false000178774000017877402025-02-182025-02-18
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Date of Report (Date of earliest event reported): February 18, 2025 |
Tivic Health Systems, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-41052 |
81-4016391 |
(State or Other Jurisdiction
of Incorporation) |
(Commission File Number) |
(IRS Employer
Identification No.) |
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47685 Lakeview Blvd. |
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Fremont, California |
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94538 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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Registrant’s Telephone Number, Including Area Code: 888 276-6888 |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
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Name of each exchange on which registered
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Common Stock, par value $0.0001 per share |
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TIVC |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On February 18, 2025, Michael Handley was appointed as Chief Operating Officer of Tivic Health Systems, Inc., a Delaware corporation (the “Company”), and President of the Company’s Tivic Biopharma division. Mr. Handley, 53 years of age, is a successful life science business professional with over two decades of cross-functional experience in drug/device commercialization, regulatory/clinical affairs, operations, strategic transactions, market development and partnering/licensing. Prior to joining the Company, from July 2021 until February 2025, Mr. Handley served as President, Chief Executive Officer and Chairman of Statera Biopharma, Inc. From July 2019 to March 2020, he served as the Chief Executive Officer and a director of Immune Therapeutics. Prior to that, from 2012 to 2018, Mr. Handley served as the Chief Executive Officer and a director of Armis Biopharma, a development-stage healthcare company, where Mr. Handley was responsible for day-to-day operations, executing a profitable growth strategy, obtaining global product approvals, overseeing intellectual property strategy, product commercialization, business development and financing. Mr. Handley founded Vessix Vascular, Inc. in 2011 and served as its Vice President of Clinical, Quality and Regulatory until 2012, when it was acquired. Mr. Handley also served as the Global Head of Regulatory at Acclarent, Inc. from 2010 to 2011 until it was acquired. Prior to that, he served in senior executive roles at Spectranetics (Nasdaq: SPNC), a medical device company, and Accelapure Corporation, a biotechnology company. Prior to beginning his business career, Mr. Handley spent several years in various consulting and drug development roles at the public biotech companies Genentech, Inc. (Nasdaq: DNA), Amgen Inc. (Nasdaq: AMGN) and Gliatech Inc. (formerly Nasdaq: GLIA). Mr. Handley graduated cum laude from Colorado State University with Bachelor of Science degrees in molecular biology, physiology and minors in chemistry, and neurobiology in 1995. Mr. Handley attended The Graziadio Business School of Pepperdine University for his Executive Master of Business Administration degree.
On February 12, 2025, in connection with his appointment as Chief Operating Officer of the Company and President of the Tivic Biopharma division, the Company and Mr. Handley entered into an executive employment agreement (the “Employment Agreement”), pursuant to which Mr. Handley (i) is entitled to receive a base salary of $300,000 per annum (subject to review and adjustment in accordance with the Company’s normal performance review practices); (ii) will be eligible to receive, at the sole discretion of the Company’s Board of Directors (“Board”), an annual end-of-year incentive bonus in an amount up to 35% of his base salary, commencing the year following the start of his employment; and (iii) may be eligible to receive annual focal grants, as determined by the Board or the Compensation Committee of the Board, pursuant to the Company’s Amended and Restated 2021 Equity Incentive Plan (the “2021 Plan”).
In addition to the foregoing compensation, as an inducement material to his entering into employment with the Company, effective as of February 18, 2025, Mr. Handley was granted 600,000 restricted stock units (the “Inducement Grant”), 25% of which shall vest upon the first anniversary of the grant date and the remaining 75% of which will vest in equal quarterly installments over the three years thereafter. The Inducement Grant was granted outside of the 2021 Plan in reliance on the employment inducement exemption provided under the Nasdaq Listing Rule 5635(c)(4). Although the Inducement Grant was granted outside of the 2021 Plan, except as otherwise set forth in the grant notice and grant agreement, the terms, conditions, and definitions set forth in 2021 Plan will apply to the Inducement Grant as though it had been granted under the 2021 Plan.
