RESEARCHNEXO© USER AGREEMENT

This user agreement will be effective for all users as of February 1st, 2023.

Welcome to ResearchNexo!

By opening and using a ResearchNexo Site account, you agree to comply with all of the terms and conditions of this user agreement, including any upcoming changes described on the Policy Updates page at the time you accept this user agreement (which changes will apply to you on the indicated effective dates). These terms include an agreement to resolve disputes by arbitration on an individual basis.

This RESEARCHNEXO© USER AGREEMENT (hereinafter, Agreement) is a contract between MEDINEXO USA LLC (hereinafter, “MEDINEXO”) located at 7733 Forsyth Blvd, Clayton, MO 63105, and the Investigative Site (hereinafter, “SITE”) you represent.

WHEREAS, MEDINEXO is a Wyoming Limited Liability Company servicing the global clinical research industry through real time coordination and integration of clinical research professionals worldwide.

WHEREAS,MEDINEXO’s ResearchNexo in collaboration with the BlueCloud® Network, provides a global telecommunication, managerial, and information system for sites to offer centralized and decentralized clinical trials globally using proprietary technology and management systems.

WHEREAS,MEDINEXO in collaboration with BlueCloud® provides research readiness using proprietary and independent applications, along with global collaborative networks including but not limited to Education, Technology, Standards, Healthcare Professional and Patient Networks among others and where providers may offer, deliver and manage their industry based products, services, specialties and technologies for business and compliance purposes collectively the BlueCloud® System.

THEREFORE,SITE wishes to become a ResearchNexo Member to leverage MEDINEXO’s extensive global networks for the benefit of the Member’s business, compliance, and/or other purpose within the proper legal and ethical constraints.

For purposes of this Agreement, SITE agrees to the following terms and conditions:

  1. Ethics and Rules of Engagement. SITE acknowledges, accepts, and agrees to abide by the code of ethics and professional conduct (see Exhibit I), and the rules of engagement (see Exhibit II) included in this Agreement.
  2. SITE Obligations. At all relevant times, SITE agrees to comply with its obligations hereunder including, but not limited to:
    1. Timely and complete submission of documents, credentials and certifications as requested by MEDINEXO.
    2. Respond in a timely and complete manner to all information requests and/or any petitions made as per established timelines.
    3. Commit to meet quality standards (including, but not limited, to patient enrollment targets, data upload speed and adherence to protocol).
    4. Provide access to relevant documents and personnel during SITE initiation and optimization visits and assessments. 
    5. SITE commits to include MEDINEXO in all discussions with Sponsors/CRO pertaining to study opportunities secured by MEDINEXO. 
  3. Compensation. All BASIC SERVICES are provided at no cost through the duration of this agreement. The cost of PRIME SERVICES provided by MEDINEXO to SITE and the compensation for such services shall be defined in additional agreements (“Prime Services Agreements”). Compensation will be due as defined in the corresponding Prime Services Agreement.
  4. Clinical Aspects of Study. SITE understands and acknowledges that it is ultimately and exclusively responsible for managing all clinical aspects of each and every study or trial under its responsibility. SITE shall be solely responsible for any reports required by the Federal Drug Administration such or any local or regional regulatory agency with oversight authority for the study or trial, such as, adverse event reports and investigational new drug reports to the Sponsor/CRO, to the Institutional Review Board (IRB), and to any applicable agency or organization. SITE shall also be responsible for submitting the information outlined in the protocol required by the Sponsor within the timelines and mode of transmission prescribed by the Sponsor.
  5. Confidentiality and Copyright. MEDINEXO hereby grants to SITE and its authorized users the right, during the term of this Agreement, to access its services and systems as further set out in Exhibit(s)MEDINEXO hereby represents and warrants that these services and systems will perform in accordance with all their published specifications and in accordance with industry standards and that they will be available at all times save and except for reasonable scheduled maintenance periods and or unforeseen acts not within the control of MEDINEXO. MEDINEXO hereby represents and warrants that these services and systems do not infringe the intellectual property rights of any third parties. MEDINEXO will indemnify and hold harmless SITE for any loss, damage or claim arising out of or related to any violation of the foregoing representations and warranties. SITE will indemnify and hold harmless MEDINEXO for any loss, damage or claim arising out of or related to any violation of the foregoing representations and warranties.

