Item 1.01
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Entry into a Material Definitive Agreement.
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On December 20, 2018, Agenus Inc. (Agenus) and Gilead Sciences, Inc. (Gilead) entered into a series of agreements, as described
below, to collaborate on the development and commercialization of up to five novel immuno-oncology therapies. Pursuant to the terms of the Transaction Agreements (as defined below), Agenus will receive an upfront cash payment from Gilead of
$120.0 million and Gilead will make a $30.0 million equity investment in Agenus. Agenus will also be eligible to receive up to $1.7 billion in aggregate potential milestones.
License Agreement
Pursuant to the terms of a license
agreement between the parties (the License Agreement), Agenus grants Gilead an exclusive, worldwide license under certain of Agenus intellectual property rights to develop, manufacture and commercialize Agenus preclinical
bispecific antibody, AGEN1423, in all fields of use. Agenus expects to file an investigational new drug (IND) application for AGEN1423 by
year-end
2018 and prior to closing of the transaction.
Pursuant to the terms of the License Agreement, Gilead will be responsible for all of the development, manufacture and commercialization costs for any products that Gilead may develop under the License Agreement. In addition, Gilead will also
receive the right of first negotiation for two of Agenus undisclosed, preclinical antibody programs. The License Agreement will continue until all of Gileads applicable payment obligations under the License Agreement have been performed
or have expired, or the agreement is earlier terminated. Under the terms of the License Agreement, Agenus and Gilead each have the right to terminate the agreement for material breach by, or insolvency of, the other party. Gilead may also terminate
the License Agreement in its entirety, or on a
product-by-product
or
country-by-country
basis, for convenience upon ninety (90) days notice. Pursuant to the terms of the License Agreement, Agenus is eligible to receive potential development and commercial milestones of up to $552.5 million in the aggregate, as well as
tiered royalty payments on aggregate net sales ranging from the high single digit to
mid-teen
percent, subject to certain reductions under certain circumstances as described in the License Agreement.
Option and License Agreements
Pursuant to the terms of
two separate option and license agreements between the parties (each, an Option and License Agreement and together, the Option and License Agreements), Agenus grants Gilead exclusive options to license exclusively
(License Option) Agenus preclinical bispecific antibody, AGEN1223, and Agenus preclinical monospecific antibody, AGEN2373 (together, the Option Programs), during the respective Option Periods (defined below).
Pursuant to the terms of the Option and License Agreements, Agenus has agreed to grant Gilead an exclusive, worldwide license under certain of Agenus intellectual property rights to develop, manufacture and commercialize AGEN1223 or AGEN2373,
as applicable, in all fields of use upon Gileads exercise of the applicable License Option. Agenus filed an IND for AGEN1223 in December 2018 and expects to file an IND for AGEN2373 in the first half of 2019. Gilead is entitled to exercise its
License Option for either or both Option Programs at any time up until ninety (90) days following Gileads receipt of a data package with respect to the first complete Phase 1b clinical trial for each Option Program (the Option
Period). During the Option Period, Agenus will be responsible for its costs and expenses related to the development of the Option Programs. After Gileads exercise of a License Option, if at all, Gilead would be responsible for all
development, manufacture and commercialization activities relating to the relevant Option Program at Gileads cost and expense.
During the Option
Period, Agenus is eligible to receive milestones of up to $30.0 million in the aggregate. If Gilead exercises a License Option, it would be required to pay an upfront license exercise fee of $50.0 million for each License Option that is
exercised. Following any exercise of a License Option, Agenus would be eligible to receive additional development and commercial milestones of up to $520.0 million in the aggregate for each such Option Program, as well as tiered royalty
payments on aggregate net sales ranging from the high single digit to
mid-teen
percent, subject to certain reductions under certain circumstances as described in each License and Option Agreement. For either,
but not both, of the Option Programs, Agenus will have the right to
opt-in
to share Gileads development and commercialization costs in the United State for such Option Program in exchange for a profit
(loss) share on a 50:50 basis and revised milestone payments. If Agenus
opts-in
under one Option and License Agreement, Agenus right to
opt-in
under the other
Option and License Agreement automatically terminates.
Unless earlier terminated, each Option and License Agreement will continue until the earlier of
(i) the expiration of the Option Period, without Gileads exercise of the License Option; and (ii) the date all of Gileads applicable payment obligations under the Option and License Agreement have been performed or have
expired. Under the terms of each Option and License Agreement, Agenus and Gilead each have the right to terminate the agreement for