Pursuant to the Employment Agreement, Mr. Handley’s employment is “at will,” meaning that either he or the Company are entitled to terminate Mr. Handley’s employment at any time and for any reason, with or without cause. In the event that his employment with the Company is terminated for any reason before December 31 of any given year, he will not be entitled to receive an annual end-of-year bonus. In the event that (i) Mr. Handley elects to terminate his employment with the Company other than for good reason, (ii) the Company terminates his employment for cause, or (iii) his employment is terminated as a result of his death or disability, then Mr. Handley will not be entitled to receive any separation benefits. In the event that Mr. Handley terminates his employment for good reason or the Company terminates his employment without cause, provided that his employment with the Company continues for at least six months after execution of the Employment Agreement, then Mr. Handley shall be entitled to receive payment equal to his base salary for a period of six months after termination, payable in accordance with the Company’s standard payroll procedures, and the Company shall pay his COBRA coverage for a period of six months after termination.
The foregoing summary of the Employment Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Employment Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated herein by reference.
Mr. Handley was appointed as Chief Operating Officer of the Company and President of Tivic Biopharma in connection with, and pursuant to, that Exclusive License Agreement entered into by and between the Company and Statera Biopharma, Inc. on February 11, 2025, which the Company disclosed in that Current Report on Form 8-K filed with Securities and Exchange Commission (the “Commission”) on February 12, 2025. There are no family relationships between Mr. Handley and any of the Company’s directors, executive officers or persons nominated or chosen by the Company to become a director or executive officer. Mr. Handley has not engaged in any related-person transactions required to be disclosed by Item 404(a) of Regulation S-K under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Item 7.01 Regulation FD Disclosure.
On February 24, 2025, the Company issued a press release announcing Mr. Handley’s appointment as Chief Operating Officer of the Company and President of the Company’s Tivic Biopharma division, among other things. A copy of that press release is furnished as Exhibit 99.1 of this Current Report and incorporated herein by reference.
The information set forth under Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibit 99.1, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing, except as expressly set forth by specific reference in such a filing. This Current Report will not be deemed an admission as to the materiality of any information in this Current Report that is required to be disclosed solely by Regulation FD.
Forward-Looking Statements
This Current Report including Exhibit 99.1, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms “anticipates,” “expects,” “estimates,” “believes,” “will” and similar expressions, as they relate to us or our management, are intended to identify such forward-looking statements.
Forward-looking statements in this Current Report, including Exhibit 99.1, or hereafter, including in other publicly available documents filed with the Commission, reports to the stockholders of the Company and other publicly available statements issued or released by us involve known and unknown risks, uncertainties and other factors which could cause our actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management’s best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Commission, each of which could adversely affect our business and the accuracy of the forward-looking statements contained herein. Our actual results, performance or achievements may differ materially from those expressed or implied by such forward-looking statements.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Certain annexes, schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant agrees to furnish supplementally a copy of any omitted attachment to the SEC on a confidential basis upon request. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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TIVIC HEALTH SYSTEMS, INC. |
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Date: |
February 24, 2025 |
By: |
/s/ Lisa Wolf |
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Name: Lisa Wolf
Title: Interim Chief Financial Officer |
Exhibit 10.1
TIVIC HEALTH EXECUTIVE EMPLOYMENT AGREEMENT
This Employment Agreement (this “Agreement”) is made and entered into as of February 18, 2025 (the “Effective Date”) by and between Tivic Health Systems, Inc., a Delaware limited liability company (the “Company”) and Michael Handley (“Employee”).
1.Duties and Scope of Employment.
(a)Position. For the term of your employment under this Agreement (your “Employment”), the Company agrees to employ you in the exempt position of Chief Operating Officer and President, Tivic Biopharma. You will report to the Company’s CEO. You will perform the duties and have the responsibilities and authority customarily performed and held by an employee in your position.
(b)Location. You will be working remotely from a location approved in advance by the Company, which approval may be revoked by the Company in its sole discretion. It also being understood that the Company may require you to perform business travel to other locations from time to time in connection with the Company’s business.
(c)Obligations to the Company. During the term of your Employment, you will devote your full business efforts and time to the Company. During your Employment, you agree that you will not engage in any other employment, occupation, consulting or other business activity without the prior written consent of the Company (beyond of those disclosed and approved in Appendix C as approved disclosures), nor will you engage in any other activities that conflict with your obligations to the Company, under this Agreement, the Confidentiality Agreement and/or any other agreement with the Company or otherwise. You shall comply with the Company’s policies and rules, including those policies located in the Company’s Handbook and the Confidentiality Agreement (defined below), as they may be in effect from time to time during your Employment.