SITE acknowledges that MEDINEXO possesses rights in certain inventions, processes, know-how, trade secrets, works, improvements, other intellectual properties and other assets, including but not limited to the day to day management, communications and delivery platform, software and network infrastructure for developing and hosting products, services, specialties, technologies and applications, analytical methods, methodologies, procedures, techniques, procedure manuals, personnel data, financial information, computer technical expertise and software, which have been independently developed by MEDINEXO and which relate to its business or operations, trademarks, patented and patent pending products, services, specialties and technologies (collectively “MEDINEXO’s Intellectual Property”). SITE and MEDINEXO agree that MEDINEXO’s Intellectual Property and improvements to its technology platform(s) thereto which are developed by MEDINEXO under or during the term of this Agreement are the sole and exclusive property of MEDINEXO, will only be “used” by the SITE and not owned by the SITE.

  1. Confidential Information: “Confidential Information” means information in any form disclosed or made available or brought to the attention of MEDINEXO or its representative(s) by SITE or its representative(s) that MEDINEXO knows or has reason to know (either because such information is marked or otherwise identified by the Disclosing Party orally or in writing as confidential or proprietary, has commercial value, or because it is not generally known in the relevant trade or industry) is confidential information of SITE and includes, without limitation, the current, future and proposed technology, products or services of SITE, as well as financial, technical, research, operational, sales and marketing information related thereto. The Receiving Party agrees to (i) regard, treat, and preserve as confidential such Confidential Information, (ii) refrain from publishing, communicating and/or disclosing any part of such Confidential Information to anyone other than the employees, agents, and/or representatives of the Receiving Party who need to know such information for the purposes of their duties, (iii) use Confidential Information only in furtherance of or in connection with the performance of the Activities or any other work, services, and/or activities to be considered and/or performed in connection with or pursuant to this Agreement, and (iv) use at least the same degree of care, but no less than a reasonable degree of care, as the Receiving Party employs generally with respect to the Receiving Party’s own confidential information of a similar nature. In the event that MEDINEXO is compelled pursuant to an order of a court of competent to disclose Confidential Information, MEDINEXO shall promptly notify Member prior to making such disclosure, to afford Member the opportunity to challenge and/or otherwise lawfully seek limits upon such disclosure of Confidential Information. In furtherance of the foregoing provisions, MEDINEXO shall ensure that all of its employees, agents, and/or representatives who are provided with or have access to Confidential Information have entered into written agreements that require them to treat and preserve as confidential the Confidential Information that are at least as restrictive as the provisions of this Section. The obligations under this Section shall continue during the term of this Agreement and for a period of five (5) years thereafter.
  2. Privacy & Compliance:  Medinexo complies with Standard Contractual Clauses regarding the collection, use, and retention of personal information transferred from the European Union and Switzerland to the United States.
  3. Intellectual Property. This Agreement does not, and is not intended to, transfer to either Party any rights in any intellectual property of the other Party.
  4. Indemnification. Each party will be responsible for its own acts and the results thereof and shall not be responsible for the acts of the other party and the results thereof. Each party therefore agrees that it will assume all risk and liability to itself, its agents or employees, for any injury to persons or property resulting in any manner from the conduct of its own operations and the operations of its agents or employees under this Agreement, and for any loss, cost, damage, or expense resulting at any time from any and all causes due to any act or acts, negligence, or the failure to exercise proper precautions, of or by itself or its agents or its own employees, while conducting activities under and pursuant to this Agreement. Notwithstanding anything herein to the contrary, SITE shall indemnify, defend, and hold harmless MEDINEXO and its partners, executives, employees and consultants and assigns from and against any and all damages, liabilities, losses, obligations, judgments, costs and expenses (including, without limitation, reasonable attorney's fees and court costs) claimed by any third-party arising out of or related in any way to the performance of this Agreement or the law.
  5. Limitation of MEDINEXO Liability. SITE agrees that MEDINEXO’s total liability toward SITE, as well as any potential liability of MEDINEXO’s directors, officers, partners, employees, representatives and/or agents toward SITE, shall be strictly limited to, and shall never be more than the total amount paid, if any, by SITE for services provided under this Agreement.
  6. Independent Contractors. The performance of this Agreement does not make or appoint either Party an agent of the other, nor does it create a partnership or joint venture between the Parties. The relationship of the Parties in connection with the performance of this Agreement is that of independent contractors, and not of employees, agents, joint employers, or the like. Each Party agrees to be individually responsible for their respective legal compliance requirements, including but not limited federal or state withholding taxes, social security taxes, worker’s compensation, and unemployment taxes or any other similar coverages or taxes regarding the other or its employees. 

