Commercial Contracts for the Pharmaceutical Industry

Author: Eustacia Smith
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28-30 November 2007 London



Commercial Contracts for the Pharmaceutical Industry A 3-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues.

Key learning points include

• New strategies and tactics to achieve a win:win situation in your negotiations every time • Key issues to be aware of when drafting horizontal and distribution agreements • Legal considerations when outsourcing clinical research • Exploiting the value of IP rights in licensing and collaboration • The new ‘Bolar provisions’ and the need for caution • Drafting techniques to avoid anti-trust infringement • Key challenges faced when drafting FTO’s licensing agreements, SPC’s • Parallel trade issues INCLUDES practical and interactive exercises in negotiation and drafting to illustrate tips, tactics and techniques to achieve your commercial goals

Substantial early booking discount available See booking form for details

Negotiating, Drafting and Understanding Commercial Contracts for the Pharmaceutical Industry 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.

‘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 contract process’

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

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

Commercial and contract managers

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 two modules; the first looks at negotiating skills and includes case studies and practical exercises. The second module focuses on the understanding and drafting of contracts and the expert presenters will familiarise participants with some of the latest legal developments and how they affect contracts in the pharmaceutical sector.

Business development managers

Purchasing and procurement

In-house counsel

Heads of legal departments

Legal advisors

Patent, IP, trademarks or licensing counsel

Who should attend?

The delivery style The key objectives of this seminar By attending this seminar, you will: •

GET-TO-GRIPS with the competitive nature of doing deals in the

pharmaceutical industry and the implications for negotiation •

LEARN how to prepare for effective negotiation

REVIEW the basics of contract formation

UNDERSTAND the key characteristics of the distribution relationship and how this impacts on contract drafting

EXPLORE the key terms of agreements for contract research

HEAR about the new regulatory requirements on contract

This highly interactive programme aims to deliver applied training through a balanced blend of practical learning. The presenters will use a mix of trainer input, a range of models and frameworks, practical exercises and business cases from the pharmaceutical sector to ensure you leave the programme with new skills and knowledge that can be put to use in the workplace straight away. Participation is limited to ensure interactivity.

manufacturing •

GRASP the impact of the new Bolar Provisions

LEARN how to draft contracts to avoid anti-trust infringement

FAMILIARISE yourself with some of the key terms of IP

licensing agreements •

FIND out what an SPC covers

GET up-to-date with latest developments in international privacy regulations

EXAMINE the latest in parallel trade issues

IN-HOUSE TRAINING Interested in this course for your whole project team? Please contact Caroline Glen on +44 (0)20 7729 6677 or email [email protected]

© 2007 Falconbury Ltd

Don’t forget our ‘Finance for Non-financial Managers in the Pharma Industry’ on 10-11 October 2007, London BOOK YOUR PLACE NOW! Call +44 (0)20 7729 6677 or email [email protected]


28-30 November 2007, London

DAY 1 Contract Negotiating Skills

DAY 2 Understanding and Drafting Contracts – Part I

Presented by Dr Fintan Walton, CEO, PharmaVentures Ltd






Introduction: Contracts – Avoiding the pain


Maintaining and exploiting the value of IP rights in licensing and collaboration deals


Registration and coffee


Welcome and introduction


What’s happening in deal making and its impact on negotiation

• • • •



Practical exercise: Successful negotiation



Preparing for negotiation (Illustrative interactive discussion) Explores what constitutes a good negotiating process in order to come to an agreement that will be effective over the long term, including: • Define the starting point • Establish the initial framework • Discover the vital clues that the early stages will provide • Understand how corporate strategy will affect your ability to negotiate




Negotiation planning • Analysis of win-win, win-lose and lose-lose scenarios • Determine personality types and their impact on the outcome • Learn the techniques of a good negotiator • Understand types of power and how to use them • Review the different negotiation styles • Conflicting management types and their application

Practical negotiation exercise Participants will be split into groups to practice a negotiation scenario under the guidance of the trainer 1715