(d)Employment at Will. Your Employment will be “at will,” meaning that either you or the Company shall be entitled to terminate your Employment at any time and with or without cause. Any contrary representations that may have been made to you shall be superseded by this Agreement. This Agreement will constitute the full and complete agreement between you and the Company on the “at-will” nature of your Employment, which may only be changed in an express written agreement signed by you and a duly authorized officer of the Company. Except as otherwise herein expressly provided for, upon the termination of your employment, you will only be entitled to the compensation and benefits earned and the reimbursements described in this Agreement for the period preceding the effective date of the termination.
2.Compensation; Business Expenses.
(a)Base Wage. In this exempt position, the Company will pay you as compensation for your Employment a base salary of $300,000, pro-rated for any partial year. Your annual base salary will be subject to annual reviews and adjustments based upon the Company’s normal performance review practices. Your base salary will continue to be payable in accordance with the Company’s standard payroll procedures. The annual base salary specified in this Section 2(a), together with any modifications thereof, is referred to in this Agreement as the “Base Salary.”
(b)Incentive Compensation. At the discretion of the Board, you will be eligible to receive a discretionary, annual end-of-year incentive bonus in an amount of up to 35% of your Base Salary, in the year following the start of your Employment (payable in the first quarter of the next year). The exact
amount of the incentive bonus you may receive will be a combination of personal and Company objectives, dependent on the achievement of Company milestones and profitability, and such other milestones as the Board deems appropriate. Payment of your incentive bonus, if any, will be paid to you as soon as practical following the end of the calendar year, contingent upon final financial results from the prior year and Board approval of meeting performance objectives whether plan or individual, and in any event, within 90 days therefrom. You will not be eligible to receive any incentive bonus (including a prorated bonus) if your employment terminates for any reason before December 31, for the year in question.
(c)Equity Inducement Award. In consideration of you entering into this Agreement, and as an inducement that is material to your employment with the Company, subject to Board approval, you shall be granted six hundred thousand (600,000) Restricted Stock Units, or an equivalent number of units adjusted for reverse splits or stock splits, which will vest on a four-year schedule, subject to 25% vesting on the 1st anniversary of the grant date and quarterly thereafter (the “Inducement Grant”). The Inducement Grant will be granted pursuant to the inducement grant exception under Nasdaq Rule 5635(c)(4) and not pursuant to the Company’s Amended and Restated 2021 Equity Incentive Plan or any other equity incentive plan of the Company, as an inducement that is material to your employment with the Company. The Inducement Grant shall be subject to approval by the Board and, if so approved, issued to you on the Effective Date (or the date of Board approval, if later).
(d)Annual Focal Grants. Additionally, you may be eligible for consideration for annual focal grants, as determined by the Board or the Compensation Committee of the Company. Equity issued to you as an annual focal grant, if any, will be governed by the terms and conditions of the Company’s Amended and Restated 2021 Equity Incentive Plan and conditioned upon Employee’s continuous employment with the Company through each vesting date.
(e)Business Expenses. The Company will reimburse you, in a timely manner, for your necessary and reasonable business expenses incurred in connection with your duties hereunder upon presentation of an itemized account and appropriate supporting documentation, all in accordance with the Company’s generally applicable policies currently in effect or to be adopted after the date hereof, as may be amended from time to time.
(f)Clawback of Incentive Compensation. Notwithstanding the foregoing, all incentive compensation payable to you during the term of this Agreement shall be subject to clawback in accordance with Company policies, as may be adopted and/or amended from time to time, in accordance with applicable law, including, without limitation, SEC rules and regulations and/or rules of the exchange on which the Company’s equity securities may be listed from time to time.
3.Employee Benefits. You will be entitled to take uncapped Paid Time Off (“PTO”), subject to advance approval from your supervisor and in alignment with the Company’s Responsible Adult Policy for discretionary time off. You must ensure that any PTO is scheduled to minimize disruption to the Company’s operations. You will remain eligible to participate in the employee benefit plans maintained by the Company and generally available to similarly situated employees of the Company, subject in each case to the generally applicable terms and conditions of the plan in question and to the determinations of any person or committee administering such plans. These benefits may change from time to time.
