Document:

Exhibit 10.11

 

EXECUTION COPY

 

Statement of Work and Account Satisfaction
Agreement

 

This Statement of Work
and Account Satisfaction Agreement (“SOW Agreement”) is made and entered into on February 4, 2015 by and between
Neurotrope Bioscience, Inc. (“NTRP” or “Neurotrope”) and Blanchette Rockefeller Neurosciences Institute
(“BRNI”) (each, a “Party” and collectively, the “Parties”), and is effective
as of October 1, 2014 (the “SOW Agreement Effective Date”), pursuant to that certain Technology License and
Services Agreement dated October 31, 2012 by and between NTRP, on the one hand, and BRNI and NRV II LLC, on the other hand, as
amended by Amendment No. 1 to the Technology License and Services Agreement dated August 21, 2013, and as further amended and restated
as of February 4, 2015 (the “TLSA”). This SOW Agreement hereby incorporates, and is subject to, the terms and conditions
of the TLSA. All capitalized terms used herein but not defined herein shall have the respective meanings ascribed to them in the
TLSA.

 

WHEREAS, the
Parties intend that this SOW Agreement shall constitute both a Statement of Work pursuant to Paragraphs 3.1 and 3.2 of the TLSA
for Services to be provided by BRNI to NTRP under the TLSA and an agreement between the Parties regarding the satisfaction of the
Outstanding Reimbursement Amounts Due (defined below) through the payment of certain Services Fees under this SOW Agreement.

 

WHEREAS, pursuant
to the TLSA, BRNI licensed certain intellectual property owned by BRNI or its affiliates to NTRP in consideration of the terms
and conditions set forth in the TLSA; and

 

WHEREAS, the
TLSA provides, in Section 3 thereof, as amended, that NTRP may submit requests for Services to BRNI pursuant to Section 3.1 and
3.2, as amended, which requests shall be confirmed by SOW’s entered into between NTRP and BRNI; and

 

    	 

    	 

    

 

WHEREAS, pursuant
to Section 3.2 of the TLSA, as amended, NTRP and BRNI entered into an SOW on August 28, 2013 for “Prospective Clinical Study
to Validate the Accuracy of 3 Proprietary Biomarkers” (the “Diagnostic SOW”); and

 

WHEREAS the
objectives of the Diagnostic SOW have not been completed within the twelve month term contemplated therein; and

 

WHEREAS the
Diagnostic SOW contained extension provisions which by agreement of the parties have been suspended pending the development of
this SOW; and

 

WHEREAS pursuant
to Section 3.1 and 3.2 of the TLSA, as amended, the Parties entered into an SOW on March 11, 2014 for “Work Products and
Tasks related to the launch of Study 201” (the “First Therapeutic SOW”); and

 

WHEREAS BRNI
has completed the work required pursuant to the First Therapeutic SOW; and

 

WHEREAS pursuant
to Section 5.6 of the TLSA, BRNI has the “sole and exclusive right (but not the obligation) to apply for, file, prosecute,
or maintain patents and applications for the Licensed IP, in each case, in any jurisdiction throughout the world;” and

 

WHEREAS Section
5.6 of the TLSA further provides that “Neurotrope shall reimburse BRNI for all of the attorneys’ fees, translation
costs, filing fees, maintenance fees, and other costs and expenses related to any of the foregoing” (i.e. applications for
filing, prosecution or maintenance) subject to certain provisos; and

 

WHEREAS BRNI
has invoiced NTRP for reimbursable patent prosecution and maintenance costs (pursuant to Section 5.6 of the TLSA) in the amount
of two hundred eighty eight thousand dollars ($288,000) covering BRNI’s costs and expenses prior to July 2014 (the “First
Patent Reimbursement Expenses”); and

 

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WHEREAS BRNI
has incurred one hundred forty two thousand dollars ($142,000) in reimbursable patent prosecution and maintenance costs (pursuant
to Section 5.6 of the TLSA) covering BRNI’s costs and expenses from July 2014 through September 2014 (the “Second
Patent Reimbursement Expenses”); and

 

