|
The Netherlands
|
| | | | |
Not Applicable
|
|
|
(State or other jurisdiction of
incorporation or organization) |
| |
(Primary Standard Industrial
Classification Code Number) |
| |
(I.R.S. Employer
Identification Number) |
|
|
Richard D. Truesdell, Jr.
Leo Borchardt Davis Polk & Wardwell LLP 450 Lexington Avenue New York, New York 10017 +1 (212) 450-4000 |
| |
Paul van der Bijl
NautaDutilh N.V. Beethovenstraat 400 1082 PR Amsterdam The Netherlands +31 (20) 717-1000 |
| |
Nathan Ajiashvili
Alison Haggerty Latham & Watkins LLP 885 Third Avenue New York, New York 10022 +1 (212) 906-1200 |
|
CALCULATION OF REGISTRATION FEE
|
| ||||||||||||||||||
Title of each class of securities to be registered
|
| |
Proposed
Maximum Aggregate Offering Price(1)(2) |
| |
Amount of
Registration Fee |
| | | ||||||||||
Common shares, par value €0.12 per share
|
| | | $ | 595,771,558 | | | | | $ | 64,999 | | | | |
| | |
Per Share
|
| |
Total
|
| ||||||
Public offering price
|
| | | $ | | | | | | $ | | | |
Underwriting discounts(1)
|
| | | $ | | | | | | $ | | | |
Proceeds, before expenses, to us
|
| | | $ | | | | | | $ | | | |
| BofA Securities | | |
Jefferies
|
| |
Evercore ISI
|
|
| | |
Page
|
| |||
| | | | 1 | | | |
| | | | 15 | | | |
| | | | 85 | | | |
| | | | 87 | | | |
| | | | 89 | | | |
| | | | 90 | | | |
| | | | 91 | | | |
| | | | 92 | | | |
| | | | 93 | | | |
| | | | 95 | | | |
| | | | 122 | | | |
| | | | 239 | | | |
| | | | 254 | | | |
| | | | 256 | | | |
| | | | 261 | | | |
| | | | 270 | | | |
| | | | 283 | | | |
| | | | 285 | | | |
| | | | 301 | | | |
| | | | 308 | | | |
| | | | 309 | | | |
| | | | 309 | | | |
| | | | 309 | | | |
| | | | 310 | | | |
| | | | F-1 | | |
| | |
For the Years Ended
December 31, |
| |
For the Nine Months Ended
September 30, |
| ||||||||||||||||||
| | |
2018
|
| |
2019
|
| |
2019
|
| |
2020
|
| ||||||||||||
| | |
(in thousands of euros, except per share amounts)
|
| |||||||||||||||||||||
| | | | | | | | | | | | | | |
(unaudited)
|
| |||||||||
Statement of Operations and Comprehensive Income (Loss) Data:
|
| | | | | | | | | | | | | | | | | | | | | | | | |
Revenue
|
| | | | 12,871 | | | | | | 17,416 | | | | | | 10,600 | | | | | | 42,830 | | |
Cost of sales
|
| | | | (17,744) | | | | | | (27,983) | | | | | | (18,872) | | | | | | (7,049) | | |
Selling and distribution expenses
|
| | | | (1,085) | | | | | | (1,755) | | | | | | (485) | | | | | | (809) | | |
Research and development expenses
|
| | | | (41,722) | | | | | | (43,242) | | | | | | (30,665) | | | | | | (76,337) | | |
General and administrative expenses
|
| | | | (25,289) | | | | | | (48,969) | | | | | | (28,504) | | | | | | (33,147) | | |
Other operating income
|
| | | | 808 | | | | | | 5,587 | | | | | | 3,838 | | | | | | 11,695 | | |
Other operating expenses
|
| | | | (663) | | | | | | (552) | | | | | | (339) | | | | | | (357) | | |
Operating loss
|
| | | | (72,824) | | | | | | (99,498) | | | | | | (64,427) | | | | | | (63,174) | | |
Finance income
|
| | | | 1,968 | | | | | | 833 | | | | | | 3,133 | | | | | | 5,103 | | |
Finance expenses
|
| | | | (275) | | | | | | (1,460) | | | | | | (2,924) | | | | | | (14,519) | | |
Loss before income tax
|
| | | | (71,131) | | | | | | (100,125) | | | | | | (64,218) | | | | | | (72,590) | | |
Income tax benefit (expense)
|
| | | | (110) | | | | | | 252 | | | | | | 335 | | | | | | 1,615 | | |
Net loss
|
| | | | (71,241) | | | | | | (99,873) | | | | | | (63,883) | | | | | | (70,975) | | |
Other comprehensive income/loss: | | | | | | | | | | | | | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss
|
| | | | | | | | | | | | | | | | | | | | | | | | |
Foreign currency adjustments
|
| | | | 66 | | | | | | 32 | | | | | | (20) | | | | | | 76 | | |
Total comprehensive loss
|
| | | | (71,175) | | | | | | (99,841) | | | | | | (63,903) | | | | | | (70,899) | | |
|
| | |
As of September 30, 2020
|
| |||||||||
| | |
Actual
|
| |
Pro Forma(1)(2)
|
| ||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Statement of Financial Position Data: | | | | | | | | | | | | | |
Cash and cash equivalents
|
| | | | 892,399 | | | | | | 1,288,680 | | |
Total assets
|
| | | | 1,021,907 | | | | | | 1,418,188 | | |
Total liabilities
|
| | | | 260,557 | | | | | | 260,557 | | |
Total equity
|
| | | | 761,350 | | | | | | 1,157,631 | | |
| | |
Actual
|
| |
Pro Forma
|
| ||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Cash and cash equivalents
|
| | | | 892,399(1) | | | | | | 1,288,680 | | |
Equity: | | | | | | | | | | | | | |
Issued capital
|
| | | | 21,560 | | | | | | 22,160 | | |
Capital reserve
|
| | | | 1,326,766 | | | | | | 1,722,447 | | |
Accumulated deficit
|
| | | | (586,922) | | | | | | (586,922) | | |
Other comprehensive income
|
| | | | (54) | | | | | | (54) | | |
Total shareholders’ equity
|
| | | | 761,350 | | | | | | 1,157,631 | | |
Total capitalization
|
| | | | 761,350 | | | | | | 1,157,631 | | |
| | |
$
|
| |
€
|
| ||||||
Assumed public offering price per common share
|
| | | | 102.69 | | | | | | 83.69 | | |
Historical net tangible book value per common share as of September 30, 2020
|
| | | | 5.11 | | | | | | 4.16 | | |
Increase in net tangible book value per common share attributable to this
offering |
| | | | 2.49 | | | | | | 2.03 | | |
Pro forma net tangible book value per common share at September 30, 2020 after giving effect to the offering
|
| | | | 7.60 | | | | | | 6.19 | | |
Dilution per common share to new investors
|
| | | | 95.09 | | | | | | 77.50 | | |
Percentage of dilution per common share to new investors
|
| | | | 92.6% | | | | | | 92.6% | | |
| | |
For the Years Ended
December 31, |
| |
For the Nine Months Ended
September 30, |
| ||||||||||||||||||
| | |
2018
|
| |
2019
|
| |
2019
|
| |
2020
|
| ||||||||||||
| | |
(in thousands of euros, except per share amounts)
|
| |||||||||||||||||||||
| | | | | | | | | | | | | | |
(unaudited)
|
| |||||||||
Statement of Operations and Comprehensive Income (Loss) Data:
|
| | | | | | | | | | | | | | | | | | | | | | | | |
Revenue
|
| | | | 12,871 | | | | | | 17,416 | | | | | | 10,600 | | | | | | 42,830 | | |
Cost of sales
|
| | | | (17,744) | | | | | | (27,983) | | | | | | (18,872) | | | | | | (7,049) | | |
Selling and distribution expenses
|
| | | | (1,085) | | | | | | (1,755) | | | | | | (485) | | | | | | (809) | | |
Research and development expenses
|
| | | | (41,722) | | | | | | (43,242) | | | | | | (30,665) | | | | | | (76,337) | | |
General and administrative expenses
|
| | | | (25,289) | | | | | | (48,969) | | | | | | (28,504) | | | | | | (33,147) | | |
Other operating income
|
| | | | 808 | | | | | | 5,587 | | | | | | 3,838 | | | | | | 11,695 | | |
Other operating expenses
|
| | | | (663) | | | | | | (552) | | | | | | (339) | | | | | | (357) | | |
Operating loss
|
| | | | (72,824) | | | | | | (99,498) | | | | | | (64,427) | | | | | | (63,174) | | |
Finance income
|
| | | | 1,968 | | | | | | 833 | | | | | | 3,133 | | | | | | 5,103 | | |
Finance expenses
|
| | | | (275) | | | | | | (1,460) | | | | | | (2,924) | | | | | | (14,519) | | |
Loss before income tax
|
| | | | (71,131) | | | | | | (100,125) | | | | | | (64,218) | | | | | | (72,590) | | |
Income tax benefit (expense)
|
| | | | (110) | | | | | | 252 | | | | | | 335 | | | | | | 1,615 | | |
Net loss
|
| | | | (71,241) | | | | | | (99,873) | | | | | | (63,883) | | | | | | (70,975) | | |
Other comprehensive income/loss: | | | | | | | | | | | | | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss
|
| | | | | | | | | | | | | | | | | | | | | | | | |
Foreign currency adjustments
|
| | | | 66 | | | | | | 32 | | | | | | (20) | | | | | | 76 | | |
Total comprehensive loss
|
| | | | (71,175) | | | | | | (99,841) | | | | | | (63,903) | | | | | | (70,899) | | |
|
| | |
As of December 31,
|
| |
As of
September 30, |
| ||||||||||||
| | |
2018
|
| |
2019
|
| |
2020
|
| |||||||||
| | | | | | | | | | | | | | |
(unaudited)
|
| |||
| | |
(in thousands of euros)
|
| |||||||||||||||
Statement of Financial Position Data: | | | | | | | | | | | | | | | | | | | |
Cash and cash equivalents
|
| | | | 21,380 | | | | | | 30,684 | | | | | | 892,399 | | |
Total assets
|
| | | | 125,659 | | | | | | 130,620 | | | | | | 1,021,907 | | |
Total liabilities
|
| | | | 93,576 | | | | | | 173,422 | | | | | | 260,557 | | |
Total equity
|
| | | | 32,083 | | | | | | (42,802) | | | | | | 761,350 | | |
| | |
For the Nine Months Ended
September 30, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
(unaudited)
|
| |||||||||
| | |
(in thousands of euros,
except per share data) |
| |||||||||
Statement of Operations and Comprehensive Income (Loss) Data: | | | | | | | | | | | | | |
Revenue
|
| | | | 10,600 | | | | | | 42,830 | | |
Cost of sales
|
| | | | (18,872) | | | | | | (7,049) | | |
Selling and distribution expenses
|
| | | | (485) | | | | | | (809) | | |
Research and development expenses
|
| | | | (30,665) | | | | | | (76,337) | | |
General and administrative expenses
|
| | | | (28,504) | | | | | | (33,147) | | |
Other operating income
|
| | | | 3,838 | | | | | | 11,695 | | |
Other operating expenses
|
| | | | (339) | | | | | | (357) | | |
Operating loss
|
| | | | (64,427) | | | | | | (63,174) | | |
Finance income
|
| | | | 3,133 | | | | | | 5,103 | | |
Finance expenses
|
| | | | (2,924) | | | | | | (14,519) | | |
Loss before income tax
|
| | | | (64,218) | | | | | | (72,590) | | |
Income tax benefit (expense)
|
| | | | 335 | | | | | | 1,615 | | |
Net loss
|
| | | | (63,883) | | | | | | (70,975) | | |
Other comprehensive income/loss: | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss
|
| | | | | | | | | | | | |
Foreign currency adjustments
|
| | | | (20) | | | | | | 76 | | |
Total comprehensive loss
|
| | | | (63,903) | | | | | | (70,899) | | |
Net loss per share (basic and diluted)
|
| | | | (0.66) | | | | | | (0.61) | | |
| | |
For the nine months ended
September 30, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Personnel
|
| | | | (7,249) | | | | | | (2,171) | | |
Materials
|
| | | | (4,022) | | | | | | (1,380) | | |
Third-party services
|
| | | | (5,339) | | | | | | (2,432) | | |
Maintenance and lease
|
| | | | (770) | | | | | | (752) | | |
Amortization and depreciation
|
| | | | (1,259) | | | | | | (250) | | |
Other
|
| | | | (233) | | | | | | (64) | | |
Total | | | | | (18,872) | | | | | | (7,049) | | |
| | |
For the nine months ended
September 30, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Personnel
|
| | | | (257) | | | | | | (755) | | |
Amortization and depreciation
|
| | | | (61) | | | | | | (77) | | |
Other
|
| | | | (167) | | | | | | 23 | | |
Total | | | | | (485) | | | | | | (809) | | |
| | |
For the nine months ended
September 30, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Materials
|
| | | | (2,605) | | | | | | (21,595) | | |
Personnel
|
| | | | (9,321) | | | | | | (16,213) | | |
Amortization and depreciation
|
| | | | (895) | | | | | | (2,589) | | |
Patents and fees to register a legal right
|
| | | | (3,143) | | | | | | (3,525) | | |
Third-party services
|
| | | | (14,426) | | | | | | (27,973) | | |
Maintenance and lease
|
| | | | (20) | | | | | | (560) | | |
Other
|
| | | | (255) | | | | | | (3,882) | | |
Total | | | | | (30,665) | | | | | | (76,337) | | |
| | |
For the nine months ended
September 30, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Key Programs (CV8102, CV7202 and CVnCoV) | | | | | | | | | | | | | |
CV8102
|
| | | | 3,871 | | | | | | 5,443 | | |
CV7202
|
| | | | 1,374 | | | | | | 4,474 | | |
CVnCoV
|
| | | | — | | | | | | 27,504 | | |
Other Research and Development Programs
|
| | | | 10,126 | | | | | | 9,050 | | |
Unallocated costs(1)
|
| | | | 15,294 | | | | | | 30,864 | | |
Total | | | | | 30,665 | | | | | | 76,337 | | |
| | |
For the nine months ended
September 30, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Personnel
|
| | | | (16,747) | | | | | | (15,847) | | |
Maintenance and lease costs
|
| | | | (2,138) | | | | | | (1,571) | | |
Third-party services
|
| | | | (4,203) | | | | | | (5,097) | | |
Legal and other professional services
|
| | | | (825) | | | | | | (2,276) | | |
Amortization and depreciation
|
| | | | (2,709) | | | | | | (4,382) | | |
Other
|
| | | | (1,882) | | | | | | (3,974) | | |
Total | | | | | (28,504) | | | | | | (33,147) | | |
| | |
For the Years Ended
December 31, |
| |||||||||
| | |
2018
|
| |
2019
|
| ||||||
| | |
(in thousands of euros, except
per share data) |
| |||||||||
Statement of Operations and Comprehensive Income (Loss) Data: | | | | | | | | | | | | | |
Revenue
|
| | | | 12,871 | | | | | | 17,416 | | |
Cost of sales
|
| | | | (17,744) | | | | | | (27,983) | | |
Selling and distribution expenses
|
| | | | (1,085) | | | | | | (1,755) | | |
Research and development expenses
|
| | | | (41,722) | | | | | | (43,242) | | |
General and administrative expenses
|
| | | | (25,289) | | | | | | (48,969) | | |
Other operating income
|
| | | | 808 | | | | | | 5,587 | | |
Other operating expenses
|
| | | | (663) | | | | | | (552) | | |
Operating loss
|
| | | | (72,824) | | | | | | (99,498) | | |
Finance income
|
| | | | 1,968 | | | | | | 833 | | |
Finance expenses
|
| | | | (275) | | | | | | (1,460) | | |
Loss before income tax
|
| | | | (71,131) | | | | | | (100,125) | | |
Income tax benefit (expense)
|
| | | | (110) | | | | | | 252 | | |
Net loss for the year
|
| | | | (71,241) | | | | | | (99,873) | | |
Other comprehensive income/loss: | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss
|
| | | | | | | | | | | | |
Foreign currency adjustments
|
| | | | 66 | | | | | | 32 | | |
Total comprehensive loss for the year
|
| | | | (71,175) | | | | | | (99,841) | | |
Net loss per share (basic and diluted)
|
| | | | (0.74) | | | | | | (1.03) | | |
| | |
For the years ended
December 31, |
| |||||||||
| | |
2018
|
| |
2019
|
| ||||||
| | |
(in thousands of euros)
|
| |||||||||
Personnel
|
| | | | (7,703) | | | | | | (9,855) | | |
Materials
|
| | | | (4,941) | | | | | | (7,542) | | |
Third-party services
|
| | | | (2,340) | | | | | | (7,268) | | |
Maintenance and lease
|
| | | | (1,758) | | | | | | (1,060) | | |
Amortization and depreciation
|
| | | | (893) | | | | | | (2,038) | | |
Other
|
| | | | (109) | | | | | | (220) | | |
Total | | | | | (17,744) | | | | | | (27,983) | | |
| | |
For the years ended
December 31, |
| |||||||||
| | |
2018
|
| |
2019
|
| ||||||
| | |
(in thousands of euros)
|
| |||||||||
Personnel
|
| | | | (581) | | | | | | (1,263) | | |
Maintenance and lease costs
|
| | | | (300) | | | | | | (167) | | |
Amortization and depreciation
|
| | | | (95) | | | | | | (81) | | |
Other
|
| | | | (109) | | | | | | (243) | | |
Total | | | | | (1,085) | | | | | | (1,755) | | |
| | |
For the years ended
December 31, |
| |||||||||
| | |
2018
|
| |
2019
|
| ||||||
| | |
(in thousands of euros)
|
| |||||||||
Materials
|
| | | | (5,867) | | | | | | (4,015) | | |
Personnel
|
| | | | (7,565) | | | | | | (14,385) | | |
Amortization and depreciation
|
| | | | (1,143) | | | | | | (474) | | |
Patents and fees to register a legal right
|
| | | | (4,847) | | | | | | (4,551) | | |
Third-party services
|
| | | | (19,921) | | | | | | (18,626) | | |
Maintenance and lease
|
| | | | (1,156) | | | | | | (670) | | |
Other
|
| | | | (1,223) | | | | | | (521) | | |
Total | | | | | (41,722) | | | | | | (43,242) | | |
| | |
For the years ended
December 31, |
| |||||||||
| | |
2018
|
| |
2019
|
| ||||||
| | |
(in thousands of euros)
|
| |||||||||
Key Programs (CV8102 and CV7202) | | | | | | | | | | | | | |
CV8102
|
| | | | (1,525) | | | | | | (4,511) | | |
CV7202
|
| | | | (1,987) | | | | | | (2,236) | | |
Other Research and Development Programs
|
| | | | (14,047) | | | | | | (14,271) | | |
Unallocated costs(1)
|
| | | | (24,163) | | | | | | (22,224) | | |
Total | | | | | (41,722) | | | | | | (43,242) | | |
| | |
For the years ended
December 31, |
| |||||||||
| | |
2018
|
| |
2019
|
| ||||||
| | |
(in thousands of euros)
|
| |||||||||
Personnel
|
| | | | (10,084) | | | | | | (31,645) | | |
Maintenance and lease costs
|
| | | | (3,239) | | | | | | (4,604) | | |
Third-party services
|
| | | | (4,006) | | | | | | (5,970) | | |
Legal and other professional services
|
| | | | (4,078) | | | | | | (2,110) | | |
Amortization and depreciation
|
| | | | (1,635) | | | | | | (2,182) | | |
Other
|
| | | | (2,247) | | | | | | (2,458) | | |
Total | | | | | (25,289) | | | | | | (48,969) | | |
| | |
For the nine months ended
September 30, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Net cash flow from (used in): | | | | | | | | | | | | | |
Operating activities
|
| | | | (67,979) | | | | | | 80,982 | | |
Investing activities
|
| | | | 33,047 | | | | | | (17,466) | | |
Financing activities
|
| | | | 48,669 | | | | | | 794,350 | | |
Effect of currency translation gains on cash and cash equivalents
|
| | | | (139) | | | | | | 3,849 | | |
Overall cash inflow
|
| | | | 13,598 | | | | | | 861,715 | | |
| | |
For the years ended
December 31, |
| |||||||||
| | |
2018
|
| |
2019
|
| ||||||
| | |
(in thousands of euros)
|
| |||||||||
Net cash flow from (used in): | | | | | | | | | | | | | |
Operating activities
|
| | | | (74,110) | | | | | | (86,963) | | |
Investing activities
|
| | | | (4,264) | | | | | | 28,181 | | |
Financing activities
|
| | | | (112) | | | | | | 67,979 | | |
Effect of currency translation gains on cash and cash equivalents
|
| | | | 213 | | | | | | 107 | | |
Overall cash inflow (outflow)
|
| | | | (78,273) | | | | | | 9,304 | | |
| | |
Payment Due by Period
|
| |||||||||||||||||||||||||||||||||||||||
| | |
Total(2)
|
| |
2021
|
| |
2022
|
| |
2023
|
| |
2024
|
| |
2025
|
| |
Thereafter
|
| |||||||||||||||||||||
| | |
(in thousands of euros)
|
| |||||||||||||||||||||||||||||||||||||||
Contractual CMO commitments(1)
|
| | | | 97,151 | | | | | | 97,151 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Lease liabilities
|
| | | | 30,087 | | | | | | 2,961 | | | | | | 3,074 | | | | | | 3,131 | | | | | | 3,310 | | | | | | 3,449 | | | | | | 14,161 | | |
Long-term debt obligations
|
| | | | 25,875 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 25,875 | | |
Total
|
| | |
|
153,112
|
| | | |
|
100,112
|
| | | |
|
3,074
|
| | | |
|
3,131
|
| | | |
|
3,310
|
| | | |
|
3,449
|
| | | |
|
30,086
|
| |
Patients with a least one event, n (%)
|
| |
Stratum 1
(n=16) |
| |
Stratum 2
(n=8) |
| |
Stratum 3
(n=2) |
| |
Overall
(n=26) |
| ||||||||||||
TEAE
|
| | | | 16 (100.0) | | | | | | 8 (100.0) | | | | | | 2 (100.0) | | | | | | 26 (100.0) | | |
BI1361849-and/or radiation-related AE
|
| | | | 16 (100.0) | | | | | | 8(100.0) | | | | | | 2(100.0) | | | | | | 26(100.0) | | |
TEAE related to BI1361849
|
| | | | 15(93.8) | | | | | | 8(100.0) | | | | | | 2(100.0) | | | | | | 26(96.2) | | |
TEAE related to radiation
|
| | | | 4(25.0) | | | | | | 1(12.5) | | | | | | 0(50.0) | | | | | | 5(19.2) | | |
Serious TEAE
|
| | | | 7(43.8) | | | | | | 3(37.5) | | | | | | 1(50.0) | | | | | | 11(42.3) | | |
Serious BI1361849-and/or radiation-related AE
|
| | | | 1(6.3) | | | | | | 0 | | | | | | 0 | | | | | | 1(3.8) | | |
Related to BI1361849
|
| | | | 0 | | | | | | 0 | | | | | | 0 | | | | | | 0 | | |
Related to radiation
|
| | | | 1(6.3) | | | | | | 0 | | | | | | 0 | | | | | | 1(3.8) | | |
TEAE toxicity grade ≥ 3(a)
|
| | | | 9(56.3) | | | | | | 4(50.0) | | | | | | 2(100.0) | | | | | | 15(57.7) | | |
BI1361849-and/or radiation-related AE toxicity grade ≥ 3(a)
|
| | | | 2(12.5) | | | | | | 1(12.5) | | | | | | 1(50.0) | | | | | | 4(15.4) | | |
Related to BI1361849
|
| | | | 1(6.3) | | | | | | 1(12.5) | | | | | | 1(50.0) | | | | | | 3(11.5) | | |
Related to radiation
|
| | | | 1(6.3) | | | | | | 0 | | | | | | 0 | | | | | | 1(3.8) | | |
Serious BI1361849-and/or radiation-related AE toxicity grade ≥ 3(a)
|
| | | | 1(6.3) | | | | | | 0 | | | | | | 0 | | | | | | 1(3.8) | | |
Related to BI1361849
|
| | | | 0 | | | | | | 0 | | | | | | 0 | | | | | | 0 | | |
Related to radiation
|
| | | | 1(6.3) | | | | | | 0 | | | | | | 0 | | | | | | 1(3.8) | | |
TEAE leading to discontinuation
|
| | | | 4(25.0) | | | | | | 0 | | | | | | 0 | | | | | | 4(15.4) | | |
TEAE toxicity grade ≥ 3 leading to discontinuation
|
| | | | 2(12.5) | | | | | | 0 | | | | | | 0 | | | | | | 2(7.7) | | |
TEAE leading to interruption/dose modification
|
| | | | 4(25.0) | | | | | | 0 | | | | | | 0 | | | | | | 4(15.4) | | |
TEAE leading to death
|
| | | | 0 | | | | | | 0 | | | | | | 0 | | | | | | 0 | | |
| | |
Patients with response, n (%) [95% confidence interval]
|
| |||||||||
Parameter
|
| |
Stratum 1
(n=16) |
| |
Stratum 2
(n=8) |
| |
Stratum 3
(n=2) |
| |
Overall
(n=26) |
|
Response (CR + PR) rate
|
| |
1 (6.3)
|
| |
0
|
| |
0
|
| |
1 (3.8)
|
|
| | |
[0.2-30.2]
|
| |
[0.0-36.9]
|
| |
[0.0-84.2]
|
| |
[0.1-19.6]
|
|
Best overall response | | | | | | | | | | | | | |
CR
|
| |
0
|
| |
0
|
| |
0
|
| |
0
|
|
| | |
[0.0-20.6]
|
| |
[0.0-36.9]
|
| |
[0.0-84.2]
|
| |
[0.0-13.2]
|
|
PR
|
| |
1 (6.3)
|
| |
0
|
| |
0
|
| |
1 (3.8)
|
|
| | |
[0.2-30.2]
|
| |
[0.0-36.9]
|
| |
[0.0-84.2]
|
| |
[0.1-19.6]
|
|
SD
|
| |
8 (50.0)
|
| |
3 (37.5)
|
| |
1 (50.0)
|
| |
12 (46.2)
|
|
| | |
[24.7-75.3]
|
| |
[8.5-75.5]
|
| |
[1.3-98.7]
|
| |
[26.6-66.6]
|
|
PD
|
| |
7 (43.8)
|
| |
4 (50.0)
|
| |
1(50.0)
|
| |
12 (46.2)
|
|
| | |
[19.8-70.1]
|
| |
[15.7-84.3]
|
| |
[1.3-98.7]
|
| |
[26.6-66.6]
|
|
NE
|
| |
0
|
| |
1 (12.5)
|
| |
0
|
| |
1 (3.8)
|
|
| | |
[0.0-20.6]
|
| |
[0.3-52.7]
|
| |
[0.0-84.2]
|
| |
[0.1-19.6]
|
|
Location
|
| |
Area
(Approximate Sq. Feet) |
| |||
Germany: | | | | | | | |
Tübingen
|
| | | | 189,000 | | |
Frankfurt am Main
|
| | | | 8,600 | | |
Total
|
| | | | 197,600 | | |
United States: | | | | | | | |
Boston
|
| | | | 12,900 | | |
Total
|
| | | | 12,900 | | |
Total
|
| | | | 210,500 | | |
Name
|
| |
Age
|
| |
Term Served
|
| |
Year in which
Term Expires |
| |
Position
|
|
Franz-Werner Haas, LLD, LLM | | | 51 | | |
6/2020 – Present
|
| | 2022 | | | Chief Executive Officer | |
Florian von der Mülbe, Ph.D., MBA
|
| | 48 | | |
9/2015 – Present
|
| | 2023 | | | Chief Production Officer | |
Mariola Fotin-Mleczek, Ph.D. | | | 53 | | |
9/2015 – Present
|
| | 2023 | | | Chief Technology Officer | |
Pierre Kemula, B.Sc. | | | 47 | | |
11/2016 – Present
|
| | 2021 | | | Chief Financial Officer | |
Antony Blanc, Ph.D.(1) | | | 52 | | |
12/2020 – Present
|
| | 2023 | | |
Chief Business Officer /
Chief Commercial Officer
|
|
Bernd Winterhalter, MD, Ph.D.(2) | | | 62 | | |
6/2018 – Present
|
| | Not Defined | | |
Chief Development Officer
(Interim)
|
|
Igor Splawski, Ph.D., MSc | | | 52 | | |
7/2020 – Present
|
| | 2023 | | | Chief Scientific Officer | |
Name
|
| |
Age
|
| |
Term Served
|
| |
Year in
which Term Expires |
| |
Functions
|
|
Baron Jean Stéphenne, MSc, MBA | | |
71
|
| |
8/2015 – Present
|
| |
2024
|
| |
Chairman and Supervisory
Director |
|
Ralf Clemens, MD, Ph.D. | | |
68
|
| |
8/2015 – Present
|
| |
2024
|
| | Supervisory Director | |
Mathias Hothum, Ph.D. | | |
53
|
| |
8/2015 – Present
|
| |
2024
|
| | Supervisory Director | |
Hans Christoph Tanner, Ph.D. | | |
69
|
| |
8/2015 – Present
|
| |
2024
|
| | Supervisory Director | |
Friedrich von Bohlen und Halbach, Ph.D. | | |
58
|
| |
8/2015 – Present
|
| |
2022
|
| |
Vice Chairman and Supervisory
Director
|
|
Timothy M. Wright, MD | | |
65
|
| |
6/2019 – Present
|
| |
2022
|
| | Supervisory Director | |
Craig A. Tooman, MBA | | |
55
|
| |
6/2019 – Present
|
| |
2022
|
| | Supervisory Director | |
Viola Bronsema, Ph.D. | | |
57
|
| |
8/2020 – Present
|
| |
2024
|
| | Supervisory Director | |
Name
|
| |
Fixed
Compensation (€) |
| |
Attendance
Fees (€) |
| |
Total
Compensation (€) |
| |||||||||
Baron Jean Stéphenne
|
| | | | 102,747 | | | | | | — | | | | | | 102,747 | | |
Ralf Clemens
|
| | | | 55,000 | | | | | | 27,500 | | | | | | 82,500 | | |
Mathias Hothum
|
| | | | 55,000 | | | | | | 27,500 | | | | | | 82,500 | | |
Hans Cristoph Tanner
|
| | | | 55,000 | | | | | | 27,500 | | | | | | 82,500 | | |
Friedrich von Bohlen und Halbach
|
| | | | 55,000 | | | | | | — | | | | | | 55,000 | | |
Ingmar Hoerr(1)
|
| | | | 21,301 | | | | | | — | | | | | | 21,301 | | |
Timothy M. Wright
|
| | | | 55,000 | | | | | | — | | | | | | 55,000 | | |
Craig A. Tooman
|
| | | | 55,000 | | | | | | — | | | | | | 55,000 | | |
Dr. Viola Bronsema(2)
|
| | | | 20,644 | | | | | | — | | | | | | 20,644 | | |
Name
|
| |
Number of
Shares |
| |
Percentage
of Shares Outstanding |
| |
Voting
Rights |
| |||||||||
Baron Jean Stéphenne
|
| | | | — | | | | | | — | | | | | | — | | |
Ralf Clemens
|
| | | | — | | | | | | — | | | | | | — | | |
Mathias Hothum
|
| | | | — | | | | | | — | | | | | | — | | |
Hans Cristoph Tanner
|
| | | | 188,172 | | | | | | 0.1% | | | | | | — | | |
Friedrich von Bohlen und Halbach
|
| | | | 241,935 | | | | | | 0.1% | | | | | | — | | |
Ingmar Hoerr(1)
|
| | | | 1,129,165 | | | | | | 0.63% | | | | | | — | | |
Timothy M. Wright
|
| | | | — | | | | | | — | | | | | | — | | |
Craig A. Tooman
|
| | | | — | | | | | | — | | | | | | — | | |
Dr. Viola Bronsema(2)
|
| | | | — | | | | | | — | | | | | | — | | |
Name
|
| |
Number
of Options |
| |
Title
|
| |
Amount
of Securities (€) |
| |
Exercise
Price (€) |
| |
Purchase
Price (€) |
| |
Expiration Date
|
| |||||||||||||||
Baron Jean Stéphenne
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Ralf Clemens
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Mathias Hothum
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Hans Cristoph Tanner
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Friedrich von Bohlen und Halbach
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Ingmar Hoerr(1)
|
| | | | 369,423 | | | |
Share Option
Awards |
| | | | 369,423 | | | | | | 1.00 | | | | | | 2,776 | | | | | | 12/31/2021 | | |
Timothy M. Wright
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Craig A. Tooman
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Dr. Viola Bronsema(2)
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Name*(9)
|
| |
Salary
(€) |
| |
Bonus(1)
(€) |
| |
All Other
Compensation(2) (€) |
| |
Total
Compensation(3) (€) |
| ||||||||||||
Daniel L. Menichella(4)(5)
|
| | | | 129,843 | | | | | | 318,218 | | | | | | 651,025 | | | | | | 1,099,086 | | |
Florian von der Mulbe
|
| | | | 258,533 | | | | | | 235,375 | | | | | | 25,482 | | | | | | 519,390 | | |
Mariola Fotin-Mleczek
|
| | | | 226,866 | | | | | | 221,875 | | | | | | 19,492 | | | | | | 468,233 | | |
Franz-Werner Haas
|
| | | | 264,866 | | | | | | 312,150 | | | | | | 24,865 | | | | | | 601,881 | | |
Pierre Kemula
|
| | | | 250,199 | | | | | | 235,375 | | | | | | 99,928 | | | | | | 585,502 | | |
Bernd Winterhalter(7)
|
| | | | 455,955 | | | | | | — | | | | | | — | | | | | | 455,955 | | |
Dimitris Voliotis(8)
|
| | | | 11,283 | | | | | | — | | | | | | 306,935 | | | | | | 318,218 | | |
Igor Splawski(10)(11)
|
| | | | 146,883 | | | | | | — | | | | | | 74,154 | | | | | | 220,037 | | |
Name*
|
| |
Number of
Shares |
| |
Percentage
of Shares Outstanding |
| |
Voting
Rights |
| |||||||||
Daniel L. Menichella(1)
|
| | | | — | | | | | | — | | | | | | — | | |
Florian von der Mulbe
|
| | | | 820,025 | | | | | | 0.45% | | | | | | — | | |
Mariola Fotin-Mleczek
|
| | | | — | | | | | | — | | | | | | — | | |
Franz-Werner Haas
|
| | | | — | | | | | | — | | | | | | — | | |
Name*
|
| |
Number of
Shares |
| |
Percentage
of Shares Outstanding |
| |
Voting
Rights |
| |||||||||
Pierre Kemula
|
| | | | — | | | | | | — | | | | | | — | | |
Bernd Winterhalter(2)
|
| | | | — | | | | | | — | | | | | | — | | |
Dimitris Voliotis
|
| | | | — | | | | | | — | | | | | | — | | |
Igor Splawski(3)
|
| | | | — | | | | | | — | | | | | | — | | |
Name*
|
| |
Number of
Options |
| |
Title
|
| |
Amount
of Securities (€) |
| |
Exercise
Price (€) |
| |
Purchase
Price (€) |
| |
Expiration
Date |
| |||||||||
Daniel Menichella(1)
|
| | | | — | | | |
—
|
| | | | — | | | |
—
|
| |
—
|
| | | | — | | |
Florian von der Mulbe
|
| | | | 268,417 | | | |
Share Option Awards
|
| | | | 268,417 | | | |
1.00
|
| |
2,017
|
| | | | 12/31/2021 | | |
Mariola Fotin-Mleczek
|
| | | | — | | | |
—
|
| | | | — | | | |
—
|
| |
—
|
| | | | — | | |
Franz-Werner Haas
|
| | | | — | | | |
—
|
| | | | — | | | |
—
|
| |
—
|
| | | | — | | |
Pierre Kemula
|
| | | | — | | | |
—
|
| | | | — | | | |
—
|
| |
—
|
| | | | — | | |
Bernd Winterhalter(2)
|
| | | | — | | | |
—
|
| | | | — | | | |
—
|
| |
—
|
| | | | — | | |
Dimitris Voliotis
|
| | | | — | | | |
—
|
| | | | — | | | |
—
|
| |
—
|
| | | | — | | |
Igor Splawski(3)(4)
|
| | | | 266,155 | | | |
LTIP Option Awards
|
| | | | 266,155 | | | |
10.04
|
| |
—
|
| | | | 7/14/2030 | | |
Name
|
| |
Program
|
| |
VS
Points Granted |
| |
Max
Vested Points |
| |
Start of
Vesting Period (Only for New Participants) |
| |
Grant date
(Date of Allocation Letter) |
| |
Vesting
Period |
| |
VSOP
Plan |
| |
Valid
until |
| |||||||||||||||||||||
Florian von der Mulbe
|
| | | | VS | | | | | | 103,534 | | | | | | 103,534 | | | | | | | | | | | | 01.01.2009 | | | | | | 36 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Florian von der Mulbe
|
| | | | VS | | | | | | 463,908 | | | | | | 463,908 | | | | | | | | | | | | 01.01.2011 | | | | | | 36 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Florian von der Mulbe
|
| | | | VS | | | | | | 97,944 | | | | | | 97,944 | | | | | | | | | | | | 01.01.2013 | | | | | | 36 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Florian von der Mulbe
|
| | | | VS | | | | | | 202,543 | | | | | | 202,543 | | | | | | | | | | | | 01.01.2015 | | | | | | 12 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Florian von der Mulbe
|
| | | | VS | | | | | | 811,774 | | | | | | 811,774 | | | | | | | | | | | | 11.12.2015 | | | | | | 12 | | | |
Prior VSOP
IPO only
|
| | | | 31.12.2025 | | |
Mariola Fotin-Mleczek
|
| | | | VS | | | | | | 42,051 | | | | | | 42,051 | | | | | | | | | | | | 01.01.2009 | | | | | | 60 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Mariola Fotin-Mleczek
|
| | | | VS | | | | | | 33,268 | | | | | | 33,268 | | | | | | | | | | | | 01.01.2013 | | | | | | 36 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Mariola Fotin-Mleczek
|
| | | | VS | | | | | | 33,268 | | | | | | 33,268 | | | | | | | | | | | | 01.01.2014 | | | | | | 36 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Mariola Fotin-Mleczek
|
| | | | VS | | | | | | 33,268 | | | | | | 33,268 | | | | | | | | | | | | 01.01.2015 | | | | | | 36 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Mariola Fotin-Mleczek
|
| | | | VS | | | | | | 309,671 | | | | | | 309,671 | | | | | | | | | | | | 01.01.2015 | | | | | | 12 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Ulrike Gnad-Vogt
|
| | | | VS | | | | | | 90,751 | | | | | | 90,751 | | | | | | | | | | | | 01.07.2011 | | | | | | 60 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Ulrike Gnad-Vogt
|
| | | | VS | | | | | | 33,268 | | | | | | 33,268 | | | | | | | | | | | | 01.01.2013 | | | | | | 36 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Ulrike Gnad-Vogt
|
| | | | VS | | | | | | 33,268 | | | | | | 33,268 | | | | | | | | | | | | 01.01.2014 | | | | | | 36 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Ulrike Gnad-Vogt
|
| | | | VS | | | | | | 33,268 | | | | | | 33,268 | | | | | | | | | | | | 01.01.2015 | | | | | | 36 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Ulrike Gnad-Vogt
|
| | | | VS | | | | | | 260,964 | | | | | | 260,964 | | | | | | | | | | | | 01.01.2015 | | | | | | 12 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Franz-Werner Haas
|
| | | | VS | | | | | | 186,307 | | | | | | 186,307 | | | | | | | | | | | | 01.06.2012 | | | | | | 36 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Franz-Werner Haas
|
| | | | VS | | | | | | 479,079 | | | | | | 479,079 | | | | | | | | | | | | 01.01.2013 | | | | | | 36 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Franz-Werner Haas
|
| | | | VS | | | | | | 202,543 | | | | | | 202,543 | | | | | | | | | | | | 01.01.2015 | | | | | | 12 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Pierre Kemula
|
| | | | VS | | | | | | 665,388 | | | | | | 665,388 | | | | | | 01.10.2016 | | | | | | 18.04.2019 | | | | | | 36 | | | |
Prior VSOP
|
| | | | 31.12.2025 | | |
Daniel Menichella*
|
| | | | * | | | | | | 3,866,308 | | | | | | 3,866,308 | | | | | | 08.01.2017 | | | | | | 14.10.2019 | | | | | | 48 | | | | * | | | | | 08.01.2027 | | |
| | |
Shares Beneficially
Owned Before This Offering |
| |
Common Shares Beneficially
Owned After Giving Effect to This Offering |
| ||||||||||||||||||||||||
| | | | | | | | | | | | | | |
No exercise
of underwriter’s option |
| |
Full exercise
of underwriter’s option |
| ||||||||||||
Shareholder
|
| |
Number
|
| |
Percentage
|
| |
Number
|
| |
Percentage
|
| |
Percentage
|
| |||||||||||||||
5% Shareholders: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Dievini Hopp BioTech holding GmbH & Co. KG(1)
|
| | | | 79,775,217 | | | | | | 44.03% | | | | | | 79,775,217 | | | | | | 42.85% | | | | | | 42.68% | | |
OH Beteiligungen GmbH & Co. KG(4)
|
| | | | 79,775,217 | | | | | | 44.03% | | | | | | 79,775,217 | | | | | | 42.85% | | | | | | 42.68% | | |
DH-Capital GmbH & Co. KG(4)
|
| | | | 79,775,217 | | | | | | 44.03% | | | | | | 79,775,217 | | | | | | 42.85% | | | | | | 42.68% | | |
Kreditanstalt fur Wiederaufbau(2)
|
| | | | 29,871,441 | | | | | | 16.49% | | | | | | 29,871,441 | | | | | | 16.05% | | | | | | 15.98% | | |
Glaxo Group Limited
|
| | | | 14,935,721 | | | | | | 8.24% | | | | | | 14,935,721 | | | | | | 8.02% | | | | | | 7.99% | | |
Managing Directors: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Florian von der Mulbe, Ph.D., MBA
|
| | | | 1,257,147 | | | | | | *% | | | | | | 1,257,147 | | | | | | *% | | | | | | *% | | |
Mariola Fotin – Mleczek, Ph.D.