Tim Worden, Associate, Taylor Wessing, Cambridge

Horizontal agreements and distribution agreements

Understanding the new Bolar Provisions and their effect on contracts

• Introduction to R&D agreements, co-promotion and co-marketing agreements • Scoping the deal – what the owner/licensor wants versus what the licensee/partner wants • Preparing for contingencies and termination • Key characteristics of the distribution relationship • Key terms – scope of rights and responsibilities, restrictions, minimum purchase requirements, territory

Delegates are asked to explore and illustrate with examples successful and unsuccessful negotiating experiences and to discuss their findings with the group 1245

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

Anna McKay, Intellectual Property Consultant

• Understanding the competitiveness for doing deals • Formulate a strategy for your product or technology • Fully review the components of a deal 1045

Formation of contracts Decide what you want Simplicity and clarity Governing law, disputes and choice of law

• 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: the need for caution

Gerry Kamstra, Partner, Bird & Bird, London

Sally Shorthose, Partner, Bird & Bird, London 1045



Agreements for contract research




Drafting to avoid anti-trust infringement • The Technology Transfer Block Exemption: Regulation 772/04 and guidelines explained • Analysing market shares of contracting parties • Analysing permissible and impermissible restrictions • Continuing review of agreements

• General legal considerations in clinical research outsourcing • Other background law • Preparation for outsourcing and contractual structure • Pre-contractual documentation • Key agreement terms

Francesca Boateng Muhammad, Solicitor, Stringer Saul, London

Jenny Pierce, Partner and Emanuela Lecchi, Partner and Head of Competition and Regulatory Group, Charles Rusell, London

Agreements for contract manufacturing/outsourcing • 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

Questions and discussion 1715

Close of day two

Allistair Booth, Partner, Stringer Saul, London

Questions and discussion

Close of day one

Book before 28 September and SAVE £200/€304 Please Call +44 (0) 20 7729 6677

Seminar speakers DAY 3 Understanding and Drafting Contracts – Part II 0900



Drafting FTO’s – ‘Freedom to Operate’ • Patents and patent term extensions, utility models and quas-patent term extensions • Managing the patent search • Evaluating your ‘Freedom to Operate’ • Scope of the pertinent 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’

Bert Oosting, Partner, Lovells, Amsterdam

Drafting IP licensing agreements – Some key licence terms: • Licence grant • Royalties • Warranties

• Improvements • Infringement • Termination

• Dispute resolution




SPC’s – Supplementary Protection Certificates SPC’s The duration of the SPC What does the SPC cover? Combination products Enantiomers

• Purified products • Actives and quasi-actives • Basic patents and basic and follow-on SPC’s • Strategies for SPC’s

Bert Oosting 1200

Questions and discussion




Dealing with data privacy/Data exclusivity and data protection • • • • • • •

Developments in international privacy regulation Personal data or anonymised information Data protection and personal data in contracts Due diligence – what are you looking for? Processor/controller agreements Licensing, transfer or sale of personal data Liabilities, remedies indemnities

Cerys Wyn Davies, Partner, Pinsent Masons, London 1500



Parallel trade issues • Art 28 EC Treaty • Free movement of goods and exhaustion of rights • Art 30 EC Treaty • Syfait v GSK • Goods intended for outside the EU • Parallel trade – the parallel trader’s perspective

Anna McKay

Questions and discussion 1630

Gerry Kamstra is a Partner at Bird & Bird in London. He is regularly named as a leading Life Sciences lawyer. He is particularly recognised as a specialist in IP and commercial agreements and in IP litigation for clients in the life sciences sector and is Joint Head of Bird & Bird’s International Life Sciences Group. Emanuela Lecchi is a partner and Head of the Competition and Regulatory Group with Charles Russell. Her experience is diverse, from mergers and joint ventures to behavioural investigations. She focuses particularly on the interface between competition and regulation, and between competition and IPRs. Anna McKay is a lawyer and former solicitor with many and varied interests. She has worked with people and ideas with IP as her focus for twenty years, most recently as Head of Intellectual Property Law at Roiter Zucker, solicitors. As a solicitor, Anna was listed as a leading practitioner for IP and life science work in all of the major legal and pharmaceutical directories. Francesca Boateng Muhammad is an Assistant Solicitor in the Commercial IP Department of Stringer Saul. She participates in business generation initiatives relating to Health Sciences, IP and IT.

