Idera Pharmaceuticals,Inc. (NASDAQ:IDRA) Files An 8-K Entry into a Material Definitive AgreementItem 1.01. Entry into a Material Definitive Agreement.
On November 23, 2016, Idera Pharmaceuticals, Inc. (the “Company”) entered into a license agreement (the “License Agreement”) with Vivelix Pharmaceuticals, Ltd. (“Vivelix”) to which the Company granted Vivelix an exclusive worldwide license (with the right of sublicense) to develop and commercialize IMO-9200, an antagonist of TLR7, TLR8 and TLR9, and selected Backup Compounds (as defined below). Under the terms of the License Agreement, Vivelix has agreed not to develop and commercialize IMO-9200 or any Backup Compound for any disease, condition or indication other than non-malignant gastrointestinal diseases, conditions or indications, including those relating to the mouth, esophagus, stomach, small intestine, colon and rectum, pancreas, gallbladder, bile ducts and liver (the “GI Field”).
Under the terms of the License Agreement, Vivelix agreed to pay the Company (a) an upfront payment of $15 million in connection with the execution and delivery of the License Agreement; (b) IMO-9200-related development, regulatory and sales milestone payments totaling up to $140 million, including development and regulatory milestones totaling up to $65 million and sales milestones totaling up to $75 million; and (c) escalating royalties ranging from the mid single-digits to the low double-digits based on annual global net sales, which percentages are subject to reduction under agreed upon circumstances.
In addition, to the terms of the License Agreement, the Company has agreed to create and characterize, at Vivelix’s request and expense, TLR7, TLR8 or TLR9 agonists and antagonists and to perform research on these compounds and specified other existing TLR7, TLR8 or TLR9 antagonists currently controlled by the Company (collectively, the “Backup Compounds”) under a research program to be agreed upon by the Company and Vivelix. The research program will continue until the first anniversary of the License Agreement but may be extended by Vivelix for two additional one-year periods. Vivelix has the right on or before the third anniversary of the end of the research program to designate one or more of the Backup Compounds upon the payment to the Company of a milestone payment for each designated Backup Compound. Vivelix will be responsible for the development and commercialization of any designated Backup Compounds, and all rights to any Backup Compounds not so designated within such period will revert to the Company. Vivelix has agreed to pay the Company designated Backup Compound-related development, regulatory and sales milestone payments totaling up to $52.5 million, including development and regulatory milestones totaling up to $35 million and sales milestones totaling up to $17.5 million, and escalating royalties ranging from the mid single-digits to the low double-digits based on annual global net sales, which percentages are subject to reduction under agreed upon circumstances.
The fields under the license may be expanded beyond the GI Field if the Company agrees and if Vivelix pays a specified fee per expanded field to the Company. The Company has agreed not to develop IMO-9200 or any designated Backup Compound for any purpose. In addition, the Company has agreed that, during the term of the License Agreement, it will not develop or commercialize any oligonucleotide whose primary mechanism of action is as a TLR agonist or TLR antagonist, in any territory for any indication in the field of human therapeutics for the treatment, palliation, diagnosis, or prevention of non-malignant gastrointestinal diseases, conditions, or indications relating to the mouth, esophagus, stomach, small intestine, colon and rectum or any expanded field.
The License Agreement will remain in effect for as long as payments are payable under the agreement, or until such date as the agreement is sooner terminated. The License Agreement may be terminated (a) by Vivelix for its convenience upon sixty days prior written notice to the Company; (b) by either party in the event