MEDINEXO CLIENT SERVICES AGREEMENT 

 

 

This MEDINEXO Client Services Agreement (“Agreement”) is made effective as of the signature of this Agreement by and between (“CLIENT”), and MEDINEXO USA, LLC, a Wyoming Limited Liability Corporation (“MEDINEXO”). 

 

WHEREAS, CLIENT is actively executing or interested in executing a series of clinical trials in support of marketing approval for the Study Device and Assay; and 

 

WHEREAS, MEDINEXO is knowledgeable and experienced in the design, management and conduct of clinical trials and studies; and 

 

WHEREAS, CLIENT wishes to retain MEDINEXO, and MEDINEXO wishes to be retained by CLIENT, to provide certain services to CLIENT on the terms and conditions set forth herein; 

 

NOW, THEREFORE, CLIENT and MEDINEXO hereby agree as follows: 

 

 

As used in this Agreement, certain capitalized terms shall have the meaning set forth herein: 

 

Act means the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et. seq., as from time to time amended. 

 

Business Associate Agreement is an agreement (Exhibit B) to comply with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and its implementing regulations (45 Code of Federal Regulations Parts 160 and 164) impose on Covered Entity and its Business Associates rules relating to the security, use, storage, transmission, and disclosure of protected health information pertaining to participants and beneficiaries of health plans in order to protect and adequately manage protected health information.

 

Cure Period means thirty (30) calendar days or if a default involves failure to pay money then five (5) business days or such other time specified in a notice of default provided pursuant to Section 5(C) as may be required to conform to a schedule imposed by a governmental authority that relates to the cause of the default or as may be necessary to prevent or limit harm to any person participating in the Study. 

 

Disputed Services means Services that are not provided in a Timely and/or Professional manner. 

 

Disputed Services Notice means written notice of Disputed Services. 

 

ICH GCPs means Good Clinical Practices formulated by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 

 

Key Personnel means the personnel identified in a Scope of Work. 

 

Materials means (in whatever form or medium): the Protocol and related documents or information provided to CLIENT or provided, developed, used or generated in connection with the Study by Study Sponsor or MEDINEXO except MEDINEXO Intellectual Property (as defined in Section 7(E)); devices and substances, including the Study Device and Assay; all regulatory forms, records and documents; and all clinical data generated, obtained or gathered by MEDINEXO as a result of or in connection with the conduct of the Study. 

 

Pass Through Costs means the actual and necessary expenses included in an SOW Budget incurred by MEDINEXO to provide the Services. 

 

Professional means that the Services have been provided as specified in a Scope of Work in a technically competent manner in view of industry standards and applicable legal requirements including, but not limited to, the Act, 21 CFR Part 312, ICH GCPs and applicable industry guidance developed by the US Food and Drug Administration. 

 

Project Management Plan means the plan detailing the services, schedule and SOPs to be followed in managing the Studies that will be agreed to by the parties. 

 

Protocol means the plans for clinical trials. 

 

Scope of Work means specifically Exhibit A or any other exhibit attached hereto that describe the nature, frequency and costs of Services to be provided by MEDINEXO for a Study or Studies and further, identifies the Key Personnel and those CLIENT responsibilities that are to be transferred to MEDINEXO by CLIENT in accordance with the Act. 

 

Services mean site qualification, monitoring, and any other services provided by MEDINEXO as specified in a Scope of Work. 

 

Study or Studies means the clinical trials conducted pursuant to the Protocol(s). 

 

Study Sponsor means the pharmaceutical company, medical device manufacturer or other type of company, introduced to CLIENT by MEDINEXO, which is sponsoring the Study or Studies. 

 

SOW Budget means the fees and Pass Through Costs to be paid MEDINEXO by CLIENT for Services provided pursuant to a Scope of Work that is incorporated in such Scope of Work. 

 

Study Device and Assay means any device and assay tested in a Study. 

 

Timely means that Services are provided in accordance with the schedule and/or frequency set forth in a Scope of Work. 

 

2. Provision of Services
   1. Services. Pursuant to the terms of this Agreement, MEDINEXO shall provide CLIENT certain Services as described in the Scope of Work. To the extent that the terms of this Agreement and a Scope of Work conflict, the terms of this Agreement shall prevail unless the conflicting provision expressly provides otherwise. MEDINEXO shall perform the Services in accordance with applicable laws and regulations of the Country and State where services are delivered.
   2. Default. Failure to complete any Services in a Timely and Professional manner shall constitute a material breach of this Agreement. In the event of any failure by MEDINEXO to complete any Services in a Timely and Professional manner, CLIENT shall have the option to provide MEDINEXO a Disputed Services Notice pursuant to Section 4(C) or a notice of default pursuant to Section 5(C), or both, and shall not be precluded from utilizing any other remedies available to it under this Agreement or applicable law.

 

3. Transfer of Obligations/Key Personnel

Certain specific CLIENT obligations transferred by CLIENT to MEDINEXO in connection with the Studies shall be identified in the Scope of Work that may be on a separate attachment to the Scope of Work under the heading “Transfer of Obligations.” CLIENT shall retain those responsibilities not expressly transferred thereby. Except for those obligations expressly transferred from CLIENT to MEDINEXO, CLIENT shall at all times be deemed to be the “CLIENT” of each Study pursuant to the terms of the Act. MEDINEXO acknowledges that any decision by CLIENT to transfer obligations to MEDINEXO hereunder will be made based on, among other things, CLIENT’s reliance on the assignment of Key Personnel. So long as Key Personnel remain in the employ of MEDINEXO and their performance does not decline, and so long as the Key Personnel are not promoted, disabled or ill, MEDINEXO agrees that it will not substitute persons for any Key Personnel or materially reduce the time commitment of Key Personnel without the prior written consent of CLIENT, which consent shall not be unreasonably withheld.

