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 is admitted to practice in Texas only; her application to the New York bar is pending. She is working under the supervision of the partners at Goodwin.

Experience

ERFAHRUNG

EXPÉRIENCE

工作经历

Ms. Otenaike’s experience includes: 

  • Advising 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.
  • Advising 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.
  • Advising 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. 
  • Advising 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. 
  • Advising 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. 
  • Advising 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.
  • Advising Achilles Therapeutics, a biopharmaceutical company developing personalized cancer immunotherapies, on the completion of its £52.7 million Series C.
  • Advising a clinical-stage biotechnology company advancing new immunometabolic therapies for cancer in a Series B Preferred Stock financing.
  • Advising 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.
  • Advising 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.
  • Advising 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.
  • Advising 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.
  • Advising 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.
  • Advising a pharmacy benefits manager on its sale and corporate reorganization and drafting the required regulatory filings.
  • Advising 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.
  • Advising 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.
  • Advising 503B outsourcing facilities on registration with the FDA, implementation of cGMP compliance standard operating procedures, and risk strategy.
  • Advising 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.
  • Advising 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.
Professional Experience
Prior to joining Goodwin, Ms. Otenaike was most recently an associate at Baker Hostetler in Houston.
Professional Activities
Ms. Otenaike is a board member for Ms. JD. She also serves on the board for Amref Health Africa: Young Professionals.

In The News

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Credentials

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专业资格

Education

J.D.
The University of Texas School of Law
B.A., Cognitive Science,
Rice University

Admissions

Bar

Texas

Languages

Sprachen

LANGUES

语言

Yoruba
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Our clients rely on us for world-class advisory services, counsel on complex transactional work and high-stakes litigation. Specializing in matters involving the financial, life sciences, private equity, real estate, and technology industries, we use a collaborative, cross-disciplinary approach to resolve our clients’ most challenging issues. To find out more, please contact us.

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