Document:

ex_405687.htm

Exhibit 10.4

 

 

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT BOTH (I) IS NOT MATERIAL AND (II) IS THE TYPE OF INFORMATION THE ISSUER BOTH CUSTOMARILY AND ACTUALLY TREATS AS PRIVATE AND CONFIDENTIAL. SUCH EXCLUDED INFORMATION HAS BEEN MARKED WITH “[***]”

 

PRE-CHALLENGE STUDY SERVICES AGREEMENT

 

THIS PRE-CHALLENGE STUDY SERVICES 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, 42 New Road, London El 2AX, UK (“hVIVO” and Vaxart, Inc., a company incorporated in Delaware, USA, whose principle place of business is at 170 Harbor Way, Suite 300, South San Francisco, CA 94080, USA (“Vaxart”).

 

hVIVO and Vaxart are each referred to herein as a “Party” and collectively as the “Parties”. WHEREAS:

 

Prior to execution of a full Clinical Trial Agreement (the “CTA”) in respect of the Challenge Study (as defined below), the Parties wish to agree to terms pertaining to the manufacture of the Challenge Agent, performance of the Characterization Study and carrying out start-up activities in preparation for performance of the Challenge Study.

 

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.    Defined Terms.

 

	 	
			1.1

				
			“Challenge Agent” means SARS CoV2 Variant Omicron BA.2 virus or a later variant as may be agreed between the Parties.

			

 

	 	
			1.2

				
			“Challenge Study” means exposing vaccinated subjects to the challenge agent in a controlled setting at a known dose, then observing for up to 14 days in quarantine, and as more fully defined in Exhibit Band subsequent mutual documents that relate to the conduct of the study.

			

 

	 	
			1.3

				
			“Characterization Study” means a challenge agent dose-titration study to identify the proper dose of challenge agent to achieve the infectivity goal in subjects.

			

 

	 	
			1.4

				
			“IMP” means Vaxart’s investigational medicinal product that is expected to be the subject of the Challenge Study.

			

 

	 	
			1.5

				
			“Quarantine Facility” means hVIVO’s quarantine facility located at [***].

			

 

2.    Services.

 

	 	
			2.1

				
			Manufacturing Services.

			

 

	 	
			(a)

				
			hVIVO shall manufacture, or procure from a third party, a quantity of Challenge Agent sufficient to challenge at least [***] in the Challenge Study targeting a viral attack rate of between [***]. The Challenge Agent shall be manufactured and released in accordance with all applicable laws and regulations, including standards for current good manufacturing practices (GMP) applicable in the jurisdictions where Challenge Agent is manufactured and administered.

			

 

	 	
			(b)

				
			Vaxart acknowledges that: (i) as between Vaxart and hVIVO, hVIVO shall retain the ownership of all rights, title and interest in or to the Challenge Agent and (ii) hVIVO will manufacture and supply Challenge Agent for use in the Characterization Study and the Challenge Study on a non-exclusive basis. Nothing in this Agreement grants to Vaxart any express or implied license or other rights, title and interest in or to the Challenge Agent.

			

 

	 	
			(c)

				
			Upon completion of Agent Manufacture activities, (hVIVO shall seek approval from the UK governing body (UK Health and Safety Executive (HSE)) and, where applicable, other relevant bodies to perform human viral challenge studies with the Challenge Agent within the Quarantine Facility. hVIVO shall use commercially reasonable efforts to obtain such approval(s) and all other licenses, approvals and certifications necessary to perform the Characterization Study (the “Required Approvals” by [***] or as soon thereafter as is practicable.

			

 

 

 

 

 

	 	
			2.2

				
			Characterization Study.

			

 

	 	
			(a)

				
			Within 30 days or as soon thereafter as is practicable (i) after receiving all Required Approvals, and (ii) conditioned upon hVIVO securing at least one (1) additional client to contribute towards the financing of the Characterization Study or if Vaxart has paid the additional amount under Section 6.1, hVIVO shall commence the Characterization Study in accordance with this Agreement. hVIVO shall act as the sponsor of the Characterization Study. All participants in the Characterization Study shall be previously vaccinated, serosuitable, healthy volunteers.