 

4. Payment of Fees and Expenses
   1. SOW Budget. In consideration of the performance of the Services, MEDINEXO shall be paid the amounts set forth in the SOW Budget as further specified in Exhibit A. The aggregate fees and expenses payable by CLIENT to MEDINEXO for the Services shall not exceed the fees and expenses specified in the SOW Budget unless otherwise authorized in writing by CLIENT. In the event that the SOW Budget provides that certain fees and expenses are estimates only, CLIENT’s obligations to pay amounts in excess of such estimates shall be expressly conditioned upon CLIENT receiving detailed advanced notice of MEDINEXO’s anticipated budget overages, and the reasons therefor, all of which must be satisfactory to CLIENT in its sole discretion. In addition, CLIENT shall only be obligated to pay the Pass Through Costs upon receipt of documentation of such expenses reasonably satisfactory to CLIENT.
   2. Invoice. MEDINEXO shall provide CLIENT an invoice for completed Services detailing fees and any Pass Through Costs incurred as specified in the SOW Budget. Invoices shall describe in detail the Services performed and expenses incurred for such Services, and shall meet the requirements specified in this Section 4. Except with regard to Disputed Services and except as otherwise provided herein, CLIENT shall submit payment in full for all invoices within ten (10) days following receipt of such invoices from MEDINEXO.
   3. Disputed Amounts. Payments due pursuant to a SOW Budget, shall be paid in accordance with this Agreement when CLIENT has determined, in its reasonable discretion, that MEDINEXO has fulfilled its current responsibilities in a Timely and Professional manner except when an incident occurs that is outside of MEDINEXO’s reasonable control. In the event that CLIENT determines that any Services have not been completed in a Timely or Professional manner, it shall provide a Disputed Services Notice to MEDINEXO together with a detailed description of the basis for such determination, within thirty (30) days of acquiring knowledge of the events or omissions leading to CLIENT’s determination that such tasks have not been completed in a Timely or Professional manner. Notwithstanding any Disputed Services Notice, CLIENT shall be obligated to pay any outstanding amounts for Services not disputed in a Disputed Services Notice when due. To the extent CLIENT reasonably believes a portion of any Services were not performed in a Timely or Professional manner, CLIENT shall not be obligated to pay any outstanding amounts for the Disputed Services until after CLIENT has reasonably determined MEDINEXO has cured all deficiencies identified by CLIENT and has submitted to CLIENT an adequate plan of correction, within the time frame requested by CLIENT in its Disputed Services Notice, to reasonably ensure that such deficiencies will not occur in the future. MEDINEXO shall be deemed to have cured a scheduling or frequency deficiency if it has provided all of the services that it was required to provide within the time frames set forth in a revised schedule approved by CLIENT. In the event that CLIENT has reasonably determined MEDINEXO has not cured all such deficiencies or has not submitted an adequate plan of correction within the required time frame as provided herein that is satisfactory to CLIENT, CLIENT may provide MEDINEXO a notice of default as provided in Section 5(C). Notwithstanding the foregoing, upon MEDINEXO’s failure to complete any Services in a Timely and Professional manner, CLIENT may, at its option, provide MEDINEXO a notice of default pursuant to Section 5(C) in lieu of providing a Disputed Services Notice pursuant to this Section 4.
   4. Change in Scope. In the event CLIENT requests MEDINEXO to perform tasks beyond the Services set forth in the Scope of Work or requests MEDINEXO to reduce or otherwise modify the Services set forth in the applicable Scope of Work, MEDINEXO shall proceed as follows: consistent with the desire of both parties not to disrupt the ongoing progress of any Study, MEDINEXO shall use its best efforts to (i) submit proposed amendments to the applicable Scope of Work to cover such additional, reduced or modified tasks prior to commencing such tasks as well as an amended SOW Budget should the modification of tasks affect the SOW Budget; (ii) submit a new Scope of Work with a new SOW Budget; and/or (iii) obtain written authorization from CLIENT to proceed with such tasks prior to final agreement on an amended or new Scope of Work. Both parties agree to use good faith efforts to negotiate and agree upon an amended or new Scope of Work as soon as practicable.

 

5. Term and Termination
   1. Commencement. The term of this Agreement shall commence as of the date first written above and shall terminate upon performance in full of all Services described in every Scope of Work, unless earlier terminated in accordance with the terms hereof. The parties may terminate this Agreement or a specific Scope of Work as provided herein except that, in the event this Agreement is terminated, every Scope of Work shall be terminated prior to or simultaneous with the effective date of termination of this Agreement, unless otherwise specifically agreed by the parties.
   2. Termination. This Agreement or any Scope of Work may be terminated immediately upon written notice from CLIENT to MEDINEXO, in the following circumstances: 
      1. Authorization and approval to perform a Study, for which Services are provided hereunder, is withdrawn by the FDA, or other applicable regulatory authority, on a permanent or temporary basis;
      2. Animal, human or toxicological test results, in the reasonable determination of CLIENT, support immediate termination of the Study; or 
      3. The emergence of adverse events that, in the sole determination of CLIENT, supports immediate termination or suspension of the Study.
   3. Notice of Default/For Cause Termination. If either party (“defaulting party”) shall be in default of its obligations under this Agreement (including, without limitation, any failure by MEDINEXO to perform any of the Services in a Timely and Professional manner), then the other party (the “non-defaulting party”) may give notice to the defaulting party in writing of any such default. The defaulting party shall have the Cure Period from the date of receipt of such notice within which to cure such default. If, in the discretion of the non-defaulting party, reasonably exercised, such default has not been cured by the expiration of the Cure Period, at any time thereafter until such default has been cured, the non-defaulting party may terminate this Agreement or a Scope of Work immediately upon written notice to the defaulting party. Such written notice shall state the effective date of termination, which may be immediately. Either party hereto may terminate this Agreement immediately upon the occurrence of an “Insolvency Event” with respect to the other party. For purposes of this Agreement, “Insolvency Event” shall mean (1) a party or any of its subsidiaries shall commence a voluntary proceeding seeking liquidation, reorganization or other relief with respect to itself or its debts under any bankruptcy, insolvency or other similar law or seeking the appointment of a trustee, receiver, liquidator, custodian or other similar official of it or any substantial part of its property, or shall consent to any such relief or to the appointment of or taking possession by any such official in an involuntary case or other proceeding commenced against it, or shall make a general assignment for the benefit of creditors, or shall fail generally to pay its debts as they become due, or shall take any action to authorize any of the foregoing; (2) an involuntary case or other proceeding shall be commenced against a party or any of its subsidiaries seeking liquidation, reorganization or other relief with respect to it or its debts under bankruptcy, insolvency or other similar law or seeking the appointment of a trustee, receiver, liquidator, custodian or other similar official of it or any substantial part of its property, and such involuntary case or other proceeding shall remain undismissed and unstayed for a period of sixty (60) days; or (3) an order for relief shall be entered against a party or any of its subsidiaries under the federal bankruptcy laws now or hereafter in effect.
   4. No Cause Termination. MEDINEXO may terminate this Agreement or any Scope of Work with at least sixty (60) days written notice; provided, however, that such notice may specify immediate suspension of recruitment or enrollment of Study subjects. CLIENT agrees to cooperate with the terms of any such notice.
   5. MEDINEXO Obligations Upon Early Termination. Both MEDINEXO and CLIENT recognize that early termination of this Agreement or a Scope of Work requires both discussion and coordination between the parties to ensure patient safety, continuity of treatment (if appropriate) and compliance with all applicable regulations. Upon early termination of this Agreement or a Scope of Work, MEDINEXO shall cooperate with CLIENT to provide for an orderly cessation of the applicable Services. MEDINEXO further agrees that it will take no action or forgo taking action if such action or forbearance would in any manner jeopardize patient safety or the utility, quality or integrity of the Study or violate or cause CLIENT to violate any applicable laws. In addition, unless otherwise stipulated by CLIENT, MEDINEXO shall perform such Services as are reasonably necessary in connection with the orderly wind-down of the Study or the transfer of MEDINEXO’s responsibilities to CLIENT or CLIENT’s designee. Upon receipt of detailed written instructions from CLIENT regarding the scope of tasks to be taken by MEDINEXO in connection with termination of this Agreement or any Scope of Work or of MEDINEXO’s duties hereunder or thereunder, MEDINEXO shall submit a reasonable budget prepared in good faith to CLIENT within five (5) business days of receipt of such instructions for CLIENT’s approval. The instruction for wind down services and approved budget are referred to herein as the “Wind Down Plan.”         Notwithstanding anything herein to the contrary, MEDINEXO shall transfer to CLIENT the Materials obtained or developed by MEDINEXO pursuant to this Agreement as soon as reasonably practical as agreed between the parties but in no event later than sixty (60) days. MEDINEXO may retain an archival copy of all Materials provided to CLIENT or developed or used in connection with the Study, provided that such archival copy remains subject to the confidentiality obligations set forth in Section 6. If CLIENT should request MEDINEXO to store the Materials beyond termination or expiration of this Agreement, CLIENT will reimburse MEDINEXO for its maintenance and storage costs.
   6. Other Remedies. MEDINEXO acknowledges and agrees that transfer of the Materials are critically important to CLIENT and that failure of MEDINEXO to comply with its obligations regarding the transfer of the Materials to CLIENT would cause CLIENT irreparable harm for which there is no adequate remedy at law. Accordingly, MEDINEXO admits that in the event of a breach by MEDINEXO of its obligations to transfer the Materials to CLIENT, upon the filing of a complaint by CLIENT, a court of competent jurisdiction may issue an order enjoining or restraining MEDINEXO from refusing or failing to transfer the Materials and requiring MEDINEXO to take any other action the court deems necessary. Nothing herein contained will be construed as prohibiting CLIENT from pursuing any other remedies available at law or in equity for any breach or threatened breach of this Agreement.
   7. CLIENT Obligations Upon Early Termination. Upon early termination of this Agreement, CLIENT shall promptly compensate MEDINEXO for all Services actually performed hereunder prior to the effective date of termination including those Services actually performed towards completion of a unit or milestone, for which Services MEDINEXO has not yet been compensated and for non-cancelable expenses incurred by MEDINEXO pursuant to the approved SOW Budget, or shall pay such compensation if applicable, in accordance with the budget included in the Wind Down Plan. CLIENT’s obligation to compensate MEDINEXO is subject, however, to CLIENT’s rights hereunder to withhold payments in the event of a breach or failure to perform such Services in a Timely and Professional Manner and provided further that MEDINEXO has first transferred the Materials requested by CLIENT. Further, CLIENT shall reimburse MEDINEXO for all Pass Through Costs expressly approved by CLIENT as provided herein.

