Document:

Exhibit

Exhibit 4.2
Second Supplemental Indenture

 
 

SECOND SUPPLEMENTAL INDENTURE 
between 
AXOS FINANCIAL, INC.  
AND 
U.S.  BANK NATIONAL ASSOCIATION 
DATED AS OF September 18, 2020 
 
 
 

SECOND SUPPLEMENTAL INDENTURE, dated as of September 18, 2020 (this “Second Supplemental Indenture”), by and between AXOS FINANCIAL, INC. (formerly known as BofI Holding, Inc.), a Delaware corporation (the “Company”), and U.S.  BANK NATIONAL ASSOCIATION, a national banking association, as Trustee (the “Trustee”).  
RECITALS 
WHEREAS, the Company and the Trustee have entered into an Indenture dated as of March 3, 2016 (the “Base Indenture” and, as supplemented by this Second Supplemental Indenture, the “Indenture”), providing for the issuance by the Company from time to time of a series of its subordinated debt securities; 
WHEREAS, Section 9.1(7) of the Base Indenture provides that the Company and the Trustee may, without the consent of any Holder, enter into a supplemental indenture to establish the form or terms of Securities of any series as permitted by Section 2.1 and Section 3.1 thereof; 
WHEREAS, the Company desires to provide for the establishment of a new series of Securities pursuant to Section 2.1 and Section 3.1 of the Base Indenture, the form and substance of such Securities and terms, provisions and conditions thereof to be set forth as provided in the Indenture; 
WHEREAS, the execution and delivery of this Second Supplemental Indenture has been authorized by a resolution of the Board of Directors of the Company; 
WHEREAS, the Company has requested that the Trustee execute and deliver this Second Supplemental Indenture and satisfy all requirements necessary to make this Second Supplemental Indenture a valid, legal and binding instrument in accordance with its terms, and to make the Notes (as defined herein), when executed by the Company and authenticated and delivered by the Trustee, the valid, legal and binding obligations of the Company; and 
WHEREAS, all acts and things necessary have been done and performed to make this Second Supplemental Indenture enforceable in accordance with its terms, and the execution and delivery of this Second Supplemental Indenture has been duly authorized in all respects.  
NOW, THEREFORE, in consideration of the covenants and agreements set forth herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows: 
ARTICLE ONE 
DEFINITIONS 
Section 1.1 Definitions and Other Provisions of General Application.  For all purposes of this Second Supplemental Indenture unless otherwise specified herein: 
(a)    All terms used in this Second Supplemental Indenture which are not otherwise defined herein shall have the meanings they are given in the Base Indenture and include the plural as well as the singular; 
(b)    The provisions of general application stated in Sections 1.2 through 1.16 of the Base Indenture shall apply to this Second Supplemental Indenture, except that the words “herein,” “hereof,” “hereto” and “hereunder” and other words of similar import refer to this Second Supplemental Indenture as a whole and not to the Base Indenture or any particular Article, Section or other subdivision of this Second Supplemental Indenture; and 
(c)    Section 1.1 of the Base Indenture is amended and supplemented, solely with respect to the Notes, by inserting the following additional defined terms in their appropriate alphabetical positions or, if applicable, by replacing in their entirety the following defined terms: 
“Administrative or Judicial Action” has the meaning provided in the definition of “Tax Event.” 

	
			
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“Benchmark” means, initially, Three-Month Term SOFR; provided that if the Calculation Agent determines on or prior to the Reference Time that a Benchmark Transition Event and its related Benchmark Replacement Date have occurred with respect to Three-Month Term SOFR or the then-current Benchmark, then “Benchmark” means the applicable Benchmark Replacement.  
“Benchmark Replacement” means the Interpolated Benchmark with respect to the then-current Benchmark, plus the Benchmark Replacement Adjustment for such Benchmark; provided that if (a) the Calculation Agent cannot determine the Interpolated Benchmark as of the Benchmark Replacement Date or (b) the then-current Benchmark is Three-Month Term SOFR and a Benchmark Transition Event and its related Benchmark Replacement Date have occurred with respect to Three-Month Term SOFR (in which event no Interpolated Benchmark with respect to Three-Month Term SOFR shall be determined), then “Benchmark Replacement” means the first alternative set forth in the order below that can be determined by the Calculation Agent as of the Benchmark Replacement Date: 
(1) Compounded SOFR; 
(2) the sum of: (a) the alternate rate that has been selected or recommended by the Relevant Governmental Body as the replacement for the then-current Benchmark for the applicable Corresponding Tenor and (b) the Benchmark Replacement Adjustment; 
(3) the sum of: (a) the ISDA Fallback Rate, and (b) the Benchmark Replacement Adjustment; 
(4) the sum of: (a) the alternate rate that has been selected by the Calculation Agent as the replacement for the then-current Benchmark for the applicable Corresponding Tenor, giving due consideration to any industry-accepted rate as a replacement for the then-current Benchmark for U.S.  dollar-denominated floating rate securities at such time, and (b) the Benchmark Replacement Adjustment.  
In the event the Calculation Agent at the Reference Time is required, but is unable, to determine the Benchmark in accordance with at least one of the procedures described above, the Benchmark will be the Benchmark as determined on the previous Reference Time.
“Benchmark Replacement Adjustment” means the first alternative set forth in the order below that can be determined by the Calculation Agent as of the Benchmark Replacement Date: 
(1) the spread adjustment, or method for calculating or determining such spread adjustment (which may be a positive or negative value or zero), that has been selected or recommended by the Relevant Governmental Body for the applicable Unadjusted Benchmark Replacement; 
(2) if the applicable Unadjusted Benchmark Replacement is equivalent to the ISDA Fallback Rate, then the ISDA Fallback Adjustment; and 
(3) the spread adjustment (which may be a positive or negative value or zero) that has been selected by the Calculation Agent giving due consideration to any industry-accepted spread adjustment or method for calculating or determining such spread adjustment, for the replacement of the then-current Benchmark with the applicable Unadjusted Benchmark Replacement for U.S.  dollar-denominated floating rate securities at such time.  
“Benchmark Replacement Conforming Changes” means, with respect to any Benchmark Replacement, any technical, administrative or operational changes (including changes to the definition of  “interest period,” timing and frequency of determining rates with respect to each interest period and making payments of interest, rounding of amounts or tenors, and other administrative matters) that the Calculation Agent decides may be appropriate to reflect the adoption of such Benchmark Replacement in a manner substantially consistent with market practice (or, if the Calculation Agent decides that adoption of any portion of such market practice is not administratively feasible or if the Calculation Agent determines that no market practice for use of the Benchmark Replacement exists, in such other manner as the Calculation Agent determines is reasonably necessary).  

	
			
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“Benchmark Replacement Date” means the earliest to occur of the following events with respect to the then-current Benchmark: 
(1) in the case of clause (1) of the definition of  “Benchmark Transition Event,” the relevant Reference Time in respect of any determination; 
(2) in the case of clause (2) or (3) of the definition of  “Benchmark Transition Event,” the later of (a) the date of the public statement or publication of information referenced therein and (b) the date on which the administrator of the Benchmark permanently or indefinitely ceases to provide the Benchmark; or 
(3) in the case of clause (4) of the definition of  “Benchmark Transition Event,” the date of the public statement or publication of information referenced therein.  
For the avoidance of doubt, for purposes of the definitions of Benchmark Replacement Date and Benchmark Transition Event, references to the Benchmark also include any reference rate underlying the Benchmark (for example, if the Benchmark becomes Compounded SOFR, references to the Benchmark would include SOFR).  
For the avoidance of doubt, if the event giving rise to the Benchmark Replacement Date occurs on the same day as, but earlier than, the Reference Time in respect of any determination, the Benchmark Replacement Date will be deemed to have occurred prior to the Reference Time for such determination.  
“Benchmark Transition Event” means the occurrence of one or more of the following events with respect to the then-current Benchmark: 
(1) if the Benchmark is Three-Month Term SOFR, (a) the Relevant Governmental Body has not selected or recommended a forward-looking term rate for a tenor of three months based on SOFR, (b) the development of a forward-looking term rate for a tenor of three months based on SOFR that has been recommended or selected by the Relevant Governmental Body is not complete or (c) the Company determines that the use of a forward-looking rate for a tenor of three months based on SOFR is not administratively feasible; 
(2) a public statement or publication of information by or on behalf of the administrator of the Benchmark announcing that such administrator has ceased or will cease to provide the Benchmark, permanently or indefinitely, provided that, at the time of such statement or publication, there is no successor administrator that will continue to provide the Benchmark; 
(3) a public statement or publication of information by the regulatory supervisor for the administrator of the Benchmark, the central bank for the currency of the Benchmark, an insolvency official with jurisdiction over the administrator for the Benchmark, a resolution authority with jurisdiction over the administrator for the Benchmark or a court or an entity with similar insolvency or resolution authority over the administrator for the Benchmark, which states that the administrator of the Benchmark has ceased or will cease to provide the Benchmark permanently or indefinitely, provided that, at the time of such statement or publication, there is no successor administrator that will continue to provide the Benchmark; or 
(4) a public statement or publication of information by the regulatory supervisor for the administrator of the Benchmark announcing that the Benchmark is no longer representative.  
“Business Day” means (A) each Monday, Tuesday, Wednesday, Thursday and Friday which is not a day on which banking institutions in New York are authorized or obligated by law or executive order to close, or (B) a day on which the corporate trust office of the Trustee is not closed for business.  
“Calculation Agent” means the agent appointed by the Company prior to the commencement of the Floating Rate Period (which may include the Company or any of its Affiliates) to act in accordance with Section 2.4.  The Company shall be the initial Calculation Agent.

	
			
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“Compounded SOFR” means the compounded average of SOFRs for the applicable Corresponding Tenor, with the rate, or methodology for this rate, and conventions for this rate being established by the Calculation Agent in accordance with: 
(1) the rate, or methodology for this rate, and conventions for this rate selected or recommended by the Relevant Governmental Body for determining compounded SOFR; provided that: 
(2) if, and to the extent that, the Calculation Agent determines that Compounded SOFR cannot be determined in accordance with clause (1) above, then the rate, or methodology for this rate, and conventions for this rate that have been selected by the Calculation Agent giving due consideration to any industry-accepted market practice for U.S.  dollar-denominated floating rate securities at such time.  
For the avoidance of doubt, the calculation of Compounded SOFR shall exclude the Benchmark Replacement Adjustment (if applicable) and the spread of 476 basis points per annum.  
“Corresponding Tenor” with respect to a Benchmark Replacement means a tenor (including overnight) having approximately the same length (disregarding business day adjustment) as the applicable tenor for the then-current Benchmark.  
“DTC” means The Depository Trust Company.  
“Federal Reserve” has the meaning provided in the definition of “Tier 2 Capital Event.” 
“Federal Reserve Bank of New York’s Website” means the website of the Federal Reserve Bank of New York at http://www.newyorkfed.org, or any successor source.  
“Fixed Rate Interest Payment Date” has the meaning provided in Section 2.4(a).  
“Fixed Rate Period” has the meaning provided in Section 2.4(a).  
“Fixed Rate Regular Record Date” has the meaning provided in Section 2.4(a).  
“Floating Rate Interest Payment Date” has the meaning provided in Section 2.4(b).  
“Floating Rate Period” has the meaning provided in Section 2.4(b).  
“Floating Rate Regular Record Date” has the meaning provided in Section 2.4(b).  
“Interest Payment Date” has the meaning provided in Section 2.4(b).  
“interest period” means the period from and including the immediately preceding Interest Payment Date in respect of which interest has been paid or duly provided for or, if no interest has been paid or duly provided for, from and including the Issue Date to, but excluding, the applicable Interest Payment Date or the Maturity Date or date of earlier redemption, if applicable.  
“Interpolated Benchmark” with respect to the Benchmark means the rate determined for the Corresponding Tenor by interpolating on a linear basis between: (1) the Benchmark for the longest period (for which the Benchmark is available) that is shorter than the Corresponding Tenor, and (2) the Benchmark for the shortest period (for which the Benchmark is available) that is longer than the Corresponding Tenor.  
“ISDA Definitions” means the 2006 ISDA Definitions published by the International Swaps and Derivatives Association, Inc.  or any successor thereto, as amended or supplemented from time to time, or any successor definitional booklet for interest rate derivatives published from time to time.  

	
			
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“ISDA Fallback Adjustment” means the spread adjustment (which may be a positive or negative value or zero) that would apply for derivatives transactions referencing the ISDA Definitions to be determined upon the occurrence of an index cessation event with respect to the Benchmark for the applicable tenor.  
“ISDA Fallback Rate” means the rate that would apply for derivatives transactions referencing the ISDA Definitions to be effective upon the occurrence of an index cessation date with respect to the Benchmark for the applicable tenor excluding the applicable ISDA Fallback Adjustment.  
“Issue Date” means September 18, 2020.  
“Maturity Date” has the meaning provided in Section 2.2.  
“Redemption Date” has the meaning provided in Section 2.5.  
“Reference Time” with respect to any determination of the Benchmark means (1) if the Benchmark is Three-Month Term SOFR, the time determined by the Calculation Agent after giving effect to the Three-Month Term SOFR Conventions, and (2) if the Benchmark is not Three-Month Term SOFR, the time determined by the Calculation Agent after giving effect to the Benchmark Replacement Conforming Changes.  
“Relevant Governmental Body” means the Federal Reserve and/or the Federal Reserve Bank of New York, or a committee officially endorsed or convened by the Federal Reserve and/or the Federal Reserve Bank of New York or any successor thereto.  
“Senior Indebtedness” means any obligation of the Company to its creditors, whether now outstanding or subsequently incurred, other than any obligation where, in the instrument creating or evidencing the obligation or pursuant to which the obligation is outstanding, it is provided that the obligation is not Senior Indebtedness. Senior Indebtedness includes, without limitation: 
 
(1) the principal of (and premium, if any) and interest in respect of indebtedness of the Company for purchased or borrowed money, whether or not evidenced by securities, notes, debentures, bonds or other similar instruments issued by the Company, including obligations incurred in connection with the acquisition of property, assets or businesses; 
(2) all capital lease obligations of the Company; 
(3) all obligations of the Company issued or assumed as the deferred purchase price of property, all conditional sale obligations of the Company and all obligations of the Company under any conditional sale or title retention agreement, but excluding trade accounts payable in the ordinary course of business; 
(4) all obligations of the Company arising from off-balance sheet guarantees and direct credit substitutes, including obligations in respect of any letters of credit, bankers’ acceptance, security purchase facilities and similar credit transactions; 
(5) all obligations of the Company associated with derivative products, including obligations in respect of interest rate swap, cap or other agreements, interest rate future or options contracts, currency swap agreements, currency future or option contracts and other similar agreements; 
(6) all obligations of the type referred to in clauses (1) through (5) of other persons for the payment of which the Company is responsible or liable as obligor, guarantor or otherwise; 
(7) all obligations of the type referred to in clauses (1) through (6) of other persons secured by any lien on any property or asset of the Company whether or not such obligation is assumed by the Company; and 
(8) any deferrals, renewals or extensions of any obligations of the type referred to in clauses (1) through (7). 
Notwithstanding the foregoing, Senior Indebtedness does not include: 
(1) the Securities; 
(2) trade accounts payable arising in the ordinary course of business; and 

	
			
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(3) any indebtedness that by its terms is subordinated to, or ranks on an equal basis with, the Securities, including: (A) the Company’s Floating Rate Junior Subordinated Debt Securities due 2035; (B) the Company’s 6.25% Subordinated Notes due 2026; (C) the Company’s $7.4 million principal amount 6.25% subordinated loans; and (D) any indebtedness issued to any statutory trust created by the Company for the purpose of issuing trust securities in connection with such issuance of indebtedness, which shall in all cases be junior to such Securities. 
“SOFR” means the secured overnight financing rate published by the Federal Reserve Bank of New York, as the administrator of the Benchmark (or a successor administrator), on the Federal Reserve Bank of New York’s website.  
“Tax Event” means the receipt by the Company of an opinion of independent tax counsel to the effect that as a result of (a) an amendment to or change (including any announced prospective amendment or change) in any law or treaty, or any regulation thereunder, of the United States or any of its political subdivisions or taxing authorities; (b) a judicial decision, administrative action, official administrative pronouncement, ruling, regulatory procedure, regulation, notice or announcement, including any notice or announcement of intent to adopt or promulgate any ruling, regulatory procedure or regulation (any of the foregoing, an “Administrative or Judicial Action”); or (c) an amendment to or change in any official position with respect to, or any interpretation of, an Administrative or Judicial Action or a law or regulation of the United States that differs from the previously generally accepted position or interpretation, in each case, which change or amendment or challenge becomes effective or which pronouncement, decision or challenge is announced on or after the original issue date of the Notes, there is more than an insubstantial risk that interest payable by the Company on the Notes is not, or, within 90 days of the date of such opinion, will not be, deductible by the Company, in whole or in part, for United States federal income tax purposes.  
“Term SOFR” means the forward-looking term rate based on SOFR that has been selected or recommended by the Relevant Governmental Body.  
“Term SOFR Administrator” means any entity designated by the Relevant Governmental Body as the administrator of Term SOFR (or a successor administrator).  
“Three-Month Term SOFR” means the rate for Term SOFR for a tenor of three months that is published by the Term SOFR Administrator at the Reference Time for any interest period, as determined by the Calculation Agent after giving effect to the Three-Month Term SOFR Conventions.  All percentages used in or resulting from any calculation of Three-Month Term SOFR shall be rounded, if necessary, to the nearest one-hundred-thousandth of a percentage point, with 0.000005% rounded up to 0.00001%.  
“Three-Month Term SOFR Conventions” means any determination, decision or election with respect to any technical, administrative or operational matter (including with respect to the manner and timing of the publication of Three-Month Term SOFR, or changes to the definition of “interest period,” timing and frequency of determining Three-Month Term SOFR with respect to each interest period and making payments of interest, rounding of amounts or tenors, and other administrative matters) that the Calculation Agent decides may be appropriate to reflect the use of Three-Month Term SOFR as the Benchmark in a manner substantially consistent with market practice (or, if the Calculation Agent decides that adoption of any portion of such market practice is not administratively feasible or if the Calculation Agent determines that no market practice for the use of Three-Month Term SOFR exists, in such other manner as the Calculation Agent determines is reasonably necessary).  
“Tier 2 Capital Event” means the Company’s good faith determination that, as a result of (a) any amendment to, or change in, the laws, rules or regulations of the United States (including, for the avoidance of doubt, any agency or instrumentality of the United States, including the Federal Reserve and other federal bank regulatory agencies) or any political subdivision of or in the United States that is enacted or becomes effective after the original issue date of the Notes; (b) any proposed change in those laws, rules or regulations that is announced or becomes effective after the original issue date of the Notes; or (c) any official administrative decision or judicial decision or administrative action or other official pronouncement interpreting or applying those laws, rules, regulations, policies or guidelines with respect thereto that is announced after the original issue date of the Notes, there is more than an insubstantial risk that the Company will not be entitled to treat the Notes then outstanding as “Tier 2 Capital” (or its equivalent) for purposes of the capital adequacy rules or regulations of the Board of Governors of the Federal Reserve 

	
			