			

 

	 	
			(b)

				
			Upon completion of Characterization Study, and in any event within 90 days after the last study subject is discharged, hVIVO will prepare and deliver to Vaxart an interim study report. hVIVO shall provide a final study report when all data is available

			

 

	 	
			(c)

				
			For the purposes of this Agreement, the Characterization Study will be deemed a “Successful Characterization Study” if the Characterization Study demonstrates a sufficient incidence of infection in inoculated subjects along with sufficient viral shedding and/or induced symptoms to make the conduct of the Challenge Study feasible both from a practical and financial perspective as jointly determined by the parties.

			

 

	 	
			(d)

				
			Authorship of any publications relating to the Characterization Study shall be determined in accordance with standard scientific convention. If hVIVO elects to publish or present the results of the Characterization Study, hVIVO shall acknowledge Vaxart’s financial contributions to the Characterization Study.

			

 

	 	
			2.3

				
			Challenge Study Start-Up Activities. hVIVO shall perform start-up activities in respect of the Challenge Study (“Start-up Activities”), including (i) the activities set forth in Exhibit A to this Agreement and (ii) consulting with Vaxart and providing Vaxart access to hVIVO’s expertise, know-how and proprietary information relating to the hVIVO platform (collectively, “hVIVO Background Materials”) to enable Vaxart to prepare documents and materials necessary for the conduct of the Challenge Study. Vaxart shall use the hVIVO Background Materials solely in connection with Challenge Study.

			

 

	 	
			(a)

				
			hVIVO shall commence the Start-up Activities no later than [***]. If, after commencing the Start-up Activities, hVIVO determines in good faith, in consultation with Vaxart, that the Characterization Study is not a Successful Characterization Study, hVIVO shall terminate the Start-up Activities once so determined and Vaxart shall reimburse hVIVO for all costs and/or expenses for such activities incurred by hVIVO up to the date of termination.

			

 

	 	
			(b)

				
			Notwithstanding anything to the contrary in this Section 2.3, 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) Vaxart ship any IMP to hVIVO; or (iii) hVIVO perform study-specific screening or any subject intervention other than required for basic generic screening assessments.

			

 

	 	
			(c)

				
			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 Act 1998; {ii) the Data Protection Act 2018; (iii) the Medicines Act 1968 (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’.

			

 

3.    Performance Standards.

 

	 	
			3.1

				
			hVIVO shall perform the Services in a diligent and professional manner in accordance with all applicable laws and regulations.

			

 

	 	
			3.2

				
			hVIVO shall keep Vaxart reasonably advised of the status of the Services. hVIVO will be available for consultation (in person, by telephone or otherwise) with Vaxart as to hVIVO’s progress in performing the Services and the results thereof and will provide written progress reports to Vaxart from time to time as reasonably requested by Vaxart.

			

 

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4.    Negotiation of the CTA. It is the intent of Vaxart and hVIVO to enter into negotiations, in good faith, to agree to the terms of a CTA to cover the full scope for the Challenge Study on such terms as each of the Parties, in their sole discretion, may agree and based on the CTA template attached as Exhibit D to this Agreement. Each Party agrees to use good faith and commercially reasonable efforts to execute the CTA no later than by [***] ( 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 on the terms of the CTA, then (i) this Agreement shall terminate in which case, provided that hVIVO is unable to use Vaxart’s Reservation for another client, then Vaxart shall owe hVIVO for all start up activities plus a cancellation fee of [***] GBP representing [***] of the Booking Fee (as defined in Section 6.4 herein); or (ii) if requested by either Party, the CTA Signature Date shall be postponed 30 days to allow for continued negotiations with respect to the CTA. The payment of a cancellation fee under this Section of this Agreement shall void any cancellation fee owed under Section 5.2.2 of this Agreement. 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.

