Exhibit 10.1


 


Note:
Certain portions of this document have been marked “[c.i.]” to indicate that confidential treatment has been requested
for this confidential information. The confidential portions have been omitted and submitted separately with the Securities and
Exchange Commission.


 


SERVICES AGREEMENT


 


This Services Agreement
(this “Agreement”) is made and entered into as of August 31, 2015, (the “Effective Date”),
by and between Worldwide Clinical Trials, Inc., with offices at 401 North Maple Drive, Beverly Hills, California 90210, (together
with its Affiliates, “WCT”) and Neurotrope Bioscience Inc., with offices at 50 Park Place, Newark NJ 07102 (“Sponsor”).
WCT 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, WCT is engaged
in providing services to pharmaceutical manufacturers in support of their clinical research and product development activities;


 


WHEREAS,
WCT and Sponsor desire that WCT provide certain services with respect to Sponsor’s clinical study, NRTP101-202 entitled “A
Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Assessing The Safety, Tolerability and Efficacy of Bryostatin in the
Treatment of Moderately Severe to Severe Alzheimer’s Disease” (the "Study") for the study of Sponsor’s
drug Bryostatin 1 ("Study Drug"); and


 


WHEREAS, Sponsor and
WCT 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


 


WCT, 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


 


WCT 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
WCT’s control, and shall be subject to adjustment [C.I.] if the work for the Services is delayed due to circumstances outside
the reasonable control of WCT, including, but not limited to:


 




     


     

    

 


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



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



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



		·	unforeseen changes in the relevant medical
practice.



 


1.2           Compliance
with Laws/Agreements


 


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


 




     


     

    

  


1.4           Changes


 


The Parties may make changes in or additions
to the Scope of Services, provided, however, that, subject to the terms of this Section 1.4, no such changes or additions shall
be implemented prior to the execution by the Parties of a change order (a “Change Order”), the form of which
is attached hereto and incorporated herein as Exhibit E. The Change Order shall include detailed information on the changes to
the Scope of Services and any associated changes to the Timeline, Budget and/or payment schedule. Sponsor acknowledges that WCT
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 WCT 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 WCT for [C.I.]. For any Change Order that affects the scope of the regulatory obligations that have been transferred
to WCT, WCT 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, WCT
shall maintain all materials and all other data or documents included in the Trial Master File obtained or generated by WCT in
the course of providing the relevant Services in accordance with WCT’s standard operating procedures, including all computerized
records and files (“Work Product”), in a secure area reasonably protected from fire, theft and destruction.
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 WCT with written
instructions as to the disposition of the Work Product created under this Agreement. Such written instructions will provide that
WCT (a) deliver the Work Product, in the form in which WCT 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 WCT is required by law or regulation to store or maintain. Upon expiration
or termination of this Agreement, [C.I.] of the Work Product will be [C.I.] as Pass-through Expenses (as defined below) in accordance
with the terms of this Agreement. Notwithstanding the foregoing, WCT may retain one electronic archival backup copy of such Work
Product in accordance with WCT’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 WCT 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 WCT, which is attached hereto as Exhibit C, and is incorporated
herein by reference. Sponsor shall pay to WCT such amounts as set forth and more fully described in the Budget. WCT 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). WCT will [C.I.] (as defined below), associated with this Agreement and to
obtain and pass along to Sponsor [C.I.].


 




     


     

    

  


3.2           Pass-through
Expenses


 


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


 


In order to facilitate payment of invoices
for WCT’s pre-approved [C.I.] incurred during the performance of Services, WCT will submit to Sponsor a report containing
at least the following details: (i) photocopies of receipts [C.I.], (ii) date and [C.I.], (iii) employee name, and [C.I.]. In addition
to copies of all receipts [C.I.], 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 [C.I.] obtained under Section 3.2 will be passed through and properly reflected in invoices to Sponsor
and shall be [C.I.]. WCT will use [C.I.] which are less than [C.I.]. For the avoidance of doubt, [C.I.] should not include [C.I.].


 


3.3           Invoices;


 


WCT shall submit a reasonably detailed
invoice by email to Sponsor (rweinstein@neurotropebioscience.com) on a [C.I.] 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
[C.I.] 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 [C.I.] of any local, state, federal or foreign sales and use taxes, VAT,
if any, [C.I.]. If such taxes are applicable under local regulations, WCT will [C.I.] at the relevant rate. For the avoidance of
doubt, the requirements of this provision shall not apply to [C.I.].


 


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


 


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


 


3.5           Project
Delays


 


In the event Sponsor delays, suspends or
places a hold on the Study for any reason, Sponsor shall promptly provide WCT with written notice of such delay, hold or suspension,
and Sponsor and WCT will, [C.I.] of such notice, [C.I.] to this Agreement and each Party will complete its respective duties and
obligations as described in any resulting Change Order. During the period following WCT’s receipt of Sponsor’s notice
of delay, hold or suspension, if Sponsor desires WCT to continue the assignment of certain WCT Study personnel to the Study, [C.I.]
to WCT hereunder, Sponsor agrees that it shall [C.I.] associated with such continued assignment at [C.I.], such [C.I.] to be agreed
upon by the Parties prior to commencement of the delay, as evidenced by a Change Order. Said personnel fees shall be [C.I.] and
shall be due and payable by Sponsor within [C.I.] days of Sponsor’s receipt of WCT’s invoice. If Sponsor does not wish
to retain certain WCT Study personnel for the duration of the delay or on hold period, WCT shall have the right to reallocate any
and all such staff after [C.I.] day period. If the delay or on-hold period continues for [C.I.] 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 WCT in writing within [C.I.] of receipt of the invoice and such notice shall contain a
reasonably detailed description of the item(s) being disputed and the basis therefor. WCT will respond to Sponsor within [C.I.]
of receipt of the notification. This written communication pattern will continue until WCT 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 [C.I.] of receipt of invoice and shall use its reasonable efforts to pay the disputed
amount within [C.I.] of resolution of the dispute pursuant to Section 17.12. In the event the Parties are unable to reach a satisfactory
resolution within [C.I.] of the original invoice, either Party may pursue alternative remedies in accordance with this Agreement.


 


4.0           THIRD
PARTY AGREEMENTS


 


WCT 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) WCT 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) WCT shall remain primarily responsible to Sponsor for the performance of such subcontracted Services, and
(iv) any subcontracting shall not relieve WCT of its obligations hereunder and WCT hereby agrees to manage the performance of
any permitted subcontractor. 


