Valion Bio, Inc. current report, 21 October 2022

Filing Overview

This Form 8-K was filed by Tivic Health Systems, Inc., not Valion Bio, Inc. The report concerns an event dated October 21, 2022 and was signed on October 25, 2022. Tivic is a Delaware corporation whose common stock trades on Nasdaq under the symbol TIVC.

Material Agreement

On October 21, 2022, Tivic entered into a Manufacturing Agreement with Microart Services Inc. Microart will manufacture, on a non-exclusive basis, specified components and sub-assemblies for Tivic’s current and future products.

  • Tivic will issue purchase orders specifying quantities and product requirements.
  • Microart will manufacture and supply products according to Tivic’s specifications and applicable purchase orders.
  • Pricing is generally fixed for each product. Microart may adjust prices once per cumulative 12-month period, subject to contractual limits and exceptions.
  • The initial term is three years, followed by automatic one-year renewals unless terminated in accordance with the agreement.
  • Termination provisions include mutual agreement, non-renewal with at least 60 days’ notice, uncured material breach with 30 days’ notice, and specified bankruptcy or liquidation events.

Financial Metrics and Liquidity

The filing does not provide revenue, profit, cash flow, margin, debt, liquidity, or other operating financial metrics. It also does not quantify purchase commitments, expected manufacturing costs, minimum order volumes, or the anticipated financial impact of the agreement.

Changes, Outlook, and Risks

The agreement establishes a manufacturing relationship intended to support Tivic’s current and future products, but the filing provides no earnings guidance or forecast. Key considerations include dependence on a third-party manufacturer, potential product-supply or quality issues, pricing changes permitted under the agreement, and the non-exclusive nature of the arrangement. The complete agreement contains additional terms, and portions of Exhibit 10.1 were redacted under Regulation S-K Item 601(b)(10).

Investor Verification Checklist

  • Confirm the issuer identity: the filing is for Tivic Health Systems, Inc. rather than Valion Bio, Inc.
  • Review the unredacted or available portions of Exhibit 10.1 for pricing limits, ordering obligations, minimum commitments, warranties, and liability provisions.
  • Determine whether the agreement creates material purchase commitments or affects cost of goods sold and gross margins.
  • Assess Tivic’s reliance on Microart and the availability of alternative manufacturing sources.
  • Review subsequent filings for amendments, termination, supply disruptions, or financial effects arising from the agreement.