Exhibit 10.1

 

SERVICES AGREEMENT

 

This Services Agreement (this “Agreement”) is made and entered into as of May 4,
2018, (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 205 East 42nd Street, New York, NY 10019
(“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, NTRP101-230 entitled “A Randomized,
Double-Blinded, Placebo-Controlled, Confirmatory Phase 2 Study Assessing the
Safety, Tolerability and Efficacy of Bryostatin in the Treatment of Moderately
Severe to 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:

 

1.0SERVICES

 

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.

 

1.1Performance

 

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:

 

 Page 1 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

·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.

 

1.2Compliance 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.

 

1.3Transfer 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 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

1.4Changes

 

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.

 

2.0WORK 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.

 

3.0PAYMENT 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.

 

3.1Compensation 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 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

3.2Pass-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 [***].

 

3.3Invoices;

 

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.

 

3.4Payment 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 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

3.5Project 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.

 

3.6Currency Management

 

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

 

3.7Disputed 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.

 

4.0THIRD 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.

 

 Page 5 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

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.

 

4.1Institutions/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 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

(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.

 

5.0CONFIDENTIAL 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.

 

 Page 7 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

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.

 

6.0OWNERSHIP 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.

 

 Page 8 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

7.0TERM AND TERMINATION

 

7.1Term

 

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.

 

7.2Termination 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 [***].

 

7.3Termination 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.

 

7.4Termination 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.

 

 Page 9 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

8.0DEBARMENT 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.

 

9.0RECORDS, AUDITS AND INSPECTIONS

 

9.1Records

 

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.

 

 Page 10 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

9.2Audits 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.

 

9.3Inspection 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.

 

9.4Inspections 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.

 

10.0INDEMNIFICATION

 

10.1Indemnification 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.

 

 Page 11 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

10.2Indemnification 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.

 

10.3Indemnification 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.

 

11.0LIMITATION 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.

 

12.0INSURANCE

 

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.

 

 Page 12 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

 

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.

 

13.0REPRESENTATIONS 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;

 

 Page 13 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

(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.

 

14.0DISCLAIMER

 

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 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

15.0EMPLOYEES; 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.

 

16.0NOTICES

 

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

 

17.0MISCELLANEOUS

 

17.1Modification

 

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.

 

17.2Assignment

 

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 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

17.3Force 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 [***].

 

17.4Severability

 

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.

 

17.5English 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.

 

17.6Entire 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.

 

17.7Survival

 

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.

 

17.8Governing 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.

 

 Page 16 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

17.9Waiver

 

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.

 

17.10Independent 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.

 

17.11Counterparts

 

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.

 

17.12Arbitration

 

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:
                   By:                          Name:       Name:              
Title:       Title:               Date:     Date:  

 

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 17 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

EXHIBIT A

SCOPE OF SERVICES

 

Assumptions:

 

Countries, Sites, Patients and CRAs Total number of countries 1 Total number of
sites [***] Total number of screened patients [***] Total number of enrolled
patients 100 Screening failure rate [***]% Total number of completed patients
[***] Drop-out rate [***]% Total number of CRAs 4 Countries and Sites - Region 1
USA ([***]) Number of Sites - Region 1 [***] Number of Patients - Region 1 100
Number of CRAs - Region 1 [***]

 

Responsibilities:

 

Worldwide Clinical Trials Responsibility Matrix Task Worldwide's
Responsibility Sponsor or
Designee
Responsibility; or
N/A for Study   Essential Document Customization & Review-US & CAN x     Prepare
and review Essential Document Review Plan x     Prepare and distribute Essential
Document (ED) templates x     Customize ED templates with Site Specific
information x     Collect ED documents from sites x     Provide first review of
ED documents for compliance x     Provide second review of ED documents for
compliance x     Communicate deficiencies to 1st reviewer x     Sign off ED
package x     Answer questions or provide clarification and training to study
team on process or requirements x     Provide weekly tracking and progress
reports x     File ED and checklist (eTMF/TMF, internal filing) x    
Investigator Agreements x     Prepare template x     Negotiate site contracts to
execution x     Coordinate the execution of site CDAs x     Ensure the
completion of site Indemnification Letters x     Review and Negotiate Agreements
x     QC all Investigator Agreements x     Update site status in Pay Flow x    
Track status of Investigator Agreements x    

 

 Page 18 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

Coordinate all required translations x   Code and send to Records Management
Compliance (RMC) for filling x   Investigator Agreements Master Template   x
Investigator Agreements Country Specific Templates x   Customize master template
with country, project and sponsor specific requirements x   Arrange translation
into local language x   Perform QC and formatting x   Investigator
Agreements-Addendum/Termination Letter   x Contract and Budget Plan x   Prepare
Contract and Budget Plan (CBP) for initial strategy. Any Substantial Amendments
to the CBP will require a contact amendment x   Investigator Grant Build x  
Build Grant Plan for the study. Any Substantial Amendments to the study country
and site strategy will require a new build and contract amendment x   Regulatory
Preparation & Tracking x   Develop Submission Strategy by reviewing technical
data (IMPD, IB) and performing a risk assessment x   Set up trackers with due
dates for core documents working backwards from study milestones x   Develop
master templates for core documents x   Coordinate collection and review of core
documents x   Set up electronic and hard copy files x   Complete core/generic
application form xml x   IRB Submissions US & CAN-Central IRB x   Prepare
regulatory packages x   Complete application forms x   QC all packages prior to
submission x   Submit Regulatory Packages to Central IRB x   Track Regulatory
Package/Submission Status x   Code and File all required documents in the
appropriate TMF (eTMF) location x   Review & customize ICF x   Maintain ICF
tracking log x   IRB Submissions US & CAN-Local IRB x   Compile regulatory
packages x   Complete application forms x   QC all packages prior to submission
x   Submit Regulatory Packages to Local IRB (when applicable) x   Track
Regulatory Package/Submission Status x   Code and File all required documents in
the appropriate TMF (eTMF) location x   Review & customization of ICF x  
Maintain ICF tracking log x   Complex Amendments   x Simple Amendments   x
Annual Regulatory Reports   x End of Trial Notifications   x Annual IB update  
x

