms that are consistent with the terms and conditions of this Agreement and the Gatekeeper Agreement.
3.8.4 0 lists the Target ID Numbers of the Targets confirmed as being Available Targets or Reference Targets as of the Effective Date by the Gatekeeper.
ARTICLE 4
DEVELOPMENT AND CommercialiZation
4.1 NME Selection.
4.1.1 At any time during the Research Term, Janssen may make an NME Selection in respect of a Research mAb2 by written notice to F-star (“Notice of NME Selection”). NME Selection shall be deemed to have occurred, as of the date of IND filing, for any Research mAb2 for which a Notice of NME Selection was not sent but an IND was in fact filed by or on behalf of Janssen or any of its Affiliates or Sublicensees.
4.1.2 As of the date of receipt of a Notice of NME Selection, or the filing date of an IND for a Research mAb2 for which a Notice of NME Selection was not previously sent, the following shall apply:
(a) the Available Target(s) in such Research mAb2 shall become a Selected Target(s);
(b) the Research mAb2 shall become a Subject mAb2; and
(c) the license granted under Section 4.2 in respect of such Subject mAb2 shall take effect.
4.1.3 At Janssen’s option, Janssen may identify the Available Target(s) in the Notice of NME Selection by name or may elect to identify the Available Target by its Target ID Number only. The Gatekeeper shall be copied on any Notice of NME Selection.
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4.1.4 In the event that NME Selection is deemed to have occurred for a Research mAb2 as a result of an IND being filed by or on behalf of Janssen or any of its Affiliates or its Sublicensees prior to a Notice of NME Selection being served, the Party first becoming aware of such IND filing shall as soon as reasonably practicable notify the other Party with details of the IND filing and identification of the Available Target by name or Target ID Number. The Gatekeeper shall be copied on any such notice.
4.2 Grant to Janssen – Exploitation Licenses.
4.2.1 Subject to the terms and conditions of the Agreement, including Section 4.1.2, Section 5.4 and Section 6.4, F-star hereby grants, on behalf of itself and its Affiliates, to Janssen, on a Subject mAb2-by-Subject mAb2 basis, an exclusive (even as to F-star and its Affiliates), worldwide, royalty-bearing right and license, with the right to grant sublicenses in accordance with Section 5.1, under the F-star IP to Exploit such Subject mAb2 and Products containing such Subject mAb2, in each case, during the Development and Commercialization Term for such Subject mAb2 in the Field and the Territory.
4.2.2 The license granted in Section 4.2.1 shall be effective as of the Effective Date (but shall only take effect in accordance with Section 4.1.2) for a term commencing in respect of any Subject mAb2 at such time as an NME Selection has been made or deemed made in respect of a given Subject mAb2. Prior to the commencement of the Development and Commercialization Term for a given Subject mAb2, Janssen shall not conduct any Development, Manufacture or Commercialization of that Subject mAb2 or Products containing such Subject mAb2 except as expressly permitted by ARTICLE 2.
4.3 Development. On a Subject mAb2-by-Subject mAb2 basis, during the Development and Commercialization Term for any Subject mAb2, Janssen shall use Commercially Reasonable Efforts to Develop, and obtain Regulatory Approval (and if applicable, Price and Reimbursement Approval) for, [***] containing such Subject mAb2 for [***].
4.4 Commercialization. Following receipt of Regulatory Approval (and if applicable Price and Reimbursement Approval) for a Product in a Major Market Country, Janssen shall use Commercially Reasonable Efforts to Commercialize that Product in that Major Market Country.
4.5 Compliance. Janssen shall conduct Development and Commercialization of Products in compliance with all Applicable Laws.
4.6 Booking of Sales; Distribution. As between the Parties, Janssen shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehousing, and distribute the Products in the Territory and to perform
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or cause to be performed all related services. As between the Parties, Janssen shall handle, and be exclusively responsible for, all returns, recalls, or withdrawals, order processing, invoicing, collection, distribution, and inventory management with respect to the Products in the Territory.
4.7 Distributors. Janssen and its Affiliates and Sublicensees shall have the right to appoint any Third Parties, in the Territory or in any country or other jurisdiction of the Territory, to distribute, market, and sell the Products in a manner that is consistent with the terms of the Agreement. Where Janssen or its Affiliates or a Sublicensee appoints such a Third-Party, that Person shall be a “Distributor” for purposes of the Agreement. For clarity, if Janssen grants to a Third-Party any rights under applicable intellectual property to make, use, sell, offer for sale or import a Product, then to that extent such Third-Party shall be a Sublicensee and not a Distributor.
4.8 Product Trademarks. As between the Parties, Janssen shall have the sole right to determine and own the trademarks to be used with respect to the Exploitation of the Products within the Territory.
ARTICLE 5
ADDITIONAL LICENSING PROVISIONS AND TECHNOLOGY TRANSFER
5.1 Sublicenses.
5.1.1 Janssen shall have the right to grant sublicenses, through multiple tiers of sublicenses, under the license granted in Section 2.2 and Section 4.2, to Sublicensees, provided that any such sublicenses shall (i) be in writing, (ii) be consistent with the terms and conditions of the Agreement, and (iii) require the applicable Sublicensee to comply with all applicable terms of the Agreement.
5.1.2 Janssen shall be responsible for the performance of any Sublicensee or Distributor as if such Sublicensee or Distributor were “Janssen” hereunder. Subject to ARTICLE 16, each sublicense granted by Janssen in respect of any rights licensed or granted under the Agreement shall terminate immediately upon the termination of the Agreement.
5.2 Subcontracting. Janssen shall have the right to enter into subcontracts with its Affiliates and Third Parties for the purposes of carrying out certain activities under the Agreement, provided that (i) such subcontracts are consistent with the Agreement; (ii) such subcontracts require the applicable Affiliate or Third-Party to comply with all applicable terms of the Agreement; and (iii) Janssen shall remain liable to F-star for the performance of such obligations, and the acts and omissions of its subcontractors.
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5.3 [***]. [***] shall be provided in electronic copies to Janssen as of the Effective Date.
5.4 No Implied Rights. Except as expressly provided herein, F-star grants no other right or license, including any rights or licenses to the F-star IP or F-star Fab IP, or any other Patent or intellectual property rights not otherwise expressly granted herein, whether by implication, estoppel, or otherwise.
5.5 Confirmatory Patent License. F-star shall if requested to do so by Janssen, at Janssen’s cost, promptly enter into confirmatory license agreements in such form as may be reasonably acceptable to both Parties for the purposes of recording the licenses granted under the Agreement with such patent offices in the Territory as Janssen considers appropriate.
ARTICLE 6
EXCLUSIVITY
6.1 Research Term. Subject to Section 6.4, during the Research Term, F-star and its Affiliates shall not (i) research, Develop, Commercialize, Manufacture or otherwise Exploit, or (ii) license, authorize or otherwise assist or enable a Third-Party to research, Develop, Commercialize, Manufacture or otherwise Exploit, any [***], in the Field and Territory.
6.2 Competing Products. On a Subject mAb2-by-Subject mAb2 basis, for each Subject mAb2 as of NME Selection and for the duration of the Development and Commercialization Term for that Subject mAb2, F-star and its Affiliates shall not (i) research, Develop, Commercialize, Manufacture or otherwise Exploit any Competing Product for use in the Field and the Territory, whether alone or in combination with one or more other API, or (ii) license, authorize or otherwise assist or enable a Third-Party to research, Develop, Commercialize, Manufacture or otherwise Exploit any Competing Product for use in the Field and the Territory, whether alone or in combination with one or more other API.
6.3 F-star Change of Control. Notwithstanding Sections 6.1 and 6.2, following a Change in Control of F-star or its Affiliates (a “Relevant Transaction”):
6.3.1 the restrictions set out in Section 6.1 shall not apply to any acquiror or the acquiror’s Affiliates immediately prior to the Relevant Transaction (“Acquiror Group Companies”) but shall continue to apply to F-star and F-star’s Affiliates immediately prior to the Relevant Transaction; and
6.3.2 Section 6.2 shall not apply to any Competing Product which was Controlled by the Acquiror Group Companies immediately prior to the Relevant Transaction but shall continue to apply to any Competing Product developed or acquired
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by the acquiror, F-star or any of their Affiliates following the Change in Control.
6.4 Reserved Rights. Subject to Section 6.3, F-star reserves all rights to research and Exploit (i) any Antibody containing any Fcab for use with any Fab Target other than where such Fcab Target and Fab Target are comprised within a Research mAb2 or Subject mAb2, and (ii) any Fcab as a stand-alone product that is not incorporated into an Antibody.
ARTICLE 7
Regulatory matters
7.1 Regulatory Filings and Approvals. As between the Parties, Janssen shall have the sole right to prepare, obtain and maintain all Regulatory Filings (including the setting of the overall regulatory strategy therefor) and Regulatory Approvals, and to conduct all communications with the Regulatory Authorities, for and in connection with the Development, Commercialization and Manufacturing of any and all Subject mAb² and Products in the Territory.
7.2 Ownership. Except to the extent prohibited by Applicable Law, as between Janssen and F-star, Janssen shall own and maintain all Regulatory Filings and Regulatory Approvals for any and all Subject mAb² and Product. At Janssen’s request and cost, F-star shall duly execute and deliver or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary under or as Janssen may reasonably request in connection with or to carry out more effectively the purpose of or to better assure and confirm unto Janssen its rights under this ARTICLE 7.
7.3 Right of Cross-Reference. At Janssen’s request, and to the extent required by a Regulatory Authority or pursuant to a requirement of a Regulatory Authority, F-star shall provide Janssen with a right of cross reference to relevant preclinical data in IND filings Controlled by F-star to the extent that these relate to the Fcab Platform Technology, for the purposes of Janssen and its Affiliates making their own Regulatory Filings in relation to relevant Products.
7.4 Adverse Event Reporting. Janssen agrees to comply with all Applicable Laws during the Term in connection with Product safety data collection and reporting, including reporting adverse events to Regulatory Authorities if and to the extent required by Applicable Law.
ARTICLE 8
Alliance MANAGEMENT
8.1 Alliance Manager. Each Party shall each appoint a person(s) who shall act as the primary point of contact for the Parties and oversee contact between the Parties for all
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matters in relation to the Agreement and have such other responsibilities as the Parties may agree in writing after the Effective Date (each, an “Alliance Manager”). Each Party may each replace its Alliance Manager at any time by notice in writing to the other Party.
8.2 Reports.
8.2.1 Research Program Updates. During the Research Term, approximately each Calendar Quarter, Janssen (through its Alliance Manager) shall provide a written update to F-star on its and its Affiliates’ research activities with respect to Research mAb2 as relates to [***] as the Fcab Target and general progress with respect to each Research mAb2, including details of [***], if any.
8.2.2 Fcab Platform Technology. During the Research Term, F-star (through its Alliance Manager) shall promptly update Janssen in writing on any Fcab Platform Technology that is generated by or on behalf of F-star and its Affiliates. In addition, at Janssen’s request, F-star shall also make available to Janssen such Know-How which it and its Affiliates Control relating to Fcab Platform Technology, provided that F-star shall not be required to make Know-How available in breach of any Third-Party Agreement or to make available Know-How that relates specifically to any product being developed under any Active Program being conducted by F-star, its Affiliates or any Third-Party.
8.2.3 Technical Discussions. Janssen and F-star will make their respective relevant technical or other personnel available, as reasonably requested by the other Party, for discussion of the information contained in their respective updates.
8.3 Development Reports. Within [***] following the end of each [***], on a Subject mAb2-by-Subject mAb2 basis, during the Development and Commercialization Term for each Subject mAb2, Janssen (through its Alliance Manager) shall update F-star on its Development activities with respect to such Subject mAb2 for so long as Janssen or its Affiliates are conducting Development activities.
8.4 Annual Commercialization Reports. Within [***] following the end of each Calendar Year, on a Product-by-Product basis, starting after the completion of the first Calendar Year after the First Commercial Sale of a Product, Janssen will provide F-star with a high-level summary of its Commercialization status (Regulatory Approvals and launch status) for the Product for the current and subsequent Calendar Year.
ARTICLE 9
MILESTONE PAYMENTS
9.1 First Technology Access Fee. Janssen shall pay to F-star a non-refundable and non-creditable payment equal to [***] (“First Technology Access Fee”) within [***] of the Effective Date.
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9.2 Second Technology Access Fee. Janssen shall pay to F-star a non-refundable and non-creditable payment equal to [***] (“Second Technology Access Fee”) within [***] of the receipt of an invoice from F-star following the earlier to occur of:
9.2.1 the first Research mAb2 attaining the [***]; and
9.2.2 Janssen exercising its right to extend the initial [***] Research Term beyond the Initial Research Term in accordance with Section 2.3.2.
9.3 Development Milestone Payments.
9.3.1 On a Product-by-Product basis, for each Product Janssen shall pay to F-star, the following one-time, non-refundable, non-creditable milestone payments as set out in Table 9.3 (a “Development Milestone Payment”) upon the first achievement of the milestone events forth below in Table 9.3 (a “Development Milestone”) for such Product.
Table 9.3
|
# |
Development Milestone |
Development Milestone Payment |
|
1 |
[***] |
$[***] |
|
2 |
[***] |
$[***] |
|
3 |
[***] |
$[***] |
|
4 |
[***] |
$[***] |
|
5 |
[***] |
$[***] |
|
6 |
[***] |
$[***] |
|
7 |
[***] |
$[***] |
|
8 |
[***] |
$[***] |
|
9 |
[***] |
$[***] |
9.3.2 Replacement Product. In the event that Development of a Product containing a particular Subject mAb2 (the “Original Product”) is terminated in favor of a
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Product containing another Subject mAb2 having Fab Target(s) binding to the same Selected Target(s) as in the Original Product (a “Replacement Product”), then any Development Milestone Payments previously paid with respect to the Original Product (including for NME Selection) shall be fully creditable (but not in any event reimbursable in whole or part), and no further amount will be due upon achievement of the same Development Milestone with respect to the Replacement Product. For clarity, a Product is not a Replacement Product for the purposes of this Section 9.3.2 where it has been modified from a Product which comprises a [***] and in modified form the [***] in the Product from which it is modified [***].
9.4 Sales-Related Milestones.
9.4.1 On a Product-by-Product basis, for each Product Janssen shall pay to F-star, the following one-time, non-refundable, non-creditable milestone payments as set out in in Table 9.4 (the “Sales Milestone Payments”) upon the first achievement of the milestone events set forth below in Table 9.4 (a “Sales Milestone”) for such Product.
