Item 1.01 Entry into Material Definitive Agreements.
Collaboration and License Agreement
On June 11,
2021, iTeos Belgium S.A., an affiliate of iTeos Therapeutics, Inc. (collectively, ITEOS) and GlaxoSmithKline Intellectual Property (No. 4) Limited (GSK) executed a Collaboration and License Agreement (the Collaboration
Agreement) pursuant to which ITEOS agrees to grant GSK a license under certain of ITEOSs intellectual property rights to develop, manufacture, and commercialize products comprised of or containing ITEOSs anti-TIGIT human
immunoglobulin G1, or IgG1, antibody referred to as EOS-448 (such products, the Licensed Products), which license is exclusive in all countries outside of the United States and co-exclusive, with ITEOS, in the United States.
Exclusivity
Subject to certain limited exceptions, other than under the Collaboration Agreement, GSK and ITEOS each agree not to, alone or with or for any Third Party,
(i) develop a monospecific, monoclonal antibody that inhibits or is an antagonist of TIGIT through direct physical interaction for a period of time following the first regulatory approval of a Licensed Product in the United States, Germany,
France, United Kingdom, Spain, or Italy or (ii) commercialize any such a product during the term of the Collaboration Agreement.
Development
The parties agree to use commercially reasonable efforts to conduct development activities with respect to Licensed Products pursuant to an
agreed-upon global development plan. The parties agree to share the costs of the development activities under the global development plan that are directed to obtaining and maintaining regulatory approvals for Licensed Products in the United States
and the European Union. GSK agrees to fund development activities set forth in the global development plan that are specifically performed in furtherance of obtaining and maintaining regulatory approvals for Licensed Products outside of the United
States and European Union. The parties intend to develop EOS-448 in combination with certain other oncology assets of GSK, and the parties will jointly own the intellectual property created under the
Collaboration Agreement that covers such combinations.
Governance
The exploitation of Licensed Products will be governed by a series of committees established to facilitate collaboration between the parties with respect to
development, manufacturing, medical affairs, patent protection, and commercialization of Licensed Products.
Financial Terms
GSK agrees to make an upfront payment of $625 million to ITEOS within 10 business days of the date on which the Collaboration Agreement becomes effective.
Additionally, ITEOS is eligible to receive up to $1.45 billion in milestone payments, contingent upon the EOS-448 program achieving certain development and commercial milestones.
Within the collaboration, GSK and ITEOS agree to share responsibility and costs for the global development of EOS-448
and will jointly commercialize and equally split profits in the United States. Outside of the United States, GSK will receive an exclusive license for commercialization, and ITEOS is eligible to receive tiered double digit royalty payments up to 20%
during a customary royalty term.
Term; Termination
Unless earlier terminated as described below, the Collaboration Agreement will continue for so long as ITEOS and GSK are commercializing Licensed Products in
the United States, unless ITEOS has opted-out of the profit share in the United States, in which case, the term of the Collaboration Agreement will expire at the end of the royalty term. The royalty term will
expire on a product-by-product and country-by-country basis on the latest to occur of (a)
12 years from first commercial sale, (b) expiration of regulatory exclusivity in such country or (c) expiration of all valid claims of specific licensed patents in such country.
Either party may terminate the Collaboration Agreement for the other partys material breach of the Collaboration Agreement, if such breach is not cured
within a specified cure period. Additionally, if GSK breaches its development diligence obligations with respect to the Licensed Products or fails to conduct any development and commercialization of Licensed Products for an extended period of time,
subject to certain excused delays, then ITEOS may terminate the Collaboration Agreement.