Tim Worden

• • • • •

Allistair Booth is a Partner at Stringer Saul and has been part of their Life Sciences team for nearly 10 years. In that time he has advised clients in the health sciences industries on intellectual property matters, product development strategies, product life cycle management strategies, licence agreements, distribution agreements, R&D agreements, contract manufacture agreements and named patient supplies.

Close of course

OR Email [email protected]

Bert Oosting is a Partner in the Amsterdam office of Lovells and heads the Intellectual Property and Information Technology Group as well as the pharmaceutical group. His practice encompasses all areas of intellectual property and information technology, as well as pharmaceutical law. Jenny Pierce is a partner in the London office of Charles Russell Solicitors, her practice focuses on intellectual property (patents, designs, copyright, database right, trade marks) and confidential information, together with competition law and IT/Internet law. She edited and was a major contributor to ‘Working with technology’ by Sweet & Maxwell. Sally Shorthose is a Partner in the Intellectual Property/Life Sciences Group of Bird & Bird, based in London. Prior to joining Bird & Bird, Sally spent 11 years working in-house firstly as senior legal advisor at ICI/Zeneca and latterly as Legal Director of Novartis UK, where she was responsible for all legal matters for the Novartis Group within the UK. Fintan Walton Ph.D., Chairman, Chief Executive Officer and Founder, PharmaVentures, Oxford, UK. Dr Walton gained broad commercial experience whilst holding management positions at Bass and Celltech. He established PharmaVentures in 1997 in order to assist pharmaceutical and biotechnology companies worldwide in all aspects of deal making including strategic alliances, mergers and acquisitions and equity financing. Since then his company has worked with clients on a global basis, delivering more than 450 projects. Tim Worden is an Associate in the Intellectual Property Department of Taylor Wessing, his practice includes both noncontentious 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. Cerys Wyn Davies is a partner at law firm Pinsent Masons and specialises in Data Privacy, Data Protection and Intellectual Property Law. Cerys advises clients in many sectors including life sciences, pharma and healthcare. Cerys is a regular speaker on these topics and technology licensing.

Date and Venue The Charing Cross Thistle is situated in the very heart of the Capital, it is adjacent to Charing Cross station and within a short walk of Covent Garden, Trafalgar Square and the West End. Wireless Internet access is available in every area of the hotel.

28-30 November 2007 Charing Cross Thistle The Strand London WC2N 5HX Tel: +44 (0)870 333 9105

Timetable Registration is at 9am on the first day. The programme consists of 3 full days of training from 9am-5.15pm. The final day will start at 9am and finish at 4.30pm to allow extra time for travel home. Refreshment breaks and 1 hour for lunch will be scheduled each day. Participants are invited to stay for drinks at the end of day one.

Booking your place To reserve your space on this programme please send your booking to: Email

[email protected]



+44 (0)20 7729 6677


+44 (0)20 7729 6110


Falconbury Ltd, 10-12 Rivington Street London EC2A 3DU, UK

Past delegate comments from other Falconbury pharma industry programmes ‘Thanks for a great course’ Lars Siim Madsen, Head of Project Management, Neurosearch AS, Denmark

‘Good examples from the pharma industry’ Dr Gregor Fachinger, Assistant to CEO, Schering AG, Germany

‘The course was really excellent’ Dr Guiseppe Giardina, Deputy Chairman and CEO, Nikem Research, Italy

‘…the standard of presenters was excellent’ Brid Brady, Solicitor, IDA, Ireland

IN-HOUSE TRAINING Falconbury are aware that a public training programme may not be the solution to commercial and contract issues within your organisation. It may be more appropriate to involve only attendees from your organisation and tailor the programme to focus on the current challenges you face as a business.

