Negotiating, Understanding & Drafting Contracts for the Pharmaceutical Industry

Date	15-17 Nov 2010
Venue	Grange White Hall Hotel · Please contact us for help with booking accommodation
Price	EUR 1749.00 / GBP 1399.00 (+VAT @ 17.50)% Members of our Training Partnership scheme pay EUR 875.00 / GBP 699.00 (+VAT @ 17.50%)
Get	Course Brochure [357kb]
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Course overview

In such a highly regulated sector understanding the key challenges of negotiation and drafting an effective and watertight contract on an international level is a complex topic. They can be difficult for even the most equipped in-house lawyer and most often it is not the lawyer in the driving seat. Commercial managers from all areas of the pharmaceutical industry are leading negotiations, drafting and managing key contracts on a daily basis. It is vital that both legal counsel and commercial executives not only have the key skills and tactics to create a win:win scenario but also the knowledge to ensure any agreement is within the laws and regulations. The alternative is the exposure of the organisation to unnecessary risk and potential costly disputes.

Falconbury have developed this unique three-day programme that looks at both elements of the process. Using practical exercises, industry examples, and discussions to examine the key skills needed from both legal and commercial viewpoints and how they integrate.

The programme has been specifically designed for commercial managers and in-house counsel from all areas of the pharmaceutical sector to understand and perfect all stages of the process.

The programme consists of FIVE modules:

• Module 1 will deliver an in-depth examination of intellectual property issues that affect pharmaceutical industry agreements
• Module 2 will focus on competition regulations pertinent to pharmaceutical industry agreements
• Module 3 analyses the commercial and legal issues affecting pharmaceutical industry agreements
• Module 4 examines collaboration and licensing agreements
• Module 5 is an in-depth workshop on effective negotiation skills

By attending this seminar, you will:

• UNDERSTAND the key intellectual property issues affecting pharmaceutical industry agreements
• FIND OUT about the implications of SPCs for pharmaceutical industry agreements
• GRASP the impact of the Bolar provisions
• LEARN how to draft contracts to avoid anti-trust infringement
• FAMILIARISE yourself with the key commercial and legal issues that affect pharmaceutical industry agreements
• GAIN knowledge of the key issues in clinical trial agreements, contract manufacturing agreements and co-promotion, co-marketing and distribution agreements
• GET-TO-GRIPS with the competitive nature of doing deals in the pharmaceutical industry and the tactics for effective and successful negotiation
• UPDATE yourself with latest developments in international privacy regulations

Who should attend?

From R&D, clinical, regulatory, commercial, sales and marketing, manufacturing, distribution and purchasing, including:

• In-house counsel
• Commercial and contract managers
• Business development managers
• Purchasing and procurement
• Heads of legal departments
• Legal advisors
• Patent, IP, trademarks or licensing counsel

Programme - Day 1

MODULE 1: INTELLECTUAL PROPERTY ISSUES AFFECTING PHARMACEUTICAL INDUSTRY AGREEMENTS

Intellectual property terms in collaboration and licensing agreements

• Ownership of internally and externally generated IP
• Joint ownership issues
• Outsourcing issues
• Improvements and grant backs

SPC’s – Supplementary Protection Certificates

• What are SPC’s?
• What are the implications for pharmaceutical industry agreements
• The duration of the SPC
• What does the SPC cover?
• Combination products
• Basic patents and basic and follow-on SPC’s

When does R&D infringe patents? Understanding the new Bolar provisions

• Implications for clinical trials agreement
• Limitations of experimental use defence to patent infringement
• The ‘Euro Bolar’ defence: Article 10(6) of Directive 2001/83/EC explained
• Varying scope of the defence across the EU
• Patent infringement warranties and indemnities in clinical trials agreements

Third party IP rights – ‘Freedom to Operate’ searches and implications for pharma industry agreements

• Patents and patent term extensions, utility models and quasi-patent term extensions
• Managing the patent search
• Evaluating your freedom to operate
• Scope of patents and infringement
• Different approaches to infringement in Europe
• Validity of the pertinent patents
• National invalidity/renovation actions and opposition proceedings or (cross) licensing
• Strategies for obtaining freedom to operate

MODULE 2: COMPETITION LAW ISSUES AFFECTING THE PHARMACEUTICAL INDUSTRY

Introduction to relevant EU competition law rules

• Article 101 TFEU: restrictive agreements and practices
• The Technology Transfer Block Exemption Regulation
• Vertical Agreements Block Exemption and Vertical Restraints Guidelines
• Specialisation Agreements Block Exemption
• R&D Agreements Block Exemption
• Horizontal Co-operation Guidelines

Case Study (1) – Restrictions in licences/settlement agreements
Delegates will be given a licensing situation and a list of restrictions and clauses the parties want to include in a patent and knowhow licence agreement. They will be asked in groups to analyse which restrictions and clauses are permissible under EU competition law and how they may need to vary those restrictions so they are compliant with the law. We will also discuss issues that could arise out of settlement agreements.

