Exhibit 10.16


 


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:


 


		1.0	SERVICES



 


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


 


		1.1	Performance



 


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


 




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



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



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



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



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



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



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



		·	unforeseen changes in the relevant medical
practice.



 


		1.2	Compliance with Laws/Agreements



 


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


 


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


 


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


 


		1.3	Transfer of Obligations



 


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


 




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		1.4	Changes



 


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


 


		2.0	WORK PRODUCT



 


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


 


		3.0	PAYMENT AND COMPENSATION



 


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


 


		3.1	Compensation for Services



 


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


 




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		3.2	Pass-through Expenses



 


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


 


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


 


		3.3	Invoices;



 


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


 


		3.4	Payment Terms



 


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


 


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


 


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


 




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		3.5	Project Delays



 


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


 


		3.6	Currency Management



 


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


 


		3.7	Disputed Invoices



 


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


 


		4.0	THIRD PARTY AGREEMENTS



 


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


 




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


 


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


 


		4.1	Institutions/Investigators



 


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


 


		(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.



 




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



 


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


 


		5.0	CONFIDENTIAL INFORMATION



 


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


 


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


 




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


 


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


 


		6.0	OWNERSHIP OF DATA AND INTELLECTUAL PROPERTY



 


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


 


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


 


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


 




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		7.0	TERM AND TERMINATION



 


		7.1	Term



 


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


 


		7.2	Termination for Material Breach



 


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


 


		7.3	Termination by Sponsor without Cause



 


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


 


		7.4	Termination for Other Reasons



 


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


 


7.5       Termination
Procedures


 


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


 




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		8.0	DEBARMENT
                                         CERTIFICATION



 


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


 


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


 


		9.0	RECORDS, AUDITS AND INSPECTIONS



 


		9.1	Records



 


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


 




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		9.2	Audits by Sponsor



 


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


 


		9.3	Inspection by Regulatory Authorities



 


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


 


		9.4	Inspections of Investigator Site(s) by Worldwide



 


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


 


		10.0	INDEMNIFICATION



 


		10.1	Indemnification by Worldwide



 


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


 




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		10.2	Indemnification by Sponsor



 


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


 


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


 


		10.3	Indemnification Procedures



 


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


 


		11.0	LIMITATION OF LIABILITY



 


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


 


		12.0	INSURANCE



 


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


 




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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.


 


		13.0	REPRESENTATIONS AND WARRANTIES



 


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


 


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


 


13.3       Worldwide
represents and warrants to Sponsor that:


 


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


 


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


 


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


 




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(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.


 


		14.0	DISCLAIMER



 


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


 


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


 




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		15.0	EMPLOYEES; NON-SOLICITATION



 


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


 


		16.0	NOTICES



 


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


 


If to Sponsor:


 


Neurotrope Bioscience Inc.


205 East 42nd Street,
New York, NY 10019


ATTN: [***]


Via email: [***]


 


If to Worldwide:


 


c/o Worldwide
Clinical Trials, Inc.


3800 Paramount
Parkway, Suite 400, 27560


Morrisville,
NC, United States


ATTN: Legal
Counsel


 


		17.0	MISCELLANEOUS



 


		17.1	Modification



 


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


 


		17.2	Assignment



 


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


 




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		17.3	Force Majeure



 


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


 


		17.4	Severability



 


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


 


		17.5	English Language



 


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


 


		17.6	Entire Agreement



 


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


 


		17.7	Survival



 


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


 


		17.8	Governing Law



 


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


 




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		17.9	Waiver



 


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


 


		17.10	Independent Contractors



 


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


 


		17.11	Counterparts



 


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


 


		17.12	Arbitration



 


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


 


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


 


	NEUROTROPE BIOSCIENCES, INC.	 	 	WORLDWIDE CLINICAL TRIALS, INC.
	 	 	 	 	 	 
	By:	              	 	 	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


 




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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	 	 


 




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	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


 




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	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	 


 




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	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	 


 




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	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	 


 




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	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	 


 




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	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	 


 




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	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	 


 




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	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	 


 




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	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	 


  




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	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	 







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	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	 


 




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	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	 


 




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	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	 


 




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	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	 


 




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	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	 


 




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	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	 


 




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	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	 
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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	[***]


 




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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	[***]	[***]	[***]










 




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	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







 




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	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	 
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	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	 
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	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	 
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	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	 
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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.



 




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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.