 

 Page 19 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

IMPD   x Start-up Planning-First core countries x   Liaise with PM, LCRA and CSS
leads to develop a start-up strategy x   Communicate start-up timelines x  
Develop a risk log and priority action items x   Provide strategic input to site
selection x   Develop start-up tracker template x   Start-up Management x  
Monitor progress and provide oversight and alignment across the study start-up
team x   Manage deliverables of the CSS team x   Provide weekly status tracking
x   Maintain the risk log as it pertains to start-up x   Provide Financial
Start-up oversight (OOS, Units grid etc…) x   Monitor progress and provide
oversight to the Regulatory Affairs, Sites Contracts and Regulatory Compliance
teams x   Maintain dashboard and additional tracking x   Translation
Coordination x   Coordinate translations for initial submissions between vendor
and CRAs for internal review x   Compile certificates of translations and
document audit trail of changes x   Forward to sponsor for approval and file
final version x   Follow internal process for approving translation quotes and
forwarding invoices to PT and Finance for approval and payment x   Master Label
Review x   Review Master Label against GMP annex 13 and EDQM standard reference
x   Finalize Master Label prior to translation x   Coordinate all required
translations x   Code and File all required documents in the appropriate TMF
(eTMF) location x   TMF Management Plan x   Draft, Review and Update Trial
Master File Management Plan (TMFMP) which includes but not limited to:
- Project timelines and deliverables, i.e., target date of submission of TMF
documents to eTMF inbox by Submitters
- Define eTMF configuration requirements
- Delivery intervals of wet-ink documents to sponsor, if required, (quarterly,
end of study, etc.)
- Final shipment of TMF to sponsor
- Forwarding applicable CR SOPs to sponsor, if needed.
- Listing of each wet-ink document required to be maintained during the course
of the study
- Description of QC/file reviews conducted by the project team
- Description of the TMF close-out process x   Approve TMF Management Plan x  
TMF Set-up: Pre-Site Activities x   Determine TMF filing structure to be used x
  Review Trial Master File Management Plan (TMFMP) for sponsor-hosted TMFs.
Check for alignment with Worldwide's TMF Management SOPs x  

 

 Page 20 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

Provide sponsor with Worldwide's SOPs describing TMF 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
what type of access sponsor and Worldwide's project team requires including
timeframes for access and review x   Prepare Annotated TMF Structure x  
Prepare/Configure the TMF according to Worldwide's SOPs and TMF Management Plan
or sponsor plans if sponsor-hosted eTMF x   Agree TMF Compliance reporting needs
with the sponsor x   Design Periodic TMF QC process x   Facilitate eTMF system
training of all users; Provide project specific training tools to PM x   TMF
Maintenance: Conduct x   Worldwide's TMF x   Provide ongoing review and
reconcile content for completeness and quality of the TMF and making corrections
as required x   Code and approve documents x   Maintain the TMF according to
Worldwide's SOPs and TMF Management Plan x   Facilitate TMF audits and/or
inspections x   Publish monthly TMF Compliance reports for distribution to
sponsor and project teams x   Ensure that the sponsor and project team access
requirements can be met, and work with sponsor to resolve any discrepancies or
feasibility issues in meeting these requirements x   TMF Close-out x   Complete
final QC and reconciliation of the TMF x   Generate TMF gap analysis  for review
with sponsor x   Complete a final review of the  TMF data due for transfer x  
Transfer TMF data to sponsor x   Obtain signed Transfer of Ownership form from
sponsor x   Investigator Meeting Attendance x x CRA Training at IM   x Internal
Kick-off Meeting x   Prepare for internal kick-off meeting x   Travel to and
from location (unless attending remotely) x   Attend and participate in meeting
x   Sponsor Kick-off Meeting x   Prepare for sponsor kick-off meeting x   Travel
to and from location x   Attend and participate in meeting x   Sponsor
Face-to-Face Meetings x   Prepare for sponsor face-to-face meeting x   Travel to
and from location x   Attend and participate in meeting x  

 

 Page 21 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

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   Feasibility/Site
Identification x   Identify Sites x   Unblinded feasibility under CDA x   Site
Selection Phone Visit x   Prepare for Visit x   Perform Visit (Phone) x   Write
Visit Report x   Complete visit follow-up x   Review and approve visit report x
  Site Selection On-Site Visit 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   Start-up Support per Site   x Start-up
Support per Country   x Site Initiation On-Site Visit 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   Interim
Monitoring Visits (on-site) 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   Site Closure
On-Site Visit 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   Reconcile final TMF x  

 