 


For purposes of this Agreement, subcontractors
do not include third party vendors providing ancillary services on the Study, provided that WCT’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
WCT’s rights under the agreement. Liability of WCT to Sponsor with respect to such third party vendors shall be limited
to the extent WCT is negligent in the performance of its obligations under this Agreement; however, WCT shall provide to Sponsor
any amounts that WCT 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 WCT use a particular
third party and WCT 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, WCT will have no responsibility for the selection, instruction or supervision of such Sponsor Designated Vendor.


 




     


     

    

  


4.1           Institutions/Investigators


 


WCT’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 WCT the responsibility
for negotiating and/or executing Clinical Trial Agreements, the following provisions will apply:


 


		(a)	Sponsor may provide WCT with a list of suggested Institutions
and/or Investigators to be recruited by WCT for a Study. WCT shall notify Sponsor in writing as to any listed Institution/Investigator
with which WCT 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 WCT.



 


		(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
WCT shall have no indemnification obligation to any Institution/Investigator relative to the Study Drug or the applicable Study
protocol. In addition, WCT 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.



 


		(f)	The Sponsor may elect that grant payments to Institutions/Investigators
be administered on its behalf by WCT, acting solely as payment agent unless otherwise agreed to by WCT in writing. WCT 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 WCT 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 WCT from Sponsor for this specific purpose.
Furthermore, Sponsor acknowledges and agrees that WCT intends to maintain a cash neutral policy with regard to Institutions/Investigators
payments. In the event WCT 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 WCT
solely from the funds that have been specifically provided by Sponsor to WCT for this purpose and not from WCT funds. WCT 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
WCT and that Investigators will be required to exercise their own independent medical judgement. WCT’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 [C.I.] 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, [C.I.]. Confidential Information shall be deemed to be all such information given by the disclosing
party to the receiving party except for information which is (i) publicly available or later becomes publicly available through
no fault of the receiving party; (ii) obtained by the receiving party from a third party entitled to disclose it; (iii) already
in possession of the receiving party as indicated in its written records; (iv) independently developed by the receiving party without
use of the Confidential Information; or (v) required by any law, rule, regulation, order, decision, decree, or subpoena or other
judicial, administrative, or legal process to be disclosed.


 


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


 


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


 


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


 




     


     

    

 


6.0           OWNERSHIP
OF DATA AND INTELLECTUAL PROPERTY


 


Any invention, discovery, processes, know-how,
trade secrets, data, copyrights, trademarks, improvements, or any other intellectual property right related to Sponsor’s
products or technology, including the Study Drug, the Protocol, Sponsor’s Confidential Information, which is conceived or
reduced to practice as a result of the performance of the Services hereunder (the “Inventions”) shall become
Sponsor property and shall be used by Sponsor as Sponsor deems appropriate. WCT 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 WCT and its officers, employees, representatives and
agents. WCT acknowledges that Sponsor has the exclusive right to file patent applications in connection with the Inventions. WCT
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 WCT possesses
certain computer programs, applications, algorithms, databases, methods, techniques, processes and other materials and ideas independently
developed by WCT which do not rely upon, reference, or inextricably incorporate Sponsor Confidential Information or Study Drug
and which relate to WCT’s business or operations (“WCT Works”). All WCT Works, and all revisions, improvements
and enhancements thereto, are the exclusive property of WCT or its licensors. Sponsor agrees that any improvements, alterations
or enhancements to the WCT Works during the term of this Agreement or the Study shall be the sole property of WCT. Subject to Section
5.0 hereof, in no event shall WCT 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. WCT
represents and warrants that it is entitled to deliver WCT Works where the same is delivered as part of the Services hereunder
for Sponsor and its Affiliates’ use, and WCT further represents and warrants that use by Sponsor and its Affiliates’
of any such WCT Works is properly authorized and will not constitute an infringement or other violation of any rights of any third
party.


 


7.0           TERM
AND TERMINATION


 


7.1           Term


 


Unless earlier terminated according to
Sections 7.2-7.5 below, this Agreement will remain in effect from the date first written above until WCT has completed performance
of all Services (including delivery of all deliverables) and WCT 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 [C.I.] 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 [C.I.] period. For the avoidance of doubt, [C.I.] by Sponsor or non-payment by WCT to Institutions/Investigators
under Section 4.1(f) shall [C.I.].


 




     


     

    

  


7.3           Termination
by Sponsor without Cause


 


Sponsor shall have the right to terminate
this Agreement (for other than breach by WCT) 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
[C.I.] 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 WCT’s Services. WCT shall [C.I.]
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, WCT will be entitled to [C.I.] and [C.I.] up to the effective date of termination. In addition, Sponsor shall [C.I.]
by WCT that are [C.I.] 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, WCT [C.I.] to the extent that the [C.I.] for the [C.I.] can reasonably be avoided
in whole or in part.


 


8.0           DEBARMENT
CERTIFICATION


 


WCT 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. WCT agrees that it shall notify Sponsor in writing within [C.I.]
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.


 


WCT 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


 


WCT 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, WCT 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 WCT’s books and records. All records
relating to this Agreement including, but not limited to, WCT’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 [C.I.] prior written notice, and for a period
of [C.I.] 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 WCT or WCT’s Affiliate
or subsidiary, as the case may be, which contains mutually agreed-upon terms. Further, Sponsor’s financial audit of WCT or
any WCT Affiliate or subsidiary hereunder shall be subject to the confidentiality obligations set forth herein.


 


9.2           Audits
by Sponsor


 


During
the term of this Agreement, WCT will permit representatives of Sponsor who are not competitors of WCT to examine, [C.I.], subject
to at least [C.I.] prior written notice to WCT (except in the case of “for cause” audits where Sponsor will provide
[C.I.] prior written notice to WCT), and [C.I.]: (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. WCT 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, WCT
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 WCT as confidential, reasonably necessary
for regulatory authorities to confirm that the Services are being conducted in compliance with Applicable Laws and regulations.
WCT 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 WCT


 


In connection with WCT’s provision
of Services as specified in this Agreement, WCT may conduct monitoring visits and/or inspections of Investigator Sites. Based on
WCT’s observations during such Investigator Site visits and inspections, WCT 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,
WCT will present to Sponsor a basis for its decision. If Sponsor disagrees with the basis for WCT’s decision, WCT 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 WCT


 


WCT 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 WCT Group of any material obligations
under this Agreement or the Protocol, (ii) any WCT Group’s negligence or intentional misconduct; or (iii) any WCT Group’s
material failure to comply with any applicable law for FDA regulations, except to the extent such Losses are caused by Sponsor’s
negligence or willful misconduct.


