Statement of Compliance with California Law

Effective December 10, 2018, to the best of our knowledge, Statera Spine Inc. (“Statera”) is in compliance with a Comprehensive Compliance Program (“CCP”) that satisfies the requirements of California Health and Safety Code §§ 119400-119402, based on our good faith understanding of the statutory provisions as they may apply to a medical device manufacturer.

Consistent with the Department of Health and Human Services Office of the Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers (“HHS-OIG Guidance”), Statera has tailored its CCP to the nature of its business as a medical device manufacturer.1.

In addition to our CCP, Statera has established an annual spending limit for certain promotional activities directed toward healthcare professionals practicing in California (“Annual Spending Limit”). The Annual Spending Limit applies to educational items, promotional materials, and other items or activities that are provided to a California healthcare professional, as defined by and required by the California Health and Safety Code §§ 119400-119402.

Statera is committed to the highest standards of ethical and legal conduct. We have developed a CCP that is reasonably designed to prevent and detect violations, and includes the following:

  1. Written Standards.  We have established and implemented a Code of Business Conduct as well as compliance policies/procedures that are consistent with the provisions of the AdvaMed Code of Ethics on Interactions with Healthcare Professionals (“AdvaMed Code”).
  2. Leadership and Structure.  We have established effective oversight over the CCP, including selection of a Compliance Officer to develop, operate, and monitor the CCP and creation of a compliance committee to provide strategic direction and oversight.
  3. Training and Education. All employees receive copies of our Code of Business Conduct and relevant compliance policies/procedures and certify that they have read, understood, and agree to abide by these written standards. We also committed to ongoing comprehensive training based on relevant job duties and classifications.
  4. Lines of Communication.  To facilitate an open door environment, we have adopted confidentiality and non-retaliation policies as well as mechanisms to facilitate anonymous reporting.
  5. Auditing and Monitoring.  Our CCP includes ongoing efforts to monitor, audit, and assess compliance.
  6. Enforcement.  Statera is committed to investigating and appropriately responding to violations.
  7. Corrective Action.  Staters will take appropriate corrective action.

    8. To obtain a print version of our CCP or this declaration, please call Customer Support at 1 (512) 334-5490, or for toll-free communications please email info@stateraspine.com. To report potential violations of Statera’s CCP, please complete a Compliance Report Form (see Code of Business Conduct), and mail it to:

    1 While California Health and Safety Code §§ 119400-119402 makes reference to compliance with the Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals (“PhRMA Code”), Statera manufactures medical devices rather than pharmaceutical products. Therefore, Statera adopted policies and procedures consistent with The AdvaMed Code of Ethics on Interactions with Healthcare Professionals (“AdvaMed Code”) which, although substantially similar to the PhRMA Code, recognizes differences applicable to the medical device industry.

    Rev. 1042-1.0 (10/2014)