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Clinical Supply Agreement Template for Austria

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Key Requirements PROMPT example:

Clinical Supply Agreement

"I need a Clinical Supply Agreement governed by Austrian law for supplying investigational cancer treatment drugs to multiple research sites across Austria, with specific provisions for temperature-controlled storage and transport, to be effective from March 2025."

Document background
The Clinical Supply Agreement is essential when establishing a formal relationship between suppliers and recipients of clinical trial materials in Austria. This document is typically used when a pharmaceutical company, biotechnology firm, or research institution requires a reliable supply of investigational products for clinical trials. The agreement must comply with Austrian legal requirements while incorporating EU regulations, particularly EU Clinical Trials Regulation 536/2014 and GMP guidelines. It addresses critical aspects such as manufacturing standards, quality control, delivery specifications, and regulatory compliance. The document becomes particularly important in multi-site clinical trials or when dealing with temperature-sensitive or specialized medical products. It serves as a cornerstone document that defines responsibilities, risk allocation, and quality standards while ensuring compliance with both Austrian and EU regulatory frameworks.
Suggested Sections

1. Parties: Identification of contracting parties including full legal names and addresses

2. Background: Context of the agreement including the clinical trial purpose and supply relationship

3. Definitions: Definitions of key terms used throughout the agreement

4. Supply Obligations: Core obligations regarding the manufacture and supply of clinical trial materials

5. Forecasting and Ordering: Process for forecasting requirements and placing orders

6. Quality Requirements: Quality standards, testing requirements, and compliance with GMP

7. Delivery and Storage: Terms for delivery, acceptance, and storage requirements

8. Price and Payment: Pricing structure, payment terms, and invoicing procedures

9. Regulatory Compliance: Compliance with applicable laws and regulations, including maintenance of authorizations

10. Quality Assurance and Audits: Quality control procedures and audit rights

11. Confidentiality: Protection of confidential information exchanged between parties

12. Intellectual Property: IP rights and obligations related to the clinical supplies

13. Representations and Warranties: Standard and specific warranties regarding the supplies and services

14. Indemnification: Allocation of risks and indemnification obligations

15. Insurance: Insurance requirements for both parties

16. Term and Termination: Duration of agreement and termination provisions

17. Force Majeure: Provisions for handling events beyond reasonable control

18. Governing Law and Jurisdiction: Application of Austrian law and jurisdiction

19. General Provisions: Standard boilerplate clauses including notices, assignment, and amendments

Optional Sections

1. Safety Stock: Requirements for maintaining minimum inventory levels, used when supply continuity is critical

2. Technology Transfer: Provisions for transfer of manufacturing technology, needed if manufacturing process is unique or complex

3. Stability Testing: Obligations for ongoing stability testing, included when required by regulatory requirements

4. Clinical Trial Support Services: Additional services beyond basic supply, included when supplier provides additional trial support

5. Import/Export Requirements: Specific provisions for cross-border supply, needed for international trials

6. Packaging and Labeling: Detailed requirements for special packaging or labeling, when non-standard requirements exist

7. Material Safety: Special handling requirements for hazardous materials, included when applicable

8. Pharmacovigilance: Safety reporting obligations, included when supplier has safety reporting responsibilities

9. Disaster Recovery: Business continuity provisions, included for critical supplies

10. Data Protection: Detailed GDPR compliance provisions, needed when personal data is processed

Suggested Schedules

1. Product Specifications: Detailed technical specifications of the clinical trial materials

2. Quality Agreement: Detailed quality requirements and responsibilities

3. Pricing Schedule: Detailed pricing information including any volume-based adjustments

4. Service Level Requirements: Specific performance metrics and service levels

5. Manufacturing Sites: List of approved manufacturing facilities

6. Key Personnel: List of key contacts and responsible persons

7. Handling and Storage Requirements: Detailed requirements for product handling and storage

8. Form of Quality Certificate: Template for certificate of analysis or conformity

9. Form of Purchase Order: Standard form for ordering supplies

10. Technical Transfer Plan: Details of any required technology transfer process

Authors

Alex Denne

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

Relevant legal definitions












































Clauses







































Relevant Industries

Pharmaceuticals

Biotechnology

Healthcare

Clinical Research

Medical Devices

Contract Manufacturing

Life Sciences

Research & Development

Relevant Teams

Legal

Procurement

Quality Assurance

Regulatory Affairs

Supply Chain

Clinical Operations

Research & Development

Compliance

Manufacturing

Logistics

Business Development

Medical Affairs

Contract Management

Relevant Roles

Clinical Operations Director

Procurement Manager

Quality Assurance Manager

Regulatory Affairs Director

Supply Chain Manager

Clinical Trial Manager

Legal Counsel

Compliance Officer

Contract Manager

Manufacturing Director

Clinical Research Director

Quality Control Manager

Logistics Manager

Business Development Director

Chief Medical 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, 聽Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination, 聽Severance Pay, Governing Law, Entire Agreemen

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