Launching a drug development company with novel technology from academia
Our corporate group has worked with hundreds of entrepreneurs at this stage to help them optimally and efficiently select and form the appropriate legal entity
Projects We Work On
CMC/Supply Chain Agreements
Establishing a responsive and reliable supply chain is a critical path item for all biotech companies.
Overview
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
We counsel clients’ CMC teams about creative problem-solving based on our deep understanding of this space, and how to make pragmatic tactical decisions about agreement negotiation to achieve time and cost goals.
A primary concern in contracting for a pharmaceutical supply chain is leverage – how does a potential supplier have leverage now and how might that leverage grow over time? How does a drug developer have leverage now and how might that leverage be maintained or grow over time?
When our lawyers start working with you, of course they’ll need to understand the type of drug product (small molecule, biologic, cell or gene therapy) and the specific manufacturing process, but in tandem, they will work to develop an understanding around leverage and a strategy for negotiating optimal economic terms, risk allocation terms, and relationship management terms based on each party’s leverage at different stages of the term of the proposed supply agreement.
Practical Counsel
Our lawyers draw on our entire teams’ experience in handling supply chain contracting for hundreds of pharmaceutical products and product candidates. We talk with clients’ CMC teams about solutions we’ve seen, with similar products and/or manufacturing processes, to successfully address the challenges of maintaining portability of process, protecting and providing access to intellectual property innovations, establishing meaningful performance metrics, and ensuring scalability to commercial forecasts.
