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What changed 10-K

Item 9A. Controls and Procedures

2023-03-24 compared with 2022-03-21 · 63 added, 41 removed, 118 unchanged (47% of the section changed)

18 unchanged sentences

Changes may include such activities as implementing new, more efficient systems, consolidating activities, and migrating processes.

During the quarter ended December 31, 2021, we implemented certain enhancements to our finance systems intended to improve the efficiency of certain financial and related transactional processes, some of which are part of our internal control over financial reporting and require testing for effectiveness.

We expect to continue to enhance our finance systems and processes for automation and efficiency and strengthen internal control over financial reporting.

There were no further changes in our internal control over financial reporting during the quarter ended December 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

There were no changes in our internal control over financial reporting during the quarter ended December 31, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Other Information

4 unchanged sentences

and “Information Regarding the Board of Directors and Corporate Governance”

in our definitive Proxy Statement for our 2022 Annual Meeting of Shareholders to be filed with the SEC by May 2, 2022 ("Proxy Statement"), and is incorporated in this Annual Report by reference.

in our definitive Proxy Statement for our 2023 Annual Meeting of Shareholders to be filed with the SEC by May 1, 2023 ("Proxy Statement"), and is incorporated in this Annual Report by reference.

We have adopted a code of ethics for directors, officers (including our principal executive officer, principal financial officer and principal accounting officer) and employees, known as the Corporate Code of Ethics and Conduct.

5 unchanged sentences

The information required by this Item will be set forth in the section headed “Executive Compensation”

in our Proxy Statement and is incorporated in this Annual Report by reference.

in the Proxy Statement and is incorporated in this Annual Report by reference.

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

The information required by this Item will be set forth in the section headed “Security Ownership of Certain Beneficial Owners and Management”

in our Proxy Statement and is incorporated in this Annual Report by reference.

in the Proxy Statement and is incorporated in this Annual Report by reference.

Information regarding our equity compensation plans will be set forth in the section headed “Executive Compensation”

in our Proxy Statement and is incorporated in this Annual Report by reference.

in the Proxy Statement and is incorporated in this Annual Report by reference.

Certain Relationships and Related Transactions, and Director Independence

The information required by this Item will be set forth in the section headed “Transactions With Related Persons”

in our Proxy Statement and is incorporated in this Annual Report by reference.

The information required by this Item will be set forth in the sections headed “Transactions With Related Persons”

and “Information Regarding the Board of Directors and Corporate Governance”

in the Proxy Statement and is incorporated in this Annual Report by reference.

Principal Accountant Fees and Services

The information required by this Item will be set forth in the section headed “—Ratification of Selection of Independent Registered Public Accounting Firm”

in our Proxy Statement and is incorporated in this Annual Report by reference.

in the Proxy Statement and is incorporated in this Annual Report by reference.

Exhibits, Financial Statement Schedules

3 unchanged sentences

All schedules have been omitted because they are not required or because the required information is given in the Financial Statements or Notes thereto set forth under Item 8 above.

(a)(3) Exhibits.

(a)(3) Exhibits.  

Exhibit Description

6 unchanged sentences

001-38079), filed with the SEC on March 2, 2020).

Investors’ Rights Agreement, dated September 18, 2014, as amended on October 1, 2015 and April 12, 2016, among the Registrant and the Registrant’s shareholders (incorporated by reference to Exhibit 10.3 to the Registrant’s Registration Statement on Form F-1 (File No.

333-217201), filed with the SEC on April 7, 2017).

Form of Officer Indemnity and Exculpation Agreement (incorporated by reference to Exhibit 99.2 to the Registrant’s Report Form 6-K (File No.

2 unchanged sentences

001-38079), filed with the SEC on March 15, 2018).

2017 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

001-38079), filed with the SEC on June 8, 2021)

2017 Equity Incentive Plan, as amended.

2017 Israeli Equity Incentive Sub Plan to the 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.7 to the Registrant’s Registration Statement on Form F-1 (File No.

1 unchanged sentence

UroGen Pharma Ltd.

2019 Inducement Plan, as amended.

2019 Inducement Plan, as amended (incorporated by reference to Exhibit 10.5 to the Registrant's Annual Report on Form 10-K (File No.

001-38079), filed with the SEC on March 21, 2022).

Form of Stock Option Grant Notice and Stock Option Agreement under the UroGen Pharma Ltd.

4 unchanged sentences

001-38079), filed with the SEC on May 28, 2019).

Amended and Restated Compensation Policy for Officer Holders.

Employment Agreement by and between the Registrant and Elizabeth Barrett, dated as of January 3, 2019 (incorporated by reference to Exhibit 10.9 to the Registrant’s Annual Report on Form 10-K (File No.

14 unchanged sentences

001-38079), filed with the SEC on May 13, 2021).

10.16 ††

Employment Agreement between the Company and Dong Kim, dated March 20, 2022 (incorporated by reference to Exhibit 10.1 to the Registrant ’

s Current Report on Form 8-K (File No.

001-38079), filed with the SEC on March 21, 2022).