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System (the “Federal Reserve”) (or, as and if applicable, the capital adequacy rules or regulations of any successor appropriate federal banking agency) as then in effect and applicable to the Company, for so long as any Notes are outstanding.  
“Unadjusted Benchmark Replacement” means the Benchmark Replacement excluding the Benchmark Replacement Adjustment.  
ARTICLE TWO 
CREATION OF THE NOTES 
Section 2.1 Designation of Series.  Pursuant to the terms hereof and Sections 2.1 and 3.1 of the Base Indenture, the Company hereby creates a series of its subordinated debt securities designated as the “4.875% Fixed-to-Floating Rate Subordinated Notes due 2030” (the “Notes”), which Notes shall be deemed “Securities” for all purposes under the Indenture.  
Section 2.2 Form and Minimum Denomination of Notes.  The definitive form of the Notes shall be substantially in the form set forth in Exhibit A attached hereto, which is incorporated herein and made part hereof.  The Notes shall bear interest and have such other terms as are stated in the form of definitive Notes or in the Indenture.  The Stated Maturity of the Notes shall be October 1, 2030 (the “Maturity Date”).  The Notes shall be issued in minimum denominations of $1,000 and integral multiples of $1,000 in excess thereof.  
Section 2.3 Initial Limit on Amount of Series.  The Notes shall initially be limited to U.S.  $175,000,000 in aggregate principal amount, and may, upon the execution and delivery of this Second Supplemental Indenture or from time to time thereafter, be executed by the Company and delivered to the Trustee for authentication, and the Trustee shall thereupon authenticate and deliver said Notes to or upon the delivery of a Company Order, Officers’ Certificate and Opinion of Counsel.  Following the initial issuance of the Notes, the aggregate principal amount of Notes may be increased as provided in Section 2.9.  
Section 2.4 Interest.  
(a)    The Notes will bear interest at a fixed rate of 4.875% per annum from and including September 18, 2020 to, but excluding, October 1, 2025 or earlier Redemption Date (the “Fixed Rate Period”).  Interest accrued on the Notes during the Fixed Rate Period will be payable semi-annually in arrears on April 1 and October 1 of each year, commencing on April 1, 2021 (each such date, a “Fixed Rate Interest Payment Date”).  The last Fixed Rate Interest Payment Date shall be October 1, 2025, unless the Notes are earlier redeemed.  The interest payable during the Fixed Rate Period will be paid to each Holder in whose name a Note is registered at the close of business on the fifteenth day (whether or not a Business Day) immediately preceding the applicable Fixed Rate Interest Payment Date (each such date, a “Fixed Rate Regular Record Date”).  
(b)    The Notes will bear a floating interest rate from, and including October 1, 2025, to, but excluding, the Maturity Date or earlier Redemption Date (the “Floating Rate Period”).  The floating interest rate will be reset quarterly, and the interest rate per annum for any Floating Rate Period shall be equal to the then-current Three-Month Term SOFR plus 476 basis points for each quarterly interest period during the Floating Rate Period.  During the Floating Rate Period, interest on the Notes will be payable quarterly in arrears on January 1, April 1, July 1 and October 1 of each year, commencing on January 1, 2026 (each such date, a “Floating Rate Interest Payment Date” and, together with a Fixed Rate Interest Payment Date, an “Interest Payment Date”).   The interest payable during the Floating Rate Period will be paid to each Holder in whose name a Note is registered at the close of business on the fifteenth day (whether or not a Business Day) immediately preceding the applicable Floating Rate Interest Payment Date (each such date, a “Floating Rate Regular Record Date”).   Notwithstanding the foregoing, if Three-Month Term SOFR (or other applicable Benchmark) is less than zero, then Three-Month Term SOFR (or other such Benchmark) shall be deemed to be zero.   The Calculation Agent will provide the Company and the Trustee with the interest rate in effect on the Notes promptly after the Reference Time (or such other date of determination for the applicable Benchmark).   
(c)    The amount of interest payable on any Fixed Rate Interest Payment Date during the Fixed Rate Period will be computed on the basis of a 360-day year consisting of twelve 30-day months to, but excluding, October 1, 2025, 

	
			
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and, the amount of interest payable on any Floating Rate Interest Payment Date during the Floating Rate Period will be computed on the basis of a 360-day year on the basis of the actual number of days elapsed.   The Company or the Calculation Agent, as applicable, shall calculate the amount of interest payable on any Interest Payment Date and the Trustee shall have no duty to confirm or verify any such calculation.  In the event that any scheduled Interest Payment Date or the Maturity Date for the Notes falls on a day that is not a Business Day, then payment of interest payable on such Interest Payment Date or of principal and interest payable on the Maturity Date will be paid on the next succeeding day which is a Business Day (any payment made on such date will be treated as being made on the date that the payment was first due and no interest on such payment will accrue for the period from and after such scheduled Interest Payment Date); provided, that in the event that any scheduled Floating Rate Interest Payment Date falls on a day that is not a Business Day and the next succeeding Business Day falls in the next succeeding calendar month, such Floating Rate Interest Payment Date will be accelerated to the immediately preceding Business Day, and, in each such case, the amounts payable on such Business Day will include interest accrued to, but excluding, such Business Day.  Dollar amounts resulting from interest calculations will be rounded to the nearest cent, with one-half cent being rounded upward.  
(d)    The Company shall take such actions as are necessary to ensure that from the commencement of the Floating Rate Period for so long as any of the Notes remain outstanding there will at all times be a Calculation Agent appointed to calculate Three-Month Term SOFR in respect of each Floating Rate Period.  The calculation of Three-Month Term SOFR for each applicable Floating Rate Period by the Calculation Agent will (in the absence of manifest error) be final and binding.  The Calculation Agent’s determination of any interest rate and its calculation of interest payments for any period will be maintained on file at the Calculation Agent’s principal offices, will be made available to any Holder of the Notes upon request and will be provided to the Trustee promptly after the Reference Time and in any event prior to the applicable Interest Payment Date.  The Calculation Agent shall have all the rights, protections and indemnities afforded to the Trustee under the Base Indenture and hereunder.  The Calculation Agent may be removed by the Company at any time.  If the Calculation Agent is unable or unwilling to act as Calculation Agent or is removed by the Company, the Company will promptly appoint a replacement Calculation Agent.  The Calculation Agent may not resign its duties without a successor having been duly appointed; provided, that if a successor Calculation Agent has not been appointed by the Company within 30 days after the giving of notice of resignation by the Calculation Agent, then the resigning Calculation Agent may petition, at the expense of the Company, any court of competent jurisdiction for the appointment of a successor Calculation Agent with respect to such series.  The Trustee shall not be under any duty to succeed to, assume or otherwise perform, any duties of the Calculation Agent, or to appoint a successor or replacement in the event of the Calculation Agent’s resignation or removal or to replace the Calculation Agent in the event of a default, breach or failure of performance on the part of the Calculation Agent with respect to the Calculation Agent’s duties and obligations hereunder.  For the avoidance of doubt, if at any time there is no Calculation Agent appointed by the Company, then the Company shall be the Calculation Agent.  The Company may appoint itself or any of its Affiliates to be the Calculation Agent.  
(e)    Effect of Benchmark Transition Event.  
(1)    If the Calculation Agent determines that a Benchmark Transition Event and its related Benchmark Replacement Date have occurred on or prior to the Reference Time in respect of any determination of the Benchmark on any date, then the Benchmark Replacement will replace the then-current Benchmark for all purposes relating to the Notes during the Floating Rate Period in respect of such determination on such date and all determinations on all subsequent dates.  In connection with the implementation of a Benchmark Replacement, the Calculation Agent will have the right to make Benchmark Replacement Conforming Changes from time to time.  
(2)    Notwithstanding anything set forth in Section 2.4(b) above, if the Calculation Agent determines on or prior to the relevant Reference Time that a Benchmark Transition Event and its related Benchmark Replacement Date have occurred with respect to Three-Month Term SOFR, then the provisions set forth in this Section 2.4(e) will thereafter apply to all determinations of the interest rate on the Notes during the Floating Rate Period.  After a Benchmark Transition Event and its related Benchmark Replacement Date have occurred, the interest rate on the Notes for each interest period during the Floating Rate Period will be an annual rate equal to the Benchmark Replacement plus 476 basis points.  

	
			
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(3)    The Calculation Agent is expressly authorized to make certain determinations, decisions and elections under the terms of the Notes, including with respect to the use of Three-Month Term SOFR as the Benchmark and under this Section 2.4(e).  Any determination, decision or election that may be made by the Calculation Agent under the terms of the Notes, including any determination with respect to a tenor, rate or adjustment or of the occurrence or non-occurrence of an event, circumstance or date and any decision to take or refrain from taking any action or selection (A) will be conclusive and binding on the Holders of the Notes and the Trustee absent manifest error, (B) if made by the Company as Calculation Agent, will be made in the Company’s sole discretion, (C) if made by a Calculation Agent other than the Company, will be made after consultation with the Company, and the Calculation Agent will not make any such determination, decision or election to which the Company reasonably objects and (D) notwithstanding anything to the contrary herein or in the Base Indenture, shall become effective without consent from the Holders of the Notes, the Trustee or any other party.  If the Calculation Agent fails to make any determination, decision or election that it is required to make under the terms of the Notes, then the Company will make such determination, decision or election on the same basis as described above.  
(4)    The Company (or its Calculation Agent) shall notify the Trustee and the Holders in writing (i) upon the occurrence of the Benchmark Transition Event or the Benchmark Replacement Date, and (ii) of any Benchmark Replacements, Benchmark Replacement Conforming Changes and other items affecting the interest rate on the Notes after a Benchmark Transition Event.  
(5)    The Trustee (including in its capacity as Paying Agent) shall have no (i) responsibility or liability for the (A) Three-Month Term SOFR Conventions, or to otherwise monitor, determine or verify the unavailability or cessation of Three-Month SOFR (or other applicable Benchmark), (B) selection of an alternative reference rate to Three-Month Term SOFR (including, without limitation, whether the conditions for the designation of such rate have been satisfied or whether such rate is a Benchmark Replacement or an Unadjusted Benchmark Replacement), (C) determination or calculation of a Benchmark Replacement, (D) determination of whether a Benchmark Transition Event or Benchmark Replacement Date has occurred, (E) selection, determination or designation of any Benchmark Replacement Adjustment, or other modifier to any replacement or successor index, or (F) to determine whether or what Benchmark Replacement Conforming Changes are necessary or advisable, if any, in connection with any of the foregoing and in each such case under clauses (A) through (F) above shall be entitled to conclusively rely upon the selection, determination, and/or calculation thereof as provided by the Company or its Calculation Agent, as applicable, and (ii) liability for any failure or delay in performing its duties hereunder as a result of the unavailability of a Benchmark rate as described in the definition thereof, including, without limitation, as a result of the Company’s or Calculation Agent’s failure to select a Benchmark Replacement or the Calculation Agent’s failure to calculate a Benchmark.  The Trustee shall be entitled to rely conclusively on all notices from the Company or its Calculation Agent regarding any Benchmark or Benchmark Replacement, including, without limitation, in regards to Three-Month Term SOFR Conventions, a Benchmark Transition Event, Benchmark Replacement Date, and Benchmark Replacement Conforming Changes.  The Trustee shall not be responsible or liable for the actions or omissions of the Calculation Agent, or any failure or delay in the performance of the Calculation Agent’s duties or obligations, nor shall it be under any obligation to monitor or oversee the performance of the Calculation Agent.  Neither the Trustee nor the Paying Agent shall be liable for any inability, failure or delay on its part to perform any of its duties set forth in the Indenture as a result of the unavailability of Three-Month SOFR (or other applicable Benchmark) and absence of a designated replacement Benchmark.  The Trustee shall be entitled to conclusively rely on any determination made, and any instruction, notice, Officers’ Certificate or other instruction or information provided by the Calculation Agent without independent verification, investigation or inquiry of any kind.  The Trustee shall not be obligated to enter into any amendment or supplement hereto that adversely impacts its rights, duties, obligations, immunities or liabilities (including, without limitation, in connection with the adoption of any Benchmark Replacement Conforming Changes).  The Trustee shall not be bound to follow or agree to any amendment or supplement to the indenture (including, without limitation, any Benchmark Replacement Conforming Changes) that would increase or materially change or affect the duties, obligations or liabilities of the Trustee (including without limitation the imposition or expansion of discretionary authority), or reduce, eliminate, limit or otherwise change any right, privilege or 

	
			
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protection of the Trustee, or would otherwise materially and adversely affect the Trustee, in each case in its reasonable judgment, without such party’s express written consent.
(6)    If the then-current Benchmark is Three-Month Term SOFR, the Calculation Agent will have the right to establish the Three-Month Term SOFR Conventions, and if any of the foregoing provisions concerning the calculation of the interest rate and the payment of interest during the Floating Rate Period are inconsistent with any of the Three-Month Term SOFR Conventions determined by the Calculation Agent, then the relevant Three-Month Term SOFR Conventions will apply.  
 
Section 2.5 Redemption.  
(a)    The Notes shall be redeemable, in each case, in whole or in part from time to time, at the option of the Company beginning with the Interest Payment Date on October 1, 2025, but not prior thereto (except upon the occurrence of certain events specified below), and on any Interest Payment Date thereafter (each, a “Redemption Date”), subject to obtaining the prior approval of the Federal Reserve to the extent such approval is then required under the rules of the Federal Reserve.  The Notes may not otherwise be redeemed prior to the Maturity Date, except that the Company may, at its option, redeem the Notes before the Maturity Date, in whole, but not in part, subject to obtaining the prior approval of the Federal Reserve to the extent such approval is then required under the rules of the Federal Reserve, upon the occurrence of a Tier 2 Capital Event or a Tax Event, or if the Company is required to register as an investment company pursuant to the Investment Company Act of 1940, as amended (15 U.S.C.  80a-1 et seq.).  Any such redemption will be at a Redemption Price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the Redemption Date fixed by the Company.  The provisions of Article 11 of the Base Indenture shall apply to any redemption of the Notes pursuant to this Section 2.5.  Any partial redemption will be made in accordance with DTC’s applicable procedures among all of the Holders of the Notes.  If any Note is to be redeemed in part only, the notice of redemption relating to such Note shall state that it is a partial redemption and the portion of the principal amount thereof to be redeemed, and a replacement Note in principal amount equal to the unredeemed portion thereof will be issued in the name of the Holder thereof upon cancellation of the original Note.  The Notes are not subject to redemption or prepayment at the option of the Holders.  
Any notice of redemption may be conditional in the Company’s discretion on one or more conditions precedent, and the Redemption Date may be delayed until such time as any or all of such conditions have been satisfied or revoked by the Company if it determines that such conditions will not be satisfied.  The Company shall promptly notify the Trustee and the Holders prior to the Redemption Date if it determines that such conditions will not be satisfied.
Section 2.6 No Repayment or Sinking Fund.  The Notes will not be subject to redemption or repayment at the option of any Holder at any time prior to the Stated Maturity.  No sinking fund will be provided with respect to the Notes.  
Section 2.7 Notes Not Convertible or Exchangeable.  The Notes will not be convertible or exchangeable for other securities or property.  
Section 2.8 Issuance of Notes; Selection of Depository.  The Notes shall be issued as Global Securities in permanent global form, without coupons.  The initial Depositary for the Notes shall be DTC.  
Section 2.9 Additional Notes.  The Company may, without consent of the Holders of the Notes but in compliance with the terms of the Indenture, increase the principal amount of the Notes by issuing additional Notes on the same terms and conditions as the Notes, except for any differences in the issue price and interest accrued prior to the date of issuance of the additional Notes, and with the same CUSIP number as the Notes; provided that such additional Notes are fungible with the Notes for U.S.  federal income tax purposes.  The Notes and any additional Notes issued by the Company will rank equally and ratably and shall be treated as a single series of Securities for all purposes under the Indenture.  
Section 2.10 No Additional Amounts.  In the event that any payment on the Notes is subject to withholding of any U.S.  federal income tax or other tax or assessment (as a result of a change in law or otherwise), the Company will not pay additional amounts with respect to such tax or assessment.  

	
			
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ARTICLE THREE
SUBORDINATION OF NOTES 
Section 3.1    Notes Subordinate to Senior Indebtedness. The Company covenants and agrees, and each Holder of a Note, by his acceptance thereof, likewise covenants and agrees, that, to the extent and in the manner hereinafter set forth in this Article, the indebtedness represented by the Notes and the payment of the principal of (and premium, if any) and interest on each and all of the Notes are hereby expressly made subordinate and subject in right of payment to the prior payment in full of all Senior Indebtedness.  
Notwithstanding the foregoing, if a deposit referred to in Section 13.4(1) of the Base Indenture is made pursuant to Section 13.2 or Section 13.3 of the Base Indenture with respect to any Notes (and provided all other conditions set out in Section 13.2 or 13.3 of the Base Indenture, as applicable, shall have been satisfied with respect to such Notes), then, following the 90th day after such deposit, or any longer preference period if applicable, no money or U.S. Government Obligations so deposited, and no proceeds thereon, will be subject to any rights of holders of Senior Indebtedness, including any such rights arising under this Article Three. 
Section 3.2    Payment Over of Proceeds Upon Dissolution, Etc. 
In the event of (a) any insolvency or bankruptcy case or proceeding, or any receivership, liquidation, reorganization or other similar case or proceeding in connection therewith, relative to the Company or to its creditors, as such, or to its assets, or (b) any liquidation, dissolution or other winding up of the Company, whether voluntary or involuntary and whether or not involving insolvency or bankruptcy, or (c) any assignment for the benefit of creditors or any other marshaling of assets and liabilities of the Company, then and in any such event the holders of Senior Indebtedness shall be entitled to receive payment in full of all amounts due or to become due on or in respect of all Senior Indebtedness, or provision shall be made for such payment, before the Holders of the Notes are entitled to receive any payment on account of principal of or interest on the Notes, and to that end the holders of Senior Indebtedness shall be entitled to receive, for application to the payment thereof, any payment or distribution of any kind or character, whether in cash, property or securities, which may be payable or deliverable in respect of the Notes in any such case, proceeding, dissolution, liquidation or other winding up or event. 
Other than a payment to the Trustee in its capacity as such,  which shall not, for the avoidance of doubt, be subordinated to Senior Indebtedness, upon the occurrence of any of the events described in clauses (a), (b) or (c) of the immediately preceding paragraph, in the event that notwithstanding the foregoing provisions of this Section the Trustee or the Holder of any Note shall have received any payment or distribution of assets of the Company of any kind or character, whether in cash, property or securities, before all Senior Indebtedness is paid in full or payment thereof provided for, and if such fact shall, at or prior to the time of such payment or distribution, have been made known to the Trustee or, as the case may be, such Holder, then and in such event such payment or distribution shall be paid over or delivered forthwith to the trustee in bankruptcy, receiver, liquidating trustee, custodian, assignee, agent or other Person making payment or distribution of assets of the Company for application to the payment of all Senior Indebtedness remaining unpaid, to the extent necessary to pay all Senior Indebtedness in full, after giving effect to any concurrent payment or distribution to or for the holders of Senior Indebtedness. 
The consolidation of the Company with, or the merger of the Company into, another Person or the liquidation or dissolution of the Company following the conveyance or transfer all or substantially all of its properties and assets to another Person upon the terms and conditions set forth in Article 8 of the Base Indenture shall not be deemed a dissolution, winding up, liquidation, reorganization, assignment for the benefit of creditors or marshaling of assets and liabilities of the Company for the purposes of this Section if the Person formed by such consolidation or into which the Company is merged or which acquires by conveyance or transfer all or substantially all properties and assets, as the case may be, shall, as a part of such consolidation, merger, conveyance or transfer, comply with the respective conditions set forth in Article 8 of the Base Indenture. 
Section 3.3    Prior Payment to Senior Indebtedness Upon Acceleration of Notes.  In the event that any Notes are declared due and payable before their Stated Maturity, then and in such event the holders of Senior Indebtedness shall be entitled to receive payment in full of all amounts due or to become due on or in respect of all Senior Indebtedness or provision shall be made for such payment in cash, before the Holders of the Notes are entitled to 

	
			
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receive any payment (including any payment which may be payable by reason of the payment of any other indebtedness of the Company being subordinated to the payment of the Notes) by the Company on account of the principal of (or premium, if any) or interest on the Notes or on account of the purchase or other acquisition of Notes; provided, however, that nothing in this Section shall prevent the satisfaction of any sinking fund payment in accordance with Article Twelve of the Base Indenture by delivering and crediting pursuant to Section 12.2 of the Base Indenture Notes which have been acquired (upon redemption or otherwise) prior to such declaration of acceleration. 
In the event that, notwithstanding the foregoing, the Company shall make any payment to the Trustee or the Holder of any Note prohibited by the foregoing provisions of this Section, and if such fact shall, at or prior to the time of such payment, have been made known to the Trustee or, as the case may be, such Holder, then and in such event such payment shall be paid over and delivered forthwith to the Company. 
The provisions of this Section shall not apply to any payment with respect to which Section 3.2 would be applicable. 
Section 3.4    No Payment When Senior Indebtedness in Default. 
In the event and during the continuation of any default in the payment of principal of (or premium, if any) or interest on any Senior Indebtedness beyond any applicable grace period with respect thereto, or, in the event any judicial proceeding shall be pending with respect to any such default, then no payment shall be made by the Company on account of principal of or interest on the Notes or on account of the purchase or other acquisition of Notes. 
In the event that, notwithstanding the foregoing, the Company shall make any payment to the Trustee or the Holder of any Note prohibited by the foregoing provisions of this Section, and if such fact shall, at or prior to the time of such payment, have been made known to a Responsible Officer of the Trustee or, as the case may be, such Holder, then and in such event such payment shall be paid over and delivered forthwith to the Company. 
The provisions of this Section shall not apply to any payment with respect to which Section 3.2 would be applicable. 
Section 3.5    Payment Permitted If No Default.  Nothing contained in this Article or elsewhere in the Indenture or in any of the Securities of any series shall prevent (a) the Company, at any time except during the pendency of any case, proceeding, dissolution, liquidation or other winding up, assignment for the benefit of creditors or other marshaling of assets and liabilities of the Company referred to in Section 3.2 or under the conditions described in Sections 3.3 or 3.4, from making payments at any time of principal of or interest on the Notes, or (b) the application by the Trustee of any money deposited with it hereunder to the payment of or on account of the principal of (and premium, if any) or interest on the Notes or the retention of such payment by the Holders, if, at the time of such application by the Trustee, a Responsible Officer of the Trustee did not have knowledge that such payment would have been prohibited by the provisions of this Article. 
Section 3.6    Subrogation to Rights of Holders of Senior Indebtedness.  Subject to the payment in full of all Senior Indebtedness, the Holders of the Notes shall be subrogated (equally and ratably with the holders of all indebtedness of the Company which by its express terms is subordinated to indebtedness of the Company to substantially the same extent as the Notes are subordinated and is entitled to like rights of subrogation) to the rights of the holders of such Senior Indebtedness to receive payments and distributions of cash, property and securities applicable to the Senior Indebtedness until the principal of (and premium, if any) and interest on the Notes shall be paid in full. For purposes of such subrogation, no payments or distributions to the holders of the Senior Indebtedness of any cash, property or securities to which the Holders of the Notes or the Trustee would be entitled except for the provisions of this Article, and no payments over pursuant to the provisions of this Article to the holders of Senior Indebtedness by Holders of the Notes or the Trustee, shall, as among the Company, its creditors other than holders of Senior Indebtedness and the Holders of the Notes, be deemed to be a payment or distribution by the Company to or on account of the Senior Indebtedness. 
Section 3.7    Provisions Solely to Define Relative Rights.  The provisions of this Article are and are intended solely for the purpose of defining the relative rights of the Holders of the Notes on the one hand and the holders of Senior Indebtedness on the other hand. Nothing contained in this Article or elsewhere in the Indenture or in the Notes 

	
			
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is intended to or shall (a) impair, as among the Company, its creditors other than holders of Senior Indebtedness and the Holders of the Notes, the obligation of the Company, which is absolute and unconditional and which, subject to the rights under this Article of the holders of Senior Indebtedness, is intended to rank equally with all other obligations of the Company, to pay to the Holders of the Notes the principal of and interest on the Notes as and when the same shall become due and payable in accordance with their terms; or (b) affect the relative rights against the Company of the Holders of the Notes and creditors of the Company other than the holders of Senior Indebtedness; or (c) prevent the Trustee or the Holder of any Note from exercising all remedies otherwise permitted by applicable law upon default under this Second Supplemental Indenture, subject to the rights, if any, under this Article of the holders of Senior Indebtedness to receive cash, property and securities otherwise payable or deliverable to the Trustee or such Holder. 
Section 3.8    Trustee to Effectuate Subordination.  Each Holder of a Note by his acceptance thereof authorizes and directs the Trustee on his behalf to take such action as may be necessary or appropriate and requested by the Company to effectuate the subordination provided in this Article and appoints the Trustee his attorney-in-fact for any and all such purposes. 
Section 3.9    No Waiver of Subordination Provisions.  No right of any present or future holder of any Senior Indebtedness to enforce subordination as herein provided shall at any time in any way be prejudiced or impaired by any act or failure to act on the part of the Company or by any act or failure to act, in good faith, by any such holder, or by any non-compliance by the Company with the terms, provisions and covenants of this Second Supplemental Indenture, regardless of any knowledge thereof any such holder may have or be otherwise charged with. 
Without in any way limiting the generality of the foregoing paragraph, the holders of Senior Indebtedness may, at any time and from time to time, without the consent of or notice to the Trustee or the Holders of the Notes, without incurring responsibility to the Holders of the Notes and without impairing or releasing the subordination provided in this Article or the obligations hereunder of the Holders of the Notes to the holders of Senior Indebtedness, do any one or more of the following: (i) change the manner, place or terms of payment or extend the time of payment of, or renew or alter, Senior Indebtedness, or otherwise amend or supplement in any manner Senior Indebtedness or any instrument evidencing the same or any agreement under which Senior Indebtedness is outstanding; (ii) sell, exchange, release or otherwise deal with any property pledged, mortgaged or otherwise securing Senior Indebtedness; (iii) release any Person liable in any manner for the collection of Senior Indebtedness; and (iv) exercise or refrain from exercising any rights against the Company and any other Person. 
Section 3.10    Notice to Trustee and the Paying Agent.  The Company shall give prompt written notice to the Trustee of any fact known to the Company which would prohibit the making of any payment to or by the Trustee in respect of the Notes. Notwithstanding the provisions of this Article or any other provision of the Indenture, the Trustee shall not be charged with knowledge of the existence of any facts which would prohibit the making of any payment to or by the Trustee in respect of the Notes, unless and until a Responsible Officer of the Trustee shall have received written notice thereof from the Company in the form of an Officers’ Certificate or a holder of Senior Indebtedness or from any trustee therefor and verified by the Company in an Officers’ Certificate; and, prior to the receipt of any such written notice, the Trustee, subject to the provisions of Section 6.1 of the Base Indenture, shall be entitled in all respects to assume that no such facts exist; provided, however, that if the Trustee shall not have received the notice provided for in this Section at least five Business Days prior to the date upon which by the terms hereof any money may become payable for any purpose, then, anything herein contained to the contrary notwithstanding, the Trustee shall have full power and authority to receive such money and to apply the same to the purpose for which such money was received and shall not be affected by any notice to the contrary which may be received by it within five Business Days prior to such date. Any notice sent to the Trustee pursuant to this Section 3.10 shall also be sent to the Paying Agent.
Subject to the provisions of Section 6.1 of the Base Indenture, the Trustee shall be entitled to rely on the delivery to it of a written notice by a Person representing himself to be a holder of Senior Indebtedness or a trustee therefor to establish that such notice has been given by a holder of Senior Indebtedness or a trustee therefor. In the event that the Trustee determines in good faith that further evidence is required with respect to the right of any Person as a holder of Senior Indebtedness to participate in any payment or distribution pursuant to this Article, the Trustee may request such Person to furnish evidence to the reasonable satisfaction of the Trustee as to the amount of Senior Indebtedness held by such Person, the extent to which such Person is entitled to participate in such payment or distribution and any other facts pertinent to the rights of such Person under this Article, and if such evidence is not 

	
			
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furnished, the Trustee may defer any payment to such Person pending judicial determination as to the right of such Person to receive such payment. 
Section 3.11    Reliance on Judicial Order or Certificate of Liquidating Agent.  Upon any payment or distribution of assets of the Company referred to in this Article, the Trustee, subject to the provisions of Section 6.1 of the Base Indenture, and the Holders of the Notes shall be entitled to rely upon any order or decree entered by any court of competent jurisdiction in which such insolvency, bankruptcy, receivership, liquidation, reorganization, dissolution, winding up or similar case or proceeding is pending, or a certificate of the trustee in bankruptcy, receiver, liquidating trustee, custodian, assignee for the benefit of creditors, agent or other Person making such payment or distribution, delivered to the Trustee or to the Holders of Notes, for the purpose of ascertaining the Persons entitled to participate in such payment or distribution, the holders of the Senior Indebtedness and other indebtedness of the Company, the amount thereof or payable thereon, the amount or amounts paid or distributed thereon and all other facts pertinent thereto or to this Article. 
Section 3.12    Trustee Not Fiduciary for Holders of Senior Indebtedness.  The Trustee shall not be deemed to owe any fiduciary duty to the holders of Senior Indebtedness and shall not be liable to any such holders if it shall in good faith mistakenly pay over or distribute to Holders of Notes or to the Company or to any other Person cash, property or securities to which any holders of Senior Indebtedness shall be entitled by virtue of this Article or otherwise. With respect to the holders of Senior Indebtedness, the Trustee undertakes to perform or to observe only such of its covenants or obligations as are specifically set forth in this Article and no implied covenants or obligations with respect to holders of Senior Indebtedness shall be read into this Second Supplemental Indenture against the Trustee. 
Section 3.13    Rights of Trustee as Holder of Senior Indebtedness; Preservation of Trustee’s Rights. The Trustee or any Authenticating Agent in its individual capacity shall be entitled to all the rights set forth in this Article with respect to any Senior Indebtedness which may at any time be held by it, to the same extent as any other holder of Senior Indebtedness, and nothing in this Second Supplemental Indenture shall deprive the Trustee of any of its rights as such holder. 
Section 3.14    Article Applicable to Paying Agents.  In case at any time any Paying Agent other than the Trustee shall have been appointed by the Company and be then acting under the Indenture, the term “Trustee” as used in this Article shall in such case (unless the context otherwise requires) be construed as extending to and including such Paying Agent within its meaning as fully for all intents and purposes as if such Paying Agent were named in this Article in addition to or in place of the Trustee; provided, however, this Section 3.14 shall not apply to the Company or any Affiliate of the Company if it or such Affiliate acts as Paying Agent. 
Section 3.15    Payment of Proceeds in Certain Cases.  Upon the occurrence of any of the events specified in clauses (a), (b) and (c) of the first paragraph of Section 3.2, the provisions of that Section shall be given effect to determine the amount of cash, property or securities which may be payable or deliverable as between the holders of Senior Indebtedness, on the one hand, and the Holders of Notes, on the other hand. 
Section 3.16    All Indenture Provisions Subject to Article Three.  Notwithstanding anything herein contained to the contrary, all the provisions of this Second Supplemental Indenture shall be subject to the provisions of this Article Three, so far as the same may be applicable thereto. The provisions of this Article Three shall not apply to amounts due and owing to the Trustee under Section 6.7 of the Base Indenture. 
ARTICLE FOUR
REMEDIES 
The provisions of Article 5 of the Base Indenture (entitled “Remedies”) shall not apply to the Notes in any respect, and such Article shall be replaced in its entirety with the following provisions of this Article Four:
Section 4.1    Events of Default.  The term “Event of Default”, wherever used herein with respect to the Notes, shall mean any of the following events (whatever the reason for such Event of Default and whether it shall be voluntary or involuntary or be effected by operation of law or pursuant to any judgment, decree or order of any court or any order, rule or regulation of any administrative or governmental body): 

	
			
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(1) the entry by a court having jurisdiction in the premises of (A) a decree or order for relief in respect of the Company in an involuntary case or proceeding under any applicable federal or state bankruptcy, insolvency, reorganization or other similar law or (B) a decree or order adjudging the Company bankrupt or insolvent, or approving as properly filed a petition seeking reorganization, arrangement, adjustment or composition of or in respect of the Company under any applicable federal or state law, or appointing a custodian, receiver, liquidator, assignee, trustee, sequestrator or other similar official of the Company or of any substantial part of its property, or ordering the winding up or liquidation of its affairs, and the continuance of any such decree or order for relief or any such other decree or order unstayed and in effect for a period of 60 consecutive days; 
(2) the commencement by the Company of a voluntary case or proceeding under any applicable federal or state bankruptcy, insolvency, reorganization or other similar law or of any other case or proceeding to be adjudicated a bankrupt or insolvent, or the consent by it to the entry of a decree or order for relief in respect of the Company in an involuntary case or proceeding under any applicable federal or state bankruptcy, insolvency, reorganization or other similar law or to the commencement of any bankruptcy or insolvency case or proceeding against it, or the filing by it of a petition or answer or consent seeking reorganization or relief under any applicable federal or state bankruptcy, insolvency, reorganization or other similar law or to the commencement of any bankruptcy or insolvency case or proceeding against it, or the filing by it of a petition or answer or consent seeking reorganization or relief under any applicable federal or state law, or the consent by it to the filing of such petition or to the appointment of or taking possession by a custodian, receiver, liquidator, assignee, trustee, sequestrator or similar official of the Company or of any substantial part of its property or the taking of corporate action by the Company in furtherance of any such action; or 
(3)(A) the appointment by a competent government agency having primary regulatory authority over the Company’s major subsidiary depository institution (which, for the avoidance of doubt, as of the date hereof, is Axos Bank) under any applicable federal or state banking, insolvency or similar law now or hereafter in effect of a receiver of any such major subsidiary depository institution or (B) the entry of a decree or order in any case or proceeding under any applicable federal or state banking, insolvency or other similar law now or hereafter in effect appointing any receiver of any major subsidiary depository institution of the Company. 
Section 4.2    Acceleration of Maturity; Rescission and Annulment.  If an Event of Default specified in Section 4.1 with respect to the Notes occurs, the principal amount of all Notes (or, if the Notes are Original Issue Discount Securities, such portion of the principal amount of such Notes as may be specified by the terms thereof) shall automatically, and without any declaration or other action on the part of the Trustee or any Holder, become immediately due and payable. 
At any time after such a declaration of acceleration with respect to the Notes has been made and before a judgment or decree for payment of the money due has been obtained by the Trustee as hereinafter in this Article provided, the Holders of a majority in principal amount of the Outstanding Notes, by written notice to the Company and the Trustee, may rescind and annul such declaration and its consequences if 
(1) the Company has paid or deposited with the Trustee a sum sufficient to pay 
(A) all overdue interest on all Notes, 
(B) the principal of (and premium, if any, on) any Notes which have become due otherwise than by such declaration of acceleration and any interest thereon at the rate or rates prescribed therefor in such Notes, 
(C) to the extent that payment of such interest is lawful, interest upon overdue interest at the rate or rates prescribed therefor in such Notes, and 
(D) all sums paid or advanced by the Trustee hereunder and the reasonable compensation, expenses, disbursements and advances of the Trustee, its agents and counsel; 
and 
(2) all Events of Default with respect to the Notes, other than the non-payment of the principal of Notes have become due solely by such declaration of acceleration, have been cured or waived as provided in Section 4.13. 

	
			
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No such rescission shall affect any subsequent default or impair any right consequent thereon. 
Section 4.3    Collection of Indebtedness and Suits for Enforcement by Trustee.  The Company covenants that if 
(1) default is made in the payment of any interest on any Note when such interest becomes due and payable and such default continues for a period of 30 days, or 
(2) default is made in the payment of the principal of (or premium, if any, on) any Note at the Maturity thereof, 
then the Company will, upon demand of the Trustee, pay to the Trustee, for the benefit of the Holders of such Notes, the whole amount then due and payable on such Notes for principal, including any sinking fund payment, and any premium and interest and, to the extent that payment of such interest shall be legally enforceable, interest on any overdue principal and premium and on any overdue interest, at the rate or rates prescribed therefor in such Notes, and, in addition thereto, such further amount as shall be sufficient to cover the costs and expenses of collection, including the reasonable compensation, expenses, disbursements and advances of the Trustee, its agents and counsel. 
If the Company shall fail to pay such amounts forthwith upon such demand, the Trustee, in its own name and as trustee of an express trust, may institute a judicial proceeding for the collection of the sums so due and unpaid, may prosecute such proceeding to judgment or final decree and may enforce the same against the Company or any other obligor upon such Notes and collect the moneys adjudged or decreed to be payable in the manner provided by law out of the property of the Company or any other obligor upon such Notes, wherever situated. 
If an Event of Default with respect to Notes occurs and is continuing, the Trustee may in its discretion proceed to protect and enforce its rights and the rights of the Holders of Notes by such appropriate judicial proceedings as the Trustee or the Holders of a majority in aggregate principal amount of the Notes shall deem most effectual to protect and enforce any such rights, whether for the specific enforcement of any covenant or agreement in this Second Supplemental Indenture or in aid of the exercise of any power granted herein, or to enforce any other proper remedy. 
Section 4.4    Trustee May File Proofs of Claim.  In case of any judicial proceeding relative to the Company (or any other obligor upon the Notes), its property or its creditors, the Trustee shall be entitled and empowered, by intervention in such proceeding or otherwise, to take any and all actions authorized under the Trust Indenture Act in order to have claims of the Holders and the Trustee allowed in any such proceeding. In particular, the Trustee shall be authorized (i) to file and prove a claim for the whole amount of principal (and premium, if any) and interest owing and unpaid in respect of the Notes in accordance with the terms thereof and to file such other papers or documents as may be necessary or advisable in order to have the claims of the Trustee (including any claim for the reasonable compensation, expense, disbursements and advances of the Trustee, its agents and counsel) and of the Holders allowed in such judicial proceeding, and (ii) to collect and receive any moneys or other property payable or deliverable on any such claims and to distribute the same; and any custodian, receiver, assignee, trustee, liquidator, sequestrator or other similar official in any such judicial proceeding is hereby authorized by each Holder to make such payments to the Trustee and, in the event that the Trustee shall consent to the making of such payments directly to the Holders, to pay to the Trustee any amount due it for the reasonable compensation, expenses, disbursements and advances of the Trustee, its agents and counsel, and any other amounts due the Trustee under Section 6.7 of the Base Indenture. 
No provision of this Second Supplemental Indenture shall be deemed to authorize the Trustee to authorize or consent to or accept or adopt on behalf of any Holder any plan of reorganization, arrangement, adjustment or composition affecting the Notes or the rights of any Holder thereof or to authorize the Trustee to vote in respect of the claim of any Holder in any such proceeding; provided, however, that the Trustee may, on behalf of the Holders, vote for the election of a trustee in bankruptcy or similar official and be a member of a creditors’ or other similar committee. 
Section 4.5    Trustee May Enforce Claims Without Possession of Notes.  All rights of action and claims under this Second Supplemental Indenture or the Notes may be prosecuted and enforced by the Trustee without the possession of any of the Notes or the production thereof in any proceeding relating thereto, and any such proceeding instituted by the Trustee shall be brought in its own name as trustee of an express trust, and any recovery of judgment shall, after provision for the payment of the reasonable compensation, expenses, disbursements and advances of the 

	
			
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Trustee, its agents and counsel, be for the ratable benefit of the Holders of the Notes in respect of which such judgment has been recovered. 
Section 4.6    Application of Money Collected.  Any money or property collected by the Trustee pursuant to this Article shall be applied in the following order, at the date or dates fixed by the Trustee and, in case of the distribution of such money or property on account of principal or any premium or interest, upon presentation of the Notes and the notation thereon of the payment if only partially paid and upon surrender thereof if fully paid: 
FIRST: To the payment of all amounts due the Trustee and any predecessor Trustee under Section 6.7 of the Base Indenture; 
SECOND: Subject to Article Three of this Second Supplemental Indenture, to the payment of the amounts then due and unpaid for principal of and any premium and interest on the Notes in respect of which or for the benefit of which such money has been collected, ratably, without preference or priority of any kind, according to the amounts due and payable on such Notes for principal and any premium and interest, respectively; and 
THIRD: The balance, if any, to the Company. 
Section 4.7    Limitation on Suits.  Subject to Section 4.8, no Holder of any Note shall have any right to institute any proceeding, judicial or otherwise, with respect to this Second Supplemental Indenture, or for the appointment of a receiver or trustee, or for any other remedy hereunder, unless 
(1) such Holder has previously given written notice to the Trustee of a continuing default with respect to the Notes; 
(2) the Holders of not less than 25% in principal amount of the Outstanding Notes shall have made written request to the Trustee to institute proceedings in respect of such default in its own name as Trustee hereunder; 
(3) such Holder or Holders have offered to the Trustee indemnity reasonably satisfactory to it against the costs, expenses and liabilities to be incurred in compliance with such request; 
(4) the Trustee for 60 days after its receipt of such notice, request and offer of indemnity has failed to institute any such proceeding; and 
(5) no direction inconsistent with such written request has been given to the Trustee during such 60-day period by the Holders of a majority in principal amount of the Outstanding Notes; 
it being understood and intended that no one or more of such Holders shall have any right in any manner whatever by virtue of, or by availing of, any provision of this Second Supplemental Indenture to affect, disturb or prejudice the rights of any other of such Holders, or to obtain or to seek to obtain priority or preference over any other of such Holders or to enforce any right under this Second Supplemental Indenture, except in the manner herein provided and for the equal and ratable benefit of all of such Holders. 
Section 4.8    Unconditional Right of Holders to Receive Principal, Premium and Interest.  Notwithstanding any other provision in this Second Supplemental Indenture, the Holder of any Note shall have the right, which is absolute and unconditional, to receive payment of the principal of and any premium and (subject to Section 3.7 of the Base Indenture) interest on such Note on the respective Stated Maturities expressed in such Note (or, in the case of redemption, on the Redemption Date) and to institute suit for the enforcement of any such payment, and such rights shall not be impaired without the consent of such Holder. 
Section 4.9    Restoration of Rights and Remedies.  If the Trustee or any Holder has instituted any proceeding to enforce any right or remedy under this Second Supplemental Indenture and such proceeding has been discontinued or abandoned for any reason, or has been determined adversely to the Trustee or to such Holder, then and in every such case, subject to any determination in such proceeding, the Company, the Trustee and the Holders shall be restored severally and respectively to their former positions hereunder and thereafter all rights and remedies of the Trustee and the Holders shall continue as though no such proceeding had been instituted. 
Section 4.10    Rights and Remedies Cumulative.  Except as otherwise provided with respect to the replacement or payment of mutilated, destroyed, lost or stolen Notes in the last paragraph of Section 3.6 of the Base 

	
			
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Indenture, no right or remedy herein conferred upon or reserved to the Trustee or to the Holders is intended to be exclusive of any other right or remedy, and every right and remedy shall, to the extent permitted by law, be cumulative and in addition to every other right and remedy given hereunder or now or hereafter existing at law or in equity or otherwise. The assertion or employment of any right or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other appropriate right or remedy. 
Section 4.11    Delay or Omission Not Waiver.  No delay or omission of the Trustee or of any Holder of any Notes to exercise any right or remedy accruing upon any Event of Default shall impair any such right or remedy or constitute a waiver of any such Event of Default or an acquiescence therein. Every right and remedy given by this Article or by law to the Trustee or to the Holders may be exercised from time to time, and as often as may be deemed expedient, by the Trustee or by the Holders, as the case may be. 
Section 4.12    Control by Holders.  The Holders of a majority in principal amount of the Outstanding Notes shall have the right to direct the time, method and place of conducting any proceeding for any remedy available to the Trustee, or exercising any trust or power conferred on the Trustee, with respect to the Notes, provided that 

(1) such direction shall not be in conflict with any rule of law or with this Second Supplemental Indenture, 
(2) the Trustee may take any other action deemed proper by the Trustee which is not inconsistent with such direction, and 
(3) subject to the provisions of Section 6.1 of the Base Indenture, the Trustee shall have the right to decline to follow such direction if a Responsible Officer or Responsible Officers of the Trustee shall, in good faith, determine that the proceeding so directed would be unjustly prejudicial to the Holders not joining in any such direction (it being agreed that the Trustee shall have no obligation to determine whether such proceeding shall be prejudicial to such Holders) or would involve the Trustee in personal liability. 
Section 4.13    Waiver of Past Defaults.  The Holders of not less than a majority in principal amount of the Outstanding Notes may on behalf of the Holders of all the Notes waive any past default hereunder and its consequences, except a default: 
(1) in the payment of the principal of or any premium or interest on any Note, or 
(2) in respect of a covenant or provision hereof which under Article Nine of the Base Indenture cannot be modified or amended without the consent of the Holder of each Outstanding Note so affected. 
Upon any such waiver, such default shall cease to exist, and any Event of Default arising therefrom shall be deemed to have been cured, for every purpose of this Second Supplemental Indenture; but no such waiver shall extend to any subsequent or other default or impair any right consequent thereon. 
Section 4.14    Undertaking for Costs.  All parties to this Second Supplemental Indenture agree, and each Holder of any Note by his acceptance thereof shall be deemed to have agreed, in any suit for the enforcement of any right or remedy under this Second Supplemental Indenture, or in any suit against the Trustee for any action taken, suffered or omitted by it as Trustee, a court may require any party litigant in such suit to file an undertaking to pay the costs of such suit, and may assess costs against any such party litigant, in the manner and to the extent provided in the Trust Indenture Act; provided that neither this Section nor the Trust Indenture Act shall be deemed to authorize any court to require such an undertaking or to make such an assessment in any suit instituted by the Trustee, a suit by a Holder pursuant to Section 4.8 or a suit by the holders of more than 10% in aggregate principal amount of Notes then outstanding. 
Section 4.15    Waiver of Usury, Stay or Extension Laws.  The Company covenants (to the extent that it may lawfully do so) that it will not at any time insist upon, or plead, or in any manner whatsoever claim or take the benefit or advantage of, any usury, stay or extension law wherever enacted, now or at any time hereafter in force, which may affect the covenants or the performance of this Second Supplemental Indenture; and the Company (to the extent that it may lawfully do so) hereby expressly waives all benefit or advantage of any such law and covenants that it will not hinder, 

	
			
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delay or impede the execution of any power herein granted to the Trustee, but will suffer and permit the execution of every such power as though no such law had been enacted. 
ARTICLE FIVE
APPOINTMENT OF THE TRUSTEE FOR THE NOTES 
Section 5.1 Security Registrar; Paying Agent.  The Company appoints U.S. Bank National Association, as Trustee, as Security Registrar and Paying Agent with respect to the Notes, and the Trustee hereby accepts such appointment.  
ARTICLE SIX
DEFEASANCE 
Section 6.1 Defeasance Applicable to Notes.  Pursuant to Section 3.1(18) and Section 13.1 of the Base Indenture, provision is hereby made for both (i) defeasance of the Notes under Section 13.2 of the Base Indenture and (ii) covenant defeasance of the Notes under Section 13.3 of the Base Indenture, in each case, upon the terms and conditions contained in Article 13 of the Base Indenture.  

ARTICLE SEVEN
MISCELLANEOUS 
Section 7.1 Application of Supplemental Indenture.  Each and every term and condition contained in this Second Supplemental Indenture that modifies, amends or supplements the terms and conditions of the Base Indenture shall apply only to the Notes created hereby and not to any future series of Securities established under the Base Indenture.  
Section 7.2 Benefits of this Second Supplemental Indenture.  Nothing contained in this Second Supplemental Indenture or in the Notes, express or implied, shall give to any Person, other than the parties to the Indenture, any Security Registrar, any Paying Agent, any Authenticating Agent and their successors under the Indenture, and the Holders, any benefit or any legal or equitable right, remedy or claim under the Base Indenture or this Second Supplemental Indenture.  
Section 7.3 Modification of the Base Indenture.  Except as expressly provided by this Second Supplemental Indenture, the provisions of the Base Indenture shall govern the terms and conditions of the Notes.  
Section 7.4 Effective Date.  This Second Supplemental Indenture shall be effective as of the date first above written and upon the execution and delivery hereof by each of the parties hereto.  
Section 7.5 Counterparts.  This Second Supplemental Indenture may be executed in any number of counterparts, each of which so executed shall be deemed to be an original, but all such counterparts shall together constitute but one and the same instrument.  The exchange of copies of this Second Supplemental Indenture and of signature pages by facsimile or PDF transmission shall constitute effective execution and delivery of this Second Supplemental Indenture as to the parties hereto and may be used in lieu of the original Second Supplemental Indenture for all purposes. Signatures of the parties hereto transmitted by facsimile or PDF shall be deemed to be their original signatures for all purposes.  
Section 7.6 Successors and Assigns.  All covenants and agreements in the Indenture, as supplemented and amended by this Second Supplemental Indenture, by the Company will bind its successors and assigns, whether so expressed or not.  
Section 7.7 Effect of Headings.  The Article and Section headings in this Second Supplemental Indenture are for convenience only and shall not affect the construction hereof.  

	
			
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Section 7.8 Separability Clause.  In case any provision in this Second Supplemental Indenture or in the Notes shall be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby.  
Section 7.9 Satisfaction and Discharge.  The Company shall be deemed to have satisfied all of its obligations under this Second Supplemental Indenture upon compliance with the provisions of Section 13.2 of the Base Indenture relating to defeasance of the Notes, to the extent set forth in Section 13.1 of the Base Indenture.  
Section 7.10 Ratification of the Base Indenture.  The Base Indenture as supplemented by this Second Supplemental Indenture, is in all respects ratified and confirmed, and this Second Supplemental Indenture will be deemed part of the Indenture in the manner and to the extent herein and therein provided.  
Section 7.11 Governing Law.  This Second Supplemental Indenture and the Notes shall be governed by, and construed in accordance with, the laws of the State of New York.  
Section 7.12 Waiver of Jury Trial.  EACH OF THE COMPANY AND THE TRUSTEE, AND EACH HOLDER OF A NOTE BY ITS ACCEPTANCE THEREOF, HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS SECOND SUPPLEMENTAL INDENTURE, THE BASE INDENTURE, THE NOTES OR THE TRANSACTIONS CONTEMPLATED HEREBY. Each of the Company and the Trustee hereby (i) certifies that no representative, agent or attorney of the other has represented, expressly or otherwise, that the other would not, in the event of a legal proceeding arising out of or relating to the Base Indenture or this Second Supplemental Indenture, seek to enforce the foregoing waiver and (ii) acknowledges that it has been induced to enter into this Second Supplemental Indenture by, among other things, the mutual waivers and certifications in this paragraph.
Section 7.13 Trustee Disclaimer. The Trustee accepts the amendments of the Base Indenture effected by this Second Supplemental Indenture, but on the terms and conditions set forth in the Base Indenture, including the terms and provisions defining and limiting the liabilities and responsibilities of the Trustee.  Without limiting the generality of the foregoing, the Trustee shall not be responsible in any manner whatsoever for or with respect to (i) any of the recitals contained herein, all of which recitals are made solely by the Company, (ii) the proper authorization hereof by the Company by action or otherwise, (iii) the due execution hereof by the Company or (iv) the consequences of any amendment herein provided for.  
Section 7.14 Written Communications.  All notices, approvals, consents, requests and any communications hereunder must be in writing (provided that any such communication sent to the Trustee hereunder must be in the form of a document that is signed manually or by way of a digital signature provided by DocuSign (or such other digital signature provider as specified in writing to the Trustee by the authorized representative), in English.  The Company agrees to assume all risks arising out of the use of using digital signatures and electronic methods to submit 

	
			
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communications to the Trustee, including without limitation the risk of the Trustee acting on unauthorized instructions, and the risk of interception and misuse by third parties.
[Signature page follows]
 

	
			
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IN WITNESS WHEREOF, the parties hereto have caused this Second Supplemental Indenture to be duly executed by their respective officers hereunto duly authorized, all as of the day and year first above written.  

AXOS FINANCIAL, INC.  
      
      
	
		
	By:
	 /s/ Andrew J. Micheletti

	Name:
	Andrew J. Micheletti

	Title:
	EVP & Chief Financial Officer

           
      
U.S. BANK NATIONAL ASSOCIATION, as Trustee 
      

	
		
	By:
	/s/ John Axt

	Name:
	John Axt

	Title:
	Vice President

	
			
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EXHIBIT A 
FORM OF FACE OF 4.875% FIXED-TO-FLOATING RATE SUBORDINATED NOTES DUE 2030 
THE FOLLOWING LEGEND SHALL APPEAR ON THE FACE OF EACH GLOBAL SECURITY: 
THIS SECURITY IS AN UNSECURED SUBORDINATED DEBT OBLIGATION OF AXOS FINANCIAL, INC.  THIS SECURITY IS NOT A DEPOSIT OR SAVINGS ACCOUNT AND IS NOT INSURED BY THE FEDERAL DEPOSIT INSURANCE CORPORATION OR ANY OTHER GOVERNMENTAL AGENCY OR INSTRUMENTALITY.  
THIS SECURITY IS A GLOBAL SECURITY WITHIN THE MEANING OF THE INDENTURE HEREINAFTER REFERRED TO AND IS REGISTERED IN THE NAME OF A DEPOSITARY OR A NOMINEE THEREOF.  THIS SECURITY MAY NOT BE EXCHANGED IN WHOLE OR IN PART FOR A SECURITY REGISTERED, AND NO TRANSFER OF THIS SECURITY IN WHOLE OR IN PART MAY BE REGISTERED, IN THE NAME OF ANY PERSON OTHER THAN SUCH DEPOSITARY OR A NOMINEE THEREOF, EXCEPT IN THE LIMITED CIRCUMSTANCES DESCRIBED IN THE INDENTURE.  
 

	
			
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AXOS FINANCIAL, INC.  
4.875% FIXED-TO-FLOATING RATE SUBORDINATED NOTES DUE 2030 
 
	
					
	 
	 
	 
	 
	 

	No.       
	 
	 
	 
	U.S.$                     

CUSIP NO.: 05465C AA8
ISIN NO.: US05465CAA80
AXOS FINANCIAL, INC. (formerly known as BofI Holding, Inc.), a corporation duly organized and existing under the laws of the State of Delaware (herein called the “Company,” which term includes any successor Person under the Indenture hereinafter referred to), for value received, hereby promises to pay to                 , or registered assigns, the principal sum of                  Dollars on October 1, 2030 (such date is hereinafter referred to as the “Stated Maturity Date”), unless redeemed prior to such date, and to pay interest thereon (i) from, and including, September 18, 2020, to, but excluding, October 1, 2025, unless redeemed prior to such date, at an interest rate of 4.875% per annum, semi-annually in arrears on April 1 and October 1 of each year, commencing on April 1, 2021 (each such date, a “Fixed Rate Interest Payment Date,” with the period from, and including, September 18, 2020 to, but excluding, the first Fixed Rate Interest Payment Date and each successive period from, and including, a Fixed Rate Interest Payment Date to, but excluding, the next Fixed Rate Interest Payment Date being a “Fixed Rate Period”) and (ii) from, and including, October 1, 2025 to, but excluding, the Stated Maturity Date, unless redeemed subsequent to October 1, 2025 but prior to the Stated Maturity Date, at an interest rate per annum equal to Three-Month Term SOFR, reset quarterly, plus 476 basis points, or such other rate as determined pursuant to the Second Supplemental Indenture, payable quarterly in arrears on January 1, April 1, July 1 and October 1 of each year through the Stated Maturity Date or earlier Redemption Date, commencing on January 1, 2026 (each, a “Floating Rate Interest Payment Date” and, together with the Fixed Rate Interest Payment Dates, the “Interest Payment Dates,” with the period from, and including, October 1, 2025 to, but excluding, the first Floating Rate Interest Payment Date and each successive period from, and including a Floating Rate Interest Payment Date to, but excluding, the next Floating Rate Interest Payment Date being a “Floating Rate Period”).  The amount of interest payable on any Fixed Rate Interest Payment Date during the Fixed Rate Period will be computed on the basis of a 360-day year consisting of twelve 30-day months up to, but excluding October 1, 2025, and, the amount of interest payable on any Floating Rate Interest Payment Date during the Floating Rate Period will be computed on the basis of a 360-day year and the number of days actually elapsed.  In the event that any scheduled Interest Payment Date for this Security falls on a day that is not a Business Day, then payment of interest payable on such Interest Payment Date will be paid on the next succeeding day which is a Business Day (any payment made on such date will be treated as being made on the date that the payment was first due and no interest on such payment will accrue for the period from and after such scheduled Interest Payment Date); provided, that in the event that any scheduled Floating Rate Interest Payment Date falls on a day that is not a Business Day and the next succeeding Business Day falls in the next succeeding calendar month, such Floating Rate Interest Payment Date will be accelerated to the immediately preceding Business Day, and, in each such case, the amounts payable on such Business Day will include interest accrued to, but excluding, such Business Day.  All percentages used in or resulting from any calculation of Three-Month Term SOFR shall be rounded, if necessary, to the nearest one hundred-thousandth of a percentage point, with 0.000005% rounded up to 0.00001%.  
The interest so payable, and punctually paid or duly provided for, on any Interest Payment Date will, as provided in the Indenture, be paid to the Person in whose name this Security (or one or more Predecessor Securities) is registered at the close of business on the fifteenth day (whether or not a Business Day) immediately preceding the applicable Interest Payment Date.  Any such interest not so punctually paid or duly provided for will forthwith cease to be payable to the Holder on such Regular Record Date and may either be paid to the Person in whose name this Security (or one or more Predecessor Securities) is registered at the close of business on a Special Record Date for the payment of such Defaulted Interest to be fixed by the Company, notice whereof shall be given 

	
			
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to Holders of Securities of this series (with a copy to the Trustee) not less than 10 days prior to such Special Record Date, or be paid at any time in any other lawful manner not inconsistent with the requirements of any securities exchange on which the Securities of this series may be listed, and upon such notice as may be required by such exchange, all as more fully provided in the Indenture.  
Payment of the principal of (and premium, if any) and interest on this Security will be made at the corporate trust office of the Trustee or at the office of any paying agent that the Company may designate, in such coin or currency of the United States of America as at the time of payment is legal tender for payment of public and private debts.  
Reference is hereby made to the further provisions of this Security set forth on the reverse hereof, which further provisions shall for all purposes have the same effect as if set forth at this place.  
Unless the certificate of authentication hereon has been executed by the Trustee referred to on the reverse hereof by manual signature, this Security shall not be entitled to any benefit under the Indenture or be valid or obligatory for any purpose.  
IN WITNESS WHEREOF, the Company has caused this instrument to be duly executed.  
[Signature Page Follows] 
  

	
			
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	A-3
	 

	
									
	 
	 
	 
	 
	 
	 
	 
	 
	 

	 
	 
	 
	 
	 
	 
	AXOS FINANCIAL, INC.

	 
	 
	 
	 
	 

	Dated:
	 
	 
	 
	 
	 
	 
	 
	 

	 
	 
	 
	 
	 

	 
	 
	 
	 
	 
	 
	By:
	 
	 

	 
	 
	 
	 
	 
	 
	Name:
	 
	 

	 
	 
	 
	 
	 
	 
	Title:
	 
	 

 
	
			
	 
	 
	 

	Attest:
	 
	 

	Name:
	 
	 

	Title:
	 
	 

	 
	 
	 

(Trustee’s Certificate of Authentication) 
This is one of the Securities of the series designated therein referred to in the within-mentioned Indenture.  
 
	
									
	 
	 
	 
	 
	 
	 
	 
	 
	 

	 
	 
	 
	 
	 
	 
	U.S.  BANK NATIONAL ASSOCIATION, as Trustee

	 
	 
	 
	 
	 

	Dated:
	 
	 
	 
	 
	 
	By:
	 
	 

	 
	 
	 
	 
	 
	 
	 
	 
	Authorized signatory

 

	
			
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[FORM OF REVERSE SIDE OF THE NOTE] 
This Security is one of a duly authorized issue of securities of the Company (herein called the “Securities”), issued and to be issued in one or more series under an Indenture, dated as of March 3, 2016 (herein called the “Base Indenture,” as supplemented by a Second Supplemental Indenture, dated as of September 18, 2020 (the “Second Supplemental Indenture”) (the Base Indenture as so supplemented, the “Indenture”)), between the Company and U.S. Bank National Association, as Trustee (herein called the “Trustee”, which term includes any successor trustee under the Indenture), and reference is hereby made to the Indenture for a statement of the respective rights, limitations of rights, duties and immunities thereunder of the Company, the Trustee, the holders of Senior Indebtedness and the Holders of the Securities and of the terms upon which the Securities are, and are to be, authenticated and delivered.  In the event of a conflict between the Indenture and this Security, the terms of the Indenture shall govern and control.  This Security is one of the series designated on the face hereof.  
The indebtedness evidenced by this Security is, to the extent provided in the Indenture, subordinate and subject in right of payment to the prior payment in full of all Senior Indebtedness, and this Security is issued subject to the provisions of the Indenture with respect thereto.  Each Holder of this Security, by accepting the same, (a) agrees to and shall be bound by such provisions, (b) authorizes and directs the Trustee on his or her behalf to take such actions as may be necessary or appropriate as requested by the Company to effectuate the subordination so provided and (c) appoints the Trustee his or her attorney-in-fact for any and all such purposes.  Each Holder hereof, by his or her acceptance hereof, waives all notice of the acceptance of the subordination provisions contained herein and in the Indenture by each holder of Senior Indebtedness, whether now outstanding or hereafter created, incurred, assumed or guaranteed, and waives reliance by each such holder upon said provisions.  
The Indenture contains provisions for defeasance at any time of certain restrictive covenants and Events of Default with respect to this Security, in each case upon compliance with certain conditions set forth in the Indenture.  
If an Event of Default with respect to Securities of this series shall occur and be continuing, the principal of the Securities of this series may be declared due and payable in the manner and with the effect provided in the Indenture.  
The Company may, at its option, redeem the Securities, in whole or in part, at a redemption price equal to 100% of the principal amount of the Securities to be redeemed, plus accrued and unpaid interest (the “Redemption Price”) to, but excluding, the date of redemption (the “Redemption Date”), on any Interest Payment Date on or after October 1, 2025.  The Company may also, at its option, redeem the Securities before the Stated Maturity Date, in whole, but not in part, at any time, upon the occurrence of a Tier 2 Capital Event, a Tax Event or if the Company is required to register as an investment company pursuant to the Investment Company Act of 1940, as amended.  Any such redemption will be at a redemption price equal to the Redemption Price to, but excluding, the Redemption Date fixed by the Company.  
Notwithstanding any of the foregoing, to the extent then required under or pursuant to applicable regulations of the Federal Reserve, this Security may not be repaid prior to the Stated Maturity Date without the prior written consent of the Federal Reserve.  In the event of redemption of this Security in part only, a new Security or Securities of this series and of like tenor for the unredeemed portion hereof will be issued in the name of the Holder hereof upon the cancellation hereof.  The provisions of Article 11 of the Base Indenture and Section 2.5 of the Second Supplemental Indenture shall apply to the redemption of any Securities by the Company.  
In the event that any payment on the Securities is subject to withholding of any U.S.  federal income tax or other tax or assessment (as a result of a change in law or otherwise), the Company will not pay additional amounts with respect to such tax or assessment.  
The Indenture permits, with certain exceptions as therein provided, the amendment thereof and the modification of the rights and obligations of the Company and the rights of the Holders of the Securities of each 

	
			
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series to be affected under the Indenture at any time by the Company and the Trustee with the consent of the Holders of a majority in principal amount of the Securities at the time Outstanding of each series to be affected.  The Indenture also contains provisions permitting the Holders of specified percentages in principal amount of the Securities of each series at the time Outstanding, on behalf of the Holders of all Securities of such series, to waive compliance by the Company with certain provisions of the Indenture and certain past defaults under the Indenture and their consequences.  Any such consent or waiver by the Holder of this Security shall be conclusive and binding upon such Holder and upon all future Holders of this Security and of any Security issued upon the registration of transfer hereof or in exchange herefor or in lieu hereof, whether or not notation of such consent or waiver is made upon this Security.  
As provided in and subject to the provisions of the Indenture, the Holder of this Security shall not have the right to institute any proceeding with respect to the Indenture or for the appointment of a receiver or trustee or for any other remedy thereunder, unless such Holder shall have previously given the Trustee written notice of a continuing Event of Default with respect to the Securities of this series, the Holders of not less than 25% in principal amount of the Securities of this series at the time Outstanding shall have made written request to the Trustee to institute proceedings in respect of such Event of Default and offered the Trustee indemnity satisfactory to it, and the Trustee shall not have received from the Holders of a majority in principal amount of Securities of this series at the time Outstanding a direction inconsistent with such request, and shall have failed to institute any such proceeding, for 60 days after receipt of such notice, request and offer of indemnity.  The foregoing shall not apply to any suit instituted by the Holder of this Security for the enforcement of any payment of principal hereof or any premium or interest hereon on or after the respective due dates expressed herein.  
No reference herein to the Indenture and no provision of this Security or of the Indenture shall alter or impair the obligation of the Company, which is absolute and unconditional, to pay the principal of and any premium and interest on this Security at the times, place and rate, and in the coin or currency, herein prescribed.  
As provided in the Indenture and subject to certain limitations therein set forth, the transfer of this Security is registrable in the Security Register, upon surrender of this Security for registration of transfer at the office or agency of the Company maintained under Section 10.2 of the Base Indenture for such purpose, duly endorsed by, or accompanied by a written instrument of transfer in form satisfactory to the Company and the Security Registrar duly executed by, the Holder hereof or his attorney duly authorized in writing, and thereupon one or more new Securities of this series and of like tenor, of authorized denominations and for the same aggregate principal amount, will be issued to the designated transferee or transferees.  
The Securities of this series are issuable only in registered form without coupons in minimum denominations of $1,000 and integral multiples of $1,000 in excess thereof.  As provided in the Indenture and subject to certain limitations therein set forth, Securities of this series are exchangeable for a like aggregate principal amount of Securities of this series and of like tenor of a different authorized denomination, as requested by the Holder surrendering the same.  
No service charge shall be made for any such registration of transfer or exchange, but the Company may require payment of a sum sufficient to cover any tax or other governmental charge payable in connection therewith.  
Prior to due presentment of this Security for registration of transfer, the Company, the Trustee and any agent of the Company or the Trustee may treat the Person in whose name this Security is registered as the owner hereof for all purposes, whether or not this Security be overdue, and neither the Company, the Trustee nor any such agent shall be affected by notice to the contrary.  
This Security shall be governed by and construed in accordance with the laws of the State of New York.  
All terms used in this Security which are defined in the Indenture shall have the meanings assigned to them in the Indenture.   

	
			
	19438429.8 
219280-10005
	A-6Exhibit 10.1

 

CERTAIN IDENTIFIED INFORMATION HAS BEEN
EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO ORAMED PHARMACEUTICALS
INC. IF PUBLICLY DISCLOSED. OMISSIONS ARE DENOTED IN BRACKETS WITH ASTERISKS THROUGHOUT THIS EXHIBIT.

 

 

 

 

 

 

 

 

CLINICAL RESEARCH ORGANIZATION SERVICES
AGREEMENT

 

 

 

 

By and Between

 

 

 

Oramed Ltd.

 

and

 

Integrium, LLC

 

 

 

 

 

 

 

Effective Date: January 15, 2020

 

 

 

 

 

 

 

 

     

     

    

 

	Integrium, LLC.	Confidential

 

CRO Agreement

 

EFFECTIVE DATE: January 15, 2020

 

Name and Address of the Contact for
Integrium, LLC

 

	Name:	Jessica Coutu
	 	 
	Title:	Sr. V.P. of Clinical Operations
	 	 
	Address:	100 East Hanover Avenue, Suite 401
	 	Cedar Knolls, NJ 07927
	 	 
	Telephone:	(908) 357-2010
	 	 
	Cell Phone:	(908) 458-3058
	 	 
	e-mail:	jessica.coutu@integrium.com

 

Name and Address of the Contact for
Oramed Ltd.

 

	Name:	Dr. Miriam Kidron
	 	 
	Title:	Chief Medical and Technology Officer
	 	 
	Address:	Hi-Tech Park 2/4 Givat-Ram,
	 	P.O. Box 39098
	 	Jerusalem, 91390, Israel
	 	 
	Telephone:	972 2 566001
	 	 
	Facsimile:	972 2 566004
	 	 
	e-mail:	miriam@oramed.com

 

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	Integrium, LLC.	Confidential

 

INDEX

 

	1.	Term	4
	 	 	 
	2.	Scope of Work	4
	 	 	 
	3.	Conditions of Work/Sponsor Responsibilities	4
	 	 	 
	4.	Compensation	5
	 	 	 
	5.	Representations of CRO	6
	 	 	 
	6.	Confidentiality	7
	 	 	 
	7.	Conflicts of Interest	8
	 	 	 
	8.	Independent Contractor	9
	 	 	 
	9.	Tax Reporting and Payment	9
	 	 	 
	10.	Ownership, Disclosure and Transfer of Developments and Study Data	10
	 	 	 
	11.	Relationship with Investigators	11
	 	 	 
	12.	Indemnification	12
	 	 	 
	13.	Limitation of Liability	13
	 	 	 
	14.	Insurance	14
	 	 	 
	15.	Termination	14
	 	 	 
	16.	Personnel Recruitment	15
	 	 	 
	17.	Equal Opportunity / Affirmative Action	15
	 	 	 
	18.	Miscellaneous Provision	15

 

	Exhibit 1	Protocol 
	Exhibit 2	Study Specifications: Assumptions, Timeline and Task Ownership Matrix
	Exhibit 3	Study Budget 
	Exhibit 4	Payment Schedule
	Exhibit 5	Transfer of Regulatory Obligations

 

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	Integrium, LLC.	Confidential

 

Oramed Ltd. (“Sponsor”),
an Israeli company, with principal offices at Hi-Tech Park 2/4 Givat-Ram, P.O. Box 39098, Jerusalem, 91390, Israel and Integrium,
LLC, (“Integrium”), a California limited liability company, located at 14351 Myford Road, Suite A, Tustin, California,
92780, hereby agree as follows:

 

		1.	Term

 

		1.1	The term of this Agreement shall be for the period beginning January 15, 2020 and ending upon the
satisfactory performance of all the Services (as defined herein) unless terminated sooner as provided herein. The initial term
of this Agreement was for the period beginning as of January 15, 2020 and ending on April 28, 2020 (the “Initial Term”)
during which Start-up activities for the Project were initiated. This Agreement now represents the US portion of the study in its
entirety. Any previous payments for the ORA-D-014 Start-up are incorporated and reconciled herein and represented in the payment
schedule.

 

		2.	Scope of Work

 

		2.1	Sponsor is conducting a Study pursuant to Protocol No. ORA-D-013-2, (“Protocol”)
entitled “A Double-Blinded, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety
of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Metformin Monotherapy.” (the “Study”).

 

		2.2	Integrium shall perform services (“Services”) as required for the execution
of the Protocol according to the Study Specifications (Study Assumptions, Timeline and Task Ownership Matrix), Exhibit 2,
attached hereto and made fully a part hereof. The designation of personnel to perform the services,
shall be within Integrium’s discretion, but Sponsor reserves the right, at its sole discretion, to reject any personnel so
designated by Integrium, and require replacement of such personnel. Prior to performing the Services under this Agreement, Integrium
will inform Sponsor of the identity of the personnel designated and Integrium shall make reasonable efforts to assure that the
personnel designated to perform the Services shall not be changed until the Services are completed; provided, however, that
where any such personnel ceases to be employed by Integrium, Integrium shall promptly notify Sponsor of such cessation and use
its best efforts to locate replacement personnel acceptable to Sponsor.

 

		3.	Conditions of Work/Sponsor Responsibilities

 

		3.1	In order for Integrium to perform the Services properly and timely, unless otherwise agreed in
writing, Sponsor shall provide Integrium with those materials and take those actions as described in the Study Specifications,
set out in Exhibit 2 attached hereto and made a part hereof. In addition, Sponsor shall cause all Sponsor contracted designees
to (i) reasonably cooperate with Integrium, and (ii) perform their services and supply to Integrium their study materials and deliverables
in a timely manner. Any failure under this Section 3.1 shall not constitute a breach of this Agreement by Sponsor but may require
changes in the budget/compensation and/or timelines for the Services in accordance with Section 4.3.

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	Integrium, LLC.	Confidential

 

		3.2	Sponsor and/or its representatives may, during the Term, visit Integrium’s facilities (and
those of Integrium’s approved contractors) at reasonable times and with reasonable frequency during normal business hours
to (i) observe the progress of the Study at Integrium’s facilities and all Study sites (it being clarified that Integrium
shall ensure that Sponsor has such rights viz-a-viz each Study site), (ii) monitor the accuracy and completeness of the Services,
including, but not limited to, quality control and assurance, and/or (iii) review the responsibilities and/or performance obligations
of Integrium personnel. Integrium will assist Sponsor in scheduling such visits and will make records and any other relevant information
available to Sponsor and/or its representatives.

 

		3.3	Both Sponsor and Integrium enter into the Agreement for the express purpose of transferring from
Sponsor to Integrium the responsibilities and obligations of a Sponsor to conduct, coordinate, manage, and/or develop the Study
in accordance with United States Food and Drug Administration (“FDA”) regulations set forth in 21 CFR Section
312, Subpart D, as such may be amended from time to time. Accordingly, if Sponsor is transferring to Integrium the responsibility
for various regulatory responsibilities under the U.S. laws and regulations as set forth in Exhibit 5 (sample form), a Transfer
of Regulatory Obligations Form will be completed. Any regulatory responsibilities not specifically stated as transferred to Integrium
shall remain the regulatory responsibility of Sponsor. Sponsor shall file the Transfer of Regulatory Obligations with the FDA or
as otherwise required by law or regulation. If an amendment to this Agreement affects the scope of regulatory obligations that
have been transferred to Integrium, Integrium and Sponsor shall execute a corresponding amendment. Such amendment shall be filed
by Sponsor with the appropriate government bodies.

 

		4.	Compensation

 

		4.1	In consideration for Integrium’s satisfactory performance of any and all of the Services,
Sponsor shall pay Integrium a fee in the amount and on the terms specified in Exhibit 3 (the “Study Budget and
Payment Schedule”) attached hereto and made fully a part hereof. All fees will be invoiced by Integrium and Sponsor shall
pay each invoice within thirty (30) days of receipt. If any portion of an invoice is disputed, then Sponsor shall pay the undisputed
amounts as provided above and the parties will use good faith efforts to reconcile the disputed amount as soon as practicable.
If any undisputed invoice is not paid within forty-five (45) days Sponsor will be considered in material breach. If the breach
is not cured within ten (10) days of written notice thereof provided by Integrium, Integrium will suspend all activity until the
breach is cured. If any breach extends beyond forty-five (45) days Integrium will terminate this Agreement. Any 3rd
Party Vendor late fee charges resulting from Sponsor delays in providing payment to Integrium will be passed on to Sponsor.

 

		4.2	Any statement or invoice for services or expenses shall be stated with sufficient specificity for
Sponsor to be able to determine the services performed, the work done, the related charges, and summary of pass through expenses.

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	Integrium, LLC.	Confidential

 

		4.3	Any material change in the Services, or the Assumptions set out in Exhibit 2 (including,
but not limited to, changes in an agreed starting date or suspension of the Study by the Sponsor) may require changes in the budget/compensation
and/or timelines and shall require a written amendment to this Agreement. Each amendment shall detail the changes to the Services,
Conditions, Compensation, Timeline or other matter. Sponsor agrees that it will not unreasonably withhold approval of an amendment
even if it involves a fixed price contract if the proposed changes in compensation or timelines result from, among other appropriate
reasons, changes in the assumptions upon which current compensation or timelines were based. Integrium shall not implement any
change in the Project scope without Sponsor’s prior written approval. Integrium reserves the right to postpone effecting
material changes in the Project’s scope until such time as the parties agree to and execute the corresponding Change Order.

 

		5.	Representations of CRO

 

		5.1	Integrium represents that it has the requisite facilities, equipment, and personnel with the requisite
expertise, experience and skill, to render the desired Services, and it shall render the Services, in a timely, competent and efficient
manner. Integrium further represents that the Services to be provided pursuant to this Agreement will represent Integrium’s
best efforts and will be of the highest professional standards and quality. Integrium further represents that it shall abide by
all laws, rules and regulations including, but not limited to, GCP Guidelines issued by the FDA that apply to the performance of
the Services at the time they are provided, including applicable requirements regarding equal employment opportunity and, when
on Sponsor’s premises, Integrium’s employees shall comply with Sponsor’s policies with respect to conduct of
visitors.

 

		5.2	Integrium certifies that neither Integrium nor any person employed by Integrium has been debarred
under Section 335a of Title 22 of the United States Code, and that no debarred person will in future be employed or utilized to
perform any Services. Integrium certifies that, to the best of its knowledge, no person performing any Services, including any
investigator, has a conviction which could lead to debarment under Section 335a. Furthermore, Integrium agrees to notify Sponsor
immediately of any action toward conviction or debarment of any person performing any Services. Integrium understands that Sponsor
shall have the right to terminate this Agreement immediately upon receipt of notice that any employee or agent of Integrium has
been debarred or is subject to any action toward conviction or debarment.

 

		5.3	Integrium shall maintain accurate and complete records specifically relating to the Services provided
hereunder in accordance with generally accepted accounting principles and practices, consistently applied. To the extent that such
records may be relevant in Sponsor’s reasonable opinion in determining whether Integrium is complying with its obligations
pursuant to this Agreement, Sponsor, or Sponsor’s authorized representative, may audit such records during Integrium’s
normal working hours and at Sponsor’s expense, upon providing five (5) working days’ written notice to Integrium. Integrium
shall retain such records for a period of three (3) years from the date of final payment by Sponsor pursuant to the Agreement.

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	Integrium, LLC.	Confidential

 

		5.4	Integrium represents and warrants that in any and all contracts between Integrium and a third party
with respect to the performance by such third party of clinical trials or tests and services associated with any such clinical
trials or tests (a “Third Party Contractor”), and in which Integrium acts as an agent or general contractor for Sponsor
and to which such contract Sponsor is not a party, Integrium will include a third party beneficiary provision naming Sponsor as
the third party beneficiary under such agreement. Notwithstanding anything to the contrary in this Agreement, prior to entering
into any contract or arrangement with any Third Party Contractor or with any subcontractor with respect to the performance by such
subcontractor of any of Integrium’s obligations under this Agreement, Integrium shall notify Sponsor thereof and be required
to obtain the written consent of Sponsor to any such contract or arrangement (such consent not to be unreasonably withheld, delayed
or conditioned).

 

		6.	Confidentiality

 

		6.1	It is understood by the parties hereto that during the performance of the Services, Integrium may
receive from Sponsor, or otherwise acquire, certain Confidential, Proprietary, and/or Trade Secret Information which is the property
of Sponsor (“Confidential Information”). Confidential Information shall include without limitation the Investigator’s
brochure, the Protocol, the data recorded during the Study and data, formulae and information on the Study drug. For purposes of
this Agreement, Confidential Information shall be understood to include all written or electronically transferred information received
from Sponsor by Integrium, and unless expressly described in this section 6.1 such written material shall be marked “Confidential.”
Confidential Information which is disclosed orally shall be deemed confidential if it is confirmed to be confidential by a writing
provided to Integrium by Sponsor within a reasonable amount of time following oral disclosure or if such information is known or
reasonably should be known by Integrium to be deemed to be Confidential Information (even without such written confirmation). Integrium
hereby warrants and affirms that it shall neither use nor disclose Confidential Information for any purpose other than as is specifically
allowed by this Agreement.

 

		6.2	Integrium shall disclose Confidential Information only to such of its employees or third parties
(approved by Sponsor in writing) as may reasonably be required to assist Integrium in the performance of this Agreement and who
have agreed to be bound by confidentiality and non-use terms and conditions similar to those in this Agreement. In the event of
such disclosure, Integrium shall advise its employees, of the confidential nature of the information and shall instruct them to
take all necessary and reasonable precautions to prevent the unauthorized use or disclosure thereof at least consistent with those
precautions undertaken by Integrium hereunder.

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	Integrium, LLC.	Confidential

 

		6.3	Upon the expiration or termination of this Agreement, Integrium shall either destroy or return
to Sponsor all tangible and electronic forms of Confidential Information, including any and all copies and/or derivatives of Confidential
Information made by Integrium (or Integrium’s employees or agents), as well as any writings, drawings, specifications, manuals
or other printed material made by Integrium (or Integrium’s employees or agents) and based on, or derived from, Confidential
Information; provided, however, that Integrium shall retain all information it is required by law to retain. Such information
shall be retained for the amount of time required by law using the same amount of care and diligence to protect Sponsor’s
information as it uses to protect its own confidential information but in any case not less than reasonable care and diligence.

 

		6.4	The foregoing obligations shall not apply to Confidential Information to the extent that
it: (a) is or becomes generally available to the public other than as a result of a disclosure by the receiving party; (b) becomes
available to the receiving party on a non-confidential basis from a source which is not prohibited from disclosing such information;
(c) was developed independently of any disclosure by the disclosing party or was known to the receiving party prior to its receipt
from the disclosing party, as shown by contemporaneous written evidence; or (d) is required by law or regulation to be disclosed
(in which case notice of such disclosure shall be given promptly to Sponsor and Integrium shall reasonably cooperate with Sponsor
in seeking to obtain assurances that any such information will be treated confidentially).

 

		6.5	Integrium shall not disclose, or otherwise make public, the terms of this Agreement, except as
may be necessary to secure enforcement of the terms of this Agreement or in response to a lawful subpoena or to comply with applicable
regulations.

 

		6.6	All of Integrium’s obligations set forth in this Article 6, including the obligations of
confidentiality and non-use, shall continue through the term of this Agreement and shall survive for a period of ten (10) years
following the expiration or termination of this Agreement.

 

		7.	Conflicts of Interest

 

		7.1	Integrium hereby warrants and represents that it has advised Sponsor, prior to the date of signing
of this Agreement, of any relationship with any third parties, including competitors of Sponsor, which would prevent Integrium
from performing the Services contemplated by this Agreement in accordance with the legal and ethical standards set out herein or
as otherwise mandated by applicable law.

 

		7.2	Integrium undertakes to advise Sponsor of any such relationships that might arise during the Term
of this Agreement. In the event such a relationship arises, the parties will discuss in good faith options to minimize or eliminate
possible effects of such conflicts of interest.

 

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	Integrium, LLC.	Confidential

 

		8.	Independent Contractor

 

		8.1	The parties hereto agree that Integrium is being retained and shall perform as an “Independent
Contractor”. Neither Integrium nor any of its employees performing Service’s, shall be employees of Sponsor, it being
understood and agreed that Integrium is an independent contractor for all purposes and at all times. All matters of compensation
and benefits and terms of employment for Integrium’s employees shall be solely a matter between Integrium and its employees.
Nothing contained herein shall be deemed or construed to create between the parties hereto a partnership or joint venture or employment
relationship. No party shall have the authority to act on behalf of any other party, or to commit any other party in any manner
or cause whatsoever or to use any other party’s name in any way not expressly authorized by this Agreement. No party shall
be liable for any act, omission, representation, obligation or debt of any other party, even if informed of such act, omission,
representation, obligation or debt.

 

		8.2	It is further understood that all Integrium services will be performed in accordance with Integrium’s
SOPs; provided, however, that in the event that the performance of such services according to such SOPs conflict with the
terms of this Agreement, performance of such services shall follow the terms of this Agreement.

 

		8.3	Integrium acknowledges and agrees that its employees are not eligible to participate in any benefits
programs offered by Sponsor to its employees, or in any pension plans, profit sharing plans, insurance plans (including but not
limited to, worker’s compensation insurance), or any other employee benefit or perquisite plans offered from time to time
by Sponsor to its employees or to receive Sponsor stock directly from Sponsor or its officers, directors, or employees.

