Presented by
Falconbury

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

Find out more

  • Format: Bespoke training
  • CPD: 12 hours for your records (depending on your requirements)
  • Certificate of completion

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

Mark Anderson

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.

More details

Laura Anderson

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.

More details

Patrick Duxbury

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.

More details

Susan Singleton

Susan Singleton is a solicitor with her own London solicitor’s firm, Singletons, which specialises in competition law, intellectual property, data protection and corporate/commercial law, both non-contentious and contentious. Until 2016 she was Vice Chairman of the Competition Law Association. She is author of 33 books and contributor to 48 more. She advises a wide range of UK and international clients. The 5th edition of her book Commercial Agency Agreements - Law and Practice was published in 2020 and the the 8th edition of Joint Ventures and Shareholders'  Agreements in 2021. She produced the  5th edition of the textbook E-Commerce and Convergence - A Guide to the Law of Digital Media in 2021.  After working as a solicitor at London law firms Slaughter and May and Bristows, she founded her own London firm of solicitors. 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 and is regularly in involved in sales and purchase of companies. She was 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).

She wrote Business, the Internet and the Law looseleaf in 1999 which she still updates three times a year.  In 2021 she was nominated as a Female Tech Law Hero for International Women's Day for The Society for Computers and Law.  In 2021 she updated the Encyclopaedia of Forms and Precedents Data Protection and Freedom of Information Act commentary for LexisNexis, legal publishers.

More details

Lindsey Woolley

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.

More details

Tim Worden

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.

More details

Run Collaboration and R&D Agreements for the Pharma Industry Bespoke training for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training expert Aleksandra Beer to discuss your requirements:

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy