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Item 9A. Controls and Procedures

2024-02-27 compared with 2023-02-27 · 40 added, 28 removed, 282 unchanged (19% of the section changed)

7 unchanged sentences

B ased upon that evaluation, our principal executive officer and our principal financial officer concluded that, as of December 31, 2023, our disclosure controls and procedures were effective at the reasonable assurance level.

As permitted by related SEC staff interpretive guidance for newly acquired businesses, the internal control over financial reporting of Smiths Medical was excluded from the evaluation of the effectiveness of our disclosure controls and procedures as of December 31, 2022.

Smiths Medical, which we acquired in January 2022, constituted approximately 40% of our total assets and 42% of our total revenues as of and for the year ended December 31, 2022.

Changes in Internal Control Over Financial Reporting

There was no change in our internal control over financial reporting that occurred during our most recent fiscal quarter that has materially affected or is reasonably likely to materially affect our internal control over financial reporting, other than changes resulting from the acquisition and integration of Smiths Medical.

Management’s Annual Report on Internal Control over Financial Reporting

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Based on this criteria, management of the Company has concluded that the Company has maintained effective internal control over its financial reporting as of December 31, 2023.

As permitted by related SEC staff interpretive guidance, we have excluded from the scope of our assessment of internal control over financial reporting the operations and related assets of Smiths Medical.

Smiths Medical constituted approximately 40% of our total assets and 42% of our total revenues as of and for the year ended December 31, 2022.

Our independent registered public accounting firm that audited the December 31, 2023 financial statements included in this Annual Report on Form 10-K has independently assessed the effectiveness of our internal control over financial reporting and its report is below.

OTHER INFORMATION

The following table shows any “ Rule 10b5-1 trading arrangement ” or “ non-Rule 10b5-1 trading arrangement, ” each as defined in Item 408(a) of Regulation S-K, adopted, modified, or terminated by our directors or "officers" (as defined in Rule 16a-1(f) under the Exchange Act) during the three months ended December 31, 2023.

Name/Title Action Type of Plan Adoption Date End Date Aggregate Number of Securities to be Sold Plan Description

Vivek Jain, Chief Executive Officer Terminated* Rule 10b5-1 trading plan March 15, 2023 February 9, 2024 206,366 Exercise and sale of options

_____________________

*Mr Jain's plan terminated as of November 3, 2023.

His plan termination was previously disclosed in our Quarterly Report on 2023 Form 10-Q for the quarter ended September 30, 2023.

Other than as disclosed above, no other officer (as defined in Rule 16a-1(f) under the Exchange Act) or director of the Company adopted, modified, or terminated a "Rule 10b5-1 trading arrangement" or “non-Rule 10b5-1 trading arrangement,” each as defined in Item 408(a) of Regulation S-K.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

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Jain served as the Executive Vice-President-Strategy and Corporate Development of Cardinal Health from 2007 until 2009.

Jain served as Senior Vice President, Business Development and M&A for the Philips Medical Systems business of Koninklijke Philips Electronics N.V., an electronics company from 2006 to August 2007.

Jain served as Senior Vice President, Business Development and M&A for the Philips Medical Systems business of Koninklijke Philips Electronics N.V.,

an electronics company from 2006 to August 2007.

Jain served as an investment banker at J.P.

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Greenberg serves on the board of directors of HomeThrive, Inc.

since October 2018 and Canadian Hospital Specialties, a privately held medical device manufacturer and specialty distributor, since April 2021.

since October 2018, Canadian Hospital Specialties, a privately held medical device manufacturer and specialty distributor, since April 2021 and Access & Integrated Practice Holdings, LLC a comprehensive variable access medical services platform since 2023.

The Board believes Mr.

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Prior to joining Varian, Ms.

Finney was with the Fox Group in Foster City, CA, and Beatrice Foods, a major food processing company, in Chicago, IL.

Finney was with the Fox Group in Foster City, CA, and Beatrice Foods, a major food processing

company, in Chicago, IL.

