Commercial Contracts for the Pharmaceutical Industry

Transcription

1 In association with 17.5 THIS COURSE QUALIFIES FOR CPD HOURS BOOK BEFORE 4 September 2017 and SAVE 300/ 420! Suitable CPD hours for those drafting commercial contracts Negotiating, Understanding and Drafting Commercial Contracts for the Pharmaceutical Industry November June 2018 London Focus on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors This programme will: Review IP terms in collaboration and licensing to ensure you are protected Update you on R&D infringements and third party rights to ensure you apply current best practice Distil the knowledge of legal experts from private practice and industry to ensure you are applying best practice from across the sector Detail how to use regulatory processes to define contractual obligations and remain compliant Describe which restrictions and clauses are permissible under EU competition law Evaluate the key challenges in clinical trials, contract manufacturing and co-promotion Examine the use of SPC s to ensure your product can realise it s full commercial potential PLUS: Drafting workshops on collaboration and licensing, and competition law issues INCLUDES: Practical and interactive exercises in negotiation and drafting to illustrate tips, tactics and techniques to achieve your commercial goals It s a great course very recommendable for in-house lawyers Patricia Campistol, In-house Lawyer, Corporacion Medichem SL The course was excellent, very useful and well organised Borislav Dakic, Hemofarm AD The course was very helpful to understand the process of the pharmaceutical industry Hannah Lee, Celltrion Inc.

2 Negotiating, Understanding and Drafting Commercial Contracts for the Pharmaceutical Industry November June 2018, London Why should you attend? 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 inhouse 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. The programme consists of five modules which will: 1 Deliver an in-depth examination of intellectual property issues that affect pharmaceutical industry 2 Focus on competition regulations pertinent to pharmaceutical industry 3 Analyse the commercial and legal issues affecting pharmaceutical industry 4 Examine collaboration and licensing 5 Feature an in-depth workshop on effective negotiation skills 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. The key objectives of this seminar By attending this seminar, you will: Understand the key intellectual property issues affecting pharmaceutical industry Find out about the implications of SPCs for pharmaceutical industry Learn how to draft contracts to avoid anti-trust infringement Familiarise yourself with the key commercial and legal issues that affect pharmaceutical industry Gain knowledge of the key issues in clinical trial, contract manufacturing and co-promotion, co-marketing and distribution 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 Dates and venue November June 2018 The Rembrandt Hotel 11 Thurloe Place London SW7 2RS Tel: +44 (0) Web: The Rembrandt Hotel is directly across from London s Victoria and Albert Museum (V&A), within a 10 minute walk of the Natural History Museum, Science Museum, Hyde Park, Harrods and the Royal Albert Hall. The location is superb surrounded by restaurants, bars, shops and cultural attractions. The venue s beautifully modernised Edwardian rooms were originally apartments for Harrods. You can stroll to South Kensington underground station in five minutes. From here, District, Circle and Piccadilly Tube lines take you straight to the City of London, Heathrow Airport and mainline train stations including Paddington and Victoria. Accommodation We have arranged a preferential rate for accommodation at this venue. To take advantage of this please contact: reservations_rembrandt@sarova.com and state you are a Falconbury delegate. There are limited rooms available at this rate so please book early to avoid disappointment. For information on alternative accommodation solutions please visit our website: falconbury.co.uk/accommodation THIS COURSE QUALIFIES FOR CPD HOURS Continuing professional development This course is accredited for 17.5 CPD hours. After successfully completing the course you will receive a certificate stating the amount of hours and type of training you have completed. Timetable Registration is at 9am on day one. The programme consists of three full days of training. The final day will start at 9.30am and finish at 4.30pm to allow extra time for travel home. Two refreshment breaks and one hour for lunch will be scheduled each day Falconbury Ltd 3 easy ways to book

