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Drafting Commercial Contracts for the Pharmaceutical Industry Training Course

A three-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.

23-25 Nov 2022

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Details

Course overview

In such a highly regulated industry and in these turbulent and uncertain times, understanding the key challenges of negotiation and drafting an effective and watertight contract on an international level are complex topics. 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, especially with the complication of Brexit.

The programme consists of five modules which will:
  • Deliver an in-depth examination of intellectual property issues that affect pharmaceutical industry agreements
  • Focus on competition regulations pertinent to pharmaceutical industry agreements
  • Analyse the commercial and legal issues affecting pharmaceutical industry agreements
  • Examine collaboration and licensing agreements
  • Feature an in-depth workshop on effective negotiation skills

The delivery style
This unique and highly interactive three-day programme looks at all 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 seminar with the knowledge and skills to perfect all stages of the process.

Who should attend?

Personnel 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 advisers
  • Patent, IP, trade marks or licensing counsel

The key objectives

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
  • Explore the current issues relating to IP including the Unified Patent Court and the challenges of Brexit
  • 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 your practical skills when drafting effective collaboration agreements
  • Get to grips with the competitive nature of doing deals in the pharmaceutical industry and the tactics for effective and successful negotiation

Programme

Practical workshop: 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

The Unitary Patent, the Unified Patent Court and Brexit

  • What are the Unitary Patent and the Unified Patent Court?
  • What are the implications for pharmaceutical industry agreements?
  • The impact of Brexit

When does R&D infringe patents? Understanding 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 ‘Euro Bolar’ defence across the EU and how it has been implemented in UK law

Supplementary protection certificates (SPCs) – securing the full commercial potential of your product

  • What are SPCs?
  • What are the implications for pharmaceutical industry agreements?
  • The duration of the SPC
  • What does the SPC cover?
  • Combination products
  • Basic patents and basic follow-on SPCs
  • Leveraging the full commercial value of your property

Third-party IP rights – freedom-to-operate searches and implications for pharmaceutical industry agreements

  • 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

Key issues in contract manufacturing agreements

  • The importance of the GMP audit
  • Issues with technology transfer
  • Apportionment of risk and reward
  • Secondary sources of supply
  • Building a supply chain
  • 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

Medicines regulations using regulatory processes to define contractual obligations

  • An introduction to regulatory law
  • Brief contrast of differing regulatory regimes: medicines/ devices
  • Milestones in approving medicines
  • Using regulatory processes and milestones in defining contractual obligations
  • Common pitfalls and hot spots

Key issues in clinical trials and related agreements

  • Outline of principal EU legislation
  • Structuring clinical trial agreements
  • Engaging CROs
  • Key agreement terms and obligations
  • Liability and indemnities

Workshop: Negotiating and drafting collaboration and licence agreements

Using a case scenario, participants will discuss issues relating to the negotiation and execution of a R&D collaboration, including:

  • Precontractual documents and the role of the term sheet
  • Scope of the licence
  • The interplay of key commercial terms, including:
    • governance and dispute resolution
    • performance obligations and termination rights
    • financial terms
  • Boilerplate clauses, including law and jurisdiction

Introduction to relevant EU competition law rules

  • Article 101 TFEU 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 – dos 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
  • Implications of Brexit

Practical workshop: Current competition law issues

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

Key principles of effective negotiation

Today to effective executive must be able to negotiate and lead others through the negotiation process.

  • The importance of negotiation
  • Key principles of good negotiation
  • Technical and commercial skills
  • Examples of current issues from participants situations

Practical exercise: Negotiate and succeed & Structure for control

Working in teams, delegates are asked to resolve a multi-variable, multi-party business problem.

Structure for control

The party that negotiates best gets the best results. 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 fallback style)
  • The PIN code to unlocking negotiating styles
  • Personal strengths and weaknesses

Practical exercise: Moving into engagement & Influencing and persuasion

Delegates are asked to use their knowledge of their own style and those of others in their teams to agree strategies and tips.

