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terminated earlier, the agreement will expire on a NCH licensed product-by-NCH licensed product and country-by-country basis upon the expiration of the royalty term for such NCH
licensed product in such country. The royalty term will expire on the later of (i) the date on which the last relevant patent underlying the relevant NCH licensed product expires or
(ii) ten years from the first commercial sale of NCH licensed product in such country. Upon expiration of the agreement with respect to a particular NCH licensed product in a particular
country, the license to us will survive and as a fully-paid up license. The NCH License may be terminated prior to its expiration:
- By us at any time by providing six months' prior written notice to NCH;
- By either party upon the other party's material breach of the NCH License that is not cured within 90 days after receiving
written notice of such breach, except in certain cases in which we may request a longer cure period;
- By NCH in the event of our bankruptcy, insolvency or certain similar occurrences; or
- By NCH if we or any of our affiliates bring any action or proceeding against NCH, other than a suit brought in response to any suit
brought by NCH.
accrued payments that we are required to make to NCH will become due in the event of termination as specified in the agreement. As of December 31, 2015, we have reimbursed
NCH $0.6 million and incurred $9.3 million in aggregate development costs.
The Research Institute at Nationwide Children's Hospital
In October 2013, we entered into a clinical trials research agreement with the Research Institute at Nationwide Children's Hospital, or
the Research Institute. This agreement governs our preclinical and clinical trials conducted at NCH by Dr. Mendell.
the NCH license agreement, we had the right to elect to become the sponsor of the IND subject to certain reversionary rights of the Research Institute. On October 14, 2015,
we entered into an amendment to the NCH License with NCH permitting us to submit to the FDA for the transfer of the IND and associated regulatory filing to us and for us to become the sponsor of such
IND. Contemporaneous with the execution of this amendment, we submitted the requisite documents to the FDA to initiate the transfer process. On November 6, 2015, the FDA approved our
sponsorship of the IND. We are responsible for all budgeted clinical trial costs that are not covered by grants or certain other sources. All data and information generated under the agreement is
subject to our agreements with NCH.
terminated earlier, the agreement expires upon the completion of the study. The agreement may be terminated prior to its
- By either party upon the other party's breach of the agreement that is not cured within 60 days after receiving written notice
of such breach; or
- By us at any time in the event we elect to become the sponsor of the IND.
clinical trial research agreement with the Research Institute also contains obligations for us to indemnify the Research Institute and its affiliates against certain losses and for
us to maintain certain insurance, as well as mutual confidentiality obligations.
In March 2014, we entered into an exclusive license agreement with ReGenX Biosciences, LLC, or ReGenX, predecessor to
REGENXBIO Inc., under certain patents and patent applications owned by the Trustees of the University of Pennsylvania and licensed to ReGenX, for the development and commercialization of
products to treat spinal muscular atrophy using AAV9, or the ReGenX License.