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
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.
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:
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.
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.