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Michael J. Halaiko, Esq., CIPP/E

Michael J. Halaiko, Esq., CIPP/E

Partner

100 S. Charles Street
Suite 1600
Baltimore, MD 21201
101 Constitution Avenue, NW
Suite 900
Washington, D.C., 20001
mike.halaiko@nelsonmullins.com

Mike is a partner on the firm’s Healthcare and Privacy Teams and leads its Pre-Clinical and Clinical Study Practice. 

Mike’s practice involves working with life science companies, clinical research organizations, and academic institutions involved in clinical research and development. He is regularly involved in drafting and negotiating agreements and advises clients involved in U.S.-based...

Mike is a partner on the firm’s Healthcare and Privacy Teams and leads its Pre-Clinical and Clinical Study Practice. 

Mike’s practice involves working with life science companies, clinical research organizations, and academic institutions involved in clinical research and development. He is regularly involved in drafting and negotiating agreements and advises clients involved in U.S.-based and global clinical trials on insurance, indemnity, and intellectual property, among other issues.  

Mike is a Certified Information Privacy Professional (CIPP/E) and has particular experience counseling clients regarding the EU’s General Data Protection Regulation (GDPR) and the EU’s Clinical Trial Information System (CTIS).  He routinely advises U.S.-based companies on international data transfers and GDPR compliance. 
Mike is a member of the firm’s A.I. Task Force and regularly publishes and presents on A.I. governance and compliance with a particular emphasis on the use of personal data in A.I. models.

Mike has several decades of litigation experience representing clients in contract and commercial disputes and catastrophic personal injury and death cases.  Mike’s background in litigation allows him the benefit of understanding how language is interpreted and applied when disputes arise, and special insight into protecting clients against third-party liability.

Mike has tried cases to verdict and arbitrated cases in Maryland, Delaware, Pennsylvania, and West Virginia. He also argued appeals before the Indiana Court of Appeals and the West Virginia Supreme Court of Appeals.

Finally, Mike serves as outside general counsel for numerous companies advising these businesses on issues of risk management, insurance, employment, and litigation. Mike develops a deep knowledge of each client’s business needs, priorities, and practices, as well as an understanding of the risk tolerance of each client, which allows him to provide pragmatic advice and counsel.
 

Michael J. Halaiko, Esq., CIPP/E

and global clinical trials on insurance, indemnity, and intellectual property, among other issues.  

Mike is a Certified Information Privacy Professional (CIPP/E) and has particular experience counseling clients regarding the EU’s General Data Protection Regulation (GDPR) and the EU’s Clinical Trial Information System (CTIS).  He routinely advises U.S.-based companies on international data transfers and GDPR compliance. 
Mike is a member of the firm’s A.I. Task Force and regularly publishes and presents on A.I. governance and compliance with a particular emphasis on the use of personal data in A.I. models.

Mike has several decades of litigation experience representing clients in contract and commercial disputes and catastrophic personal injury and death cases.  Mike’s background in litigation allows him the benefit of understanding how language is interpreted and applied when disputes arise, and special insight into protecting clients against third-party liability.

Mike has tried cases to verdict and arbitrated cases in Maryland, Delaware, Pennsylvania, and West Virginia. He also argued appeals before the Indiana Court of Appeals and the West Virginia Supreme Court of Appeals.

Finally, Mike serves as outside general counsel for numerous companies advising these businesses on issues of risk management, insurance, employment, and litigation. Mike develops a deep knowledge of each client’s business needs, priorities, and practices, as well as an understanding of the risk tolerance of each client, which allows him to provide pragmatic advice and counsel.
 

Mike is a partner on the firm’s Healthcare and Privacy Teams and leads its Pre-Clinical and Clinical Study Practice. 

Mike’s practice involves working with life science companies, clinical research organizations, and academic institutions involved in clinical research and development. He is regularly involved in drafting and negotiating agreements and advises clients involved in U.S.-based... and global clinical trials on insurance, indemnity, and intellectual property, among other issues.  

