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
Date of Report (Date of earliest event reported): November 25, 2022 |
Tivic Health Systems, Inc.
(Exact name of Registrant as Specified in Its Charter)
Delaware |
001-41052 |
81-4016391 |
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(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
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25821 Industrial Blvd., Suite 100 |
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Hayward, California |
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94545 |
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(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s Telephone Number, Including Area Code: 888 276-6888 |
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(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:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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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 1.01 Entry into a Material Definitive Agreement.
On November 25, 2022, Tivic Health Systems, Inc., a Delaware corporation (the “Company”), entered into a Fulfillment Services Agreement (the “Agreement”), with ALOM Technologies Corporation (“ALOM”). Pursuant to the Agreement, commencing on November 28, 2022 (the “Effective Date”), ALOM will provide, on a non-exclusive basis, certain assembly, procurement, storage, returns, and fulfillment services (collectively, the “Services”) to the Company’s end customers and retailers within the United States. During the term of the Agreement, ALOM shall complete the Services in accordance with purchase orders issued by the Company from time to time. The consideration payable by the Company to ALOM for Services rendered will be calculated and invoiced based on fixed hourly rates and fixed unit pricing, as applicable, subject to certain exceptions; provided that, commencing April 1, 2023, the Company will be subject to certain minimum periodic purchase requirements.
The Agreement has a three-year initial term, with automatic annual renewals until terminated by one of the parties in accordance with the terms of the Agreement. The Agreement may be terminated as follows: (i) for cause upon sixty calendar days’ written notice describing with particularity the conduct constituting such breach, if such breach is not cured to the reasonable satisfaction of the aggrieved party within such 60-day period; (ii) for failure to pay any invoices when due, if full payment is not made within twenty calendar days after delivery of a written notice; or (iii) for convenience, upon sixty calendar days’ written notice.
The foregoing description of the Agreement does not purport to be complete, and is qualified in its entirety by reference to the complete text of such Agreement, a copy of which is attached hereto as Exhibit 10.1 and incorporated by reference herein.
Item 7.01 Regulation FD Disclosure.
On December 1, 2022, the Company issued a press announcing execution of the Agreement, amongst other things. A copy of that press release is furnished as Exhibit 99.1 hereto and incorporated herein by reference.
The information set forth under Item 7.01 of this Current Report on Form 8-K (“Current Report”), including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (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 attached hereto, 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 attached hereto, 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 Securities and Exchange 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.
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(d) |
Exhibits. |
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Exhibit No. |
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Description |
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10.1 |
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99.1 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document).
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Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(b)(10). |
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 SYSEMS, INC. |
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Date: |
December 1, 2022 |
By: |
/s/ Veronica Cai |
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Name: Veronica Cai |
Exhibit 10.1
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE IT IS NOT MATERIAL AND IS THE TYPE OF INFORMATION THAT THE
REGISTRANT CUSTOMARILY AND ACTUALLY TREATS AS PRIVATE AND CONFIDENTIAL.
REDACTED INFORMATION IS INDICATED BY [***].
Fulfillment Services Agreement
This Agreement is between Tivic Health Systems, Inc. (“Tivic Health”), a California corporation having an address at 25821 Industrial Blvd., Suite 100, Hayward, CA 94025, and ALOM Technologies Corporation, a California Corporation having an address at 48105 Warm Springs Blvd., Fremont, CA 94539, USA.
The term of this Agreement will commence on November 28, 2022 (the “Effective Date”) and continue for three (3) years, after which it will automatically renew for successive one (1) year periods until cancelled in writing by either party, at least 60 calendar days prior to the expiration of the then-current term. During the term of this Agreement, ALOM shall provide Fulfillment and related services requested by Tivic Health. The anticipated services and associated pricing are set forth in this document and Addendum A, attached.
Prices and specifications set forth in this Agreement are subject to change, as follows:
Summary of services to be provided:
ALOM will provide assembly, procurement, storage, returns, and fulfillment to end customers and to retailers, within the United States, on behalf of Tivic Health from our Fremont California location (subject to Section 4 of the Terms). Orders will be submitted and supported through an API connection or other mutually agreed upon processes between our teams.
ALOM will assign an Account Manager to be Tivic Health’s primary point of contact.
ALOM will provide a copy of our Receiving Policy to Tivic Health prior to any inventory being transferred or received. Adherence to the Receiving Policy reduces the time and cost in getting Tivic Health products into inventory. Upon receipt of Tivic Health products, ALOM will perform a visual inspection of the shipment to verify that it has received the correct quantity of products based on labeling and to confirm that there are no observable defects in the condition of the products received. For the purposes of this document, “observable defects” shall mean only those defects plainly and readily visible to the human eye and require no technical skills or background, and only pertaining to outer boxes or pallets. ALOM will immediately notify Tivic Health of any observable defects of the products it has received, and will use reasonable efforts to aid Tivic Health with respect to the return of, or other actions regarding, such products. For additional testing or inspection compliance, please see the Quality Management Services Agreement, dated as of the date hereof (the “QMS Agreement”), in regards to ISO 13485 compliance.
ALOM will be supporting activities for Tivic Health’s “ClearUP” product, which is a medical device – Class 2 FDA (no Rx), and potential future products owned or produced by Tivic Health. All requirements for the products will be
communicated by Tivic Health to ALOM. A risk analysis and validation requirements will be required for all product changes.
Materials furnished to ALOM by Tivic Health shall not include or contain any hazardous or Restricted Substances (as defined in Section 8 of the below Terms and Conditions) without ALOM’s prior informed consent in writing.