Influencing and persuasion

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.

  • Structuring and starting your negotiation
  • Influence techniques and how to use them
  • Focusing your persuasion on key objectives

Effective negotiation – planning and theory

Success in negotiation is based on doing the right kind of preparation and planning. This session looks at a case example to develop best practise forward thinking.

  • How to plan and structure your negotiation
  • Win-win and win-perceived win forms of negotiation
  • Push and pull styles of persuasion; the five modes
  • Case study: Planning for a customer negotiation around contract and project issues

Effective negotiation – practice and reality

A simple practise session to look at some of the different negotiation behaviours and skills in action.

  • How to plan and structure your negotiations
  • Behavioural skills in negotiation
  • The most made negotiation errors
  • Case study: Role-play of above situation
  • Negotiation best-practice checklist and summary

Action plan and learning summary

  • Presentation of learning summary and action points from the training

Presenters

Niels Ersbøll (More...)

Niels Ersbøll, Partner, Arnold & Porter LLP, advises clients on EU competition law in relation to cartels and restrictive practices, merger control, abuse of dominance and State aid. He is currently involved in several pending EU cartel investigations. He advises on merger control investigations by the European Commission and competition authorities worldwide for clients such as General Electric, Boston Scientific, Pfizer, and Sanyo. Where investigations (mergers or cartels) are run by several authorities in parallel, he assists with overall strategy and coordination. Niels also has significant experience helping clients with designing and implementing compliance measures and conducting internal investigations and audits.

Sean Constable (More...)

Sean Constable is an associate in the life sciences group at Mewburn Ellis LLP and is a European and Chartered Patent Attorney based in London. His work focusses on patent prosecution before the European Patent Office (EPO) and he has experience of both offensive and defensive opposition proceedings. He has experience filing and prosecuting patent applications on a broad variety of different technologies, with particular expertise in gene editing, protein engineering and antibody-based therapeutics. Sean also has experience working in-house at a biotechnology company in Cambridge, having been seconded there during his training and where he assisted the company with their patent portfolio and due diligence. He has a bachelor’s degree in Biochemistry from Imperial College London and a PhD in Neuroscience from University College London.

Winsome Cheung (More...)

Winsome Cheung is an associate at Covington & Burling LLP assisting clients in the life sciences sector on their strategic transactions and investments, and intellectual property and commercial matters relating to the discovery, development, and commercialisation of their products. Winsome has a particular focus on the structuring, drafting, and negotiation of collaboration, co-development, license, and other complex strategic agreements, as well as manufacturing, clinical trial, and other agreements fundamental to the day-to-day running of life sciences businesses. She also advises on intellectual property and commercial aspects of M&A transactions and venture capital investments.

Daniel Pavin (More...)

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 (More...)

Stephen Reese is a partner at Clifford Chance and advises clients on both contentious and non-contentious 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.

Mario Subramaniam (More...)

Mario Subramaniam is a Legal Director in the Life Sciences Transactions team at Pinsent Masons. As a former research scientist, he has a passion for the life sciences and has expertise in advising clients on intellectual property, commercial and regulatory aspects of the pharma, biotech, medtech and digital health sectors. He has advised on agreements that span the product life cycle, including strategic licensing and research collaboration arrangements, clinical trials, manufacturing, supply and distribution agreements. Having previously been in-house counsel at a number of prominent life science companies, Mario has a deep understanding of clients’ needs in this sector and is renowned for his clear and practical advice.

Ben Thomas (More...)

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.

James Agnew (More...)

James Agnew is a supervising associate at Simmons & Simmons. He has worked on a range of contentious and non-contentious intellectual property matters including commercial licensing, collaboration agreements, software protection, settlement proceedings and the intellectual property aspects of corporate transactions, financings and commercial arrangements. James also advises on life sciences regulatory issues including the promotion of medicines and devices and interactions with healthcare professionals. He has experience in a wide range of industries, including life sciences, TMT, finance, Fintech, energy and defence, with a focus on transactions involving intellectual property.

