New Strategies for Cost-Effective, High Value, Low Risk FTO ... - C5

Business Information
In A Global Context
9 th International Forum on
Freedom
Gain insights
from FTO experts
from 12 countries!
to Operate
9–10 May 2012
Le Méridien Parkhotel
Frankfurt, Germany
New Strategies for Cost-Effective, High Value, Low Risk FTO Assessments
Latest Legal and Regulatory Developments for Successful Opinion Writing
Led by Industry Experts from:
Merck Serono (Switzerland)
Sanovel (Turkey)
MorphoSys AG (Germany)
Lonza AG (USA)
Siena Biotech (Italy)
Ablynx (Belgium)
Actelion Pharmaceuticals Ltd
(Switzerland)
Astex Pharmaceuticals (UK)
Angelini (Italy)
CEPIUG (Confederacy of European
Patent Information User Groups)
European Patent Office
Session Sponsor:
Get practical advice on the biggest challenges facing Freedom to Operate (FTO)
searches, analysis and opinion writing today and cut through the complexities of:
• Current EPO, US and European National case law on claim interpretation
and validity
• Conducting FTO searches more time efficiently and cost effectively
- Hear best practice approaches to good search strategy by leading in-house experts
- Explore new technology tools and trends
- Assess search strategies for different sized projects
• New developments on SPCs and paediatric exclusivity and how they could
threaten your patent strategy
• Stratifying and quantifying FTO risks: how to deal with the grey areas
• Downstream effects of EPO divisional applications and the America Invents Act
on your FTO strategy
• New considerations for FTO practice arising from recent gene patenting
decisions (Lilly v HGS and Brüstle v Greenpeace)
• Addressing FTO challenges in emerging markets: China, India, Brazil
Plus, add further value to your experience by attending our
expert-led and interactive workshop on:
Analysing Claims in Patents and Patent Applications:
Practical and Strategic Insights into EU and US Specific FTO Issues
Up to
14.0 CPD
Media Partners:
To register call +44 (0) 20 7878 6888 or register online at www.C5-Online.com/FTO

Strategies for Effective FTO Searches and Analysis, Opinion Writing
and Reducing the Risk of Future Litigation
An effective Freedom to Operate search strategy and patent landscape analysis is vital to
the pharmaceutical, biotechnology and chemical industries. It is critical that IP Counsel
and patent strategy advisors have the information they need to create a successful and costeffective
FTO strategy which not only protects their firms from the increasing threat of
litigation but also maximises profit and secures future revenue.
C5’s Forum on Freedom to Operate is the only event in Europe specifically designed for
IP and Information Science experts involved with FTO practices in pharma, biotech and
chemical sectors. Our unparalleled speaker faculty, including FTO experts from at least 12
different countries, will provide you with the clarity and information you need to sharpen,
refine and improve your FTO assessment and patent due diligence procedures.
Hear from your direct peers how to conduct FTO searches more efficiently –
in-house or with the support of service and technology providers, gain best practice advice
on interpreting search results and patent validity and get insights on how the latest case law
developments will impact your FTO strategy.
You will walk away with fresh insights, tactics and tools to strategise your FTO assessment
and keep up with the latest legal and regulatory developments and their implications on
your patent strategy in this competitively heated market.
In addition, if you are new to Freedom to Operate activities or would like a refresher
on patent claims analysis, don’t miss our practical and interactive workshop immediately
following the conference.
Workshop, afternoon of 10 th May:
Analysing Claims in Patents and Patent Applications:
Practical and Strategic Insights into EU and US Specific FTO Issues
Taking on board the knowledge gained in the conference this hands-on afternoon session
will provide in-depth insights into a wide range of European and US-specific FTO
issues that will assist you to read and examine patent claims and overcome barriers of
interpretation within key EU jurisdictions and the US.
The emphasis throughout the session will be on worked examples and delegate
participation. By the end of the seminar delegates will be able to:
• Examine various aspects of validity and patent scope
• Identify and analyse infringement risk and infringement risk mitigation strategies
• Combat the challenges of prior art, reduce the risk of damages and expand your
patent portfolio to exploit new opportunities
Unparalleled Learning and Networking
C5 understands that sharing experiences and building relationships with your fellow
delegates during the breaks can be just as valuable as the structured conference sessions.
