DEPARTMENT OF DEFENSE (DOD)CUSTOMER LIFECYCLE

Eric H. Hanson MD, MPHOregon Biosciences AssociationSeptember 17, 20132:40-3:30 pm

Cooperative Research and Development Agreements (CRADA)

and Creating Long-Term Relationships with the DoD

WILL A CRADA HELPMY COMPANY?

1. What is DoD technology transfer?2. What is a CRADA?3. What are the benefits of a CRADA to my

company? To the DoD?4. How can I find DoD scientists to collaborate with? 5. How does a CRADA impact my company’s IP?6. What are the steps to obtain a CRADA?7. Can a CRADA help my company sell

products/services to the DoD?

2

Cooperative Research and Development

Agreement

US AIR FORCE• Uniformed Services University of the Health Sciences• US Air Force Flight Surgeon• Aerospace Medicine• Preventive Medicine• Genetic Epidemiology

• Chief, Operational Genomics & Bioinformatics• US Air Force Lead, Congressionally Directed Medical

Research Program (CDMRP)• Division Chief of Science & Technology, US Air Force

Surgeon General’s Office

3

Image source

4

WHAT IS DOD TECHNOLOGY TRANSFER (T2)?

What is DoD Technology Transfer?

• The intentional communication of expertise, facilities,

equipment, other resources for application in DoD and non-DoD systems/settings…”dual-use”

Why create a bioscience-related agreement with

the DoD?

• Few small businesses have all the skills and resources

required to innovate and develop viable new technology,

and most importantly, successfully commercialize it

• Research, marketing/sales, manufacturing, RA/QA,…

5

Some of the most successful firms

are the best at partnering!

DOD T2 MECHANISMSAGREEMENTS• Patent license agreement

(PLA)

• Cooperative research and development agreement (CRADA)

• Material transfer agreement (MTA)

• Non disclosure agreement (NDA)

6

Least transfer

http://www.mset.org/resources/sbc/meeting_05222012/Presentation3Childs.ppt

Most transfer

NDA

MTA

CRADA

PLA

WHAT IS A CRADA?

• Legally-binding agreement

• Neither a procurement

contract nor grant

• One or more federal parties

• One or more non-federal

parties…“collaborator”

• R&D conducted must be

consistent with DoD mission

• CRADAs allow…

• DoD to provide personnel,

services, use of property

• But NOT funds

• DoD to accept, retain and use

funds, personnel, services and

property from the collaborator

• Collaborators may be…

• Industrial organizations

• Corporation

• LLC

• Partnership

• Other Federal agencies

• State or local government units

• Public and private foundations

• Nonprofit organizations

• Individual person

7http://www.jhuapl.edu/ott/NewsEvents/events/PatentsAndPizza/documents/P&P%20presentation.ppt

WHAT ARE BENEFITS OF A CRADA TO MY COMPANY?

• Jointly seek non-dilutive

funding opportunities

• Information exchange and

data sharing

• Access to top experts unique

skill sets, shared expertise

• Access to unique facilities

and research capabilities

• Calibrated blast tube

• Joint publications with DoD

scientists

• Pooling of financial and

human resources

• Shared responsibility

• Developing new

commercial opportunities

• Increased familiarity with

DoD commercialization

8

“Cooperative Research and Development efforts,

especially CRADAs, have the greatest potential

for long-term payoff of any T2 mechanism”USAMRIID

http://www.usamriid.army.mil/businessopspage.cfm

WHAT ARE THE BENEFITS OF CRADAS TO THE DOD?

• DoD views CRADAs as mission extenders

• Mechanism for industry to talk openly with the DoD

• Eliminate contract barriers

• Provide access to civilian facilities that may not be available in the DoD

• Result in new, improved, or more cost-effective products/processes

• Advance research requirements for both partners leading to new

programs/contracts

9http://www.jhuapl.edu/ott/NewsEvents/events/PatentsAndPizza/documents/P&P%20presentation.ppt

“The continuation of CRADAs between

the collaborator and DoD is an indicator

of progress”…a long-term relationship

HOW CAN I FIND DOD SCIENTISTS TO WORK WITH?