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Table 9.4
|
Sales Milestone |
Payment |
|
[***] |
$[***] |
|
[***] |
$[***] |
|
[***] |
$[***] |
9.5 First occurrence. For each Product, each Development Milestone Payment and Sales Milestone Payment shall only be payable upon the first occurrence of the respective Development Milestone or Sales Milestone in respect of that Product.
9.6 Skipped Development or Sales Milestones. If any of the Development Milestones numbered 4, 5 or 6 in Table 9.3 or any of the Sales Milestones have not occurred in respect of a Product (a “Skipped Milestone Event”) as of the achievement of a subsequent Development Milestone or Sales Milestone (the “Triggering Milestone Event”) (as applicable), then the achievement of the Triggering Milestone Event shall trigger the payment of the Development Milestone Payment(s) or Sales Milestone Payment(s) (as applicable) for the Skipped Milestone Event(s), as well as the Triggering Milestone Event.
9.7 Notice and Invoice. On a Product-by-Product basis, Janssen shall notify F-star within [***] after each Development Milestone or Sales Milestone (as applicable) is first achieved in respect of a Product (whether by Janssen, its Affiliates or Sublicensees).
9.8 Invoice. Following receipt of notice from Janssen under Section 9.7, F-star shall issue an invoice for the relevant milestone payment due for achieving the relevant milestone and Janssen shall make that payment within:
9.8.1 in respect of Development Milestone Payments for Development Milestones 1 to 6 (inclusive), [***] of receipt of F-star’s invoice for the relevant payment;
9.8.2 in respect of Development Milestone Payments for Development Milestones 7 to 9 (inclusive), [***] of receipt of F-star’s invoice for the relevant payment; and
9.8.3 in respect of Sales Milestone Payments, [***] of receipt of F-star’s invoice for the relevant payment.
9.9 Payment Methods. Unless otherwise specified hereunder, Janssen shall make payments required hereunder to F-star within [***] from the date an invoice is received by Janssen.
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F-star shall submit all invoices for payments under the Agreement to the Johnson & Johnson Accounts Payable (J&J AP) web portal via www.ap.jnj.com. All invoices shall contain such information concerning the account (such as a valid Janssen purchase order number, supplier number, IBAN Numbers, bank name, etc.) necessary to make payment of the invoice and as will be set forth on the Accounts Payable section of www.ap.jnj.com. When logging into the website, F-star will be prompted for its supplier number, which can be found on the purchase order. If using web-based invoicing, all invoices will be paid via electronic funds transfer to a bank account designated by F-star in accordance with instructions given in writing by F-star from time to time.
ARTICLE 10
Royalties
10.1 Royalty Payments for Products. During the Product Royalty Term for each Product, Janssen will pay F-star royalties calculated as follows with respect to aggregate annual worldwide Net Sales of such Product in each [***] (provided, however, that Net Sales of a Product in a country occurring after expiration of the Product Royalty Term for such Product in such country will be disregarded in the calculation of royalties pursuant to this Section 10.1):
10.1.1 [***] of that portion of aggregate worldwide Net Sales in a [***] that are less than or equal to [***];
10.1.2 [***] of that portion of aggregate worldwide Net Sales in a [***] that are greater than [***] but less than or equal to [***]; and
10.1.3 [***] of that portion of aggregate worldwide Net Sales in a [***] that are greater than [***].
10.2 Definition of Net Sales.
10.2.1 “Net Sales” means, with respect to a Product, the gross amounts invoiced on sales of such Product by Janssen or any of its Affiliates or Sublicensees to a Third-Party purchaser, less the following customary and commercially reasonable deductions, determined in accordance with US generally accepted accounting principles and internal policies, and which are actually taken, paid, accrued, allocated, or allowed based on good faith estimates:
(a) trade, cash or quantity discounts, allowances, and credits, excluding commissions for commercialization;
(b) excise taxes, use taxes, tariffs, sales taxes and customs duties, or other government charges imposed on the sale of Product (including value added tax, but only to the extent that such value added taxes
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are not reimbursable or refundable), specifically excluding, for clarity, any income taxes assessed against the income arising from such sale;
(c) compulsory or negotiated payments and cash rebates or other expenditures to Government Authorities (or designated beneficiaries thereof) in the context of any national or local health insurance programs or similar programs; including, but not limited to, pay-for-performance agreements, risk sharing agreements as well as government levied fees as a result of the U.S. Affordable Care Act;
(d) rebates, chargebacks, administrative fees, and discounts (or equivalent thereof) to managed health care organizations, group purchasing organizations, insurers, pharmacy benefit managers (or equivalent thereof), specialty pharmacy providers, Government Authorities, or their agencies or purchasers, reimbursors, or trade customers, as well as amounts owed to patients through co-pay assistance cards or similar forms of rebate to the extent the latter are directly related to the prescribing of the Product;
(e) outbound freight, shipment and insurance costs to the extent included in the price of such Product and separately itemized on the invoice price;
(f) retroactive price reductions, credits or allowances actually granted upon claims, rejections or returns of the Product, including for recalls or damaged or expired goods, billing errors and reserves for returns;
(g) any invoiced amounts which are not collected by the selling party or its Affiliates, including bad debts, provided that if any such amounts are subsequently collected then they shall be added to Net Sales; and
(h) any deductions in the context of payments that are due or collected significantly after invoice issuance.
All aforementioned deductions shall only be allowable to the extent they are commercially reasonable and shall be determined, on a country-by-country basis, as incurred in the ordinary course of business in type and amount verifiable based on Janssen’s and its Affiliates’ reporting system. All such discounts, allowances, credits, rebates, and other deductions shall be fairly and equitably allocated to Product and other products of the Janssen and its Affiliates and sublicensees such that Product does not bear a disproportionate portion of such deductions.
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10.3 Sales between Affiliates/Sublicensees. Sales of a Product by and between a Party and its Affiliates and sub-licensees, or between the Parties (or their respective Affiliates or sub-licensees), in each case unless the Affiliate, sub-licensee, or Party is the end purchaser, are not sales to Third Parties and shall be excluded from Net Sales calculations; provided, however, that if such Product is subsequently resold to a Third-Party end user such resale shall be included in the determination of Net Sales.
10.4 Clinical Trials; Compassionate and Named Patient Sales. Sales of a Product for the use in conducting Clinical Studies of the Product in a country in order to obtain the first Regulatory Approval of the Product in such country shall be excluded from Net Sales calculations for all purposes. Compassionate use, “named patient sales”, sales made in connection with Clinical Studies, and product donations shall be excluded from Net Sales calculations for all purposes.
10.5 Combination Products.
10.5.1 In the event a Product is sold as part of a Combination Product (as defined below) in a country, the Parties shall negotiate in good faith, at the latest [***] before the launch of such Combination Product, an allocation of Net Sales of such Combination Product to the respective API components or product components thereof, as the case may be, based on the fair market value of such components for the purposes of determining Product-specific or Subject mAb2-specific allocated Net Sales. Payments related to such Combination Product under the Agreement, including royalty payments, will be calculated, due and payable based only on such allocated Net Sales. Without limiting the foregoing and following negotiation, the Parties anticipate that allocated Net Sales will be calculated according to one of the following paradigms with paradigm (a) being most preferable and paradigm (c) being least preferable.
(a) Net Sales for the determination of royalties of Combination Products will be calculated by the fraction A/(A+B) where A is the Average Net Selling Price of the Product or Subject mAb2 component contained in the Combination Product, if sold separately or subject to reasonable and good faith estimation, and B is the sum of the Average Net Selling Prices of any other product components included in the Combination Product, if sold separately or subject to reasonable and good faith estimation.
(b) Net Sales for the determination of royalties of Combination Products will be calculated by multiplying Net Sales of such Combination Product by the fraction A/C where A is the Average Net Selling Price of the Product or Subject mAb2 component contained in the Combination Product, if sold separately or subject
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to reasonable and good faith estimation, and C is the Average Net Selling Price of the entire Combination Product.
(c) Net Sales for the determination of royalties of Combination Products will be calculated by multiplying Net Sales of such Combination Product by the fraction 1/n where n is the total number of product components included in the Combination Product.
10.5.2 If the Parties do not agree on an allocation of Net Sales of such Combination Product to the respective API components or Product components thereof no later than [***] prior to the estimated launch date of such Combination Product, then the calculation approach described in paradigm (a) above will be used. Where the foregoing refers to “subject to reasonable and good faith estimation” such estimation shall be made by Janssen and promptly provided to F-star. If F-star disagrees with such estimation, it shall notify Janssen and the matter shall be referred for Dispute Resolution under Section 17.8, followed by Dispute Resolution by Expedited Arbitration in accordance with Section 17.9.6, and, except in the case of an event of misconduct by the arbitrator or fraud by either Party, the decision of the arbitrator shall be final and binding on the Parties.
10.5.3 The term “Combination Product” means any Product:
(a) containing (i) as a single formulation, two or more APIs as components including (1) a Subject mAb2, and (2) one or more other APIs, or (ii) in a single package or container and intended for coordinated use, two or more products as components including (1) a Product, and (2) one or more other products for therapeutic administration or diagnostic use; or
(b) that falls within the scope of a “combination product” as defined by the FDA pursuant to 21 C.F.R. §3.2(e) or any equivalent legislation outside of the United States.
10.5.4 The term “Average Net Selling Price” shall mean, on a product-by-product basis, for a given product in a given country and Calendar Year, expressed in the applicable local currency, the aggregate Net Sales, divided by the number of units of such product for which revenue has been recognized by the Parties.
10.6 Term of Royalty Payments. On a country-by-country and Product-by-Product basis, the period in which royalties are payable for a Product (the “Product Royalty Term”) shall commence on the First Commercial Sale of such Product in such country and end upon the latest to occur of Sections 10.6.1, 10.6.2, and 10.6.3:
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10.6.1 expiry of the period of [***] from the date of First Commercial Sale of such Product in such country; and
10.6.2 the date of expiration or determination of unenforceability or invalidation by a competent authority (from which no appeal can be taken) of the last Valid Claim of (a) and (b):
(a) an [***] Patent Right, that Covers the Product in such country; and
(b) an F-star Product Patent Right in such country that Covers the Subject mAb2 in such Product as [***];
either (a) or (b), that would be infringed by the sale of such Product in such country but for the licenses granted in the Agreement; and
10.6.3 where there is a [***] Patent Right in such country that Covers the Subject mAb2 in such Product as [***], the earlier of (a) and (b):
(a) the date of expiration or determination of unenforceability or invalidation by a competent authority (from which no appeal can be taken) of the last Valid Claim of such Patent Right; and
(b) expiry of the period of [***] from the date of First Commercial Sale of such Product in such country.
10.7 Royalty Reductions.
10.7.1 Generic Entry. On a Product-by-Product and country-by-country basis, the royalties payable under Section 10.1 shall be reduced to [***] of the indicated rate with respect to Net Sales of such Product in a given country in the event that a Third-Party is selling a Generic to the Product in such country. Such reduction shall apply from the date that sales of the Generic to the Product commence in the country in question.
10.7.2 No Valid Claim. On a Product-by-Product and country-by-country basis, the royalties payable under Section 10.1 shall be reduced to [***] of the indicated rate with respect to Net Sales of such Product in a given country in the event that a Valid Claim qualifying under Sections 10.6.2 or 10.6.3 does not exist in such country.
10.7.3 Third-Party Royalties. On a Product-by-Product and country-by-country basis, the royalties payable under Section 10.1 may be reduced by Janssen up to an amount equal to [***] of any royalties that Janssen pays to a Third-Party for a license of Patent Rights that Cover the Product in such country, provided
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that (a) Janssen reasonably believes that without such license Exploitation of the Subject mAb2 would infringe such Third-Party Patent Rights (and Janssen shall notify F-star in writing where it has such reasonable belief and shall provide F-star with any factual information reasonably available in support such belief); and (b) a reduction shall not be applied to the extent that royalties are paid for the use of any Fab component of the Subject mAb2. Any such Patent Rights may be Controlled by Janssen on or after the Effective Date. For any license from a Third-Party that falls under this Section 10.7.3, Janssen will to the extent reasonably able to provide F-star in confidence with the name of the Third-Party licensor, a summary of the subject matter of such license, a list of the patent(s) being licensed, and a summary of the royalty provisions covered by this Section.
10.7.4 Cumulative Deductions. Notwithstanding Sections 10.7.1, 10.7.2, and 10.7.3, in no circumstances shall any royalty payable to F-star under Section 10.1 on a Product-by-Product and country-by-country basis in any Calendar Year be reduced to less than [***] of the original royalties otherwise payable had Sections 10.7.1, 10.7.2, and 10.7.3 not applied.
10.8 Expiration of Product Royalty Term. On a Product-by-Product and country-by-country basis, upon expiration of the Product Royalty Term for a given Product in a given country (a) the Licenses shall become fully paid-up and perpetual with respect to such Product and the Subject mAb2 therein in such country, without any further obligation to pay royalties, and (b) Net Sales with respect to such Product therein in such country shall no longer be included in the aggregate annual worldwide Net Sales for the purposes of royalty rate calculations. This Section 10.8 shall survive termination or expiration of the Agreement in its entirety, and termination of Janssen’s rights to a Subject mAb2.
10.9 Reports and Royalty Payments. Within [***] after the end of each Calendar Quarter, beginning with the Calendar Quarter in which the First Commercial Sale of a Product is made, Janssen shall send to F-star a written report stating, separately for each Product for such Calendar Quarter: (i) Net Sales; and (ii) Janssen’s calculation of the royalties owed to F-star pursuant to Section 10.1 for Net Sales of Products during such Calendar Quarter, with all such amounts reflected in Dollars (each, a “Royalty Report”). Promptly following the delivery of the applicable Calendar Quarter Royalty Report, F-star shall invoice Janssen for the royalties due to F-star with respect to Net Sales for such Calendar Quarter, and Janssen shall make payment of the royalties due hereunder with respect to all Net Sales within [***] after the end of each Calendar Quarter. The Royalty Reports shall be deemed Confidential Information of Janssen subject to the obligations of ARTICLE 13.
