2008 Fall Seminar Valencia

OPENING & WELCOME

Laurent Mieville, President ASTP, Welcome
Belen Juste, Regional Minister of Industry, Commerce & Innovation Valencia, Spain, Welcome
Frédéric Caillaud, Director Licensing & Business Development L’Oréal R&D, France, Building a Market for Intellectual Property

I: Introduction to Licensing
1. General Principles

II: Who are these people? Intermediaries & market makers
1. IP auctions & showcases

III: It’s not quite that simple!
1. Drug development: realistic versus idealistic

Morag Macdonald, Partner Bird & Bird, United Kingdom
Karen Hersey, Former Sr. Counsel for Intellectual Property, MIT & Visiting Professor of Law Franklin Pierce Law Center Concord, USA
In this first session the speakers will go back to basic and will set-up the framework for the twoday introductory course. The general principles of licensing will be articulated and the overall structure of a license will be portrayed. Basic terminology will be sharply defined and a first set of “must have” clauses will be discussed.

Isabel von Korff, Project Director Ascenion, Germany
Antti Sinisalo, Business Development Manager, VTT, Finland
Patent auctions have received quite some publicity in the last few years as a new and innovative way of commercializing your patents. But how does the system actually work and what are the success rates? Or is it better to make your technologies known in a showcase presentation? Can both systems be used for all our patents or is selectivity the key?

Jean-Marc Combette, CEO Ribovax Biotechnologies, Switzerland
The road from an idea to a medicinal product is very long, and an extremely low percentage of ideas finally make it to the market: in a lot of cases it already goes wrong quite early because the concept of drug development is not very well understood in a university setting. What are the essential elements to take into account, and what are the obvious and less obvious pitfalls to avoid?

I: Introduction to Licensing
2. Moving research to commercialization through industry iollaboration

II: Who are these people? Intermediaries & market makers
2. Brokers / field experts

III: It’s not quite that simple!
2. Drug development and regulatory affairs: free style or required figure?

Karen Hersey & Morag Macdonald
Licensing is basically commercialising your research results, but one often forgets that your research agreements actually set the stage for future licensing agreements. So getting it straight right from the beginning is of crucial importance: how to structure your agreement for success and really use research agreements with industry as part of the commercialization process? In other words: turning your research agreement into licenses!

Guido von Scheffer, Director Public Affairs, IP-Bewertungs AG, Germany
Jon Wulff Petersen, CEO, TTO Denmark
Support in our complex job is more than welcome for all of us. This session is about people who can help you to identify, protect and develop technologies, and/or also further develop the technologies themselves. How to select the right partner? What is the ideal way to collaborate with them and remunerate them?

Ulrich Granzer, Managing Director, Granzer Regulatory Consulting & Services, Germany
Too often we try to commercialise research results without realising the impact of regulatory affairs once the results leave the research institute. It is nevertheless a crucial element that should be taken into consideration in a very early stage. Our expert speaker will guide you through marketing authorization, FDA/EMEA, orphan drug status, accelerated approval possibilities, compassionate use, and much more.

I: Introduction to Licensing
3. Pitfalls in Licensing - I

II: Who are these people? Intermediaries & market makers
3. Royalty monetization

III: It’s not quite that simple!
3. Food: from the farm (or the lab) to the fork

Karen Hersey & Morag Macdonald
The third and fourth session will dive into the specific articles of a license agreement. The following topics will pass the review : parties, recitals, definitions, field, territory, license clause, sublicensing, considerations, diligence, transfer of technology, reservation of rights, third party intellectual property rights, access to improvements, infringement, representations and warranties, choice of law, assignment, dispute resolution, other boiler plate provisions. Special attention will be given to approaches to avoid pitfalls

Ken MacLeod, Partner Paul Capital Partners, United Kingdom
Phil L'Huillier, Executive Director, Business Management, Cancer Research Technology, United Kingdom
George Pickering, Associate Reed Smith Richards Butler, United Kingdom
What to do when the royalties finally kick in? Royalty monetization allows you to transfer (part of) the future income streams in return for upfront cash. Real life cases show you the advantages and pitfalls when considering and negotiating a monetization deal.

