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| CONFIDENTIAL | SUBJECT TO CONTRACT |
Exhibit 10.1
Reservation and Start-up Agreement
THIS RESERVATION AND START-UP AGREEMENT (“Agreement”), effective as of the date of execution by the last party to sign below (the “Effective Date”) is by and between hVIVO Services Limited, a company registered in England (company registration number 02326557) whose registered office is at QMB Innovation Centre, 00 Xxx Xxxx, Xxxxxx X0 0XX, XX (“hVIVO”) and AIM ImmunoTech Inc., a company incorporated in Delaware, USA, whose registered office or principle place of business is at 0000 XX Xxxxxxx 000 Xxxxx, XX 00000, XXX (“Sponsor”).
hVIVO and Sponsor are each referred to herein as a “Party” and collectively as the “Parties”.
WHEREAS:
hVIVO has provided Sponsor with a proposal dated 8 July 2021 (the “Proposal”) in relation to Sponsor’s Ampligen HRV and Influenza human viral challenge study (the “Study”).
WHEREAS:
Prior to execution of a full Clinical Trial Agreement (the “CTA”), Sponsor wishes to (i) reserve space in hVIVO’s quarantine facility for the quarantine phase of the Study (the “Reserved Quarantine Bed Days”) to commence in November 2021 (“Quarantine Start Date”). Together, the Quarantine Start Date and the Reserved Quarantine Bed Days are referred to as the “Reservation”; and (ii) access hVIVO’s expertise, know-how and proprietary information relating to the hVIVO platform in order to undertake certain start-up activities.
NOW, THEREFORE, in consideration of the premises and the mutual covenants herein contained, the adequacy and sufficiency of which is hereby acknowledged, the Parties agree as follows:
1. Booking Fee. Upon signature of this Agreement and in consideration of the Reservation, Sponsor shall pay hVIVO 50% of the booking fee £317,152 GBP and the remaining 50% (£317,152 GBP) due on signing of the CTA, total of £634,304 GBP (the “Booking Fee”), equating to the value of the Quarantine Bed Days stated in the Proposal.
If no changes to the Reservation occur, the Booking Fee will be credited against payments due under the CTA.
2. Negotiation of CTA. It is the intent of Sponsor and hVIVO to enter into negotiations, in good faith, to agree to the terms of a CTA to cover the full scope and budget for the Study on such terms as each of the Parties, in their sole discretion, may agree. Each Party agrees to use commercially reasonable efforts to execute the CTA by 01 Sept 2021 (“the CTA Signature Date”). Subject to the Parties’ obligation to negotiate in good faith, in the event that the CTA is not signed by the CTA Signature Date or the Parties are unable to agree the terms of the CTA, then (i) this Agreement shall terminate, such termination will be considered a Cancellation and the provisions of Sections 3.1 and 3.2 shall apply; or (ii) hVIVO may, at its sole discretion, extend the CTA Signature Date. Neither this Agreement nor the performance by the Parties of any obligations arising from this Agreement, shall bind either Party to enter into the CTA.
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For the avoidance of doubt, it is hereby agreed that with the exception of budget changes required due to changes in study assumptions (as currently agreed as per the proposal attached to this Agreement as Appendix A), the final budget to be negotiated under the CTA shall not exceed more than 5% of the agreed budget under this Agreement.
3. Changes to the Reservation. Sponsor may change the Quarantine Start Date, reduce the number of Quarantine Bed Days or cancel the Reservation, subject to the provisions of this Agreement. In the event Sponsor should, for any reason, (i) change the Quarantine Start Date and reschedule the Study to commence at a later date within one year of the original Quarantine Start Date (a “Postponement”); (ii) reduce the number of Quarantine Bed Days by greater than or equal to 10% (a “Scope Reduction”); or (iii) cancel the Reservation (a “Cancellation”):
3.1 Cost Reimbursement. Sponsor shall reimburse hVIVO for all costs and/or expenses incurred by hVIVO as a direct result of the Postponement, Scope Reduction or Cancellation. In addition, Sponsor shall pay any applicable charges described in Sections 3.2 and 3.3 herein
3.2 Cancellation and/or Scope Reduction. [***]
3.3 Postponement. [***]
3.4 Waiver of Cancellation, Postponement Fees. hVIVO shall assess such Postponement or Cancellation with respect to (i) the timing of event; and (ii) the impact on hVIVO’s business (as determined solely by hVIVO) and may at its sole discretion, choose to waive part or all of the cancellation or postponement fees due under sections 3.2 and 3.3 herein.