4.Termination of this Agreement; Separation Benefits.
(a)Termination of this Agreement. This Agreement and your employment with the Company shall terminate under any of the following conditions: (i) your death; (ii) Disability or Disabilities that would prevent the Employee from completing their job duties; (iii) upon your receipt of written notice from the Company that your employment is being terminated for Cause; (iv) upon your receipt of written notice from the Company that your employment is being terminated other than for Cause; (v) upon sixty
(60) days’ written notice by you that you are resigning from your employment with the Company; (vi) upon sixty (60) days’ written notice by you that you are resigning from your employment with the Company for Good Reason.
(b)Separation Benefits. You will be entitled to receive separation benefits upon termination of employment only as set forth in Section 4(b)(iv) hereof (the “Severance Benefits”); provided, however, that in the event you are entitled to any severance pay under a Company-sponsored severance pay plan, any such severance pay to which you are entitled under such severance pay plan will reduce the amount of severance pay to which you are entitled pursuant to Section 4(b)(iv) hereof.
(i)Voluntary Resignation. If you voluntarily elect to terminate your employment with the Company (other than in the event of a termination by you for Good Reason), you will not be entitled to any Severance Benefits.
(ii)Termination for Cause. If the Company or any successor in interest terminates your employment for Cause (as defined below), you will not be entitled to receive any Severance Benefits.
(iii)Termination for Death or Disability. If your employment with the Company is terminated as a result of your death or Disability, you will not be entitled to receive any Severance Benefits.
(iv)Involuntary Termination. Subject to the provisions of Section 4(b)(iv) and Section 5 hereof, if there is an Involuntary Termination you will be entitled to receive the following:
(A)Severance Payment. The Company will pay you six months of your Base Salary, payable in accordance with the Company’s standard payroll procedures over the Severance Period, if your Employment continued for at least six months following the execution of this Agreement.
(B)Health Insurance. Provided that you timely elect such coverage, the Company shall pay your group health continuation coverage under the Consolidated Omnibus Budget Reconciliation Act of 1986 (“COBRA”) during the Severance Period of six months; provided, however, that in the event that you become eligible for group insurance coverage in connection with new employment, such COBRA premium payments by the Company shall terminate immediately and, in furtherance thereof, you represent, warrant, covenant and agree to promptly, and in any event, within seven (7) days therefrom, notify the Company of your new employment and eligibility for group insurance coverage related thereto.
(i)“Cause” means the occurrence of any of the following: (A) your conviction for, or plea of no contest to, a felony or a crime involving moral turpitude; (B) your commission of an act of personal dishonesty that is intended to result in your personal enrichment (excluding inadvertent acts that are promptly cured following notice); (C) a continued material failure or failures by you to perform your lawful and reasonable duties of employment (including, but not limited to, compliance with material written policies of the Company and material written agreements with the Company) (but only after the Company has delivered a written demand for performance to you that describes the basis for the Company’s belief that you have committed material violations and you have not cured within a period of 15 days following notice); (D) your willful failure (other than due to physical incapacity) to reasonably cooperate with any audit or investigation by a governmental authority or the Company of the Company’s business or financial conditions or practices that continues after written notice from the Board and at least fifteen (15)
days to cure; (E) it is determined that you have conducted yourself in an unprofessional, unethical, illegal or fraudulent manner, or have acted in a manner detrimental to the reputation, character or standing of the Company, or to the financial condition of the Company, including, but not limited to theft or misappropriation of Company’s assets, engaging in unlawful discriminatory or harassing conduct, working while under the influence of alcohol or illegal drugs, or the filing of false expense or related reports; (G) a material breach of any of your fiduciary duties to the Company; (H) any willful, material violation by you of any law or regulation applicable to the business of the Company; (I) a material breach of any of the covenants, representations and warranties contained herein; or (J) insubordinate conduct so divergent from the Company’s purpose, that a majority vote by the Board necessitates your immediate removal without any notice.
(ii)“Change in Control” shall have the meaning as set forth in the Company’s 2021 Equity Incentive Plan. as may be amended from time to time.
(iii)“Disability or Disabilities” shall mean your inability to perform your duties under this Agreement, whether with reasonable accommodation, by reason of any incapacity, physical or mental, which the Company, based upon medical advice or an opinion provided by an independent licensed physician acceptable to the Company, determines to have incapacitated you from satisfactorily performing all of your usual services for the Company, with reasonable accommodation, for a period of at least one hundred eighty (180) days during any twelve (12) month period (whether or not consecutive). Based upon such medical advice or opinion, the determination of the Company shall be final and binding and the date such determination is made shall be the date of such Disability for purposes of this Agreement.
(iv)“Good Reason” means the occurrence of one or more of the following (through a single action or series of actions) without your written consent: (A) the assignment to you of any authority, duties or responsibilities or the reduction of your authority, duties or responsibilities, either of which results in a material diminution in your authority, duties or responsibilities at the Company; (B) a material reduction of 20% or more by the Company in your Base Salary, other than a one-time reduction that is applicable to substantially all other similarly-situated executives; or (C) except as otherwise herein contemplated, a non-temporary relocation of your principal work location office to a location that increases your one way commute from your principal residence by more than 50 miles.
An event or action will not constitute Good Reason unless (1) you give the Company written notice within 60 days after you know or should know of the initial existence of such event or action, (2) such event or action is not reversed, remedied or cured, as the case may be, by the Company as soon as possible but in no event later than 30 days of receiving such written notice from you, and (3) you terminate employment within 60 days following the end of the cure period.
(v)“Involuntary Termination” means a termination of your employment by the Company without Cause, or you terminate your employment with the Company for Good Reason.
5.Conditions to Receipt of Severance or other Benefits Pursuant to this Agreement.
(a)Release of Claims Agreement. Notwithstanding anything herein contained to the contrary, in order for you to receive any Severance Benefits, you will be required to sign and not revoke a separation and release of claims agreement in a form reasonably satisfactory to the Company (the “Release”) and the Employee. In all cases, the Release must become effective and irrevocable no later than the 60th day following your Involuntary Termination (the “Release Deadline Date”). If the Release does not become effective and irrevocable by the Release Deadline Date, you will forfeit any right to the Severance Benefits. In no event will the Severance Benefits be paid or provided until the Release becomes effective and irrevocable.
(i)Notwithstanding anything to the contrary in this Agreement, no Severance Benefits to be paid or provided to you, if any hereunder that, when considered together with any other severance payments or separation benefits, are considered deferred compensation under Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”), and the final regulations and any guidance promulgated thereunder (“Section 409A”) (together, the “Deferred Payments”) will be paid or provided until you have a “separation from service” within the meaning of Section 409A. Similarly, no Severance Benefits payable to you, if any, under this Agreement that otherwise would be exempt from Section 409A pursuant to Treasury Regulation Section 1.409A-1(b)(9) will be payable until you have a “separation from service” within the meaning of Section 409A.
(ii)It is intended that none of the Severance Benefits will constitute Deferred Payments but rather will be exempt from Section 409A as a payment that would fall within the “short-term deferral period” as described in Section 5(b)(iii) below or resulting from an involuntary separation from service as described in Section 5(b)(iv) below. In no event will you have discretion to determine the taxable year of payment of any Deferred Payment.
(iii)Notwithstanding anything to the contrary in this Agreement, if you are a “specified employee” within the meaning of Section 409A at the time of your separation from service (other than due to death), then the Deferred Payments, if any, that are payable within the first 6 months following your separation from service, will become payable on the date 6 months and 1 day following the date of your separation from service. All subsequent Deferred Payments, if any, will be payable in accordance with the payment schedule applicable to each payment or benefit. Notwithstanding anything herein to the contrary, in the event of your death following your separation from service, but before the 6 month anniversary of the separation from service, then any payments delayed in accordance with this paragraph will be payable in a lump sum as soon as administratively practicable after the date of your death and all other Deferred Payments will be payable in accordance with the payment schedule applicable to each payment or benefit. Each payment and benefit payable under this Agreement is intended to constitute a separate payment under Section 1.409A-2(b)(2) of the Treasury Regulations.
(iv)Any amount paid under this Agreement that satisfies the requirements of the “short-term deferral” rule set forth in Section 1.409A-1(b)(4) of the Treasury Regulations will not constitute Deferred Payments for purposes of this Section 5.
