What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2021-03-05 compared with 2020-03-16 · 118 added, 74 removed, 136 unchanged (59% of the section changed)

2 unchanged sentences

Under the supervision of and with the participation of our management, including our chief executive officer, who is our principal executive officer, and our chief financial officer, who is our principal financial officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of December 31, 2020, the end of the period covered by this Annual Report.

The term “disclosure controls and procedures,”

as set forth in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to provide reasonable assurance that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms promulgated by the Securities and Exchange Commission (the “SEC”).

Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.

The term “disclosure controls and procedures,” as set forth in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to provide reasonable assurance that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms promulgated by the Securities and Exchange Commission (the “SEC”).

Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

2 unchanged sentences

There was no change 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 has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

As we are no longer an emerging growth company and adapted our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act, we identified a material weakness in our internal control over financing reporting during the fourth quarter of 2019 related to inventory controls.

This was successfully remediated during the same quarter of 2019.

As a result, we have no material weaknesses in internal control over financial reporting at December 31, 2019, which aligns with our independent registered public accounting firm’s attestation report included elsewhere in this Annual Report on Form 10-K, which is required to include disclosure of any material weaknesses identified by the Company in its internal control over financial reporting that existed at the reporting date.

Management’s Report on Internal Control over Financial Reporting and Attestation Report of the Registered Public Accounting Firm

As we are no longer an emerging growth company and adapted our system of internal controls over financial reporting pursuant to Section 404(a) of the Sarbanes-Oxley Act, we did not identify any material weakness in our internal control over financing reporting at December 31, 2020.

Management’s Report on Internal Control over Financial Reporting and Attestation Report of the Registered Public Accounting Firm

Our management is responsible for establishing and maintaining adequate internal control over financial reporting.

1 unchanged sentence

Based on our evaluation under this framework, our management concluded that our internal control over financial reporting was effective as of December 31, 2020.

The Annual Report on Form 10-K includes an attestation report of our independent registered public accounting firm regarding internal control over financial reporting, which appears in Part II, Item 8 of this Annual Report on Form 10-K.

As a “smaller reporting company” and a “non-accelerated filer,” we are exempt from the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002.

As a result, Ernst & Young LLP, our independent registered public accounting firm, has not audited or issued an attestation report with respect to the effectiveness of our internal control over financial reporting as of December 31, 2020.

Other Information

Not applicable.

On March 3, 2021, the Board of Directors of the Company adopted an amendment to the Company’s Amended and Restated Bylaws (the “Bylaw Amendment”), to add a new Section 47, which provides that, unless the Company consents in writing to the selection of an alternative forum, to the fullest extent permitted by law, the federal district courts of the United States of America shall be the sole and exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended.

We will file a definitive Proxy Statement for our 2021 Annual Meeting of Stockholders, or the 2021 Proxy Statement, with the SEC, pursuant to Regulation 14A, not later than 120 days after the end of our fiscal year.

2 unchanged sentences

Directors, Executive Officers and Corporate Governance.

The information required by Item 10 is hereby incorporated by reference to the sections of the 2020 Proxy Statement under the captions “Information Regarding the Board of Directors and Corporate Governance,”

“Election of Directors,”

“Information about our Executive Officers”

and “Section 16(a) Beneficial Ownership Reporting Compliance.

The information required by Item 10 is hereby incorporated by reference to the sections of the 2021 Proxy Statement under the captions “Information Regarding the Board of Directors and Corporate Governance,” “Election of Directors,” “Information about our Executive Officers” and “Section 16(a) Beneficial Ownership Reporting Compliance.

Executive Compensation.

The information required by Item 11 is hereby incorporated by reference to the sections of the 2020 Proxy Statement under the captions “Executive Compensation”

and “Non-Employee Director Compensation.”

The information required by Item 11 is hereby incorporated by reference to the sections of the 2021 Proxy Statement under the captions “Executive Compensation” and “Non-Employee Director Compensation.”

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

The information required by Item 12 is hereby incorporated by reference to the sections of the 2020 Proxy Statement under the captions “Security Ownership of Certain Beneficial Owners and Management”

and “Securities Authorized for Issuance under Equity Compensation Plans.”

The information required by Item 12 is hereby incorporated by reference to the sections of the 2021 Proxy Statement under the captions “Security Ownership of Certain Beneficial Owners and Management” and “Securities Authorized for Issuance under Equity Compensation Plans.”

Certain Relationships and Related Transactions and Director Independence.

The information required by Item 13 is hereby incorporated by reference to the sections of the 2020 Proxy Statement under the captions “Transactions with Related Persons”

and “Independence of the Board of Directors.”

