Document:

Exhibit

Exhibit 10.2

SUMMIT COMMUNITY BANK
SUPPLEMENTAL EXECUTIVE RETIREMENT PLAN 
This Summit Community Bank Supplemental Executive Retirement Plan (“Plan”) is adopted as of this ____ day _________, 2020 (the “Effective Date”), by Summit Community Bank, a bank organized and existing under the laws of the State of West Virginia (the “Company”), for the benefit of [Robert S. Tissue/Patrick N. Frye/Bradford E. Ritchie] (the “Executive”).  The purpose of the Plan is to provide certain supplemental nonqualified pension benefits to certain executives who have contributed substantially to the success of the Company and the Company desires to incentivize the executives to continue in its employ.
Company and Executive acknowledge and agree that the only Supplemental Executive Retirement Plan by and between Company and Executive that is in effect as of the date hereof other than this Plan, is that certain Supplemental Executive Retirement Plan dated ________________1.  The parties further acknowledge and agree that any Supplemental Executive Retirement Plan document not specified herein, whether or not offered to, awarded to and/or previously signed by the Executive, that has not been executed on behalf of the Company or any affiliate by an officer of the Company or any affiliate, regardless of whether or not any benefit accrued thereunder, is null, void and superseded by this Plan.
This Plan is intended to be and shall be administered as an income tax nonqualified, unfunded plan primarily for the purpose of providing deferred compensation for a select group of management or highly compensated employees within the meaning of the Employee Retirement Income Security Act of 1974, as amended (“ERISA”), Sections 201(2), 301(a)(3) and 401(a)(1).  This Plan is intended to comply with the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”) and, accordingly, the intent of the parties hereto is that the Plan shall be operated and interpreted consistent with the requirements thereof.
ARTICLE 1
DEFINITIONS

Whenever used in this Plan, the following terms have the meanings specified:
1.1    “Account Balance” means, as of any date, the liability that should be accrued by the Company on behalf of the Executive under generally accepted accounting principles (“GAAP”), to the extent consistent with the provisions below.  Prior to the date on which Executive attains Executive’s Normal Retirement Age and during the time that Executive continues in the employment of Company, and prior to any determination of Disability of Executive prior to Executive attaining Normal Retirement Age, (or after Separation from Service but before Executive has attained Executive’s Normal Retirement Age if a Change in Control has occurred and Executive has had a Separation from Service as set forth in Section 3.2) and provided this Agreement is in effect, the Company shall establish an accrued liability retirement account for the Executive into which appropriate reserves shall be accrued sufficient so that if the account were increased ratably each year prior to Executive attaining Normal Retirement Age, and using a compound interest rate as set forth in Schedule 1 attached hereto and incorporated herein by reference, sufficient funds would be available to pay the Retirement Benefit to Executive for the life expectancy of Executive, based upon the United States Life Insurance Company mortality tables (or tables of a reasonably comparable life insurance company if such 

1 The date is January 25, 2002 in Robert S. Tissue's Plan and the dates are January 1, 2009 and January 1, 2016 for Bradford E. Ritchie's Plan. This paragraph is not included in Patrick N. Frye's Plan.

mortality tables are no longer available) in effect from time to time as such accruals are made.  The interest rate set forth on Schedule 1 may be changed, for purposes of the calculation of the accrued liability retirement account hereunder, by the Compensation Committee of Company at any time and from time to time, but only in good faith and in a manner that the Compensation Committee of the Company reasonably determines to be consistent with industry standards at the time of such change of interest rate herein.  The accrued liability retirement account established hereunder shall be for accounting and bookkeeping purposes only, and is not, nor shall be construed to be, an account or trust for the benefit of the Executive.  Once payments to Executive commence pursuant to Sections 3.1, 3.2 or 3.4, such payments shall be applied so as to reduce the balance in the accrued liability retirement account for purposes of any payout of an amount equal to the remaining balance thereof under Sections 3.3 or 3.4 herein.

1.2    “Annuity Contract” means the following annuity contract(s) purchased and solely owned by the Company:  a Flexible Premium Indexed Deferred Annuity Contract issued by _________________ Insurance Company, contract #________, or such other annuity contracts (a) as the Company may purchase from time to time in accordance with Plan Section 2.3 or otherwise, the income value of which the Company intends to serve as the measure of the Plan benefit for Executive, and (b) are identified by Policy number in writing by the Company as an “Annuity Contract” under this Plan.

1.3    “Beneficiary” means the person or entity designated, or otherwise determined in accordance with Article 4, in writing by the Executive to receive death benefits pursuant to this Plan in the event of the Executive’s death.

1.4    “Beneficiary Designation Form” means the form established from time to time by the Plan Administrator that the Executive completes, signs and returns to the Plan Administrator to designate one or more Beneficiaries.

1.5    “Board” means the Board of Directors of the Company.

1.6    “Change in Control” means with respect to (i) the Company or an affiliate for whom the Executive is performing services at the time of the Change in Control Event, (ii) the Company or any affiliate that is liable for the payment to the Executive hereunder, (or all corporations liable for the payment if more than one corporation is liable) but only if either the deferred compensation is attributable to the performance of service by the Executive for such corporation (or corporations) or there is a bona fide business purpose for such corporation or corporations to be liable for such payment and, in either case, no significant purpose of making such corporation or corporations liable for such payment is the avoidance of Federal Income tax, or (iii) a corporation that is a majority shareholder of a corporation identified in paragraph (i) or (ii) of this section, or any corporation in a chain of corporations in which each corporation is a majority shareholder of another corporation in the chain, ending in a corporation identified in paragraph (i) or (ii) of this section, a Change in Ownership or Effective Control or a Change in the Ownership of a Substantial Portion of the Assets of a Corporation as defined in Section 409A of the Code, and the regulations or guidance issued by the Internal Revenue Service thereunder, meeting the requirements of a “Change in Control Event” thereunder.

1.7    “Disability” shall mean the Executive (i) is unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of not less than twelve (12) months or (ii) is, by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of not less than twelve (12) months, receiving income replacement benefits for a period of not less than three (3) months under an accident and health plan covering employees of the Company.

1.8    “ERISA” means the Employee Retirement Income Security Act of 1974.

1.9    “Rider” means the income rider attached to the Annuity Contract as an endorsement or other product feature that operates as an income rider, with such feature providing for a withdrawal or payment feature for the life of the annuitant.

1.10    “Normal Retirement Age” means age sixty-five (65). 

1.11    “Separation from Service” means separation from service as that term is defined and interpreted in Section 409A of the Code and Treasury Regulation §1.409A-1(h) or in subsequent regulations or other guidance issued by the Internal Revenue Service.

ARTICLE 2
ASSET FINANCING, OWNERSHIP AND RIGHTS

2.1    Annuity Contract and Other Investments.  For purposes of satisfying its obligations to provide benefits under this Plan, the Company has initially invested in the Annuity Contract and may invest in other investments.  However, nothing in this Section shall require the Company to invest in any particular form of investment.

2.2    Ownership of the Annuity Contract.  The Company is the sole owner of the Annuity Contract, and other such investments, and shall have the right to exercise all incidents of ownership.  The Company shall be the beneficiary of the death proceeds of the Annuity Contract.  The Company shall at all times be entitled to the Annuity Contract’s cash surrender value, as that term is defined in the Annuity Contract.

2.3    Right to Annuity Contract.  Notwithstanding any provision hereof to the contrary, the Company shall have the right to sell or surrender any Annuity Contract without terminating this Plan, provided the Company replaces the Annuity Contract with a comparable annuity policy, or asset of comparable value, with a comparable lifetime withdrawal feature and comparable benefit value.  Without limitation, the Annuity Contract at all times shall be the exclusive property of the Company and shall be subject to the claims of the Company’s creditors.

2.4    Rabbi Trust.  Company may establish a “rabbi trust” to which contributions may be made to provide the Company with a source of funds for purposes of satisfying the obligations of the Company under the Plan.  The trust shall constitute an unfunded arrangement and shall not affect the status of the Plan as an unfunded plan.  Neither the Executive nor the Beneficiary shall have any beneficial ownership interest in any assets held in the trust.

ARTICLE 3
RETIREMENT AND OTHER BENEFITS

3.1    Normal Retirement Benefit.  Upon the Executive’s attainment of the earlier of twenty (20) years in the Plan or Normal Retirement Age while in continuous service with the Company or an affiliate, the Executive will be entitled to the Normal Retirement Benefit.  The amount of the benefit will equal an annual benefit in the amount of $25,000.00.  The annual benefit will be paid in monthly installments commencing on the first (1st) day of the first month following the date of the later of (i) the Executive’s attainment of Normal Retirement Age, or (ii) the Executive’s Separation from Service, and continuing for the Executive’s lifetime.  Subject to paragraph 3.3, this shall be the Executive’s benefit in lieu of any other benefit under this Plan.

3.2    Change in Control Benefit.  If the Executive is actively employed at the time of a Change in Control, (provided that there has been no determination of Disability of the Executive prior to such Change in Control) the Executive will fully vest in the Normal Retirement Benefit as provided for in paragraph 3.1, with such benefit payable in the amount as provided for in paragraph 3.1.  The Company will establish a “rabbi trust”, if one has not already been established, for the purposes of this Plan, to which assets will be contributed to provide the Company with a source of funds for purposes of satisfying the obligations of the Company under the Plan.  The amount of the contribution to the “rabbi trust” will be the amount sufficient to satisfy the benefit under paragraph 3.1.  Benefits payable under this paragraph 3.2 will commence on the first day of the first month following the date of the later of the Executive’s attainment of Normal Retirement Age or Separation from Service and will continue for the Executive’s lifetime.  Subject to paragraph 3.3, this shall be the Executive’s benefit in lieu of any other benefit under this Plan.

3.3    Death Benefits.  Upon the death of the Executive while in active service with the Company, following a determination of Disability or a Separation from Service but prior to commencement of benefits, or after benefit payments have commenced, provided that the Executive, as of the date of death, has attained twenty (20) years in the Plan or Normal Retirement Age while in continuous service with the Company or an affiliate, or was actively employed with the Company at the time of a Change in Control or determination of Disability, the Company shall pay to the Executive’s Beneficiary the Account Balance, (or in the case of a determination of Disability prior to death, then the balance of the Disability Account under Section 3.4) which shall be payable in a lump sum on the first day of the second month following the date of such death.  This shall be the Executive’s benefit in lieu of any other benefit under this Plan.

3.4    Disability Benefit.  In the event a determination of Disability is made respecting the Executive, during any period of employment prior to Executive attaining Normal Retirement Age [and the Executive, notwithstanding any other provision of this Agreement, including but not limited to any provision of Section 1.7, shall not be considered disabled for purposes of this Section 3.4, and no determination of Disability for purposes of this Section 3.4 shall be made, if:  (i) the Executive has had a Separation from Service prior to such Disability, or (ii) such determination of Disability has taken place after a Change in Control and Executive is eligible for a Retirement Benefit pursuant to Section 3.2 or otherwise], the Company shall establish an account (hereinafter sometimes referred to as the “Disability Account”) in an amount equal to the balance as of the date of Disability of Executive of the accrued liability retirement account established on the Executive’s behalf pursuant to Section 1.1 of this Agreement (provided that the Company shall be required to do so only once for each Executive, and with respect to an Executive who has a determination of Disability prior to Normal Retirement Age and who returns to active employment with the Company and a subsequent determination of Disability, also prior to Normal Retirement Age, is made respecting the Executive, the Company shall not be required to establish a Disability Account other than any Disability Account established upon the first determination of Disability of the Executive).  Interest at a rate equivalent to the Moody’s Seasoned Baa Corporate Bond Yield per annum then in effect (or if no such rate is then published or in effect, then at the rate equivalent to the yield of reasonably comparable instruments selected by the Compensation Committee of the Company) shall be accrued and added to the Disability Account and distributions subtracted therefrom until complete distribution hereunder.  Upon Executive attaining Normal Retirement Age after a determination of Disability, the Company shall distribute to the Executive, (commencing on the first day of the month following the date Executive attains the Executive’s Normal Retirement Age, and subject to the ‘Restriction on Timing of Distribution’ as defined in Section 3.5 of this Agreement) an amount equal to the balance in the Disability Account of Executive in One Hundred Twenty (120) equal monthly installments.  In the event of the death of Executive after a determination of Disability and regardless of whether Executive has attained Normal Retirement Age, any portion of any Disability Account of Executive not yet distributed to Executive hereunder shall be distributed in a lump sum as set forth in Section 3.3 to the Beneficiary.  Said payment due hereunder shall be made on the first day of the second month following the Executive’s death.  

After a determination of Disability prior to Executive’s Normal Retirement Age, no other benefits than those set forth in this Section 3.4 will be owed or payable to the Executive or any Beneficiary under this Agreement under any circumstances, including but not limited to, during the period of Disability, upon death, upon attaining Normal Retirement Age or Retirement Date, or in the event of any subsequent return to active service or subsequent period of Disability.  The Disability Account established hereunder shall be for accounting and bookkeeping purposes only, and is not, nor shall be construed to be, an account or trust for the benefit of the Executive.  Once payments to Executive commence pursuant to this Section 3.4, such payments shall be applied so as to reduce the balance in the Disability Account for purposes of any payout of an amount equal to the remaining balance.

3.5    Restriction on Timing of Distributions.  Notwithstanding the applicable provisions of this Plan regarding timing of payments, the following special rules shall apply if the stock of the Company is publicly traded at the time of the Executive’s Separation from Service in order for this Plan to comply with Section 409A of the Code:  (i) to the extent the Executive is a “specified employee” (as defined under Section 409A of the Code) at the time of a distribution and to the extent such applicable provisions of Section 409A of the Code and the regulations thereunder require a delay of such distributions by a six-month period after the date of such Executive’s Separation from Service with the Company, no such distribution shall be made prior to the date that is six months after the date of the Executive’s Separation from Service with the Company, and (ii) any such delayed payments shall be paid to the Executive in a single lump sum on the first day of the seventh month after the date of the Executive’s Separation from Service.

ARTICLE 4
BENEFICIARIES

4.1    Beneficiary Designations.  The Executive shall have the right to designate at any time a Beneficiary to receive any benefits payable under this Plan upon the death of the Executive.  The Beneficiary designated under this Plan may be the same as or different from the Beneficiary designation under any other benefit plan of the Company in which the Executive participates.

4.2    Beneficiary Designation; Changes.  The Executive shall designate a Beneficiary by completing and signing the Beneficiary Designation Form and delivering it to the Plan Administrator or its designated agent.  The Executive’s Beneficiary designation shall be deemed automatically revoked if the Beneficiary predeceases the Executive or if the Executive names a spouse as Beneficiary and the marriage is subsequently dissolved.  The Executive shall have the right to change a Beneficiary by completing, signing and otherwise complying with the terms of the Beneficiary Designation Form and the Plan Administrator’s rules and procedures, as in effect from time to time.  Upon the acceptance by the Plan Administrator of a new Beneficiary Designation Form, all Beneficiary designations previously filed shall be cancelled.  The Plan Administrator shall be entitled to rely on the last Beneficiary Designation Form filed by the Executive and accepted by the Plan Administrator before the Executive’s death.

4.3    Acknowledgment.  No designation or change in designation of a Beneficiary shall be effective until received in writing by the Plan Administrator or its designated agent.

4.4    No Beneficiary Designation.  If the Executive dies without a valid Beneficiary designation, or if all designated Beneficiaries predecease the Executive, then the benefits shall be distributed to the personal representative of the Executive’s estate.

4.5    Facility of Payment.  If a benefit is payable to a minor, to a person declared incapacitated, or to a person incapable of handling the disposition of his or her property, the Company may pay such benefit 

to the guardian, legal representative, or person having the care or custody of the minor, incapacitated person, or incapable person.  The Company may require proof of incapacity, minority, or guardianship as it may deem appropriate before distribution of the benefit.  Distribution shall completely discharge the Company from all liability for the benefit.

ARTICLE 5
GENERAL LIMITATIONS

5.1    Limits on Payments.  Notwithstanding anything contained in this Plan to the contrary, it is understood and agreed that the Company shall not be required to make any payment or take any action under this Plan if:  (a) such payment or action is prohibited by any governmental agency having jurisdiction over the Company (hereinafter referred to as “Regulatory Authority”) in light of the fact that the Company has been declared by Regulatory Authority to be troubled, or operating in an unsafe or unsound matter; or (b) such payment or action (i) would be prohibited by or would violate any provision of state or federal law applicable to the Company, as now in effect or hereafter amended, (ii) would be prohibited by or would violate any applicable rules, regulations, orders or statements of policy, whether now existing or hereafter promulgated, of any Regulatory Authority, or (iii) otherwise would be prohibited by any Regulatory Authority.

5.2    Excess Parachute or Golden Parachute Payment.  Notwithstanding any provision of this Agreement to the contrary, any benefit provided under this Agreement when added to all other amounts or benefits provided to or on behalf of Executive in connection with his termination of employment, would result in the imposition of an excise tax under Section 4999 of the Code, such payments shall be retroactively (if necessary) reduced to the extent necessary to avoid such excise tax imposition, or shall be forfeited to the extent the benefit would be a prohibited golden parachute payment pursuant to 12 C.F.R. §359.2 and for which the appropriate federal banking agency had not given written consent to pay pursuant to 12 C.F.R. §359.4.  Upon written notice to Executive, together with calculations of Company’s independent auditors, Executive shall remit to Company the amount of the reduction, plus such interest as may be necessary to avoid the imposition of such excise tax.  Notwithstanding the foregoing or any other provision of this contract to the contrary, if any portion of the amount herein payable to the Executive is determined to be non-deductible pursuant to the regulations promulgated under Section 280G of the Code, the Company shall be required only to pay to Executive the amount determined to be deductible under Section 280G of the Code.

5.3    Termination for Cause.  Notwithstanding anything to the contrary contained herein, in the event of the Executive’s termination for Cause, this Plan shall terminate and no benefits shall be payable under the Plan.  For this purpose, “Cause” shall mean the conviction of Executive for commission of a felony against the Company or any Affiliate.  If a dispute arises as to discharge “for cause”, such dispute shall be resolved by arbitration as set forth in this Plan.  In the alternative, if the Executive is permitted to resign due to conviction of a felony as described above, the Board of Directors may vote to deny all benefits.  A majority decision by the Board of Directors is required for forfeiture of the Executive’s benefits under the preceding sentence.

