Falconbury courses now available at IPI Academy - visit IPI for an updated experience and a broader selection of courses and subjects

Collaboration and R&D Agreements for the Pharma Industry

A practical 2-day seminar focusing on the key legal and commercial challenges to achieving a successful collaboration agreement in the pharma, biotech and life sciences sector

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

Contact us

Details

Course Overview

Pharmaceutical and biotech companies are turning with increasing frequency to R&D and collaboration agreements – for pharmaceutical companies to put new products in their pipelines and for biotech companies to access the resources needed for final stage development, clinical trials, manufacturing and distribution.

This In-house seminar from Falconbury offers you a unique opportunity to learn from an expert faculty to tackle the key challenges that arise when negotiating and drafting these agreements. It will enable you to draft effective watertight agreements and create the foundation to build long lasting and profitable relationships.

Includes a case study exercise and group discussion to ensure a complete learning experience.

Benefits of attending

  • Examine how to make the right deal and find the right partner
  • Understand more about the due diligence process which is a key element for successful contracts
  • Learn more about the key terms of R&D and collaboration agreements
  • Familiarise yourself with the different ways of allocating ownership of IP and the problems and solutions of joint ownership
  • Gain knowledge of the regulatory regime affecting patents and R&D
  • Get-to-grips with the legal structures and special features of business-to-business collaborations
  • Learn about the unique features of industry/ university collaborations including the typical contractual arrangements
  • Update yourself with the latest developments of EU competition law aspects

Who should attend?

From R&D, clinical, regulatory, commercial, sales and marketing, manufacturing, distribution and purchasing functions, including:

  • Commercial and contract managers
  • Business development managers
  • In-house counsel
  • Heads of legal departments
  • Legal advisors
  • Patent, IP, trademarks or licensing counsel

Sample Programme

Day 1

  • Selecting your partner and choosing the right deal structure
    • How to make the right deal
    • Structuring the deal: research sponsorship, collaboration or joint venture?
    • Financing the deal: sources of research funding (eg EC Framework 7, charitable funders)
    • Finding the right partner
    • Sources of information
    • Deal valuation
  • Due diligence
    • The scope of due diligence required: freedom to operate, scientific, contractual, etc
    • The team: scientists, patent attorneys, lawyers, business executives, et al
    • Due diligence process: questionnaires, review of documents, use of data rooms
    • Specific issues in pharma transactions: killer MTAs, inventors who can’t be found, Government walk-in rights in academic research, limited academic licences (eg for diagnostic kits)
  • Understanding and drafting the key terms of pharma R&D and collaboration agreements
    • What are the objectives of the agreement?
    • Key work obligations, committees, decision-making, reporting procedures
    • What happens next: terms dealing with success or failure of the R&D project, who can take the project forward, etc
    • Negotiating and drafting the financial clauses
  • IP terms, rights, ownership and protection
    • Intellectual property in the context of R&D
    • Who owns what: different ways of allocating ownership of foreground IP – inventorship, field, territory
    • Problems and solutions with joint ownership
    • Rights to background IP – ownership and licensing
    • Securing ownership rights: employment and consultancy contracts, third party rights
    • Management of IP: responsibilities for filing patents, suing infringers, etc
    • IP warranties, disclosures and disclaimers
  • Patents, the regulatory regime and R&D
    • Bolar and friends: research exemptions from patent infringements in different countries
    • Data exclusivity rules and Directive 2004/27/EC
    • Compliance with regulations on clinical trials, etc
    • Impact of regulatory regime generally on R&D
  • More than just R&D – when R&D agreements include licensing and supply obligations
    • Use of material collections and libraries
    • Manufacture of product for R&D
    • Licensing of critical pre-existing IP
    • Development and licence agreements

Day 2

  • Legal structures and decision making in R&D collaboration and commercialisation
    • Joint venture companies, LLCs and LLPs
    • Non-profit and charitable legal entities
    • Contractual collaborations
    • EC consortium agreements
    • Technology transfer companies
    • University spin-out companies
  • Special features of business-to-business collaborations
    • IP terms: cross-licensing and pooling, joint commercialisation, separate commercialisation by field or territory
    • Financial contributions: cost-sharing, funding of one party by the other
    • Allocation of commercial revenues – royalty-sharing etc
    • Warranties, liability and insurance
  • Special features of industry/ university collaborations
    • Advantages and disadvantages of collaborating with universities
    • Human issues in university collaborations
    • The key players and their respective expectations
    • Some of the common pre-deal concerns
    • Typical contractual arrangements between industry and universities
    • Types of agreement
    • Parties – when are trilateral agreements needed?
    • Main and ancillary documents involved in such arrangements
    • Template agreements in common use
    • Can the university transfer to industry only patentable inventions?
    • IP terms, confidentiality and publications
  • EU competition law (antitrust) aspects – latest developments
    • EU 2008/09 investigations and raids in the pharmaceutical sector
    • EU R&D Block Exemption
    • EU Technology Transfer Regulation
  • EU competition law – CASE STUDY

Delegates will be divided into small groups and given a case study based on latest EU developments.

