Collaboration and R&D Agreements for the Pharma Industry

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

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 new 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.

The key objectives of this seminar
By attending this seminar, you will:
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

Sample Programme Day 2

Legal structures and decisionmaking 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-tobusiness 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

Recommended Trainer

Mark Anderson is a solicitor 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. At the date of writing, he has advised 17 of the current members of the UK BioIndustry Association, and participated in negotiations with 20 other members (not his clients). He specialises in drafting, negotiating and advising on commercial contracts, particularly those which are concerned with intellectual property. He is the author of several legal textbooks, published by Oxford University Press, Butterworths, Tottel and the Law Society.

Laura Anderson is a Partner at Bristows in London. Since joining Bristows 12 years ago, Laura has specialised in non-contentious IP matters. She has considerable experience of commercial arrangements relating to the development and exploitation of all kinds of intellectual property rights. Laura has expertise in the competition law aspects of commercial IP transactions and has spent time working in Brussels, both at the EU Council of Ministers and in private practice. Laura acts for clients across a range of sectors including life sciences.

Dr. jur. Christian Czychowski is an Attorney at Law, Certified Information Technology Lawyer, Certified Copyright and Media Lawyer, admitted at the European Trade Mark Office, Partner in the Berlin office of Boehmert & Boehmert. He is a co-editor of the Manual of Intellectual Property in the Internet, a co-author of the Manual of Copyright and has specialised in IT law, copyright law, cyberlaw and licensing. He has worked for Boehmert & Boehmert since 1997 (since 2002 as a partner) in their Berlin office. He holds lectures at the University of Potsdam and is electedmember of the Committee for Copyright and Publishing Rights of the German Society of Industrial Property and Copyright (GRUR).

Patrick Duxbury is IP Partner and head of the six-partner Life Sciences Sector Team at Wragge & Co. The team delivers a unique mix of regulatory, anti-trust, IP, corporate and dispute resolution advice to many of the sector’s key players.

Susan Singleton is a solicitor with her own London firm, Singletons, which specialises in intellectual property law, including trade marks and competition law and Internet law and general commercial law. Articled at Nabarro Nathanson, she joined Slaughter and May’s EC/Competition Law Department on qualifying in 1985, moving to Bristows in March 1988, where she remained until founding her own firm in 1994. Since then she has advised over 410 clients. In 2002 she acted for the claimant in the first damages action for breach of the EU competition rules to come before the English courts Arkin v Borchard and Others.

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.

Tim Worden is an Associate in the Intellectual Property Department of Taylor Wessing. His practice includes both non-contentious and contentious intellectual property and he specialises in the life sciences and healthcare sectors. Tim was previously Legal Counsel and Company Secretary at Eli Lilly and Company Limited, the UK subsidiary of the US pharmaceutical company.

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

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