 

6. Confidentiality
   1. Confidential Information. During the term of this Agreement the parties may exchange confidential or proprietary information. In each case the party disclosing the confidential information will be the “Disclosing Party” and the recipient of the information will be the “Recipient,” as such terms are used herein. The Materials and any and all inventions, products, product development plans, standard operating procedures, costs, profits, markets, sales, services, investigator lists, key personnel, pricing policies, billing rates, operational methods, trade secrets, know-how, scientific and technical processes, technical and business information, patent information, structures, models, techniques, formula, processes, compositions, compounds, apparatus, specifications, samples, ideas, other business affairs and methods, plans for future developments, and other information not readily available to the public relating to the Disclosing Party or to any aspect of the business of the Disclosing Party or of the business of any affiliate of the Disclosing Party (collectively, the “Confidential Information”) shall be treated as confidential information, regardless of whether or not marked as proprietary or confidential. Confidential Information may be disclosed orally, visually or in tangible form (whether by document, electronic media, or other form).
   2. Non-Disclosure. The Recipient agrees to hold the Disclosing Party’s Confidential Information in confidence and shall use such Confidential Information only for the purpose of performing the Services. The Recipient shall not reproduce the Confidential Information, or disclose any Confidential Information to any third party, without prior written approval of the Disclosing Party. The Recipient agrees to protect the Confidential Information with at least the same degree of care as it normally exercises to protect its own proprietary information of a similar nature, but in any case using no less than a reasonable degree of care. The Recipient shall take all appropriate steps to ensure that all of its employees, consultants, affiliates or others only receive the Disclosing Party’s Information on a need-to-know basis, within the scope of this Agreement, and then, only if such parties are bound by obligations of confidentiality substantially similar to the terms of this Section 6; provided, however, that MEDINEXO shall not disclose CLIENT’s Confidential Information to anyone other than Key Personnel of MEDINEXO without CLIENT’s prior written consent. Without limiting any other provision of this Section 6, the Recipient shall not use the Disclosing Party’s Information, in whole or in part, to compete with the Disclosing Party, to develop blocking technology, or otherwise to damage the Disclosing Party or to enable or assist any other person in doing so.
   3. No Transfer of Rights. Nothing in this Section 6 shall be construed as granting or implying any license or right under any trademark, service mark, patent, copyright or any other intellectual property right. None of the Confidential Information which may be disclosed by the Disclosing Party shall constitute any representation, warranty, assurance, guarantee or inducement by the Disclosing Party to the Recipient, including, without limitation, with respect to the non-infringement of intellectual property rights, or other rights of third persons, or as representing any commitment to enter into any additional agreement, by implication or otherwise.
   4. Return/Destruction of Confidential Information. The Recipient, upon the written request of the Disclosing Party, shall, at the option of the Disclosing Party, (i) return, at the Disclosing Party’s expense, or (ii) destroy, all tangible or electronic forms of the Confidential Information; provided, however, that the Recipient may retain a single copy of the Confidential Information and related materials in its archives solely for the purpose of ensuring its compliance with this Agreement and applicable laws, provided that the single copy is maintained in a secure system and remains subject to the confidentiality obligations of this Section 6. The Recipient agrees to provide a written certification of destruction in accordance with clause (ii) above upon the written request of the Disclosing Party.
   5. Length of Obligation. The obligations of the Recipient with respect to Confidential Information set forth herein shall continue for a period of seven (7) years from the date of disclosure of Confidential Information, or for a longer period if so required by law, unless otherwise specified in a writing signed by both of the parties.
   6. Exceptions. For purposes of this Agreement, Confidential Information shall not include:
      1. information that is or becomes public other than by breach of these provisions of this Agreement;
      2. information required to be disclosed in any legal, administrative or governmental proceeding, or by court order, law or applicable regulation, provided that, if possible, the Recipient has provided notice to the Disclosing Party of such requirement to disclose and affords to the Disclosing Party an opportunity to challenge such disclosure;
      3. information that becomes available to the Recipient without any obligation of confidentiality on Recipient from a source other than the Disclosing Party, or its representatives or affiliates, as evidenced by written records; or 
      4. information that was independently developed by or for the Recipient without access to the Confidential Information, as evidenced by written records. 

