The BioNJ Clinical Trials Master Service Agreement

Background

BioNJ is pleased to present the Clinical Trials Master Service Agreement which is intended to enable, encourage and streamline the path for clinical trials Phases 2–4 by providing a template of an agreement between two entities. The purpose is to shorten the negotiation time for translation studies being conducted at New Jersey institutions, and as a result, freeing up much needed resources and time for research. Developed by a Working Group including BioNJ; Rutgers, The State University of New Jersey, and the law firm of Sheppard Mullin Richter & Hampton LLP, the agreement has been reviewed and endorsed by Rutgers University and Rowan University.

The Form

The form is available by contacting BioNJ at BioNJ@BioNJ.org (use MSA in the subject line). While some studies may require modification to the form for a specific trial’s needs, the form provides a reliable starting point for Sponsors collaborating with New Jersey research institutions.

Suggestions for improvements to the form or questions regarding its’ provisions, should be submitted to BioNJform@Sheppardmullin.com. They will be considered for future updates.

Continuing Efforts of the Working Group

The Working Group is continuing its efforts and will now turn to a Guidance Document that will help BioNJ Members and users of the form better understand key issues raised therein. Once the Guidance Document is complete, the Working Group will consider other forms, such as, forms for Letters of Indemnification, Guidance on Subject Injury and Sponsor Insurance Coverages. These documents will only be available to BioNJ members.

Acknowledgments

BioNJ gratefully acknowledges the contributions of the following individuals and organizations in the development of this document.

BioNJ

Spiro Rombotis, President and CEO of Cyclacel Pharmaceuticals, Inc., Chair of the BioNJ Translational Institute of New Jersey Committee and BioNJ Board Member

Rutgers University

Kathleen Scotto, Ph.D., Vice Chancellor for Research, Rutgers Biomedical and Health Sciences and BioNJ Board Advisor

Vince Smeraglia, Executive Director of the Office of Technology Commercialization

Michael Nagy, Director, Office of the Senior Vice President and General Counsel

Terra Pfund Kroll, Corporate Contracts, Office of Research and Economic Development

Sheppard Mullin Richter & Hampton LLP

Blaine Templeman, Managing Partner of the NY office, Life Sciences Practice Head

Sean Cornely, Associate and graduate of Rutgers

Rowan University

Julie Kligerman, Associate Counsel for Health Services

Carl Hock, Ph.D., Associate Dean for Research at Rowan School of Osteopathic Medicine

Sreekant Murthy, Ph.D., Chief Research Compliance Officer

Bristol-Myers Squibb

Cyclacel Pharmaceuticals

NPS Pharmaceuticals

Sanofi

Endorsements

The following organizations have reviewed and endorsed the Clinical Trials Master Service Agreement.