Drafting Commercial Contracts for the Pharmaceutical Industry

In such a highly regulated industry, 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 well 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 and 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 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 consists of FIVE modules which:

1 Will deliver an in-depth examination of intellectual property issues that affect pharmaceutical industry agreements
2 Will focus on competition regulations pertinent to pharmaceutical industry agreements
3 Will analyse the commercial and legal issues affecting pharmaceutical industry agreements
4 Will examine collaboration and licensing agreements
5 Features an in-depth workshop on effective negotiation skills

The key objectives of this seminar

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
• 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 your practical skills when drafting effective collaboration agreements

Who should attend?

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

The delivery style

This unique 3-day highly interactive programme looks at all the stages of the contracting process and aims to deliver applied training through a balanced blend of practical learning. The presenters will use a mixture of practical exercises and cases from the pharmaceutical industry to ensure you leave the programme with the knowledge and skills to perfect all stages of the process.

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
• Sample clauses

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 experimental use and Bolar provisions

• Limitations of experimental use defence to patent infringement
• The ‘Euro Bolar’ defence: Article 10(6) of Directive 2001/83/EC explained
• The varying scope of the defence across the EU and proposed harmonisation of the UK defence

Third party IP rights – ‘Freedom to Operate’ searches and implications for pharmaceutical 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 rules

• Article 101 TFEU (formerly Article 81 EC) and 102 TFEU: restrictive agreements and practices and abuse of dominance in pharmaceutical markets
• The December 2010 Horizontal Cooperation Guidelines
• The Jan 2011 R&D Block Exemption – strategy for early joint research
• The Technology Transfer Block Exemption – do’s and don’ts for licensing in and out
• The Vertical Agreements Block Exemption and Vertical Restraints Guidelines – designing distribution models in the EU
• Specialisation Agreements Block Exemption

Practical Workshop

Current competition law issues

• Reduced and exclusive distribution agreements
• Licensing in and out
• Quota schemes and other devices for protecting domestic needs
• Discount schemes for dominant companies

MODULE 3: COMMERCIAL AND LEGAL ISSUES AFFECTING PHARMACEUTICAL INDUSTRY AGREEMENTS

Using regulatory processes to define contractual obligations

• An introduction to regulatory law
• Brief contrast of the differing regimes: ATMP/medicines/devices
• Milestones in approving a drug or device
• Common pitfalls and due diligence hot spots
• Using regulatory processes to define contractual obligations

Key issues in clinical trials and related agreements

• Pre-contractual documentation
• Key agreement terms
• General legal consideration in clinical research outsourcing
• Dealing with privacy and data exclusivity issues
• 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

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

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. The keys 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

Chair

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. A substantial amount of her work is for the pharmaceutical industry including advice on and litigation relating to parallel imports, competition and IP law, compliance and related matters. She sits on the EC Laws Committee, which she used to chair, of the Licensing Executives Society and she is Vice Chairman of the Competition Law Association. Since founding her firm she has advised over 750 clients in the UK and abroad. 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.

Speaking 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.

Robin Blaney is an associate in the London Life Sciences practice of Covington & Burling LLP. He has broad experience in the life sciences sector including involvement in corporate, commercial, litigation, data privacy, and regulatory matters. He has gained particular experience in licensing, collaborative, and commercial transactions for life sciences clients. His regulatory practice includes pharmaceutical, medical device, food, and consumer product regulation.

Clive Douglas is General Counsel, European Licensing & Transactions for Teva Pharmaceuticals Europe BV, the Teva group’s European parent company. Clive works on a wide range of commercial and IP matters, including European licensing and supply, development, contract manufacturing, distribution and other commercial agreements, clinical trial agreements, disputes and litigation, patent settlement agreements and provides advice on commercial, regulatory and competition law issues.

Tim Frazer is a partner at Arnold & Porter LLP. He has over 25 years experience in competition and antitrust law. He has obtained merger clearance at the European Commission (EC) and national competition authorities for complex cases requiring econometric evidence and Phase 1 disposals, such as Kraft Foods’ hostile bid for Cadbury’s plc and Kraft Foods/Danone. His practice includes advising leading pharmaceutical companies on parallel trade, abuse, and other conduct issues, and on State aids.

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.

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 and mentoring and skills development interactions, he helps major organisations transform their approach to their commercial relationships.

Gareth Morgan is a partner at Winston & Strawn’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. He has represented firms on the UK Bioindustry Association’s intellectual property advisory committee (IPAC). He is currently a member of the European Union of IP Practitioners’ Biotechnology Commission.

Marjan Noor is a partner in the London office of Simmons & Simmons. Recommended as one of the UK’s leading patent litigators and regulatory specialists, Chambers 2009 and 2010 comment that she “specialises in patent and regulatory law, particularly in the life sciences sector, is ‘someone who knows how to deal with issues in the right way’”, Marjan graduated in 1991 with a degree in Pharmacology (having completed the preclinical years of a degree in Medicine) before going onto study law.

Lucinda Osborne is a partner at Covington & Burling LLP. She is a member of the firm’s corporate and intellectual property practice groups and concentrates on transactional matters for pharmaceutical and biotech clients. She regularly advises clients in connection with their in and out-licensing activities, joint ventures, and collaborations and other strategic transactions, as well as the full range of commercial agreements that span the product life-cycle in the life sciences sector. She has particular experience structuring and documenting global collaborations to reflect market practices and requirements in the United States.

Daniel Pavin is a partner in the Corporate Practice of Covington & Burling LLP’s London office. He has broad non-contentious and contentious experience, with an emphasis on advising companies for whom intellectual property rights are of paramount importance. In particular, Daniel advises life sciences clients on their licensing, partnering, collaboration and other strategic and commercial agreements, and on the IP aspects of mergers, acquisitions and strategic investments in the life sciences and technology sectors.

Stephen Reese is a partner at Olswang where he advises clients on both contentious and noncontentious intellectual property matters including patents, trade marks, trade secrets and copyright. He has significant experience representing those clients within the life sciences sector and he 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 a 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.

Finance for Non-financial Managers in the Pharma Industry

The Pharma 'Business Masters'

The 'Mini-MBA' for Pharma and Biotech Industry

Understanding the Pharmaceutical Industry

Pharmaceutical Law Update

This course qualifies for the following CPD programmes:

• Solicitors Regulation Authority: 17.50 hours

• Almac Group
• AMT BV
• Angelini Farmaceutica
• Ark Therapeutics Ltd
• AstraZeneca Farmaceutica Spain, ss
• Bluepharma Industria Farmaceutica SA
• British American Tobacco
• Corporación Medichem, SL
• Dako Denmark AS
• Debiopharm SA
• Dr Reddys
• Eli Lilly Italia Spa
• Fondazione Centro San Raffaele Del Monte Tabor
• Friesland Consumer Products
• Genesis Pharma SA
• Ginsana SA
• Jerini AG
• K2 Events
• Laboratories Bouchara Recordati
• Medochemie Ltd
• MN Pharmaceuticals
• Novo Nordisk
• Oxagen Ltd
• Pfizer Ireland
• Pronova Biopharma AS
• Recipharm AB (publ)
• Seven Seas Ltd
• Synth-Isis Ltd
• Veloxis Pharmaceuticals AS
• Vetter Pharma-Fertigung GmbH & Co KG

“‘… presentations were interesting and useful’”

Olesia Smilianets, Manager, Farmak Joint Stock Company