The Recipient shall have the burden of proving the existence of any of the foregoing exceptions. 

7. Equitable Relief. The Recipient hereby acknowledges that the Disclosing Party would be irreparably damaged if the Disclosing Party’s Confidential Information were disclosed to any third party, or utilized in any manner not permitted herein, which damage could not be adequately compensated for by money damages. In the event of a breach or threatened breach by the Recipient of the provisions hereof, the Recipient agrees that the Disclosing Party may seek an injunction restraining the Recipient from such breach. Nothing herein shall be construed as prohibiting the Disclosing Party from pursuing any other remedies available at law or in equity for any breach or threatened breach of this Agreement.
8. Privacy Laws. All information containing personal data shall be handled in accordance with all applicable privacy laws, rules and regulations.

 

7. Intellectual Property
   1. Ownership. The Materials are and shall remain the exclusive property of Study Sponsor.
   2. Inventions. As used herein this Agreement, “Inventions” means any information, ideas, methods, data, inventions, works, rights, properties, technology and know-how that is conceived, created, discovered, developed or invented by CLIENT, its agents, officers or employees which in any manner use, arise from, rely on or incorporate the Materials or Confidential Information of a Study Sponsor. CLIENT shall disclose in writing to Study Sponsor any and all Inventions promptly upon becoming aware of the existence of such Inventions. CLIENT represents that it has taken all reasonable business measures to ensure that all personnel performing work pursuant to the terms of this Agreement have executed legally binding agreements necessary to assign to the Study Sponsor, any and all patent, copyright, trade secret, trade mark, service mark, know-how and any other intellectual property rights whatsoever to all Inventions made by such personnel during the course of their work pursuant to this Agreement (collectively, “Intellectual Property”).
   3. Assignment. CLIENT agrees to assign, and does hereby assign, to the rightful owner, MEDINEXO or Study Sponsor, all right, title and interest that CLIENT may have in any of the Intellectual Property.
   4. MEDINEXO Intellectual Property. All inventions, know-how, trade secrets, improvements, other intellectual property, computer programs, software (including codes), databases, applications, data collection, data management processes, proposals and other documentation, all devoid of CLIENT’s Materials and Confidential Information, laboratory analyses, analytical methods, procedures and techniques, which are generally used or developed solely by MEDINEXO and not pertaining particularly to any Study, and any improvement, alteration or enhancement to the same, which are not specifically requested and paid for by CLIENT during the course of performance of the Services, are the exclusive and confidential property of MEDINEXO or the third parties from whom MEDINEXO has secured the right of use (“MEDINEXO Intellectual Property”). Notwithstanding anything to the contrary, Study data are and shall remain the property of CLIENT. 
   5. Non-Exclusive License. In a Scope of Work, MEDINEXO may grant CLIENT a limited license to use certain MEDINEXO Intellectual Property. To the extent such license is granted, unless otherwise specified in the Scope of Work, the license shall be a limited, non-transferable, royalty-free non-exclusive license to use such MEDINEXO Intellectual Property as is required to give CLIENT full benefit of the work product, and for no other purpose, and shall include the right to authorize others, such as research collaborators, service providers, and reviewing regulatory agencies, to use such MEDINEXO Intellectual Property in connection with their use of the work product only. CLIENT agrees that all such licenses shall be (i) restricted to use in conjunction with the work product, (ii) if software, shall only be in object code form which CLIENT agrees to hold confidential and which CLIENT agrees that it will not reverse engineer, decompile or disassemble, copy, translate, adapt, vary or modify; (iii) will not take any action in conflict with MEDINEXO’s ownership interest, and (iv) will indemnify and hold MEDINEXO harmless from any claim with respect to CLIENT’s use. 

 

8. Warranties and Representations
   1. General Warranties and Representations. Each party warrants and represents that (i) it is a corporation duly organized, validly existing and in good standing under the laws of the state of its incorporation; (ii) it has the power and authority and legal right to enter into this Agreement and to perform the obligations hereunder, including under each Scope of Work, and that it has taken all necessary corporate action to authorize execution of this Agreement; (iii) all necessary consents, approvals and authorizations of governmental authorities and other persons required to be obtained have been obtained; (iv) the execution and delivery of this Agreement will not conflict with or violate any requirement of any applicable laws or regulations, and do not conflict with or constitute a default under any contractual obligation enforceable against it.
   2. MEDINEXO’s Warranties and Representations. MEDINEXO warrants and represents that (i) the Services will be performed in a Professional manner and that none of the Services or any part of this Agreement, including any Scope of Work, is or will be inconsistent with any obligation MEDINEXO may have to any other person or entity; (ii) neither MEDINEXO nor any of the Key Personnel has been the subject of any adverse action by the FDA or other applicable governmental authorities of any kind whatsoever, including without limitation debarment or disqualification, and, further that neither MEDINEXO nor any of the Key Personnel has received notice of any kind that it may be the subject of adverse action by the FDA or other applicable governmental authorities; (iii) neither MEDINEXO nor any of the Key Personnel has ever been convicted of a crime involving theft, fraud, dishonesty or similar acts and, further, that each of the Key Personnel has the education, training and experience to perform the Services; (iv) no study or site managed by MEDINEXO has been the subject of adverse action by the FDA as a result of MEDINEXO’s negligence or misconduct in the performance of its duties with respect to that study or site; (v) MEDINEXO is not now and never has been the subject of a lawsuit involving negligence, misconduct, or breach of contract brought by a third party to whom MEDINEXO was engaged to provide services similar to the Services to be provided hereunder, (vi) in accordance with applicable FDA Guidance for Industry Computerized Systems Used in Clinical Trials, currently in force, MEDINEXO will develop and adhere to adequate compliance plans for the design, use, operation and maintenance of MEDINEXO’s computer software and hardware that will be utilized to perform the collection, storage, management and analysis of Study data (“MEDINEXO’s Computerized System”); and (v) MEDINEXO’s Computerized System complies with applicable law and regulations governing computerized systems used in clinical trials. As used herein, “MEDINEXO’s Computerized System” includes software developed by MEDINEXO and software developed by third parties and licensed to MEDINEXO.
9. Indemnification
   1. Indemnification by CLIENT. CLIENT shall hold harmless, defend and indemnify MEDINEXO, its successors in interest, shareholders, directors, officers, employees, representatives, agents, subsidiaries, affiliates, from and against, any and all damages, losses, costs, expenses, liabilities, claims, demands, actions, suits, proceedings, causes of action, accountings, obligations, and judgments whatsoever, in law or equity, whether civil, criminal, administrative or investigative, whether pending or threatened, including, without limitation, reasonable attorneys’ fees and disbursements (“Covered Claims”) incurred in connection with the conduct of a Study including, without limitation, those arising before, during or after a Study and relating to actual or alleged harmful effects of Study Device(s) and Assay(s), including comparators ; provided, however, CLIENT shall have no obligation hereunder to the extent any such claim arises primarily from the negligence or misconduct of MEDINEXO or breach of this Agreement by MEDINEXO.
   2. Indemnification by MEDINEXO. MEDINEXO shall hold harmless, defend and indemnify CLIENT, its successors in interest, shareholders, directors, officers, employees, representatives, agents, subsidiaries, affiliates, from and against, any and all Covered Claims incurred in connection with the negligence or misconduct of MEDINEXO in the performances of their duties hereunder or other breach of this Agreement, or of a Scope of Work; provided, however, MEDINEXO shall have no obligation hereunder to the extent any such claim arises primarily from, the Study Device and Assay or the administration thereof, the negligence or misconduct of CLIENT or a material breach of this Agreement by CLIENT.

 

10. Process for Indemnification
    1. Defense. The obligation to indemnify a party in accordance with Section 9 is specifically contingent upon the party seeking indemnification (the “Indemnified Party”) providing notice of any actual or threatened Covered Claims as soon as practicable to the party from whom indemnification is sought (the “Indemnifying Party”) to enable the Indemnifying Party to arrange for and assume control of defense of such Covered Claims, provided, however, that failure to give prompt notice shall not limit the Indemnified Party’s rights to indemnification under this Agreement to the extent that the Indemnifying Party fails to establish that the Indemnifying Party was prejudiced by such failure. The Indemnifying Party shall be entitled, at its option, to assume and control the defense or settlement of any Covered Claims unless (i) the Indemnifying Party fails to notify the Indemnified Party in writing within ten (10) days after the Indemnified Party has given to the Indemnifying Party notice of the actual or threatened Covered Claims that the Indemnifying Party will assume the defense of a Covered Claim and indemnify, defend, and hold harmless the Indemnified Party from and against the Covered Claims, (ii) counsel for the Indemnified Party determines that there exists a conflict of interest between the Indemnified Party and the Indemnifying Party in the conduct of any such defense or settlement, or (iii) the Indemnified Party determines, in its reasonable discretion, that the Indemnifying Party has failed to conduct the defense or settlement of such Covered Claims actively and diligently.
    2. Cooperation. The Indemnified Party shall cooperate with the Indemnifying Party in the investigation, defense and settlement of any Covered Claims when the latter controls the defense of any such Covered Claims. As long as the Indemnifying Party is conducting the defense of a Covered Claim, (i) the Indemnified Party may retain separate co-counsel at its sole cost and expense and participate in the defense of the Covered Claims, (ii) the Indemnified Party will not consent to the entry of any judgment or enter into any settlement with respect to the Covered Claims without the prior written consent of the Indemnifying Party, which consent may not be unreasonably withheld, and (iii) the Indemnifying Party will not consent to the entry of any judgment or enter into any settlement with respect to the Covered Claims where such settlement involves an admission of guilt, negligence or wrongdoing by the Indemnified Party without the prior written consent of the Indemnified Party, which consent may not be unreasonably withheld.
    3. Control by Indemnified Party. In the event any of the conditions in Section 10(A)(i)-(iii) occur, (i) the Indemnified Party may defend against, consent to the entry of any judgment on, or enter into any settlement with respect to, the Covered Claims in any manner the Indemnified Party reasonably may deem appropriate (and the Indemnified Party need not consult with or obtain any consent from the Indemnifying Party in connection therewith provided that the Indemnified Party has provided to the Indemnifying Party notice of its intent to defend against, consent to entry of judgment on, or enter into settlement with respect to the Covered Claims at least five (5) business days prior thereto); (ii) the Indemnifying Party will reimburse the Indemnified Party promptly and periodically, but in no event later than thirty (30) days after a written request for payment therefor has first been made by the Indemnified Party, for the costs of defending against the Covered Claims (including reasonable attorneys’ fees and expenses) and all other amounts for which the Indemnifying Party is responsible hereunder; and (iii) the Indemnifying Party will remain responsible for any damages, attorneys’ fees, costs, judgments, fines and amounts paid in settlement, that the Indemnified Party may incur resulting from, arising out of, relating to, in the nature of, or caused by the Covered Claims to the fullest extent provided in this Agreement.
    4. Non-exclusivity. The indemnification provided by this Agreement shall not be deemed exclusive of any other rights to which the Indemnified Party may be entitled under this Agreement, any other agreement, applicable law, or otherwise.

 

11. Independent Contractors

The parties hereto are independent contractors. Neither party shall have any authority to, or offer or agree to, incur or assume any obligations or commitments in the name of, or on behalf of, the other party, except as expressly provided herein. MEDINEXO will be solely responsible for all FICA taxes and all obligations to governments or other organizations arising out of this Agreement, and MEDINEXO acknowledges that no income or other taxes shall be withheld or accrued by CLIENT for the benefit of MEDINEXO or any of its employees. Unless CLIENT has provided prior written approval, MEDINEXO shall not use any contractors to perform MEDINEXO’s obligations hereunder; except that, MEDINEXO may subcontract with clinical research associates (CRA) provided that MEDINEXO remains responsible for the performance of such subcontracted CRAs. Specifically, MEDINEXO shall be solely responsible for injuries and damages of any kind whatsoever that result from the actions of its employees, agents and subcontractors.

 

12. Insurance

Notice. Both parties shall immediately notify the other in writing no less than thirty (30) days in advance, in the event the insurance coverage required to be maintained pursuant to this Agreement is proposed to be materially modified, canceled, not renewed or otherwise terminated.

