Master Service and Technology Agreement dated May 9, 2023

Exhibit 10.1

Master Service and Technology Agreement

THIS AGREEMENT is effective as of May 9, 2023 (this “Agreement”).

Parties

Background

Agreed terms

The definitions in this clause apply in this Agreement.

Applicable Laws: all supranational, national, state, and local laws and regulations including, without limitation, the regulations and guidelines of the United States Federal Food, Drug and Cosmetic Act (21 U.S.C. 301, et. seq.) (the “FDA Act”), the Canadian Food and Drugs Act, RSC 1985, C F-27 and its associated regulations (the “CA FDA Act”) and, as applicable, accepted standards of practice that may be applicable to a Study or the Services including but not limited to:

(a) the FDA Act, the CA FDA Act and associated legislation and Health Canada regulations, policies, and guidelines in effect from time-to-time governing investigational drugs;

(b) all International Conference on Harmonization (ICH) guidance documents as appropriate including ICH E6: Guidelines on Good Clinical Practice (ICH/GCP);

(c) United States Federal anti-kickback statutes and related safe harbor regulations and associated Canadian legislation;

(d) all relevant anti-corruption and anti-bribery laws (including, without limitation, the Federal Corrupt Practices Act)

Company Data: the data generated in the clinical trial or trials referenced in an executed SOW if applicable, as well as data imported or inputted by Company, Authorized Users, or Prevail or others on Company’s behalf in connection the Services or facilitating Company’s use of the Services.

Authorized Users: those officers, directors, employees, agents, and independent contractors of Company who are authorized by Company to use the Services and the Documentation, as further described in clause 3.

Business Day: any day which is not a Saturday, Sunday or public holiday in the USA.

Confidential Information: is defined in clause 10.

Debarment Act: the Generic Drug Enforcement Act of 1992, as amended, 21 U.S.C. §§ 306.

Documentation: the documents made available to Company by Prevail from time to time which sets out a description of the Services and the user instructions for the Services, including any executed SOWs.

Effective Date: the effective date of this Agreement as specified above.

Initial Term: the initial term of this Agreement is 28 months.

Normal Business Hours: 8:00 a.m. to 5:00 p.m. Eastern Time, USA, each Business Day.

Renewal Period: the period described in clause 14.1.

Services: the services provided by Prevail to Company under this Agreement as set forth in a Statement of Work attached hereto and any other executed Statements of Work.

Software: the online software applications provided by Prevail as part of the Services.

Study Invention: any (a) trade secrets, discovery, invention, technology, copyright, moral rights, trademarks, trade names, logos, know how, method, result, data, material, information, concept, ideas, concepts, processes, works, formulas, source and object codes, programs, other works of authorship, improvements, developments, designs, techniques and any other intellectual or proprietary assets whether or not patentable or protectable by any other intellectual property law, that Company or Prevail or their respective employees, agents, and/or subcontractors, either alone or jointly with others, makes conceives, creates, develops, or reduces to practice or causes to be conceived, developed or reduced to practice as a result of, (a) the use of the Company’s investigational product in a Study, (b) conducting a Study, (c) performing any obligations or activities assigned to such Party or Parties in connection with this Agreement or any Study, or (d) using Company’s investigational product or Confidential Information. “Study Invention” shall not include any inventions, processes, patents, know-how, trade secrets, improvements, other intellectual property and assets, including but not limited to analytical methods, procedures and techniques, procedure manuals, data, computer technical expertise, hardware and/or software, which (i) have been independently developed by Prevail, (ii) relate to Prevail’s business or operations, and (iii) are used, improved, modified or developed by Prevail during the term of this Agreement, without the use of any of Company’s resources or equipment, or any reference to Company’s investigational product or Confidential Information.

Subscription Fees: the subscription fees payable by Company to Prevail for the Software and Services, as set forth in Schedule 1 attached hereto and any other executed SOWs.

Term: period of time between the commencement of this Agreement and its expiration or termination, whichever is earlier.

User Subscriptions: the user subscriptions purchased by Company pursuant to clause 5 which entitle Authorized Users to access and use the Services and the Documentation in accordance with this Agreement.

