CRA Research Contracts and Agreements 3 — Questions and Answers
Question 1: A Material Transfer Agreement (MTA) covers the transfer of biological samples from a university to a biotech company. Which provision MOST protects the university's publication rights?
- A confidentiality clause limiting disclosure for 5 years
- A publication review period capped at 30–60 days (Correct answer)
- A clause granting the company an exclusive license to results
- A warranty disclaimer for the transferred materials
Correct answer: A publication review period capped at 30–60 days
Capping the company's review period at 30–60 days prevents indefinite delays to academic publication while allowing IP protection review.
Question 2: Under the Bayh-Dole Act, which entity has the right to 'march-in' and require licensing to third parties if a federally funded invention is not being adequately commercialized?
- The inventor
- The funding federal agency (Correct answer)
- The institution's tech transfer office
- Congress via a joint resolution
Correct answer: The funding federal agency
The Bayh-Dole Act grants federal agencies march-in rights to require licensing when the contractor fails to take effective steps to commercialize the invention.
Question 3: A consortium research agreement involves three universities sharing data and IP. Which governance document typically controls how IP ownership and revenue sharing are allocated?
- Subaward agreement
- Consortium Agreement (Correct answer)
- Memorandum of Understanding
- Data Use Agreement
Correct answer: Consortium Agreement
A Consortium Agreement sets out IP ownership, publication rights, and revenue sharing among multiple institutional partners in a research collaboration.
Question 4: A sponsor requires a university to include a 'right of first refusal' on licensing any IP developed under a sponsored research agreement. This provision primarily benefits the:
- University's technology transfer office
- Sponsor company (Correct answer)
- Federal government
- Principal investigator
Correct answer: Sponsor company
A right of first refusal gives the sponsor the option to negotiate an exclusive license before the university can offer it to others.
Question 5: Which federal regulation governs the procurement of research and development under federal contracts and distinguishes R&D from standard supply and service contracts?
- FAR Part 35 (Correct answer)
- FAR Part 15
- 2 CFR Part 200
- OMB Circular A-21
Correct answer: FAR Part 35
FAR Part 35 specifically addresses the procurement of research and development and sets out unique acquisition policies for R&D contracts.
Question 6: When a federally funded research agreement includes export control restrictions under EAR, which action is MOST important before adding a foreign national to the research team?
- Submitting a visa sponsorship application
- Conducting a deemed export review (Correct answer)
- Notifying the IRB of the personnel change
- Obtaining written consent from the foreign national
Correct answer: Conducting a deemed export review
Sharing controlled technology with a foreign national in the U.S. constitutes a deemed export, requiring a license review before the individual accesses controlled information.
Question 7: A sponsored research agreement (SRA) is silent on publication rights. Under standard academic norms, what right does the university TYPICALLY retain?
- No right to publish without sponsor approval
- The right to publish results after a reasonable review period (Correct answer)
- The right to publish only non-proprietary data
- The right to publish only with joint authorship from the sponsor
Correct answer: The right to publish results after a reasonable review period
Even when an SRA is silent, universities typically assert the right to publish research results after a reasonable sponsor review period, consistent with academic freedom.
CRA Research Contracts and Agreements 3
A Material Transfer Agreement (MTA) covers the transfer of biological samples from a university to a biotech company.
Which provision MOST protects the university's publication rights?