(v)Any amount paid under this Agreement that qualifies as a payment made as a result of an involuntary separation from service pursuant to Section 1.409A- 1(b)(9)(iii) of the Treasury Regulations that does not exceed the Section 409A Limit will not constitute Deferred Payments for purposes of this Section 5.
(vi)The foregoing provisions are intended to comply with or be exempt from the requirements of Section 409A so that none of the Severance Benefits will be subject to the additional tax imposed under Section 409A, and any ambiguities herein will be interpreted to so comply or be exempt. You and the Company agree to work together in good faith to consider amendments to this Agreement and to take such reasonable actions which are necessary, appropriate or desirable to avoid imposition of any additional tax or income recognition prior to actual payment to you under Section 409A. In no event will the Company reimburse you for any taxes that may be imposed on you as a result of Section 409A.
6.Pre-Employment Conditions.
(a)Confidentiality Agreement. Your acceptance of this offer and the terms of this Agreement is contingent upon the execution, and delivery to an officer of the Company, of the Employee
Invention Assignment and Confidentiality Agreement attached hereto as Attachment A (the “Confidentiality Agreement”), concurrent with the execution hereof.
(b)Arbitration Agreement. To facilitate speedy resolution of disputes, employees are asked to sign a mutual agreement to arbitrate claims, a copy of which is attached hereto as Attachment B (the “Arbitration Agreement”). Arbitration is a private forum where parties can resolve disputes over legal claims. A neutral party called an arbitrator presides over the arbitration. There is no jury. This is different from court where the forum is public, a judge presides over the proceeding, and a jury determines a verdict. An arbitrator is normally a retired judge or practicing attorney who has many years of experience in resolving issues between companies and their employees. The arbitrator is selected by the employee and the Company. The decision made by the arbitrator is final and binding on both the employee and the Company. As set forth in more detail in the Arbitration Agreement, you and the Company agree to submit to mandatory binding arbitration any and all claims arising out of or related to your employment with the Company and your termination thereof, including but not limited to, claims for unpaid wages, wrongful termination, torts, stock or stock options or other ownership interest in the Company and/or discrimination based upon any federal, state or local ordinance, statute, regulation or constitutional provision, except for claims expressly excluded by the Arbitration Agreement. THE PARTIES HEREBY WAIVE ANY RIGHTS THEY MAY HAVE TO TRIAL BY JURY IN REGARD TO SUCH CLAIMS.
(c)Right to Work. For purposes of federal immigration law, you will be required to provide to the Company documentary evidence of your identity and eligibility for employment in the United States. Such documentation must be provided to us within three (3) business days of your hire date or our employment relationship with you may be terminated.
(d)Verification of Information. This offer of employment is also contingent upon the successful verification of the information you provided to the Company during your application process, as well as a general background check performed by the Company to confirm your suitability for employment. By accepting this offer of employment, you warrant that all information provided by you is true and correct to the best of your knowledge, you agree to execute any and all documentation necessary for the Company to conduct a background check and you expressly release the Company from any claim or cause of action arising out of the Company’s verification of such information.
(a)Company’s Successors. This Agreement shall be binding upon any successor (whether direct or indirect and whether by purchase, lease, merger, consolidation, liquidation or otherwise) to all or substantially all of the Company’s business and/or assets. For all purposes under this Agreement, the term “Company” shall include any successor to the Company’s business or assets that becomes bound by this Agreement.
(b)Your Successors. This Agreement and all of your rights hereunder shall inure to the benefit of, and be enforceable by, your personal or legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees.
(a)Notice. All notices and other communications contemplated under this Agreement shall be in writing and shall be deemed to have been duly given, made and received (i) when delivered personally; (ii) two (2) days following the day when deposited with a reputable, established overnight courier service for delivery to the intended addressee, the first of which such delivery shall have been with signature required from the recipient; (iii) five (5) days following the day when deposited with the United States Postal Service as first class, registered or certified mail, postage prepaid; and (iv) by confirmed
electronic (email) transmission or facsimile. In your case, mailed notices shall be addressed to you at the home address that you most recently communicated to the Company in writing. In the case of the Company, mailed notices shall be addressed to its corporate headquarters, and all notices shall be directed to the attention of the Board.
