---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-23-023364"
form_type: "8-K"
ticker: "DARE"
cik: "0001401914"
company_name: "Dare Bioscience, Inc."
filed_at: "2023-07-05T23:59:59+00:00"
generated_at: "2026-06-13T12:37:38.304858+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Daré receives $1M from Organon, revises milestone payments for XACIATO; targeting 2023 US launch

## Summary
- Organon pays Daré $1.0M in July 2023 to reimburse PDUFA fees and manufacturing costs under amended license.
- Upon first US commercial sale of XACIATO, Organon to pay Daré $1.8M (revised from prior amount).
- Daré eligible for up to $180M in future milestones and tiered double-digit royalties on net sales.
- Manufacturing validation completed; additional activities ongoing for continuity of supply for 2023 US launch.
- XACIATO is FDA-approved for bacterial vaginosis in females 12+; Organon is commercial partner.

## SEC filing metadata
- accession: 0001493152-23-023364
- form_type: 8-K
- ticker: DARE
- cik: 0001401914
- company_name: Dare Bioscience, Inc.
- filed_at: 2023-07-05T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 1.01, 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1401914/000149315223023364/0001493152-23-023364-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1401914/000149315223023364/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-23-023364
- JSON: https://secwatch.observer/filing/0001493152-23-023364.json
- Plain text: https://secwatch.observer/filing/0001493152-23-023364.txt

## Key facts
- Material Agreements
  Dare Bioscience, Inc. amended the Amendment with Organon International GmbH valued at $1.0 million (effective 2023-07-04).
  - Action: amendment
  - Agreement: license
  - Counterparty: Organon International GmbH
  - Value: $1.0 million
  - Effective: 2023-07-04
  source text: On July 4, 2023, Daré Bioscience, Inc. (“Daré”), and an affiliate of Organon & Co., Organon International GmbH (“Organon”), entered into an amendment (the “Amendment”) to the exclusive license agreement dated as of March 31, 2022 between the parties. Under the Amendment, Organon will pay $1.0 million to Daré to reimburse Daré for PDUFA fees and other manufacturing expenses and to support continued advancement of the development and commercialization of XACIATO, and the amount payable by Organon to Daré following the first commercial sale of a licensed product in the United States was revised to $1.8 million.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1401914/000149315223023364/0001493152-23-023364-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.