We strive to make both the formal and informal aspects of the conference as productive as
possible; and so we would like to invite you to join our:
Apple Wine Tasting Evening
Enjoy this regional speciality with your new industry contacts in the evening of the first
conference day.
Reserve your place at this invaluable conference today! Register now by calling
+44 (0) 20 7878 6888, by faxing your registration form to +44 (0) 20 7878 6885 or by
registering online at www.C5-Online.com/FTO
WHO SHOULD ATTEND
C5’s 9 th International Forum on Freedom to Operate will provide valuable insights for:
From Pharma, Biotech and Chemical Companies:
• In-house Counsel, Patent/IP Counsel
• Heads/Directors of Patent/IP departments
and Patent/IP Managers
• Patent Specialists and Experts
• Heads/ Directors of Licensing
• Chief Scientific Officer / Information Officer
and Information Scientists / Analysts
• Heads/ Directors Research & Development
and Research Scientists
• Head of Business Development
Private Practice Patent Attorneys specialising in:
• Life Science/ Biotech/ Pharma / Chemicals
• IP and Patents
Conference Chair:
Raymond Mandra, Partner, Fitzpatrick, Cella,
Harper & Scinto (USA)
Meet our Expert Faculty:
Giampiero De Luca, VP Intellectual Property,
Merck Serono (Switzerland)
Aalt van de Kuilen, President of the CEPIUG
(Confederacy of European Patent Information
User Groups) (Netherlands)
Bernd Hutter, Director, Head of Intellectual
Property, European Patent Attorney,
MorphoSys AG (Germany)
Michelle Jones, PhD, EPA CPA, Associate
Director IP, Astex Pharmaceuticals (UK)
Eric Ruhlmann, European Patent Attorney,
Director, Senior Patent Counsel, Actelion
Pharmaceuticals (Switzerland)
Gaye Ramazanoglu, Intellectual Property
Specialist – Patent and Trademark Attorney,
Sanovel (Turkey)
Marco Nievo, PhD EPA, IP and Competitive
Intelligence, Siena Biotech SPA (Italy)
Harry Kraft, Senior Patent Attorney, Ablynx
(Belgium)
Lorenzo Polenzani, R&D Strategy Manager,
Angelini (Italy)
Dr. Klaus-Peter Döpfer, European Patent Office
Ilian Iliev, CEO, Cambridge IP (UK)
Otto Licks, Partner, Leonardos & Licks
Advogados (Brazil)
Raymond Mandra, Partner, Fitzpatrick, Cella,
Harper & Scinto (USA)
Jeroen den Hartog, PhD, Partner, European
and Dutch Patent Attorney, Hoyng Monegier
(Netherlands)
Sandra Pohlman, Partner, df. mp (Germany)
Michael Eder, Partner, df. mp (Germany)
Gareth Morgan, Partner, Winston & Strawn
(UK)
Daniel Becker, Partner, Dechert (USA)
Gertjan Kuipers, Partner, De Brauw Blackstone
Westbroek (Netherlands)
Dr. Malathi Lakshmikumaran, Head (Life
Sciences), Lakshmi Kumaran & Sridharan
(India)
Dr. Qinghong Xu, Partner, Lung Tin
International Intellectual Property Agent Ltd.
