CLE 069 Technology Transfer Exam

CLE 069 Technology Transfer Exam | Questions and Answers | 2026 | 100% Correct - Defense Acquisition University Technology Transfer Core Concepts (CLE 069 Topics): 1. Legal & Policy Framework: • • • • Bayh-Dole Act (1980): Key legislation allowing universities/businesses to retain title to inventions from federallyfunded research Stevenson-Wydler Act (1980): Requires federal labs to have technology transfer programs Federal Technology Transfer Act (1986): Authorized Cooperative Research and Development Agreements (CRADAs) National Technology Transfer and Advancement Act (1995): Streamlined technology transfer processes 2. Key Mechanisms: • • • CRADAs (Cooperative R&D Agreements): Collaborative agreements between federal labs and non-federal partners Patent License Agreements: Licensing federally-owned inventions Educational Partnership Agreements: Collaboration on STEM education • Memoranda of Understanding (MOUs): General cooperation agreements 3. DoD-Specific Processes: • • • • Technology transfer vs. transition Dual-use technology applications Foreign disclosure considerations Export control implications (ITAR/EAR) 4. Roles & Responsibilities: • • • • Technology Transfer Office (TTO) functions Patent Counsel involvement Program Manager responsibilities Laboratory Director authorities 5. Ethical Considerations: • • • Conflict of interest management Fair use of government resources Balancing public vs. private interests. 1. What is the primary goal of the Department of Defense's Technology Transfer (T2) program? Answer: The primary goal is to promote collaboration between DoD laboratories and private industry/academia to accelerate the development and commercialization of technologies with dual-use potential, thereby enhancing national security, economic competitiveness, and the effectiveness of the U.S. industrial base. 2. Which U.S. law first required federal laboratories to establish Offices of Research and Technology Applications (ORTAs)? Answer: The Stevenson-Wydler Technology Innovation Act of 1980. This was the first major legislation to mandate that federal labs actively engage in technology transfer. 3. What is a CRADA, and what makes it a unique collaborative agreement? Answer: A Cooperative Research and Development Agreement (CRADA) is a contractual agreement between a federal laboratory and a nonfederal partner (company, university) to collaborate on a specific R&D project. Its uniqueness lies in its ability to allow the government partner to provide personnel, services, facilities, equipment, and intellectual property (but not funds) to the partner, while the partner can provide funds, personnel, services, facilities, equipment, and IP. It also includes provisions for protecting the partner's proprietary information and for negotiating IP rights upfront. 4. Explain the fundamental change introduced by the Bayh-Dole Act of 1980. Answer: Before Bayh-Dole, the U.S. government typically retained title to inventions made with federal research funding. The Bayh-Dole Act allowed universities, small businesses, and non-profits to elect to retain title to such inventions, with the obligation to commercialize them. This incentivized the private sector to invest in developing and bringing federally-funded research to the market. 5. What is the key distinction between "technology transfer" and "technology transition"? Answer: Technology Transfer is the process of moving knowledge, skills, and artifacts from the laboratory (e.g., a DoD lab) to a non-federal entity (e.g., a company). Technology Transition is the subsequent process within the DoD of moving a matured technology from development (e.g., a Science & Technology program) into an acquisition program of record for fielding to warfighters. Transfer is outward; transition is inward to operational use. 6. What are the typical responsibilities of a Technology Transfer Office (TTO) or ORTA? Answer: Responsibilities include: identifying technologies with commercial potential; marketing lab capabilities and inventions; negotiating agreements (CRADAs, licenses); managing intellectual property (patent filings); ensuring compliance with relevant laws/policies; and educating lab researchers on T2 processes. 7. Under a typical Patent License Agreement (PLA), what rights does a licensee receive? Answer: A licensee receives the right to practice a government-owned invention, typically defined by field of use, territory, and exclusivity (which can be exclusive, co-exclusive, or non-exclusive). In exchange, the licensee usually agrees to terms like upfront fees, running royalties, and a commitment to commercialize the invention. 8. Why is protecting Intellectual Property (IP) rights critical in technology transfer agreements? Answer: IP protection (patents, copyrights, trade secrets) provides the legal framework that defines ownership, controls access, and enables the economic valuation of technology. It gives companies the confidence to invest significant resources in commercialization by offering a period of market protection. For government labs, it ensures sensitive technologies are controlled and that the public receives a benefit (e.g., royalties, products) from federally-funded inventions. 9. What is a "dual-use" technology? Answer: A dual-use technology is one that has application in both military/defense and commercial/civilian markets. Examples include GPS, the internet (originally ARPANET), and advanced materials. DoD T2 programs actively seek to identify and transfer such technologies. 10. What ethical considerations are paramount in technology transfer? Answer: Key ethical considerations include: avoiding conflicts of interest (e.g., a lab employee having a financial stake in a partner company); ensuring fair access and opportunity for all potential partners (especially small businesses); protecting sensitive and export-controlled information; and safeguarding the public's interest in federally-funded research (ensuring reasonable pricing, availability). 