Jim Irwin Email & Phone Number

Cleveland/Akron, Ohio Area

• Provide legal counsel and operational support to the Cleveland Clinic and its foreign and domestic affiliates on a variety of governance, transactional, regulatory, compliance, and operational matters.• Serve as practice group chair for the areas of commercial contracts, research, and supply chain.• Manage a team of 22 attorneys, paralegals, and support staff as well as outside counsel within the aforementioned practice areas• Experienced in drafting and negotiating, inter alia… Show more • Provide legal counsel and operational support to the Cleveland Clinic and its foreign and domestic affiliates on a variety of governance, transactional, regulatory, compliance, and operational matters.• Serve as practice group chair for the areas of commercial contracts, research, and supply chain.• Manage a team of 22 attorneys, paralegals, and support staff as well as outside counsel within the aforementioned practice areas• Experienced in drafting and negotiating, inter alia, supply chain, operating a, software-as-a-service (SaaS) , clinical trial a, licensing , joint development, sponsored research , inter institution, data use, business associate, data processing , evaluation, material transfer, fee-for-service, assets purchase, and other similar agreements related to commercial transactions.• Provide counsel to business partners regarding various compliance and regulatory matters, including, Anti-Trust, Privacy and Cybersecurity, Anti-Kickback, Stark, Patient Referral, Sunshine Act, Export Controls, CLIA, and FDA matters (i.e., IND/IDEs, NDA/ANDA, 510ks, etc.).• Counsel business partners regarding intellectual property-related matters, commercialization strategies, and marketing approval pathways for new products, including patent and trademark filings, trade secrets protections, and licensing.• Contribute to the definition and development of corporate policies, procedures, and programs, offering continuous counsel on legal matters and risk mitigation strategies.• Provide support and counsel for issues pertaining to Federal Acquisition Regulations and other government contracting matters.• Counsel business partners regarding compliance with applicable state, federal and foreign data privacy laws, including HIPAA, FERPA and the GDPR.• Serve as a member and/or advisor to CC’s Institutional Review Board, Compliance Committee, Conflict of Interest Committee, Data Governance, and EPIC Governance Committee. Show less

Cleveland/Akron, Ohio Area

• Provided guidance and operational support to the CWRU on a variety of corporate transactional, regulatory compliance, and operational matters, including research contracting, technology licensing, and other operational issues relevant to a non-profit academic institution.• Drafted, reviewed, and negotiated corporate contracts, including sponsored research, clinical trial, fee-for-service, consulting, and procurement agreements. • Drafted, reviewed, and negotiated commercial option… Show more • Provided guidance and operational support to the CWRU on a variety of corporate transactional, regulatory compliance, and operational matters, including research contracting, technology licensing, and other operational issues relevant to a non-profit academic institution.• Drafted, reviewed, and negotiated corporate contracts, including sponsored research, clinical trial, fee-for-service, consulting, and procurement agreements. • Drafted, reviewed, and negotiated commercial option, license and other intellectual property related agreements in connection with CWRU’s Office of Technology Transfer.• Provided operational guidance and support for issues associated with federal and state laws and regulations in the university setting, including those related to research compliance, Bayh Dole Act, International Traffic in Arms Regulations, Export Administration Regulations, inurement/private benefit under IRC 501(c)(3), and rules and regulations relating to the operation of institutional review boards.• Developed and expand corporate research alliances that result in sponsored agreements between CWRU and its corporate partners.• Train and direct staff to ensure compliance with uniform administrative requirements, cost principles, and audit requirements as well as other legal requirements associated with maintaining CWRU’s non-profit status. Show less

Independence, Ohio

• Prepare and prosecute patent and trademark applications, with an emphasis in the chemical, software, and medical arts. • Draft, negotiate, and review commercial agreements, such as intellectual property licensing agreements, non-disclosure agreements, product sourcing agreements, sales agreements, lease agreements, outsourcing agreements, and the like.• Counsel clients regarding regulatory and compliance related matters, such as by developing and reviewing compliance practices for… Show more • Prepare and prosecute patent and trademark applications, with an emphasis in the chemical, software, and medical arts. • Draft, negotiate, and review commercial agreements, such as intellectual property licensing agreements, non-disclosure agreements, product sourcing agreements, sales agreements, lease agreements, outsourcing agreements, and the like.• Counsel clients regarding regulatory and compliance related matters, such as by developing and reviewing compliance practices for clients operating in industries with frequently changing regulations. o Perform risk assessments associated with corporate actions, such as taking products to market, outsourcing duties associated with existing agreements, and the like.• Generate infringement, validity, and freedom to operate opinions, with an emphasis on counseling clients with respect to patent and trademark litigation, validity, and infringement issues.• Prepare and file new product applications with the Food and Drug Administration (FDA), including filing medical device applications through the Center for Device and Radiological Health (CDRH) and Abbreviated New Drug Applications (ANDA’s) containing Paragraph IV challenges under the Hatch-Waxman Act. Show less

Cleveland/Akron, Ohio Area

• Practice focused on the generation of infringement, validity, and freedom to operate opinions, with an emphasis on counseling clients with respect to patent and trademark litigation, validity, and infringement issues.• Prepared commercial agreements including, inter alia, intellectual property licensing agreements, non-disclosure agreements, sales agreements, and the like.• Prepared Abbreviated New Drug Applications (ANDA) containing Paragraph IV challenges under the Hatch-Waxman… Show more • Practice focused on the generation of infringement, validity, and freedom to operate opinions, with an emphasis on counseling clients with respect to patent and trademark litigation, validity, and infringement issues.• Prepared commercial agreements including, inter alia, intellectual property licensing agreements, non-disclosure agreements, sales agreements, and the like.• Prepared Abbreviated New Drug Applications (ANDA) containing Paragraph IV challenges under the Hatch-Waxman Act.• Prepared and reviewed marketing materials, product packaging, and labeling inserts in compliance with FDA regulatory requirements.• Assisted with Federal and State Court litigation and counseled clients regarding intellectual property, unfair competition, false advertising, and other commercial matters. Show less

Cleveland/Akron, Ohio Area

Performed chemical testing on chemotherapy drugs via FDA, USP, ISO and ASTM testing procedures. Additionally, perform tests on polymer samples to determine gas and chemical permeation rates. Responsibilities included taking projects from start to finish independently, working closely with customers, supervising lab technicians and drafting reports.

Recipient of a National Science Foundation Grant. Preformed research on the purification and characterization of the SilE protein under Dr. Charles Dameron with the overall goal of circumventing the proteins silver resistance for burn cream production.

Recipient of a National Science Foundation and National Institute of Health grant. Research included providing initial testing on possible cancer drugs under the advisement of Dr. Stephan Balaz. Worked with a wide range of departments to try and achieve a common goal. The research conducted was published in a paper about the inhibition of MMP-1 and MMP-9 cancer causing enzymes and their testing methods. Testing was done in cooperation with the Mayo Clinic.

J.D., Law

Activities and Societies: Law Review

Masters Of Science In Management

Doctor Of Law (Jd), Contracts And Intellectual Property

Activities and Societies: Executive Editor of the Intellectual Property Journal

B.S., Bio-Chemistry

Education record