Yonalink Inc. (“Yonalink” or “us”, “our”, “we”) provides an EDC / eCRF solution allowing for the collection of clinical and other data from clinical trial participants through varied sources, including questionnaires, medical (including wearable) hardware and the linking of Electronic Health Records with the applicable clinical trial database (“Solution”).
The Solution and any ancillary services offered by Yonalink shall be collectively referred to as the “Services”. The scope of Services offered to any Customer will be defined in a separate Order Form (which may come in the form of an electronic form and/or a webpage). Any customer listed in the Order Form shall be referred to as a “Customer” and any of Customer’s patients, participants in clinical trials, personnel or Customer’s affiliates’ personnel who are specifically authorized by Customer to access the Services will be referred to as a “User”. Customer’s patients and participants in clinical trials will be referred to as a “Participant”.
1. Use of the Services
1.1. Subject to the terms and conditions of this Agreement, Yonalink hereby grants the Customer a non-exclusive, non-transferable, non-sublicensable license to use, access and permit Users on its behalf to use and access, the Services on the conditions specified in the Order Form. All rights in the Solution and Services not expressly granted hereunder are reserved to Yonalink (or its licensors).
2. Support and Maintenance.
YonaLink will (i) provide commercially reasonable support and maintenance services for the Solution, (ii) provide for a 99% Uptime Commitment of the Solution, (iii) will commence work on a Critical Error detected in the Solution within 1 Business Day of receiving notice to that effect in the form of a written notice by the Customer or an automated notification by Yonalink’s monitoring systems; and (iv) make commercially reasonable efforts to provide hardware and software upgrades in relation thereto to maintain operation at industry accepted levels. The most recent version of the Solution will be available to the Customer throughout the Term. In this section, “Uptime Commitment” means availability measured over each calendar year excluding scheduled maintenance and/or downtime caused outside the reasonable control of a party. The Company will notify the Customer in advance of any scheduled maintenance (email to suffice). Scheduled maintenance will not exceed (i) 6 hours in duration for any individual instance and (ii) 12 hours in the aggregate during any calendar month. “Critical Error” means errors that cause a complete outage of the material functionality of the Solution. A “Business Day” means Sunday through Thursday, during Business Hours, not including any national or bank holidays in the United States of America. A “Business Hour” means 9:00 am to 5:00 pm Eastern Standard Time.
3. Fees and Payment
In consideration for the Services and rights granted herein, Customer shall pay Yonalink the fees listed in the applicable Order Form and on the terms listed therein (the “Fees”). Except to the extent set forth otherwise in the Order From, amounts due hereunder do not include VAT and other taxes, and Customer shall make payment in respect of such taxes in addition to other amounts due hereunder. Customer shall make payment to Yonalink without deduction or withholding of any taxes or other government charges. Late payments shall bear interest at the rate of 3% per annum, provided that interest shall only accrue after 7 days had passed since the relevant due date. Except to the extent expressly stated otherwise, all amounts in this Agreement are stated and payable in United States Dollars.
4. Restrictions and Obligations
Customer shall not, and shall not allow any User or third party to (a) rent, lease, modify, copy, loan, transfer, sublicense, distribute or create derivative works of the Solution and/or the Services; (b) disassemble, reverse engineer, attempt to find the underlying code of, or decompile the Solution and/or the Services; (c) circumvent any security mechanisms of the
Solution and/or the Services; or (d) remove or obscure any copyright or other notices from the Solution and/or the Services; (e) use the Solution and/or the Services to “stalk” or otherwise harass another person or collect or store unauthorised personal data in relation to any individual; (f) use the Solution and/or the Services to transmit or distribute any unsolicited or unauthorised advertising, marketing or promotional material or other form of solicitation (spam); (g) transmit or distribute any virus and/or other code that has contaminating or destructive elements; and/or (h) otherwise engage in any unlawful activity; and/or (i) attempt to override or circumvent any of the usage rules embedded into the Solution and/or Services. To the extent any of the restrictions set forth in this Section are not enforceable under applicable law, Customer will inform Yonalink in writing in each instance prior to engaging in the activities set forth above.
