Item 1.01. Entry into a Material Definitive Agreement.
On January 26, 2018, Genocea Biosciences, Inc. (the “
”) entered into a License and Supply Agreement (the “
”) with Oncovir, Inc. (“
”). The Agreement relates to the manufacture and supply of Hiltonol® (poly-ICLC) (“
”), an immunomodulator and vaccine adjuvant. Hiltonol is the adjuvant component of GEN-009, the Company’s investigational personal neoantigen cancer vaccine which will consist of synthetic long peptides of neoantigens identified using the Company’s proprietary ATLAS
platform, formulated with Hiltonol. When paired with synthetic long peptides, Hiltonol has shown the ability to induce T cell responses, which the Company believes will be important for driving clinical efficacy of GEN-009. Hiltonol is manufactured under Good Manufacturing Practice conditions, has an existing Drug Master File and has an extensive tolerability record when used alone and in combination with vaccine antigens.
The Agreement provides the terms and conditions under which Oncovir will manufacture and supply Hiltonol to the Company for use in connection with the research, development, use, sale, manufacture, commercialization and marketing of products combining the Hiltonol with the Company’s technology (the “
”), including GEN-009. The Company is not required to purchase any minimum quantity of Hiltonol from Oncovir.
Oncovir granted the Company a non-exclusive, assignable, royalty-bearing worldwide license, with the right to grant sublicenses through one tier, to certain of Oncovir’s intellectual property in connection with the research, development or commercialization of Combination Products, including the use of Hiltonol, but not the use of Hiltonol for manufacturing or the use or sale of Hiltonol alone. The license shall become perpetual, fully paid-up and royalty-free on the later of January 25, 2028 or the date on which the last valid claim of any patent licensed to the Company under the Agreement expires.
Under this Agreement, the Company is obligated to pay Oncovir (i) an up-front payment in the mid-six figures in consideration of the license granted to Genocea and for the initial supply of Hiltonol for the planned GEN-009 Phase 1/2 trial, (ii) a supply price for Hiltonol in the low-three figures per vial of Hiltonol for use in clinical trials or commercial use, (iii) a milestone payment in the low-six figures upon the achievement of certain clinical trial milestones for each Combination Product, (iv) a milestone payment in the mid-six figures upon the first marketing approval of commercial sales for each Combination Product in certain territories, and (v) tiered royalties in the low-single digits on a product-by-product basis based on the net sales of Combination Products.
The Company may terminate the Agreement upon a decision to discontinue the development of the Combination Product or upon a determination by the Company or an applicable regulatory authority that Hiltonol or Combination Product is not clinically safe or effective. The Agreement may also be terminated by either party due to a material uncured breach by the other party, or due to the other party’s bankruptcy, insolvency or dissolution.