Drafting Agreements in Life Sciences

Erscheinungsjahr 2027
ISBN: 978-1-5265-3241-1
Verlag: Bloomsbury Publishing PLC

Buch, Englisch, 848 Seiten, Hardback, Format (B × H): 156 mm x 248 mm, Gewicht: 503 g

Previously known as Drafting Agreements in the Biotechnology and Pharmaceutical Industries, this title provides precedent agreements for the main types of commercial transaction encountered in the life sciences, biotechnology and pharmaceutical industries. In addition to the print version, each precedent is available via an accompanying website in a format which can be easily downloaded and edited.

Detailed commentary on legal, commercial and practice issues accompanies every precedent. Provided by specialist lawyers from across Europe, this commentary also highlights important differences between English law and that of other key EU jurisdictions: Germany, France, the Netherlands, Spain and Sweden. Commentary on specific considerations for the US is also provided.

In addition to precedent commentaries, the book also contains detailed commentary and discussion of legal issues common to the life sciences, biotechnology and pharmaceutical industries, as well as links to relevant materials (eg regulatory materials on clinical trials).

This title is included in Bloomsbury Professional's Intellectual Property and IT online service.

Autoren/Hrsg.

Anderson, Mark

Allebone, Lisa

Wozniak, Agnieszka

Fachgebiete

• Naturwissenschaften Biowissenschaften Biowissenschaften
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie
• Rechtswissenschaften Ausländisches Recht Common Law (UK, USA, Australien u.a.)
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie
• Rechtswissenschaften Internationales Recht und Europarecht Internationales Recht

Inhaltsverzeichnis

1. Introduction to Agreements in the Bio/Pharma Sector
2. Preliminary Agreements
a) Non-Binding Term Sheet (Plus Binding Provisions: Exclusivity, Stand-Still, Confidentiality)
b) Confidentiality Agreement
c) Material Transfer Agreement
d) Data Transfer Agreement
3. Collaborative Research and Development Agreements
Introduction to Chapter
a) Research Collaboration Agreement (With Various IP Optional Clauses)
b) Commercial Development and Licence Agreement
4. Services Agreements
Introduction to Chapter
a) Master Services Agreement
b) Simple Consultancy Services Agreement
c) Agreement With Scientific Advisory Board Member
d) Agreement to Develop Manufacturing Process and Manufacture for Clinical Trials
e) Software-as-a-Service Agreement
5. Clinical Trials Agreements
Introduction to Chapter
a) Agreement to Manage Clinical Trials
b) Site Agreement
c) Clinical Trials Consent Form
6. Manufacturing, Supply, Distribution and Marketing Agreements
Introduction to Chapter
a) Contract Manufacturing Agreement
b) Agreement for Licensor to Supply Product to Licensee
c) Product Distribution Agreement
d) Co-Promotion Agreement
7. Licence Agreements
Introduction to Chapter
a) Detailed Patent and Know-How Licence Agreement
b) Short-Form Licence for Registration With Patent Offices, Etc.
c) Detailed Software Licence Agreement (With AI Provisions)
d) Licence Termination Agreement
e) Extensive IP Warranties for Licence Agreement
8. Assignments and Management Agreements
Introduction to Chapter
a) General IP Assignment (Including Patents, Copyright, Know-How, Materials, etc)
b) Employee IP Assignment and Confidentiality Agreement
c) Co-Ownership Agreement
9. Regulations Affecting the Research and Development of Medicinal Products
10. Regulations Affecting the Research and Development of Medical Devices
11. IP and Data Protection Laws
12. Competition Law Issues

Über Autor(innen)

Anderson, Mark
Mark Anderson is Managing Partner of Anderson Law LLP and is top-ranked as a leading individual in Chambers & Partners Directory UK 2022 for both life science transactions and intellectual property. He is a visiting professor at the Faculty of Laws, University College London, and a member of the Council of the Law Society of England and Wales, representing Business and Commercial Law. He has over 35 years' experience of drafting, negotiating and advising on commercial contracts. Most of his clients are technology-based companies and universities, based in the UK, continental Europe and the United States.
Together with other members of Anderson Law, Mark is the author of several legal textbooks, loose-leaf works and volumes of legal encyclopaedias in the areas of intellectual property and commercial law including A-Z Guide of Boilerplate and Commercial Clauses (4th Ed), Technology Law (4th Ed) and Macdonald's Exemption Clauses and Unfair Terms (3rd Ed) published by Bloomsbury Professional.

Wozniak, Agnieszka
Agnieszka Wozniak is an Associate Partner at Anderson Law LLP with extensive experience in commercial and intellectual property related transactions. She specialises in life science, advising pharma, biotech and medical technology companies. She also has a strong focus on academic institutions, having worked closely with universities, research institutes and spinouts for many years.
Agnieszka advises her clients on complex IP and commercial arrangements, including intellectual property licensing, clinical trials, technology development collaborations, and supply agreements. She also regularly delivers courses on research contracts, IP licensing and clinical trial agreements.

Mark Anderson, Solicitor and Managing Partner, Anderson Law, UK
Lisa Allebone, Solicitor and Partner, Anderson Law, UK
Agnieszka Wozniak, Solicitor and Associate Partner, Anderson Law, UK