|
| | | | 45,887 | | | | | | *% | | | | | | 45,887 | | | | | | *% | | | | | | *% | | |
Franz – Werner Haas, LLD, LLM
|
| | | | 87,527 | | | | | | *% | | | | | | 87,527 | | | | | | *% | | | | | | *% | | |
Pierre Kemula, B.Sc.
|
| | | | 67,273 | | | | | | *% | | | | | | 67,273 | | | | | | *% | | | | | | *% | | |
Supervisory Directors: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Ralf Clemens, MD, Ph.D.
|
| | | | — | | | | | | —% | | | | | | — | | | | | | —% | | | | | | —% | | |
Mathias Hothum, Ph.D.(3)
|
| | | | 79,775,217 | | | | | | 44.03% | | | | | | 79,775,217 | | | | | | 42.85% | | | | | | 42.68% | | |
Baron Jean Stephenne, MSc, MBA
|
| | | | — | | | | | | —% | | | | | | — | | | | | | —% | | | | | | —% | | |
| | |
Shares Beneficially
Owned Before This Offering |
| |
Common Shares Beneficially
Owned After Giving Effect to This Offering |
| ||||||||||||||||||||||||
| | | | | | | | | | | | | | |
No exercise
of underwriter’s option |
| |
Full exercise
of underwriter’s option |
| ||||||||||||
Shareholder
|
| |
Number
|
| |
Percentage
|
| |
Number
|
| |
Percentage
|
| |
Percentage
|
| |||||||||||||||
Hans Cristoph Tanner, Ph.D.
|
| | | | 188,172 | | | | | | *% | | | | | | 188,172 | | | | | | *% | | | | | | *% | | |
Friedrich von Bohlen und Halbach, Ph.D.(3)
|
| | | | 80,017,152 | | | | | | 44.17% | | | | | | 80,017,152 | | | | | | 42.98% | | | | | | 42.81% | | |
Timothy M. Wright, MD
|
| | | | — | | | | | | —% | | | | | | — | | | | | | —% | | | | | | —% | | |
Craig A. Tooman, MBA
|
| | | | — | | | | | | —% | | | | | | — | | | | | | —% | | | | | | —% | | |
All Managing Directors and Supervisory Directors as a Group:
|
| | | | 81,663,159 | | | | | | 45.08% | | | | | | 81,663,159 | | | | | | 43.87% | | | | | | 43.69% | | |
Underwriter
|
| |
Number
of Shares |
| |||
BofA Securities, Inc.
|
| |
|
| |||
Jefferies LLC
|
| | | | | | |
Evercore Group L.L.C.
|
| | | | | | |
UBS Securities LLC
|
| | | | | | |
Guggenheim Securities, LLC
|
| | | | | | |
Berenberg Capital Markets LLC
|
| | | | | | |
Kempen & Co U.S.A., Inc.
|
| | | | | | |
Total
|
| | | | 5,000,000 | | |
| | |
Per Share
|
| |
Without Option
|
| |
With Option
|
| |||||||||
Public offering price
|
| | | $ | | | | | $ | | | | | $ | | | |||
Underwriting discount
|
| | | $ | | | | | $ | | | | | $ | | | |||
Proceeds, before expenses, to us
|
| | | $ | | | | | $ | | | | | $ | | | |
Expenses
|
| |
Amount
|
| |||
U.S. Securities and Exchange Commission registration fee
|
| | | $ | 64,999 | | |
FINRA filing fee
|
| | | | 86,750 | | |
Printing and engraving expenses
|
| | | | 175,000 | | |
Legal fees and expenses
|
| | | | 490,840 | | |
Accounting fees and expenses
|
| | | | 175,000 | | |
Miscellaneous costs
|
| | | | 55,888 | | |
Total
|
| | | $ | 1,048,477 | | |
| Unaudited Interim Condensed Consolidated Financial Statements — CureVac N.V. | | | | | | | |
| | | | | F-2 | | | |
| | | | | F-3 | | | |
| | | | | F-4 | | | |
| | | | | F-5 | | | |
| | | | | F-6 | | | |
| Consolidated Financial Statements — CureVac AG | | | | | | | |
| | | | | F-17 | | | |
| | | | | F-18 | | | |
| | | | | F-19 | | | |
| | | | | F-20 | | | |
| | | | | F-21 | | | |
| | | | | F-22 | | |
| | | | | | | | |
Nine Months ended
September 30, |
| |||||||||
| | |
Note
|
| |
2019
|
| |
2020
|
| |||||||||
(in thousands of EUR, except per share amounts)
|
| | | | | | | |
(unaudited)
|
| |||||||||
Revenue
|
| | | | 3.1 | | | | | | 10,600 | | | | | | 42,830 | | |
Cost of sales
|
| | | | 3.2 | | | | | | (18,872) | | | | | | (7,049) | | |
Selling and distribution expenses
|
| | | | 3.3 | | | | | | (485) | | | | | | (809) | | |
Research and development expenses
|
| | | | 3.4 | | | | | | (30,665) | | | | | | (76,337) | | |
General and administrative expenses
|
| | | | 3.5 | | | | | | (28,504) | | | | | | (33,147) | | |
Other operating income
|
| | | | 3.6 | | | | | | 3,838 | | | | | | 11,695 | | |
Other operating expenses
|
| | | | | | | | | | (339) | | | | | | (357) | | |
Operating loss
|
| | | | | | | | | | (64,427) | | | | | | (63,174) | | |
Finance income
|
| | | | | | | | | | 3,133 | | | | | | 5,103 | | |
Finance expenses
|
| | | | | | | | | | (2,924) | | | | | | (14,519) | | |
Loss before income tax
|
| | | | | | | | | | (64,218) | | | | | | (72,590) | | |
Income tax benefit/(expense)
|
| | | | | | | | | | 335 | | | | | | 1,615 | | |
Net loss for the period
|
| | | | | | | | | | (63,883) | | | | | | (70,975) | | |
Other comprehensive income: | | | | | | | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss | | | | | | | | | | | | | | | | | | | |
Foreign currency adjustments
|
| | | | | | | | | | (20) | | | | | | 76 | | |
Total comprehensive loss for the period
|
| | | | | | | | | | (63,903) | | | | | | (70,899) | | |
Net loss per share (basic and diluted)*
|
| | | | | | | | | | (0.66) | | | | | | (0.61) | | |
| | |
Note
|
| |
December 31,
2019 |
| |
September 30,
2020 |
| |||||||||
(in thousands of EUR)
|
| | | | | | | | | | | | | |
(unaudited)
|
| |||
Assets | | | | | | | | | | | | | | | | | | | |
Non-current assets | | | | | | | | | | | | | | | | | | | |
Intangible assets
|
| | | | 6.1 | | | | | | 5,698 | | | | | | 10,138 | | |
Property, plant and equipment
|
| | | | 6.2 | | | | | | 48,075 | | | | | | 59,364 | | |
Right-of-use assets
|
| | | | 6.3 | | | | | | 13,611 | | | | | | 34,693 | | |
Other assets
|
| | | | 6.4 | | | | | | 6,061 | | | | | | 2,147 | | |
Deferred tax assets
|
| | | | | | | | | | — | | | | | | 65 | | |
Total non-current assets
|
| | | | | | | | | | 73,445 | | | | | | 106,407 | | |
Current assets | | | | | | | | | | | | | | | | | | | |
Inventories
|
| | | | 8 | | | | | | 6,197 | | | | | | 1,426 | | |
Trade receivables
|
| | | | | | | | | | 15,690 | | | | | | — | | |
Contract assets
|
| | | | | | | | | | 1,463 | | | | | | 535 | | |
Other financial assets
|
| | | | 9 | | | | | | 1,458 | | | | | | 1,129 | | |
Prepaid expenses and other assets
|
| | | | 7 | | | | | | 1,683 | | | | | | 20,011 | | |
Cash and cash equivalents
|
| | | | | | | | | | 30,684 | | | | | | 892,399 | | |
Total current assets
|
| | | | | | | | | | 57,175 | | | | | | 915,500 | | |
Total assets
|
| | | | | | | | | | 130,620 | | | | | | 1,021,907 | | |
Equity and liabilities | | | | | | | | | | | | | | | | | | | |
Equity
|
| | | | 4 | | | | | | | | | | | | | | |
Issued capital*
|
| | | | | | | | | | 11,603 | | | | | | 21,560 | | |
Capital reserve*
|
| | | | | | | | | | 461,520 | | | | | | 1,326,766 | | |
Accumulated deficit
|
| | | | | | | | | | (515,947) | | | | | | (586,922) | | |
Other comprehensive income
|
| | | | | | | | | | 22 | | | | | | (54) | | |
Total equity
|
| | | | | | | | | | (42,802) | | | | | | 761,350 | | |
Non-current liabilities | | | | | | | | | | | | | | | | | | | |
Convertible loans
|
| | | | 11 | | | | | | 65,018 | | | | | | — | | |
Lease liabilities
|
| | | | | | | | | | 12,126 | | | | | | 27,724 | | |
Contract liabilities
|
| | | | 3.1 | | | | | | 66,040 | | | | | | 121,778 | | |
Deferred tax liabilities
|
| | | | | | | | | | 1,623 | | | | | | — | | |
Other liabilities
|
| | | | | | | | | | 530 | | | | | | 530 | | |
Total non-current liabilities
|
| | | | | | | | | | 145,336 | | | | | | 150,032 | | |
Current liabilities | | | | | | | | | | | | | | | | | | | |
Lease liabilities
|
| | | | | | | | | | 2,004 | | | | | | 2,921 | | |
Trade and other payables
|
| | | | 10 | | | | | | 6,475 | | | | | | 50,225 | | |
Other liabilities
|
| | | | | | | | | | 12,015 | | | | | | 27,052 | | |
Income taxes payable
|
| | | | | | | | | | 111 | | | | | | 130 | | |
Contract liabilities
|
| | | | 3.1 | | | | | | 7,481 | | | | | | 30,197 | | |
Total current liabilities
|
| | | | | | | | | | 28,086 | | | | | | 110,525 | | |
Total liabilities
|
| | | | | | | | | | 173,422 | | | | | | 260,557 | | |
Total equity and liabilities
|
| | | | | | | | | | 130,620 | | | | | | 1,021,907 | | |
(in thousands of EUR)
|
| |
Issued
capital* |
| |
Capital
reserve* |
| |
Accumulated
deficit |
| |
Currency
translation reserve |
| |
Total
equity |
| |||||||||||||||
Balance as of January 1, 2020
|
| | | | 11,603 | | | | | | 461,520 | | | | | | (515,947) | | | | | | 22 | | | | | | (42,802) | | |
Net loss
|
| | | | — | | | | | | — | | | | | | (70,975) | | | | | | — | | | | | | (70,975) | | |
Other comprehensive income (loss)
|
| | | | — | | | | | | — | | | | | | — | | | | | | (76) | | | | | | (76) | | |
Total comprehensive income (loss)
|
| | |
|
—
|
| | | |
|
—
|
| | | | | (70,975) | | | | | | (76) | | | | | | (71,051) | | |
Share-based payment expense
|
| | | | — | | | | | | 7,399 | | | | | | — | | | | | | — | | | | | | 7,399 | | |
Equity component of convertible loans (net of tax)
|
| | | | — | | | | | | 87 | | | | | | — | | | | | | — | | | | | | 87 | | |
Exercise of options
|
| | | | 288 | | | | | | (288) | | | | | | — | | | | | | — | | | | | | — | | |
Issuance of share capital (net of transaction costs)
|
| | | | 9,669 | | | | | | 858,048 | | | | | | — | | | | | | — | | | | | | 867,717 | | |
Balance as of September 30, 2020 (unaudited)
|
| | | | 21,560 | | | | | | 1,326,766 | | | | | | (586,922) | | | | | | (54) | | | | | | 761,350 | | |
(in thousands of EUR)
|
| |
Issued
capital* |
| |
Capital
reserve* |
| |
Accumulated
deficit |
| |
Currency
translation reserve |
| |
Total
equity |
| |||||||||||||||
Balance as of January 1, 2019
|
| | | | 11,603 | | | | | | 436,564 | | | | | | (416,074) | | | | | | (10) | | | | | | 32,083 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | (64,671) | | | | | | — | | | | | | (64,671) | | |
Other comprehensive income
|
| | | | — | | | | | | — | | | | | | — | | | | | | 21 | | | | | | 21 | | |
Total comprehensive income (loss)
|
| | |
|
—
|
| | | |
|
—
|
| | | | | (64,671) | | | | | | 21 | | | | | | (64,650) | | |
Share-based payment expense
|
| | | | — | | | | | | 6,073 | | | | | | — | | | | | | — | | | | | | 6,073 | | |
Equity component of convertible loans (net of tax)
|
| | | | — | | | | | | 5,744 | | | | | | — | | | | | | — | | | | | | 5,744 | | |
Balance as of September 30, 2019 (unaudited)
|
| | | | 11,603 | | | | | | 448,381 | | | | | | (480,745) | | | | | | 11 | | | | | | (20,750) | | |
| | |
Nine months ended
September 30, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
(in thousands of EUR)
|
| |
(unaudited)
|
| |||||||||
Operating activities | | | | | | | | | | | | | |
Loss before income tax
|
| | |
|
(64,218)
|
| | | |
|
(72,590)
|
| |
Adjustments to reconcile loss before tax to net cash flows | | | | | | | | | | | | | |
Finance income
|
| | | | (3,133) | | | | | | (5,103) | | |
Finance expense
|
| | | | 2,924 | | | | | | 14,519 | | |
Depreciation and amortization
|
| | | | 4,924 | | | | | | 7,244 | | |
Loss on disposal of fixed assets
|
| | | | 46 | | | | | | 357 | | |
Share-based payment expense
|
| | | | 6,074 | | | | | | 7,399 | | |
Working capital changes | | | | | | | | | | | | | |
Decrease / (increase) in trade receivables and contract assets
|
| | | | 1,707 | | | | | | 16,662 | | |
Decrease / (increase) in inventory
|
| | | | (4,442) | | | | | | 4,775 | | |
Decrease / (increase) in prepaid expenses and other assets
|
| | | | (765) | | | | | | (19,336) | | |
Receipts from grants from government agencies and similar bodies
|
| | | | 2,178 | | | | | | 17,630 | | |
(Decrease) / increase in trade and other payables and contract liabilities
|
| | | | (11,912) | | | | | | 116,457 | | |
Decrease / (increase) in deferred taxes
|
| | | | (312) | | | | | | (65) | | |
(Decrease) / Increase in other current financial and other liabilities
|
| | | | (417) | | | | | | — | | |
Income taxes paid
|
| | | | — | | | | | | (98) | | |
Interest paid
|
| | | | (633) | | | | | | (6,869) | | |
Net cash flow provided by (used in) operating activities
|
| | | | (67,979) | | | | | | 80,982 | | |
Investing activities | | | | | | | | | | | | | |
Purchase of property, plant and equipment
|
| | | | (6,629) | | | | | | (15,149) | | |
Purchase of intangible assets
|
| | | | (681) | | | | | | (5,883) | | |
Proceeds from asset-related grants
|
| | | | 1,501 | | | | | | 3,237 | | |
Proceeds from sale of other financial assets
|
| | | | 38,856 | | | | | | 329 | | |
Net cash flow provided by (used in) investing activities
|
| | | | 33,047 | | | | | | (17,466) | | |
Financing activities | | | | | | | | | | | | | |
Payments on lease obligation
|
| | | | (1,331) | | | | | | (3,478) | | |
Proceeds from the issuance of shares (net of transaction costs)
|
| | | | — | | | | | | 867,717 | | |
Proceeds from the convertible loans
|
| | | | 50,000 | | | | | | 24,860 | | |
Repayments of convertible loans
|
| | | | — | | | | | | (94,749) | | |
Net cash flow provided by financing activities
|
| | | | 48,669 | | | | | | 794,350 | | |
Currency translation gains (losses) on cash and cash equivalents
|
| | | | (139) | | | | | | 3,849 | | |
Increase in cash and cash equivalents
|
| | | | 13,737 | | | | | | 857,867 | | |
Cash and cash equivalents, beginning of period
|
| | | | 21,750 | | | | | | 30,684 | | |
Cash and cash equivalents, end of period
|
| | | | 35,348 | | | | | | 892,399 | | |
| | |
Nine months ended
September 30, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
United States | | | | | | | | | | | | | |
Eli Lilly and Company
|
| | | | 8,694 | | | | | | 34,854 | | |
Germany | | | | | | | | | | | | | |
Boehringer Ingelheim
|
| | | | 1,569 | | | | | | 1,418 | | |
Switzerland | | | | | | | | | | | | | |
CRISPR
|
| | | | 337 | | | | | | 618 | | |
Netherlands | | | | | | | | | | | | | |
Genmab
|
| | | | — | | | | | | 1,893 | | |
Belgium | | | | | | | | | | | | | |
GSK
|
| | | | — | | | | | | 4,047 | | |
Total | | | | | 10,600 | | | | | | 42,830 | | |
| | |
Upfront payments
September 30, 2020 |
| |
Upfront
payments included in contract liabilities at |
| |
Upfront
payments included in contract liabilities at |
| |
Revenue recognized
from upfront payments for nine months ended September 30, |
| |||||||||||||||
Customer
|
| |
September 30,
2019 |
| |
September 30,
2020 |
| |
2019
|
| |
2020
|
| |||||||||||||||
| | |
(in thousands)
|
| |
(EUR k)
|
| |
(EUR k)
|
| |
(EUR k)
|
| |||||||||||||||
Eli Lilly
|
| |
USD 50,000 (EUR 42,200)*
|
| | | | 35,733 | | | | | | — | | | | | | 2,637 | | | | | | 34,854 | | |
CRISPR
|
| | USD 3,000 (EUR 2,524)* | | | | | 1,936 | | | | | | 1,627 | | | | | | 232 | | | | | | 232 | | |
Boehringer Ingelheim
|
| | EUR 30,000 | | | | | 16,336 | | | | | | 14,469 | | | | | | 1,485 | | | | | | 1,400 | | |
Genmab
|
| |
USD 10,000 (EUR 8,937)*
|
| | | | — | | | | | | 7,597 | | | | | | — | | | | | | 1,341 | | |
GSK
|
| | EUR 120,000 | | | | | — | | | | | | 116,255 | | | | | | — | | | | | | 3,718 | | |
Total | | | | | | | | 54,006 | | | | | | 139,948 | | | | | | 4,354 | | | | | | 41,545 | | |
Contract balances:
|
| |
December 31,
2019 |
| |
September 30,
2020 |
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Trade receivables
|
| | | | 15,690 | | | | | | — | | |
Contract assets
|
| | | | 1,463 | | | | | | 535 | | |
Contract liabilities
|
| | | | 73,521 | | | | | | 151,975 | | |
| | |
Nine months ended
September 30, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Personnel
|
| | | | (7,249) | | | | | | (2,171) | | |
Materials
|
| | | | (4,022) | | | | | | (1,380) | | |
Third-party services
|
| | | | (5,339) | | | | | | (2,432) | | |
Maintenance and lease
|
| | | | (770) | | | | | | (752) | | |
Amortization and depreciation
|
| | | | (1,259) | | | | | | (250) | | |
Other
|
| | | | (233) | | | | | | (64) | | |
Total | | | | | (18,872) | | | | | | (7,049) | | |
| | |
Nine months ended
September 30, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Personnel
|
| | | | (257) | | | | | | (755) | | |
Amortization and depreciation
|
| | | | (61) | | | | | | (77) | | |
Other
|
| | | | (167) | | | | | | 23 | | |
Total | | | | | (485) | | | | | | (809) | | |
| | |
Nine months ended
September 30, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Materials
|
| | | | (2,605) | | | | | | (21,595) | | |
Personnel
|
| | | | (9,321) | | | | | | (16,213) | | |
Amortization and depreciation
|
| | | | (895) | | | | | | (2,589) | | |
Patents and fees to register a legal right
|
| | | | (3,143) | | | | | | (3,525) | | |
Third-party services
|
| | | | (14,426) | | | | | | (27,973) | | |
Maintenance and lease
|
| | | | (20) | | | | | | (560) | | |
Other
|
| | | | (255) | | | | | | (3,882) | | |
Total | | | | | (30,665) | | | | | | (76,337) | | |
| | |
Nine months ended
September 30, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Personnel
|
| | | | (16,747) | | | | | | (15,847) | | |
Maintenance and lease
|
| | | | (2,138) | | | | | | (1,571) | | |
Third-party services
|
| | | | (4,203) | | | | | | (5,097) | | |
Legal and other professional services
|
| | | | (825) | | | | | | (2,276) | | |
Amortization and depreciation
|
| | | | (2,709) | | | | | | (4,382) | | |
Other
|
| | | | (1,882) | | | | | | (3,974) | | |
Total | | | | | (28,504) | | | | | | (33,147) | | |
| | |
Nine months ended
September 30, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Grants and other cost reimbursements from government agencies and similar bodies
|
| | | | 3,781 | | | | | | 11,313 | | |
Other
|
| | | | 57 | | | | | | 382 | | |
Total | | | | | 3,838 | | | | | | 11,695 | | |
| | |
Nine months ended
September 30, |
| ||||||
| | |
2019
|
| |
2020
|
| |||
| | |
EUR k
|
| |
EUR k
|
| |||
Research and development expenses
|
| | | | — | | | |
2,985
|
|
Sales and marketing expenses
|
| | | | — | | | |
467
|
|
General and administrative expenses
|
| | | | 6,074 | | | |
3,947
|
|
Total | | | | | 6,074 | | | |
7,399
|
|
| | |
Nine months ended
September 30, |
| |||||||||
Program
|
| |
2019
|
| |
2020
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Former Chief Executive Officer Grant
|
| | | | — | | | | | | 2,551 | | |
New VSOP
|
| | | | — | | | | | | 1,327 | | |
Prior VSOP
|
| | | | 6,074 | | | | | | 3,521 | | |
Total | | | | | 6,074 | | | | | | 7,399 | | |
| | | | | | | | |
Years ended December 31,
|
| |||||||||
(in thousands of EUR, except per share data)
|
| |
Note
|
| |
2018
|
| |
2019
|
| |||||||||
Revenue
|
| | | | 3.1 | | | | | | 12,871 | | | | | | 17,416 | | |
Cost of sales
|
| | | | 3.2 | | | | | | (17,744) | | | | | | (27,983) | | |
Selling and distribution expenses
|
| | | | 3.3 | | | | | | (1,085) | | | | | | (1,755) | | |
Research and development expenses
|
| | | | 3.4 | | | | | | (41,722) | | | | | | (43,242) | | |
General and administrative expenses
|
| | | | 3.5 | | | | | | (25,289) | | | | | | (48,969) | | |
Other operating income
|
| | | | 3.6 | | | | | | 808 | | | | | | 5,587 | | |
Other operating expenses
|
| | | | 3.7 | | | | | | (663) | | | | | | (552) | | |
Operating loss
|
| | | | | | | | | | (72,824) | | | | | | (99,498) | | |
Finance income
|
| | | | | | | | | | 1,968 | | | | | | 833 | | |
Finance expenses
|
| | | | | | | | | | (275) | | | | | | (1,460) | | |
Loss before income tax
|
| | | | | | | | | | (71,131) | | | | | | (100,125) | | |
Income tax benefit / (expense)
|
| | | | 14 | | | | | | (110) | | | | | | 252 | | |
Net loss for the year
|
| | | | | | | | | | (71,241) | | | | | | (99,873) | | |
Other comprehensive income | | | | | | | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss | | | | | | | | | | | | | | | | | | | |
Foreign currency adjustments
|
| | | | | | | | | | 66 | | | | | | 32 | | |
Total comprehensive loss for the year
|
| | | | | | | | | | (71,175) | | | | | | (99,841) | | |
Net loss per share (basic and diluted)*
|
| | | | | | | | | | (0.74) | | | | | | (1.03) | | |
| | | | | | | | |
December 31,
|
| |||||||||
(in thousands of EUR)
|
| |
Note
|
| |
2018
|
| |
2019
|
| |||||||||
Assets | | | | | | | | | | | | | | | | | | | |
Non-current assets | | | | | | | | | | | | | | | | | | | |
Intangible assets
|
| | | | 4 | | | | | | 6,213 | | | | | | 5,698 | | |
Property, plant and equipment
|
| | | | 4 | | | | | | 40,472 | | | | | | 48,075 | | |
Other assets
|
| | | | 4 | | | | | | 5,771 | | | | | | 6,061 | | |
Right-of-use assets
|
| | | | 2 | | | | | | — | | | | | | 13,611 | | |
Deferred tax assets
|
| | | | 14 | | | | | | 133 | | | | | | — | | |
Total non-current assets
|
| | | | | | | | | | 52,589 | | | | | | 73,445 | | |
Current assets | | | | | | | | | | | | | | | | | | | |
Inventories
|
| | | | 5 | | | | | | 2,951 | | | | | | 6,197 | | |
Trade receivables
|
| | | | 3 | | | | | | 5,476 | | | | | | 15,690 | | |
Contract assets
|
| | | | 3 | | | | | | 1,382 | | | | | | 1,463 | | |
Other financial assets
|
| | | | 6 | | | | | | 39,253 | | | | | | 1,458 | | |
Prepaid expenses and other assets
|
| | | | 7 | | | | | | 2,628 | | | | | | 1,683 | | |
Cash and cash equivalents
|
| | | | | | | | | | 21,380 | | | | | | 30,684 | | |
Total current assets
|
| | | | | | | | | | 73,070 | | | | | | 57,175 | | |
Total assets
|
| | | | | | | | | | 125,659 | | | | | | 130,620 | | |
Equity and liabilities | | | | | | | | | | | | | | | | | | | |
Equity | | | | | | | | | | | | | | | | | | | |
Issued capital*
|
| | | | | | | | | | 11,610 | | | | | | 11,610 | | |
Capital reserve*
|
| | | | | | | | | | 436,557 | | | | | | 461,513 | | |
Accumulated deficit
|
| | | | | | | | | | (416,074) | | | | | | (515,947) | | |
Other comprehensive income
|
| | | | | | | | | | (10) | | | | | | 22 | | |
Total equity
|
| | | | 8 | | | | | | 32,083 | | | | | | (42,802) | | |
Non-current liabilities | | | | | | | | | | | | | | | | | | | |
Convertible loans
|
| | | | 12 | | | | | | — | | | | | | 65,018 | | |
Lease liabilities
|
| | | | 2 | | | | | | — | | | | | | 12,126 | | |
Contract liabilities
|
| | | | 3 | | | | | | 64,583 | | | | | | 66,040 | | |
Deferred tax liabilities
|
| | | | 13 | | | | | | — | | | | | | 1,623 | | |
Other liabilities
|
| | | | | | | | | | 863 | | | | | | 529 | | |
Total non-current liabilities
|
| | | | | | | | | | 65,446 | | | | | | 145,336 | | |
Current liabilities | | | | | | | | | | | | | | | | | | | |
Other financial liabilities
|
| | | | | | | | | | 77 | | | | | | — | | |
Lease liabilities
|
| | | | 2 | | | | | | — | | | | | | 2,004 | | |
Trade and other payables
|
| | | | 11 | | | | | | 10,913 | | | | | | 6,475 | | |
Other liabilities
|
| | | | 12 | | | | | | 11,146 | | | | | | 12,015 | | |
Income Taxes payable
|
| | | | 13 | | | | | | 217 | | | | | | 111 | | |
Contract liabilities
|
| | | | 3 | | | | | | 5,777 | | | | | | 7,481 | | |
Total current liabilities
|
| | | | | | | | | | 28,130 | | | | | | 28,086 | | |
Total liabilities
|
| | | | | | | | | | 93,576 | | | | | | 173,422 | | |
Total equity and liabilities
|
| | | | | | | | | | 125,659 | | | | | | 130,620 | | |
(in thousands of EUR)
|
| |
Issued
capital* |
| |
Capital
reserve* |
| |
Accumulated
deficit |
| |
Currency
translation reserve |
| |
Total equity
|
| |||||||||||||||
Balance as of January 1, 2018
|
| | | | 11,610 | | | | | | 436,555 | | | | | | (345,320) | | | | | | (76) | | | | | | 102,769 | | |
Effects from the first-time adoption of IFRS 9
|
| | | | — | | | | | | — | | | | | | (183) | | | | | | — | | | | | | (183) | | |
Effects from the first-time adoption of IFRS 15
|
| | | | — | | | | | | — | | | | | | 670 | | | | | | — | | | | | | 670 | | |
Adjusted balance as of January 1, 2018
|
| | | | 11,610 | | | | | | 436,555 | | | | | | (344,833) | | | | | | (76) | | | | | | 103,256 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | (71,241) | | | | | | — | | | | | | (71,241) | | |
Other comprehensive income (loss)
|
| | | | — | | | | | | — | | | | | | — | | | | | | 66 | | | | | | 66 | | |
Total comprehensive income (loss)
|
| | | | — | | | | | | — | | | | | | (71,241) | | | | | | 66 | | | | | | (71,175) | | |
Expenses from share-based payment plan
|
| | | | — | | | | | | 2 | | | | | | — | | | | | | — | | | | | | 2 | | |
Balance as of December 31, 2018
|
| | | | 11,610 | | | | | | 436,557 | | | | | | (416,074) | | | | | | (10) | | | | | | 32,083 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | (99,873) | | | | | | — | | | | | | (99,873) | | |
Other comprehensive income (loss)
|
| | | | — | | | | | | — | | | | | | — | | | | | | 32 | | | | | | 32 | | |
Total comprehensive income (loss)
|
| | | | — | | | | | | — | | | | | | (99,873) | | | | | | 32 | | | | | | (99,841) | | |
Equity component of convertible loans
|
| | | | — | | | | | | 7,604 | | | | | | — | | | | | | — | | | | | | 7,604 | | |
Deferred taxes on convertible loans
|
| | | | — | | | | | | (2,212) | | | | | | — | | | | | | — | | | | | | (2,212) | | |
Expenses from share-based payment plan
