Coming Soon Drafting Agreements in Life Sciences

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Drafting Agreements in Life Sciences

By Anderson. Mark
Coming Soon Bloomsbury Professional (formerly Tottel Publishing) Available March 2027

Specifications

ISBN-13
9781526532411
Publisher
Bloomsbury Professional (formerly Tottel Publishing)
Publication
March 2027
Format
Hardback
Jurisdiction
U.K. ? Countri(es) for reference only

Details

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).

Table of Contents

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
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