# Presentation: 301137

## “T” Stands for Teamwork and for Technology Transfer :Resources for Acquisition Officers

**Michael R. Mowatt, Ph.D.**, Director, Office of Technology Development
- and
**Richard Lambert, J.D.**, Consultant
**National Institute of Allergy and Infectious Diseases**
- National Institutes of Health
- U.S. Department of Health and Human Services

## “Who am I?  Why am I here?”

- - Vice Admiral (retired) James Bond Stockdale, 1992 Vice Presidential candidate of the Reform Party and running mate of H. Ross Perot, during 1992 Vice Presidential Debate

## Take Home Messages

- NIH’s technology transfer community is a _resource_ available to you
- Legal, business and scientific expertise to help you understand intellectual property and data rights and their relevance to your contracting project
- TT and acquisitions have a lot in common
- Project requirements _must_ drive the contract terms
- a sound SOW and clear description of deliverables form the foundation of an effective contract
- Effective contracts are _not_ accidents
- they result from collaboration and highly effective communication among members of a NIH team

## Today’s Agenda

- Technology Transfer
- Collaboration, Teamwork and Communication
- Nuts and Bolts
- SOW and Deliverables
- Intellectual Property
- Data
- Determination of Exceptional Circumstances
- Questions

## What is Technology Transfer?

## Technology Transfer

**Public institutions**
- 	- Government agencies & universities
- 	- Basic research

- 	**Private industry**
- 		- Applied research
- 		- Product commercialization

***Technology Transfer***

## Technology Transfer

- Science

- Business

- Law

**Technology Transfer**

- At the Intersection of Disciplines

## Technology Transfer at NIH:Shared Responsibilities

- Institute/Center Technology Development Coordinator (TDC)
- Employee Invention Reports
- Transactional agreements (CDA, MTA, CTA, CRADA)
- Institute IP issues
- NIH Office of Technology Transfer (OTT)
- Patenting of technologies arising from ICs
- Licensing of patents and tangible materials from ICs
- PHS Technology Transfer Policy

## Other Contributors to NIH TT

- Office of the General Counsel (OGC)
- Organized under DHHS
- NIH office headed by NIH Legal Adviser
- Office of Policy for Extramural Research Administration (OPERA)
- Organized under NIH OD, OER
- Includes DEITR, Division of Extramural Inventions and Technology Resources, with oversight for reporting of extramural inventions (Interagency Edison)

## The National Institute of Allergy and Infectious Diseases

## About Us

- J.D., M.B.A., M.S., Ph.D., and combos
- Patent agents and attorneys
- Former patent examiners (USPTO)
- Research and R&D experience in industry, academia, government
- Business development and technology licensing experience
- Paralegal and administrative experience

## Who We Are – Part 1

- NIAID Mission:
- 	To conduct and **support research** that strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives

## Who We Are – Part 2

- NIAID’s subject matter experts on technology transfer and intellectual property
- NIAID’s resource for the negotiation and management of “technology transfer” and other transactional agreements
- NIAID’s “patent department” responsible for oversight and management of NIAID’s intellectual property portfolio and licensing activities

## What We Do

- Negotiate and manage agreements to govern collaborations and the exchange of materials and information by NIAID staff (e.g., MTAs, CDAs, CRADAs, CTAs, MOUs, IAAs)
- Ensure that the provisions of these agreements comport with applicable laws, regulations and policies
- Support the development of EM program solicitations and NIAID acquisitions
- Manage NIAID’s patent portfolio

## Steps to Creating an Effective Transactional Agreement

- _Understand_ goal(s) of project
- _Define_ project requirements
- Research Plan
- What is needed
- Materials
- Data or other information
- Other?
- Anticipate
- Dissemination of results (publication)
- Disposition of new materials and inventions (patents)
- _Structure_ the agreement to meet the project requirements

## Technology Transfer

- Science

- Business

- Law

**Technology Transfer**

- At the Intersection of Disciplines

## Collaboration:

- The act of working together, especially in a joint intellectual effort, to achieve common goals
_**Collaboration = Relationship**_
_**Relationship = Communication**_

## Attributes ofSuccessful Collaboration

- Understanding, respect and trust
- Common goals
- Mutual benefits
- _Complementary contributions_
- Subject matter expertise
- Familiarity with applicable rules
- Skills required for the jobs at hand

## Anatomy of a Research Collaboration Agreement

**Research Plan**
- Goal(s)
- Plan to achieve the goal(s)
**Terms and Conditions**
- Confidentiality and publication of results
- Transfer/exchange and use of materials
- Ownership and disposition of intellectual property rights and data
- Other requirements of the parties

## Steps to Creating an Effective Contract

- _Understand_ goal(s) of project
- _Define_ project requirements
- Statement of Work (SOW)
- Deliverables
- Materials
- Data
- Software
- Other, e.g., draft reports, final reports
- _Structure_ the agreement to meet the project requirements

