Outset Medical, Inc. 10-K

Item 9A. Controls and Procedures. Evaluation of Disclosure Controls and Procedures Our management, with the participation and supervision of our Chief Executive Officer and Chief Financial Officer, have evaluated the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15(e) and 15d-15(e) under the Exchange Act as of the end of the period covered by this Annual Report. Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including the Chief Executive Officer and the Chief Financial Officer, to allow timely decisions regarding required disclosures. Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of December 31, 2020. Management’s Annual Report on Internal Control over Financial Reporting This Annual Report does not include a report of management’s assessment regarding internal control over financial reporting or an attestation report of our independent registered public accounting firm due to a transition period established by the rules of the SEC for newly public companies. Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) 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 control over financial reporting. Item 9B. Other Information. None. 128 PART III Item 10. Directors, Executive Officers and Corporate Governance. The information required by this Item 10 with respect to executive officers may be found under the heading “Information About Our Executive Officers” in Part I, Item 1 of this Annual Report. We have adopted a code of conduct applicable to our principal executive, financial and accounting officers and all persons performing similar functions. A copy of our code of conduct is available on our principal corporate website at www.outsetmedical.com in the Investors section under “Corporate Governance”. We intend to post any required disclosures regarding an amendment to, or waiver from, a provision of our code of conduct on the same website. The remaining information required by this Item 10 is incorporated by reference from the sections entitled “ Board and Corporate Governance Matters,” “Audit Matters” and “ Delinquent Section 16(a) Reports ” to be included in our definitive proxy statement to be filed with the Securities and Exchange Commission in connection with our 2021 Annual Meeting of Stockholders within 120 days of our fiscal year ended December 31, 2020 (the “Proxy Statement”). Item 11. Executive Compensation. The information required by this Item 11 will be set forth in the sections entitled “ Director Compensation ,” “ Executive Compensation ” and “ Compensation Committee Interlocks and Insider Participation ” to be included in the Proxy Statement and is incorporated herein by reference. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. The information required by this Item 12 will be set forth in the section entitled “ Security Ownership of Certain Beneficial Owners and Management ” and “ Equity Plan Information ” to be included in the Proxy Statement and is incorporated herein by reference. Item 13. Certain Relationships and Related Transactions, and Director Independence. The information required by this Item 13 will be set forth in the sections entitled “ Certain Relationships and Related Party Transactions ” and “ Director Independence ” to be included in the Proxy Statement and is incorporated herein by reference. Item 14. Principal Accounting Fees and Services. The information required by this Item 14 will be set forth in the section entitled “ Audit Matters ” to be included in the Proxy Statement and is incorporated herein by reference. 129 PART IV Item 15. Exhibits, Financial Statement Schedules. We have filed the following documents as part of this Annual Report: 1. Financial Statements: The financial statements included in “Index to Financial Statements” in Part II, Item 8 are filed as part of this Annual Report. 2. Exhibits: The exhibits listed in the accompanying Exhibit Index are filed or incorporated by reference as part of this Annual Report. Item 16. Form 10-K Summary. None. 130 Exhibit Index Incorporation by Reference Exhibit Number Description Form File No. Exhibit Filing Date 3.1 Form of Amended and Restated Certificate of Incorporation of Outset Medical, Inc. S-1/A 333-248225 3.1 September 9, 2020 3.2 Form of Amended and Restated Bylaws of Outset Medical, Inc. S-1/A 333-248225 3.2 September 9, 2020 4.1 Form of Common Stock Certificate S-1/A 333-248225 4.1 September 9, 2020 4.2 Amended and Restated Registration Rights Agreement S-1 333-248225 4.2 August 21, 2020 4.3 Form of Series A Warrant Agreement #1 S-1 333-248225 4.3 August 21, 2020 4.4 Form of Series A Warrant Agreement #2 S-1 333-248225 4.4 August 21, 2020 4.5* Description of Outset Medical, Inc.’s Securities Registered Pursuant to Section 12 of the Exchange Act 10.1† Form of Indemnification Agreement S-1/A 333-248225 10.1 September 9, 2020 10.2† Outset Medical, Inc. 2010 Equity Incentive Plan and related form agreements S-1 333-248225 10.2 August 21, 2020 10.3† Outset Medical, Inc. 2019 Equity Incentive Plan and related form agreements S-1 333-248225 10.3 August 21, 2020 10.4† Outset Medical, Inc. 2020 Equity Incentive Plan S-1/A 333-248225 10.4 September 9, 2020 10.5†* Form of Stock Option Grant Notice and Option Agreement for Outset Medical, Inc. 2020 Equity Incentive Plan 10.6†* Form of Restricted Stock Unit Award Grant Notice and Award Agreement for Outset Medical, Inc. 2020 Equity Incentive Plan 10.7†* Form of Restricted Stock Award Grant Notice and Award Agreement for Outset Medical, Inc. 2020 Equity Incentive Plan 10.8†* Form of Performance Stock Unit Award Grant Notice and Award Agreement for Outset Medical, Inc. 2020 Equity Incentive Plan 10.9† Outset Medical, Inc. 2020 Employee Stock Purchase Plan S-1/A 333-248225 10.5 September 9, 2020 10.10† Employment Agreement by and between Outset Medical and Leslie Trigg, dated as of