|
| | | | — | | | | | | 19,564 | | | | | | — | | | | | | — | | | | | | 19,564 | | |
Balance as of December 31, 2019
|
| | | | 11,610 | | | | | | 461,513 | | | | | | (515,947) | | | | | | 22 | | | | | | (42,802) | | |
| | |
Years ended December 31,
|
| |||||||||
(in thousands of EUR)
|
| |
2018
|
| |
2019
|
| ||||||
Operating activities | | | | | | | | | | | | | |
Loss before income tax
|
| | | | (71,131) | | | | | | (100,125) | | |
Adjustments to reconcile loss before tax to net cash flows | | | | | | | | | | | | | |
Finance income
|
| | | | (1,968) | | | | | | (833) | | |
Finance expense
|
| | | | 275 | | | | | | 1,460 | | |
Depreciation and amortization
|
| | | | 3,781 | | | | | | 7,164 | | |
Loss on disposal of fixed assets
|
| | | | 52 | | | | | | 241 | | |
Share-based payment expense
|
| | | | (4,248) | | | | | | 19,564 | | |
Working capital changes | | | | | | | | | | | | | |
Decrease / (increase) in trade receivables and contract assets
|
| | | | (5,595) | | | | | | (10,117) | | |
Decrease / (increase) in inventory
|
| | | | 878 | | | | | | (3,246) | | |
Decrease / (increase) in other assets
|
| | | | (6,106) | | | | | | 630 | | |
Receipts from grants from government agencies and similar bodies
|
| | | | 214 | | | | | | 9,304 | | |
(Decrease) / increase in trade and other payables and contract liabilities
|
| | | | 9,402 | | | | | | (9,584) | | |
(Decrease) / Increase in other current financial and other liabilities
|
| | | | 336 | | | | | | (334) | | |
Income taxes paid
|
| | | | (26) | | | | | | (345) | | |
Interest received
|
| | | | 15 | | | | | | 81 | | |
Interest paid
|
| | | | 11 | | | | | | (824) | | |
Net cash flow (used in) operating activities
|
| | | | (74,110) | | | | | | (86,963) | | |
Investing activities | | | | | | | | | | | | | |
Purchase of property, plant and equipment
|
| | | | (9,406) | | | | | | (11,172) | | |
Purchase of intangible assets
|
| | | | (5,317) | | | | | | (1,052) | | |
Proceeds from asset-related grants
|
| | | | — | | | | | | 2,325 | | |
Proceeds from other financial assets
|
| | | | 10,459 | | | | | | 38,080 | | |
Net cash flow from (used in) investing activities
|
| | | | (4,264) | | | | | | 28,181 | | |
Financing activities | | | | | | | | | | | | | |
Payments on lease obligation
|
| | | | (112) | | | | | | (1,910) | | |
Proceeds from the convertible loans
|
| | | | — | | | | | | 69,889 | | |
Net cash flow from (used in) financing activities
|
| | | | (112) | | | | | | 67,979 | | |
Net increase (decrease) in cash and cash equivalents
|
| | | | (78,486) | | | | | | 9,197 | | |
Effect of currency translation gains on cash and cash equivalents
|
| | | | 213 | | | | | | 107 | | |
Cash and cash equivalents, beginning of period
|
| | | | 99,653 | | | | | | 21,380 | | |
Cash and cash equivalents, end of period
|
| | | | 21,380 | | | | | | 30,684 | | |
|
Software and Licenses
|
| |
3 to 8 years
|
|
|
Buildings:
|
| |
1 to 10 years
|
|
|
Technical equipment and machines:
|
| |
3 to 14 years
|
|
|
Other equipment, furniture and fixtures:
|
| |
3 to 14 years
|
|
| | |
EUR k
|
| |||
Existing commitments as at December 31, 2018 | | | | | | | |
Operating lease commitments
|
| | | | 48,008 | | |
Minimum lease payments (notional amount) on finance lease liabilities
|
| | | | 78 | | |
Relief option for short-term leases
|
| | | | (110) | | |
Leases with commencement date after January 1, 2019 in the amounts included above as existing commitments as at December 31, 2018
|
| | | | (28,557) | | |
Other
|
| | | | 123 | | |
Gross lease liabilities as at January 1, 2019
|
| | | | 19,542 | | |
Effect of discounting
|
| | | | (3,655) | | |
Lease liabilities as at January 1, 2019
|
| | | | 15,887 | | |
Present value of finance lease liabilities as at December 31, 2018
|
| | | | (77) | | |
Lease liabilities upon initial application of IFRS 16 as at January 1, 2019
|
| | | | 15,810 | | |
Weighted average incremental borrowing rate as at January 1, 2019
|
| | | | 5.64% | | |
|
Land and Buildings:
|
| |
1 to 15 years
|
|
|
Vehicles:
|
| |
3 to 4 years
|
|
|
Other equipment:
|
| |
2 to 5 years
|
|
| | |
Right-of-use assets
|
| |||||||||||||||||||||
| | |
Land and
Buildings |
| |
Vehicles
|
| |
Other
equipment |
| |
Total
|
| ||||||||||||
| | |
EURk
|
| |
EURk
|
| |
EURk
|
| |
EURk
|
| ||||||||||||
As at January 1, 2019
|
| | | | 15,536 | | | | | | 132 | | | | | | 239 | | | | | | 15,907 | | |
Additions
|
| | | | 82 | | | | | | 59 | | | | | | 13 | | | | | | 154 | | |
Depreciation expense
|
| | | | (2,322) | | | | | | (65) | | | | | | (142) | | | | | | (2,529) | | |
Foreign currency translation
|
| | | | 79 | | | | | | — | | | | | | — | | | | | | 79 | | |
As at December 31, 2019
|
| | | | 13,375 | | | | | | 126 | | | | | | 110 | | | | | | 13,611 | | |
| | |
EUR k
|
| |||
As at January 1, 2019
|
| | |
|
15,887
|
| |
Additions
|
| | | | 153 | | |
Accretion of interest
|
| | | | 824 | | |
Payments
|
| | | | (2,812) | | |
Foreign currency translation
|
| | | | 78 | | |
As at December 31, 2019
|
| | | | 14,130 | | |
Current
|
| | | | 2,004 | | |
Non-current
|
| | | | 12,126 | | |
| | |
EUR k
|
| |||
Depreciation expense of right-of-use assets
|
| | | | (2,529) | | |
Interest expense on lease liabilities
|
| | | | (824) | | |
Expense relating to short-term leases (included in cost of sales)
|
| | | | (167) | | |
Expense relating to leases of low-value assets (included in administrative expenses)
|
| | | | (94) | | |
Total amount recognized in profit or loss
|
| | | | (3,614) | | |
| | |
December 31,
2018 |
| |
December 31,
2019 |
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
United States | | | | | | | | | | | | | |
Eli Lilly and Company
|
| | | | 8,927 | | | | | | 14,319 | | |
Germany | | | | | | | | | | | | | |
Boehringer Ingelheim
|
| | | | 3,337 | | | | | | 2,474 | | |
Others
|
| | | | 5 | | | | | | 104 | | |
Switzerland | | | | | | | | | | | | | |
CRISPR
|
| | | | 602 | | | | | | 519 | | |
Total
|
| | | | 12,871 | | | | | | 17,416 | | |
Customer
|
| |
Upfront payments
received or receivable at December 31, 2019 (in thousands) |
| |
Upfront payments
included in contract liabilities at December 31, 2019 (in EUR k) |
| |
Revenue recognized
from upfront payments (in EUR k) |
| ||||||||||||
|
2018
|
| |
2019
|
| |||||||||||||||||
Eli Lilly and Company
|
| |
USD 50,000 (EUR 42,200)
|
| | | | 34,854 | | | | | | 3,516 | | | | | | 3,516 | | |
CRISPR
|
| | USD 3,000 (EUR 2,524) | | | | | 1,859 | | | | | | 310 | | | | | | 310 | | |
Boehringer Ingelheim
|
| | EUR 30,000 | | | | | 15,870 | | | | | | 2,035 | | | | | | 1,951 | | |
Genmab
|
| | USD 10,000 (EUR 8,937) | | | | | 8,937 | | | | | | — | | | | | | — | | |
Total | | | | | 61,520 | | | | | | 5,861 | | | | | | 5,777 | | |
| | |
January 1,
2018 |
| |
December 31,
2018 |
| |
December 31,
2019 |
| |||||||||
| | |
EUR k
|
| |
EUR k
|
| |
EUR k
|
| |||||||||
Trade receivables
|
| | | | 463 | | | | | | 5,476 | | | | | | 15,690 | | |
Contract assets
|
| | | | — | | | | | | 1,382 | | | | | | 1,463 | | |
Contract liabilities
|
| | | | 69,220 | | | | | | 70,360 | | | | | | 73,521 | | |
| | |
Year ended
|
| |||||||||
| | |
2018
EUR k |
| |
2019
EUR k |
| ||||||
Within one year
|
| | | | 5,777 | | | | | | 7,481 | | |
More than one year
|
| | | | 64,583 | | | | | | 66,040 | | |
Total | | | | | 70,360 | | | | | | 73,521 | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Personnel
|
| | | | (7,703) | | | | | | (9,855) | | |
Materials
|
| | | | (4,941) | | | | | | (7,542) | | |
Third-party services
|
| | | | (2,340) | | | | | | (7,268) | | |
Maintenance and lease
|
| | | | (1,758) | | | | | | (1,060) | | |
Amortization and depreciation
|
| | | | (893) | | | | | | (2,038) | | |
Other
|
| | | | (109) | | | | | | (220) | | |
Total
|
| | | | (17,744) | | | | | | (27,983) | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Personnel
|
| | | | (581) | | | | | | (1,263) | | |
Maintenance and lease costs
|
| | | | (300) | | | | | | (167) | | |
Amortization and depreciation
|
| | | | (95) | | | | | | (81) | | |
Other
|
| | | | (109) | | | | | | (243) | | |
Total | | | | | (1,085) | | | | | | (1,755) | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Materials
|
| | | | (5,867) | | | | | | (4,015) | | |
Personnel
|
| | | | (7,565) | | | | | | (14,385) | | |
Amortization and depreciation
|
| | | | (1,143) | | | | | | (474) | | |
Patents and fees to register a legal right
|
| | | | (4,847) | | | | | | (4,551) | | |
Third-party services
|
| | | | (19,921) | | | | | | (18,626) | | |
Maintenance and lease
|
| | | | (1,156) | | | | | | (670) | | |
Other
|
| | | | (1,223) | | | | | | (521) | | |
Total | | | | | (41,722) | | | | | | (43,242) | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Personnel
|
| | | | (10,084) | | | | | | (31,645) | | |
Maintenance and lease costs
|
| | | | (3,239) | | | | | | (4,604) | | |
Third-party services
|
| | | | (4,006) | | | | | | (5,970) | | |
Legal and other professional services
|
| | | | (4,078) | | | | | | (2,110) | | |
Amortization and depreciation
|
| | | | (1,635) | | | | | | (2,182) | | |
Other
|
| | | | (2,247) | | | | | | (2,458) | | |
Total | | | | | (25,289) | | | | | | (48,969) | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Grants and other cost reimbursements from government agencies and similar bodies
|
| | | | 808 | | | | | | 5,385 | | |
Other
|
| | | | — | | | | | | 202 | | |
Total
|
| | | | 808 | | | | | | 5,587 | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Renumeration of supervisory board
|
| | | | (343) | | | | | | (521) | | |
Other
|
| | | | (320) | | | | | | (30) | | |
Total
|
| | | | (663) | | | | | | (552) | | |
(in thousands of EUR)
|
| |
Software and
licenses |
| |
Advance
payments |
| |
Total
|
| |||||||||
Acquisition costs | | | | | | | | | | | | | | | | | | | |
As of January 1, 2018
|
| | | | 3,402 | | | | | | 235 | | | | | | 3,638 | | |
Additions
|
| | | | 5,314 | | | | | | 2 | | | | | | 5,317 | | |
As of December 31, 2018
|
| | | | 8,717 | | | | | | 238 | | | | | | 8,954 | | |
Cumulative amortization and impairment charges | | | | | | | | | | | | | | | | | | | |
As of January 1, 2018
|
| | | | 1,545 | | | | | | — | | | | | | 1,545 | | |
Amortization
|
| | | | 1,197 | | | | | | — | | | | | | 1,197 | | |
As of December 31, 2018
|
| | | | 2,742 | | | | | | — | | | | | | 2,742 | | |
|
(in thousands of EUR)
|
| |
Software and
licenses |
| |
Advance
payments |
| |
Total
|
| |||||||||
Acquisition costs | | | | | | | | | | | | | | | | | | | |
As of January 1, 2019
|
| | | | 8,717 | | | | | | 238 | | | | | | 8,954 | | |
Additions
|
| | | | 738 | | | | | | 44 | | | | | | 782 | | |
Disposals
|
| | | | (6) | | | | | | — | | | | | | (6) | | |
As of December 31, 2019
|
| | | | 9,449 | | | | | | 282 | | | | | | 9,731 | | |
Cumulative amortization and impairment charges | | | | | | | | | | | | | | | | | | | |
As of January 1, 2019
|
| | | | 2,742 | | | | | | — | | | | | | 2,742 | | |
Amortization
|
| | | | 1,295 | | | | | | — | | | | | | 1,295 | | |
Disposals
|
| | | | (4) | | | | | | — | | | | | | (4) | | |
As of December 31, 2019
|
| | | | 4,033 | | | | | | — | | | | | | 4,033 | | |
Carrying amount | | | | | | | | | | | | | | | | | | | |
As of January 1, 2018
|
| | | | 1,858 | | | | | | 235 | | | | | | 2,093 | | |
As of December 31, 2018
|
| | | | 5,975 | | | | | | 238 | | | | | | 6,213 | | |
As of December 31, 2019
|
| | | | 5,416 | | | | | | 282 | | | | | | 5,698 | | |
(in thousands of EUR)
|
| |
Buildings
|
| |
Technical
equipment and machines |
| |
Other
equipment, furniture and fixtures |
| |
Assets
under construction |
| |
Total
|
| |||||||||||||||
Acquisition costs | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
As of January 1, 2018
|
| | | | 5,398 | | | | | | 12,230 | | | | | | 4,665 | | | | | | 27,103 | | | | | | 49,397 | | |
Additions
|
| | | | 490 | | | | | | 953 | | | | | | 719 | | | | | | 7,244 | | | | | | 9,406 | | |
Disposals
|
| | | | — | | | | | | (150) | | | | | | (157) | | | | | | — | | | | | | (307) | | |
Reclassifications
|
| | | | — | | | | | | 1,303 | | | | | | 19 | | | | | | (1,323) | | | | | | — | | |
Currency translation
|
| | | | — | | | | | | — | | | | | | — | | | | | | 1 | | | | | | 1 | | |
As of December 31, 2018
|
| | | | 5,888 | | | | | | 14,336 | | | | | | 5,247 | | | | | | 33,025 | | | | | | 58,497 | | |
Cumulative depreciation and impairment charges | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
As of January 1, 2018
|
| | | | 1,337 | | | | | | 4,610 | | | | | | 2,654 | | | | | | 7,120 | | | | | | 15,721 | | |
Depreciation
|
| | | | 371 | | | | | | 1,299 | | | | | | 890 | | | | | | — | | | | | | 2,559 | | |
Disposals
|
| | | | — | | | | | | (99) | | | | | | (157) | | | | | | — | | | | | | (255) | | |
As of December 31, 2018
|
| | | | 1,708 | | | | | | 5,810 | | | | | | 3,387 | | | | | | 7,120 | | | | | | 18,025 | | |
|
(in thousands of EUR)
|
| |
Buildings
|
| |
Technical
equipment and machines |
| |
Other
equipment, furniture and fixtures |
| |
Assets
under construction |
| |
Total
|
| |||||||||||||||
Acquisition costs | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
As of January 1, 2019
|
| | | | 5,888 | | | | | | 14,336 | | | | | | 5,247 | | | | | | 33,025 | | | | | | 58,497 | | |
Additions
|
| | | | 854 | | | | | | 2,152 | | | | | | 712 | | | | | | 7,435 | | | | | | 11,152 | | |
Disposals
|
| | | | (65) | | | | | | (319) | | | | | | (248) | | | | | | — | | | | | | (632) | | |
Reclassifications
|
| | | | 167 | | | | | | 883 | | | | | | 187 | | | | | | (1,237) | | | | | | — | | |
Currency translation
|
| | | | — | | | | | | — | | | | | | 3 | | | | | | 4 | | | | | | 6 | | |
As of December 31, 2019
|
| | | | 6,844 | | | | | | 17,051 | | | | | | 5,902 | | | | | | 39,226 | | | | | | 69,023 | | |
Cumulative depreciation and impairment charges | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
As of January 1, 2019
|
| | | | 1,708 | | | | | | 5,810 | | | | | | 3,388 | | | | | | 7,120 | | | | | | 18,026 | | |
Depreciation
|
| | | | 779 | | | | | | 1,637 | | | | | | 899 | | | | | | — | | | | | | 3,315 | | |
Disposals
|
| | | | (37) | | | | | | (190) | | | | | | (164) | | | | | | — | | | | | | (392) | | |
Currency translation
|
| | | | — | | | | | | — | | | | | | 1 | | | | | | — | | | | | | 1 | | |
As of December 31, 2019
|
| | | | 2,449 | | | | | | 7,257 | | | | | | 4,123 | | | | | | 7,120 | | | | | | 20,949 | | |
Carrying amount | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
As of January 1, 2018
|
| | | | 4,061 | | | | | | 7,621 | | | | | | 2,011 | | | | | | 19,982 | | | | | | 33,675 | | |
As of December 31, 2018
|
| | | | 4,181 | | | | | | 8,526 | | | | | | 1,860 | | | | | | 25,904 | | | | | | 40,472 | | |
As of December 31, 2019
|
| | | | 4,395 | | | | | | 9,795 | | | | | | 1,779 | | | | | | 32,105 | | | | | | 48,075 | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Raw materials
|
| | | | 2,742 | | | | | | 6,177 | | |
Finished goods
|
| | | | — | | | | | | 14 | | |
Other
|
| | | | 209 | | | | | | 6 | | |
Total
|
| | | | 2,951 | | | | | | 6,197 | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Short-term investments
|
| | | | 39,024 | | | | | | 430 | | |
Other
|
| | | | 229 | | | | | | 1,028 | | |
Total | | | | | 39,253 | | | | | | 1,458 | | |
|
Series
|
| |
Shares
|
| |||
A
|
| | | | 3,114,021 | | |
B
|
| | | | 91,649,616 | | |
C
|
| | | | 1,929,628 | | |
Total
|
| | | | 96,693,265 | | |
| | |
2018
|
| |
2019
|
| ||||||
Outstanding at the beginning of the period
|
| | | | 7,972,425 | | | | | | 6,640,449 | | |
Granted during the period
|
| | | | — | | | | | | 665,389 | | |
Expired during the period
|
| | | | (1,331,976) | | | | | | — | | |
Outstanding at the end of the period
|
| | | | 6,640,449 | | | | | | 7,305,838 | | |
Thereof vested (and expensed)
|
| | | | 6,640,449 | | | | | | 7,305,838 | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Research and development expenses
|
| | | | 4,229 | | | | | | — | | |
General and administrative expenses
|
| | | | 21 | | | | | | (6,074) | | |
Total | | | | | 4,250 | | | | | | (6,074) | | |
|
Weighted average fair value
|
| | | | EUR3.80 | | |
|
Weighted average share price
|
| | | | EUR9.19 | | |
|
Exercise price (USD 6.21)
|
| | | | EUR5.64 | | |
|
Expected volatility (%)
|
| | | | 50.0% | | |
|
Expected life (years)
|
| | | | 1.16 | | |
|
Risk-free interest rate (%)
|
| | | | 1.77% | | |
|
Outstanding at the beginning of the period
|
| | | | — | | |
|
Granted during the period
|
| | | | 745,236 | | |
|
Outstanding at the end of the period
|
| | | | 745,236 | | |
|
Thereof vested
|
| | | | 175,397 | | |
|
Thereof expensed
|
| | | | 284,387 | | |
| | |
2019
|
| |||
| | |
EUR k
|
| |||
Research and development expenses
|
| | | | (258) | | |
Selling and distribution expenses
|
| | | | (743) | | |
General and administrative expenses
|
| | | | (79) | | |
Total | | | | | (1,080) | | |
|
Weighted average fair value
|
| | | | EUR3.87 | | |
|
Weighted average share price
|
| | | | EUR9.19 | | |
|
Exercise price (USD 8.27)
|
| | | | EUR7.50 | | |
|
Expected volatility (%)
|
| | | | 50.0% | | |
|
Expected life (years)
|
| | | | 4.77 | | |
|
Risk-free interest rate (%)
|
| | | | 1.71% | | |
|
Outstanding at the beginning of the period
|
| | | | — | | |
|
Granted during the period
|
| | | | 3,866,309 | | |
|
Outstanding at the end of the period
|
| | | | 3,866,309 | | |
|
Thereof vested
|
| | | | 2,819,120 | | |
|
Thereof expensed
|
| | | | 3,207,042 | | |
| | |
2019
|
| |||
| | |
EUR k
|
| |||
General and administrative expenses
|
| | | | (12,409) | | |
Total | | | | | (12,409) | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Trade payables
|
| | | | (9,029) | | | | | | (5,331) | | |
License fees payable
|
| | | | (501) | | | | | | (537) | | |
Miscellaneous liabilities
|
| | | | (1,383) | | | | | | (607) | | |
Total | | | | | (10,913) | | | | | | (6,475) | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Accrued bonuses
|
| | | | 1,903 | | | | | | 2,477 | | |
Accrued vacation
|
| | | | 682 | | | | | | 780 | | |
Outstanding invoices
|
| | | | 6,812 | | | | | | 3,478 | | |
Professional fees
|
| | | | 292 | | | | | | 578 | | |
Grants from government agencies and similar bodies
|
| | | | 1,186 | | | | | | 4,148 | | |
Other
|
| | | | 271 | | | | | | 554 | | |
Total | | | | | 11,146 | | | | | | 12,015 | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Loss before tax
|
| | | | (71,131) | | | | | | (100,125) | | |
Expected tax benefit (based on statutory tax rate of 29.13% in 2019 and 2018)
|
| | | | 20,744 | | | | | | 29,162 | | |
Adjustments in respect of current income tax of previous years
|
| | | | 42 | | | | | | — | | |
Effects from differences between Group and local tax rates
|
| | | | 10 | | | | | | 8 | | |
Effects resulting from non-recognition of tax loss carryforwards
|
| | | | (22,428) | | | | | | (22,836) | | |
Effects resulting from non-recognition of DTA/DTL
|
| | | | — | | | | | | — | | |
First-time-recognition of tax loss carryforwards
|
| | | | 430 | | | | | | — | | |
Non-deductible expenses for tax purposes
|
| | | | | | | | | | | | |
− Effects from non-deductible share-based-payments
|
| | | | 1,209 | | | | | | (5,698) | | |
− Effects from (additions/ deductions) for local trade taxes
|
| | | | (65) | | | | | | (191) | | |
− Other non-deductible expenses
|
| | | | (53) | | | | | | (78) | | |
Other effects
|
| | | | — | | | | | | (114) | | |
Effective tax benefit/ (expense)
|
| | | | (110) | | | | | | 252 | | |
Tax loss carryforwards
|
| |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Unused tax losses for corporate income tax
|
| | | | 330,753 | | | | | | 407,434 | | |
Unused tax losses for trade tax
|
| | | | 329,210 | | | | | | 405,123 | | |
2019
|
| |
less than
3 months EURk |
| |
3 to 12 months
EURk |
| |
1 to 5 years
EURk |
| |
> 5 years
EURk |
| |
Total
EURk |
| |||||||||||||||
Convertible loans
|
| | | | — | | | | | | — | | | | | | (83,940) | | | | | | — | | | | | | (83,940) | | |
Lease liabilities (Note 2)
|
| | | | (732) | | | | | | (1,985) | | | | | | (9,192) | | | | | | (5,086) | | | | | | (16,995) | | |
Other liabilities
|
| | | | — | | | | | | (12,015) | | | | | | (362) | | | | | | (167) | | | | | | (12,544) | | |
Trade and other payables
|
| | | | (5,938) | | | | | | (537) | | | | | | — | | | | | | — | | | | | | (6,475) | | |
Total | | | | | (6,670) | | | | | | (14,537) | | | | | | (93,494) | | | | | | (5,253) | | | | | | (119,954) | | |
|
2018
|
| |
less than
3 months EURk |
| |
3 to 12 months
EURk |
| |
1 to 5 years
EURk |
| |
> 5 years
EURk |
| |
Total EURk
|
| |||||||||||||||
Finance lease liabilities
|
| | | | (29) | | | | | | (48) | | | | | | — | | | | | | — | | | | | | (77) | | |
Other liabilities
|
| | | | — | | | | | | (11,146) | | | | | | (688) | | | | | | (175) | | | | | | (12,009) | | |
Trade and other payables
|
| | | | (10,378) | | | | | | (535) | | | | | | — | | | | | | — | | | | | | (10,913) | | |
Total | | | | | (10,407) | | | | | | (11,729) | | | | | | (688) | | | | | | (175) | | | | | | (22,999) | | |
2018
|
| |
less than
3 months EURk |
| |
3 to 12 months
EURk |
| |
1 to 5 years
EURk |
| |
> 5 years
EURk |
| |
Total EURk
|
| |||||||||||||||
Operating lease commitments
|
| | | | — | | | | | | (84) | | | | | | (91) | | | | | | — | | | | | | (175) | | |
Rental agreements
|
| | | | (683) | | | | | | (2,576) | | | | | | (21,160) | | | | | | (23,589) | | | | | | (48,008) | | |
Total | | | | | (683) | | | | | | (2,660) | | | | | | (21,251) | | | | | | (23,589) | | | | | | (48,183) | | |
| | |
2019
(in thousands) |
| |||
Cash and cash equivalents
|
| |
22,608 EUR
|
| |
25,398 USD
|
|
Trade and other receivables
|
| |
9,458 EUR
|
| |
10,585 USD
|
|
Other receivables
|
| |
105 EUR
|
| |
93 GBP
|
|
| | |
84 EUR
|
| |
92 CHF
|
|
| | |
81 EUR
|
| |
91 USD
|
|
Monetary assets in foreign currency
|
| |
32,336 EUR
|
| | | |
Trade and other payables
|
| |
505 EUR
|
| |
567 USD
|
|
| | |
219 EUR
|
| |
186 GBP
|
|
| | |
10 EUR
|
| |
11 CHF
|
|
Monetary liabilities in foreign currency
|
| |
734 EUR
|
| | | |
| | |
2018
(in thousands) |
| |||
Cash and cash equivalents
|
| |
16,941 EUR
|
| |
19,398 USD
|
|
Trade and other receivables
|
| |
2,059 EUR
|
| |
3,374 USD
|
|
Monetary assets in foreign currency
|
| |
19,000 EUR
|
| |
22,772 USD
|
|
Trade and other payables
|
| |
8,002 EUR
|
| |
9,162 USD
|
|
| | |
132 EUR
|
| |
118 GBP
|
|
| | |
46 EUR
|
| |
51 CHF
|
|
Monetary liabilities in Foreign Currency
|
| |
8,180 EUR
|
| | | |
| 2018 (1 EUR= 1.1450 USD) | | | 2019 (1 EUR = 1.1234 USD) | |
| EUR 10,544k from USD 13,090k | | | EUR 30,656k from USD 34,400k | |
in thousands of EUR
|
| |
January 1,
2019 |
| |
Cash
flows |
| |
Reclassification
|
| |
New
leases |
| |
Accrued
interest |
| |
Foreign
Exchange Movements |
| |
December 31,
2019 |
| |||||||||||||||||||||
Convertible loans
|
| | | | — | | | | | | 69,889 | | | | | | (7,604) | | | | | | — | | | | | | 2,733 | | | | | | — | | | | | | 65,018 | | |
Lease liabilities
|
| | | | 15,810 | | | | | | (1,910) | | | | | | — | | | | | | 153 | | | | | | — | | | | | | 77 | | | | | | 14,130 | | |
Total liabilities from financing
activities |
| | | | 15,810 | | | | | | 67,979 | | | | | | (7,604) | | | | | | 153 | | | | | | 2,733 | | | | | | 77 | | | | | | 79,148 | | |
in thousands of EUR
|
| |
January 1,
2018 |
| |
Changes from
financing cash flows |
| |
December 31,
2018 |
| |||||||||
Lease liabilities
|
| | | | 188 | | | | | | (112) | | | | | | 77 | | |
Total liabilities from financing activities
|
| | | | 188 | | | | | | (112) | | | | | | 77 | | |
Remuneration of key management in 2019
|
| |
Management
Board |
| |
Supervisory
Board |
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Short-term benefits
|
| | | | 3,166 | | | | | | 521 | | |
Share-based payments
|
| | | | 18,483 | | | | | | — | | |
Total | | | | | 21,649 | | | | | | 521 | | |
Remuneration of key management in 2018
|
| |
Management
Board |
| |
Supervisory
Board |
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Short-term benefits
|
| | | | 2,195 | | | | | | 343 | | |
Total | | | | | 2,195 | | | | | | 343 | | |
| 23.3 | | | Consent of FALK GmbH & Co KG (included in Exhibit 8.2). | |
| 23.4 | | | Consent of Davis Polk & Wardwell LLP (included in Exhibit 8.3). | |
| 24.1 | | | Powers of attorney. | |
|
Name
|
| |
Title
|
|
|
/s/ Franz-Werner Haas, LLD, LLM
Franz-Werner Haas, LLD, LLM
|
| | Chief Executive Officer | |
|
/s/ Pierre Kemula, B.Sc.