Finney has served on the boards of:

54 unchanged sentences

Kennedy received BS degrees in Radiation Oncology and Psychology from Wayne State University as well as an MS degree in Medical Physics from the University of Colorado.

Kennedy currently serves on the board of Wayne State University Foundation since 2018, served on the board of the City Cancer Challenge Foundation from 2018 to 2022, and served on the board of the Radiation Oncology Institute from 2018 to 2021.

Kennedy currently serves on the boards of IPG Photonics since 2023 and Wayne State University Foundation since 2018, served on the board of the City Cancer Challenge Foundation from 2018 to 2022, and served on the board of the Radiation Oncology Institute from 2018 to 2021.

The Board believes Ms.

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Earlier in his career Mr.

Seeger spent 30 years at TRW, a U.S.-based automotive and aerospace group, where he held various senior finance positions.

Seeger spent 30 years at

TRW, a U.S.-based automotive and aerospace group, where he held various senior finance positions.

Seeger currently serves on the board of Spectris plc since 2015, Smiths Group PLC since 2014 and served on the board of GKN plc from 2007 to 2014.

27 unchanged sentences

Share Sale and Purchase Agreement, dated September 8, 2021, by and between Smiths Group International Holdings Limited, a private limited company incorporated in England and Wales, and ICU Medical, Inc., a Delaware corporation.

Filed as an Exhibit to Registrant's Current Report on Form 8-K filed September 8, 2021.

Filed as an Exhibit to Registrant's Current Report on Form 8-K filed on September 8, 2021 (File No.

Put Option Deed from ICU Medical, Inc., a Delaware corporation to Smiths Group International Holdings Limited, a private limited company incorporated in England and Wales.

Filed as an Exhibit to Registrant's Current Report on Form 8-K filed September 8, 2021.

Filed as an Exhibit to Registrant's Current Report on Form 8-K filed on September 8, 2021 (File No.

Registrant's Certificate of Incorporation, as amended and restated.

Filed as an exhibit to Registrant's Current Report on Form 8-K filed on June 10, 2014.

Filed as an Exhibit to Registrant's Current Report on Form 8-K filed on June 10, 2014 (File No.

Registrant's Bylaws, as amended and restated.

Filed as an Exhibit to Registrant's Current Report on Form 8-K filed August 3, 2016.

Filed as an Exhibit to Registrant's Current Report on Form 8-K filed on November 3, 2023 (File No.

Description of Securities Registered Under Section 12 of the Exchange Act.

Filed as an Exhibit to Registrant's Annual Report on Form 10-K for the year ended December 31, 2019, filed March 2, 3020.

Filed as an Exhibit to Registrant's Annual Report on Form 10-K for the year ended December 31, 2019, filed on March 2, 3020 (File No.

Form of Indemnification Agreement with Directors and Executive Officers.

Filed as an Exhibit to Registrant's Quarterly Report on Form 10-Q for the Quarter ended September 30, 2010, filed October 22, 2010 (File No.

Filed as an Exhibit to Registrant's Quarterly Report on Form 10-Q for the Quarter ended September 30, 2010, filed on October 22, 2010 (File No.

Registrant's 2002 Employee Stock Purchase Plan.* Filed as an Exhibit to Registrant's definitive Proxy Statement filed pursuant to Regulation 14A on April 3, 2002 (File No.

3 unchanged sentences

Amended and Restated ICU Medical, Inc.

2011 Stock Incentive Plan.*

2011 Stock Incentive Plan.* Filed as an Exhibit to Registrant's Quarterly Report on Form 10-Q for the Quarter ended March 31, 2018 (File No.

First Amendment to ICU Medical, Inc.

Amended and Restated 2011 Stock Incentive Plan.

Filed as an exhibit to Registrant's Annual Report on Form 10-K for the year ended December 31, 2019, filed March 2, 2020 (File No.001-34634).

Filed as an Exhibit to Registrant's Annual Report on Form 10-K for the year ended December 31, 2019, filed on March 2, 2020 (File No.001-34634).

Second Amendment to ICU Medical, Inc.

Amended and Restated 2011 Stock Incentive Plan.

