Array BioPharma Inc. (NASDAQ:ARRY) Files An 8-K Entry into a Material Definitive Agreement

Array BioPharma Inc. (NASDAQ:ARRY) Files An 8-K Entry into a Material Definitive Agreement

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Item1.01

Entry into a Material Definitive Agreement.

Effective May 31, 2017, Array BioPharma entered into a License,
Development and Commercialization Agreement (the
Agreement) with Ono Pharmaceutical Co.,
Ltd., a company duly organized and existing under the laws of
Japan (Ono), to which Array granted Ono
exclusive rights to commercialize two of Arrays late-stage
oncology products, binimetinib and encorafenib, in Japan and the
Republic of Korea (the Ono Territory),
along with the right to develop these products in the Ono
Territory. Array retains all rights outside the Ono Territory, as
well as the right to conduct development and manufacturing
activities in the Ono Territory. In November 2015, Array entered
into a binimetinib and encorafenib agreement with Pierre Fabre
under which Array granted Pierre Fabre exclusive commercial
rights to countries outside the US, Canada, Japan, South Korea
and Israel, including Europe.

Under the terms of the Agreement, Array will receive an upfront
cash payment of 3.5 billion Japanese Yen, and Array retains all
rights to conduct, either itself or through third parties, all
clinical studies and file related regulatory filings with respect
to binimetinib and encorfenib and to develop, manufacture and
commercialize binimetinib and encorafenib outside the Ono
Territory (subject to rights Array has granted to Pierre Fabre
Medicament in certain countries). Array is entitled to receive up
to 1.8 billion Japanese Yen in milestone payments from Ono if
certain development goals are achieved, 5.5 billion Japanese Yen
in milestone payments from Ono if certain regulatory milestones
are achieved, and 10.0 billion Japanese Yen in milestone payments
from Ono if certain sales milestones are achieved. A portion of
these milestones represent Onos co-funding obligation as part of
Onos participation in the Phase 3 BEACON CRC trial. Array is
further eligible for tiered double-digit royalties on annual net
sales of binimetinib and encorafenib in the Ono Territory,
starting at 22% for annual net sales under 10.0 billion Japanese
Yen and increasing to 25% for annual net sales in excess of 10.0
billion in Japanese Yen, subject to certain adjustments.

All ongoing clinical trials involving binimetinib and
encorafenib, including the BEACON CRC and COLUMBUS trials, will
continue as currently being conducted. As part of the agreement,
Ono obtains the right to participate in any future global
development of binimetinib and encorafenib by contributing 12% of
those future costs. Ono is responsible for seeking, and for any
development of binimetinib and encorafenib specifically necessary
to obtain, regulatory and marketing approvals for products in the
Ono Territory. Array will furnish clinical supplies of drug
substance to Ono for use in Onos development efforts, and Ono may
elect to have Array provide commercial supplies of drug product
to Ono to a commercial supply agreement to be entered into by
Array and Ono, in each case the costs of which will be borne by
Ono. Array has also agreed to discuss and agree on a strategy
with Ono to ensure the supply to Ono of companion diagnostics for
use with binimetinib and encorafenib in certain indications in
the Ono Territory.

Each party has also agreed not to distribute, sell or promote
competing MEK or RAF products in the Ono Territory during the
term of the Agreement. Each party has also agreed to indemnify
the other party from certain liabilities specified in the
Agreement.

The Agreement will continue in effect on a product-by-product,
country-by-country basis for a period that expires ten years
after the later of expiration of patent protection or marketing
exclusivity for the applicable product. The Agreement may be
terminated by either party for breach of the Agreement by the
other party, in the event of the insolvency or bankruptcy of the
other party, by Ono with 180 days prior notice after the fifth
year after first commercial sale of either binimetinib or
encorafenib in the Ono Territory, or by Ono on a
product-by-product basis for certain safety reasons.

Array expects to file the Agreement as an exhibit to its
Quarterly Report on Form10-K for the year ending June 30, 2017.
The foregoing description is qualified in its entirety by
reference to the text of the Agreement when filed.

Item9.01 Financial Statements and Exhibits.

(d)Exhibits

Exhibit No. Description
99.1 Press Release Announcing License, Development and
Commercialization Agreement with Ono Pharmaceutical Co.


About Array BioPharma Inc. (NASDAQ:ARRY)

Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer. The Company’s programs include approximately three cancer drugs, binimetinib, encorafenib and selumetinib (partnered with AstraZeneca, PLC). Its binimetinib and encorafenib are in Phase III trials in advanced cancer patients, including the COLUMBUS trial studying encorafenib in combination with binimetinib in patients with BRAF-mutant melanoma and has initiated BEACON CRC trial to study encorafenib in combination with binimetinib and cetuximab in patients with BRAF V600E-mutant colorectal cancer (BRAFm CRC). Its selumetinib is a mitogen-activated protein kinase (MEK) inhibitor for cancer, which is in Phase III trial. Its advanced clinical-stage drugs include Filanesib, ARRY-797, ASC08/Danoprevir, Ipatasertib/GDC-0068, Motolimod/VTX-2337, LOXO-101, ONT-380/ARRY-380, GDC-0575, GDC-0994 and ARRY-382.

Array BioPharma Inc. (NASDAQ:ARRY) Recent Trading Information

Array BioPharma Inc. (NASDAQ:ARRY) closed its last trading session down -0.30 at 7.86 with 4,563,244 shares trading hands.

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