(b)Modifications and Waivers. No provision of this Agreement shall be modified, waived or discharged unless the modification, waiver or discharge is agreed to in writing and signed by you and by an authorized officer of the Company (other than you). No waiver by either party of any breach of, or of compliance with, any condition or provision of this Agreement by the other party shall be considered a waiver of any other condition or provision or of the same condition or provision at another time.
(c)Whole Agreement. No other agreements, representations or understandings (whether oral or written and whether express or implied) which are not expressly set forth in this Agreement have been made or entered into by either party with respect to the subject matter hereof. This Agreement, the Confidentiality Agreement and the Arbitration Agreement contain the entire understanding of the parties with respect to the subject matter hereof.
(d)Withholding Taxes. All payments made under this Agreement shall be subject to reduction to reflect taxes or other charges required to be withheld by law.
(e)Choice of Law and Severability. To the extent permitted by law, this Agreement shall be interpreted in accordance with the laws of the State of Delaware without giving effect to provisions governing the choice of law. If any provision of this Agreement becomes or is deemed invalid, illegal or unenforceable in any applicable jurisdiction by reason of the scope, extent or duration of its coverage, then such provision shall be deemed amended to the minimum extent necessary to conform to applicable law so as to be valid and enforceable or, if such provision cannot be so amended without materially altering the intention of the parties, then such provision shall be stricken and the remainder of this Agreement shall continue in full force and effect. If any provision of this Agreement is rendered illegal by any present or future statute, law, ordinance or regulation (collectively, the “Law”) then that provision shall be curtailed or limited only to the minimum extent necessary to bring the provision into compliance with the Law. All the other terms and provisions of this Agreement shall continue in full force and effect without impairment or limitation.
(f)No Assignment. This Agreement and all of your rights and obligations hereunder are personal to you and may not be transferred or assigned by you at any time.
(g)Interpretation; Construction. The headings set forth in this Agreement are for convenience of reference only and shall not be used in interpreting this Agreement. This Agreement has been drafted by legal counsel to the Company, but you acknowledge your understanding that you have been advised to consult with an attorney prior to executing this Agreement (and by your execution hereof, you acknowledge that you have so consulted with an attorney of your choice or have knowingly and voluntarily waived such consultation), and the normal rule of construction to the effect that any ambiguities are to be resolved against the drafting party will not be employed in the interpretation of this Agreement.
(h)Representations and Warranties. You represent and warrant that you are not restricted or prohibited, contractually or otherwise, from entering into and performing each of the terms and covenants contained in this Agreement, and that your execution and performance of this Agreement will not violate or breach any other agreements between you and any other person or entity. You further represent and warrant that you will not, during the term hereof, enter into any oral or written agreement in conflict with any of the provisions of this Agreement, the agreements referenced herein and the Company’s policies.
(i)Return of Company Property. Upon termination of this Agreement or earlier as requested by the Company, you shall deliver to the Company any and all equipment, and, at the election of the Company, either deliver or destroy, and certify thereto, any and all drawings, notes, memoranda, specifications, devices, formulas and documents, together with all copies, extracts and summaries thereof, and any other material containing or disclosing any third-party information or proprietary information.
(j)Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.
TIVIC HEALTH SYSTEMS, INC.
By: /s/ Jennifer Ernst
Name: Jennifer Ernst, Chief Executive Officer
ACCEPTED AND AGREED:
Michael Handley
/s Michael Handley
Signature
Date: February 18, 2025
ATTACHMENT A
EMPLOYEE INVENTION ASSIGNMENT AND
CONFIDENTIALITY AGREEMENT
ATTACHMENT B
ARBITRATION AGREEMENT
ATTACHMENT C
APPROVED DISCLOSURES
Exhibit 99.1
TIVIC HEALTH NAMES BIOTECH INDUSTRY VETERAN MICHAEL K. HANDLEY
TO EXECUTIVE LEADERSHIP TEAM
Handley Joins as President of Tivic Biopharma and Chief Operating Officer of Tivic Health Following its Licensing of Strategic Biopharma Assets from Statera Biopharma
FREMONT, Calif. – February 24, 2025– Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today that Michael K. Handley, formerly Chief Executive Officer, President and Chairman of Statera Biopharma, Inc., has joined Tivic Health as the President of Tivic Biopharma, a newly formed division of Tivic Health. Additionally, he will assume the role of Chief Operating Officer of Tivic Health and will work closely with the CEO and other leadership team members to develop and operationalize company-wide strategies.