During the Initial Term and any Renewal Period, and from time to time, Company may purchase Services from Prevail that will be set forth in a Statement of Work (“SOW”) agreed by and duly executed by both Parties, beginning with SOW 1 attached hereto. Each executed SOW shall be governed by this Agreement and include: (i) description of Services to be provided, (ii) fee and payment schedule for the Services and a reasonably detailed budget, (iii) description of deliverables to be delivered by Prevail and their intended use, and (iv) a project timeline. Any changes or modifications to the SOW shall be mutually agreed upon in writing by the Parties as provided for in this Agreement. Once executed by both Parties, each SOW shall be deemed incorporated into this Agreement by reference. There will be no limit to the number of SOWs that may be added to this Agreement. In the event that the terms of an executed SOW conflict with the terms of this Agreement, the terms of this Agreement shall govern unless the SOW specifically references Section 2 of this Agreement and indicates such specific terms of the SOW shall govern.

In the event that Company would like Prevail to alter the Services under a given SOW or the assumptions underlying the budget, the Parties shall agree upon a signed written amendment to the SOW prior to the provision of said Services. Prevail has no obligation to perform and Company has no obligation to pay for any additional or modified Services absent written amendment to the SOW by the Parties with respect thereto.

If the Services described in a particular SOW require Prevail to pay Sites and/or Investigators to perform a Study on Company’s behalf, Company acknowledges and agrees Prevail will only pay Investigators from advances or pre-payments received from Company for Investigators’ services, and that Prevail will not make payments to Investigators prior to receipt of sufficient funds from Company. Company further acknowledges and agrees that payments for Investigators’ services are expenses payable to third parties, are their sole responsibility and are separate from payments for Prevail Services.

Subject to terms and conditions set forth in this Agreement and SOWs duly signed by both Parties (including the attached SOW 1), Prevail hereby grants to Company a non-exclusive, non-transferable right to permit Authorized Users to use the Services and the Documentation during the Term solely for Company’s product research, development and commercialization and business operations (which, for the avoidance of doubt, shall include use by Company’s Authorized Users in connection with Company’s clinical studies). Company may, from time to time during any Subscription Term, purchase additional User Subscriptions in excess of the number set out in a SOW and Prevail shall grant access to the Services and the Documentation to such additional Authorized Users in accordance with the provisions of this Agreement.

(a) Availability:

The Software Availability for any given month shall be at least 99.9% (“Availability”) uptime, and is measured by subtracting from the total minutes in a given month, the total minutes of Service Interruption in such month, divided by the total minutes in such month and then multiplied by 100.

For purposes of the foregoing “Service Interruption” means, except for Scheduled Maintenance, the period of time that the Software is either: (i) not available for Company log-in; or (ii) substantially not functioning. By way of example: If in a given 30 day month there are 60 minutes of Service Interruption, then the Service Availability for such month would be calculated as follows:

= (43,200 being the total minutes in a 30 day month) – (60 minutes of Service Interruption) / 43,200

= 43,140 / 43,200

= 0.999

Service Availability for the month would be 99.9%

For purposes of the foregoing “Scheduled Maintenance” means routine, planned maintenance for the Software as made known to Company in advance.

If Prevail does not meet the Availability for a given month, then Prevail will provide a credit (each, a “Service Credit”) to Company equal to the percentages as set forth in the table below of the prior one (1) month’s Subscription Fees paid to Prevail for the impacted Software: Such Service Credits, if applicable, will be applied to any monies owed by Company in the following month or if no such monies are owed, then Prevail shall refund the amount of the Service Credit to Company.

(b) Priority Level Definitions:

(i) Critical: defined as any problem that completely prevents the operation of the Software or Services and for which there is no work-around. 


(ii) Priority: defined as any problem that substantially restricts the operations of the Software or Services for which there is no alternative solution or work- around.

(iii) General: defined as any problem that does not substantially restrict the operations of the Software or Services or any other error for which there is an alternative solution or work-around. 


The Initial Response Times in the above chart commence from the time Company first notifies Prevail of the problem or failure, while the other times commence from the earlier of first notification by Company of the problem or failure or Prevail otherwise becoming aware of the problem or failure.

