1

AIPLA Spring Meeting Committee Educational

SessionApril 30, 2015, Los Angeles,

CACo-Sponsored by:

AIPLABiotechnology & Corporate Practice

Committees

2

DISCLAIMER

The story of Soteria Biosciences is entirely a work of fiction, based on the presenters’ and organizers’ collective imagination.

All events, plant species, chemical compounds, characters and/or corporate entities appearing in this work are fictitious. Any resemblance to real events, corporate entities, or to any persons, living or dead, or to any real plant species or chemical compounds, is purely coincidental.

3

Soteria Biosciences: The Early IP Adventures of an

Agri-Biotech Startup Company as it Morphs into a Global Multidisciplinary

Giant•Moderator: Angela Sebor, GlobeImmune, Inc.• Playing: Soteria Biosciences Chief Business

Officer • Session Organizer: Debora Plehn-Dujovich,

Drinker Biddle & Reath LLP• Playing: Chief Operating Officer & Time Shifter

4

The Cast of Panelists: Section 1Early Stage Corporate Issues

• Lee Johnson, Wilson, Sonsini Goodrich & Rosati• Playing: Outside Patent & IP Counsel, U.S.

•Mark Pidkowich, Smart & Biggar• Playing: Outside Patent & IP Counsel,

International

• Jen Zarutskie Sieczkiewicz, Biogen Idec, Inc.• Playing: Soteria Biosciences IP, Research &

Business Development Counsel

5

The Cast of Panelists: Section 2Foreign Filing Issues

•Angela Domitrovich, Sheridan Ross P.C.• Playing: Outside Counsel, Patent Agent

• Joel Silver, Gilead Sciences, Inc.• Playing: Soteria Biosciences Vice President

Intellectual Property, International

6

The Cast of Panelists: Section 3Legal and Diligence Issues

•Bonnie Weiss-McLeod, Cooley LLP• Playing: Outside Counsel, IP Strategy and Due

Diligence

•Carey Jordan, McDermott Will & Emery• Playing: Outside Counsel, Licensing and

Transactions

7

Section 1

Early Stage Corporate Issues:

Research & DevelopmentPatent Landscape

Due DiligenceOwnership

Funding

Soteria Biosciences

Intellectual Property Strategy MeetingRe: State A&M Technology

Due Diligence & License Negotiations

9

Soteria BiosciencesCorporate Overview

• Early Stage Startup Company focused on agricultural science•Mission: Discover and develop new plant varieties

of Humurus sativa (common name “Humor”) for use in agricultural and other biotechnology commercial applications• Special interest in varieties of Humor having

modified humurbidiol (HBD) and/or tetrahydrohumurbinol (THH)

10

State A&M License Evaluation

• Extensive R & D program: Dr. Metamorphosis, distinguished Professor at State A&M• Discovery of “NuHumor” varieties (genetically

modified Humurus sativa) • High HBD content (beneficial medical effects)• THH KO (no/low psychoactive effects)

• Plant Application and Provisional and PCT Applications filed• Early data presented at scientific meeting(s) and in

graduate student dissertation (post-provisional filing)

11

State A&M License Evaluation• Soteria License Term Sheet (proposed):• Ask:• License to all IP related to NuHumor,

and control of patent prosecution• License to NuHumor plant varieties• License to all State A&M

technology/”know how” related to NuHumor

• Terms: Milestones, Royalties

12

A FEW YEARS LATER…..

13

Soteria Biosciences Today• License from StateA&M completed• Filed “NuHumor” PCT Application globally• Significant financing rounds completed• Soteria Biosciences internal R&D program

advanced• Soteria AG (European division) formed• Selling plants to farmers for industrial and

foodstuff uses under license

14

Section 2

Foreign Filing Issues:

Foreign Filing ConsiderationsNovelty/Absolute NoveltyPotential Priority PitfallsForeign Filing Licenses

Special Issues

Soteria Biosciences

Intellectual Property Strategy MeetingRe: Foreign Filing

16

Soteria BiosciencesRecent Developments• Soteria AG reports “high oil” NuHumor• Discuss possible new global patent filings

• State A&M issue: alleged memo from Dr. Derivation, visiting scientist• Discussions with Mr. Cheechong re: plant

discovery, “NoPain”• Research program: Soteria discovers

“NoPainNoGain”

17

MOVING FORWARD AGAIN…..

Patent Landscape

18

Section 3

Legal and Diligence Issues:

Preserving Confidential InformationPreserving Privileged Information

Common Interest AgreementsPrivilege Waiver

Soteria Biosciences

Intellectual Property Strategy MeetingRe: BigPharma NegotiationsConfidentiality and Privilege