 Page 22 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

Site Management x   Communicate with the site during start up, solving site
issues. x   Support sites during start-up, sites set-up (includes back-up sites)
x   Update CTMS as needed x   Write telephone contact reports x   Assist with
account / payments to sites x   Communicate with study team regarding site
issues x   Collect documentation required from each site for bio-samples Export
x   Import/supply study material (lab kits, diaries, etc.) x   General site
contacts and communication x   Provide Remote monitoring x   Follow up with site
for protocol violations/deviations and query/data management issues x   Provide
assistance with IMP site issues (i.e. shipment, acknowledgement, IRT site entry,
IRT review) x   Send/deliver safety information to sites (if not performed by
Safety Department) x   Communicate with sites regarding any SAE issues x  
Provide eTMF ongoing updates and QC of site documents collected in between site
visits x   Lead CRA Support x   Communicate with sponsor, project team and
vendors x   Attend and participate in the internal project CRA Trainings x  
Provide COTL/LCRA project oversight x   Create and disseminate project metrics x
  Create study 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 TMF review x  
Organizes, tracks and ensures the Clinical Study Report is delivered to all
sites, IRBs, and Competent Authorities (in countries where applicable). Ensures
Acknowledgment of Receipts are available/filed. x   CRA Training (not at IM) x  
Internal CRA Calls & Project Communication x   Protocol Amendment per Site   x
Protocol Amendment per Country (ROW)   x Set-up Grant Payments x   Enter new
payees in Finance system (GP) x   Acquire and save all W-9's (US sites only) x  
Process Grant Payments x   Initiate and print PO from Pay Flow x   Process check
or wire x   Enter voucher and payment transactions in GP x   Update status in
Pay Flow x   Track and Record all payments x   Sponsor & Regulatory Reporting x
  Audit payment history x  

 

 Page 23 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

Run report from Pay Flow x   Complete any missing information x   Set-up Vendor
Payments x   Enter new payees in Finance system (GP) x   Acquire and save all
W-9's (US sites only) x   Process Vendor Payments x   Process check or wire upon
PM approval x   Enter voucher and payment transactions in GP x   Database Set-up
& Configuration x   Define Argus DB Specifications x   Build Database x   Test
Database x   Validate Database x   Safety Management Plan Development x   Write
SMP to define roles and responsibilities of the sponsor and Worldwide  and
describe the procedures for the management, processing, and reporting of serious
adverse events and pregnancies x   Arrange for review and incorporation of
comments x   Obtain approval from all relevant parties x   Safety Training
(Sites, CRAs, Project Team) x   Develop training materials x   Train all
relevant Worldwide's/Sponsor/Site Staff of PV requirements and obligations x  
Provide follow-up training as required x   SAE Processing, Investigation,
Narrative, Approval & Query Generation x   Assess Each SAE for seriousness,
listedness and causality x   Review coding, querying and narratives and analyze
similar events x   Provide Approval and Follow-up for each SAE x   Safety
Management Maintenance x   Maintain and Update the SMP 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 and pregnancies x   Arrange for review of updated and incorporation of
comments x   Obtain approval of updates from all relevant parties x  
Preparation of LL and ASR x   Prepare and write the LL and ASR x   Arrange for
review and incorporation of comments x   Obtain approval from all relevant
parties x   SUSAR/ASR/LL submission to Investigators x   Arrange for the timely
submission of PV documents to relevant Investigators to ensure regulatory
compliance x   SUSAR/ASR/LL submission to Ethics Committees x   Arrange for the
timely submission of PV documents to relevant EC to ensure regulatory compliance
x   SUSAR/ASR/LL submission to Competent Authorities   x Eudravigilance/FDA
submission x  

 

 Page 24 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

Arrange for the timely submission of PV documents to EMA and FDA to ensure
regulatory compliance x   Audit/Inspection   x Database Transfer x   Arrange for
the preparation of PV data stored in Argus to be transferred to the sponsor x  
Medical Planning x   Review the Protocol and Investigator Drug Brochure to gain
an understanding of the trial x   Prepare Medical Monitoring Plan x   Provide
additional study document review and comment (draft ICF, draft CRF, Safety
Monitoring Plan, Data Management Plan, Statistical Analysis Plan, Communications
Plan) x   Prepare and conduct CRA training x   Prepare Investigator Meeting
presentations (includes safety and medical monitoring presentations) x  
Communicate with vendors to determine their specifications documents (normal
ranges, alerts set up, etc.) x   Medical Management x   Communicate with
sites/CRAs/project team/sponsor on protocol-medical issues x   Document and log
discussions x   Review Protocol Deviation Log x   Eligibility Review x   Review
selected screening data sets for prospective assessment of eligibility x  
Develop Subject Eligibility Form x   Discuss process design x   Listings Reviews
x   Provide AEs, SAEs, Medical History, Con meds, VSs, Demographics listings
review. Assumes one cycle. x   Coded Data Review x   Provide medical review of
non direct hits for medical coding of AEs, Con Meds and Medical History x  
Ongoing Safety Reviews of Labs and ECG alerts x   Review predefined Lab and ECG
alerts x   Follow up with sites as needed x   Study alert assessment review
(MRI, Scans, etc.)   x Maintain MM Log x   Site Selection x   Provide Medical
input on site selection  (site identification, response to issues raised to
address is site is appropriate) x   Feasibility Questionnaire Review, Analysis &
Report   x Medical Input on Regulatory Submissions x   Provide medical input to
local and national submission documentation to give clinical guidance and
address potential medical and/or safety questions x   CSR Review x  

