Experience | Mintz

Serves as regulatory specialist on royalty and revenue interest financing transactions led by Mintz Corporate and Intellectual Property attorneys on behalf of biopharmaceutical clients.
Successfully represented a foreign API manufacturer in front of the FDA with respect to a sensitive product recall and U.S. removal action.
Represented a diagnostic developer during an FDA investigation into its alleged distribution of an unauthorized test for COVID-19 and subsequent recall activities.
Supported Mintz Corporate Team in negotiating and executing the sale of a client’s FDA Priority Review Voucher to another party for over $100 million.
Negotiated the release of consumer goods by FDA on behalf of a retailer client following the agency’s erroneous conclusion that the shipments contained laser components that did not comply with U.S. law, thereby leading to their detention at the port of entry.
Counseled a nationally recognized health system regarding the construction of advertising claims for various services involving regenerative medicine-based therapeutic procedures.
Served as FDA specialist and regulatory team leader on a client’s complex bid for a bankrupt pharmaceutical company’s U.S. and European drug-related assets, including marketing authorizations and distribution permits.
Handled regulatory due diligence and related contractual negotiations for two acquisitions of independent testing laboratories by a global client.
Worked with several Mintz clients operating in non-FDA regulated industries to determine how to manufacture and distribute face shields, face masks, and alcohol-based hand sanitizers in compliance with FDA’s enforcement discretion policies during the COVID-19 pandemic, including by providing promotion and labeling advice.
Guided clients developing COVID-19 diagnostic or serological tests on various promotional risks and regulatory obligations both before and after they secured Emergency Use Authorizations from FDA that allowed the test to be distributed and used in the United States.
Prepared a Breakthrough Designation Request on behalf of a therapeutic developer client and helped another client secure Orphan Drug Designation for its innovative drug product.
Participates in the Medical, Legal, and Regulatory (“MLR”) Committees that are engaged in promotional review activities on behalf of multiple clients with recently approved new drugs and biologics.
Negotiated with FDA on behalf of a cosmetic client when a large shipment of imported products was detained by Customs and Border Protection due to non-compliant labeling and assisted company in developing plans for reconditioning the products.
Counseled a cosmetic company on its response to an FDA Warning Letter related to the use of drug claims to promote cosmetic products and then assisted in the company’s implementation of internal processes and procedures to avoid similar issues in the future.
Represented an innovative beverage company with a national profile on FDA compliance issues, labeling, promotional activities, and distribution agreements.
Served as FDA/FTC regulatory counsel on multiple private equity acquisitions of consumer product companies with high-end, global skincare and haircare brands.

Mintz Advises S2G Investments on $40M Series B Financing of Sojo Industries

Mintz represented S2G Investments in its $40 million Series B financing of Sojo Industries.

Mintz Advises Underwriters in Assembly Biosciences' $175 Million Underwritten Offering and Concurrent Private Placement

Mintz advised the underwriters in connection with Assembly Biosciences, Inc.’s underwritten offering of an aggregate of 5,591,840 shares of common stock and pre-funded warrants to purchase up to 1,040,820 shares of common stock, together with accompanying Class A and Class B warrants to purchase up to an aggregate of 6,632,660 shares of common stock at a combined price per share of common stock and accompanying Class A warrant and Class B warrant of $19.60 and a combined price per pre-funded warrant and accompanying Class A warrant and Class B warrant of $19.599.

Mintz Advises PHLUR on Acquisition by TSG Consumer

Mintz advised PHLUR, a modern fragrance brand recognized for its emotion-led storytelling and accessible positioning, in its acquisition by TSG Consumer, a leading private equity firm specializing in consumer brands.

Mintz Advises on Larimar Therapeutics’ $69 Million Public Offering

Mintz advised the underwriters in connection with a $69 million public offering by Larimar Therapeutics, Inc. of 21,562,500 shares of its common stock at a price to the public of $3.20 per share. The gross proceeds to Larimar from the offering were $69 million before deducting underwriting discounts and commissions and other offering expenses.

Mintz Advises on Soleno Therapeutics’ $200 Million Public Offering

Mintz advised the underwriters in connection with a $200 million public offering by Soleno Therapeutics, Inc. of 2,352,941 shares of its common stock at a price to the public of $85.00 per share.

Mintz Advises on Cogent Biosciences’ $230 Million Public Offering

Mintz advised the underwriters in connection with a $230 million public offering by Cogent Biosciences, Inc. of 25,555,556 shares of common stock, which includes 3,333,333 shares issued pursuant to the exercise in full by the underwriters of their option to purchase additional shares of common stock, offered at a public offering price of $9.00 per share.

Mintz Advises Sixth Street on $500M Strategic Financing with Arrowhead Pharmaceuticals

Mintz completed a $500 million senior secured credit facility for Arrowhead Pharmaceuticals on behalf of our client Sixth Street, enabling Arrowhead to fund innovation and growth opportunities across the company’s pipeline of RNAi therapeutics.

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.

FDA Team Helps Novel Therapeutic Developer Obtain Orphan Drug Designation

Mintz advised Glia, LLC on its successful bid to obtain orphan drug status from the FDA for its topical gel to treat ocular Graft-versus-Host Disease. The disease can affect stem cell or bone marrow transplant recipients and cause intense eye pain, ocular degeneration, and blindness.

MGH/Mass General Brigham Monetize Entyvio Royalties

Mintz represented Massachusetts General Hospital and Partners HealthCare in a deal that enables them to monetize part of their royalty interests in Entyvio, an antibody used to treat digestive diseases, to invest in research. Royalty Pharma paid $94 million in the true sale roll-up transaction.

FDA Team Advises Innovative Drug Company in Phase II

Mintz represents a company developing new drug therapies to treat neurodegenerative diseases and developmental disorders. Mintz advises the company on FDA issues, presentations to the company's board, and publication and presentation of the data.

Health Law Team is Trusted Advisor to Boston-Based System

Mintz represents a major Boston-based health care system that includes academic medical centers, community hospitals, physician practices, and a managed care plan. Mintz attorneys helped the system establish a specialty pharmacy and developed new provider contract templates for the health plan.