Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Conclusions Regarding the Effectiveness of Disclosure Controls and Procedures
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements in accordance with GAAP. This Annual Report does not include a report of management’s assessment regarding internal control over financial reporting or an attestation report of the of the Company’s registered public accounting firm due to a transition period established by rules of the SEC for newly public companies. We will be required, under Section 404 of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting beginning with our Annual Report on Form 10-K for the year ending December 31, 2021. This assessment will need to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting. The SEC defines a material weakness as a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of a company’s annual or interim consolidated financial statements will not be detected or prevented on a timely basis.
In accordance with the provisions of the Sarbanes-Oxley Act, neither we nor our independent registered public accounting firm has performed an evaluation of our internal control over financial reporting during any period included in this annual report.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended December 31, 2020 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.
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Item 9B. Other Information
None.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this item is incorporated herein by reference to our Proxy Statement with respect to our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of the fiscal year covered by this Annual Report on Form 10-K.
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Item 11. Executive Compensation
The information required by this item is incorporated herein by reference to our Proxy Statement with respect to our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of the fiscal year covered by this Annual Report on Form 10-K
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Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this item is incorporated herein by reference to our Proxy Statement with respect to our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of the fiscal year covered by this Annual Report on Form 10-K.
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Item 13. Certain Relationships and Related Transactions and Director Independence
The information required by this item is incorporated herein by reference to our Proxy Statement with respect to our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of the fiscal year covered by this Annual Report on Form 10-K.
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Item 14. Principal Accountant Fees and Services
The information required by this item is incorporated herein by reference to our Proxy Statement with respect to our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of the fiscal year covered by this Annual Report on Form 10-K.
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PART IV
Item 15. Exhibits and Financial Statement Schedules
(1) Financial Statements:
The financial statements required by Item 15(a) are filed as part of this Annual Report on Form 10-K under Item 8 “Financial Statements and Supplementary Data.”
(2) Financial Statement Schedules
The financial statement schedules required by Item 15(a) are omitted because they are not applicable, not required or the required information is included in the financial statements or notes thereto as filed in Item 8 of this Annual Report on Form 10-K.
(3) Exhibits.
Exhibit
Number
Description
Form
File No.
Exhibit
Filing
Date
Filed/
Furnished
Herewith
3.1
Restated Certificate of Incorporation, dated March 3, 2020.
10-Q
001-39231
May 11, 2020
3.2
Amended and Restated Bylaws, dated March 26, 2020.
8-K
001-39231
March 27, 2020
4.1
Form of Common Stock Certificate
S-1/A
333-236214
February 18, 2020
4.2
Amended and Restated Investors' Rights Agreement, dated August 21, 2019, by and among the Registrant and certain of its stockholders.
S-1
333-236214
February 3, 2020
4.3
Description of Registrant’s Securities
X
10.1 †^
Development Services and Clinical Supply Agreement, dated April 13, 2020, by and between the Registrant and Catalent Maryland, Inc.
10-Q
001-39231
May 11, 2020
10.3
Lease, dated April 10, 2020, by and between the Registrant and Commerce Square Partners - Philadelphia Plaza, L.P.
10-Q
001-39231
May 11, 2020
10.4
First Amendment to Lease, dated April 10, 2020, by and between the Registrant and Philadelphia Plaza – Phase II LP
10-Q
001-39231
May 11, 2020
10.5
Form of Indemnification Agreement between the Registrant and its directors and officers
S-1
333-236214
February 3, 2020
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10.6
Amended and Restated 2018 Equity Incentive Plan, as amended, and forms of award agreements.
S-1
333-236214
February 3, 2020
10.7
2020 Equity Incentive Plan of the Registrant, and forms of award agreements.
S-1/A
333-236214
February 18, 2020
10.8
2020 Employee Stock Purchase Plan of the registrant
S-1/A
333-236214
February 18, 2020
10.9
Consulting Agreement, dated January 31, 2020, by and between the Registrant and Stephen Squinto, Ph.D.
S-1
333-236214
February 3, 2020
10.10
Amended and Restated Employment Agreement dated February 14, 2020, by and between the Registrant and Bruce Goldsmith.
S-1/A
333-236214
February 18, 2020
10.11
Amended and Restated Employment Agreement, dated February 14, 2020, by and between the Registrant and Gary Romano.
S-1/A
333-236214
February 18, 2020
10.12
Employment Agreement, dated January 18, 2019, as amended, by and between the Registrant and Jill Quigley.
X
10.13
Consulting Agreement, dated January 8, 2019, as amended on January 31, 2020, by and between the Registrant and James Wilson, M.D., Ph.D.
