Introduction: Technology transfer documentation is essential for B. Pharm students working at the interface of pharmaceuticals, regulatory affairs and industry collaboration. Key documents — confidentiality agreement (NDA), licensing agreements, Memoranda of Understanding (MoUs), material transfer agreements (MTAs) and technology transfer plans — protect intellectual property, define roles, set royalty terms, and ensure data integrity during scale‑up and commercialization. Understanding clauses on exclusivity, sublicensing, duration, enforcement, and regulatory compliance helps students evaluate collaborations, manage risk, and support downstream manufacturing and clinical activities. Grasping these documents strengthens technical and legal literacy for future pharmacists and researchers. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of a Confidentiality Agreement (NDA) in technology transfer?
- To assign patent rights to the receiving party
- To outline manufacturing specifications
- To protect shared confidential information from disclosure
- To set royalty rates for commercial products
Correct Answer: To protect shared confidential information from disclosure
Q2. Which document typically records preliminary intentions between parties but is not usually legally binding?
- Exclusive license agreement
- Memorandum of Understanding (MoU)
- Material Transfer Agreement (MTA)
- Patent assignment deed
Correct Answer: Memorandum of Understanding (MoU)
Q3. In a licensing agreement, what does ‘exclusive license’ mean?
- The licensee can grant sublicenses to anyone
- The licensor retains full commercial rights
- Only the licensee has the right to use the IP in the specified field and territory
- The license is limited to non-commercial research
Correct Answer: Only the licensee has the right to use the IP in the specified field and territory
Q4. Which clause in an NDA defines the time period that information must remain confidential?
- Grant clause
- Confidentiality duration clause
- Royalty clause
- Termination clause
Correct Answer: Confidentiality duration clause
Q5. What is a Material Transfer Agreement (MTA) used for?
- To transfer manufacturing equipment ownership
- To govern transfer and use of biological or chemical materials between institutions
- To license a patent to a third party
- To set up a joint venture company
Correct Answer: To govern transfer and use of biological or chemical materials between institutions
Q6. Which element is essential in a licensing agreement for pharmaceuticals?
- List of lab personnel
- Royalty rates and payment terms
- Clinical trial participant names
- Detailed marketing plan
Correct Answer: Royalty rates and payment terms
Q7. Who usually negotiates technology transfer agreements at universities?
- Laboratory technicians
- Technology Transfer Office (TTO) or Technology Licensing Office
- Clinical trial coordinators
- Procurement managers
Correct Answer: Technology Transfer Office (TTO) or Technology Licensing Office
Q8. Which clause specifies what happens if confidential information is disclosed in breach of an NDA?
- Governing law clause
- Remedies and injunctive relief clause
- Background IP clause
- Assignment clause
Correct Answer: Remedies and injunctive relief clause
Q9. In a licensing context, what is ‘sublicensing’?
- The licensor receiving royalties from the licensee
- The licensee granting part of its rights to a third party
- A clause that terminates the license automatically
- The transfer of materials without documentation
Correct Answer: The licensee granting part of its rights to a third party
Q10. What is an important IP-related clause in MoUs when research collaboration is planned?
- Clinical endpoint definitions
- Ownership and sharing of intellectual property arising from collaboration
- Daily work-hour schedules
- List of required reagents
Correct Answer: Ownership and sharing of intellectual property arising from collaboration
Q11. Which document should detail quality specifications and transfer of manufacturing know-how?
- Confidentiality agreement
- Technology transfer plan or agreement
- Patent application
- Purchase order
Correct Answer: Technology transfer plan or agreement
Q12. Which of the following is typically NOT covered as confidential under an NDA?
- Publicly available information prior to disclosure
- New formulation data shared under agreement
- Proprietary manufacturing process diagrams
- Unpublished clinical trial results disclosed between parties
Correct Answer: Publicly available information prior to disclosure
Q13. What is a common duration for confidentiality obligations after disclosure?
- 1 week
- 6 months
- 2–5 years depending on sensitivity
- Perpetual without exception
Correct Answer: 2–5 years depending on sensitivity
Q14. Which section in an MTA addresses permitted uses of transferred materials?
- Permitted use and scope clause
- Governing law clause
- Signature block
- Payment schedule
Correct Answer: Permitted use and scope clause
Q15. What is ‘background IP’ in a collaboration agreement?
- IP created jointly during the collaboration
- Pre-existing intellectual property owned by a party before the collaboration
- IP that is publicly available
- IP owned by a third-party vendor
Correct Answer: Pre-existing intellectual property owned by a party before the collaboration
Q16. Why is including a publication clause important in research agreements?