11. What is the role of "consideration" in a technology transfer agreement? Answer: Consideration is what each party gives to make the contract legally binding. For the government in a CRADA, consideration might be the provision of lab expertise and facilities. For an industry partner, it could be funding and proprietary data. In a license, the government's consideration is the grant of rights to the IP; the partner's is the payment of royalties/fees and the commitment to develop the technology. 12. What statutory authority allows DoD labs to accept funds, personnel, and services from a non-federal partner? Answer: The Federal Technology Transfer Act (FTTA) of 1986, which amended Stevenson-Wydler, specifically authorizes federal labs to enter into CRADAs and to accept these resources from partners. 13. What is an "Educational Partnership Agreement (EPA)" and its typical purpose? Answer: An EPA is a formal agreement between a DoD laboratory and an educational institution (e.g., a K-12 school, college) to encourage STEM education. The lab can loan equipment, provide personnel as guest lecturers, and offer student internships. Its purpose is to enhance science and engineering education and develop future talent. 14. What key reporting requirement is placed on a licensee of a government-owned invention under the Bayh-Dole framework? Answer: Licensees are generally required to submit periodic reports on their efforts to commercialize the invention (e.g., development milestones, sales data). This allows the government to monitor progress and exercise "march-in" rights if the licensee is not making effective efforts to bring the invention to practical application. 15. Briefly describe what "march-in rights" are under Bayh-Dole. Answer: March-in rights are a provision that allows the federal funding agency (e.g., DoD) to require the patent holder (e.g., a university) to grant additional licenses to other applicants, or to itself grant a license, if the original licensee fails to commercialize the invention adequately or if it's necessary to address health/safety needs. These rights are rarely exercised but are a key safeguard for the public. 16. How do Export Control regulations (ITAR/EAR) impact technology transfer? Answer: The International Traffic in Arms Regulations (ITAR) and Export Administration Regulations (EAR) control the export of defense-related and dual-use technologies, respectively. Before sharing any technical data, software, or hardware with a foreign national (even within the U.S.) or a foreign company, a TTO must perform a commodity jurisdiction/classification and, if required, obtain an export license. This is critical for national security. 17. What is the purpose of a "Materials-CRADA" or "M-CRADA"? Answer: An M-CRADA is a simplified, shorter-form agreement used specifically for the transfer of tangible research materials (e.g., biological samples, chemical compounds, prototype components) from a lab to a partner. It focuses on terms like permitted use, safety, liability, and disposition of the materials, rather than complex collaborative R&D terms. 18. What is the main difference between an "exclusive" and a "nonexclusive" license? Answer: An exclusive license grants rights to a single licensee, preventing the government from licensing the same invention to others within the defined field/territory. A non-exclusive license grants rights to multiple licensees simultaneously. Exclusive licenses are often necessary to justify large commercialization investments but require a more rigorous justification to ensure it serves the public interest. 19. What is the "Federal Laboratory Consortium (FLC)" and its role? Answer: The FLC is a nationwide network of over 300 federal labs and agencies established by the FTTA. Its mission is to promote, educate, and facilitate technology transfer across the federal government. It provides training, resources, and a clearinghouse for lab capabilities and technologies. 20. What principle guides the allocation of Intellectual Property rights in a CRADA? Answer: The governing principle is that each party typically retains ownership of Background IP (IP they bring into the agreement) and owns the Foreground IP (IP created during the CRADA) that its employees invent. Jointly created Foreground IP is jointly owned. The agreement must include a "Patent Rights" clause that details how rights to Foreground IP are allocated, including options for the non-federal partner to negotiate licenses to the government's Foreground IP. 21. What is the "two-way street" principle in DoD technology transfer? Answer: It refers to the mutual benefit of T2: technologies and knowledge flow out from DoD labs to the commercial sector (enhancing the economy), while commercial best practices, innovations, and products flow in to the DoD (enhancing military capabilities). It emphasizes collaboration, not just a one-way transfer. 22. What is a "Technical Data Package (TDP)" and when is it transferred? Answer: A TDP is a comprehensive set of design, manufacturing, and testing documentation needed to produce a technology or system. It is often transferred under a license agreement when a company is tasked with producing a government-developed item or when commercializing an invention requires detailed production know-how. 23. What are "residual rights" clauses in collaboration agreements? Answer: These clauses state that knowledge retained in the unaided memory of personnel after exposure to proprietary information (not written down or recorded) can be used freely for future projects, provided it is not deliberately memorized. They balance the need to protect proprietary data with the need for researchers to continue their work. 24. What key element must be included in a CRADA to protect a partner's trade secrets? Answer: A "Protection of Proprietary Information" clause. This legally binds the government to mark, secure, and not disclose the partner's confidential business information for a specified period (often 5 years), providing the legal framework needed for companies to share sensitive data. 25. What is an "Other Transaction Authority (OTA)" and how can it relate to T2? Answer: OTAs are flexible procurement authorities (e.g., 10 U.S.C. § 2371b) that allow DoD to negotiate agreements outside standard Federal Acquisition Regulation (FAR) contracts. They are often used for prototyping and research with non-traditional defense contractors. While not a T2 mechanism itself, technologies developed under OTAs may later be licensed or transitioned, involving T2 offices. 