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ARTICLE 11
ADDITIONAL Payment TERMS
11.1 Mode of Payment; Foreign Currency Exchange. All payments to either Party under the Agreement shall be made by deposit of Dollars in the requisite amount to such bank account as the receiving Party may from time to time designate by notice to the paying Party. Janssen shall use the Currency Hedge Rate(s) to convert Net Sales to Dollars for the purpose of calculating royalties and Sales Milestones, in accordance with the following clauses:
11.1.1 For each upcoming Calendar Year following the First Commercial Sale, Janssen shall provide the Currency Hedge Rate(s) to be used for the local currency of each country of the Territory in writing to F-star not later than ten (10) Business Days after the Currency Hedge Rate(s) are available, which is customarily at the end of October for the following Calendar Year. Such Currency Hedge Rate(s) will remain constant throughout the upcoming Calendar Year.
11.1.2 The foregoing shall apply for so long as Janssen and its Affiliates calculates conversion of other currencies into Dollars in the manner described above consistently for its transactional foreign exchange risk exposures across the business, including across its licensors. In the event that the foregoing no longer applies, or in the event that Janssen assigns the Agreement to a Third-Party, then Net Sales for the applicable Calendar Quarter shall be converted to Dollars using the average exchange rate for the conversion of such foreign currency into Dollars quoted for current transactions for both buying and selling Dollars, as reported in The Wall Street Journal (U.S. Western Edition) for the last New York Business Day of the Calendar Quarter to which such payment pertains.
11.2 Designation of Paying Agent. Without prejudice to Janssen’s obligations to make payments under the Agreement, Janssen Research & Development, LLC, an Affiliate of Janssen acting as a paying agent for Janssen, may make certain payments due under the Agreement.
11.3 Financial Audits.
11.3.1 Records. Janssen shall maintain complete and accurate records regarding all items to be reported in each Royalty Report and any other items necessary to determine the accuracy of the Milestone Payments payable hereunder for a period of [***] following the end of the Calendar Quarter to which such records pertain.
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11.3.2 Procedure. Up to one time per Calendar Year, upon [***] prior written notice from F-star, Janssen shall, and shall procure its Affiliates and its and their Sublicensees shall, make available all such records to an independent, certified public accountant, selected by F-star and reasonably acceptable to Janssen, for such accountant to review and audit such records at F-star’s expense in the location(s) where such records are maintained, during regular business hours and under obligations of confidence, for the sole purpose of verifying the accuracy of Janssen’s Royalty Reports and the corresponding royalty payments or any Milestone Payments hereunder with respect to Products within the [***] period preceding such review and audit. F-star shall treat any records of Janssen that are so reviewed and audited as Confidential Information of Janssen subject to ARTICLE 13, and shall cause the independent, certified public accountant to retain all such records and information in confidence. The report of the independent, certified public accountant shall be shared with Janssen prior to distribution to F-star such that Janssen can provide the independent, certified public accountant with justifying remarks for inclusion in the report prior to sharing the conclusions of such audit with F-star; provided that such report shall be distributed to F-star no later than [***] after its distribution to Janssen. The final audit report shall be shared with Janssen and F-star at the same time and specify whether the amounts paid to F-star were correct or, if incorrect, the amount of any underpayment or overpayment.
11.3.3 Under/Over Payments. If such review and audit reveals an underpayment of royalties or Milestone Payments due to F-star hereunder, Janssen shall promptly pay F-star any underpaid amounts due, together with interest calculated in the manner provided in Section 11.4, and if such review and audit reveals an overpayment of royalties or Milestone Payments due to F-star hereunder, Janssen shall be entitled to credit such overpayments against subsequent payments that may become due hereunder; provided, however, that the foregoing shall not be construed to limit the application of Section 17.8 with respect to any dispute regarding royalties or Milestone Payments due hereunder. In the event that such a review and audit identifies an underpayment of royalties due to F-star hereunder greater than [***] of the royalty amounts actually due for the period reviewed and audited or identifies any unpaid Milestone Payment that should have been paid, Janssen shall reimburse F-star for reasonable and documented Out-of-Pocket Costs incurred by F-star for the conduct of such review and audit. Upon the expiration of [***] following the end of any Calendar Year, except with respect to (i) ongoing unresolved Disputes, if any, regarding royalties or Milestone Payments due hereunder, and (ii) fraudulent activities by Janssen, the calculation of royalties and Milestone Payments payable with respect to such year shall be binding and conclusive upon the Parties and Janssen shall be released from any liability or accountability with respect to royalties and Milestones for such Calendar Year.
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11.4 Interest on Late Payments. If any payment due to a Party under the Agreement is not paid when due, then the paying Party shall pay interest thereon (before and after any judgment) at a rate equal to the lesser of (a) [***]; or (b) [***], in each case, compounded annually and computed on the basis of a three hundred sixty-five (365) day year.
11.5 Taxes.
11.5.1 Subject to Section 11.5.2, all payments under the Agreement shall be made without deduction or withholding for Taxes (as that term is defined in Section 11.5.4 below) except to the extent that any such deduction or withholding is required by Applicable Law in effect at the time of payment.
11.5.2 Any Tax required to be withheld by a Party on amounts payable under the Agreement will promptly be paid by such Party making the payment (the “Payor”) on behalf of the Party receiving the payment (the “Payee”) to the appropriate Government Authority, and Payor will furnish Payee with proof of payment of such Tax. Any such Tax required to be withheld will be an expense of and borne by Payee.
11.5.3 Janssen and F-star shall cooperate with respect to all documentation required by any taxing authority or reasonably requested by Janssen or F-star to secure a reduction in the rate of applicable withholding Taxes. On the Effective Date, F-star shall deliver to Janssen an accurate and complete Internal Revenue Service Form W-8BEN-E certifying that F-star is entitled to the applicable benefits under the Income Tax Treaty between the UK and the United States (and shall deliver to Janssen any other form as may replace such form from time to time upon Janssen’s request). If any F-star IP licensed to Janssen under the Agreement includes any rights registered in Germany (“in ein deutsches öffentliches Buch oder Register eingetragene Rechte”), F-star shall provide Janssen with an exemption certificate under the respective treaty between the UK and Germany prior to First Commercial Sale. The Parties hereby provide their consent to disclose the Agreement to the German tax authorities for purposes of obtaining such an exemption certificate.
11.5.4 For purposes of this Section 11.5, “Tax” or “Taxes” means any present or future taxes, levies, duties, charges or assessments in the nature of tax, payable to or imposed by any Tax Authority (including any interest thereon).
11.5.5 All fees charged by F-star shall be exclusive of value added, sales, use, goods and services, transfer, services, consumption, or transaction taxes (“Indirect Taxes”), as well as gross receipts, excise, and other taxes. Each party shall be responsible for: taxes based on its own income (“Income Taxes”); gross receipts, capital stock, and net worth taxes; franchise and privilege taxes on its business; employment taxes of its employees; and taxes on any property it owns
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or leases. F-star shall not pass on to Janssen and Janssen shall not be responsible for any taxes that F-star incurs in subcontracting the performance of any services under the Agreement except to the extent such taxes are included in the pricing set forth in the Agreement. Janssen and F-star will reasonably cooperate with each other to more accurately determine a Party’s tax liability and to minimise such liability, to the extent legally permissible.
11.5.6 F-star may charge Janssen for Indirect Taxes, as long as the amount of Indirect Taxes are specified in a valid invoice compliant with Applicable Law. Janssen shall either pay such invoiced amount or supply valid exemption documentation. If F-star does not provide Janssen with a valid invoice (including separate identification of Indirect Taxes where required by Applicable Law), F-star shall assume responsibility for such non-compliance, including payment of any tax-related interest and penalties. F-star shall segregate on the invoice fees for taxable services from fees for non-taxable services.
11.6 Transaction Costs. Each Party shall be responsible for all costs incurred by such Party related to entering into the Agreement, including but not limited to the business, legal and regulatory costs.
ARTICLE 12
INTELLECTUAL PROPERTY
12.1 Ownership of Intellectual Property Rights.
12.1.1 Ownership. As between the Parties:
(a) F-star or its Affiliates shall solely own or Control all right, title, and interest in and to any and all F-star IP and F-star Fab IP; and.
(b) Janssen or its Affiliates shall solely own or Control all right, title, and interest in and to any and all Janssen Fab IP and Product IP.
12.1.2 Inventorship. Inventorship for Inventions shall be determined in accordance with United States patent law.
12.1.3 Disclosure Obligation.
(a) Janssen (on behalf of itself and its Affiliates or Sublicensees) shall promptly disclose in writing to F-star any Fcab Platform Improvements of which it becomes aware.
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(b) F-star (on behalf of itself and its Affiliates) shall promptly disclose in writing to Janssen any F-star Product Know-How of which it becomes aware.
(c) The written disclosures under this Section 12.1.3 shall include reasonable details concerning the conception, discovery, development and/or making of the Know-How.
12.1.4 Assignment Obligation.
(a) F-star, for itself and on behalf of its Affiliates, hereby assigns (and to the extent such assignment can only be made in the future hereby agrees to assign) to Janssen all its right, title and interest in and to any F-star Product Know-How, including all rights and title, in and to, including to Prosecute and Maintain, Patent Rights Covering such F-star Product Know-How and rights to sue for past infringement of such F-star Product Know-How.
(b) Janssen, hereby assigns (and shall ensure its Affiliates assign, as applicable) (and to the extent such assignment can only be made in the future hereby agrees to assign) to F-star all its right, title and interest in and to any Fcab Platform Improvements, including all rights and title, in and to, including to Prosecute and Maintain, Patent Rights Covering such Fcab Platform Improvements and rights to sue for past infringement of such Fcab Platform Improvements.
(c) Janssen shall cause its Affiliates and any other Persons who perform research and Development activities for or on behalf of Janssen under the Agreement to be under an obligation to assign their rights in any Fcab Platform Improvements and Patent Rights Covering such Fcab Platform Improvements to Janssen. Janssen shall not employ or otherwise engage any Person to perform any such activities where such Person has standard policies against, or otherwise refuses to grant, such an assignment, except with F-star’s prior written consent.
(d) F-star shall cause its Affiliates and any other Persons who perform activities for or on behalf of F-star under the Agreement to be under an obligation to assign their rights in any F-star Product Know-How and Patent Rights Covering such F-star Product Know-How to Janssen. F-star shall not employ or otherwise engage any Person to perform any such activities where such Person has standard policies
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against, or otherwise refuses to grant, such an assignment, except with Janssen’s prior written consent.
12.1.5 Obligation to Perfect Rights. Each of the Parties shall, from time to time and at the reasonable request of the other Party, do all such acts and things and execute all such deeds and documents as may be necessary or desirable for them to perfect each Party’s title or rights in Know-How and Patent Rights under the Agreement and otherwise implement the provisions of this ARTICLE 12.
12.2 Prosecution and Maintenance of Patents.
12.2.1 Patent Prosecution and Maintenance of F-star IP and Fcab Platform Patent Rights.
(a) Subject to Section 12.7 and Section 12.2.3(c), F-star shall have the sole right to Prosecute and Maintain all Patent Rights comprised within the F-star IP including the Fcab Platform IP (“Licensed F-star Patent Rights”) and all costs of such Prosecution and Maintenance shall be borne by F-star.
(b) Upon Janssen’s request, F-star shall keep Janssen informed with respect to the status of the Prosecution and Maintenance of the Licensed F-star Patent Rights and with respect only to those Licensed F-star Patent Rights set out in Part A of Schedule 2 (the “Licensed F-star [***] Patent Rights”) shall provide electronic copies of submissions and communications to [***], along with a reasonable opportunity to review and comment on in accordance with Section 12.2.3(a).
(c) F-star shall give advance notice to Janssen of the actual or anticipated grant, lapse, revocation, surrender, invalidation or abandonment of any Licensed F-star Patent Rights. Subject to Section 12.2.3(c), F-star may elect to cease Prosecution or Maintenance of any Licensed F-star Patent Rights on a country-by-country basis, and if it does so, F-star shall give timely notice to Janssen.
12.2.2 Patent Prosecution and Maintenance of Product Patent Rights.
(a) Subject to Section 12.2.3(d), Janssen shall have the sole right to Prosecute and Maintain all Patent Rights comprised within the Product IP and all costs of such Prosecution and Maintenance shall be borne by Janssen.
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(b) Upon F-star’s request, Janssen shall keep F-star informed with respect to the status of the Prosecution and Maintenance of the Product Patent Rights by providing electronic copies of submissions and communications to [***], along with a reasonable opportunity to review and comment on in accordance with Section 12.2.3(a)..
(c) Janssen shall give advance notice to F-star of the actual or anticipated grant, lapse, revocation, surrender, invalidation or abandonment of any Product Patent Rights. Subject to Section 12.2.3(d), Janssen may elect to cease prosecution or maintenance of any Product Patent Rights on a country-by-country basis, and if it does so, Janssen shall give timely notice to F-star.
12.2.3 Review and Comment; Abandonment; Scope; Cooperation; Confidentiality.
(a) Review and Comment. Subject to Sections 12.2.1, 12.2.2 and 12.2.3(b): with regard to the Licensed F-star [***] Patent Rights and the Product Patent Rights, upon request of the Non-Filing Party, the Party responsible for the Prosecution and Maintenance (the “Filing Party”) shall provide the other Party (the “Non-Filing Party”) with a reasonable opportunity to review and comment on its efforts to prepare, file, prosecute and maintain the patent, including by providing the Non-Filing Party with an electronic copy of all communications from any patent authority, drafts of any substantive filings or responses to be made in advance of submitting such filings or responses, and the Filing Party shall in any event provide to the Non-Filing Party a copy of any final filing or response made. The Filing Party shall consider the Non-Filing Party’s comments regarding such communications and drafts in good faith; provided, however, that final decision with regard to the Prosecution and Maintenance of such patent rights shall reside solely with the Filing Party, subject to Section 12.7 and Section 12.2.3(c) with regard to Licensed F-star Patent Rights, and subject to Section 12.2.3(d) with regard to Product Patent Rights.
(b) Pre-Publication Product Patent Rights. When providing requested information pursuant to Section 12.2.3(a), Janssen shall have the right to redact Confidential Information relating to its Fab Targets, its Fab IP or other proprietary Product Know-How not related to the Fcab.
