Establishing a Pharmaceutical Supply Chain
Overview
The need to establish a steady and receptive supply chain is critical for all pharmaceutical and 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 understand the industry-specific facets of a complex supply chain.
Industry Knowledge
Establishing leverage
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?
A comprehensive approach
When our lawyers start working with you, understanding the type of drug product (small, biologic, cell, or gene therapy) and the specific manufacturing process is only one part of a much larger picture.
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 team’s experience in handling supply chain contracting for hundreds of pharmaceutical products and product candidates.
We’ll talk with clients’ chemistry, manufacturing, and controls (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.
Our practical understanding of what works and what doesn’t in the real world is unmatched by other firms.
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 contract development and manufacturing organizations (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.
Our licensing lawyers have extensive experience operationalizing complex license and collaboration agreements with strategic partners in the context of supply chain contracting.
Freedom to operate
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.
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