James R.

McGarrah

Co-Founder and Principal

Industry Experience

Counsel

Millennium Pharmaceuticals, Inc. (now Takeda Pharmaceutical Company Limited)

Counsel

The Institute for Genomic Research (TIGR) (now The J. Craig Venter Institute)

Jim handles a wide range of agreements for life sciences clients. 

His focus is on early-stage companies engaged in research based on novel therapeutic assets, or technologies with novel applications. The agreements cover the spectrum from discovery to development and commercialization - evaluations, sponsored research, option rights and exclusive development and commercialization licenses.  Many agreements are with leading academic or non-profit entities with research expertise of strategic importance to a client’s near-term goals. 

Jim also works on multi-party consortium agreements with industry and non-profit entities, sorting the respective interests and goals for the background contributions of each party and the results of joint work.  He frequently advises clients on how to approach the often complex relationships with academic or non-profit research institutions and helps set realistic expectations regarding technology access and transfer.

Jim is a co-founder of Faber.

experience +

experience –

Millennium Pharmaceuticals, Inc. (now Takeda Pharmaceutical Company Limited)

Counsel

  • Provided legal support for the company’s drug discovery activities and major corporate alliances
  • Negotiated many multi-year, sponsored research collaborations with leading academic institutions involving millions of dollars in funding
  • Served as Millennium’s primary counselor on evolving issues in the areas of medical privacy and informed consent requirements for research
  • Legal representative on business development initiatives to license discovery tools and early stage drug candidates, and to establish and conclude product-specific development programs

The Institute for Genomic Research (TIGR) now The J. Craig Venter Institute, one of the first non-profit research centers to incorporate novel technologies in large-scale gene discovery research.

Counsel

  • Established key parts of the legal framework for its activities with industry and academia
  • Negotiated the terms of early stage research collaborations and agreements covering transfer of materials and confidential information, database access and publication of research results
  • Member of the Institute’s Institutional Review Board; helped assure its compliance with applicable regulations and conditions of federal research grants

Recent Client Work +

Recent Client WOrk –

  • ‍Exclusive license for bioprocessing technology for Alnylam Pharmaceuticals with Massachusetts Institute of Technology
  • Exclusive license agreement accompanied by substantial sponsored research funding for Alnylam Pharmaceuticals with Mount Sinai School of Medicine
  • Over-arching agreement for sponsored research related to client’s work in gene therapy for bluebird bio with Institut National de la Santé et de la Recherche Médicale (INSERM) of France on behalf of multiple European based research entities
  • Exclusive license between the Whitehead Biomedical Institute and new company relating to cell survival technology invented by Howard Hughes Medical Institute investigator
  • Exclusive license for core technology rights for Ember Therapeutics with Dana Farber Cancer Institute
  • Consolidation of multiple licenses with predecessor entities into comprehensive amended and restated license agreement for Siamab Therapeutics with University of California - San Diego
  • Sponsored research template agreements for new, industry-recognized leading biotech and advice with respect to several unique academic research arrangements, including with University of North Carolina - Chapel Hill, Weizmann Institute of Science in Israel and Vanderbilt University
  • Sponsored research, subcontracts and collaborative research and development agreements (CRADAs) with NIH and defense agencies, universities and companies for clients with novel technologies and funding sources, including government grants and private grant programs.  Recent work for AesRx, Antidote Therapeutics, Vedantra Therapeutics, Paratek Pharmaceuticals
  • ‍Novel technology access agreement with Northwestern University to permit access to early stage work of leading principal investigator for Lysosomal Therapeutics
  • Sponsored research and license agreement with Brown University for Takeda Pharmaceuticals covering research with propriety materials of Takeda, and including specific rights and commercialization terms applicable to results
  • Advice with respect to technology access for strategic uses complementing a client’s novel approach to discovery and funding for key research with Columbia University
  • Continuing advice to nonprofit Global Alliance for TB drug development on multiple matters for exchanges of materials, including for studies of combination therapies for tuberculosis among multiple parties; standardized documents with hybrid terms covering research and commercialization rights for results among mix of non-profit research entities and industry
  • Continuing advice to a Boston-based research university with respect to multiple out-licenses in negotiation or previously completed, and industry relationships, including payment issues, winding down of agreements and return of license rights

Community +

Community –

Bar Admissions
  • Maryland
  • Massachusetts
Education 
  • ‍William & Mary Law School, J.D.
  • Georgetown University, School of Foreign Service, B.S.F.S.