26. What is the purpose of a "Memorandum of Understanding (MOU)" in T2? Answer: An MOU is a non-binding statement of intent to collaborate on general areas of mutual interest. It establishes a framework for future, more specific agreements (like CRADAs) and facilitates early discussions without committing resources. It is not a legally binding contract for performance. 27. Describe the typical royalty structure in a government patent license. Answer: Royalties often include: 1) an upfront, non-refundable license issue fee, 2) minimum annual royalties (to maintain the license), and 3) earned/running royalties (a percentage of net sales). Royalty rates are negotiable and vary based on exclusivity, development risk, and market potential. A percentage of royalties is usually shared with the inventor(s). 28. What is the role of the "Interagency Workgroup on Technology Transfer" (IAWG-T2)? Answer: This group, co-chaired by DoD and the Department of Commerce, coordinates T2 policy and practices across all federal agencies. It works to streamline processes, share best practices, and resolve interagency issues to create a more uniform and efficient federal T2 system. 29. What is "technology maturation" and why is it a critical step before transfer? Answer: Technology maturation involves advancing a laboratory prototype or concept (Technology Readiness Level 3-4) to a more robust, scalable, and demonstrable state (TRL 6-7). It's critical because industry partners are often unwilling to invest in technologies that are too earlystage or carry high technical risk. DoD programs like the Defense Advanced Research Projects Agency (DARPA) and lab internal funds support maturation. 30. What is a "Field of Use" restriction in a patent license? Answer: It limits the licensee's right to practice the invention to a specific, defined application area. For example, a license for a new composite material might be restricted to "commercial aircraft manufacturing" while the government retains the right to license it separately for "military vehicle armor." This allows the technology to be commercialized in multiple markets by different companies. 31. What is the "Nunn-Warner Amendment" and its significance? Answer: Officially part of the FY87 Defense Authorization Act, it required DoD labs to dedicate at least 0.5% of their R&D budget to T2 activities. This provided the initial, dedicated funding stream that enabled labs to establish and staff T2 offices (ORTAs), giving the DoD T2 program the resources to become operational. 32. How does the "Freedom of Information Act (FOIA)" impact T2 negotiations? Answer: FOIA requires federal agencies to disclose records upon request, with specific exemptions. During T2 negotiations, proprietary information from a potential partner shared with the government could be subject to release under FOIA unless it falls under Exemption 4, which protects "trade secrets and commercial or financial information obtained from a person [that is] privileged or confidential." Properly marking information and using agreements with protective clauses is essential. 33. What is a "Bailment Agreement"? Answer: A bailment agreement governs the temporary, physical transfer of government property (e.g., a prototype, a piece of test equipment) to a non-federal entity for evaluation, testing, or demonstration. It details responsibilities for care, liability, insurance, and return of the property. It does not transfer any IP rights. 34. What distinguishes a "License" from an "Assignment" of a patent? Answer: A license grants permission to use the patent but the ownership (title) remains with the licensor (e.g., the government). An assignment is a permanent transfer of ownership (title) of the patent to another party. The U.S. government almost never assigns its patents; it licenses them. 35. What is the purpose of a "Negotiation Memorandum" in the T2 process? Answer: This internal government document records the justification for the key terms of an agreement (like a license or CRADA). It explains why the agreed-upon structure (e.g., royalty rate, exclusivity) is fair, reasonable, and in the best interest of the government, providing an audit trail and ensuring transparency and accountability in negotiations. 36. What does "Fair Access" mean in the context of licensing government IP? Answer: It is a principle stemming from federal policy that requires licensing opportunities for government-owned inventions to be made available to all interested parties on reasonable terms. This doesn't mean everyone gets a license, but that the process should be transparent and non-discriminatory. Exclusive licenses require a public notice and justification that exclusivity is necessary to incentivize commercialization. 37. What is an "Inter-Institutional Agreement (IIA)"? Answer: An IIA is used when multiple laboratories or agencies (e.g., an Air Force lab and a Navy lab) collaborate with a single external partner. It establishes the internal government framework for how the labs will work together, manage the project, and handle IP before engaging with the external partner via a master CRADA or other agreement. 