## Nuts and Bolts

- Deliverables
- Intellectual property (IP)
- Data Rights
- Determination of Exceptional Circumstances

## What’s the difference between a SOW and a deliverable?

- Statement of Work (_SOW_) defines the work to be performed by the contractor
- _Deliverables_ include tangible materials, data, software, and other things produced by the contractor in performance of the SOW that the contractor _must_ deliver in order to fulfill its contractual obligation to the USG

## Shouldn’t we describe deliverables vaguely to increase our flexibility?

- In general it is advantageous to have a well defined list of deliverables, especially data deliverables, in order to meet the contract objectives
- If the definition of the deliverable is too vague, you may not get what you want and/or it may cost you more ($$ and time) to get what you want

## Who owns contract deliverables?

- In general, the USG owns the deliverables, BUT _it depends on what the contract says_
- It is essential to clearly define and, to the extent possible, to list deliverables in the contract

## Who can use contract deliverables?

- In general, the USG can use the deliverables, BUT _it depends on what the contract says_
- Certain data deliverables may be delivered with limited or restricted rights
- In general, the contractor can retain and use deliverables for its own purposes, BUT _it depends on what the contract says_

## What happens if the contract is not clear about deliverables?

- Contractor may argue that it owns the materials and has no obligation to deliver them to the USG
- Disputes and possibly litigation can result
_**The contract should be very clear on this**_

## What is intellectual property?

- Protectable creation of the mind
- Intangible personal property created by law
- Examples
**Patent**
**Copyright**
**Trademark**
**Trade Secret**

## What is a patent?

- Statutory property right authorized by the US Constitution and granted by the USG
- Reward to inventors for publicly disclosing their inventions
- Time-limited right to exclude others from making, using, selling, offering for sale, or importing the patented invention
- Does _not_ give the owner the right to practice the invention her/himself

## Who owns patents made under a USG contract?

- Under the Bayh-Dole Act of 1980, implemented by FAR 52.227-11, contractors have the right to elect to retain title to inventions they make under Government R&D contracts
- Such inventions are subject to non-exclusive irrevocable license to the Government and March In rights

## What rights in data are available to the USG?

**FAR 52.227-14**
- Normally, USG obtains unlimited rights in data first produced under the contract
- Contractor can withhold its privately developed data and provide form, fit and function data
- Use of Alternates II and III may require delivery of marked copies of data that would have been withheld - USG rights are subject to the markings.
**FAR 52.227-17, Special Works**
- USG can obtain assignment of rights in data and copyright
- Clause should NOT be used if the contractor will be using proprietary data under the contract.

## Does the contract guarantee the USG’s right to use data made by a contractor?

- It depends on what the contract says
- Simply paying for the development of data does NOT provide the USG with rights in that data
- Unless the contract is clear, the contractor may not be required to deliver such data to the USG

## What data rights clause should always be in a contract?

- FAR 52.227-16 Additional Data Requirements can be a lifesaver
- Allows the Contracting Officer at any time during the contract performance or within 3 years after acceptance of all items to be delivered under the contract, to call up any data first produced or specifically used under the contract
- Provides safety net in the event you forgot to ask for certain data

## What is a DEC?

- Determination of Exceptional Circumstances
- Under Bayh-Dole, contractors normally are allowed to elect to retain title to inventions they make under Government funding agreements (R&D contracts), however, the law provides that the contractor’s right can be limited when the Government determines that exceptional circumstances exist

## When can and should a DEC be used?

- DEC may be appropriate where a limitation on the contractor’s rights is necessary to accomplish programmatic objectives
- For example, to entice drug developers to subject their proprietary compounds to screening by USG contractor
- Often, such developers will not provide the materials because of a concern that the contractor will invent a new method of using the materials
- _REMEMBER_: DEC’s should only be used when there is a demonstrated need!

## I think I need a DEC.  How do I go about getting one?

- Consult your IC’s TDC office
- Determine whether a viable alternative exists
- If appropriate, initiate proceedings!

## Who’s on your team?

- Contracting Officer
- Contracting Officer
- Program/Project Officer
- NIH Technology Transfer Community

## Resources

- NIAID Office of Technology Development
- www.niaid.nih.gov/ttb/ttb.htm
- PHS Technology Development Coordinators
- ott.od.nih.gov/nih_staff/tdc.html
- NIH Office of Technology Transfer
- ott.od.nih.gov

## Questions?

## “T” Stands for Teamwork and for Technology Transfer :Resources for Acquisition Officers

**Michael R. Mowatt, Ph.D.**, Director, Office of Technology Development
- and
**Richard Lambert, J.D.**, Consultant
**National Institute of Allergy and Infectious Diseases**
- National Institutes of Health
- U.S. Department of Health and Human Services