Pierre Kemula, B.Sc.
|
| | Chief Financial Officer | |
|
/s/ Florian von der Mülbe, Ph.D., MBA
Florian von der Mülbe, Ph.D., MBA
|
| | Chief Production Officer | |
|
/s/ Mariola Fotin-Mleczek, Ph.D
Mariola Fotin-Mleczek, Ph.D
|
| | Chief Technology Officer | |
|
/s/ Igor Splawski, Ph.D., MSc
Igor Splawski, Ph.D., MSc
|
| | Chief Scientific Officer | |
|
/s/ Antony Blanc
Antony Blanc
|
| | Chief Business Officer and Chief Commercial Officer | |
|
/s/ Baron Jean Stéphenne, MSc, MBA
Baron Jean Stéphenne, MSc, MBA
|
| | Chairman and Supervisory Director | |
|
/s/ Ralf Clemens, MD, Ph.D.
Ralf Clemens, MD, Ph.D.
|
| | Supervisory Director | |
|
Name
|
| |
Title
|
|
|
/s/ Mathias Hotum, Ph.D.
Mathias Hotum, Ph.D.
|
| | Supervisory Director | |
|
/s/ Hans Christoph Tanner, Ph.D.
Hans Christoph Tanner, Ph.D.
|
| | Supervisory Director | |
|
/s/ Friedrich von Bohlen und Halbach, Ph.D.
Friedrich von Bohlen und Halbach, Ph.D.
|
| | Vice Chairman and Supervisory Director | |
|
/s/ Timothy M. Wright, MD
Timothy M. Wright, MD
|
| | Supervisory Director | |
|
/s/ Craig A. Tooman, MBA
Craig A. Tooman, MBA
|
| | Supervisory Director | |
|
/s/ Viola Bronsema, Ph.D.
Viola Bronsema, Ph.D.
|
| | Supervisory Director | |
Exhibit 1.1
CureVac N.V.
(a Dutch company)
[ • ] Common Shares
UNDERWRITING AGREEMENT
Dated: [ • ], 2020
1 |
CureVac N.V.
(a Dutch company)
[ • ] Common Shares
UNDERWRITING AGREEMENT
[ • ], 2020
BofA Securities, Inc.
Jefferies LLC
as Representatives of the several Underwriters
c/o BofA Securities, Inc.
One Bryant Park
New York, New York 10036
c/o Jefferies LLC
520 Madison Avenue
New York, New York 10022
Ladies and Gentlemen:
CureVac N.V., a Dutch public company with limited liability (naamloze vennootschap) (the “Company”) confirms its agreement with BofA Securities, Inc. (“BofAS”), and Jefferies LLC (“Jefferies”) and each of the other Underwriters named in Schedule A hereto (collectively, the “Underwriters,” which term shall also include any underwriter substituted as hereinafter provided in Section 10 hereof), for whom BofAS and Jefferies are acting as representatives (in such capacity, the “Representatives”), with respect to (i) the sale by the Company and the purchase by the Underwriters, acting severally and not jointly, of the respective numbers of Common Shares, par value €0.12 per share, of the Company (“Common Shares”) set forth in Schedules A and B hereto and (ii) the grant by the Company to the Underwriters, acting severally and not jointly, of the option described in Section 2(b) hereof to purchase all or any part of [ • ] additional Common Shares. The aforesaid [ • ] Common Shares (the “Initial Securities”) to be purchased by the Underwriters and all or any part of the [ • ] Common Shares subject to the option described in Section 2(b) hereof (the “Option Securities”) are herein called, collectively, the “Securities.”
The Company understands that the Underwriters propose to make a public offering of the Securities as soon as the Representatives deem advisable after this Agreement has been executed and delivered.
The Company has filed with the Securities and Exchange Commission (the “Commission”) a registration statement on Form F-1 (No. 333-[ • ]), including the related preliminary prospectus or prospectuses, covering the registration of the sale of the Securities under the Securities Act of 1933, as amended (the “1933 Act”). Promptly after execution and delivery of this Agreement, the Company will prepare and file a prospectus in accordance with the provisions of Rule 430A (“Rule 430A”) of the rules and regulations of the Commission under the 1933 Act (the “1933 Act Regulations”) and Rule 424(b) (“Rule 424(b)”) of the 1933 Act Regulations. The information included in such prospectus that was omitted from such registration statement at the time it became effective but that is deemed to be part of such registration statement at the time it became effective pursuant to Rule 430A(b) is herein called the “Rule 430A Information.” Such registration statement, including the amendments thereto, the exhibits thereto and any schedules thereto, at the time it became effective, and including the Rule 430A Information, is herein called the “Registration Statement.” Any registration statement filed pursuant to Rule 462(b) of the 1933 Act Regulations is herein called the “Rule 462(b) Registration Statement” and, after such filing, the term “Registration Statement” shall include the Rule 462(b) Registration Statement. Each prospectus used prior to the effectiveness of the Registration Statement, and each prospectus that omitted the Rule 430A Information that was used after such effectiveness and prior to the execution and delivery of this Agreement, is herein called a “preliminary prospectus.” The final prospectus, in the form first furnished to the Underwriters for use in connection with the offering of the Securities, is herein called the “Prospectus.” For purposes of this Agreement, all references to the Registration Statement, any preliminary prospectus, the Prospectus or any amendment or supplement to any of the foregoing shall be deemed to include the copy filed with the Commission pursuant to its Electronic Data Gathering, Analysis and Retrieval system or any successor system (“EDGAR”).
As used in this Agreement:
“Applicable Time” means [ • ] P.M., New York City time, on January [ • ], 2021 or such other time as agreed by the Company and the Representatives.
“General Disclosure Package” means any Issuer General Use Free Writing Prospectuses issued at or prior to the Applicable Time, the most recent preliminary prospectus that is distributed to investors prior to the Applicable Time and the information included on Schedule B-1 hereto, all considered together.
“Issuer Free Writing Prospectus” means any “issuer free writing prospectus,” as defined in Rule 433 of the 1933 Act Regulations (“Rule 433”), including without limitation any “free writing prospectus” (as defined in Rule 405 of the 1933 Act Regulations (“Rule 405”)) relating to the Securities that is (i) required to be filed with the Commission by the Company, (ii) a “road show that is a written communication” within the meaning of Rule 433(d)(8)(i), whether or not required to be filed with the Commission, or (iii) exempt from filing with the Commission pursuant to Rule 433(d)(5)(i) because it contains a description of the Securities or of the offering that does not reflect the final terms, in each case in the form filed or required to be filed with the Commission or, if not required to be filed, in the form retained in the Company’s records pursuant to Rule 433(g).
“Issuer General Use Free Writing Prospectus” means any Issuer Free Writing Prospectus that is intended for general distribution to prospective investors (other than a “bona fide electronic road show,” as defined in Rule 433 (the “Bona Fide Electronic Road Show”)), as evidenced by its being specified in Schedule B-2 hereto.
“Issuer Limited Use Free Writing Prospectus” means any Issuer Free Writing Prospectus that is not an Issuer General Use Free Writing Prospectus.
“Testing-the-Waters Communication” means any oral or written communication with potential investors undertaken in reliance on Section 5(d) of the 1933 Act.
“Written Testing-the-Waters Communication” means any Testing-the-Waters Communication that is a written communication within the meaning of Rule 405 under the 1933 Act.
2 |
SECTION 1. Representations and Warranties.
(a) Representations and Warranties by the Company. The Company represents and warrants to each Underwriter as of the date hereof, the Applicable Time, the Closing Time (as defined below) and any Date of Delivery (as defined below), and agrees with each Underwriter, as follows:
(i) Registration Statement and Prospectuses. Each of the Registration Statement and any amendment thereto has become effective under the 1933 Act. No stop order suspending the effectiveness of the Registration Statement or any post-effective amendment thereto has been issued under the 1933 Act, no order preventing or suspending the use of any preliminary prospectus or the Prospectus has been issued and no proceedings for any of those purposes have been instituted or are pending or, to the Company’s knowledge, contemplated. The Company has complied with each request (if any) from the Commission for additional information.
Each of the Registration Statement and any post-effective amendment thereto, at the time it became effective, complied in all material respects with the requirements of the 1933 Act and the 1933 Act Regulations. Each preliminary prospectus, the Prospectus and any amendment or supplement thereto, at the time each was filed with the Commission, complied in all material respects with the requirements of the 1933 Act and the 1933 Act Regulations. Each preliminary prospectus delivered to the Underwriters for use in connection with this offering and the Prospectus was or will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T.
(ii) Accurate Disclosure. Neither the Registration Statement nor any amendment thereto, at its effective time, at the Closing Time or at any Date of Delivery, contained, contains or will contain an untrue statement of a material fact or omitted, omits or will omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading. At the Applicable Time, none of (A) the General Disclosure Package, (B) any individual Issuer Limited Use Free Writing Prospectus, when considered together with the General Disclosure Package and (C) any individual Written Testing-the-Waters Communication, when considered together with the General Disclosure Package, included, includes or will include an untrue statement of a material fact or omitted, omits or will omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. Neither the Prospectus nor any amendment or supplement thereto, as of its issue date, at the time of any filing with the Commission pursuant to Rule 424(b), at the Closing Time or at any Date of Delivery, included, includes or will include an untrue statement of a material fact or omitted, omits or will omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading.
The representations and warranties in this subsection shall not apply to statements in or omissions from the Registration Statement (or any amendment thereto), the General Disclosure Package or the Prospectus (or any amendment or supplement thereto) made in reliance upon and in conformity with written information furnished to the Company by any Underwriter through the Representatives expressly for use therein. For purposes of this Agreement, the only information so furnished shall be the information in the first paragraph under the heading “Underwriting—Commissions and Discounts,” the information in the fourth paragraph under the heading “Underwriting—Nasdaq Global Select Market Listing,” the information in the second, third and fourth paragraphs under the heading “Underwriting—Price Stabilization, Short Positions and Penalty Bids” and the information under the heading “Underwriting—Electronic Offer, Sale and Distribution of Shares” in each case contained in the Prospectus (collectively, the “Underwriter Information”).
3 |
(iii) Issuer Free Writing Prospectuses. No Issuer Free Writing Prospectus conflicts or will conflict with the information contained in the Registration Statement or the Prospectus, and any preliminary or other prospectus deemed to be a part thereof that has not been superseded or modified.
(iv) Testing-the-Waters Materials. The Company (A) has not engaged in any Testing-the-Waters Communication other than Testing-the-Waters Communications with the consent of the Representatives with entities that are qualified institutional buyers within the meaning of Rule 144A under the 1933 Act or institutions that are accredited investors within the meaning of Rule 501 under the 1933 Act and (B) has not authorized anyone other than the Representatives to engage in Testing-the-Waters Communications. The Company reconfirms that the Representatives have been authorized to act on its behalf in undertaking Testing-the-Waters Communications. The Company has not distributed any Written Testing-the-Waters Communications other than those listed on Schedule D hereto.
(v) Company Not Ineligible Issuer. At the time of filing the Registration Statement and any post-effective amendment thereto, at the earliest time thereafter that the Company or another offering participant made a bona fide offer (within the meaning of Rule 164(h)(2) of the 1933 Act Regulations) of the Securities and at the date hereof, the Company was not and is not an “ineligible issuer,” as defined in Rule 405, without taking account of any determination by the Commission pursuant to Rule 405 that it is not necessary that the Company be considered an ineligible issuer.
(vi) Emerging Growth Company Status. From the time of the initial confidential submission of the Registration Statement to the Commission (or, if earlier, the first date on which the Company engaged directly or through any Person authorized to act on its behalf in any Testing-the-Waters Communication) through the date hereof, the Company has been and is an “emerging growth company,” as defined in Section 2(a) of the 1933 Act (an “Emerging Growth Company”).
(vii) Independent Accountants. The accountants who certified the financial statements and supporting schedules included in the Registration Statement, the General Disclosure Package and the Prospectus are independent public accountants as required by the 1933 Act, the 1933 Act Regulations, the Securities Exchange Act of 1934, as amended (the “1934 Act”), the Commission’s rules and regulations under the 1934 Act (the “1934 Act Regulations”) and the Public Company Accounting Oversight Board.
(viii) Financial Statements. The financial statements included in the Registration Statement, the General Disclosure Package and the Prospectus, together with the related schedules and notes, present fairly, in all material respects, the financial position of each of the Company and its consolidated subsidiaries at the dates indicated and the statement of operations, stockholders’ equity and cash flows of the Company and its consolidated subsidiaries for the periods specified; said financial statements have been prepared in conformity with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board applied on a consistent basis throughout the periods involved. The supporting schedules, if any, present fairly in accordance with IFRS the information required to be stated therein in all material respects. The selected financial data and the summary financial information included in the Registration Statement, the General Disclosure Package and the Prospectus present fairly in all material respects the information shown therein and have been compiled on a basis consistent with that of the audited financial statements included therein. Except as included therein, no historical or pro forma financial statements or supporting schedules are required to be included or incorporated by reference in the Registration Statement, the General Disclosure Package or the Prospectus under the 1933 Act, the 1933 Act Regulations, the 1934 Act or the 1934 Act Regulations.
4 |
(ix) No Material Adverse Change in Business. Except as otherwise stated therein, since the respective dates as of which information is given in the Registration Statement, the General Disclosure Package or the Prospectus, (A) there has been no material adverse change in the condition, financial or otherwise, or in the earnings, business affairs or business prospects of the Company and its subsidiaries considered as one enterprise, whether or not arising in the ordinary course of business (a “Material Adverse Effect”), (B) there have been no transactions entered into by the Company or any of its subsidiaries, other than those in the ordinary course of business, which are material with respect to the Company and its subsidiaries considered as one enterprise, and (C) except for regular dividends on the Common Shares in amounts per share that are consistent with past practice, there has been no dividend or distribution of any kind declared, paid or made by the Company on any class of its capital stock.
(x) Good Standing of the Company. The Company has been duly incorporated or otherwise organized and is validly existing as a corporation in good standing (where such concept exists) under the laws of the jurisdiction of its organization and has corporate power and authority to own, lease and operate its properties and to conduct its business as described in the Registration Statement, the General Disclosure Package and the Prospectus and to enter into and perform its obligations under this Agreement; and the Company is duly qualified as a foreign corporation to transact business and is in good standing in each other jurisdiction in which such qualification is required, whether by reason of the ownership or leasing of property or the conduct of business, except where the failure to so qualify or to be in good standing would not result in a Material Adverse Effect.
(xi) Good Standing of Subsidiaries. Each of the Company’s subsidiaries (each, a “Subsidiary” and, collectively, the “Subsidiaries”) has been duly incorporated or otherwise organized and is validly existing in good standing (where such concept exists) under the laws of the jurisdiction of its incorporation or organization, has corporate or similar power and authority to own, lease and operate its properties and to conduct its business as described in the Registration Statement, the General Disclosure Package and the Prospectus and is duly qualified to transact business and is in good standing in each jurisdiction in which such qualification is required, whether by reason of the ownership or leasing of property or the conduct of business, except where the failure to so qualify, to have such power or authority or to be in good standing would not result in a Material Adverse Effect. Except as otherwise disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, all of the issued and outstanding capital stock of each Subsidiary has been duly authorized and validly issued, is fully paid and non-assessable and is owned by the Company, directly or through subsidiaries, free and clear of any security interest, mortgage, pledge, lien, encumbrance, claim or equity. None of the outstanding shares of capital stock of any Subsidiary were issued in violation of the preemptive or similar rights of any security holder of such Subsidiary. The only Subsidiaries of the Company are (A) the Subsidiaries listed on Exhibit 21.1 to the Registration Statement and (B) certain other Subsidiaries which, considered in the aggregate as a single Subsidiary, do not constitute a “significant subsidiary” as defined in Rule 1-02 of Regulation S-X.
(xii) Capitalization. The authorized, issued and outstanding shares of capital stock of the Company is as set forth in the Registration Statement, the General Disclosure Package and the Prospectus in the column entitled “Actual” under the caption “Capitalization” (except for subsequent issuances, if any, pursuant to this Agreement, pursuant to reservations, agreements or employee benefit plans referred to in the Registration Statement, the General Disclosure Package and the Prospectus or pursuant to the exercise of convertible securities or options referred to in the Registration Statement, the General Disclosure Package and the Prospectus). There are no authorized or outstanding phantom equity, rights to receive shares, options, conversion rights, warrants, preemptive rights, rights of first refusal or other rights to purchase, or equity or debt securities convertible into or exchangeable or exercisable for or that can be settled in, any share capital of the Company or any of its subsidiaries other than those described in the Registration Statement, the General Disclosure Package and the Prospectus. The issued shares of capital stock of the Company have been duly authorized and validly issued and are fully paid and non-assessable. None of the issued shares of capital stock of the Company were issued in violation of the preemptive or other similar rights of any security holder of the Company.
5 |
(xiii) Authorization of Agreement. This Agreement has been duly authorized, executed and delivered by the Company.
(xiv) Authorization and Description of Securities. The Securities to be purchased by the Underwriters from the Company have been duly authorized for issuance and sale to the Underwriters pursuant to this Agreement and, when issued and delivered by the Company pursuant to this Agreement against payment of the consideration set forth herein, will be validly issued and fully paid and non-assessable; and the issuance of the Securities is not subject to the preemptive or other similar rights of any security holder of the Company, except as have been duly and validly waived. The Securities conform in all material respects to all statements relating thereto contained in the Registration Statement, the General Disclosure Package and the Prospectus and such description conforms in all material respects to the rights set forth in the instruments defining the same. No holder of Securities will be subject to personal liability by reason of being such a holder.
(xv) Registration Rights. There are no persons with registration rights or other similar rights to have any securities registered for sale pursuant to the Registration Statement or otherwise registered for sale or sold by the Company under the 1933 Act pursuant to this Agreement, other than those rights that have been disclosed in the Registration Statement, the General Disclosure Package and the Prospectus or that have been waived.
(xvi) Absence of Violations, Defaults and Conflicts. Neither the Company nor any of its subsidiaries is (A) in violation of its articles of association or similar organizational document, (B) in default in the performance or observance of any obligation, agreement, covenant or condition contained in any contract, indenture, mortgage, deed of trust, loan or credit agreement, note, lease or other agreement or instrument to which the Company or any of its subsidiaries is a party or by which it or any of them may be bound or to which any of the properties or assets of the Company or any subsidiary is subject (collectively, “Agreements and Instruments”), except for such defaults that would not, singly or in the aggregate, result in a Material Adverse Effect, or (C) in violation of any law, statute, rule, regulation, judgment, order, writ or decree of any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency having jurisdiction over the Company or any of its subsidiaries or any of their respective properties, assets or operations (each, a “Governmental Entity”), except for such violations that would not, singly or in the aggregate, result in a Material Adverse Effect. The execution, delivery and performance of this Agreement and the consummation of the transactions contemplated herein and in the Registration Statement, the General Disclosure Package and the Prospectus (including the issuance and sale of the Securities and the use of the proceeds from the sale of the Securities as described therein under the caption “Use of Proceeds”) and compliance by the Company with its obligations hereunder have been duly authorized by all necessary corporate action and do not and will not, whether with or without the giving of notice or passage of time or both, conflict with or constitute a breach of, or default or Repayment Event (as defined below) under, or result in the creation or imposition of any lien, charge or encumbrance upon any properties or assets of the Company or any subsidiary pursuant to, the Agreements and Instruments (except for such conflicts, breaches, defaults or Repayment Events or liens, charges or encumbrances that would not, singly or in the aggregate, result in a Material Adverse Effect), nor will such action result in any violation of (i) the provisions of the articles of association or similar organizational document of the Company or any of its subsidiaries or (ii) any law, statute, rule, regulation, judgment, order, writ or decree of any Governmental Entity, except in the case of clause (ii) for any violation that would not, singly or in the aggregate, result in a Material Adverse Effect. As used herein, a “Repayment Event” means any event or condition which gives the holder of any note, debenture or other evidence of indebtedness (or any person acting on such holder’s behalf) the right to require the repurchase, redemption or repayment of all or a portion of such indebtedness by the Company or any of its subsidiaries.
6 |
(xvii) Absence of Labor Dispute. Other than that which would not result in a Material Adverse Effect, (i) no labor dispute with the employees of the Company or any of its subsidiaries exists or, to the knowledge of the Company, is imminent, and (ii) the Company is not aware of any existing or imminent labor dispute with the employees of any of its or any subsidiary’s principal suppliers, manufacturers, customers or contractors.
(xviii) Absence of Proceedings. Except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, to the knowledge of the Company, there is no action, suit, proceeding, inquiry or investigation before or brought by any Governmental Entity now pending or, to the knowledge of the Company, threatened, against the Company or any of its subsidiaries, which would reasonably be expected to result in a Material Adverse Effect, or which would reasonably be expected to materially and adversely affect their respective properties or assets or the consummation of the transactions contemplated in this Agreement or the performance by the Company of its obligations hereunder; and the aggregate of all pending legal or governmental proceedings to which the Company or any such subsidiary is a party or of which any of their respective properties or assets is the subject which are not described in the Registration Statement, the General Disclosure Package and the Prospectus, including ordinary routine litigation incidental to the business, would not reasonably be expected to result in a Material Adverse Effect.
(xix) Accuracy of Exhibits. There are no contracts or documents which are required to be described in the Registration Statement, the General Disclosure Package or the Prospectus or to be filed as exhibits to the Registration Statement which have not been so described and filed as required.
(xx) Absence of Further Requirements. No filing with, or authorization, approval, consent, license, order, registration, qualification or decree of, any Governmental Entity is necessary or required for the performance by the Company of its obligations hereunder, in connection with the offering, issuance or sale of the Securities hereunder or the consummation of the transactions contemplated by this Agreement, except such as have been already obtained or as may be required under the 1933 Act, the 1933 Act Regulations, the rules of The Nasdaq Global Select Market, state securities laws or the rules of Financial Industry Regulatory Authority, Inc. (“FINRA”).
(xxi) Possession of Licenses and Permits. The Company and its subsidiaries possess such permits, licenses, approvals, consents and other authorizations (collectively, “Governmental Licenses”) issued by the appropriate Governmental Entities necessary to conduct the business now operated by them, except where the failure so to possess would not, singly or in the aggregate, result in a Material Adverse Effect. The Company and its subsidiaries are in compliance with the terms and conditions of all Governmental Licenses, except where the failure so to comply would not, singly or in the aggregate, result in a Material Adverse Effect. All of the Governmental Licenses are valid and in full force and effect, except when the invalidity of such Governmental Licenses or the failure of such Governmental Licenses to be in full force and effect would not, singly or in the aggregate, result in a Material Adverse Effect. Neither the Company nor any of its subsidiaries has received any notice of proceedings relating to the revocation or modification of any Governmental Licenses which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would result in a Material Adverse Effect.
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(xxii) Title to Property. The Company and its subsidiaries have good and marketable title to all real property owned by them and good title to all other properties owned by them, in each case, free and clear of all mortgages, pledges, liens, security interests, claims, restrictions or encumbrances of any kind except such as (A) are described in the Registration Statement, the General Disclosure Package and the Prospectus or (B) do not, singly or in the aggregate, materially affect the value of such property and do not interfere with the use made and proposed to be made of such property by the Company or any of its subsidiaries; and all of the leases and subleases material to the business of the Company and its subsidiaries, considered as one enterprise, and under which the Company or any of its subsidiaries holds properties described in the Registration Statement, the General Disclosure Package or the Prospectus, are in full force and effect, and neither the Company nor any such subsidiary has any notice of any material claim of any sort that has been asserted by anyone (A) adverse to the rights of the Company or any subsidiary under any of the leases or subleases mentioned above, or (B) affecting or questioning the rights of the Company or such subsidiary to the continued possession of the leased or subleased premises under any such lease or sublease.
(xxiii) Possession of Intellectual Property. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus or where it would not, singly or in the aggregate, result in a Material Adverse Effect, (A) the Company and its subsidiaries own, possess or have the right to use, or can acquire the right to use on reasonable terms, all patents, licenses, inventions, copyrights, know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information, systems or procedures), trademarks, service marks, trade names or other intellectual property (collectively, “Intellectual Property”) necessary to carry on the business now operated by them and as currently proposed to be conducted as described in the Registration Statement, the General Disclosure Package or the Prospectus, (B) to the knowledge of the Company, all Intellectual Property owned by or exclusively licensed to the Company or its subsidiaries (such Intellectual Property, the “Company Intellectual Property”) has been duly and properly filed and maintained, is free and clear of liens or security interests, and is in full force and effect, valid, subsisting and enforceable, (C) there is no pending or, to the knowledge of the Company, threatened action, suit, proceeding or claim by any third party challenging the validity, ownership, registrability, enforceability or scope of any Company Intellectual Property and the Company is unaware of any facts which would form a reasonable basis for any such claim, (D) no third party, to the knowledge of the Company, is infringing, misappropriating or otherwise violating any Company Intellectual Property and there is no pending or threatened action, suit, proceeding or claim by the Company or any of its subsidiaries against a third party regarding the foregoing, (E) (1) neither the Company nor any of its subsidiaries has received any written notice of nor, to the knowledge of the Company, has engaged in, any infringement, misappropriation or other violation of any Intellectual Property of any third party, (2) there is no pending or, to the knowledge of the Company, threatened action, suit, proceeding or claim regarding the subject matter of the foregoing, and (3) the Company and its subsidiaries are unaware of any facts which would form a reasonable basis for any such claim, (F) to the knowledge of the Company, the parties prosecuting patent applications within the Company Intellectual Property have complied with their duty of candor and disclosure to the USPTO or foreign patent offices, as applicable, in connection with such applications and the Company is not aware of any facts required to be disclosed to the USPTO or foreign patent offices that were not disclosed and which would preclude the grant of a patent in connection with any such patent application or could form the basis of a finding of invalidity or unenforceability with respect to any patents that have issued with respect to such patent applications, (G) each person who is or was an employee or contractor of the Company or any of its subsidiaries and who is or was involved in the creation or development of any Company Intellectual Property for or on behalf of the Company has executed a valid agreement containing an assignment or exclusive license to the Company or any of its subsidiaries of such person’s rights in and to such Company Intellectual Property, (H) the Company has taken reasonable steps in accordance with standard industry practice to maintain and protect the confidentiality of the trade secrets and other confidential Intellectual Property used in connection with the business of the Company and its subsidiaries and, to the knowledge of the Company, such confidential Intellectual Property has not been compromised or disclosed to or accessed by any third party except pursuant to nondisclosure and confidentiality agreements.
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(xxiv) Environmental Laws. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus or where it would not, singly or in the aggregate, result in a Material Adverse Effect, (A) neither the Company nor any of its subsidiaries is in violation of any federal, state, local or foreign statute, law, rule, regulation, ordinance, code, legally binding policy or rule of common law or any judicial or administrative interpretation thereof, including any judicial or administrative order, consent, decree or judgment, relating to pollution or protection of worker health and safety, the environment (including, without limitation, ambient air, surface water, groundwater, land surface or subsurface strata) or wildlife, including, without limitation, laws and regulations relating to the release or threatened release of chemicals, pollutants, contaminants, wastes, toxic substances, hazardous substances, petroleum or petroleum products, asbestos-containing materials or mold, but excluding the Company’s or any of its subsidiaries’ products (collectively, “Hazardous Materials”) or to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Hazardous Materials (collectively, “Environmental Laws”), (B) the Company and its subsidiaries have all permits, authorizations and approvals required under any applicable Environmental Laws and are each in compliance with their requirements, (C) there are no pending or threatened administrative, regulatory or judicial actions, suits, demands, demand letters, claims, liens, notices of noncompliance or violation, investigations or proceedings relating to any Environmental Law against the Company or any of its subsidiaries and (D) to the Company’s knowledge, there are no events or circumstances that would reasonably be expected to form the basis of an order for clean-up or remediation, or an action, suit or proceeding by any private party or Governmental Entity, against the Company or any of its subsidiaries relating to Hazardous Materials or any Environmental Laws.
(xxv) Accounting Controls and Disclosure Controls. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company and each of its subsidiaries maintain a system of internal control over financial reporting (as defined under Rule 13-a15 and 15d-15 under the 1934 Act Regulations) and a system of internal accounting controls designed to provide reasonable assurances that (A) transactions are executed in accordance with management’s general or specific authorization; (B) transactions are recorded as necessary to permit preparation of financial statements in conformity with IFRS and to maintain accountability for assets; (C) access to assets is permitted only in accordance with management’s general or specific authorization; and (D) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, since the end of the Company’s most recent audited fiscal year, there has been (1) no material weakness in the Company’s internal control over financial reporting (whether or not remediated) and (2) no change in the Company’s internal control over financial reporting that has materially and adversely affected, or is reasonably likely to materially and adversely affect, the Company’s internal control over financial reporting. The Company and each of its subsidiaries maintain an effective system of disclosure controls and procedures (as defined in Rule 13a-15 and Rule 15d-15 under the 1934 Act Regulations) that are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the 1934 Act is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules and forms, and is accumulated and communicated to the Company’s management, including its principal executive officer or officers and principal financial officer or officers, as appropriate, to allow timely decisions regarding disclosure.
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(xxvi) Compliance with the Sarbanes-Oxley Act. There is and has been no failure on the part of the Company or any of the Company’s directors or officers, in their capacities as such, to comply in all material respects with any provision of the Sarbanes-Oxley Act of 2002 and the rules and regulations promulgated in connection therewith (the “Sarbanes-Oxley Act”), including Section 402 related to loans and Section 302 and 906 related to certifications.
(xxvii) Payment of Taxes. All United States federal income tax returns of the Company and its subsidiaries required by law to be filed have been filed and all taxes shown by such returns or otherwise assessed, which are due and payable, have been paid, except assessments against which appeals have been or will be promptly taken and as to which adequate reserves have been provided in accordance with GAAP. The United States federal income tax returns of the Company through the fiscal year ended December 31, 2019 have been settled and no assessment in connection therewith has been made against the Company. The Company and its subsidiaries have filed all other tax returns that are required to have been filed by them pursuant to applicable foreign, state, local or other law except insofar as the failure to file such returns would not result in a Material Adverse Effect, and has paid all material taxes due pursuant to such returns or pursuant to any assessment received by the Company and its subsidiaries, except for such taxes, if any, as are being contested in good faith and as to which adequate reserves have been established by the Company in accordance with IFRS. The charges, accruals and reserves on the books of the Company in respect of any income and corporation tax liability for any years not finally determined are adequate to meet any assessments or re-assessments for additional income tax for any years not finally determined, except to the extent of any inadequacy that would not result in a Material Adverse Effect.
(xxviii) Transfer Taxes. No stamp duty, stamp duty reserve, registration, issuance, transfer taxes or other similar documentary taxes, duties, fees or charges (“Transfer Taxes”) are payable or required to be paid by or on behalf of the Underwriters in the Netherlands or any political subdivision, authority or agency thereof or therein having power to tax in connection with (i) the execution, delivery and performance of this Agreement, (ii) the issuance and delivery of the Securities in the manner contemplated by this Agreement and the Prospectus, or (iii) the sale and delivery by the Underwriters of the Securities as contemplated herein and in the Prospectus.
(xxix) PFIC Status. Based on the current and anticipated value of its assets and the nature and composition of its income and assets, and subject to the qualifications set forth in the Registration Statement, the General Disclosure Package and the Prospectus, the Company does not believe it was a “passive foreign investment company” within the meaning of Section 1297 of the Code for the taxable year ending December 31, 2019.
(xxx) Insurance. The Company and its subsidiaries carry or are entitled to the benefits of insurance, with reputable insurers, in such amounts and covering such risks as is generally maintained by companies of established repute and of comparable size engaged in the same or similar business, and all such insurance considered to be material for operating the Company’s and its subsidiaries’ businesses is in full force and effect. The Company has no reason to believe that it or any of its subsidiaries will not be able (A) to renew its existing insurance coverage as and when such policies expire or (B) to obtain comparable coverage from similar institutions as may be necessary or appropriate to conduct its business as now conducted and at a cost that, in each case, would not reasonably be expected to result in a Material Adverse Effect. Neither of the Company nor any of its subsidiaries has been denied any material insurance coverage which it has sought or for which it has applied.