 

5.    Challenge Study Slot Reservation.

 

	 	
			5.1

				
			Reservation. Vaxart wishes to reserve space in the Quarantine Facility for the quarantine phase of the Challenge Study (the “Reservation”). The Reservation will commence on the Quarantine Start Date (as defined below) (the “Quarantine Bed Days”). For purposes of this Agreement, “Quarantine Start Date” means the date on which the quarantine phase of the Challenge Study is expected to commence. Vaxart shall select a date as the Quarantine Start Date and provide written notice thereof to hVIVO on or before [***]. Unless otherwise agreed by hVIVO in writing, the Quarantine Start Date shall be no earlier than [***] and no later than [***].

			

 

	 	
			5.2

				
			Changes to the Reservation. Vaxart may change the Quarantine Start Date, reduce the number of Quarantine Bed Days or cancel the Reservation, subject to the provisions of this Agreement. Upon written notice to hVIVO, Vaxart may change the Quarantine Start Date, without penalty, (a) to a date that is up to 30 days before or after the originally scheduled Quarantine Start Date or (b) as reasonably necessary to meet the requirements of any applicable regulatory authority or Ethics Committee (EC) (any such change, a “Permitted Change”). In the event Vaxart should, for any reason, (i) change the Quarantine Start Date, other than a Permitted Change, and reschedule the Challenge Study to commence within one year after the original Quarantine Start Date (a “Postponement”); or (ii) cancel the Reservation (a “Cancellation”), then, subject to Section 5.3:

			

 

	 	
			5.2.1

				
			Cost Reimbursement. Vaxart 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, Vaxart shall pay any applicable charges described in Sections 5.2.2 herein.

			

 

	 	
			5.2.2

				
			(a) Cancellation. In the event of a Cancellation, a cancellation fee equating to value of the cancelled Quarantine Bed Days shall become due as follows:

			

 

	
			Period between Notice of Cancellation and Reserved Quarantine Start Date

				
			Amount of Cancellation Fee

			
	
			Less than 5 months

				
			[***]

			
	
			More than 5 months but less than 12 months

				
			[***]

			
	
			More than 12 months

				
			[***]

			

 

hVIVO shall retain the appropriate proportion of the Booking Fee as payment of the cancellation fee.

 

In the event of a Cancellation Without Cause by hVIVO, hVIVO shall, upon Sponsor’s request, provide to Sponsor the protocol for the Challenge Study and, at Sponsor’s cost, adequate supply of Challenge Agent for the Challenge Study contracted by Sponsor within the United Kingdom. for the purpose of this section, “Cancellation Without Cause” means (i) cancellation that is not due to a material breach by Vaxart of this Agreement under Section 10, or (ii) cancelation that is not due to Unsuccessful Characterization Study under Section 2.3 (b).

 

	 	
			(b)

				
			Postponement. In the event of a Postponement, a postponement fee equating to [***] become due. The postponement fee will be invoiced by hVIVO upon the re-scheduling of the Quarantine Start Date. The Booking Fee shall continue in effect in relation to the rescheduled Reservation. For the avoidance of doubt, (i) the Quarantine Start Date shall be deemed re-scheduled when the Parties have agreed in writing upon a new Quarantine Start Date; (ii} if the reserved Quarantine Start Date is not, within [***] of Postponement, re-scheduled to commence at a date that is [***] the original Quarantine Start Date, such re-scheduling shall be deemed to be a Cancellation and the provisions of Clause 5.2.2(a) shall apply.

			

 

No postponement fee shall be payable if the Quarantine Start Date is rescheduled to an earlier available date in hVIVO’s schedule.