Mike is a Certified Information Privacy Professional (CIPP/E) and has particular experience counseling clients regarding the EU’s General Data Protection Regulation (GDPR) and the EU’s Clinical Trial Information System (CTIS).  He routinely advises U.S.-based companies on international data transfers and GDPR compliance. 
Mike is a member of the firm’s A.I. Task Force and regularly publishes and presents on A.I. governance and compliance with a particular emphasis on the use of personal data in A.I. models.

Mike has several decades of litigation experience representing clients in contract and commercial disputes and catastrophic personal injury and death cases.  Mike’s background in litigation allows him the benefit of understanding how language is interpreted and applied when disputes arise, and special insight into protecting clients against third-party liability.

Mike has tried cases to verdict and arbitrated cases in Maryland, Delaware, Pennsylvania, and West Virginia. He also argued appeals before the Indiana Court of Appeals and the West Virginia Supreme Court of Appeals.

Finally, Mike serves as outside general counsel for numerous companies advising these businesses on issues of risk management, insurance, employment, and litigation. Mike develops a deep knowledge of each client’s business needs, priorities, and practices, as well as an understanding of the risk tolerance of each client, which allows him to provide pragmatic advice and counsel.
 

Experience

Following is a selected sampling of matters and is provided for informational purposes only. Past success does not indicate the likelihood of success in any future matter.

Representative Contracting/Risk Management Matters

 

  • Developed master clinical trial agreements for numerous pharmaceutical companies entering the clinical study phase of research and development.

  • Developed “playbooks” for pharmaceutical companies for use in negotiating and enrolling clinical trial sites. The “playbooks” provide a negotiating matrix of acceptable alternative language to most provisions of the master clinical trial agreement. The “playbooks” allow clinical research organizations (CROs), and the clients’ in-house contract management staff, to negotiate with the clinical trial sites without escalation to legal on many routine contract negotiation issues.

  • Drafted, revised, and negotiated numerous clinical site agreements, letters of indemnification, nondisclosure agreements, informed consent forms, and other documents involved in all phases of clinical research and product development for U.S.-based and global clinical trials.

  • Developed master service agreements for CROs and Sponsors for clients engaging in clinical research and development.

  • Drafted, revised, and negotiated numerous master service, laboratory, and vendor agreements for pharmaceutical companies.

  • Drafted master form agreements of sale, construction contracts, terms and conditions, warranty disclaimers and subcontract agreements for product manufacturers, contractors, and construction companies.

Education

  • The Ohio State University Moritz College of Law, JD (1999)
  • Capital University, BA, magna cum laude (1996)

Admissions

  • District of Columbia
  • Maryland
  • Pennsylvania
  • West Virginia
  • Supreme Court of the United States
  • U.S. Court of Appeals for the Fourth Circuit
  • U.S. District Court for the District of Columbia
  • U.S. District Court for the District of Maryland
  • U.S. District Court for the Eastern District of Pennsylvania
  • U.S. District Court for the Northern District of West Virginia
  • U.S. District Court for the Southern District of West Virginia

Practice Areas

Industries

The bar rules of some states require that the standards for an attorney's inclusion in certain public accolades or recognitions be provided. When such accolades or recognitions are listed, a hyperlink is provided that leads to a description of the respective selection methodology.

  • American Bar Association
  • Baltimore City Bar Association
  • Maryland Bar Association
  • Sports and Fitness Industry Association – Legal Task Force
  • International Association of Privacy Professionals
  • Board Vice President, Gorilla Doctors (2023–present)
  • KIND (Kids In Need of Defense) Pro Bono Attorney (2019–present)
  • Board member, Gorilla Doctors (2013–present)
  • Maryland Volunteer Legal Services Pro Bono Lawyer (2003–present)
  • Board President, Gorilla Doctors (2018–2022)