His key responsibilities will include building and leading Tivic’s Biopharma team, advancing Tivic’s recently licensed, late-stage product candidate, Entolimod™ through manufacturing validation, regulatory approval processes and commercialization, and directing pipeline development activity.
“Mike brings to Tivic a rare blend of device and pharmaceutical background, as well as proven operational, business and scientific experience that sets Tivic up for a smooth and successful expansion into drug development,” stated Tivic Health Chief Executive Officer, Jennifer Ernst.
“With our recent licensing of the late-stage TLR5 agonist, Entolimod, from Statera Biopharma, and Mike’s deep experience in immunology and biotech, we believe that he is the ideal leader to establish Tivic’s biopharmaceutical capabilities and advance our therapeutics pipeline. In tandem, we continue to pursue the development and exciting promise of our non-invasive bioelectronic vagus nerve stimulation, creating a portfolio of device and drug therapeutics from which to build shareholder value,” added Ernst.
Over the course of his career, Michael has successfully led or assisted in the global commercialization of 17 drugs and devices that represented ~$7 billion in annual sales. Additionally, he served as part of the management teams of successful exits to Johnson & Johnson and Boston Scientific. He has successfully led teams in a variety of capacities in high growth organizations. As CEO, President and Chairman of the Board of Statera, Michael created and executed the company’s growth strategy, advanced clinical development and intellectual property strategies, and spearheaded the company’s business development and financing activities.
“This is an exciting and critical time at Tivic Health, and I am thrilled to join the Tivic leadership team to continue the essential work of advancing Entolimod towards potential commercialization,” stated Handley. “With compelling evidence of preventing death following a potential lethal dose of radiation and the opportunity to expand to adjacent indications in radiation toxicity and immune system dysregulation, I believe that Entolimod serves as a great foundation on which to build and potentially expand Tivic Health’s biopharma pipeline.”
Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
In connection with, and as a material inducement to, the hiring and appointment of Michael as Chief Operating Officer of Tivic Health and President of Tivic Biopharma, Tivic agreed to grant Michael 600,000 restricted stock units (RSUs), which shall vest over four years, with one fourth of the RSUs vesting on the one-year anniversary of the date of grant and the remaining RSUs vesting in 12 equal quarterly installments thereafter until fully vested. The vesting of shares of common stock underlying the RSUs will be subject to Michael’s continuous service with Tivic through each applicable vesting date.
The foregoing RSU grant was unanimously approved by Tivic’s board of directors and the compensation committee of the board, and such grants were inducements material to Michael entering into employment with Tivic, in accordance with Nasdaq Listing Rule 5635(c)(4). The foregoing equity grant was made outside of Tivic’s Amended and Restated 2021 Equity Incentive Plan or any other equity incentive plan of the company.
About Tivic Health
Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health takes a multi-pronged approach to treating diseases caused by immune and autonomic nervous system dysregulation. The complement of bioelectronic and biologic medicines allows Tivic to target disorders and disease via both neural pathways and molecular approaches. Tivic Health’s first FDA approved product ClearUP™ is clinically proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: https://ir.tivichealth.com
Forward-Looking Statements
This press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: statements regarding Tivic Health’s development and advancement of Entolimod for the treatment of acute radiation syndrome (ARS) and any other indications that it may elect to license from Statera in the future; the future development of ncVNS treatment, Tivic Health’s ability to commercialize products arising out of the license from Statera and Tivic Health’s ncVNS treatment; the Tivic Health’s plans to seek regulatory approval for such clinical products and Tivic Health’s continued focus on developing Entolimod, including for the treatment of ARS and/or any other indications it may elect to license in the future, and its ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility, including which patient populations may be pursued; the timing and success of clinical studies and trials; market and other conditions; macroeconomic factors; and unexpected costs, charges or expenses that reduce Tivic Health’s capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic Health’s actual results to differ from those contained in the forward-looking statements, see Tivic Health’s filings with the SEC, including, its Annual
Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading “Risk Factors”; as well as the company’s subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.
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Investor Contact:
Hanover International, Inc.
ir@tivichealth.com