(China)
Alex Denoon, Partner, Lawford Davis Denoon
(UK)
Dr. Manja Epping, Partner, Taylor Wessing
(Germany)
Joachim Wachenfeld, Partner, Vossius & Partner
(Germany)
Henrik Skødt, Ph.D., European Patent Attorney,
Partner, Plougmann & Vingtoft (Denmark)
Ronald Eisenstein, Partner, Co-Leader Patents,
Nixon Peabody (USA)
Matthew Royle, Senior Associate, Taylor Wessing
(UK)

Main Conference Day One: 9 May 2012
8.00 Coffee and Registration
8.30 Chair’s Opening Remarks
Raymond Mandra, Partner, Fitzpatrick, Cella, Harper
& Scinto (USA)
8.40 Best Practice Approaches to Freedom to Operate
Patent Research
Aalt van de Kuilen, President of the CEPIUG (Confederacy
of European Patent Information User Groups) (Netherlands)
• Definition of a FTO search
• Clarifying the legal context of a FTO search
• Addressing guidelines for FTO searching
• Defining scope of a FTO search
• Introducing different types of FTO searches
• Best Practices: examining real life examples
• Common pitfalls and challenges and how to overcome them
9.15 Interpreting FTO Search Results and Patent Validity
to Reduce Risks and Maximise Your Revenue Potential
Sandra Pohlman, Partner, df. mp (Germany)
Michael Eder, Partner, df. mp (Germany)
1. Determining which products or processes require clearance
• Geographic considerations:
- identifying jurisdictions that provide the greatest exposure
- extraterritorial reach of certain claim types
• Temporal considerations:
- stratifying risk based on expected product launch date
- assessing likelihood of third party applications granting in
the intended market for intended use
- how to deal with uncertainty of earlier and/or expiring patents
2. Challenging validity to overcome blocking patents
• Highlighting the EPO and National Patent Office approaches
to validity
- what are the differences between interpretations How do
the different approaches affect invalidation approaches
- which factors are most important when choosing the EPO
over National Patent Offices
10.15 Morning Refreshments
10.45 Practical Advice for Conducting FTO Searches more
Time Efficiently and Cost Effectively
PANEL SESSION
Gaye Ramazanoglu, Intellectual Property Specialist –
Patent and Trademark Attorney, Sanovel (Turkey)
Marco Nievo, PhD EPA, IP and Competitive Intelligence,
Siena Biotech SPA (Italy)
Lorenzo Polenzani, R&D Strategy Manager, Angelini (Italy)
Harry Kraft, Senior Patent Attorney, Ablynx (Belgium)
Ilian Iliev, CEO, Cambridge IP (UK)
• Conducting searches in-house v outsourcing
- when to try searching in-house and when is an external
search necessary
- building in-house expertise: establishing internal guidelines
and policies and how to monitor those
- how to find the right search partner
- managing the risks of outsourcing the FTO search function
• Classifying and maintaining comprehensive search records
- how to organise and document search results
- identifying and categorising “relevant” data for the future
• Search strategies for different budgets and different sized projects
- how diligent do you have to be When can you stop your search
- how can search budgets be managed and allocated across
varying drugs
12.30 Lunch
• Exploring new tools and trends to ensure effective FTO
searches and analysis
- best practice on using search engines and databases
- comparing solutions available - how to decide which is
the most suitable one for your needs
- using translation machines effectively
- pros and cons to using crowd sourcing be used for FTO
- open innovation initiatives – what are the implications for FTO
- moving beyond silos – using collaborative tools for patent
intelligence
• How to get the most out of your FTO searches with Data Mining
- what is data mining How can it benefit your firm
- what data can be used at a later stage: reporting, storing
and retrieving data from searches
13.30 Impact of the Recent Court Decisions on Your FTO
Strategy: Discussing the Pro and Cons of Lilly v HGS
and Brustle v Greenpeace
Gareth Morgan, Partner, Winston & Strawn (UK)
Alex Denoon, Partner, Lawford Davis Denoon (UK)
EXPERT DISCUSSION
Our experts will share their first-hand insights and discuss the
advantages and disadvantages these recent decisions will have for FTO
practices; followed by an open discussion with the audience on the wider
implications of both cases for FTO and patent strategies in Europe.