ALOM’s storage of Tivic Health products will include the provision of one free annual physical inventory/inventory certification to Tivic Health or its CPA per calendar year. Additional physical inventories are available at extra cost. In addition to tracking the physical inventory, ALOM will perform industry standard cycle counting and reconciliation of inventory.
Inventory data will be available to view via COMPASSTM, our online client portal. Inventory is typically received and put away same day, but in no event more than two (2) business days after ALOM has received it and tracked in the COMPASSTM system is in real time.
ALOM will create assembly instructions based on the assembly information and instruction provided by Tivic Health, which it will provide to Tivic Health for its review and approval. Once approved in writing, ALOM will build a first article and present this to the Tivic Health for final approval (or other agreed means of approval). Assembly builds will be organized with your ALOM Account Manager.
After assembly, we will hold your assembled kits in inventory.
The QMS Agreement, Fulfillment Agreement and all Statements of Work describing the details of the services to be provided by ALOM in accordance with this Agreement will be entered into by the parties and will be incorporated into and become part of this Agreement.
Terms and Conditions
The following terms and conditions apply to all transactions between ALOM Technologies Corporation (“ALOM”) and Tivic Health Systems, Inc. (“Customer”).
Signatures
ALOM Technologies Corporation |
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Tivic Health Systems, Inc. |
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Date: |
11/22/2022 |
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Date: |
11/25/2022 |
By: |
/s/ Hannah Kain |
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By: |
/s/ Veronica Cai |
Name: |
Hannah Kain |
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Name: |
Veronica Cai |
Title: |
Chief Executive Officer |
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Title: |
Chief Financial Officer |
Addendum A
PRICING
Exhibit 99.1
PRESS RELEASE
Tivic Health Signs Agreement with ALOM to Manage Product Supply Chain, Assembly, and Logistics
Significant progress made to supply chain to support cost improvements and scaling
SAN FRANCISCO – December 1, 2022 – Tivic Health® Systems, Inc. (“Tivic”) (Nasdaq: TIVC), a commercial-phase health technology company that develops and commercializes bioelectronic medicine, today announced it has hired ALOM Technologies Corporation (“ALOM”), a leader in global supply chain product and service delivery programs, to manage product supply chain, assembly, and logistics.
Headquartered in the U.S., ALOM will be the company’s 3rd party logistics (3PL) warehouse, fulfillment, and production partner responsible for storing, packaging, and shipping Tivic product orders. Operating out of 19 global locations, ALOM’s technology-driven supply chain offerings include inventory management, contract manufacturing, procurement, fulfillment, warehouse operations, and logistics systems technology.
ALOM is a privately held, woman-owned company with a 25-year history of operational, quality, and sustainability excellence, including two consecutive years as a Multichannel Merchant Top 3PL Provider, and a 2022 Manufacturing Leadership Award recipient by the National Association of Manufacturers (NAM). In the medical industry, ALOM is ISO 13485 certified with FDA-registered facilities.
“ALOM’s relationship with Tivic Health brings together two organizations that share a commitment to improving the quality of people’s lives,” said Hannah Kain, president, and CEO, of ALOM. “Leveraging ALOM’s medical supply chain expertise, we have created a customized assembly, fulfillment, and reverse logistics program that delivers on both companies’ core values of technology-driven innovation, quality, and service level excellence.”
“Adding the expertise and technology stack of ALOM empowers us to unify sales channels and optimize fulfillment and shipping so we can focus on scalable growth and customer needs,” said
Ryan Sabia, COO of Tivic Health. “We are excited to add ALOM as our strategic partner as we continue to streamline our omnichannel and e-commerce operations.”
The company also recently announced additional cost reduction and margin improvement steps, including:
“Improving gross margin and our scalability are areas of focus for us in 2022. We believe the new relationships with Microart Services and ALOM will help in our cost reduction implementation processes creating a strong foundation for the company as we enter the peak holiday season and the New Year,” added Sabia.
About ALOM
ALOM is a global supply chain management services and solutions provider serving as a partner to its Fortune 500 clients in the medical, life sciences, technology, automotive, government, and utility/energy sectors. Headquartered in Fremont, CA, its expert team of strategists, technology engineers, and supply chain specialists operate globally from 19 locations. ALOM manages the physical supply chain from procurement, inventory management, contract assembly, digital media, and print as well as omnichannel fulfillment. ALOM also manages the data supply chain with e-commerce solutions, visibility tools, digital delivery tools, data management, and strong back-end systems, as well as the financial supply chain. ALOM is proud to deliver its clients’ products and services impeccably, enrich the end-user experience, and uphold their brand reputations. http://www.alom.com
About Tivic
Tivic Health Systems, Inc. is a commercial-phase health technology company delivering non-invasive bioelectronic treatments that provide consumers with a choice in the treatment of inflammation and certain other related conditions. For more information visit https://tivichealth.com @TivicHealth.
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: market and other conditions; supply chain constraints; macroeconomic factors, including inflation; the risks that the ongoing COVID-19 pandemic may disrupt Tivic’s business more severely than anticipated; and unexpected costs, charges or expenses that reduce Tivic’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’s actual results to differ from those contained in the forward-looking statements, see Tivic’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 31, 2022, under the heading “Risk Factors”; its Registration Statement on S-1, filed with the SEC on October 26, 2022, 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.
Media Contact:
Cheryl Delgreco
Cheryl.Delgreco@tivichealth.com
617-429-6749
Investor Contact:
Hanover International, Inc.
ir@tivichealth.com