 

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			5.3

				
			Waiver of Fees: Mitigation. If there is a Postponement or Cancellation, hVIVO shall use best efforts to allocate quarantine capacity made available as a result thereof to other customers of hVIVO and to otherwise mitigate hVIVO’s losses in relation to such Postponement, Scope Reduction, or Cancellation. To the extent quarantine capacity is reallocated or hVIVO’s losses are otherwise mitigated, hVIVO shall provide notice thereof to Vaxart and the fees payable by Vaxart pursuant to Section 5.2 shall be reduced by a corresponding amount. In addition, in connection with any Postponement, or Cancellation, 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 Section 5.2.

			

 

6.    Project Fees and Costs.

 

	 	
			6.1

				
			Services. Upon execution of this Agreement, hVIVO shall invoice Vaxart the amount of [***] as its contribution towards hVIVO’s cost of the manufacturing & characterisation [***] (the “Initial Payment”}. The Initial Payment shall be non-refundable. Upon such payment, the parties agree that hVIVO shall make diligent efforts to contract with a second client for similar support of the characterization study as well as a separate challenge study. Any additional client shall not impact Vaxart’s timelines for the Challenge Study booking reservations. In the event that hVIVO is unable to secure at least one additional client as per Section 2.2.(a), then Vaxart shall have the option to pay hVIVO an additional [***] towards completion of the Characterisation Study [***] (“Additional Payment”). Said Additional Payment shall be invoiced once regulatory submission for the Characterization Study occurs. If hVIVO subsequently signs a second client for a contribution towards the Characterisation Study [***].

			

 

	 	
			6.2

				
			Challenge Study. The total estimated fee for the Challenge Study is [***] (based on the table of Assumptions attached as Exhibit B to this Agreement and the Roles & Responsibilities table attached as Exhibit C to this Agreement) (“Challenge Study Fee”). Any changes in the Assumptions or Roles and Responsibilities may result in a change of this budget. [***].

			

 

	 	
			6.3

				
			Upon commencement of the Start-up Activities, hVIVO shall invoice Vaxart an amount of [***] (the “Startup Fee Deposit”), in consideration of hVIVO allowing Vaxart to access hVIVO’s expertise, know-how and proprietary information. The Fee Deposit paid under this Agreement is fully reconcilable against the final agreed budget in the CTA and shall 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 the Start-up Activities prior to hVIVO’s receipt of the Fee Deposit.

			

 

	 	
			6.4

				
			If the Characterization Study is a Successful Characterization Study, hVIVO shall invoice Vaxart [***] in respect of the Reservation (the “Booking Fee”). Except as provided in Section 5.2, the Booking Fee shall be credited against payments due under the CTA.

			

 

7.    Invoicing. Invoices from hVIVO shall be sent to Vaxart by email to [***]. Except in the event of a good faith dispute, all payments under this Agreement are payable [***] after Vaxart’s receipt of hVIVO’s invoice. The Parties agree to work together in good faith to promptly and reasonably resolve any disputed invoices.

 

8.    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 Vaxart, and Vaxart will pay such applicable taxes to hVIVO in addition to the amounts specified under this Agreement.

 

9.    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 or, if later, completion of the Characterization Study; (ii) cancellation of the Reservation; or (iii) the termination of this Agreement pursuant to Section 10 of this Agreement.

 

 

10.    Termination. This Agreement may be terminated (i) by Vaxart, without cause, upon the provision of [***] prior written notice to hVIVO; or (ii) by hVIVO subject to Section 2.3(b), and (iii) 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 [***] receiving notice in writing to do so.

 

In the event of termination by Vaxart, for any reason other than as a result of hVIVO’s material breach, such termination shall be considered a Cancellation of the Reservation and the provisions of Sections 5.2 shall apply. Upon termination, 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 4; (b) hVIVO’s fees for services completed; and (c) any non-cancellable costs and expenses reasonably incurred prior to the date of termination.

 

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Within [***] of agreement the statement of account, hVIVO shall invoice or refund the outstanding balance, as appropriate.

 

Sections 10, 11, 12, 13, 14, 15, 16, 17, 18 and 19 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.