 


10.2         Indemnification
by Sponsor


 


Sponsor shall indemnify,
defend and hold harmless WCT and its Affiliates and their respective officers, directors, employees and agents (the “WCT
Group”) from any Losses arising from any Claim arising out of (i) WCT’s adherence to written instructions provided
by Sponsor to WCT, 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 WCT Group’s negligence or wilful misconduct.


 


In the event WCT 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 WCT’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 WCT 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 WCT’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 WCT under Sections 5 and 10.1, respectively, in no event shall the collective, aggregate liability of the WCT Group
to Sponsor [C.I.] 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 [C.I.] 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 WCT 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 WCT of any changes in coverage which impact the coverage requirements set forth above.


 


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


 


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


 


(2)        Commercial
Umbrella Liability. This policy must include the following limits: Occurrence Limit: [C.I.]; Aggregate Limit (where applicable);
[C.I.] 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: [C.I.]; Aggregate Limit: [C.I.]. 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, WCT 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 [C.I.] the end of the Agreement.


 


Upon request, WCT shall provide Sponsor
with a copy of WCT’s Certificates of Insurance or such other documented evidence to confirm that it has all of the foregoing
coverage. WCT 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         WCT
represents and warrants to Sponsor that:


 


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


 


(b)          WCT
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 WCT 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 WCT and its Affiliates,
as applicable, enforceable in accordance with its terms, except to the extent enforceability may be affected by applicable bankruptcy,
reorganization, insolvency, and moratorium laws and other laws applicable generally to creditors’ rights and debtors’
remedies from time to time in effect;


 


(d)          neither
the execution and delivery of this Agreement nor WCT’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 WCT’s registration documents or its By-Laws
or any equivalent document or of any material contract, commitment or other obligation to which WCT 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 WCT is subject; and


 


(e)          WCT
has developed a business interruption and disaster recovery program and is executing such program to assess and reduce the extent
to which WCT’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 WCT to Sponsor are inaccurate, and
WCT does not reasonably dispute such inaccuracy, and such inaccuracy is caused by errors or failures of WCT’s personnel,
hardware, software or embedded systems then WCT 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 WCT mutually agree that WCT is not capable of timely or satisfactory re-performance and WCT has been paid for such Services,
then WCT 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 WCT received for the performance the inaccurate Services.


 


(f)         WCT 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 WCT, during normal business hours and at mutually agreed upon dates and times, to periodically inspect WCT’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 WCT 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 WCT’s involvement
in Study design or protocol-writing (or lack thereof).


 


15.0         EMPLOYEES;
NON-SOLICITATION


 


WCT’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 WCT’s prior written consent, during the term of this Agreement and
for a [C.I.] 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 WCT and who had been employed/contracted
by WCT 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 [C.I.]. Sponsor acknowledges that in the event of a breach of
this Section 15.0, WCT 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.


50 Park Place, Newark NJ 07102


ATTN: [C.I.]


 


If to WCT:


 


c/o Worldwide
Clinical Trials, Inc.


401 North
Maple Drive


Beverly Hills,
California 90210


ATTN: General
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. WCT 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.


 


17.3         Force
Majeure


 


Neither Sponsor nor WCT 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 [C.I.] from the date of notification of its existence
shall give the non-affected Party the right to terminate this Agreement [C.I.].


 


17.4         Severability


 


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


 


17.5         English
Language


 


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


 


17.6         Entire
Agreement


 


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


 


17.7         Survival


 


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


 




     


     

    

  


		17.8	Governing Law



 


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


 


		17.9	Waiver



 


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


 


		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 [C.I.] of the
initiation of the procedure, the dispute shall be settled by arbitration administered by the American Arbitration Association under
its Commercial Arbitration Rules in Delaware. Judgment shall be rendered by a mutually agreed upon single arbitrator. The provisions
of this Section may be enforced by any court of competent jurisdiction, and the Party seeking enforcement shall be entitled to
an award of all costs, fees and expenses, including reasonable attorneys’ fees, to be paid by the Party against whom enforcement
is ordered.


 




     


     

    

  


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


 


	NEUROTROPE BIOSCIENCES, INC.	 	WORLDWIDE CLINICAL TRIALS, INC.
	 	 	 
	By:	/s/
    Warren W. Wasiewski MD 	 	By:	/s/
    James Avery Miles 
	 	 	 	 	 
	Name:	Warren W. Wasiewski MD	 	Name:	James Avery Miles
	 	 	 	 	 
	Title:	 Chief Medical Officer	 	Title:	Authorized Signatory
	 	 	 	 	 
	Date:	09 October
    2015 	 	Date:	09 October
    2015 


 


LIST OF EXHIBITS:


 


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



 



     


     

    

 


EXHIBIT A


SCOPE OF SERVICES


 


 


	Cost Driver	 	WCT’s Assumptions
	 
	Countries, Sites, Patients and CRAs
	Total number of countries	 	1
	Total number of sites	 	[C.I.]
	Total number of screened patients	 	[C.I.]
	Total number of enrolled patients	 	150
	Screening failure rate	 	[C.I.]
	Total number of completed patients	 	[C.I.]
	Drop-out rate	 	[C.I.]
	Total number of CRAs	 	5
	Countries and Sites - Region 1	 	USA [C.I.]
	Number of Sites - Region 1	 	[C.I.]
	Number of Patients - Region 1	 	150
	Number of CRAs - Region 1	 	[C.I.]
	Study Duration
	Duration of WCT Involvement	 	[C.I.]
	Start-up  	 	[C.I.]
	Conduct	 	[C.I.]
	Close-out 	 	[C.I.]
	Project Management
	Provide Project Management	 	Yes
	Regional Project Director	 	Yes - USA
	Regional Project Manager	 	Yes - USA
	Lead CRA / Clinical Trial Manager	 	Yes - USA, USA
	Clinical Trial Associate	 	Yes - USA
	Study document preparation	 	Yes
	Project Tracking (CTMS)	 	Yes
	Study Supply Management	 	Yes
	Project Oversight	 	Yes
	Vendor Management	 	Yes
	 Identify and contract with vendors	 	[C.I.]
	  Manage vendors	 	[C.I.]
	  Manage payment of vendors	 	[C.I.] payments
	Prepare and distribute Investigator newsletters  	 	Yes
	Sponsor Metrics Reports	 	Yes
	Day to day management of all WCT study activities  	 	Yes
	Oversee Investigator selection  	 	Yes
	Set up WCT electronic Trial Master File (eTMF) 	 	Yes


