Drafting Agreements in the Biotechnology and Pharmaceutical Industries

• Offers precedent agreements and legal commentary in relation to the main types of commercial transaction encountered in the life-cycle of a product in in the biotechnology and pharmaceutical industries
• Supported by an online resource providing plain versions of all the precedents which can be downloaded and edited by the user
• Provides detailed commentary to each precedent on legal, commercial and practice issues
• Highlights the important differences between English law and other key EU jurisdictions comprising Germany, France, the Netherlands, Spain and Sweden. The first updating release highlights differences between English and US law
• Incorporates commentary from specialist lawyers within key EU jurisductions and the US

New to this edition

• The updated material in this first release consists principally of comments from our US contributors on the precedents (template agreements) in chapters 2 to 9, as well as a limited number of changes to the text of those precedents in light of the US contributors' comments. There are also some minor changes to chapter 1 and an updated set of website references in chapter 16.
• The comments take the form of side notes on most of the agreements in chapters 2 to 9, and accompany the existing side notes from the contributors from the UK, France, Germany, Netherland, Spain and Sweden. The only exceptions are a few agreements that are not encountered in the US, where no US comments have been made (eg the NHS Clinical Trials Agreement included in chapter 5).
• The US comments are extensive and cover a wide range of legal, commercial and practice issues. General topics, briefly discussed in most or all of the precedents, include the following: · US laws on contractual issues, eg the Uniform Commercial Code · Implied terms in contracts made under US laws · The meaning of particular expressions, eg best efforts · Confidentiality issues and clause wording · Limitation of liability · Choice of law and jurisdiction clauses · Typical drafting practices in US contracts
• A few examples of agreement-specific issues covered by our US contributors are mentioned below.
• Chapter 2 (Preliminary Agreements): · Whether term sheets are legally binding · Obligations of good faith in negotiations · How to define confidential information in confidentiality agreements · Regulations on the use of materials under MTAs · The rights of co-owners of patents
• Chapter 3 (Collaborative Research and Development Agreements): · Whether an academic scientist (eg the principal investigator) should be a part to a research agreement instead of, or as well as, his or her employing university. · The requirements of the Bayh-Dole Act, and associated practices of US universities when negotiating intellectual property ownership and licensing terms · The sovereign immunity of US state universities, and its effect on choice of law and liability provisions
• Chapter 4 (Services Agreements): · The allocation of intellectual property rights · Liability terms in services agreements Certain US regulatory requirements
• Chapter 5 (Clinical Trial Agreements): · In relation to references in the chapter to EU regulatory requirements affecting clinical trials, referring to the equivalent US regulatory requirements under the Code of Federal Regulations (CFRs). · Whether the principal investigator should be a party to the agreement · Data protection obligations (eg for protected health information) in the US · Ethics committee (Institutional Review Board) issues in the US · Patient consents
• Chapter 6 (Product Manufacturing and Supply Agreements): · Warranties and acceptance procedures · Regulatory issues
• Chapter 7 (Distribution and Marketing Agreements): · Licensing terms in distribution agreements · Exhaustion of rights issues and the Quanta decision · Regulations on the distribution of pharmaceutical products · Ordering procedures
• Chapter 8 (Licence Agreements): · The wording of US licence grant clauses, and associated definitions of Patents, etc. · Implied warranties in licence agreements · Other detailed points on the wording of licence agreements
• Chapter 9 (Assignments): · The registration of US patent assignments · The rights of joint owners of a US patent · Certain USPTO procedures, eg where an inventor cannot be found · US practice on the notarization of patent assignments

Readership: Lawyers and commercial managers who are involved in drafting and negotiating agreements in the biotechnology and pharmaceutical industries, including university technology transfer managers, IP licensing practitioners and product development managers in biotechnology or pharmaceutical companies.

In Release 3, new commentary will be added to the regulatory chapter (Chapter 10) about generic medicinal products and also to the collaborative R&D agreements chapter (Chapter 3) about the developments in the Framework 7 and future "Horizon 2020" programmes. New precedents will also be included, namely a right of first refusal agreement, an anti-bribery policy and a pro-licensor licence agreement to Chapters 2, 4, and 8 respectively. The footnotes and commentary will also be updated to reflect changes in the law since the last release.

Edited by Mark Anderson, Anderson & Company

"Drafting Agreements in the Biotechnology and Pharmaceutical Industries is a "must-have" reference for life science lawyers and Business Development executives. The short but insightful commentary to each sample form agreement provides the essential context, while the footnote annotations to the clauses of each form drill down for a more focused commentary. Although initially prepared for use in the European market, American readers will benefit greatly from this important compilation." - Brian D. Beglin, Bingham McCutchen LLP, USA

"[T]his is a book that can thoroughly be recommended for anyone who is drafting or negotiating agreements in Europe in the pharmaceutical and biotechnology sectors. " - Trevor Cook, Bird & Bird

Part A: Introduction
1: Introduction to agreements in the Bio/Pharma sector
Part B: Annotated precedents
2: Preliminary agreements
3: Collaborative research and development agreements
4: Services agreements
5: Clinical trials agreements
6: Product manufacturing and supply agreements
7: Distribution and marketing agreements
8: Licence agreements
9: Assignments
Part C: General commentary
10: Regulations affecting the research and development of pharmaceutical products
11: Intellectual property law in Europe
12: Competition law issues
13: Contract law and practice
14: Tax and currency issues
Part D: Materials
16: Selected EC competition law materials
17: Web-site links to other selected materials

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