 

11.    Regulatory Audit. hVIVO shall cooperate with any request by any regulatory authority for an audit or inspection related to the Characterization Study or the Challenge Study and if such regulatory audit or inspection are in connection with the Start-up Activities, hVIVO shall notify Vaxart in writing within twenty-four (24) hours of such request. hVIVO shall keep Vaxart fully informed of the progress of any such relevant inspection, investigation or examination by the regulatory authority and shall inform Vaxart 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 the Characterization Study or the Challenge Study. Unless prohibited by the applicable regulatory authority, Vaxart may be present on site for any such inspection, investigation or examination in Vaxart’s sole discretion.

 

12.    Confidential Information. In this Agreement, Vaxart’s Confidential Information shall include the IMP (including any information relating to the IMP that is provided to or otherwise obtained by hVIVO), and all other material, data, know-how and information which is disclosed or provided by the Vaxart 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 Vaxart 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, or directly involved in matters relating to the Characterization Study or the Challenge Study, 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. The receiving Party shall cooperate reasonably with the disclosing Party, at the disclosing Party’s cost, in any effort to obtain a protective order or other relief relating to any such required disclosure. Each Party undertakes not to make use of any Confidential Information of the other Party, other than in accordance with the exercise of rights or 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 Section shall survive termination or expiry of this Agreement.

 

13.    Indemnification; Insurance. hVIVO shall indemnify, defend and hold harmless Vaxart and its affiliates and their respective employees, officers, directors, agents, and representatives against any liability, loss, damage, cost, or expense (including reasonable attorneys’ fees) arising from any third-party claim that arises from or relates to the conduct of the Characterization Study, including, without limitation, any claim arising from personal injury or death suffered by any study subject. hVIVO shall maintain during the term of this Agreement and [***] after termination or expiration of this Agreement, commercial general liability insurance, including contractual liability and product liability or clinical trials liability, with coverage limits of not less than [***] occurrence and in the aggregate. The minimum level of insurance set forth herein shall not be construed to create a limit on hVIVO’s liability hereunder. The Parties shall discuss possible extension of the above cover once a study protocol draft is available and an extended cover can be quoted.

 

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14.    Liability. Except with respect to losses arising from hVIVO’s negligence or intentional misconduct, breach of confidentiality obligations, or indemnification obligations under Section 13, the liability of hVIVO, of whatever nature and howsoever arising, to Vaxart in relation to its performance under this Agreement is limited to the amounts paid to hVIVO by Vaxart under this Agreement.

 

15.    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.

 

16.    Prior Agreements. This Agreement supersedes any prior written agreements previously entered into by and between the Parties.

 

17.    Governing Law. The validity, interpretation and performance of this Agreement shall be governed .by the laws of England and Wales. Any disputes arising under or relating to this agreement, or any breach of this agreement, shall be resolved through arbitration administered under the applicable rules of London court of International Arbitration (LCIA). The arbitral tribunal shall consist of a sole arbitrator to be appointed jointly by the Parties, failing which, a sole arbitrator shall be appointed in accordance with the rules of the LCIA. The venue of such arbitration shall be London, England. The arbitration shall be conducted in English. The arbitral award will be final and binding upon the parties and the prevailing party may apply to a court of competent jurisdiction for enforcement of the award. This clause shall not preclude parties from seeking provisional remedies in aid of arbitration from a court of appropriate jurisdiction

 

18.    Waiver. A delay in exercising or failure to exercise a right or remedy under or in connection with this Agreement will not constitute a waiver of, or prevent or restrict future exercise of, that or any other right or remedy, nor will the single or partial exercise of a right or remedy prevent or restrict the further exercise of that or any other right or remedy. No waiver by a Party of any right, remedy, breach or default of any covenants contained herein shall be deemed a waiver as to any subsequent and/or similar breach or default. A waiver of any right, remedy, breach or default will only be valid if it is in writing and signed by the Party giving it.

 

19.    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.

 

20.    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.

 

IN WITNESS WHEREOF, the Parties hereto have entered into this Agreement by their duly authorized representative as of the Effective Date.