 






     


     

    

 


	Ongoing maintenance of eTMF	 	Yes
	Set-up and maintain Clinical Trial Management System (CTMS)	 	Yes
	Data from multiple sources will be integrated	 	Yes
	Organization of Data Monitoring Committee	 	Yes
	Recruitment tracking	 	Yes
	Visit report review	 	Yes
	Data query review	 	Yes
	Prepare and present CRA training	 	Yes
	Prepare for archive and return of Trial Master File to Sponsor	Yes
	Return Investigational Product and other study supplies to sponsor	Yes
	Investigator Meeting
	Investigator Meeting involvement	Yes
	Investigator Meeting(s) - organize	 	Yes
	Investigator Meeting(s) - attend	 	Yes
	Number of Investigator Meeting(s)	 	1
	Investigator Meeting 1 - Location and number of attendees	USA - [C.I.]
	Duration of Investigator Meeting 1	 	[C.I.] days
	Communication
	Prepare and distribute regular study progress reports 	Yes
	General communication with sponsor, sites and vendors 	Yes
	Project team teleconferences	Yes
	 Number of internal teleconferences	[C.I.]
	 Number of sponsor teleconferences	[C.I.]
	 Number of  months of sponsor medical teleconferences	[C.I.]
	Face-to-face meetings with sponsor	Yes
	Number of meetings (excluding kick-off meeting)	[C.I.]
	Regulatory and Ethics Submissions
	Provide regulatory services	Yes
	Costs & required effort are based on the receipt of quality documents. If document quality does not meet required standards, and additional work is required, hours & cost will be adjusted accordingly.	 	 
	Site regulatory document collection / QC	 	Yes
	Collect essential documents from sites	 	Yes
	Review essential documents for completeness and accuracy prior to drug release	 	Yes
	IRB Submissions (US)	 	Yes
	Number of Central IRBs	 	[C.I.]
	Number of Local IRBs	 	[C.I.]
	Annual Regulatory Reports	 	Yes



 




     


     

    

 








	Start-up Activities
	Provide start-up services	 	Yes
	Costs & required effort are based on the receipt of quality documents. If document quality does not meet required standards, and additional work is required, hours & cost will be adjusted accordingly.	 	 
	Prepare for and attend internal kick-off meeting	 	Yes
	Prepare for and attend sponsor kick-off meeting	 	Yes
	CRF design	 	Yes
	Informed Consent Form - create	 	Yes
	Informed Consent Form - adapt to local requirements	 	Yes
	Investigator Agreement Negotiation	 	Yes
	WCT master contract templates, WCT site specific templates, and WCT country contract templates. Templates require minimal sponsor changes. WCT maintains flexibility in budget and language negotiation.	 	Yes
	Number of site contracts	 	[C.I.]
	Translation of Study Documents 	 	Yes
	  Informed Consent Form 	 	Yes
	Study Initiation
	Site identification	 	Yes
	No. of Sites to contact  	 	[C.I.]
	Pre-study site visits  	 	Yes
	[C.I.]	 	[C.I.]
	Initiation visits	 	Yes
	[C.I.]	 	[C.I.]
	Study Conduct
	Provide Clinical Monitoring	 	Yes
	Create study manual and procedure guidelines  	 	Yes
	Site Management throughout study  	 	Yes
	Perform drug accountability  	 	Yes
	Resolve queries with sites  	 	Yes
	Build Investigator Budget   	 	Yes
	Process investigator payments  	 	Yes
	• Prepare & distribute invoices 

• Track payments	 	 
	Frequency and Total number of site payments	 	 
	  Region 1	 	[C.I.] payments
	Interim monitoring visits	 	Yes
	[C.I.]	 	[C.I.] visits
	Additional time on site 	 	Yes
	  [C.I.]	 	[C.I.] units
	Remote EDC monitoring in conduct period	 	No
	Close-out visits	 	Yes
	[C.I.]	 	[C.I.] visits
	Drug Safety / Pharmacovigilance
	Provide Pharmacovigilance	 	Yes


 


 




     


     

    

  


	SAE Processing - WCT Argus Database (actual units completed will be charged)	 	Yes - [C.I.]
	Argus Database Set-up	 	Yes
	Safety Plan - High Complexity	 	Yes
	SUSARs to FDA (actual units completed will be charged)	 	Yes - [C.I.] reports
	SUSARs to EC / IRB (actual units completed will be charged)	 	Yes - [C.I.] ECs or IRBs
	SUSAR to Investigators (actual units completed will be charged)	 	Yes - [C.I.] investigators
	DSUR to EC/IRB	 	Yes - [C.I.] reports
	Drug Safety Administration	 	Yes
	Drug Safety Monitoring Board (DSMB)
	Participate in DSMB Meetings	 	Yes
	Identification of DSMB	 	No
	Prepare DSMB Charter	 	No
	DSMB Meeting Preparation	 	Yes
	Number of DSMB meetings to attend	 	[C.I.]
	Medical Monitoring
	Provide Medical Monitoring	 	Yes
	• Manage site inquiries regarding inclusion/ exclusion criteria, documenting these interactions 

• Provide protocol clarifications to sites and Project team members 

• Prepare for and conduct team training  

• Serve as the expert internal resource to optimize the team’s overall performance	 	 
	Medical Monitoring Plan	 	Yes
	• Incorporates any sponsor’s preferences regarding the medical oversight of the trial 

• Guides the Medical Monitoring of the trial, helps ensure standardization for global studies (for which a global team of MMs provides medical oversight) and serves as the official "living" reference regarding medical management of the study 	 	 
	Provide Medical Monitor support during start-up	 	Yes
	Review abnormal laboratory data	 	Yes
	• Includes time to document site awareness and follow-up	 	 
	Provide 24/7 medical coverage to support urgent subject and site situations	 	Yes
	Data Management
	Provide Data Management Services	 	Yes
	Paper or EDC?	 	EDC
	EDC System	 	eCOS
	No. of CRF pages per completed patient	 	[C.I.]
	No. of unique CRF pages	 	[C.I.]
	Total CRF pages to process for all subjects	 	[C.I.]
	Develop database (EDC)	 	Yes - eCOS
	Statistician Review of CRF and DB 	 	WCT
	Code data (MedDRA/WHODRUG)	 	Yes
	  Coding - AE per patient	 	[C.I.]
	  Con Meds per patient	 	[C.I.]
	  Medical Histories per patient	 	[C.I.]


