Simone Otenaike is an associate in the firm’s Life Sciences group and Healthcare practice. Ms. Otenaike counsels investors, hospitals and healthcare systems, digital health companies, mobile health companies, and biotechnology and pharmaceutical companies on how to navigate the maze of healthcare laws and address operational, regulatory, transactional, and compliance concerns. She also advises FDA-regulated companies in the food and beverage, dietary supplement, pharmaceutical and medical device, and technology industries on regulatory and compliance issues. On the transactional side, Ms. Otenaike handles regulatory due diligence review and agreement drafting and negotiation for acquisitions and financings involving a wide variety of healthcare providers and FDA-regulated entities.
Ms. Otenaike’s experience includes:
- Advised Ampersand Capital Partners on their $140 million acquisition of Alliance Pharma Inc., which operates a Contract Research Organization (“CRO”) specializing in Drug Metabolism and Pharmacokinetics (“DMPK”) and bioanalytical services for both small and large molecules.
- Great Hill Partners in its acquisition of a controlling equity stake in Clearwave Parent, Inc. at an enterprise value of $300 million.
- Advised Aura Biosciences, a clinical stage biopharmaceutical company leveraging their novel targeted oncology platform to develop a potential new standard of care across multiple cancer indications, on their $77.9 million initial public offering.
- Advised Nuvalent, Inc., a preclinical stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, on their $190.6 million initial public offering.
- Advised Aldrich Capital Partners in its acquisition of Rhythm Management Group Corp., a minority-owned provider of remote monitoring services for cardiac patients.
- Advised Cano Health in its of acquisition of University Health Care, Inc., a provider of primary care to communities in South Florida.
- Advised TA Associates Management, L.P. in its sale of CCRM Fertility, the nation's leading network in fertility care and research, to Unified Women’s Healthcare, LP, a leading practice. management platform in women’s healthcare backed by Altas Partners.
- Advised Cano Health in its of acquisition of Doctor’s Medical Center, a provider of primary care and multi-specialty healthcare services.
- Advised York Capital Management in its minority investment in Advanced Monitoring Caregiving Inc., a telehealth company that offers remote patient monitoring services.
- Advised Chardan Capital Markets as underwriters in Femasys’, a biomedical company focused on transforming women’s healthcare worldwide by developing novel solutions and next-generation advancements, $34.45 million initial public offering.
- Advised Centessa Pharmaceuticals, a clinical-stage company employing its innovative asset-centric business model to discover, develop, and deliver impactful medicines to patients, in its $379.5 million initial public offering.
- Advised the underwriters in AFC Gamma’s, a commercial real estate finance company that originates, structures and underwrites senior secured loans for established cannabis industry operators in states that have legalized medicinal and/or adult use cannabis, $56.4 million follow-on offering.
- Advised Monte Rosa Therapeutics, Inc., a clinical-stage developing a portfolio of novel small molecule precision medicines, on their $222.3 million initial public offering.
- Advised Achilles Therapeutics, a clinical-stage biopharmaceutical company developing precision T cell therapies for the treatment of cancer, on their $175.5 million initial public offering.
- Advised Autolus Therapeutics plc, a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer, on their $115 million follow-on offering.
- Advised the underwriters in Sensei Biotherapeutics’, a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of the next generation of immunotherapies for the treatment of cancer and infectious diseases, $133 million initial public offering.
- Advised Kingswood Capital Management, LP, a private investment firm primarily focused on investing in businesses in transition, in connection with its acquisition of Cost Plus World Market from Bed Bath and Beyond Inc.
- Advised Collective Medical Technologies, a real-time care collaboration network used by payors and healthcare organizations to improve patient outcomes, in connection with its sale to PointClickCare Corp. for approximately $600 million.
- Advised the Special Committee of the Board of Directors of NantKwest in connection with the company’s agreement to merge with ImmunityBio in a stock-for-stock transaction.
- Advised Achilles Therapeutics, a biopharmaceutical company developing personalized cancer immunotherapies, on the completion of its £52.7 million Series C.
- Advised a clinical-stage biotechnology company advancing new immunometabolic therapies for cancer in a Series B Preferred Stock financing.
- Advised a growth equity investment group in connection with the purchase of Series B Preferred Stock of a pre-clinical life sciences company studying the proteins that drive cancer and other diseases.
- Advised a private equity fund in connection with the acquisition of a large specialty pharmacy and drafting the required regulatory filings for multiple pharmacy licenses across all fifty states and the pharmacy’s Medicare and Medicaid enrollment.
- Advised a pharmacy in connection with the acquisition of a veterinary compounding pharmacy and drafting the required regulatory filings for multiple pharmacy and sterile compounding licenses across all fifty states.
- Advised a private equity fund in connection with the acquisition of a drug distributor and wholesaler and drafting the required regulatory filings for multiple wholesaler and distributor licenses across all fifty states.
- Advised a 503B outsourcing facility and sterile compounding pharmacy in connection with its change of location and drafting the required regulatory filings for multiple pharmacy licenses across all fifty states.
- Advised a pharmacy benefits manager on its sale and corporate reorganization and drafting the required regulatory filings.
- Advised investors and alternative lenders in the healthcare industry on the regulatory risks of potential investments and negotiating agreements to minimize high-risk regulatory concerns.
- Counseling investor and portfolio company clients on post-closing compliance obligations, developing and implementing compliance programs, and managing compliance through multi-state growth.
- Advised pharmacy, wholesaler, drug distributor, virtual manufacturer and third-party logistics provider clients on state licensing issues and compliance with state pharmacy practice and drug distribution laws.
- Advised 503B outsourcing facilities on registration with the FDA, implementation of cGMP compliance standard operating procedures, and risk strategy.
- Advised a dietary supplement and prescription drug distributor on the Drug Supply Chain Security Act and the implementation of standard operating procedures to ensure compliance.
- Drafting standard operating procedures for nutritional supplement manufacturers, nutritional supplement distributors, and prescription drug distributors.
- Conducting mock inspections to prepare pharmacy and nutritional supplement clients for an auction sale or acquisition.
- Advised food and dietary supplement manufacturers on compliance matters, including registration, labeling, advertising, inspections and recalls.
- Negotiating supply and quality agreements on behalf of food manufacturers.
The University of Texas School of Law
- New York