The information required by Item 13 is hereby incorporated by reference to the sections of the 2021 Proxy Statement under the captions “Transactions with Related Persons” and “Independence of the Board of Directors.”

Principal Accounting Fees and Services.

The information required by Item 14 is hereby incorporated by reference to the sections of the 2020 Proxy Statement under the caption “Ratification of Selection of Independent Registered Public Accounting Firm.”

The information required by Item 14 is hereby incorporated by reference to the sections of the 2021 Proxy Statement under the caption “Ratification of Selection of Independent Registered Public Accounting Firm.”

Exhibits and Financi al Statement Schedules.

5 unchanged sentences

Description of Document

Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on March 23, 2016).

Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on March 23, 2016).

Certificate of Amendment to Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.3 to the Registrant’s Quarterly Report on Form 10-Q for the Quarter ended June 30, 2018 (File No.

001-37717) filed on August 8, 2018).

Registration Rights Agreement by and among the Registrant and certain of its stockholders, dated as of December 7, 2015 (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No.

Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on August 18, 2020).

Certificate of Amendment to Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on October 26, 2020).

Form of Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on November 9, 2020).

Bylaw Amendment

333-198168) filed on December 10, 2015).

Base Indenture, dated January 30, 2018, between the Registrant and U.S.

Bank National Association, as Trustee (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on January 30, 2018).

First Supplemental Indenture, dated January 30, 2018, between the Registrant and U.S.

Bank National Association, as Trustee (including the form of 5.25% convertible senior subordinated notes due 2023) (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on January 30, 2018).

Second Supplemental Indenture, dated July 25, 2019, between the Registrant and U.S.

Bank National Association, as Trustee (incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on July 27, 2019).

Description of Document

Indenture, dated July 25, 2019, between the Registrant and U.S.

Bank National Association, as Trustee (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on July 29, 2019).

Form of Note representing the Company’s 5.25% Convertible Senior Notes due 2025 (included as Exhibit A to the Indenture filed as Exhibit 4.1), filed with the Commission on July 29, 2019).

Form of Note representing the Company’s 5.25% Convertible Senior Notes due 2025 (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No.

001-37717), filed with the Commission on July 29, 2019).

Registration Rights Agreement, dated as of August 9, 2020, by and between the Registrant and PHC Holding Corporation (incorporated herein by reference to Exhibit 4.1 to Amendment No.

1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717), filed with the Commission on August 31, 2020).

Registration Rights Agreement, dated as of August 9, 2020, by and between the Registrant and certain purchasers named therein (incorporated herein by reference to Exhibit 4.2 to Amendment No.

1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717), filed with the Commission on August 31, 2020).

Investor Rights Agreement, dated as of August 9, 2020, by and between the Registrant and PHC Holding Corporation (incorporated herein by reference to Exhibit 4.3 to Amendment No.

1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717), filed with the Commission on August 31, 2020).

Investor Rights Agreement, dated as of August 9, 2020, by and between the Registrant and PHC Holding Corporation (incorporated herein by reference to Exhibit 4.4 to Amendment No.

1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717), filed with the Commission on August 31, 2020).

Description of Senseonics Holdings, Inc.

Common Stock.

Lease Agreement, dated as of February 4, 2008, by and between Senseonics, Incorporated and Seneca Meadows Corporate Center III Limited Partnership, as amended by the First Amendment to Lease, dated as of September 25, 2012 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

Common Stock (incorporated by reference to Exhibit 4.7 to the Registrant’s Annual Report on Form 10-K (File No.

001-37717) filed on March 16, 2020).

333-198168) filed on December 10, 2015).

Description of Document

Second Amendment to Lease, by and between Senseonics, Incorporated and Seneca Meadows Corporate Center III L.L.L.P., dated as of January 21, 2016 (incorporated by reference to Exhibit 10.1.1 to Amendment No.

1 to the Registrant’s Registration Statement on Form S-1 (File No.

333-208984) filed on February 17, 2016).

Amended and Restated 1997 Stock Option Plan of Senseonics, Incorporated, as amended to date (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

Form of Incentive Stock Option Agreement under Senseonics, Incorporated Amended and Restated 1997 Stock Option Plan (incorporated by reference to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

Form of Nonqualified Stock Option Agreement under Senseonics, Incorporated Amended and Restated 1997 Stock Option Plan (incorporated by reference to Exhibit 10.5 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

2015 Equity Incentive Plan of Senseonics, Incorporated (incorporated by reference to Exhibit 10.6 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

Amended and Restated 2015 Equity Incentive Plan, (incorporated by reference to Exhibit 10.7 to the Registrant’s Registration Statement on Form S-8 (File No.

333-210586) filed on April 4, 2016).