3 The programme Day one MODULE 1: Intellectual Property Issues Affecting Pharmaceutical Industry Agreements Chair: Susan Singleton, Solicitor, Principal, Singletons 0900 Registration and refreshments 0930 Introduction from the chair PRACTICAL WORKSHOP 0935 Intellectual property terms in collaboration and licensing Ownership of internally and externally generated IP Joint ownership issues Outsourcing issues Improvements and grant backs Sample clauses Tim Worden, Partner, Taylor Wessing and Clive Douglas, General Counsel, European Licensing & Transactions, Teva Pharmaceuticals 1100 Refreshments 1115 SPC s Supplementary Protection Certificates Securing the full commercial potential of your product What are SPC s? What are the implications for pharmaceutical industry The duration of the SPC What does the SPC cover? Combination products Basic patents and basic follow-on SPC s Leveraging the full commercial value of your property Chris Milton, Partner, J A Kemp 1200 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) Directive 2001/83/EC explained The varying scope of the defence across the EU and proposed harmonisation of the UK defence Dr Sean Jauss, Solicitor and Head of Legal, Mewburn Ellis LLP 1245 Lunch 1345 Third party IP rights Freedom to Operate searches and implications for pharmaceutical industry Evaluating your freedom to operate Different approaches to infringement in Europe Assessment of injunction risk Mitigating risk and pre-launch patent strategies more generally Strategies for obtaining freedom to operate including via licensing Freedom to operate warranties and indemnities Payments and royalty stacking Enforcement against infringers No challenge clauses Benefits of recording your licence Lydia Torne, Managing Associate and Ben Thomas, Supervising Associate, Simmons & Simmons LLP 1445 Refreshments MODULE 2: Commercial and Legal Issues Affecting Pharmaceutical Industry Agreements 1500 Key issues in contract manufacturing The importance of the GMP audit Issues with technology transfer Apportionment of risk and reward Secondary sources of supply Building a supply chain The impact of the new regulatory requirements on contract manufacturing Other key issues Robin Blaney, Partner, Covington & Burling LLP 1545 Key issues in co-promotion, co-marketing and distribution Introduction to the 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 Stephen Reese, Partner, Clifford Chance 1645 The EMA as a regulator for the pharmaceutical industry EMA s role and missions Juxtaposition with other regulatory bodies Partners and network The requirements of the EMA for the pharmaceutical industry The interaction between the European Commission and the EMA Dr John Warren, Director, Medicines Assessment Ltd 1730 Close of day one Day two 0900 Refreshments 0930 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 Catherine Drew, Partner, Pinsent Masons 1030 Refreshments 1045 Key issues in clinical trials and related Outline of principal EU legislation Structuring clinical trial Engaging CROs Key agreement terms and obligations Liability and indemnities Laura Anderson, Partner, Bristows MODULE 3: Workshop on Collaboration and R&D Agreements 1145 Negotiating and drafting collaboration and licence Using a case scenario participants will discuss issues relating to the negotiation and execution of a R&D collaboration, including: The role of the term sheet The interplay of key commercial terms, including: governance and dispute resolution performance obligations and termination rights financial terms Boilerplate clauses, including law and jurisdiction Lucinda Osborne, Partner, and Daniel Pavin, Partner, Covington & Burling LLP 1315 Lunch falconbury.co.uk bookings@falconbury.co.uk +44 (0)

4 MODULE 4: Competition Law Workshop 1415 Introduction to relevant EU competition law rules Article 101 TFEU (formerly Article 81 EC) and 102 TFEU: restrictive 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 Tim Frazer, Partner, Arnold & Porter Kaye Scholar LLP 1530 Refreshments PRACTICAL WORKSHOP 1545 Current competition law issues Reduced and exclusive distribution Licensing in and out the new technology transfer exemption Quota schemes and other devices for protecting domestic needs Discount schemes for dominant companies Tim Frazer, Partner, Arnold & Porter Kaye Scholar LLP 1700 Close of day two Day three MODULE 5: Negotiation Skills in the Pharma Sector Workshop leader: Rob Maguire 0900 Refreshments 0930 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 AND REFRESHMENTS 1015 Negotiate and succeed 1245 Lunch 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 1400 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 1500 Refreshments PRACTICAL EXERCISE 1515 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 1630 Close of seminar the standard of presenters was excellent Brid Brady, Solicitor, IDA I learnt a great deal about new areas and potential strategies to deal with these. The case studies were well thought out Dr Paul Madeley, Managing Director, Synth-Isis Ltd The course was really excellent Dr Guiseppe Giardina, Deputy Chairman and CEO Nikem Research Enjoyable and informative Mike Isaacson, Company Lawyer, Dexcel Pharma Ltd Falconbury In-house training Coming to Falconbury for your in-house training will provide an all-inclusive service which gives you access to a wide variety of content, learning platforms and delivery mechanisms as well as your own personal training adviser who will work with you from the initial enquiry through to feedback and follow-up after the programme. With over 600 trainers, all practitioners and experts across a huge range of fields, we can provide the training you need, where you need it, when you need it, and at a price which suits your budget. Our approach to tailored learning and development consists of designing and delivering the appropriate solution for each client. To find out more please contact Customer Services on +44 (0) or inhouse@falconbury.co.uk