Eli Lilly v Human Genome Sciences
• Addressing the basis of the UK Supreme Court appeal
• UK Court of Appeal vs TBA
• How will “target” patents be assessed in Europe the future
• Is the protection on offer commensurate with the innovation
• Examining the impact on freedom to operate for drug
discovery/diagnostics companies
Brüstle v Greenpeace
• What did the Court of Justice decide
• How does this affect existing patents (including patents relating to
stem cells broadly rather than just human embryonic stem cells)
• How might this affect companies’ patenting activities
• Practical ramifications given the regulatory hurdles to generics
of cell-based therapies
• Will this lead to an increased reliance on trade secrets
• Analysing the impact on freedom to operate
• Wrap up: Is the impact on investor confidence greater than the
patenting issues given the commercial hurdles to developing
these products
14.20 Understanding the Effects of Patent Extensions on
FTO: How SPCs and Regulatory Data Protection Could
Threaten your Patent Strategy
Gertjan Kuipers, Partner, De Brauw Blackstone Westbroek
(Netherlands)
• Interpreting the latest SPC developments and trends
• Analysing the latest ECJ decisions regarding SPCs for
combination products and what they mean for the
‘infringement test’ and further FTO considerations:
- Medeva (C-322/10)
- Georgetown University (C422/10)
• Addressing cross-border challenges – how are SPCs dealt with
by national courts
• Extend your SPC protection or extend your data exclusivity
protection
- determining which exclusivity right is more beneficial
• Reviewing recent case law on data exclusivity
14.55 FTO and Paediatric Exclusivity – What the Patent
Practitioner Should Know
Eric Ruhlmann, European Patent Attorney, Director, Senior
Patent Counsel, Actelion Pharmaceuticals (Switzerland)
• EC regulations and access to paediatric exclusivity in Europe
To register call +44 (0) 20 7878 6888 or register online at www.C5-Online.com/FTO

- what are the rewards
- what are the requirements (Paediatric Investigation Plan
(PIP), SPCs, timelines...)
- main pitfalls
• European case law update
- E I du Pont Nemours & Co v. UKIPO
- C 125/10 (Merck & Co Inc. v. Deutsches Patent- und
Markenamt - “Negative Term SPCs”)
• FDA regulations and access to paediatric exclusivity in the US
- what are the rewards
- what are the requirements (written request from the FDA,
timelines...)
• US case law update
- In re Omeprazole Patent Litigation
- the Norvasc case – Pfizer v. Apotex and related decisions
15:30 Refreshment Break
16.00 Finding the Right Balance When Reporting Your
FTO Strategy: Privilege and Confidentiality
Jeroen den Hartog, PhD, Partner, European and Dutch
Patent Attorney, Hoyng Monegier (Netherlands)
• Assessing how to report in a clear way while dealing with
uncertainty and later potential discovery
• Best practice strategies for ensuring confidentiality of information
• Understanding privilege issues and overcoming challenges for
in-house counsel
- examining the impact of e-discovery
- how to keep communication with R&D private
- what information in an FTO assessment remains confidential
- handling privilege issues during incoming due diligence
• Latest update on privilege for in-house attorneys and
the potential impact on any US proceedings of reported
assessments of your FTO reports
16.40 Stratifying and Quantifying FTO Risks – How Do You
Advise on and Deal With Grey Areas
Michelle Jones, PhD, EPA CPA, Associate Director IP,
Astex Pharmaceuticals (UK)
Giampiero De Luca, VP Intellectual Property, Merck Serono
(Switzerland)
Daniel Becker, Partner, Dechert (USA)
PANEL SESSION
• Quantifying the risk of third party patents
• Assessing the likelihood of preliminary injunction
• Addressing damage claims – discussing the latest case law and
its implication for FTO considerations
• Using licensing as a tool to circumvent FTO roadblocks:
- when should licensing become a consideration
- evaluating your licensing options
• Reporting FTO risks – what does the upper management need
to know
17.20 Conference Adjourns
18.00 Networking Event –
Apple Wine Tasting Evening
Relax after a long day of conferencing as you
sample traditional Frankfurter apple wine
(cider) with your new industry contacts and
fellow Freedom to Operate experts.