Tom Carver (More...)

Tom Carver is a partner at White & Black Legal. He has broad experience in patent litigation (infringement and validity) in pharmaceuticals, medical and mechanical devices and electronics, including advice concerning threats provisions. Tom co-ordinates and manages litigation in multiple jurisdictions, and has particular expertise in biotech patent litigation. Tom has a degree in genetics and worked on the first patent case in the UK relating to genetically modified organisms, Monsanto v Cargill, and the first patent case in the UK on DNA sequences, Eli Lilly v Human Genome Sciences. He has been involved in some of the most significant patent cases in the UK in recent years. Tom lived in China for three years, where he managed intellectual property enforcement for Western clients, including Dyson. His experience includes patent (design, utility and invention), trade secret, trade mark and copyright litigation against companies in provinces across China in sectors including capital and consumer goods, cosmetics and medical devices. He also has experience of non-judicial IPR enforcement in China at trade fairs, online and by Customs seizures.

Graham Roberts-Phelps (More...)

Graham Robert-Phelps is an international trainer and consultant, specialising in sales management. He shares his ideas and insights with thousands of people and organisations every year in all parts of the world. With an extensive background in management and business development, Graham works with organisations of many different types and sizes.




Ellen Lambrix (More...)

Ellen is a senior associate in the Bristows Commercial IP team. Ellen has a broad IP experience and specialises in advising clients on non-contentious IP matters with a focus on transactions which involve the development, exploitation and transfer of IP rights. She advises clients across a range of sectors including life sciences and consumer products and her clients range from large multinational companies, start-ups and growing companies to spin outs and research organisations.

Ellen frequently advises on high value research and development collaborations and licensing and option deals. She also advises on a range of other commercial agreements including franchising agreements and manufacturing and supply arrangements. Ellen also supports our IP litigation practice by advising on settlement agreements, and supports our corporate and financing teams advising on IP issues arising in the context of corporate transactions.

Claire Smith (More...)

Claire is a partner at Bristows specialising in commercial and intellectual property transactions, most notably in the life sciences and technology sectors. She advises on a wide range of commercial arrangements (the large majority of which are cross-border) and on corporate and investment deals where IP is an important asset. Her work includes advising pharmaceutical, biotech, medical device and digital health companies on joint ventures, R&D collaborations, strategic partnerships and licensing deals (with commercial and academic partners), and on manufacturing, supply and distribution contracts and clinical trial agreements.

Before becoming a lawyer, Claire spent a number of years working for Abbott Laboratories’ medical device business in quality assurance and operations roles. Since being at Bristows, Claire has also spent time seconded to the in-house legal team of a leading global pharmaceutical company. She is also a member of the UK Bio Industry Association’s Intellectual Property Advisory Committee. Claire’s expertise is recognised by legal directories, including as a next generation partner for Life Sciences and Healthcare in the Legal 500.

Nick Finnie (More...)

Nick is a European and UK Patent Attorney with over 25 years’ experience in the patent profession, both in private practice and in-house.   Prior to his current position at ADC Therapeutics, a small pharma company developing cancer therapies, he spent 11 years at Novartis in various senior positions as well as two years at Lonza, a contract manufacturer for the pharmaceutical industry. 

George Jenkins (More...)

George Jenkins sits in Covington’s Band 1 ranked Life Sciences Transactions team, specializing in advising life sciences and digital health clients on complex, strategic commercial agreements. In particular, he advises clients on structuring, negotiating and drafting their collaborations, joint ventures, IP licensing, co-development arrangements, and agreements for the manufacture, distribution, and supply of goods. George also regularly works closely with the firm's Corporate Practice Group on product divestments, asset transfers, and related transitional agreements.

George has experience in advising on regulatory matters in the life sciences sector, including advising on regulatory and licensing requirements to enable clients to develop and commercialize their products in the EU. He understands the regulatory environment affecting the life sciences industry and is able to assist clients in setting their commercial arrangements and transactions in their wider regulatory context.

