Item 1.01. Entry into a Material Definitive Agreement.
On May 28, 2019, Amicus Therapeutics, Inc. (“Amicus” or the “Company”) entered into an Amended and Restated Research, Collaboration and License Agreement (the “Agreement”) with The Trustees of the University of Pennsylvania (“Penn”) pursuant to which Amicus and the Wilson Laboratory at Penn will continue to collaborate with respect to the pre-clinical research and development of next generation parvovirus gene therapy products for the treatment of Pompe disease, Fabry disease and CDKL5 deficiency and will initiate pre-clinical research and development of next generation parvovirus gene therapy products for the treatment of Niemann Pick Type C, Mucopolysaccharidosis Type IIIA and Mucopolysaccharidosis Type IIIB (collectively, the “Indications”).
Under the Agreement, Amicus also has the right to initiate additional programs for pre-clinical research and development of next generation parvovirus gene therapy products for the treatment of certain lysosomal storage diseases and other rare metabolic disorders specified in the Agreement.
As under the Research, Collaboration and License Agreement we entered into with Penn on October 8, 2018 (“Original Agreement”), under the Agreement, Penn granted the Company exclusive, worldwide licenses (with the right to sublicense) under certain patent rights arising out of the research programs or covering an Amicus-selected parvovirus gene therapy product developed at Penn and non-exclusive, worldwide licenses (with the right to sublicense) under certain patent rights pertaining to manufacturing, background patent rights and know-how, in each case, to make, have made, use, sell, offer for sale and import licensed products for the Indications.
As under the Original Agreement, the pre-clinical research and development activities of Penn under the Agreement will be overseen by James M. Wilson, M.D., Ph.D. and will be conducted by the Wilson Laboratory at Penn in accordance with a mutually-agreed research plan for a specified period of time and the Company will fund such research and development activities in accordance with a mutually-agreed budget. As under the Original Agreement, the Company will be responsible for clinical development and commercialization of the licensed products for the Indications and is obligated to make certain milestone and royalty payments with respect to licensed products for each Indication.
In addition, the Wilson Laboratory will conduct a discovery research program in accordance with a mutually-agreed research plan for five years beginning on the date of the Agreement. The Company will provide $10 million each year during such five year period to fund such discovery research program. Pursuant to the Agreement, in connection with the Company’s funding of the discovery research program, the Company is eligible to receive a low double-digit percentage share of revenue Penn receives from third-party licensees of certain patent rights generated in the discovery research program.
Following the effective date of the Agreement, the Company paid to Penn an option fee in the low single-digit millions to select the Niemann Pick Type C, Mucopolysaccharidosis Type IIIB and next generation Mucopolysaccharidosis Type IIIA Indications. Following the selection of each additional Indication, the Company will be obligated to pay Penn an option fee in the low single-digit millions.
If Amicus terminates the Agreement during the term of the pre-clinical research and development activities or the discovery research program, other than for Penn’s uncured breach or bankruptcy, the Company will be obligated to pay Penn any portion of the initial budget for such pre-clinical research and development activities or discovery research program, as applicable, that has not yet been paid.
The foregoing description of the Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of such agreement. The Company intends to seek confidential treatment for certain portions of the Agreement and expects to file a copy of the Agreement as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2019.