- To prevent any form of publication forever
- To balance academic freedom with protection of confidential information and IP
- To guarantee immediate open access to all data
- To set royalty rates for published articles
Correct Answer: To balance academic freedom with protection of confidential information and IP
Q17. Which party is typically responsible for regulatory filings when licensed technology moves to clinical development?
- The licensor unless otherwise agreed
- The original inventor only
- The clinical site without sponsor involvement
- The journal publishing the work
Correct Answer: The licensor unless otherwise agreed
Q18. What is a key difference between an MoU and a contract?
- MoU always includes royalty clauses
- MoU is generally non-binding while a contract is legally enforceable
- Contracts cannot be signed by universities
- MoUs provide IP ownership assignments automatically
Correct Answer: MoU is generally non-binding while a contract is legally enforceable
Q19. In licensing, what is a ‘field of use’ restriction?
- Restriction preventing use of the IP in any context
- Limitation specifying the particular application areas where the licensee may exploit the IP
- Clause that sets the royalty currency
- Clause allowing unlimited sublicensing
Correct Answer: Limitation specifying the particular application areas where the licensee may exploit the IP
Q20. What is the role of a ‘due diligence’ review before signing a license?
- To finalize the royalty payment schedule
- To assess IP validity, freedom to operate, regulatory status and commercial potential
- To appoint lab staff for transfer
- To register the product with regulatory authorities
Correct Answer: To assess IP validity, freedom to operate, regulatory status and commercial potential
Q21. What does ‘assignment of inventions’ clause typically do?
- Allows inventors to sell equipment
- Transfers ownership of inventions from inventors to an institution or company
- Grants a license to third parties
- Lists the background literature
Correct Answer: Transfers ownership of inventions from inventors to an institution or company
Q22. Which clause determines which country’s laws govern a technology transfer agreement?
- Confidentiality clause
- Governing law and jurisdiction clause
- Payment clause
- Indemnity clause
Correct Answer: Governing law and jurisdiction clause
Q23. What is ‘freedom to operate’ (FTO) analysis?
- Assessment of lab space availability
- Review of whether a product can be made, used or sold without infringing third-party IP
- Calculation of royalty percentages
- Validation of analytical methods
Correct Answer: Review of whether a product can be made, used or sold without infringing third-party IP
Q24. Which documentation helps ensure technology is reproducibly transferred to manufacturing?
- Marketing brochures
- Standard Operating Procedures (SOPs), batch records and transfer protocols
- Patent prosecution history
- Conference abstracts
Correct Answer: Standard Operating Procedures (SOPs), batch records and transfer protocols
Q25. What does a royalty clause in a license define?
- The confidentiality period
- Payment terms based on sales, milestones or fixed fees
- Laboratory safety protocols
- The list of inventors
Correct Answer: Payment terms based on sales, milestones or fixed fees
Q26. Which term best describes an MoU that becomes binding once signatures are exchanged and consideration is provided?
- Non-binding MoU
- Legally binding agreement by intent
- Patent application
- Confidential disclosure only
Correct Answer: Legally binding agreement by intent
Q27. What should be included in the annexures of a technology transfer agreement?
- Detailed technical specifications, SOPs, validation data and equipment lists
- Only the signatures of witnesses
- Irrelevant promotional material
- Personal medical records of researchers
Correct Answer: Detailed technical specifications, SOPs, validation data and equipment lists
Q28. Why include an audit right in MTAs or licenses?
- To allow the provider to inspect compliance with use, reporting and payment obligations
- To permit unlimited data publication by the provider
- To assign inventorship to the provider
- To increase confidentiality duration automatically
Correct Answer: To allow the provider to inspect compliance with use, reporting and payment obligations
Q29. What is a practical first step for students preparing to draft or review technology transfer documents?
- Ignore legal terms and focus on experiments
- Learn key clauses, consult templates, and seek guidance from the institution’s TTO or legal counsel
- Publish all data before signing anything
- Assume all MoUs are legally binding
Correct Answer: Learn key clauses, consult templates, and seek guidance from the institution’s TTO or legal counsel
Q30. In a collaborative research agreement, what best practice protects each party’s pre-existing know-how?
- Omitting any IP clauses
- Clearly defining and listing background IP and ownership in the agreement
- Allowing unrestricted use of all materials
- Setting royalties only after commercialization
Correct Answer: Clearly defining and listing background IP and ownership in the agreement
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com