4. Start-up Activities and Fee Deposit. Upon execution of this Agreement, hVIVO shall invoice Sponsor for the amount of £184,928 GBP (the “Fee Deposit”), in consideration of (i) hVIVO allowing Sponsor to access hVIVO’s expertise, know-how and proprietary information; (ii) hVIVO’s performance of certain start-up activities in relation to the Study prior to signature of the CTA. Sponsor shall use hVIVO’s expertise, know-how, proprietary information relating to the hVIVO platform solely to prepare documents and materials necessary for the conduct of the Study, and for no other use. The Fee Deposit paid under this Agreement is fully reconcilable against the final agreed budget in the CTA and will be credited against the payments due under the CTA. For the avoidance of doubt, hVIVO shall be under no obligation to provide any access to its expertise, know-how or proprietary information; or to conduct any start-up activities prior to hVIVO’s receipt of the Fee Deposit.
Notwithstanding the foregoing, prior to the execution of the CTA, under no circumstances will (i) hVIVO perform site activation or any services beyond the point of site activation; (ii) Sponsor ship any IMP to hVIVO; or (iii) hVIVO perform study specific screening or any subject intervention.
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Any start-up activities conducted by hVIVO shall be conducted in accordance with this Agreement and in accordance with all applicable laws, rules and regulations, including, without limitation; (i) the Human Rights Xxx 0000; (ii) the Data Protection Xxx 0000; (iii) the Medicines Xxx 0000 (including all subsequent amendments); (iv) the Medicines for Human Use (Clinical Trial) Regulations 2004; and (v) all relevant guidance relating to medicines and clinical trials from time to time in force including, but not limited to; (a) the ICH GCP; and (b) the World Medical Association Declaration of Helsinki entitled ‘Ethical Principles for Medical Research Involving Human Subjects’.
5. Invoicing. Invoices from hVIVO shall be sent to Sponsor by email to [***]. The Booking Fee is payable upon Sponsor’s receipt of hVIVO’s invoice. All other invoices shall be payable within thirty (30) days from the date of hVIVO’s invoice. The Parties agree to work together in good faith to promptly and reasonably resolve any disputed invoices.
Payment shall be made in British pounds sterling by BACS payable to hVIVO Services Limited to the following bank account:
[***]
6. Term. The term of this Agreement shall commence as of the Effective Date and shall end upon the earlier of (i) the date of execution of the CTA; (ii) cancellation of the Reservation; or (iii) the termination of this Agreement pursuant to Section 7 of this Agreement.
7. Termination. This Agreement may be terminated (i) by Sponsor, without cause, upon the provision of at least ten (10) business days’ prior written notice to hVIVO; or (ii) by either Party if the other Party commits a material breach of this Agreement, and where such breach is capable of remedy, fails to remedy such breach within twenty-eight (28) days of receiving notice in writing to do so.
[***] hVIVO shall cease any start up activities and, as soon as is reasonably practicable, issue a statement of account detailing the balance of the Fee Deposit and Booking Fee less (a) any cancellation charges and other charges due pursuant to Section 3; (b) hVIVO’s fees for Services completed; and (c) any non-cancellable costs and expenses reasonably incurred prior to the date of termination.
Within thirty (30) days of agreement of the statement of account, hVIVO shall invoice or refund the outstanding balance, as appropriate.
Clauses 7, 8, 9, 10, 11, 12, 14, 15 and 16 shall survive any termination or expiry of this Agreement.
Termination of this Agreement shall not relieve either Party from any obligation accrued hereunder prior to such termination.
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8. Regulatory Audit. hVIVO shall cooperate with any request by any regulatory authority for an audit or inspection related to the Study and shall notify Sponsor in writing within twenty-four (24) hours of such request. hVIVO shall keep Sponsor fully informed of the progress of any inspection, investigation or examination by the regulatory authority and shall inform Sponsor of the results of such inspection, investigation or examination, to the extent the result directly concerns or affects the past or future performance by hVIVO of a Study.
9. Confidential Information. In this Agreement, Sponsor’s Confidential Information shall include the study drug (including any information relating to the study drug provided to hVIVO), and all other materials and information provided by the Sponsor to hVIVO on or after the Effective Date.
