Compliance

CrossRoads Extremity Systems, LLC Code of Conduct

Introduction.

CrossRoads Extremity System’s (“CRE) is committed to conducting its affairs in compliance with all applicable laws and regulations and in accordance with the highest ethical standards. This Code of Conduct has been established to help ensure that CRE meet our commitment to ethical and lawful conduct. This Code of Conduct applies to all employees, officers, and directors of CRE as well as contractors, consultants and distributors that provide services on CRE’s behalf.  

This Code of Conduct establishes policies and procedures that are intended to guide employees, officers, directors, contractors, consultants and distributors in the performance of their duties and responsibilities and ensure compliance with CRE’s commitment to ethical and lawful conduct.

Basic Policies:

1. Compliance with Laws. CRE will conduct its business and affairs in compliance with all laws, rules, and regulations and in accordance with CRE’s high ethical standards.

2. Work Environment. CRE will maintain a safe and drug-free work place that is free from discrimination and harassment based on race, color, creed, religion, sex, age, disability, national origin, ancestry, citizenship, armed forces service, marital or veteran status, sexual orientation, or any other impermissible factor.

3. Manufacturing Products. CRE is committed to producing products that are safe and effective. In developing and manufacturing medical devices and other products, CRE has established and will comply with standards that meet or exceed regulations promulgated by the Food and Drug Administration or the laws and regulations of the country of development and manufacture. In manufacturing its products, CRE will comply with all applicable laws and regulations, including those relating to the environment and occupational health and safety.

4. Competitive Practices. CRE will compete for all business opportunities vigorously, fairly, ethically, and legally. CRE will comply with all antitrust and other laws regulating competition and trade in each country where it conducts business and will not discuss pricing, cost, production plans, business strategies, or any other proprietary or confidential information with its competitors.

5. Marketing and Sales. CRE will represent its products and services accurately and will comply with applicable regulatory and legal requirements governing the marketing and sale of its products and services.

6. Recording and Reporting Information. In recognition of the fact that accurate information is essential to CRE’s ability to satisfy legal and regulatory obligations, all employees and directors will record and report all information accurately and honestly. No employee or director will sign or submit, or permit others to sign or submit on behalf of CRE, any document or statement that he or she knows or has reason to believe is false.

7. Payments. CRE and its employees and directors will not make any improper payments to government or non-government officials, employees, customers, persons, or entities, nor will CRE or its employees and directors request or accept any improper payment from suppliers, customers, or anyone seeking to do business with CRE.

8. Fair Dealing. Each employee and director will deal fairly with CRE’s customers, suppliers, competitors, independent auditors, and other employees and will not take unfair advantage of anyone through manipulation, concealment, abuse of privileged information, misrepresentation of material facts, or any other unfair dealing or practice.

9. Confidential Information. No employee or director will use, for his or her own personal gain, or disclose to any third party, any confidential or proprietary information that he or she obtained as a result of his or her employment with or relationship to CRE. Confidential or proprietary information includes all nonpublic information that might be of use to competitors or harmful to CRE and its customers if disclosed.

10. Political Contributions. CRE will make no corporate political contributions to parties or individuals, even where such contributions may be legal, but encourages employees and directors to participate in community affairs and to exercise citizenship responsibilities.

11. Corporate Opportunities. Employees and directors owe a duty to CRE to advance its legitimate interests when the opportunity to do so arises. Employees and directors are prohibited from (a) taking for themselves personally opportunities that are discovered through the use of corporate property, information, or position, (b) using corporate property, information, or position for personal gain, or (c) competing with CRE.

12. Conflicts of Interest. No employee or director will engage in any activity or have any outside interest that might deprive CRE of his or her loyalty, interfere with the satisfactory performance of his or her duties, and make it difficult to perform his or her duties for CRE objectively and effectively, or be harmful or detrimental to CRE. Employees and directors must immediately disclose in writing any actual or potential conflict of interest that they may have to the Chief Executive Officer of CRE, for resolution. A conflict of interest occurs when a person's private interest interferes or appears to interfere in any way with CRE’s interests and may also arise when an employee or director or a member of his or her family receives improper personal benefits as a result of his or her position with CRE.

Examples of actual or potential conflicts of interest include whenever:

(a) An employee or director holds an outside position or is engaged in an outside activity that affects the performance of his or her work for CRE.

(b) An employee or director, or any member of his or her family, is employed by, is a consultant to, or holds an ownership or other interest (other than a nominal investment in stock of a publicly traded company) in any concern that is a competitor of CRE, a supplier or dealer for CRE, or is involved in a joint venture with CRE.

13. Protection and Proper Use of Company Assets. Theft, carelessness, and waste have a direct impact on CRE’s profitability. All employees and directors will take appropriate actions to protect CRE’s assets and ensure their efficient use for legitimate business purposes.

The Advanced Medical Technology Association ("AdvaMed")

The Advanced Medical Technology Association (“AdvaMed”) is dedicated to the advancement of medical science, the improvement of patient care, and in particular to the contribution that high quality, cost-effective health care technology can make toward achieving those goals. In pursuing this mission, AdvaMed members recognize that adherence to ethical standards and compliance with applicable laws are critical to the medical device industry’s ability to continue its collaboration with health care professionals.

Members encourage ethical business practices and socially responsible industry conduct related to their interactions with health care professionals. Members also respect the obligation of health care professionals to make independent decisions regarding Member products.
Consequently, AdvaMed adopted this voluntary Code of Ethics, effective January 1, 2004 and revised and restated with an effective date of July 1, 2009, to facilitate Members’ ethical interactions with those individuals or entities that purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Members’ medical technology products in the United States.

Without reservation, CrossRoads Extremity Systems strongly endorses both the letter and spirit of the AdvaMed Code of Ethic.

https://www.advamed.org/sites/default/files/resource/112_112_code_of_ethics_0.pdf

California Declaration of Compliance Program

Declaration of Adoption of Comprehensive Compliance Program Pursuant to California Health and Safety Code Section 119402 CrossRoads Extremity Systems, LLC. (“CRE”) is in the business of designing, manufacturing and selling orthopedic medical devices. As a medical device manufacturer, CRE has developed a Comprehensive Compliance Program that is specific to the nature of the business as a medical device manufacturer and consistent with the United States Department of Health and Human Services Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers. The purpose of our Compliance program is to prevent and detect violations of law or company policy. Our Compliance program is based upon the principles set forth in the Advanced Medical Technology Association Code of Ethics on Interactions with Health Care Professionals (“AdvaMed Code”) and the Company’s Code of Business Conduct. The AdvaMed Code is substantially equivalent to the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (PhRMA Code), but reflects the unique interactions between medical technology companies and health care professionals. CRE’s Code of Business Conduct is our statement of ethical and compliance principles that guide our daily operations and articulates our fundamental principles, values and framework for action within our organization. Additional compliance guidance is communicated through our Compliance Manual for the U.S. which applies to interactions with health care professionals to the extent that they provide services or medical technologies in the United States. This guidance establishes explicit limits on gifts, promotional material or items, or activities that CRE or its representatives may provide to an individual health care professional. CRE declares that to the best of its knowledge,  CRE is in compliance with the provisions of California Health and Safety Code Section 119402 as of November 10, 2011. To access a copy of CRE’s Code of Business Conduct or a copy of this Declaration of Adoption of Comprehensive Compliance Program; please visit our corporate website at http://www.CRExtremity.com/compliance.