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(xxxi) Investment Company Act. The Company is not required, and upon the issuance and sale of the Securities as herein contemplated and the application of the net proceeds therefrom as described in the Registration Statement, the General Disclosure Package and the Prospectus will not be required, to register as an “investment company” under the Investment Company Act of 1940, as amended (the “1940 Act”).
(xxxii) Absence of Manipulation. Neither the Company nor, to the Company’s knowledge, any affiliate of the Company has taken, nor will the Company or any affiliate controlled by the Company take, directly or indirectly, any action which is designed, or would reasonably be expected, to cause or result in, or which constitutes, the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Securities or to result in a violation of Regulation M under the 1934 Act.
(xxxiii) No Rights of Immunity. Except as provided by laws or statutes generally applicable to transactions of the type described in this Agreement, neither the Company nor any of its respective properties, assets or revenues has any right of immunity under the laws of the Netherlands, New York or United States law, from any legal action, suit or proceeding, from the giving of any relief in any such legal action, suit or proceeding, from set-off or counterclaim, from the jurisdiction of any Dutch, New York or United States federal court, from service of process, attachment upon or prior judgment, or attachment in aid of execution of judgment, or from execution of a judgment, or other legal process or proceeding for the giving of any relief or for the enforcement of a judgment, in any such court, with respect to its obligations, liabilities or any other matter under or arising out of or in connection with this Agreement. To the extent that the Company or any of its respective properties, assets or revenues may have or may hereafter become entitled to any such right of immunity in any such court in which proceedings may at any time be commenced, the Company waives or will waive such right to the extent permitted by law and has consented to such relief and enforcement as provided in Section 18 of this Agreement.
(xxxiv) Foreign Corrupt Practices Act. None of the Company, any of its subsidiaries or, to the knowledge of the Company, any director, officer, agent, employee, affiliate or other person acting on behalf of the Company or any of its subsidiaries is aware of or has taken any action, directly or indirectly, that would result in a violation by such persons of the Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder (the “FCPA”), including, without limitation, making use of the mails or any means or instrumentality of interstate commerce corruptly in furtherance of an offer, payment, promise to pay or authorization of the payment of any money, or other property, gift, promise to give, or authorization of the giving of anything of value to any “foreign official” (as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign political office, in contravention of the FCPA and the Company and, to the knowledge of the Company, its affiliates have conducted their businesses in compliance with the FCPA and have instituted and maintain policies and procedures designed to ensure, and which are reasonably expected to continue to ensure, continued compliance therewith.
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(xxxv) Money Laundering Laws. The operations of the Company and its subsidiaries are and have been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money laundering statutes of all jurisdictions, the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any Governmental Entity (collectively, the “Money Laundering Laws”); and no action, suit or proceeding by or before any Governmental Entity involving the Company or any of its subsidiaries with respect to the Money Laundering Laws is pending or, to the knowledge of the Company, threatened.
(xxxvi) OFAC. None of the Company, any of its subsidiaries or, to the knowledge of the Company, any director, officer, agent, employee, affiliate or representative of the Company or any of its subsidiaries is an individual or entity (“Person”) currently the subject or target of any officially released sanctions administered or enforced by the United States Government, including, without limitation, the U.S. Department of the Treasury’s Office of Foreign Assets Control (“OFAC”), the United Nations Security Council (“UNSC”), the European Union, Her Majesty’s Treasury (“HMT”), the Swiss Secretariat of Economic Affairs, or other relevant sanctions authority (collectively, “Sanctions”), nor is the Company located, organized or resident in a country or territory that is the subject of Sanctions; and the Company will not directly or indirectly use the proceeds of the sale of the Securities, or lend, contribute or otherwise make available such proceeds to any subsidiaries, joint venture partners or other Person, to fund any activities of or business with any Person, or in any country or territory, that, at the time of such funding, is the subject of Sanctions or in any other manner that will result in a violation by any Person (including any Person participating in the transaction, whether as underwriter, advisor, investor or otherwise) of Sanctions.
(xxxvii) Lending Relationship. Except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company (i) does not have any material lending or other relationship with any bank or lending affiliate of any Underwriter and (ii) does not intend to use any of the proceeds from the sale of the Securities to repay any outstanding debt owed to any affiliate of any Underwriter.
(xxxviii) Statistical and Market-Related Data. Any statistical and market-related data included in the Registration Statement, the General Disclosure Package or the Prospectus are based on or derived from sources that the Company believes, after reasonable inquiry, to be reliable and accurate and, to the extent required, the Company has obtained the written consent to the use of such data from such sources.
(xxxix) Cybersecurity. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus or where it would not, singly or in the aggregate, result in a Material Adverse Effect, (A) to the knowledge of the Company, there has been no security breach or incident, unauthorized access or disclosure, or other compromise of or relating to the Company’s or its subsidiaries’ information technology and computer systems, networks, hardware, software, confidential data and databases (including the confidential data and information of their respective customers, employees, suppliers, vendors and any third-party confidential data maintained, processed or stored by the Company and its subsidiaries, and any such data processed or stored by third parties on behalf of the Company and its subsidiaries), equipment or technology (collectively, “IT Systems and Data”), (B) neither the Company nor its subsidiaries have been notified in writing, or have any knowledge, of any event or condition that is reasonably likely to result in any security breach or incident, unauthorized access or disclosure or other compromise to their IT Systems and Data, (C) the Company and its subsidiaries have implemented commercially reasonable controls, policies, procedures, and technological safeguards to maintain and protect the integrity, continuous operation, redundancy and security of their IT Systems and Data reasonably consistent with industry standards and practices, or as required by applicable regulatory standards and (D) to the knowledge of the Company, the Company and its subsidiaries are presently in compliance with all applicable laws or statutes and all applicable material judgments, orders, rules and regulations of any court, arbitrator or governmental or regulatory authority and contractual obligations relating to the privacy and security of their IT Systems and Data and to the protection of such IT Systems and Data from unauthorized use, access, misappropriation or modification.
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(xl) Regulatory Compliance. Except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, each of the Company and its subsidiaries: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of the Health Care Laws (as defined below) of the Food and Drug Administration (“FDA”), the Department of Health and Human Services (“HHS”) and any comparable foreign or other regulatory authority to which they are subject (collectively, the “Applicable Regulatory Authorities”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company’s or its subsidiaries’ product candidates or any product manufactured or distributed by the Company and its subsidiaries; (ii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted, except where the failure to possess the same would not, individually or in the aggregate, have a Material Adverse Effect, and such Regulatory Authorizations are valid and in full force and effect and neither the Company nor any of its subsidiaries are in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) has not received written notice of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action from the Applicable Regulatory Authorities or any other third party alleging that any product of the Company is in material violation of any Health Care Laws or Regulatory Authorizations and has no knowledge that the Applicable Regulatory Authorities or any other third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has not received written notice that any of the Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Regulatory Authorizations and has no knowledge that any of the Applicable Regulatory Authorities is considering such action; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Regulatory Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (vii) is not a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Applicable Regulatory Authority; and (viii) along with its employees, officers and directors has not been excluded, suspended or debarred from participation in any government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension or exclusion. The term “Health Care Laws” means Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act, 42 U.S.C. 1320a-7b(a); any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1001, 1035, 1347 and 1349, and the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. §§ 1320d et seq., (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h; the Exclusion Laws, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, 42 U.S.C. §§ 17921 et seq.; the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; each as amended, and the regulations promulgated pursuant to such laws; and any similar foreign, federal, state and local laws and regulations.
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(xli) Manufacturing and Suppliers. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in with all applicable statutes, rules, regulations and policies of the Applicable Regulatory Authorities, including, without limitation, the Health Care Laws, except for such non-compliance that would not, singly or in the aggregate reasonably be expected to result in a Material Adverse Effect.
(xlii) Studies, Tests and Trials. None of the Company’s product candidates have received marketing approval or licensure from any Applicable Regulatory Authority. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, all clinical and pre-clinical studies and trials conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has participated, with respect to the Company’s product candidates, including any such studies and trials that are described in the Registration Statement, General Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement, General Disclosure Package and the Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending are, to the Company's knowledge, being conducted in all material respects in accordance with the Health Care Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices, and with standard medical and scientific research procedures and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions in the Registration Statement, General Disclosure Package and the Prospectus of the results of any Company Trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; the Company has no knowledge of any other studies or trials not described in the Registration Statement, General Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, General Disclosure Package and the Prospectus; the Company and each of its subsidiaries have not received, any written notices, correspondence or other communications from the Applicable Regulatory Authorities or any other governmental entity requiring or threatening the termination, material modification or suspension of Company Trials that are described in the Registration Statement, the General Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. No investigational new drug application or comparable submission filed by or on behalf of the Company or any of its subsidiaries has been terminated or suspended by the FDA or any other Applicable Regulatory Authority. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in a Company Trial. In using or disclosing patient information received by the Company or any of its subsidiaries in connection with a Company Trial, the Company or such subsidiary has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, HIPAA and the rules and regulations thereunder. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct.
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(xliii) Maintenance of Rating. At the date of this Agreement, neither the Company nor its subsidiaries have any debt securities or preferred shares that are rated by any “nationally recognized statistical rating agency” (as defined in Section 3(a)(62) of the 1934 Act).
(xliv) Dividend Restrictions. Other than as prohibited or restricted by law, no subsidiary of the Company is prohibited or restricted, directly or indirectly, from paying dividends to the Company, or from making any other distribution with respect to such subsidiary’s equity securities or from repaying to the Company or any other subsidiary of the Company any amounts that may from time to time become due under any loans or advances to such subsidiary from the Company or from transferring any property or assets to the Company or to any other subsidiary.
(b) Officer’s Certificates. Any certificate signed by any officer of the Company or any of its subsidiaries delivered to the Representatives or to counsel for the Underwriters shall be deemed a representation and warranty by the Company to each Underwriter as to the matters covered thereby.
SECTION 2. Sale and Delivery to Underwriters; Closing.
(a) Initial Securities. On the basis of the representations and warranties herein contained and subject to the terms and conditions herein set forth, the Company agrees to sell to each Underwriter, severally and not jointly, and each Underwriter, severally and not jointly, agrees to purchase from the Company, at the price per share set forth in Schedule A, that number of Initial Securities set forth in Schedule A opposite the name of such Underwriter, plus any additional number of Initial Securities which such Underwriter may become obligated to purchase pursuant to the provisions of Section 10 hereof, subject, in each case, to such adjustments among the Underwriters as the Representatives in their sole discretion shall make to eliminate any sales or purchases of fractional shares.
(b) Option Securities. In addition, on the basis of the representations and warranties herein contained and subject to the terms and conditions herein set forth, the Company hereby grants an option to the Underwriters, severally and not jointly, to purchase up to an additional [ ●˜ ] Common Shares at the price per share set forth in Schedule A, less an amount per share equal to any dividends or distributions declared by the Company and payable on the Initial Securities but not payable on the Option Securities. The option hereby granted may be exercised for 30 days after the date hereof and may be exercised in whole or in part at any time from time to time upon notice by the Representatives to the Company setting forth the number of Option Securities as to which the several Underwriters are then exercising the option and the time and date of payment and delivery for such Option Securities. Any such time and date of delivery (a “Date of Delivery”) shall be determined by the Representatives, but shall not be later than seven full business days after the exercise of said option, nor in any event prior to the Closing Time. If the option is exercised as to all or any portion of the Option Securities, each of the Underwriters, acting severally and not jointly, will purchase that proportion of the total number of Option Securities then being purchased which the number of Initial Securities set forth in Schedule A opposite the name of such Underwriter bears to the total number of Initial Securities, subject, in each case, to such adjustments as BofAS in its sole discretion shall make to eliminate any sales or purchases of fractional shares.
(c) Payment. Payment of the purchase price for, and delivery of, the Initial Securities shall be made at the offices of Latham & Watkins LLP, 885 Third Avenue, New York, New York 10022, or at such other place as shall be agreed upon by the Representatives and the Company, at [9:00] A.M. (New York City time) on the second (third, if the pricing occurs after 4:30 P.M. (New York City time) on any given day) business day after the date hereof (unless postponed in accordance with the provisions of Section 10), or such other time not later than ten business days after such date as shall be agreed upon by the Representatives and the Company (such time and date of payment and delivery being herein called “Closing Time”).
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In addition, in the event that any or all of the Option Securities are purchased by the Underwriters, payment of the purchase price for, and delivery of, such Option Securities shall be made at the above-mentioned offices, or at such other place as shall be agreed upon by the Representatives and the Company, on each Date of Delivery as specified in the notice from the Representatives to the Company.
Payment shall be made to the Company by wire transfer of immediately available funds to a bank account designated by the Company against delivery to the Representatives for the respective accounts of the Underwriters of the Securities to be purchased by them, or pursuant to other arrangements as shall be agreed upon by the Company and the Representatives prior to the Closing Time. It is understood that each Underwriter has authorized the Representatives, for its account, to accept delivery of, receipt for, and make payment of the purchase price for, the Initial Securities and the Option Securities, if any, which it has agreed to purchase. BofAS, individually and not as representative of the Underwriters, may (but shall not be obligated to) make payment of the purchase price for the Initial Securities or the Option Securities, if any, to be purchased by any Underwriter whose funds have not been received by the Closing Time or the relevant Date of Delivery, as the case may be, but such payment shall not relieve such Underwriter from its obligations hereunder.
Delivery of the Initial Securities and any Option Securities shall be made through the facilities of The Depository Trust Company.
SECTION 3. Covenants of the Company. The Company covenants with each Underwriter as follows:
(a) Compliance with Securities Regulations and Commission Requests. The Company, subject to Section 3(b), will comply with the requirements of Rule 430A, and will notify the Representatives as soon as practicable, and confirm the notice in writing, (i) when any post-effective amendment to the Registration Statement shall become effective or any amendment or supplement to the Prospectus shall have been filed, (ii) of the receipt of any comments from the Commission, (iii) of any request by the Commission for any amendment to the Registration Statement or any amendment or supplement to the Prospectus or for additional information, (iv) of the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or any post-effective amendment or of any order preventing or suspending the use of any preliminary prospectus or the Prospectus, or of the suspension of the qualification of the Securities for offering or sale in any jurisdiction, or of the initiation or threatening of any proceedings for any of such purposes or of any examination pursuant to Section 8(d) or 8(e) of the 1933 Act concerning the Registration Statement and (v) if the Company becomes the subject of a proceeding under Section 8A of the 1933 Act in connection with the offering of the Securities. The Company will effect all filings required under Rule 424(b), in the manner and within the time period required by Rule 424(b) (without reliance on Rule 424(b)(8)), and will take such steps as it deems necessary to ascertain promptly whether the form of prospectus transmitted for filing under Rule 424(b) was received for filing by the Commission and, in the event that it was not, it will promptly file such prospectus. The Company will make every reasonable effort to prevent the issuance of any stop order, prevention or suspension and, if any such order is issued, to obtain the lifting thereof at the earliest possible moment.
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(b) Continued Compliance with Securities Laws. The Company will comply with the 1933 Act and the 1933 Act Regulations so as to permit the completion of the distribution of the Securities as contemplated in this Agreement and in the Registration Statement, the General Disclosure Package and the Prospectus. If at any time when a prospectus relating to the Securities is (or, but for the exception afforded by Rule 172 of the 1933 Act Regulations (“Rule 172”), would be) required by the 1933 Act to be delivered in connection with sales of the Securities, any event shall occur or condition shall exist as a result of which it is necessary, in the opinion of counsel for the Underwriters or for the Company, to (i) amend the Registration Statement in order that the Registration Statement will not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading, (ii) amend or supplement the General Disclosure Package or the Prospectus in order that the General Disclosure Package or the Prospectus, as the case may be, will not include any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein not misleading in the light of the circumstances existing at the time it is delivered to a purchaser or (iii) amend the Registration Statement or amend or supplement the General Disclosure Package or the Prospectus, as the case may be, in order to comply with the requirements of the 1933 Act or the 1933 Act Regulations, the Company will promptly (A) give the Representatives notice of such event, (B) prepare any amendment or supplement as may be necessary to correct such statement or omission or to make the Registration Statement, the General Disclosure Package or the Prospectus comply with such requirements and, a reasonable amount of time prior to any proposed filing or use, furnish the Representatives with copies of any such amendment or supplement and (C) file with the Commission any such amendment or supplement; provided that the Company shall not file or use any such amendment or supplement to which the Representatives or counsel for the Underwriters shall reasonably object. The Company will furnish to the Underwriters such number of copies of such amendment or supplement as the Underwriters may reasonably request. The Company has given the Representative(s) notice of any filings made pursuant to the 1934 Act or 1934 Act Regulations within 48 hours prior to the Applicable Time; the Company will give the Representative(s) notice of its intention to make any such filing from the Applicable Time to the Closing Time and will furnish the Representative(s) with copies of any such documents a reasonable amount of time prior to such proposed filing, as the case may be, and will not file or use any such document to which the Representative(s) or counsel for the Underwriters shall reasonably object.
(c) Delivery of Registration Statements. The Company has furnished or will deliver to the Representatives and counsel for the Underwriters, without charge, copies of the Registration Statement as originally filed and each amendment thereto (including exhibits filed therewith) and copies of all consents and certificates of experts. The copies of the Registration Statement and each amendment thereto furnished to the Underwriters will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T.
(d) Delivery of Prospectuses. The Company has delivered to each Underwriter, without charge, as many copies of each preliminary prospectus as such Underwriter reasonably requested, and the Company hereby consents to the use of such copies for purposes permitted by the 1933 Act. The Company will furnish to each Underwriter, without charge, during the period when a prospectus relating to the Securities is (or, but for the exception afforded by Rule 172, would be) required to be delivered under the 1933 Act, such number of copies of the Prospectus (as amended or supplemented) as such Underwriter may reasonably request. The Prospectus and any amendments or supplements thereto furnished to the Underwriters will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T.
(e) Blue Sky Qualifications. The Company will use its reasonable best efforts, in cooperation with the Underwriters, to qualify the Securities for offering and sale under the applicable securities laws of such states and other jurisdictions (domestic or foreign) as the Representatives may reasonably designate and to maintain such qualifications in effect so long as required to complete the distribution of the Securities; provided, however, that the Company shall not be obligated to file any general consent to service of process or to qualify as a foreign corporation or as a dealer in securities in any jurisdiction in which it is not so qualified or to subject itself to taxation in respect of doing business in any jurisdiction in which it is not otherwise so subject.
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(f) Rule 158. The Company will timely file such reports pursuant to the Securities Exchange Act of 1934, as amended (the “1934 Act”) as are necessary in order to make generally available to its security holders as soon as practicable an earnings statement for the purposes of, and to provide to the Underwriters the benefits contemplated by, the last paragraph of Section 11(a) of the 1933 Act.
(g) Use of Proceeds. The Company will use the net proceeds received by it from the sale of the Securities in the manner specified in the Registration Statement, the General Disclosure Package and the Prospectus under “Use of Proceeds.”
(h) Listing. The Company will use its reasonable best efforts to maintain its listing of the Common Shares (including the Option Securities) on The Nasdaq Global Select Market.
(i) Restriction on Sale of Securities. During a period of 60 days from the date of the Prospectus, the Company will not, without the prior written consent of the Representatives, (i) directly or indirectly, offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase or otherwise transfer or dispose of any capital stock of the Company, or any securities convertible into or exercisable or exchangeable for capital stock of the Company or file any registration statement under the 1933 Act with respect to any of the foregoing or (ii) enter into any swap or any other agreement or any transaction that transfers, in whole or in part, directly or indirectly, the economic consequence of ownership of the Common Shares, whether any such swap or transaction described in clause (i) or (ii) above is to be settled by delivery of Common Shares or other securities, in cash or otherwise. The foregoing sentence shall not apply to: (A) the Securities to be sold hereunder, (B) any Common Shares issued or delivered by the Company upon the exercise of an option or warrant or the conversion of a security outstanding on the date hereof and referred to in the Registration Statement, the General Disclosure Package and the Prospectus, (C) any Common Shares issued or delivered or options to purchase Common Shares granted pursuant to existing employee benefit plans of the Company or CureVac AG referred to in the Registration Statement, the General Disclosure Package and the Prospectus, (D) any Common Shares issued pursuant to any non-employee director stock plan or dividend reinvestment plan referred to in the Registration Statement, the General Disclosure Package and the Prospectus, (E) the filing by the Company of any registration statement on Form S-8 or a successor form thereto with respect to the registration of securities to be offered under any employee benefit or equity incentive plan referred to in the Registration Statement, the General Disclosure Package and the Prospectus, and (F) Common Shares or other securities issued in connection with a transaction that includes a commercial relationship (including strategic alliances, commercial lending relationships, joint ventures, licensing agreements, collaboration agreements and strategic acquisitions), provided that (i) the aggregate number of shares issued pursuant to this clause (F) shall not exceed 10.0% of the total number of outstanding Common Shares immediately following the issuance and sale of the Common Shares and (ii) the recipient of any such Common Shares or securities issued pursuant to this clause (F) during the 60-day restricted period shall enter into an agreement substantially in the form of Exhibit D hereto. For the avoidance of doubt the restrictions in this section 3(i) shall not apply to any obligation of the Company in effect as of the date of this Agreement and described in the General Disclosure Package and the Prospectus.
(j) [Reserved.]
(k) Reporting Requirements. The Company, during the period when a Prospectus relating to the Securities is (or, but for the exception afforded by Rule 172, would be) required to be delivered under the 1933 Act, will file all documents required to be filed with the Commission pursuant to the 1934 Act within the time periods required by the 1934 Act and 1934 Act Regulations. Additionally, the Company shall report the use of proceeds from the issuance of the Shares as may be required under Rule 463 under the 1933 Act.
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(l) Issuer Free Writing Prospectuses. The Company agrees that, unless it obtains the prior written consent of the Representatives, it will not make any offer relating to the Securities that would constitute an Issuer Free Writing Prospectus or that would otherwise constitute a “free writing prospectus,” or a portion thereof, required to be filed by the Company with the Commission or retained by the Company under Rule 433; provided that the Representatives will be deemed to have consented to the Issuer Free Writing Prospectuses listed on Schedule B-2 hereto and any “road show that is a written communication” within the meaning of Rule 433(d)(8)(i) that has been reviewed by the Representatives. The Company represents that it has treated or agrees that it will treat each such free writing prospectus consented to, or deemed consented to, by the Representatives as an “issuer free writing prospectus,” as defined in Rule 433, and that it has complied and will comply with the applicable requirements of Rule 433 with respect thereto, including timely filing with the Commission where required, legending and record keeping. If at any time following issuance of an Issuer Free Writing Prospectus there occurred or occurs an event or development as a result of which such Issuer Free Writing Prospectus conflicted or would conflict with the information contained in the Registration Statement, any preliminary prospectus or the Prospectus or included or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances existing at that subsequent time, not misleading, the Company will promptly notify the Representatives and will promptly amend or supplement, at its own expense, such Issuer Free Writing Prospectus to eliminate or correct such conflict, untrue statement or omission.
(m) [Reserved.]1
(o) Testing-the-Waters Materials. If at any time following the distribution of any Written Testing-the-Waters Communication there occurred or occurs an event or development as a result of which such Written Testing-the-Waters Communication included or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances existing at that subsequent time, not misleading, the Company will promptly notify the Representatives and will promptly amend or supplement, at its own expense, such Written Testing-the-Waters Communication to eliminate or correct such untrue statement or omission.
(p) Emerging Growth Company Status. The Company will promptly notify the Representatives if the Company ceases to be an Emerging Growth Company at any time prior to the later of (i) completion of the distribution of the Securities within the meaning of the Securities Act and (ii) completion of the 60-day restricted period referred to in Section 3(i).
(q) Tax Indemnity. The Company will indemnify and hold harmless the Underwriters against any Transfer Taxes, including any interest and penalties, which are required to be paid on (i) the execution, delivery and performance of this Agreement, or (ii) the issuance and delivery of the Securities in the manner contemplated by this Agreement and the Prospectus.
(r) No Withholding Taxes. The Company agrees that all amounts payable hereunder shall be paid free and clear of, and without any deduction or withholding for or on account of, any current or future taxes, levies, imposts, duties, charges or other deductions or withholdings levied in any jurisdiction from or through which payment is made on behalf of the Company, unless such deduction or withholding is required by applicable law, in which event the Company will pay additional amounts so that the persons entitled to such payments will receive the amount that such persons would otherwise have received had such deduction or withholding not been required; provided, however, that, upon request, each such person shall cooperate reasonably with the Company to reduce or eliminate amounts required to be so deducted or withheld.
1 Note to LW: CureVac is not a public company and this is not required any more.
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SECTION 4. Payment of Expenses.
(a) Expenses. The Company will pay or cause to be paid all expenses incident to the performance of their obligations under this Agreement, including (i) the preparation, printing and filing of the Registration Statement (including financial statements and exhibits) as originally filed and each amendment thereto, (ii) the preparation, printing and delivery to the Underwriters of copies of each preliminary prospectus, each Issuer Free Writing Prospectus and the Prospectus and any amendments or supplements thereto and any costs associated with electronic delivery of any of the foregoing by the Underwriters to investors, (iii) the preparation, issuance and delivery of the Securities to the Underwriters, including any stock or other Transfer Taxes, (iv) the fees and disbursements of the Company’s counsel, accountants and other advisors, (v) the qualification of the Securities under securities laws in accordance with the provisions of Section 3(e) hereof, including filing fees and the reasonable fees and disbursements of counsel for the Underwriters in connection therewith and in connection with the preparation of the Blue Sky Survey and any supplement thereto, (vi) the fees and expenses of any transfer agent or registrar for the Securities, (vii) the costs and expenses of the Company relating to investor presentations on any “road show” undertaken in connection with the marketing of the Securities, including without limitation, expenses associated with the production of road show slides and graphics, fees and expenses of any consultants engaged by the Company in connection with the road show presentations, travel and lodging expenses of the representatives and officers of the Company and any such consultants (provided that the travel, lodging and any car travel expenses of representatives of the Underwriters shall be paid for by the Underwriters), and fifty percent (50%) of the cost of any aircraft chartered in connection with the road show (with the Underwriters agreeing to pay for the other fifty percent (50%) of the cost of the aircraft, as well as any other travel and lodging expenses of the Underwriters in connection with the road show), (viii) the filing fees incident to, and the reasonable fees and disbursements of counsel to the Underwriters in connection with, the review by FINRA of the terms of the sale of the Securities provided that the amount payable by the Company pursuant to clause (v) above and this clause (viii), excluding requisite filing fees, shall not exceed $25,000, (ix) the fees and expenses incurred in connection with the listing of the Securities on The Nasdaq Global Select Market and (x) the costs and expenses (including, without limitation, any damages or other amounts payable in connection with legal or contractual liability) associated with the reforming of any contracts for sale of the Securities made by the Underwriters caused by a breach of the representation contained in the third sentence of Section 1(a)(ii).
(b) Termination of Agreement. If this Agreement is terminated by the Representatives in accordance with the provisions of Section 5, Section 9(a)(i) or (iii), or Section 10 hereof, the Company shall reimburse the non-defaulting Underwriters for all of their reasonable, documented out-of-pocket expenses, including the reasonable fees and disbursements of counsel for the Underwriters, provided, however, that if this Agreement is terminated pursuant to Section 10, the Company shall not be required to reimburse any costs, expenses, fees and disbursements whatsoever of the defaulting Underwriters that have failed to purchase the Securities that they have agreed to purchase hereunder.
SECTION 5. Conditions of Underwriters’ Obligations. The obligations of the several Underwriters hereunder are subject to the accuracy of the representations and warranties of the Company contained herein or in certificates of any officer of the Company or any of its subsidiaries delivered pursuant to the provisions hereof, to the performance by the Company of its covenants and other obligations hereunder, and to the following further conditions:
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(a) Effectiveness of Registration Statement; Rule 430A Information. The Registration Statement, including any Rule 462(b) Registration Statement, has become effective and, at the Closing Time, no stop order suspending the effectiveness of the Registration Statement or any post-effective amendment thereto has been issued under the 1933 Act, no order preventing or suspending the use of any preliminary prospectus or the Prospectus has been issued and no proceedings for any of those purposes have been instituted or are pending or, to the Company’s knowledge, contemplated; and the Company has complied with each request (if any) from the Commission for additional information. A prospectus containing the Rule 430A Information shall have been filed with the Commission in the manner and within the time frame required by Rule 424(b) without reliance on Rule 424(b)(8) or a post-effective amendment providing such information shall have been filed with, and declared effective by, the Commission in accordance with the requirements of Rule 430A.
(b) Opinion of Counsel for Company. At the Closing Time, the Representatives shall have received the favorable opinion, dated the Closing Time, of Davis Polk & Wardwell LLP, counsel for the Company, in form and substance satisfactory to counsel for the Underwriters, together with signed or reproduced copies of such letter for each of the other Underwriters to the effect set forth in Exhibit A hereto.
(c) Opinion of Intellectual Property Counsel for the Company. At the Closing Time, the Representatives shall have received the favorable opinion, dated the Closing Time, of each of ParkerHighlander PLLC and Graf von Stosch Patentanwaltsgesellschaft mbH, intellectual property counsel for the Company, in form and substance satisfactory to counsel for the Underwriters, together with signed or reproduced copies of such letter for each of the other Underwriters to the effect set forth in Exhibits B-1 and B-2 hereto.
(d) Opinion of Dutch Counsel for the Company. At the Closing Time, the Representatives shall have received the favorable opinion, dated the Closing Time, of NautaDutilh N.V., Dutch counsel for the Company, in form and substance satisfactory to counsel for the Underwriters, together with signed or reproduced copies of such letter for each of the other Underwriters to the effect set forth in Exhibit C hereto.
(e) Opinion of Counsel for Underwriters. At the Closing Time, the Representatives shall have received the favorable opinion, dated the Closing Time, of Latham & Watkins LLP, counsel for the Underwriters, in such form and substance as satisfactory to the Underwriters.
(f) Officers’ Certificate. At the Closing Time, there shall not have been, since the date hereof or since the respective dates as of which information is given in the Registration Statement, the General Disclosure Package or the Prospectus, any material adverse change in the condition, financial or otherwise, or in the earnings, business affairs or business prospects of the Company and its subsidiaries considered as one enterprise, whether or not arising in the ordinary course of business, and the Representatives shall have received a certificate of the Chief Executive Officer or the President of the Company and of the chief financial or chief accounting officer of the Company, dated the Closing Time, to the effect that (i) there has been no such material adverse change, (ii) the representations and warranties of the Company in this Agreement are true and correct with the same force and effect as though expressly made at and as of the Closing Time, (iii) the Company has complied with all agreements and satisfied all conditions on its part to be performed or satisfied at or prior to the Closing Time, and (iv) no stop order suspending the effectiveness of the Registration Statement under the 1933 Act has been issued, no order preventing or suspending the use of any preliminary prospectus or the Prospectus has been issued and no proceedings for any of those purposes have been instituted or are pending or, to their knowledge, contemplated.
(g) Chief Financial Officer’s Certificate. At the time of the execution of this Agreement and at the Closing Time, the Representatives shall have received a certificate of the Chief Financial Officer of the Company, dated the date of this Agreement or the Closing Time, as applicable, reasonably satisfactory to the Representatives, as to the accuracy of certain data contained in the Registration Statement, the General Disclosure Package and the Prospectus;
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(h) Accountant’s Comfort Letter. At the time of the execution of this Agreement, the Representatives shall have received from Ernst & Young GmbH Wirtschaftsprüfungsgesellschaft a letter, dated such date, in form and substance satisfactory to the Representatives, together with signed or reproduced copies of such letter for each of the other Underwriters containing statements and information of the type ordinarily included in accountants’ “comfort letters” to underwriters with respect to the financial statements and certain financial information contained in the Registration Statement, the General Disclosure Package and the Prospectus.
(i) Bring-down Comfort Letter. At the Closing Time, the Representatives shall have received from Ernst & Young GmbH Wirtschaftsprüfungsgesellschaft a letter, dated as of the Closing Time, to the effect that they reaffirm the statements made in the letter furnished pursuant to subsection (i) of this Section, except that the specified date referred to shall be a date not more than three business days prior to the Closing Time.
(j) [Reserved.]
(k) No Objection. FINRA has confirmed that it has not raised any objection with respect to the fairness and reasonableness of the underwriting terms and arrangements relating to the offering of the Securities.
(l) Lock-up Agreements. At the date of this Agreement, the Representatives shall have received an agreement substantially in the form of Exhibit D hereto signed by the persons listed on Schedule C hereto.
(m) Conditions to Purchase of Option Securities. In the event that the Underwriters exercise their option provided in Section 2(b) hereof to purchase all or any portion of the Option Securities, the representations and warranties of the Company contained herein and the statements in any certificates furnished by the Company and any of its subsidiaries hereunder shall be true and correct as of each Date of Delivery and, at the relevant Date of Delivery, the Representatives shall have received:
(i) Officers’ Certificate. A certificate, dated such Date of Delivery, of the President or a Vice President of the Company and of the chief financial or chief accounting officer of the Company confirming that the certificates delivered at the Closing Time pursuant to Section 5(f) hereof remains true and correct as of such Date of Delivery.
(ii) Chief Financial Officer’s Certificate. A certificate, dated such Date of Delivery, of the Chief Financial Officer of the Company confirming that the certificate delivered at the Closing Time pursuant to Section 5(g) hereof remains true and correct as of such Date of Delivery.
