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Biobank Agreement

Biobank Agreement Template for Switzerland

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Key Requirements PROMPT example:

Biobank Agreement

"I need a Biobank Agreement for our university research facility in Geneva that will collect and store human tissue samples from multiple hospitals starting March 2025, with a focus on cancer research collaboration and data sharing with other Swiss academic institutions."

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Document background
The Biobank Agreement serves as a critical legal instrument for organizations operating or participating in biobank facilities within Switzerland. This document is essential when establishing or managing facilities that collect, store, and distribute biological samples and associated data for research, medical, or commercial purposes. It ensures compliance with Swiss regulatory requirements, including the Human Research Act (HRA), Federal Act on Data Protection (FADP), and relevant cantonal regulations. The agreement addresses key operational aspects such as sample handling procedures, data protection measures, quality standards, and access protocols, while incorporating necessary ethical safeguards and consent requirements. It is particularly relevant for research institutions, healthcare facilities, and commercial entities involved in biomedical research and development.
Suggested Sections

1. Parties: Identification of the contracting parties - typically the biobank operator and the participating institution/researcher

2. Background: Context of the agreement, purpose of the biobank, and general objectives

3. Definitions: Detailed definitions of technical and legal terms used throughout the agreement

4. Scope of Agreement: Details of the biological materials and data covered by the agreement

5. Ethical and Legal Compliance: Compliance requirements with Swiss laws, ethical guidelines, and relevant international standards

6. Collection and Storage: Procedures for sample collection, processing, and storage requirements

7. Data Protection and Privacy: Measures for protecting personal and genetic data, including compliance with FADP

8. Access and Usage Rights: Terms governing access to and use of stored samples and data

9. Quality Management: Quality control measures and standard operating procedures

10. Safety and Security: Physical and digital security measures for samples and data

11. Duration and Termination: Term of agreement, renewal provisions, and termination conditions

12. Liability and Indemnification: Allocation of risks and responsibilities between parties

13. General Provisions: Standard legal clauses including governing law, jurisdiction, and amendment procedures

Optional Sections

1. Commercialization Rights: Include when there's potential commercial use of samples or derived products

2. International Transfer: Required when samples or data may be transferred across borders

3. Cost and Pricing: Include when the biobank charges for services or sample access

4. Research Collaboration: Add when the agreement includes specific research projects or collaborations

5. Publication Rights: Include when addressing rights to publish research results from biobank samples

6. Intellectual Property: Required when dealing with potential IP rights from sample usage

7. Emergency Procedures: Add for biobanks storing critical or sensitive materials requiring special handling

8. Return of Results: Include when addressing how research findings are communicated back to sample donors

Suggested Schedules

1. Schedule 1: Technical Specifications: Detailed specifications for sample collection, processing, and storage

2. Schedule 2: Fee Schedule: Pricing structure for services and sample access if applicable

3. Schedule 3: Quality Management Procedures: Detailed quality control and assurance procedures

4. Schedule 4: Security Protocols: Detailed security measures and access procedures

5. Appendix A: Consent Forms: Template consent forms for sample collection

6. Appendix B: Material Transfer Forms: Templates for documenting sample transfers

7. Appendix C: Data Protection Protocols: Detailed data protection and privacy procedures

8. Appendix D: Emergency Contact List: List of emergency contacts and response procedures

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok³ÉÈË°æ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co
Relevant legal definitions


































Clauses




























Relevant Industries

Healthcare

Biotechnology

Pharmaceutical

Medical Research

Academic Research

Life Sciences

Clinical Trials

Public Health

Personalized Medicine

Genetic Research

Relevant Teams

Legal

Compliance

Research and Development

Quality Assurance

Laboratory Operations

Data Management

Regulatory Affairs

Ethics Committee

Clinical Operations

Information Security

Sample Management

Scientific Affairs

Relevant Roles

Research Director

Laboratory Manager

Biobank Coordinator

Quality Assurance Manager

Data Protection Officer

Ethics Committee Member

Principal Investigator

Legal Counsel

Compliance Officer

Research Scientist

Clinical Trial Manager

Regulatory Affairs Specialist

Facility Manager

Sample Management Coordinator

Chief Scientific Officer

Medical Director

Industries









Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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