Main Conference Day Two: 10 May 2012
8.00 Coffee and Registration
8:30 Chair’s Welcome
Raymond Mandra, Partner, Fitzpatrick, Cella, Harper
& Scinto (USA)
8.35 How are EPO Divisional Applications and the America
Invents Act Impacting FTO Strategies
Bernd Hutter, Director, Head of Intellectual Property,
European Patent Attorney, MorphoSys AG (Germany)
Eric Ruhlmann, European Patent Attorney, Director, Senior
Patent Counsel, Actelion Pharmaceuticals (Switzerland)
Dr. Klaus-Peter Döpfer, European Patent Office
PANEL SESSION
• Latest Insight from the EPO
- update and feedback regarding divisional applications
- strategies and perception of patents not granted yet
- what is the impact of the new rules on FTO How the EPO
is making processes more efficient and user-friendly
• Implications for the America Invents Act on FTO
- US ex parte and inter partes re-examination
- US post grant and inter pates reviews
- declaratory judgement actions
• Industry Response: What is the downstream effect of the
legal changes
- how are divisional applications impacting the FTO strategies:
what are people doing Filing divisional What are your
options when you are concerned someone will file a divisional
- what strategies are available for overcoming delays by the
EPO and USPTO (e.g. filing a third party application in the
meantime)
- overcoming validity when you have a pending application
- discussing ways to circumvent the law to get your divisional
filed
FTO IN EMERGING MARKETS
9.20 Latest Developments in the Indian Patent Landscape
and Their Impact on FTO
Dr. Malathi Lakshmikumaran, Head (Life Sciences),
Lakshmi Kumaran & Sridharan (India)
• How are the processes and procedures to gain FTO in India
different
• Understanding the requirements for obtaining a valid patent
- what data records should be maintained
• Overcoming the challenges of obtaining reliable search data
- National Patent Office (NPO) assistance vs. using search
databases
- safeguarding confidential information
• Protecting your products from infringement in India
- identifying the key examiners, regulators and Courts
• Discussing latest case law update
10.00 Latest IP Trends and Regulatory Changes in China
and the FTO Implications
Dr. Qinghong Xu, Partner, Lung Tin International
Intellectual Property Agent Ltd. (China)
• Developing and executing an effective FTO search in China
• Overcoming challenges of acquiring reliable data for FTO searches
• Conducting an efficient infringement analysis
• Dealing with infringement in courts: hear an update on latest
case law developments
• Challenging validity of blocking pharmaceutical or biotech patents
10.40 Morning Refreshments
11.10 Patent Filing and Litigation in Brazil – Optimise your
Chances of Success
Otto Licks, Partner, Leonardos & Licks Advogados (Brazil)
• Examining criteria adopted by the Brazilian PTO
• Overcoming challenges of acquiring reliable data for FTO
searches
• Clarifying the requirements for obtaining a valid patent –
what data records should be maintained
Fax order form to +44 (0) 20 7878 6885 or register online at www.C5-Online.com/FTO

• Gain practical insights in enforcement: how strong are
pharmaceutical and biotech patents
• Analyse the latest case law developments
• Understanding the new rules issued by Brazil’s Regulatory
agency regarding biosimilars
11:50 The Impact of US Developments on European FTO
Analysis
Raymond Mandra, Partner, Fitzpatrick, Cella, Harper &
Scinto (USA)
• Addressing the America Invents Act and its impact on FTO
strategies
- is the expanded Prior Use Defense applicable
- priority examination - does it create a potential minefield
- considering Interpartes Review and Post Grant Review –
are they in play or could they be useful
• Examining recent case law developments on (in)validity
and infringement
- how does the obviousness analysis after KSR continue
to be refined by the Federal Circuit
- when are method claims requiring the acts of multiple
parties infringed
• Analysing case law developments on claim construction
- do reexam arguments create intrinsic evidence for claim
construction
• Considering Biosimilars
- will the legislation survive Supreme Court review
- will US data exclusivity under the biosimilars legislation
remain unchanged
12.35 Adapting your Patent Tactics for Biosimilars:
Keeping Abreast with Regulatory Changes while
Staying Competitive
Dr. Manja Epping, Partner, Taylor Wessing (Germany)
Matthew Royle, Senior Associate, Taylor Wessing (UK)
• Analysing the regulatory risks for biosimilars
- Comparing the EU biosimilars legislation and Hatch-
Waxman Act procedures in the US
- Antibody claims – exploring breadth of claims in the
biosimilars era
• Pricing and reimbursement issues and their impact on your
patent strategy
• Examine patent strategies for biosimilars
- Patent thickets as delaying tactic
- Follow-on patents
13.15 Chair’s Closing Remarks and End of Conference
13.15 Lunch (for Workshop Attendees)
At Fitzpatrick, IP is not just a
practice area – it is our sole focus.
