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Exclusive Manufacturing And Supply Agreement
"I need an Exclusive Manufacturing And Supply Agreement for my medical device company to secure a manufacturer in California who will exclusively produce our patented cardiac monitoring devices, with strict quality control requirements and FDA compliance measures."
1. Parties: Identification and details of the manufacturer and buyer
2. Background: Context of the agreement and business relationship
3. Definitions: Key terms used throughout the agreement
4. Scope of Manufacturing: Detailed description of products to be manufactured
5. Exclusivity Terms: Terms of exclusive manufacturing arrangement including territorial restrictions and exceptions
6. Quality Requirements: Manufacturing standards, quality control processes, and compliance requirements
7. Pricing and Payment: Price structure, payment terms, and price adjustment mechanisms
8. Forecasting and Orders: Process for submitting forecasts and purchase orders
9. Delivery and Acceptance: Delivery terms, inspection rights, and acceptance procedures
10. Intellectual Property Rights: Ownership and protection of IP related to manufacturing process and products
11. Warranties and Indemnification: Product warranties, quality guarantees, and indemnification obligations
12. Term and Termination: Duration of agreement and grounds for termination
13. Confidentiality: Protection of confidential information and trade secrets
14. Force Majeure: Circumstances excusing performance and related procedures
15. Governing Law and Dispute Resolution: Applicable law and mechanisms for resolving disputes
1. International Trade Compliance: Provisions for import/export regulations and customs requirements when manufacturing involves cross-border activities
2. Environmental Compliance: Environmental standards, certifications, and compliance requirements for manufacturing processes with environmental impact
3. Technology Transfer: Terms for sharing manufacturing technology and technical knowledge when proprietary processes are involved
4. Capacity Commitment: Specific commitments regarding manufacturing capacity and facility dedication
5. Business Continuity: Disaster recovery and business continuity provisions
1. Schedule 1 - Product Specifications: Detailed technical specifications of products to be manufactured
2. Schedule 2 - Quality Control Procedures: Detailed quality control processes, standards, and testing requirements
3. Schedule 3 - Pricing Schedule: Detailed pricing structure, volume-based discounts, and price adjustment mechanisms
4. Schedule 4 - Manufacturing Facility Details: Specifications of manufacturing facilities, capabilities, and certifications
5. Schedule 5 - Key Performance Indicators: Metrics for measuring manufacturing performance and quality standards
6. Schedule 6 - Forecast and Order Procedures: Detailed procedures for submitting forecasts and purchase orders
Authors
Applicable Laws
Authorized Representative
Batch
Business Day
Certificate of Analysis
Change Control Procedures
Confidential Information
Delivery Date
Effective Date
Exclusive Territory
Force Majeure Event
Forecast
Good Manufacturing Practice
Improvement
Inspection Period
Intellectual Property Rights
Key Performance Indicators
Lead Time
Manufacturing Facility
Manufacturing Process
Manufacturing Schedule
Minimum Purchase Commitment
Non-Conforming Products
Permitted Sub-contractors
Products
Product Specifications
Production Capacity
Purchase Order
Quality Control Procedures
Quality Standards
Raw Materials
Regulatory Approvals
Rejection Notice
Safety Stock
Specifications
Technical Documentation
Technology Transfer
Term
Territory
Third Party
Unit Price
Warranty Period
Exclusivity
Product Specifications
Quality Control
Price and Payment
Minimum Purchase Commitments
Delivery Terms
Intellectual Property Rights
Confidentiality
Warranties
Term and Termination
Force Majeure
Indemnification
Insurance
Manufacturing Process
Capacity Commitments
Raw Materials
Quality Assurance
Product Testing
Acceptance and Rejection
Change Control
Forecasting
Purchase Orders
Shipping and Logistics
Regulatory Compliance
Environmental Compliance
Health and Safety
Record Keeping
Audit Rights
Good Manufacturing Practice
Product Recall
Governing Law
Dispute Resolution
Assignment
Severability
Entire Agreement
Notices
Amendment
Waiver
Relationship of Parties
Survival
Technology Transfer
Non-Competition
Most Favored Nation
Business Continuity
Sustainability Requirements
Export Control
Anti-Corruption
Data Protection
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