Gert-Jan Schaafsma, Schaafsma Advisory Services, the Netherlands
Filip Knudde, Manager Green Biotech Europe, Europabio, Belgium
What is functional food, novel food, the European Food Safety Authority and a health claim? A basic knowledge on all these items (and more) is a prerequisite when you try to find a buyer or a licensee for whatever food ingredient. The second speaker will elaborate on genetically modified organisms: to what extent can you actually commercialize GM-food today, and what does it take to have it end upon your plate.

OPENING SESSION

Karl Koster, Director of Corporate Relations, MIT Office of Corporate relations,What companies really value in their interaction with MIT.

I: Introduction to Licensing
4. Pitfalls in Licensing - II

II: Who are these people? Intermediaries & market makers
4. Web-based facilities (IP portals & exchanges)

III: It’s not quite that simple!
4. Medical devices: regulatory

Karen Hersey & Morag Macdonald
This session is a continuation of session 3.

Christophe Sevrain,, Founder and CEO e-IP (TechTransferOnline), USA and France
Adrian Sigrist, Associate Director, Head Life Sciences Group, Unitectra, Switzerland
Are current webbased facilities nothing more than just another patent database or can they be a real help in reaching out to interested partners? This topic is discussed from a double angle. One speaker shows what commercial webbased tools can mean for you, while the second speaker highlights a system developed by a tech transfer community itself.

Corinne Lebourgeois, Medc. Partners, Switzerland
Medical devices are subject to a quite different regulatory environment than drugs ... but not necessarily an easier one. Find your way through the complex system and learn all about CE Mark, Pre-market Approval, 510k, FDA, Notified Body, Quality Management System, etc.

I: Introduction to Licensing
5. Good management through enforceable royalty obligations

II: Who are these people? Intermediaries & market makers
5. Structural investors

III: It’s not quite that simple!
5. Medical devices: reimbursement

Karen Hersey & Morag Macdonald
Generating income for your organisation is undoubtedly one of the key objectives of your licensing activities. The way you structure your payments from licensees can have a dramatic impact on your returns. The speakers will demonstrate how to be creative with structuring considerations. They will explain what can be the basis for royalties, exemplify the use of lump sums and running royalties, clarify multiple approaches to royalty structures, present reference royalty rates and illustrate the importance of royalty reports and payment procedures.

Tony Raven, Director of Research & Innovation Services, University of Southampton, United Kingdom
Charles Tavner, Partnership Director, IPGroup, United Kingdom
More and more deals are announced under which companies invest a large amount in a certain research department in return for a part of all future IP/spin-offs generated in that department. What are the constituents of such a deal? Is this “the way universities should be financed in future” (Financial Times) or are we selling out the university in this way?.

Corinne Lebourgeois, Medc. Partners, Switzerland
Regulatory issues are not the only hurdle to be overcome on its way to the market. Also the question whether the product will benefit from reimbursement by the national health authorities will determine on the level of interest of potential licensees. Can this be assessed beforehand? What are the steps to be taken in this respect and how can the process be optimized?

FINAL SESSION : The nine points

Panel discussion with Karl Koster, Kevin Cullen, Jon Wulff Petersen, Tony Raven

We spend a lot of time looking at the technical aspects of licensing, but sometimes forget the most important question....why are we doing it? There is an interesting debate on whether financial gain or public good is the key objective. On this topic, a number of leading US public research institutions released a paper containing "Nine Points to Consider in Licensing" (www.autm.net/aboutTT/Points_to_Consider.pdf), which outlines where a number of universities feel we should position ourselves in terms of delivering in the public interest. This session will look at whether this is simply common sense or whether there are important lessons for us to learn from this approach.