 

 Page 25 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

Conduct medical review of selected draft CSR sections for safety and efficacy x
  Protocol Development   x IDB Development   x Site Calls (Boost Recruitment,
Discuss Protocol Changes)   x Sponsor Medical Team Calls x   Participate in
stand alone calls between sponsor and Worldwide's Medical Team x   Lead Medical
Monitor Coordination   x 24/7 Medical Monitoring   x Documentation, Training and
Reporting x   Prepare Data Management File and filing of TMF documents x   Draft
Data Management Plan for sponsor approval x   Draft eCRF completion guidelines
and EDC training manuals for sponsor approval x   Create data transfer programs
and transfer of data during the course of the study x   Provide Specification,
Creation and Running of Study DM reports x   Database Build x   Define EDC roles
and responsibilities (study attributes) x   Create Database\EDC\eCRF
Specifications x   Build and validate Database\EDC\eCRF x   Conduct User
Acceptance Testing of EDC database x   Specify electronic, manual and SAS data
validation checks x   Program and validate electronic, manual and SAS data
validation checks x   Vendor Reconciliation Set-up x   Draft Data Transfer
Agreement x   Programming and validation of reconciliation program x   UAT of
reconciliation process x   Vendor Integration Set-up x   Draft Data Transfer
Agreement x   Program and validate integration program x   Conduct UAT of
integration process x   CEC Set-up   x Data Cleaning x   Provide Data Cleaning
and Listing Review x   Database and clean local laboratory normal ranges 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 Maintenance x   Upon receipt of data for
integration, run integration programs x   Resolve issues that arise from
integration with vendors x   CEC Maintenance   x SAE Reconciliation x   Program
and validate SAE reconciliation program x   Run SAE reconciliation program x  

 

 Page 26 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Resolve issues that arise from SAE reconciliation x   EDC Support x   Manage
access to study specific EDC x   Train users on EDC x   Provide site support
(access and eCRF questions) x   QC/Data Report/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 eCRFs to the
study sites and sponsor for archiving x   Coding for MedDRA x   Provide Medical
coding and raise appropriate queries x   Manage Dictionary x   Coding for
WHODRUG x   Provide Medical coding and raise appropriate queries x   Manage
Dictionary x   DM Consultancy   x Lab Normal Set-up   x Lab Normal Maintenance  
x Statistical Input to Protocol Development   x Randomization x   Create
randomization specification x   Create and validate one dummy randomization x  
Create and validate one final randomization x   Data Mgmt. Specifications x  
Review one draft of the data management deliverables (eCRFs, edit checks,
database setup) for appropriate and necessary data collection with a focus
towards study objectives and endpoints x   SAP   x Ops Report Development   x
Monthly Database Transfer   x Data sets SDTM x   Provide SDTM datasets from raw
data files provided by the data management team in accordance with the CDISC
implementation guide and Worldwide's standards (if sponsor specific standards
are required information should be provided at project outset) x   Create
dataset specification document x   Create one draft version of SDTM datasets x  
Validate draft version of SDTM datasets via independent QC and Open CDISC x  
Create one final version of SDTM datasets x   Validate final version of SDTM
datasets via independent QC and Open CDISC x   Data sets ADaM x  

  

 Page 27 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Provide 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
specification document x   Create one draft version of ADaM datasets x  
Validate draft version of ADaM datasets via independent QC x   Create one final
version of ADaM datasets x   Validate final version of ADaM datasets via
independent QC x   Define.xml and Data Reviewers Guide for SDTM/ADaM, aCRF 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 DB & TFLs   x Final Unique Study Tables   x Final Repeat Study
Tables   x Final Unique Study Listings   x Final Unique Study Figures   x Final
Repeat Study Figures   x Deliver Interim Analysis DB & TFLs   x Interim Analysis
Unique Tables   x Interim Analysis Repeat Tables   x Interim Analysis Unique
Listings   x Interim Analysis Unique Figures   x Interim Analysis Repeat Figures
  x Deliver DSMB DB & TFLs x   DSMB Unique Tables x   Create unique study table
(one draft post DBL) x   Validate unique study table x   Finalize unique study
table after sponsor review x   Validate final unique study table x   If study is
unblinded then unblinded team to apply the randomization before finalizing the
DSMB unique table. x   DSMB Repeat Tables x   Create repeat study table (one
draft post DBL) x   Validate repeat study table x   Finalize repeat study table
after sponsor review x   Validate final repeat study table x   If study is
unblinded then unblinded team to apply the randomization before finalizing the
DSMB unique table. x   DSMB Unique Listings x   Create unique study listing (one
draft post DBL) x   Validate unique study table x   Finalize unique study
listing after sponsor review x  