5 Chair Susan Singleton is a solicitor with her own London firm, Singletons, which specialises in intellectual property law, including trade marks and competition 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. Speaking faculty Laura Anderson is a partner at Bristows in London. Since joining Bristows 16 years ago, Laura has specialised in commercial IP matters. She has considerable experience of commercial arrangements relating to the development and exploitation of all kinds of intellectual property rights across several industry sectors. In the life sciences sector, Laura advises on collaborations and licensing deals as well as downstream arrangements relating to clinical trials, manufacturing, marketing and supply. Robin Blaney is a partner in Covington & Burling s Life Sciences practice, advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial that span the product lifecycle in the life sciences sector. His expertise includes clinical trial, manufacturing and supply, distribution and other marketing, regulatory services, and tenders. He has particular experience structuring and documenting EU pharmaceutical distribution arrangements and transitional arrangements relating to product acquisitions. Clive Douglas is General Counsel, European Licensing & Transactions for Teva Pharmaceuticals. Clive drafts, negotiates and advises on a wide range of commercial and IP matters, including collaboration, licensing, supply, development, manufacturing and other commercial. Catherine Drew is a partner at Pinsent Masons. She advises on all aspects within and on the border of the life sciences and healthcare sector. Catherine assists on both contentious and non-contentious matters, in particular advising on patent litigation and regulatory matters, whether in the life sciences sector or other related fields, on a multi-jurisdictional basis and has experience in conducting patent litigation before all courts in the UK. Catherine has also spent time working in-house at one of the world s largest pharmaceutical companies, with responsibility for coordinating all patent litigation in Europe. She has also advised on regulatory issues arising in relation to borderline products and in related fields, including consideration of the UK and European regulation of such products and compliance with the relevant advertising codes of practice. With her expertise Catherine is able to provide a complete picture assisting clients in negotiating the various intellectual property and regulatory hurdles to bringing a regulated product such as a medicine to market in Europe. Tim Frazer is a partner at Arnold & Porter Kay Scholar 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 Sean Jauss is a qualified solicitor and Head of the Legal Team at Mewburn Ellis LLP. Sean advises his clients on technology transfer and the exploitation of intellectual property. This includes advising on strategy, conducting due diligence and preparing and negotiating transactional (often in the context of corporate transactions). He also advises on life science/pharma regulatory issues. With a PhD in Microbiology and his experience establishing the technology transfer office at the London School of Tropical Medicine, Sean has a particular focus in the life science, clean technology and defence/ engineering sectors. 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 approach to their commercial relationships. Chris Milton is a partner at J A Kemp. He has experience of patent work in all aspects of chemistry, including pharmaceuticals, drug formulations, polymers and catalysts. He has particular expertise in the field of respiratory medicine. Chris works with a variety of clients, from universities and start-up companies to large multi-national corporations. He handles drafting of new patent applications, particularly in the pharmaceutical and polymer fields, and subsequent prosecution of patent applications at the United Kingdom Intellectual Property Office and the European Patent Office (EPO). Chris also has considerable experience of filing and prosecuting patent applications throughout the rest of the world, and consequently in advising clients in relation to the management of their patent portfolios. He has experience of EPO opposition and appeal work, including both defending and opposing patents in the pharmaceutical field, and has attended oral proceedings at Opposition Division and Board of Appeal levels. Chris has also been involved in advising on freedom to operate and due diligence matters. 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 outlicensing activities, joint ventures, and collaborations and other strategic transactions, as well as the full range of commercial 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, and on the IP aspects of mergers, acquisitions and strategic investments in the life sciences and technology sectors. Stephen Reese is a partner at Clifford Chance and advises clients on both contentious and noncontentious intellectual property matters including patents, trade marks, trade secrets and copyright. Stephen represents and advises a broad range of clients in relation to the protection, exploitation and enforcement of their intellectual property rights. With significant experience representing clients within the life sciences and technology fields, Stephen has acted on some of the most significant licensing transactions in the life sciences industry. Since 2010, Stephen has been listed as one of IAM s Top 250 Patent Licensing specialists. Ben Thomas is a Supervising Associate at Simmons & Simmons. He has experience of working across a range of contentious and non-contentious intellectual property matters, with a focus on patent and supplementary protection certificate litigation. Assisted by his strong technical background in biochemistry, Ben has a particular interest in the life sciences sector. He has acted for clients in a wide variety of industries, including pharmaceuticals, vaccines and medical devices, TMT and consumer goods (e.g. laundry detergents, vaping devices). He has acted for clients in disputes before the English Patents Court, the UK and European Union Intellectual Property Offices, and the General Court and Court of Justice of the European Union. Lydia Torne is Managing Associate at Simmons & Simmons and has been involved on a range of contentious and non-contentious intellectual property matters, with a particular focus on transactional IP, in the life sciences sector. Lydia regularly advises on a range of contractual issues including commercial licensing arrangements, research and development, consortium, material transfer, manufacturing and distribution, clinical trial, monetisations and IP aspects of corporate transactions and financings. She also advises on life sciences regulatory issues including the promotion of medicines and devices, borderline product classification and interactions with healthcare professionals. John Warren is a clinical scientist who established Medicines Assessment Ltd as a pharmaceutical consultancy in He advises multiple pharmaceutical companies on their clinical development programmes, including non-executive director advice to the biotech and pharma industry. Previously he worked for the UK Medicines Healthcare products Regulatory Agency (MHRA) as an Expert Medical Assessor from evaluating new drug applications for the UK and Europe across the therapeutic spectrum. He was a member of the European Scientific Advice Working Party and the European Pharmacokinetic Subgroup of the Efficacy Working Party 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. falconbury.co.uk bookings@falconbury.co.uk +44 (0)

