Kim represents life science companies (including both publicly held and privately owned international pharmaceutical, biotech, and medical device companies), clinical research organizations (CROs), academic medical centers, hospital systems, and non-profit research foundations in a wide range of matters related to medical research.
Overview
Kim represents life science companies (including both publicly held and privately owned international pharmaceutical, biotech, and medical device companies), clinical research organizations (CROs), academic medical centers, hospital systems, and non-profit research foundations in a wide range of matters related to medical research.
Practice Areas
Experience
- Representation of pharmaceutical, medical device, and biotech companies and various types of research organizations on issues related to medical research conducted in the United States and over 40 other countries including by way of example Austria, Australia, Belgium, Brazil, Canada, China, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Nigeria, Peru, Poland, Russia, South Africa, South Korea, Spain, Ukraine, and the United Kingdom.
- Over 12 years of daily representation of pharmaceutical, medical device, and biotech companies and various types of research organizations in the review and negotiation of a wide range of medical research-related agreements such as clinical trial agreements, consent forms and HIPAA authorizations, network and consortium agreements, grant agreements and subawards, publication agreements, consulting and advisory board agreements, and service agreements.
- Conducting the review and, as required, restructure of research-related contracting templates organization-wide. Drafting and implementing “playbooks” of acceptable fallback positions. Training of the client’s contracting team, including third party CROs, on the client’s preferred contract negotiation and escalation process and the proper use of templates and playbooks.
- Advising clients regarding compliance with U.S. and international laws and requirements related to medical research performed in the United States and abroad including clinical trial conduct, human subject protection, data privacy, anti-bribery, independent review boards/ethic committees, and product marketing and promotion.
- Directly interfacing with CROs and vendors on behalf of pharmaceutical and medical device companies on a broad range of issues throughout the lifecycle of a clinical trial.
- Representation of pharmaceutical, and medical device companies including advice and services regarding grants, sponsorships, publications, and marketing and promotional activities.
- Review of privacy and compliance policies and programs.
- Member of Deferred Prosecution Federal Monitor Team for a medical device company.
- Advising clients on contractual and legal risk utilizing insight gained from more than 8 years representing pharmaceutical and medical device companies, healthcare providers and insurance companies in civil litigation on a local and national level.
Distinctions
- Best Lawyers in America®
- Health Care Law, 2024
- Pro Bono Award, Memphis Area Legal Services, 2010
Bar Admissions
- Tennessee, 2000
- Mississippi, 1999
- U.S. District Courts
- Mississippi: Northern, Southern
- Tennessee: Western
- U.S. Court of Appeals
- 5th Circuit
- 6th Circuit
- U.S. Supreme Court
Education
- University of Mississippi, J.D., cum laude, 1999
- Associate Notes & Comments Editor, Mississippi Law Journal
- Moot Court Board
- Millsaps College, B.A., History, 1995
Associations
- American Bar Association
- Mississippi Bar Association
- Tennessee Bar Association
- Memphis Bar Association
- American Health Lawyers Association
Papers, Presentations & Publications
- Presenter, "Contracting with Academic Medical Centers - Primary Issues and Practical Solutions," Exact Sciences CLE, May 3, 2023.
- Author, "The European Commission’s New Standard Contractual Clauses: Transferring Personal Data from the EU (A Long Overdue 'Take Two')," Pro Te: Solutio, Vol. 14 No. 3, September 2021.
- Author, “The Cures Act,” Pro Te: Solutio, Vol. 10 No. 2, July 2017.
- Author, “The 21st Century Cures Act,” Pro Te: Solutio, Vol. 9 No. 3, March 2017.
- Author, “Balancing the Needs of Sponsors and Research Sites to Effectively and Efficiently Negotiate Clinical Trial Agreements”, Pro Te: Solutio, Vol. 8 No. 4, February 2016.
- Co-Presenter, “Recent Developments in Clinical Trial Agreements” MAGI Clinical Research Conference, 2014 East.
- Co-Presenter, “Informed Consent in Clinical Research”, Tennessee Bar Association CLE, November 12, 2013.
- Co-Presenter, “Publication Rights in Clinical Trial Agreements: Using the 5W’s (and 1H) to Understand & Balance the Interest of Research Sites and Sponsors”, MAGI Clinical Research Conference, 2013 East.
- Author, "50 State Consumer Protection Laws and Their Application to Prescription Drugs", Pro Te: Solutio, Vol. 4 No. 4, November 2011.
- Author, “You’ve Been Warned: FDA Warning and Untitled Letters,” Pro Te: Solutio, Vol. 3, No. 4, October 2010.
- Author, “Bell Atlantic Corporation v. Twombly – The Supreme Court Provides New Ammunition to Attack Factually Deficient Complaints,” Pro Te: Solutio, Vol. 2. No. 1, February 2009.
- Author, “Letters Of Intent: Friend or Foe?” Pro Te: Solutio, Vol. 1 No. 2, April 2008.
- Author, "Worker’s Compensation – Statutory Immunity – General Contractors and Subcontractors Immune from Common Law Suits brought by Insured Subcontractor’s Employees", 67 Miss. L. J. 359 (1997) reprinted in 21 Worker’s Comp. L.R. 271 (1999).