Neither Party will use the name or logo of the other Party, or any component subsidiaries, except in factual publicity, without obtaining prior written approval by the other Party. Factual publicity includes dates, times, locations, purposes, agendas, and fees, if any, involved with the activities related to any activity performed under this Agreement.

  1. No Warranty. SITE acknowledges that MEDINEXO has not made and will not make warranties or representations of any kind (whether express, implied, or statutory) including, without limitations, that the services provided will result in any amount or level of income, or introduction of sponsors or referral of studies to SITE. SITE acknowledges being ultimately and exclusively responsible for managing its operations including, but not limited to any and all clinical aspects of a study or trial for which it is selected and for managing contracts with any third party, including contracts or relationships with parties introduced to SITE by MEDINEXO.
  2. Term and Expiration.
    1. This Agreement shall become effective as of the Effective Date and remain in effect for a term of five (5) years (the "Term").
    2. Either party may terminate this Agreement without cause or penalty at any time on ninety (90) days prior written notice to the other party.
    3. Either party may terminate this Agreement immediately for cause in the event of a material breach by the other party.
  3. Effect of Termination. The following SITE obligations shall survive termination of this Agreement by either Party: (i) to provide access to, as well as updated and truthful information to MEDINEXO and governmental authorities regarding any study or matter related thereto; (ii) to protect Confidential Information and Intellectual Property, and to return the same as may be requested by MEDINEXO; (iii) to compensate and/or reimburse MEDINEXO for all amounts owed under the terms of any services agreement executed among the Parties including any extension studies; (iv) any SITE obligation under a CTA and (v) any other SITE obligations arising under state or federal law, and including those included in any other agreement executed among the Parties.
  4. Remedies/Enforcement. In addition to any and all other rights a party may have available according to this Agreement, any other services agreement, and the law, SITE acknowledges that violations of certain provisions will cause irreparable harm to MEDINEXO, and that damages for such harm will be incapable of precise measurement, and that, as a result, MEDINEXO will not have an adequate remedy at law to redress the harm caused by such violation. Therefore, in the event of any such violations, the parties agree that, in addition to its other remedies, MEDINEXO shall be entitled to temporary restraining orders and preliminary and permanent injunctions to enjoin any violation of these terms by SITE or any related third-party. In addition, if the Party seeking such enforcement prevails, the other Party shall be entitled to recover reasonable attorney’s fees expended in connection with the enforcement of the covenants contained in this Agreement.
  5. Notices. Any notice or communication required or permitted under this Agreement shall be sufficiently given if delivered in person or by certified mail, return receipt requested, to the address set forth in the opening paragraph or to such other address as one party may have furnished to the other in writing.
  6. Governing Law & Jurisdiction:The validity, interpretation, enforceability, and performance of this Agreement shall be governed by and construed in accordance with the laws of the State of Missouri. Venue for any and all disputes arising out of this Agreement shall be the City of St Louis, State of Missouri.
  7. Severability. If any provision of this Agreement will be held to be invalid or unenforceable for any reason, the remaining provisions will continue to be valid and enforceable. If a court finds that any provision of this Agreement is invalid or unenforceable, but that by limiting such provision it would become valid and enforceable, then such provision will be deemed to be written, construed, and enforced as so limited. 
  8. Attorney’s Fees. If either party is required to enforce its rights under this Agreement against the other party, the prevailing party shall be entitled to reasonable attorneys' fees and costs from the other party.
  9. No Assignment. No party may assign any of its rights and obligations, or otherwise delegate any of its duties under this Agreement to any party without the prior written consent of the other.
  10. Requisite Authority. Everyone executing this Agreement hereby represents that he or she is authorized to execute and deliver the document on behalf of the party entering into this Agreement. 
  11. Force Majeure: Except as otherwise herein provided, neither party shall be liable or deemed in default for failure to perform any duty or obligation that such party may have under this Agreement where such failure has been occasioned by any act of God, fire, strike, inevitable accidents, war, or any other cause outside the reasonable control of that party and occurring without its fault or negligence.
  12. Entire Agreement; Modification: This Agreement contains the entire understanding of the parties with respect to the matters herein contained and supersedes all previous agreements and undertakings with respect thereto. This Agreement may be modified only by written agreement signed by the parties herein

