Drafting Agreements in Life Sciences

Mark Anderson, Solicitor and Managing Partner, Anderson Law, UKLisa Allebone, Solicitor and Partner, Anderson Law, UK

• 1. Introduction to Agreements in the Bio/Pharma Sector2. Preliminary Agreementsa) Non-Binding Term Sheet (Plus Binding Provisions: Exclusivity, Stand-Still, Confidentiality)b) Confidentiality Agreementc) Material Transfer Agreementd) Data Transfer Agreement3. Collaborative Research and Development AgreementsIntroduction to Chaptera) Research Collaboration Agreement (With Various IP Optional Clauses)b) Commercial Development and Licence Agreement4. Services AgreementsIntroduction to Chaptera) Master Services Agreementb) Simple Consultancy Services Agreementc) Agreement With Scientific Advisory Board Memberd) Agreement to Develop Manufacturing Process and Manufacture for Clinical Trialse) Software-as-a-Service Agreement5. Clinical Trials AgreementsIntroduction to Chaptera) Agreement to Manage Clinical Trialsb) Site Agreementc) Clinical Trials Consent Form6. Manufacturing, Supply, Distribution and Marketing AgreementsIntroduction to Chaptera) Contract Manufacturing Agreementb) Agreement for Licensor to Supply Product to Licenseec) Product Distribution Agreementd) Co-Promotion Agreement7. Licence AgreementsIntroduction to Chaptera) Detailed Patent and Know-How Licence Agreementb) Short-Form Licence for Registration With Patent Offices, Etc.c) Detailed Software Licence Agreement (With AI Provisions)d) Licence Termination Agreemente) Extensive IP Warranties for Licence Agreement8. Assignments and Management AgreementsIntroduction to Chaptera) General IP Assignment (Including Patents, Copyright, Know-How, Materials, etc)b) Employee IP Assignment and Confidentiality Agreementc) Co-Ownership Agreement9. Regulations Affecting the Research and Development of Medicinal Products10. Regulations Affecting the Research and Development of Medical Devices11. IP and Data Protection Laws12. Competition Law Issues

[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