Biographies

Hani has a broad range of experience in drafting and negotiating the terms of various types of contracts required for clinical trial research. He has worked with globally operating entities to prepare agreements for many large, multi-center international clinical studies.

Jim is a co-founder of Faber and successfully handles a wide range of agreements for pre-clinical research and related activities at companies and non-profit organizations in the life sciences. He focuses on transactions that advance early stage research and development of novel therapeutic assets and applications for unique technologies. These agreements cover the spectrum from discovery to development and commercialization - evaluations, sponsored research, option rights and exclusive development and commercialization licenses. His work in recent years includes helping commercial clients access scientific expertise at prominent academic or non-profit entities as part of a strategy to investigate or validate technologies.

Jim drafted several agreements covering multi-party consortia among industry and non-profit entities, sorting the respective interests and goals for the contributions of each party and providing advice on how to manage the results of joint work. He advises venture-backed companies about and assists in their negotiations with universities and non-profit research institutions for research programs, licenses and options, helping to align respective interests for the transfer of intellectual property from academia to industry.

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

Counsel

Provided legal support for the company’s drug discovery activities and major corporate alliances
Negotiated numerous multi-year, sponsored research collaborations with leading academic institutions involving multi-million-dollar research budgets
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 +

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Exclusive license agreements with Stanford University, Dana-Farber Cancer Institute, the Broad Institute, Massachusetts General Hospital, Albert Einstein College of Medicine, Dartmouth College, and Whitehead Institute for Biomedical Research for portfolio companies of leading venture funds
Exclusive license agreement with Italian research university and novel technology access agreement with Northwestern University for Lysosomal Therapeutics
Collaboration and sponsorship agreements for staged research projects among multiple universities and a single disease-focused start-up company with significant federal funding
Establish core principles and agreement terms for treatment of research results and collaborative research projects for newly established Boston-based non-profit research institute
Terms for template documents (material transfer, sponsored research and consulting) for multiple start-up companies
Exclusive license for bioprocessing technology for Alnylam Pharmaceuticals with Massachusetts Institute of Technology
Exclusive license agreement and sponsored research funding for Alnylam Pharmaceuticals with Mount Sinai School of Medicine
Exclusive license between the Whitehead Institute for Biomedical Research and new company relating to cell survival technology invented by Howard Hughes Medical Institute investigator
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, 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, Elicio Therapeutics, Paratek Pharmaceuticals
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

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Joe is or has been involved in a wide range of philanthropic and community organizations, including:

The Center for Discovery. Pro bono counsel for R&D initiatives at a leading provider of medical and clinical care and education services for people with complex developmental disabilities.
Dana-Farber Cancer Institute and Partners in Health. Pro bono counsel for an international health services joint venture.
Center for Maine Contemporary Art, Board of DirectorsTrustees.
Partners Healthcare Center for Personalized Genetic Medicine, Genetics Advisory Council, past member.
Columbia University’s College of Physicians and Surgeons, Medical Science and Technology Council, past member.
CAVU Foundation, Board of Directors, past member. CAVU supported community programs that enhance the health care of underserved children in Massachusetts.
Venturing Out, Board of Directors, past member. Venturing Out was an innovative not-for-profit organization that taught entrepreneurship to incarcerated and court-involved adults and high-risk youth.
The Possible Project, Co-Founder of a not-for-profit that helps young people imagine, create and run their own business.
Slow Money, Maine and New York chapters. Joe worked with leadership to create pathways for individuals and families to provide financial assistance to farmers and agriculture businesses promoting sustainable local food systems. He also developed novel “patient loan” structures that have been used to raise critical financing for businesses that are re-building agricultural and fisheries food infrastructures.

Joe has spoken on business law and ethics at the Massachusetts Institute of Technology (Program of Health Sciences and Technology), Ross School of Business at the University of Michigan (Net Impact Conference), and Boston College Law School.

Joe was a member of the National Finance Council and actively involved in the voter protection team for the Stacey Abrams for Governor campaign.

Bar Admissions

Maryland
Massachusetts

Education

‍William & Mary Law School, J.D.
Georgetown University, School of Foreign Service, B.S.F.S.

James R.

McGarrah

Co-Founder and Principal

Industry Experience

Counsel

Counsel

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Bar Admissions

Education