Last Updated: October 21, 2024

Important Notice

These Terms and Conditions ("Terms") form a binding legal agreement between VERTEQ PTY LTD (ACN 657 435 615) trading as Leafy Labs ("Leafy Labs," "we," "us," "our") and healthcare professionals and licensed pharmacies ("Partners," "you," "your") utilising our pharmaceutical supply services.

1. Definitions and Interpretation

1.1 Definitions

In these Terms:

• AHPRA: Australian Health Practitioner Regulation Agency
• ARTG: Australian Register of Therapeutic Goods
• Authorisation: Any licence, permit, registration, or approval required by law
• Compliance Requirements: All applicable laws, regulations, and standards, including:
  • Therapeutic Goods Act 1989
  • Therapeutic Goods Regulations 1990
  • State and Territory pharmacy legislation
  • Professional practice standards
  • TGA guidelines and requirements
• Controlled Substances: Substances regulated under relevant State and Territory legislation
• GDP: Good Distribution Practice as defined by current TGA guidelines
• Healthcare Professional: Registered medical practitioners authorised to prescribe medication in Australia
• Law: Includes federal, state, and local legislation, regulations, statutory instruments, amendments, and regulatory guidelines
• Licensed Pharmacy: Pharmacies registered with the Pharmacy Board of Australia
• Products: Pharmaceutical products supplied by Leafy Labs
• Quality Management System: Documented procedures and processes for ensuring product quality
• TGA: Therapeutic Goods Administration

1.2 Interpretation

• Singular includes plural and vice versa
• References to legislation include amendments and replacements
• Headings are for reference only
• "Including" means "including, but not limited to"

2. Scope of Services

2.1 Product Supply

Leafy Labs:

• Provides pharmaceutical products to authorised healthcare professionals and facilities
• Maintains strict quality control throughout the supply chain
• Ensures full compliance with regulatory requirements
• Offers product support and technical information

2.2 Qualified Partners

Products are available exclusively to:

• Registered medical practitioners
• Licensed pharmacies
• Authorised healthcare facilities
• Approved wholesale distributors

3. Regulatory Compliance

3.1 Our Obligations

We maintain:

• All necessary licences and permits
• Full compliance with TGA requirements
• Certification under our Quality Management System
• Adherence to GDP standards
• Proper facilities and operational protocols

3.2 Partner Requirements

Partners must:

• Maintain current registration or licensing
• Adhere to all relevant laws and regulations
• Follow applicable professional standards
• Ensure their facilities and security measures are compliant

4. Quality Assurance

4.1 Product Standards

All Products:

• Are registered with ARTG
• Comply with TGA regulatory requirements
• Include full batch traceability
• Are stored and handled to prevent degradation
• Meet or exceed applicable quality specifications

4.2 Storage and Handling

Partners must ensure:

• Correct temperature and humidity controls
• Secure storage facilities
• Procedures to prevent contamination
• Stock rotation practices are followed

5. Ordering and Supply

5.1 Order Process

Orders must be placed through authorised channels, with:

• Complete and accurate documentation
• Verification of professional credentials
• Compliance with any applicable quantity limits
• Adherence to any special handling requirements

5.2 Verification

We verify:

• Professional credentials
• Authenticity of the order
• Delivery and handling requirements
• Payment arrangements

6. Delivery and Receipt

6.1 Delivery Requirements

All deliveries will comply with GDP standards, including:

• Temperature control and monitoring
• Secure transport and handling
• Real-time tracking
• Accurate delivery documentation

6.2 Receipt Procedures

Partners are responsible for:

• Inspecting deliveries immediately upon receipt
• Verifying the condition of products
• Checking delivery documentation for accuracy
• Reporting any discrepancies
• Maintaining thorough records

7. Safety and Pharmacovigilance

7.1 Safety Monitoring

Leafy Labs ensures:

• A system for reporting adverse events
• Investigation of product quality complaints
• Regular safety reviews and quality assessments
• Safety signal detection mechanisms

7.2 Partner Obligations

Partners must report to us promptly:

• Any adverse events related to products
• Product complaints or quality issues
• Safety concerns or usage problems

8. Security Requirements

8.1 Physical Security

Partners must implement and maintain:

• Secure storage areas for products
• Access control systems
• Continuous monitoring of facilities
• Strict inventory management and control

8.2 Information Security

Leafy Labs adheres to robust security standards, ensuring:

• Protection of sensitive data
• Comprehensive system security
• Access management and encryption
• Compliance with privacy laws and standards

9. Documentation and Records

9.1 Required Records

Partners are required to maintain:

• Detailed supply chain records
• Documentation for all quality control procedures
• Temperature and environmental logs
• Security and compliance records

9.2 Record Retention

All records must be retained for at least seven years, with:

• Secure, accessible storage
• Ensured confidentiality
• Reliable backup systems

10. Audit and Inspection

10.1 Audit Rights

Leafy Labs reserves the right to:

• Inspect partner facilities
• Review documentation and records
• Assess compliance with regulatory and quality standards
• Investigate incidents or breaches of procedure

10.2 External Audits

Partners must facilitate:

• Regulatory and compliance inspections
• Quality and procedural audits
• Documentation reviews

11. Liability and Insurance

11.1 Our Liability

Our liability is limited to:

• Ensuring product quality and safety
• Compliance with all applicable regulations
• Maintaining supply chain integrity
• Accuracy of documentation

11.2 Partner Liability

Partners are responsible for:

• Maintaining professional standards and practices
• Compliance of facilities and operations
• Adequate staff training and supervision
• Implementing and enforcing security measures
• Ensuring patient safety and care

11.3 Insurance

Partners must have comprehensive insurance coverage, including:

• Professional indemnity
• Public liability
• Product liability
• Business and operational insurance
• Workers' compensation insurance

12. Breach and Remedies

12.1 Material Breach

A material breach includes:

• Regulatory non-compliance
• Loss of licence or authorisation
• Security breaches
• Quality control failures
• Falsification or failure to maintain documentation

12.2 Remedies

In the event of a breach, Leafy Labs reserves the right to:

• Suspend supply of products
• Terminate the agreement
• Report breaches to relevant authorities
• Seek damages or take legal action

13. Privacy and Confidentiality

13.1 Data Protection

We ensure compliance with data privacy laws, including:

• Robust data security measures
• Protection of sensitive personal and business information
• Access controls and encryption of sensitive data

13.2 Confidential Information

Confidential information includes:

• Business operations and strategies
• Technical data and product specifications
• Partner details and contracts
• Pricing and financial arrangements

14. General Provisions

14.1 Amendments

These Terms may be amended as necessary. Notice of any changes will be provided, and continued use of our services constitutes acceptance of the updated Terms. Partners may object to amendments through the specified procedures.

14.2 Governing Law

These Terms are governed by the laws of Queensland, applicable Australian federal laws, and all relevant TGA regulations, professional standards, and industry codes.

Contact Information

Leafy Labs
9/204 Alice Street
Brisbane QLD 4000
Email: hello@leafylabs.com.au

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