Drafting Agreements in Life Sciences
Autor Mark Anderson, Lisa Allebone, Agnieszka Wozniaken Limba Engleză Hardback – 24 sep 2026
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.
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Specificații
ISBN-13: 9781526532411
ISBN-10: 1526532417
Pagini: 848
Dimensiuni: 156 x 248 x 28 mm
Greutate: 0.5 kg
Editura: Bloomsbury Publishing
Colecția Bloomsbury Professional
Locul publicării:London, United Kingdom
ISBN-10: 1526532417
Pagini: 848
Dimensiuni: 156 x 248 x 28 mm
Greutate: 0.5 kg
Editura: Bloomsbury Publishing
Colecția Bloomsbury Professional
Locul publicării:London, United Kingdom
Cuprins
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
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
Recenzii
[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. One can have every confidence in the drafting, edited as the book is by Mark Anderson, whose area of speciality this is, and who has already written a number of valuable books on technology licensing
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
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