Terms & Conditions

Clear Treatment Planning Services (ClearTPS) Scope of Clinical Consulting Services and HIPPA Compliance Agreement, Terms and Conditions

1) Scope of Consulting Services. Consultant shall provide the following consulting services to the Company (collectively the “Services”):

  a) One-time ClearTPS account set up (Invisalign Doctor Site user name and password required to set up account);

  b) Clinical evaluation to determine the clinical applicability of Invisalign treatment (all appropriate records and prescription forms must be submitted online through Invisalign Doctor Site);

  c) Complimentary on-going review of Invisalign Clinical Treatment Preferences in Invisalign Doctor Site;

  d) Unlimited ClinCheck® modifications for each individual treatment i.e. Full or Express Service; and

2) Fees. The Fees for the Services described in Section 1 hereinabove shall be a one-time fee of $299 per Full Service or $149 per Express, Mid Course Correction Service or $99 for Case Evaluation Service, payable in advance.

 3) Term and Termination. It is the intention of the parties hereto that the Services and Additional Services provided shall be on a case by case basis. Either party may terminate this Agreement at any time upon notice to the other party. In the event Consultant terminates this Agreement prior to providing all of the Services, Consultant shall refund the Fees paid to the Consultant pursuant to Section 2 of this Agreement.

 4) Independent Contractor Relationship. Consultant is an independent contractor and is not an employee, servant, partner or joint venturer of Company. Company shall determine the work to be done by Consultant, but Consultant shall determine the legal means by which it accomplishes the work specified by Company. Company is not responsible for withholding, and shall not withhold, FICA or taxes of any kind from any payments it owes Consultant; moreover, Consultant shall indemnify Company for any claims of taxes owed on sums paid to Consultant. Neither Consultant nor its employees shall be entitled to receive any benefits which employees of Company are entitled to receive and shall not be entitled to workers’ compensation, unemployment compensation, medical insurance, life insurance, paid vacations, paid holidays, pension, profit sharing, or Social Security on account of their work for Company.

 5) Indemnification. Company does hereby agree to defend, indemnify and hold harmless Consultant and its trustees, officers, employees, directors, agents, contractors, and servants from any and all claims and liabilities of any type or nature whatsoever arising out of any act, omission or negligence by Company, its officers, employees, directors, agents, contractors, or servants which may now or hereafter arise out of or result from or in any way be related to the provision of services pursuant to this Agreement.

 6) Confidential Information. Consultant understands and agrees that it shall receive and contribute to the Company’s Confidential Information. Consultant shall keep secret all such Confidential Information and will not make known the same to any person, firm, or corporation without first obtaining the written consent of Company. At any time Company may so request, Consultant shall turn over to Company all charts, notes, memoranda, notebooks, spreadsheets, databases or other documents made, compiled by, or delivered to it concerning any such Confidential Information, including copies thereof in its possession, it being agreed that the same and all information contained therein are and shall remain at all times the property of Company. The non-disclosure covenants and agreements contained in this section shall be continuing in nature, such that they shall continue to bind Consultant after the termination of its consulting relationship with Company. Consultant further acknowledges and agrees that Company will suffer great loss and damage if, at any time, Consultant should disclose information about such business to anyone, and that it may be difficult or impossible to compute the amount of such loss or damages, thereby leaving Company without adequate legal remedy should Consultant violate the covenants of this Agreement. Consultant acknowledges that the covenants and conditions of this Agreement are reasonable and necessary for the protection of Company’s business.

 7) HIPPA Compliance; Business Associate Agreement. The parties hereto intend to comply with the Health Insurance Portability and Accountability Act (“HIPPA”). The parties acknowledge that Consultant is a “business associate” under HIPPA. The parties hereby agree as follows:

  a)Definitions.
     (I) The following terms used in this Agreement shall have the same meaning as those terms in the HIPAA Rules: Breach, Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices, Protected Health Information, Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.

     (II) Specific definitions:
          A. Business Associate. “Business Associate” shall generally have the same meaning as the term “business associate” at 45 CFR 160.103, and in reference to the party to this agreement, shall mean Clear Treatment Planning Solutions, B.V.

          B. Covered Entity. “Covered Entity” shall generally have the same meaning as the term “covered entity” at 45 CFR 160.103, and in reference to the party to this agreement, shall mean the Company

          C. HIPAA Rules. “HIPAA Rules” shall mean the Privacy, Security, Breach Notification, and Enforcement Rules at 45 CFR Part 160 and Part 164.

     (b) Obligations and Activities of Business Associate. The Business Associate agrees to:

          (I) Not use or disclose protected health information other than as permitted or required by the Agreement or as required by law;

          (II) Use appropriate safeguards, and comply with Subpart C of 45 CFR Part 164 with respect to electronic protected health information, to prevent use or disclosure of protected health information other than as provided for by the Agreement;

          (III) Report to covered entity any use or disclosure of protected health information not provided for by the Agreement of which it becomes aware, including breaches of unsecured protected health information as required at 45 CFR 164.410, and any security incident of which it becomes aware;

          (IV) In accordance with 45 CFR 164.502(e)(1)(ii) and 164.308(b)(2), if applicable, ensure that any subcontractors that create, receive, maintain, or transmit protected health information on behalf of the business associate agree to the same restrictions, conditions, and requirements that apply to the business associate with respect to such information;

          (V) Make available protected health information in a designated record set to the covered entity as necessary to satisfy covered entity’s obligations under 45 CFR 164.524;

          (VI) Make any amendment(s) to protected health information in a designated record set as directed or agreed to by the covered entity pursuant to 45 CFR 164.526, or take other measures as necessary to satisfy covered entity’s obligations under 45 CFR 164.526;

          (VII) Maintain and make available the information required to provide an accounting of disclosures to the covered entity as necessary to satisfy covered entity’s obligations under 45 CFR 164.528;

          (VII) To the extent the business associate is to carry out one or more of covered entity’s obligation(s) under Subpart E of 45 CFR Part 164, comply with the requirements of Subpart E that apply to the covered entity in the performance of such obligation(s); and

          (IX) Make its internal practices, books, and records available to the Secretary for purposes of determining compliance with the HIPAA Rules.

