EMA of tivozanib (FOTIVDA) and the $2.0 million payment upon EUSAs election in September 2017 to
opt-in
to
co-develop
the TiNivo trial were not subject to sublicense revenue payments to KHK. In addition, if EUSA elects to
opt-in
to the
TIVO-3
trial, the additional research and development reimbursement payment from EUSA of 50% of the total trial costs, up to $20.0 million, would also not be subject to a sublicense revenue payment to
KHK, subject to certain limitations. We would, however, owe KHK 30% of other,
non-research
and development payments we may receive from EUSA pursuant to the EUSA Agreement, including reimbursement approvals
for RCC in up to five specified European Union countries, marketing approvals for RCC in three specified
non-European
Union licensed territories, European Union marketing approval filings and corresponding
marketing approvals by the EMA for up to three additional indications beyond RCC, and sales-based milestones and royalties. The $2.0 million milestone we earned in February 2018 upon EUSAs reimbursement approval for FOTIVDA in the United
Kingdom as a first-line treatment for aRCC was subject to the 30% KHK
sub-license
fee, or $0.6 million, which was paid in April 2018.
We are also required to pay tiered royalty payments on net sales we make of tivozanib in our North American territory, which range from
the low to
mid-teens
as a percentage of net sales. The royalty rate escalates within this range based on increasing tivozanib sales. Our royalty payment obligations in a particular country in our territory
begin on the date of the first commercial sale of tivozanib in that country, and end on the later of 12 years after the date of first commercial sale of tivozanib in that country or the date of the last to expire of the patents covering
tivozanib that have been issued in that country.
The KHK Agreement will remain in effect until the expiration of all of our
royalty and sublicense revenue obligations to KHK, determined on a
product-by-product
and
country-by-country
basis, unless we elect to terminate the KHK Agreement earlier. If we fail to meet our obligations under the KHK Agreement and are unable to cure such
failure within specified time periods, KHK can terminate the KHK Agreement, resulting in a loss of our rights to tivozanib and an obligation to assign or license to KHK any intellectual property or other rights we may have in tivozanib, including
our regulatory filings, regulatory approvals, patents and trademarks for tivozanib.
Recent Developments
As described above, on August 14, 2018, we announced that the IND submitted by CANbridge to the CNDA had been accepted. This acceptance
triggered a $2.0 million milestone payment to us from CANbridge, which we expect to receive in the third quarter of 2018. We are required to pay a pre-specified portion of such payment upon receipt to Biogen as a sublicensing fee.
Our Corporate Information
We were incorporated under the laws of the State of Delaware on October 19, 2001 as GenPath Pharmaceuticals, Inc. and changed our name to AVEO Pharmaceuticals, Inc. on March 1, 2005. Our principal executive offices are
located at One Broadway, 14th Floor, Cambridge, Massachusetts 02142, and our telephone number is (617)
588-1960.
Our internet website is www.aveooncology.com. Information found on, or accessible through, our
website is not a part of, and is not incorporated into, this prospectus supplement and the accompanying prospectus, and you should not consider it part of this prospectus supplement and the accompanying prospectus. Our website address is included in
this document as an inactive textual reference only. Unless the context otherwise requires, references in this prospectus to AVEO, the Company, we, us, and our refer to AVEO
Pharmaceuticals, Inc. and our subsidiaries.
The trademarks, trade names and service marks appearing in this prospectus are
the property of their respective owners.
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