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, 3^rd 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:

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.

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 [***].

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:

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.

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:

(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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

(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.

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).

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.

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 42^nd 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

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.

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.

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 [***].

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.

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.

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.

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.

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.

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.

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.

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.

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.

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