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

2. 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

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

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

5. 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

6. 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

7. 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

8. 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

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

10. 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

11. 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