George has also spent time in the in-house legal teams of a number of clients, including at the headquarters of a global pharmaceutical company.

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NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate
  • 40% off the 3rd delegate
  • 50% off the 4th delegate
23-25 Nov 2022
Live webinar
09:30-17:30
UK (London)
23-25 Nov 2022
Live webinar
09:30-17:30
UK (London)
GBP 1,799 1,499
EUR 2,519 2,099
USD 2,806 2,338
Until 19 Oct*
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Live webinar

Please note: this event is being organised by our training partner Falconbury; clicking Enrol will take you to falconbury.co.uk to complete your purchase.

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* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 18 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

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Previous customers include...

  • Abbott Ireland Ltd
  • Abbott Products
  • BERLIN-CHEMIE AG
  • Boehringer Ingelheim Pharma GmbH & Co. KG
  • Clinuvel UK Ltd
  • DNDi
  • Drugs for Neglected Diseases initiative (DNDi)
  • ELPEN S.A.
  • F. Hoffmann-La Roche AG
  • Gilead Sciences
  • Helsinn Healthcare SA
  • Holst, Law Firm
  • Jerini AG
  • Kancelaria Radcy Prawnego
  • LFB BIOMEDICAMENTS
  • MEDICHEM, S.A.
  • Morphosys AG
  • Napp
  • Nicoventures Limited
  • Nottingham University Hospitals NHS Trust
  • Orion Corporation
  • Pharmaq AS
  • Research and Markets
  • Samsung Bioepis
  • SPD Development Company Limited
  • Starpharma Malta
  • Tech Trans Unit
  • UCB Pharma SA
  • University of Southampton
  • VIB vzw

Overall it was very good

Cristina Bertulli, Director of Business Development and Operations , Exactmer Ltd, Nov 21

I found the webinar very informative and helpful. The speakers were very clear and practice-oriented.

Maria João Rodrigues, Legal Counsel, BIAL - Portela & Companhia SA, Nov 21

This course was brilliant and covered all the key points. The speakers were highly knowledgeable and had practical insights and fresh perspectives on drafting issues and implications. Having multiple speakers allowed for a fresh and dynamic course, and increased the amount of information absorbed.

James Langston, Contracts Manager, AstraZeneca, Nov 19

Good overview of content, great organisation.

Amish Unka, Legal Counsel, Morningside Healthcare Limited, Nov 19

High quality content and course materials. Professional presentation within a relaxed learning environment. Fantastic speakers who were happy to answer questions during their talks and the breaks.

Grace Hamlett, Legal Counsel, Mereo BioPharma, Jun 19

Great and useful course.

Taisier Adil, Legal Counsel, Xendo Holding B.V. – A ProPharma Group Company, Nov 18

A fantastic program and great speakers/participants.

Mia Rensch-Jacobsen, Business Operations Manager, Roche Innovation Center Copenhagen, Nov 18

Very useful course for my future career.

Christopher France, Business Development Associate, GSK Vaccines Srl, Nov 18

Insightful teachers, great take-home material, stupendous learning environment.

Luis Briseno Roa, Associate Director, Alexion R&D France, Nov 18

I particularly liked the quality of the speakers and the various workshops.

Zian Bertrand, In-House Counsel , ERYTECH PHARMA, Jun 18

Excellent and immediately useful.

Dan Hudson, Manager, GSK Vaccines SRL, Jun 18

All speakers are excellent and experts in their fields – I really enjoyed listening to them. The course is very extensive covering a wide variety of topics.

Avadhanula Yagna Praveen Kumar, Head of Intellectual Property Management, Pharmaniaga Berhad, Jun 18

Good topics and speakers.

Wan Intan Idura Wan Ismail, Deputy Director, PHARMANIAGA BERHAD, Jun 18

I found the course very practical and engaging

Tania Damianova, Company Lawyer, UCB S.A., Nov 17

Very knowledgeable experts.

Olivia Chalwin, Major Contracts Manager, University of Southampton, Nov 17