ARDELYX, INC. (NASDAQ:ARDX) Files An 8-K Entry into a Material Definitive AgreementItem 1.01
On November27, 2017, Ardelyx, Inc. (the “Company”) entered into a license agreement (“License Agreement”) with Kyowa Hakko Kirin Co., Ltd (“KHK”) under which the Company granted KHK an exclusive license to develop and commercialize tenapanor in Japan for the treatment of cardiorenal diseases and conditions, excluding cancer (“Field”). The Company retained the rights to tenapanor outside of Japan, and also retained the rights to tenapanor in Japan for indications other than those in the Field. to the License Agreement, KHK is responsible for all of the development and commercialization costs for tenapanor in the Field in Japan.
Under the License Agreement, the Company is responsible for supplying the tenapanor drug product for KHK’s use in development and during commercialization until KHK has assumed such responsibility. Additionally, the Company is responsible for supplying the tenapanor drug substance for KHK’s use in development and commercialization throughout the term of the License Agreement, provided that KHK may exercise an option to manufacture the tenapanor drug substance under certain conditions.
Under the terms of the License Agreement, the Company will receive a $30.0million upfront payment and is eligible to receive up to an additional $130.0million in development and commercialization milestones, based upon currency exchange rates as of the effective date of License Agreement.
The Company is also eligible to receive royalties based on aggregate annual net sales of the licensed products at a high teen percentage, subject to certain single digit reductions under certain circumstances described in the License Agreement.
The License Agreement will continue until all of KHK’s 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 KHK each have the right to terminate the agreement for material breach by the other party. In addition, KHK may terminate the agreement for convenience; for certain safety reasons or if certain primary endpoints under an applicable development plan are not met despite KHK’s commercially reasonable efforts and KHK reasonably determines that it cannot obtain regulatory approval. KHK may also terminate the agreement if certain pivotal clinical trials conducted by the Company do not meet their primary endpoints. The Company may terminate the License Agreement if KHK challenges any patents licensed to KHK 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 Company’s Annual Report on Form 10-K for the year ended December31, 2017.
About ARDELYX, INC. (NASDAQ:ARDX)
Ardelyx, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of minimally systemic therapeutic drugs that work in the gastrointestinal (GI) tract to treat GI and cardio-renal diseases. The Company operates through research, development and commercialization of biopharmaceutical products segment. It has discovered and designed its lead product candidate, tenapanor, which is a minimally systemic small molecule that acts locally in the GI tract to inhibit the sodium transporter sodium-hydrogen exchanger 3 (NHE3) and reduce sodium and phosphorus uptake from the gut. It is evaluating tenapanor in over two pivotal Phase III clinical studies in patients with constipation-predominant irritable bowel syndrome (IBS-C). It is developing RDX022 for the treatment of hyperkalemia. RDX022 is its oral, non-absorbed potassium-binder. Its development programs also include RDX009 Program, RDX013 Program and RDX011 Program.