Filed as an Exhibit to Registrant's Current Report on Form 8-K filed on May 22, 2023 (File No.

Amended and Restated Executive Employment Agreement, dated as of April 15, 2022, by and between ICU Medical, Inc.

and Vivek Jain.* Filed as an Exhibit to Registrant's Current Report on Form 8-K filed April 20, 2022.

Letter agreement between the Registrant and Alison Burcar, effective April 1, 2019.

Filed as an Exhibit to Registrant's Quarterly Report on Form 10-Q for the Quarter ended March 31, 2019.

and Vivek Jain.* Filed as an Exhibit to Registrant's Current Report on Form 8-K filed on April 20, 2022 (File No.

Letter agreement between the Registrant and Alison Burcar, effective April 1, 2019.* Filed as an Exhibit to Registrant's Quarterly Report on Form 10-Q for the Quarter ended March 31, 2019 (File No.

ICU Medical, Inc.

Executive Severance Plan.* Filed as an Exhibit to Registrant’s Current Report on Form 8-K filed January 6, 2017.

Executive Severance Plan.* Filed as an Exhibit to Registrant’s Current Report on Form 8-K filed on January 6, 2017 (File No.

First Amendment to the ICU Medical, Inc.

Executive Severance Plan.

*Filed as an Exhibit to Registrant's Current Report on Form 8-K filed January 6, 2020.

*Filed as an Exhibit to Registrant's Current Report on Form 8-K filed on January 6, 2020 (File No.

Second Amendment to the ICU Medical, Inc.

Executive Severance Plan.

*Filed as an Exhibit to Registrant's Current Report on Form 8-K filed January 3, 2023.

*Filed as an Exhibit to Registrant's Current Report on Form 8-K filed on January 3, 2023 (File No.

Credit Agreement, dated as of January 6, 2022, by and among ICU Medical, Inc.

as Borrower, certain subsidiaries as guarantors, Wells Fargo Bank, National Association, as Administrative Agent, Wells Fargo Securities, LLC and Barclays Bank PLC as joint bookrunners and joint lead arrangers and the other joint bookrunners and joint lead arrangers listed therein.# Filed as an Exhibit to Registrant's Current Report on Form 8-K filed January 7, 2022.

Shareholders Agreement, dated as of January 6, 2022, by and between ICU Medical, Inc.

and Smiths Group International Holdings Limited.

Filed as an Exhibit to Registrant's Current Report on Form 8-K filed January 7, 2022.

Filed as an Exhibit to Registrant's Current Report on Form 8-K filed on January 7, 2022 (File No.

Subsidiaries of Registrant.

3 unchanged sentences

Certifications of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Policy Relating to Recovery of Erroneously Awarded Compensation

Exhibit 101.INS The instance document does not appear in the interactive data file because its XBRL (Extensible Business Reporting Language) tags are embedded within the Inline XBRL document.

25 unchanged sentences

Warranty and return reserve - accounts receivable (1)

Warranty and return reserve - inventory $ ( 1,613 ) $ 263 $ ( 533 ) $ — $ ( 1,883 )

$ 2,485 $ ( 364 ) $ 3,742 $ — $ 5,863

Warranty and return reserve - inventory/accrued (2)

$ ( 1,883 ) $ 5,266 $ 47,436 $ — $ 50,819

Deferred tax asset valuation allowance $ 2,934 $ — $ 8,232 $ — $ 11,166

2 unchanged sentences

Warranty and return reserve - accounts receivable $ 5,863 $ 1,627 $ 15 $ — $ 7,505

$ 2,485 $ ( 364 ) $ 3,742 $ — $ 5,863

Warranty and return reserve - inventory/accrued (3)

4 unchanged sentences

(2) Includes an acquired balance of $55.2 million in short-term and long-term accrued warranty reserve related to the Smiths Medical acquisition.

(3 Additional charges to expense were primarily related to additional field corrective actions identified and initiated during the period related to the Smiths Medical business FDA warning letter (See Note:

15 Commitments and Contingencies in our accompanying consolidated financial statements).

FORM 10-K SUMMARY

26 unchanged sentences

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