We have over 175 attorneys in
New York, California, and Washington D.C. practicing in all areas of
intellectual property law, including patents, trademarks, copyrights, unfair
competition, and trade secrets. Our practice covers the spectrum of
intellectual property services, including applying for patent and trademark
protection, litigation, appeals, interferences, alternative dispute resolution,
licensing, opinions, corporate transactions and due diligence.
GLOBAL SPONSORSHIP OPPORTUNITIES
C5 works closely with sponsors to create the perfect business development
solution catered exclusively to the needs of any practice group, business
line or corporation. With over 500 conferences held in Europe, Russia and
the CIS, China, India, the US and Canada, C5, ACI and CI provide a
diverse portfolio of first-class events tailored to the senior level executive.
For more information about this program or our global portfolio, please contact:
Jo Menzer on +44 (0)20 7878 6978 or email j.menzer@C5-Online.com
Post-Conference Workshop: 10 May 2012
14.00 – 17.15 (refreshment break included)
Analysing Claims in Patents and Patent Applications:
Practical and Strategic Insights into EU and US
Specific FTO Issues
Workshop leaders:
Joachim Wachenfeld, Partner, Vossius & Partner (Germany)
Henrik Skødt, Ph.D., European Patent Attorney, Partner,
Plougmann & Vingtoft (Denmark)
Ronald Eisenstein, Partner, Co-Leader Patents, Nixon
Peabody (USA)
EU-SPECIFIC ISSUES:
Examining Infringement Risk in Major EU Jurisdictions
• Scope of Bolar exemption in major European jurisdictions
• Existence and scope of other infringement exemptions
• Bases for, and likelihood of, injunction in major European
jurisdictions
• Prior user rights
• Compulsory license regimes
• Claim construction differences: UK, DE, other major EU
jurisdictions
• Non-literal infringement under EU law
• Damages calculations in major European jurisdictions
Clarifying Validity Issues Though Analysis of EPO Cases
• The pros and cons of trying to invalidate European patents
through central opposition proceedings vs. national
revocation actions
• In the case where the EPO found the patent valid
(Atorvastatin case)
• In the case where the EPO has found the patent invalid (in
the first instance – Esomeprazole case)
• Special advantages in the EPO opposition proceedings
(extension of subject-matter – Yasmin (drospirenone/
ethinylestradiol) case)
• The role of party-appointed experts in national proceedings
vs. opposition proceedings
US-SPECIFIC ISSUES:
• Clarifying Post Issuance Procedures
- Post-Grant Review
- Inter-partes Proceeding
- Interferences
• The Effects of Bilski, Prometheus, Myriad and Classen on
Method Claims
Mayo Collaborative Services. v. Prometheus Laboratories, Inc.
(at U.S. Supreme Court)
Association for Molecular Pathology v. USPTO
(ACLU v. Myriad – Certiorari requested from U.S. Supreme Court)
Classen Immunotherapies, Inc. v. Biogen IDEC
(awaiting certiorari petition)
- Is it patent eligible
- Can the claims be saved by a reissue
- Does the claim cover a natural phenomenon
- How do you deal with these cases
• The Effects of Myriad on Claims to Isolated and/or Purified
Compositions
- Nucleic acids
- Proteins
- Antibodies
- Cells
• Enforcing Claims that Involve Multiple Parties –
the McKesson Problem
McKesson Technologies, Inc. v Epic Systems, Corp
• Understanding How Safe Harbor Under 35 USC §271 (e) (1)
Avoids Infringement
To register call +44 (0) 20 7878 6888 or register online at www.C5-Online.com/FTO
©C5, 2012

9 th International Forum on
Freedom
to Operate
New Strategies for Cost-Effective, High Value, Low Risk FTO Assessments
Latest Legal and Regulatory Developments for Successful Opinion Writing
9 – 10 May 2012 • Le Méridien Parkhotel, Frankfurt, Germany
Business Information
In A Global Context
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