38. What are the three main phases of the standard T2 process? Answer: 1) Discovery & Disclosure: An inventor recognizes a potential invention and submits a disclosure to the TTO. 2) Protection: The TTO evaluates the invention for patentability and market potential, then files for patent protection if justified. 3) Marketing & Commercialization: The TTO markets the technology, finds partners, and negotiates agreements (CRADAs, licenses) to develop and bring it to market. 39. How does "technical assistance" differ from a CRADA? Answer: Technical assistance is a simpler, often shorter-term arrangement where lab experts provide a specific service (e.g., testing, analysis, consultation using unique government facilities) to an external party, usually for a fee. It does not involve collaborative R&D or the creation of new intellectual property, which is central to a CRADA. 40. What is "Data Rights" and how are they typically defined in DoD contracts? Answer: Data Rights govern who can use and release technical data and software. Key categories in DoD contracts (DFARS) include: Unlimited Rights (government can use/ disclose for any purpose), Government Purpose Rights (use within the government and for government purposes), Limited Rights (restricted use, not for disclosure), and Restricted Rights (for software). In T2, negotiating the appropriate license to government-owned data is crucial for a partner. 41. What is a "Biological Materials License"? Answer: A specialized license for tangible biological research materials (e.g., cell lines, plasmids, antibodies) developed in government labs. It grants the right to use and sometimes modify the materials for research or commercial purposes, under terms that address safety, prohibited uses (e.g., weapons), and third-party distribution. 42. What is the primary challenge in valuing early-stage government inventions for licensing? Answer: The high degree of technical and market uncertainty. The invention may only be a lab proof-of-concept (low TRL), with unproven scalability, performance in real conditions, and market demand. This makes it difficult to set a "fair market value" royalty rate, often leading to agreements with milestone-based payments that align with de-risking the technology. 43. What does "Equitable Title" refer to in the context of Bayh-Dole? Answer: It is the conditional title a contractor (e.g., university) holds to a federally-funded invention after they elect to retain it but before the patent is officially issued. The government holds legal title until the patent is granted, at which point legal title transfers to the contractor, provided all Bayh-Dole reporting and invention disclosure obligations have been met. 44. What is the "National Technical Information Service (NTIS)" and its role? Answer: NTIS, part of the Department of Commerce, is a central repository for federally-funded scientific, technical, engineering, and business-related information. Labs may submit final reports on unclassified R&D. While it serves as a public dissemination channel, T2 offices often market and license patent-protected inventions before detailed technical reports become widely available via NTIS. 45. What is a "Spin-Off" or "Spin-Out" company? Answer: A new, independent company formed specifically to commercialize a technology originating from a federal laboratory. Often, the inventors may leave the lab to join the company. T2 offices facilitate this through licensing agreements (often exclusive to the spin-off) and sometimes through Entrepreneurial Leave Programs for lab employees. 46. What is the purpose of a "Demonstration Agreement"? Answer: This agreement allows a company to temporarily install and operate its commercial equipment or technology on a government site to demonstrate its capabilities to potential government users. It clarifies liability, insurance, safety, and intellectual property ownership during the demo period. It is a marketing tool, not a procurement action. 47. How does "Foreign Ownership, Control, or Influence (FOCI)" affect T2? Answer: FOCI is a national security concern. If a potential industry partner is under FOCI, especially for sensitive or critical technologies, it may be barred from certain T2 agreements or require special security arrangements (like a Special Security Agreement or Proxy Agreement) to mitigate the risk of unauthorized technology transfer to foreign entities. The Defense Counterintelligence and Security Agency (DCSA) assesses FOCI. 48. What is the role of the "U.S. Patent and Trademark Office (USPTO)" in T2? Answer: The USPTO examines and grants U.S. patents. For federal agencies, it also provides a mechanism to waive patent maintenance fees on government-owned patents, helping to keep technologies available for licensing for their full term. It also publishes patent applications and grants, which is a primary source of public information on government-owned inventions. 49. What is a "Technical Cooperation Program (TTCP)" agreement? Answer: TTCP is a long-standing collaborative R&D framework between the Five Eyes allies (U.S., UK, Canada, Australia, New Zealand). TTCP agreements are government-to-government (G2G) and facilitate the sharing of defense-related research and technology information among these nations, with strict protocols for handling classified and controlled information. DoD T2 offices may interface with TTCP-related collaborations. 50. What is the ultimate measure of success for a technology transfer agreement? Answer: While intermediate metrics include number of agreements signed or royalty income, the ultimate success is commercialization and utilization. For a license: a new product or service in the market benefiting the public and generating a return. For a CRADA: either a new capability transitioned to the warfighter or a successfully commercialized dual-use product.