Item 1.01
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Entry into a Material Definitive Agreement.
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On December 18, 2018, AVEO Pharmaceuticals, Inc. (AVEO) entered into an Agreement with Novartis International Pharmaceutical Ltd.
(Novartis) regarding AVEOs AV380 program (the AV380 Agreement).
In August 2015, AVEO and Novartis entered into a
License Agreement (the License Agreement) to grant Novartis the exclusive right to develop and commercialize the proprietary antibody
AV-380,
which inhibits Growth Differentiation Factor 15
(GDF15) for the prevention and treatment of disease and other conditions, including cachexia, worldwide (the AV380 Program). Effective August 2018, Novartis terminated the License Agreement, without cause, following a change
in strategic direction at Novartis. Since the termination, AVEO and Novartis have initiated the process of transferring the AV380 Program back to AVEO in accordance with the terms of the License Agreement. The parties have entered into the AV380
Agreement to further establish and clarify the terms on which the AV380 Program will be returned to AVEO, and to support AVEOs continuing development of the AV380 Program.
The AV380 Agreement provides for the continued transfer to AVEO of the preclinical, technical, manufacturing and other data and materials developed by
Novartis, as well as cooperation regarding future regulatory filings by AVEO relating to the AV380 Program. The Agreement also provides that in order to support AVEOs further development of the AV380 Program, Novartis will (a) make a
one-time
payment to AVEO of $2.3 million on or before January 2, 2019, and (b) provide the AV380 drug supply, valued at approximately $4.0 million, to AVEO at no charge.
AVEO intends to use the $2.3 million payment to cover the milestone obligation due in January 2019 to St. Vincents Hospital Sydney Ltd. (St.
Vincents) under AVEOs Amended and Restated License Agreement with St. Vincents dated August 13, 2015, pursuant to which AVEO
in-licensed
certain of the intellectual property
underlying the AV380 Program.
The AV380 Agreement contains mutual releases by both parties of all claims arising out of the License Agreement, other than
indemnification obligations. Novartis has also agreed that it will not develop, manufacture or commercialize any anti-GDF15 antagonist antibody for three years following the date of the AV380 Agreement.
The foregoing summary of the AV380 Agreement does not purport to be complete and is qualified in its entirety by the full text of the AV380 Agreement, which
AVEO intends to file as an exhibit to its future filings with the Securities and Exchange Commission.