 

	hVIVO Services Ltd	 	Vaxart, Inc.	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	Signature	/s/ Yamin Khan	 	Signature	/s/ Andrei Floroiu	 
	 	 	 	 	 	 
	Name	Yamin Khan	 	Name	Andrei Floroiu	 
	 	 	 	 	 	 
	Title	CEO	 	Title	CEO	 
	 	 	 	 	 	 
	Date	29/06/2022	 	Date	6/28/2022	 

 

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Exhibit A - List of Start-up ServicesDocument

			
	

NATIONAL HEALTH INVESTORS, INC.

Senior Notes Issuable in Series

$50,000,000 3.99% Series 2015-1 Tranche A Senior Note due November 3, 2023

$50,000,000 4.33% Series 2015-1 Tranche B Senior Notes due November 3, 2025

______________

FIRST AMENDMENT TO 
NOTE PURCHASE AGREEMENT DATED NOVEMBER 3, 2015

______________

Dated August 15, 2016

			
	

    

1184649:2:NASHVILLE 

National Health Investors, Inc.
222 Robert Rose Drive
Murfreesboro, TN 37129

$50,000,000 3.99% Series 2015-1 Tranche A Senior Notes due 2023
$50,000,000 4.33% Series 2015-1 Tranche B Senior Notes due 2025

August 15, 2016
To Each of the Purchasers Listed on
    Schedule B Attached to the 
Note Purchase Agreement:

Ladies and Gentlemen:
NATIONAL HEALTH INVESTORS, INC., a Maryland corporation (together with any successor thereto that becomes a party pursuant to the terms of the Note Purchase Agreement (as defined below), the “Company”) agrees with each of the Purchasers party hereto as follows:
STATEMENT OF PURPOSE:
The Company and Purchasers are parties to the Note Purchase Agreement dated as of November 3, 2015 (as amended hereby and as may be further amended, restated, supplemented or otherwise modified from time to time, the “Note Agreement”).
The Company has requested that the Purchasers agree to amend the Note Agreement in certain respects as more specifically set forth herein (this “Amendment”).
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:
1.Capitalized Terms.  All capitalized undefined terms used in this Amendment (including, without limitation, in the introductory paragraph and the statement of purpose hereto) shall have the meanings assigned thereto in the Note Agreement.
2.Amendments to Note Agreement.  
(a)Section 10.2(f) of the Note Agreement is hereby amended and restated to read in its entirety as follows:
“(f)  Investments by the Company or any Subsidiary in any Health Care Facilities (including, for the avoidance of doubt, investments in any Excluded Subsidiary that owns or operates Health Care Facilities as its primary business); provided that, prior to and after giving effect to any such Investment and any Indebtedness incurred in connection therewith, (i) no Default will exist and (ii) the Borrower shall be in compliance, on a Pro Forma Basis, with each financial covenant contained in Section 9.12 hereof; provided further that, prior to the consummation of any such Investment involving aggregate consideration with respect thereto in excess of $25,000,000, the Borrower shall deliver to each holder of a Note a certification, together with financial and other information in detail reasonably requested by the Administrative Agent, (A) certifying that no Default will exist and (B) demonstrating such compliance;”
1184649:2:NASHVILLE 