 

13. Regulatory Inspections; Audits.
    1. Regulatory Matters. Each party acknowledges that the other party may respond independently to any regulatory correspondence or inquiry in which such party or its affiliates is named. Each party, however, shall: a) notify the other party in writing immediately of any governmental or regulatory inspection or inquiry concerning any Study, including, without limitation, inspections of investigational sites or laboratories; b) forward to the other party copies of any correspondence from any regulatory or governmental agency relating to any Study; and, c) obtain the written consent of the other party, which will not unreasonably be withheld, before referring to the other party or any of its affiliates in any regulatory correspondence. Each party will be given the opportunity to have a representative present and participate during a regulatory inspection relating to any Study. Each party, however, acknowledges that it may not direct the manner in which the other party fulfills its obligations to permit inspection by governmental entities.
    2. Regulatory Audits. Each party agrees that, during an inspection by a regulatory authority concerning any Study, it will not disclose information and materials that are not required to be disclosed to such agency, without the prior consent of the other party, which shall not be unreasonably withheld. Such information and materials includes, but are not limited to, the following: 1) financial data and pricing data; 2) sales data (other than shipment data); and, 3) personnel data (other than data as to qualification of technical and professional persons performing functions subject to regulatory requirements).

 

14. Dispute Resolution
    1. Governing Law. The validity, interpretation, and performance of this Agreement will be determined in accordance with the laws of the State of Missouri without regard to its conflicts of laws, rules and principles.
    2. Resolution of Disputes. The parties shall first attempt to settle any and all disputes arising out of or in connection with or relating to the execution, interpretation, performance, or nonperformance of this Agreement or any other certificate, agreement, or other instrument between, involving, or affecting the parties (including the validity, scope, and enforceability of this arbitration agreement) (each, a “Dispute”) through good faith negotiation before resorting to arbitration.
    3. Arbitration. Should the parties be unable in good faith to resolve such Dispute by way of good faith negotiation within twenty (20) days, such Dispute shall be solely and finally settled by confidential, binding arbitration before a panel of three arbitrators appointed in accordance with the Commercial Rules of the American Arbitration Association (the “Rules”); provided, however, that in the event of conflict between the Rules and the terms of this Agreement, the terms of this Agreement shall govern. The arbitration panel shall render its award based on the explicit terms of this Agreement; and in instances where it is silent, on the basis of strict principles consistent with terms of the Agreement. To commence arbitration of any such dispute, the party desiring arbitration shall notify the other party in writing in accordance with the Rules. The place of arbitration shall be Saint Louis, Missouri, and the law applicable to the arbitration procedure shall be the Federal Arbitration Act (9 USC § 2). To commence arbitration of any such dispute, the party desiring arbitration shall notify the other party in writing in accordance with the Rules. Each party shall choose one arbitrator and the two arbitrators shall choose the third member of the panel.
    4. Exclusive Remedy. The parties agree that the award of the arbitration panel shall (1) be the sole and exclusive remedy between them regarding any claims, counterclaims, or issues presented to the arbitrator; (2) be final and subject to no judicial review, except as otherwise as required by applicable law; and (3) be made and shall promptly be payable in U.S. dollars free of any tax, withholding, deduction, or offset. The parties further agree that any costs, fees (including reasonable attorney’s fees and disbursements), or taxes incident to enforcing the award shall, to the maximum extent permitted by law, be charged against the party resisting such enforcement. The parties hereto agree that judgment on the arbitration award may be entered and enforced in any court having jurisdiction over the parties or their assets. 
    5. Payment. Initial payment of arbitration filing fees, arbitration administrative fees, arbitration expenses, and arbitrators’ compensation, shall be made in accordance with the Rules. However, the prevailing party, as determined by the arbitrators, shall be entitled to reimbursement of the arbitration filing fees, arbitration administrative fees, arbitration expenses, and arbitrator’s compensation, and reasonable attorney’s fees, costs and expenses associated with the arbitration.
    6. Equitable Relief. Nothing in this Section 14 shall be construed to restrict either party’s right to seek and obtain injunctive relief in a court of competent jurisdiction in the event a party has breached or threatens to breach any of its obligations under Sections 6 or 7.

 

15. Miscellaneous
    1. Binding Agreement. This Agreement shall be binding on and inure to the benefit of the parties hereto and their respective legal representatives, successors and permitted assigns; provided, however, that CLIENT shall not transfer or assign its rights or delegate its duties under this Agreement without the prior written consent of MEDINEXO. Any such assignment or delegation in violation of this Section 15(A) shall be null and void.
    2. Force Majeure. A party shall be excused from performing its obligations hereunder if its performance is directly delayed or prevented by any cause beyond such party’s reasonable control including, but not limited to, acts of God, fire, explosion, weather, disease, war, insurrection, civil strife, riots, government action, or power failure; provided that (a) the delayed or prevented party (i) gives the other party written notice of such cause promptly, and in any event within fifteen (15) days of discovery thereof, and (ii) uses its reasonable best efforts to perform its obligations notwithstanding such circumstances. Performance shall be excused only to the extent of and during the reasonable continuance of such cause if such cause continues to directly delay or prevent performance. Any deadline or time for performance of a Service falling due during or subsequent to the occurrence of any of the causes referred to herein shall be extended for a period of time equal to the period such cause delayed or prevented the affected party from performing its obligation hereunder. Suspension by a party of its obligations hereunder during a force majeure event shall not constitute a breach of this Agreement or such obligations hereunder, nor shall a party have any liability to the other party for such suspension. If an event of force majeure extends for a period exceeding twenty (20) days, MEDINEXO may, at its sole option, elect to terminate this Agreement or the applicable Scope of Work, in which case the provisions of Section 5(B) shall apply. 
    3. Amendments. This Agreement may be modified or amended only by a writing executed by both parties hereto. 
    4.  Notices. All notices shall be in writing and shall be personally delivered or sent by certified mail, return receipt requested, to the parties at the addresses set forth above or at such other addresses as may be furnished in writing to the other party hereto. Notices to CLIENT shall also be sent to:

Notices to CLIENT via email using email address provided during registration.

 

Notices to MEDINEXO: 

 

MEDINEXO USA,LLC

725 Kingsland Avenue, Suite 100

Saint Louis, MO 63130

USA

Attention: Jorge H. Toro

Tel: (314) 662-4498

 

Notices shall be deemed given on the date of actual receipt.

