Current Report Filing (8-k)
January 09 2017 - 4:17PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): January 5, 2017
Kite Pharma, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-36508
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27-1524986
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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2225 Colorado Avenue
Santa Monica, California
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90404
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(Address of principal executive offices)
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(Zip Code)
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(310)
824-9999
(Registrants telephone number, including area code)
Not Applicable
(Former
Name or Former Address, if Changed Since Last Report)
Check the appropriate box below
if the Form
8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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Item 1.01. Entry into a Material Definitive Agreement
On January 5, 2017, Kite Pharma EU B.V. (Kite), a wholly owned indirect subsidiary of Kite Pharma, Inc., entered into a Collaboration and
License Agreement (the Agreement) with Daiichi Sankyo Company, Limited (DS) pursuant to which Kite has granted to DS an exclusive license to develop and commercialize axicabtagene ciloleucel, also known as
KTE-C19,
in Japan. Axicabtagene ciloleucel, Kites lead product candidate, is an investigational therapy in which a patients T cells are engineered to express a chimeric antigen receptor (CAR)
to target the antigen CD19, a protein expressed on the cell surface of
B-cell
lymphomas and leukemias, and redirect the T cells to kill cancer cells.
In addition, under the Agreement, DS has a certain period of time to exclusively license, at its option, additional Kite product candidates in Japan,
including
KITE-718,
Kites T cell receptor (TCR) product candidate targeting
MAGE-A3/A6
and certain other product candidates that proceed to an U.S.
investigational new drug application filing over the next three years. If the parties agree to include a licensed product in Japan in a global development program, then DS will be responsible for the associated incremental costs. Under the
Agreement, Kite will provide certain technology transfer services relating to the licensed products to DS.
In connection with the execution of the
Agreement, DS will make an upfront payment to Kite of $50 million. Kite will be eligible to receive future payments totaling up to $200 million for development and commercial milestones relating to axicabtagene ciloleucel. In addition, for
each additional product candidate for which DS exercises its option to acquire an exclusive license, the option exercise and milestone payments to Kite could equal up to $200 million. Kite is also entitled to receive tiered royalties in the low
to mid double digit range on DSs sales of licensed products for the term of the Agreement, subject to certain reductions.
The term of the Agreement
will continue on a licensed
product-by-licensed
product basis until DS permanently ceases at its sole discretion all development, manufacture and commercialization of
such licensed product in Japan. Either party may also terminate the agreement with written notice upon material breach by the other party, if such breach has not been cured within a defined period of receiving such notice, or in the event of the
other partys bankruptcy. Kite may terminate the Agreement if DS challenges certain of Kites patents. DS may terminate the Agreement with respect to a licensed product if Kite later acquires additional necessary intellectual property for
such licensed product, and a license or sublicense to such intellectual property is not available to DS on terms that DS deems to be commercially reasonable.
Contemporaneously with execution of the Agreement, Kite Pharma, Inc. and DS executed a guarantee agreement pursuant to which Kite Pharma, Inc. guarantees
Kites performance under the Agreement.
The foregoing description of the Agreement is only a summary and is qualified in its entirety by reference
to the Agreement. Kite intends to file a copy of the Agreement as an exhibit to its Quarterly Report on Form
10-Q
for its fiscal quarter ending March 31, 2017, portions of which will be subject to a FOIA
Confidential Treatment Request to the Securities and Exchange Commission pursuant to Rule
24b-2
under the Securities Exchange Act of 1934, as amended, for certain portions of the Agreement. The omitted
material will be included in the request for confidential treatment.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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KITE PHARMA, INC.
(Registrant)
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Dated: January 9, 2017
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By:
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/s/ Paul Jenkinson
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Name:
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Paul Jenkinson
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Title:
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Chief Financial Officer
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