(iii) Opinion of Counsel for Company. If requested by the Representatives, the favorable opinion of Davis Polk & Wardwell LLP, counsel for the Company, together with the favorable opinion of ParkerHighlander PLLC and Graf von Stosch Patentanwaltsgesellschaft mbH, intellectual property counsel for the Company and NautaDutilh N.V., Dutch counsel for the Company , each in form and substance satisfactory to counsel for the Underwriters, dated such Date of Delivery, relating to the Option Securities to be purchased on such Date of Delivery and otherwise to the same effect as the opinion required by Section 5(b), 5(c) and 5(d) hereof.
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(iv) Opinion of Counsel for Underwriters. If requested by the Representatives, the favorable opinion of Latham & Watkins LLP, counsel for the Underwriters, dated such Date of Delivery, relating to the Option Securities to be purchased on such Date of Delivery and otherwise to the same effect as the opinion required by Section 5(e) hereof.
(v) Bring-down Comfort Letter. If requested by the Representatives, a letter from Ernst & Young GmbH Wirtschaftsprüfungsgesellschaft, in form and substance satisfactory to the Representatives and dated such Date of Delivery, substantially in the same form and substance as the letter furnished to the Representatives pursuant to Section 5(h) hereof, except that the “specified date” in the letter furnished pursuant to this paragraph shall be a date not more than three business days prior to such Date of Delivery.
(n) Additional Documents. At the Closing Time and at each Date of Delivery (if any) counsel for the Underwriters shall have been furnished with such additional customary documents and opinions as they may reasonably require for the purpose of enabling them to pass upon the issuance and sale of the Securities as herein contemplated, or in order to evidence the accuracy of any of the representations or warranties, or the fulfillment of any of the conditions, herein contained; and all proceedings taken by the Company in connection with the issuance and sale of the Securities as herein contemplated shall be reasonably satisfactory in form and substance to the Representatives and counsel for the Underwriters.
(o) Termination of Agreement. If any condition specified in this Section shall not have been fulfilled when and as required to be fulfilled, this Agreement, or, in the case of any condition to the purchase of Option Securities on a Date of Delivery which is after the Closing Time, the obligations of the several Underwriters to purchase the relevant Option Securities, may be terminated by the Representatives by notice to the Company at any time at or prior to Closing Time or such Date of Delivery, as the case may be, and such termination shall be without liability of any party to any other party except as provided in Section 4 and except that Sections 1, 6, 7, 8, 13 and 14 shall survive any such termination and remain in full force and effect.
SECTION 6. Indemnification.
(a) Indemnification of Underwriters. The Company agrees to indemnify and hold harmless each Underwriter, its affiliates (as such term is defined in Rule 501(b) under the 1933 Act (each, an “Affiliate”)), its selling agents and each person, if any, who controls any Underwriter within the meaning of Section 15 of the 1933 Act or Section 20 of the 1934 Act as follows:
(i) against any and all loss, liability, claim, damage and expense whatsoever, as incurred, arising out of any untrue statement or alleged untrue statement of a material fact contained in the Registration Statement (or any amendment thereto), including the Rule 430A Information, or the omission or alleged omission therefrom of a material fact required to be stated therein or necessary to make the statements therein not misleading or arising out of any untrue statement or alleged untrue statement of a material fact included (A) in any preliminary prospectus, any Issuer Free Writing Prospectus, any Written Testing-the-Waters Communication, the General Disclosure Package or the Prospectus (or any amendment or supplement thereto), or (B) in any materials or information provided to investors by, or with the approval of, the Company in connection with the marketing of the offering of the Securities (“Marketing Materials”), including any roadshow or investor presentations made to investors by the Company (whether in person or electronically), or the omission or alleged omission in any preliminary prospectus, Issuer Free Writing Prospectus, any Written Testing-the-Waters Communication, Prospectus or in any Marketing Materials of a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading;
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(ii) against any and all loss, liability, claim, damage and expense whatsoever, as incurred, to the extent of the aggregate amount paid in settlement of any litigation, or any investigation or proceeding by any governmental agency or body, commenced or threatened, or of any claim whatsoever based upon any such untrue statement or omission, or any such alleged untrue statement or omission; provided that (subject to Section 6(c) below) any such settlement is effected with the written consent of the Company;
(iii) against any and all expense whatsoever, as incurred (including the reasonable fees and disbursements of counsel chosen by the Representatives), reasonably incurred in investigating, preparing or defending against any litigation, or any investigation or proceeding by any governmental agency or body, commenced or threatened, or any claim whatsoever based upon any such untrue statement or omission, or any such alleged untrue statement or omission, to the extent that any such expense is not paid under (i) or (ii) above;
provided, however, that this indemnity agreement shall not apply to any loss, liability, claim, damage or expense to the extent arising out of any untrue statement or omission or alleged untrue statement or omission made in the Registration Statement (or any amendment thereto), including the Rule 430A Information, the General Disclosure Package or the Prospectus (or any amendment or supplement thereto) in reliance upon and in conformity with the Underwriter Information.
(b) Indemnification of Company, Directors and Officers. Each Underwriter severally agrees to indemnify and hold harmless the Company, its directors, each of its officers who signed the Registration Statement, and each person, if any, who controls the Company within the meaning of Section 15 of the 1933 Act or Section 20 of the 1934 Act, against any and all loss, liability, claim, damage and expense described in the indemnity contained in subsection (a) of this Section, as incurred, but only with respect to untrue statements or omissions, or alleged untrue statements or omissions, made in the Registration Statement (or any amendment thereto), including the Rule 430A Information, the General Disclosure Package or the Prospectus (or any amendment or supplement thereto) in reliance upon and in conformity with the Underwriter Information.
(c) Actions against Parties; Notification. Each indemnified party shall give notice as promptly as reasonably practicable to each indemnifying party of any action commenced against it in respect of which indemnity may be sought hereunder, but failure to so notify an indemnifying party shall not relieve such indemnifying party from any liability hereunder to the extent it is not materially prejudiced as a result thereof and in any event shall not relieve it from any liability which it may have otherwise than on account of this indemnity agreement. In the case of parties indemnified pursuant to Section 6(a) above, counsel to the indemnified parties shall be selected by the Representatives. An indemnifying party may participate at its own expense in the defense of any such action; provided, however, that counsel to the indemnifying party shall not (except with the consent of the indemnified party) also be counsel to the indemnified party. In no event shall the indemnifying parties be liable for fees and expenses of more than one counsel (in addition to any local counsel) separate from their own counsel for all indemnified parties in connection with any one action or separate but similar or related actions in the same jurisdiction arising out of the same general allegations or circumstances. No indemnifying party shall, without the prior written consent of the indemnified parties, settle or compromise or consent to the entry of any judgment with respect to any litigation, or any investigation or proceeding by any governmental agency or body, commenced or threatened, or any claim whatsoever in respect of which indemnification or contribution could be sought under this Section 6 or Section 7 hereof (whether or not the indemnified parties are actual or potential parties thereto), unless such settlement, compromise or consent (i) includes an unconditional release of each indemnified party from all liability arising out of such litigation, investigation, proceeding or claim and (ii) does not include a statement as to or an admission of fault, culpability or a failure to act by or on behalf of any indemnified party.
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(d) Settlement without Consent if Failure to Reimburse. If at any time an indemnified party shall have requested an indemnifying party to reimburse the indemnified party for fees and expenses of counsel, such indemnifying party agrees that it shall be liable for any settlement of the nature contemplated by Section 6(a)(ii) effected without its written consent if (i) such settlement is entered into more than 45 days after receipt by such indemnifying party of the aforesaid request, (ii) such indemnifying party shall have received notice of the terms of such settlement at least 30 days prior to such settlement being entered into and (iii) such indemnifying party shall not have reimbursed such indemnified party in accordance with such request prior to the date of such settlement.
SECTION 7. Contribution. If the indemnification provided for in Section 6 hereof is for any reason unavailable to or insufficient to hold harmless an indemnified party in respect of any losses, liabilities, claims, damages or expenses referred to therein, then each indemnifying party shall contribute to the aggregate amount of such losses, liabilities, claims, damages and expenses incurred by such indemnified party, as incurred, (i) in such proportion as is appropriate to reflect the relative benefits received by the Company, on the one hand, and the Underwriters, on the other hand, from the offering of the Securities pursuant to this Agreement or (ii) if the allocation provided by clause (i) is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative benefits referred to in clause (i) above but also the relative fault of the Company, on the one hand, and of the Underwriters, on the other hand, in connection with the statements or omissions that resulted in such losses, liabilities, claims, damages or expenses, as well as any other relevant equitable considerations.
The relative benefits received by the Company, on the one hand, and the Underwriters, on the other hand, in connection with the offering of the Securities pursuant to this Agreement shall be deemed to be in the same respective proportions as the total net proceeds from the offering of the Securities pursuant to this Agreement (before deducting expenses) received by the Company, on the one hand, and the total underwriting discount received by the Underwriters, on the other hand, in each case as set forth on the cover of the Prospectus, bear to the aggregate public offering price of the Securities as set forth on the cover of the Prospectus.
The relative fault of the Company, on the one hand, and the Underwriters, on the other hand, shall be determined by reference to, among other things, whether any such untrue or alleged untrue statement of a material fact or omission or alleged omission to state a material fact relates to information supplied by the Company or by the Underwriters and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission.
The Company and the Underwriters agree that it would not be just and equitable if contribution pursuant to this Section 7 were determined by pro rata allocation (even if the Underwriters were treated as one entity for such purpose) or by any other method of allocation which does not take account of the equitable considerations referred to above in this Section 7. The aggregate amount of losses, liabilities, claims, damages and expenses incurred by an indemnified party and referred to above in this Section 7 shall be deemed to include any legal or other expenses reasonably incurred by such indemnified party in investigating, preparing or defending against any litigation, or any investigation or proceeding by any governmental agency or body, commenced or threatened, or any claim whatsoever based upon any such untrue or alleged untrue statement or omission or alleged omission.
Notwithstanding the provisions of this Section 7, no Underwriter shall be required to contribute any amount in excess of the underwriting commissions received by such Underwriter in connection with the Shares underwritten by it and distributed to the public.
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No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the 1933 Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation.
For purposes of this Section 7, each person, if any, who controls an Underwriter within the meaning of Section 15 of the 1933 Act or Section 20 of the 1934 Act and each Underwriter’s Affiliates and selling agents shall have the same rights to contribution as such Underwriter, and each director of the Company, each officer of the Company who signed the Registration Statement, and each person, if any, who controls the Company within the meaning of Section 15 of the 1933 Act or Section 20 of the 1934 Act shall have the same rights to contribution as the Company. The Underwriters’ respective obligations to contribute pursuant to this Section 7 are several in proportion to the number of Initial Securities set forth opposite their respective names in Schedule A hereto and not joint.
SECTION 8. Representations, Warranties and Agreements to Survive. All representations, warranties and agreements contained in this Agreement or in certificates of officers of the Company or any of its subsidiaries submitted pursuant hereto, shall remain operative and in full force and effect regardless of (i) any investigation made by or on behalf of any Underwriter or its Affiliates or selling agents, any person controlling any Underwriter, its officers or directors or any person controlling the Company and (ii) delivery of and payment for the Securities.
SECTION 9. Termination of Agreement.
(a) Termination. The Representatives may terminate this Agreement, by notice to the Company, at any time at or prior to the Closing Time (i) if there has been, in the judgment of the Representatives, since the time of execution of this Agreement or since the respective dates as of which information is given in the Registration Statement, the General Disclosure Package or the Prospectus, any material adverse change in the condition, financial or otherwise, or in the earnings, business affairs or business prospects of the Company and its subsidiaries considered as one enterprise, whether or not arising in the ordinary course of business, or (ii) if there has occurred any material adverse change in the financial markets in the United States or the international financial markets, any outbreak of hostilities or escalation thereof or other calamity or crisis or any change or development involving a prospective change in national or international political, financial or economic conditions, in each case the effect of which is such as to make it, in the judgment of the Representatives, impracticable or inadvisable to proceed with the completion of the offering or to enforce contracts for the sale of the Securities, or (iii) if trading in any securities of the Company has been suspended or materially limited by the Commission or The Nasdaq Global Select Market, or (iv) if trading generally on The Nasdaq Global Select Market has been suspended or materially limited, or minimum or maximum prices for trading have been fixed, or maximum ranges for prices have been required, by any of said exchanges or by order of the Commission, FINRA or any other governmental authority, or (v) a material disruption has occurred in commercial banking or securities settlement or clearance services in the United States or with respect to Clearstream or Euroclear systems in Europe, or (vi) if a banking moratorium has been declared by either Federal or New York authorities.
(b) Liabilities. If this Agreement is terminated pursuant to this Section, such termination shall be without liability of any party to any other party except as provided in Section 4 hereof, and provided further that Sections 1, 6, 7, 8, 13 and 14 shall survive such termination and remain in full force and effect.
SECTION 10. Default by One or More of the Underwriters. If one or more of the Underwriters shall fail at the Closing Time or a Date of Delivery to purchase the Securities which it or they are obligated to purchase under this Agreement (the “Defaulted Securities”), the Representatives shall have the right, within 24 hours thereafter, to make arrangements for one or more of the non-defaulting Underwriters, or any other underwriters, to purchase all, but not less than all, of the Defaulted Securities in such amounts as may be agreed upon and upon the terms herein set forth; if, however, the Representatives shall not have completed such arrangements within such 24-hour period, then:
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(i) if the number of Defaulted Securities does not exceed 10% of the number of Securities to be purchased on such date, each of the non-defaulting Underwriters shall be obligated, severally and not jointly, to purchase the full amount thereof in the proportions that their respective underwriting obligations hereunder bear to the underwriting obligations of all non-defaulting Underwriters, or
(ii) if the number of Defaulted Securities exceeds 10% of the number of Securities to be purchased on such date, this Agreement or, with respect to any Date of Delivery which occurs after the Closing Time, the obligation of the Underwriters to purchase, and the Company to sell, the Option Securities to be purchased and sold on such Date of Delivery shall terminate without liability on the part of any non-defaulting Underwriter.
No action taken pursuant to this Section shall relieve any defaulting Underwriter from liability in respect of its default.
In the event of any such default which does not result in a termination of this Agreement or, in the case of a Date of Delivery which is after the Closing Time, which does not result in a termination of the obligation of the Underwriters to purchase and the Company to sell the relevant Option Securities, as the case may be, either the (i) Representatives or (ii) the Company shall have the right to postpone Closing Time or the relevant Date of Delivery, as the case may be, for a period not exceeding seven days in order to effect any required changes in the Registration Statement, the General Disclosure Package or the Prospectus or in any other documents or arrangements. As used herein, the term “Underwriter” includes any person substituted for an Underwriter under this Section 10.
SECTION 11. Notices. All notices and other communications hereunder shall be in writing and shall be deemed to have been duly given if mailed or transmitted by any standard form of telecommunication. Notices to the Underwriters shall be directed to BofAS at One Bryant Park, New York, New York 10036, attention of Syndicate Department (facsimile: (646) 855-3073), with a copy to ECM Legal (facsimile: (212) 230-8730) or Jefferies at 520 Madison Avenue New York, New York 10022, attention of General Counsel (facsimile: (646) 619-4437); notices to the Company shall be directed to it at Friedrich-Miescher-Strasse 15, 72076, Tübingen, Germany, attention of Mr. Franz-Werner Haas.
SECTION 12. No Advisory or Fiduciary Relationship. The Company acknowledges and agrees that (a) the purchase and sale of the Securities pursuant to this Agreement, including the determination of the public offering price of the Securities and any related discounts and commissions, is an arm’s-length commercial transaction between the Company, on the one hand, and the several Underwriters, on the other hand, (b) in connection with the offering of the Securities and the process leading thereto, each Underwriter is and has been acting solely as a principal and is not the agent or fiduciary of the Company, any of its subsidiaries or their respective shareholders, creditors, employees or any other party, (c) no Underwriter has assumed or will assume an advisory or fiduciary responsibility in favor of the Company with respect to the offering of the Securities or the process leading thereto (irrespective of whether such Underwriter has advised or is currently advising the Company or any of its subsidiaries on other matters) and no Underwriter has any obligation to the Company with respect to the offering of the Securities except the obligations expressly set forth in this Agreement, (d) the Underwriters and their respective affiliates may be engaged in a broad range of transactions that involve interests that differ from those of the Company and (e) the Underwriters have not provided any legal, accounting, regulatory or tax advice with respect to the offering of the Securities and the Company has consulted its own respective legal, accounting, regulatory and tax advisors to the extent it deemed appropriate.
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SECTION 13. Recognition of the U.S. Special Resolution Regimes.
(a) In the event that any Underwriter that is a Covered Entity becomes subject to a proceeding under a U.S. Special Resolution Regime, the transfer from such Underwriter of this Agreement, and any interest and obligation in or under this Agreement, will be effective to the same extent as the transfer would be effective under the U.S. Special Resolution Regime if this Agreement, and any such interest and obligation, were governed by the laws of the United States or a state of the United States.
(b) In the event that any Underwriter that is a Covered Entity or a BHC Act Affiliate of such Underwriter becomes subject to a proceeding under a U.S. Special Resolution Regime, Default Rights under this Agreement that may be exercised against such Underwriter are permitted to be exercised to no greater extent than such Default Rights could be exercised under the U.S. Special Resolution Regime if this Agreement were governed by the laws of the United States or a state of the United States.
For purposes of this Section 13, a “BHC Act Affiliate” has the meaning assigned to the term “affiliate” in, and shall be interpreted in accordance with, 12 U.S.C. § 1841(k). “Covered Entity” means any of the following: (i) a “covered entity” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 252.82(b); (ii) a “covered bank” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 47.3(b); or (iii) a “covered FSI” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 382.2(b). “Default Right” has the meaning assigned to that term in, and shall be interpreted in accordance with, 12 C.F.R. §§ 252.81, 47.2 or 382.1, as applicable. “U.S. Special Resolution Regime” means each of (i) the Federal Deposit Insurance Act and the regulations promulgated thereunder and (ii) Title II of the Dodd-Frank Wall Street Reform and Consumer Protection Act and the regulations promulgated thereunder.
SECTION 14. Parties. This Agreement shall each inure to the benefit of and be binding upon the Underwriters and the Company and their respective successors. Nothing expressed or mentioned in this Agreement is intended or shall be construed to give any person, firm or corporation, other than the Underwriters and the Company and their respective successors and the controlling persons and officers and directors referred to in Sections 6 and 7 and their heirs and legal representatives, any legal or equitable right, remedy or claim under or in respect of this Agreement or any provision herein contained. This Agreement and all conditions and provisions hereof are intended to be for the sole and exclusive benefit of the Underwriters and the Company and their respective successors, and said controlling persons and officers and directors and their heirs and legal representatives, and for the benefit of no other person, firm or corporation. No purchaser of Securities from any Underwriter shall be deemed to be a successor by reason merely of such purchase.
SECTION 15. Trial by Jury. The Company (on its behalf and, to the extent permitted by applicable law, on behalf of its shareholders and affiliates) and each of the Underwriters hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Agreement or the transactions contemplated hereby.
SECTION 16. GOVERNING LAW. THIS AGREEMENT AND ANY CLAIM, CONTROVERSY OR DISPUTE ARISING UNDER OR RELATED TO THIS AGREEMENT SHALL BE GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF, THE STATE OF NEW YORK WITHOUT REGARD TO ITS CHOICE OF LAW PROVISIONS.
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SECTION 17. Consent to Jurisdiction; Waiver of Immunity. Any legal suit, action or proceeding arising out of or based upon this Agreement or the transactions contemplated hereby (“Related Proceedings”) shall be instituted in (i) the federal courts of the United States of America located in the City and County of New York, Borough of Manhattan or (ii) the courts of the State of New York located in the City and County of New York, Borough of Manhattan (collectively, the “Specified Courts”), and each party irrevocably submits to the exclusive jurisdiction (except for proceedings instituted in regard to the enforcement of a judgment of any such court (a “Related Judgment”), as to which such jurisdiction is non-exclusive) of such courts in any such suit, action or proceeding. Service of any process, summons, notice or document by mail to such party’s address set forth above shall be effective service of process for any suit, action or other proceeding brought in any such court. The parties irrevocably and unconditionally waive any objection to the laying of venue of any suit, action or other proceeding in the Specified Courts and irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such suit, action or other proceeding brought in any such court has been brought in an inconvenient forum. Each party not located in the United States irrevocably appoints CureVac Inc. as its agent to receive service of process or other legal summons for purposes of any such suit, action or proceeding that may be instituted in any state or federal court in the City and County of New York. With respect to any Related Proceeding, each party irrevocably waives, to the fullest extent permitted by applicable law, all immunity (whether on the basis of sovereignty or otherwise) from jurisdiction, service of process, attachment (both before and after judgment) and execution to which it might otherwise be entitled in the Specified Courts, and with respect to any Related Judgment, each party waives any such immunity in the Specified Courts or any other court of competent jurisdiction, and will not raise or claim or cause to be pleaded any such immunity at or in respect of any such Related Proceeding or Related Judgment, including, without limitation, any immunity pursuant to the United States Foreign Sovereign Immunities Act of 1976, as amended.
SECTION 18. TIME. TIME SHALL BE OF THE ESSENCE OF THIS AGREEMENT. EXCEPT AS OTHERWISE SET FORTH HEREIN, SPECIFIED TIMES OF DAY REFER TO NEW YORK CITY TIME.
SECTION 19. Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed to be an original, but all such counterparts shall together constitute one and the same Agreement.
SECTION 20. Effect of Headings. The Section headings herein are for convenience only and shall not affect the construction hereof.
SECTION 21. Affiliates. Sales of Common Shares made outside of the United States may be made by affiliates of the Underwriters acting as their agents.
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If the foregoing is in accordance with your understanding of our agreement, please sign and return to the Company a counterpart hereof, whereupon this instrument, along with all counterparts, will become a binding agreement among the Underwriters and the Company in accordance with its terms.
Very truly yours, | ||
CureVac N.V. | ||
By | ||
Title: |
CONFIRMED AND ACCEPTED, as of the date first above written:
BOFA SECURITIES, INC. JEFFERIES LLC
By: BOFA SECURITIES, INC.
By | ||
Authorized Signatory |
By: JEFFERIES LLC
By | ||
Authorized Signatory |
For themselves and as Representatives of the other Underwriters named in Schedule A hereto.
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SCHEDULE A
The public offering price per share for the Securities shall be $[ ● ].
The purchase price per share for the Securities to be paid by the several Underwriters shall be $[ • ], being an amount equal to the public offering price set forth above less $[ ● ] per share.
Name of Underwriter |
Number of
Initial Securities |
|||
BofA Securities, Inc. | [ ● ] | |||
Jefferies LLC | [ ● ] | |||
[ ● ] | [ ● ] | |||
[ ● ] | [ ● ] | |||
[ ● ] | [ ● ] | |||
Total | [ ● ] |
Sch A-1 |
SCHEDULE B-1
Pricing Terms
1. The Company is selling [ ● ] Common Shares.
2. The Company has granted an option to the Underwriters, severally and not jointly, to purchase up to an additional [ ● ] Common Shares.
3. The public offering price per share for the Securities shall be $[ ● ].
Sch B-1 |
SCHEDULE B-2
Free Writing Prospectuses
[None.]
Sch B-2 |
SCHEDULE C
List of Persons and Entities Subject to Lock-up
1. | Florian von der Mülbe |
2. | Mariola Fotin-Mleczek |
3. | Franz-Werner Haas |
4. | Pierre Kemula |
5. | Ralf Clemens |
6. | Mathias Hothum |
7. | Baron Jean Stéphenne |
8. | Hans Cristoph Tanner |
9. | Friedrich von Bohlen und Halbach |
10. | Timothy M. Wright |
11. | Craig A. Tooman |
12. | Bernd Winterhalter |
13. | Igor Splawski |
14. | Antony Blanc |
15. | Viola Bronsema |
Sch C
SCHEDULE D
Written Testing-the-Water Communications
None.
Sch D-1 |
Exhibit A
FORM OF OPINION OF COMPANY’S
AND CUREVAC’S COUNSEL
TO BE DELIVERED PURSUANT TO SECTION 5(b)
Exhibit B-1
FORM OF OPINION OF PARKERHIGHLANDER PLLC, THE COMPANY’S INTELLECTUAL PROPERTY COUNSEL TO BE DELIVERED PURSUANT TO SECTION 5(c)
Exhibit B-2
FORM OF OPINION OF GRAF VON STOSCH PATENTANWALTSGESELLSCHAFT MBH, THE COMPANY’S INTELLECTUAL PROPERTY COUNSEL TO BE DELIVERED PURSUANT TO SECTION 5(c)
Exhibit C
FORM OF OPINION OF NAUTADUTILH N.V., THE COMPANY’S DUTCH COUNSEL TO BE DELIVERED PURSUANT TO SECTION 5(d)
Exhibit D
Form of
lock-up from directors, officers or other stockholders
pursuant to Section 5(l)
Exhibit 3.4
1
DEED OF ISSUE OF ORDINARY SHARES
CUREVAC N.V.
THIS DEED IS ENTERED INTO ON [date] 2021 BY
CureVac N.V., a public company with limited liability, having its corporate seat in Amsterdam (address: Friedrich-Miescher-Strasse 15, 72076 Tübingen, Germany, trade register number: 77798031) (the "Company").
NOW HEREBY DECLARES THE FOLLOWING
1 | DEFINITIONS AND INTERPRETATION |
1.1 | Definitions |
1.1.1 | In this Deed the following definitions shall apply: |
Deed |
This deed of issue.
|
DTC |
Cede & Co., a partnership under the laws of the State of New York, United States of America, as nominee for The Depository Trust Company, a corporation under the laws of the State of New York, United States of America.
|
Issue Price |
The issue price per Share of USD [amount].
|
Offering |
The follow-on offering of ordinary shares in the Company's capital and the admission to listing and trading of the ordinary shares in the Company's capital on the NASDAQ Stock Market.
|
Resolutions |
The written resolutions of the Company's management board dated [date] 2021 and the Company's pricing committee dated [date] 2021.
|
Shares |
[number] ordinary shares in the Company's capital, having a nominal value of EUR 0.12 each.
|
Transfer Agent |
American Stock Transfer & Trust Company, LLC, a limited liability company under the laws of the State of New York, United States of America, in its capacity of the Company's transfer agent.
|
2
Underwriters |
The underwriters in the Offering, listed in Schedule A to the Underwriting Agreement.
|
Underwriting Agreement |
The underwriting agreement dated [date] 2021 between the Company and (representatives of) the Underwriters.
|
1.2 | Interpretation |
1.2.1 | Terms that are defined in the singular have a corresponding meaning in the plural and vice versa. |
1.2.2 | Although this Deed has been drafted in the English language, this Deed pertains to Dutch legal concepts. Any consequence of the use of English words and expressions in this Deed under any law other than Dutch law shall be disregarded. |
1.2.3 | The titles and headings in this Deed are for construction purposes as well as for reference. No party may derive any rights from such titles and headings. |
2 | ISSUANCE |
2.1 | Issuance of Shares |
2.1.1 | In giving effect to the Resolutions and the Company's obligations under the Underwriting Agreement, the Company issues the Shares to DTC, for further credit to, or as directed by, the several Underwriters in accordance with the terms and conditions of the Underwriting Agreement. |
2.1.2 | Upon the Shares being credited to the several Underwriters in the book-entry systems of DTC, DTC shall be considered to have accepted the Shares. |
2.2 | Payment |
2.2.1 | The aggregate Issue Price for the Shares has been satisfied in accordance with the terms of the Underwriting Agreement and the Company grants a discharge for the payment thereof. |
2.2.2 | The Company approves payment of the aggregate Issue Price in a currency other than euro. |
2.2.3 | To the extent that the aggregate Issue Price for the Shares exceeds the aggregate nominal value of the Shares, such excess shall be considered to be share premium and shall be added to the share premium reserve attached to the ordinary shares in the Company's capital. |
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2.3 | Registration |
2.3.1 | Promptly following the execution of this Deed, the Company shall (i) register the present issuance of the Shares in its register within the meaning of Section 2:85 of the Dutch Civil Code and (ii) cause the Transfer Agent to register the Shares in the register maintained by the Transfer Agent in respect of the ordinary shares in the Company's capital. |
3 | MISCELLANEOUS PROVISIONS |
3.1 | No rescission or nullification |
3.1.1 | To the extent permitted by law, the Company waives its rights to rescind or nullify or to demand the rescission, nullification or amendment of this Deed, in whole or in part, on any grounds whatsoever. |
3.2 | Governing law |
3.2.1 | Without prejudice to the relevant provisions of Chapters 4 and 5 of Title 10 of Book 10 of the Dutch Civil Code, this Deed shall be governed by and construed in accordance with the laws of the Netherlands. |
3.3 | Jurisdiction |
3.3.1 | Any dispute in connection with this Deed shall be submitted to the exclusive jurisdiction of the competent court in Amsterdam, the Netherlands. |
(signature page follows)
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Signature page to the deed of issue | ||
CureVac N.V. | ||
Name: | F.W. Haas | |
Title: | Chief Executive Officer |
Exhibit 5.1 | ||
ATTORNEYS • CIVIL LAW NOTARIES • TAX ADVISERS | ||
P.O. Box 7113 1007 JC Amsterdam Beethovenstraat 400 1082 PR Amsterdam T +31 20 71 71 000 F +31 20 71 71 111 |
Amsterdam, January 25, 2021 To the Company |
|
Amsterdam
Brussels
London
Luxemburg
New York
Rotterdam
Ladies and Gentlemen:
We have acted as legal counsel as to Dutch law to the Company in connection with the Offering. This opinion letter is rendered to you in order to be filed with the SEC as an exhibit to the Registration Statement.
Capitalised terms used in this opinion letter have the meanings set forth in Exhibit A to this opinion letter. The section headings used in this opinion letter are for convenience of reference only and are not to affect its construction or to be taken into consideration in its interpretation.
This opinion letter is strictly limited to the matters stated in it and may not be read as extending by implication to any matters not specifically referred to in it. Nothing in this opinion letter should be taken as expressing an opinion in respect of any representations or warranties, or other information, contained in the Reviewed Documents.
In rendering the opinions expressed in this opinion letter, we have reviewed and relied upon drafts of the Reviewed Documents and pdf copies or drafts, as the case may be, of the Corporate Documents and we have assumed that the Reviewed Documents shall be entered into for bona fide commercial reasons. We have not investigated or verified any factual matter disclosed to us in the course of our review.
This opinion letter sets out our opinion on certain matters of the laws with general applicability of the Netherlands, and, insofar as they are directly applicable in the Netherlands, of the European Union, as at today's date and as presently interpreted under published authoritative case law of the Dutch courts, the General Court and the Court of Justice of the European Union. We do not express any opinion on Dutch or European competition law, data protection law, tax law or regulatory law. No undertaking is assumed on our part to revise, update or amend this opinion letter in connection with or to notify or inform you of, any developments and/or changes of Dutch law subsequent to today's date. We do not purport to opine on the consequences of amendments to the Reviewed Documents or the Corporate Documents subsequent to the date of this opinion letter.
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The opinions expressed in this opinion letter are to be construed and interpreted in accordance with Dutch law. The competent courts at Amsterdam, the Netherlands, have exclusive jurisdiction to settle any issues of interpretation or liability arising out of or in connection with this opinion letter. Any legal relationship arising out of or in connection with this opinion letter (whether contractual or non-contractual), including the above submission to jurisdiction, is governed by Dutch law and shall be subject to the general terms and conditions of NautaDutilh. Any liability arising out of or in connection with this opinion letter shall be limited to the amount which is paid out under NautaDutilh's insurance policy in the matter concerned. No person other than NautaDutilh may be held liable in connection with this opinion letter.
In this opinion letter, legal concepts are expressed in English terms. The Dutch legal concepts concerned may not be identical in meaning to the concepts described by the English terms as they exist under the law of other jurisdictions. In the event of a conflict or inconsistency, the relevant expression shall be deemed to refer only to the Dutch legal concepts described by the English terms.