5. Representations and Warranties.
Each party hereto represents and warrants that: (a) it is duly organized under applicable law, (b) it has the authority to enter into this Agreement; (c) it will perform their obligations hereunder while upholding any applicable law or regulation; and (d) the execution and performance of this Agreement does not conflict with any contractual obligations it has to any third party or with any legal requirements to which it is subject. Customer represents and warrants that (i) it has received all necessary consents, approvals, licenses and/or certifications as needed for its business, including with respect to the clinical trials and transfer of Clinical Data as contemplated herein, and is fully compliant with GCP; and (ii) the Clinical Data delivered to the Solution by Customer is accurate. Yonalink represents and warrants that (i) to the best of its knowledge, the Solution does not infringe the intellectual property rights of any third party, and (ii) the Solution will not contain any virus, trojan horse, worm, backdoor, time bomb, drop dead, or other harmful code. Subject to the foregoing, the Solution and Services are provided “as is”. Except as expressly provided hereunder, to the maximum extent permitted by applicable law, Yonalink disclaims all implied and statutory warranties, including, but not limited to, any implied warranty of merchantability, fitness for a particular purpose or non-infringement.
6. Data; Privacy.
6.1. Customer acknowledges and agrees that Customer shall have the sole responsibility to ensure that Participants sign an appropriate Informed Consent Form which would allow Yonalink to access and process their personal data as required to use the Solution and Services (the “Clinical Data”) and to ensure that Participants accept the Solution’s User
Terms, as amended from time to time. Customer shall solely own all title and interest to the Clinical Data, which shall be considered Customer’s Confidential Information and, except as expressly set forth in this Agreement, Yonalink shall not disclose such Clinical Data to third parties or use such Clinical Data except in connection with the Services as contemplated herein.
6.2. For the avoidance of doubt, the parties may disclose Clinical Data to the extent required by applicable law or to cooperate with a law enforcement investigation or to enforce its rights under this Agreement. Customer expressly agrees that Yonalink may transfer Clinical Data to jurisdictions outside of the United States of America.
6.3. Customer shall be considered the party controlling the database of the Clinical Data and Yonalink serves as an outsourced service provider on its behalf. Yonalink will implement reasonable security measures to protect the security of the Clinical Data including without limitation, technical, physical, administrative and organizational controls, and will maintain the confidentiality, security and integrity of the Clinical Data.
6.4. It is hereby acknowledged that the operation of the Solution may alter technical aspects of the Clinical Data and other information stored therewith, including with respect to coding systems and data formats.
7. Intellectual Property.
Yonalink has all right, title and interest in and to the Services, including all enhancements, improvements and modifications thereof, including without limitation the Customization Work Product, and all intellectual property rights in all of the foregoing (the “Yonalink IP”). To the extent that the ownership of the Yonalink IP does not already vest with Yonalink, the Customer shall and hereby does assign all right, title and interest in and to the Yonalink IP to Yonalink and irrevocably waives all moral rights thereto. Should the Customer and/or any User provide Yonalink with any feedback regarding the Services, Yonalink may use all such feedback without restriction and shall not be subject to any non-use obligations in respect thereof.
Either party (“Disclosing Party”) may disclose to the other party (“Receiving Party”) certain confidential or proprietary information of the Disclosing Party (“Confidential
Information”). The Receiving Party agrees to keep confidential and not disclose or use any Confidential Information except in order to comply with its obligations in the Agreement, and all subject to applicable law. Confidential Information shall not include information that the Receiving Party can show: (a) was already lawfully known to the Receiving Party, (b) was independently developed by the Receiving Party without access to or use of Confidential Information, (c) was received from any third party without restrictions, (d) is publicly and generally available, free of confidentiality restrictions, or (e) is required to be disclosed by court order or law, provided that the Receiving Party provides the Disclosing Party with prompt notice of such requirement and cooperates (at the expense of the Disclosing Party) in order to minimize such requirement, to the fullest extent permitted by such order or applicable law. The Receiving Party shall restrict disclosure of Confidential Information of the Disclosing Party to those of its employees and/or independent contractors and/or any third parties on its behalf, with a reasonable need to know such information for the purposes outlined herein. For the avoidance of doubt: the terms of this Agreement are the Confidential Information of both parties. The confidentiality obligations hereunder shall survive for a period of five (5) years following the termination or expiration of the Agreement for any reason; provided, however, that the obligations with respect to trade secrets shall survive for as long as the applicable Confidential Information constitutes a trade secret under applicable law. Following the termination or expiration of this Agreement, the Receiving Party shall, at Disclosing Party’s discretion, return or destroy any Confidential Information in its possession or control and provide the Disclosing Party written confirmation thereof; provided, however, that: (i) one copy of any information may be maintained for audit and/or regulatory purposes in accordance with applicable law, and (ii) Receiving Party will not be required to destroy or return information that is contained on back-up media and other storage devices that are not readily accessible in the ordinary course of business. Such retained information shall continue to be subject to the foregoing obligations, for as long as such information is in Receiving Party’s possession or control. Confidential Information may be disclosed as part of, or during negotiations of, any merger, sale of company shares and/or assets or acquisition and provided that any recipients are subject to reasonable confidentiality undertakings no less stringent than those set out herein.