Case Study (2) – Co-promotion/co-marketing agreements
Delegates will be presented with a case study involving a series of competition law issues, which may arise from co-operation in R&D, promotion and sales, including exclusivity restrictions in the context of these kinds of agreements.

Programme - Day 2

MODULE 3: COMMERCIAL AND LEGAL ISSUES AFFECTING PHARMACEUTICAL INDUSTRY AGREEMENTS

Key issues in clinical trials and related agreements

• Pre-contractual documentation
• Key agreement terms
• General legal consideration in clinical research outsourcing
• Other background law

Key issues in contract manufacturing agreements

• The impact of the new regulatory requirements on contract manufacturing
• The importance of the GMP audit
• Issues with technology transfer
• Apportionment of risk and reward
• Secondary sources of supply
• Other key issues

Key issues in co-promotion, co-marketing and distribution agreements

• Introduction to the agreements
• Scoping the deal
• Preparing for contingencies and termination
• Key characteristics of the distribution relationship
• Key terms – scope of rights and responsibilities, restrictions, minimum purchase requirements, territory

MODULE 4: WORKSHOP ON COLLABORATION AND R&D AGREEMENTS

Negotiation of collaboration and licence agreements concerning pharmaceutical product

• Introduction to case study
• Attendees to discuss case study in groups
• General discussion of group findings
• Key issues arising out of the case study:
  • Use of term sheets
  • R&D collaboration; regulatory issues
  • Licensing and IP issues
  • Financial terms
  • Warranties
  • Performance obligations and termination rights
  • Boilerplate clauses, including law and jurisdiction

Programme - Day 3

MODULE 5: NEGOTIATION SKILLS IN THE PHARMA SECTOR

The rise and rise of the negotiator

Nothing exemplifies the modern pharma company as much as the growth of joint ventures, sub-contracting and licensing. All of these require the pharma executive to be able to negotiate and, often, to be able to lead others through the negotiation process.

• The increase in negotiated relationships
• Technical AND commercial skills
• Recognising a negotiation
• Great role models

Practical exercise (including refreshments):

Negotiate and succeed

Working in teams, delegates are asked to resolve a multi-variable, multi-party business problem. The output of the exercise will form the backdrop for the following sessions on structure and influencing.

Structure for control
The research tells us that negotiation success is not related to any single aspect of the complex interactions that take place in any negotiation. However, above all else the party that negotiates best gets the best result. Key to negotiating well are controlling the negotiation and managing the process.

• Control for success: Key planning checklist to negotiate well
• Structure for success: Creating the space to agree
• Trading for success: Understanding relative values

Personal style and negotiation
This session helps us hold a mirror up so that participants can reflect on their own style. We look at why other styles irritate us – and how we negotiate with those people we find difficult to deal with.

• Our lead style (and our fall back style)
• The A to E of negotiating styles
• Personal strengths and weaknesses

Practical exercise: moving into engagement
Working in teams, delegates are asked to use their knowledge of their own style and those of others in their teams to agree strategies and tips for dealing with other styles and getting the most out of the negotiation.

Influencing and persuasion
It can be argued that the more we can influence someone to our position and the greater agreement we can build, the less we have to give away in our negotiation. This session looks at how people are persuaded and how the expert negotiator can use this knowledge to their benefit.

• Persuasion psychology
• The range of levers available
• Focusing your persuasion

The expert faculty

Expert Faculty

Laura Anderson is a Partner at Bristows in London. Since joining Bristows 12 years ago, Laura has specialised in non-contentious IP matters. She has considerable experience of commercial arrangements relating to the development and exploitation of all kinds of intellectual property rights. Laura has expertise in the competition law aspects of commercial IP transactions and has spent time working in Brussels, both at the EU Council of Ministers and in private practice. Laura acts for clients across a range of sectors including life sciences.

Allistair Booth is a partner in Fasken Martineau DuMoulin LLP and Fasken Martineau Stringer Saul LLP (London) and a member of the Technology and Intellectual Property and life sciences practice groups. His experience includes in and out licensing, product sales and acquisitions, contract manufacture, distribution, clinical trials, pharmacovigilance and outsourcing agreements, advice on product development and product lifecycle management strategies, intellectual property and competition law as it affects the industry.

Rob Maguire runs his own consultancy and his experience spans the full range of issues from developing an appropriate contract strategy and building a performance dashboard to negotiation and conflict resolution to deal with the inevitable management issues that arise in any long-term relationship.Through his consulting, coaching, mentoring and skills development interactions, he helps major organisations transform their thinking and approach to their commercial relationships.