10.18 †

License Agreement, dated November 8, 2019, by and between the Registrant and Agenus Inc.

5 unchanged sentences

001-38079), filed with the SEC on March 2, 2020).

Amendment to Lease Agreement, dated June 8, 2022, by and between the Registrant and Witman Properties, L.L.C.

and Alexander Road at Davanne, L.L.C.

(incorporated by reference to Exhibit 10.2 to the Registrant ’

s Quarterly Report on Form 10-Q (File No.

001-38079), filed with the SEC on August 11, 2022).

10.21 †

Manufacturing and Supply Agreement, dated May 30, 2020, by and between the Registrant and Isotopia Molecular Imaging Ltd.

(the “

Isotopia Agreement ”

) and the extension to the Isotopia Agreement, dated August 25, 2022, by and between the Registrant and Isotopia Molecular Imaging Ltd.

(incorporated by reference to Exhibit 10.1 to the Registrant ’

s Quarterly Report on Form 10-Q (File No.

001-38079), filed with the SEC on November 10, 2022).

10.22 †

Manufacturing & Supply Agreement, dated as of April 24, 2020 and amended as of March 2, 2022, by and between UroGen Pharma Ltd.

and Cenexi-Laboratoires Thissen s.a.

(incorporated by reference to Exhibit 10.2 to the Registrant ’

s Quarterly Report on Form 10-Q (File No.

001-38079), filed with the SEC on May 10, 2022).

Loan Agreement, dated as of March 7, 2022, by and among UroGen Pharma Ltd.

(the “

Company ”

), UroGen Pharma, Inc., as the borrower, and certain direct and indirect subsidiaries of the Company party thereto from time to time, as guarantors, BPCR Limited Partnership, as a lender, BioPharma Credit Investments V (Master) LP, as a lender, and BioPharma Credit PLC, as collateral agent for the lenders (incorporated by reference to Exhibit 10.1 to the Registrant ’

s Quarterly Report on Form 10-Q (File No.

001-38079), filed with the SEC on May 10, 2022).

Subsidiary of the Registrant.

Consent of PricewaterhouseCoopers LLP, an independent registered public accounting firm.

23.2††

Consent of Independent Registered Public Accounting Firm

Power of Attorney (see signature page hereto).

Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

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

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.

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.

Certification of Principal Executive and Financial Officers Pursuant to 18 U.S.C.

Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

The following financial information from the Annual Report on Form 10-K of UroGen Pharma Ltd.

3 unchanged sentences

Management contract or compensatory plan.

Registrant has been granted confidential treatment for certain portions of this exhibit.

This exhibit omits the information subject to this confidentiality treatment.

Omitted portions have been filed separately with the SEC.

††

Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.

Schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K.

A copy of any omitted schedules will be furnished to the SEC upon request.

††

Correction of the hyperlink for Exhibit 23.1 to the Form S-3 (File Number 333-268398), filed with the SEC on November 15, 2022.

Form 10-K Summary

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

UROGEN PHARMA, LTD.

UROGEN PHARMA LTD.

March 24, 2023

3 unchanged sentences

SIGNATURES AND POWER OF ATTORNEY

We, the undersigned directors and officers of UroGen Pharma, Ltd.

(the “Company”), hereby severally constitute and appoint Elizabeth Barrett and Molly Henderson, and each of them singly, our true and lawful attorneys, with full power to them, and to each of them singly, to sign for us and in our names in the capacities indicated below, any and all amendments to this Annual Report on Form 10-K, and to file or cause to be filed the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys, 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 each of us might or could do in person, and hereby ratifying and confirming all that said attorneys, and each of them, or their substitute or substitutes, shall do or cause to be done by virtue of this Power of Attorney.

We, the undersigned directors and officers of UroGen Pharma Ltd.

(the “Company”), hereby severally constitute and appoint Elizabeth Barrett and Don Kim, and each of them singly, our true and lawful attorneys, with full power to them, and to each of them singly, to sign for us and in our names in the capacities indicated below, any and all amendments to this Annual Report on Form 10-K, and to file or cause to be filed the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys, 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 each of us might or could do in person, and hereby ratifying and confirming all that said attorneys, and each of them, or their substitute or substitutes, shall do or cause to be done by virtue of this Power of Attorney.

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.

4 unchanged sentences

(Principal Executive Officer)

/s/ Molly Henderson

Chief Financial Officer

 March 21, 2022

Molly Henderson

March 24, 2023

(Principal Financial and Accounting Officer)

/s/ Arie Belldegrun

 March 21, 2022

March 24, 2023

Arie Belldegrun, M.D.

/s/ Cynthia Butitta

 March 21, 2022

March 24, 2023

Cynthia Butitta

 March 21, 2022

/s/ Kathryn Falberg

 March 21, 2022

Kathryn Falberg

March 24, 2023

March 24, 2023

/s/ Stuart Holden

 March 21, 2022

March 24, 2023

Stuart Holden, M.D.

/s/ Ran Nussbaum

 March 21, 2022

 March 21, 2022

March 24, 2023

/s/ Dan Wildman

March 24, 2023

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.