CMC/Supply Chain Agreements

Overview

Establishing a responsive and reliable supply chain is a critical path item for all biotech companies. Effective preparation, negotiation and deployment of service agreements for pre-clinical laboratory services, formulation and development, and cGMP manufacturing of drug substance and drug product for clinical and/or commercial use requires experienced legal counsel that understands the industry-specific drivers of a complex supply chain.

Experience

At Faber, a core part of our day-to-day practice includes the representation of both drug sponsors and contract development and manufacturing organizations in the negotiation of supply chain documentation for biologics and APIs.  Our CMC/supply chain practice develops and customizes suites of supply chain agreements that are tailored to reflect both current industry practices and client priorities regarding intellectual property, performance metrics, quality assurance, and termination rights and remedies.

The following supply chain agreements are typical of the types of contracts we regularly prepare and negotiate for our clients:

  • Master Contract Service Agreements (pre-clinical services, including GLP and other non-GMP services)
  • Development and Manufacturing Agreements for Clinical Supply (including formulation, scale-up and validation services)
  • Manufacturing Agreements for Commercial Supply (including exclusive and non-exclusive supply arrangements)
  • Quality Agreements that work hand-in-hand with Supply Agreements

Contact us to learn how we develop and negotiate customized supply chain documentation designed to meet client-driven priorities and timelines.

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