Gareth Morgan is a partner in the London office of DLA Piper’s intellectual property department. Gareth has experience in all areas of contentious and non-contentious intellectual property law with a particular focus in the life sciences and healthcare sector including multi-jurisdictional patent litigation and enforcement strategies; contractual disputes and High Court contract litigation, negotiating commercial agreements including licences, technology transfer agreements and collaboration and development agreements and advising on the interpretation of EU medicines law and EMEA/MHRA guidance documentation.

Dr Luke Kempton is a partner in the intellectual property team of Wragge & Co, specialising in the life sciences sector. He has a PhD in biochemistry and works closely with other members of the experienced life sciences team. He specialises in patent litigation, licensing, collaborations and manufacturing agreements in the life sciences industry.

Marleen Van Kerckhove heads up Arnold & Porter LLP’s European competition practice and its Brussels office. Her practice encompasses advice and representation before EU and national antitrust agencies on merger control, abusive conduct, price fixing and other restrictive practices, as well as litigation before European courts. She also advises on international trade regulation matters. She has advised extensively on the application of EU competition law to the pharmaceutical sector, and on the interplay between antitrust and intellectual property law.

Bonella Ramsay is a partner in the technology, media and commercial group of DLA Piper in London. She heads the London IP group and is joint head of the UK pharmaceutical and biosciences practice. As an intellectual property specialist, Bonella is involved in IP rights management and strategy for a wide range of clients as well as structuring and negotiating the exploitation of IP rights, including franchising arrangements. She has a particular focus on technology transactions for the pharmaceutical and biosciences sector.

Stephen Reese is a partner at Olswang where he advises clients on both contentious and non-contentious intellectual property matters including patents, trade marks, trade secrets and copyright. He has significant experience representing those clients within the life sciences and technology fields. In connection with his life sciences practice Stephen also advises clients on UK and EU regulatory matters within that sector.

Lindsey Woolley is Partner and Patent Attorney at Mewburn Ellis LLP, which she joined in 2002. Lindsey deals mainly with drafting and prosecution work and advises on portfolio management of interrelated patent families. Lindsey also deals with patent work in the biotechnology field, in particular molecular biology, biochemistry and biotechnology. Her clients include universities, research institutions and biotechnology companies. Lindsey has a degree in plant sciences from the University of Cambridge.

Tim Worden is Partner in the intellectual property department of Taylor Wessing. His practice includes both non-contentious and contentious intellectual property and he specialises in the life sciences and healthcare sectors. Tim was previously Legal Counsel and Company Secretary at Eli Lilly and Company Limited, the UK subsidiary of the US pharmaceutical company.

Past delegates’ comments

Some of the comments received by participants on this course:

“Enjoyable and informative”

Mike Isaacson, Dexcel Pharma Ltd

“Calibre and knowledge of speakers was very high and impressive”

Isla Irvine, Britannia Pharmaceuticals Ltd

“I learnt a great deal about new areas and potential strategies to deal with these. The case studies where well thought out”

Dr Paul Madeley, Synth-Isis Ltd

“Overall calibre of speakers was very high”

Alex Moulson, Morphosys AG

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Client portfolio

Our client portfolio for this course includes the following companies:

ABBOTT IRELAND LTD	Fondazione Centro San Raffaele Del Monte Tabor	Novartis Pharma AG
Abbott Laboratories Ltd	Fresenius Medical Care	NsGene AS
Actavis EAD	Friesland Consumer Products	Otsuka Pharmaceutical Europe Ltd
Ajinomoto Omnichem_Omnichem Division	Generics (UK) Ltd	Oxagen Ltd
Almac Group Ltd	GenesisPharma SA	Penn Pharma
Angelini Farmaceutica	IDIS Ltd	Pharmathen International SA
AstraZeneca Czech Republic sro	Intendis GmbH	Recipharm
Axellia Pharmaceuticals ApS	LEK Pharmaceuticals dd	Sandoz
BERLIN-CHEMIE AG	Laboratories Bouchara Recordati	Sanofi Aventis
Britannia Pharmaceuticals Ltd	Laboratorios Almirall SA	Solvay Pharma
CMC Biopharmaceuticals	Laboratorios Liconsa, SA	Synth-Isis Ltd
Crucell Holland BV	MN Pharmaceaticals	TEVA Pharmaceuticals
Dako Denmark AS	Medochemie Ltd	Tech Trans Unit
Debiopharm SA	Merck Serono SA	UCB Pharma SA
Dexcel Pharma Ltd	Molmed SpA	UCB SA/NV
Dishman Europe Ltd	Morphosys AG	VIB
Ebewe Pharma	Mundipharma GmbH	Wilex AG