February 23, 2015 S-1 333-248225 10.6 August 21, 2020 10.11† Form of Amended and Restated Change in Control and Severance Agreement for Chief Executive Officer S-1/A 333-248225 10.7 September 9, 2020 10.12† Form of Amended and Restated Change in Control and Severance Agreement for non-Chief Executive Officer executive officers S-1/A 333-248225 10.8 September 9, 2020 10.13 Amended and Restated Stockholders Agreement by and among the Institutional Investors, the Other Investors, the Key Common Holders and Outset Medical, dated as of January 27, 2020 S-1 333-248225 10.9 August 21, 2020 10.14# Lease by and between WH Silicon Valley IV LP and Outset Medical, Inc., dated as of September 19, 2019 S-1 333-248225 10.10 August 21, 2020 10.15# Sublease Agreement by and among Inmobiliaria IAMSA, S.A. de C.V. (Sublessor), Baja Fur S.A. de C.V. (Sublessee) and Outset Medical, Inc. (Guarantor), dated as of May 5, 2020 S-1 333-248225 10.11 August 21, 2020 10.16# First Amendment Agreement by and among Inmobiliaria IAMSA, S.A. de C.V. (Sublessor), Baja Fur S.A. de C.V. (Sublessee) and Outset Medical, Inc. (Guarantor), dated as of June 26, 2020 S-1 333-248225 10.12 August 21, 2020 10.17# Guaranty by and between Inmobiliaria IAMSA, S.A. de C.V. and Outset Medical, Inc dated as of May 6, 2020 S-1 333-248225 10.13 August 21, 2020 10.18# Loan and Security Agreement by and between Silicon Valley Bank and Outset Medical, Inc. dated as of July 2, 2020 S-1 333-248225 10.14 August 21, 2020 10.19# Manufacturing Services Agreement by and between Paramit Corporation and Outset Medical, Inc. dated as of April 15, 2016 S-1 333-248225 10.15 August 21, 2020 10.20# Amendment to Contract Manufacturer Agreement by and between Paramit Corporation and Outset Medical, Inc. dated as of January 26, 2018 S-1 333-248225 10.16 August 21, 2020 10.21# Manufacturing Services Agreement by and between Tacna Services, Inc. and Outset Medical, Inc. dated as of January 15, 2020 S-1 333-248225 10.17 August 21, 2020 131 10.22# Authorized Reseller Agreement by and between SDV Office Systems, LLC dba SDV Medical and Outset Medical, Inc. dated as of October 14, 2019 S-1 333-248225 10.18 August 21, 2020 10.23# Amendment 1 to the Authorized Reseller Agreement by and between SDV Office Systems, LLC dba SDV Medical and Outset Medical, Inc. dated as of March 26, 2020 S-1 333-248225 10.19 August 21, 2020 10.24# Amendment 2 to the Authorized Reseller Agreement by and between SDV Office Systems, LLC dba SDV Medical and Outset Medical, Inc. dated as of May 6, 2020 S-1 333-248225 10.20 August 21, 2020 10.25# Purchasing Agreement by and between HCA Management Services, L.P. and Outset Medical, Inc. dated as of May 1, 2020 S-1 333-248225 10.21 August 21, 2020 10.26# Award/Contract from the Biomedical Advanced Research and Development Authority to Outset Medical, Inc., effective September 30, 2019 S-1 333-248225 10.22 August 21, 2020 10.27# Amendment of Solicitation/Modification of Contract from the Biomedical Advanced Research and Development Authority to Outset Medical, Inc., effective May 9, 2020 S-1 333-248225 10.23 August 21, 2020 10.28# Solicitation/Contract/Order for Commercial Items from ASPR/SNS to Outset Medical, Inc., effective August 17, 2020 S-1/A 333-248225 10.24 September 9, 2020 10.29#* Amendment to Solicitation/Modification of Contract from ASPR-BARDA to Outset Medical, Inc., dated November 25, 2020 10.30#* Supply Agreement by and between Carlisle Interconnect Technologies, Inc. and Outset Medical, Inc., dated January 12, 2021 23.1* Consent of KPMG LLP, independent registered public accounting firm 24.1* Power of Attorney (included on the signature page) 31.1* Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Exchange Act, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 31.2* Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 32.1* Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 101.INS XBRL Instance Document 101.SCH XBRL Taxonomy Extension Schema Document 101.CAL XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF XBRL Taxonomy Extension Definition Linkbase Document 101.LAB XBRL Taxonomy Extension Label Linkbase Document 101.PRE XBRL Taxonomy Extension Presentation Linkbase Document * Filed herewith † Indicates a management contract or compensatory plan or arrangement. # Portions of the exhibit have been or will be excluded because it both (i) is not material and (ii) would be competitively harmful if publicly disclosed. 132 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized . Outset Medical, Inc. Date: March 22, 2021 By: /s/ Leslie Trigg Leslie Trigg President and Chief Executive Officer KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Leslie Trigg and Rebecca Chambers, and each of them, his or her true and lawful agent, proxy and attorney-in-fact, with full power of substitution and resubstitution , for him or her and in his or her name, place and stead, in any and all capacities, to sign 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 attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, or their or his substitutes, may lawfully do or cause to be done by virtue thereof. Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the registrant in the capacities and on the dates indicated. Signature Title Date /s/ Leslie Trigg President and Chief Executive Officer; Director ( Principal Executive Officer ) March 22 , 2021 Leslie Trigg /s/ Rebecca Chambers Chief Financial Officer ( Principal Financial Officer and Principal Accounting Officer ) March 22 , 2021 Rebecca Chambers /s/ D. Keith Grossman Chairman of the Board of Directors March 22, 2021 D. Keith Grossman /s/ Karen Drexler Director March 22, 2021 Karen Drexler /s/ Patrick T. Hackett Director March 22, 2021 Patrick T. Hackett /s/ Jim Hinrichs Director March 22, 2021 Jim Hinrichs /s/ Ali Osman Director March 22, 2021 Ali Osman 133