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

Dare Bioscience, Inc.

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.

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.95

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

Exact text from the filing

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.

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Source: SEC EDGAR

accession 0001493152-23-023364

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