 

5. Waiver. The waiver or breach of any term or condition of this Agreement shall not be deemed to constitute a waiver of any other term or condition hereof. The failure in any one or more instances of a party to insist upon performance of any of the terms, covenants or conditions of this Agreement, to exercise any right or privilege conferred in this Agreement, or the waiver by said party of any breach of any of the terms, covenants or conditions of this Agreement, shall not be construed as a subsequent waiver of any such terms, covenants, conditions, rights or privileges, but the same shall continue and remain in full force and effect as if no such forbearance or waiver had occurred. No waiver shall be effective unless it is in writing and signed by an authorized representative of the waiving party.
6. Surviving Provisions. The termination or expiration of this Agreement shall not relieve either party of its obligations to the other with respect to (a) maintaining the confidentiality of Confidential Information, (b) assignment of Inventions and assistance with respect thereto, or (c) indemnification.
7. Entire Agreement. This Agreement, together with all exhibits and attachments hereto and thereto, constitutes the entire agreement among the parties hereto with respect to the subject matter hereof. There are no representations, warranties, covenants or undertakings with respect to the subject matter hereof other than those expressly set forth herein. This Agreement supersedes all prior and contemporaneous agreements, understandings, negotiations and discussions between the parties with respect to the subject matter hereof. In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any of the provisions of this Agreement.
8. Severability. The invalidity or unenforceability of any provision hereof shall in no way affect the validity or enforceability of any other provision. 
9. Further Assurances. The parties each agree to execute additional instruments and documents and to do all such further things as the other party may reasonably require in order to carry out the intent of this Agreement. In addition, the parties agree to reasonably cooperate with one another in connection with the execution of the other parties’ obligations hereunder.
10. Counterparts. This Agreement may be executed in any one or more counterparts, each of which shall be deemed to be an original but all of which together shall constitute one and the same instrument.
11. Publicity. Except as required by law, neither party shall use the name of the other party or of any Agent thereof for purposes of publicizing this Agreement or any Project performed hereunder, or for any other public disclosure purposes without the prior written consent of the other party.
12. Use of Copyrighted Materials. If in connection with a Scope of Work, CLIENT requests MEDINEXO to make and/or distribute copies of copyrighted materials such as journal articles or excerpts from publications, MEDINEXO agrees to pay the cost of any copyright fees incurred by MEDINEXO that are necessary for MEDINEXO to produce and distribute such copies and CLIENT agrees to reimburse MEDINEXO for such costs.
13. Construction. The captions of sections in this Agreement are for convenience only, and this Agreement shall not be construed or interpreted by reference to such captions. All references to sections, exhibits or schedules refer to the sections of this Agreement, unless the context clearly indicates otherwise.
14. Non-Solicitation. Both parties agree that during the term of this Agreement and for a period of one (1) year thereafter or, if not enforceable, the maximum length of time enforceable under law, neither party shall directly recruit employees of the other party without the prior written consent of the other party.
     

 

WITNESSED and AGREED upon by the Parties :

 

 

For CLIENT,     Electronic Signature: By submitting Online Registration for Medinexo® Client Services, CLIENT is signing this document electronically. CLIENT agrees that electronic signature is the legal equivalent of CLIENT’s manual signature on this document.

For MEDINEXO,   Jorge H. Toro President & CEO

 

 

 

 

EXHIBIT A - SCOPES OF WORK (“SOW” OR “SOWs”)

 

Includes all SOWs signed by both parties and attached to this document during the term of this agreement and all online purchase orders for Medinexo Services by CLIENT.

 

 

EXHIBIT B: BUSINESS ASSOCIATE AGREEMENT

 

BUSINESS ASSOCIATE AGREEMENT 

REGARDING THE USE AND DISCLOSURE OF PROTECTED HEALTH INFORMATION

 

This Agreement is entered into, effective as of the date of online registration by and between  CLIENT (heretofore, the “Covered Entity”) and MEDINEXO USA LLC, located at 725 Kingsland Avenue, Suite 100, St. Louis, MO 63130 .(heretofore, the “Business Associate”).  

 

WHEREAS, pursuant to an underlying agreement between Covered Entity and Business Associate (the “Underlying Agreement”), the Parties shall be working together in a project described in such Underlying Agreement that will require the execution of this Agreement. 

WHEREAS, a Business Associate performs functions, activities, or services for, or on behalf of, a Covered Entity.  Business Associates and Covered Entities are defined in 45 CFR 160.10.  As applicable to its assigned role, a Business Associate creates, receives, maintains, or transmits Protected Health Information ("PHI"), including Electronic Protected Health Information ("EPHI"), in order to perform such functions, activities, or services on behalf of the Covered Entity.  If approved by the Covered Entity, a Business Associate can further disclose PHI and EPHI in order to accomplish the objectives established by the Covered Entity for the disclosure.  

WHEREAS, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and its implementing regulations (45 Code of Federal Regulations Parts 160 and 164) impose on Covered Entity and its Business Associates rules relating to the security, use, storage, transmission, and disclosure of protected health information pertaining to participants and beneficiaries of health plans in order to protect and adequately manage protected health information; and 

WHEREAS, Business Associate shall require access to PHI of Covered Entity to perform its obligations under the Underlying Agreement. 

WHEREAS, The purpose of this Business Associate Agreement (this “Agreement”) is to set forth the terms and conditions of disclosure of PHI by the Covered Entity to Business Associate; to set forth the terms and conditions of Business Associate’s use and disclosure of PHI, and to ensure the confidentiality, integrity, and availability of EPHI that Business Associate creates, receives, maintains, or transmits on behalf of Covered Entity.  

NOW, THEREFORE, in consideration of the mutual promises and covenants contained herein and other good and valuable consideration, intending to be legally bound hereby, Covered Entity and Business Associate hereby agree as follows:

Section 1.         Definitions

1. “Breach” shall have the same meaning as “breach” in HITECH Act §13400(1) and in 45 C.F.R. §164.402.
2. “Breach is Treated as Discovered” shall have the same meaning as “breach is treated as discovered” in HITECH Act §13402(c) and in 45 C.F.R. §164.410(a)(2).
3. “Breach Notification Rule” shall mean the notification in the case of Breach of Unsecured Protected Health Information requirements at 45 C.F.R. Part 164, Subpart D.
4. “Business Associate” shall mean Medinexo.
5. “Covered Entity” shall mean CLIENT.
6. “Designated Record Set” (1) A group of records maintained by or for the Covered Entity that is: (i) the medical records and billing records about individuals maintained by or for a covered health care provider;  (ii) the enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or (iii) used, in whole or in part, by or for the covered entity to make decisions about individuals.  (2) For purposes of this definition the term record means any item, collection, or grouping of information that includes Protected Health Information and is maintained, collected, used, or disseminated by or for the Covered Entity. 
7.  “Disclosure” shall mean the release, transfer, access to or publication in any manner of information outside the entity holding the information.
8. “Effective date” shall mean the day and year first above written.
9. “Electronic Protected Health Information” or “EPHI” shall have the same meaning as the term “electronic protected health information” in 45 C.F.R. § 160.103,  but shall be limited to the EPHI that Business Associate creates, receives, maintains, or transmits on behalf of Covered Entity.