Form of Stock Option Grant Notice and Stock Option Agreement under 2015 Equity Incentive Plan (incorporated by reference to Exhibit 10.7 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under 2015 Equity Incentive Plan (incorporated by reference to Exhibit 10.8 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

Form of Indemnification Agreement between the Registrant and its directors and executive officers (incorporated by reference to Exhibit 10.9 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

Description of Document

Amended and Restated Executive Employment Agreement by and between Senseonics, Incorporated and Timothy T.

Goodnow, dated as of July 24, 2015 (incorporated by reference to Exhibit 10.10 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

Amended and Restated Executive Employment Agreement by and between Senseonics, Incorporated and Mukul Jain, dated as of July 30, 2015 (incorporated by reference to Exhibit 10.11 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

Executive Employment Agreement by and between Senseonics, Incorporated and Mirasol Panlilio, dated as of August 10, 2015 (incorporated by reference to Exhibit 10.12 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

Form of Secured Promissory Note issued to Oxford Finance LLC by Senseonics, Incorporated, dated as of July 31, 2014 and December 23, 2014 (incorporated by reference to Exhibit 10.15 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

Form of Secured Promissory Note issued to Oxford Finance LLC by Senseonics, Incorporated, dated as of December 7, 2015 (incorporated by reference to Exhibit 10.16 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

Form of Replacement Warrant to Purchase Common Stock issued to Oxford Finance LLC by Senseonics, Incorporated, dated as of December 7, 2015 (incorporated by reference to Exhibit 10.17 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

Form of Warrant to Purchase Preferred Stock issued by Senseonics, Incorporated in bridge loan financings (incorporated by reference to Exhibit 10.18 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

Form of 2016 Employee Stock Purchase Plan (incorporated by reference to Exhibit 4.10 to the Registrant’s Registration Statement on Form S-8 (File No.

333-210586) filed on April 4, 2016).

Non-Employee Director Compensation Policy, as amended (incorporated by reference to Exhibit 10.19 to the Registrant’s Annual Report on Form 10-K (File No.

333-198168) filed on March 15, 2019).

Description of Document

Letter Agreement, by and among the Registrant, Senseonics, Incorporated and Stephen P.

DeFalco, dated June 20, 2016 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on June 21, 2016) .

Restricted Stock Award Grant Notice and Restricted Stock Award Agreement, by and between the Registrant and Stephen P.

DeFalco, dated June 20, 2016 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on June 21, 2016) .

Distribution Agreement, by and among Senseonics, Incorporated, Roche Diagnostics International AG and Roche Diabetes Care GmbH, dated as of May 24, 2016 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-37717) filed on August 9, 2016).

Form of Warrant to Purchase Stock issued by the Registrant to Oxford Finance LLC and Silicon Valley Bank, dated as of June 30, 2016 (incorporated by reference to Exhibit 10.5 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-37717) filed on August 9, 2016) .

Amendment to Distribution Agreement, by and among Senseonics, Incorporated, Roche Diagnostics International AG and Roche Diabetes Care GmbH, dated as of November 28, 2016 (incorporated by reference to Exhibit 10.28 to the Registrant’s Annual Report on Form 10-K (File No.

001-37717) filed on February 23, 2017).

Open Market Sales Agreement, dated November 27, 2019, by and between the Registrant and Jefferies LLC (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on November 27, 2019) .

Registration Rights Agreement, dated as of July 25, 2019, by and among the Company, the Subsidiary and Jefferies LLC (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717), filed with the Commission on July 29, 2019).

Loan and Security Agreement among Solar Capital Ltd., the Lenders, Senseonics, Incorporated and the Company dated as of July 16, 2019 (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717), filed with the Commission on July 17, 2019).

Form of Warrant issued pursuant to the Solar Loan Agreement (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No.

001-37717), filed with the Commission on July 29, 2019).

Executive Employment Agreement, by and between Senseonics, Incorporated and Francine Kaufman, effective as of May 4, 2019 (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-37717) filed with the Commission on May 9, 2019).

Fourth Amendment to Distribution Agreement, dated as of January 31, 2019, by and among Senseonics, Incorporated, Roche Diagnostics International AG, Basel Branch Diabetes Care and Roche Diabetes Care GmbH (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-37717) filed with the Commission on May 9, 2019).

Senseonics Holdings, Inc.

Inducement Plan (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717), filed with the Commission on June 5, 2019).

Form of Stock Option Grant Notice and Stock Option Agreement used in connection with the Senseonics Holdings, Inc.

Inducement Plan (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No.

001-37717), filed with the Commission on June 5, 2019).

Fifth Amendment to Distribution Agreement, by and among Senseonics, Incorporated, Roche Diagnostics International AG and Roche Diabetes Care GmbH, dated as of December 12, 2019.