(c) Abandonment of Licensed F-star Patent Rights. If F-star determines, in its sole discretion, to not file, to abandon or to not
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maintain any Licensed F-star Patent Rights in any country, then F-star shall provide Janssen with written notice of such determination within a period of time sufficiently in advance (which shall be no later than no later than [***] prior to any final deadline for any pending action or response that may be due with respect to such Patent Right with the applicable patent authority) to enable Janssen to determine whether such Patent Right relates to a Product or Subject mAb2. If such Patent Right is determined to relate to a Product or Subject mAb2, Janssen shall have the right to assume responsibility for such Patent Right at its expense and shall notify F-star of such decision, at which time ownership for such Patent Right shall be promptly transferred to Janssen, subject to any Third-Party right, title or interest in or to the Licensed F-star Patent Rights granted prior to the Effective Date, including execution of any documents necessary to effect the transfer. Upon completion of such transfer, Janssen shall have the right to Prosecute and Maintain such Patent Right in such country at its sole expense and such Patent Right shall be considered a Product Patent Right.
(d) Scope of Product Patent Right Filings. Janssen shall use reasonable efforts to Prosecute and Maintain: (i) the F-star Product Patent Rights described in Section 10.6.2(b), and (ii) the Janssen Product Patent Rights described in Section 10.6.3 in at least the countries listed in 0 until such time as a Patent Right no longer qualifies for royalty payments under the aforementioned subsections of Section 10.6, provided that once granted Janssen shall then maintain, to the extent reasonably able to do so, those Patent Rights in force until such time as those Patent Rights no longer qualify for royalty payments under the aforementioned subsections of Section 10.6. For instance, with regard to a Janssen Product Patent Right described in Section 10.6.3, Janssen’s obligations to Prosecute and Maintain such Patent Right in a given country in accordance with this 12.2.3(d) shall cease as of [***] from the date of First Commercial Sale of such Product in such country.
(e) Confidentiality. All communications between the Parties relating to the preparation, filing, prosecution or maintenance of Patents, including copies of any draft or final documents or any communications received from or sent to patent offices or patenting authorities with respect to such Patents, shall be considered Confidential Information and be subject to ARTICLE 13. For clarity, all such communications regarding the Fcab Platform Patent Rights shall be the Confidential Information of F-star; all such
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communications regarding the Product Patent Rights shall be the Confidential Information of Janssen.
12.3 Liability for Prosecution and Maintenance. Each Party acknowledges that the Party responsible for Prosecution and Maintenance of Patent Rights licensed or subject to the royalty payments under the Agreement does not guarantee the issuance, validity, or enforceability of any such Patent Right or any claim resulting from its efforts hereunder. Neither Party shall have any liability to the other Party for any negligent acts or misconduct of outside counsel or agents utilized in connection with the Prosecution and Maintenance. The foregoing provisions of this Section 12.3 are without prejudice to either Party’s potential liability for breach of its obligations under Section 12.1 or Section 12.2.
12.4 Enforcement and Defense.
12.4.1 Notice of Infringement. Each Party shall provide prompt notice to the other Party of any infringement of a Licensed F-star Patent Right or Product Patent Right of which such Party becomes aware (each, a “Third-Party Infringement”). The Parties shall thereafter consult and cooperate fully to determine a course of action, including the commencement of legal action by either or both of Janssen and F-star, to terminate any such Third-Party Infringement.
12.4.2 Fcab Platform Patent Rights. F-star shall have the first right to enforce a Licensed F-star Patent Right with respect to any Third-Party Infringement, and to defend any declaratory judgment action with respect thereto, at its own expense and by counsel of its own choice and in the name of F-star (or a F-star Affiliate) and shall notify Janssen of such enforcement actions. If F-star fails to bring or defend any such action against a Third-Party Infringement within [***] following the notice of alleged Third-Party Infringement provided pursuant to Section 12.4.1, Janssen shall have the right to bring and control any such action at its own expense and by counsel of its own choice, and F-star shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. In no event shall Janssen admit the invalidity of any Licensed F-star Patent Right or take any other action that would adversely impact any Licensed F-star Patent Right without F-star’s prior written consent.
12.4.3 Product Patent Rights. Janssen shall have the first right to enforce a Product Patent Right with respect to any Third-Party Infringement, and to defend any declaratory judgment action with respect thereto, at its own expense and by counsel of its own choice and in the name of Janssen (or a Janssen Affiliate) and shall notify F-star of such enforcement actions.
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12.4.4 Third-Party Infringement Action. In the event a Party brings an action to enforce a Patent Right with respect to any Third-Party Infringement in accordance with this Section 12.4 (an “Enforcement Action”), such Party (the “Controlling Party”), shall keep the other Party reasonably informed of the progress of such Enforcement Action, and the other Party shall cooperate fully with the Controlling Party, at the Controlling Party’s request and expense, including by providing information and materials and, if required to bring such action, the furnishing of a power of attorney or being named as a party in such Enforcement Action.
12.4.5 Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realised as a result of an Enforcement Action (whether by way of settlement or otherwise) shall be first, allocated to reimburse the Parties for their costs and expenses in making such recovery (which amounts shall be allocated pro rata if insufficient to cover the totality of such expenses). Any remainder after such reimbursement is made shall be retained by the Controlling Party; provided, that to the extent that any award or settlement (whether by judgment or otherwise) obtained by Janssen is attributable to loss of sales with respect to a Product such amount shall be treated as Net Sales relating to the relevant Product for the purposes of the Agreement.
12.5 Defense of Infringement Claims. In the event that a claim is brought against either Party alleging the infringement, violation or misappropriation of any Third-Party intellectual property right based on the manufacture, use, sale or importation of any Product, the Parties shall promptly meet to discuss the defense of such claim, and the Parties shall, as appropriate, enter into a joint defense agreement with respect to the common interest privilege protecting communications regarding such claim in a form reasonably acceptable to the Parties.
12.6 Inventor’s Remuneration. Each Party shall be solely responsible for any remuneration that may be due to such Party’s inventors under any applicable contract, employment agreement and/or inventor remuneration laws.
12.7 Patent Term Extension.
12.7.1 As between the Parties, Janssen shall have the sole right and discretion to determine which Product Patent Rights and Licensed F-star Patent Rights, if any, are extended for a Product (for example, a Supplementary Protection Certificate in the EU, a patent term extension pursuant to Title II of the Drug Price Competition and Patent Term Restoration Act of 1984 and other similar measures in any other country), but only to the extent relating to that Product. F-star shall not extend a Licensed F-star Patent Right to the extent relating to a Product without Janssen’s consent.
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12.7.2 Janssen shall not extend a Licensed F-star Patent Right for a Product without F-star’s consent, which shall not be unreasonably withheld with regard to the Licensed F-star [***] Patent Rights. F-star shall cooperate with Janssen to gain such patent term extension, including making a filing in its name, as requested by Janssen, if required by Applicable Law in the applicable country.
12.8 Purple Book. With respect to a Product, as between the Parties, Janssen shall have sole discretion to determine which Patent Rights, if any, shall be listed in the “Purple Book” in the U.S., or any analogous or similar listing in the Territory.
12.9 Patent Working Group. Janssen and F-star shall establish a patent working group (“Patent Working Group”) comprising one or more patent attorneys or agents from each Party, with one patent attorney designated by each Party as its lead contact (“Patent Representative”), for discussing any patent matters. No patent matters shall be discussed by the Parties outside of the Patent Working Group unless both Parties’ Patent Representatives or other patent counsel are present. The Parties’ Patent Representatives shall be solely responsible for documenting at their discretion any issues discussed relating to any Patent Rights, which documents, and the content of such discussions, shall be held in strict confidence by the Parties to protect their common interests and preserve the privileged status of any attorney-client communication, advice, or legal opinion reflected therein.
ARTICLE 13
Confidentiality and Non-Disclosure
13.1 Confidentiality Obligations. To facilitate any activities hereunder, a Party (a “disclosing Party”) may provide to the other Party (a “receiving Party”), or a Party (in this case a “receiving Party”) may otherwise through activities contemplated by the Agreement come into possession of Confidential Information. A disclosing Party shall take reasonable measures to identify confidential information and material provided by it to the other Party with a “CONFIDENTIAL” or “TRADE SECRET” marking or similar notation. For clarity: Janssen shall be deemed a disclosing Party with respect to the information contained in the Research Program updates, Development reports, annual Commercialization reports, and all Know-How data and other information from the Research Program, and the Development and Commercialization of Subject mAb2 and Products in exploitation or support of Janssen’s Licenses (including as discussed at any meeting or disclosed in any report provided to F-star hereunder), and Product IP, and such information shall be treated as Janssen’s Confidential Information hereunder; and F-star shall be deemed a disclosing Party with respect to Fcab Platform IP and such information shall be treated as F-star’s Confidential Information hereunder. During the applicable period of confidentiality specified in Section 13.2 below, each receiving Party shall, and shall cause its Affiliates and its and their respective officers, directors, employees, consultants, contractors and agents to, keep confidential and not publish or otherwise disclose to a Third-Party and not use, directly or indirectly, for any purpose,
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any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the disclosing Party, except to the extent such disclosure or use is expressly permitted by the terms of the Agreement.
13.2 Term of Confidentiality. A receiving Party’s obligation of confidentiality and restriction on use as to a disclosing Party’s Confidential Information, shall last during the Term and for a period of [***] thereafter. A receiving Party’s obligation of confidentiality and restriction on use with respect to the disclosing Party’s Confidential Information identified as trade secrets, or typically held in the pharmaceutical industry as trade secrets, (together “Trade Secrets”) shall continue perpetually for so long as such Confidential Information is unpublished by the disclosing Party and no provision of Section 13.4 shall apply to such Confidential Information. Notwithstanding the foregoing, the Parties agree that Janssen, at its sole discretion, may disclose F-star Confidential Information to consultants, contract research organizations, potential clinical trial sites, clinical trial sites, clinical investigators, subcontractors of any of the foregoing and any other necessary Third Parties for the clinical and preclinical Development to the extent necessary for the purpose of designing and conducting Clinical Studies of Product(s) and analyzing and interpreting data obtained from Clinical Studies (“Clinical Study Purposes”). Where Janssen is to disclose F-star Confidential Information for Clinical Trial Purposes then it shall use all reasonable efforts to secure confidentiality undertakings from Persons who are to receive such Confidential Information on terms consistent with the first sentence of this Section 13.2 (i.e. with regard to the term of confidentiality) but where, having used such efforts, it is unable to do so then the Parties agree that the term of confidentiality defined in this Section 13.2 of the Agreement shall be modified for such disclosures to such Persons and shall be for a minimum period of [***] from the execution date of any consultancy agreement, confidential disclosure agreement, clinical trial agreement or any other agreement necessary for the design and conduct of the Clinical Studies and analysis and interpretation of data obtained from Clinical Studies, provided that Janssen ensures that disclosure of Confidential Information is limited to the extent strictly required for the Clinical Study Purposes and the Confidential Information disclosed includes no Trade Secrets of F-star or its Affiliates or Sublicensees. Janssen shall have sole discretion in negotiating the term of confidentiality with the Third Parties subject to the [***] minimum period.
13.3 Exceptions. Notwithstanding the foregoing, to the extent the receiving Party can demonstrate by documentation or other competent proof, the confidentiality and non-use obligations under Section 13.1 with respect to any Confidential Information shall not include any information that:
13.3.1 was publicly known when received from the disclosing Party or thereafter becomes publicly known through no wrongful act, fault or omission on the part of the receiving Party;
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13.3.2 was in the receiving Party’s possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information;
13.3.3 is subsequently received by the receiving Party from a Third-Party without restriction and without breach of any agreement between such Third-Party and the disclosing Party;
13.3.4 is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or
13.3.5 has been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Party’s Confidential Information.
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.
For the avoidance of doubt, Janssen may use and disclose F-star’s Confidential Information under appropriate confidentiality obligations substantially equivalent to those in the Agreement, to Janssen’s Affiliates and, as set forth in written subcontracts as otherwise provided herein, to its Third-Party licensees, sublicensees, subcontractors and any other Third Parties to the extent such use and/or disclosure is reasonably necessary to perform its obligations or to exercise the rights granted to it, or reserved by it, under the Agreement.
13.4 Permitted Disclosures. Each Party may disclose Confidential Information to the extent that such disclosure is:
13.4.1 in the reasonable opinion of the receiving Party’s legal counsel, required to be disclosed pursuant to law, regulation or a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental body of competent jurisdiction, (including by reason of filing with securities regulators, but subject to Section 13.8); provided that the receiving Party shall first have given prompt written notice (and to the extent practically possible, at least ten (10) Business Days’ notice) to the disclosing Party and given the disclosing Party a reasonable opportunity to take whatever action it deems necessary to protect its Confidential Information (for
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example, to quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or governmental body or, if disclosed, be used only for the purposes for which the order was issued). In the event that no protective order or other remedy is obtained, or the disclosing Party waives compliance with the terms of the Agreement, the receiving Party shall furnish only that portion of Confidential Information which the receiving Party is advised by counsel is legally required to be disclosed;
13.4.2 made by or on behalf of Janssen (or its Affiliates or Sublicensees) as the receiving Party to a Regulatory Authority as required in connection with any filing, application or request for Regulatory Approval in accordance with the terms of the Agreement, provided that reasonable measures shall be taken to assure confidential treatment of such Confidential Information to the extent practicable and consistent with Applicable Law;
13.4.3 made to the receiving Party’s or its Affiliates’ financial and legal advisors who have a need to know such disclosing Party’s Confidential Information and are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements of confidentiality and non-use, in each case, at least as restrictive as those set forth in the Agreement; provided that the receiving Party shall remain responsible for any failure by such financial and legal advisors, to treat such Confidential Information as required under this ARTICLE 13;
13.4.4 subject to the disclosing Party’s consent and, with regard to Janssen, the right to redact certain information, made to the receiving Party’s or its Affiliates’ (i) actual or potential investment bankers; (ii) to existing and potential investors in connection with an offering or placement of securities for purposes of obtaining financing for its business and to actual and prospective lenders for the purpose of obtaining financing for its business; or (iii) to a bona fide potential acquirer or merger partner for the purposes of evaluating entering into a merger or acquisition, provided, however, any such persons must be obligated to substantially the same extent as set forth in this ARTICLE 13 to hold in confidence and not make use of such Confidential Information for any purpose other than those permitted by the Agreement; or
13.4.5 made to the receiving Party’s or its Affiliates’ advisors, consultants, clinicians, vendors, service providers, contractors, prospective (i) collaboration partners, (ii) licensees, (iii) sublicensees, or other Third Parties, as may be necessary or useful in connection with the performance of its obligations or exercise of its rights as contemplated by the Agreement, provided, however, any such persons shall be subject to obligations of confidentiality and non-use with respect to
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such Confidential Information that are at least equivalent to those set out in this ARTICLE 13.
13.5 Disclosure to Tax Authority. The Parties hereby consent to the disclosure of a copy of the Agreement to any Tax Authority by the other Party (1) upon receipt of any legally enforceable information request by such Tax Authority, (2) in compliance with any legally enforceable filing requirement, or (3) in connection with a submitted transfer pricing analysis. In the event of such disclosure, the disclosing Party will make reasonable efforts to ensure that the information is maintained in confidence by the applicable Tax Authority, including marking any disclosed document as confidential.
13.6 Loss, Theft or Misuse. In the event of loss, theft, actual or suspected misuses, or misappropriation of any of the disclosing Party’s Confidential Information by the receiving Party (or any Person to whom it has disclosed the disclosing Party’s Confidential Information), the disclosing Party must be notified as soon as reasonably possible by the receiving Party.
13.7 Use of Name. Except as expressly provided herein, neither Party or any of its respective Affiliates shall mention or otherwise use the name, logo, or trademark of the other Party or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of such other Party.
13.8 Public Announcements.
13.8.1 Initial Press Release. Janssen has agreed the content of the press release attached hereto as 0, which F-star intends to issue promptly upon execution of the Agreement.
13.8.2 Further Publicity. Neither Party shall issue any other public announcement, press release, or other public disclosure regarding the Agreement or its subject matter without the other Party’s prior written consent, except for any such disclosure that is (i) required by Applicable Law or (ii) the rules of a stock exchange on which the securities of the disclosing entity are listed (or to which an application for listing has been submitted). In the case of (i) and (ii) above:
(a) such Party shall submit the proposed disclosure in writing to the other Party as far in advance as reasonably practicable (and in no event less than ten (10) Business Days prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon, and the disclosing Party shall give reasonable consideration to the concerns of the non-disclosing Party in respect of such disclosure; and
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(b) the scope and content of the disclosure shall not (without the prior written consent of the non-disclosing Party) extend beyond the information which the disclosing Party is required by Applicable Law or the rules of the relevant stock exchange to disclose (as supported by written opinion from the disclosing Party's counsel).
13.9 Publications.
13.9.1 Rights of Each Party to Publish. As between the Parties, only Janssen shall have a right to make publications, presentations or public disclosures relating to (a) Subject mAb2 and/or Products, (b) the results of the Research Program (subject to Section 2.5.2), and/or (c) the Development and Commercialization activities under the Agreement; provided that Janssen shall not have the right to disclose any of F-star’s Confidential Information. F-star and its Affiliates shall not make any publications, presentations or public disclosures relating to a Research mAb2, without Janssen’s written consent. Notwithstanding the foregoing:
(a) F-star and its Affiliates shall have the right to make any publications, presentations or public disclosures relating to (a) any Fcabs or (b) any Antibody other than a Research mAb2 (during the Research Term and thereafter where such Research mAb2 becomes a Subject mAb2), Subject mAb2 or Product; provided that F-star shall not have the right to disclose any of Janssen’s Confidential Information; and
(b) Janssen and its Affiliates shall, after making an NME Selection in respect of a Research mAb2, have the right to make publications relating to such Research mAb2 (and corresponding Subject mAb2) and Product, provided that it provides F-star with a copy of such publication at least [***] prior to submission and on F-star’s reasonable request (i) removes from such publication any of F-star’s Confidential Information (other than information related to the Fcab portion of such Research mAb2, Subject mAb2 or Product) and (ii) takes into account any reasonable comments F-star may have in respect of such publication.
13.9.2 Authorship. Any publications made pursuant to this Section 13.9 during the Term, shall comply with standard academic practice regarding authorship of scientific publications and recognition of contribution of the Parties. Consistent with the International Committee of Medical Journal Editors (“ICMJE”) guidelines, the Parties recognize and agree that in order to be listed as an author, an investigator must: (i) meet the criteria established by the ICMJE guidelines; (ii) have the opportunity to guide, review, and modify the
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scientific manuscript throughout the development process; and (iii) help ensure that the scientific manuscript is objective and unbiased.
13.10 Return of Confidential Information. Upon the effective date of the termination of the Agreement with respect to, as the case may be, any Research mAb2 or Subject mAb2 for any reason, the receiving Party shall promptly return or destroy (and shall cause its Representatives to do the same) all tangible items containing or consisting of the disclosing Party’s Confidential Information; provided that each Party shall have the right to retain Confidential Information (x) to the extent necessary or useful for purpose of performing any continuing obligations or exercising any surviving rights hereunder in accordance with the Agreement, and, in any event, a single copy of Confidential Information may be retained by the receiving Party in a secured location (to which the terms and conditions of the Agreement shall continue to apply), solely to the extent necessary to allow the receiving Party to ensure its continued compliance with the Agreement and (y) in any computer records or files containing such Confidential Information that have been created solely by such non-requesting Party’s automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such non-requesting Party’s standard archiving and back-up procedures, but not for any other uses or purposes. All Confidential Information shall continue to be subject to the terms of the Agreement for the period set forth in Section 13.2.
ARTICLE 14
representations and warranties
14.1 Fundamental Warranties. F-star and Janssen each represent and warrant to the other, that as at the Effective Date:
14.1.1 Organization. It is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform the Agreement.
14.1.2 Authorization. The execution and delivery of the Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action and do not violate (a) such Party’s charter documents, bylaws, or other organizational documents, (b) in any material respect, any agreement, instrument, or contractual obligation to which such Party is bound, (c) any requirement of any Applicable Law, or (d) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to such Party.
14.1.3 Binding Agreement. The Agreement is a legal, valid and binding obligation of such Party, enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency, or other laws of
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general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity).
14.1.4 No Inconsistent Obligation. It is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of the Agreement, or that would impede the diligent and complete fulfilment of its obligations hereunder.
14.2 Additional Representations and Warranties of F-star. F-star further represents and warrants to Janssen that, as of the Effective Date:
14.2.1 F-star has and shall retain through the Term the full right, power and authority to enter into the Agreement on behalf of itself and its Affiliates and to perform its respective obligations under the Agreement and that it has the right to grant to Janssen the Licenses as contemplated under the Agreement, including on behalf of its Affiliates.
14.2.2 All Licensed F-star Patent Rights are (i) solely and exclusively owned by F-star or its Affiliates, and (ii) being diligently prosecuted in the respective patent offices in the Territory in accordance with Applicable Law, and all applicable fees in respect of such Patents have been paid on or before the due date for such payments.
14.2.3 Neither F-star nor any of its Affiliates are aware of any claim, made against it by any Person (a) asserting or alleging that any Licensed F-star Patent Right is invalid, unenforceable, or unregistrable, or (b) asserting or alleging that the use of F-star IP, or the disclosing, copying, making, assigning, or licensing of the F-star IP, as contemplated by the Agreement, violates, infringes, misappropriates or otherwise conflicts or interferes with any intellectual property right of any Third-Party, or (c) challenging F-star’s or its Affiliates’ ownership of or license rights in any of the Licensed F-star Patent Rights or making any adverse claim of ownership (whether sole or joint) thereof, nor have F-star or any of its Affiliates received written notice from any Person that is likely to give rise to any such claim where such Person is making such allegation, assertion or challenge on the basis of rights that it controls.
14.2.4 Neither F-star, nor any of its Affiliates has previously assigned, transferred, conveyed or otherwise encumbered its right, title or interest in or to the F-star IP in a manner that would preclude or prevent Janssen or its Affiliates, subcontractors, or Sublicensees from (i) making, having made, using, having used, importing, and having imported a Reference mAb² or Research mAb2 during the Research Term for the conduct of the Research Program, or (ii)
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researching, Developing, Manufacturing or Commercializing a Subject mAb² or Product or from otherwise exploiting the full scope of the Licences granted to Janssen as contemplated hereunder.
14.2.5 To the best of F-star’s knowledge, no Person is infringing, misappropriating, or threatening to infringe or misappropriate F-star IP.
14.2.6 Schedule 2 lists all of the Fcab Platform Technology Patent Rights as of the Effective Date and, to the best of F-star’s knowledge, the Fcab Platform Technology Patent Rights Cover all material patentable subject matter within the Fcab Platform IP.
14.2.7 To the best of F-star’s knowledge, the inventorship named as of the Effective Date in each Fcab Platform Technology Patent Rights is correct.
14.2.8 To the best of F-star’s knowledge, as of the Effective Date, neither F-star, nor any of its Affiliates has entered into, and neither F-star nor any of its Affiliates will enter into during the Term, any agreements with any Third -Party by virtue of which any royalty or milestone payment or other payment would be owed by Janssen to such Third -Party on account of any Commercialization of any Product by or on behalf of Janssen as contemplated hereunder.
14.2.9 As of the Effective Date, F-star has identified all Targets to the Gatekeeper in accordance with Section 3.3 that to the best of its knowledge are Unavailable Targets.
14.3 Where an F-star warranty is qualified by the expression “so far as F-star is aware” or “to its knowledge” or any similar expression, this shall mean the actual knowledge or awareness of the Chief Executive Officer, Chief Scientific Officer, Chief Financial Officer, Chief Medical Officer, Director of Business Development, and in-house IP counsel of F-star (having (in each case) made reasonable enquiries).
14.4 Covenant. F-star will not assign, transfer, convey or otherwise encumber its right, title and interest in the F-star IP in any manner that would prevent it from granting the Licenses or bestowing other rights expressly contemplated in the Agreement.
14.5 Additional Mutual Representations, Warranties and Covenants. Each Party warrants and covenants to the other Party that during the Term:
14.5.1 Each Party further acknowledges and ensures that it and its Affiliates, Sublicensees and subcontractors are familiar with the provisions of the United States Foreign Corrupt Practices Act, the UK Bribery Act and applicable local bribery and corruption laws, and each Party represents and warrants to the other Party that it will not take or permit any action that may either constitute a
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violation under, or cause the other Party to be in violation of, the provisions of the United States Foreign Corrupt Practices Act, the UK Bribery Act or applicable local bribery and corruption law, environmental, labour and social standards.
14.5.2 Outcomes. The Parties acknowledge and agree that no outcome or success of any research or Development carried out pursuant to the Agreement is or can be assured and that the failure of a mAb² to achieve the results desired of it will not in and of itself constitute a breach of the Agreement.
ARTICLE 15
Indemnity
15.1 Indemnification Obligation. Each Party (the “Indemnifying Party”) shall indemnify and hold harmless the other Party and its Indemnified Persons (collectively, the “Indemnified Party”) from and against any and all Losses resulting from any Action brought by a Third-Party against any Indemnified Party to the extent such Losses arise from or are based on a claim (“Claim”) arising from or occurring as a result of:
15.1.1 the negligence or wilful misconduct of the Indemnifying Party or any of its Indemnified Persons or Third-Party sublicensees or subcontractors, in each case in connection with the exercise of such Indemnifying Party’s rights, or performance of such Party’s obligations, under the Agreement, or
15.1.2 the violation of Applicable Law by the Indemnifying Party or any of its Indemnified Persons or Third-Party sublicensees or subcontractors in connection with the exercise of such Indemnifying Party’s rights, or performance of such Party’s obligations, under the Agreement;
15.1.3 in the case of Janssen as the Indemnifying Party, the research and Exploitation by or for Janssen or any of its Affiliates, Sublicensees, subcontractors, agents and consultants of any Research mAb2, Subject mAb2 or Products in the Territory, or
15.1.4 in the case of F-star as the Indemnifying Party, the research and Exploitation by or for F-star or any of its Affiliates, sublicensees, subcontractors, agents and consultants of any mAb2 under the licenses granted in Section 2.7 or Section 16.7.2.
15.1.5 Neither Party shall be obliged to indemnify the other to the extent such Losses arise as a result of the Indemnified Party’s breach of the Agreement, negligence or wilful misconduct.
15.2 Claims for Indemnification.
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15.2.1 Notice. In the case of any Action for which an Indemnifying Party may be liable to an Indemnified Person under Section 15.1, the Indemnified Party shall as soon as practicable notify the Indemnifying Party in writing of such Action (a “Notice of Claim”). Failure or delay in notifying the Indemnifying Party shall not relieve the Indemnifying Party of any liability it may have to the Indemnified Party, except and only to the extent that such failure or delay causes actual harm to the Indemnifying Party with respect to such Action. The Notice of Claim shall specify in reasonable detail the Action with respect to which such Indemnified Party or any of its Indemnified Persons intends to base a request for indemnification or reimbursement under Section 15.1. Failure to provide such reasonable detail will not relieve the Indemnifying Party of any liability it may have to the Indemnified Party, except and only to the extent that such failure causes actual harm to the Indemnifying Party with respect to such Action. The Indemnified Party shall enclose with the Notice of Claim a copy of all papers served with respect to such Action, if any. The Indemnifying Party shall have the right to assume the defense of such Action, unless it provides notice within [***] from the date on which it received the Notice of Claim that it waives its right to assume the defense of such Action and any litigation resulting therefrom with counsel of its choice.
15.2.2 Control of Defense. Provided that the Indemnifying Party has not waived its right to assume the defense of an Action pursuant to Section 15.2.1, then, subject to Section 15.2.4, the Indemnifying Party shall have the right to defend, settle and otherwise dispose of such Action. The assumption of the defense of an Action by the Indemnifying Party shall not be construed as an acknowledgment that the Indemnifying Party is liable to indemnify the Indemnified Party in respect of the Action, nor shall it constitute a waiver by the Indemnifying Party of any defenses it may assert against the Indemnified Party’s claim for indemnification.
15.2.3 Cooperation. The Parties shall act in good faith in responding to, defending against, settling or otherwise dealing with such Action pursuant to the terms hereof; provided that (a) an Indemnified Party shall not be obligated to enter into or consent to the entry of any judgment or settlement in relation to any Action as provided in Section 15.2.4, and (b) in any event, an Indemnifying Party shall not be relieved of its obligations under this Section 15.2.3 as a result of any failure of the Indemnified Party to cooperate as provided in this Section 15.2.3, except to the extent that the Indemnifying Party is actually prejudiced by such breach. The Parties shall also cooperate in any such defense by giving each other reasonable access to all non-privileged information relevant thereto to the extent permitted by Applicable Law.