  • Exit strategies and dealing with disputes
    • Drafting an exit strategy at the negotiation stage
    • How to manage the risks
    • What can go wrong during the term of an agreement
    • Establishing the term of the agreement and termination strategy
    • Preparing for the typical consequences of termination
    • Dealing with post exit issues

Presenters

Susan Singleton (More...)

Susan Singleton is a solicitor with her own London solicitor’s firm, Singletons, which specialises in competition law, intellectual property and commercial law, both non-contentious and contentious. Until 2016 she was Vice Chairman of the Competition Law Association and author of 30 law books. She advises a wide range of UK and international clients including in the pharmaceutical sector. The 4th edition of her book on Commercial Agency Agreements was published in 2015. After working as a solicitor at London law firms Slaughter and May and Bristows, she founded her own law firm. She brought the first action for damages for breach of the competition rules to reach an English court (Arkin v Borchard Lines) and in 2015 was involved in litigation for clients in both the CJEU and UK in relation to challenges to EU and UK tobacco legislation. She advises lots of clients in particular about EU competition law and selective distribution agreements including in the pharma/ veterinary sectors, both for parallel importers and for brand owners. She is editor of the looseleaf Kluwer’s Comparative Law of Monopolies. In 2015-16 she was heavily involved in litigation before the English courts and CJEU in litigation relating to EU and UK legislation in the tobacco sector and in 2017 won damages for a client in trade infringement litigation (IPEC)

Mark Anderson (More...)

Mark Anderson is an English solicitor (attorney) and former barrister, who established his law firm, Anderson & Company, in 1994. His clients are mostly technology-based companies and universities in the UK and Northern Europe. He specialises in drafting, negotiating and advising on commercial contracts, particularly those that are concerned with intellectual property. He is the author of several legal textbooks, published by Oxford University Press, Butterworths, Tottel and the Law Society.

Tim Worden (More...)

Tim Worden is a partner in Taylor Wessing LLP’s intellectual property department, and is based in the firm’s Cambridge and London offices. He specialises in transactional, non-contentious and regulatory intellectual property in the life sciences and healthcare sectors.
He advises on:
A range of intellectual property and commercial agreements, such as licensing and collaboration agreements, research and development agreements, clinical trials agreements and a range of services agreements.
Regulatory issues in the pharmaceutical industry – in particular in relation to the promotion of medicines in the UK – and in the medical devices sector.
Intellectual property and commercial contract disputes.
Intellectual property and commercial issues arising out of mergers and acquisitions, venture capital investments and IPOs.
He was previously Legal Counsel and Company Secretary at Eli Lilly and Company Limited, the UK subsidiary of the US pharmaceutical company.
He has a degree in Natural Sciences (Chemistry and Biochemistry) from Cambridge University and a Diploma in Intellectual Property Law and Practice from Bristol University.
He regularly writes articles on issues affecting the life sciences industry, in publications including Bioscience Law Review, Pharmaceutical Marketing Europe, Pharmaceutical Law Insight, International Clinical Trials, RAJ Devices and Pharma.

Laura Anderson (More...)

Laura Anderson is a Partner at Bristows in London. Since joining Bristows 16 years ago, Laura has specialised in commercial IP matters. She has considerable experience of commercial arrangements relating to the development and exploitation of all kinds of intellectual property rights across several industry sectors. In the life sciences sector, Laura advises on collaborations and licensing deals as well as downstream arrangements relating to clinical trials, manufacturing, marketing and supply.

Patrick Duxbury (More...)

Patrick is a Partner at Gowling WLG (UK) LLP and Head of their Life Sciences Team. He specialises in all aspects of transactional intellectual property law in the life sciences sector. Recent transactions include several M&A transactions and licensing and collaboration deals for biotech and pharmaceutical company clients such as arGEN-X, AstraZeneca, Astellas, MedImmune, Astex Therapeutics, Chroma Therapeutics, Eisai, GSK, Heptares Therapeutics, PanGenetics and others.

Lindsey Woolley (More...)

Lindsey Woolley is Partner and Patent Attorney at Mewburn Ellis LLP, which she joined in 2002. Lindsey deals mainly with drafting and prosecution work and advises on portfolio management of interrelated patent families. Lindsey also deals with patent work in the biotechnology field, in particular molecular biology, biochemistry and biotechnology. Her clients include universities, research institutions and biotechnology companies. Lindsey has a degree in plant sciences from the University of Cambridge.

Customise

Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7729 6677, email us at inhouse@falconbury.co.uk or contact us below:

Please complete all fields marked as required.

By submitting your enquiry, you explicitly consent to us us processing the personal data you have included in this form in accordance with our privacy policy.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Training options

You may also be interested in