Exhibit I – Code of Ethics and Professional Conduct

This Code of Ethics establishes the legal and ethical standards of conduct for all employees, consultants, contractors, and sites doing business with Medinexo (herein, “Collaborators”). This Code promotes the conduct of business with integrity and compliance with all applicable guidelines, laws and regulations which govern the practice of clinical research including, but not limited to, the Declaration of Helsinki, the Belmont Report, ICH GCP, the US Codes of Federal Regulations, and the WHO Ethical Standards and Procedures for Research in Human Beings. Employees, consultants, contractors, and Site shall abide and adhere to the following ethical standards and professional conduct:

  1. Protection of Research Participants. A key principle in clinical research is the respect for the human dignity of research participants, their self-determination and full disclosure of information throughout the research process. Research participants should be free from harm and exploitation in accordance with the risks and benefits of the research project. Furthermore, research participants should have the right to receive fair and confidential treatment during the selection process and throughout the research project.
  2. Confidentiality and Privacy. There is an obligation to protect private information about an individual or organization from unauthorized disclosure. Also, there are legal rights of individuals to limit public scrutiny; to limit access to their private acts and their personal information; and to limit disclosure of such personal information. Collaborators must maintain the confidentiality of information entrusted to them unless disclosure is authorized or legally mandated. Appropriate precautions shall be in place to ensure that confidential or sensitive business information is only communicated to people who need to know such information to perform their responsibilities and is not communicated to anyone outside unless an appropriate confidentiality agreement is in place. Collaborators shall ensure that all aspects of the privacy of research participants and their families is respected prior to, during, and following, any clinical research study.
  3. Integrity. Collaborators shall apply sound ethical values, scientific principles, and judgment in all relevant aspects of clinical studies as well as in the interpretation of the results. It is expected that collaborators report research findings accurately and shall not misrepresent, fabricate, or falsify results; also, they shall conduct research in accordance with an approved research protocol or plan and make all research data available to authorized persons for verification in accordance with established standards of the clinical research profession.
  4. Conflicts of Interest. Conflicts of interest may arise when personal, professional, business, political and/or financial influences have the potential to significantly impair professional judgment which could lead to acts of research misconduct. Collaborators shall identify, in a timely manner, when they may have a conflict of interest, and disclose such conflict as soon as the potential conflict is recognized. Collaborators are also expected to comply with other policies on Conflict of Interest which may be part of their organization, institution, or government. Steps should be taken to comply with this ethical principle.
  5. Compliance with Laws, Rules and Regulations. Collaborators must comply with governmental laws, rules and regulations that are applicable, wherever it does business.
  6. Professional Discipline. Collaborators shall be committed to engage in safe, and sound research practices consistent with the relevant ethical and scientific standards and the requirements of their professional discipline. They shall uphold standards of equality and nondiscrimination in all professional interactions and shall cooperate with other professionals as appropriate and ethical. Additionally, those who are also involved in the clinical care of patients shall take steps to avoid contributing to therapeutic misconception of research participants, and to ensure that the roles and responsibilities of physicians and other healthcare professionals acting as investigators and care providers remain clear.
  7. Anti-Bribery. Collaborators shall comply with all anti-bribery laws prohibiting domestic and foreign bribery of government officials including, but not limited to, the Foreign Corrupt Practices Act (FCPA), or successor legislations as well as similar non-US anti-bribery laws. They shall also refrain from making or offering payments or gifts if its acceptance might be deemed by others to have influenced the recipient’s business decision.

