Legal note


TRADEMARK STATEMENT

The Inova Diagnostics logo, QUANTA Flash, QUANTA Lite, NOVA Dot, NOVA Lite, NOVA View, BIO-FLASH, QUANTA-Lyser and QUANTA Link are trademarks of Inova Diagnostics Company and/or one of its subsidiaries or parent companies, and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners.

POLICIES

Environmental Policy

Inova Diagnostics (Inova) maintains an environmental management system for the design, development, manufacture, distribution and servicing of IVD Systems and Reagents.

Inova is committed to reducing the adverse impact of our activities, products, and services through recognition and support of:

  • The key influential role of design and operational activities in environmental management 
  • The link between public health and the environment

Inova is committed to training and participating in environmental policy issues for the benefit of our employees, customers and the public. Inova will achieve these through:

  • Continuous improvement of energy usage and waste management 
  • Pollution evaluation and prevention, wherever possible and practicable, by the use of non-polluting techniques and practices 
  • Continuing to inform and train our employees on environmental initiatives and waste management programs 
  • Compliance with all laws and regulations pertaining to relevant environmental legislation, regulations and other public sector requirements

Quality Policy

To ensure our Customer Service support:

  1. Inova Service is prepared to maintain worldwide Service and Support to our products through our network of Affiliates, Distributors and Dealers. This will be accomplished through redundancies in both our labor force and parts supply chain.
  2. Each Service group has multiple individuals trained on each of the products. In case of illness to one individual, others can step in to service the product. As a result, the labor force will not be compromised and can maintain support.
  3. Service parts are maintained in multiple locations throughout the world including Distribution Centers in San Diego, CA, Roncello, Italy, Devens, MA as well as Hong Kong. In addition, the individual Affiliates maintain a quantity of service parts, located in both their home offices and in the personal possession of their Field Service Representatives.
  4. In total; the Affiliate Service Managers have been instructed to maintain a local inventory level equal to 2 months of the Service and Support needs.

We feel that the steps we have implemented above, and our internal programs, will sufficiently mitigate any risk of interrupted product delivery or support to our customers.

Please feel free to call if you have any additional questions at 858-586-9900

Sunshine Act

Inova Corporate Fact Sheet on the Sunshine Act

What is the Sunshine Act and who does it affect?

On August 1, 2013, the "Physician Payments Sunshine Act" portion of the Affordable Care act was put into effect. This requires manufacturers of medical devices and biologicals who participate in U.S. federal healthcare programs to report all transfers of value given to physicians and teaching institutions. This includes, but is not limited to, meals, gifts, travel, lodging, educational materials, and consulting fees. The law is designed to prevent potential conflicts of interests.

What does this mean for physicians and teaching institutions relative to Inova Diagnostics?

Per the Sunshine Act, Inova Diagnostics must document all transfers of value between our company and physicians/teaching institutions when they occur, and report them to CMS on an annual basis. The Sunshine Act allows physicians/teaching hospitals to review and correct the submitted data, to ensure that inaccuracies are not reported. Specifically, when a “transfer of value” occurs, Inova Diagnostics will ask physicians and teaching institutions to provide basic information such as: National Provider ID, Teaching Hospital Tax ID, Physician License Number, and other publicly available information. This information will be combined with details about the payment amount, nature of the payment (e.g., royalty fees, consulting fees, charitable contribution), and the form of the payment. This will then be submitted to CMS.

Compliance – Our policy and perspective

Inova Diagnostics deeply values the vital role of physicians and teaching institutions. We believe healthcare professionals and institutions play an essential role in our research and development process, as well as in the continuous improvement of existing products and services. Inova Diagnostics actively solicits support from key opinion leaders to substantiate product claims, drive innovation and develop superior Autoimmune products to enhance diagnostic testing, and ultimately patient care. The Sunshine Act does not prohibit nor discourage the mutually beneficial exchanges between physicians and the medical device industry; however, it does ensure transparency. Thus, our compliance with the Sunshine act is essential in protecting these invaluable relationships. More information on the Sunshine Act can be found at http://go.cms.gov/openpayments. Please consult CMS for additional information.

California Supply Chain Act

At Inova Diagnostics we are dedicated to conducting business in a lawful and ethical manner. We are unconditionally opposed to human trafficking and believe that all workers have the right to freely choose employment, and have a workplace free of unlawful harassment and discrimination. Therefore, Inova Diagnostics expects its suppliers to equally act as responsible corporate citizens and to take affirmative actions to protect the rights of their workers against human trafficking.

Before engaging in business with any supplier, Inova Diagnostics, as part of its Initial Supplier Assessment Process, asks the supplier whether it respects internationally recognized standards prohibiting child and slave labor and whether it promotes safe and healthy working conditions.

In addition, Inova Diagnostics includes in the standard terms and conditions of its purchase orders that any vendor or contractor providing goods or services comply with all applicable laws, statutes, rules, regulations and orders in effect in the countries and jurisdictions in which they do business. Finally, To ensure our contractors and suppliers respect and enforce our company standards, Inova Diagnostics requests that all suppliers sign Inova Diagnostics Supplier Certification which requires the supplier to respect internationally recognized standards prohibiting child and slave labor and promoting safe and healthy working conditions.

The focus on slavery and human trafficking is part our larger commitment to corporate responsibility and respecting human rights in our own operations and in our global supply chain.

With specific regard to the California Transparency in Supply Chains Act, Inova Diagnostics provides the following information:

  1. Verification: Before engaging with any new supplier, Inova Diagnostics requests that the supplier verify, as a part of its Initial Supplier Assessment Process, that the supplier respects internationally recognized standards prohibiting child and slave labor and promotes safe and healthy working conditions. Verification is not conducted by a third party.
  2. Audits: Inova Diagnostics does not currently audit our suppliers specifically for compliance with company standards on trafficking and slavery in supply chains. Inova Diagnostics, however, periodically audit its suppliers for compliance to relevant quality systems and standards.
  3. Certification: To ensure our contractors and suppliers respect and enforce our company standards, Inova Diagnostics requests that all suppliers sign Inova Diagnostics Supplier Certification which requires the supplier to respect internationally recognized standards prohibiting child and slave labor and promoting safe and healthy working conditions. Inova Diagnostics also includes a clause in our general terms and conditions of purchase that requires all suppliers to certify they are in full compliance with all applicable laws, statutes, rules, regulations and orders in the country or countries in which they are doing business.
  4. Internal Accountability: Inova Diagnostics does not currently have internal corporate policies specific to slavery and human trafficking. We do, however, expect all employees and third parties who interact on behalf of the Company to adhere to the WerfenLife Code of Ethics, which requires compliance with all national and local laws, regulations and professional codes that apply to the areas within the scope of their work responsibilities.
  5. Training: Inova Diagnostics periodically provides training to appropriate members of its procurement staff on the California Supply Chain Act.

AdvaMed Code

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