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
Jacqui M. Hall
Senior Of Counsel
Jacqui’s experience in the biopharmaceutical and technology industries includes a variety of roles - both business and legal. Her experience is an asset when it comes to understanding clients’ business needs and developing pragmatic approaches to helping them.
Jacqui often assists clients with developing contracting processes and standardized agreement terms for various client relationships. She has extensive experience negotiating manufacturing and supply chain-related agreements (including for manufacture of biologics), SaaS and other software and technology-related agreements, clinical study agreements, the extensive range of agreements required for support of clinical trials including trials outside the U.S. and a range of agreements with academic and non-profit organizations including for transfer of materials and sponsored research.
Jacqui’s clients include biopharmaceutical companies of many types and in various phases of life cycle: virtual and in discovery phase, companies with their first product launch, and clients with multiple products on the market.
Jacqui’s clients include biopharmaceutical companies of many types and in various phases of life cycle: virtual and in discovery phase, companies with their first product launch, and clients with multiple products on the market.
More about Jacqui
Contracts Manager
Novartis Pharmaceuticals Corporation
- Worked on clinical trial agreements
- Helped develop guidance on negotiating clinical trial agreements
In-house Counsel
Millennium Pharmaceuticals, Inc. (now Takeda Pharmaceutical Company Limited)
- Handled a broad range of transactions including licensing of biotechnology and software technologies
- Drafted a variety of consulting agreements, and service and manufacturing agreements
Industry Collaborations
- Edimer Pharmaceuticals and CMC Biologics Manufacturing Contract to support the development of EDI200, a clinical-stage recombinant protein for the treatment of X-linked Hypohidrotic Ectodermal Dysplasia (XLHED), a rare genetic disease with orphan designation in the USA and Europe
- Evaluation Agreement for combination of client compound with other party’s proprietary delivery formulation
- Services Agreement for a collection of human blood samples with certain specified infectious diseases for use by client in producing monoclonal antibodies
Customer Agreements
- SaaS Agreement for access and use by client of cloud-based trial master file application for use in client’s worldwide clinical trials
- Agreement for management of client’s speaker bureau including facilitation of speaker training, payments to speakers and logistics
- Agreement for consulting services such as PK analysis of client drug in combination with other drugs and to determine existence of drug-drug interaction
Academic Research
- Short term Collaboration Agreement between nonprofit client and commercial organization for targeted drug design
- Sponsored Research Agreement to explore the activity of client compound against CNS tumors with specified mutations in vitro and in vivo
- Academic Research Agreement for sequencing of samples from tumor bank for specified mutations in patients with cancer, and description of baseline characteristics of the patient population
Clinical Trials
- Supply Agreement for supply and distribution throughout the world of client’s clinical product in multiple studies
- Multi-party Agreement for investigator-initiated study for which client provided product and commercial entity provided funding
- Services Agreement for engagement of contract research organization for client’s clinical trial
Contracts Manager
Novartis Pharmaceuticals Corporation
- Worked on clinical trial agreements
- Helped develop guidance on negotiating clinical trial agreements
In-house Counsel
Millennium Pharmaceuticals, Inc. (now Takeda Pharmaceutical Company Limited)
- Handled a broad range of transactions including licensing of biotechnology and software technologies
- Drafted a variety of consulting agreements, and service and manufacturing agreements
Industry Collaborations
- Edimer Pharmaceuticals and CMC Biologics Manufacturing Contract to support the development of EDI200, a clinical-stage recombinant protein for the treatment of X-linked Hypohidrotic Ectodermal Dysplasia (XLHED), a rare genetic disease with orphan designation in the USA and Europe
- Evaluation Agreement for combination of client compound with other party’s proprietary delivery formulation
- Services Agreement for a collection of human blood samples with certain specified infectious diseases for use by client in producing monoclonal antibodies
Customer Agreements
- SaaS Agreement for access and use by client of cloud-based trial master file application for use in client’s worldwide clinical trials
- Agreement for management of client’s speaker bureau including facilitation of speaker training, payments to speakers and logistics
- Agreement for consulting services such as PK analysis of client drug in combination with other drugs and to determine existence of drug-drug interaction
Academic Research
- Short term Collaboration Agreement between nonprofit client and commercial organization for targeted drug design
- Sponsored Research Agreement to explore the activity of client compound against CNS tumors with specified mutations in vitro and in vivo
- Academic Research Agreement for sequencing of samples from tumor bank for specified mutations in patients with cancer, and description of baseline characteristics of the patient population
Clinical Trials
- Supply Agreement for supply and distribution throughout the world of client’s clinical product in multiple studies
- Multi-party Agreement for investigator-initiated study for which client provided product and commercial entity provided funding
- Services Agreement for engagement of contract research organization for client’s clinical trial
Interested in working with Jacqui?
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