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15.2.4 Control by the Indemnifying Party. If the Indemnifying Party assumes control of an Action in accordance with Section 15.2.2: (a) the Indemnified Party may retain separate co-counsel at its sole cost and expense and participate in the defense of the Action, but the Indemnifying Party shall continue to control the investigation, defense and settlement thereof, and (b) the Indemnifying Party will not, without the prior written consent of the Indemnified Party, consent to the entry of any judgment or enter into any settlement with respect to the Action to the extent such judgment or settlement (1) provides for equitable relief (or any other relief other than solely for money damages) against the Indemnified Party or any of its Indemnified Persons, or liability or obligation that cannot be assumed and performed by the Indemnifying Party in full (without any recourse to the Indemnified Party and its Indemnified Persons), (2) provides for any monetary relief that will not be fully discharged by the Indemnifying Party (without any recourse to the Indemnified Party and its Indemnified Persons) concurrently with the effectiveness of such judgment or settlement; provided that the Indemnified Party’s consent shall not be unreasonably withheld, conditioned or delayed to the extent that the sole relief is monetary, (3) does not effect a full and unconditional release of the Indemnified Party and its Indemnified Persons with respect to all claims in such Action (or the portion thereof to which the judgment or settlement relates), or (4) that contains an admission of wrongdoing on the part of the Indemnified Party or its Indemnified Persons. Notwithstanding anything contained herein to the contrary, an Indemnifying Party shall not be entitled to assume the defense of any Action that seeks an injunction or other equitable relief (or any other relief other than solely money damages) against the Indemnified Party.
15.2.5 Interim Control. Unless and until the Indemnifying Party (if any) is determined with respect to any particular Action, the Party subject to such Action shall have the right to defend and control such Action, but shall not have the right to consent to the entry of any judgment or enter into any settlement with respect to the Action for which it would be seeking indemnification or reimbursement hereunder without the prior written consent of the other Party (which consent shall not be unreasonably withheld, conditioned or delayed).
15.2.6 Election Not to Control. If the Indemnifying Party waives control of an Action in accordance with Section 15.2.1, then the Indemnified Party will be entitled to assume control of the Action upon delivery of notice to such effect to the Indemnifying Party; provided that the Indemnifying Party shall have the right to participate in the Action at its sole cost and expense, but the Indemnified Party shall control the investigation, defense and settlement thereof.
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15.2.7 Unauthorized Settlements. Whether or not the Indemnifying Party has assumed control of the Action, the Indemnified Party will not consent to the entry of any judgment or enter into any settlement with respect to any Action for which it is seeking indemnification hereunder without the prior written consent of the Indemnifying Party (which consent shall not be unreasonably withheld, conditioned or delayed), and such Indemnifying Party shall not be obligated to indemnify or reimburse the Indemnified Party hereunder for any settlement entered into, or any judgment that was consented to, by the Indemnified Party without the Indemnifying Party’s prior written consent.
15.2.8 Allocation. If, in any Action under this ARTICLE 15, the Indemnified Party incurs an amount consisting of both Losses for which the Indemnifying Party is obliged to indemnify the Indemnified Party and Losses not covered by such indemnification, then, to the extent not otherwise determined in a court of competent jurisdiction, the Parties agree to act in good faith and use their reasonable endeavors to determine a fair and reasonable allocation of such Losses. The allocation between the Parties of any such Losses, if not otherwise determined in a court of competent jurisdiction, shall, if the Parties do not reach agreement in writing on such allocation, be determined by arbitration pursuant to Section 17.9. The Parties or the arbitrator, as the case may be, shall make such allocation based on the indemnification and reimbursement principles set forth in this ARTICLE 15. Notwithstanding the foregoing, the Parties shall not be entitled to refer any Dispute with respect to Losses arising under an Action pursuant to this Section 15.2.8 to arbitration to the extent that the liability of either Party for such Losses is being contested in such Action (or any other Action that would be binding with respect to such first Action).
15.2.9 Mitigation. The Indemnified Party shall, and shall procure that its Indemnified Persons shall, in each instance, take reasonable steps to mitigate any Losses they suffer arising in connection with any Action in respect of which they seek an indemnity from the other Party under the Agreement.
15.2.10 Special, Indirect, and Other Losses. NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY SPECIAL OR PUNITIVE, INDIRECT OR CONSEQUENTIAL OF PROFITS SUFFERED BY THE OTHER PARTY.
15.3 Limitation on Liability.
15.3.1 Exclusions. No provision of the Agreement shall operate to limit or exclude any liability, right or remedy:
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(a) to a greater extent than is permissible under English law including in relation to death or personal injury caused by the negligence of a Party to the Agreement or fraudulent misrepresentation or deceit; or
(b) for gross negligence, wilful misconduct
15.3.2 F-star’s Liability. Subject to Section 15.3.1, the aggregate liability of F-star under or in connection with the Agreement, except in relation to any indemnified loss, shall:
(a) for claims brought during the Initial Research Term, be limited to the greater of (i) the aggregate sums paid to F-star under the Agreement during the Initial Research Term plus any interest accrued on such sums since the date of payment, and (ii) [***],
(b) where the Research Term is extended for a further [***] period in accordance with Section 2.3, for claims brought during that further [***] period, be limited to the greater of (i) the aggregate sums paid to F-star under the Agreement during that [***] period plus any interest accrued on such sums since the date of payment, and (ii) [***], and
(c) for claims brought after the Research Term, be limited to the greater of (i) the aggregate sums paid to F-star under the Agreement during that Calendar Year and the immediately preceding [***] period plus any interest accrued on such sums since the date of payment, and (ii) [***].
15.4 Insurance.
15.4.1 Each of the Parties shall, at their own respective expense, procure and maintain during the Term, insurance policies adequate to cover their respective obligations hereunder and consistent with the normal business practices of (i) with respect to Janssen, a prudent global pharmaceutical company; and (ii) with respect to F-star, a prudent biotechnology company, in each case of similar size and scope. Such insurance shall not create a limit to either Party's liability hereunder.
15.4.2 Upon request by Janssen or F-star, the other Party shall provide certificates of insurance evidencing compliance with Section 15.4.1. The insurance policies shall be under an occurrence form, but if only a claims-made form is available to a Party, then such Party shall continue to maintain such insurance after the expiration or termination of the Agreement for the longer of (a) a period of [***] following termination or expiration of the Agreement in its entirety, or
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(b) with respect to a particular Party, the last sale of a Product (or but for expiration or termination, would be considered a Product) sold under the Agreement by a Party.
ARTICLE 16
TERM AND TERMINATION
16.1 Term. The Agreement shall commence on the Effective Date and, unless earlier terminated in accordance with its terms, shall continue until the later of:
16.1.1 the expiry of the Research Term, if Janssen has not (i) designated at least one (1) Available Target as a Selected Target for a Subject mAb2; or
16.1.2 the expiry of the Product Royalty Term for all Products,
(the “Term”).
16.2 Termination by Janssen for Convenience. Janssen may terminate the Agreement in its entirety for any or no reason upon [***] prior written notice to F-star.
16.3 Early Termination for Material Breach.
16.3.1 Notice of Breach and Cure Period. If either Party (the “Non-Breaching Party”) believes that the other Party (the “Breaching Party”) has materially breached one (1) or more of its material obligations under the Agreement, then the Non-Breaching Party may deliver notice of such material breach to the Breaching Party (a “Default Notice”) specifying the nature of such material breach. If the breach of the Agreement is curable, then the Breaching Party shall have a period of:
(a) [***] from the date of receipt of the notice for any breach of a payment obligation hereunder, or
(b) [***] from the date of receipt of the notice for any other breach,
(the “Cure Period”) to cure such material breach in a manner that effectively remedies the harm to the Non-Breaching Party caused by the material breach. Notwithstanding the foregoing, if such breach, by its nature, is curable, but is not reasonably curable within the Cure Period, then provided that such breach is not of a payment obligation hereunder, such Cure Period shall be extended if the Breaching Party provides a written plan for curing such breach to the Non-Breaching Party and uses diligent efforts to cure such breach in accordance with such written plan, provided that no such extension shall exceed [***] for an extended Cure Period totalling [***] without the consent of the Non-Breaching Party. For clarity, this provision shall not restrict in any
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way either Party’s right to notify the other Party of any other breach or to demand the cure of any other breach
16.3.2 Termination Right for Material Breach. The Non-Breaching Party shall have the right to terminate the Agreement, upon written notice to the Breaching Party: (a) in the event the Breaching Party does not notify the Non-Breaching Party within [***] of receipt of a notice under Section 16.3.1 that the Breaching Party disputes that it has committed a material breach or that it intends to cure such breach in accordance with Section 16.3.1; and (b) in the event that the Breaching Party has not cured the material breach within the Cure Period or within any extension in accordance with Section 16.3.1. If a Party in good faith raises a Dispute regarding any such termination (including with respect to the existence or materiality of a breach or the sufficiency of a cure) pursuant to the Dispute resolution procedures under Sections 17.8 and 17.9, such termination shall be effective only upon a conclusion of the Dispute resolution procedures in Section 17.9 resulting in a determination that there has been an uncured material breach (or, if earlier, abandonment of the Dispute by the Breaching Party). For the avoidance of doubt, the exercise of a termination right under this Section 16.3 by a Non-Breaching Party shall be without prejudice to its right to seek damages or any other remedy on account of the Breaching Party’s material breach that may be available at law or in equity, subject to the terms hereof.
16.4 Termination by F-star for Patent Challenge.
16.4.1 Subject to Section 16.4.2, F-star will have the right to terminate the Agreement in its entirety upon [***] advance written notice to Janssen in the event that Janssen or any of its Affiliates, individually or in association with any other Person (including any Sublicensee), commences a Patent Challenge unless, Janssen or its Affiliate:
(a) permanently and unconditionally dismisses or withdraws the applicable Patent Challenge before the effective date of a termination under this Section 16.4; or
(b) in the case of a Patent Challenge that Janssen or its Affiliate is unable by reason of Applicable Law to unilaterally withdraw or cause to be withdrawn on a permanent and unconditional basis, ceases participating (other than by referencing in any documentation relating to the Patent Challenge in question that Janssen or its Affiliate commenced such Patent Challenge) or assisting in such Patent Challenge before the effective date of a termination under this Section 16.4, provided that any subsequent participation or assistance in such Patent Challenge thereafter shall be regarded as
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being a Patent Challenge to which Sections 16.4.1(a) and 16.4.1(b) do not apply;
provided that, with regard to Sections 16.4.1(a) and 16.4.1(b), such Patent Challenge is made without use of Confidential Information of F-star and its Affiliates.
16.4.2 Notwithstanding Section 16.4.1, Janssen and its Affiliates shall have the right to dispute or challenge the validity, enforceability or scope of any claim of a [***] Patent, provided that in doing so no use is made of any Confidential Information of F-star and its Affiliates, in the event F-star, its Affiliates, or (any other Person having a legal right to enforce such Patent Rights), commences a proceeding in a court of law to enforce such claim of such [***] Patent against Janssen or its Affiliates, solely as a defense to such enforcement action.
16.4.3 “Patent Challenge” means any claim in a legal or administrative proceeding alleging that any claim in any Patent Right [***] is invalid, unenforceable, or otherwise not patentable including by (i) filing or pursuing a declaratory judgment action in which any claim of the [***] is alleged to be invalid or unenforceable, (ii) filing a request for or pursuing a re-examination of any of the [***], or (iii) filing or pursuing any opposition, cancellation, nullity or other like proceedings against any of the [***]. Without prejudice to the definition of Patent Challenge above the Parties do not consider the following activities to amount to a Patent Challenge:
(a) good faith arguments or comments made by or on behalf of Janssen or its Affiliate in the course of prosecution of Janssen’s or its Affiliates’ patents or patent applications where patents or patent applications are rejected on the basis of a [***]; and
(b) any counterclaim or affirmative defense Janssen or its Affiliate makes against a Third-Party in which a [***] Patent is used to challenge the validity, enforceability, or patentability of Janssen's or any of its Affiliates' patents or patent applications; and
(c) in an administrative proceeding relating to patents or patent applications in which of Janssen's or any of its Affiliates' have a property or contractual interest (but other than in respect of Patent Rights comprised within the F-star IP), to defend through good faith assertions such interest in satisfaction of a requirement of the proceeding in the case where such [***] Patent is cited as a reference in the proceeding; and
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(d) Janssen's or any of its Affiliates' good faith assertion pursuant to a Dispute resolution procedure under Sections 17.8 and 17.9, commenced by F-star, in the context of whether a payment of a royalty is due to F-star under ARTICLE 10, that no Valid Claim within the [***] Patents applies with respect to a Product; and
(e) any proceeding commenced by a Third Party that becomes an Affiliate of Janssen after the Effective Date, whether by stock purchase, merger, asset purchase, or otherwise, which proceeding commenced before the closing of such transaction; provided that such proceeding continues upon the same or substantially the same legal basis as was the case before the closing of such transaction; and
(f) upon acquisition of a license granted to Janssen or its Affiliates to a pharmaceutical product or program, the affirmative defense by the licensor of such product or program of a pre-existing challenge made by F-star, its Affiliates, or any other Person deriving a right to do so through F-star or its Affiliates, restricting the making, using, or selling of such product (as long as the pre-existing challenge is not amended to include claims regarding a Subject mAb2 or Product);
provided that in taking any of the steps described above under Sections 16.4.3(a) through 16.4.3(f), no use is made by Janssen and its Affiliates of any Confidential Information of F-star and its Affiliates.
16.4.4 If a Party in good faith raises a Dispute pursuant to the Dispute resolution procedures under Sections 17.8 and 17.9, regarding any termination under this Section 16.4 (including with respect to the existence of a Patent Challenge and/or the dismissal or withdrawal of a Patent Challenge in accordance with Sections 16.4.1(a) or 16.4.1(b) above) such termination shall be effective only upon a conclusion of the Dispute resolution procedures in Section 17.9 resulting in a determination that there is a Patent Challenge not dismissed or withdrawn in accordance with Sections 16.4.1(a) or 16.4.1(b) above (or, if earlier, abandonment of the Dispute by the Party(ies)).
16.5 Insolvency.
16.5.1 Termination. In the event that a Party (or its successor in interest in the event the Agreement is assigned as permitted hereunder), (i) files for protection under bankruptcy or insolvency laws; (ii) makes an assignment for the benefit of creditors; (iii) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is not discharged within [***] after such
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filing; (iv) proposes a written agreement of composition or extension of its debts; (v) proposes or is a party to any dissolution or liquidation; (vi) files a petition under any bankruptcy or insolvency act or has any such petition filed against that is not discharged within [***] of the filing thereof; or (vii) admits in writing its inability generally to meet its obligations as they fall due in the general course, (individually and collectively, each of (i) through (vii) referred to as an “Insolvency Event”) then the other Party may terminate the Agreement in its entirety effective immediately upon written notice to such Party.