 

		8.4	Nothing contained in this Agreement shall be construed as making the parties joint venturers or
as granting to either party the authority to bind or contract any obligations in the name of or on the account of the other party
or to make any representations, guarantees or warranties on behalf of the other party except to the extent such authority is expressly
provided in writing and agreed by the parties.

 

		9.	Tax Reporting and Payment

 

		9.1	Integrium acknowledges and agrees that it shall be solely responsible for paying the appropriate
amount of all federal, state and local taxes with respect to all compensation paid to Integrium pursuant to this Agreement, and
that Sponsor shall have no responsibility whatsoever for withholding or paying any such taxes for or on behalf of Integrium.

 

		9.2	Integrium further agrees to indemnify and hold Sponsor harmless from and against any and all damages,
losses, expenses, or penalties arising from or in connection with any claim brought by any federal, state or local taxing authority
with regard to Integrium’s failure to pay required taxes or failure to file required forms with regard to compensation paid
to Integrium by Sponsor pursuant to this Agreement.

 

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		10.	Ownership, Disclosure and Transfer of Developments
and Study Data

 

		10.1	Sponsor acknowledges that Integrium possesses certain computer technical expertise, software and
methodologies for administration of clinical trials, data collection, data management and statistical analyses methods which have
been independently developed by Integrium without the benefit of any information provided by Sponsor. Sponsor and Integrium agree
that any computer software programs, methodologies or other formulae or analyses or methodologies developed by Integrium in the
administration and the conduct of clinical trials used by Integrium under or during the term of this Agreement are the product
of Integrium’s technical expertise possessed and developed by Integrium prior to the date of this Agreement and remain the
sole property of Integrium and Sponsor agrees that such technology is commercially valuable to Integrium and Sponsor agrees not
to disclose such technology to any other party without Integrium’s prior written consent.

 

		10.2	All written materials and other works which may be subject to copyright and all patentable and
un-patentable inventions, discoveries, data, and ideas (including but not limited to any computer software) which are made, conceived
or reduced to practice or written by Integrium or Integrium’s employees or third party contractors authorized by Integrium
pursuant to the terms hereof and which are based upon or arise from the Services performed by Integrium specifically for
Sponsor (“Developments”) shall become Sponsor’s exclusive property, and may be used by Sponsor as Sponsor
deems appropriate in its sole discretion without any obligation of any nature (including financial, reporting, accounting or otherwise)
to Integrium. Integrium, by signing this Agreement, expressly agrees to Sponsor’s ownership of all Developments, and represents
and warrants that it has appropriate provisions in its agreements with third party contractors approved to provide services hereunder
that would enable Integrium to meet the obligations set out in this Article 10.

 

		10.3	Integrium agrees to hold all Developments in strict confidence in accordance with Article 6 of
this Agreement.

 

		10.4	Integrium shall disclose promptly to Sponsor each Development and, upon Sponsor’s request
and at Sponsor’s expense, Integrium shall assist Sponsor, or its designees, in filing patent or copyright applications in
any country in the world. Each copyrightable work, to the extent permitted by law, shall be considered a work made for hire and
the authorship and copyright of the work shall be in Sponsor’s name and, if not so considered, Integrium hereby assigns to
Sponsor all of Integrium’s rights, title, and interests in such works, and agrees to the waiver of all moral rights therein
- to the extent that same may exist. Integrium shall execute or cause to be executed by the inventor(s) or a duly authorized agent
of Integrium, as the case may be, all papers and do all things which may be necessary or advisable, in the opinion of Sponsor,
to prosecute such applications and to vest in Sponsor, or its designee, all the right, title and interest in and to the Developments.

 

		10.5	To avoid doubt, Integrium acknowledges and agrees that Sponsor and its licensors retain all right,
title and interest in and to the Confidential Information, the Investigator’s brochure, the Protocol, and all rights
and information underlying and related to the Study drug, and that no license (whether express or implied) to any of the foregoing
is granted to Integrium under this Agreement.

 

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		10.6	Upon the expiration or termination of this Agreement, Integrium shall transfer to Sponsor all Developments
including any and all copies and/or derivatives hereof, made by Integrium (or Integrium employees) as well as any writings, drawings,
specifications, manuals or other printed material made by Integrium (or Integrium employees or contractors), to the extent such
Development is not already transferred prior to expiration or termination. Notwithstanding the reason for expiration or termination
of this Agreement, Integrium shall under no circumstances be entitled to retain Confidential Information.

 

		10.7	All data developed relating to the Study shall be the sole and exclusive property of Sponsor, and
Sponsor may use all data relating to the Study for any lawful purpose, including but not limited to submission to the FDA or other
regulatory agencies. All agreements with Investigators and/or Trial Sites shall provide for the foregoing rights of Sponsor.

 

		10.8	Sponsor’s authorised representative(s) and, to the extent permitted by law, regulatory authorities
may, during regular business hours, arrange in advance with Integrium and/or the respective Principal Investigator(s) and/or Trial
Site(s) to inspect all data and work products relating to the respective Study and to examine Integrium’s facilities required
for performance of this Agreement.

 

		11.	Relationship with Investigators and Third Party
Contractors

 

		11.1	If this Agreement requires Integrium to contract with investigators or investigative sites (collectively,
“Investigators”), then any such contract shall be in a form mutually acceptable to Integrium and Sponsor. If
an Investigator requests any material changes to such form effecting Sponsor’s rights, Integrium shall submit the proposed
change to Sponsor, and Sponsor shall promptly review, comment on and/or approve such proposed change(s). The parties acknowledge
and agree that Investigators shall not be considered the employees, agents, or subcontractors of Integrium or Sponsor, and that
Investigators shall exercise their own independent medical judgement. Integrium’s responsibilities with respect to Investigators
shall be limited to those responsibilities specifically set forth in this Agreement and any amendments hereto.

 

		11.2	It is hereby agreed that Exhibit 3 (the “Study Budget and Payment Schedule”)
represents the entire consideration that will be paid by Sponsor to Integrium on behalf of the Study, and that the Sponsor will
not pay directly or indirectly to any third party, including Investigators, and/or any other third party vendors (IRBs, labs, meeting
planners, subcontracting CROs, IVRS, etc.), any amount that is not included in Exhibit 3. Sponsor acknowledges that Integrium
shall not be responsible for any Study timeline delays as a result of site enrollment delays due to lack of payment or late payment
from Sponsor. Integrium warrants that all up-front and advance payment or any monies made by Sponsor to Integrium will be allocated
only to the Sponsor study specified on the invoice and will not be used for any other purposes. Integrium will provide Sponsor
with a monthly pass-through reconciliation report indicating the status of these funds. Notwithstanding anything contained herein
to the contrary, Sponsor agrees to indemnify and hold Integrium harmless for any and all claims from any sites and 3rd
Party Vendors for unpaid invoices submitted to Sponsor.

 

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		11.3	Sponsor agrees that, although Integrium will assume responsibility for disbursing fees and/or expenses
to Investigators, and Third Party Contractors, Integrium is not liable for payment to Investigators and Third Party Contractors
until Sponsor has pre-paid Integrium in advance for these fees and expenses. Upon contract execution of this Agreement, Sponsor
agrees to provide the start-up and vendor advance requirements in accordance with Exhibit 4, Payment Schedule.

 

		11.4	Reserved

 

		11.5	Sponsor acknowledges and agrees that Integrium will not be responsible for delays in a Study or
Project to the extent that such delays are caused by Sponsor’s failure to make adequate pre-payment for Investigators’
services. Sponsor further acknowledges and agrees that payments for Investigator’s/vendors’ services are pass-through
payments at actual costs to Third Party Contractors and are separate from payments for Integrium’s Services. Sponsor agrees
that it will not withhold Investigator payments except to the extent that it has reasonable questions about the services performed
by a particular Investigator.

 

		12.	Indemnification

 

		12.1	Sponsor hereby agrees to indemnify, defend, and hold Integrium, and its respective agents, servants,
employees, officers, and directors (“Integrium Indemnities”) harmless from and against any and all losses, costs,
damages, expenses, claims, actions, liability, and/or suits (including court costs and reasonable attorney fees) (“Liabilities”)
suffered or incurred by Integrium or any of the foregoing as a result of personal injury to or death of a participant in any Study,
and such personal injury or death arises from or is, by unappealable judgment or binding settlement between the parties, attributed
to: (a) a claim of product liability or claim arising from the design, production, manufacture, or instructions for use of any
Study Product; (b) a claim of strict liability in tort; (c) the design of the Study; and (d) Sponsor’s negligence with respect
to performance of its obligations under this Agreement; provided, however, that if a claim with respect to the matters set
forth in this Section 12.1 hereof arises in whole or in part from Integrium’s negligence or intentional misconduct or fraud,
then the amount of Claim that Sponsor shall indemnify Integrium pursuant to this Section 12.1 shall be reduced by an amount in
proportion to the percentage of Integrium’s responsibilities for such Claim as determined by a court of competent jurisdiction
in a final and non-appealable decision or in a binding settlement between the parties. Under no circumstances shall Integrium be
liable for any Third Party Contractor’s (i) adherence to the Study Protocol, (ii) adherence to project specifications or
the Study timeline, (iii) breach of contract, (iv) the negligence or willful misconduct, or (v) any infringement, misappropriation
or violation by Third Party Contractors of any right of any other party.

 

		12.2	Integrium hereby agrees to indemnify, defend, and hold Sponsor and its respective affiliates, employees,
directors, agents, approved subcontractors and consultants (“Sponsor Indemnitees”) harmless from and against
any and all Liabilities suffered or incurred by and Sponsor Indemnitee arising out of (a) any Integrium Indemnitee’s error,
omission, gross negligence or willful misconduct, or (b) any breach of any covenant or warranty, or the inaccuracy of any representation
of Integrium in this Agreement, or (c) Integrium’s failure to comply with the terms of this Agreement.

 

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		12.3	Integrium Indemnitees agree: (a) to promptly notify Sponsor of any such Liability or Liabilities;
(b) to cooperate fully in the handling of such Liability or Liabilities and, in the event of litigation, to attend hearings and
trials and assist in securing and giving evidence, and obtaining the attendance of necessary and proper witnesses, and (c) to Sponsor’s
control of the defense and settlement, with Integrium’s consent which shall not be unreasonably withheld, of all Liability
or Liabilities by Sponsor. Sponsor will reimburse Integrium for all reasonable expenses incurred at Sponsor’s request in
connection with this Section 12.2 (b) except to the extent and in the proportion that Integrium is responsible under 12.1 Sponsor
shall carry out the management and defense of such claims or suits at their own expense.

 

		12.4	In the event that a patient participating in a Study suffers an illness or injury that the Investigator(s)
and Sponsor determine to be directly associated with Study participation, and for which Sponsor would be obligated to indemnify
Integrium under section 12.1, then – provided such illness or injury is not excluded by Sponsor’s insurance policy
-Sponsor shall pay all medical and hospital expenses directly associated with the medical treatment of such adverse reaction which
are in excess of that portion covered by the patient’s own insurance. In the event diagnostic procedures are required to
determine the etiology of the patient’s symptoms, Sponsor shall pay the reasonable expense of such diagnostic workup without
regard to the final diagnosis, but up to the amount covered by the Sponsor’s insurance policy and in accordance with its
terms.

 

		13.	Limitation of Liability; Damages

 

		13.1	Except in the case of gross negligence, willful misconduct, fraud or non-adherence to the Protocol,
neither Integrium, nor its affiliates, nor any of its or their respective directors, officers, employees or agents shall have any
liability of any type (including, but not limited, to contract, negligence, and tort liability), for any special, incidental, indirect
or consequential damages, including, but not limited to the loss of opportunity, loss of use, or loss of revenue or profit, in
connection with or arising out of this Agreement, or any service order, even if such damages may have been foreseeable to Integrium.
In addition, except in the case of gross negligence, willful misconduct, fraud or non-adherence to the Protocol, in no event shall
the collective, aggregate liability (including, but not limited to, contract, negligence and tort liability) of Integrium and its
affiliates and its and their respective directors, officers, employees and agents under this Agreement or any service order hereunder
exceed the CRO Service Fees Grand Total amount set out in the Study Budget.

 

		13.2	For Failure to Perform. In the event that the Services provided hereunder (or any portion
thereof) do not meet the specifications or other performance criteria agreed to by Integrium and Sponsor in writing, then Integrium
will, at Sponsor’s option, promptly (i) re-perform such Services at Integrium’s cost, or (ii) refund to Sponsor all
amounts paid by Sponsor to Integrium in connection with such Services.

 

		13.3	Except in the case of gross negligence, willful misconduct or fraud, neither Sponsor, nor its affiliates,
nor any of its or their respective directors, officers, employees or agents shall have any liability of any type (including, but
not limited, to contract, negligence, and tort liability), for any special, incidental, indirect or consequential damages, including,
but not limited to the loss of opportunity, loss of use, or loss of revenue or profit, in connection with or arising out of this
Agreement, or any service order, even if such damages may have been foreseeable to Sponsor.

 

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		14.	Insurance

 

		14.1	Each party will maintain, for the duration of this Agreement, insurance in an amount reasonably
adequate to cover its obligations under this Agreement and any and all Service Orders then in effect, and, upon request, each party
will provide to the other party a certificate of insurance showing that such insurance is in place.

 

		14.2	Sponsor will supply Integrium with the Clinical Trial Insurance Certificate for each Study covered
under a Service Order prior to commencement of subject screening for each Service Order. Integrium will not be responsible for
enrollment delays due to Sponsor’s delay in providing said Certificate.

 

		15.	Termination

 

		15.1	In the event that a party hereto shall commit a material breach of this Agreement, the other party
hereto shall have the right to terminate this Agreement immediately unless the breaching party can cure its breach and provide
full performance within thirty (30) days of notice to it that a material breach has been declared. Upon termination of this Agreement,
the non-breaching party shall have no further obligation to the breaching party, other than for Sponsor to pay for Services performed
by Integrium as of the date of such termination and any rights and duties which the parties expressly stated herein as surviving
termination.

 

		15.2	Sponsor may terminate this Agreement at any time by giving Integrium thirty (30) days written notice
of such termination. If Sponsor should terminate pursuant to this Article 15.2, Sponsor will pay for all Service units performed
up to the point of termination in accordance with the Budget, as well as costs reasonably incurred for the Services and which Integrium
is unable to cancel (for the avoidance of doubt, Sponsor shall be responsible for any and all 3rd Party Vendor cancellation fees
due upon Study cancellation), and all administrative costs incurred in the conduct of this Agreement up to the point of termination
for those Services which are necessary to be performed for patient safety, government requirement compliance and/or expressly requested
by Sponsor; provided, however, that no amounts shall be required to be paid which are in excess of the corresponding amounts
set forth for such activities in this Agreement. Integrium shall use its best efforts to minimize the costs incurred following
its receipt of notice of such termination.

 

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		15.3	Either party may terminate this Agreement upon receipt of written notice to the other party and
regard the other party as in breach of this Agreement, if the other party becomes insolvent, makes a general assignment for the
benefit of creditors, files a voluntary petition of bankruptcy, suffers or permits the appointment of a voluntary petition of bankruptcy,
suffers or permits the appointment of a receiver for its business or assets, or becomes subject to any proceeding under any bankruptcy
or insolvency law, whether domestic or foreign, or has wound up or liquidated, voluntary or otherwise. In the event that any of
the above events occur, that party shall immediately notify the other, in writing, of its occurrence.

 

		15.4	Upon receipt of notice of termination of this Agreement by either party: (i) Integrium will, as
soon as reasonably practicable discontinue providing the applicable Services, except to the extent reasonably required to safely
close out a Study or to transfer the remaining Services to another Service Provider selected by Sponsor, and (ii) Integrium will
terminate or, if requested by Sponsor, assign existing 3rd Party obligations to the extent cancelable or assignable, as applicable.
Any amounts paid by Sponsor which exceed the amounts owed to Integrium as of expiration or termination of this Agreement shall
be refunded to Sponsor within thirty (30) days after expiration or termination. Any amounts owed by Sponsor, including 3rd
Party Vendor cancellation fees, shall be paid to Integrium within thirty (30) days after expiration or termination.

 

		16.	Personnel Recruitment

 

		16.1	Neither Sponsor nor Integrium will solicit or make offers of employment to or enter into consultant
relationships with employees or consultants of the other party if such person was involved, directly or indirectly, in the performance
of this Agreement, at any time during the term of this Agreement; provided, however, that nothing contained herein will
prevent a party from hiring any such employee or consultant who responds to a general hiring program conducted in the ordinary
course of business or who approaches such party on a wholly unsolicited basis.

 

		17.	Reserved

 

		18.	Miscellaneous Provision

 

		18.1	Assignment. This Agreement may not be assigned by either party without the prior written
consent of the other party, except that either of the parties may assign this Agreement to a successor in connection with the merger,
consolidation or sale of all or substantially all of its assets. No assignment whether consensual or permissive shall relieve either
party of its responsibility for performance of its obligations under this Agreement.

 

		18.2	Complete Agreement. This Agreement, together with its exhibits and Change Orders then in
effect, supersedes all prior Agreements and understandings between the parties related to the subject matter of this Agreement.
	 	 	 

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		18.3	Waiver. No waiver by Sponsor with respect to any breach or default or of any right or remedy,
and no course of dealing by Sponsor shall be deemed to constitute a continuing waiver of any other breach or default or of any
other right or remedy, unless such waiver be expressed in writing, signed by Sponsor. No payment made by Sponsor shall be considered
as acceptance of satisfactory performance of the Services, or as in any way relieving Integrium from its full responsibility pursuant
to this Agreement.

 

		18.4	Amendment. This Agreement may not be altered, changed or amended except in writing signed
by each of the parties hereto.

 

		18.5	Survival. The provisions of this Agreement dealing with confidentiality, independent contractor,
ownership of developments, indemnification, limitations of liability, termination, governing law and survival shall survive the
expiration and/or termination of this Agreement.

 

		18.6	Severability. In the event that any provision of this Agreement is held illegal or invalid
for any reason, such provision shall not affect the remaining parts of this Agreement, but this Agreement shall be construed and
enforced as if that illegal and invalid provision had never been inserted herein.

 

		18.7	Extraordinary Relief. In the event of the actual or threatened breach by Integrium of any
of the terms of the Articles 6, 7, and 11 hereof, Sponsor shall have the right to specific performance and injunctive relief. The
remedies in this paragraph are in addition to all other remedies and rights available at law or in equity.

 

		18.8	Force Majeure. Performance of this Agreement by each party shall be pursued with
due diligence in all requirements hereof; however, neither party shall be liable for any loss or damage for delay or nonperformance
due to causes not reasonably within its control. In the event of any delay resulting from such causes, the time for performance
and payment hereunder shall be extended for a period of time necessary to overcome the effect of such delays. In the event of any
delay or nonperformance caused by such uncontrollable forces, the party affected shall promptly notify the other in writing of
the nature, cause, date of commencement thereof, and the anticipated extent of such delay, and shall indicate whether it is anticipated
that the completion date of the Agreement would be affected thereby.

 

		18.9	Captions and Headings. The captions, numbering and headings in this Agreement are for convenience
and reference only, and they shall in no way be held to explain, modify, or construe the meaning of the terms of this Agreement.

 

		18.10	Counterpart Originals. This Agreement may be executed in any number of counterparts, each
of which, when executed, shall be deemed to be an original and all of which together shall constitute one and the same document.

 

		18.11	Governing Law. It is understood and agreed that this Agreement shall be governed by the
laws of the State of Delaware in all respects of validity, construction and performance without regard to its conflict of laws
rules.
	 	 	 

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		18.12	Arbitration. Any controversy or claim arising out of or relating to this Agreement, or the
breach thereof, may be submitted to binding arbitration under the auspices of, and in accordance with, the then existing rules
of JAMS, in a forum selected by the party to whom a request for arbitration is directed. Notwithstanding the foregoing, either
party may seek injunctive or equitable relief from any court of competent jurisdiction.

 

		18.13	Notices. Except as otherwise provided, all communications and notices concerning payments
required under this Agreement shall be mailed by certified mail, return receipt requested postage prepaid, or sent by Federal Express
or telecopy to the addresses set forth below, or to such other addresses as the parties from time to time specify in writing

 

	 	If to Integrium for contractual matters:
	 	 	Integrium, LLC
	 	 	100 East Hanover Ave., Suite 401
	 	 	Cedar Knolls, NJ 07927
	 	 	Attn:  Jessica Coutu, Sr. VP Clinical Operations
	 	 	 
	 	If to Integrium for financial matters:
	 	 	 
	 	 	Integrium, LLC
	 	 	14351 Myford Road, Suite A
	 	 	Tustin, CA 92780
	 	 	Attn:  David Hyman, Financial Controller
	 	 	 
	 	If to Sponsor:	Oramed Ltd.
	 	 	Hi-Tech Park 2/5 Givat-Ram
	 	 	P.O. Box 39098
	 	 	Jerusalem 91390, Israel
	 	 	Attn: Dr. Miram Kidron

 

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of Page Intentionally Left Blank)

 

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IN WITNESS WHEREOF, the parties
hereto have executed, or have caused their duly authorized representatives to execute, this Agreement as of its initial effective
date.

