Amanda L. Kutz, J.D. Email & Phone Number

Virginia Beach, Virginia, United States

Virginia Beach, Virginia

Serves as the sole in-house counsel at LifeNet Health, a $500MM leading global biomedical company and the world's largest organ procurement organization, tissue bank and cell provider. Provides legal support for corporate transactions including product distribution and OEM relationships, regulatory matters, consulting and outsourced labor issues, health care compliance issues, day-to-day operational issues, and corporate maintenance. Manages legal portfolio of corporate and… Show more Serves as the sole in-house counsel at LifeNet Health, a $500MM leading global biomedical company and the world's largest organ procurement organization, tissue bank and cell provider. Provides legal support for corporate transactions including product distribution and OEM relationships, regulatory matters, consulting and outsourced labor issues, health care compliance issues, day-to-day operational issues, and corporate maintenance. Manages legal portfolio of corporate and regulatory filings in the United States, Canada and Austria for parent company and seven subsidiary entities, including a foundation. Oversees corporate restructuring, mergers and acquisitions, due diligence and entity maintenance.Oversees an active litigation docket for collection and other matters and manages outside counsel assisting with legal matters worldwide. Assists and coordinates internal support with outside litigation counsel on matters ranging from employee issues, product liability, IP issues and state and congressional investigations.Supervise the Contracts Administration Department, which processes over 2000 company contracts annually from corporate approvals, contract generation, negotiation, execution and on-going contract lifecycle maintenance. Serves as the subject matter expert for all corporate transactions and agreements.Drafts internal policies in compliance with applicable laws, including the LifeNet Health Code of Conduct, Anti-Corruption and Anti-Bribery Policy, Conflicts of Interest Policy, and provides annual training on compliance matters for global staff and distribution partners.Coordinates and manages global legal efforts with legal counsel outside the United States, including Canada, European countries, South American countries. Middle Eastern countries, and Asian countries for transaction and regulatory support. Selects outside counsel after performing due diligence and confirming appropriate expertise needed for project. Show less

Corporate attorney concentrating on transactional and regulatory compliance matters in the health care space. Advises clients regarding transactions, including strategic partnerships, joint ventures, mergers and acquisitions, health care industry contracting matters and assisting health care providers throughout the change of ownership process. Extensive experience counseling health care providers in compliance matters involving the Medicare and Medicaid programs, state and federal licensing… Show more Corporate attorney concentrating on transactional and regulatory compliance matters in the health care space. Advises clients regarding transactions, including strategic partnerships, joint ventures, mergers and acquisitions, health care industry contracting matters and assisting health care providers throughout the change of ownership process. Extensive experience counseling health care providers in compliance matters involving the Medicare and Medicaid programs, state and federal licensing programs, the Anti-Kickback Statute, False Claims Act, Stark Law, HIPAA, EMTALA, matters involving the FDA and Public Health Service Act, and the U.S. Foreign Corrupt Practices Act. Expertise in state requirements for change of ownership and corporate practice of medicine as applicable to hospitals, pharmacies and other health care entities. Active administrative practice, representing health care providers before professional licensing boards, medical staff hearings, through the certificate of need process and in Medicare and Medicaid appeals. Represents tissue banks, medical device companies, organ procurement organizations, pharmaceutical and biologic companies on transactional matters, including joint ventures, distributorships, product development agreements, supply agreements and consulting agreements. Regularly negotiates clinical trial agreements and assists clinical trial sponsors, investigators, and institutions in meeting FDA requirements throughout the clinical trial process. Experience in reviewing labeling and advertising claims, off-label promotion, social media guidance, and sales and marketing practices that meet FDA, OIG and AdvaMed Ethics Code compliance guidelines. Show less

Member of the corporate and health law legal sections, representing a wide variety of health care providers, including hospitals, medical device and pharmaceutical companies, biotech firms, eye and tissue banks, organ procurement organizations, and individual health care professionals. Advise on regulatory compliance and transactional matters. Negotiate mergers, acquisitions, joint ventures and other transaction. Challenge adverse licensure and accreditation decisions of administrative… Show more Member of the corporate and health law legal sections, representing a wide variety of health care providers, including hospitals, medical device and pharmaceutical companies, biotech firms, eye and tissue banks, organ procurement organizations, and individual health care professionals. Advise on regulatory compliance and transactional matters. Negotiate mergers, acquisitions, joint ventures and other transaction. Challenge adverse licensure and accreditation decisions of administrative boards. Prepare corporate compliance plans and provide compliance training. Show less

Collaborate with team of agency analysts and provide legal support for audits of federal programs and agencies as requested by Congress and required by law. Analyze actions of federal agencies to determine legal compliance of programs under audit. Advise members of Congress and federal agencies on legal complexities associated with draft legislation and proposed changes to federal programs. Draft legal opinions on behalf of GAO regarding federal appropriations. Review GAO reports for… Show more Collaborate with team of agency analysts and provide legal support for audits of federal programs and agencies as requested by Congress and required by law. Analyze actions of federal agencies to determine legal compliance of programs under audit. Advise members of Congress and federal agencies on legal complexities associated with draft legislation and proposed changes to federal programs. Draft legal opinions on behalf of GAO regarding federal appropriations. Review GAO reports for legal sufficiency and contribute legal analysis for final reports. Show less

J.D., Law

Activities and Societies: William and Mary Law Review, Notes Editor; William and Mary Bill of Rights Journal; Benjamin Rush Health Law.

B.A., History And Political Science

Activities and Societies: Phi Beta Kappa; Graduated Summa Cum Laude; University Honors; Wittenberg Choir