16.5.2 Licenses Constitute IP under Bankruptcy Code. All licenses and other rights granted pursuant to the Agreement by one Party to the other are, and will otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code (or comparable provisions of laws of other jurisdictions), licenses of right to "intellectual property" as defined under Section 101 of the U.S. Bankruptcy Code (or comparable provisions of Applicable Laws of other jurisdictions). Upon the occurrence of any Insolvency Event with respect to F-star, F-star agrees that Janssen, as licensee of such rights under the Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code. Without limiting the generality of the foregoing, F-star and Janssen intend and agree that any sale of F-star’s assets under Section 363 of the Bankruptcy Code shall be subject to Janssen’s rights under Section 365(n), that Janssen cannot be compelled to accept a money satisfaction of its interests in the intellectual property licensed pursuant to the Agreement, and that any such sale therefore may not be made to a purchaser “free and clear” of Janssen’s rights under the Agreement and Section 365(n) without the express, contemporaneous consent of Janssen. Further, notwithstanding anything to the contrary herein, the Parties agree that, in lieu of Janssen terminating the Agreement in its entirety as provided in Section 16.5.1 above: (a) Janssen may, upon F-star’s undergoing an Insolvency Event, retain and may fully exercise all of the rights and elections under the U.S. Bankruptcy Code (or comparable Applicable Laws of other jurisdictions); and (b) in the event of the commencement of a bankruptcy proceeding by or against F-star under the U.S. Bankruptcy Code (or comparable provisions of Applicable Laws of other jurisdictions), Janssen shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property to which it is granted license or other rights hereunder, and the same, if not already in its possession, will be promptly delivered to it upon any such commencement of an Insolvency Event. All rights, powers and remedies granted hereunder to Janssen as a licensee of any intellectual property rights as provided in this Section 16.5.2 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, in the event of the commencement of
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an Insolvency Event by or against F-star under Applicable Law, and Janssen, in addition to the rights, powers and remedies expressly provided herein, shall be entitled to exercise all other such rights and powers and resort to all other such remedies as may now or hereafter exist at law or in equity in such event.
16.5.3 Right of Negotiation on Insolvency of F-star. F-star hereby grants Janssen a first right to negotiate with F-star (and/or the insolvency practitioner), terms pursuant to which Janssen shall purchase from F-star the Fcab Platform Patent Rights, subject to any pre-existing rights of any Third-Party to such Fcab Platform Patent Rights, in the event F-star is subject to an Insolvency Event. F-star shall notify Janssen promptly in the event that F-star (i) reasonably believes that one or more Insolvency Events will occur in relation to F-star in the subsequent [***] period; or (2) one or more Insolvency Events occurs in relation to F-star. Upon such notification, and without prejudice to any other rights or remedy available to Janssen, Janssen shall notify F-star whether or not it wishes to exercise its right of first negotiation. If Janssen elects to exercise its right of first negotiation, it shall notify F-star and following receipt of such notification from Janssen, the Parties shall in good faith seek to discuss commercially based fair market value terms for purchase of the Fcab Platform Patent Rights. Any purchase of the Fcab Platform Patent Rights under this Section 16.5.3 shall be subject to the Parties agreeing to binding terms.
16.6 Termination of a Subject mAb2. On a Subject mAb2-by- Subject mAb2 basis during the Development and Commercialization Term for a given Subject mAb2, Janssen may terminate at will its rights and obligations with respect to that Subject mAb2 (including all Products containing such Subject mAb2 as an active ingredient):
(a) on [***] advance written notice, or
(b) with immediate effect for Safety Reasons relating to Product(s) including such Subject mAb2.
16.7 Effects of Termination or Expiration. If the Term expires pursuant to Section 16.1.1 or a Party terminates the Agreement (except as a result of F-star’s material breach or bankruptcy):
16.7.1 Subject to Section 10.8 with regard to any expired Product Royalty Term(s) for a given country and Product, all rights and licenses granted by F-star relating to the Relevant Terminated Subject mAb2 hereunder shall immediately terminate, subject to Janssen’s continued right to use the Selected Target(s) in the Relevant Terminated Subject mAb2 in other Subject mAb2 that have such Selected Target(s) as a Fab Target as of the effective date of termination for the Relevant Terminated Subject mAb2.
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16.7.2 Janssen (for itself and its Affiliates) shall grant to F-star with respect to each Relevant Terminated Subject mAb2 that has Selected Target(s) that are not included in any other Subject mAb2 as a Fab Target.as of the effective date of termination for the Relevant Terminated Subject mAb2, a non-exclusive, worldwide, irrevocable and perpetual license, with a right to sublicense through multiple tiers, to any Product Patent Right Covering such Subject mAb2 (but excluding any rights to Janssen Fab IP contained therein) for the purposes of Exploiting mAb2 which bind Fab Targets other than Available Targets and Selected Targets. For clarity, the license granted under this Section 16.7.2 does not include a right to Exploit any Janssen Fab Construct, or any formulation, methods of manufacturing, or treatment regimens other than treatment regimens that claim activity based on mechanism of action and which do not specifically relate to mAb2 Constructs.
16.7.3 Right of First Negotiation for Exclusive License. Except in the event of termination by Janssen for Safety Reasons under Section 16.6(b) or termination by F-star for Patent Challenge under Section 16.4, for any Relevant Terminated Subject mAb2 for which an IND has been filed for a Product containing such Relevant Terminated Subject mAb2 as its sole API, provided that F-star gives written notice to Janssen within [***] from the effective date of termination of the Agreement, F-star shall have the following rights:
(a) a first right to negotiate in good faith an exclusive license for the sole purpose only of Exploiting such Relevant Terminated Subject mAb2 in the same mAb2 Construct as then in Development or Commercialization as of the effective date of termination under any (i) Janssen Fab IP, and (ii) Product IP (including all regulatory filings and data, including under any IND) (including sublicensing through multiple tiers), that is necessary to Exploit such Relevant Terminated Subject mAb2 in the same mAb2 Construct as then in Development or Commercialization as of the effective date of termination, in the Field in the Territory, on commercially based fair market value terms to be agreed upon by Janssen and F-star in a separate written agreement within [***] of F-star’s written notice or such longer period as the Parties may agree in writing (such period the “Negotiation Period”); and
(b) a right to request a delay in Janssen’s wind-down of any Ongoing Clinical Study until the Conclusion of the Negotiation Period,, subject to Section 16.7.5, provided that any such request is included in a timely written notice by F-star exercising its right to negotiate an exclusive license under Section 16.7.3(a) above.
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16.7.4 Any license under Section 16.7.3(a) above shall be subject to the Parties agreeing in writing to binding terms. If Janssen and F-star are not able to agree upon and execute an agreement within the Negotiation Period, Janssen shall have no further obligation to F-star under Section 16.7.3. The Negotiation Period shall be considered concluded at the earlier of (a) the execution of a written license agreement under Section 16.7.3(a) above or (b) the expiration of the Negotiation Period in the event that Janssen and F-star are not able to agree upon and execute an agreement (“Conclusion of the Negotiation Period”).
16.7.5 In the event that F-star gives timely written notice of its desire to negotiate an exclusive license under Section 16.7.3(a), and requests in accordance with Section 16.7.3(b) that Janssen delay wind-down of any Ongoing Clinical Study until the Conclusion of the Negotiation Period the following shall apply:
(a) Within [***] of receipt of F-star’s notice pursuant to Section 16.7.3, Janssen shall provide F-star with a good faith estimate of its and its Affiliates’ expected costs (fully-loaded FTE personnel costs and out-of-pocket costs) for the conduct of the Ongoing Clinical Study through the expected date of the Conclusion of the Negotiation Period.
(b) Within [***] of receipt of F-star’s notice pursuant to Section 16.7.3, Janssen shall provide F-star with a proposed plan for the transfer at F-star’s cost (except to the extent transfer is prohibited by any Regulatory Authority, and subject to any Third-Party consents) of sponsorship and control to F-star of the Ongoing Clinical Study, which transfer shall be completed no later than [***] after the Conclusion of the Negotiation Period. The transfer plan shall be included in the written license agreement under Section 16.7.3(a) above subject to any modification as agreed upon by the Parties.
(c) Janssen shall use Commercially Reasonable Efforts to conduct the Ongoing Clinical Study until the Conclusion of the Negotiation Period and the licenses granted under the Agreement shall remain in place for such a purpose. Janssen shall have sole responsibility for all operational and administrative decisions with respect to the conduct of the Ongoing Clinical Study and shall continue to have the sole right to prepare, obtain and maintain all Regulatory Filings (including the setting of the overall regulatory strategy therefor) and Regulatory Approvals, and to conduct all communications with the Regulatory Authorities, in connection with the Ongoing Clinical Study and the Relevant Terminated Subject mAb2.
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(d) At the Conclusion of the Negotiation Period, F-star shall reimburse Janssen for its and its Affiliates actual costs (fully-loaded FTE and out-of-pocket costs) incurred for the conduct of the Ongoing Clinical Study through the Conclusion of the Negotiation Period.
16.7.6 Subject to Section 16.7.3(b), unless prohibited by any Regulatory Authority, and subject to any Third-Party consents, Janssen shall, at Janssen’s cost, wind-down as soon as reasonably possible following the effective date of termination, any Ongoing Clinical Study, whereby it is understood that the licenses granted under the Agreement shall remain in place for such a purpose.
16.7.7 Except as set forth in Section 13.10, each Party shall return or destroy all Confidential Information and all substances or compositions of the other Party or its Affiliates delivered or provided by or on behalf of such other Party, as well as any other material provided by or on behalf of such other Party in any medium, in connection with the relevant Subject mAb2 or Products for which the Agreement has been terminated.
16.7.8 Where Janssen terminates its rights and obligations with respect to a Subject mAb2 pursuant to Section 16.6(a) during the Development and Commercialization Term for such Subject mAb2, then Section 16.7 shall apply only to the extent relating to the Subject mAb2 in respect of which the Agreement has been terminated (the “Relevant Terminated Subject mAb2”). For clarity, where the Agreement is terminated in its entirety, then Section 16.7 shall apply to all Subject mAb2.
16.8 Remedies. Except as otherwise expressly provided herein, termination of the Agreement in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity.
16.9 Accrued Rights; Surviving Obligations.
16.9.1 Termination or expiration of the Agreement in its entirety or in respect of a Subject mAb2 or Product for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of the Agreement.
16.9.2 Without limiting the foregoing, in respect of the termination or expiration of the Agreement in its entirety or of a Subject mAb2 or Product, unless otherwise expressly provided herein, the following provisions shall survive termination or expiration of this Agreement (including any other Sections, Articles or defined terms referred to in such provisions or necessary to give them effect),
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as well as any other provision which by its terms or by the context thereof, is intended to survive such termination or expiration: ARTICLE 1 (DEFINITIONS AND INTERPRETATION); Sections 2.5.1 and 2.5.2 (Limitations on Use of Reference mAb2); Section 2.7 (Janssen Licensed Patent Rights); Section 3.3.4 (Unavailable Target List); Section 3.6 (Gatekeeper Obligations of Confidentiality); Section 5.4 (No Implied Rights); Section 6.4 (Reserved Rights); Section 10.8 (Expiration of Product Royalty Term); Section 11.3 (Financial Audits); Section 11.4 (Interest on Late Payments); Section 11.5 (Taxes); Section 12.1.1 (Ownership); Section 12.1.2 (Inventorship); Section 12.1.4 (Assignment Obligation); Section 12.1.5 (Obligation to Perfect Rights); Section 12.2.3(e) (Confidentiality); Section 12.3 (Liability for Prosecution and Maintenance); Section 12.6 (Inventor’s Remuneration); ARTICLE 13 (Confidentiality and Non-Disclosure); ARTICLE 14 (representations and warranties); ARTICLE 15 (Indemnity); in the event of a termination by Janssen for under Section 16.5 (Insolvency), Section 16.5.2 (Licenses Constitute IP under Bankruptcy Code) and Section 16.5.3 (Right of Negotiation on Insolvency of F-star); Section 16.7 (Effects of Termination or Expiration); Section 16.8 (Remedies); Section 16.9 (Accrued Rights; Surviving Obligations); and Section 17.1 (Performance and Exercise by Affiliates); Sections 17.5 through 17.19.
ARTICLE 17
Miscellaneous
17.1 Performance and Exercise by Affiliates. Each Party shall have the right to exercise its rights and perform its obligations hereunder through its Affiliates (including by licensing rights hereunder where such rights are held in the name of any such Affiliate); provided that such Party shall be responsible for its Affiliates' performance hereunder.
17.2 Force Majeure. Neither Party shall be held liable or responsible to the other or be deemed to have defaulted under or breached the Agreement for failure or delay in fulfilling or performing any term of the Agreement when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, shortages, epidemics, pandemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes or lockouts (whether involving the workforce of the non-performing Party or of any other Person), acts of God or acts, omissions or delays in acting by any governmental authority (except to the extent such delay results from the breach by the non-performing Party or any of its Affiliates of any term or condition of the Agreement). The non-performing Party shall notify the other Party of such force majeure within [***] after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimise its effect. The suspension of performance shall be of
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no greater scope and no longer duration than is necessary and the non-performing Party shall use all reasonable options and diligent efforts to remedy its inability to perform.
17.3 Export Control. The Agreement is made subject to any restrictions concerning the export of products or technical information from the United States and/or the United Kingdom and/or other countries that may be imposed on the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party under the Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other governmental entity in accordance with Applicable Law.
17.4 Assignment.
17.4.1 Without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed, no Party shall sell, transfer, assign, delegate, pledge, or otherwise dispose of the Agreement or any of its rights or duties hereunder; provided that a Party may make such an assignment without the other Parties' consent to (a) its Affiliate (subject to the condition that, if such Person ceases for any reason to be an Affiliate of the Party, all such right shall be transferred back to the original Party), (b) to a Third-Party who acquires all or substantially all of the business or assets to which the Agreement relates of such Party; or (c) to a Third-Party in the course of a transaction the purpose of which is the raising of finance by such Party, for example, by way of the granting of security, sale of any rights to receive royalties, Development costs payments or milestone payments hereunder provided in each case that the other Party shall be under no greater obligation or liability under the Agreement than if the assignment had never occurred. With respect to any such assignment, the assigning Party shall remain responsible for the performance by such assignee or transferee of the obligations hereunder. Any attempted assignment or delegation in violation of this Section 17.4 shall be void and of no effect. Without limiting the foregoing, the grant of rights to the assigning Party set forth in the Agreement shall be binding upon any successor or permitted assignee of the assigning Party, and the obligations of the other Parties, including the payment obligations, shall run in favour of any such successor or permitted assignee of the assigning Party's benefits under the Agreement.