For the purposes of this opinion letter, we have assumed that:
a. | drafts of documents reviewed by us will be signed in the form of those drafts, each copy of a document conforms to the original, each original is authentic, and each signature is the genuine signature of the individual purported to have placed that signature; |
b. | the Registration Statement has been declared effective by the SEC in the form reviewed by us; |
c. | (i) no internal regulations (reglementen) have been adopted by any corporate body of the Company which would affect the validity of the resolutions recorded in the Resolutions and (ii) the Current Articles are the Articles of Association currently in force; |
d. | the resolutions recorded in the Resolutions are in full force and effect, the factual statements made and the confirmations given in the Resolutions and each Deed of Issue are complete and correct at each Relevant Moment and the Resolutions correctly reflect the resolutions recorded therein; |
e. | each Deed of Issue has been validly signed and executed on behalf of the Company; |
f. | the Offering, to the extent made in the Netherlands, has been, is and will be made in conformity with the Prospectus Regulation, the DFSA and the rules promulgated thereunder; |
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g. | the Option (i) has been validly granted as a right to subscribe for Common Shares (recht tot het nemen van aandelen), (ii) shall be in full force and effect upon being exercised and (iii) shall have been validly exercised in accordance with the terms of the Underwriting Agreement; and |
h. | at the Relevant Moment, each of the assumptions made in this opinion letter will be correct in all aspects by reference to the facts and circumstances then existing. |
Based upon and subject to the foregoing and subject to the qualifications set forth in this opinion letter and to any matters, documents or events not disclosed to us, we express the following opinions:
Corporate Status
1. | The Company has been duly incorporated as a besloten vennootschap met beperkte aansprakelijkheid and is validly existing as a naamloze vennootschap. |
Offer Shares and Option Shares
2. | Subject to receipt by the Company of payment in full for the Offer Shares and the Option Shares as provided for in the Reviewed Documents, and when issued and accepted in accordance with the Resolutions and the Reviewed Documents, the Offer Shares and the Option Shares shall be validly issued, fully paid and non-assessable. |
The opinions expressed above are subject to the following qualifications:
A. | Opinion 1 must not be read to imply that the Company cannot be dissolved (ontbonden). A company such as the Company may be dissolved, inter alia by the competent court at the request of the company's board of directors, any interested party (belanghebbende) or the public prosecution office in certain circumstances, such as when there are certain defects in the incorporation of the company. Any such dissolution will not have retro-active effect. |
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B. | Pursuant to Section 2:7 DCC, any transaction entered into by a legal entity may be nullified by the legal entity itself or its liquidator in bankruptcy proceedings (curator) if the objects of that entity were transgressed by the transaction and the other party to the transaction knew or should have known this without independent investigation (wist of zonder eigen onderzoek moest weten). The Dutch Supreme Court (Hoge Raad der Nederlanden) has ruled that in determining whether the objects of a legal entity are transgressed, not only the description of the objects in that legal entity's articles of association (statuten) is decisive, but all (relevant) circumstances must be taken into account, in particular whether the interests of the legal entity were served by the transaction. Based on the objects clause contained in the Current Articles, we have no reason to believe that, by entering into the Reviewed Documents, the Company would transgress the description of the objects contained in its Articles of Association. However, we cannot assess whether there are other relevant circumstances that must be taken into account, in particular whether the interests of the Company are served by entering into the Reviewed Documents since this is a matter of fact. |
C. | Pursuant to Section 2:98c DCC, a naamloze vennootschap may grant loans (leningen verstrekken) only in accordance with the restrictions set out in Section 2:98c DCC, and may not provide security (zekerheid stellen), give a price guarantee (koersgarantie geven) or otherwise bind itself, whether jointly and severally or otherwise with or for third parties (zich op andere wijze sterk maken of zich hoofdelijk of anderszins naast of voor anderen verbinden) with a view to (met het oog op) the subscription or acquisition by third parties of shares in its share capital or depository receipts. This prohibition also applies to its subsidiaries (dochtervennootschappen). It is generally assumed that a transaction entered into in violation of Section 2:98c DCC is null and void (nietig). Based on the content of the Reviewed Documents, we have no reason to believe that the Company or its subsidiaries will violate Section 2:98c DCC in connection with the issue of the Offer Shares or the Option Shares. However, we cannot confirm this definitively, since the determination of whether a company (or a subsidiary) has provided security, has given a price guarantee or has otherwise bound itself, with a view to the subscription or acquisition by third parties of shares in its share capital or depository receipts, as described above, is a matter of fact. |
D. | The opinions expressed in this opinion letter may be limited or affected by: |
a. | any applicable bankruptcy, insolvency, reorganisation, moratorium or other similar laws or procedures now or hereafter in effect, relating to or affecting the enforcement or protection of creditors' rights generally; |
b. | the provisions of fraudulent preference and fraudulent conveyance (Actio Pauliana) and similar rights available in other jurisdictions to insolvency practitioners and insolvency office holders in bankruptcy proceedings or creditors; |
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c. | claims based on tort (onrechtmatige daad); |
d. | sanctions and measures, including but not limited to those concerning export control, pursuant to European Union regulations, under the Sanctions Act 1977 (Sanctiewet 1977) or other legislation; |
e. | the Anti-Boycott Regulation and related legislation; and |
f. | the rules of force majeure (niet toerekenbare tekortkoming), reasonableness and fairness (redelijkheid en billijkheid), suspension (opschorting), dissolution (ontbinding), unforeseen circumstances (onvoorziene omstandigheden) and vitiated consent (i.e., duress (bedreiging), fraud (bedrog), abuse of circumstances (misbruik van omstandigheden) and error (dwaling)) or a difference of intention (wil) and declaration (verklaring). |
E. | The term "non-assessable" has no equivalent in the Dutch language and for purposes of this opinion letter such term should be interpreted to mean that a holder of a share will not by reason of merely being such a holder be subject to assessment or calls by the Company or its creditors for further payment on such share. |
F. | This opinion letter does not purport to express any opinion or view on the operational rules and procedures of any clearing or settlement system or agency. |
We consent to the filing of this opinion letter as an exhibit to the Registration Statement and also consent to the reference to NautaDutilh in the Registration Statement under the caption "Legal Matters". In giving this consent we do not admit or imply that we are a person whose consent is required under Section 7 of the United States Securities Act of 1933, as amended, or any rules and regulations promulgated thereunder.
Sincerely yours,
/s/ NautaDutilh N.V.
6
EXHIBIT A
LIST OF DEFINITIONS
"Anti-Boycott Regulation" | The Council Regulation (EC) No 2271/96 of 22 November 1996 on protecting against the effects of the extra-territorial application of legislation adopted by a third country, and actions based thereon or resulting therefrom. |
"Articles of Association" | The Company's articles of association (statuten) as they read from time to time. |
"Commercial Register" | The Dutch Commercial Register (handelsregister). |
"Common Shares" | Common shares in the Company's capital, with a nominal value of EUR 0.12 each. |
"Company" | CureVac N.V., a public company (naamloze vennootschap), registered with the Commercial Register under number 77798031. |
"Corporate Documents" | The Deed of Incorporation, the Deed of Conversion, the Current Articles, the Resolutions and the Registration Statement. |
"Current Articles" | The Articles of Association as contained in the Deed of Conversion. |
"DCC" | The Dutch Civil Code (Burgerlijk Wetboek). |
"Deed of Incorporation" | The Company's deed of incorporation (akte van oprichting), dated April 7, 2020. |
"Deed of Conversion" | The deed of conversion and amendment to the Articles of Association, dated August 14, 2020. |
"Deed of Issue"
|
The draft deed of issue of the Offer Shares or Option Shares, as the case may be, prepared by us with references 82044152 M 30566769 and 82044152 M 30582659, respectively. |
"DFSA" | The Dutch Financial Supervision Act (Wet op het financieel toezicht). |
7
"General Meeting" | The Company's general meeting (algemene vergadering). |
"Management Board" | The Company's management board (bestuur). |
"NautaDutilh" | NautaDutilh N.V. |
"the Netherlands" | The European territory of the Kingdom of the Netherlands. |
"Offering" | The follow-on offering of the Offer Shares and, if any, the Option Shares, as contemplated by the Registration Statement. |
"Offer Shares" | 5,000,000 Common Shares. |
"Option" | The option to acquire Option Shares to be granted to the Underwriters pursuant to the Underwriting Agreement and the Resolutions. |
"Option Shares" | Up to 750,000 Common Shares or such lesser number of Common Shares in respect of which the Option is exercised. |
"Prospectus Regulation" | Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC. |
"Registration Statement" | The Company's registration statement on Form F-1 filed or to be filed with the SEC in connection with the Offering in the form reviewed by us. |
"Relevant Moment" | Each time that Offer Shares or Option Shares are issued pursuant to the execution of a Deed of Issue. |
8
"Resolutions" |
i. the written resolution of the General Meeting, dated August 10, 2020;
ii. the written resolution of the Management Board, dated [date];
iii. the written resolution of the Supervisory Board, dated [date];
iv. the draft written resolution of the Management Board prepared by us with reference 82044152 M 30584267; and
v. the draft written resolution of the Company's pricing committee prepared by us with reference 82044152 M 30578210. |
"Reviewed Documents" | Each Deed of Issue and the Underwriting Agreement. |
"SEC" | The United States Securities and Exchange Commission. |
"Supervisory Board" | The Company's supervisory board (raad van commissarissen). |
"Underwriters" | The Underwriters, as defined in the Underwriting Agreement. |
"Underwriting Agreement" | The draft underwriting agreement to be entered into between the Company and the Underwriters in connection with the Offering, in the form reviewed by NautaDutilh. |
Exhibit 8.1 | |||
ATTORNEYS • CIVIL LAW NOTARIES • TAX ADVISERS | |||
P.O. Box 7113 1007 JC Amsterdam Beethovenstraat 400 1082 PR Amsterdam T +31 20 71 71 000 F +31 20 71 71 111 |
Amsterdam, January 25, 2021
To the Company |
Amsterdam
Brussels
London
Luxemburg
New York
Rotterdam
Ladies and Gentlemen:
We have acted as tax counsel as to Dutch law to the Company in connection with the Offering. This opinion letter is rendered to you in order to be filed with the SEC as an exhibit to the Registration Statement.
Capitalised terms used in this opinion letter have the meanings set forth in Exhibit A to this opinion letter. The section headings used in this opinion letter are for convenience of reference only and are not to affect its construction or to be taken into consideration in its interpretation.
This opinion letter is strictly limited to the matters stated in it and may not be read as extending by implication to any matters not specifically referred to in it. Nothing in this opinion letter should be taken as expressing an opinion in respect of any representations or warranties, or other information, contained in any document reviewed by us.
In rendering the opinion expressed in this opinion letter, we have reviewed and relied upon a draft of the Registration Statement. We have not investigated or verified any factual matter disclosed to us in the course of our review.
This opinion letter sets out our opinion on certain matters of the tax laws with general applicability of the Netherlands, and, insofar as they are directly applicable in the Netherlands, of the European Union, as at today's date and as presently interpreted under published authoritative case law of the Dutch courts, the General Court and the Court of Justice of the European Union. We do not express any opinion on Dutch law or European competition law, data protection law or regulatory law. No undertaking is assumed on our part to revise, update or amend this opinion letter in connection with or to notify or inform you of, any developments and/or changes of Dutch law subsequent to today's date. We do not purport to opine on the consequences of amendments to the Registration Statement subsequent to the date of this opinion letter.
The opinion expressed in this opinion letter is to be construed and interpreted in accordance with Dutch tax law. The competent courts at Amsterdam, the Netherlands, have exclusive jurisdiction to settle any issues of interpretation or liability arising out of or in connection with this opinion letter. Any legal relationship arising out of or in connection with this opinion letter (whether contractual or non-contractual), including the above submission to jurisdiction, is governed by Dutch law and shall be subject to the general terms and conditions of NautaDutilh. Any liability arising out of or in connection with this opinion letter shall be limited to the amount which is paid out under NautaDutilh's insurance policy in the matter concerned. No person other than NautaDutilh may be held liable in connection with this opinion letter.
2 |
In this opinion letter and in the Dutch Tax Summary, legal and tax concepts are expressed in English terms. The Dutch legal and tax concepts concerned may not be identical in meaning to the concepts described by the English terms as they exist under the law of other jurisdictions. In the event of a conflict or inconsistency, the relevant expression shall be deemed to refer only to the Dutch legal and tax concepts described by the English terms.
For the purposes of this opinion letter, we have assumed that:
a. | the Registration Statement has been or will be declared effective by the SEC in the form reviewed by us; and |
b. | the place of effective management of the Company is in Germany, and not in the Netherlands, and the Company will therefore be solely a tax resident of Germany under German national tax law. |
Based upon and subject to the foregoing and subject to any matters, documents or events not disclosed to us, we express the following opinion:
Fair Dutch Tax Summary
The Dutch Tax Summary constitutes our opinion, is true and accurate and provides a fair summary of the matters of Dutch tax law described therein.
We consent to the filing of this opinion letter as an exhibit to the Registration Statement and also consent to the reference to NautaDutilh in the Registration Statement under the caption "Legal Matters". In giving this consent we do not admit or imply that we are a person whose consent is required under Section 7 of the United States Securities Act of 1933, as amended, or any rules and regulations promulgated thereunder.
Sincerely yours,
/s/ NautaDutilh N.V.
3 |
EXHIBIT A
LIST OF DEFINITIONS
"Commercial Register" | The Dutch Commercial Register (handelsregister). |
"Common Shares" | Common shares in the Company's capital, with a nominal value of EUR 0.12 each. |
"Company" | CureVac N.V., a public company (naamloze vennootschap), registered with the Commercial Register under number 77798031. |
"Dutch Tax Summary" | The statements contained in the Registration Statement under the caption "Taxation — Material Dutch Tax Considerations". |
"NautaDutilh" | NautaDutilh N.V. |
"the Netherlands" | The European territory of the Kingdom of the Netherlands. |
"Offering" | The follow-on offering of Common Shares as contemplated by the Registration Statement. |
"Registration Statement" | The Company's registration statement on Form F-1 filed or to be filed with the SEC in connection with the Offering in the form reviewed by us. |
"SEC" | The United States Securities and Exchange Commission. |
Exhibit 8.2
Attn
Pierre Kemula
|
FALK GmbH & Co KG
Im Breitspiel 21
Telefon: +49 6221 399-0
January 25, 2021
Me/Dr.Vk/Oz
34832645 |
US SEC Form F-1 Registration Statement CureVac N.V. dated January 25, 2021
Dear Mr. Kemula,
We act as German Tax Advisors to the Issuer in connection with the Registration. Certain terms used in this opinion are defined in Annex 1 (Definitions).
This opinion is limited to German tax law in effect on the date of this opinion. This opinion (including all terms used in it) is to be construed in accordance with German tax law.
For the purpose of this opinion, we have examined the Registration Statement which we determined to be the only document relevant to rendering this opinion, while relying upon the accuracy of the factual statements therein.
For the purpose of this opinion, we have made the following assumptions:
· | The Registration Statement has been or will be filed with the SEC in the form referred to in this opinion. | |
· | The effective place of management of the Issuer is located in T0bingen, Germany. | |
· | The factual statement in the Registration Statement are true and correct in all respects. |
FALK GmbH & Co KG Wirtschaftsprüfungsgesellschaft Steuerberatungsgesellschaft Sitz der Gesellschaft: Heidelberg | AG Mannheim HRA 702086 | USt.-Identifikations-Nr. DE 258 256 316
Persönlich haftende Gesellschafterin: FALK & Co Verwaltungs-GmbH Wirtschaftsprüfungsgesellschaft Steuerberatungsgesellschaft Sitz der Gesellschaft: Heidelberg AG Mannheim HRB 705586
Geschäftsführer: WP StB Gerhard Meyer, WP StB Dr. Martin Ziegler, StB Gerd Fuhrmann, WP StB Thomas Rohling, WP StB Markus Schmidtke, WP StB Philip Roth, WP StB Stephan Hilbig, WP CPA Gerhard Müller, WP StB Dr. Stefan Tichy, WP StB Andreas Dörschell, WP StB RA Dr. Steffen Bangert, WP StB Dr. Alexander Wünsche, WP StB CPA Steffen Ahrens, WP StB Thorsten Bischoff, WP StB Kathrin Mindnich |
- 2 -
|
Opinion
Based on the documents referred to and the assumptions made above, we hereby confirm that the statements set forth in the Registration Statement under the section “Taxation-Material German Tax Considerations” constitute the opinion of FALK as to the material German tax consequences of purchasing, owning or transferring the shares in the capital of the Issuer.
This opinion is an exhibit to the Registration Statement and may only be relied upon for the purpose of the Registration. It may not be supplied, and its contents or existence may not be disclosed, to any person other than as an Exhibit to (and therefore together with) the Registration Statement and may not be relied upon for any purpose other than the Registration.
Each person relying on this opinion agrees, in so relying, that only FALK shall have any liability in connection with this opinion.
The Issuer may:
· | file this opinion as an exhibit to the Registration Statement, and | |
· | refer to FALK giving this opinion under the heading “Taxation-Material German Tax Considerations” in the prospectus included in the Registration Statement. |
The previous sentence is no admittance from us (or FALK) that we are (or FALK is) in the category of persons whose consent for the filing and reference in that paragraph is required under Section 7 of the Securities Act or any rules or regulations of the SEC promulgated under it.
Yours faithfully,
/s/ Gerhard Meyer | /s/ Dr. Michael Vituschek | ||
(Gerhard Meyer) | (Dr. Michael Vituschek) | ||
Steuerberater | Steuerberater |
FALK GmbH & Co KG
Wirtschaftsprüfungsgesellschaft
Steuerberatungsgesellschaft
- 3 -
|
Annex 1 – Definitions
“German Tax” means any tax pursuant to Section 3 (1) through to (3) German Fiscal Code (Abgabenordnung) levied by or on behalf of Germany or any of its subdivisions or taxing authorities.
“FALK” means FALK GmbH & Co KG Wirtschaftsprüfungsgesellschaft Steuerberatungsgesellschaft.
“Issuer” means CureVac N.V. with corporate seat in Amsterdam, the Netherlands.
“Registration” means the registration of shares in the capital of the Issuer with the SEC under the Securities Act.
“Registration Statement” means the registration statement on form F-1 in relation to the Registration to be filed with the SEC in the date hereof (excluding any documents incorporated by reference in it and any exhibits to it).
“SEC” means the U.S. Securities and Exchange Commission.
“Securities Act” means the U.S. Securities Act of 1933, as amended.
Exhibit 8.3
New York
Northern California Washington DC São Paulo London |
Paris
Madrid Tokyo Beijing Hong Kong |
|||
|
||||
Davis Polk & Wardwell LLP
450 Lexington Avenue
|
212 450 4000 tel 212 701 5800 fax
|
|||
January 25, 2021
CureVac N.V.
Friedrich-Miescher-Strasse 1572076
Tübingen, Germany
Ladies and Gentlemen:
We are acting as United States counsel to CureVac N.V., a Dutch public company with limited liability (naamloze vennootschap) (the “Company”), in connection with the preparation of the Registration Statement on Form F-1 (the “Registration Statement”) filed with the United States Securities and Exchange Commission.
We, as your counsel, have examined originals or copies of such documents, corporate records, certificates of public officials and other instruments as we have deemed necessary or advisable for the purpose of rendering this opinion.
We hereby confirm that our opinion as to the material U.S. federal income tax consequences to U.S. holders of an investment in the Company’s common shares is set forth in full under the caption “Material U.S. Federal Income Tax Considerations to U.S. Holders” in the Registration Statement.
We are members of the Bar of the State of New York and the foregoing opinion is limited to the laws of the State of New York and the federal laws of the United States.
We hereby consent to the use of our name under the captions “Material U.S. Federal Income Tax Considerations to U.S. Holders” and “Legal Matters” in the Registration Statement and to the filing, as an exhibit to the Registration Statement, of this letter. In giving this consent we do not admit that we come within the category of persons whose consent is required under Section 7 of the United States Securities Act of 1933.
Very truly yours,
/s/ Davis Polk & Wardwell LLP
Exhibit 10.42
REDACTED
Certain identified information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
1st Amendment to the
DEVELOPMENT AND LICENSE AGREEMENT (“Agreement”),
effective as of November 9, 2017
between
CureVac AG
Friedrich-Miescher-Straße
15, 72076 Tübingen, Germany
(hereinafter called "CureVac")
and
CRISPR Therapeutics AG
Baarerstrasse
14, 6300 Zug, Switzerland
(hereinafter called "CRISPR")
WHEREAS, CRISPR and CUREVAC entered into the Agreement.
WHEREAS, The Parties wish to adjust the Agreement regarding substitution of Program 1 and the [*****] Program.
THEREFORE, the Parties consent and mutually agree to amend the Agreement as follows.
1. | Definition of Reserved Program shall be amended to read: |
1.73 “Reserved Program” shall mean any program that [*****].
2. | Section 4.2(b) shall hereby be replaced in its entirety and amended to read: |
Program 1 Substitution Process. With respect to Program 1, until [*****], CRISPR shall be permitted once to substitute [*****] [*****] for an alternative indication, provided the intended indication has an incidence approximately the same or less than the indication [*****]. The substitution process shall be as follows: CRISPR shall provide CureVac written notice of its request to substitute a target for Program 1 by [*****]. If CureVac provides CRISPR notice that a proposed substitution for Program 1 is a Reserved Program, CureVac shall notify CRISPR within [*****] days after the date on which CureVac receives notice of the proposed substitution if such proposed substitution is a Reserved Program. CureVac shall, if requested by CRISPR in writing, provide CRISPR with such evidence to support that such proposed substitution is a Reserved Program. If after providing such evidence, CRISPR concludes that such a substitution is not a Reserved Program, CRISPR will so notify CureVac, and CureVac will provide such evidence as CureVac believes is reasonably required to establish that such substitution is a Reserved Program to an independent attorney or other expert with experience that is relevant to the dispute and reasonably acceptable to both Parties. Such independent expert will review and make a determination in accordance with this Agreement regarding whether such proposed substitution is a Reserved Program. The independent expert shall promptly notify the Parties of its determination as to whether a proposed substitution is a Reserved Program, but shall not disclose to CRISPR information provided by CureVac in connection with such determination. The independent expert’s determination shall be binding on the Parties, absent a manifest error of such expert's determination. If the independent expert determines such proposed substitution is a Reserved Program, CRISPR shall be permitted to substitute another target for Program 1; if the independent expert determines such proposed substitution is not a Reserved Program, such proposed substitution shall become the target for Program 1. For clarity, the replacement of the primary gene for a back-up gene (as set forth in Attachment G) in accordance with 4.2(a) is not considered a Program 1 substitution.
3. | Section 4.2(c) shall hereby be added and shall read: |
Substitution Fee. In the event CRISPR substitutes Program 1, a Substitution Fee of [*****] is due within [*****] business days of confirmation of the new target by CureVac, or once the target is confirmed not to be a Reserved Program in accordance with the procedures set forth in Section 4.2(b) above.
2
4. | Section 4.3(a) of the Agreement shall hereby be replaced in its entirety and amended to read: |
Substitution. With respect to the [*****] Program, until [*****], CRISPR shall be permitted once to substitute an alternative program for [*****], using the procedures set forth in Section 4.3(b), provided the intended indication has an incidence approximately the same or less than the indication [*****]. The substitution is subject to the substitution fee set forth below in Section 4.3(c), and the milestones set forth in Section 5.4(c) shall not be adjusted for any [*****] Program substitution. For clarity, even if the [*****] Program had already achieved several milestones, the substitution program would have to pay those milestones again.
5. | In Section 4.3(b) shall hereby be replaced in its entirety and amended to read: |
[*****] Program Substitution Process. CRISPR shall provide CureVac written notice of its request to substitute a target for the [*****] Program by [*****]. If CureVac provides CRISPR notice that a proposed substitution for the [*****] Program is a Reserved Program, CureVac shall notify CRISPR within [*****] days after the date on which CureVac receives notice of the proposed substitution if such proposed substitution is a Reserved Program. CureVac shall, if requested by CRISPR in writing, provide CRISPR with such evidence to support that such proposed substitution is a Reserved Program. If after providing such evidence, CRISPR concludes that such a substitution is not a Reserved Program, CRISPR will so notify CureVac, and CureVac will provide such evidence as CureVac believes is reasonably required to establish that such substitution is a Reserved Program to an independent attorney or other expert with experience that is relevant to the dispute and reasonably acceptable to both Parties. Such independent expert will review and make a determination in accordance with this Agreement regarding whether such proposed substitution is a Reserved Program. The independent expert shall promptly notify the Parties of its determination as to whether a proposed substitution is a Reserved Program, but shall not disclose to CRISPR information provided by CureVac in connection with such determination. The independent expert’s determination shall be binding on the Parties, absent a manifest error of such expert's determination. If the independent expert determines such proposed substitution is a Reserved Program, CRISPR shall be permitted to select another target for the [*****] Program; if the independent expert determines such proposed substitution is not a Reserved Program, such proposed substitution shall become the target for the [*****] Program.
3
6. | In Article 6 “Confidentiality”, the following shall be added to the end of Section 6.1: |
For the purposes of this Article 6 and its Sections 6.1-6.5 and 6.7, Casebia may be a Receiving Party or a Disclosing Party, as the case may be, to allow exchange of Confidential Information amongst CureVac, CRISPR and Casebia.
7. | In Article 15.2 CureVac’s address shall be changed to: |
CureVac AG
Friedrich-Miescher-Str. 15
72076 Tübingen
Germany
Attention: CEO and General Counsel
8. | This 1st Amendment shall enter into force upon signature by both Parties. The remaining terms and conditions of the Agreement shall remain in full force and effect. Capitalized terms used in this 1st Amendment shall have the same meaning as defined in the Agreement. |
CUREVAC AG | CRISPR Therapeutics AG | |||
By: | /s/ [*****] | By: | /s/ [*****] | |
Name: | [*****] | Name: | [*****] | |
Title: | Senior Legal Counsel | Title: | President | |
By: | /s/ [*****] | |||
Name: | [*****] | |||
Title: | Legal Counsel |
4
Exhibit 10.43
REDACTED
Certain identified information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
AMENDMENT 4
to
DEFINITIVE AGREEMENT 1
Investment ID INV-020846 (previously 25808)
AMENDMENT SUMMARY AND SIGNATURE PAGE
AMENDMENT INFORMATION | |
Agreement to be Amended: | Definitive Agreement 4 between the Bill & Melinda Gates Foundation and CureVac AG, effective May 15, 2014, and bearing Investment ID INV-020846 |
Agreement Title: | Assessment of RNA Vaccine Technology for Non-live Rotavirus Vaccines in Pre- clinical Models |
“Amendment Effective Date”: | Date of last signature below |
Amendment Purpose: | Supplement |
This Amendment includes | This Amendment Summary and Signature Page and: |
and incorporates into the | · Amended Timeline (Attachment C-4 – Appendix 1, Section I,4) |
Agreement by this reference: | · Amended Budget and Payment (Attachment D-4 - Appendix 1, Section II, 1) |
THIS AMENDMENT amends, and is made part of, the above-referenced Agreement and is effective as of the Amendment Effective Date. Capitalized terms not defined in this Amendment will have the meaning provided in the Agreement. Except as modified by this Amendment, all other terms and conditions of the Agreement remain in full force and effect. By signing below, each Party acknowledges that it has carefully read and fully understood this Amendment, and each agrees to be bound by its terms. Facsimile and electronic signatures will be binding for all purposes.
BILL & MELINDA GATES FOUNDATION | CUREVAC AG | |
/s/ [*****] | /s/ [*****] | |
By:[*****] | By: [*****] | |
Title: /[*****] | Title: [*****] | |
November 3, 2020 | 2020.11.10 | |
Date | Date | |
/s/ [*****] | ||
By: [*****] | ||
Title: [*****] | ||
2020.11.13 | ||
Date |
1 of 3
AMENDMENT 4
to
WORK ORDER
Investment ID INV-020846 (previously 25808)
ATTACHMENT C-4
AMENDED TIMELINE
The Parties agree to amend Appendix 1 of the Agreement as provided below.
2 of 3
AMENDMENT 4
to
WORK ORDER
Investment ID INV-020846 (previously 25808)
ATTACHMENT D-4
AMENDED BUDGET AND PAYMENT
1. Overall Cost Estimates
3 of 3
Exhibit 10.44
Addendum to the
Shareholders' Agreement
in relation
to the parties' share holdings
in CureVac N.V. (NL-Amsterdam)
dated June 16, 2020
between
KfW
Palmengartenstr. 5-9
60325 Frankfurt am Main
- hereinafter referred to as "Investor Bund
on the one hand
and
dievini
Hopp BioTech holding GmbH & Co KG
represented by its general partner dievini Verwaltungs GmbH
Johann-Jakob-Astor-Str. 57
69190 Walldorf
- hereinafter referred to as "dievini
Mr. Dietmar Hopp
Johann-Jakob-Astor-Str. 57
69190 Walldorf
- hereinafter referred to as "DH" - -
and
DH-LT Investments
GmbH
Opelstraße 28
68789 St. Leon-Rot
on the other hand
- Investor Bund, dievini, DH and DH-LT Investments GmbH
hereinafter jointly referred to as the "Parties" or individually as a "Party
Page 1of 6 |
Addendum to the Addendum to the
Shareholders' Agreement between Investor Bund, dievini and DH
Preamble
A | In clause 8 ("Investment Commitment DH") of the shareholders' agreement concluded between the parties (with the exception of DH-LT Investments GmbH) with regard to the parties' shareholdings in CureVac N.V. (NL-Amsterdam) dated 16 June 2020 ("Shareholders' Agreement"), DH has undertaken to invest an amount of EUR 100 million into CureVac N.V. on the occasion of the IPO in order to acquire shares at economic terms and in particular at a share price corresponding to the issue price of a share in the IPO ("concurrent private placement") ("Investment Amount"). |
B | DH intends to fulfil this obligation not personally, but rather through DH-LT Investments GmbH, headquartered in St. Leon-Rot, registered in the Commercial Register of the Local Court in Mannheim under HRB 732866 ("DH-LT"), of which DH is the sole shareholder. |
C | Therefore, the other parties and DH-LT agree to include DH-LT in the Shareholder Agreement alongside DH by way of this Addendum to the Shareholders' Agreement. |
This aforesaid, the Parties agree on the following:
1 | Accession of DH-LT to the Shareholders’ Agreement; Consent of the other Parties |
DH-LT hereby accedes to the shareholders' agreement alongside of DH. DH-LT shall therefore have the same rights and obligations as DH under the shareholders' agreement. The shares in CureVac N.V. already acquired or to be acquired in the future by DH-LT in the course of the concurrent private placement shall be deemed IPO shares within the meaning of the Shareholders' Agreement.
1.2 | In particular, but without limitation, DH-LT shall be obligated under clause 8, 2nd sentence in connection with clause 4.5 of the shareholders' agreement to exercise the rights from IPO shares in the case of resolutions of the general meeting on Restricted Items of Resolution in the same way as the voting rights from the Restricted Shares. |
Page 2of 6 |
Addendum to the Addendum to the
Shareholders' Agreement between Investor Bund, dievini and DH
1.3 | For the avoidance of doubt, even with DH-LT's accession to the shareholders' agreement, as described above, the investment amount is only due and payable once. |
1.4 | The other Parties hereby agree to DH-LT's accession to the Shareholders' Agreement as described in clause 1.1. |
2 | Notices to DH-LT |
All declarations and other notices from and in connection with the Shareholders’ Agreement and this addendum to the Shareholders’ Agreement shall be sent by the parties to the persons listed below at the contact details, who shall act as authorized service agents for DH-LT until such authorization is revoked:
DH-LT Investments GmbH:
Opelstrasse 28
68789 St. Leon-Rot
Fax:
+ 49 (0) 6227 8608 470
E-Mail: contact@dievini.com
each with a copy:
Prof. Dr. Christof Hettich
c/o RITTERSHAUS Rechtsanwälte Partnerschaftsgesellschaft mbB
Harrlachweg 4
68163 Mannheim
Fax:
+49 (0) 621 4256 250
E-Mail: christof.hettich@rittershaus.net
3 | Final provisions |
3.1 | The provisions of the shareholders' agreement shall otherwise remain unchanged and continue to apply. |
Page 3of 6 |
Addendum to the Addendum to the
Shareholders' Agreement between Investor Bund, dievini and DH
3.2 | Terms defined in this Addendum (including the list of parties and the preamble) shall have the same meaning when they are written in small caps. Terms written in small caps in this Addendum and not defined separately in this Addendum shall have the meaning assigned to them in the Shareholders’ Agreement. |
3.3 | This Addendum is subject to the laws of the Federal Republic of Germany. |
3.4 | Revisions or amendments to this Addendum or an agreement on its cancellation must be made in writing to be effective. The written form shall not be fulfilled in this respect by means of telecommunication transmission (fax), exchange of letters, electronic form (e-mail) or other text form (sec 126b German Civil Code (BGB)). The requirement of written form requirement agreed herein may only be waived, if the requirement of written form is complied with. Oral agreements do not exist. |
3.5 | Should individual provisions of this amended are or become invalid or unenforceable or should this Addendum contain gaps, the validity of the remaining provisions of this Addendum shall unaffected. In place of the invalid, unenforceable or missing provision, such valid provision shall be deemed to be agreed which the parties would reasonably have agreed upon if they had been aware of the invalidity, unenforceability or gap at the time of conclusion of this Addendum. If any provision of this Addendum is or becomes invalid because of the scope of performance or time periods agreed therein, the scope of performance or time periods agreed in the provision shall be adjusted to the legally permissible scope(s) or periods which comes closest to the agreed scope(s) or measure. The parties agree that the above provisions not only represent a reversal of the burden of proof, but that § 139 BGB is waived in its entirety. |
- intentionally left blank -
Page 4of 6 |
Addendum to the Addendum to the
Shareholders' Agreement between Investor Bund, dievini and DH
Walldorf, 14.08.2020
/s/ Dietmar Hopp | |
Dietmar Hopp |
Frankfurt,
KfW
/s/ Dr. Nils Reichhelm | /s/ Dr. Elina Pradkhan | |
Dr. Nils Reichhelm | Dr. Elina Pradkhan |
Walldorf, ……………………….
dievini Hopp BioTech holding GmbH& Co KG represented by
dievini Verwaltungs GmbH, which in turn is represented by
/s/ Dietmar Hopp | /s/ Dr. Mathias Hothum | |
Dietmar Hopp | Dr. Mathias Hothum |
Page 5of 6 |
Addendum to the Addendum to the
Shareholders' Agreement between Investor Bund, dievini and DH
St. Leon-Rot, 14.08.2020
DH-LT Investments GmbH
/s/ Dietmar Hopp | |
Dietmar Hopp |
Page 6of 6 |
Exhibit 10.46
REDACTED
Certain identified information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
SECOND AMENDMENT TO
COLLABORATION
AND LICENSE
AGREEMENT
Dated 19 December 2019
BETWEEN
GENMAB B.V.
