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Distribution Agreement Pharmaceutical Products
"I need a Distribution Agreement for Pharmaceutical Products for our new line of generic antibiotics, where we will appoint an exclusive distributor in Wales with strict GDP compliance requirements and quarterly minimum purchase obligations, starting from March 2025."
1. Parties: Identification of distributor and manufacturer/supplier, including registered addresses and company numbers
2. Background: Context of the agreement, including brief description of the products and parties' authority to enter into agreement
3. Definitions: Key terms used throughout the agreement, including Product, Territory, GDP, Regulatory Requirements
4. Appointment and Territory: Scope of distribution rights (exclusive/non-exclusive) and defined territory
5. Regulatory Compliance: GDP compliance, licenses, permits, and regulatory requirements under UK law including MHRA guidelines
6. Supply and Ordering: Order processes, forecasting, minimum quantities, delivery terms
7. Quality Requirements: Storage, handling, transportation requirements and quality standards in accordance with GDP
8. Prices and Payment: Pricing structure, payment terms, and currency
9. Term and Termination: Duration, renewal, and termination provisions
1. Marketing and Promotion: Marketing obligations and restrictions in compliance with ABPI Code of Practice
2. Performance Targets: Minimum purchase or sales requirements for exclusive distribution arrangements
3. Training: Training requirements for distributor's personnel on product handling and compliance
4. Sub-distributors: Rights and restrictions regarding appointment of sub-distributors and their compliance obligations
1. Schedule 1 - Products: Detailed list of pharmaceutical products covered by the agreement
2. Schedule 2 - Price List: Current prices and any agreed discount structure
3. Schedule 3 - Quality Agreement: Detailed GDP and quality control requirements including MHRA compliance standards
4. Schedule 4 - Territory Definition: Detailed description or map of distribution territory
5. Schedule 5 - Performance Metrics: KPIs and measurement criteria for distributor performance
6. Schedule 6 - Technical Requirements: Storage, handling, and transportation specifications including cold chain requirements if applicable
7. Schedule 7 - Returns and Recall Procedures: Detailed procedures for product returns and recalls in compliance with MHRA guidelines
Authors
Applicable Laws
Business Day
Commencement Date
Confidential Information
Effective Date
Force Majeure
GDP (Good Distribution Practice)
GMP (Good Manufacturing Practice)
Initial Term
Intellectual Property Rights
License
MHRA
Minimum Order Quantity
Order
Personnel
Products
Product Specifications
Purchase Price
Quality Agreement
Quality Standards
Quarter
Recall
Regulatory Approvals
Regulatory Authority
Regulatory Requirements
Related Persons
Storage Requirements
Sub-distributor
Technical Documentation
Term
Territory
Third Party
Trade Marks
VAT
Warranty Period
Wholesale Dealer's License
Regulatory Compliance
Licenses and Permits
Supply and Ordering
Forecasting
Prices and Payment
Quality Control
Storage and Handling
Transportation
Product Recalls
Pharmacovigilance
Record Keeping
Warranties
Intellectual Property
Confidentiality
Data Protection
Non-Competition
Force Majeure
Term and Termination
Insurance
Indemnification
Limitation of Liability
Audit Rights
Marketing and Promotion
Training
Reporting
Sub-distribution
Assignment
Governing Law
Dispute Resolution
Notices
Entire Agreement
Severability
Amendments
Anti-Corruption
Export Control
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