Item 1.01 Entry into a Material Definitive Agreement.
On January 10, 2017, Ziopharm Oncology, Inc. (the “Company”) announced the signing of a Cooperative Research and Development Agreement (the “CRADA”) with the National Cancer Institute (“NCI”) for the development of adoptive cell transfer (“ACT”) -based immunotherapies genetically modified using theSleeping Beauty system to expressT-cell receptors (“TCRs”) for the treatment of solid tumors.
Under the CRADA, the Company is granted an option to exclusively license inventions made pursuant to the research plan included in the CRADA, as described in more detail below. On May 28, 2019, the Company entered into a patent license agreement (the “License”) with the NCI, pursuant to which the Company holds an exclusive, worldwide license to certain intellectual property for manufacturing technologies, invented under the CRADA’s research plan, to develop and commercialize autologous, peripheral bloodT-cell therapy products engineered bynon-viral gene transfer to express TCRs. In addition, pursuant to the License, the Company holds an exclusive, worldwide license to certain intellectual property to develop and commercialize patient-derived (autologous), peripheral bloodT-cell therapy products engineered by transposon-mediated gene transfer to express TCRs reactive to mutated KRAS, p53 and EGFR. The terms of the License were described in the Company’s Current Report on Form8-K filed with the Securities and Exchange Commission (the “SEC”) on May 28, 2019.
On June 11, 2019, the Company announced that the investigational new drug application submitted by the NCI had received clearance from the U.S. Food and Drug Administration for a clinical trial to evaluate TCRT-cell therapy in solid tumors utilizing the Company’sSleeping Beauty system pursuant to the CRADA. As a result of recent updates from the NCI, the Company has now determined that the CRADA is material to the Company.
The CRADA, dated January 9, 2017, was entered into by the NCI, the Company and Intrexon Corporation (“Intrexon”). Intrexon assigned its rights and obligations under the CRADA to Precigen, Inc. (“Precigen”) pursuant to Amendment #1 to the Cooperative Research and Development Agreement, dated March 23, 2018 (the “First Amendment”), and Precigen assigned its rights and obligations to the Company pursuant to Amendment #2 to the Cooperative Research and Development Agreement, dated February 1, 2019 (the “Second Amendment”).
Under the CRADA, the parties intend to develop and evaluate ACT for patients with advanced cancers using autologous peripheral blood lymphocytes genetically modified using thenon-viralSleeping Beauty system to express TCRs that recognize neoantigens expressed within a patient’s cancer. Research conducted under the CRADA will be at the direction of Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI, in collaboration with the Company.
Under the CRADA, as amended by the First Amendment and the Second Amendment, the Company is required to pay the NCI $2.5 million per year, payable quarterly, during the term of the CRADA. To date, the Company has paid the NCI $6.9 million. The CRADA terminates on January 9, 2022 unless it is extended in writing by the parties. Either party may terminate the CRADA by providing at least 60 days’ prior written notice to the other party.
Each party has granted the other party rights to use their respective background inventions solely to the extent necessary to conduct the research and development activities under the CRADA. Subject to the U.S. government’s nonexclusive, nontransferable, irrevocable right to practice any CRADA invention for research or other government purposes, the producing party will own any inventions, data and materials produced by its employees, and the parties will jointly own all any inventions jointly invented by the parties. The Company is granted an exclusive option to elect an exclusive or nonexclusive commercialization license with a field of use that does not exceed the scope of the CRADA research plan. Any such license will be in substantially the form of the applicable U.S. Public Health Service’s model agreement, with terms that reflect the nature of the licensed technology, among other things. The CRADA also contains customary representations, warranties, indemnification and confidentiality obligations.
The foregoing descriptions of the CRADA, the First Amendment and Second Amendment are not complete and are qualified in their entireties by reference to the full texts of the CRADA, the First Amendment and Second Amendment, copies of which are filed herewith as Exhibits 10.1, 10.2, and 10.3 respectively, and are incorporated by reference herein.
