Ira Rosenau

Biography

Ira Rosenau is a partner in the firm’s Corporate & Business and Litigation practices, where he advises companies operating in highly regulated industries, including medical devices, pharmaceuticals, food products, additive manufacturing, and life sciences. With 30 years of experience as a commercial attorney and business leader—and a background as a trial lawyer, business executive, and in-house counsel—Ira is an exceptional problem-solver who helps clients navigate complex legal and regulatory environments. He offers a practical, commercially grounded perspective, particularly in matters where regulatory, business, and litigation considerations intersect, to advance his clients’ commercial goals.

Ira’s practice spans the full business lifecycle, from formation and product development through commercialization, growth, and exit. He advises clients on corporate structuring, regulatory compliance, intellectual property strategy, joint development and strategic partnership agreements, commercial contracting, mergers and acquisitions, and dispute resolution. His counsel is shaped by years of hands-on leadership experience managing regulated businesses in both domestic and international markets, enabling him to deliver practical, business-aligned legal solutions. His lawyer side of careful, conservative consideration works in harmony with Ira’s creative, entrepreneurial streak, allowing Ira to truly view the entirety of a problem before attacking it with out-of-the-box ideas that drives value to the client’s business.

MedTech & Life Sciences 

Bringing a medical device or pharmaceutical product to market compliantly is a complicated process requiring detailed cross-functional planning and execution. Ira helps guide FDA-regulated clients through the processes for regulatory and quality compliance in product commercialization, including:

• FDA and International product roadmap 

• Product development requirements and documentation 

• Obtaining FDA and international product clearances 

• ISO, FDA & cGMP Quality Management  

• QMS Implementation 

• Site Registration and Audits 

Prior to joining Royer Cooper Cohen Braunfeld, Ira served as Keystone Industries’ dental division president and general counsel of the consolidated businesses, overseeing all facets of Keystone’s comprehensive manufacturing of dental medical devices and pharmaceuticals, including the development and commercialization of its digital dental materials such as the KeyPrint® line of 3D printing resins. In those roles, he managed legal, regulatory, and compliance functions in commercializing multiple FDA Class II medical devices in the United States and international markets, including negotiating strategic partnerships, and handling acquisitions and other corporate transactions.

In addition to focusing on organic growth through product innovations, Ira also oversaw several acquisitions to improve processes or sales channels for the dental group, including the legal and business issues that needed to be addressed. 

Litigation 

In his litigation practice, Ira represents businesses in a wide range of commercial disputes, including contract and business tort matters, partnership and shareholder disputes, real estate and construction litigation, tax disputes, and matters involving regulated products. He draws on extensive courtroom and trial experience to develop practical, business-oriented litigation strategies. His advanced law degree (LLM) in trial advocacy helped hone his advocacy skills. 

Earlier in his career, Ira was a Partner in the Commercial Litigation group at Klehr Harrison Harvey Branzburg LLP, where he represented regional and national clients in complex commercial litigation and also advised on mergers and acquisitions, real estate transactions, and intellectual property matters. 

CLIENT EXPERIENCE 

• Life sciences, medical device, and dental companies operating in regulated environments 

• Commercial manufacturing companies utilizing a variety of production methods, including deep experience with additive manufacturing (3D printing), particularly for medical device production 

• Companies leveraging digital workflows and automation, like AI-driven software and CAD/CAM technologies  

• Middle-market businesses with established operations and ongoing legal and regulatory needs 

• Founders, executives, and management teams seeking strategic legal guidance 

• Investors and strategic partners, including private equity and venture-backed companies 

Representative Matters

Business & Corporate 

• Led the reinvention and growth of a dental business unit to profit growth of 550% over seven years, and revenue growth of more than 55% (11%+ CAGR per annum) following the launch of medical device 3D printing materials. 

• Established and positioned a global dental business as an early leader in the digital dentistry 3D printing market. 

• Directed the cross-functional commercialization of multiple FDA Class II medical devices across four continents.  Commercialized 12+ medical devices and drugs. 

• Investigated, documented and closed multiple strategic acquisition transactions and oversaw their integration into business operations. 

• Developed and negotiated global strategic alliances with leading dealers, Dental Support Organizations, dental laboratories, and dental OEMs. 

• Negotiated and documented a detailed Joint Development Project and Agreement for AI-driven software to digitally design the EMA sleep apnea device. 

Litigation 

• Litigated and successfully resolved multi-jurisdiction patent litigation concerning polymer technologies used in cosmetic nail applications.
• Successfully litigated, mediated, and resolved a $250 million claim involving fraudulent second mortgages against a major U.S. bank, a national financial services company, and the country’s largest title insurance company.
• Obtained an injunction against intellectual property theft and breach of fiduciary duty by cancer researchers on behalf of a major university and healthcare system.
• Obtained preliminary and permanent injunctions based on trademark infringement for a production company against holders of a counterfeit film library.
• Litigated and tried multiple employment, trade secret, and restrictive covenant matters, including: 

  • Securing multiple injunctions against former employees for restrictive covenant and trade secret violations.

  • First-chair federal court trial involving an alleged breach of an executive compensation agreement by a terminated CEO.

  • First-chair bench trial and appeal involving an employee’s alleged violation of restrictive covenants.

  • Second-chair jury trial involving breach of contract and fiduciary duty claims for a major university and healthcare system.

• Obtained summary judgment to quiet title for a commercial camping property against the recording of a fraudulent mortgage.
• Successfully litigated and resolved a complex federal court real estate dispute involving multiple high-value surface parking lots in a major metropolitan area.
• Obtained a $2 million bench trial victory on behalf of a national bank seeking enforcement of commercial loan agreements and notes.
• Second-chair bench trial victory exceeding $2 million involving a tax shelter and investment scheme related to Christmas tree farms.