Tailoring the programme to fit your needs We can deliver the ‘Negotiating, Understanding and Drafting Commercial Contracts for the Pharmaceutical Industry’ to you as an in-house tailored programme. In this format you will benefit from the intensive, practical and challenging programme that provides a solid grounding in the essential skills and techniques all legal and commercial managers need when dealing with pharma contracts. Also the programme will be developed to directly reflect your corporate culture and current business issues. The structure and the content of the programme can be modified to suit your logistical requirements as well as your training needs.

Extensive bank of exceptional trainers Falconbury has brought together our most motivated and forward-thinking trainers to deliver tailored in-house programmes developed specifically around the needs within your organisation. All our trainers have a practical commercial background and highly refined people skills. During the course of the programme they act as facilitator, trainer and mentor, adapting their style to ensure that each individual benefits equally from their knowledge to develop new skills.

Practical applied training Our trainers use a balanced blend of practical and theoretical learning. Participants always benefit from the opportunity to practice new skills and develop real competence in business management skills. A case study based on current challenges facing your organisation can be developed. This will enable the attendees to examine several solutions under the guidance of our expert trainers and then take these solutions back to the workplace for implementation. For more information please contact Caroline Glen on: +44 (0)20 7729 6677 or email: [email protected]

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For more than two delegates please photocopy this booking form Early Booking Discount: The full rate for the programme is £1399/€2129 + VAT, but book before 28 September 2007 and attend at the discounted rate of £1199/€1825 + VAT a saving of £200/€304.

IT IS IMPORTANT TO FILL OUT ALL THE INFORMATION BELOW First delegate details: £1399 + VAT = £1643.83 • €2129 + VAT = €2501.58 Early booking details: £1199 + VAT = £1408.83 • €1825 + VAT = €2144.38

+44 (0)20 7729 6677 +44 (0)20 7729 6110 [email protected] Falconbury Ltd., 10-12 Rivington Street London EC2A 3DU, UK

Date and location This training course will be held on:

28-30 November 2007 Charing Cross Thistle The Strand, London WC2N 5HX Tel: +44 (0)870 333 9105

Full Price Early booking


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Second delegate details – 10% saving: £1259.10 + VAT = £1479.44 €1916.10 + VAT = €2251.42 Second delegate details – 10% saving: £1079.10 + VAT = £1267.94 €1642.50 + VAT = €1929.94

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Payment can be made by credit card, by bank transfer (for bank account details please see payment details section of booking form) or by cheque made payable to Falconbury Ltd and posted to the address above. VAT no. 770008751. Any questions please contact Customer Services on +44 (0)20 7729 6677. ALL PAYMENTS MUST BE RECEIVED IN ADVANCE OF THE EVENT

Multiple booking discounts A multiple booking discount of 10% is available on the 2nd and subsequent delegates booked at the same time from the same organisation. This discount can apply to any online discount but, unless otherwise stated this may not be used in conjunction with any other offer.

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Accommodation is not included in the course fee but we are able to help you find accommodation in the area. An information sheet will be sent through with the booking confirmation.

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Always read the small print Cancellations and transfers Once we have received the booking form the places are confirmed. Any cancellations received 14 days or more before the date of the course will be charged a 10% administration fee. After that date the full course fee will be charged. Transfers can be made free of charge up to 14 days before the event (on payment of the difference on higher value courses). NB: A maximum of one transfer is allowed. After the transfer no cancellation can be accepted and the full course fee will be charged. Between 13-8 days before the event a 10% administration fee will be charged. 7 days or less before the event no transfers can be accepted. Substitute delegates may be named.

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Falconbury Ltd reserve the right to change the content and timing of the programme, the speakers and the date and venue due to reasons beyond their control. If in the unlikely event that the course is cancelled Falconbury will refund the full amount and disclaim any further liability.

Data protection The personal information provided by you on this form will be held on a database. Sometimes your details may be made available to external companies for marketing purposes. If you do not wish your details to be used for this purpose please write to: The Database Manager, Falconbury Ltd, 10-12 Rivington Street, London EC2A 3DY, UK.

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If you have any queries about registration or payment please do not hesitate to contact our customer services department on +44 (0)20 7729 6677. Falconbury registered address: Acre House, 11-15 Williams Road, London, NW1 3ER. Company No. 3937398

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