(b)Schedule A (Defined Terms) of the Note Agreement is hereby amended by adding the following new definitions in proper alphabetical order:
“Shoreline Acquisition” means that certain purchase by Senior Living NHI Purchaser, or its assignee, pursuant to the Shoreline Acquisition Agreement, of a continuing care retirement community consisting of approximately 250 independent and assisted living apartment units and 50 skilled nursing beds located at 88 Notch Hill Road, North Branford, Connecticut, and commonly known as “Evergreen Woods”.”
“Shoreline Acquisition Agreement” means the Purchase Agreement (including all schedules and exhibits thereto), dated as of August 3, 2016, by and among Shoreline Life Care, LLC and Senior Living NHI Purchaser.”
“Shoreline Acquisition Agreement Documents” means, collectively, the Shoreline Acquisition Agreement and all other material documents entered into by any Loan Party in connection with the Shoreline Acquisition.”
“Shoreline Mortgage Lien” means the Lien pursuant to that certain Open-End Mortgage Deed in favor of Bank of New York Mellon Trust Company, N.A., as Successor Trustee to First Interstate Bank of Des Moines, N.A. in the amount of $70,000,000.00 dated and recorded July 25, 1991, as amended, on Real Property acquired in the Shoreline Acquisition.”.
(c)Schedule A (Defined Terms) of the Note Agreement is hereby amended by amending and restating the definition of “Material Credit Facility” to read in its entirety as follows:
“Material Credit Facility” means, as to the Company and its Subsidiaries, (a) the Credit Agreement,  including any renewals, extensions, amendments, supplements, restatements, replacements or refinancing thereof; (b) the Existing Note Agreement, including any renewals, extensions, amendments, supplements, restatements, replacements or refinancing thereof; and (c) any other agreement or series of related agreements creating, evidencing or governing Indebtedness in an aggregate principal amount of $50,000,000 or more incurred after the Closing Date by the Company or any of its Subsidiaries pursuant to Section 10.3(b) or Section 10.3(i) (but excluding (A) Indebtedness incurred after the Closing Date owed to the U.S. Department of Housing and Urban Development (“HUD”), Fannie Mae or a HUD or Fannie Mae qualified lender, in each case, of a type similar to the Indebtedness listed as items 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 16 on Schedule 10.3 and (B) the Indebtedness in respect of the Shoreline Mortgage Lien).”.
3.Conditions to Effectiveness.  Upon the satisfaction of each of the following conditions, this Amendment shall be deemed to be effective (the date of such satisfaction, the “Amendment Effective Date”):
(a)Executed Amendment.  This Amendment shall have been duly authorized, executed and delivered by the Company and the Required Holders.
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(b)No Default or Event of Default.  No Default or Event of Default shall exist under the Note Agreement or any other document entered into in connection with the Note Agreement as of the Amendment Effective Date or would result after giving effect to the transactions contemplated by this Amendment.
(c)Prudential Amendment.  The Purchasers shall have received a fully-executed copy of an amendment to the Existing Note Agreement with respect to the Shoreline Acquisition, in form and substance satisfactory to the Purchasers, certified as true, correct and complete as of the Amendment Effective Date by a Responsible Officer of the Company.
(d)Wells Fargo Amendment.  The Purchasers shall have received a fully-executed copy of an amendment to the Credit Agreement with respect to the Shoreline Acquisition, in form and substance satisfactory to the Purchasers, certified as true, correct and complete as of the Amendment Effective Date by a Responsible Officer of the Company.
(e)Shoreline Acquisition Agreement Documents.  The Purchasers shall have received fully executed copies of the Shoreline Acquisition Agreement Documents, in form and substance satisfactory to the Purchasers, certified as true, correct and complete as of the Amendment Effective Date by a Responsible Officer of the Company.1 
(f)Other Documents.  The Purchasers shall have received copies of all other documents, certificates and instruments reasonably requested thereby with respect to the transactions contemplated by this Amendment.
4.Effect of this Amendment.  Except as expressly provided herein, the Note Agreement and the other documents executed in connection therewith shall remain unmodified and in full force and effect.  Except as expressly set forth herein, this Amendment shall not be deemed (a) to be a waiver of, consent to, or modification or amendment of, any other term or condition of the Note Agreement or any other document executed in connection therewith, (b) to prejudice any other right or rights which the Purchasers may now have or may have in the future under or in connection with the Note Agreement or the other documents executed in connection therewith or any of the instruments or agreements referred to therein, as the same may be amended, restated, supplemented or otherwise modified from time to time, (c) to be a commitment or any other undertaking or expression of any willingness to engage in any further discussion with the Company or any other Person with respect to any waiver, amendment, modification or any other change to the Note Agreement or the documents executed in connection therewith or any rights or remedies arising in favor of the Purchasers, or any of them, under or with respect to any such documents or (d) to be a waiver of, consent to, or modification or amendment of, any other term or condition of any other agreement by and among the parties, on the one hand, and the Purchasers, on the other hand.  References in the Note Agreement to “this Agreement” (and indirect references such as “hereunder”, “hereby”, “herein”, and “hereof”) and in any document executed in connection therewith shall be deemed to be references to the Note Agreement as modified hereby.
5.Representations and Warranties/No Default.  By its execution hereof, the Company hereby certifies, represents and warrants to the Purchasers that:
(a)each of the representations and warranties set forth in the Note Agreement and the other documents executed in connection therewith is true and correct in all material respects as of the date hereof (except to the extent that (i) any such representation or warranty that is qualified by materiality or by reference to Material Adverse Effect, in which case such representation or warranty is true and correct in all respects as of the date hereof or (ii) any such 

