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Biobank Agreement

Biobank Agreement Template for Netherlands

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Key Requirements PROMPT example:

Biobank Agreement

"I need a Biobank Agreement for a research collaboration between Amsterdam University Medical Center and three regional hospitals, starting March 2025, focusing on cancer research sample collection and storage, with strict GDPR compliance and data sharing protocols."

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Document background
A Biobank Agreement is essential when establishing or participating in a biological materials repository in the Netherlands. This document is used to formalize arrangements between parties involved in collecting, storing, and managing human biological samples and associated data for research purposes. The agreement must comply with Dutch legal requirements, including the Medical Research Involving Human Subjects Act (WMO), the Human Tissue and Safety Act (WVKL), and EU GDPR regulations. It typically includes detailed provisions for quality management, informed consent procedures, data protection measures, access protocols, and intellectual property rights. The document is particularly relevant for research institutions, hospitals, and organizations involved in medical research, ensuring proper governance and compliance in biobank operations.
Suggested Sections

1. Parties: Identification of the contracting parties, typically including the biobank operator and the contributing institution(s)

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

3. Definitions: Detailed definitions of technical terms, legal concepts, and specific terminology used in biobanking

4. Scope and Purpose: Detailed description of the biobank's scope, types of biological materials to be stored, and intended uses

5. Governance Structure: Description of the management structure, decision-making processes, and oversight committees

6. Collection and Storage: Procedures for collecting, processing, and storing biological materials

7. Quality Standards: Quality management requirements, including ISO standards compliance and quality control procedures

8. Access and Use: Rules and procedures for accessing and using stored materials and associated data

9. Data Protection and Privacy: GDPR compliance measures and data protection protocols

10. Intellectual Property Rights: Ownership and rights regarding samples, data, and research outcomes

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

12. General Provisions: Standard legal clauses including governing law, dispute resolution, and amendments

Optional Sections

1. Commercial Terms: Include when the biobank operates on a commercial basis, covering pricing, cost recovery, and revenue sharing

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

3. Research Collaboration: Include when the biobank is part of a larger research collaboration framework

4. Material Transfer Provisions: Specific terms for transferring materials to third parties

5. Emergency Procedures: Include for biobanks storing critical or irreplaceable samples

6. Benefit Sharing: Include when there are potential commercial benefits from research using the stored materials

Suggested Schedules

1. Technical Specifications: Detailed technical requirements for sample collection, processing, and storage

2. Quality Management System: Detailed quality control procedures and standards

3. Data Processing Agreement: GDPR-compliant data processing terms and conditions

4. Access Request Form: Standard form for requesting access to stored materials and data

5. Informed Consent Template: Template for obtaining donor consent

6. Fee Schedule: List of applicable fees and charges if relevant

7. SOPs: Standard Operating Procedures for key processes

8. Contact Details: List of key contacts and responsible persons

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

Life Sciences

Biotechnology

Pharmaceutical

Medical Research

Academic Research

Clinical Trials

Laboratory Services

Relevant Teams

Legal

Research and Development

Laboratory Operations

Quality Assurance

Regulatory Affairs

Data Protection

Clinical Operations

Information Technology

Ethics Committee

Contract Management

Compliance

Relevant Roles

Research Director

Biobank Manager

Laboratory Manager

Quality Assurance Manager

Data Protection Officer

Legal Counsel

Clinical Research Coordinator

Principal Investigator

Regulatory Compliance Officer

Ethics Committee Member

Research Scientist

Medical Director

Contract Manager

Information Security Officer

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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