In this Agreement, hVIVO’s Confidential Information shall include any and all material, data, know-how and information which is disclosed by hVIVO to the Sponsor on or after the Effective Date, including but not limited to technology, intellectual property, patented, patent pending and unpatented improvements and inventions, trade secrets, financial information, business plans, marketing data, the existence, scope and activities of its research, development, manufacturing, marketing or other projects and any other information related to hVIVO’s business and viral challenge model.
Each Party shall ensure that only those of their personnel directly concerned with carrying out each Party’s obligations under this Agreement shall have access to the Confidential Information of the other Party. Each Party undertakes to treat as strictly confidential and not to disclose to any third party any Confidential Information of the other Party, save where disclosure is required by a regulatory authority or by law or allowed under this Agreement. In the event that a receiving Party is required by a Regulatory Authority or by law to disclose Confidential Information of the disclosing Party, the receiving Party shall within a reasonable period of time after being made aware of the disclosure requirement, inform the disclosing Party of (i) the requirement for said disclosure; and (ii) the information that is required to be disclosed. Each Party undertakes not to make use of any Confidential Information of the other Party, other than in accordance with the performance of obligations under this Agreement, without the prior written consent of the other Party.
The obligations of confidentiality herein shall not apply to Confidential Information of a disclosing Party which is: (i) published or becomes generally available to the public other than as a result of a breach of the undertakings hereunder by the receiving Party; (ii) prior to its receipt, in the possession of the receiving Party without any obligations of confidentiality or restrictions on its use as evidenced by contemporaneous written evidence; (iii) independently developed by or on behalf of the receiving Party by individuals that do not have any knowledge of the information and/or materials of the disclosing Party; or (iv) obtained by the receiving Party from a third party not subject to a duty of confidentiality to the disclosing Party.
This Clause shall survive termination or expiry of this Agreement.
10. Liability. The liability of hVIVO, of whatever nature and howsoever arising, to Sponsor in relation to its performance under this Agreement is limited to the amount of the fees received by hVIVO from Sponsor under this Agreement.
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11. Entire Agreement. This Agreement constitutes the entire agreement and understanding of the Parties with respect to the subject matter hereof and the Parties (i) acknowledge that by entering into this Agreement they do not rely on any statement, representation (other than a fraudulent misrepresentation), warranty, course of dealing, custom or understanding except for those expressly set out in this Agreement; and (ii) irrevocably an unconditionally waive any rights and/or remedies they may have to the fullest extent permitted by law (including the right to claim damages and/or to rescind this Agreement) in respect of any misrepresentation other than a misrepresentation which is expressly set out in this Agreement or a misrepresentation which was made fraudulently.
12. Prior Agreements. This Agreement supersedes any prior written agreements previously entered into by and between the Parties.
13. VAT and Tax. All sums in this Agreement are exclusive of value added tax (VAT) or any other sales tax or duties which are applicable. hVIVO will include any such applicable taxes on its invoices to Sponsor, and Sponsor will pay such applicable taxes to hVIVO in addition to the amounts specified under this Agreement.
14. Governing Law. The validity, interpretation and performance of this Agreement shall be governed by the laws of England and Wales. The Parties submit solely for the purpose of this agreement to the exclusive jurisdictions of the English Courts.
15. Waiver. No waiver by the Parties of any breach or default of any covenants contained herein shall be deemed a waiver as to any subsequent and/or similar breach or default.
16. Severability. If any provision of the Agreement is held to be invalid, void or unenforceable, such provision shall be deemed to be restated to reflect as nearly as possible the original intention of the Parties in accordance with applicable law, and the remaining provisions of this Agreement shall remain in full force and effect.
17. Counterparts/Delivery of Signatures. This Agreement shall not be effective until signed by a duly authorized representative of each Party. This Agreement may be executed and delivered by facsimile or electronically transmitted signature and/or in any number of counterparts, all of which together shall constitute one and the same instrument. If this Agreement is executed in counterparts, it shall not be effective unless and until each Party has executed a counterpart.
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IN WITNESS WHEREOF, the Parties hereto have entered into this Agreement by their duly authorized representative as of the Effective Date.
| hVIVO Services Ltd | AIM ImmunoTech Inc. | |||
| Signature | /s/Xxxx Xxxxxx | Signature | /s/ Xxxxx X. Xxxxxx | |
| Name | Xxxx Xxxxxx | Name | Xxxxx X. Xxxxxx, III | |
| Title | Head of Legal | Title | General Counsel & COO | |
| Date | 08 July 2021 | Date | 08 July 2021 | |
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