6 To book online go to: falconbury.co.uk/234 Book before 4 September 2017 and SAVE 300/ 420! Negotiating, Understanding and Drafting Commercial Contracts for the Pharmaceutical Industry Dates and venue November 2017 Ref: June 2018 Ref: The Rembrandt Hotel 11 Thurloe Place London SW7 2RS Tel: +44 (0) Web: Accommodation We have arranged a preferential rate for accommodation at this venue. To take advantage of this please contact: reservations_rembrandt@sarova.com and quote FALCON. There are limited rooms available at this rate so please book early. For alternative accommodation solutions please visit our website: falconbury.co.uk/accommodation Three ways to book falconbury.co.uk bookings@falconbury.co.uk +44 (0) Fees and payment EARLY BOOKING DISCOUNT Book BEFORE 4 September VAT = VAT = FULL PRICE Book AFTER 4 September VAT = VAT = Multiple booking discount for 2nd or subsequent delegates 15% VAT = VAT = Falconbury In-house training Coming to Falconbury for your in-house training provides an all-inclusive service which gives you access to a wide variety of content, learning platforms and delivery mechanisms as well as your own personal training adviser who will work with you from the initial enquiry through to feedback and follow-up after the programme. With over 600 trainers, all practitioners and experts across a huge range of fields, we can provide the training you need, where you need it, when you need it, and at Payment options 1. Invoice which can be paid by BACS (for bank account details please see the section in The Small Print below) or by credit card to Falconbury Ltd. 2. Online through our secure website when registering. a price which suits your budget. Our approach to tailored learning and development consists of designing and delivering the appropriate solution for each client. To get a FREE consultation and to find out how we can work with you call Customer Services on +44 (0) or inhouse@falconbury.co.uk To find out more please visit: falconbury.co.uk Falconbury registered address: Rivington Street, London EC2A 3DU. Company No The Small Print FEE: The fee includes all meals and refreshments for the duration of the course and a complete set of course materials. If you have any particular requirements please advise customer services when booking. HOW TO REGISTER AND PAY: A VAT invoice and booking confirmation will be sent within 7 days, please contact us if you have not heard anything after that time. Payment can be made by credit card or by bank transfer (for bank account details please see bank account details section). VAT no Any questions please contact Customer Services on +44 (0) ALL PAYMENTS MUST BE RECEIVED IN ADVANCE OF THE EVENT. VAT RECLAIM INTERNATIONAL DELEGATES: If you are attending the course from outside the UK you can reclaim the VAT payable through HM Customs and Excise please visit their website at for a downloadable form or contact our customer services on info@falconbury.co.uk for more information. MULTIPLE BOOKING DISCOUNTS: This discount may not be used in conjunction with any other offer. CANCELLATIONS AND TRANSFER: Once we have received your booking the place(s) are confirmed. Delegate Up to 28 days before course 27 to 14 days before course 13 to 0 days before course Cancellation 10% admin fee 100% admin fee 100% admin fee Transfers Free 10% admin fee 100% admin fee Substitution Free Free Free A maximum of one transfer is allowed. After the transfer no cancellation can be accepted and the full invoiced fee will be charged. Transfers are subject to payment of the difference on higher value courses. All cancellations must be received in written form. PLEASE NOTE: Falconbury Ltd reserve the right to change the content and timing of the programme, the speakers, 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 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 info@falconbury.co.uk NATWEST BANK ACCOUNT DETAILS: STERLING ACCOUNT DETAILS: Account Number: Sort Code: VAT NUMBER: IBAN: GB81NWBK SWIFT: NWBKGB2L EURO ACCOUNT DETAILS: Account Number: IBAN: GB78NWBK SWIFT: NWBKGB2L 7271