 Page 28 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Validate final unique study listing x   If study is unblinded then unblinded
team to apply the randomization before finalizing the DSMB unique table. x  
DSMB Unique Figures x   Create unique study figure (one draft post DBL) x  
Validate unique study figure x   Finalize unique study figure after sponsor
review x   Validate final unique study figure x   If study is unblinded then
unblinded team to apply the randomization before finalizing the DSMB unique
table. x   DSMB Repeat Figures x   Create repeat study figure (one draft post
DBL) x   Validate repeat study figure x   Finalize repeat study figure after
sponsor review x   Validate final repeat study figure x   If study is unblinded
then unblinded team to apply the randomization before finalizing the DSMB unique
table. x   BioStat Post Study Support   x Ops Report Ongoing   x Annual Update
Report x   Establish Annual Update Report Template x   Collect safety and other
data from sponsor and PT (DM/Stats/PVG etc.) x   Generate Draft 1 for sponsor
review x   Generate Draft 2 for sponsor approval x   Submit report for
electronic publishing x   Deliver eCTD-ready published report x   Manuscript   x
Protocol Amendment   x Protocol Synopsis     x Protocol     x Protocol Risk
Assessment x   Model ICF(s) x   Obtain final protocol x   Establish template to
be utilized x   Generate Draft 1 for sponsor review x   Generate Draft 2 for
sponsor approval x   Deliver final global model ICF x   Investigator Brochure  
x Investigator Brochure Update   x CSR Shell   x CSR Body Text   x CSR Published
  x CSR Narratives   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  

 

 Page 29 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

Apply Header/Footer to Scales x   Coordinate with Regulatory for EC/IRB
Submission x   Approve Source Documents x   Make scales available for use by the
sites x   TMF IRB 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 TMF x   Develop Rater Training
Database/Tracker x   Create Rater Experience Qualification (survey) x   Rater
Experience Verification x   Work with study 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 previously agreed upon qualifications x   Approve Raters for
Study who do not meet sponsor previously agreed upon qualifications (overrides)
x   File Rater Experience Qualification (Survey) forms into TMF x   Rater
Training and Certification x   Track/Manage Raters at each Site x   Process IM
Raters for Training/Certification x   Process New Raters for
Training/Certification in-Study x   Follow up with Raters to complete
Training/Certification x   Issue Training/Certification Certificates x   File
Training/Certification Certificates into TMF x   Applied Skill Assessment not at
IM x   Site rater provided instructions on how to submit Applied Skills
Assessment (ASA) to CAT x   Clinical review and feedback for Applied Skills
Assessment (ASA) x   Complete ASA form (for each Raters' ASA) x   File ASA form
into TMF x   Coordinate with sponsor on next steps when Rater fails ASA x  
Remediation of Rater Training x   Provide Clinical Remediation to Rater x  
Didactic Presentation   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  

 

 Page 30 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

Set-up of CAT 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   CAT Data Management Reports x   EDC Flag Clinical Review x   Provide
clinical review of flagged subject visits x   EDC Flag Clinical Contact x   Act
as Clinical contact for flagged subject visits x   File Clinical Feedback into
TMF x   Collection & Review of Source Doc x   Document IVR 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   Remediation Clinical Contact
x   Provide Clinical remediation for source document review x   CAT Final Report
x   Develop Data Surveillance Final Report x   Approve Data Surveillance Final
Report x   File Data Surveillance Final Report into TMF x   KAPPA Report   x
Clinical Assessment Start-up & Planning x   Clinical Assessment Maintenance &
Reporting x   CAT Virtual Training Session x   Confirm attendees and
communication details x   Create and distribute invitation to attend training
session x   Conduct Virtual Training Session x   Close out Virtual Training
Session (document attendees, distribute training certificates) x   CAT Site
Training   x Pre go-live PM, Reqs Gathering & Design (SaaS) x   Lead IRT focused
requirements gathering meetings x   Write user requirements specification
according to protocol design x   Write IRT Project Plan x   Configuration/Coding
(SaaS) x   Configure IRT 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   System Integrations (SaaS) x   Manage the set up of any
integrations between IRT and other systems x  

 

 Page 31 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

Coordinate data transfers x   Configure and test integration x   Sponsor UAT
(SaaS) x   Set up data for UAT x   Facilitate the performance of user acceptance
testing for the sponsor x   IRT Inventory Implementation and Review x  
Facilitate movement of drug kits between depots x   Process material
randomization schedules (kit list), inventory releases and perform quality
checks x   IRT Post go-live Project Management (SaaS) x   Oversight and
accountability for the project x   Act as point of escalation for any IRT
related issues for the study x   Production Support (SaaS) x   Daily support of
IRT x   Production Randomization Monitoring and Audit x   Monitoring patient and
material randomization to ensure correct execution in production x  
Decomissioning (SaaS) x   Coordinate decommissioning of the system and data
archiving at study end x   Amendment to IRT System   x CTMS Set-up x   Develop
User Requirement Specifications and UAS x   MVR Review and Configuration x  
CTMS OnPoint and SharePoint Build/Configuration x   CTMS OnPoint and SharePoint
UAT 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   CTMS Help Desk/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   PayFlow Set-up: Regulatory Payments   x
PayFlow Set-up: Grant Payments x   Create Study in Pay flow x   Add Sites x  
Create Pay flow Specification x   Create Visit Plug-In Specification x   PayFlow
Maintenance, Support, Changes x   Grant System Access x   Respond to help desk
queries x   Add Sites x  

 