 

4. “HITECH Act” shall mean the Health Information Technology for Economic and Clinical Health Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (Public Law 111 5).

 

5. “Individual” shall mean the person who is the subject of Protected Health Information and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g).
6. “Minimum Necessary” shall have the same meaning as "minimum necessary" described in 45 C.F.R. § 164.502(b) and Section 13405(b) of ARRA.

 

7. “Notice” shall mean a writing that includes identification of each Individual whose Unsecured Protected Health Information has been or is reasonably believed by Business Associate to have been accessed, acquired, or disclosed as a result of a Breach.  Notice shall also include any other information available to Business Associate that Covered Entity is required to disclose to an Individual as required under 45 C.F.R. §164.404(c).
8. “Privacy Rules” shall mean the Standards for Privacy of Individually Identifiable Health Information as set forth under 45 CFR Part 160 and Part 164, Subparts A and E, as amended.
9. “Protected Health Information” or “PHI” shall have the same meaning as the term “protected health information” in 45 C.F.R. § 160.103, but shall be limited to the information that Business Associate creates, receives, maintains or transmits on behalf of Covered Entity, regardless of the media used to create, receive, maintain or transmit such PHI.
10. “Required By Law” shall have the same meaning as the term “required by law” in 45 C.F.R. § 164.103.
11. “Secretary” shall mean the Secretary of the U.S. Department of Health and Human Services or his/her designee.
12. “Security Incident” shall have the same meaning as “security incident” in 45 C.F.R. § 164.304.
13. “Security Rule” shall mean the Security Standards for the Protection of EPHI at 45 C.F.R. Parts 160 and 164, subparts A and C.
14. "Subcontractor" shall have the same meaning as "subcontractor" in 45 C.F.R. § 160.103.
15. “Unsecured Protected Health Information” shall mean Protected Health Information that is not secured by a technology standard that renders Protected Health Information unusable, unreadable, or undecipherable to unauthorized individuals and is developed or endorsed by the Secretary or a standards developing organization that is accredited by the American National Standards Institute.

Other terms used in this Agreement, but not defined above shall be defined as they are defined in the HIPAA Privacy Rule.

Section 2.        Business Associate Duties

 

 

 

100. Business Associate's Reporting Obligations. 
     1. Reports of Non-Permitted Use or Disclosure.  Business Associate agrees to report to Covered Entity within thirty (30) days of discovery any use or disclosure of the PHI not provided for by this BAA of which Business Associate becomes aware.  Where applicable, such report shall comply with the requirements outlined in Sections 3.b.2 and 3.b.3.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Section 3.        Permitted Uses and Disclosures by Business Associate

 

 

 

 

1. Business Associate may use or disclose Protected Health Information, including Electronic Protected Health Information, as may be required by applicable law  and to report violations of law to appropriate state and federal authorities, to the extent permitted or required by 45 C.F.R. § 164.502(j)(1) and state law. 
2. Business Associate may use or disclose PHI to carry out Business Associate's legal responsibilities and for the proper management and administration, or to carry out the legal responsibilities, of  the Business Associate, provided that any such disclosures are either (1) Required By Law, or (2) Business Associate obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as Required By Law or for the purpose for which it was disclosed to the person, and the person notifies Business Associate of any instances of which the person becomes aware in which the confidentiality of the information has been breached.
3. Business Associate may use PHI to provide Data Aggregation services to PRCCI as permitted by 45 C.F.R. § 164.504(e)(2)(i)(B). 
4. Business Associate may use PHI to create de-identified information in accordance with the requirements outlined in the Privacy Rule in accordance with 45 C.F.R. 164.514(a)-(c).  Data that has been de-identified will no longer be subject to the terms of this Agreement.

 

Section 4. Obligations of Covered Entity

 

Covered Entity shall:

 

1. Notify Business Associate of any notice of privacy practices that Covered Entity produces in accordance with 45 CFR 164.520, and any changes or limitations to such notice.

 

2. Notify Business Associate of any limitations and changes in, or revocation of, permission by an Individual to use or disclose PHI, to the extent that such changes may affect Business’s Associate’s uses or disclosures of PHI. 

 

3.  Notify Business Associate of any restriction to the use or disclosure of PHI that Covered Entity has agreed to or is require to abide by under 45 CFR 164.522, to the extent that such restriction may affect Business Associate’s use or disclosure of PHI.

 

4. Covered Entity shall not request Business Associate or Business Associate’s subcontractors to use or disclose PHI in any manner that would not be permissible under the Privacy Rule or the Security Rule if done by the Covered Entity or otherwise not permissible under Subpart E of 45 CFR Part 164.

 

5. If Business Associate receives a request to restrict the disclosure of PHI directly from an Individual, Business Associate shall notify Covered Entity of such request and Covered Entity shall be responsible for working with Business Associate and its designee or subcontractor impacted by the request to determine, in accordance with the Privacy Rule, as to whether Business Associate shall comply with the Individual's request.

 

Section 5.         Term and Termination.

 

 

 

 

 

 

In the event that Business Associate determines that returning or destroying the PHI is infeasible, Business Associate shall provide Covered Entity notification in writing, and Business Associate shall extend the protections of this Agreement to such PHI and limit further uses and disclosures of such PHI to those purposes that make the return or destruction infeasible, for so long as Business Associate maintains such PHI.  

 

 

Section 6. Miscellaneous provisions

 

1. Governing law.        The formation, interpretation and performance of this Agreement shall be governed by and construed in accordance with the laws of the State of Missouri (USA) without giving effect to the doctrine of conflict of laws.  If any controversy may arise regarding the interpretation or performance of this Agreement, the Parties shall voluntarily submit the controversy to the jurisdiction of the Courts of the State of Missouri (USA.).

 

 

              

              TO COVERED ENTITY: 

                             Name: Register User on behalf of CLIENT            

 

              TO BUSINESS ASSOCIATE: MEDINEXO USA, LLC

 

                             Name: _Jorge Toro__________________

                             

Title: __President___________________ 

                             

 

 

 

 

 

IN WITNESS WHEREOF, each of the following undersigned has caused this Agreement to be duly executed.

 

For Covered Entity,     Electronic Signature: By submitting Online Registration for Medinexo® Client Services, CLIENT is signing this document electronically. CLIENT agrees that electronic signature is the legal equivalent of CLIENT’s manual signature on this document.

Business Associate: MEDINEXO USA, LLC   Jorge H. Toro President & CEO