9.1. Yonalink Indemnification Obligations. Yonalink shall defend, indemnify and hold Customer harmless from and against any and all damages, costs, losses, liabilities or expenses (including court costs and reasonable attorneys’ legal fees) which Customer may suffer or incur in connection with any actual claim, demand, action or other proceeding by any third party against Customer arising from any claims that the Solution infringes the intellectual property rights of a third party. Yonalink shall not have any liability to the extent any claim is the result of (a) Yonalink’s compliance with specifications provided by Customer, (b) the combination of the Solution with other hardware, software or services not provided by Yonalink, (c) the collection, use or transfer of Clinical Data in compliance with this Agreement, or (d) Customer’s actions, omissions or breach of this Agreement. If the Solution shall be the subject of an indemnifiable claim, or Yonalink reasonably believes that the Solution shall be the subject of an indemnifiable claim, Yonalink may terminate this Agreement with written notice.
9.2. Customer Indemnification Obligations. Customer shall indemnify, defend and hold harmless Yonalink and its respective employees, representatives and agents, from and against any third party claims and proceedings, and related loss, damage, liability and expense (including reasonable legal costs), arising out of or resulting from (a) the willful, reckless, or negligent acts or omissions, or professional malpractice of Customer or any of its trustees, officers, agents or employees; (b) the infringement by Customer of a third party’s privacy rights relating to the data provided in connection with this Agreement, including for lack of Informed Consent under medical laws and regulations.
9.3. Procedure. The obligations of either party to provide indemnification under this Agreement will be contingent upon the indemnified party (i) providing the indemnifying party with prompt written notice of any claim for which indemnification is sought, (ii) reasonably cooperating with the indemnifying party (at the indemnifying party’s expense), and (iii) allowing the indemnifying party to control the defense and settlement of such claim, provided that no settlement may be entered into without the consent of the indemnified party if such settlement would require any action on the part of the indemnified party other than to cease using any allegedly infringing or illegal content or services. Subject to the foregoing, an indemnified party will at all times have the option to participate in any matter or litigation through counsel of its own election at its own expense.
10. Limitation of Liability.
TO THE MAXIMUM EXTENT PROVIDED BY APPLICABLE LAW, IN NO EVENT SHALL YONALINK (OR ITS DIRECTORS, OFFICERS, AFFILIATES, AGENTS OR EMPLOYEES) HAVE ANY LIABILITY FOR ANY MATTERS RELATED TO A CLINICAL TRIAL CONDUCTED BY THE CUSTOMER, INCLUDING WITHOUT LIMITATION ANY MATTERS RELATED TO TRIAL SUBJECT INJURIES OR DEATH. IN NO EVENT SHALL THE PARTIES (OR THEIR DIRECTORS, OFFICERS, AFFILIATES, AGENTS OR EMPLOYEES) HAVE ANY LIABILITY FOR ANY CONSEQUENTIAL, INDIRECT, SPECIAL OR PUNITIVE DAMAGES, ARISING OUT OF OR RELATING TO THIS AGREEMENT TO THE OTHER PARTY. TO THE MAXIMUM EXTENT PROVIDED BY APPLICABLE LAW, THE ENTIRE LIABILITY OF EITHER PARTY (OR ITS DIRECTORS, OFFICERS, AFFILIATES, AGENTS OR EMPLOYEES) HEREUNDER SHALL NOT EXCEED THE TOTAL FEES DUE BY CUSTOMER HEREUNDER IN THE 3 MONTHS PRIOR TO THE CLAIM. THE FOREGOING LIMITATIONS AND EXCLUSIONS OF LIABILITY DO NOT APPLY TO THE LIABILITY OF EACH PARTY PURSUANT TO THE INDEMNIFICATION OBLIGATIONS SET FORTH HEREIN.