 Page 32 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

Rater Web Portal Set-up x   Rater Web Portal Maintenance, Support, Changes x  
Integration Set-up x   Create Study Specific Integration documents for IRT to
EDC x   Create Study Specific Integration documents for EDC to OnPoint CTMS x  
Integration Maintenance, Support, Changes x   Technology Project Management   x
Project Management - Start Up x   Identify Sites/PIs (develop questionnaire,
create potential site list, all site recruitment activities, unblinded
feasibility) x   Create or review Project Plans x   Execute Project Plans x  
Prepare for and Plan Investigator Meeting x   Participate in and present at
Investigator Meeting x   Provide and receive Project Specific Training (develop
training, presenting, receive training, includes protocol review time) x  
Set-Up Internal/External Systems x   Review Non-Worldwide's SOPs 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   Maintain and QC TMF (including response to internal or
sponsor audits) and Deliver to customer x   Manage study Vendors (includes
identification, selection, contract negotiation and management) x   Complete all
Internal System Data Entry - project related  (such as time entry, scorecard,
MPR, WEST, Anaplan or other internal systems) x   Prepare Site/Study Documents
(Site reference material, study binders, recruitment tools) x   Manage Site
Supplies x   Provide CTA Support of Medical Monitoring or Clinical Assessment
Team x   Manage Site Grant and PI reimbursement payments (includes initiating
grant fund replenishment invoicing requests and approval of payments in Pay
flow) x   Complete revenue Reporting and Projections x   Manage change orders
and OOS log x   Procure invoice Approval ( includes follow up internally or with
customer) x   Manage vendor Payments x   Complete Financial Reconciliation x  
Monitor, Evaluate and Adjust KPIs 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 IMs occurring after startup) x  

 

 Page 33 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

Participate in and present at Investigator Meeting (for IMs occurring after
startup) 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 QC TMF (including response to internal or
sponsor audits) and Deliver to customer x   Manage study Vendors (includes
identification, selection, contract negotiation and management) x   Complete all
Internal System Data Entry - project related  (such as time entry, scorecard,
MPR, WEST, Anaplan or other internal systems) x   Prepare Site/Study Documents
(Site reference material, study binders, recruitment tools) x   Manage Site
Supplies x   Provide CTA Support of Medical Monitoring or Clinical Assessment
Team x   Manage Site Grant and PI reimbursement payments (includes initiating
grant fund replenishment invoicing requests and approval of payments in Pay
flow) x   Complete revenue Reporting and Projections x   Manage change orders
and OOS log x   Procure invoice Approval ( includes follow up internally or with
customer) x   Manage vendor Payments x   Complete Financial Reconciliation x  
Monitor, Evaluate and Adjust KPIs 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, includes
protocol review time) 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 QC TMF (including response to internal or sponsor audits) and
Deliver to customer x   Manage study Vendors (includes identification,
selection, contract negotiation and management) x  

 

 Page 34 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

Complete all Internal System Data Entry - project related  (such as time entry,
scorecard, MPR, WEST, Anaplan or other internal systems) x   Prepare Site/Study
Documents (Site reference material, study binders, recruitment tools) x   Manage
Site Supplies x   Provide CTA Support of Medical Monitoring or Clinical
Assessment Team x   Manage Site Grant and PI reimbursement payments (includes
initiating grant fund replenishment invoicing requests and approval of payments
in Pay flow) x   Complete revenue Reporting and Projections x   Manage change
orders and OOS log x   Procure invoice Approval ( includes follow up internally
or with customer) x   Manage vendor Payments x   Complete Financial
Reconciliation x   Monitor, Evaluate and Adjust KPIs x   Generate Status Reports
x   Track Project related data to facilitate and inform status reporting and
study management x  

 

 Page 35 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

EXHIBIT B

TIMELINE

 

Milestones Project Start Date [***] Final Protocol Available (Note: changes to
this date will impact all study timelines) [***] First Site Initiated [***]
First Patient Screened [***] First Patient In (First patient randomized) [***]
Last Patient In (LPI) [***] Last Patient Out (LPO) [***] Last Patient out of
Long Term Follow-up [***] Last CRF to Data Management [***] Database Lock [***]
Topline Results (Neurotrope Consultant) [***] Final TFLS (Neurotrope Consultant)
[***] CSR Delivery/ End of Project [***]

 

 Page 36 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

EXHIBIT C

BUDGET

 

  Worldwide Clinical Trials Budget           Sponsor: Neurotrope Bioscience     
  Study: A Randomized, Double-Blind, Placebo-Controlled, Confirmatory
Phase 2 Study Assessing the Safety, Tolerability and Efficacy of
Bryostatin in the Treatment of Moderately Severe to Severe
Alzheimer’s Disease Subjects Not Receiving Memantine Treatment                
Services Unit # Units Unit Cost
USD Total Cost USD Study Start-up & Regulatory Affairs          o Essential
Document Customization & Review-US & CAN Site [***] [***] [***] o Investigator
Agreements Contract [***] [***] [***] o Investigator Agreements Country Specific
Templates Template [***] [***] [***] o Contract and Budget Plan Plan [***] [***]
[***] o Investigator Grant Build Build [***] [***] [***] o Regulatory
Preparation & Tracking Study [***] [***] [***] o IRB Submissions US &
CAN-Central IRB Site [***] [***] [***] o IRB Submissions US & CAN-Local IRB Site
[***] [***] [***] o Start-up Planning-First core countries Plan [***] [***]
[***] o Start-up Management Site Months [***] [***] [***] o Translation
Coordination Language [***] [***] [***] o Master Label Review Country [***]
[***] [***]   Sub-Total Study Start-up & Regulatory Affairs     [***] Trial
Master File         o TMF Management Plan Plan [***] [***] [***] o TMF Set-up:
Pre-Site Activities Sites [***] [***] [***] o TMF Maintenance: Conduct Site
Months [***] [***] [***] o TMF Close-out Sites [***] [***] [***]   Sub-Total
Trial Master File       [***] Project Meetings         o Investigator Meeting  
        >USA Meeting [***] [***] [***] o Internal Kick-off Meeting Meeting [***]
[***] [***] o Sponsor Kick-off Meeting Meeting [***] [***] [***] o Sponsor
Face-to-Face Meetings Meeting [***] [***] [***] o Sponsor Teleconferences Months
[***] [***] [***] o Internal Teleconferences Months [***] [***] [***]  
Sub-Total Project Meetings       [***] Clinical Monitoring           o  
Feasibility/Site Identification Site [***] [***] [***] o Site Selection Phone
Visit Visit [***] [***] [***] o Site Selection On-Site Visit Visit [***] [***]
[***] o Site Initiation On-Site Visit Visit [***] [***] [***] o Interim
Monitoring Visits (on-site) Visit [***] [***] [***]

