Dublin, May 12, 2023 (GLOBE NEWSWIRE) -- The "Drafting Commercial Contracts for the Pharmaceutical Industry Training Course" training has been added to ResearchAndMarkets.com's offering.
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 current laws and regulations. The alternative is the exposure of the organisation to unnecessary risk and costly disputes.
The 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
The delivery style
This unique and highly interactive two-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 contracting process.
The key objectives
By attending this seminar, 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
- Find out about 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 the tactics
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
Key Topics Covered:
Day 1
Understanding licensing and collaboration agreements
- 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
Intellectual property terms in licensing and collaboration agreements
- Ownership of internally and externally generated IP
- Joint ownership issues
- Outsourcing issues
- Improvements and grant backs
- Sample clauses
The Unitary Patent and the Unified Patent Court
- Latest developments
- Implications for the pharmaceutical industry
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
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
Understanding and drafting R&D agreements
- The scope and purpose of R&D agreements
- Key terms and conditions
- 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
Day 2
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
- Introduction to clinical trials
- Outline of principal EU and UK legislation
- Structuring clinical trial agreements
- Engaging CROs
- Key agreement terms and obligations
- Liability and indemnities
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
Key issues in material transfer agreements
- The purpose of the agreement
- The scope of the agreement
- Key terms and conditions
- Key issues to be aware of
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
Speakers
Niels Ersboll
Arnold & Porter LLP
Niels Ersboll, 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.
Stephen Reese
Clifford Chance LLP
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
Pinsent Masons
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
Simmons & Simmons LLP
Ben Thomas is a Managing 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
Simmons & Simmons LLP
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.
Ellen Lambrix
Bristows LLP
Ellen Lambrix is a Partner in the Bristows Commercial IP team. She 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.
Tom Carver
White & Black Legal
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.
Claire Smith
Bristows LLP
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.
Fred Nicolle
Simmons & Simmons
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 NoctivaT (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.
George Jenkins
Covington & Burling
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.
For more information about this training visit https://www.researchandmarkets.com/r/k2idzj
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