The term of this Agreement shall commence upon the date listed in the Order Form and shall continue in effect for a period of 12 months (the “Initial Term”), unless specified otherwise in the Order Form. Following the Initial Term, this Agreement shall automatically renew for subsequent terms of 12 months each (each, a “Renewal Term” and, together with the Initial Term, the “Term”), unless either party shall provide written notice of its intention that the Agreement shall not renew at least 30 days prior to the commencement of the applicable Renewal Term. Either party may terminate this Agreement for any reason upon 30 days’ prior written notice, unless specified otherwise in the Order Form. Upon termination of this Agreement for any reason Yonalink will be entitled to a prorated amount representing the Services actually provided, unless the Customer has selected a prepayment plan embodying a discount, in which case any Fees paid will be non-refundable. Except as otherwise set forth herein, each party may also terminate this Agreement: (a) immediately in case of breach by the other party by written notice to the breaching party, provided such breach has not been cured within thirty (30) days of being notified thereof; or (b) in the event the other party: (i) makes a general assignment for the benefit of its creditors, (ii) applies for, consents to, or acquiesces to the appointment of a receiver, trustee, custodian, or liquidator for its business or assets, or (iii) files, consents to, or acquiesces in a petition seeking relief or reorganization under any bankruptcy or insolvency laws.
12. Effects of Termination.
Upon termination of the Agreement for any reason Customer shall cease the use of the rights licensed hereunder including, for the avoidance of doubt, with respect to the Solution and Services. Sections 4, 5,6, 7, 8, 9, 10, 11, 14 and 15 will survive expiration or termination of these Terms for any reason.
Yonalink shall have the right to include a reference to the Customer, its official name and logo on its website, marketing literature, labeling and in its promotional materials.
14.1. Notices. Any and all notices and communications hereunder shall be in writing and shall be deemed to have been duly given when delivered personally or by mail or courier or, with respect to Customer, to the email address of Customer provided to Yonalink, including without limitation, upon registration.
14.2. Relationship of Parties. Yonalink and the Customer, including any of its Users, are and intend to remain independent parties. Nothing contained in these Terms shall be deemed or construed to create the relationship of principal and agent or of partnership or joint venture, and neither party shall hold itself out as an agent, legal representative, partner, subsidiary, joint venturer, servant or employee of the other.
14.3. Entire Agreement; Modification, Amendment, Waiver; Severability. The Agreement and its exhibits constitute the entire and sole agreement and understanding between the parties hereto with respect to the subject matter hereof and supersede any prior or contemporaneous understanding, agreements, representations or warranties, whether oral or written, with respect to the subject matter. No party shall be deemed to have waived compliance by any other party with any provision of the Agreement unless such waiver is in writing, and the failure of any party at any time to enforce any of the provisions of the Agreement shall in no way be construed as a waiver of such or any other provision and shall not affect the rights of any party thereafter to enforce such provisions in accordance with their terms. No waiver of any breach of any provision of the Agreement shall be deemed the waiver of any subsequent breach thereof or of any other provision of the Agreement. In the event that any provision of the Agreement is held invalid or unenforceable in any circumstances by a court of competent jurisdiction, such section shall be interpreted to give maximum effect to its terms as possible under law, and the remainder
of the Agreement, and the application of such provision in any other circumstances, shall not be affected thereby.
14.4. Assignment; Successors. The Customer shall not assign any of its rights or obligations hereunder without the prior written consent of Yonalink, and any assignments in violation of the foregoing shall be void. Yonalink may assign its rights or obligations hereunder.
15. Governing Law.
The Agreement shall be governed by and construed and enforced in accordance with the laws of the United States of America without regard to principles of conflict of laws. Any action, suit or other proceeding arising under or relating to the Agreement shall be brought in a court of competent jurisdiction in the state of Delaware and the parties hereby consent to the sole jurisdiction of such courts. Notwithstanding the foregoing, Yonalink may seek injunctive relief in any jurisdiction in order to enforce the Agreement.
Last updated: December 2022