 




     


     

    

 


	Develop edit checks	 	Yes
	Data entry	 	Site to perform
	Data receipt for reconciliation	 	Yes - [C.I.] transfers
	SAE Reconciliation	 	Yes - [C.I.] SAEs
	Process data edits, query editing and resolution	 	Yes
	Extract data in SAS format	 	Yes
	Database Lock	 	Yes
	  No. of interim database locks	 	[C.I.]
	Data Transfers of raw data	 	Yes
	  No. of data transfers in study	 	[C.I.]
	Archive Database	 	Yes
	Statistics
	Provide Statistics	 	Yes
	Study design support	 	Yes
	Preparation of Statistical Analysis Plan	 	Yes
	To be approved by Sponsor prior to the release of treatment codes to WCT	 	 
	Randomization	 	Yes
	Prepare shell tables, listings and figures	 	Yes
	Programming of SDTM datasets  	 	Yes
	  # domains	 	[C.I.]
	Programming of ADaM datasets  	 	Yes
	  # datasets	 	[C.I.]
	Programming of TLFs - for interim analysis 	 	Yes
	  No. of Unique Tables	 	[C.I.]
	  No. of Repeat Tables	 	[C.I.]
	  No. of Unique Listings	 	[C.I.]
	  No. of Repeat Listings	 	[C.I.]
	  No. of Unique Figures	 	[C.I.]
	  No. of Repeat Figures 	 	[C.I.]
	Perform interim analysis  	 	Yes
	  # interim analyses	 	[C.I.]
	Programming of TLFs - for final analysis 	 	Yes
	  No. of Unique Tables (Final)	 	[C.I.]
	  No. of Repeat Tables (Final)	 	[C.I.]
	  No. of Unique Listings (Final)	 	[C.I.]
	  No. of Unique Figures (Final)	 	[C.I.]
	  No. of Repeat Figures (Final)	 	[C.I.]
	Perform final statistical analysis	 	Yes
	Production of statistical analysis tables as per WCT SOPs  using validated macros with SAS 9.2 (or later) or S-PLUS 6.2 (or later) as appropriate	 	 
	Data transfers of derived datasets  	 	[C.I.]
	CRF Review  	 	Yes
	Database Review  	 	Yes


 




     


     

    

  


	Edit Check Review  	 	Yes
	Electronic Data Transfer Specification  	 	Yes
	Electronic Data Transfer Review  	 	Yes
	Final Statistical report   	 	Yes
	Contribution to final CSR  	 	Yes
	
        • Appendices will only include Sections 16.2 and 16.4

        • Will meet ICH guidelines
	 	 
	Medical Writing
	Provide Clinical Writing  	 	Yes
	Patient Informed Consent Form  	 	Yes
	Prepare shell CSR, including study methodology, draft results text, and shell in-text tables	 	Yes
	Prepare first draft CSR  	 	Yes
	
        • Includes final results text and in-text tables

        • Includes review of project team

        • Includes QC from Scientific and Medical Affairs
	 	 
	Review and provide comments on draft CSR  	 	Yes
	Prepare second draft CSR, including changes made during SPONSOR’s review  	 	Yes
	Finalize CSR, including appendices and complete CSR data  	 	Yes
	Publish CSR 	 	Yes
	Number of Safety/Efficacy Narratives (Unit cost for 1 SAE narrative represented and are charged based on actual)	 	[C.I.]
	Annual Report Update	 	Yes
	Clinical Assessment and Training
	Provide Rater Training Services	 	Yes
	Survey sites to assess raters and their backgrounds 	 	Yes
	  Total number of initial raters	 	[C.I.]
	 Expected number of raters requiring remediation	 	[C.I.]
	Expected number of raters requiring remediation	 	[C.I.]
	Prepare all training and  certification	 	Yes
	  No. of scales for training	 	[C.I.]
	  No. of scales for certification	 	[C.I.]
	Conduct training sessions	 	Yes
	Provide scale management	 	Yes
	Scales	 	[C.I.]
	Develop Training Materials	 	Yes
	  No. of simple presentations	 	[C.I.]
	  No. of complex presentations	 	[C.I.]
	Provide translations	 	No
	  No. of improvisational actors	 	[C.I.]
	Screening Reviews	 	Yes - [C.I.]
	Baseline Reviews	 	Yes - [C.I.]
	EDC Reviews	 	Yes - [C.I.]


  




     


     

    

  


	Web Portal	 	Yes
	Final Report	 	Yes
	IxRS
	Provide IxRS  	 	Yes
	  IxRS System	 	[C.I.]
	  IVRS or IWRS?	 	[C.I.]
	Implement standard security measures  	 	Yes
	
        • Provide user registration mechanism to allow personnel
        at sites to register as users

        • Register Sponsor personnel who access the IVRS

        • Track individual user authority to access the system
        for both call modules available and sites for which they can be used
	 	 
	Create menu with the following options:  	 	Yes
	
        • Screening

        • Randomization

        • Scheduled visits with re-supply of treatment

        • Study completion/discontinuation at any point

        • Confirm shipment receipt

        • Obtain replacement treatment

        • Obtain a code-break

        • Special assistance 24/7

        • Demonstration mode operation
	 	 
	System Setup  	 	Yes
	User requirements specification 

Study specific user materials 

Archiving of study records	 	 
	Provide mechanism for sponsor or third parties to amend a site’s status	 	Yes
	IxRS project Management	 	Yes
	Ongoing project management 

Completion of project deliverables 

Communication of status to the customer and project team 

System maintenance (included scheduled backups)

 Data corrections 

User account administration	 	 
	Manage Drug Distribution	 	Yes
	• Control drug supply 

• Full tracking of kit status and expiry dates

 • Site to call to confirm that treatment kits have been received 

• Resupply mechanism for each study medication 

• Software can be adapted to accommodate client procedures 	 	 
	Confirm calls via a fax/email to the site	 	Yes
	Make toll-free lines available to all sites  	 	Yes
	System Maintenance (24/7 support)	 	Yes
	Provide data transfers of all data collected via the IVRS 	 	Yes
	  Assumes one way integration with one system	 	 
	Site Training	 	Yes
	• The Project Manager will be available to make presentations at the Investigators’ Meeting to explain the functions of the IVRS (and the website, if appropriate), or to participate in conference calls with site personnel.  This proposal does not include such costs.  However, if required in the future, attendance at meetings will be charged on a time and expenses basis	 	 
	No. of Calls per Site	 	[C.I.]
	No. of Calls per Patient	 	[C.I.]