WHEREAS NTRP
agreed that BRNI should undertake, pursuant to BRNI’s authority from the United States Food and Drug Administration (the
 “FDA”), human compassionate use trials and NTRP’s Board of Directors authorized NTRP’s management
to spend up to $500,000 of funding to BRNI therefor; and

 

WHEREAS BRNI
has invoiced NTRP for compassionate use trial expenses and one hundred thousand dollars ($100,000) of those invoices remains outstanding
(the “Compassionate Use Invoices,”) (together with the First Patent Reimbursement Expenses and Second Patent
Reimbursement Expenses, being the “Outstanding Reimbursement Amounts Due”) and as part of the settlement hereunder
NTRP is reimbursing BRNI for the Outstanding Reimbursement Amounts Due; and

 

WHEREAS NTRP
agrees to engage BRNI, pursuant to Section 3.1 and 3.2 of the TLSA, as amended, and this SOW Agreement, to 1) perform additional
therapeutic drug development; 2) perform additional diagnostic test development; 3) perform additional compassionate use trials,
now known as expanded access trials; 4) conduct initial research on the application of BRNI’s PKC epsilon platform to treat
Fragile X disease; 5) conduct research on PUFA derivatives as alternatives to Bryostatin for commercial purposes as PKC epsilon
activators; and 6) may wish to engage appropriate BRNI personnel for activities not related to items 1, 2 3 4, and 5 of this paragraph;
and

 

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WHEREAS NTRP
and BRNI wish to establish procedures whereby BRNI will advise NTRP on the design and implementation of prospective clinical trials
using the licensed BRNI Intellectual Property;

 

NOW THEREFORE,
in consideration of the mutual promises and covenants set forth herein, and for other good and valuable consideration, the receipt
and sufficiency of which are hereby acknowledged, the parties, intending to be legally bound, agree as follows.

 

		1.	This SOW Agreement shall commence as of the SOW Agreement Effective Date and shall expire on September
30, 2015 (the “SOW Agreement Term”). The Diagnostic SOW is hereby terminated by mutual agreement of the Parties effective
as of August 30, 2014 and neither Party has or shall have any rights, claims, damages or obligations for Services or costs pursuant
to the Diagnostic SOW.

 

 

		2.	NTRP shall pay BRNI two million four hundred thousand dollars ($2,400,000) in Service Fees payable
in the amount of two hundred thousand dollars ($200,000) per month for each month from October 1, 2014 through September 30, 2015.
NTRP agrees that the full two million four hundred thousand dollars ($2,400,000) is a binding obligation of NTRP, and any failure
to pay the full amount shall constitute a breach of TLSA, as amended, and this SOW Agreement. The payments for October and November
of 2014 in the amount of four hundred thousand dollars ($400,000) have been paid by Neurotrope and are hereby acknowledged by BRNI.
Notwithstanding anything to the contrary contained in Section 4.7 of the TLSA, Neurotrope may not credit any such Services Fees
against any Fixed Research Fee.

 

		3.	NTRP and BRNI agree that the first three (3) payments referred to in Paragraph 2 of this SOW Agreement
(ie., the first six hundred thousand dollars ($600,000), if and when fully made to BRNI, shall satisfy the Outstanding Reimbursement
Amounts Due, which total five hundred and thirty thousand dollars ($530,000), including in the aggregate the Compassionate Use
Invoices, the First Patent Reimbursement Expenses and the Second Patent Reimbursement Expenses all of which were incurred prior
to the SOW Agreement Term.

 

		4.	The payments set forth in Paragraph 2 above, as and when made to BRNI, shall also satisfy NTRP’s
obligations to reimburse BRNI pursuant to Section 5.6 of the TLSA for any attorneys’ fees, translation costs, filing fees,
maintenance fees, and other costs and expenses related to applying for, filing, prosecuting, and maintaining patents and applications
for the Licensed IP incurred by BRNI during the SOW Agreement Term (but, for the avoidance of doubt, such payments shall not satisfy
any attorneys’ fees, translation costs, filing fees, maintenance fees, or other costs or expenses related to applying for,
filing, prosecuting, and maintaining patents and applications for the Licensed IP incurred by BRNI after the expiration or termination
of the SOW Agreement Term).

