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
The need to establish a steady and receptive supply chain is critical for all biotech companies. Effective preparation, negotiation and deployment of service agreements for all stages of pre-clinical, clinical, and commercial use requires experienced legal counsel that understands the industry-specific facets of a complex supply chain.
In the current environment, with scarcities of supply capabilities and capacity, 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?
Our lawyers know the implications of not having comprehensive knowledge about a project, and as such they work hard to develop both a deep 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.
We will draw on our entire teams’ experience in handling supply chain contracting for hundreds of pharmaceutical products and product candidates.
We’ll 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.
We’ll also counsel clients’ CMC teams on creative problem-solving based on our deep understanding of this space, as well as how to make pragmatic tactical decisions about agreement negotiation to achieve time and cost goals.
If you are developing your product in collaboration with a strategic partner such as Big Pharma, that strategic partner has likely imposed obligations on you designed to protect intellectual property rights, preserve confidentiality and data privacy, ensure compliance, and address liability. Typically, you will be required to pass these obligations along to your CDMOs.
We can help you understand your obligations and can incorporate these kinds of requirements effectively into your CDMO agreements in a way that helps you meet aggressive timelines and manage your legal costs.
We can also help you structure, draft and negotiate intellectual property license agreements that will give you “freedom to operate” with respect to the manufacture of your product.
Whether you need to obtain a non-exclusive license to blocking patent rights of a third party identified by your intellectual property counsel, or you only have a research license for an off-the-shelf cell line and need to obtain a license to use the cell line for clinical development and commercialization – we have the practical experience to help you efficiently and effectively obtain the rights that you need.