VERACYTE, INC. (NASDAQ:VCYT) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01 Entry into a Material Definitive Agreement.
On December 28, 2018 (the “Execution Date”), Veracyte, Inc. (“Veracyte”) entered into a Diagnostics Development Agreement (the “Agreement”) with Johnson & Johnson Services, Inc. (“JJSI”) (i) to cooperate on a program to enable Veracyte to use JJSI samples and clinical data to develop a next generation bronchial genomic classifier diagnostic for lung cancer diagnosis (“Percepta v.2”) and a nasal genomic classifier diagnostic for lung cancer (“NasaRISK”) and (ii) for JJSI to use Veracyte data generated in the AEGIS and the Percepta Registry studies for therapeutic purposes and for purposes of developing a companion diagnostic product used in conjunction with a JJSI therapeutic. The Agreement includes the following terms, among others:
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Subject to the terms and conditions in the Agreement, (i) JJSI grants to Veracyte a non-exclusive license to use the JJSI clinical data and samples solely for the purposes of developing and seeking regulatory approval for Percepta v.2 and NasaRISK under JJSI intellectual property rights concerning JJSI clinical data and samples, provided that such license is limited to diagnostic tests for lung cancer and (ii) Veracyte grants to JJSI a non-exclusive license to use data generated by Veracyte during the development for any therapeutic purpose and to seek regulatory approval for a companion diagnostic product used in conjunction with a JJSI therapeutic. |
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Veracyte shall use commercially reasonable efforts to seek regulatory approval for, and to commercialize, Percepta v.2 and NasaRISK, in each case in the United States and any other countries to which Veracyte and JJSI have agreed. |
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JJSI will make an initial upfront payment of $5 million to Veracyte for the delivery of RNA sequencing data on existing Percepta v.2 cohorts. In addition, JJSI will make up to $15 million in additional payments conditioned upon the achievement of certain milestones relating to the development and reimbursement of Percepta v.2 and NasaRISK. |
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For a period of ten years commencing with the first commercial sale of Percepta v.2 and NasaRISK, respectively, Veracyte will make payments to JJSI of one percent (1%) of net cash collections for Percepta v.2 and in the low-single digits of net cash collections for NasaRISK, depending on the number and timing of JJSI samples and associated clinical data Veracyte receives from JJSI. |
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Veracyte shall solely own any technology generated under the development that relates to diagnostics and associated intellectual property rights. JJSI shall solely own any technology generated under the development that relates to therapeutics and associated intellectual property rights. JJSI and Veracyte shall jointly own any other technology generated under the development and associated intellectual property rights. Each party will otherwise retain ownership of its respective technology, data and intellectual property. |
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The Agreement shall become effective as of the Effective Date and remain in full force and effect until the date that the last to expire revenue sharing obligation under the Agreement expires. For the first two years following the Effective Date, the Agreement may only be terminated due to an uncured material breach or the insolvency of a party. |
The foregoing summary of the Agreement does not purport to be complete and is subject to, and qualified in its entirety by the Agreement, which will be filed as an exhibit to Veracyte’s Annual Report on Form 10-K for the year ended December 31, 2018.
About VERACYTE, INC. (NASDAQ:VCYT)
Veracyte, Inc. is a genomic diagnostics company. The Company uses genomic technology to resolve diagnostic ambiguity. It targets diseases in which patients undergo invasive diagnostic procedures. Its products combine genomic technology, clinical science and machine learning. The Company commercializes over three genomic tests, which are transforming the diagnosis of thyroid cancer, lung cancer and idiopathic pulmonary fibrosis. The Company’s commercial solution, the Afirma Thyroid fine needle aspiration (FNA) Analysis, centers on the Afirma Gene Expression Classifier (GEC). The Afirma GEC is offered directly or as part of a solution that also includes cytopathology. The Company operates in the pulmonology diagnostics market. It offers Percepta Bronchial Genomic Classifier, a genomic test to resolve ambiguity in lung cancer diagnosis. It also offers the Envisia Genomic Classifier, which is designed to help in the assessment of patients suspected to have idiopathic pulmonary fibrosis.