 


 




     


     

    

 


EXHIBIT B


TIMELINE


  


	Milestone	 	 	Date
	WCT Begins Full Service Activities	 	[C.I.]
	First Patient Randomized	 	[C.I.]
	Last Patient In	 	[C.I.]
	Last Patient Out of Treatment	 	[C.I.]
	Last CRF to Data Management	 	[C.I.]
	Database Lock	 	[C.I.]
	Final Tables, Listings and Figures	 	[C.I.]
	Clinical Study Report 	 	[C.I.]



 



     


     

    

 


EXHIBIT C


BUDGET


 


Worldwide Clinical Trials Budget


Client: Neurotrope


Study: A randomized double-blind placebo controlled study of 2 doses of bryostatin 1 to assess the safety, tolerability and efficacy of bryostatin 1 for the treatment severe Alzheimer’s disease.  




 





	 	Services	 	Unit	 	# Units	 	Unit Cost

 USD $	 	
        WCT Fees

        USD $
	 
	 	 	 	 	 	 	 	 	 	 	 
	Clinical Start Up	 	 	 	 	 	 	 	 	 
	o	Identify Investigators / Investigative Sites	 	Site	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	
        Internal Training/Protocol Review

        (Completed under LOI)
	 	Protocol	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Essential Document Review Plan	 	Plan	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Collect Essential Documents	 	Site	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Essential Document Review	 	Site	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Investigator Agreements	 	Contract	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Creation of study manuals, procedures guidelines	 	Manual	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Adapt ICF to local requirements	 	Country	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Investigator Meeting Preparation 	 	Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Investigator Meeting Attendance 	 	 	 	 	 	 	 	 	 
	 	>USA	 	Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	CRA Training at IM	 	CRA	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Other CRA Training	 	CRA	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Study Start Up	 	 	 	 	 	 	 	[C.I.]	 
	Regulatory Affairs	 	 	 	 	 	 	 	 	 
	o	IRB Submissions (US and Canada)	 	 	 	 	 	 	 	 	 
	 	 North America - Local IRB	 	Site	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	 North America - Central IRB	 	Site	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Annual Regulatory Reports	 	Year	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Regulatory Affairs	 	 	 	 	 	 	 	[C.I.]	 
	Trial Master File	 	 	 	 	 	 	 	 	 
	o	TMF Set-up (Completed under LOI)	 	TMF	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	TMF Maintenance and Ongoing QC	 	Sites x Months	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	TMF Final Reconciliation and Transfer	 	Site	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Trial Master File	 	 	 	 	 	 	 	[C.I.]	 
	Communication	 	 	 	 	 	 	 	 	 
	o	
        Internal Kick-off Meeting

        (Completed under LOI)
	 	Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Sponsor Kick-off Meeting	 	Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Sponsor Face-to-Face Meetings	 	Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Sponsor Teleconferences	 	Teleconference	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Internal Teleconferences	 	Teleconference	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	CRA Teleconferences/Meetings	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 




     


     

    

 


	o	Sponsor Medical Teleconferences	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Communication	 	 	 	 	 	 	 	[C.I.]	 
	Vendor Contracting & Management	 	 	 	 	 	 	 	 	 
	o	Identify and Contract with Vendors	 	Vendor	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Vendor Specifications	 	Vendor	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Vendor Management	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Third Party Vendor Payment Set-up	 	Vendor	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Vendor Payment Processing	 	Payment	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Vendor Contracting & Management	 	 	 	 	 	[C.I.]	 
	Clinical Monitoring	 	 	 	 	 	 	 	 	 
	o	Pre-Study Site Visits	 	Site	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Site Initiation Visits	 	Visit	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Interim Monitoring Visits	 	Visit	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Additional Time on Site	 	Buckets of Time	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Site Close-Out Visits 	 	Visit	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Site Management	 	Site Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Lead CRA Support	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Review of Site Visit Reports	 	Visit	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub Total Clinical Monitoring	 	 	 	 	 	 	 	[C.I.]	 
	Grant Payments	 	 	 	 	 	 	 	 	 
	o	
        Contracts and Budgets Plan

        (Completed under LOI)
	 	Plan	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	
        Investigator Budget Build

        (Completed under LOI)
	 	Build	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Grant Payment Setup	 	Contract	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Grant Payment Processing	 	Payment	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Sunshine Act Reporting (US)	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Grant Payments	 	 	 	 	 	 	 	[C.I.]	 
	Drug Safety Services 	 	 	 	 	 	 	 	 	 
	o	Case Processing - High Complexity Service 	 	 	 	 	 	 	 	 	 
	 	Initial SAE Processing - Argus Database	 	SAE	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	SAE Processing - Substantive Follow Ups***	 	SAE	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Argus Database Set-up & Configuration	 	Database	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Argus Database Hosting	 	Months	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Safety Plan 	 	Plan	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Safety Reporting/Communication Activities 	 	 	 	 	 	 	 	 	 
	 	SUSARs to FDA	 	Report*SUSAR	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	SUSARs to EC / IRB	 	SUSAR*EC/IRB	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	SUSAR to Investigators	 	Investigators* SUSARs	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	DSUR to EC/IRB	 	Report*EC/IRB	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Drug Safety Oversight	 	Months	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Safety 	 	 	 	 	 	 	 	[C.I.]	 
	Drug Safety Monitoring Board (DSMB)	 	 	 	 	 	 	 	 	 




     


     

    

 


	o	DSMB Report Recommendation	 	Report	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	DSMB Meeting Preparation	 	DSMB Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	DSMB Meeting Attendance	 	DSMB Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total DSMB	 	 	 	 	 	 	 	[C.I.]	 
	Medical Monitoring	 	 	 	 	 	 	 	 	 
	o	Medical Monitor Start-up Activities	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Medical Management	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Medical Monitoring	 	 	 	 	 	 	 	[C.I.]	 
	Data Management	 	 	 	 	 	 	 	 	 
	o	Data Management Ongoing Support	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Preparation of Data Management File including DMP	 	Plan	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	EDC System  	 	 	 	 	 	 	 	 	 
	 	Design, Build and Validate EDC	 	System	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Training Materials and Site Support	 	Set-up	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Query generation, listing review and resolution of eCRF data	 	Page	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Edit Checks - Programmed	 	Project	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Coding of AE's	 	Unique Term	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Coding of concomitant medications using WHODDE	 	Unique Term	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Coding of Medical History	 	Unique Term	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Database Quality Assessment	 	Report	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Database Locks	 	DB Lock	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Study DM Reports	 	System	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Receipt of data for reconciliation	 	Vendor	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Receipt of data for reconciliation	 	Upload	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	SAE Reconciliation	 	SAE	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Data Transfers of raw data	 	Transfer	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	EDC System use and ongoing data management	 	EDC System	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	EDC Archival	 	Archival	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Data Management	 	 	 	 	 	 	 	[C.I.]	 
	Biostatistics	 	 	 	 	 	 	 	 	 
	o	
        Study Design Support / Consultancy

