Life Science Compliance Program

John E. Nause

** ****** **** ****, ********, NJ *7825 *******@*****.*** 908-***-****

CORPORATE ETHICS & COMPLIANCE LEADER:

Dynamic and accomplished compliance and ethics leader with over 20-years of life science industry experience, and over 10-years of experience driving a culture of ethics and integrity in life science industry companies. Proven expert in the design, implementation and testing of best-in-class compliance programs, providing pragmatic solutions to transform compliance departments into in-demand business assets. AREAS OF EXPERTISE

Healthcare Compliance Project Management 7-Elements of a Compliance Program

Cost and Price Analysis Training and Presentations Government Contract Negotiations

Federal Regulations Internal/External Audits Confidential Disclosure Hotlines

Internal Investigations Code of Conduct Development Anti-Kickback and Antitrust

PhRMA/AdvaMed Code Aggregate Spend Reporting Policy and Procedure Development PROFESSIONAL EXPERIENCE:

PIRAMAL PHARMA LIMITED Bethlehem, PA 10/2021 – Present Director, International Compliance

Established a new comprehensive compliance program for a global pharmaceutical company.

• Conducted compliance assessments for Piramal Critical Care and Piramal Pharma Solutions.

• Developed new promotional policies and procedures for Piramal Critical Care’s US operations, and trained Sales and Marketing personnel on those policies and procedures.

• Developed materials and conducted new-hire compliance training.

• Updated the Quarterly Compliance Certification process, along with the development of new compliance grids that tracked all statutory reporting and licensing requirements.

• Led quarterly Compliance Committee meetings.

• Developed and launched an updated Code of Conduct.

• Partnered with HR on the implementation and launch of a global anonymous reporting hotline.

• Performed compliance investigations into suspected or reported concerns of misconduct. AUROBINDO PHARMA USA and ACROTECH BIOPHARMA East Windsor, NJ 11/2020 – 10/2021 Director, Ethics and Compliance

Managed corporate compliance program for all U.S. subsidiaries of a global pharmaceutical manufacturer.

• Conducted a compliance assessment of the existing program, and updated policies and procedures to reduce risks.

• Developed new training modules for the field sales force and updated existing materials for new hire orientation.

• Collected and uploaded data into MediSpend and generated and submitted reports for Sunshine/Aggregate Spend reporting to federal and state agencies.

• Reviewed and approved promotional materials in Veeva Vault while on the Promotional Review Committee.

• Managed the quarterly compliance grid tracking all federal and state reporting requirements.

• Reviewed and approved the sales team’s incentive compensation plans on the Incentive Compensation Committee. G & M HEALTH, LLC Somerset, NJ 10/2018 – 11/2020 Vice President, Ethics and Compliance

Provided Compliance consulting services and solutions to a variety of companies in the Life Science Industries.

• Established comprehensive compliance programs for manufacturers preparing to launch their first commercial NDA products, by partnering with internal leaders and external business partners.

• Developed a suite of compliance training modules, available to clients through an online LMS system.

• Reviewed clients’ commercial policies and procedures and recommended areas for improvement and risk reduction.

• Functioned as the outsourced Compliance Officer for small pharmaceutical manufacturers and a CSO.

• Performed audits of Fortune 500 pharmaceutical companies to identify gaps and recommendations changes.

• Reviewed, corrected, and uploaded data from various clients, into G & M’s Sunshine/Aggregate Spend system.

• Conducted compliance training for clients’ new employees. John E. Nause Page 2 of 2

• Partnered with the GC/CCO from a mid-size pharmaceutical manufacturer, to present at the Sharing Alliance’s State Compliance Short Course in January of 2019.

• Developed playbooks, policies, and training materials, to identify and mitigate potential regulatory risks for a client selling customized MSL and Clinical Nurse Educator offerings to their pharmaceutical clients. DR. REDDY’S LABORATORIES, INC. and PROMIUS PHARMA LLC Princeton, NJ 2/2012-9/2018 Associate Director/North American Head, Corporate Ethics and Compliance/Privacy Officer (1/2013 – 9/2018) Senior Manager, Government Contracts and Pricing – Finance Dept. (2/2012 - 1/2013) Managed corporate compliance program for all U.S. and Canadian subsidiaries for a global pharmaceutical company.

• Saved over $300K annually by designing and conducting in-house, classroom-based compliance training to mitigate risks while containing costs; ensured attendees were fully engaged during the training to increase retention.

• Drove the implementation of system and procedural changes associated with CMS’ Open Payments final rule for the PPACA/Sunshine Act; implementation was completed ahead of schedule and under budget.

• Led compliance activities in support of new product launches for the branded Neurology and Dermatology businesses; developed and conducted compliance training for sales forces, and monitored results after launch.

• Drove a cross-functional project, with Finance and IT, to implement MedPro® connectivity within Concur to improve compliance with the Open Payments program and Aggregate Spend reporting requirements.

• Established, reviewed, and updated Fair Market Value grids to mitigate risks of Anti-Kickback Statute violations.

• Investigated misconduct and presented findings with proposed resolution plans to the Compliance Committee.

• Prepared data and presentations for the Chief Compliance Officer, used to update the Board of Directors.

• Saved over $1-million with the implementation of MMIS’ MediSpend system for Dr. Reddy’s; the new system increased efficiency and allowed for more accurate reporting of transfers-of-value provided to U.S. licensed HCPs ensuring compliance with the Sunshine Act/Open Payments program, as well as several states’ requirements. WATSON PHARMACEUTICALS, INC. Parsippany, NJ 11/2006 – 2/2012 Manager, Government Contracts and Managed Markets

Managed a team of 6 professionals, supporting both brand and generic divisions, who negotiated and administered government contracts, performed and reported statutory calculations, administered rebates for federal programs, etc.

• Increased Government revenues from $25 million to $90 million annually by adding new and existing products onto federal contracts, and utilizing new contract vehicles, while ensuring compliance with contract terms and conditions.

• Oversaw the processing of 1,200 Medicaid rebate payments annually, valued at about $90 million.

• Led efforts to implement Government Pricing changes required by legislation (DRA of 2005; PPACA of 2010; etc.).

• Successfully managed integration of Andrx Corp. (2006) and Cobalt Labs (2009) after they were acquired. JOHNSON & JOHNSON HEALTH CARE SYSTEMS, INC. Piscataway, NJ 2/2002 – 11/2006 Government Contract Manager

Administered several federal contracts, allowing J&J’s Operating Companies to achieve business goals in the Government market.

DIAGNOSTIC IMAGING INC., a division of PSS World Medical Jacksonville, FL/Delran, NJ 7/2001 – 2/2002 Account Manager - Philadelphia

Accountable for increasing revenue in the Philadelphia Territory, for a national distributor or radiology equipment, supplies, and services.

EDUCATION & CERTIFICATIONS:

Healthcare Compliance Certificate Program (2014), Seton Hall University School of Law, Newark, NJ Bachelor of Arts Degree in Criminal Justice, Stockton University, Pomona, NJ Associate of Science Degree in Criminal Justice, County College of Morris, Randolph, NJ AWARDS AND RECOGNITION:

Dr. Reddy’s – 2018 Dr. Anji Reddy Award for Excellence for efforts surrounding launch of a revised code of conduct. Dr. Reddy’s – 2017 Spot Award for efforts to track city/county/state laws affecting commercial operations.

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