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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.

18-20 Nov 2020

& 9-11 Jun 2021 , 24-26 Nov 2021

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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

Current key issues relating to IP in the pharma industry

  • Patents – including overview of the current system and the proposed UPC
  • Trade marks – including post-Brexit arrangements
  • Design rights – including post-Brexit arrangements

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

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

Third-party IP rights – freedomto-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

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: Negotiate and succeed & Structure for control

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 fallback style)
  • The A to E of negotiating styles
  • Personal strengths and weaknesses

Practical exercise: Moving into engagement & Influencing and persuasion

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

Presenters

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.

Rob Maguire (More...)

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 dealing 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.

Clive Douglas (More...)

Clive Douglas is a consulting commercial and life sciences lawyer and until recently he was General Counsel European Licensing & Transactions with Teva Pharmaceuticals, where he worked for 12 years. Clive handles a wide range of pharma-related commercial and corporate transactions, including IP, licensing, development, manufacturing, supply and distribution arrangements. Clive has previously held in-house commercial/corporate legal roles in telecommunications and property investment businesses and also has substantial law firm experience specialising in commercial, IT/telecoms and property law.

Catherine Drew (More...)

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. Catherine also advises on patent litigation, in particular on a multi-jurisdictional basis and has experience in conducting patent litigation before all courts in the UK in a variety of sectors. 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. Given her technical background Catherine is able to provide support in creating persuasive written advocacy pieces directed to decision making bodies on matters such as medicine regulatory exclusivity, pricing and reimbursement and classification of products for the purposes of allocation of exclusivity rewards or value attribution. Catherine has also advised on regulatory issues arising in relation to borderline products and in related fields, such as the cosmetic sector, 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.

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.

Tom Carver (More...)

Tom Carver is a partner at JA Kemp. 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.

Colin McCall (More...)

Colin McCall is a partner in the IP/IT group at Taylor Wessing. His practice focuses on the life sciences and medtech sectors. Colin advises biotech, pharmaceutical and medtech companies ranging from early stage fast growth biotechs to listed multinational pharmaceutical and medical devices companies across the full range of commercial contracts – from general commercial agreements to the more complex manufacturing, R&D collaboration and licensing/partnering agreements. Colin also has particular expertise in advising on the commercial and intellectual property aspects of technology transactions including spin-outs, start-ups, venture capital investments, M&A and IPOs.

Chris Milton (More...)

Chris Milton is a partner at JA 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. In some cases the opposition work has been just one aspect of global litigation, and so Chris has gained experience of working alongside teams of litigators throughout Europe and the rest of the world. Chris has also been involved in advising on freedom to operate and due diligence matters.

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.

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.

Sarah Cowlishaw (More...)

Sarah Cowlishaw is an associate in the London Life Sciences group at Covington & Burling LLP. Her practice focuses on life sciences regulatory and commercial law for pharmaceutical, medical device, food and consumer products. Her advice on general regulatory matters includes borderline determinations, food classifications, adverse event and other reporting obligations, manufacturing controls and labelling and promotion. On the commercial side, she advises on the full range of agreements that span the product life-cycle in the life sciences sector. Sarah’s expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements and regulatory services agreements. She also regularly advises on regulatory aspects of corporate/commercial transactions, particularly regulatory due diligence.

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.

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.

Mario Subramaniam (More...)

Mario Subramaniam is a senior associate in the life sciences and health transactional 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, from strategic licensing transactions to research collaboration, clinical trial, manufacturing to supply and distribution. Having previously been in-house counsel at a number of prominent life science companies, Mario has a deep understanding of clients’ needs and is renowned for his clear and practical advice.

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.

Alex Denoon (More...)

Alex Denoon is head of the regulatory team at Bristows, primarily advising life sciences clients. He has more than 20 years’ experience advising clients in the sector. In addition to his LLB, Alex has a BSc in Human Genetics. Alex spent more than five years in-house, including as GC and Company Secretary of Biotech Australia. He works with clients to devise and implement regulatory strategies throughout the product life cycle of pharmaceuticals and medical devices, and has advised clients in relation to more challenging issues including: genomics, cell therapies, tissue and cells requirements, borderline products, combination products, 3D printing, healthcare apps and remote diagnostics, and has been involved in the development of a number of regulatory frameworks and guidelines. In addition to a range of contentious (judicial review) and advisory matters, he has a breadth of international experience in structuring, negotiating and drafting commercial agreements. Alex is widely published and speaks regularly at conferences.

Book now

Book now

18-20 Nov 2020
Face-to-face, Rembrandt Hotel London
18-20 Nov 2020
Face-to-face
Rembrandt Hotel London
GBP 1,499.00
EUR 2,099.00
USD 2,338.00
Until 7 Oct*
Enrol now
to attend
Face-to-face
Rembrandt Hotel London
  • 3 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
9-11 Jun 2021
Face-to-face, (venue not yet confirmed)
9-11 Jun 2021
Face-to-face
(venue not yet confirmed)
GBP 1,499.00
EUR 2,099.00
USD 2,338.00
Until 28 Apr 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 3 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
24-26 Nov 2021
Face-to-face, (venue not yet confirmed)
24-26 Nov 2021
Face-to-face
(venue not yet confirmed)
GBP 1,499.00
EUR 2,099.00
USD 2,338.00
Until 13 Oct 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 3 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for the following CPD programmes:

  • CPD certificate of attendance: 17.30 hours
  • CLE: 14.30 hours

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.

Contact us

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  • Almac Group
  • Apotex
  • Boehringer Ingelheim RCV GmbH & Co KG
  • Celltrion Inc.
  • Debiopharm International SA
  • Dexcel Pharma Ltd
  • Dishman Europe Ltd
  • Ebewe Pharma
  • ERYtech Pharma
  • Hikma Pharmaceuticals
  • JADRAN-GALENSKI LABORATORIJ d.d.
  • Kent Pharmaceuticals Ltd
  • Laboratoires Bouchara Recordati
  • Lonza Braine
  • Mereo BioPharma
  • Morningside Healthcare Limited
  • Mundipharma International Limited
  • Novartis Consumer Health S.A.
  • Novartis Pharma Maroc SA
  • Orion Corporation
  • PHARMANIAGA BERHAD
  • Samsung Bioepis
  • Savara Inc.
  • Siegfried AG
  • Statens Serum Institut
  • Teva UK Ltd
  • VIB
  • Xellia d.o.o (Xellia Ltd)
  • Xendo Holding B.V. – A ProPharma Group Company

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

The content was very good and I appreciated the booklet provided. I found ... the speakers very engaging and everything was well organised and well presented.

Leah Baker, Pharmacovigilance Scientist, Norgine Ltd, Nov 17

Very good course and good presentations/topics.

Ilaria Pastorello, Manager Vaccines Business Development, GSK Biologicals SA, Nov 17