Amended and Restated Employment Agreement, by and between Senseonics, Incorporated and Nick B.

Tressler, effective as of November 12, 2019.

Tressler , effective as of November 12, 2019 (incorporated herein by reference to Exhibit 10.32 to the Registrant’s Annual Report on Form 10-K (File No.

0101-37717) filed with the Commission on March 16, 2020).

Description of Document

Registration Rights Agreement, dated as of April 21, 2020, by and between the Company and Highbridge Tactical Credit Master Fund, L.P.

(incorporated herein by reference to Exhibit 10.2 to Amendment No.

1 to the Registrant’s Annual Report on Form 10-K (File No.

001-37717) filed with the Commission on April 28, 2020).

Registration Rights Agreement, dated as of April 21, 2020, by and between the Company and Highbridge Tactical Credit Master Fund, L.P.

(incorporated herein by reference to Exhibit 10.3 to Amendment No.

1 to the Registrant’s Annual Report on Form 10-K (File No.

001-37717) filed with the Commission on April 28, 2020).

Loan and Security Agreement among Wilmington Savings Fund Society, SCB as collateral agent, Highbridge Tactical Credit Master Fund, L.P., the Company and the Subsidiary, dated as of April 21, 2020 (incorporated herein by reference to Exhibit 10.4 to Amendment No.

1 to the Registrant’s Annual Report on Form 10-K (File No.

001-37717) filed with the Commission on April 28, 2020).

Note Purchase and Exchange Agreement among Wilmington Savings Fund Society, SCB, as collateral agent, Highbridge Tactical Credit Master Fund, L.P., the Company and the Subsidiary, dated as of April 21, 2020 (incorporated herein by reference to Exhibit 10.5 to Amendment No.

1 to the Registrant’s Annual Report on Form 10-K (File No.

001-37717) filed with the Commission on April 28, 2020).

Form of Note representing the Registrant’s Secured Promissory Second Lien Notes (incorporated herein by reference to Exhibit 10.7 to Amendment No.

1 to the Registrant’s Annual Report on Form 10-K (File No.

001-37717) filed with the Commission on April 28, 2020).

Form of Warrant to Purchase Common Stock issued to Highbridge Tactical Credit Master Fund, L.P.

(incorporated herein by reference to Exhibit 10.8 to Amendment No.

1 to the Registrant’s Annual Report on Form 10-K (File No.

001-37717) filed with the Commission on April 28, 2020).

Note Purchase Agreement, dated as of August 9, 2020, by and between the Registrant and PHC Holding Corporation (incorporated herein by reference to Exhibit 10.1 to Amendment No.

1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed with the Commission on August 31, 2020).

Stock Purchase Agreement, dated as of August 9, 2020, by and between the Registrant and certain purchasers named therein (incorporated herein by reference to Exhibit 10.2 to Amendment No.

1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed with the Commission on August 31, 2020).

Equity Line Agreement by and between the Company and Energy Capital, LLC dated as of November 9, 2020 (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed with the Commission on November 9, 2020).

Warrant to purchase common stock of the Company by and between the Company and Energy Capital, LLC, dated as of November 9, 2020 (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed with the Commission on November 9, 2020).

Side Letter Agreement by and between the Company and certain purchasers named therein, dated as of November 9, 2020 (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed with the Commission on November 9, 2020).

Collaboration and Commercialization Agreement, by and between the Subsidiary and Ascensia Diabetes Care Holdings AG, dated as of August 9, 2020 (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-37717) filed with the Commission on November 9, 2020).

Form of Securities Purchase Agreement by and between the Company and certain purchases named therein, dated as of January 17, 2021 (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed with the Commission on January 19, 2021).

Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1 to the Registrant's Current Report on Form 8-K (File No.

1 unchanged sentence

Consent of Ernst & Young LLP, independent registered public accounting firm.

Power of Attorney (contained on signature page hereto).

Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002.

1 unchanged sentence

Description of Document

32.1* †

Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rules 13a- 14(b) and 15d-14(b) promulgated under the Securities Exchange Act of 1934 and 18 U.S.C.

6 unchanged sentences

XBRL Taxonomy Extension Presentation Linkbase Document

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

Filed herewith.

2 unchanged sentences

Indicates management contract or compensatory plan.

# Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment and have been separately filed with the Securities and Exchange Commission.

Certain portions of this exhibit, indicated by asterisks, have been omitted pursuant to Item 601(b)(10) of Regulation S-K because they are not material and would likely cause competitive harm to the registrant if publicly disclosed.

43 unchanged sentences

Francine Kaufman, M.D.

/s/ ROBERT SCHUMM

March 5, 2021

Robert Schumm

/s/ANTHONY RAAB

March 5, 2021

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures