Perspectives on Licensing “How to be the Best Partner” 2018 DHS S&T SBIR Workshop May 17, 2018 Richard Smerbeck Dawnbreaker, Inc. Dawnbreaker proprietary

Richard Smerbeck Business Acceleration Manager at Dawnbreaker – 10+ Years 25+ Years in Pharmaceutical and Medical Device Industry 20+ In Licensing Opportunities In Licensing Responsibilities: Technology Scouting Business Development Technical Due Diligence Product Development Due Diligence

Characteristics of Best Small Business Partners Needed Technology Strong IP Position Knowledgeable Collaborative Attitude They Mitigate Risk!!!! 3

Technology Realized product solves unmet need When launched! Advantage vs. future competition Product Attributes = Financial Benefit Innovative leap is desirable Incremental improvement less so

Technology Meaningful Results Support projected benefits Performance vs. competition/gold standard Presentable in publication-ready format Raw data well organized, easily accessible Next – Intellectual Property 5

Intellectual Property Patent – Most desired by licensee. Effectiveness is limited by the will and resources to enforce it. Copyright – Very useful for software CDA/NDA – Very effective. Limited in scope and time. Specific only to agreed parties. Trade Secret – Can be very effective. No recourse if lost. Risk of 3rd party patenting your technology 6

Intellectual Property Patents Patent protection or well defined/ documented patenting strategy Progress shown against patent strategy Full Applications preferred to Provisional Applications Global patent rights protected You have the primary IP rights not the government In most cases Patents are the best IP. The best partner small businesses have a patent IP strategy somewhere along these lines. Notice, not a lot of $$ need to be spent to get there. 7

Knowledgeable Regulatory Approval Process Market Product Development Process Licensor Regulatory Approval Process – Time, - Biologic, Drug, Device – Your development activities support regulatory approval, minimize need for repeated work Market – Market leaders, Competition, meaningful difference at time of launch, not today, Large market, niche market, sales and distribution processes for product channel Product Development Process – multiplexed, multi tasked – takes time. Online resources Licensor – Product launch history, financials, stance on licensing, global reach 8

Collaborative Spirit Recognize Partner’s Expertise Marketing Sales Distribution Regulatory Affairs Product Development Quality Systems Internal RD&E Manufacturing Requirements

Collaborative Spirit Work within deal structure Don’t over-involve Communication Progress Rate Action items Development milestones Conflict resolution Don’t over-involve Be manageable Provide support all the way to launch Start from a position of trust – Not a position of wariness 10

Best Small Business Partners Mitigate Risk Technology IP Save Time and Money Knowledge Collaborative Spirit Well thought experiments and studies results – predict superior future product IP – Time to properly develop and exclusively market product – prevents me too products - maximal earnings potential Knowledge – basis for realistic relationship in negotiations and partnership. Expectations are met on both sides preserving good relationship Collaborative Spirit – Ultimately a matter of trust – Partner is doing its best to develop your technology. You are partners not adversaries 11