User Agreement

THIS ORTHO SELECT SERVICES AGREEMENT (THIS “AGREEMENT”) IS A LEGAL AGREEMENT BETWEEN BREG, INC.(“BREG”) AND SUCH INDIVIDUAL, ASSOCIATION OR ENTITY THAT IS IDENTIFIED IN AN ORDER (AS DEFINED BELOW) AS THE PRACTICE (“YOU” AND “YOUR” AS APPLICABLE) CONCERNING THE PURCHASE BY YOU, UNDER THE TERMS AND CONDITIONS OF THIS AGREEMENT, OF THOSE SERVICES SET FORTH HEREIN IDENTIFIED AS ORTHO SELECT SERVICES. “ORDER” MEANS A SEPARATE ORDER BETWEEN BREG AND YOU FOR YOUR PURCHASE OF THE SERVICES UNDER THE TERMS AND CONDITIONS OF THIS AGREEMENT.

BY CLICKING ON THE “ACCEPT” BUTTON, COPYING, OR IN ANY WAY ACCESSING THE INFORMATION PROVIDED ONLY TO THOSE HAVING ORDERED ORTHO SELECT SERVICES, YOU ACKNOWLEDGE THAT YOU HAVE READ THIS AGREEMENT AND THE TERMS AND CONDITIONS HEREIN, UNDERSTAND EACH, AND AGREE TO BE BOUND BY SUCH TERMS OF THIS AGREEMENT.  IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT CLICK ON THE “CANCEL” BUTTON AND DO NOT COPY OR IN ANY WAY ACCESS THE INFORMATION PROVIDED SOLELY TO ORTHO SELECT CUSTOMERS. 

1.  Services Provided by Breg.  Breg will provide the Practice with the assistance and education necessary to implement the Ortho Select Program (the “Program”). This shall include customized system development for dispensing and billing orthopedic supplies and services, program coordinator evaluation / initial training, general coding and billing instruction based on publicly available information and continuing access to a Program consultant, product identification and education appropriate for use with the Program, assistance in inventory management system development, customized documentation and forms, and post-implementation account support (“Ortho Select Services.”)

2.  Obligations of Practice.  Practice will ensure that its employees fully cooperate with Breg in connection with the implementation of the Program. Practice physicians agree to inform all patients of their right to select their orthotic supplier and Practice’s physicians will honor the patient’s choice. Practice acknowledges and agrees that it maintains sole and ultimate responsibility to determine the appropriateness of submitting a particular code for a particular patient and product.  Practice is responsible for addressing specific coding questions to the relevant Medicare authority.

3.   Non-Exclusion.  Practice represents and warrants to Breg that neither it nor any of its employees, officers, directors, owners or affiliates (a) is or has been excluded from participation in any federal health care program, as defined under 42 U.S.C. Section 1320a-7b(f), for the provision of items or services for which payment may be made under such federal health care programs, or (b) has arranged or contracted (by employment or otherwise) with any employee, contractor or agent that such party or its affiliates knows or should know is excluded from participation in any federal health care program to provide items or services hereunder. 

4.   Basis for Compensation.  The agreed upon compensation set forth herein represents the fair market value of the Services negotiated in an arm’s-length transaction and has not been determined in a manner that considers the volume or value of referrals or business, if any, that may otherwise be generated between the parties.  Nothing contained in this Agreement will be construed in any manner as requiring Practice to purchase any orthopedic products or supplies from, or otherwise refer any business to, Breg.  Practice’s physicians should use their professional judgment in recommending and prescribing orthopedic products and supplies in the best interest of their patients.  The parties further agree that this Agreement does not involve the counseling or promotion of a business arrangement that violates federal or state law.

5.         Term and Termination. The term of this Agreement will commence on the Effective Date and will continue until the Ortho Select Services set forth in Section 1 of this Agreement have been performed and an invoice has been submitted by Breg to Practice upon the completion of said services (the “Term”), unless earlier terminated due to a material default in the performance of any material covenant or term of this Agreement still existing after a period of thirty (30) days after written notice is delivered to the breaching party. Termination of this Agreement will not release or discharge either party from any obligation, debt or liability which has previously accrued and remains to be performed upon the date of termination.

6.         Compliance with Laws.  Each party will at all times comply with all applicable federal and state laws, rules, regulations and guidelines pertaining to the Services, including but not limited to: (a) the disclosure requirements and self-referral prohibitions of the Federal Ethics in Patient Referrals Act, 42 U.S.C. § 1395nn (the “Stark Law”) and any applicable state self-referral laws, (b) the federal anti-fraud and abuse statute, 42 U.S.C. § 1320a-7b(b) (the “Anti-Kickback Statute”) and any applicable state anti-kickback laws; and (c) the patient privacy requirements in the Health Insurance Portability and Accountability Act (“HIPAA”) and its implementing regulations at 45 C.F.R. Parts 160 and 164 and any applicable state patient privacy laws.  

7.         Confidential Information. During the Term and at all times thereafter, each party will treat as confidential and not disclose, publish or otherwise make available to the public or to any individual, firm or corporation any Confidential Information (as hereinafter defined). The term “Confidential Information” will mean all information acquired by either party during the Term and in contemplation of the same in any way concerning the products, projects, activities, business or affairs of either party and its subsidiaries, or affiliates, including, without limitation, all information concerning trade secrets and the products or projects of such party and its subsidiaries or affiliates and/or any improvements therein, all sales and financial information concerning either party and its subsidiaries or affiliates, all customer and supplier lists, and all information concerning projects in research and development or marketing plans for any such products or projects; provided, however, that the term “Confidential Information” will not include information that (a) is or becomes generally available to the public other than through the fault of  the party receiving the Confidential Information or (b) becomes available to the party receiving the Confidential Information on a non‑confidential basis from a source other than a party or its subsidiaries or affiliates, provided that such source is not bound by a confidentiality agreement with a party or its subsidiaries or affiliates.  The parties agree to use their reasonable efforts to safeguard the Confidential Information from unauthorized disclosure and to disclose said Confidential Information to their respective employees or advisors strictly on a “need to know” basis only.  The parties agree to advise any and all such employees and advisors of the confidential nature of the Confidential Information and will take appropriate steps to ensure that any employee or advisor to whom Confidential Information is disclosed will abide by the provisions of this Agreement and will be responsible for the failure of any of its employees or advisors to abide by the provisions of this Agreement.  Except as provided in this Section 7, neither Party will disclose Confidential Information to any third party without the prior written consent of the other Party hereto.

In the event that either Party is requested pursuant to, or required by, applicable laws, rules, regulations or legal process to disclose any of the Confidential Information, the Party requested to disclose (the “Disclosure Party”) will notify the other party promptly so that the other Party may seek a protective order or other appropriate remedy (with the Disclosure Party’s help, if necessary) or, in the other Party’s sole discretion, waive compliance with the terms of this paragraph.  In the event that no such protective order or other remedy is obtained, or that the other party waives compliance with the terms of this paragraph, the Disclosure Party will furnish only that portion of the Confidential Information which it is advised by legal counsel is legally required and will exercise all reasonable efforts to obtain reliable assurance that confidential treatment will be afforded the Confidential Information.

8.         Indemnification.  To the extent permitted by law, each party (each, an “Indemnifying Party”) agrees to defend, indemnify and hold harmless the other party, its directors, officers, employees, agents, succes­sors, and assigns (the “Indemnified Party”), from and against all actions, causes of action, suits, claims and demands whatso­ever, and from all costs, damages, ex­penses, charges, debts and liabili­ties whatso­ever (including attorneys’ fees) (the “Losses”), whether known or un­known, present or future, that arise from or are connected with (a) a breach by the Indemnifying Party of any representation, warranty or covenant, contained in this Agree­ment, or (b) the gross negligence or willful misconduct by the Indemnifying Party or its directors, officers, employees, agents, successors or assigns in the performance of its obligations under this Agreement, except in the case of either clause (a) or clause (b) for those Losses that are due to the gross negligence or willful misconduct of the Indemnified Party.  

9.         Independent Contractor.  This Agreement is intended to create a relationship of independent contractors that are contracting with one another solely for the purpose of carrying out the objectives of this Agreement.  The parties nor their respective affiliates, agents, employees or representatives, will be construed solely by reason of this Agreement or their participation in any Agreement to be the affiliate, agent, employer, employee, partner, joint venturer or representative of the other party.  Neither party is authorized to enter into or execute any contract, order or other commitments on behalf of the other party, and neither party has the authority to otherwise obligate the other party.

10.       Warranties.  EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, BREG MAKES NO WARRANTIES OR REPRESENTATIONS, EXPRESS OR IMPLIED, AND DISCLAIMS ALL EXPRESS, IMPLIED AND STATUTORY WARRANTIES AND REPRESENTATIONS, INCLUDING ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, TITLE AND WORKMANSHIP AND SPECIFICALLY DISCLAIMS ALL WARRANTIES AND REPRESENTATIONS WITH RESPECT TO REVENUE PROJECTIONS, HEATHCARE LAWS OR REGULATIONS, AND CODING AND REIMBURSEMENT FOR PRODUCTS.