• Peer-reviewed medical

literature reviews

• Congressionally-directed

Centers of Excellence (CoE)

• TBI, Vision, Hearing, Universities, VA

• DoD personnel identification

• Program managers and officials

• R&D team leaders at DoD or

federal labs

• Congressional professional staff

• Active duty/Reserve/National

Guard physicians and providers

• Scientists/expertise via exchange

programs

• Technologies on Partnership

Intermediary sites

• Patent searches

• Conferences

• Military Health System Research

Symposium (MHSRS)

• Formerly known as ATACCC

• Special Operations Medical

Association (SOMA) and mini-

SOMA

• National Small Business

Conferences

• Veteran-owned Small Business

Conferences

10National Intrepid Center of Excellence (NICoE), Bethesda, MD

HOW DOES A CRADA IMPACT MY COMPANY’S IP?

• The Government, at a minimum, must retain a

nonexclusive, nontransferable, irrevocable, paid-

up license to make or have made for

governmental purposes any inventions made in

the performance of work completed under the

CRADA

• Provisions addressing a variety of IP issues such as

data rights, property, ownership, and rights to future

inventions are contained in the CRADA

11http://nsrdec.natick.army.mil/media/print/DoingBusiness-Guidebook_Web.pdf

WHAT ARE THE STEPS TO OBTAIN A CRADA?1. Identify collaborator and draft CRADA statement of work (SOW)

2. Scientist works with Office of Research, Technology and Applications (ORTA) to prepare draft CRADA

3. ORTA obtains legal and programmatic review of SOW

4. ORTA prepares two copies and sends to collaborator for signature

5. Signed CRADA copies sent to WRAIR for Director signature

6. CRADA is processed through legal and Dept. of the Army; assigned an identifying number; countersigned CRADA is sent to collaborator

12http://wrair-www.army.mil/OtherServices_PBioprod_CRADA.aspx

PARTNERSHIP INTERMEDIARIESAGREEMENTS

• Assist the DoD with establishing licensing and other T2 agreements with Collaborators• Identify collaborators for joint R&D• Assist in defining a CRADA

Statement of Work (SoW)• Facilitate the entire CRADA and

licensing agreement process• Some sites also have expertise for

providing phase II+ SBIR assistance

13

http://www.jhuapl.edu/ott/NewsEvents/events/PatentsAndPizza/documents/P&P%20presentation.ppthttp://techlinkcenter.org/

CAN A CRADA HELP MY COMPANY SELL TO THE DOD?

• CRADAs do not create a simple linear route to

commercialization, but it can serve as a useful

starting point in a series of steps in that pursuit

• Some CRADAS can serve as a continuation of an

earlier contractual agreements (e.g., BAA, SBIR) in the

pursuit of commercialization

• Each CRADA can provide advances/innovations in a

specific technology area, which over time may lead

to multiple products/services/processes for the DoD to

procure

• Numerous CRADAs can also be pursued simultaneously

14http://www.jhuapl.edu/ott/NewsEvents/events/PatentsAndPizza/documents/P&P%20presentation.ppt

13THERAPEUTICSCRADA

• Noise-induced hearing loss (NIHL) therapeutic candidate

• Literature review identified the Congressionally-directed Hearing Center of Excellence (HCE)• Pharmaceutical Intervention

Hearing Loss Committee presentation

• Goals• Jointly seek funding• Increase visibility of current

non-dilutive funding opportunities

15

SONIVATEACTIVE CRADAS

16

• Fingertip ultrasound probe• Identified providers mainly

via demonstrations • Goals

1. Rapidly demonstrate clinical and operational utility of their disruptive US probe form factor

2. Increase visibility via publications

3. Identify additional non-dilutive funding opportunities

ERIC HANSON MD, MPH

Thank you!

17

503.747.7326

eric@tier7.us

www.tier7.us