Drafting Commercial Contracts for the Pharmaceutical Industry

A 3-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors

10-12 Jun 2020

& 18-20 Nov 2020

GBP 1,799 1,499 *
EUR 2,519 2,099 *
USD 2,806 2,338 *
* When you book before 7 Apr

Book now

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 at a glance

MODULE 1: Intellectual property issues relevant to pharmaceutical industry agreements

  • PRACTICAL WORKSHOP: Intellectual property terms in collaboration and licensing agreements
  • Current key issues relating to IP in the pharma industry
  • Supplementary protection certificates (SPCs) – securing the full commercial potential of your product
  • When does R&D infringe patents? Understanding experimental use and Bolar provisions
  • Third-party IP rights – freedomto- operate searches and implications for pharmaceutical industry agreements

MODULE 2: Key pharmaceutical industry commercial agreements and legal and regulatory issues related to their drafting

  • Key issues in contract manufacturing agreements
  • Key issues in co-promotion, co-marketing and distribution agreements
  • Medicines regulations using regulatory processes to define contractual obligations
  • Key issues in clinical trials and related agreements

MODULE 3: Workshop on collaboration and R&D agreements

  • Negotiating and drafting collaboration and licence agreements – a practical workshop

MODULE 4: Competition law workshop

  • Introduction to relevant EU competition law rules

MODULE 5: Negotiation skills in the pharma sector

  • The rise and rise of the negotiator
    • Negotiate and succeed
    • Structure for control
  • Personal style and negotiation
    • Moving into engagement
    • Influencing and persuasion


Stephen Reese

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

Continuing professional development

This course qualifies for the following CPD programmes:

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

Book now

10-12 Jun 2020
10-12 Jun 2020 Rembrandt Hotel, London GBP 1,799.00
EUR 2,519.00
USD 2,806.00
+ VAT @ 20.00%
GBP 1,499.00
EUR 2,099.00
USD 2,338.00
Until 7 Apr*
Enrol now
18-20 Nov 2020
18-20 Nov 2020 Rembrandt Hotel, London GBP 1,799.00
EUR 2,519.00
USD 2,806.00
+ VAT @ 20.00%
Enrol now

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

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  • Acino International
  • Almirall, SA
  • Assesora estudio jurídico y tributario S.L.P
  • Bachem AG
  • Bech-Bruun Lawfirm
  • Biofocus DPI
  • Biogen Idec
  • BioMarin Pharmaceutical
  • CHEMO SA, Lugano Branch
  • ELPEN Pharmaceutical Co. Inc.
  • ELPEN S.A.
  • Emergent Product Development UK Ltd
  • Ferring International Center S.A.
  • Fondazione Centro San Raffaele Del Monte Tabor
  • Genmab A/S
  • GlaxoSmithKline Services Unlimited
  • Gulf Pharmaceutical Industries (Julphar)
  • K2 Events
  • Laboratorios Liconsa, SA
  • Morningside Healthcare Limited
  • Morphosys AG
  • Orion Corporation
  • PharmaMatch BV
  • Roche Romania SRL
  • Roche SpA
  • Siegfried Ltd
  • Stragen Pharma SA
  • TEVA Pharmaceuticals

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

Great and useful course.

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

Very useful course. I'm sure it will be useful for my future career

Christopher France, Business Development Associate, GSK Vaccines Srl

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

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

Great, professional outline; fantastic program and great speakers/participants

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

All speakers are excellent and experts in their fields. Really enjoyed listening to them. Course is very extensive - covering wide variety of topics. Speakers are really knowledgable in their respective domains.

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

Excellent and immediately useful.

Dan Hudson, Manager, GSK Vaccines SRL

Every speaker was practical and a specialist. The course presents various subjects and allows to share with other practician. The speakers are of quality and the timing is very well.

Zian Bertrand, In-House Counsel , ERYTECH PHARMA

Good topics and speakers.

Wan Intan Idura Wan Ismail, Deputy Director, PHARMANIAGA BERHAD

I think that overall the course material was comprehensive and touched back on a lot of different topics. I would recommend this course

Angele Azzopardi , In House Legal Counsel , Starpharma Malta

Very knowledgable experts

Olivia Chalwin, Major Contracts Manager, University of Southampton

Very good course, and good presentations/topics

Ilaria Pastorello, Manager Vaccines Business Development, GSK Biologicals SA

I found the course very practical and engaging

Tania Damianova, Company Lawyer, UCB S.A.

Very informative, very knowledgable speakers, content good but could have a glossary added to the material for those not familiar with all terms

Luciana Schwambach, Contract Manufacturing Business Development Director, Xellia Pharmaceuticals ApS

The content was very good, I appreciate the booklet provided. Most of the speakers I found very engaging. Everything was well organised and well presented

Leah Baker, Pharmacovigilance Scientist, Norgine Ltd

Very good, good alignment with professional practice.

Erik Popping, Corporate & Legal Counsel, Intravacc

The content is excellent. The speakers are highly qualified and talented in terms of lecturing.

Moataz Mahmoud, Legal & Compliance Advisor, EBN Sina Medical Establishment

Great material and speakers

Paraskevi Sakallaridi, Lawyer, ELPEN Pharmaceutical Co. Inc.

Very interesting topics

Khady Seck, Mylan S.A.S.

Good overall impression. Certain topics remained at introductory level without going into depth

Lina Yaneva, Legal Counsel, Mylan SAS

The course was well organised. Unfortunately patent issues were skimmed over

Jeremy Whitman, Legal Department, Sterling S.p.A.

Very well organised, really enjoyed the higher energy speakers as I find it difficult to sit through three days if the speakers are low energy

Darragh O'Dea, Legal Counsel, BioMarin Pharmaceutical

Overall good. The seminar room with no windows and fresh air was the only negative.

Kristina Anna Reitmeier, European PharmInvent Services, s.r.o.

Days 1-2 were very detailed, although some presenters did not encourage interaction

Neil Thompson, Supply Chain Manager, Suir Pharma Ireland

The course was good. I would suggest more practical examples.

Elda Selfo, Site Contract Specialist , INC Research

Enough but not very deep

Eva Rosal Negre, Legal Advisor , Laboratories Hipra, S.A

Very professional. Some of the speaker were too fast, but all of them very friendly and kind.

Roberto Aldovini, Legal Counsel, APR Applied Pharma Research s.a

Organisations are paying a considerable amount for their employees to attend this course and the speakers should therefore deliver better presentations. The good speakers were engaging, interested in feedback and seemed to care. Given the professional level of the speakers the lack of professionalism in the way that they presented their subject in the time available was surprising.

Rachel Simpson, Contracts Manager, University of Dundee

The content was really interesting and useful, was communicated effectively and all the presenters were good. The negotiation part was great!

Eleni Pentafragka, ELPEN S.A.

Generally high quality speakers. Good all-round refresher and networking opportunity.

Nick Plummer, Senior Director, EU Legal Services , Patheon UK Ltd

Speakers were fine and knew the subject well but some presentations were superficial

Maria Teresa Vazquez Calo, Lawyer, Assesora estudio jurídico y tributario S.L.P

More case studies would be better

Jan Smidrkal, Tech Transfer Manager, Institute of Chemical Technology Prague

Very helpful for practising in-house lawyers courses. The negotiation strategies workshop should have been adapted to lawyers.

Maria Ganeva, Contracts Manager, Genzyme

Very good course, but many details covered in a short time.

Christopher Lambert, Chief Legal Officer, Fertin Pharma A/S

The course was excellent, very useful and well organized.

Borislav Dakic, Director of Legal Department, Hemofarm AD

Really excellent including Susan Sungleton

Patricia Hoyle, Global Head Intellectual Property, Evolva Holding SA

Content was useful, but I would recommend a bit more focus on generics as well. All speakers were competent and presented well.

Milica Milekic, Senior Legal Counsel, HEMOFARM AD

Lots of content, some very good presentations and speakers.

Rebecca Flory, Solicitor, Edinburgh Research & Innovation Ltd

Speakers were well prepared and had good presentation skills. I enjoyed the course.


Very helpful and detailed material, good coverage of all pharma legal issues considering time available.

Roberta Comerro, Ginsana SA

Given the various topics being covered in a span of 3 days I think the speaker couldn't have done better

Sangeeta Shah, Mercury Pharma

Very relevant and useful to the topic of drafting commercial agreements in the pharma industry

Asif Altaf, Allergan Ltd