In the event that (a) Prevail fails to meet the same Service Level in each of three consecutive months, or (b) Prevail fails to meet any Service Levels in any of four months within a six month rolling period, then Company may terminate this Agreement for material breach, and Prevail shall not have any right to cure such breach.

If Prevail becomes aware of any unlawful access to any Company Data stored by and/or on behalf of Prevail, or unauthorized access to such equipment or facilities resulting in loss, disclosure, or alteration of Company Data (“Security Incident”), Prevail will promptly (1) notify Company of the Security Incident; (2) investigate the Security Incident and provide Company with detailed information about the Security Incident; and (3) promptly take reasonable steps to mitigate the effects and to minimize any damage resulting from the Security Incident. Prevail shall cooperate fully with Company, with its authorized agent and with any regulatory agency and/or any law enforcement agency in the investigation and remediation of such Security Incident. All notices and communications to Company relating to a suspected, alleged, or actual Security Incident shall be the Confidential Information of Company.

Company shall:

Company shall pay the Fees to Prevail for the Services and Software in accordance with the executed SOW(s).

For the purposes herein, “Confidential Information” shall mean any non-public information relating to the business, operations and, more generally, any activities of a Party, whether or not marked or identified as confidential or proprietary, which the receiving Party should reasonably understand to be confidential information under the circumstances, including know-how, trade secret and, in the case of Company, Company Data and Study Inventions.

Each Party shall (i) maintain the confidentiality of the other Party’s Confidential Information, using, at a minimum, the same safeguards afforded its own confidential, proprietary trade secrets, but in no event no less than reasonable care; (ii) use the other Party’s Confidential Information only to the extent required for the performance of this Agreement; (iii) restrict disclosure and access to the other Party’s Confidential Information only to its employees, suppliers, permitted subcontractors, advisors and consultants who have a need to know for the performance of this Agreement, provided that they are bound by confidentiality and restricted use obligations no less restrictive than those contained herein; and (iv) not disclose, provide, transfer, rent, sublicense, or otherwise make available any portion of the other Party’s Confidential Information to any third party except as permitted under (iii) above. The non-disclosure and restricted use obligations shall not apply to information which receiving Party can prove through competent proof (i) is now or hereafter known to the public through no fault of the receiving Party, (ii) was in the possession of the receiving Party prior to disclosure by the disclosing Party, (iii) has been properly obtained without restriction from a third party who is not bound by an obligation of confidentiality, (iv) is independently developed by receiving Party without reference to, use of or reliance upon the disclosing Party’s Confidential Information or (v) information disclosed by court order or as otherwise required by law or regulation, provided that the Party required to disclose the information provides prompt advance notice to enable the other Party to seek a protective order or otherwise to prevent such disclosure. The obligations in this article 11 shall continue indefinitely after the expiration or termination of this Agreement.

Each Party shall maintain in effect during the Term of this Agreement adequate forms and levels of insurance as may reasonably be expected by a going concern in the jurisdictions in which it conducts business.

and the Initial Term together with any subsequent Renewal Periods shall constitute the Term.

This agreement, and any documents referred to in it, constitute the whole agreement between the parties and supersede any previous arrangement, understanding or agreement between them relating to the subject matter they cover.

This Agreement (including its SOWs) may be executed in any number of counterparts, all of which together shall constitute a single document. This Agreement and its SOWs may be executed by facsimile or digital file showing a Party’s signature (e.g., a .pdf). Such facsimile or digital file shall be deemed an original and fully enforceable and admissible in any legal proceeding.

No supplement or modification of this Agreement shall be binding unless executed in writing by both parties.

Neither Party shall, without the prior written consent of the other Party, assign, transfer, charge, or sub-contract all or any of its rights or obligations under this Agreement; provided that either Party may assign its rights and delegate its duties under this Agreement, in whole or in part, to an affiliate or to a successor to such Party’s business by merger, acquisition, purchase of the business related to this Agreement or other similar corporate transaction.

This Agreement shall be governed by the laws of the Commonwealth of Pennsylvania, U.S.A. without regard to the conflicts of law provisions thereof.

Any notice required to be given under this Agreement shall be in writing and shall be delivered by hand or overnight delivery to the other Party at its address set out in this Agreement, or such other address as may have been notified by that Party for such purposes.

This Agreement has been entered into on the date stated at the beginning of it.