What we do
We provide life sciences companies with corporate legal and IP services that are needed to successfully advance drug therapies from pre-clinical stage to clinical stage and commercialization across any of the practice areas detailed below:
Fractional General Counsel or Chief IP Counsel to either augment legal departments or serve in these capacities in the absence of in-house legal counsel
Fractional Support:
General Counsel
Chief IP Counsel
Perfect for companies that do not have an in-house General Counsel or Chief IP Counsel and cannot justify the expense of having one. We can fill that void on a short-term or long-term basis with flexible billing arrangements to help companies manage their budgets. Even for companies with in-house counsel, having us as your partner on a fractional basis provides cost-effective seasoned executive legal support to help navigate inevitable legal challenges and execute opportunities encountered by life sciences companies. Expect the range of services to be comprehensive of what you can anticipate from in-house counsel without the fully-loaded cost or commitment. We do not aim to replace your current outside counsel though we can offset that higher priced expense, efficiently manage your outside counsel, and offer suggestions for alternative counsel as desired with our deep global network of trusted and effective outside counsel. Representative work that we can either directly support or efficiently manage in this capacity include:
General Counsel:
Corporate governance
Board minutes and resolutions
SEC reporting
Corporate financings
Strategic transactions: planning & execution
Negotiation of clinical and supply chain agreements
Contract template preparation
Chief IP Counsel:
Patent strategy
Patent application preparation and global prosecution management
Freedom-To-Operate assessments & risk analysis
Patent challenges and dispute management
Trade secret protection
Branding strategies; trademarks & domain names
Publication and disclosure review
Strategic IP Counseling
IP is the lifeblood of biotech companies. With decades of experience on both the buy-side and sell-side, we know what investors and strategic partners, and their counsel, want to see before investing in a company’s IP. Our IP Counseling practice typically begins with an IP Audit during which we assess how your therapeutic drug candidate is protected and provide strategic direction based on existing or proposed patent filings. Following an IP Audit, we can lead the execution of our IP strategy to not only develop a desirable patent portfolio to progress investment decisions but also protect therapeutic drug candidates from innovative, generic or biosimilar competition.
While we are experienced with virtually all types of modalities, we have deep knowledge and expertise in the protection of small molecules, oligonucleotides, peptides, and gene therapies.
IP Risk, Litigation Strategy & Management
Identifying competitors with threatening IP before they identify you is a key element of a successful drug development program. We help companies look around the corner by conducting freedom to operate (FTO) analyses. An important step overlooked without an experience in-house counsel is translating a FTO analysis to an action plan that can take many forms. It may involve simply monitoring the landscape in a wait-and-see mode. Or, it may involve preparing to challenge a threating competitive patent position. Alternatively, it may involve going on the offensive to enforce your rights. No matter the situation, we are well-prepared and experienced in conducting FTO analyses, developing an accompanying action plan, and managing the implementation of the plan.
IP Licensing, M+A & Transactions
IP is typically central to a deal, yet it is often overlooked by a seller seeking a strategic partnership or sale. Working with us before engaging potential strategic partners to prepare for legal and IP diligence can help avoid stumbling blocks and distractions in negotiations that can be used by a buyer to de-value the asset of interest. Backed by significant experience on the buy-side in addition to the sell-side, we have successfully handled challenging IP issues during diligence to give buyers confidence in pursuing a strategic transaction. With diligence in order, we have supported the negotiation and drafting of a wide variety of M+A, licensing and other strategic transactions.
R+D Transactions
R+D Transactions and other significant operational agreements are necessary prior to the real work of drug discovery and development getting underway. Prolonged negotiations can frustrate the stakeholders involved and whittle away a first mover advantage in a competitive space. It is thus invaluable to have outside counsel who can effectively negotiate these important agreements with an in-house perspective. We have experience with a wide-variety of agreements and can serve to negotiate these agreements directly or with outside counsel depending upon the circumstances. Representative agreements in which we have experience include:
Research Agreements:
Material Transfer Agreements
Consulting Agreements
Testing Evaluation Agreements
Master Research Services Agreements
Clinical Agreements:
Clinical Research Organization Services Agreements
Clinical Site Agreements
Informed Consents
Data Protection Agreements
CMC Agreements:
Drug Supply and Drug Product Supply Agreements
Logistics (3PL) Vendor Agreements
Quality Agreements
Corporate Financings
Capital is the fuel for generating valuable data to advance innovative drug therapies. We are prepared to support your financing efforts whether dilutive or non-dilutive, public or private. Having experience with a variety of financing deals with an in-house perspective, we can help ensure that your legal and IP assets are in order for diligence and collaborate with outside counsel to negotiate agreements that strike a proper balance of risk mitigation while moving with speed to secure timely execution.