 

 Page 37 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

o Additional Time on Site Visit [***] [***] [***] o Site Closure On-Site Visit
Visit [***] [***] [***] o Site Management Site Months [***] [***] [***] o Lead
CRA Support Month [***] [***] [***] o CRA Training (not at IM) Attendee [***]
[***] [***] o Internal CRA Calls & Project Communication Month [***] [***] [***]
  Sub Total Clinical Monitoring       [***] Grant & Vendor Payments         o
Set-up Grant Payments Contract [***] [***] [***] o Process Grant Payments Month
[***] [***] [***] o Sponsor & Regulatory Reporting Month [***] [***] [***] o
Set-up Vendor Payments Vendor [***] [***] [***] o Process Vendor Payments Month
[***] [***] [***]   Sub-Total Grant & Vendor Payments       [***] Drug Safety  
        o Database Set-up & Configuration Database [***] [***] [***] o Safety
Management Plan Development Plan [***] [***] [***] o Safety Training (Sites,
CRAs, Project Team) Training [***] [***] [***] o SAE Processing, Investigation,
Narrative, Approval & Query Generation SAE [***] [***] [***] o Safety Management
Maintenance Month [***] [***] [***] o Preparation of LL and ASR Report [***]
[***] [***] o SUSAR/ASR/LL submission to Investigators Country [***] [***] [***]
o SUSAR/ASR/LL submission to Ethics Committees Country [***] [***] [***] o
Eudravigilance/FDA submission Submission [***] [***] [***] o Database Transfer
Transfer [***] [***] [***]   Sub-Total Drug Safety       [***] 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 MM Log Month [***]
[***] [***] o Site Selection Country [***] [***] [***] o Medical Input on
Regulatory Submissions Country [***] [***] [***] o CSR Review CSR [***] [***]
[***] o Sponsor Medical Team Calls Month [***] [***] [***]   Sub-Total Medical
Monitoring       [***] Data Management         o Documentation, Training and
Reporting Month [***] 4,123.11 61,846.65

 

 Page 38 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

o Database Build Build [***] [***] [***] o Vendor Reconciliation Set-up Vendor
[***] [***] [***] o Vendor Integration Set-up Vendor [***] [***] [***] o Data
Cleaning Screen [***] [***] [***] o Vendor Reconciliation Maintenance Upload
[***] [***] [***] o Vendor Integration Maintenance Upload [***] [***] [***] o
SAE Reconciliation SAE [***] [***] [***] o EDC Support User [***] [***] [***] o
QC/Data Report/Database Lock Lock [***] [***] [***] o Coding for MedDRA Term
[***] [***] [***] o Coding for WHODRUG Term [***] [***] [***]   Sub-Total Data
Management       [***] Biostatistics          o Randomization  List [***] [***]
[***] o Data Mgmt. Specifications  Protocol [***] [***] [***] o Data sets SDTM
 Dataset [***] [***] [***] o Data sets ADaM  Dataset [***] [***] [***] o
Define.xml and Data Reviewers Guide for SDTM/ADaM, aCRF  Specification [***]
[***] [***] o Deliver DSMB DB & TFLs  Delivery [***] [***] [***]   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 Biostatistics       [***] Medical Writing  
      o Protocol Risk Assessment Protocol [***] [***] [***] o Annual Update
Report Update [***] [***] [***] o Model 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 not at IM  ASA/Rater [***] [***] [***] o Remediation of Rater
Training  Rater [***] [***] [***] o Web Portal  Portal [***] [***] [***] o Data
Surveillance Plan  Plan [***] [***] [***] o Set-up of CAT EDC Data Monitoring
System  System [***] [***] [***] o CAT Data Management Reports  Month [***]
[***] [***] o EDC Flag Clinical Review  Visit [***] [***] [***] o EDC Flag
Clinical Contact  Contact [***] [***] [***] o Collection & Review of Source Doc
 Visit x Scale [***] [***] [***]

 

