TreMonti Brochure - Compliance 2016
- 2. Along with enabling universities and other recipients of federal funding to retain title to resulting inventions, the Bayh-Dole Act also imposes a number of policy and reporting requirements on grantee institutions. Recent interest from admin- istration and the government have caused federal funding agencies to place more emphasis on ensuring that grantee institutions comply with these requirements. TreMonti Consulting, LLC (TreMonti) is focused on providing industry leading re- search compliance management services to universities, research institutes, and government organizations. We serve our clients at all levels of their organization. For every engagement, we assemble a team with the most appropriate experience and expertise. We have fully dedicated professionals with broad experience and in- depth knowledge in all aspects of research compliance. We utilize state-of-the-art tools and methods to assure our client institutions that they are and remain com- pliant with applicable statutes, regulations, rules, and guidelines. TreMonti’s team of business and technology professionals has hands-on experi- ence in managing intellectual property portfolios, including reporting technologies and intellectual property to federal funding agencies. Our team stems from organi- zations such as Deloitte & Touche, KPMG, and various industrial sectors. They are recognized as noted authorities and industry leaders in technology transfer, compliance, commercialization, and licensing of intellectual property. Our success is based on developing strong working relationships with clients as well as the funding agencies themselves. By listening to our clients’ specific issues and working directly with agencies, we are able to develop management and busi- ness improvement-based strategies to bring and keep our clients in compliance. We have rendered advice on best practices in Bayh-Dole compliance and advise clients regarding policy requirements, compliance management process, reporting (including iEdison reporting), best practices, educational programs, auditing, and other issues relating to federal reporting compliance. Our services cover the entire Bayh-Dole compliance process. Whether you are cleaning up existing reporting files, entering previously unreport- ed technologies, starting a research compliance program, or analyzing the compli- ance and effectiveness of your existing programs we can provide you with the sup- port and advice to succeed. Federal Compliance Solutions
- 3. Representative Services Service Purpose Key Tasks Policy & Procedure Review Review of existing policies and procedures to assess compli- ance with the Bayh-Dole Act. ï‚· Evaluate existing intellectual property policy, employment agreements, grant and technology transfer procedures, and reporting procedures (if any) ï‚· Determine areas of potential non-compliance Program Set-up Develop compliant policies and procedures for institutions es- tablishing a Bayh-Dole compli- ance program. ï‚· Assist in drafting new policies and procedures compliant with the Act for review by University Counsel ï‚· Develop management process flow including cross-check points and an au- dit function Reporting Clean-up Assist in reconciling known outstanding reporting deficien- cies. ï‚· Review outstanding iEdison notifications and other known reporting deficiencies ï‚· Correspond (as needed and where possible) with federal agencies regarding unique situations to determine correct pathway to proceed ï‚· Assist staff in reducing or eliminating number of outstanding iEdison notifications or reporting deficiencies ï‚· Review existing patents and patent appli- cations for required government support language and licenses for necessary re- porting requirements Audit Review of grants and intellectu- al property documentation to determine if all appropriate in- ventions have been disclosed and all reporting requirements have been met. ï‚· Review of outstanding iEdison notifications and other known reporting deficiencies ï‚· Review of grant reporting to identify technologies that were not reported to the University but may have been related to federal funding ï‚· Establish and run test to confirm that policies and procedures relating to reporting are being followed ï‚· Review of existing Patents, applications, and licenses Faculty In-Reach Educate faculty and appropri- ate personnel and staff who are associated with Bayh-Dole re- lated activities and reporting on the importance of Bayh-Dole and reporting of inventions. ï‚· Conduct faculty training programs in per- son or electronically relating to the im- portance of Bayh-Dole and invention re- porting as well as associated roles and obligations ï‚· Provide training materials for faculty and staff ï‚· Conduct annual updates to remind faculty and staff of processes and obligations under the Act Technology Marketing Marketing of federally funded technologies to ensure compli- ance with requirements of Act. ï‚· Qualify individual companies, including U.S. companies with manufacturing ca- pabilities, if available ï‚· Determine licensing strategy considering the desires of all parties ï‚· Identify licensing comparables ï‚· Facilitate negotiations/partnership formation
- 4. Common Concerns & Issues  I know my institution is not reporting in a timely manner, but I don’t know how to fix it!  Is our institution compliant in our Bayh-Dole/federal reporting obligations?  How and when do we report inventions to the federal government?  What information does the government need?  How do I navigate iEdison?  How do I get rid of all of these iEdison notifications?  What about federal agencies that do not use iEdison?  How can our office be more timely and efficient in our reporting obligations?  How do I assign rights to an inventor or a third party for federally funded technologies?  What is a U.S. manufacture waiver and how do I get one? TreMonti Can Help  Align your policies and procedures with federal compliance regulations  Identify areas of non-compliance and develop strategies to correct non-compliance  Reconcile existing iEdison notifications  Submit unreported technologies and documentation required by the federal government  Educate faculty, administration, and staff on the importance of timely invention disclosure and their obligations under the Bayh-Dole Act  Review existing patents and license agreements for Bayh-Dole compliance  Liason between your office and federal agencies regarding special circumstances and rectifying past compliance issues  Yearly audit of federal reporting to ensure continued compliance 2944 Hunter Mill Rd Suite 204 Oakton, VA 22124 (703) 865-5211 1120 South Freeway Suite 208 Fort Worth, TX 76104 (817) 335-6003 info@tremonticonsulting.com | www.tremonticonsulting.com