ENTEROMEDICS INC. (NASDAQ:ETRM) Files An 8-K Entry into a Material Definitive AgreementItem 1.01. Entry into a Material Definitive Agreement.
On April 26, 2017, EnteroMedics Inc. (the “Company”) entered into a Clinical Trial Agreement (the “Agreement”) with Southern California Permanente Medical Group (“Southern”) with an effective date of June 1, 2017. Under the Agreement, the Company is sponsoring an investigator-initiated study with Southern California Permanente Medical Group, a division of Kaiser Permanente, to study vBloc therapy as a treatment for Type 2 diabetic patients with obesity. The three-year study will be led by co-investigators Dr. Anny Xiang and Dr. Robert Zane. As sponsor of the study, the Company is obligated to pay Southern approximately $3.4 million over three years to fund the study.
All clinical data generated during the Study will be promptly disclosed to the Company and may be used by the Company for any purpose stated in the informed consent form or otherwise in compliance with applicable law. Southern and the Company will each have the right to publish, present or use any final results arising out of the study.
The Agreement may be terminated by the Company or Southern at any time upon 30 days’ written notice to the other party, by Southern immediately for safety reasons, or by either party if the other party materially breaches any of its obligations or provisions in the Agreement as long as the breaching party is given at least 30 days prior written notice of the breach and the opportunity to cure the breach during such period.
The Agreement will be filed as an exhibit to the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2017.