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Data Disclosure Agreement
"I need a Data Disclosure Agreement under German law for sharing clinical trial data with a research institution in Munich, with specific provisions for handling sensitive medical data and compliance with healthcare regulations, to be effective from March 2025."
1. Parties: Identification of the data discloser and recipient, including full legal names, registration details, and addresses
2. Background: Context of the agreement, purpose of data disclosure, and relationship between the parties
3. Definitions: Detailed definitions of key terms including 'Confidential Information', 'Personal Data', 'Processing', 'Technical Data' and other relevant terms
4. Scope and Purpose of Data Disclosure: Detailed description of what data will be disclosed and the specific permitted purposes for its use
5. Data Protection Obligations: GDPR and BDSG compliance requirements, including legal basis for processing, data subject rights, and security measures
6. Confidentiality Obligations: Obligations regarding data confidentiality, permitted uses, and protection requirements
7. Technical and Organizational Measures: Required security measures for data protection, including specific GDPR Article 32 requirements
8. Data Transfer and Processing: Rules for data handling, including any international transfers and sub-processor requirements
9. Breach Notification: Procedures and timelines for reporting data breaches or security incidents
10. Term and Termination: Duration of the agreement and conditions for termination
11. Return or Destruction of Data: Obligations regarding data handling upon termination
12. Liability and Indemnification: Allocation of risks and responsibilities between parties
13. Governing Law and Jurisdiction: Specification of German law application and jurisdiction for disputes
1. Audit Rights: Optional section for when regular auditing of data handling practices is required, particularly relevant for sensitive data or regulated industries
2. Insurance Requirements: Optional section specifying required insurance coverage, relevant for high-risk data processing activities
3. Data Transfer to Third Countries: Required when data may be transferred outside the EU/EEA, including Standard Contractual Clauses
4. Specific Industry Compliance: Additional requirements for specific industries (e.g., healthcare, financial services)
5. Sub-processor Management: Detailed procedures for appointing and managing sub-processors, relevant when sub-processing is anticipated
6. Joint Controller Provisions: Required when parties act as joint controllers under GDPR Article 26
7. Service Levels: Optional section defining performance metrics and standards for data handling
1. Schedule 1: Description of Data Processing: Detailed description of data categories, processing purposes, and data subjects
2. Schedule 2: Technical and Organizational Measures: Detailed specification of security measures and controls
3. Schedule 3: Authorized Sub-processors: List of approved sub-processors and their roles, if applicable
4. Schedule 4: Transfer Mechanisms: Details of mechanisms for international data transfers, including SCCs if needed
5. Schedule 5: Contact Points: List of key contacts for operational, technical, and legal matters
6. Appendix A: Data Fields and Categories: Specific listing of data fields and categories to be disclosed
7. Appendix B: Standard Contractual Clauses: EU SCCs if required for international transfers
Authors
Authorized Purpose
Authorized Recipients
Breach Notification
Business Day
Confidential Information
Consent
Controller
Data
Data Protection Laws
Data Subject
Data Subject Rights
Disclosing Party
Effective Date
Force Majeure
GDPR
German Data Protection Act
Information Security Incident
Intellectual Property Rights
Law
Notice
Personal Data
Processing
Processor
Receiving Party
Representatives
Security Measures
Sensitive Personal Data
Services
Special Categories of Personal Data
Sub-processor
Technical and Organizational Measures
Term
Third Party
Trade Secrets
Transfer Mechanisms
Permitted Purpose
Supervisory Authority
Working Hours
Interpretation
Data Protection
Confidentiality
Data Security
Access Rights
Use Restrictions
Technical Requirements
Breach Notification
Audit Rights
Warranties
Indemnification
Liability
Force Majeure
Term and Termination
Assignment
Sub-processing
Notice
Governing Law
Dispute Resolution
Severability
Entire Agreement
Amendment
Data Transfer
Compliance
Return of Data
Destruction of Data
Reporting
Insurance
Third Party Rights
Records and Audit
Costs
Waiver
Technology
Healthcare
Financial Services
Manufacturing
Research & Development
Pharmaceuticals
Automotive
Energy
Telecommunications
Professional Services
Education
Insurance
Biotechnology
Consumer Goods
Industrial Manufacturing
Legal
Compliance
Information Security
IT
Data Protection
Risk Management
Operations
Research & Development
Business Development
Privacy
Information Governance
Procurement
Corporate Affairs
Data Protection Officer
Chief Privacy Officer
Legal Counsel
Compliance Manager
Information Security Manager
Chief Information Security Officer
IT Director
Chief Technology Officer
Risk Manager
Contract Manager
Privacy Manager
General Counsel
Chief Operating Officer
Project Manager
Business Development Manager
Research Director
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