ARDELYX, INC. (NASDAQ:ARDX) Files An 8-K Entry into a Material Definitive AgreementItem 1.01
On December11, 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. 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 Fosun’s use in development and during commercialization until Fosun has assumed such responsibility. Additionally, the Company is responsible for supplying the tenapanor drug substance for Fosun’s 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 $12million and is eligible to receive additional milestones of up to $113million 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 Fosun’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 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 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.