        (Completed under LOI)
	 	Project	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Biostats - ongoing PM support	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Statistical Analysis Plan 	 	Plan	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Patient Populations	 	Study	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Annotated CRF	 	CRF	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Design Unique Table Shells (Mocks)	 	Table	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Design Repeat Table Shells (Mocks)	 	Table	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Design Unique Listings Shells (Mocks)	 	Listing	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	
        Randomization Schedule

        (Completed under LOI)
	 	Randomization	 	[C.I.]	 	[C.I.]	 	[C.I.]	 




     


     

    

 


	o	Randomization Kit List (Completed under LOI)	 	Kit List	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Programming/QC of ADaM datasets	 	ADaM Dataset	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Programming/QC of Data Displays - Interim 	 	 	 	 	 	 	 	 	 
	 	Unique Tables	 	Table	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Repeat Tables	 	Table	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Unique Listings	 	Listing	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	 Repeat simple table 	 	Table	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	 Repeat compl table 	 	Table	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	 Unique listing 	 	Listing	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Repeat Figures	 	Figure	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Programming/QC of Data Displays -Week 12 	 	 	 	 	 	 	 	 	 
	 	Unique Tables	 	Table	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Repeat Tables	 	Table	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Unique Listings	 	Table	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Unique Figures	 	Figure	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Repeat Figures	 	Figure	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	SDTM Datasets	 	Data Domain	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	PK Data	 	Dataset	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Define XML	 	CDISC Dataset Types	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Statistical Analysis	 	Analysis	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Interim Analysis	 	Analysis	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Week 12 Analysis Delivery	 	Analysis	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	CRF Review (Completed under LOI)	 	Review	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Database Review	 	Review	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Edit Check Review	 	Review	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Electronic Data Transfer Specification	 	Specification	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Electronic Data Transfer Review	 	Review	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o 	Statistical Contribution to CSR	 	Report	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o 	Data Transfers	 	Transfer	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Biostatistics	 	 	 	 	 	 	 	[C.I.]	 
	Clinical Writing	 	 	 	 	 	 	 	 	 
	o	
        Informed Consent (ICF) Creation

        (Completed under LOI)
	 	ICF	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Clinical Study Report (CSR)	 	CSR	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	CSR Appendices	 	CSR	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	CSR Appendices (Narratives)	 	Narrative	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Safety/Efficacy Narratives	 	Narrative	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Annual Report Update	 	Update	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Clinical Writing	 	 	 	 	 	 	 	[C.I.]	 
	Clinical Assessment and Training	 	 	 	 	 	 	 	 	 
	o	Start-up communication, planning, preparation, scheduling and outreach to sites/raters	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Initial Site Contact	 	Site	 	[C.I.]	 	[C.I.]	 	[C.I.]	 




     


     

    

 


	o	Conduct communication, sponsor meetings, scheduling and outreach to sites/raters	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Rater Experience Survey	 	 	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	 Database Set-up	 	Database	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	 Data Entry & Review	 	Rater	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Rater Remediation	 	Rater	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Scale Management (Completed under LOI)	 	Language	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Development of Training Material	 	 	 	 	 	 	 	 	 
	 	 Simple	 	Presentation	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	 Complex (Completed under LOI)	 	Presentation	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	On Site Training	 	Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	CRA Co-Monitoring Visits	 	Visit	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Screening Reviews	 	Review	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Baseline Reviews	 	Review	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	EDC Reviews	 	Review	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Fast Track Site Training	 	Visit	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	FTP Site Setup	 	Setup	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Web Portal	 	Portal	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Final Report	 	Report	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Clinical Assessment and Training	 	 	 	 	 	[C.I.]	 
	IxRS 	 	 	 	 	 	 	 	 	 
	o	SMART IVRS  Build (Tier 4)	 	Build	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	SMART IVRS  Monthly maintenance (Tier 2)	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Custom integration	 	Integration	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	ANSWRS - Build	 	Build	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	ANSWRS - Support	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	SMART hosting	 	System	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total IxRS	 	 	 	 	 	 	 	[C.I.]	 
	Technology	 	 	 	 	 	 	 	 	 
	o	System Set-up	 	System	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	System Maintenance	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Technology	 	 	 	 	 	 	 	[C.I.]	 
	Project Management 	 	 	 	 	 	 	 	 	 
	o	LOI Start-up through September 2015 (Completed under LOI)	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	WO Start-up September 2015 to study end	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Conduct	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Closure	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Project Management	 	 	 	 	 	 	 	[C.I.]	 
	 	 	 	 	 	 	 	 	 	 	 
	 	Total Estimated Service Fees	 	 	 	 	 	 	 	[C.I.]	 
	 	 	 	 	 	 	 	 	 	 	 
	 	[C.I.]	 	 	 	 	 	 	 	[C.I.]	 
	 	 	 	 	 	 	 	 	 	 	 




     


     

    

 


	 	Total Estimated Service Fees [C.I.]	 	 	 	 	 	[C.I.]	 
	 	 	 	 	 	 	 	 	 	 	 