Reporting Procedures and Disciplinary Actions. Collaborators shall notify Medinexo if they become aware of the violation of laws, rules, or regulations in the conduct of business activities. It is also encouraged to report illegal activity to the appropriate regulatory authorities. In addition to reporting and following the appropriate due diligence, Medinexo personnel and associates will be subject to disciplinary action if there are actions that constitute gross negligence, misconduct, unethical or unprofessional conduct in violation of this Code of Ethics and Professional Conduct. The disciplinary actions include, but are not limited to, reprimands, warning, probation, or suspension without pay, discharge and, if applicable, termination of employment or contract.

Exhibit II – Rules of Engagement

This document outlines the main guidelines and rules of engagement in the conduct of business between Medinexo USA, LLC and the Clinical Trial Sites.

  1. Code of ethics and professional conduct is at the core of our business practices and execution.
  2. Engagement processes
    1. Electronic and phone communications are the most widely used modes outside of regular meetings. It is expected that all parties respond promptly to messages and inquiries or assign an appropriate representative. Communications should proceed with the respect that is expected in business interactions.
    2. Sites can expect timely invitations, sharing of relevant documents and the specific agenda for meetings. It is expected that meetings start on time, last no longer than the stipulated time scheduled and have appropriate representation from Sites.
  3. Critical success factors. The following factors are essential to a successful business relationship. All parties adhere to these expectations:
  1. Responsiveness to communications
  2. Participation in meetings and special activities
  3. Collaboration with collaborators and partners
  4. Confidentiality of the information that is shared internally or by external parties
  5. Respectful and timely communications
  6. Respect for all the stakeholders involved in clinical research activities
  1. All Sites will be evaluated using the following indicators, which are standard expectations from Sponsors:
  1. Facilities and equipment
  2. Regulatory documentation
  3. Clinical documentation
  4. Training, certifications, and credentials of Site staff
  5. Standard Operating Procedures
  6. Data management Processes
  7. Patient records and databases
  8. Quality and compliance program
  9. Subject recruitment process
  10. Communication and relationships
  11. Workflows
  12. Study start-up cycle times
  13. Availability and access to Institutional Review Boards and relevant committees
  14. Availability and relationship with key clinical services, including outsourced ones
  15. Implementation of a clinical trial management system
  16. Identification and access to administrative, financial, and legal support at institution
  17. Engagement with relevant regulatory agencies and committees at country-level
  1. The following are key performance metrics that are essential to high-performing clinical research sites:
  1. Fast turnaround time in responses to study leads and opportunities
  2. Complete and evidence-based information in surveys and questionnaires
  3. Commitment to a speedy contract and budget negotiation process
  4. Completeness in the submission of documentation to the Institutional Review Board (IRB) and any amendments
  5. Fully compliant with documented Informed Consent Form (ICF) with all subjects
  6. Fast turnaround time from contract to study initiation
  7. Quality and timely entrance of data in electronic data capture platforms as well as clinical trial management systems
  8. Attain patient recruitment goals within the study timelines
  9. Maintain all credentials, documents, and certifications in good standing
  10. Maintain the best facilities for clinical interactions which abide by the standard regulations and policies outlined by the relevant regulatory agencies and government
  11. Enforce protocol implementation with no deviations
  12. Successful audits and corrective action plans