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representation or warranty relates only to an earlier date, in which case such representation or warranty shall remain true and correct as of such earlier date) and that no Default or Event of Default has occurred or is continuing or would result after giving effect to this Amendment and the transactions contemplated hereby; 
(b)it has the right, power and authority and has taken all necessary corporate and other action to authorize the execution, delivery and performance of this Amendment, the Shoreline Acquisition Agreement Documents and each other document executed in connection herewith to which it is a party in accordance with their respective terms and the transactions contemplated hereby; and
(c)this Amendment and each other document executed in connection herewith has been duly executed and delivered by an duly authorized officer of the Company, and each such document constitutes the legal, valid and binding obligation of the Company, enforceable in accordance with its terms, except as may be limited by bankruptcy, insolvency, reorganization, moratorium or similar state or federal debtor relief laws from time to time in effect which affect the enforcement of creditors’ rights in general and the availability of equitable remedies.
6.Governing Law.  THIS AMENDMENT SHALL BE GOVERNED BY, CONSTRUED AND ENFORCED IN ACCORDANCE WITH, THE LAW OF THE STATE OF NEW YORK.
7.Counterparts.  This Amendment may be executed by one or more of the parties hereto in any number of separate counterparts and all of said counterparts taken together shall be deemed to constitute one and the same instrument.
8.Electronic Transmission.  A facsimile, telecopy, pdf or other reproduction of this Amendment may be executed by one or more parties hereto, and an executed copy of this Amendment may be delivered by one or more parties hereto by facsimile or similar instantaneous electronic transmission device pursuant to which the signature of or on behalf of such party can be seen, and such execution and delivery shall be considered valid, binding and effective for all purposes.  At the request of any party hereto, all parties hereto agree to execute an original of this Amendment as well as any facsimile, telecopy, pdf or other reproduction hereof.
[Signature Pages Follow]
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IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed as of the date and year first above written.
COMPANY:
NATIONAL HEALTH INVESTORS, INC., 
a Maryland corporation

By:      /s/ Eric Mendelsohn            
        Eric Mendelsohn, 
        President and Chief Executive Officer

PURCHASERS:
AMERICAN GENERAL LIFE INSURANCE COMPANY
THE UNITED STATES LIFE INSURANCE COMPANY IN THE CITY OF NEW YORK
THE VARIABLE ANNUITY LIFE
INSURANCE COMPANY AMERICAN HOME ASSURANCE
COMPANY
LEXINGTON INSURANCE COMPANY NATIONAL UNION FIRE INSURANCE
COMPANY OF PITTSBURGH, PA UNITED GUARANTY RESIDENTIAL
INSURANCE COMPANY
UNITED GUARANTY MORTGAGE INDEMNITY COMPANY

By:  AIG Asset Management (U.S.) LLC, 
        Investment Adviser

By:       /s/ Bryan W. Eells            
Name: Bryan W. Eells        
Title:      Vice President                
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