 Page 39 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

o Remediation Clinical Contact  Visit [***] [***] [***] o CAT Final Report
 Report [***] [***] [***] o Clinical Assessment Start-up & Planning  Month [***]
[***] [***] o Clinical Assessment Maintenance & Reporting  Month [***] [***]
[***] o CAT Virtual Training Session  WebEx [***] [***] [***] o CAT Training at
IM  Training [***] [***] [***]   Sub-Total Clinical Assessment Technologies    
  [***] IRT         o Pre go-live PM, Reqs Gathering & Design (SaaS) Build [***]
[***] [***] o Configuration/Coding (SaaS) Build [***] [***] [***] o Validation
(SaaS) Build [***] [***] [***] o Review testing materials Build [***] [***]
[***] o System Integrations (SaaS) Build [***] [***] [***] o Sponsor UAT (SaaS)
Build [***] [***] [***] o IRT Inventory Implementation and Review Build [***]
[***] [***] o IRT Post go-live Project Management (SaaS) Month [***] [***] [***]
o Production Support (SaaS) Month [***] [***] [***] o Production Randomization
Monitoring and Audit System [***] [***] [***] o Decomissioning (SaaS) System
[***] [***] [***]   Sub-Total IRT       [***] Technology         o CTMS Set-up
System [***] [***] [***] o CTMS Help Desk/Maintenance Month [***] [***] [***] o
PayFlow Set-up: Grant Payments System [***] [***] [***] o Payflow Customization
System [***] [***] [***] o PayFlow 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       [***] 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       [***]

 

 Page 40 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

System Expenses         o IBMCD EDC Start-up & Build System [***] [***] [***] o
IBMCD EDC Maintenance & Hosting Month [***] [***] [***] o IBMCD EDC Close-out
System [***] [***] [***] o Argus Safety Database Set-up & Configuration System
[***] [***] [***] o Argus Safety Database Hosting Month [***] [***] [***] o CTMS
User Access System [***] [***] [***] o IBMCD IRT Database Expenses System [***]
[***] [***] o eTMF Set-up System [***] [***] [***] o eTMF Set-up (discounted)
System [***] [***] [***] o eTMF Monthly Hosting Fees Site months [***] [***]
[***] Total System Expenses       [***]             Estimated Pass-Through Costs
                    Study Start-up & Regulatory Affairs Pass-through Costs      
o Print and Ship Investigator Site File to Sites Site [***] [***] [***] o IRB
Site Regulatory Documents (includes preparation, collection, SC, annual renewals
if needed)   [***] [***] [***]   North America - Local IRB Site [***] [***]
[***]   North America - Central IRB Site [***] [***] [***]   Sub-Total
Regulatory Affairs Pass-through Costs       [***] Trial Master File Pass-through
Costs         o Final Transfer of Study Records to Sponsor (Disk) Transfer [***]
[***] [***]   Sub-Total Trial Master File Pass-through Costs       [***] Project
Meetings Pass-through Costs         o Sponsor Kick-off Meeting Meeting [***]
[***] [***] o Sponsor Face-to-Face Meetings Meeting [***] [***] [***]  
Sub-Total Project Meetings Pass-through Costs       [***] Clinical Monitoring
Pass-through Costs         o Site Selection Visit Visit [***] [***] [***] o Site
Initiation Visits Visit [***] [***] [***] o Interim Monitoring Visits Visit
[***] [***] [***] o Additional Time on Site Visit [***] [***] [***] o Site
Close-Out Visits Visit [***] [***] [***] o Site Management Site Month [***]
[***] [***] o Print & Ship study documents, Quarterly to each site Shipment
[***] [***] [***] o Vendor Payment Processing (Bank Fees) Payment [***] [***]
[***]   Sub Total Study Conduct Pass-through Costs       [***] Drug Safety
Pass-through Costs        

  

 Page 41 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

o FDA Submission Electronic Submission [***] [***] [***]   Sub Total Drug Safety
Pass-through Costs       [***] Clinical Assessment Technologies Pass-through
Costs       o Scale Licenses License [***] [***] [***] o Scale Translations
Scales* Languages [***] [***] [***]   Sub-Total Clinical Assessment Technologies
Pass-through Costs       [***] Archiving Pass-through Costs         o Shipment
of completed eCRFs back to sites (archive copy, disc for EDC) Shipment [***]
[***] [***] o Shipment of completed eCRFs back to Sponsor (disc ) Shipment [***]
[***] [***]   Sub-Total Archiving Pass-through Costs       [***] o PM PTCs Month
[***] [***] [***]   Sub-Total Project Management Pass-through Costs       [***]
Third Party Vendor Costs         o Central Lab Eurofins Study [***] [***] [***]
o ECG Provider ERT Study [***] [***] [***] o Investigator Meeting Planner Dallas
Fanfare Study [***] [***] [***] o Patient Payments Patient [***] [***] [***]  
Sub-Total Third Party Vendors       [***] PI Fees         o PI - Grants -
Completed patients Patient [***] [***] [***] o PI - Grants - Screen failure
patients Patient [***] [***] [***] o PI - Grants - Dropped patients Patient
[***] [***] [***] o Site Costs Site [***] [***] [***] o Grant Payment Processing
(Bank Fees) Payment [***] [***] [***]   Sub-Total PI Fees       [***] Total
Estimated Pass Through Costs       [***]             Total Estimated Budget    
  [***]

 

 Page 42 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

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
$642,923.72 due upon ten (10) days of receipt, (advance payment represents
[***]% of the Service Fee 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
reduced by 20% until the advance payment is exhausted. With the exception of the
first payment described above in the amount of $642,923.72, payment terms shall
be as defined in this Agreement. Any outstanding balances will be reconciled at
the end of the Study.

 

1.2.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 $123,470.93 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 $432,672.00 due upon twenty (20) day
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 43 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

  

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 44 of 44 Portions of this Exhibit, indicated by the mark “[***],” were
omitted and have been filed separately with the Secretary of the Commission
pursuant to the Registrant’s application requesting confidential treatment
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.