11.      Limitation of Liability.  OTHER THAN LIABILITY UNDER OR FOR BREACH OF SECTIONS 7 OR 8 OF THIS AGREEMENT, NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY (NOR TO ANY PERSON CLAIMING RIGHTS DERIVED FROM THE OTHER PARTY'S RIGHTS) FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE, OR EXEMPLARY DAMAGES OF ANY KIND (INCLUDING WITHOUT LIMITATION LOST PROFITS, LOSS OF BUSINESS, OR OTHER ECONOMIC DAMAGE) AS A RESULT OF A BREACH OF ANY WARRANTY OR OTHER TERM OF THIS AGREEMENT, REGARDLESS OF WHETHER THE PARTY LIABLE OR ALLEGEDLY LIABLE WAS ADVISED, HAD OTHER REASON TO KNOW, SHOULD HAVE ANTICIPATED, OR IN FACT KNEW OF THE POSSIBILITY THEREOF.  THE PROVISIONS OF THIS SECTION 11 ARE INDEPENDENT OF, SEVERABLE FROM, AND TO BE ENFORCED INDEPENDENTLY OF ANY OTHER ENFORCEABLE OR UNENFORCEABLE PROVISION OF THIS AGREEMENT.  IF AND TO THE EXTENT THAT A PARTY AND/OR ANY AFFILIATE OF SUCH PARTY, NOTWITHSTANDING THE FOREGOING PROVISION OF THIS SECTION 11, IS LIABLE FOR DAMAGES UNDER ANY APPLICABLE LAW OF MANDATORY APPLICATION, THE TOTAL AND AGGREGATE LIABILITY OF SUCH PARTY AND ANY AFFILIATE OF SUCH PARTY SHALL NOT EXCEED THE AGGREGATE AMOUNT OF THE SERVICE FEE PAID BY PRACTICE TO BREG IN RETURN FOR THE PROVISION OF THE SERVICES.  ONLY IF AND TO THE EXTENT THAT ANY APPLICABLE LAW OF MANDATORY APPLICATION PROVIDES, NOTWITHSTANDING THE FOREGOING PROVISIONS OF THIS SECTION 11, THAT ANY LIMITATION OF LIABILITY SET FORTH HEREUNDER, OR PART THEREOF, IS NOT VALID OR ENFORCEABLE, THE LIMITATION OF LIABILITY UNDER THIS SECTION 11 SHALL BE INTERPRETED TO BE EFFECTIVE TO THE GREATEST EXTENT PERMISSIBLE UNDER SUCH APPLICABLE LAW OF MANDATORY APPLICATION.

12.       Governing Law / Jurisdiction.  This Agreement will be construed and governed by the laws of the State of California, without regard to the conflict of laws principles thereof. Practices consents and submits to the exclusive jurisdiction of competent State and Federal Courts in the State of California   for any litigation or proceeding and to the venue of such litigation or proceeding in the County of San Diego, California.

13.       Entire Agreement. This Agreement contains the entire and final agreement among the parties hereto with respect to Practice’s engagement of Breg and supersedes all prior agreements, whether written or oral, with respect thereto.  No provision hereof may be modified, amended, or waived in any manner whatsoever other than by a supplemental writing signed by the parties hereto or their respective successors in interest.  This Agreement will be binding upon and inure to the benefit of the parties and their respective successors, assigns, heirs, executors and legal representatives. 

14.       Notices.  All notices and communication to any party hereto will be in writing and will be addressed to the receiving party’s address set forth in the first paragraph of the Ortho Select Services Order or to any other address as a party may designate by notice hereunder. All such notices will be deemed effective (a) if by hand, at the time of the delivery thereof to the receiving party, (b) if sent by overnight courier, on the next business day following the day such notice is delivered to the courier service, or (c) if sent by certified mail, five (5) business days following the day such mailing is made.

15.       Assignment.  Except as otherwise provided herein, neither party may assign any of its rights or delegate any of its duties under this Agreement without the prior written consent of the other party; provided, however, that Breg may assign its rights and/or delegate its duties to an affiliate of Breg without the prior written consent of Practice.  Any unauthorized attempted assignment will be null and void and of no force and effect.

16.       No Third Party Beneficiary.  Except as expressly provided in this Agreement, no person or entity that is not a party to this Agreement shall be a third party beneficiary of any rights or obligations hereunder or be entitled to enforce any of said rights or obligations. 

17.       Waivers.  The waiver by any party of any breach of any term, covenant or condition contained herein shall not be deemed to be a waiver of any subsequent breach of the same or any other term, covenant or condition contained herein.  The subsequent acceptance of performance or payment of compensation hereunder by a party shall not be deemed to be a waiver of any preceding breach by the other party of any term, covenant or condition of this Agreement regardless of such party’s knowledge of such preceding breach at the time of acceptance of such performance.

18.       Severable Provisions; Headings.  The provisions of this Agreement are severable, and if any one or more provisions are determined to be illegal or otherwise unenforceable, in whole or in part, the remaining provisions, and any partially unenforceable provision to the extent enforceable, shall nevertheless be binding and enforceable.  The headings of paragraphs in this Agreement are for convenience only and shall not affect or limit the interpretation of its provisions.

19.       Counterparts.  This Agreement may be executed in any number of counterparts, each of which shall be deemed to be an original, but all of which together shall constitute one and the same instrument.