AND
CUREVAC AG
SECOND AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT
This SECOND AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT (“ Second Amendment”) is made the 15thnd day of December 2020 (“Second Amendment Effective Date”), by and between:
Genmab B.V., KvK no. 3016 9902, a Dutch corporation having its principal office at Uppsalalaan 15, 3584 CM Utrecht, the Netherlands (“Genmab”); and
CureVac AG, a German corporation having its principal office at Friedrich-Miescher-Strasse 15, 72076 Tübingen, Germany (“CureVac”).
(Genmab and CureVac are sometimes hereinafter referred to collectively as the "Parties" or individually as a "Party")
RECITALS:
A. | Genmab and CureVac entered into a Collaboration and License Agreement dated 19 December 2019 (the “Agreement”); and |
B. | Under the Agreement the Parties committed to negotiate and enter into a clinical supply agreement within [*****] after the Effective Date of the Agreement. |
C. | Genmab and CureVac then entered into a First Amendment to Collaboration and License Agreement dated 19 December 2019 (the “First Amendment”) to extend the deadline to negotiate and enter into a clinical supply agreement within [*****] after the Effective Date of the Agreement |
D. | Genmab and CureVac would like to again extend the term for entering into such clinical supply agreement. |
NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements herein contained, and for good and valuable consideration the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree to the following:
1. | Except as otherwise defined herein, the words and phrases in the Agreement shall have the same meaning in this Second Amendment. |
2. | The first sentence of Section 6.2 of the Agreement is hereby deleted in its entirety and replaced with the following: |
“6.2. No later than [*****], the Parties will enter into a clinical supply agreement and related agreements (including a quality agreement) according to which CureVac shall Manufacture or have Manufactured for Genmab by an approved subcontractor under Section 5.11 or by a CMO approved by Genmab, and will supply or have supplied to Genmab, Genmab’s demand for the Single Antibody Product which is the subject of the First Program Research Plan (whether related to the First Collaboration Target or any Replacement Target) to perform Clinical Phase I Studies (“Early Clinical Supply Agreement”). […]”
For avoidance of doubt, the remainder of Section 6.2 of the Agreement shall remain in effect unchanged.
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3. | This Second Amendment shall be subject to the same governing law as set forth in Section 17.4 of the Agreement. |
4. | Save as set forth in this Second Amendment, all other terms and conditions of the Agreement shall remain in full force and effect. |
5. | The Parties agree that this Second Amendment may be signed using a DocuSign® electronic signature. Such electronic signature is the legally binding equivalent to a Party’s handwritten signature and it has the same validity, enforceability and meaning as a handwritten signature and the Parties hereby waive any objection to the contrary. |
***
IN WITNESS WHEREOF, the Parties hereto have caused this Second Amendment to be executed and delivered as of the Second Amendment Effective Date.
Genmab B.V. | CureVac AG | |||
By: | /s/ Birgitte Stephensen | By: | /s/ Daniel Babka | |
Name: | Birgitte Stephensen | Name: | Daniel Babka | |
Title: | Senior Vice President, IPR & Legal | Title: | Senior Legal Counsel | |
By: | /s/ Dr. Ulrich Kruse | |||
Name: | Dr. Ulrich Kruse | |||
Title: | Senior Director IP Licensing |
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Exhibit 10.47
REDACTED
Certain identified information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
Amendment Three to Development and Option Agreement
This Amendment Three to the Development and Option Agreement (this "Amendment"), dated as of December 24, 2020 (the "Amendment Three Effective Date"), is made by and between CureVac AG, a German stock corporation with offices at Friedrich-Miescher-Strasse 15, 72076 Tübingen, Germany ("CureVac"), and Acuitas Therapeutics Inc., a British Columbia corporation with offices at 6190 Agronomy Road, Suite 405, Vancouver, British Columbia, V6T 1Z3, Canada ("Acuitas") and amends the Development and Option Agreement dated April 29, 2016 (as amended by Side Agreement and Amendment Number One dated December 1, 2016 and Amendment Two to the Development and Option Agreement dated July 10, 2020) between CureVac and Acuitas (as amended, the “Development and Option Agreement”). Each of CureVac and Acuitas may be referred to herein as a "Party" or together as the "Parties."
WHEREAS, Acuitas and CureVac entered into the Development and Option Agreement relating to the evaluation of and options to license Acuitas LNP Technology for the research, development, manufacture and/or commercialisation of products incorporating Acuitas LNP Technology and CureVac Technology;
WHEREAS, pursuant to the Side Agreement and Amendment Number One dated December 1, 2016 to the Development and Option Agreement, Acuitas and CureVac agreed, inter-alia, to include in the Work Plan the evaluation of Acuitas LNP Technology together with CureVac Technology relating to Gene Editing and to discuss and negotiate in good faith the terms and conditions under which the Development and Option Agreement will be amended to encompass Licensed Products useful for Gene Editing purposes;
WHEREAS, pursuant to Amendment Two to the Development and Option Agreement, Acuitas and CureVac agreed that CureVac will have the right to exchange up to [*****] Targets, and any associated [*****] Targets being the subject of Non-exclusive License Agreement(s), with [*****] alternate [*****] Targets and, optionally, any alternate [*****] Targets associated therewith for a period of [*****] from the Amendment Two Effective Date.
WHEREAS, CureVac and Acuitas now wish to amend the Development and Option Agreement to include therein the terms and conditions for Extension Term Options (as defined below);
NOW, THEREFORE, in consideration of the mutual covenants and representations contained herein, and for other good and valuable consideration, the amount and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
Section One.
Defined Terms and Amendment of Article 1 of the Development and Option Agreement.
1.1 | Capitalized terms not defined herein have the definitions set forth in the Development and Option Agreement. |
1.2 | The following new definitions are hereby added to Article 1 of the Development and Option Agreement: |
“1.12a “Base Term” means the period starting on April 29, 2016 and ending on April 29, 2021.”
“1.12b “Base Term Option” has the meaning set forth in Section 5.1.”
“1.32a “Extension Term” means the period starting on April 29, 2021 and ending on April 29, 2025.”
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“1.32b “Extension Term License Agreement” means each Non-exclusive License Agreement entered into by the Parties upon exercise by CureVac of an Extension Term Option as set forth in Section 5.1.”
“1.32c “Extension Term Option” has the meaning set forth in Sections 5.1.”
“1.32d “Extension Term Start Date” means April 29, 2021.”
1.3 | Each of the following definitions of the Development and Option Agreement are hereby replaced in their entirety with the respective following amended definition: |
“1.34 "FTE Costs" mean the actual FTEs employed by Acuitas in the conduct of the Works and Services multiplied by an annual rate per FTE equal to [*****] (U.S. $[*****]) for the Base Term and [*****] (U.S. $[*****]) for the Extension Term. Such FTE Costs represent reimbursement for all costs of providing the Works and Services (including salaries, benefits, lab supplies, reagents, equipment and overhead, as well as other G&A costs).”
“1.56 “Option” means each Base Term Option or each Extension Term Option, as the case may be.”
“1.57 “Option Exercise Fee”,
(a) with respect to each Base Term Option, means: (i) with respect to each Non-exclusive License Agreement for which CureVac has exercised a Base Term Option in accordance with Article 5, [*****] (U.S, $[*****]); and (ii) with respect to each Exclusive License Agreement for which CureVac has exercised a Base Term Option to enter into in accordance with Article 5, [*****] (U.S. $[*****]). In addition, in the event that upon a Base Term Option exercise a License Agreement includes more than [*****] Targets, each [*****] Target in excess of [*****] will have an additional Option Exercise Fee under a Non-exclusive License Agreement of [*****] (U.S. $[*****]) [*****] (U.S. $[*****]) [*****] and under an Exclusive License Agreement an additional Option Exercise Fee of [*****] (U.S. $[*****]) [*****] (U.S. $[*****]) [*****]; and
(b) with respect to each Extension Term Option, for each Non-exclusive License Agreement for which CureVac has exercised an Extension Term Option in accordance with Article 5: (i) [*****] (U.S. $[*****]) for each such exercised Extension Term Option for a Licensed Product that is not a Licensed Vaccine Product; and (ii) [*****] (U.S. $[*****]) for each such exercised Extension Term Option for a for a Licensed Product that is a Licensed Vaccine Product. In addition, in the event that upon an Extension Term Option exercise a Non-exclusive License Agreement includes more than [*****] Targets, each [*****] Target in excess of [*****] will have an additional Option Exercise Fee under such a Non-exclusive License Agreement of [*****] (U.S. $[*****]) [*****] (U.S. $[*****]) [*****].”
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Section Two.
Amendment of Article 4 of the Development and Option Agreement.
2.1 | Sections 4.2(d) (ii) and (iii) of the Development and Option Agreement are hereby replaced in their entirety with the respective following amended Sections: |
“(ii) Maximum Number Reserved Targets. CureVac will have the right to select up to [*****] Targets to be subject to Base Term Options at any one time to be placed on the Reserved Target List provided no more than [*****] may be exclusive Reserved Targets. Furthermore, CureVac will have the right during the Extension Term to select up to an additional [*****] Targets to be subject to Extension Term Options at any one time to be placed on the Reserved Target List, but each of such [*****] Targets only as a non-exclusive Reserved Target.”
“(iii) Reserved Vaccine Target List. In the case of Targets intended to be used in a Licensed Vaccine Product, CureVac will notify the Escrow Agent of the [*****] Target and the [*****] Targets, if any. The [*****] Target will count as a single Reserved Target, however, [*****] Targets will not be counted against the total number of Reserved Targets available to CureVac, provided, however, that the total number of [*****] Targets on the Reserved Target List: (i) subject to Base Term Options cannot be more than [*****] at any time, of which not more than [*****] and (ii) subject to Extension Term Options cannot be more than [*****] of which up to [*****] can be [*****]. For the avoidance of doubt, if CureVac exercises an Option in respect of a License Agreement that includes [*****] Targets, the number of [*****] Targets on the Reserved Target List reduces respectively by the number of [*****] Targets included in such License Agreement.”
2.2 | Section 4.4 of the Development and Option Agreement is hereby replaced in its entirety with the following amended Section: |
“4.4 Fees.
(a) Target Reservation and Maintenance Fees. CureVac will pay to Acuitas the fees shown below per Contract Year for each Reserved Target added to the Reserved Target List pursuant to Section 4.2 as a non-exclusive Target:
(i) | [*****]; and |
(ii) | [*****]; and |
(iii) | [*****]; or |
(iv) | [*****]. |
or the fees shown below per Contract Year for each Reserved Target added to the Reserved Target List pursuant to Section 4.2 as an exclusive Target:
(v) | [*****]; and |
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(vi) | [*****]; and |
(vii) | [*****]. |
In the case of Targets for Vaccines, instead of the fees set forth in (i) to (vii) above, CureVac will pay to Acuitas the fees shown below per Contract Year for each non-exclusively Reserved [*****] Target added to the Reserved Target List pursuant to Section 4.2 together with each associated [*****] Target:
(viii) | [*****]; and |
(ix) | [*****]; and |
(x) | [*****]. |
(xi) | [*****]. |
or the fees shown below per Contract Year for each exclusively Reserved [*****] Target added to the Reserved Target List pursuant to Section 4.2 together with each associated [*****] Target:
(xii) | [*****]; and |
(xiii) | [*****]; and |
(xiv) | [*****].” |
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Section Three.
Amendment of Article 5 of the Development and Option Agreement.
3.1 | Section 5.1 of the Development and Option Agreement is hereby replaced in its entirety with the following amended Section: |
“5.1 Options. From the period commencing on the Effective Date and ending on the expiration of the Term (the "Option Period"), on a Reserved Target by Reserved Target basis, CureVac will have: (i) options originating from those granted during the Base Term (each a "Base Term Option), to enter into a maximum of [*****] License Agreements; and (ii) options originating from those granted during the Extension Term (each an “Extension Term Option”) to enter into a maximum of an additional [*****] Extension Term License Agreements in each case, under the Acuitas LNP Technology with respect to Licensed Product(s) containing mRNA Construct(s) intended to express such Reserved Targets in the applicable form (non-exclusive or exclusive as the case may be for Base Term Options and non-exclusive for Extension Term Options) set forth in Exhibit 1.54 and Exhibit 1.31, provided that the Exhibits to such template agreements are to be prepared or updated in accordance with the terms of the respective License Agreement and this Agreement. In the event CureVac opts for an exclusive license of a Reserved Target for Licensed Vaccine Products, the exercise notice will identify the [*****] Target and the [*****] Target(s), if any, and the exclusivity will apply with respect to the [*****] Target only. Such license will cover any combination of the [*****] Target, with or without and with one or several of the [*****] Targets, if any. CureVac may exercise each such Option by providing to Acuitas, prior to the expiration of the Term, written notice of Option exercise, setting forth the particular Reserved Target which is intended to be expressed by the Licensed Products (each such notice, an "Option Notice"). A separate Option Notice and Option Exercise Fee will be required for each License Agreement with respect to which CureVac exercises an Option pursuant to this Section 5.1, and CureVac will pay to Acuitas the Option Exercise Fee for each such License Agreement as set forth in Section 5.3. If not exercised prior to the expiration of the Term, the Options granted to CureVac under this Article 5 with respect to all Licensed Products will terminate in full and will no longer be exercisable. In the event that, during the Term, CureVac terminates a license(s) granted during the Base Term other than an Exchange License as set forth in Section 5.4, the Target(s) subject to the license(s) will be removed from the Reserved Target List and CureVac may during the Term replace such Target(s) on the Reserved Target List in accordance with Article 4 and may during the Term exercise a Base Term Option to take a license to such Target(s) in accordance with this Article 5, provided, however, that if CureVac terminates such license(s) and replaces such Target(s) during the Term, CureVac may only take a Non-exclusive License Agreement, and the financial terms applicable for an Extension Term License Agreement shall apply mutatis mutandis. In the event that CureVac terminates an Extension Term License Agreement(s) during the Extension Term, the Target(s) subject to the Extension Term License Agreement(s) will be removed from the Reserved Target List and CureVac may during the Extension Term replace such Target(s) on the Reserved Target List in accordance with Article 4 and may during the Extension Term exercise an Extension Term Option to take a Non-exclusive License Agreement to such Target(s) in accordance with this Article 5. For clarity no more than [*****] Base Term active License Agreements and no more than [*****] Extension Term active License Agreements can be held at any one time. For avoidance of doubt, milestones and fees paid with respect to any license that is terminated will not be creditable against any future Option exercise.”
3.2 | A new Section 5.5 is hereby appended to the end of Article 5 of the Development and Option Agreement as follows: |
“5.5 Extension Term Technology Access Fee. CureVac will pay to Acuitas a technology access fee for the Extension Term equal to Three Million Dollars (U.S. $3,000,000) payable within thirty (30) days of the Amendment Three Effective Date and Two Hundred and Fifty Thousand Dollars (U.S. $250,000) per Extension Term Option within [*****] of the first and second anniversaries of the Extension Term Start Date for each of the Extension Term Options not yet exercised on such anniversary.”
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Section Four.
Amendment of Article 9 of the Development and Option Agreement
Section 9.1 of the Development and Option Agreement is hereby replaced in its entirety with the following amended Section:
“9.1 Term. This Agreement will commence as of the Effective Date and, unless sooner terminated or extended in accordance with the terms hereof or by mutual written consent, will continue for a period of nine (9) years (the "Term").”
Section Five.
Amendment of the Exhibit 1.54 of the Development and Option Agreement
5.1 | Section 4.1 of Exhibit 1.54 of the Development and Option Agreement is hereby replaced in its entirety with the following amended Section, but only in respect of each Non-exclusive License Agreement that results from an exercise of an Extension Term Option. |
“4.1 Milestone Payments. Subject to any crediting as set forth in Section 4.2b, CureVac will make milestone payments (each, a "Milestone Payment") to Acuitas upon the first occurrence of each of the milestone events (each, a "Milestone Event") by Licensed Product as set forth below in the respective table of this Section 4.1, as is applicable to whether the respective Licensed Product is a Licensed Vaccine Product or not. CureVac will notify Acuitas of the achievement of each Milestone Event within [*****] of such achievement. Each Milestone Payment will be payable to Acuitas by CureVac within [*****] of the achievement of the specified Milestone Event and receipt of a respective invoice from Acuitas, and such payments when owed or paid will be non-refundable and non-creditable. If one or more of the Milestone Events set forth below are not achieved or not required for any reason, the payment for such skipped Milestone Event will be due [*****]. The maximum total of all Milestone Payments for all Licensed Products that all are not Licensed Vaccine Products payable under this License Agreement is U.S.$ [*****]. The maximum total of all Milestone Payments for all Licensed Products that all are Licensed Vaccine Products payable under this License Agreement is U.S.$ [*****], provided, however, that such maximum amounts do not apply in the event CureVac elects the Alternative Royalty, as set forth below.
Milestone Event for Licensed Products not | Milestone Payment |
being Licensed Vaccine Products | |
[*****] | [*****] |
[*****] | [*****] |
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Milestone Event for Licensed Products not | Milestone Payment |
being Licensed Vaccine Products | |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
Milestone Event for Licensed Vaccine Products | Milestone Payment |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
” |
5.2 | A new Section 4.2b is hereby added after Section 4.2 of Exhibit 1.54 of the Development and Option Agreement as follows, but only in respect of each Non-exclusive License Agreement that results from an exercise of an Extension Term Option. |
“4.2b License Maintenance Fee. On the [*****] anniversary of the Effective Date, and on each of the next [*****] subsequent anniversaries thereof, Acuitas shall be due a license maintenance fee from CureVac, for maintaining the license for [*****] starting on such anniversary, in an amount of: (i) [*****] (U.S. $[*****]) per year for this License Agreement being in respect of Licensed Product that is not Licensed Vaccine Product; or (ii) [*****] (U.S. $[*****]) per year for this License Agreement being in respect of Licensed Product that is Licensed Vaccine Product (each, a “License Maintenance Fee”); provided however, that in each case no such License Maintenance Fee shall be due or payable [*****]. Any License Maintenance Fees due under this License Agreement will be payable to Acuitas by CureVac within [*****] of receipt of a respective invoice from Acuitas issued within [*****] of the respective anniversary, and any and all such License Maintenance Fees actually paid will be creditable, up to a maximum amount of: (a) [*****] (U.S. $[*****]) for Licensed Product that is not Licensed Vaccine Product; or (b) [*****] (U.S. $[*****] for Licensed Product that is Licensed Vaccine Product, in each case against the Milestone Payment payable under this License Agreement in respect of the [*****].”
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5.3 | Section 4.3(a) of Exhibit 1.54 of the Development and Option Agreement is hereby replaced in its entirety with the following amended Section, but only in respect of each Non-exclusive License Agreement that results from an exercise of an Extension Term Option. |
“(a) Royalty. Subject to the remainder of this Section 4.3, on a country-by-country basis and a Covered Product-by-Covered Product basis, "Covered Product" being a Licensed Product which is Covered by one or more Valid Claims, CureVac will pay to Acuitas a royalty of [*****] ([*****]%) of Net Sales of the Covered Product that is not a Licensed Vaccine Product, or will pay to Acuitas a royalty of [*****] ([*****]%) of Net Sales for the Covered Product that is a Licensed Vaccine Product. On a country-by-country basis, in the event a Licensed Product is not a Covered Product in such country, CureVac will pay to Acuitas a royalty on Net Sales equal to the Minimum Royalty set forth in subsection (c) below.”
5.4 | Section 4.3(c) of Exhibit 1.54 of the Development and Option Agreement is hereby replaced in its entirety with the following amended Section, but only in respect of each Non-exclusive License Agreement that results from an exercise of an Extension Term Option. |
“(c) Minimum Royalty. Except as set forth in subsection (d) below, in no event will the Royalty payable by CureVac to Acuitas for any Licensed Product (whether or not a Covered Product) be less than: (i) [*****] ([*****]%) for any Licensed Product that is not a Licensed Vaccine Product; (ii) or [*****] ([*****]%) for any Licensed Product that is a Licensed Vaccine Product.”
5.5 | Section 4.3(d) of Exhibit 1.54 of the Development and Option Agreement is hereby replaced in its entirety with the following amended Section, but only in respect of each Non-exclusive License Agreement that results from an exercise of an Extension Term Option. |
“(d) Alternative Royalty. If CureVac sublicenses a Licensed Product to a Sublicensee, CureVac may elect to substitute the royalty payments set forth in subparagraphs (a) and (c) above for alternative royalty payments consisting of all of the payments set forth in this subparagraph (d) (each or collectively, as applicable, the “Alternative Royalty/ies”). CureVac will be entitled to make such election by providing Acuitas with written notice thereof within [*****] of the effective date of the respective sublicense, and cannot change such election afterwards, provided that if CureVac grants several sublicenses under a License Agreement, such election can be made separately for each sublicense.
(i) Sublicensee Royalties. CureVac will pay to Acuitas, on a Calendar Quarter-by-Calendar Quarter basis, [*****] ([*****]%) of the net royalty payments that CureVac actually receives from such Sublicensee for net sales of Licensed Product under the sublicense hereunder after any deductions for royalties CureVac actually pays under any license agreement for Technology that Covers a Licensed Product and CureVac or its Affiliate or Sublicensee, in its reasonable judgment, considers it necessary or useful to obtain a license to develop, manufacture or commercialize such Licensed Product (“Revised Royalty”). CureVac warrants to Acuitas that it will use commercially reasonable efforts to maximize royalties in sublicensing transactions in which it elects to pay Alternative Royalties.
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(ii) Sublicensee Upfront Payments. In the event that CureVac elects to take a Revised Royalty, CureVac will, in addition to the Revised Royalty, pay Acuitas [*****] ([*****]%) of the Upfront Payments actually received by CureVac from such Sublicensee for such sublicense rights. “Upfront Payments” means the [*****].
(iii) Sublicensee Sales-based Milestones. In addition, in the event and to the extent such sublicense hereunder includes Sales-based Milestones for Licensed Product, CureVac will pay to Acuitas [*****] ([*****]%) of such sales-based milestones as CureVac actually receives from such Sublicensee. “Sales-based Milestones” means milestone payment based on net sales, units sold, market share or any other commercial measure.”
(iv) For avoidance of doubt, if CureVac elects Alternative Royalties for a Third Party sublicense with respect to Licensed Products, the Revised Royalty, the Upfront Payments and the Sales-based Milestones will include all royalty, upfront payments and sales based milestones received by CureVac from such Sublicensee for such Licensed Products, including royalty and upfront payments made in consideration for the license to the CureVac Technology required for the Licensed Products subject to the Alternative Royalty.
5.6 | Section 4.4(c) of Exhibit 1.54 of the Development and Option Agreement is amended by appending the following text to its end, but only in respect of each Non-exclusive License Agreement that results from an exercise of an Extension Term Option or exercise of a Base Term Option for which financial terms of an Extension Term License Agreement apply. |
“In the event that CureVac elects to substitute the royalties payments set forth in subparagraphs (a) and (c) of Section 4.3 above for the Alternative Royalty, then (x) in addition to the foregoing reporting obligations, CureVac shall (a) furnish Acuitas an alternative written report (“Alternative Report”) for each Calendar Quarter showing the amount of Revised Royalty, Upfront Payment and/or Sales-based Milestones (as applicable) received from the respective Sublicensee and the Alterative Royalty due for such Calendar Quarter and (b) a reasonably redacted copy of such sublicense agreement as set forth in Section 2.3(b)(ii), but disclosing all financial terms. Alternative Reports shall be provided within [*****] of the end of the Calendar Quarter for which any Alternative Royalties are due; and (y) notwithstanding the foregoing payment obligation, instead, Alternative Royalty payments for each such Calendar Quarter shall be due at the same time as the Alternative Reports for such Calendar Quarter.”
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5.7 | For clarity, any Non-exclusive License Agreement for which Base Term Option license financial terms apply, Article 4 of Exhibit 1.54 of the Development and Option Agreement shall remain in the form as set forth in Article 4 of Exhibit 1.54 of the Development and Option Agreement on the Effective Date. |
Section Six.
Amendment of the
definition of “Sublicensee” in each of Exhibits 1.31, 1.54 of the Development and
Option Agreement and each License Agreement
6.1 | Each of: (i) definition 1.52 of Exhibit 1.31 of the Development and Option Agreement; (ii) definition 1.52 of Exhibit 1.54 of the Development and Option Agreement; and (iii) definition 1.52 of each and all License Agreements entered into between the Parties prior to the Amendment Three Effective Date is hereby replaced in its entirety with the following amended definition: |
“1.52 “Sublicensee” means any Third Party that is granted a sublicense as permitted by Section 2.3, either directly by CureVac or its Affiliates or indirectly by any other Sublicensee hereunder.”
Section Seven.
Miscellaneous.
Except as amended hereby, all other provisions of the Development and Option Agreement (including Exhibit 1.54 thereof) shall remain unchanged and in full force and effect in accordance with their terms. In the event of a conflict between the terms and conditions of this Amendment and the terms and conditions of the Development and Option Agreement, the terms and conditions of this Amendment shall control.
This Amendment may be executed simultaneously in two (2) or more counterparts, and by PDF or other electronic transmission, each of which counterparts shall be deemed an original, but all of which together shall constitute one and the same instrument, provided that all such counterparts, in the aggregate, shall contain the signatures of all parties hereto.
[Signature page to follow]
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IN WITNESS WHEREOF, the parties have duly executed this Amendment as of the date first written above.
CUREVAC AG
By: | /s/ [*****] | ||
(Signature) | |||
Name: | [*****] | ||
Title: | [*****] |
By: | /s/ [*****] | ||
(Signature) | |||
Name: | [*****] | ||
Title: | [*****] |
ACUITAS THERAPEUTICS INC.
By: | /s/ [*****] | ||
(Signature) | |||
Name: | [*****] | ||
Title: | [*****] |
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Exhibit 10.48
REDACTED
Certain identified information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
Amendment Number 1
To the "Framework Partnering Agreement" Dated 15 February 2019
(CEPI Identification #: [•])
Summary
COUNTERPARTY INFORMATION | |
Name: | CureVac AG (“Partner”) |
Mailing Address: | [*****] |
Project Lead: | [*****] |
Management Contact: | [*****] |
CEPI INFORMATION | |
Name: | Coalition for Epidemic Preparedness Innovations ("CEPI") |
Mailing Address: | PO Box 123 Torshov, N-0412 Oslo, Norway |
Visiting Address: | Marcus Thranes gate 2, N-0412 Oslo, Norway |
Project Lead: | [*****] |
Management Contact: | [*****] |
AMENDMENT AGREEMENT INFORMATION | |
Project Name | Vaccine Platform Development |
CEPI Programme Name | |
Effective Date | Date of last signature below |
This Amendment: | The Amendment Number 1 means this Summary sheet together with the following pages. |
THIS AMENDMENT NUMBER 1 is made by and between Partner and CEPI, either of which may be referred to individually as a "Party" and together as the "Parties."
Recitals:
A. | This Amendment Number 1 amends the Framework. Partnering Agreement between the Parties having an effective date of 15 February 2019 ("FPA"). |
B. | The Parties wish to make certain amendments to the FPA to facilitate the development and commercialization of Partner's COVID-19 vaccine candidate ("CVnCoV"), the initial development of which is described in the "Work Package Statement for the Development of CureVac Outbreak Response to Novel Coronovirus (2019-nCoV)" having an effective date of 29 January 2020. For convenience, this Work Package is referred to as the "CVnCoV Work Package." |
C. | The Parties contemplate that Partner shall negotiate and sign one or more agreements to provide CVnCoV to organizations operating under the auspices of the COVAX Facility. Such organizations presently include Gavi and UNICEF. |
D. | The FPA is amended as follows only for CVnCoV. For the avoidance of doubt, the following amendments shall not be applicable to any vaccine covered by the FPA other than CVnCoV and shall not be applicable to the results of any Work Package other than the CVnCoV Work Package. |
Agreement:
1. | Trusted Manufacturers. The FPA provisions related to trusted manufacturers in Clauses 7.6 (Trusted Manufacturers), 7.7 (Partner Nominees for Trusted Manufacturers), 7.8 (CEPI Nominees for Trusted Manufacturers), 7.9 (Additional Trusted Manufacturers) and 7.10 (Disputes as to Trusted Manufacturers) as well as Section 7.5 (Meetings with Regulatory Authorities) are waived for CVnCoV. For the avoidance of doubt, Partner maintains the full right to partner the vaccine for further development (i.e., beyond the CVnCoV Work Package), manufacture, distribution and commercialisation subject only to Partner's various obligations in this Amendment Number 1 and the FPA. |
2. | Reporting Requirements. The FPA provisions related quarterly reports in Clause 7.11.5 (Quarterly Reports) are waived for CVnCoV. Notwithstanding the foregoing, Partner shall submit an annual report. In lieu of the obligations under Section 7.5, Partner shall inform CEPI of the outcome of any major meetings with Regulatory Authorities, and any significant communications from Regulatory Authorities relating to the Platform and/or CVnCoV. |
3. | Notification and Approval of Additional Funders. The FPA provisions related to notification and prior written consent requirement of CEPI regarding other funders and supporters in Clause 7.11.10 (Partner Funder Requirements) and Clause 3.11 (Third Party funding or support of the Project) are waived for CVnCoV. | |
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4. | Achieving Equitable Access. A new Section 7.11.16 (Achieving Equitable Access) is added after Clause 7.11.15 (Regulatory Filings - which is waived for CVnCoV) to apply only for CVnCoV: |
"7.11.16. Achieving Equitable Access for Utilization of CVnCoV.
(i) | Equitable access commitments of Partner pursuant to Clause 7.11.9 (iv) to (vi) shall be considered to be fulfilled upon (a) the timely, and good faith participation in the 2021 UNICEF/PAHO tender, and any subsequent corresponding tender for 2022 and 2023 (if applicable); and (b) if such tenders are successful, supply of Partner's capacity for distribution of CVnCoV vaccine based on the following terms: |
- For 2021 10%, through participation in the currently ongoing UNICEF/PAHO tender process;
- For 2022 and 2023 (if applicable) 15%, through participation in the applicable COVAX process (i.e., Gavi/UNICEF/PAHO, as applicable)
with a priority towards Gavi/LICs, and at tiered prices, in both cases as may be agreed in the tender process.
(ii) | Partner to participate in the ongoing UNICEF/PAHO tender to secure up to [*****] doses of COVID vaccine in 2021. Of Partner's planned total capacity for distribution of CVnCoV vaccines in 2021 (est. [*****] mds.), 10% allocation (est. [*****] mds.) to the UNICEF/PAHO tender starting in Q3 2021. |
(iii) | For the avoidance of doubt, the definitive number of doses and pricing for the supply of the CVnCoV vaccine shall be as determined by agreement between Partner and Gavi/UNICEF/PAHO, and will be no higher than the lowest price charged by Partner for the sale of CVnCoV vaccines to a third party of a similar volume and to a country of similar income level. |
(iv) | Proposed pricing by Partner for negotiations with Gavi/UNICEF/PAHO for supply in 2021: |
- [*****]
- [*****]
- [*****]
- [*****]
(v) | Supply of CVnCoV vaccines in 2022 based on the same principles, but providing up to 15% of Partner's capacity for distribution of CVnCoV vaccine (est. [*****] mds.), at the same pricing as 2021. |
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(vi) | Partner makes no supply commitments beyond 2022, except as may be agreed between Partner and Gavi/UNICEF/PAHO. | |
(vii) | The commitment to participate in the tender / negotiate with Gavi/UNICEF/PAHO Facility shall remain binding on Partner through [*****] and continue as long as good faith negotiations between the parties continue. |
(viii) | Terms and conditions of supply of CVnCoV doses must be made in a timely manner that enables COVAX represented economies to receive the vaccine as soon as reasonably possible after receipt of Marketing Authorization, respecting Partner's existing contractual obligations, and latest [*****]. Partner will equally respect its supply commitments towards its customers that receive CVnCoV on a [*****], both with respect to timing and completeness of commitments. |
(ix) | Distribution of CVnCoV doses shall be made to any and all country income levels based upon COVAX country participation and associated allocation model. |
(x) | For the avoidance of doubt, Partner is otherwise is free to dispose of the remaining doses of CVnCoV in its sole discretion. |
5. | Approvals for Contractors and Subcontractors. The FPA provisions related to approvals by the JMAG for the use of contractors and subcontractors in Clause 10.1 (Contractors and Sub-Contrators) are waived for CVnCoV. |
6. | Public Health License. The FPA provisions related to the public health license in Sections 11 (Public Health License) and 12 (Conditions Precedent and Exercise of the Public Health License) are waived for CVnCoV. |
7. | Commercial Benefit Sharing. The FPA provisions related to the sharing of commercial benefits in Section 13 (Commercial Benefits Arising from Commercial Use) are waived for CVnCoV. |
8. | No Additional Funding from CEPI. For the avoidance of doubt, CEPI will not provide any additional funding beyond the previously agreed $15.3M for the CVnCoV Work Package. |
Save as set out above, all terms and conditions of the FPA shall remain unchanged and shall remain in full force and effect.
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Signed for and on behalf of COALITION FOR EPIDEMIC PREPAREDNESS INNOVATIONS by:
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Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
We consent to the reference to our firm under the caption “Experts” and to the use of our report dated April 29, 2020 (except Note 1, as to which the date is November 27, 2020), with respect to the consolidated financial statements of CureVac AG, included in the Registration Statement (Form F-1) and related Prospectus of CureVac N.V. for the registration of its common shares.
/s/ Ernst & Young GmbH Wirtschaftsprüfungsgesellschaft
Stuttgart, Germany
January 25, 2021