Current Report Filing (8-k)
12 December 2017 - 9:08AM
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): December 11, 2017
ARDELYX, INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-36485
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26-1303944
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification Number)
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34175 Ardenwood Blvd., Suite 200
Fremont, CA 94555
(Address of principal executive offices, including Zip Code)
Registrants telephone number, including area code:
(510) 745-1700
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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Indicate by check mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule
12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this chapter).
Emerging growth company ☒
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange
Act. ☒
Item 1.01
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Entry into a Material Definitive Agreement.
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On December 11, 2017, Ardelyx, Inc. (the
Company) entered into a license agreement (the License Agreement) with Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun) under which the Company granted Fosun an exclusive license to develop
and commercialize tenapanor in China for the treatment, diagnosis or prevention of (i) irritable bowel syndrome with constipation and chronic idiopathic constipation, (ii) hyperphosphatemia related to chronic kidney disease and
(iii) other diseases or conditions for which the Company obtains marketing approval in either the US or China (collectively, Field). Field excludes the treatment of cancer. The Company retained the rights to tenapanor outside of
China, and also retained the rights to tenapanor in China for indications other than those in the Field. Pursuant to the terms of the License Agreement, Fosun is responsible for all of the development and commercialization costs for tenapanor in the
Field in China.
Under the terms of the License Agreement, the Company is responsible for supplying the tenapanor drug product for Fosuns use in
development and during commercialization until Fosun has assumed such responsibility. Additionally, the Company is responsible for supplying the tenapanor drug substance for Fosuns use in development and commercialization throughout the term
of the License Agreement.
Under the terms of the License Agreement, the Company will receive an upfront payment of $12 million and is eligible to
receive additional milestones of up to $113 million in the aggregate, as well as tiered royalty payments on aggregate net sales ranging from the
mid-teen
percent to twenty percent, subject to certain
reductions under certain circumstances, as described in the License Agreement.
The License Agreement will continue until all of Fosuns 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, the Company and Fosun each have the right to terminate the agreement for material
breach by the other party or in the event of insolvency by the other party. In addition, Fosun may terminate the agreement for convenience and the Company may terminate the agreement if Fosun challenges any patents licensed to Fosun under the
agreement.
The License Agreement includes various representations, warranties, covenants, dispute escalation and resolution mechanisms, indemnities and
other provisions customary for transactions of this nature.
The foregoing description of the License Agreement is qualified in its entirety by reference
to the License Agreement, a copy of which will be filed as an exhibit to the Companys Annual Report on Form
10-K
for the year ended December 31, 2017.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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Date: December 11, 2017
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ARDELYX, INC.
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By:
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/s/ Mark Kaufmann
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Mark Kaufmann
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Chief Financial Officer
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