Michael D. Orlando

Michael Orlando is a corporate and intellectual property transactions attorney in the firm's San Diego (Del Mar) office. He is Team Leader of the firm's Technology Transactions Team, and a member of the Life Sciences and Healthcare teams.

Michael founded a software-as-a-service (SaaS) business prior to attending law school, and worked at a publicly-traded biotechnology company on an in-house secondment, and brings a practical, business-oriented approach to his engagements that focuses on problem solving. 

Areas of Practice

Michael uses his technical expertise and legal skills to advise cutting-edge technology companies and innovators in developing, commercializing, and procuring technology, including in connection with licensing, outsourcing, joint ventures, mergers and acquisitions, collaborations, strategic partnerships and commercial agreements. Michael’s cross-disciplines in both intellectual property and corporate law allow him to leverage both practice areas when structuring transactions for his clients. 

Michael’s legal practice spans across multiple industries, with particular emphasis on biotechnology/pharmaceuticals, medical devices, digital health and healthcare IT, aerospace, and automotive technologies, including electric, autonomous and connected vehicle technologies.

Michael has extensive experience assisting clients, from start-ups to Fortune 500 companies, with their intellectual property and commercial transactions, including:

• patent and know-how licenses, research, development and strategic collaboration agreements, co-promotion agreements, clinical trial agreements, and supply, manufacturing, distribution, logistics and other outsourcing agreements for pharmaceutical, biotechnology and medical device companies, including for pre-clinical, clinical, and commercial products;
• Telehealth services agreements, wearable device and remote patient monitoring agreements, mobile health application terms of service, data use agreements, healthcare information exchange agreements, revenue cycle management agreements, EHR system procurement, installation and services agreements, AI/ML and clinical decision support software development and licensing, research agreements, and collaborations and joint ventures for digital health technology companies, health insurers, and healthcare systems and physician organizations;
• software and hardware technology licenses, IT procurement agreements, SaaS/PaaS/IaaS agreements, Service Level Agreements, maintenance and support agreements, connected (IOT) device agreements, and OEM, VAR, reseller and distribution agreements; and
• outsourcing agreements, including information technology outsourcing (ITO), business process outsourcing (BPO), outsourced development, manufacturing and supply agreements; and offshoring arrangements.

Experience

Representative Transactions

Life Sciences:

• Represented Immunis in a Patent and Know-How License Agreement with Toray Industries for the development and commercialization of an opioid receptor agonist in the treatment of sarcopenia and other diseases.

• Represented Tharimmune, in its exclusive worldwide licensing agreement with Avior Bio to develop, market, and commercialize a clinical-stage asset, including a treatment of pruritus associated with chronic liver disease.
• Represented a biopharmaceutical company in licensing patents from AstraZeneca for the development and commercialization of monoclonal antibody treatments.
• Represented a medical technology company in a strategic license and collaboration with Thermo Fisher Scientific for the development and commercialization of genetic testing products using next generation sequencing technology.
• Represented a drug development company in an asset sale, license and commercialization agreement with Mayne Pharma Group Limited regarding an FDA-approved dermatology product for treating plaque psoriasis.

• Represented a privately held CDMO in a license, manufacturing, and supply arrangement with Hikma Pharma for the commercialization of an antibiotic.
• Represented Cellares in a joint development and collaboration agreement with Sony for the creation and supply of a modular system and flow cytometry technology for integration into the Cellares cell shuttle manufacturing platform.
• Represented Lorem Vascular in the purchase of intellectual property assets related to cell therapies, including medical device technology, from Cytori Therapeutics, with associated intellectual property licenses, and commercial agreements.
• Represented HEC Pharm Group (HEC) of China in a strategic collaboration and license agreement with Lannett Company for the development of a diabetes drug-device combination therapy.

Healthcare:

• Represented R1 RCM (Nasdaq: RCM) in a strategic outsourcing agreement with Intermountain Healthcare to take over revenue cycle management operations for Utah’s largest healthcare system.
• Represented a major healthcare insurance company in negotiating a telemedicine platform services agreement with Teladoc for use by network providers and members.
• Represented a large healthcare system in the negotiation of an EMR solution and integration project with Epic System Corporation.

Autonomous Vehicles:

• Represented Jaguar Land Rover in a strategic collaboration with Waymo for the development of autonomous vehicles using the Jaguar I-PACE for Waymo’s driverless robotaxi service.
• Represented Continental Automotive in a strategic partnership with Aurora to develop the first commercially scalable autonomous driving system for the trucking industry.
• Represented Pony.ai in a collaboration agreement with a major automobile manufacturer for an autonomous vehicle robotaxi project.
• Represented a major automotive technology company in a license and joint development agreement with a chip manufacturer for the design and deployment of self-driving vehicle control units.

Honors

Technology Transactions, Legal 500 US, 2016-2023

Articles

• "Using Term Sheets to Optimize Important Licensing Transactions," Intellectual Property Licensing Strategies 2016 ed. (Thomson Reuters/Aspatore Books), 2016

• "Key Contract Considerations and Governance Issues for Managing Outsourcing Risks," Best Practice for Managing Outsourcing Transactions (Thomson Reuters/Aspatore Books), 2014

Healthcare Law Blog Posts

• "HIMSS19 Kicks-Off Addressing Leading Topics in Healthcare Information Technology," February 13, 2019 

Speaking Engagements

• “Health Wearables and Mobile Medical Devices: Keeping Pulse on Legal Issues,” International Technology Law Association (ITechLaw), Speaker, November 10, 2016
• “Cross-Border Issues,” International Technology Law Association (ITechLaw), Panelist, May 19, 2016
• “Know how and trade secrets - a global view,” Terralex, Presenter, June 2015
• “Managing Sourcing Successfully,” Connect, Panelist, April 22, 2014
• “What's New in China Pharma Partnering,” BioPharma Partnering Forum, Panelist, April 29, 2013
• “Venture Capital Financing in the Life Science Industry,” Cal State San Marcos, Master of Biotechnology Program, Guest Lecturer, November 2012
• “Legal Issues for Sports Startups,” San Diego State University, Sports MBA Program, Guest Lecturer, 2011
• "Increasing Income and Profit By Outsourcing Professional Help," ASR Tradeshow, Panelist, February 4, 2010
• “Doing Business in China,” California Society of CPAs, October 22, 2009
• “Financing and Managing Your Business in a Down Economy,” IASC Skateboarding Industry Summit, Panelist, April 4, 2009
• “Bridging the Gap for Transactional Lawyers,” San Diego County Bar Association, Panelist, June 24, 2008
• “Internet Business Agreements: Key Issues and Practical Advice,” Whittier Law School, Guest Lecturer, 2008
• “Trials and Tribulations of Bringing a Product to Market,” CEO Strategy Forum (Connect), Panelist, March 27, 2008

Events

Memberships

San Diego County Bar Association

State Bar of California

Hawaii State Bar Association

National Eagle Scout Association

Biocom

HIMSS (Healthcare Information and Management Systems Society)

International Technology Law Association

Tech San Diego

Digital Media