 

	For and on behalf of	 	For and on behalf of
	Integrium, LLC	 	Oramed Ltd. 

 

	/s/ Jessica Coutu	 	/s/
                                         Nadav Kidron /s/ Josh Hexter

	By:	Jessica Coutu	 	By:	Nadav Kidron Josh Hexter
	 	 	 
	Title: 	Sr. Vice President, Clinical Operations	 	Title: 	CEO COO
	 	 	 	 	 
	Date:	September
                                         16, 2020
	 	Date: 	September 16, 2020

 

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Integrium/
Oramed

 

Exhibit
1

 

Protocol
Number: ORA-D-013-2

Version:
1 

Date:
26 AUG 2020

 

 

 

(Remainder
of Page Intentionally Left Blank)

 

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 Integrium/Oramed

 

Exhibit
2

 

Study
Specifications

 

 

 

(Remainder
of Page Intentionally Left Blank)

 

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	Project Identifiers	 	Version #2
	Sponsor Company	 	Oramed Ltd.
	Protocol Number	 	ORA-D-013-2
	Protocol Title	 	A Double-Blinded, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Metformin Monotherapy.
	Investigational Product(s)	 	ORMD-0801
	Indication	 	Type 2 Diabetes Mellitus 
	Therapeutic Area	 	Metabolic
	Study Phase	 	III
	Sponsor Country	 	Israel
	Country Locations	 	US, EU
	 	 	 
	Study Assumptions	 	 
	Subjects	 	Total	 	US	 	EU, Israel
	# Subjects Screened	 	1112	 	658	 	454
	% Screen Failure Rate	 	46%	 	46%	 	46%
	# Screen Failures 	 	512	 	303	 	209
	# Subjects Entering Run-In Phase	 	600	 	355	 	245
	% Run-In Failure Rate	 	0%	 	0%	 	0%
	# Run-In Failures 	 	0	 	0	 	0
	# Subjects Randomized	 	600	 	355	 	245
	% Early Termination Rate	 	30%	 	30%	 	30%
	# Early Terminations 	 	179	 	106	 	73
	# Subjects Complete	 	421	 	249	 	172
	 	 	 
	Country	 	US	Country 1	Country 2	Country 3	Israel
	Sites/Country	 	36	5	5	5	2
	 	 	 
	Sites	 	Total	 	US	 	EU, Israel
	# Sites Identified	 	79	 	39	 	40
	Total Sites 	 	61	 	36	 	25
	# Central IRB Sites	 	59	 	36	 	23
	# Local IRB Sites	 	2	 	0	 	2
	 	 	 
	Enrollment	 	 
	# Screened/site	 	18.23
	# Screened/site/week	 	0.35
	# Enrolled/site	 	9.84
	# Enrollment Rate (per site/per month)	 	0.82
	# Randomized/site	 	9.84
	# Randomization Rate (per site/ month)	 	0.82

 

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	Third Party Vendors	 	 
	Meeting Planner	 	1
	Central IRB	 	1
	Central Lab	 	1
	CGM Monitors/Glucometer Vendor	 	1 - Contracted by Sponsor
	Product Packaging & Distribution	 	1 - Contracted by Sponsor
	IWRS	 	1 - Contracted by Sponsor
	 	 	 
	Project Meetings	 	# Meetings	Assumptions
	Webcast Investigators’ Meeting	 	1	Assumes 1 3-hour WebEx meeting in US and 1 in EX-US (TBD)
	Launch Meeting 	 	1	Assumes 3-hour launch Meeting
	Sponsor Team Teleconferences	 	67	Assumes calls will be every other week on start-up and enrollment period then for the duration of the study
	Internal Team Teleconferences	 	6	Ad hoc as needed
	CRA Training Teleconference	 	1	Assumes a 3-hour CRA training teleconference.
	CRA Teleconferences	 	12	Assumes monthly from FPFV to Database Lock
	 	 	 
	Monitoring Assumptions - US	 	 
	# CRAs	 	6
	# Pre-Study Selection Visits	 	0 – Cost included in ORA-D-013-1
	# Initiation Visits	 	36
	# In Person Site Initiation Visits	 	33
	# Remote Site Initiation Visits	 	3
	# Interim Monitoring Visits	 	 
	Monitoring Interval (Maximum - weeks)	 	Assumed every 6-8 weeks dependent upon enrollment
	# Interim Monitoring Visits/site 	 	11.18
	# Additional Days on-site/site	 	2.45
	# 1-day Interim Monitoring Visits	 	402
	# Additional Days 	 	88
	# Close-out Visits	 	36
	 	 	 
	Safety Assumptions	 	 
	SAE rate (%)	 	6%
	Estimated # SAEs	 	36
	 	 	 
	Data Management	 	 
	CRF pgs per randomized patient	 	115
	Unique CRFs/Subject	 	53
	Standard	 	24
	Non-Standard	 	29
	Non-Unique CRFs/Subject 	 	62
	Standard	 	53
	Non-Standard	 	9

 

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	CRF pgs per early term	 	86
	CRF pgs per screen failure	 	29
	Total CRF Pages	 	78657
	Complete subjects	 	48415
	Early Terms	 	15394
	Screen Failures	 	14848
	Total DM Datasets	 	20
	Total Edit Checks	 	300
	Estimated # Total Queries	 	15731
	Est. # Queries/Patient (1/5 pages)	 	26.22
	Manual Coding	 	 
	# Medical History/Subject	 	2
	# ConMeds/Subject	 	2
	# AEs/Subject	 	2
	Data Transfers	 	 
	# Sponsor Transfers	 	2
	 	 	test,  final
	#  Lab Transfers	 	26
	 	 	test, monthly, final
	# Central CGM Reader Transfers	 	10
	 	 	test, quarterly, final
	# IWRS Transfers	 	2
	 	 	prior to primary lock and final lock
	 	 	 
	Statistical Analysis	 	The following assumptions are estimates. The total number of TLGs will be defined upon the finalization of the Statistical Analysis Plan. An amendment to the budget will be issued at that time, if applicable.
	# SAS Datasets	 	22
	Estimated Tables	 	 
	# Standard and Non-Standard Repeat	 	70
	# Non-Standard Unique	 	0
	Estimated Listings	 	 
	# Standard and Non-Standard Repeat	 	40
	# Non-Standard Unique	 	0
	Estimated Graphs	 	 
	# Standard and Non-Standard Repeat	 	20
	# Non-Standard Unique	 	0
	Exploratory Output	 	 
	# Exploratory Tables	 	0
	# Exploratory Listings	 	0
	# Exploratory Graphs	 	0
	Post-hoc Analysis	 	200

 

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	EDC - ClinPlus	 
	Number of Screens	 
	Unique Screens	53
	Redundant Screens	62
	Site Patient Activity Duration (Months)	13.1
	Enrollment Duration (Months)	12
	Server Activity Duration (Months)	15
	Usage Fee/Help Desk Fees	 	 	 	 	 
	Product Usage Fee/Month	[**]
	Intregrium Archiving Pricing	 
	CD/DVD per site	[**]
	Clinical Study Report	The budget is based on one draft and one final version of the CSR, assuming there will be no hyperlinking. If hyperlinking and/or additional versions of the CSR are requested, they will be provided at the study hourly rate for the actual additional hours.

 

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Project Timeline

 

	Project Activity	 	Date	 	Month #	 	Week #
	Study Start Date	 	January 15, 2020	 	0.0	 	0.0
	Create Site Feasibility Questionnaire	 	January 17, 2020	 	0.1	 	0.3
	Draft Protocol Date	 	April 27, 2020	 	3.4	 	14.7
	Identify 28 US sites	 	May 25, 2020	 	4.3	 	18.7
	Final Protocol Date	 	June 29, 2020	 	5.5	 	23.7
	Submission of Protocol to FDA	 	May 4, 2020	 	3.6	 	15.7
	Response from FDA	 	June 24, 2020	 	5.3	 	23.0
	Submission of Revised Protocol to FDA	 	July 31, 2020	 	6.5	 	28.3
	Response from FDA	 	September 29, 2020	 	8.5	 	36.9
	Submission of Protocol to EU Regulatory Authorities	 	August 30, 2020	 	7.5	 	32.6
	Initial Paper Representation of eCRF	 	August 21, 2020	 	7.2	 	31.3
	Final Paper Representation of eCRF	 	September 11, 2020	 	7.9	 	34.3
	Programming of Database Complete	 	October 16, 2020	 	9.0	 	39.3
	UAT/Pre-production Audit of Database Complete	 	November 2, 2020	 	9.6	 	41.7
	Drug Available at US Sites	 	November 2, 2020	 	9.6	 	41.7
	First Patient Screened in US	 	November 17, 2020	 	10.1	 	43.9
	Response from EU RegulatoryAuthorities	 	November 28, 2020	 	10.5	 	45.4
	First Patient Randomized to 26w Treatment Phase	 	December 8, 2020	 	10.8	 	46.9
	Identify 25 EU sites	 	December 26, 2020	 	11.4	 	49.4
	EU Pre-study Visits Complete	 	January 25, 2021	 	12.4	 	53.7
	EU Investigators' Meeting	 	February 10, 2021	 	12.9	 	56.0
	First Patient Screened in EU	 	February 12, 2021	 	13.0	 	56.3
	First Patient Enter 26w Extension Phase	 	June 8, 2021	 	16.8	 	72.9
	First Patient Last Visit	 	December 21, 2021	 	23.2	 	100.9
	Last Patient Screened	 	November 16, 2021	 	22.1	 	96.0
	Last Patient Randomized to 26w Treatment Phase	 	December 7, 2021	 	22.8	 	99.0
	Last Patient Completes 26 Treatment Period	 	June 7, 2022	 	28.8	 	125.0
	Last IMV 26w Treatment Phase	 	July 5, 2022	 	29.7	 	129.0
	Primary Database Lock	 	September 13, 2022	 	32.0	 	139.0
	Last Patient Enter 26w Extension Phase	 	June 8, 2022	 	28.8	 	125.1
	Last Patient Last Visit	 	December 20, 2022	 	35.2	 	153.0
	Last IMV	 	January 17, 2023	 	36.1	 	157.0
	Final Database Lock	 	March 28, 2023	 	38.4	 	167.0
	Draft Final TLGs	 	April 4, 2023	 	38.7	 	168.0
	Final TLGs	 	April 18, 2023	 	39.1	 	170.0
	Draft CSR	 	May 16, 2023	 	40.1	 	174.0
	Final CSR	 	June 13, 2023	 	41.0	 	178.0
	CRO End Date	 	June 23, 2023	 	41.3	 	179.4
	Total Project Duration (Months)	 	41.3	 	 	 	 

 

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	 	 	Months	 	Weeks	 	Phase
	Start-up	 	10.1	 	43.9	 	I
	Enrollment	 	12.0	 	52.1	 	II
	Treatment	 	13.1	 	57.0	 	III
	LPLV-DBL	 	3.2	 	14.0	 	IV
	DBL-CRO End	 	2.9	 	12.4	 	V
	 	 	41.3	 	179.4	 	 

 

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 Integrium/Oramed

 

EXHIBIT 3 

 

Study Budget

 

	 	 	STUDY START-UP	 	 	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	1	 	Project Management (Start Up)	 	[**]	 	10.1	 	Month	 	[**]
	2	 	Develop/Finalize Project Management Plan	 	[**]	 	1	 	Plan	 	[**]
	3	 	Project Launch Webcast Meeting/Training	 	[**]	 	1	 	Meeting	 	[**]
	4	 	Study Materials Management	 	[**]	 	61	 	Site	 	[**]
	5	 	CRA Training Teleconferences	 	[**]	 	1	 	Telecon	 	[**]
	6	 	Source Documentation Development	 	[**]	 	1	 	Total	 	[**]
	7	 	Site Identification	 	[**]	 	36	 	Site	 	[**]
	8	 	Pre-study Site Evaluation Visit	 	[**]	 	0	 	Visit	 	[**]
	9	 	Develop/Finalize CRA Monitoring Plan	 	[**]	 	1	 	Plan	 	[**]
	10	 	Data Management Plan ("DMP")	 	[**]	 	1	 	Total	 	[**]
	11	 	Regulatory Document Collection - Start Up	 	[**]	 	36	 	Site	 	[**]
	12	 	Investigator Budget/Contract Negotiations	 	[**]	 	36	 	Site	 	[**]
	13	 	WebEx Investigators' Meeting and Preparation	 	[**]	 	2	 	Meeting	 	[**]
	14	 	Clinical System Set-Up Configuration/Maintenance	 	[**]	 	37	 	Total	 	[**]
	 	 	STUDY START-UP FEES TOTAL	 	 	 	 	 	 	 	[**]

 

	 	 	EDC STUDY START-UP	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	15	 	eCRF Development	 	[**]	 	1	 	Total	 	[**]
	16	 	eCRF Completion Instructions	 	[**]	 	1	 	Total	 	[**]
	17	 	Edits Specifications and Programming	 	[**]	 	1	 	Total	 	[**]
	18	 	Validate/Test Data Entry Screens (UAT)	 	[**]	 	1	 	Total	 	[**]
	19	 	Annotate CRF	 	[**]	 	1	 	Total	 	[**]
	20	 	Clinical Database Development-SDTM Dataset Creation/Documentation	 	[**]	 	1	 	Total	 	[**]
	21	 	Database Design and Validation Specifications	 	[**]	 	1	 	Database	 	[**]
	22	 	EDC Kick-Off Meeting	 	[**]	 	1	 	Meeting	 	[**]
	23	 	Set-up Standard Data Entry Screens	 	[**]	 	1	 	Total	 	[**]
	24	 	Training Session	 	[**]	 	1	 	Study	 	[**]
	25	 	Project Manage all aspects of EDC start-up	 	[**]	 	1	 	Start-up	 	[**]
	26	 	Create Enrollment Screen	 	[**]	 	1	 	Total	 	[**]
	27	 	Data Export Programming	 	[**]	 	20	 	Dataset	 	[**]
	28	 	Register users and maintain passwords for life of study (per user (4 per site + 6 for sponsor))	 	[**]	 	250	 	Per User	 	[**]
	 	 	EDC START-UP FEES TOTAL	 	 	 	 	 	 	 	[**]

 

	 	 	CLINICAL MONITORING	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	29	 	Project Management (enrollment phase)	 	[**]	 	12.0	 	Month	 	[**]

 

    	Project: Oramed Ltd.
               ORA-D-013-2
	
 
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	 	 	CLINICAL MONITORING	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	30	 	Project Management (treatment phase)	 	[**]	 	13.1	 	Month	 	[**]
	31	 	Project Management Study (LPLV to DBL)	 	[**]	 	3.2	 	Month	 	[**]
	32	 	Project Management Study (DBL to CRO end)	 	[**]	 	2.9	 	Month	 	[**]
	33	 	Sponsor Team Teleconferences	 	[**]	 	67	 	Telecon	 	[**]
	34	 	Internal Team Teleconferences	 	[**]	 	6	 	Telecon	 	[**]
	35	 	CRA Teleconferences	 	[**]	 	24	 	Telecon	 	[**]
	36	 	Trial Master File	 	[**]	 	37	 	Site	 	[**]
	37	 	Regulatory Document Maintenance	 	[**]	 	1830	 	Month	 	[**]
	38	 	Protocol Amendment	 	[**]	 	36	 	Amendment	 	[**]
	39	 	Site Initiation Visits	 	[**]	 	33	 	Site	 	[**]
	40	 	Remote Site Initiation Visits	 	[**]	 	3	 	Visit	 	[**]
	41	 	Site Management/Patient Review/Query Resolution	 	[**]	 	1044	 	Site*Month	 	[**]
	42	 	Interim Monitoring Visits - One Day	 	[**]	 	402	 	Visit	 	[**]
	43	 	Interim Monitoring Visits - Additional Day On-site	 	[**]	 	88	 	Day	 	[**]
	44	 	Close-out Visits	 	[**]	 	36	 	Visit	 	[**]
	45	 	Site Grant Administration	 	[**]	 	936	 	Site*Month	 	[**]
	 	 	CLINICAL MONITORING/LOGISTICS SERVICES SUBTOTAL	 	 	 	 	 	 	 	[**]

 

	 	 	MEDICAL/SAE MANAGEMENT	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	46	 	Medical Management	 	[**]	 	28	 	Month	 	[**]
	47	 	Create Safety Plan	 	[**]	 	1	 	Plan	 	[**]
	48	 	Review Protocol Deviation Log	 	[**]	 	28	 	Month	 	[**]
	49	 	Tracking Protocol Waivers	 	[**]	 	28	 	Month	 	[**]
	50	 	Lab Alert/Patient Review	 	[**]	 	28	 	Month	 	[**]
	51	 	Review of AE Data Listings on a Monthly basis	 	[**]	 	28	 	Month	 	[**]
	52	 	Create Safety Database	 	[**]	 	2	 	Database	 	[**]
	53	 	SAE Management	 	[**]	 	36	 	SAE	 	[**]
	 	 	MEDICAL/SAE MANAGEMENT SERVICES SUBTOTAL	 	 	 	 	 	 	 	[**]

 

	 	 	DATA MANAGEMENT	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	54	 	Data Entry Activities	 	[**]	 	78,657	 	CRF Pg	 	[**]
	55	 	Generate/Track/Resolve Queries	 	[**]	 	15,731	 	Query	 	[**]
	56	 	Data Cleaning/Manual Listing Review	 	[**]	 	600	 	Patient	 	[**]
	57	 	Import Other Data	 	[**]	 	38	 	Transfer	 	[**]
	58	 	Export Data to Sponsor	 	[**]	 	2	 	Transfer	 	[**]
	59	 	Manual Coding	 	[**]	 	3,600	 	Manual Code	 	[**]
	60	 	Archive Study Records, Database	 	[**]	 	1	 	Database	 	[**]
	61	 	Data Base Lock Activities - Cohort A	 	[**]	 	2	 	Total	 	[**]
	 	 	DATA MANAGEMENT FEES SUBTOTAL	 	 	 	 	 	 	 	[**]

 

    	Project: Oramed Ltd.
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	 	 	EDC SYSTEM MAINTAINANCE	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	62	 	Coding System (Set-up Cost) [WHO/MEDRA]	 	[**]	 	1	 	Access User	 	[**]
	63	 	Third Party Data Integrations	 	[**]	 	43	 	Transfer	 	[**]
	64	 	SAS Platform (months)	 	[**]	 	41	 	Month	 	[**]
	65	 	Ongoing Support Project Management	 	[**]	 	15	 	Month	 	[**]
	66	 	CRF Export Programming (Site Archives, submission eCRFs)	 	[**]	 	1	 	Total	 	[**]
	67	 	Provide End of Study Archives to All Sites; 2 Copies to Sponsor	 	[**]	 	1	 	Total	 	[**]
	 	 	EDC SYSTEM SET-UP AND MAINTAINANCE SUBTOTAL	 	 	 	 	 	 	 	[**]

 

	 	 	BIOSTATISTICAL ANALYSIS	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	68	 	Draft & Final Statistical Analysis Plan (SAP)	 	[**]	 	1	 	SAP	 	[**]
	69	 	Analysis DataSets	 	[**]	 	22	 	Dataset	 	[**]
	70	 	Create/Document ADaM (Submission Ready) Datasets	 	[**]	 	22	 	Dataset	 	[**]
	71	 	Statistical Programming Deliverables (TLGs)	 	[**]	 	130	 	T/L/G	 	[**]
	72	 	Generate/QC TLFs	 	[**]	 	152	 	Appendix	 	[**]
	73	 	Output Review/Dry Runs	 	[**]	 	3	 	Dry Run	 	[**]
	74	 	Post-hoc Analysis Hours	 	[**]	 	200	 	Hour	 	[**]
	75	 	Annual IND Listings	 	[**]	 	3	 	Annual IND	 	[**]
	 	 	BIOSTATISTICAL ANALYSIS SUBTOTAL	 	 	 	 	 	 	 	[**]

 

	 	 	MEDICAL WRITING	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	76	 	Finalize Protocol	 	[**]	 	1	 	Protocol	 	[**]
	77	 	Develop/Finalize  ICF	 	[**]	 	1	 	Total	 	[**]
	78	 	Final CSR	 	[**]	 	1	 	Total	 	[**]
	 	 	MEDICAL WRITNG SUBTOTAL	 	 	 	 	 	 	 	[**]
	 	 	CRO SERVICE FEES GRAND TOTAL	 	 	 	 	 	 	 	[**]

 

	 	 	PASS THROUGH COSTS	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	1	 	Pre-study Site Evaluation Visit	 	[**]	 	0	 	Visit	 	[**]
	2a	 	Site Initiation Visit	 	[**]	 	36	 	Visit	 	[**]
	2b	 	Remote Site Initiation Visits	 	[**]	 	3	 	Visit	 	[**]
	3a	 	Interim Monitoring Visits - One Day	 	[**]	 	402	 	Visit	 	[**]
	3b	 	Interim Monitoring Visits - Additional Day On-site	 	[**]	 	88	 	Day	 	[**]
	4	 	Close-out Visits	 	[**]	 	36	 	Visit	 	[**]
	5	 	WebEx Investigators' Meeting Planner	 	[**]	 	1	 	Meeting	 	[**]
	6	 	Investigator Grants	 	[**]	 	 	 	 	 	[**]
	6a	 	# Patients Completed	 	[**]	 	249	 	Patient	 	[**]
	6b	 	# Screen Failures	 	[**]	 	303	 	Patient	 	[**]
	6c	 	# Early Terminations	 	[**]	 	106	 	Patient	 	[**]
	6d	 	# Rescue Visits	 	[**]	 	34	 	Visit	 	[**]
	6e	 	# Unscheduled visits	 	[**]	 	34	 	Visit	 	[**]
	7	 	Site: Advertising/Patient Recruitment	 	[**]	 	36	 	Site	 	[**]

 

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	 	 	PASS THROUGH COSTS	 	UNIT COST	 	UNITS	 	MEASURE OF UNIT	 	TOTAL
	8	 	Site: Archive Fees	 	[**]	 	36	 	Site	 	[**]
	9	 	Site: Database Recruitment Fee	 	[**]	 	36	 	Site	 	[**]
	10	 	Site: Start-up Costs	 	[**]	 	36	 	Site	 	[**]
	11	 	Site: Regulatory Fee	 	[**]	 	0	 	Site	 	[**]
	12	 	Site: Pharmacy Fee	 	[**]	 	36	 	Site	 	[**]
	13	 	Site: IRB Fees	 	[**]	 	0	 	Total	 	[**]
	14a	 	Central IRB - Protocol Submission	 	[**]	 	1	 	Protocol	 	[**]
	14b	 	Central IRB - Site Submissions	 	[**]	 	36	 	Protocol	 	[**]
	14c	 	Central IRB annual renewal	 	[**]	 	36	 	Amend.	 	[**]
	14d	 	Central IRB - Site Specific Translations	 	[**]	 	10	 	Site	 	[**]
	14e	 	Central IRB annual renewal	 	[**]	 	36	 	Total	 	[**]
	14f	 	Central IRB Closeout Fee	 	[**]	 	36	 	Site	 	[**]
	14g	 	Central IRB - Advertising Approval	 	[**]	 	36	 	Site	 	[**]
	15	 	Estimated Central Laboratory Fees	 	[**]	 	1	 	Total	 	[**]
	16	 	Estimated CGM/Glucometer Fees	 	[**]	 	0	 	Total	 	[**]
	17	 	Estimated IWRS Fees	 	[**]	 	1	 	Total	 	[**]
	18	 	EDC Platform Product Usage	 	[**]	 	31	 	Total	 	[**]
	19	 	EDC Coding System Integration Fee [WHO/MEDRA]	 	[**]	 	1	 	Total	 	[**]
	20	 	End of study archive CDs to sites; 2 copies to Sponsor	 	[**]	 	63	 	Total	 	[**]
	21	 	Regulatory Binders	 	[**]	 	39	 	Binder	 	[**]
	22	 	Copying/ Printing	 	[**]	 	1	 	Total	 	[**]
	23	 	Postal & Shipping Fees	 	[**]	 	1	 	Total	 	[**]
	 	 	PASS-THROUGH COSTS TOTAL	 	 	 	 	 	 	 	[**]
	 	 	PROJECT'S OVER-ALL TOTAL COST	 	 	 	 	 	 	 	$ 	12,342,808.81

 

    	Project: Oramed Ltd.
               ORA-D-013-2
	
 
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 Integrium/Oramed

 

EXHIBIT 4 

 

Study Payment Schedule

 

Payment
Schedule

 

	Monthly Management Fees	 	Month	 	$ Amount	 	Verification of Milestone Completion/Deliverables
	Project Management Fees	 	January 2020	 	[**]	 	Paid (ORA-D-014 Start-up)
	Project Management Fees	 	February 2020	 	[**]	 	Paid (ORA-D-014 Start-up)
	Project Management Fees	 	March 2020	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	April 2020	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	May 2020	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	June 2020	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	July 2020	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	August 2020	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	September 2020	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	October 2020	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	November 2020	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	December 2020	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	January 2021	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	February 2021	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	March 2021	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	April 2021	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	May 2021	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	June 2021	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	July 2021	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	August 2021	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	September 2021	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	October 2021	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	November 2021	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	December 2021	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	January 2022	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	February 2022	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	March 2022	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	April 2022	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	May 2022	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	June 2022	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	July 2022	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	August 2022	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	September 2022	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	October 2022	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	November 2022	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	December 2022	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	January 2023	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	February 2023	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	March 2023	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	April 2023	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	May 2023	 	[**]	 	Invoiced Monthly
	Project Management Fees	 	June 2023	 	[**]	 	Invoiced Monthly
	 	 	Total Monthly Management Fees:	 	[**]	 	 

 

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	Monthly Service Fees	 	Date	 	% Total Service Budget	 	% Milestone Service Budget	 	$ Amount	 	Verification of Milestone Completion/Deliverables
	Contract Execution	 	12/1/2017	 	5.15%	 	10.49%	 	[**]	 	Contract Execution
	EDC System Complete	 	11/2/2020	 	0.82%	 	1.68%	 	[**]	 	UAT complete
	1st Subject Randomized	 	12/8/2020	 	2.06%	 	4.20%	 	[**]	 	Enrollment log
	25% Subjects Randomized	 	3/9/2021	 	5.15%	 	10.49%	 	[**]	 	Enrollment log
	50% Subjects Randomized	 	6/8/2021	 	5.15%	 	10.49%	 	[**]	 	Enrollment log
	75% Subjects Randomized	 	9/7/2021	 	5.15%	 	10.49%	 	[**]	 	Enrollment log
	100% Subjects Randomized	 	12/7/2021	 	5.15%	 	10.49%	 	[**]	 	Enrollment log
	1st Subject Last Visit	 	12/21/2021	 	2.68%	 	5.45%	 	[**]	 	Enrollment log
	25% Subjects Last Visit	 	3/22/2022	 	2.68%	 	5.45%	 	[**]	 	Enrollment log
	50% Subjects Last Visit	 	6/21/2022	 	2.68%	 	5.45%	 	[**]	 	Enrollment log
	Primary Database Lock	 	9/13/2022	 	3.71%	 	7.55%	 	[**]	 	Database Lock
	75% Subjects Last Visit	 	9/20/2022	 	2.68%	 	5.45%	 	[**]	 	Enrollment log
	100% Subjects Last Visit	 	12/20/2022	 	2.68%	 	5.45%	 	[**]	 	Enrollment log
	Final Database Lock	 	3/28/2023	 	2.68%	 	5.45%	 	[**]	 	Database Lock
	Draft Final TLGs	 	4/4/2023	 	0.69%	 	1.41%	 	[**]	 	Draft Final TLGs
	Total Milestone Based Services:	 	 	 	49.09%	 	100.00%	 	[**]	 	 
	 	 	 	 	 	 	 	 	 	 	 
	Unit Based Payments: 
 Actual Units Invoiced Monthly	 	% Total Services Budget	 	# Units	 	Unit Cost	 	$ Amount	 	Verification of Milestone Completion/Deliverables
	SAE Management	 	1.83%	 	36	 	[**]	 	[**]	 	Invoiced monthly as occurred
	 	 	 	 	 	 	Total Unit Based Services:	 	[**]	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Total Services:	 	[**]	 	 
	 	 	 	 	 	 	 	 	 	 	 
	Pass-through expenses	 	$ Amount	 	Verification of Milestone Completion/Deliverables
	Monitoring Visit Travel Expenses	 	[**]	 	Invoiced as Actuals Monthly
	Investigator Grants	 	[**]	 	Invoiced and Paid in Advance of Payment to Vendor
	Site Start-up Costs	 	[**]	 	Invoiced and Paid in Advance of Payment to Sites
	Site Advertising	 	[**]	 	Invoiced as Actuals Monthly
	Site Archiving Fees	 	[**]	 	Invoiced as Actuals Monthly
	IRB Fees	 	[**]	 	Invoiced as Actuals Monthly
	Meeting Planner	 	[**]	 	Invoiced and Paid in Advance of Payment to Vendor
	Central Lab Vendor	 	[**]	 	Invoiced and Paid in Advance of Payment to Vendor
	IWRS Vendor	 	[**]	 	Invoiced and Paid in Advance of Payment to Vendor
	CGM/Glucometer Vendor	 	[**]	 	Invoiced and Paid in Advance of Payment to Vendor
	EDC Platform Usage Fees	 	[**]	 	Invoiced as Actuals Monthly
	Copying/Printing/Supplies	 	[**]	 	Invoiced as Actuals Monthly
	Postal & Shipping Fees	 	[**]	 	Invoiced as Actuals Monthly
	Total Pass-through Budget:	 	[**]	 	 
	 	 	 	 	 	 	 	 	 	 	 
	Grand Total Budget:	 	$  12,342,808.81	 	 

 

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Pass Through Advance Payment Schedule

 

	 	 	Contract Execution	 	TBD	 	 Study Total
	Investigators' Meeting Planner:
 80% invoiced start-up payment

    20% paid upon final reconciliation	 	[**]	 	[**]	 	[**]
	Site Start-up Costs:
 [**]/site x 36 sites	 	[**]	 	[**]	 	[**]
	Site Grant Payments: 
 Advance Payment = [**]/site X 36 sites	 	[**]	 	[**]	 	[**]
	Site Pharmacy Fees:
 [**]/site x 36 sites	 	[**]	 	[**]	 	[**]
	Central Lab Vendor:
 Start-up payment	 	[**]	 	[**]	 	[**]
	Pass-Through Advance Payment	 	[**]	 	[**]	 	[**]

 

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EXHIBIT 5 

 

Transfer of Regulatory Obligations

 

TRANSFER OF US FDA REGULATORY OBLIGATIONS FOR INVESTIGATIONAL PHARMACEUTICAL AND BIOLOGIC PRODUCTS UNDER AN INVESTIGATIONAL NEW DRUG (IND) APPLICATION (21 CFR 312.52 and ICH E6) 

 

	Study Drug:	ORMD-0801

 

IND
#:

 

Protocol Title: A Double-Blinded, Placebo-controlled,
Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus
with Inadequate Glycemic Control on Metformin Monotherapy.

 

Pursuant to 21 CFR 312.52 and ICH E6, the following obligation(s)
of the Sponsor, Oramed Ltd. have been transferred to:

 

	CRO Name:	Integrium, LLC
	CRO Address:	14351 Myford Road
	 	Tustin, CA 92780

 

	 	 	 	 	 	 	 	Obligation Assigned to:1
	Responsibility	 	Reference	 	Integrium	 	Oramed	 	Third
    Party Vendor
	A.	1.	Preparation
    of all or part of an IND application	 	312.23 21CFR	 	N/A	 	N/A	 	N/A
	 	 	 	 	 	 	 	 	 	 	 	 
	 	2.	Submission
    of IND application to FDA, submit all Amendments to FDA	 	 	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	B.	Maintain
    an IND with the following amendments, as necessary:	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	1.	Preparation
    of Protocol amendments (includes new protocols, changes in protocols, adding new investigators)	 	312.30 21CFR	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	2.	Preparation
    of  Chemistry, Manufacturing, and Control amendments	 	312.31 21CFR	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	3.	Preparation
    of Pharmacology and Toxicology amendments	 	312.31 21CFR	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	4.	Preparation
    of Clinical amendments	 	312.31 21CFR	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	5.	Safety
    Reports	 	312.32
    21CFR	 	 	 	 	 	 
	 	 	(a)	Preparation
    of initial report	 	 	 	☒	 	☐	 	☐
	 	 	(b)	Preparation
    of follow-up reports	 	 	 	☒	 	☐	 	☐
	 	 	(c)	Notifications
    to FDA (phone/fax or written)	 	 	 	☐	 	☐	 	☒
	 	 	(d)	Notifications
    to investigators	 	 	 	☒	 	☐	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	6.	Preparation
    of Annual Reports	 	312.33 21CFR	 	☐	 	☐	 	☒
	 	 	 	 	 	 	 	 	 	 	 	 
	 	7.	Preparation
    of response to request for information or clinical hold	 	312.41,
    312.42 CFR	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	8.	Preparation
    of letter to withdraw an IND	 	312.38 CFR	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 

 

    	Project: Oramed Ltd.
               ORA-D-013-2
	
 
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	Integrium, LLC.	Confidential

 

	 	 	 	 	 	 	 	Obligation Assigned to:1
	Responsibility	 	Reference	 	Integrium	 	Oramed	 	Third
    Party Vendor
	C.	Preparation
    and Update Investigative Brochure	 	21
    CFR 312.55 (a)

 ICH
    E6 5.12, 7.3	 	☐	 	☒	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	D.	Selecting
    investigators and monitors	 	21 CFR 312.53	 	☒	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 
	 	1.	Select
    qualified investigators	 	21
CFR 312.53 (a);	 	 	 	 	 	 
	 	 	(a)	Identify
    qualified investigators/sites	 	ICH E6 5.6.1 	 	☒	 	☒	 	☐
	 	 	(b)	Approve
    investigators/sites for participation	 	 	 	☒	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	2.	Control
    of drug	 	 	 	 	 	 	 	 
	 	 	(a)	Obtain
    required information from investigator (including signed Form FDA 1572, CV)	 	21
    CFR 312.53 (c);

 ICH E6 5.14.2, 8.2	 	☒	 	☐	 	☐
	 	 	(b)	Approved
    investigators for receipt of drug shipment	 	21
    CFR 312.53 (b);

 ICH E6 5.14.2	 	☒	 	☐	 	☐
	 	 	(c)	Ship
    drug to approved investigators	 	21
    CFR 312.53 (b);

 ICH E6 5.14.1,
    5.14.4(a)	 	☒	 	☐	 	☒
	 	 	(d)	Maintain
    shipment records	 	21
    CFR 312.57 (a);

 ICH E6 5.14.4(b)	 	☒	 	☐	 	☒
	 	3.	Provide
    qualified monitors	 	21
    CFR 312.53 (d);

 ICH E6 5.18.2	 	☒	 	☐	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	4.	Informing
    investigators	 	 	 	 	 	 	 	 
	 	 	(a)	Review
    with investigators their regulatory responsibilities	 	Guideline
    for the Monitoring of Clinical Investigations; ICH E6 5.18.4 (f)(g)	 	☒	 	☐	 	☐
	 	 	(b)	Deliver
    investigator’s brochure	 	21
    CFR 312.55 (a);

 ICH E6 5.6.2	 	☒	 	☐	 	☐
	 	 	(c)	Inform
    participating investigators of new safety information about the study drug	 	21
    CFR 312.55 (b);

 ICH E6 5.16.2	 	☒	 	☐	 	☐
	 	 	(d)	Notify
    participating investigators of all serious unexpected adverse drug reactions	 	21
    CFR 312.32 (c);

 ICH E6 5.17.1	 	☒	 	☐	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	E.	Review
    of ongoing investigations	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	1.	Monitoring
    the investigation	 	21 CFR 312.56	 	☒	 	☐	 	☐
	 	 	 	 	 	21
    CFR 312.56 (a);

 ICH E6 5.18.4	 	 	 	 	 	 
	 	2.	Discontinue
    investigator participation if not compliant	 	 	 	☒	 	☒	 	☐
	 	 	(a)	Notify
    FDA	 	 	 	☒	 	☐	 	☐
	 	 	(b)	Assure
    disposal or return of investigational drug	 	21
    CFR 312.56 (b);

 ICH E6 5.20	 	☒	 	☐	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	3.	Provide
    medical expertise to evaluate safety information	 	21
    CFR 312.56 (c);

 ICH E6 5.16.1	 	☒	 	☐	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	 	4.	Upon
    premature termination or suspension of a trial:	 	 	 	 	 	 	 	 
	 	 	(a)	Notify
    IRBs or notify investigators of their responsibility to notify IRBs	 	21
    CFR 312.56 (d);

 ICH E6 5.21	 	☒	 	☐	 	☐
	 	 	(b)	Notify
    investigators	 	 	 	☒	 	☐	 	☐
	 	 	(c)	Assure
    disposition of drug from sites to sponsor	 	 	 	☒	 	☐	 	☐
	 	 	(d)	Notify
    FDA	 	 	 	☐	 	☐	 	☒

 

    	Project: Oramed Ltd.
               ORA-D-013-2
	
 
 Page 35	 

     

    

 

	Integrium, LLC.	Confidential

 

	 	 	 	 	 	 	 	Obligation
    Assigned to:1
	Responsibility	 	Reference	 	Integrium	 	Oramed	 	Third
    Party Vendor
	F.	Trial
    Data Handling and Reporting	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	(a)	Manage
    an independent date safety monitoring committee	 	ICH
    E6 5.5.2	 	NA	 	NA	 	NA
	 	 	(b)	Data
    Management	 	ICH
    E6 5.5.1	 	☒	 	☐	 	☐
	 	 	(c)	Statistical
    plan and/or analysis	 	ICH
    E6 5.5.1	 	☒	 	☐	 	☐
	 	 	(d)	Final
    study report	 	ICH
    E6 5.5.1	 	☒	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	G.	Recordkeeping
    and record retention	 	21
    CFR 312.57	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	1.	Maintain
    sponsor records and reports, other than shipment records (see C.2.d), during the course of the investigation	 	21
    CFR 312.57 (b),

    312.58 (a); ICH E6

    5.5.6, 5.5.7, 8	 	☒	 	☐	 	☐
	 	2.	Archive
    sponsor records and reports according to applicable regulatory requirements.	 	21
    CFR 312.57

    (a)(b)(c), 312.58 (a);

    ICH E6 5.5.8, 5.5.11, 8	 	☐	 	☒	 	☐
	 	3.	Retain
    reserve samples of the test articles and reference standards used in bioequivalence or bioavailability studies	 	21
    CFR 312.57 (d);

    ICH E6 5.14.5(b)	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 
	H.	 Disposition
    of unused supply of investigational drug	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	1.	Assure
    return of drug from site to sponsor	 	21
    CFR 312.59; ICH	 	☒	 	☐	 	☒
	 	2.	Conduct
    final disposition or destruction of drug	 	E6
    5.14.4 (c)(d),

    5.18.4 (c)(iv)(v)	 	☐	 	☐	 	☒
	 	 	 	 	 	 	 	 	 	 	 
	I.	Application
    for FDA approval to export investigational drug	 	 	 	 	 	 	 	 
	 	 	(a)	Content	 	21
    CFR 312.110;	 	☐	 	☒	 	☐
	 	 	(b)	Format	 	ICH
    E6 5.14.2	 	☐	 	☒	 	☐
	 	 	 	 	 	 	 	 	 	 	 	 
	J.	Obtain
    investigator financial disclosure information	 	21
    CFR 312.53 (c)(4)	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	1.	Initial
    collection prior to study participation	 	 	 	☒	 	☐	 	☐
	 	2.	Responsibility
    for the one year follow-up financial disclosure collection shall remain with the Sponsor (one year following the completion
    of the study)	 	 	 	☐	 	☒	 	☐

 

		1	If responsibility
                                         for an item is shared between Oramed and Integrium, both boxes will be checked.

 

According to 21 CFR 312.52(b), “A contract research organization
that assumes any obligation of a sponsor shall comply with the specific regulations in this chapter applicable to this obligation
and shall be subject to the same regulatory action as a sponsor for failure to comply with any obligation assumed under these regulations.”
The assignment of responsibility does not preclude either the sponsor or the CRO from participating in the requirements of the
CFR.

 

	Oramed Ltd.	 	 	 	 
	 	 	 	 	 
	 	 	/s/ Miriam Kidron	 	September 16, 2020
	 	 	Name: Miriam Kidron	 	Date
	 	 	Title: CSO	 	 
	Integrium LLC.	 	 	 	 
	 	 	 	 	 
	 	 	/s/ Jessica Coutu  	 	September 16, 2020
	 	 	Name: Jessica Coutu	 	Date
	 	 	Title: Sr. VP of Clinical Operations	 	 

 

 

	Project: Oramed Ltd.
               ORA-D-013-2
	
 
 Page 36

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