Higher Education Institutions

K&L Gates represents many universities in various intellectual property (IP) matters. The development, commercialization, and protection of patents, trademarks, trade secrets, and copyrights, as well as the formulation of business strategies, are critical to the success of many universities in today’s competitive landscape.

Whether developing and implementing strategies for worldwide protection of a patent or trademark; drafting and negotiating licensing and strategic partnering agreements for life sciences, computer technologies, robotics, advanced materials, and other innovative products and services; or creating spin-off companies from university innovations, we can help clients protect valuable intellectual property assets.

Our comprehensive IP representation includes U.S. and foreign patent prosecution, including utility applications, reissue applications, re-examinations, and U.S. and foreign trademark prosecution; agreements of various kinds, including confidentiality agreements, material transfer agreements, R&D agreements, patent, trademark, copyright and technology license agreements, option agreements, assignments, and patent infringement litigation and other dispute resolution matters.

K&L Gates represents higher education institutions across the United States on a broad range of federal policy and programmatic funding matters, as well as identifying competitive grant opportunities. We assist clients in identifying and developing federal priorities to achieve their organization’s strategic goals. Whether the institution has an interest in federal public policy, competitive grant funding, the congressional appropriations process, or building relationships with federal administrative agencies, K&L Gates understands the legislative and political process from beginning to end and is well positioned to assist colleges and universities in dealing with the dynamic funding and policy climate in Washington, D.C.

With more than 40 offices across four continents, K&L Gates can often deliver local experience within our global platform. We advise domestic and foreign organizations with respect to corporate, tax, employment, immigration, and other areas as an institution may consider global operations.

K&L Gates represents universities, pension funds, foundations, and other exempt organizations and their investment advisors regarding a wide range of legal issues in connection with structuring and managing the investment of endowments and other funds, including providing counsel regarding compliance with the complex tax rules applicable to tax-exempt organizations and negotiating and drafting investment agreements.

K&L Gates lawyers assist exempt organizations with:

• Mergers and acquisitions
• Partnerships and other joint ventures with for-profit entities and other exempt organizations
• Formation of for-profit or limited liability company subsidiaries
• Formation of U.S. entities to support foreign charitable activities
• Creation of organizational and transactional structures to achieve complex fundraising and operational objectives both in the United States and internationally

In addition, K&L Gates lawyers advise exempt organizations regarding IRS and state tax audits; employee benefits (including 403(b) and 457 plans) structuring and compliance; community and economic development projects; social enterprise ventures; public/private partnerships; and private letter ruling requests to the IRS.

K&L Gates has one of the largest dedicated health care practices in the United States, representing startup enterprises and new ventures, as well as established health care businesses, institutional review boards, hospitals, and academic medical centers. Our lawyers have successfully represented teaching hospitals, medical schools, and faculty practice plans for more than 25 years and have substantial knowledge in dealing with the unique legal challenges they face.

Outside Counsel
The firm currently serves as outside counsel to a number of medical centers located in Connecticut, Florida, Massachusetts, North Carolina, Ohio, Pennsylvania, Tennessee, and Texas, among others.

Our work includes a full range of regulatory, taxation, transactional, litigation, employment, and operations advice and counseling. We have extensive experience counseling clients on compliance with Medicare/Medicaid reimbursement regulations and guidance and Stark and Anti-Kickback law. We also represent our health care clients in government investigations alleging legal non-compliance including False Claims Act violations, a costly and common occurrence in a highly regulated industry.

Transactional Matters
Our experienced transactional lawyers represent academic medical centers in mergers and acquisitions, divestitures, joint ventures, and affiliations, all of which are becoming increasingly common as the industry consolidates.

Food and Drug Administration Compliance
We advise our academic medical center clients on all aspects of federal and state regulation of preclinical and clinical research. Together with lawyers in our Food, Drugs, Medical Devices, and Cosmetics practice, we help these clients comply with the Food and Drug Administration (FDA) and Health and Human Services (HHS) regulations, establishment of institutional review boards (IRBs) and other regulated activities, and we have advocated on their behalf in connection with regulatory actions and congressional inquiries. The firm’s lawyers also have significant experience in representing academic medical centers in a wide array of international programs, including international research programs.

Whether through due diligence investigations for acquisitions or public financing, or by drafting and negotiating clinical trial agreements and budgets, cooperative research and development agreements, Material Transfer Agreements, HIPAA data use agreements, and business associate agreements, we assist our clients in moving their research forward. In collaboration with our colleagues in our Intellectual Property, Litigation, Government Contracts and Procurement Policy, and Life Sciences practices, we advise clients on all stages of government contracting, preparation of RFPs, compliance with Federal Acquisition Regulations (FAR), drafting of subcontracts for pre-clinical and clinical research, National Institutes of Health (NIH) grants, SBIR and STTR grants, and genetic privacy issues. We also represent client in accessing procurements under relevant federal programs, including BioShield legislation.