Panel Presentation at AUTM 2009 on socially responsible licensing and research agreements featuring "charitable use" rights.

1. Public Private PartnershipsPublic Private Partnerships
That Promote Global HealthThat Promote Global Health
AUTM 2009 Annual MeetingAUTM 2009 Annual Meeting
February 13, 2009February 13, 2009
Eric Giegerich
Industry Relations Manager
Office of Intellectual Property &
Industry Research Alliances (IPIRA)
University of California, Berkeley

2. Berkeley Principles
for Socially Responsible IP Management
Principles:
– Berkeley TT reflects Berkeley campus culture -- strong record of public
service and reputation for affordability of and public access to tools.
– Berkeley strives to use university resources for public benefit and to
effect lasting societal change.
– Berkeley views helping the developing world as a moral imperative.
Countries with resources should help those that are resource poor.
– Berkeley recognizes that most TT occurs in traditional ways --(teaching,
internships, graduates, consulting, informing, visiting fellows, IABs).
– Berkeley is not harmed by Socially Responsible IP Management.
• Reputational gains from good will  Gift funding
• Keep eye on retained commercial rights.

3. Practices
• Highlight societal benefit as an explicit motivation.
• Stimulate business & societal change by reducing TT barriers.
• Give away technologies for humanitarian use in disadvantaged populations.
• Make IP Accessible and Affordable for Humanitarian Use.
• Retain commercial rights, or offer commercial rights under separate terms.
• Engender new contract and business models to develop and deploy technologies for
charitable use.
• Leverage resources by attracting additional collaborations, research funding, donations,
in-kind contributions.
Model Clauses and Guidance:
http://otl.berkeley.edu/show_news_flashes.php?
This is one approach on a full spectrum of
IP management strategies
Berkeley Principles
for Socially Responsible IP Management

4. Example 1 – Aquaya Institute
with a Social Impact Goal:
• Make clean drinking water accessible
• At little or no cost
• In countries with poor drinking water and
poor public infrastructure
• By developing a new class of household
consumer products for disinfecting water
(using surface-bound cationic antimicrobial
compounds)
Two Collaborative Research Agreements

5. • Berkeley Contributes:
– Research expertise, collaboration in antimicrobial filters,
chemistry
– Lab access to Visiting Industrial Fellow (VIF) from
Aquaya
• Aquaya Contributes:
– Expertise in developing and delivering clean drinking
water innovations in developing countries
– Visiting Industrial Fellow (VIF) in Berkeley’s lab
– International partner network.
• Joint Contribution:
– Research in safe water treatments and sanitation
– Market and user adoption studies.
• Deployment Focus:
– Aquaya’s partner network provides a channel in the
developing world for technology transfer.
– Market, user adoption helps deployment.
Example 1 – Aquaya Institute

6. Example 1 – Aquaya Institute
Agreement Features:
• Charitable Purpose in recital
• Economically Disadvantaged Countries list in Appendix
• IP Licensing – Charitable Use clause
Further Considerations
• Research continues – no IP outcome yet
• Keep eye on retained commercial rights
• In the works…working toward same terms for a Berkeley
Water Center industry affiliate program

7. Low Cost Artemisinin Combination Therapy
$42.6M Bill & Melinda Gates Foundation
3-way collaboration agreement, 2 license agreements
$8M to Berkeley
Basic
Research
$12M to Amyris
Biotechnologies
Applied
Research
Regulatory,
Distribution
$22.6M to iOWH
3 - way research
Collaboration
Agreement
License #1
Berkeley to Amyris.
Developed world. No profit
for malaria drug. Profit for
flavors & fragrances
License #2
Berkeley to iOWH.
Sell drug at cost
in developing world.
Example 2 – Amyris - iOWH
LEVERAGING PHILANTHROPY

8. A Single Grant to Expedite Translational Research and
Clinical/Regulatory Approvals
$8M to Berkeley
BASIC RESEARCH
$12M to Amyris
Biotechnologies
TRANSLATIONAL
RESEARCH
CLINICAL &
REGULATORY AFF.
$22.6M to iOWH
(sub to Sanofi-Aventis)
Instead of a “relay race” a single donor makes one grant
to fund basic research, translational research, & clinical/regulatory activities
• No uncertainty in finding the next partner
• No uncertainty in future contract terms
• No gaps between stages
(time, expertise, additional transactions)
Example 2 – Amyris - iOWH

