Mintz Advises Daré on Going Public and Licensing Deals for Women’s Health Products

When Daré Bioscience Operations, Inc. first became a Mintz client, it was a private health care company working to develop innovative product candidates in women’s reproductive health. Due to the significant expenses associated with product development and regulatory compliance for innovative drug, device, and combination products, the San Diego-based company sought to raise capital through entering the public markets. Since becoming a public company, Daré Bioscience has in-licensed multiple exciting product candidates focused on women’s sexual health, vaginal health, fertility, and contraception and prioritized a goal of achieving FDA marketing approval for one or more products.

Mintz, with its significant experience helping clients access capital markets and finance their operations, helped Daré meet the challenge by leveraging an innovative transaction — a variation of a reverse merger into a publicly traded fallen angel. The transaction resulted in Daré becoming a wholly owned subsidiary of Cerulean and the stockholders of Daré gaining a controlling interest in the public company. As part of the transaction, which was completed in 2017, Cerulean changed its name to “Daré Bioscience, Inc.,” and the post-transaction entity currently trades on the Nasdaq Capital Market under the symbol “DARE.” The company’s Mintz team supported the negotiations and transactions for Daré’s licensing agreements and handled patent and regulatory matters related to commercializing an FDA-approved drug.

In addition to licensing a number of women’s health products, Daré also successfully achieved its first-ever FDA marketing approval in December 2021 for a single-use antibacterial gel treatment for bacterial vaginosis, which is considered to be the most common cause of vaginal symptoms among women. The Mintz team assisted Daré with submitting the relevant patents for listing in the FDA’s Orange Book following approval of the new drug. Patent prosecutors at the firm continue to work with Daré to expand and strengthen the company’s patent portfolio for its licensed and pipeline technologies.

Daré subsequently announced an exclusive license agreement in the summer of 2022 with global women’s health care company Organon (NYSE: OGN) under which Organon will commercialize the FDA-approved drug product on the company’s behalf. The Mintz team again played a key role in negotiating this significant agreement with Organon, which included complex intellectual property considerations and rights for both parties. Regulatory specialists from the firm have also been working with Daré to operationalize certain aspects of the arrangement with Organon in order to ensure Daré is taking necessary steps to comply with any obligations that may apply to the company in its current role — post-license agreement ahead of the drug’s commercial launch by Organon that is expected in the first half of 2023.