	Estimated Pass-Through Costs	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	Clinical Start-Up Pass-through Costs	 	 	 	 	 	 	 	 	 
	o	Print and Ship Investigator Site File to Sites	 	Site	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Translations	 	Page	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Investigator Meeting Attendance 	 	 	 	 	 	 	 	 	 
	 	>USA	 	Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	CRA Training	 	CRA	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Clinical Start Up Pass-through Costs	 	 	 	 	 	[C.I.]	 
	Regulatory Affairs Pass-through Costs	 	 	 	 	 	 	 	 	 
	o	IRB Site Regulatory Documents preparation/collection/ QC; includes annual renewals if needed	 	 	 	 	 	 	 	 	 
	 	North America - Local IRB	 	Site	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	North America - Central IRB	 	Site	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Regulatory Affairs Pass-through Costs	 	 	 	 	 	[C.I.]	 
	Trial Master File Pass-through Costs	 	 	 	 	 	 	 	 	 
	o	TMF System Set-up	 	TMF	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Trial Master File Pass-through Costs	 	 	 	 	 	[C.I.]	 
	Communication Pass-through Costs	 	 	 	 	 	 	 	 	 
	o	Sponsor Kick-off Meeting	 	Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Sponsor Face-to-Face Meetings	 	Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	CRA Teleconferences/Meetings	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Communication Pass-through Costs	 	 	 	 	 	[C.I.]	 
	Study Conduct Pass-through Costs	 	 	 	 	 	 	 	 	 
	o	Pre-study Site Visits	 	Visit	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Site Initiation Visits	 	Visit	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Interim Monitoring Visits	 	Visit	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Site Close-Out Visits	 	Visit	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Site Management	 	Site Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Print & Ship study documents, quarterly to each site	 	Shipment	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	DSMB Meeting Travel	 	Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Grant Payment Processing	 	Payment	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Vendor Payments	 	Payment	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub Total Study Conduct Pass-through Costs	 	 	 	 	 	[C.I.]	 
	Clinical Assessment and Training Pass-through Costs	 	 	 	 	 	 	 
	o	CRA Co-Monitoring Visit	 	Visit	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Scale Licenses and Translation fees	 	Study	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	On Site Training 	 	Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Fast Track Site Training	 	Visit	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Video Recording at IM	 	Video	 	[C.I.]	 	[C.I.]	 	[C.I.]	 




     


     

    

 


	 	Sub-Total Clinical Assessment and Training Pass-through Costs	 	 	 	[C.I.]	 
	IxRS Pass-through Costs	 	 	 	 	 	 	 	 	 
	o	Fax confirmation notifications	 	Faxes	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Free-phone telephone number for each country (1 countries x 6 quarters)	 	Country * Quarter	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Interpreting service	 	Calls	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total IxRS Pass-through Costs	 	 	 	 	 	 	 	[C.I.]	 
	Archiving Pass-through Costs	 	 	 	 	 	 	 	 	 
	o	Shipment of completed eCRFs back to sites (archive copy, disc for EDC)	 	Shipment	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Shipment of completed eCRFs back to Sponsor (disc )	 	Shipment	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Final shipment of study records to Sponsor	 	Shipment	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Archiving Pass-through Costs	 	 	 	 	 	 	 	[C.I.]	 
	Project Management Pass-through Costs	 	 	 	 	 	 	 	 	 
	o	Start-up	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Conduct	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	Closure	 	Month	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Project Management Pass-through Costs	 	 	 	 	 	 	 
	Third Party Vendor Costs	 	 	 	 	 	 	 	 	 
	o	Central Lab 	 	Study	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	ECG Provider	 	Study	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total Third Party Vendors	 	 	 	 	 	 	 	[C.I.]	 
	PI Fees	 	 	 	 	 	 	 	 	 
	o	PI - Grants - Completed patients	 	Patient	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	PI - Grants - Screen failure patients	 	Patient	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	PI - Grants - Dropped patients	 	Patient	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o 	Site Fees	 	Site	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total PI Fees	 	 	 	 	 	 	 	[C.I.]	 
	DSMB Member Fees	 	 	 	 	 	 	 	 	 
	o	DSMB Payments for Kick-off Meeting	 	Member * Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	DSMB Payments for Interim Analysis WebEx Meeting (2)	 	Member * Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	DSMB Payments for Chairman Minute Preparation	 	Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	o	DSMB Travel for Meetings (3 members, 1 F2F meetings)	 	Member * Meeting	 	[C.I.]	 	[C.I.]	 	[C.I.]	 
	 	Sub-Total DSMB Member Fees	 	 	 	 	 	 	 	[C.I.]	 
	 	 	 	 	 	 	 	 	 	 	 
	Total Estimated Pass Through Costs	 	 	 	 	 	 	 	[C.I.]	 
	 	 	 	 	 	 	 	 	 	 	 
	Total Estimated Budget	 	 	 	 	 	 	 	11,562,514.60	 


 





	**	SAEs are charged based on actual at the unit cost noted in the budget.
	***	On average there are approximately [C.I.] per initial SAE. These are charged [C.I.].







 






     


     

    

 


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 WCT
an advance payment of $200,000.00. On November 1, 2015, WCT shall invoice Sponsor an additional advance payment of $927,792.10
due upon ten (10) days of receipt (collective [C.I.] of the estimated Work Order Service fees). Work Order was reconciled against
amounts already invoiced and units completed by WCT based on the LOI dated March 30, 2015 and LOI Amendment #1 dated July 1, 2015.
All subsequent invoices will be submitted to Sponsor by email based on the Payment Schedule. With the exception of the first two
payments described above in the amount of $1,127,792.10, 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: 	[C.I.]
	 	Bank Address: 	[C.I.] 
	 	 	 
	 	ABA Routing No.: 	[C.I.]
	 	Bank Account No.:	[C.I.]
	 	Swift Code:	[C.I.]
	 	Taxpayer ID#:	[C.I.]


 


		2.	Pass-through Expenses:



		2.1.	Notwithstanding the payment terms in Section 3.4 of the Agreement, on November 1, 2015 WCT shall invoice Sponsor an advance
payment of $267,932.82 due upon ten (10) days of receipt [C.I.]. Work Order advance payment was reconciled against amounts already
invoiced and expensed incurred by WCT based on the LOI dated March 30, 2015 and LOI Amendment #1 dated July 1, 2015. WCT will submit
subsequent monthly invoices by email for incurred Pass-through Expenses based on actuals, with each subsequent invoice for Pass-through
Expenses until the advance payment is exhausted. With the exception of the first payment described above in the amount of [C.I.],
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, on November 1, 2015, WCT shall invoice Sponsor an advance
payment of $680,136.00 due upon twenty (20) day of receipt [C.I.]. Periodically, WCT will invoice Sponsor by email to replenish
this advance back-up to an amount equivalent to [C.I.] 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, WCT will provide appropriate support justifying such increase. Any outstanding balances will be reconciled
and provided no earlier than [C.I.] after at the end of the Study. For avoidance of doubt, WCT will make all grant payments only
from funds received from Sponsor specifically for this purpose. WCT shall not be liable for any payments delays due to the delay
in receipt of funds from Sponsor.





     


     

    

 


EXHIBIT E


FORM OF CHANGE ORDER


 


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


 


Worldwide Clinical Trials, Inc. (“WCT”)
and Sponsor Name (“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 WCT
was to provide certain

Services to Sponsor in connection with Study [insert Protocol number] (“Study”). WCT 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 WCT 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: