Drafting Commercial Contracts for the Pharmaceutical Industry (ONLINE EVENT: November 11-12, 2026)

Course overview

In such a highly regulated industry and in these turbulent and uncertain times, understanding the key challenges of negotiating 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 current laws and regulations. The alternative is the exposure of the organisation to unnecessary risk and costly disputes.

This training programme 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

This unique and highly interactive two-day training course 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 course with the knowledge and skills to perfect all stages of the contracting process.

Benefits of attending

By attending this training course, you will:

Update your practical skills when drafting effective licensing and collaboration agreements
Explore the current issues relating to IP including the Unitary Patent and Unified Patent Court
Understand the key intellectual property issues affecting pharmaceutical industry agreements
Explore the implications of SPCs for pharmaceutical industry agreements
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, and material transfer agreements
Get to grips with competition law relevant to doing deals in the pharmaceutical industry and best practice tactics to use

CPD Hours: 12

Course Content

Day 1
- Understanding licensing and collaboration agreements
- Workshop: Understanding licensing and collaboration agreements
- The Unitary Patent and the UPC
- Third-party IP rights - freedom-to-operate searches and implications for pharmaceutical industry agreements
- Supplementary protection certificates (SPCs) - securing the full commercial potential of your product
- Understanding and drafting R&D agreements
Day 2
- Medicines regulations using regulatory processes to define contractual obligations
- Key issues in clinical trials and related agreements
- Key issues in contract manufacturing agreements
- Key issues in co-promotion, co-marketing and distribution agreements
- Key issues in material transfer agreements
- Introduction to relevant EU competition law rules
- Practical workshop: Current competition law issues

Speakers

Mario Subramaniam

Mario is a partner at Bird & Bird and an IP and transactions specialist with extensive experience in the Life Sciences. He advises global Life Science clients on strategic IP licensing, collaboration and partnering transactions. He also supports those clients with M&A, joint ventures, asset acquisitions and disposals, strategic manufacturing, supply and outsourcing arrangements. Prior to qualifying as a solicitor, Mario worked as a research scientist in the fields of tumour immunology and molecular biology. Having spent a significant period of his career in-house advising Life Science clients, Mario brings a wealth of experience and a unique perspective to clients contemplating strategic transactions and partnerships. His experience and approach also brings great synergy to Bird & Bird's outstanding Life Sciences offerings, allowing an unrivalled opportunity to support clients with their most pressing challenges.

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.

Fred Nicolle

Fred Nicolle is a UK and European qualified patent attorney (CPA, EPA) at Simmons & Simmons. He has over 15 years experience specialising in patent prosecution and contentious matters for the life sciences sector. He has particular expertise in pharmaceuticals, medical devices, consumer health products, cosmetics, foods and health supplements. He graduated from the University of Cambridge with a Master of Natural Sciences degree with a final year research project in synthetic organic chemistry.

Fred has extensive experience of contentious patent proceedings in opposition at the European Patent Office and in national litigation, having defended patents for numerous commercially important products. Notable examples include the defence of patents for Noctiva™ (desmopressin acetate nasal spray), Bendeka® (bendamustine HCl injection), Revlimid® (lenalidomide), Xeplion®/Invega Sustenna® (paliperidone palmitate), wound dressings, and contact lenses.

Fred is featured in The Legal 500 and IAM Patent 1000 as a recommended patent attorney.

Ewan Townsend

Ewan Townsend is a Partner at Arnold & Porter’s London office and assists clients in the life sciences sector on regulatory and commercial matters. He has experience with a broad range of regulatory issues that arise throughout the medicinal product and medical device life cycle, including research and development, clinical trials, marketing authorisations, manufacturing, distribution, advertising, pricing and reimbursement. Ewan’s work also includes drafting and negotiating commercial agreements for his life sciences clients, such as licence agreements, manufacturing, distribution and supply agreements, clinical trial agreements and service agreements, and advising on the intellectual property and regulatory issues that arise in the context of those transactions.

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.

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.

Peter Rudd-Clarke

Peter Rudd-Clarke specialises in helping businesses navigate regulatory challenges and liability risks, particularly in the life sciences, healthcare and consumer products sectors.

Peter advises a range of businesses including medical device companies, software producers, pharmaceutical manufacturers, service providers and producers of lifestyle products.

His regulatory experience includes advising on the regulation of medical devices and consumer products, as well as CE/UKCA marking, clinical trials, regulatory investigations, the application of industry codes and ongoing compliance matters.

The litigation and risk management side to Peter’s practice involves defending manufacturers of complex products against liability claims, often across multiple jurisdictions; as well as advising clients on product recalls and corrective actions.

Peter is ranked in the Legal 500.

Sharmela Kalmer

Sharmela Kalmer is a Partner at Gowling WLG (UK) LLP. Sharmela is a trusted advisor to a number of emerging and established innovative technology and life sciences companies operating in a range of sectors, including biotech and medtech. With a wealth of industry experience, Sharmela's sector knowledge gives her a solid understanding of the opportunities and issues faced by clients and how to navigate these issues to access new market opportunities.

Sam Fisher

Sam is an Associate Solicitor in CMS’ Intellectual Property team in London. He advises clients principally in the biotechnology, technology and media sectors, on a range of hard and soft IP and connected commercial issues. He has experience litigating in the High Court, Court of Appeal and at the Intellectual Property Office.

Prior to his legal career, Sam spent eight years managing trade mark licensing campaigns as well as at a biotechnology start-up.

Niels Ersbøll

Niels Christian Ersbøll is a partner in the EU Antitrust practice, chair of the European Competition practice, and head of the Brussels office. He mainly advises clients on EU competition law in relation to merger control, cartels and restrictive practices, and abuse of dominance, where he has more two decades’ experience. Niels also has significant expertise in advising clients on EU sanctions and export control matters.

He has assisted clients in obtaining merger control clearance on a number of significant transactions before the European Commission and coordinating submissions to competition authorities worldwide for clients such as Pfizer, Boston Scientific and AT&T. He has significant experience assessing filing requirements, devising strategy, dealing with review and designing and negotiating remedies.

In relation to cartels, Niels has successfully acted for companies seeking leniency (immunity as well as fine reductions) before the European Commission, he has appeared before the EU General Court on appeal of European Commission decisions, and is advising on follow-on damage claims. Recently, Niels also has represented individual directors in cartel proceedings, and acted for a whistle blower. He also has significant experience helping clients with designing and implementing compliance measures and conducting internal investigations and audits.

Outside investigations related work, Niels regularly advises clients in relation to, for example, distribution and pricing arrangements, parallel trade, and various forms of cooperation agreements and strategic alliances between competitors. He acts for clients in many industries, and has particular experience within the life sciences, media and the transport & logistics sectors.

As a reflection of his deep understanding of the industry, since the declaration of the Covid-19 pandemic, Niels has also been working extensively with the vaccine industry to advise on a multitude of aspects of vaccine and antiviral procurement by governments and international organisations including the EU, the African Union, COVAX and CARICOM.

Moreover, Niels also regularly advises clients on EU sanctions questions, notably in rapidly changing regulatory environments, especially regarding EU sanctions on Russia. He helps companies establish EU sanctions compliance plans and commercial strategies as well as obtaining authorisations from competent Member States authorities.