17.4.2 Notwithstanding anything to the contrary herein, in the event of a Relevant Transaction, the Acquiror Group Companies shall not be considered to be Affiliates of F-star for the purposes of the Agreement including for the purposes of the definition Control in respect of the intellectual property of the Parties or Section 6.1. For clarity (and without limitation), any Know-How,
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Patents or other intellectual property rights or other assets owned or Controlled by the Acquiror Group Companies prior to the date of the Relevant Transaction or which are generated by the Acquiror Group Companies and which are not generated under the Agreement, will not be subject to Section 6.1.
17.5 Severability. If any provision of the Agreement (or part of a provision) is held to be illegal, invalid, or unenforceable under any present or future law by any court or administrative body of a competent jurisdiction, and if the rights or obligations of either Party under the Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) the Agreement shall be construed and enforced as if such illegal, invalid, or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of the Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid, or unenforceable provision or by its severance herefrom, and (d) in lieu of such illegal, invalid, or unenforceable provision, there shall be added automatically as a part of the Agreement a legal, valid, and enforceable provision as similar in terms to such illegal, invalid, or unenforceable provision as may be possible and reasonably acceptable to the Parties. To the fullest extent permitted by Applicable Law, each Party hereby waives any provision of law that would render any provision hereof illegal, invalid, or unenforceable in any respect.
17.6 Successors. The rights and obligations of the Parties under the Agreement shall continue for the benefit of, and shall be binding on, their respective successors and permitted transferees.
17.7 Governing Law. The Agreement or the performance, enforcement, breach or termination hereof shall be interpreted, governed by and construed in accordance with the laws of England, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of the Agreement to the substantive law of another jurisdiction. Notwithstanding anything to the contrary herein, the interpretation and construction of any Patent Rights shall be governed in accordance with the laws of the jurisdiction in which such Patent Rights were filed or granted, as the case may be.
17.8 Dispute Resolution. If a Dispute arises between the Parties in connection with or relating to the Agreement or any document or instrument delivered in connection herewith, then either Party shall have the right to refer such Dispute to the Senior Officers for attempted resolution by good faith negotiations during a period of [***]. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of any such issue within [***] (or such other period of time as mutually agreed by the Senior Officers) after such issue was first referred to them, then, upon the written request of either Party to the other Party, the Dispute shall be subject to arbitration in accordance with Section 17.9.
17.9 Arbitration.
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17.9.1 If the Parties fail to resolve the Dispute through escalation process under Section 17.8, and a Party desires to pursue resolution of the Dispute, the Dispute shall be submitted by either Party for resolution in arbitration administered by the International Chamber of Commerce (“ICC”) pursuant to its arbitration rules and procedures then in effect.
17.9.2 The arbitration shall be conducted by a panel of three (3) arbitrators who have appropriate subject matter expertise in the pharmaceutical sector. If, however, the aggregate award sought by the Parties is less than [***] and equitable relief is not sought, and for matters designated for “Dispute Resolution by Expedited Arbitration,” the arbitration shall be conducted by a single arbitrator.
17.9.3 The seat of arbitration shall be London and the language of the proceedings shall be English. The governing law of this arbitration clause shall be English law.
17.9.4 The Parties agree that any award or decision made by the arbitral tribunal shall be final and binding upon them and may be enforced in the same manner as a judgment or order of a court of competent jurisdiction. The arbitral tribunal shall determine the dispute by applying the provisions of the Agreement and the governing law set forth in Section 17.7.
17.9.5 Each Party shall bear its own attorney’s fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the administrator and the arbitrator; provided, however, that (except for matters designated for “Dispute Resolution by Expedited Arbitration”) the arbitrator shall be authorised to determine whether a Party is the prevailing party, and if so, to award to that prevailing party reimbursement for any or all of its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), or the fees and costs of the administrator and the arbitrator.
17.9.6 Dispute Resolution by Expedited Arbitration. For matters designated in the Agreement for Dispute Resolution by Expedited Arbitration, the following shall apply:
(a) Pursuant to Article 30(2)(b) of the Rules of Arbitration of the International Chamber of Commerce, the Expedited Procedure Rules shall apply irrespective of the amount in dispute.
(b) Each Party shall provide the arbitrator and the other Party with a written report setting forth its position with respect to the substance of the dispute within [***] after the Case Management Conference (as defined by the ICC Rules of Arbitration). Each Party may submit
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a revised report and position to the arbitrator within [***] of receiving the other Party’s report.
(c) If so requested by the arbitrator, each Party shall make oral and/or other written submissions to the arbitrator; provided that the other Party shall have the right to be present during any oral submissions.
(d) Within [***] after receiving the last report or, if requested by the arbitrator, the oral and/or other written submissions, the arbitrator shall select one of the Party’s positions as his or her decision. The arbitrator shall not have the authority to render any substantive decision other than to so select the position of Janssen or F-star as set forth in their respective written reports (as initially submitted, or as revised in accordance with the foregoing, as applicable.) For clarity, it is understood that the Parties intend the arbitration under this Section 17.9.6 to be a “Final Offer Arbitration” (also known as “baseball arbitration”) type proceeding, and the arbitrator may fashion such detailed procedures as the arbitrator considers appropriate to implement this intent. In any arbitration under this Section 17.9.6, the arbitrator and the Parties shall use their best efforts to resolve such dispute within [***] after the selection of the arbitrator. The arbitrator’s ruling shall be final and binding upon the Parties, provided that a Party may challenge such ruling solely in the event of misconduct by the arbitrator or fraud by either Party.
17.10 Equitable Relief. Each Party acknowledges and agrees that the restrictions set forth in ARTICLE 13 are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into the Agreement in the absence of such restrictions and that any breach or threatened breach of any provision of such Articles may result in irreparable injury to such other Party for which there will be no adequate remedy at law. Notwithstanding Sections 17.8 to 17.9, in the event of a breach or threatened breach of any provision of ARTICLE 13, the non-breaching Party shall be authorized and entitled to seek from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, specific performance and an equitable accounting of all earnings, profits and other benefits arising from such breach, which rights shall be cumulative and in addition to any other rights or remedies to which such non-breaching Party may be entitled in law or equity. Nothing in this Section 17.10 is intended or should be construed, to limit either Party’s right to equitable relief or any other remedy for a breach of any other provision of the Agreement.
17.11 Consent to Jurisdiction. Each Party, for the purpose of enforcing an award under Section 17.9 or for seeking interim or provisional relief as contemplated in Section 17.10 with respect to any Disputed breach of the Agreement, agrees not to raise any objection at any time to the laying or maintaining of the venue of any action, suit or proceeding for
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such purpose in any such court, irrevocably waives any claim that such action, suit or other proceeding has been brought in an inconvenient forum, and further irrevocably waives the right to object, with respect to such action, suit or other proceeding, that such court does not have any jurisdiction over such Party. Each Party further agrees that service of any process, summons, notice or document by registered mail to such Party’s notice address provided for in the Agreement shall be effective service of process for any action, suit or proceeding in the court with respect to any matters to which it has submitted to jurisdiction in this Section 17.11.
17.12 Patent Controversies. Notwithstanding anything in the Agreement to the contrary, any Patent Controversy shall be subject to adjudication in accordance with the Applicable Laws of the country or jurisdiction in which the relevant Patent Right is pending or has been issued. The Parties agree that the venue of any such adjudication involving a Patent Right pending in or issued by the United States shall be a U.S. federal district court (or appellate body, as necessary) sitting in New York, and for a Patent Right pending in or issued by any other country, any competent court having jurisdiction over the subject of the Patent Controversy sitting in the capital of such country (or if there is not any such competent court in the capital, a location reasonably proximate to the capital), and each Party irrevocably submits to the jurisdiction of such court. Each Party agrees not to raise any objection at any time to the laying or maintaining of the venue of any action, suit or proceeding for such purpose in any such court, irrevocably waives any claim that such action, suit or other proceeding has been brought in an inconvenient forum, including any forum non conveniens argument, and further irrevocably waives the right to object, with respect to such action, suit or other proceeding, that such court does not have any jurisdiction over such Party.
17.13 No Claims against Employees. Each Party undertakes to make no claim and bring no proceedings in connection with the Agreement or its subject matter against any director, officer, employee or agent of the other Party (apart from claims based on fraud or willful misconduct). This undertaking is intended to give protection to individuals: it does not prejudice any right which a Party might have to claim against another Party.
17.14 Notices.
17.14.1 Notice Requirements. Any notice, request, demand, waiver, consent, approval, or other communication permitted or required under the Agreement shall be in writing and shall be deemed given as of (i) the date delivered if delivered by hand, or reputable courier service; (ii) the date sent if sent by email (with transmission confirmed); (iii) the second (2nd) Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service; or (iv) the fifth (5th) Business day after mailing if mailed by registered or certified mail, postage prepaid and return receipt requested, addressed to the other Party at the addresses specified below, or to such other addresses of which notice shall have been given in accordance with this Section 17.14. This
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Section 17.14.1 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of the Agreement. All notices and communications between the Parties hereunder shall be in the English language.
17.14.2 Address for Notice.
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F-star |
To:
F-star Therapeutics Limited, Eddeva B920, Babraham Research Campus, Cambridge CB22 3AT United Kingdom Attention: [***]
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With copies to:
[***]
[***] |
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Janssen |
To:
Janssen Biotech, Inc. 800/850 Ridgeview Drive Horsham, Pennsylvania 19044 USA Attention: [***] |
With a copy to:
Office of the General Counsel Johnson & Johnson One Johnson Drive New Brunswick, New Jersey 08933 USA Attn: [***]
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17.14.3 Where proceedings have been commenced in any arbitration hereunder or court of competent jurisdiction, any documents issued in the course of those proceedings will be served in accordance with the procedural rules governing the service of documents in those proceedings.
17.15 Entire Agreement; Amendments. The Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises, and representations, whether written or oral, with respect thereto are superseded hereby. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in the Agreement. No amendment, modification, release, or discharge shall be binding upon the Parties unless in writing and duly executed by authorised representatives of both Parties.
17.16 Waiver and Non-Exclusion of Remedies. Any term or condition of the Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument, which is clearly marked
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as a waiver of rights and duly executed by an authorised signatory on behalf of the Party waiving such term or condition and delivered in accordance with Section 17.14. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise and does not affect its rights in relation to any other Party. No single or partial exercise of any such right or remedy under the Agreement shall preclude or restrict the further exercise of any such right or remedy. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein.
17.17 No Benefit to Third Parties. Except for any rights and immunities granted in the Agreement to any Affiliates, the Contracts (Rights of Third Parties) Act 1999 shall not apply to the Agreement. Except as expressly provided in ARTICLE 17, a Person who is not a party to the Agreement (including any employee, officer, agent, representative or subcontractor of either Party) shall not have the right (whether under the Contracts (Rights of Third Parties) Act 1999 or otherwise) to enforce any provision of the Agreement which expressly or by implication confers a benefit on that Person without the express prior agreement in writing of the Parties, which agreement must refer to this Section 17.17.
17.18 Further Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party may reasonably request in connection with the Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under the Agreement.
17.19 Relationship of the Parties. It is expressly agreed that F-star, on the one hand, and Janssen, on the other hand, shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture, or agency. Neither F-star, on the one hand, nor Janssen, on the other hand, shall have the authority to make any statements, representations, or commitments of any kind, or to take any action that will be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party.
17.20 Counterparts. The Agreement may be executed in two (2) counterparts, each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument. The Agreement may be executed by facsimile, PDF format via email or other electronically transmitted signatures and such signatures shall be deemed to bind each Party hereto as if they were original signatures.
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[SIGNATURE PAGE FOLLOWS.]
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THIS AGREEMENT IS EXECUTED by the authorised representatives of the Parties as of the date first written above.
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F-STAR THERAPEUTICS LIMITED |
JANSSEN BIOTECH, INC. |
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By: Name: Eliot Forster Title: CEO |
By: Name: Sarkis Messerlian Title: Vice President, North American Oncology |
Attached:
Schedule 1: Johnson & Johnson Universal Calendar
Schedule 2: Fcab Platform Technology Patent Rights
Schedule 3: [***]
Schedule 4: NME Selection Research Package
Schedule 5: Form of Identified Target Notice
Schedule 6: Form of Replacement Target Notice
Schedule 7: Gatekeeper Agreement and Engagement Letter
Schedule 8: Target ID Numbers for Identified Targets Confirmed as Available Targets
Schedule 9: Scope of Product Patent Right Filings
Schedule 10: Press Release
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Schedule 1
Johnson & Johnson Universal Calendar
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Schedule 2
Fcab Platform Technology Patent Rights
[***]
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Schedule 3
[***]
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Schedule 4
NME Selection Research Package
[***]
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Schedule 5
Form of Identified Target Notice
[***]
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Schedule 6
Form of Replacement Target Notice
[***]
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Schedule 7
Gatekeeper Agreement and Engagement Letter
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Schedule 8
Target ID Numbers for Identified Targets Confirmed as Available Targets
[***]
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Schedule 9
Scope of Product Patent Right Filings
[***]
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Schedule 10
Press Release
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Exhibit 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Eliot R. Forster, certify that:
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Date: November 10, 2021 |
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By: |
/s/ Eliot R. Forster |
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Eliot R. Forster, Ph.D. |
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President and Chief Executive Officer |
Exhibit 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Darlene Deptula-Hicks, certify that:
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Date: November 10, 2021 |
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By: |
/s/ Darlene Deptula-Hicks |
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Darlene Deptula-Hicks |
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Chief Financial Officer, Treasurer & Secretary |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of F-star Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ending September 30, 2021, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
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Date: November 10, 2021 |
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By: |
/s/ Eliot R. Forster |
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Eliot R. Forster, Ph.D. |
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President and Chief Executive Officer |
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of F-star Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ending September 30, 2021, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
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Date: November 10, 2021 |
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By: |
/s/ Darlene Deptula-Hicks |
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Darlene Deptula-Hicks |
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Chief Financial Officer, Treasurer & Secretary |