S-1
333-236214
February 3, 2020
10.14
Offer Letter, dated January 24, 2020, by and between the Registrant and Athena Countouriotis.
S-1
333-236214
February 3, 2020
10.15 †^
Amended and Restated Sponsored Research, Collaboration and License Agreement, dated May 5, 2020, by and between the Registrant and The Trustees of the University of Pennsylvania .
10-Q
001-39231
August 13, 2020
10.16 ^
Amendment No. 1, dated August 13, 2020, to the Amended and Restated Sponsored Research, Collaboration and License Agreement by and between the Registrant and the Trustees of the University of Pennsylvania
10-Q
001-39231
November 10, 2020
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10.17 ^
Amendment No. 2, dated November 2, 2020, to the Amended and Restated Sponsored Research, Collaboration and License Agreement by and between the Registrant and the Trustees of the University of Pennsylvania
S-1
333-252313
January 19, 2021
10.18 †^
Amendment No. 3, dated December 9, 2020, to the Amended and Restated Sponsored Research, Collaboration and License Agreement by and between the Registrant and the Trustees of the University of Pennsylvania
S-1
333-252313
January 19, 2021
10.19^
Lease, dated December 15, 2020 by and between the Registrant and Hopewell Campus Owner, LLC
8-K
001-39231
December 18, 2020
23.1
Consent of KPMG LLP, an independent registered public accounting firm.
X
24.1
Power of Attorney. Reference is made to the signature page hereto.
X
31.1
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
31.2
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
32.1*
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
X
32.2*
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
X
101.INS
XBRL Instance Document
X
101.SCH
XBRL Taxonomy Extension Schema Document
X
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101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document.
X
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document.
X
101.LAB
XBRL Taxonomy Extension Label Linkbase Document.
X
101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document.
X
†
Registrant has omitted portions of the exhibit as permitted under Item 601(b)(10) of Regulations S-K.
^
Registrant has omitted schedules and exhibits pursuant to Item 601(a)(5) of Regulation S-K. The Registrant agrees to furnish supplementally a copy of the omitted schedules and exhibits to the SEC upon request.
*
This certification is deemed not filed for purposes of section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
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Item 16. Form 10- K Summary.
Registrants may voluntarily include a summary of information required by Form 10-K under Item 16. We have elected not to include such summary.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) the Securities Exchange Act of 1934, the registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized.
PASSAGE BIO, INC.
Date: March 3, 2021
By:
/s/ Bruce Goldsmith, Ph.D
Name:
Dr. Bruce Goldsmith, Ph.D.
Title:
Chief Executive Office and President
Date: March 3, 2021
By:
/s/ Richard Morris
Name:
Richard Morris
Title:
Chief Financial Officer
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POWER OF ATTORNEY
Each person whose individual signature appears below hereby authorizes and appoints Bruce Goldsmith, Ph.D., Richard Morris and Edgar B. Cale, and each of them, with full power of substitution and resubstitution, as his or her true and lawful attorney-in-fact and agent to act in his or her name, place and stead and to execute in the name and on behalf of each person, individually and in each capacity stated below, and to file any and all amendments to this Annual Report on Form 10-K and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agents full power and authority to do and perform each and every act and thing, ratifying and confirming all that said attorney-in-fact and agents or his substitute or substitutes may lawfully do or cause to be done by virtue thereof. Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
/s/ Bruce Goldsmith, Ph.D
President, Chief Executive Officer and Director
March 3, 2021
Bruce Goldsmith, Ph.D
(Principal Executive Officer)
/s/ Richard Morris
Chief Financial Officer and Corporate Secretary
March 3, 2021
Richard Morris
(Principal Financial and Accounting Officer)
/s/ Tadataka Yamada, M.D.
Director
March 3, 2021
Tadataka Yamada, M.D.
/s/ Athena Countouriotis, M.D.
Director
March 3, 2021
Athena Countouriotis, M.D.
/s/ Patrick Heron
Director
March 3, 2021
Patrick Heron
/s/ Saqib Islam
Director
March 3, 2021
Saqib Islam
/s/ Sandip Kapadia
Director
March 3, 2021
Sandip Kapadia
/s/ Liam Ratcliffe M.D., Ph.D.
Director
March 3, 2021
Liam Ratcliffe M.D., Ph.D.
/s/ Maxine Gowen, Ph.D.
Director
March 3, 2021
Maxine Gowen, Ph.D.
/s/ Tom Woiwode, Ph.D.
Director
March 3, 2021
Tom Woiwode, Ph.D.
170