Negotiating, Understanding & Drafting Contracts for the Pharmaceutical Industry

Date	7-9 Jun 2010
Venue	Grange Holborn 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 [218kb]
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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
• UPDATE yourself with latest developments in international privacy regulations
• GET-TO-GRIPS with the competitive nature of doing deals in the pharmaceutical industry and the tactics for effective and successful negotiation

Who should attend?

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

• Commercial and contract managers
• Business development managers
• Purchasing and procurement
• In-house counsel
• 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
• What does the SPC cover?
• Combination products
• The duration of the SPC
• Purified products
• Activities and quasi-activities
• 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 WORKSHOP

Introduction to relevant EU competition law in Article 81 of the Treaty of Rome

• The Technology Transfer Block Exemption 772/2004
• Patent and knowhow licensing in the EU
• Abuse of dominant market positions

Case Study (1) – Restrictions in licences
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 the Technology Transfer Block Exemption regulation and how they may need to vary those restrictions so they are compliant with the law.

Case Study (2) – Other agreements encountered in the pharma industry
Delegates will be presented with a case study involving a series of competition law issues, which arise from agreements such as R&D, clinical trial, consultancy and distribution agreements 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: COLLABORATION AND LICENSING AGREEMENTS WORKSHOP

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
  • Boilerplate clauses,

Programme - Day 3

MODULE 5: WIN-WIN 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: The A.C.T.I.V.E™ model of negotiation
• Options 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 relation to 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. She focuses on transactions which have IP rights at their core, as well as advising on the intellectual property aspects of corporate and funding transactions.

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. Allistair primarily focuses on advising clients in the life sciences sector having worked in that sector since 1997. He has experience with 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. He lectures extensively on product lifecycle management strategies. Allistair has given advice to a range of client’s from start up biotechnology companies through to mid to large sized pharmaceutical companies.

Rob Maguire runs his own consultancy and his experience spans the full range of outsourcing and vendor-management issues from determining what to outsource, through 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. Robert’s clients span a range of industries including pharma, consumer products, telecoms, transport and public sector both in the UK, the US and the Middle East.

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 represents and advises a broad range of clients in relation to the protection, exploitation and enforcement of their intellectual property rights. He has significant experience representing those clients within the life sciences and technology fields. He also has considerable experience in commercial transactions including research and development, licensing, acquisitions and due diligence. In connection with his life sciences practice Stephen also advises clients on UK and EU regulatory matters within that sector.

Susan Singleton is a solicitor with her own London firm, Singletons which specialises in intellectual property law, including trade marks and competition law and Internet law and general commercial law. Articled at Nabarro Nathanson, she joined Slaughter and May’s EC/Competition Law Department on qualifying in 1985, moving to Bristows in March 1988, where she remained until founding her own firm in 1994. Since then she had advised over 410 clients. According to the Chambers and Partners Legal Directory she is one of the UK’s leading IT Lawyers. In 2002 she acted for the claimant in the first damages action for breach of the EU competition rules to come before the English courts Arkin v Borchard and Others. Her clients range from major plcs and institutions to small start up businesses.

Sarah Turner is Of Counsel in the Intellectual Property Group of Lovells. She is based in London and is a member of the firm’s Life Sciences Team. Sarah advises on all aspects of intellectual property but specialises in patent litigation and the protection of confidential information. Sarah has a particular interest in the pharmaceutical and biotechnology sectors and has acted for companies in these sectors in large pan-European patent infringement and revocation actions.

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 an Associate 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.

Dr Gordon Wright is a Partner at Elkington and Fife LLP. Having worked over 20 years in the pharmaceutical industry, most recently as Head of Intellectual Property for Sanofi-Synthélabo in France, he handles mainly chemical and pharmaceutical subject matter. Gordon has an in-depth knowledge of IP topics specifically related to the pharmaceutical industry, including in particular supplementary protection certificates (SPCs), regulatory data exclusivity and often taking a key part in structuring the deal and drafting the agreements.

Past delegates’ comments

Some of the comments received by participants on this course:

“Overall calibre of speakers was very high”

Alex Moulson, Morphosys AG

“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

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Client portfolio

Our client portfolio for this course includes the following companies:

ABBOTT IRELAND LTD	Ebewe Pharma	MN Pharmaceaticals
ALK-Abelló AS	Fertin Pharma AS	Medochemie Ltd
AMT Bv	Fondazione Centro San Raffaele Del Monte Tabor	Merck Serono SA
ANGELINI FARMACEUTICA LDA	GPC Biotech AG	Molmed SpA
Actavis EAD	Genesis Pharma SA	Morphosys AG
Actelion Pharmaceutical Ltd	GenesisPharma SA	Mundipharma GmbH
Ajino Moto – Omnichem	GlaxoSmithKline	Novartis Pharma AG
Ajinomoto Omnichem_Omnichem Division	GlaxoSmithKline plc	NsGene AS
Almac Group Ltd	Helsinn Chemicals SA	Oxagen Ltd
AstraZeneca Czech Republic sro	Intercell AG	Penn Pharma
Bluepharma Industria Farmaceutica SA	Jerini AG	Pronova Biopharma AS
Britannia Pharmaceuticals Ltd	Kent Pharmaceuticals Ltd	Sandoz
CORPORACION MEDICHEM SL	LACER SA	Solvay Pharma
Crucell Holland BV	LFB	TRANSGENE
Dako Denmark AS	Laboratories Bouchara Recordati	Teva UK Ltd
Dexcel Pharma Ltd	Laboratorios Almirall SA	Transition Therapeutics
Dickinson Dees LLP	Leo Pharma AS	UCB Pharma SA