9. BASIC RESEARCH
TRANSLATIONAL
RESEARCH
CLINICAL &
REGULATORY AFF.
• This model provides seamless transitions, accelerates and streamlines
translational research, commercialization, & economic development
• The model exemplifies “bench to bedside” translational research.
• A model to bootstrap start-ups with philanthropic donations
• Resulted in equipment & material donations, additional public funding
Gates hopes this structure will serve as a model for other U’s
Current Status
• Berkeley research completed December, 2007
• Beat all milestone by 6 months
• Sanofi-Aventis expects to have an artemisinin combination
therapy on the market in 2010
• 6 years after – a 2-fold compression of bench to bedside
• At the end of the day, an affordable malaria drug
Example 2 – Amyris - iOWH

10. • Master Agreement across campus
• Focused on EE, CE, CS
• Initially a typical agreement, but…
• Lead professor has history in
technology for social change,
healthcare applications
• BigIT has a Corporate
Responsibility Program
• Berkeley actively introduced
Socially Responsible IP
Management terms early in
discussion
Example 3 – Big IT Company
Background
Big
IT

11. A. From Nonprofit to For Profit sponsor
– How can the same entity hold both
humanitarian use NERFs and
commercial rights?
B. Commercial Sale is main purpose.
Charitable Use is just one purpose.
C. From Bio to IT sector
– From long to short time-to-market
– Broader IP focus than patents
– Many IP rights go into a product, only
one of which may be Berkeley’s
Three Conceptual Hurdles
Example 3 – Big IT Company Big
IT

12.  Focus on Opportunity, Not Penalty
Example 3 – Big IT Company
A. From Nonprofit to For Profit sponsor
1. BigIT will manage Humanitarian Use Rights under its
Corporate Responsibility program.
2. BigIT will offer Humanitarian Products in EDCs at
the EDC Rate—ie., for free, below market rate, or at cost,
but not at market rate according to generally accepted
accounting practice (“GAAP”)
-- IP provisions and fees for commercial use outside EDCs.
3. Humanitarian Use Rights are convertible to a paid license
(a “Conversion”), if BigIT offers Humanitarian Products
commercially, or outside EDC, or if EDC graduates.
Big
IT

13. B. Both Charitable and Commercial Purposes
• Initially: Humanitarian use rights intended to induce investment
and create markets for populations where no market
incentive exists.
• BigIT said, “There are probably no markets in the world in
which BigIT has no market reasons to enter.”
• Our rewrite: to induce investment and create markets for
populations where
1.) it is presumed BigIT does not expect to make a near term profit
under GAAP.
– There is a Conversion term for when BigIT makes a profit.
2.) strong social impact potential for EDCs
3.) Corporate Responsibility can leverage investment
from business units
Example 3 – Big IT Company Big
IT

14. • Humanitarian Product is any product incorporating
one or more IP rights licensed under Humanitarian
Use terms.
• Humanitarian Products, offered alone or coupled
with other products and services, will be offered
altogether at an EDC Rate.
– Addresses anti-competitive practices
– If services are core to their business, it’s a good thing
• IP is Patents and Copyrights -- everything else is
offered in Reports with full use rights
Example 3 – Big IT Company
C. From Bio to IT
Big
IT

15. Summary
• Berkeley has clear Principles and Model Clauses
for Socially Responsible IP Management
• Berkeley employs Principles and Model Clauses
in sponsored research and licensing
– This is one approach on a full spectrum of IP
management strategies
• Berkeley employs Principles across sectors—
health, water, IT, energy, agriculture, food
• Berkeley continues experimenting with new forms
– industry affiliates, technology access programs,
sponsored research…

16. Eric Giegerich
Industry Relations Manager
Office of Intellectual Property &
Industry Research Alliances (IPIRA)
egiegerich@berkeley.edu
510-642-5850
http://ipira.berkeley.edu/