     (c) Permitted Uses and Disclosures by Business Associate.

          (I) Business associate may only use or disclose protected health information as necessary to perform the Services and the Additional Services described in this Agreement.

          (II) Business associate may use or disclose protected health information as required by law.

          (III) Business associate agrees to make uses and disclosures and requests for protected health information consistent with covered entity’s minimum necessary policies and procedures.

         (IV) Business associate may not use or disclose protected health information in a manner that would violate Subpart E of 45 CFR Part 164 if done by covered entity except for the specific uses and disclosures set forth below.

               A. Business associate may use protected health information for the proper management and administration of the business associate or to carry out the legal responsibilities of the business associate.

               B. Business associate may disclose protected health information for the proper management and administration of business associate or to carry out the legal responsibilities of the business associate, provided the disclosures are required by law, or business associate obtains reasonable assurances from the person to whom the information is disclosed that the information will remain confidential and used or further disclosed only as required by law or for the purposes for which it was disclosed to the person, and the person notifies business associate of any instances of which it is aware in which the confidentiality of the information has been breached.

               C. Business associate may provide data aggregation services relating to the health care operations of the covered entity.

     (d) Covered Entity’s Privacy Practices and Restrictions. Covered entity shall notify business associate of any limitation(s) in the notice of privacy practices of covered entity under 45 CFR 164.520, to the extent that such limitation may affect business associate’s use or disclosure of protected health information.

     (e) Obligations of Business Associate Upon Termination. Upon termination of this Agreement for any reason, business associate, with respect to protected health information received from covered entity, or created, maintained, or received by business associate on behalf of covered entity, shall:

          (I) Retain only that protected health information which is necessary for business associate to continue its proper management and administration or to carry out its legal responsibilities;

          (II) Destroy the remaining protected health information that the business associate still maintains in any form;

          (III) Continue to use appropriate safeguards and comply with Subpart C of 45 CFR Part 164 with respect to electronic protected health information to prevent use or disclosure of the protected health information, other than as provided for in this Section, for as long as business associate retains the protected health information;

          (IV) Not use or disclose the protected health information retained by business associate other than for the purposes for which such protected health information was retained and subject to the same conditions set out hereinabove; and

          (V) Destroy the protected health information retained by business associate when it is no longer needed by business associate for its proper management and administration or to carry out its legal responsibilities.

          (VI) The obligations of business associate under this Section shall survive the termination of this Agreement.

8. Miscellaneous

  (a) Authority to Execute Agreement. The undersigned parties to this Agreement warrant and represent that they have the power and authority to enter into this Agreement in the names, titles and capacities herein stated and on behalf of any entities, persons or firms represented or purported to be represented by such respective party.

  (b) Waiver. A waiver by either party of any of the terms and conditions of this Agreement in any instances shall not be deemed or construed to be a waiver of such term or condition for the future, or of any subsequent breach thereof, or of any other term and condition of the Agreement.

  (c) Amendments. This Agreement may be amended only by an instrument in writing executed by the undersigned parties.

  (d) Notice. Any notice, request, demand or other communication permitted to be given hereunder shall be in writing and shall be deemed to be duly given when personally delivered to an executive officer of Company or to Consultant, as the case may be, or upon confirmation of delivery by a bona fide international courier service. Either party may change, by written notice transmitted in the manner prescribed above, the address to which notices are to be sent.

  (e) Dispute Resolution. Any dispute arising out of or in connection with this Agreement, including any question regarding its existence, validity or termination, shall be referred to and finally resolved by arbitration under the LCIA Rules, which Rules are deemed to be incorporated by reference into this clause. The number of arbitrators shall be one. The seat, or legal place, of arbitration shall be London, England. The language to be used in the arbitral proceedings shall be English. The governing law of the contract shall be the substantive law of the Netherlands.

  (f) Headings. The headings in this contract are inserted for convenience of reference only and will not effect interpretation of this contract.

  (g) Assignment. This Agreement is personal to each of the parties hereto, and, except as herein otherwise provided, neither party may assign, transfer in any way or delegate any of the rights or obligations hereunder without first obtaining the written consent of the other party. This Agreement and all of Consultant’s rights and obligations hereunder may be assigned or transferred by it, in whole or in part, to and shall be binding upon and inure to the benefit of, any “successor” of Consultant. As used herein, the term “successor” shall mean only any person, firm, corporation or other business entity which at any time by merger, consolidation or otherwise shall have acquired all or substantially all of the stock of Consultant or to which Consultant shall have transferred all or substantially all of its assets. Any such successor shall be deemed to be substituted for all purposes as Consultant hereunder.

  (h) Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original but all of which shall constitute one instrument. A signed photocopy or facsimile of this Agreement shall have the same force and effect as that of an original.