AIPLA Spring Meeting Committee Educational Session April 30, 2015, Los Angeles, CA Co-Sponsored by: AIPLA Biotechnology & Corporate Practice Committees 1 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. 2 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 3 The Cast of Panelists: Section 1 Early 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 4 The Cast of Panelists: Section 2 Foreign 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 5 The Cast of Panelists: Section 3 Legal 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 6 Section 1 Early Stage Corporate Issues: Research & Development Patent Landscape Due Diligence Ownership Funding 7 Soteria Biosciences Intellectual Property Strategy Meeting Re: State A&M Technology Due Diligence & License Negotiations Soteria Biosciences Corporate 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) 9 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) 10 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 11 A FEW YEARS LATER….. 12 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 13 Section 2 Foreign Filing Issues: Foreign Filing Considerations Novelty/Absolute Novelty Potential Priority Pitfalls Foreign Filing Licenses Special Issues 14 Soteria Biosciences Intellectual Property Strategy Meeting Re: Foreign Filing Soteria Biosciences Recent 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” 16 MOVING FORWARD AGAIN….. Patent Landscape 17 Section 3 Legal and Diligence Issues: Preserving Confidential Information Preserving Privileged Information Common Interest Agreements Privilege Waiver 18 Soteria Biosciences Intellectual Property Strategy Meeting Re: BigPharma Negotiations Confidentiality and Privilege