Genomics
l Authorship on publications using the material. l Grantback of rights to modified materials
MTAs may restrict use of transferred material to
a defined research scope and may have an expira- tion date, after which material must be destroyed by the recipient.
Licence agreements GEMs may also be distributed under commercial licences, for example, when a pharmaceutical or biotech company requests access to a model made at an academic institution. Such licences typically carry upfront and/or annual maintenance fees and grant rights for commercial use such as drug dis- covery and development.
Distribution terms from commercial animal vendors GEMs are now widely available from several non- profit repositories as well as commercial animal ven- dors. Terms of use vary by source. Non-profit repos- itories commonly use MTAs. By way of example, The Jackson Laboratory distributes many GEMs under a set of relatively simple terms of use, but access to certain other models is predicated on first negotiating and obtaining a licence from one or more third parties which have an IP interest for that model. Taconic Biosciences distributes its most pop- ular GEM products under a simple label licence, which is a concept taken from software ‘shrink- wrap’ licences. These terms are deemed accepted upon purchase, and this type of label licence can greatly speed up acquisition of GEMs since no nego- tiation or signatures are required prior to purchase.
Tracking and compliance problems can lead to severe consequences Negotiation and execution of MTAs take up signif- icant time at most university technology transfer offices. Professional licensing officers focus on pro- tecting their institutions and obtaining materials needed by their scientists, and tech transfer offices may have complex systems in place for negotiation and tracking of agreements. Unfortunately, the academic researchers actually using the materials transferred under such agreements may forget what they have agreed to. Examples of compliance problems include:
l Use of materials in work which is beyond the scope of permitted research as defined in the MTA. l Neglecting to renew an expired agreement, despite continued use of the transferred material. l Unpermitted transfers of material to third parties.
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Such violations can lead to various problems.
For example, many MTAs permit use only for internal, non-commercial research. As the interface between academic institutions and for-profit com- panies changes, with more universities engaging in sponsored research, contract research and even spin-off companies, GEMs and other research tools are sometimes used for commercial purposes in violation of distribution terms. Any tool, includ- ing genetically-engineered mouse and rat models, that is transferred under terms which permit only internal non-profit research should not be used in projects involving an external commercial partner without obtaining further rights from the tool provider.
High stakes A widely-reported dispute between St Jude Children’s Research Hospital and the University of Pennsylvania over technology related to chimeric antigen receptor
(CAR) T-cell
immunotherapy illustrates the risks involved in transfer of valuable
research materials.
Researchers at St Jude developed a DNA construct for a chimeric T-cell receptor and shared it with Penn under an MTA which permitted only preclin- ical use and prohibited any commercial use of the provided materials. The Penn researchers devel- oped a new vector which incorporated St Jude’s DNA sequence. They failed to credit St Jude in resulting journal articles and Penn licensed CAR- T technology incorporating DNA from the St Jude vector to Novartis. Meanwhile, St Jude patented its CAR T-cell technology and licensed it to Juno Therapeutics. With immunotherapy offering such promise in cancer treatment, anything related to it has enormous value and correspondingly high stakes. Each side filed lawsuits against the other, and in the end Novartis agreed to pay Juno $12.25 million plus milestone payments and roy- alties to settle the dispute. The case of the Jackson Laboratory (Jax) versus
Nanjing University is another example of a dispute over biological materials and transfer agreements. Jax executed a Use of Strains Agreement with the Nanjing University Model Animal Research Center, which permitted Nanjing to use animal models pro- vided by Jax solely for internal research and restricted further transfer or resale of purchased animals or progeny. Jax alleged that Nanjing was selling progeny of strains provided by Jax and filed a lawsuit against Nanjing in September 2017. This dispute has now gone to arbitration, but purchasers of disputed strains from Nanjing, including a super immunodeficient strain distributed in the US by a
Drug Discovery World Fall 2018
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