ARTICLE 6
CLAIMS AND REVIEW PROCEDURES

6.1    Claims Procedure.  A person or Beneficiary (a “claimant”) who has not received benefits under the Plan that he or she believes should be paid shall make a claim for such benefits as follows:

(a)Initiation - Written Claim.  The claimant initiates a claim by submitting to the Plan Administrator a written claim for the benefits.  If the claim relates to the contents of a notice received by 

the claimant, the claim must be made within sixty (60) days after the notice was received by the claimant.  All other claims must be made within one hundred eighty (180) days after the date of the event that caused the claim to arise.  The claim must state with particularity the determination desired by the claimant.

(b)Timing of Plan Administrator Response.  The Plan Administrator shall respond to such claimant within ninety (90) days after receiving the claim (within forty-five (45) days for Disability benefits).  If the Plan Administrator determines that special circumstances require additional time for processing the claim, the Plan Administrator can extend the response period by an additional ninety (90) days, (thirty (30) days for Disability) by notifying the claimant in writing, prior to the end of the initial ninety (90)-day period (or forty-five (45) days, as applicable), that an additional period is required.  The notice of extension must set forth the special circumstances and the date by which the Plan Administrator expects to render its decision.  If the extension is with respect to Disability benefits, the notice shall specifically explain the standards on which entitlement to a benefit is based, the unresolved issues that prevent a decision on the claim, and the additional information needed to resolve those issues, and the claimant shall be given 45 days to provide the specified information.  The time period shall begin at the time a claim is filed, whether or not all information necessary for a determination accompanies the filing.  If the time period is extended due to insufficient information needed to decide a Disability claim, the period for making the Disability determination shall be tolled from the date on which the notification of the extension is sent to the claimant until the date on which the claimant responds to the request for additional information.

(c)Notice of Decision.  If the Plan Administrator denies part or all of the claim, the Plan Administrator shall notify the claimant in writing of such denial.  The Plan Administrator shall write the notification in a manner calculated to be understood by the claimant.  The notification shall set forth:

(i)The specific reasons for the denial,

(ii)A reference to the specific provisions of the Plan on which the denial is based,

(iii)A description of any additional information or material necessary for the claimant to perfect the claim and an explanation of why it is needed,

(iv)An explanation of the Plan’s review procedures and the time limits applicable to such procedures, and

(v)in the case involving Disability, a copy of any internal rule, guideline, protocol or other similar criterion that was relied upon in making the decision and, if based on a medical necessity or experimental treatment or similar exclusion or limit, either an explanation of the scientific or clinical judgment for the determination, or a statement that such explanation will be provided free of charge upon request.

6.2    Review Procedure.  If the Plan Administrator denies part or all of the claim, the claimant shall have the opportunity for a full and fair review by the Plan Administrator of the denial, as follows:

(a)    Initiation - Written Request.  To initiate the review, the claimant, within sixty (60) days (180 days for a Disability claim) after receiving the Plan Administrator’s notice of denial, must file with the Plan Administrator a written request for review.

(b)    Additional Submissions - Information Access.  The claimant shall then have the opportunity to submit written comments, documents, records and other information relating to the claim.  

The Plan Administrator shall also provide the claimant, upon request and free of charge, reasonable access to, and copies of, all documents, records and other information relevant (as defined in applicable ERISA regulations) to the claimant’s claim for benefits.

(c)    Considerations on Review.  In considering the review, the Plan Administrator shall take into account all materials and information the claimant submits relating to the claim, without regard to whether such information was submitted or considered in the initial benefit determination.

(d)    Additional Information For Disability.  In a claim for Disability, the following shall also apply:

(i)    the review shall not give any deference to the initial adverse determination;

(ii)    if the appeal is based in whole or in part on a medical judgment, the Company shall consult with a health care professional who has appropriate training and experience in the field of medicine involved in the medical judgment;

(iii)    any medical or vocational experts whose advice was obtained in connection with the adverse determination shall be identified, without regard to whether the advice was relied upon in making the benefit determination; and

(iv)    the health care professional engaged for purposes of a consultation under (b) above shall not be the individual who was consulted in connection with the adverse determination that is the subject of the appeal, nor the subordinate of any such individual.

(e)    Timing of Plan Administrator Response.  The Plan Administrator shall respond in writing to such claimant within sixty (60) days after receiving the request for review.  If the Plan Administrator determines that special circumstances require additional time for processing the claim, the Plan Administrator can extend the response period by an additional sixty (60) days by notifying the claimant in writing, prior to the end of the initial sixty (60)-day period, that an additional period is required.  The notice of extension must set forth the special circumstances and the date by which the Plan Administrator expects to render its decision.

(f)    Notice of Decision.  The Plan Administrator shall notify the claimant in writing of its decision on review.  The Plan Administrator shall write the notification in a manner calculated to be understood by the claimant.  The notification shall set forth:

(i)    The specific reasons for the denial,

(ii)    A reference to the specific provisions of the Plan on which the denial is based,

(iii)    A statement that the claimant is entitled to receive, upon request and free of charge, reasonable access to, and copies of, all documents, records and other information relevant (as defined in applicable ERISA regulations) to the claimant’s claim for benefits,

(iv)    A statement of the claimant’s right to bring a civil action under ERISA Section 502(a), and

(v)    in the case involving Disability benefits, a copy of any internal rule, guideline, protocol or other similar criterion that was relied upon in making the decision and, if the adverse determination is based on a medical necessity or experimental treatment or similar exclusion or limit, either an explanation of the scientific or clinical judgment for the determination, or a statement that such explanation will be provided free of charge upon request; and the following statement:  “You and your Plan may have other voluntary alternative dispute resolution options, such as mediation.  One way to find what may be available is to contact your local U.S. Department of Labor Office or your State insurance regulatory agency.

ARTICLE 7
MISCELLANEOUS

7.1    Amendments and Termination.  Subject to paragraph 7.13 of this Plan, this Agreement may be amended or terminated solely by a written agreement signed by the Company and by the Executive. 

7.2    No Guarantee of Employment.  This Plan is not an employment policy or contract.  It does not give any Executive the right to remain an employee of the Company, nor does it interfere with the Company’s right to discharge the Executive.  It also does not require any Executive to remain an employee nor interfere with any Executive’s right to terminate employment at any time.

7.3    Non-Transferability.  Benefits under this Plan cannot be sold, transferred, assigned, pledged, attached, or encumbered in any manner.

7.4    Tax Withholding.  The Company shall withhold any taxes that are required to be withheld from the benefits provided under this Plan.

7.5    Applicable Law.  Except to the extent preempted by the laws of the United States of America, the validity, interpretation, construction and performance of this Plan shall be governed by and construed in accordance with the laws of the State of West Virginia, without giving effect to the principles of conflict of laws of such state.

7.6    Unfunded Arrangement.  The Executive and the Beneficiary are general unsecured creditors of the Company for the payment of benefits under this Plan.  The benefits represent the mere promise by the Company to pay such benefits.  The rights to benefits are not subject in any manner to anticipation, alienation, sale, transfer, assignment, pledge, encumbrance, attachment, or garnishment by creditors.  Any insurance, annuity contract or other asset purchased by Company to fund its obligations under this Plan shall be a general asset of the Company to which the Executive and Beneficiary have no preferred or secured claim.

7.7    Benefit Provision.  Notwithstanding the provisions of this Plan in the payment of the benefits under Article 3, any benefits payable under this Plan are contingent solely upon the amount that is provided by the Annuity Contract(s) as identified in this Plan or other provision as provided for in Article 2.

7.8    Severability.  If any provision of this Plan is held invalid, such invalidity shall not affect any other provision of this Plan, and each such other provision shall continue in full force and effect to the full extent consistent with law.  If any provision of this Plan is held invalid in part, such invalidity shall not affect the remainder of the provision, and the remainder of such provision together with all other provisions of this Plan shall continue in full force and effect to the full extent consistent with law.

7.9    Headings.  The headings of articles herein are included solely for convenience of reference and shall not affect the meaning or interpretation of any provision of this Plan.

7.10    Notices.  All notices, requests, demands and other communications hereunder shall be in writing and shall be deemed to have been duly given if delivered by hand or mailed, certified or registered mail, return receipt requested, with postage prepaid.  Unless otherwise changed by notice, notice shall be properly addressed to the Executive if addressed to the address of the Executive on the books and records of the Company at the time of the delivery of such notice, and properly addressed to the Company if addressed to the Board, at P.O. Box 179, Moorefield, WV 26836.

7.11    Arbitration.  If a claimant(s) for benefits continues to dispute a benefit denial after following the Claims and Review Procedures provided in Article 6 herein, then claimant(s) may submit the dispute to an Arbitrator in West Virginia for final arbitration.  The Arbitrator shall be selected by mutual agreement of the Company and the claimant(s).  The Arbitrator shall operate under the rules then in effect of the American Arbitration Association.  The parties hereto agree that they and their heirs, personal representatives, successors and assigns shall be bound by the decision of such Arbitrator with respect to any controversy properly submitted to it for determination.  Where a dispute arises as to the Company’s discharge of the Executive “for cause”, such dispute shall likewise be submitted to arbitration as above described and the parties hereto agree to be bound by the decision thereunder.

7.12    Payment of Legal Fees.  In the event litigation ensues between the parties concerning the enforcement of the obligations of the parties under this Plan, the Company shall pay all costs and expenses in connection with such litigation until such time as a final determination (excluding any appeals) is made with respect to the litigation.  If the Company prevails on the substantive merits of each material claim in dispute in such litigation, the Company shall be entitled to receive from the Executive all reasonable costs and expenses, including without limitation attorneys’ fees, incurred by the Company on behalf of the Executive in connection with such litigation, and the Executive shall pay such costs and expenses to the Company promptly upon demand by the Company.

7.13    Termination or Modification of Plan Because of Changes in Law, Rules or Regulations.  The Company is entering into this Plan on the assumption that certain existing tax laws, rules and regulations will continue in effect in their current form.  If that assumption materially changes and the change has a material detrimental effect on this Plan, then the Company reserves the right to terminate or modify this Plan accordingly.

ARTICLE 8
ADMINISTRATION OF AGREEMENT

8.1    Plan Administrator Duties.  This Plan shall be administered by a Plan Administrator consisting of the Board or such committee or person(s) as the Board shall appoint.  The Plan Administrator shall have the sole and absolute discretion and authority to interpret and enforce all appropriate rules and regulations for the administration of this Plan and the rights of the Executive under this Plan, to decide or resolve any and all questions or disputes arising under this Plan, including benefits payable under this Plan and all other interpretations of this Plan, as may arise in connection with the Plan.  No benefit shall be payable hereunder to any person unless the Plan Administrator, in its sole discretion, determines such benefit is due.

8.2    Agents.  In the administration of this Plan, the Plan Administrator may employ agents and delegate to them such administrative duties as it sees fit (including acting through a duly appointed representative) and may from time to time consult with counsel, who may be counsel to the Company.

8.3    Binding Effect of Decisions.  The decision or action of the Plan Administrator with respect to any question arising out of or in connection with the administration, interpretation, and application of the Plan and the rules and regulations promulgated hereunder shall be final and conclusive and binding upon all persons having any interest in the Plan.  Without limiting the foregoing, it is acknowledged that the value of the benefits payable hereunder may be difficult to determine in the event the Company does not actually purchase and maintain the Annuity Contract as contemplated hereunder; therefore, in such event, the Company shall have the right to make any reasonable assumptions in determining the benefits payable hereunder and any such determination made in good faith shall be binding on the Executive.

8.4    Indemnity of Plan Administrator.  The Plan Administrator shall not be liable to any person for any action taken or omitted in connection with the interpretation and administration of this Plan, unless such action or omission is attributable to the willful misconduct of the Plan Administrator or any of its members.  The Company shall indemnify and hold harmless the members of the Plan Administrator against any and all claims, losses, damages, expenses, or liabilities arising from any action or failure to act with respect to this Plan, except in the case of willful misconduct by the Plan Administrator or any of its members.

8.5    Company Information.  To enable the Plan Administrator to perform its functions, the Company shall supply full and timely information to the Plan Administrator on all matters relating to the date and circumstances of the retirement, Disability, death, or Separation of Service of the Executive and such other pertinent information as the Plan Administrator may reasonably require.

This Supplemental Executive Retirement Plan Agreement is hereby adopted as of the date written above.
	
			
	THE EXECUTIVE:
	 
	SUMMIT COMMUNITY BANK

	 
	 
	 

	[ROBERT S. TISSUE/Patrick N. Frye/Bradford E. Ritchie]
	By:
	 

	 
	Title:
	 

SCHEDULE 1
to
SUMMIT COMMUNITY BANK
SUPPLEMENTAL EXECUTIVE RETIREMENT PLAN 

This Schedule 1 to the Summit Community Bank Supplemental Executive Retirement Plan between Summit Community Bank and ______________ sets forth the rate of interest under Section 1.1 of the Agreement for purposes of determining accrual of appropriate reserves in the accrued liability retirement account and is incorporated as a part of the Agreement.  This Schedule 1 is effective ________________, 2020, and shall remain in effect unless amended or revised according to the provisions set forth in Section 1.1 of the Agreement.

Interest Rate    7 %

BENEFICIARY DESIGNATION
SUMMIT COMMUNITY BANK
SUPPLEMENTAL EXECUTIVE RETIREMENT PLAN 

I, [Robert S. Tissue/Patrick N. Frye/Bradford E. Ritchie], designate the following as Beneficiary of any death benefits under the Summit Community Bank Supplemental Executive Retirement Plan:
Primary:                                                                                                 
Contingent:                                                                                                 
Note:  To name a trust as Beneficiary, please provide the name of the trustee(s) and the exact name and date of the trust agreement.
I understand that I may change these Beneficiary designations by filing a new written designation with the Company.  I further understand that the designations will be automatically revoked if the Beneficiary predeceases me, or if I have named my spouse as Beneficiary and our marriage is subsequently dissolved.
	
							
	 
	 
	 
	Signature:     
	 
	 
	 

	 
	 
	 
	 
	 
	 
	 

	 
	 
	 
	Date:    
	 
	,20
	 

Accepted by the Company this _______ day of ________________, 20__. 
	
					
	 
	 
	 
	By:    
	 

	 
	 
	 
	 
	 

	 
	 
	 
	Print Name:
	 

	 
	 
	 
	 
	 

	 
	 
	 
	Title:Exhibit 10.1

 

Certain
information in this exhibit marked [***] has been excluded 

from this exhibit because it is both (i) not material and (ii) would

be competitively harmful if publicly disclosed.

 

SERVICES AGREEMENT

 

This Services Agreement
(this “Agreement”) is made and entered into as of July 23, 2020, (the “Effective Date”),
by and between Worldwide Clinical Trials, Inc., with offices at 3800 Paramount Parkway, Suite 400, 27560, Morrisville, NC, United
States, (together with its Affiliates, “Worldwide) and Neurotrope Bioscience, Inc., with offices at 1185 Avenue of
the Americas, 3rd Floor, New York, NY 10036 (“Sponsor”). Worldwide and Sponsor are sometimes individually
referred to herein as a “Party” and collectively as the “Parties”.

 

For purposes of this
Agreement, “Affiliates” means any entity that controls, is controlled by or is under common control with, that
Party. “Control” means the possession, directly or indirectly, of at least 50% of the share capital or voting
rights or of the power to direct or cause the direction of the management and policies of an entity, whether through the ownership
of voting securities, by contract or otherwise.

 

WHEREAS, Sponsor is
engaged in the research and development of pharmaceutical products;

 

WHEREAS, Worldwide
is engaged in providing services to pharmaceutical manufacturers in support of their clinical research and product development
activities;

 

WHEREAS, Worldwide
and Sponsor desire that Worldwide provide certain services with respect to Sponsor’s clinical study, NTRP101-204 entitled
 “A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Assessing Safety, Tolerability and Long-term Efficacy of Bryostatin
in the Treatment of Moderately Severe Alzheimer’s Disease Subjects Not Receiving Memantine Treatment” (the "Study")
for the study of Sponsor’s drug Bryostatin 1 ("Study Drug"); and

 

WHEREAS, Sponsor and
Worldwide desire to enter into this Agreement in order to set forth definitively their respective rights and obligations with respect
to the conduct of the Study.

 

NOW THEREFORE, in consideration
of the premises and the mutual promises and undertakings herein contained, the receipt and sufficiency of which is hereby acknowledged,
the Parties agree as follows:

 

1.0              
SERVICES

  

Worldwide, itself or through one of its
Affiliates (if applicable) hereby agrees to perform the services (the “Services”) in accordance with the terms
of the scope of Services attached hereto as Exhibit A, incorporated herein by reference (the “Scope of Services”),
and this Agreement.

 

1.1       Performance

 

Worldwide shall perform the Services and
shall use its commercially reasonable efforts to complete the Services within the estimated time frame as set forth in the timeline
attached hereto as Exhibit B and incorporated herein by reference (“Timeline”). Such time estimate assumes,
however, the full cooperation of Sponsor, Regulatory Authorities, Ethics Committees and investigators and other third parties not
under Worldwide’s control, and shall be subject to adjustment [***] if the work for the Services is delayed due to circumstances
outside the reasonable control of Worldwide, including, but not limited to:

 

     

     

    

  

		·	failure of Sponsor to deliver clinical
supplies in due time, provided such failure is the actual cause of the delay; 
	 	 	 

		·	amendments to previously agreed upon protocols,
procedures or documents required for the Services at the request of Sponsor or Sponsor’s (or its advisors’); 
	 	 	 

		·	significant delays in pre-Study meetings
or in other tasks to be performed by Worldwide caused by Sponsor;
	 	 	 

		·	delays in obtaining or subsequent withdrawal
of regulatory or ethical review approvals concerning the Services; 
	 	 	 

		·	death or disability of any investigator
or other research specialist on the Study; 
	 	 	 

		·	higher ratio of drop-outs among trial
subjects than anticipated in this Agreement; 
	 	 	 

		·	lower enrollment rates than expected and
agreed to by Worldwide and Sponsor; or
	 	 	 

		·	unforeseen changes in the relevant medical
practice.

 

1.2       Compliance
with Laws/Agreements

 

Worldwide shall perform Services under
this Agreement in accordance with the terms of this Agreement, the Protocol for the Study, the Sponsor approved standard operating
procedures for the Study (the “Standard Operating Procedures”), the current Guidelines for Good Clinical Practice
promulgated by the FDA ("GCP Guidelines"), the Declaration of Helsinki of the 41st World Medical Assembly, South
Africa 1996 as amended, and all other applicable laws and regulations, including the following as applicable, 21 CFR Part 11, 312,
50, 54, 56, the Health Information Portability and Accountability Act of 1996 and all regulations and official guidelines promulgated
thereunder and the Health Information Technology for Economic and Clinical Health Act (the “Applicable Laws”).

 

The Parties and their respective owners,
officers, directors, employees or agents have not and shall not pay, give, offer or promise to pay or give, or authorize the payment,
directly or indirectly, of any money or anything of value to any foreign government official or employee (including employees of
state-owned institutions), for the purpose of (i) influencing any act or decision of such official or of such government, (ii)
inducing that person to do or omit doing any act in violation of his or her lawful duty, (iii) securing an improper advantage,
or (iv) influencing such official to use his influence with the government to effect or influence the decision of such government,
in order to assist Sponsor or Worldwide in obtaining or retaining business for or with or directing business to any person.

 

Each Party agrees to comply with all applicable
anticorruption laws, rules and regulations. The Parties agree to reasonably cooperate with each other’s diligence efforts
in order to satisfy each Party’s obligations under the United States Foreign Corrupt Practices Act, as amended (“FCPA”),
the UK Bribery Act and any implementing legislation under the OECD Convention Against Bribery of Foreign Government Officials in
International Business Transactions.

 

1.3        Transfer
of Obligations

 

Pursuant to Title 21 CFR Part 312.52, Sponsor
hereby transfers to Worldwide all of the obligations identified in Exhibit A attached hereto and incorporated by reference herein.
Notwithstanding the foregoing, Sponsor will retain the ultimate authority and control over and responsibility for the Study. The
Parties acknowledge and agree that Sponsor shall at all times be deemed to be the “sponsor” of the Study pursuant to
the terms of the Federal Food, Drug and Cosmetic Act, as from time to time amended, and the regulations of the U.S. Food and Drug
Administration (“FDA”), as promulgated in Title 21 of U.S. Code of Federal Regulations.

 

    Page 2 of 47

     

    

  

1.4       Changes

 

The Parties may make changes in or additions
to the Scope of Services, provided, however, that, subject to the terms of this Section 1.4, no such changes or additions shall
be implemented prior to the execution by the Parties of a change order (a “Change Order”), the form of which
is attached hereto and incorporated herein as Exhibit E. The Change Order shall include detailed information on the changes to
the Scope of Services and any associated changes to the Timeline, Budget and/or payment schedule. Sponsor acknowledges that Worldwide
is not obligated to perform any out-of-scope work described in a Change Order until the Change Order is signed by both Parties.
Provided, however, in the event that Worldwide provides additional Services or expends additional resources, at Sponsor’s
written request and in strict accordance with Sponsor’s written requirements, in the absence of a Change Order, Sponsor will
compensate and/or reimburse Worldwide for [***]. For any Change Order that affects the scope of the regulatory obligations that
have been transferred to Worldwide, Worldwide and Sponsor shall execute a corresponding amendment to Exhibit A. Sponsor shall file
such amendment where appropriate, or as required by applicable law.

 

2.0       WORK
PRODUCT

 

During the term of this Agreement, Worldwide
shall maintain all materials and all other data or documents included in the Trial Master File obtained or generated by Worldwide
in the course of providing the relevant Services in accordance with Worldwide’s standard operating procedures, including
all computerized records and files (“Work Product”), in a secure area reasonably protected from fire, theft
and destruction with duplicate copies retained with the same care as the original Work Product. All Work Product shall be the Confidential
Information and the exclusive property of Sponsor. At the expiration or termination of this Agreement, and subject to satisfaction
of the Parties’ obligations thereunder, Sponsor shall provide Worldwide with written instructions as to the disposition of
the Work Product created under this Agreement. Such written instructions will provide that Worldwide (a) deliver the Work Product,
in the form in which Worldwide currently holds them, to a designated Sponsor location or to such other entity or at such other
address as Sponsor may specify, (b) retain the materials for the period of time specified in this Agreement, or (c) destroy all
such materials except for those which Worldwide is required by law or regulation to store or maintain. Upon expiration or termination
of this Agreement, [***] of the Work Product will be [***] as Pass-through Expenses (as defined below) in accordance with the terms
of this Agreement. Notwithstanding the foregoing, Worldwide may retain one electronic archival backup copy of such Work Product
in accordance with Worldwide’s Data Retention Policy, subject to its ongoing obligation to maintain the confidentiality of
such materials.

 

3.0        PAYMENT
AND COMPENSATION

 

The Parties agree that the fees and other
reimbursements that Worldwide will receive for performing the Services hereunder are subject to the following terms and conditions.

 

3.1        Compensation
for Services

 

This Agreement includes a budget for the
Services (the, “Budget”) to be performed by Worldwide, which is attached hereto as Exhibit C, and is incorporated
herein by reference. Sponsor shall pay to Worldwide such amounts as set forth and more fully described in the Budget until such
time as Worldwide and Sponsor agree that the Sponsor’s monetary obligations to Worldwide are fully satisfied. Worldwide agrees
that it shall not incur any cost or expense in excess of the amounts set forth in the Budget for any item, without the prior written
approval of Sponsor (in accordance with Section 1.4). Worldwide will [***], associated with this Agreement and to obtain and pass
along to Sponsor [***].

 

    Page 3 of 47

     

    

 

3.2       Pass-through
Expenses

 

Sponsor will reimburse Worldwide [***]
as agreed to by Sponsor and identified in the Budget or otherwise pre-approved in writing by the Sponsor, which Worldwide will
invoice to Sponsor without mark-up (“Pass-through Expenses”). All reimbursement of Pass-through Expenses hereunder
must be supported by receipts provided by Worldwide. Pass-through Expenses may include, [***].

 

In order to facilitate payment of invoices
for Worldwide’s pre-approved [***] incurred during the performance of Services, Worldwide will submit to Sponsor a report
containing at least the following details: (i) photocopies of receipts [***], (ii) date and [***], (iii) employee name, and (iv)
[***]. In addition to copies of all receipts [***], Sponsor shall have the right to obtain additional backing documentation for
any line item which requires further clarifications. Such requests shall be made in good faith and where there is a specific concern
with the line item(s) in question. All [***] obtained under Section 3.2 will be passed through and properly reflected in invoices
to Sponsor and shall be [***]. Worldwide will use [***] which are less than [***], and [***] which are [***]. For the avoidance
of doubt, [***] should not include [***].

 

3.3       Invoices;

 

Worldwide shall submit a reasonably detailed
invoice by email to Sponsor (rweinstein@neurotropebioscience.com) on a [***] basis in accordance with the Payment Schedule with
appropriate supporting documentation, including those set forth in Section 3.2.

 

3.4       Payment
Terms

 

Sponsor agrees to pay for Services and
Pass-through Expenses in accordance with the Payment Schedule, the (“Payment Schedule”) attached hereto as Exhibit
D and incorporated herein by reference. Sponsor will pay for all Services, Pass-through Expenses and other invoiced items within
[***] days of receipt of invoice. All payments will be made in the currency noted in the Payment Schedule. All fees for Services
and Pass-through Expenses under this Agreement are stated [***] of any local, state, federal or foreign sales and use taxes, VAT,
if any, [***]. If such taxes are applicable under local regulations, Worldwide will [***] at the relevant rate. For the avoidance
of doubt, the requirements of this provision shall not apply to [***].

 

Payments shall be made by Sponsor via wire
transfer of immediately available funds to Worldwide’s account set forth below:

 

	Account Holder: 	Worldwide Clinical Trials, Inc.
	Bank Name: 	[***]
	Bank Address: 	[***]
	 	 
	ABA Routing No.: 	[***]
	Bank Account No.: 	[***]
	Swift Code:	[***]
	Taxpayer ID#: 	[***]

 

    Page 4 of 47

     

    

 

3.5       Project
Delays

 

In the event Sponsor delays, suspends or
places a hold on the Study for any reason, Sponsor shall promptly provide Worldwide with written notice of such delay, hold or
suspension, and Sponsor and Worldwide will, [***] of such notice, [***] to this Agreement and each Party will complete its respective
duties and obligations as described in any resulting Change Order. During the period following Worldwide’s receipt of Sponsor’s
notice of delay, hold or suspension, if Sponsor desires Worldwide to continue the assignment of certain Worldwide Study personnel
to the Study, [***] to Worldwide hereunder, Sponsor agrees that it shall [***] associated with such continued assignment at [***],
such [***] to be agreed upon by the Parties prior to commencement of the delay, as evidenced by a Change Order. Said personnel
fees shall be [***] and shall be due and payable by Sponsor within [***] days of Sponsor’s receipt of Worldwide’s invoice.
If Sponsor does not wish to retain certain Worldwide Study personnel for the duration of the delay or on hold period, Worldwide
shall have the right to reallocate any and all such staff after [***] day period. If the delay or on-hold period continues for
[***] either Party may, by provision of written notice, terminate this Agreement without penalty.

  

3.6       Currency
Management

 

All invoices and amounts to be paid under
this Agreement shall be in US currency.

 

3.7       Disputed
Invoices

 

In the event Sponsor disputes one or more
items in an invoice, Sponsor will notify Worldwide in writing within [***] of receipt of the invoice and such notice shall contain
a reasonably detailed description of the item(s) being disputed and the basis therefor. Worldwide will respond to Sponsor within
[***] of receipt of the notification. This written communication pattern will continue until Worldwide has provided Sponsor with
sufficient justification for the disputed item(s) or until the Parties agree to a resolution of the disputed amount. Sponsor shall
pay the undisputed portion of the invoice within [***] of receipt of invoice and shall use its reasonable efforts to pay the disputed
amount within [***] of resolution of the dispute pursuant to Section 17.12. In the event the Parties are unable to reach a satisfactory
resolution within [***] of the original invoice, either Party may pursue alternative remedies in accordance with this Agreement.

 

4.0       THIRD
PARTY AGREEMENTS

 

Worldwide may contract with various third
parties to perform part of the Services, with the prior written consent of the Sponsor, provided that (i) the subcontractor agrees
in writing to be bound by terms consistent with this Agreement, including without limitation, regarding maintaining the confidentiality
of proprietary information, and regarding ownership of intellectual property in connection with the Services, assignment to Sponsor
of any intellectual property in connection with the Services; (ii) Worldwide shall use its best efforts to ensure that any subcontractor
has the capability to perform the subcontracted services to the standards required under this Agreement and in compliance with
Applicable Laws, (iii) Worldwide shall remain primarily responsible to Sponsor for the performance of such subcontracted Services,
and (iv) any subcontracting shall not relieve Worldwide of its obligations hereunder and Worldwide hereby agrees to manage the
performance of any permitted subcontractor.

 

For purposes of this Agreement, subcontractors
do not include third party vendors providing ancillary services on the Study, provided that Worldwide’s agreement with any
such third-party vendor includes a provision making Sponsor an intended third-party beneficiary of the agreement with a right to
enforce Worldwide’s rights under the agreement. Liability of Worldwide to Sponsor with respect to such third-party vendors
shall be limited to the extent Worldwide is negligent in the performance of its obligations under this Agreement; however, Worldwide
shall provide to Sponsor any amounts that Worldwide may recover from such third party vendors as a result of any error or service
failure on the part of such vendors in connection with Services under this Agreement.

 

    Page 5 of 47

     

    

 

If Sponsor requests that Worldwide use
a particular third party and Worldwide does not wish to contract with that third party based upon commercially reasonable reasons
(such as the inability to agree with such provider upon mutually acceptable terms or a negative assessment of such provider’s
performance or abilities), then Sponsor shall contract directly with such provider (a “Sponsor Designated Vendor”)
and, unless otherwise agreed in writing, Worldwide will have no responsibility for the selection, instruction or supervision of
such Sponsor Designated Vendor.

 

4.1       Institutions/Investigators

 

Worldwide’s Services under this Agreement
may include identifying potential medical institutions (“Institutions”) or clinical investigators (“Investigators”)
and/or negotiating, executing and/or administering contracts with such parties which will govern their participation in the Study
(“Clinical Trial Agreements”). If, pursuant to the Scope of Services, Sponsor delegates to Worldwide the responsibility
for negotiating and/or executing Clinical Trial Agreements, the following provisions will apply:

 

		(a)	Sponsor may provide Worldwide with a list of suggested Institutions and/or Investigators to be
recruited by Worldwide for a Study. Worldwide shall notify Sponsor in writing as to any listed Institution/Investigator with which
Worldwide does not wish to contract.

 

		(b)	Selection of all Institutions or Investigators will be subject to approval by Sponsor prior to
initiation of any Study-related activities involving that Institution/Investigator or the start of any negotiations with such Institution/Investigator.

 

		(c)	Each Clinical Trial Agreement shall be consistent with this Agreement. The Clinical Trial Agreement
used with each Institution and Investigator will be in a form approved in advance by Sponsor. Any
material changes to the form Clinical Trial Agreement shall be replaced with fall-back language that has been pre-approved by Sponsor.
If outside of the fall-back language, the change shall require the prior written approval of the Sponsor.

 

(d) In
the event that local law prohibits Sponsor from being a party to a Clinical Trial Agreement, Sponsor (a) shall have the right to
approve the Clinical Trial Agreement template; (b) shall be a named third-party beneficiary to each Clinical Trial Agreement if
possible; and, (c) shall have the right but no obligation to approve all finalized Clinical Trial Agreements prior to execution
by Worldwide.

 

		(e)	If an Institution/Investigator requests indemnification from Sponsor, standard indemnification
language, generated by the Sponsor, will be provided to the Institution/Investigator. If the Institution/Investigator requests
changes to the standard language, Sponsor will negotiate with the Institution/Investigator, if agreed, Sponsor will issue a letter
of indemnification directly to the Institution/Investigator. Sponsor acknowledges that Worldwide shall have no indemnification
obligation to any Institution/Investigator relative to the Study Drug or the applicable Study protocol. In addition, Worldwide
shall not be deemed to have failed to perform under this Agreement in the event an Institution/Investigator declines participation
in a Study as a result of Sponsor’s refusal to indemnify such Institution/Investigator.

 

    Page 6 of 47

     

    

 

		(f)	The Sponsor may elect that grant payments to Institutions/Investigators be administered on its
behalf by Worldwide, acting solely as payment agent unless otherwise agreed to by Worldwide in writing. Worldwide shall distribute
all payments to Institutions/Investigators according to the provisions of the applicable Clinical Trial Agreement and this Agreement.
Sponsor acknowledges and agrees that Worldwide will manage all administration of payments or other obligations to Investigators/Institutions
for Services rendered in connection with relevant Studies solely out of funds provided to Worldwide from Sponsor for this specific
purpose. Furthermore, Sponsor acknowledges and agrees that Worldwide intends to maintain a cash neutral policy with regard to Institutions/Investigators
payments. In the event Worldwide or the Institutions/Investigators incur bank fees with respect to the remittance of these grant
payments, such fees will be borne by Sponsor. All payments to Institutions/Investigators and any associated bank fees will be made
by Worldwide solely from the funds that have been specifically provided by Sponsor to Worldwide for this purpose and not from Worldwide
funds. Worldwide will not be liable for payments not made on a timely basis to any Institution/Investigator as a result of Sponsor’s
failure to provide, in advance, sufficient funds for such payments.

  

The Parties acknowledge and agree that,
for the purposes of this Agreement, Institutions/Investigators shall not be considered as employees, agents or subcontractors of
Worldwide and that Investigators will be required to exercise their own independent medical judgement. Worldwide’s responsibilities
with respect to Institutions/Investigators shall be limited to those specifically set forth in this Agreement.

 

5.0       CONFIDENTIAL
INFORMATION

 

The Parties acknowledge and agree that
in the course of performing Services hereunder, either Party may be exposed to or be given confidential or proprietary information
of the other Party (“Confidential Information”). The Parties agree to hold all Confidential Information in secrecy
for a period of [***] from the effective date of the expiration or earlier termination of this Agreement and shall disclose Confidential
Information to third parties only on a need-to-know basis. Without limiting the generality of the foregoing, Confidential Information
shall include, without limitation, [***]. Confidential Information shall be deemed to be all such information given by the disclosing
party to the receiving party except for information which is (i) publicly available or later becomes publicly available through
no fault of the receiving party; (ii) obtained by the receiving party from a third party entitled to disclose it; (iii) already
in possession of the receiving party as indicated in its written records; (iv) independently developed by the receiving party without
use of the Confidential Information; or (v) required by any law, rule, regulation, order, decision, decree, or subpoena or other
judicial, administrative, or legal process to be disclosed.

 

Both Parties shall ensure that all of its
officers, employees, consultants, agents, investigators or contractors who receive such Confidential Information understand and
shall be bound by the confidentiality provisions of this Agreement.

 

Unless otherwise agreed in writing, within
thirty (30) days after the termination of the Agreement or the written request by the disclosing party, the receiving party shall
return to the disclosing party all Confidential Information in documentary or permanent form including any and all copies thereof,
except for one archival copy that the receiving party can keep for its records (which may be electronic). The Parties agree that
each party is and shall remain the exclusive owner of its own Confidential Information and all patent, copyright, trade secret
and other intellectual property rights therein unless and until a further agreement is executed.

 

The Parties acknowledge that any violation
of the terms of this Section 5.0 may result in irreparable injury and damage to disclosing party that is not adequately compensable
in money damages, and for which disclosing party may have no adequate remedy at law. Accordingly, the receiving party agrees that
the disclosing party shall be entitled to seek (without waiving any additional rights or remedies, including monetary damages,
otherwise available to the disclosing party at law, in equity, or by statute) preliminary and permanent injunctive relief in the
event of a breach or intended or threatened breach by the receiving party.

 

    Page 7 of 47

     

    

 

6.0       OWNERSHIP
OF DATA AND INTELLECTUAL PROPERTY

 

Any invention, discovery, processes, know-how,
trade secrets, data, copyrights, trademarks, improvements, or any other intellectual property right related to Sponsor’s
products or technology, including the Study Drug, the Protocol, Sponsor’s Confidential Information, which is conceived or
reduced to practice as a result of the performance of the Services hereunder (the “Inventions”) shall become
Sponsor property and shall be used by Sponsor as Sponsor deems appropriate. Worldwide agrees to, and shall contractually require
and use reasonable efforts to cause Institutions and Investigators to execute and have executed assignments of the Inventions to
Sponsor, along with other documents that be necessary or helpful to Sponsor in filing patent applications, or which may relate
to any litigation or interference and/or controversy in connection therewith. The entire control, prosecution, and conduct of any
patent application filed by Sponsor shall be outside the jurisdiction of and without expense to Worldwide and its officers, employees,
representatives and agents. Worldwide acknowledges that Sponsor has the exclusive right to file patent applications in connection
with the Inventions. Worldwide warrants that neither it, nor its employees, agents and representatives, will prevent Sponsor from
filing patent applications for, or from applying the results of the research carried out for Sponsor hereunder.

 

All reports, data, technical information,
original works of authorship and all other information, furnished by or on behalf of Sponsor, or created specifically for Sponsor
as a deliverable under a this Agreement, shall be the sole property of Sponsor. Nothing under this Section or any other Section
of this Agreement shall be construed as (i) granting to any Party any rights under any patent, copyright or other intellectual
property right of the other Party (ii) granting to any Party any rights in or to the Confidential Information of the other Party
other than the limited right to use such Confidential Information solely for the purposes expressly permitted by Section 5.0 of
this Agreement.

 

Sponsor acknowledges that Worldwide possesses
certain computer programs, applications, algorithms, databases, methods, techniques, processes and other materials and ideas independently
developed by Worldwide which do not rely upon, reference, or inextricably incorporate Sponsor Confidential Information or Study
Drug and which relate to Worldwide’s business or operations (“Worldwide Works”). All Worldwide Works,
and all revisions, improvements and enhancements thereto, are the exclusive property of Worldwide or its licensors. Sponsor agrees
that any improvements, alterations or enhancements to the Worldwide Works during the term of this Agreement or the Study shall
be the sole property of Worldwide. Subject to Section 5.0 hereof, in no event shall Worldwide be precluded from use of its general
knowledge, skills and experience, and any of its ideas, concepts, know-how and techniques used or developed by it in the course
of providing Services under this Agreement. Worldwide represents and warrants that it is entitled to deliver Worldwide Works where
the same is delivered as part of the Services hereunder for Sponsor and its Affiliates’ use, and Worldwide further represents
and warrants that use by Sponsor and its Affiliates’ of any such Worldwide Works is properly authorized and will not constitute
an infringement or other violation of any rights of any third party.

 

7.0       TERM
AND TERMINATION

 

7.1        Term

 

Unless earlier terminated according to
Sections 7.2-7.5 below, this Agreement will remain in effect from the date first written above until Worldwide has completed performance
of all Services (including delivery of all deliverables) and Worldwide has received from Sponsor all of the payments due hereunder.

 

    Page 8 of 47

     

    

 

7.2       Termination
for Material Breach 

 

In the event that either Party commits
a material breach in any of the terms or conditions of this Agreement, and that Party fails to cure the breach [***] after receipt
of notice of the default or breach from the other Party, the Party giving notice may, at its option, immediately terminate this
Agreement at the end of the [***] period. For the avoidance of doubt, [***] by Sponsor or non-payment by Worldwide to Institutions/Investigators
under Section 4.1(f) shall [***].

 

7.3       Termination
by Sponsor without Cause

 

Sponsor shall have the right to terminate
this Agreement (for other than breach by Worldwide) at any time by giving appropriate written notice at least sixty (60) days prior
to the desired termination date.

 

7.4       Termination
for Other Reasons

 

Sponsor shall have the right to terminate
this Agreement due to patient safety at any time by giving appropriate written notice. Either Party shall have the right to terminate
this Agreement at any time upon receipt of written notice to the other Party, if the other Party shall be adjudicated insolvent
or shall petition for or consent to any relief under any insolvency, re-organization, receivership, liquidation, compromise, or
any moratorium statute, whether now or hereafter in effect, or shall make an assignment for the benefit of its creditors, or shall
petition for the appointment of a receiver, liquidator, trustee, or custodian for all or a substantial part of its assets, or if
a receiver, liquidator, trustee or custodian is appointed for all or a substantial part of its assets and is not discharged within
[***] after the date of such appointment. In the event that any of the above events occur, that Party shall immediately notify
the other, in writing, of its occurrence.

 

7.5       Termination
Procedures

 

Upon termination of this Agreement, the
Parties will reasonably cooperate with each other to provide for an orderly cessation of Worldwide’s Services. Worldwide
shall [***] the cessation of the Services. In the event Sponsor terminates only part of the Services, the Parties will cooperate
in good faith to enter into a Change Order amending the terms of this Agreement accordingly. In the event the Agreement or any
of the Services is terminated, Worldwide will be entitled to [***] and [***] up to the effective date of termination. In addition,
Sponsor shall [***] by Worldwide that are [***] in connection with the orderly cessation of the Services. If a Study or the Agreement
is cancelled or terminated before the Services have been performed completely, Worldwide [***] to the extent that the [***] for
the [***] can reasonably be avoided in whole or in part.

 

8.0       DEBARMENT
CERTIFICATION

 

Worldwide and its Affiliates represent
and certify that neither they, nor any of their respective employees or Study personnel have ever been (a) debarred or voluntarily
excluded or convicted of a crime for which a person can be debarred under Section 306 of the Federal Food, Drug, and Cosmetic Act,
21 U.S.C. §335a(a) , as amended, or any equivalent local law, regulation or guidelines thereof, in any country in which any
portion of the Study is conducted (“§335a”); nor (b) threatened to be debarred or voluntarily excluded or indicted
for a crime or otherwise engaged in conduct for which a person can be debarred under § 335a, or subject to any governmental
sanction that would prevent the rendering of Services hereunder in any jurisdiction in which the Study is to be conducted, nor
(c) excluded from participation in any federally-funded health-care program. Worldwide agrees that it shall notify Sponsor in writing
within [***] in the event of any debarment, voluntary exclusion, conviction, threat, indictment or exclusion prohibited by this
Section occurring during the Term of this Agreement and will suspend all activity of such individual immediately upon notification
of investigation or debarment.

  

    Page 9 of 47

     

    

 

 

Worldwide represents and certifies that
it has not and will not knowingly use in any capacity the services of any individual, corporation, partnership, or association
which has been (a) debarred or voluntarily excluded or convicted of a crime for which a person can be debarred under § 335a;
(b) threatened to be debarred or voluntarily excluded or indicted for a crime or otherwise engaged in conduct for which a person
can be debarred under § 335a, or subject to any governmental sanction that would prevent the rendering of Services hereunder
in any jurisdiction in which the Study is to be conducted or (c) excluded from participation in any federally funded health care
program.

 

		9.0	RECORDS, AUDITS AND INSPECTIONS

 

 

		9.1	Records

 

Worldwide shall keep full and accurate
records and accounts of all its activities in connection with this Agreement, including reasonable substantiation of all Services
provided, expenses incurred. Additionally, Worldwide shall maintain a system of internal controls sufficient to provide reasonable
assurance that all transactions related to this Agreement are executed and are properly recorded in Worldwide’s books and
records. All records relating to this Agreement including, but not limited to, Worldwide’s invoices shall be available for
inspection and audit by Sponsor as set forth in Section 9.2, or any independent auditors designated by Sponsor, upon [***] prior
written notice, and for a period of [***] following the completion of the Study, unless a longer retention period is required by
Applicable Laws. Sponsor agrees that its independent auditors may be required to execute a reasonable confidentiality agreement
with Worldwide or Worldwide’s Affiliate or subsidiary, as the case may be, which contains mutually agreed-upon terms. Further,
Sponsor’s financial audit of Worldwide or any Worldwide Affiliate or subsidiary hereunder shall be subject to the confidentiality
obligations set forth herein.

 

		9.2	Audits by Sponsor

 

During
the term of this Agreement, Worldwide will permit representatives of Sponsor who are not competitors of Worldwide to examine, [***],
subject to at least [***] prior written notice to Worldwide (except in the case of “for cause” audits where Sponsor
will provide [***] prior written notice to Worldwide), and [***]: (i) the facilities where the Services are being, will be or have
been conducted; (ii) related Study documentation; and (iii) any other relevant information necessary for Sponsor to confirm that
the Services are being or will be or have been conducted in conformance with applicable standard operating procedures, this Agreement
and in compliance with Applicable Laws and regulations, including related financial information relating to Worldwide service fees,
Pass-through Expenses and grant payments to Investigators. Worldwide will provide copies of any materials reasonably requested
by Sponsor during such inspection.

 

 

		9.3	Inspection by Regulatory Authorities

 

During the term of this Agreement, Worldwide
will permit regulatory authorities to examine, (i) the facilities where the Services are being conducted; (ii) study documentation;
and (iii) any other relevant information, including information that may be designated by Worldwide as confidential, reasonably
necessary for regulatory authorities to confirm that the Services are being conducted in compliance with Applicable Laws and regulations.
Worldwide will immediately notify Sponsor if any regulatory authority schedules, or without scheduling, begins an inspection that
relates to the Services, and, unless expressly prohibited by such regulatory authority, permit Sponsor to attend such inspection.

 

    Page 10 of 47

     

    

 

		9.4	Inspections of Investigator Site(s) by Worldwide

 

In connection with Worldwide’s provision
of Services as specified in this Agreement, Worldwide may conduct monitoring visits and/or inspections of Investigator Sites. Based
on Worldwide’s observations during such Investigator Site visits and inspections, Worldwide may decide: i) that enrollment
should be suspended at the Investigator Site; ii) that an Investigator Site’s non-compliance needs to be reported to Sponsor
and/or regulatory authorities; and/or (iii) Investigator Site’s participation in a Study needs to be terminated. Upon such
a determination, Worldwide will present to Sponsor a basis for its decision. If Sponsor disagrees with the basis for Worldwide’s
decision, Worldwide will assign its contract with the Investigator Site to Sponsor and Sponsor agrees to accept such assignment
and to be responsible for all contractual duties and obligations to the Investigator Site.

 

		10.0	INDEMNIFICATION

 

		10.1	Indemnification by Worldwide

 

Worldwide shall indemnify, defend and hold
harmless Sponsor and its Affiliates and their respective officers, directors, employees and agents from any loss, damage, cost
or expense (including reasonable attorney’s fees) (“Losses”) arising from any third party claim, demand,
assessment, action, suit or proceeding (a “Claim”) arising out of (i) any material breach by Worldwide Group
of any material obligations under this Agreement or the Protocol, (ii) any Worldwide Group’s negligence or intentional misconduct;
or (iii) any Worldwide Group’s material failure to comply with any applicable law for FDA regulations, except to the extent
such Losses are caused by Sponsor’s negligence or willful misconduct.

 

		10.2	Indemnification by Sponsor

 

Sponsor shall indemnify,
defend and hold harmless Worldwide and its Affiliates and their respective officers, directors, employees and agents (the “Worldwide
Group”) from any Losses arising from any Claim arising out of (i) Worldwide’s adherence to written instructions
provided by Sponsor to Worldwide, including adherence to the Protocol and proper performance of the Services in accordance with
this Agreement and the Protocol; (ii) the Study drug’s harmful or otherwise adverse effect, including, without limitation,
a Claim based upon the consumption, sale, distribution or marketing of any substance, including the Study drug, (iii)any breach
by Sponsor of any material obligations under this Agreement, or (iv) the negligence or intentional misconduct of Sponsor, except
to the extent such Losses are caused by Worldwide Group’s negligence or wilful misconduct.

 

In the event Worldwide
incurs reasonable and necessary costs or out-of-pocket expenses as a result of it becoming involved in, or being required to appear
or otherwise participate in, a matter (i) relating to the Study that is the subject of a claim or any proceeding, litigation, arbitration
or some other dispute resolution mechanism, and (ii) where Worldwide’s performance of the Services in a manner other than
in compliance with this Agreement is not at issue in such claim, then Sponsor shall reimburse Worldwide for pre-approved reasonable
and necessary costs or out-of-pocket expenses. The Parties agree to cooperate with each other and to use commercially reasonable
best efforts in good faith to minimize Worldwide’s participation in and the costs or out-of-pocket expenses relating to such
disputes.

 

    Page 11 of 47

     

    

 

		10.3	Indemnification Procedures

 

Upon receipt of written
notice of any Claim which may give rise to a right of indemnity from the other Party hereto, the Party seeking indemnification
(the “Indemnified Party”) shall give written notice thereof to the other Party, (the “Indemnifying
Party”). The Indemnified Party shall permit the Indemnifying Party, at its own option and expense, to assume the complete
defense of such Claim, provided that the Indemnified Party will have the right to participate in the defense of any such Claim
at its own cost and expense. As to those Claims with respect to which the Indemnifying Party does not elect to assume control,
the Indemnified Party will afford the Indemnifying Party an opportunity to participate in such defense, at the Indemnifying Party’s
own cost and expense.

 

		11.0	LIMITATION OF LIABILITY

 

Under no circumstances shall either Party
be liable under this Agreement for any indirect, incidental, special or consequential damages of the other Party resulting from
such Party’s performance or failure to perform under this Agreement. In addition and except for the confidentiality and indemnification
obligations of Worldwide under Sections 5 and 10.1, respectively, in no event shall the collective, aggregate liability of the
Worldwide Group to Sponsor [***] pursuant to this Agreement.

 

		12.0	INSURANCE

 

Sponsor hereby represents
and warrants that it shall maintain adequate clinical trial and product liability insurance coverage, with insurance companies
having an A. M. Best Rating of [***] to cover all personal injury, death or loss suffered as a result of the Study Drug, participation
in the trial or the trial screening process. Sponsor shall provide Worldwide with a copy of Sponsor’s effective Certificate
of Insurance or such other documented evidence to confirm that it has such coverage. Sponsor shall maintain such insurance for
the entire duration of the Study and shall notify Worldwide of any changes in coverage which impact the coverage requirements set
forth above.

 

Prior to commencement of any work under
this Agreement, Worldwide shall, at its sole expense, maintain the following insurance on its own behalf, with insurance companies
having an A. M. Best Rating of [***]:

 

(1)       Commercial General Liability
(including Premises Operations). The policy must be on an occurrence form and include the following limits: Each Occurrence: $[***];
General Aggregate: $[***].

 

(2)       Commercial Umbrella Liability.
This policy must include the following limits: Occurrence Limit: $[***]; Aggregate Limit (where applicable); $[***] Policy to be
excess of the Commercial General Liability, Commercial Automobile Liability and Employers Liability.

 

(3)       Product/Professional Liability
Coverage (Errors & Omissions): Each Claim Limit: $[***]; Aggregate Limit: $[***]. Throughout the term of this Agreement, the
Errors & Omissions Liability insurance's retroactive date will be no later than the effective date of this agreement. Upon
expiration or termination of this Agreement, Worldwide will either continue to maintain an active insurance policy, or purchase
an extended reporting period coverage for claims first made and reported to the insurance company [***] the end of the Agreement.

 

Upon request, Worldwide shall provide Sponsor
with a copy of Worldwide’s Certificates of Insurance or such other documented evidence to confirm that it has all of the
foregoing coverage. Worldwide shall maintain such insurance for the entire duration of the Study and shall notify Sponsor of any
reduction in coverage which impact the coverage requirements set forth above.

 

    Page 12 of 47

     

    

 

		13.0	REPRESENTATIONS AND WARRANTIES

 

13.1       Each
Party represents that it is authorized to enter into this Agreement and that the terms of this Agreement are not inconsistent with
or a violation of any contracted or other legal obligation to which it is subject.

 

13.2       Each
Party represents that it has all qualifications, authorizations, licenses or permits which are necessary for performance of its
obligations under this Agreement.

 

13.3       Worldwide
represents and warrants to Sponsor that:

 

(a)       Worldwide
is a duly incorporated and validly existing corporation under the laws of the Delaware;

 

(b)       Worldwide
represents that taken together with its Affiliates it has personnel, equipment, experience and expertise sufficient in quality
and quantity to provide all comprehensive Services requested by Sponsor hereunder and agreed to by Worldwide and its Affiliates
and that any and all such Services will be performed commensurate with the commercially reasonable standards generally applicable
to the conduct and management of clinical drug studies by a clinical research organization throughout the world;

 

(c)       upon
execution and delivery of this Agreement, this Agreement shall constitute a legal, valid and binding agreement of Worldwide and
its Affiliates, as applicable, enforceable in accordance with its terms, except to the extent enforceability may be affected by
applicable bankruptcy, reorganization, insolvency, and moratorium laws and other laws applicable generally to creditors’
rights and debtors’ remedies from time to time in effect;

 

(d)       neither
the execution and delivery of this Agreement nor Worldwide’s performance of its obligations hereunder will violate or breach,
or otherwise constitute or give rise to a default under, the terms or provisions of Worldwide’s registration documents or
its By-Laws or any equivalent document or of any material contract, commitment or other obligation to which Worldwide is a party,
or violate or result in a breach of or constitute a default under any judgment, order, decree, rule or regulation of any court
or governmental agency to which Worldwide is subject; and

 

(e)       Worldwide
has developed a business interruption and disaster recovery program and is executing such program to assess and reduce the extent
to which Worldwide’s hardware, software and embedded systems may be susceptible to errors or failures in various crisis (or
force majeure) situations. In the event that any data, reports or materials that are delivered by Worldwide to Sponsor are inaccurate,
and Worldwide does not reasonably dispute such inaccuracy, and such inaccuracy is caused by errors or failures of Worldwide’s
personnel, hardware, software or embedded systems then Worldwide will, to the extent possible, fix, or if necessary, re-perform
the deliverables at its own expense within mutually agreeable time frames. If Sponsor and Worldwide mutually agree that Worldwide
is not capable of timely or satisfactory re-performance and Worldwide has been paid for such Services, then Worldwide will reimburse
Sponsor for the reasonable costs related to a third party’s re-performance of such services or reimburse Sponsor for the
reasonable internal costs allocated for the re-performance of such services; provided, however, such reimbursement shall not exceed
the amount of money Worldwide received for the performance the inaccurate Services.

 

    Page 13 of 47

     

    

 

(f) Worldwide will
employ commercially reasonable efforts to ensure that all data collected and stored by it pursuant to this Agreement will be safeguarded
against loss, damage and destruction arising from any cause including, but not limited to, theft, fire, flood, earthquake, lightning,
and electrical disruption. Such measures and processes will include, but not be limited to, (a) storage of hard-copy documents
and computer storage disks in locked, fireproof containers, and (b) back-up and recovery systems (which are periodically tested)
for computer-based systems. Sponsor has the right, but not the obligation, subject to at least ten (10) business days prior written
notice to Worldwide, during normal business hours and at mutually agreed upon dates and times, to periodically inspect Worldwide’s
premises to determine whether the foregoing measures and processes are in effect and being implemented. Such inspections shall
be subject to the confidentiality obligations set forth herein.

 

		14.0	DISCLAIMER

 

Sponsor acknowledges that the results of
the Studies for which the Services are to be provided hereunder are inherently uncertain and that, accordingly, there can be no
assurance, representation or warranty by Worldwide that the product covered by this Agreement can, either during the term of this
Agreement or thereafter, be successfully developed or receive the required approval by the regulatory authorities.

 

Sponsor acknowledges that the development
of the protocol concept and scientific rationale shall be the sole responsibility of Sponsor regardless of Worldwide’s involvement
in Study design or protocol-writing (or lack thereof).

 

    Page 14 of 47

     

    

 

		15.0	EMPLOYEES; NON-SOLICITATION

 

Worldwide’s staff is not, nor shall
they be deemed to be at any time during the term of this Agreement, the employees of Sponsor. In consideration of the fees and
benefits provided in this Agreement, Sponsor agrees that, without Worldwide’s prior written consent, during the term of this
Agreement and for [***] following its expiration or other termination, neither Sponsor nor any of its Affiliates shall directly
or indirectly solicit for employment or contract, attempt to employ or contract with, or assist any other entity in employing,
contracting with or soliciting for employment or contract any employee who is at that time employed/contracted by Worldwide and
who had been employed/contracted by Worldwide in connection with this Agreement issued hereunder. In the event that legal action
becomes necessary for the enforcement of all or any part of this provision, the prevailing party shall [***]. Sponsor acknowledges
that in the event of a breach of this Section 15.0, Worldwide shall be entitled to seek injunctive relief for any such breach.

 

		16.0	NOTICES

 

All notices provided for in this Agreement
shall be in English and shall be sent by registered first class mail, postage prepaid, return receipt requested, addressed to the
respective Parties as follows:

 

If to Sponsor:

 

Neurotrope Bioscience Inc.

205 East 42nd Street,
New York, NY 10019

ATTN: [***]

Via email: [***]

 

If to Worldwide:

 

c/o Worldwide
Clinical Trials, Inc.

3800 Paramount
Parkway, Suite 400, 27560

Morrisville,
NC, United States

ATTN: Legal
Counsel

 

		17.0	MISCELLANEOUS

 

		17.1	Modification

 

This Agreement may be supplemented, amended
or modified only by mutual agreement of the Parties. No supplement, modification or amendment of this Agreement will be binding
unless it is in writing and signed by both Parties.

 

		17.2	Assignment

 

Neither Party shall have the right to assign
this Agreement or any of its rights or obligations hereunder without the prior written consent of the other Party, except that
either Party may assign this Agreement to an Affiliate, any purchaser of or successor to that area of its business to which this
Agreement is related, any purchaser of all or substantially all of such Party’s assets or in excess of 50% of such Party’s
voting securities, and any successor corporation resulting from any merger, consolidation, reorganization, business organization,
joint venture or similar transaction of such Party with or into such corporation. Worldwide assignment, delegation or subcontracting
to any third parties shall be in accordance with the terms of this Agreement. Any permitted assignment by either party will not
relieve such Party of its obligations or liability incurred prior to assignment. Any assignment not in compliance with the terms
of this provision shall be void.

 

    Page 15 of 47

     

    

 

		17.3	Force Majeure

 

Neither Sponsor nor Worldwide shall be
liable for delays in performing or any failure to perform any of the terms of this Agreement caused by the effects of fire, strike,
war (declared or undeclared), insurrection, acts of terror, government restriction or prohibition, or other causes reasonably beyond
its control and without its fault, but the Party failing to perform shall use all commercially reasonable efforts to resume performance
of this Agreement as soon as feasible. Any episode of force majeure which [***] from the date of notification of its existence
shall give the non-affected Party the right to terminate this Agreement [***].

 

		17.4	Severability

 

If any provision of this Agreement is found
by a court to be void, invalid or unenforceable, the same shall either be reformed to comply with applicable laws and regulations
or stricken if not so conformable, so as not to affect the validity or enforceability of the remaining provisions of this Agreement,
except if the principal intent of this Agreement is frustrated by such reformation or deletion in which case this Agreement shall
terminate.

 

		17.5	English Language

 

Unless the Parties otherwise agree, any
document that is provided in connection with this Agreement must be (a) in English, or (b) accompanied by a certified English translation,
in which case the English translation shall prevail unless the document is a statutory or other official document.

 

		17.6	Entire Agreement

 

The Parties hereto acknowledge that each
has read this Agreement, understands it and agrees to be bound by its terms. The Parties agree that this Agreement is the complete
agreement between the Parties on the subject matter and supersedes all proposals (oral or written), letters of intent, understandings,
representations, conditions, warranties, covenants and other communications between the Parties relating to the same subject matter.

 

		17.7	Survival

 

The terms, contained in Section 3, Sections
6.0, 7.6, 8.0, 10.0, 11.0, and 17.0 of this Agreement shall survive the completion of performance, expiration or termination of
this Agreement. Sections 5.0, and 15.0 shall survive for the period expressly set forth in such Section or, if none, the applicable
statute of limitations period applicable to a claim for breach of such provision.

 

		17.8	Governing Law

 

This Agreement shall be interpreted and
enforced in accordance with the laws of the State of Delaware and each Party hereby specifically consents to the personal jurisdiction
thereof.

 

		17.9	Waiver

 

No waiver of any term, provision or condition
of this Agreement whether by conduct or otherwise in any one or more instances will be deemed to be construed as a further or continuing
waiver of such term, provision or condition or of any other term, provision or condition of this Agreement.

 

    Page 16 of 47

     

    

 

		17.10	Independent Contractors

 

The Parties’ relationship, as established
by this Agreement, is solely that of independent contractors. This Agreement does not create any partnership, joint venture or
similar business relationship between the Parties. Subject to Section 10.0 and/or as may be expressly agreed otherwise in the case
of legal representation in the EU, neither Party is a legal representative of the other Party, and neither Party can assume or
create any obligation, representation, warranty or guarantee, express or implied, on behalf of the other Party for any purpose
whatsoever.

 

		17.11	Counterparts

 

This Agreement may be executed in counterparts,
each of which shall be deemed an original but all of which taken together shall constitute one and the same instrument. In the
event that any signature is delivered by facsimile transmission, by e-mail delivery of a “.pdf” format data file or
other electronic means, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such
signature is executed) with the same force and effect as if such signature page were an original thereof.

 

		17.12	Arbitration

 

In the event a dispute relating to this
Agreement arises between the Parties, the Parties shall confer in good faith to resolve the dispute through negotiations between
respective senior executives of the Parties. In the event that the Parties are unable to resolve the dispute, the Parties will
attempt to resolve the dispute in good faith through mediation. If the dispute has not been resolved by mediation [***] of the
initiation of the procedure, the dispute shall be settled by arbitration administered by the American Arbitration Association under
its Commercial Arbitration Rules in Delaware. Judgment shall be rendered by a mutually agreed upon single arbitrator. The provisions
of this Section may be enforced by any court of competent jurisdiction, and the Party seeking enforcement shall be entitled to
an award of all costs, fees and expenses, including reasonable attorneys’ fees, to be paid by the Party against whom enforcement
is ordered.

 

IN WITNESS WHEREOF, the undersigned have
caused this Agreement to be executed by their respective duly authorized representatives effective as of the Effective Date.

 

	NEUROTROPE BIOSCIENCES, INC.	WORLDWIDE CLINICAL TRIALS, INC.

 

	By:	 /s/ Robert Weinstein	 	By:	/s/
Anthony Hinman
	 
	Name: 	Robert
Weinstein	 	Name:  	Anthony Hinman
	 
	Title:	Chief Financial
Officer	 	Title:	Legal Counsel
	 
	Date:	July 23,
2020	 	Date:	July 23,
2020

 

    Page 17 of 47

     

    

 

LIST OF EXHIBITS:

 

	EXHIBIT A:	Scope of Services
	EXHIBIT B:	Timeline
	EXHIBIT C:	Budget
	EXHIBIT D:	Payment Schedule
	EXHIBIT E:	Form of Change Order

 

    Page 18 of 47

     

    

 

 

EXHIBIT A

SCOPE OF SERVICES

 

Assumptions:

 

	Study Assumptions and Specifications
	General Study Information	 
	Drug/Compound	Bryostatin
	Indication	Alzheimer's Disease
	Study Phase	 Phase II
	Bid Currency	USD
	 	 
	Study Sites	 
	Number of Countries	1
	Number of Sites	[***]
	North America	[***]
	USA	[***]
	Patients	 
	Number of Screened Patients	[***]
	Number of Enrolled Patients	100
	Number of Drop Outs	[***]
	Number of Completed Patients	[***]
	Site Monitoring and Site Management	 
	Number of CRAs (Headcount Based)	3
	Monitoring Visits	 
	Number of Phone Qualification Visits	[***]
	Number of Site Qualification Visits	[***]
	Number of Site Initiation Visits	[***]
	Number of Remote Monitoring Visits	[***]
	Number of Interim Monitoring Visits	[***]
	Pool of Additional Visits	[***]
	Number of Close-outs Visits	[***]
	Site Maintenance Months	[***]
	Remote Data Review	[***]
	Meetings	 
	Internal Alignment (KO) Meeting	[***]
	Sponsor Alignment (KO) Meeting	[***]
	Project team teleconferences	[***]
	Number of internal teleconferences	[***]
	Number of sponsor teleconferences	[***]
	Site Activation	 
	Feasibility/ Site Identification	[***]
	Essential Documents & Review	[***]
	Investigator Agreements 	[***]
	Central Institutional Review Board (IRB) Site Submissions	[***]

 

    Page 19 of 47

     

    

 

	Study Assumptions and Specifications
	Medical Affairs	 
	Number of Months for Medical Planning	[***]
	Eligibility Review	[***] 
	Listings Reviews	100 Enrolled Subjects
	Coded Data Review	100 Enrolled Subjects
	Ongoing Safety Reviews of Labs and ECG alerts	[***]
	Pharmacovigilance	 
	Estimated Number of SAE(s)	[***]
	Estimated Number of Expedited SUSAR(s)	[***]
	Safety Database Setup and Maintenance	[***]
	Number of Follow-up Reports per Event	[***]
	Data Management	 
	CRF Pages	 
	Number of Pages/Enrolled Patient	[***]

  ([***])
	Number of Pages/Screen Fail Patient	[***]
	Clinical Data Management System	[***]
	Randomization System	[***]
	Number of Edit Checks	[***]
	Number of Dictionary Coding Terms (AEs, MedHistory, Medications)	[***]
	MedDRA Coding	[***]
	WHODRUG Coding 	[***]
	Number of External Vendor Data Loads	[***]
	Data Cleaning	[***] 
	Manual Listings	[***]
	Reconciliation of SAE(s)	[***]
	Number and Type of Database Transfers	[***]
	Biometrics	 
	Statistical Analysis Plan	[***]
	Randomization Schedule	[***]
	Number and Type of Analyses:	 
	Dry Runs	[***]
	Full Analysis	[***]
	PK Analysis	[***]
	Final Analysis Data Displays:	 
	Number of Tables	[***]
	Number of Listings	[***]
	Number of Figures/Graphs	[***]
	Datasets:	 
	Data sets SDTM	[***]
	Data sets ADaM	[***]
	Ongoing CDISC Transfers	[***]
	Medical Writing	 
	Informed Consent Form	[***]
	Clinical Study Report (Shell and body text)	[***]
	CSR Published	[***]
	Data Safety Monitoring Board (DSMB)	 
	Number of Meetings	[***]
	DSMB Data Displays	 
	Number of Tables	[***]
	Number of Listings	[***]
	Number of Figures/Graphs	[***]

 

    Page 20 of 47

     

    

  

Responsibilities:

 

	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's 

Responsibility
	Feasibility/ Site Identification	X
	Identify Sites	X
	Unblinded Feasibility under Confidentiality Disclosure Agreement	X
	Site Activation Lead Planning Per Country	X
	Liaise with Global Project Lead, Regional Project Manager, Lead 

Clinical Research Associate and Site Activation Lead to Develop a 

Site Activation Strategy	X
	Communicate Start-up Timelines	X
	Develop a Risk Log and Priority Action Items	X
	Provide Strategic Input to Site Selection	X
	Develop Site Activation Tracker Template	X
	Trial Master File (TMF) Filing & QC	X
	Regulatory Project Plan	X
	Regulatory Set-up	X
	Set Up Electronic and Hardcopy Files	X
	Familiarize with Protocol, Investigator Brochure and 

Investigational Medicinal Product Dossier (IMPD)	X
	Set Up Trackers or Databases, Including Country Requirements	X
	Core Documents Master Templates	X
	Develop Master Templates for Core Documents 	X
	Essential Documents & Review (US)	X
	Prepare and Distribute Essential Documents Templates	X
	Customize Essential Document Templates with Site Specific Information	X
	Collect Essential Document from Sites	X
	Provide First Review of Essential Documents for Compliance	X
	Provide Second Review of Essential Documents for Compliance 	X
	Communicate Deficiencies to First Reviewer	X
	Sign Off Essential Documents Package	X
	Answer Questions or Provide Clarification and Training to Project 

Team on Process or Requirements	X
	Provide Weekly Tracking and Progress Reports	X
	File Essential Documents and Checklist (Electronic Trial Master File/ Trial Master 

File, Internal Filing)	X
	Essential Documents Review Plan	X
	Essential Documents Checklist	X
	Investigator Agreements 	X

 

    Page 21 of 47

     

    

 

	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's Responsibility

	Prepare Template	X
	Negotiate Site Contracts to Execution	X
	Ensure the Completion of Site Indemnification Letters	X
	Administrative Quality Control all Investigator Agreements	X
	Track Status of Investigator Agreements	X
	Coordinate all Required Translations	X
	Investigator Agreements Country Specific Templates	X
	Customize Master Template with Country, Project and

 Sponsor-specific Requirements 	X
	Arrange Translation into Local Languages	X
	Perform Final Review and Formatting	X
	Contract and Budget Plan (CBP)	X
	Prepare Contract and Budget Plan for Initial Strategy.  Any 

Substantial Amendments to the Contract and Budget Plan will 

Require a Contract Amendment	X
	Investigator Grant Build	X
	Build Grant Plan for the Study.  Any Substantial Amendments to the 

Country and Site Strategy will Require a New Build and Contract

 Amendment	X
	Submission Strategy & Risk Assessment	X
	Develop Submission Strategy and Perform a Risk Assessment	X
	Central Institutional Review Board (IRB) Site Submissions (US)	X
	Prepare Regulatory Packages for Initial Submission	X
	Complete Application Forms	X
	Quality Control all Packages Prior to Submission	X
	Submit Regulatory Packages to Central Institutional Review Board

 (IRB)	X
	Track Regulatory Package/ Submission Status	X
	Review & Customize Informed Consent Form	X
	Maintain Informed Consent Form Tracking Log	X
	Central Institutional Review Board (IRB) Submission, Study Level (US)	X
	Preparation of Package, Quality Control, Submission, Response to 

Queries at Study Level to the Central Institutional Review Board

 (IRB)	X
	Master Informed Consent Form (ICF) Review	X
	TMF Management Plan & TMF Risk Assessment	X

 

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	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's Responsibility

	Draft, Review and Update Trial Master File Management Plan which Includes but is not Limited to:

- Project Timelines and Deliverables, i.e., Target Date of Submission of Trial Master File Documents to the Electronic Trial Master File Inbox by Submitters

- Define Electronic Trial Master File Configuration Requirements

- Delivery Intervals of Wet-ink Documents to Sponsor, if Required, (Quarterly, End of Study, etc.)

- Final Shipment of Trial Master File to Sponsor

- Forwarding applicable Records Management Compliance Standard Operating Procedures to sponsor, if needed.

- Listing of each wet-ink document required to be maintained during the course of the study

- Description of Quality Control/file reviews conducted by the project team

- Description of the Trial Master File close-out process	X
	Approve Trial Master File Management Plan	X
	Worldwide TMF: TMF Set-up: Pre Site Activation Activities	X
	Determine Trial Master File Filing Structure	X
	Review Trial Master File Management Plan for Sponsor-hosted Trial Master Files.  Check for Alignment with Worldwide's Record Management Compliance Standard Operating Procedures	X
	Provide Sponsor with Worldwide's Standard Operating Procedures Describing Trial Master File Document Protection (Scanning for Disaster Recovery), Secure File Area Conditions (Protection Against Fire/ Environmental Factors), and Secure Access to File Area Locations (Controlled and Restricted Access)	X
	Provide Detailed Expectations Regarding Type of Access Requirements of Sponsor and Worldwide's Project Team Including Timeframes for Access and Review	X
	Prepare Annotated Trial Master File Structure	X
	Prepare/ Configure the Trial Master File According to Worldwide's Standard Operating Procedures and Trial Master File Management Plan or Sponsor Plans if Sponsor-hosted Electronic Trial Master File.	X
	Agree Trial Master File Compliance Reporting Needs with the Sponsor	X
	Design Periodic Trial Master File Quality Control Process	X
	Facilitate Electronic Trial Master File System Training of all Users; Provide Project-specific Training Tools to Project Management	X
	Worldwide TMF: TMF Final Reconciliation & Transfer	X
	Complete Final Quality Control and Reconciliation of the Trial Master File	X
	Generate Trial Master File Gap Analysis for Review with Sponsor	X
	Complete a Final Review of the Trial Master File Data Due for Transfer	X
	Transfer Trial Master File Data to Sponsor 	X
	Obtain Signed Transfer of Ownership Form from Sponsor	X

 

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	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's Responsibility

	Internal Alignment (KO) Meeting	X
	Prepare for Internal Alignment Meeting 	X
	Attend and Participate in Meeting	X
	Sponsor Alignment (KO) Meeting	X
	Prepare for Sponsor Alignment Meeting 	X
	Attend and Participate in Meeting	X
	Sponsor Teleconferences	X
	Prepare for Teleconference - Gather Metrics, Issues and Any Action Item Updates	X
	Attend and Participate in Meeting	X
	Internal Teleconferences	X
	Prepare for Teleconference - Gather Metrics, Issues and Any Action Item Updates	X
	Attend and Participate in Meeting	X
	Lead Clinical Research Associate Support	X
	Communicate with Sponsor, Project Team and Vendors	X
	Attend and Participate in the Internal Project Clinical Research Associate (CRA) Training	X
	Provide Project Oversight	X
	Create and Disseminate Project Metrics	X
	Create Study Monitoring Manuals, Plans and Tools 	X
	Review Vendor Portals (Not in Preparation for Site Visit or Meetings)	X
	Provide Ongoing Review of and Updates to Study tools, Trackers, Reports and Metrics	X
	Provide Ongoing Trial Master File Review 	X
	Organizes, Tracks and Ensures the Clinical Study Report is Delivered to All Sites, Institutional Review Boards, and Competent Authorities (In Countries Where Applicable).  Ensures Acknowledgment of Receipts are Available/ Filed.	X

 

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	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's 

Responsibility
	Site Management	X
	Communicate with Sites During Start-up, Conduct and Closure and Resolve Site Issues Throughout the Study	X
	Support Sites During Start-up, Sites Set-up (Includes Back-up Sites), Conduct and Closure	X
	Update Clinical Trial Management System as Needed	X
	Write Telephone Contact Reports	X
	Communicate with the Project Team Regarding Site Issues	X
	General Site Contact and Communication	X
	Provide Remote Monitoring 	X
	Follow Up with Sites on Protocol Violations/ Deviations and Queries/ Data Management Issues	X
	Provide Assistance with Investigational Medicinal Product (IMP) Site Issues (i.e. Shipment, Acknowledgement, Interactive Response Technologies Site Entry and Review review)	X
	Send/ Deliver Safety Information to Sites (if not performed by the Pharmacovigilance Team)	X
	Communicate with Sites Regarding any Serious Adverse Events (SAE) Issues	X
	Provide Electronic Trial Master File Updates on an Ongoing Basis and Quality Control of Site Documents Collected in-between Site Visits	X
	Internal Clinical Research Associate Calls & Project Communication	X
	Clinical Research Associate Training (not at Investigator Meeting)	X
	Remote Pre-site Selection Visits	X
	Prepare for Visit	X
	Perform Visit (Remote)	X
	Write Visit Report	X
	Complete Visit Follow-up	X
	Review and Approve Visit Report	X
	On-site Pre-site Selection Visits	X
	Prepare for Visit	X
	Travel to and from Location	X
	Perform Visit	X
	Write Visit Report	X
	Complete Visit Follow-up	X
	Review and Approve Visit Report	X
	On-site Site Initiation Visits	X
	Prepare for Visit	X
	Travel to and from Location	X
	Perform Visit	X
	Write Visit Report	X
	Complete Visit follow-up	X
	Review and Approve Visit Report	X
	Remote Monitoring Visits Conduct 	X
	Prepare for Visit	X
	Perform Visit (Remote)	X
	Write Visit Report	X
	Complete Visit Follow-up	X
	Review and Approve Visit Report	X
	On-Site Monitoring Visits Conduct	X
	Prepare for Visit	X
	Travel to and from Location	X
	Perform Visit	X
	Write Visit Report	X
	Complete Visit Follow-up	X
	Review and Approve Visit Report	X
	Additional Time On-site	X
	On-site Close-out Visits	X
	Prepare for Visit	X
	Travel to and from Location	X
	Perform Visit	X
	Write Visit Report	X

 

    Page 25 of 47

     

    

 

	Worldwide
    Clinical Trials Responsibility Matrix
	Task	Worldwide's
    

    Responsibility
	Complete
    Visit Follow-up	X
	Review
    and Approve Visit Report	X
	Reconcile
    Final Trial Master File	X
	Remote
    Electronic Data Capture (EDC) Review Conduct	X
	Set-up
    Grant Payments	X
	Enter
    New Payees into the Finance System	X
	Acquire
    and Save all W-9's (US Sites Only)	X
	Process
    Grant Payments 	X
	Initiate
    and Print Purchase Orders	X
	Process
    Check or Wire	X
	Enter
    Voucher and Payment Transactions into the Finance System	X
	Provide
    Status Updates	X
	Track
    and Record all Payments	X
	Process
    Site Cost Payments 	X
	Set-up
    Vendor Payments	X
	Enter
    New Payees into the Finance System 	X
	Acquire
    and Save all W-9's (US Sites Only)	X
	Process
    Vendor Payments	X
	Process
    Check or Wire upon Project Management Approval	X
	Enter
    Voucher and Payment Transactions into the Finance System	X
	Risk
    Based Quality Management	X
	Protocol
    Risk Assessment	X
	Database
    Set-up & Configuration	X
	Define
    Argus Database Specifications	X
	Build
    Database	X
	Test
    Database	X
	Validate
    Database	X
	Safety
    Management Plan Development	X
	Write
    Safety Management Plan to Define Roles and Responsibilities of the Sponsor and Worldwide and Describe the Procedures for the
    Management, Processing, and Reporting of Serious Adverse Events (SAE) and Pregnancies	X
	Arrange
    for Review and Incorporation of Comments	X
	Obtain
    Approval from All Relevant Parties	X
	Safety
    Training (Sites, Clinical Research Associates, Project Team)	X
	Develop
    Training Materials	X
	Train
    All Relevant Worldwide/ Sponsor/ Site Staff of Pharmacovigilance Requirements and Obligations	X
	Provide
    Follow-up Training as Required	X
	Serious
    Adverse Events (SAE) Processing, Investigation, Narrative, Approval & Query Generation 	X
	Assess
    Each Serious Adverse Event (SAE) for Seriousness, Listedness and Causality	X
	Review
    Coding, Querying and Narratives and Analyze Similar Events	X

 

    Page 26 of 47

     

    

 

	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's 

Responsibility
	Provide Approval and Follow-up on each Serious Adverse Event (SAE)	X
	Analysis of Similar Events (AOSE) (US SUSARs only)	X
	Safety Management Maintenance	X
	Maintain and Update the Safety Management Plan as Necessary to Define Roles and Responsibilities of the Sponsor and Worldwide and Describe the Procedures for the Management, Processing, and Reporting of Serious Adverse Events (SAE) and Pregnancies	X
	 Review and Incorporate Updated Comments	X
	Approve Updates 	X
	Preparation of Line Listings (LL)	X
	Prepare and Write the Line Listings and Annual Safety Reports	X
	Review and Incorporate Comments	X
	Approve Updates 	X
	Suspected Unexpected Serious Adverse Reaction (SUSAR)/ Annual Safety Reports (ASR)/ Line Listings (LL) submission to Investigators	X
	Arrange for the Timely Submission of Pharmacovigilance Documents to Relevant Investigators to Ensure Regulatory Compliance	X
	DSUR Preparation (Writing and Compiling)	X
	Pharmacovigilance Closeout	X
	Arrange for the Preparation of Pharmacovigilance Data Stored in Argus to be Transferred to the Sponsor	X
	Deliver Data Safety Monitoring Board (DSMB) Database & Tables, Figures & Listings (TFLs)	X
	DSMB Statistical Analysis Plan (SAP)	X
	DSMB Unique Tables	X
	Create Unique Study Tables (One Draft)	X
	Validate Unique Study Tables	X
	Finalize Unique Study Tables After Sponsor Review	X
	Validate Final Unique Study Tables	X
	DSMB Repeat Tables	X
	Create Repeat Study Tables (One Draft Post Database Lock)	X
	Validate Repeat Study Tables	X
	Finalize Repeat Study Tables After Sponsor Review	X
	Validate Final Repeat Study Tables	X
	DSMB Unique Listings	X
	Create Unique Study Listings (One Draft Post Database Lock)	X
	Validate Unique Study Tables	X
	Finalize Unique Study Listings After Sponsor Review	X
	Validate Final Unique Study Listings	X
	DSMB Unique Figures	X
	Create Unique Study Figures (One Draft Post Database Lock)	X
	Validate Unique Study Figures	X
	Finalize Unique Study Figures After Sponsor Review	X
	Validate Final Unique Study Figures	X

 

    Page 27 of 47

     

    

 

	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's 

Responsibility
	DSMB Repeat Figures	X
	Create Repeat Study Figures (One Draft Post Database Lock)	X
	Validate Repeat Study Figures	X
	Finalize Repeat Study Figures After Sponsor Review	X
	Validate Final Repeat Study Figures	X
	Medical Planning	X
	Review the Protocol and Investigator Brochure to Gain an Understanding of the Trial	X
	Prepare Medical Monitoring Plan	X
	Provide Additional Study Document Review and Comment 	X
	Prepare and Conduct Clinical Research Associates (CRA) Training	X
	Communicate with Vendors to Determine Specifications Documents (Normal Ranges, Alerts Set-up, etc.)	X
	Medical Management	X
	Communicate with Sites/ Clinical Research Associates/ Project Team/ Sponsor on Protocol-medical Issues	X
	Document and Log Discussions	X
	Review Protocol Deviation Log	X
	Eligibility Review	X
	Review Selected Screening Datasets for Prospective Assessment of Eligibility	X
	Develop Subject Eligibility Form	X
	Discuss Process Design	X
	Listings Reviews	X
	Provide Adverse Events (AE), Serious Adverse Events (SAE), Medical History, Concomitant Medications, Vital Signs, Demographics Listings Review. Assumes One Cycle.	X
	Coded Data Review	X
	Provide Medical Review of Non-direct Hits for Medical Coding of Adverse Events, Concomitant Medications and Medical History	X
	Ongoing Safety Reviews of Labs and ECG Alerts	X
	Review Predefined Lab and Electrocardiogram Alerts	X
	Follow Up with Sites as Needed	X
	Maintain Medical Monitor Log	X
	Data Management Plan	X
	Prepare Data Management File and Filing of Trial Master File Documents	X
	Draft Data Management Plan for Sponsor Approval	X
	Training	X
	Electronic Case Report Form (eCRF) Development	X
	Create Database/ Electronic Data Capture (EDC)/ Electronic Case Report Form (eCRF)Specifications	X
	Electronic Case Report Form (eCRF) Completion Guidelines	X
	Draft Electronic Case Report Form Completion Guidelines and Electronic Data Capture Training Manuals for Sponsor Approval	X
	Edit Check Specifications	X

 

    Page 28 of 47

     

    

 

	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's 

Responsibility
	Specify Electronic, Manual and Statistical Analysis Software (SAS) Data Validation Checks	X
	Manual Listings Creation	X
	User Acceptance Testing	X
	Define Electronic Data Capture (EDC) Roles and Responsibilities (Study Attributes)	X
	Build and Validate Data Management Database	X
	Conduct User Acceptance Testing of Database	X
	Program and Validate Electronic, Manual and SAS Data Validation Checks	X
	Set-up of Standard Reports	X
	Provide Specification, Creation and Running of Data Management Reports	X
	User Manual Development	X
	Electronic Data Capture (EDC) Support	X
	Manage Access to Study-specific Electronic Data Capture (EDC)	X
	Train Users on EDC	X
	Provide Site Support (Access and eCRF Questions)	X
	Serious Adverse Event (SAE) Reconciliation	X
	Program and Validate SAE Reconciliation Program	X
	Serious Adverse Event (SAE) Reconciliation Maintenance	X
	Run SAE Reconciliation Program	X
	Resolve Issues that Arise from SAE Reconciliation	X
	Data Cleaning	X
	Provide Data Cleaning and Listing Review	X
	Reconcile Database and Clean Local Lab Normal Ranges	X
	Manual Listing Review	X
	Vendor Reconciliation Set-up	X
	Draft Data Transfer Agreement	X
	Programming and Validation of Reconciliation Program	X
	User Acceptance Testing of Reconciliation Process	X
	Vendor Reconciliation Maintenance	X
	Upon Receipt of Data for Reconciliation, Run Reconciliation Programs	X
	Resolve Issues that Arise from Reconciliation with Vendors	X
	Vendor Integration Set-up	X
	Draft Data Transfer Agreement	X
	Program and Validate Integration Program	X
	Conduct User Acceptance Testing of Integration Process	X
	Upon Receipt of Data for Integration, Run Integration Programs	X
	Resolve Issues that Arise from Integration with Vendors	X
	Vendor Integration Maintenance	X
	Upon Receipt of Data for Reconciliation, Run Reconciliation Programs	X
	Resolve Issues that Arise from Integrations	X
	MedDRA Coding (via Coding Tool within EDC)	X
	Provide Medical Coding and Raise Appropriate Queries	X
	Manage Dictionary	X

 

    Page 29 of 47

     

    

 

	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's 

Responsibility
	WHODRUG Coding (via Coding Tool within EDC)	X
	Provide Medical Coding and Raise Appropriate Queries	X
	Manage Dictionary	X
	Coding Dictionary Updates	X
	Data Transfer Set-up	X
	Create Data Transfer Programs and Transfer of Data During the Course of the Study	X
	Data Transfers	X
	Database Lock	X
	Conduct Database Quality Assessments	X
	Provide Data Report	X
	Create Database Lock Authorization Form	X
	Lock Database	X
	Provide Database Lock Report	X
	Conduct Final Data Transfer of Raw Data	X
	Distribute PDFs of Electronic Case Report Forms (eCRF) to the Sites and Sponsor for Archiving	X
	Archive CDs	X
	Randomization/ Kit list/ Interactive Response Technologies Review	X
	Create Randomization Specification	X
	Create and Validate One Dummy Randomization	X
	Create and Validate One Final Randomization	X
	Data Management Specifications	X
	Review One Draft of the Data Management Deliverables (eCRFs, Edit Checks, Database Set-up) for Appropriate and Necessary Data Collection with a Focus Towards Study Objectives and Endpoints	X
	Statistical Analysis Plan & Mock Shells	X
	Create One Draft Statistical Analysis Plan (SAP), Formatted, to be Inserted Directly into the Methods Section of an ICH-E3 Compliant Clinical Study Report	X
	Create One Draft of Table and Listing Shells for Each Unique Table and Listing	X
	Quality Control Draft Statistical Analysis Plan (SAP) and Table and Listing shells	X
	Create Final Statistical Analysis Plan (SAP) and Final Table and Listing Shells	X
	Study Data Tabulation Model (SDTM) Datasets	X
	Provide Study Data Tabulation Model (SDTM) Datasets from Raw Data Files Provided by the Data Management Team in Accordance with the Clinical Data Interchange Standards Consortium (CDISC) Implementation Guide and Worldwide's Standards (If Sponsor-specific Standards are Required Information Should be Provided at the Beginning of the Project)	X
	Create Dataset Specifications Document	X
	Create One Draft Version of SDTM Datasets	X

 

    Page 30 of 47

     

    

 

	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's 

Responsibility
	Validate Draft Version of SDTM Datasets via Independent Quality Control and Open CDISC	X
	Create One Final Version of SDTM Datasets	X
	Validate Final Version of SDTM Datasets via Independent Quality Control and Open CDISC	X
	Analysis Datasets	X
	Provide Analysis Data Model (ADaM) Datasets (Or Derived Datasets) Based on SDTM Data,  Implementation Guide and Worldwide's Standards (If Sponsor-specific Standards are Required Information Should be Provided at Project Outset)	X
	Create Dataset Specifications Document	X
	Create One Draft Version of ADaM Datasets	X
	Validate Draft Version of ADaM Datasets via Independent Quality Control	X
	Create One Final Version of ADaM Datasets	X
	Validate Final Version of ADaM Datasets via Independent Quality Control	X
	Define.xml and Data Reviewers Guide for SDTM, Annotated CRF	X
	Create One Draft and One Final “Define.xml” Document for SDTM Datasets	X
	Create One Draft and One Final “Define.xml” Document for ADaM Datasets	X
	Create One Draft and One Final Annotated CRF, Annotated with the Variables in the SDTM Datasets	X
	Create One Draft and One Final Study Data Reviewers Guide, Adding Further Detail to the SDTM Datasets	X
	Create One Draft and One Final Analysis Data Reviewers Guide, Adding Further Detail to the ADaM Datasets	X
	Deliver Final Database & Table, Figures & Listings	X
	Final Unique Study Tables	X
	Create Unique Study Tables (One Draft Post Database Lock)	X
	Validate Unique Study Tables	X
	Finalize Unique Study Tables After Sponsor Review	X
	Validate Final Unique Study Tables	X
	Final Repeat Study Tables	X
	Create Repeat Study Tables (One Draft Post Database Lock)	X
	Validate Repeat Study Tables	X
	Finalize Repeat Study Tables After Sponsor Review	X
	Validate Final Repeat Study Tables	X
	Final Unique Study Listings	X
	Create Unique Study Listings (One Draft Post Database Lock)	X
	Validate Unique Study Listings	X
	Finalize Unique Study Listings After Sponsor Review	X
	Validate Final Unique Study Listings	X
	Final Unique Study Figures	X
	Create Unique Study Figures (One Draft Post Database Lock)	X
	Validate Unique Study Figures	X

 

    Page 31 of 47

     

    

 

	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's 

Responsibility
	Finalize Unique Study Figures After Sponsor Review	X
	Validate Final Unique Study Figures	X
	Final Repeat Study Figures	X
	Create Repeat Study Figures (One Draft Post Database Lock)	X
	Validate Repeat Study Figures	X
	Finalize Repeat Study Figures After Sponsor Review	X
	Validate Final Repeat Study Figures	X
	Statistical Input to Clinical Study Report (CSR)	X
	Delivery Dry Run Database & Table, Figures & Listings	X
	Model Inform Consent Form(s) (ICF(s))	X
	Obtain Final Protocol	X
	Establish Template to be Utilized	X
	Generate First Draft for Sponsor Review	X
	Generate Second Draft for Sponsor Approval	X
	Deliver Final Model Informed Consent Form	X
	Scale Identification and Acquisition	X
	Contact Copyright Holder to Identify/ Acquire Scales (Including Translated Versions as Applicable)	X
	Approve Correct Scales Acquired	X
	Coordinate with Contracts to Obtain Scales	X
	Creation of Source Documents	X
	Apply Header/ Footer to Scales	X
	Coordinate with Regulatory for Ethics Committees/ Institutional Review Board Submission	X
	Approve Source Documents	X
	Make Scales Available for Use by Sites	X
	Approve Scales	X
	Rater Training Plan	X
	Develop Rater Training Plan (Methodology, Experience Requirements)	X
	Approve Rater Training Plan	X
	File Rater Training Plan into Trial Master File	X
	Develop Rater Training Database/ Tracker	X
	Create Rater Experience Qualification (Survey)	X
	Rater Experience Verification	X
	Work with Project Team to Develop Process for Obtaining Potential Site Raters to Complete Rater Experience Qualification (Survey)	X
	Distribute Rater Experience Qualification (Survey)	X
	Collect Rater Experience Qualification (Survey) from Sites	X
	Review Rater Experience against Rater Training Plan	X
	Recommend Next Steps for Proposed Raters Who do Not Meet Sponsor-agreed-Qualifications	X
	Approve Raters for Study Who do Not Meet Sponsor-agreed Qualifications (Overrides)	X
	File Rater Experience Qualification (Survey) Forms into the Trial Master File	X
	Rater Training and Certification	X

 

    Page 32 of 47

     

    

 

	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's 

Responsibility
	Track/ Manage Raters at Each Site	X
	Process Investigator Meeting Raters for Training/ Certification	X
	Process New Raters for Training/ Certification throughout the study	X
	Follow Up with Raters to Complete Training/ Certification	X
	Issue Training/ Certification Certificates	X
	File Training/ Certification Certificates into the Trial Master File	X
	Applied Skill Assessment (ASA) not at Investigator Meeting	X
	Instructions for Site Raters on How to Submit Applied Skills Assessment (ASA) to Worldwide	X
	Clinical Review and Feedback for Applied Skills Assessment (ASA)	X
	Complete Applied Skills Assessment Form (For Each Rater's ASA)	X
	File Applied Skills Assessment Form into the Trial Master File	X
	Coordinate Next Steps with Sponsor when Rater Fails the Applied Skills Assessment	X
	Didactic Presentation	X
	Develop Didactics for the Study	X
	Approve Didactics	X
	Web Portal	X
	Define Requirements for Study Web Portal	X
	Provide Training Materials to be Uploaded to the Web Portal	X
	Develop/ Configure Study Web Portal	X
	User Acceptance Test Study Web Portal	X
	Data Surveillance Plan	X
	Develop Data Surveillance Plan (Methodology)	X
	Approve Data Surveillance Plan	X
	Develop Source Document Review Database/ Tracker	X
	Develop EDC Monitoring Database/ Tracker	X
	Set-up of Clinical Assessment Technologies EDC Data Monitoring System	X
	Provide Data Management with Flags to be Programmed into EDC/ SAS	X
	Develop and Test EDC/ SAS Flags	X
	Define Requirements for EDC Monitoring Reports	X
	Develop and Test EDC Monitoring Reports	X
	Clinical Assessment Technologies Data Management Reports	X
	Electronic Data Capture (EDC) Flag Clinical Review	X
	Provide Clinical Review of Flagged Subject Visits	X
	Collection & Review of Source Documents	X
	Document Interactive Response Technology Notifications in Source Document Database/ Tracker	X
	Collect Source Documents from Sites for Clinical Review	X
	Follow Up with Sites for Missing (Not Submitted) Source Documents	X
	Review Clinical Source Documents	X
	Clinical Assessment Start-up & Planning	X

 

    Page 33 of 47

     

    

 

 

	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's Responsibility
	Clinical Assessment Maintenance & Reporting	X
	Clinical Assessment Technologies Virtual Training Session 	X
	Confirm Attendees and Communication Details	X
	Create and Distribute Invitation to Attend Training Sessions	X
	Conduct Virtual Training Sessions	X
	Close Out Virtual Training Sessions (Document Attendees, Distribute Training Certificates)	X
	Pre go-live Project Management, Requirements Gathering & Design (SaaS)	X
	Lead Interactive Response Technology-focused Gathering Meetings	X
	Write User Requirements Specifications According to Protocol Design	X
	Write Interactive Response Technology Project Plan	X
	Configuration/Coding (SaaS)	X
	Configure Interactive Response Technology System for Study According to Specifications	X
	Write Custom Code if Required	X
	Validation (SaaS)	X
	Develop Test Plan	X
	Perform Testing of System Against Specifications	X
	Review testing materials	X
	Review and Sign Test Plan	X
	Review and Sign Test Summary Report (Including a Review of any Defects)	X
	Systems Integrations (SaaS)	X
	Manage the Set-up of Any Integrations Between Interactive Response Technology and Other Systems 	X
	Coordinate Data Transfers	X
	Configure and Test Integration	X
	Sponsor User Acceptance Testing (SaaS)	X
	Set Up Data for User Acceptance Testing	X
	Facilitate the Performance of User Acceptance Testing for the Sponsor	X
	Interactive Response Technologies Inventory Implementation and Review	X
	Interactive Response Technology Project Management (SaaS)	X
	Oversight and Accountability for the Project	X
	Act as Point of Escalation for Any Interactive Response Technology-related Issues for the Study	X
	Production Support (SaaS)	X
	Daily Support of Interactive Response Technology	X
	Production Randomization Monitoring and Audit	X
	Monitoring Patient and Material Randomization to Ensure Correct Execution in Production	X
	Decommissioning (SaaS)	X

 

    Page 34 of 47

     

    

	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's Responsibility
	Coordinate Decommissioning of the System and Data Archiving at End of Study	X
	Clinical Trial Management System (CTMS) Set-up	X
	Develop User Requirement Specifications	X
	Monitoring Visit Report (MVR) Review and Configuration	X
	CTMS OnPoint and SharePoint Build/ Configuration	X
	CTMS OnPoint and SharePoint User Acceptance Testing	X
	Create Study-specific Guides	X
	Create System Alerts	X
	Develop Sponsor Training Slides	X
	Create Study Specific Access Form	X
	Submit Documents to the eTMF as required	X
	Conduct Study Team Q&A Session	X
	Conduct Sponsor Training	X
	Clinical Trial Management System Helpdesk/ Maintenance	X
	Administer Required Training	X
	Grant CTMS User and Study Access	X
	Respond to CTMS service desk requests	X
	Support MVR Issues and Changes	X
	Edge Payments Customization	X
	Edge Payments Maintenance, Support, Changes	X
	Grant System Access	X
	Respond to Helpdesk Queries	X
	Add Sites	X
	Edge Payments Maintenance, Support, Changes	X
	Rater Web Portal Set-up	X
	Rater Web Portal Maintenance, Support, Changes	X
	Create Study Specific Integration documents for Interactive Response Technologies to EDC	X
	Create Study Specific Integration documents for EDC to OnPoint CTMS	X
	Integration Set-up	X
	Project Management - Start-up	X
	Identify Sites/ Principal Investigators 	X
	Create or Review Project Plans	X
	Execute Project Plans	X
	Prepare for and Plan Site Training	X
	Provide and Receive Project-specific Training (Develop Training, Presenting, Receive Training, Includes Protocol Review Time)	X
	Set Up Internal/ External Systems	X
	Review Sponsor Standard Operating Procedures	X
	Review Scope of Work and Finalize Study Specifications	X
	Develop Project Timelines	X
	Prepare for and Attend Internal and External Meetings and Calls Including Agenda/ Minute Preparation	X
	Prepare and Distribute Study Newsletters and Other Site Communications	X

 

    Page 35 of 47

     

    

 

	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's Responsibility
	Maintain and Quality Control Trial Master File (Including Response to Internal or Sponsor Audits) and Deliver to Sponsor	X
	Manage Study Vendors (Includes Identification, Selection, Contract Negotiation and Management)	X
	Complete all Project-related Internal System Data Entry such as Time Entry, Monthly Operational Reviews, Resource Planning, Financial Tracking or Other Internal Systems	X
	Prepare Site/ Study Documents (Site Reference Material, Study Binders, Recruitment Tools)	X
	Manage Site Supplies	X
	Manage Site Grant and Principal Investigator Reimbursement Payments (Includes Initiating Grant Fund Replenishment Invoicing Requests and Approval of Payments)	X
	Complete Revenue Reporting and Projections	X
	Manage Changes to Contracts	X
	Procure Invoice Approval (Includes Follow-up Internally or with Sponsor	X
	Manage Vendor Payments	X
	Complete Financial Reconciliation	X
	Monitor, Evaluate and Adjust Key Performance Indicators	X
	Generate Status Reports	X
	Track Project-related Data to Facilitate and Inform Status Reporting and Study Management	X
	Project Management - Conduct	X
	Oversee Patient Recruitment	X
	Prepare for and Plan Investigator Meeting (For Those Occurring after Start-up)	X
	Participate in and Present at Investigator Meeting (For Those Occurring after Start-up)	X
	Oversee the Management, Monitoring, Adjustment and Ongoing Revision of Project Plans (Updates to Study Plans, Review of Risks and Identification of New Mitigation Strategies)	X
	Provide and Receive Project-specific Training (Develop Training, Presenting, Receive Training, Includes Protocol Review Time)	X
	Oversee Changes to Internal/ External Systems	X
	Revise Project Timelines	X
	Prepare for and Attend Internal and External Meetings and Calls including Agenda/ Minute Preparation	X
	Prepare and Distribute Study Newsletters and Other Site Communications	X
	Maintain and Quality Control Trial Master File (Including Response to Internal or Sponsor Audits) and Deliver to Sponsor	X
	Manage Study Vendors (Includes Identification, Selection, Contract Negotiation and Management)	X
	Complete all Project-related Internal System Data Entry such as Time Entry, Monthly Operational Reviews, Resource Planning, Financial Tracking or Other Internal Systems	X

 

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	Worldwide Clinical Trials Responsibility Matrix
	Task	Worldwide's Responsibility
	Prepare Site/ Study Documents (Site Reference Material, Study Binders, Recruitment Tools)	X
	Manage Site Supplies	X
	Manage Site Grant and Principal Investigator Reimbursement Payments (Includes Initiating Grant Fund Replenishment Invoicing Requests and Approval of Payments)	X
	Complete Revenue Reporting and Projections	X
	Manage Changes to Contracts	X
	Procure Invoice Approval (Includes Follow-up Internally or with Sponsor	X
	Manage Vendor Payments	X
	Complete Financial Reconciliation	X
	Monitor, Evaluate and Adjust Key Performance Indicators	X
	Generate Status Reports	X
	Track Project-related Data to Facilitate and Inform Status Reporting and Study Management	X
	Project Management - Close-out	X
	Oversee the final management, monitoring, adjustment and ongoing revision of project plans	X
	Provide and receive Project Specific Training (develop training, presenting, receive training)	X
	Revise Project Timelines	X
	Prepare for and attend Internal and External Meetings and Calls including Agenda/Minute Preparation	X
	Prepare and Distribute Site Communications	X
	Maintain and Quality Control Trial Master File (Including Response to Internal or Sponsor Audits) and Deliver to Sponsor	X
	Manage Study Vendors 	X
	Complete all Project-related Internal System Data Entry 	X
	Prepare Site/ Study Documents 	X
	Manage Site Supplies	X
	Manage Site Grant and Principal Investigator Reimbursement Payments 	X
	Complete Revenue Reporting and Projections	X
	Manage Changes to Contracts	X
	Procure Invoice Approval (Includes Follow-up Internally or with Sponsor	X
	Manage Vendor Payments	X
	Complete Financial Reconciliation	X
	Monitor, Evaluate and Adjust Key Performance Indicators	X
	Generate Status Reports	X
	Track Project-related Data to Facilitate and Inform Status Reporting and Study Management	X

 

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EXHIBIT B

TIMELINE

 

	Study Timeline	Estimated Start Date	Estimated End Date	Duration (Months)
	Commencement of Work (Start Date)	[***]	 	 
	Protocol Finalized	[***]	 	 
	Study Start-up	[***]	[***]	[***]
	Patient Enrollment Period	[***]	[***]	[***]
	Patient Active Treatment	[***]	[***]	[***]
	Patient Follow-up Phase	[***]	[***]	[***]
	Last eCRF Submitted to Data Management	[***]	[***]	[***]
	Database Lock	[***]	[***]	[***]
	Final Tables, Listings, Figures/Graphs	[***]	[***]	[***]
	Final Clinical Study Report	[***]	[***]	[***]
	Total Study Duration (Months)	 	 	[***]

 

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EXHIBIT C

BUDGET

 

	 	 	 	Service Agreement Budget
	 	Services	Unit	# Units	Unit Cost USD	Total Cost USD
	Site Activation	 	 	 	 
	o	Feasibility/ Site Identification	Site	[***]	[***]	[***]
	o	Site Activation Lead Planning Per Country	Country	[***]	[***]	[***]
	o	Site Activation Lead Oversight - Start Up Phase	Site Months	[***]	[***]	[***]
	o	Site Activation Lead Oversight - Conduct Phase	Site Months	[***]	[***]	[***]
	o	Trial Master File (TMF) Filing & QC	Site/Quarter	[***]	[***]	[***]
	o	Regulatory Project Plan	Plan	[***]	[***]	[***]
	o	Regulatory Set-up	Study	[***]	[***]	[***]
	o	Regulatory Tracking & Follow-up	Country/Month	[***]	[***]	[***]
	o	Core Documents Master Templates	Study	[***]	[***]	[***]
	o	Essential Documents & Review (US)	Site	[***]	[***]	[***]
	o	Essential Documents Review Plan	Plan	[***]	[***]	[***]
	o	Essential Documents Checklist	Country	[***]	[***]	[***]
	o	Investigator Agreements 	CTA	[***]	[***]	[***]
	o	Investigator Agreements Country Specific Templates	Country Template	[***]	[***]	[***]
	o	Contract and Budget Plan (CBP)	Plan	[***]	[***]	[***]
	o	Investigator Grant Build	Build	[***]	[***]	[***]
	o	Submission Strategy & Risk Assessment	Country	[***]	[***]	[***]
	o	Central Institutional Review Board (IRB) Site Submissions (US)	Site	[***]	[***]	[***]
	o	Central Institutional Review Board (IRB) Submission, Study Level (US)	Study	[***]	[***]	[***]
	o	Central IRB Site Submissions (US)- Yearly Maintenance	Site/Year	[***]	[***]	[***]
	o	Central IRB Submissions (Study Level)- Yearly Maintenance	Study/Year	[***]	[***]	[***]
	o	Central IRB Site Submissions (US)- End of Trial Notifications	Site	[***]	[***]	[***]
	o	Central IRB Submissions (Study Level)- End of Trial Notifications	Study	[***]	[***]	[***]
	o	Master Informed Consent Form (ICF) Review	ICF	[***]	[***]	[***]
	o	Translation Coordination	Language	[***]	[***]	[***]
	 	Sub-Total Study Site Activation	 	 	 	[***]
	Trial Master File	 	 	 	 
	o	TMF Management Plan & TMF Risk Assessment	Plan	[***]	[***]	[***]
	o	Worldwide TMF: TMF Set-up: Pre Site Activation Activities	Sites	[***]	[***]	[***]
	o	Worldwide TMF: TMF Maintenance & QC	Site Months	[***]	[***]	[***]
	o	Worldwide TMF: TMF Final Reconciliation & Transfer	Sites	[***]	[***]	[***]
	 	Sub-Total Trial Master File	 	 	 	53,983.98

 

    Page 39 of 47

     

    

 

	 	 	 	Service Agreement Budget
	 	Services	Unit	# Units	Unit Cost USD	Total Cost USD
	Project Meetings	 	 	 	 
	o	Internal Alignment (KO) Meeting	Meeting	[***]	[***]	[***]
	o	Sponsor Alignment (KO) Meeting	Meeting	[***]	[***]	[***]
	o	Webex Trainings	Meeting	[***]	[***]	[***]
	o	Sponsor Teleconferences	Teleconferences	[***]	[***]	[***]
	o	Internal Teleconferences	Teleconferences	[***]	[***]	[***]
	 	Sub-Total Project Meetings	 	 	 	[***]
	Clinical Monitoring	 	 	 	 
	o	Lead Clinical Research Associate Support	Month	[***]	[***]	[***]
	o	Site Management	Site Months	[***]	[***]	[***]
	o	Internal Clinical Research Associate Calls & Project Communication	Month	[***]	[***]	[***]
	o	Clinical Research Associate Training (not at Investigator Meeting)	Attendee	[***]	[***]	[***]
	o	Remote Pre-site Selection Visits	Visit	[***]	[***]	[***]
	o	On-site Pre-site Selection Visits	Visit	[***]	[***]	[***]
	o	On-site Site Initiation Visits	Visit	[***]	[***]	[***]
	o	Remote Monitoring Visits Conduct 	Visit	[***]	[***]	[***]
	o	On-Site Monitoring Visits Conduct	Visit	[***]	[***]	[***]
	o	Additional Time On-site	Visit	[***]	[***]	[***]
	o	On-site Close-out Visits	Visit	[***]	[***]	[***]
	o	Remote Electronic Data Capture (EDC) Review Conduct	Site Months	[***]	[***]	[***]
	 	Sub Total Clinical Monitoring	 	 	 	[***]
	Grant & Vendor Payments	 	 	 	 
	o	Set-up Grant Payments	Contract	[***]	[***]	[***]
	o	Process Grant Payments 	Payment	[***]	[***]	[***]
	o	Process Site Cost Payments 	Site	[***]	[***]	[***]
	o	Set-up Vendor Payments	Vendor	[***]	[***]	[***]
	o	Process Vendor Payments	Month	[***]	[***]	[***]
	 	Sub-Total Grant & Vendor Payments	 	 	 	[***]
	Risk Based Quality Management	 	 	 	 
	o	Protocol Risk Assessment	Risk Assessment	[***]	[***]	[***]
	 	Sub Total Quality Assurance Audits	 	 	 	[***]
	Drug Safety 	 	 	 	 
	o	Database Set-up & Configuration	Database	[***]	[***]	[***]
	o	Safety Management Plan Development	Plan	[***]	[***]	[***]
	o	Safety Training (Sites, Clinical Research Associates, Project Team)	Training	[***]	[***]	[***]
	o	Serious Adverse Events (SAE) Processing, Investigation, Narrative, Approval & Query Generation 	SAE	[***]	[***]	[***]
	o	Analysis of Similar Events (AOSE) (US SUSARs only)	SUSAR Report	[***]	[***]	[***]
	o	Safety Management Maintenance	Month	[***]	[***]	[***]
	o	Preparation of Line Listings (LL)	Report	[***]	[***]	[***]
	o	Suspected Unexpected Serious Adverse Reaction (SUSAR)/ Annual Safety Reports (ASR)/ Line Listings (LL) submission to Investigators	Country * Submissions	[***]	[***]	[***]
	o	DSUR Preparation (Writing and Compiling)	DSUR	[***]	[***]	[***]
	o	Pharmacovigilance Closeout	Transfer	[***]	[***]	[***]
	 	Sub-Total Drug Safety 	 	 	 	[***]

 

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	 	 	 	Service Agreement Budget
	 	Services	Unit	# Units	Unit Cost USD	Total Cost USD
	Data Safety Monitoring Board (DSMB)	 	 	 	 
	o	Deliver Data Safety Monitoring Board (DSMB) Database & Tables, Figures & Listings (TFLs)	 Delivery 	[***]	[***]	[***]
	 	DSMB Statistical Analysis Plan (SAP)	 Plan 	[***]	[***]	[***]
	 	DSMB Unique Tables	 Unique Table 	[***]	[***]	[***]
	 	DSMB Repeat Tables	 Repeat Table 	[***]	[***]	[***]
	 	DSMB Unique Listings	 Unique Listing 	[***]	[***]	[***]
	 	DSMB Unique Figures	 Unique Figure 	[***]	[***]	[***]
	 	DSMB Repeat Figures	 Repeat Figure 	[***]	[***]	[***]
	 	Sub-Total Data Safety Monitoring Board 	 	 	 	[***]
	Medical Monitoring	 	 	 	 
	o	Medical Planning	Month	[***]	[***]	[***]
	o	Medical Management	Screened Subject	[***]	[***]	[***]
	o	Eligibility Review	Screened Subject	[***]	[***]	[***]
	o	Listings Reviews	Enrolled Subject	[***]	[***]	[***]
	o	Coded Data Review	Enrolled Subject	[***]	[***]	[***]
	o	Ongoing Safety Reviews of Labs and ECG Alerts	Alert	[***]	[***]	[***]
	o	Maintain Medical Monitor Log	Month	[***]	[***]	[***]
	 	Sub-Total Medical Monitoring	 	 	 	[***]
	Data Management	 	 	 	 
	o	Data Management Plan	Plan	[***]	[***]	[***]
	o	Training	Study	[***]	[***]	[***]
	o	Electronic Case Report Form (eCRF) Development	Unique Pages	[***]	[***]	[***]
	o	Electronic Case Report Form (eCRF) Completion Guidelines	Database	[***]	[***]	[***]
	o	Edit Check Specifications	Edit Check	[***]	[***]	[***]
	o	Manual Listings Creation	Listing	[***]	[***]	[***]
	o	User Acceptance Testing	Database	[***]	[***]	[***]
	o	Set-up of Standard Reports	Study	[***]	[***]	[***]
	o	User Manual Development	Study	[***]	[***]	[***]
	o	Electronic Data Capture (EDC) Support	Users	[***]	[***]	[***]
	o	Serious Adverse Event (SAE) Reconciliation	SAE	[***]	[***]	[***]
	o	Serious Adverse Event (SAE) Reconciliation Maintenance	Months	[***]	[***]	[***]
	o	Data Cleaning	Total Pages	[***]	[***]	[***]
	o	Manual Listing Review	Listings	[***]	[***]	[***]

 

    Page 41 of 47

     

    

 

	 	 	 	Service Agreement Budget
	 	Services	Unit	# Units	Unit Cost USD	Total Cost USD
	o	Vendor Reconciliation Set-up	Vendor	[***]	[***]	[***]
	o	Vendor Reconciliation Maintenance	Upload	[***]	[***]	[***]
	o	Vendor Integration Set-up	Integration	[***]	[***]	[***]
	o	Vendor Integration Maintenance	Upload	[***]	[***]	[***]
	o	MedDRA Coding (via Coding Tool within EDC)	Terms	[***]	[***]	[***]
	o	WHODRUG Coding (via Coding Tool within EDC)	Meds	[***]	[***]	[***]
	o	Coding Dictionary Updates	Year	[***]	[***]	[***]
	o	Data Transfer Set-up	Database	[***]	[***]	[***]
	o	Data Transfers	Transfer	[***]	[***]	[***]
	o	Database Lock	Database Lock	[***]	[***]	[***]
	o	Archive CDs	Site	[***]	[***]	[***]
	o	Data Management Coordination	Month	[***]	[***]	[***]
	 	Sub-Total Data Management	 	 	 	[***]
	Biostatistics	 	 	 	 
	o	Randomization/ Kit list/ Interactive Response Technologies Review	 List 	[***]	[***]	[***]
	o	Data Management Specifications	 Protocol 	[***]	[***]	[***]
	o	Statistical Analysis Plan & Mock Shells	 Plan 	[***]	[***]	[***]
	o	Study Data Tabulation Model (SDTM) Datasets	 Dataset 	[***]	[***]	[***]
	o	Analysis Datasets	 Dataset 	[***]	[***]	[***]
	o	Define.xml and Data Reviewers Guide for SDTM, Annotated CRF	 Specification 	[***]	[***]	[***]
	o	Deliver Final Database & Table, Figures & Listings	 Delivery 	[***]	[***]	[***]
	 	Final Unique Study Tables	 Unique Table 	[***]	[***]	[***]
	 	Final Repeat Study Tables	 Repeat Table 	[***]	[***]	[***]
	 	Final Unique Study Listings	 Unique Listing 	[***]	[***]	[***]
	 	Final Unique Study Figures	 Unique Figure 	[***]	[***]	[***]
	 	Final Repeat Study Figures	 Repeat Figure 	[***]	[***]	[***]
	o	Statistical Input to Clinical Study Report (CSR)	 CSR 	[***]	[***]	[***]
	o	Delivery Dry Run Database & Table, Figures & Listings	 Delivery 	[***]	[***]	[***]
	 	Sub-Total Biostatistics	 	 	 	[***]
	Medical Writing	 	 	 	 
	o	Model Inform Consent Form(s) (ICF(s))	ICF(s)	[***]	[***]	[***]
	 	Sub-Total Medical Writing	 	 	 	[***]
	Clinical Assessment Technologies	 	 	 	 
	o	Scale Identification and Acquisition	 Scale 	[***]	[***]	[***]
	o	Creation of Source Documents	 Language* Scale 	[***]	[***]	[***]
	o	Rater Training Plan	 Plan 	[***]	[***]	[***]
	o	Rater Experience Verification	 Rater 	[***]	[***]	[***]
	o	Rater Training and Certification	 Rater 	[***]	[***]	[***]
	o	Applied Skill Assessment (ASA) not at Investigator Meeting	 ASA*Rater 	[***]	[***]	[***]

 

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	 	 	 	Service Agreement Budget
	 	Services	Unit	# Units	Unit Cost USD	Total Cost USD
	o	Didactic Presentation	 Presentation  	[***]	[***]	[***]
	o	Web Portal	 Portal 	[***]	[***]	[***]
	o	Data Surveillance Plan	 Plan 	[***]	[***]	[***]
	o	Set-up of Clinical Assessment Technologies EDC Data Monitoring System	 System 	[***]	[***]	[***]
	o	Clinical Assessment Technologies Data Management Reports	 Month 	[***]	[***]	[***]
	o	Electronic Data Capture (EDC) Flag Clinical Review	 Visit 	[***]	[***]	[***]
	o	Collection & Review of Source Documents	 Visit * Scale 	[***]	[***]	[***]
	o	Clinical Assessment Start-up & Planning	 Month 	[***]	[***]	[***]
	o	Clinical Assessment Maintenance & Reporting	 Month 	[***]	[***]	[***]
	o	Clinical Assessment Technologies Virtual Training Session 	 WebEx 	[***]	[***]	[***]
	 	Sub-Total Clinical Assessment Technologies	 	 	 	[***]
	Interactive Response Technology	 	 	 	 
	o	Pre go-live Project Management, Requirements Gathering & Design (SaaS)	Build	[***]	[***]	[***]
	o	Configuration/Coding (SaaS)	Build	[***]	[***]	[***]
	o	Validation (SaaS)	Build	[***]	[***]	[***]
	o	Review testing materials	Build	[***]	[***]	[***]
	o	Systems Integrations (SaaS)	Build	[***]	[***]	[***]
	o	Sponsor User Acceptance Testing (SaaS)	Build	[***]	[***]	[***]
	o	Interactive Response Technologies Inventory Implementation and Review	Build	[***]	[***]	[***]
	o	Interactive Response Technology Project Management (SaaS)	Month	[***]	[***]	[***]
	o	Production Support (SaaS)	Month	[***]	[***]	[***]
	o	Production Randomization Monitoring and Audit	System	[***]	[***]	[***]
	o	Decommissioning (SaaS)	System	[***]	[***]	[***]
	 	Sub-Total Interactive Response Technology	 	 	 	[***]
	Technology	 	 	 	 
	o	Clinical Trial Management System (CTMS) Set-up	System	[***]	[***]	[***]
	o	Clinical Trial Management System Helpdesk/ Maintenance	Month	[***]	[***]	[***]
	o	Edge Payments Set-up: Grant Payments	System	[***]	[***]	[***]
	o	Edge Payments Customization	System	[***]	[***]	[***]
	o	Edge Payments Maintenance, Support, Changes	Month	[***]	[***]	[***]
	o	Rater Web Portal Set-up	System	[***]	[***]	[***]
	o	Rater Web Portal Maintenance, Support, Changes	Month	[***]	[***]	[***]
	o	Integration Set-up	System	[***]	[***]	[***]
	o	Integration Maintenance, Support, Changes	Month	[***]	[***]	[***]
	 	Sub-Total Technology	 	 	 	[***]

 

    Page 43 of 47

     

    

 

 

	 	 	 	Service Agreement Budget
	 	Services	Unit	# Units	Unit Cost USD	Total Cost USD
	Project Management 	 	 	 	 
	o	Project Management - Start-up	Month	[***]	[***]	[***]
	o	Project Management - Conduct	Month	[***]	[***]	[***]
	o	Project Management - Close-out	Month	[***]	[***]	[***]
	 	Sub-Total Project Management	 	 	 	[***]
	 	 	 	 	 	 
	 	Total Estimated Service Fees	 	 	 	[***]
	 	 	 	 	 	 
	 	Discount	 	 	 	[***]
	 	 	 	 	 	 
	 	Total Estimated Service Fees including Discount	 	 	 	[***]
	 	 	 	 	 	 
	System & General Expenses	 	 	 	 
	o	IBMCD Electronic Data Capture (EDC) Maintenance & Hosting	Month	[***]	[***]	[***]
	o	Argus Safety Database Set-up & Configuration	System	[***]	[***]	[***]
	o	Argus Safety Database Hosting	Month	[***]	[***]	[***]
	o	Clinical Trial Management System User Access	System	[***]	[***]	[***]
	o	IBMCD IRT System Fees	System	[***]	[***]	[***]
	o	Electronic Trial Master File (eTMF) Monthly Hosting Fees	Site months	[***]	[***]	[***]
	o	Regulatory System Fees	Site	[***]	[***]	[***]
	Total System & General Expenses	 	 	 	[***]
	 	 	 	 	 	 
	Estimated Pass-through Costs	 	 	 	 
	 	 	 	 	 	 
	Study Start-up Pass-through Costs	 	 	 	 
	o	Print and Ship Investigator Site File to Sites	Site	[***]	[***]	[***]
	o	Institutional Review Board (IRB) Site Regulatory Documents (includes preparation, collection, annual renewals if needed)	 	[***]	[***]	[***]
	 	North America - Central IRB	Site	[***]	[***]	[***]
	 	Sub-Total Start-up Pass-through Costs	 	 	 	[***]
	Clinical Monitoring Pass-through Costs	 	 	 	 
	o	Pre-site Selection Visits	Visit	[***]	[***]	[***]
	o	Site Initiation Visits	Visit	[***]	[***]	[***]
	o	Interim Monitoring Visits	Visit	[***]	[***]	[***]
	o	Additional Time on Site	Visit	[***]	[***]	[***]
	o	Close-Out Visits	Visit	[***]	[***]	[***]
	o	Site Management	Site Months	[***]	[***]	[***]
	 	Sub Total Study Conduct Pass-through Costs	 	 	 	[***]

 

    Page 44 of 47

     

    

 

	 	 	 	Service Agreement Budget
	 	Services	Unit	# Units	Unit Cost USD	Total Cost USD
	Clinical Assessment Technologies Pass-through Costs	 	 	 	 
	o	Scale Licenses	License	[***]	[***]	[***]
	o	Scale Translations	Scales* Languages	[***]	[***]	[***]
	o	Rater Experience Surveys/Trial Interactive	Raters*Surveys	[***]	[***]	[***]
	 	Sub-Total Clinical Assessment Technologies Pass-through Costs	 	 	 	[***]
	Archiving Pass-through Costs	 	 	 	 
	o	Shipment of Completed Case Report Forms (CRF) Back to Sites (archive copy, disc for EDC)	Shipment	[***]	[***]	[***]
	o	Shipment of Completed electronic Case Report Forms (eCRF)Back to Sponsor (disc )	Shipment	[***]	[***]	[***]
	 	Sub-Total Archiving Pass-through Costs	 	 	 	[***]
	Trial Master File Pass-through Costs	 	 	 	 
	o	Final Transfer of Study Records to Sponsor (Disk)	Transfer	[***]	[***]	[***]
	 	Sub-Total Project Management Pass-through Costs	 	 	 	[***]
	Project Management Pass-through Costs	 	 	 	 
	o	Project Management Passthrough Costs	Month	[***]	[***]	[***]
	 	Sub-Total Project Management Pass-through Costs	 	 	 	[***]
	Third Party Vendor Costs	 	 	 	 
	o	Central Lab: ACM	Study	[***]	[***]	[***]
	o	ECG Provider: ERT	Study	[***]	[***]	[***]
	o	Avantor Sciences (ballpark)	Study	[***]	[***]	[***]
	 	Sub-Total Third Party Vendors	 	 	 	[***]
	PI Fees	 	 	 	 	 
	o	Investigator Grants- Completed patients	Patient	[***]	[***]	[***]
	o	Investigator Grants- Screen failure patients	Patient	[***]	[***]	[***]
	o	Investigator Grants- Dropped patients	Patient	[***]	[***]	[***]
	o	Site Costs	Site	[***]	[***]	[***]
	 	Sub-Total PI Fees	 	 	 	[***]
	Total Estimated Pass-Through Costs	 	 	 	[***]
	 	 	 	 	 	 
	Total Estimated Budget	 	 	 	[***]
	Note that the unit costs are derived from the total cost after regional & annual rates have been applied and therefore result in a blended rate.	 

 

    Page 45 of 47

     

    

 

EXHIBIT D

PAYMENT SCHEDULE

 

1.      
Service Fees:

		1.1.	Notwithstanding the payment terms in Section 3.4 of the Agreement, upon signature of this Work
Order, Sponsor will pay Worldwide an advance payment of $488,781.35 due upon ten (10) days of receipt, (advance payment represents
[***]% of the Service Fee and System and General Expenses total). All subsequent invoices will be submitted to Sponsor by email
monthly based on units completed in the preceding month according to the Budget above, with each subsequent invoice for Service
Fees and System and General Expenses reduced by 10% until the advance payment is exhausted. With the exception of the first payment
described above in the amount of $488,781.35, payment terms shall be as defined in this Agreement. Any outstanding balances will
be reconciled at the end of the Study.

 

		1.2.	The bottom line discount (“Discount”) shall be defined as a one-time discount applied
to the service fees of this study budget, based on the current scope and specifications detailed within this Work Order. Should
these parameters vary from what is presented within, Worldwide reserves the right to adjust any discounts or commercial incentives
based on the revised scope and budget values.

 

		1.3.	Payment shall be issued by check or wire transfer at Sponsor’s option. Wiring instructions are as follows:

 

	 	Account Holder: 	Worldwide Clinical Trials, Inc.
	 	Bank Name: 	[***]
	 	Bank Address: 	[***]
	 	 	 
	 	ABA Routing No.: 	[***]
	 	Bank Account No.: 	[***]
	 	Swift Code:	[***]
	 	Taxpayer ID#: 	[***]

 

2.      
Pass-through Expenses:

		2.1.	Notwithstanding the payment terms in Section 3.4 of the Agreement, Worldwide shall invoice Sponsor
an advance payment of $137,163.80 due upon ten (10) days of receipt ([***]). Worldwide will submit subsequent monthly invoices
by email for incurred Pass-through Expenses based on actuals, with each subsequent invoice for Pass-through Expenses reduced by
20% until the advance payment is exhausted. With the exception of the first payment described above [***] payment terms shall be
as defined in this Agreement. Any outstanding balances will be reconciled at the end of the Study.

 

3.      
Investigator/Institution Fees:

		3.1.	Notwithstanding the payment terms in Section 3.4 of the Agreement, Worldwide shall invoice Sponsor
an advance payment of $314,412.45 due upon ten (10) days of receipt ([***]). Periodically, Worldwide will invoice Sponsor by email
to replenish this advance back-up to an amount equivalent to [***]% of the anticipated Investigator/Institution grants or
such other amount of funds needed to bring the balance to the sufficient amount to ensure that payments are made to sites in a
timely manner. The invoice will be accompanied by a report which itemizes the Investigator/Institution grants that have been paid
in the period, and will reconcile the use of funds received from Sponsor. If an increase in the amount of anticipated Investigator/Institution
grants is necessary, Worldwide will provide appropriate support justifying such increase. Any outstanding balances will be reconciled
and provided no earlier than [***] after at the end of the Study. For avoidance of doubt, Worldwide will make all grant payments
only from funds received from Sponsor specifically for this purpose. Worldwide shall not be liable for any payments delays due
to the delay in receipt of funds from Sponsor.

 

    Page 46 of 47

     

    

 

EXHIBIT E

FORM OF CHANGE ORDER

 

	Client:
    	Worldwide
    Project Manager:
	Protocol
    Number:	Worldwide
    ID:
	Change
    Order #: 	Date:
    

 

Worldwide Clinical Trials, Inc.
(“Worldwide”) and Neurotrope Bioscience, Inc. (“Sponsor”) entered into an agreement dated [effective
date] (“Agreement”) [as amended by Change Order # 1 effective [effective date]] [and further amended by Change
Order # 2 effective [effective date]] in which Worldwide was to provide certain Services to Sponsor in connection with Study
[insert Protocol number] (“Study”). Worldwide and Sponsor wish to amend the Agreement as follows:

 

1. Revisions to the Scope of Services.
The Scope of Services has been revised as described below, and Worldwide will provide the following additional services [will
not provide the following services initially contracted]:

 

	Description
    of Service	Cost
	 	 
	 	 

 

2. Revisions to the Study Budget. As a
result of the changes to the Services and Scope of Services, this Change Order # [Insert] [increases] [decreases] the Service
fees as shown above. A revised total budget value is below.

 

	 	Services
    Fees	Estimated
    Pass Through Costs	Total
	Original
    Agreement Value:	 	 	 
	Change
    Order #1 Value:	 	 	 
	[Add
    additional Change Orders as necessary]	 	 	 
	Revised
    Contract Value:	 	 	 

 

3. Revisions to the Payment Schedule.
A revised and restated payment schedule, as amended by Change Order # [Insert#] is detailed below.

 

Payment
Schedule, as amended by Change Order # [Insert]

 

Except to the extent specifically
modified by this Change Order # [Insert], the provisions of the Agreement remain unmodified and the Agreement as amended by this
Change Order # [Insert] is confirmed as being in full force and effect. All defined terms within the Agreement shall have the
same meaning when used herein.

 

Authorized representatives of
the Parties have executed this Change Order # [insert] effective as of the Effective Date written above.

 

	Worldwide Clinical Trials, Inc.	 	Neurotrope Bioscience, Inc.	 
	 	 	 	 	 	 
	By: 	      Sample	 	By:	       Sample	 
	 	 	 	 	 	 
	Name:  	 	 	Name:  	 	 
	 	 	 	 	 	 
	Title:	 	 	Title: 	 	 
	 	 	 	 	 	 
	Date:	 	 	Date: 	 	 

 

    Page 47 of 47

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