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		5.	NTRP and BRNI hereby agree to establish the following consultative process to facilitate clinical
trials and other scientific and commercial development of the licensed Intellectual Property: a) Warren Wasiewski, M.D., Executive
Vice President of Development and Chief Medical Officer of NTRP (“Dr. Wasiewski”), and Dan Alkon, M.D., Chief Scientific
Officer of NTRP and Scientific Director of BRNI (“Dr. Alkon”), shall at least once a week have a conference call to
be scheduled at their mutual convenience; b) Dr. Wasiewski and Dr. Alkon shall meet in person at least once a month to be scheduled
at their mutual convenience, alternating locations with Neurotrope paying reasonable travel expenses for both Parties; c) in the
event that there are issues of significant scientific disagreement between Dr. Wasiewski and Dr. Alkon, NTRP will promptly convene
a meeting of as many members of its Clinical Advisory Board (“CAB”) as feasible, but in no event less than 50% of the
members who shall provide advice to Dr. Wasiewski and Dr. Alkon regarding the matter in disagreement; and, d) in the event that,
having received the advice of the CAB members who attended the meeting, the matter is still in disagreement between Dr. Wasiewski
and Dr. Alkon, the matter shall be referred to the NTRP Board of Directors for resolution consistent with Paragraphs 3.1 and 3.2
of the TLSA. In addition, Dr. Wasiewski and Dr. Alkon shall be permitted to participate at the meeting of the CAB, whose current
members are listed on Attachment A to this SOW Agreement, which is incorporated herein and made a part hereof BRNI shall
be advised of proposed replacements to the members of the CAB and Neurotrope shall consider BRNI’s comments concerning any
such replacement but BRNI’s consent shall not be required.

 

		6.	BRNI agrees to use commercially reasonable efforts to enroll at least four (4) additional compassionate
use or expanded access patients, in trials of BRNI’s Alzheimer’s (“AD”) therapeutic drug platform
during the SOW Agreement Term, and the payments set forth in Paragraph 2 above, shall satisfy any and all of NTRP’s obligation
whatsoever to BRNI or to any other Third Party for costs incurred or to be incurred by BRNI relating to such trials during the
SOW Agreement Term. It is understood and agreed by the Parties that BRNI may receive cost reimbursement from patients, patients’
families, or other Third Parties in connection with such enrolled patients and administration of these trials. It is further understood
and agreed by the Parties that (i) the FDA approval for an additional six month trial performed on a pre-existing patient shall
constitute one of the four additional compassionate use or expanded access patients, and (ii) BRNI shall use best reasonable efforts
to enroll a 5th compassionate use or expanded access patient during the SOW Agreement Term. With respect to such patients,
BRNI will consult with Dr. Warren Wasiewski concerning the protocol and suitability of the patients, and if there is a disagreement
between Dr. Alkon and Dr. Wasiewski, then they shall seek the advice of the CAB pursuant to Paragraph 5 above.

 

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		7.	Consistent with the provisions of Paragraph 5 hereof, BRNI shall perform the Services requested
by NTRP for the further development of BRNI’s AD therapeutic drug platform as set forth in Attachment B to this SOW
Agreement, which is incorporated herein and made a part hereof and BRNI’s costs therefore shall be satisfied pursuant to
the payments set forth in Paragraph 2 above. It is understood and agreed by the Parties that nothing herein shall constitute a
waiver by BRNI of any of its rights under Paragraphs 3.1 and 3.2 of the TLSA following the date of this SOW Agreement, and any
proposed agreements between NTRP and any third party provider for services relating to clinical trials or other development of
the BRNI AD therapeutic drug platform shall be subject to the provisions of Paragraphs 3.1 and 3.2 of the TLSA and Attachment B
hereto.

 

		8.	Consistent with the provisions of Paragraph 5 hereof, BRNI shall perform the Services for the further
development of BRNI’s AD diagnostic test, as set forth in Attachment C to this SOW Agreement, which is incorporated
herein and made a part hereof, and BRNI’s costs therefor shall be satisfied pursuant to the payments set forth in Paragraph
2 above. NTRP shall reimburse Alere, Inc. in the amount of one hundred fifty thousand dollars ($150,000), as evidenced by a copy
of the appropriate invoice from Alere to BRNI, in order to obtain the blinded clinical diagnoses and autopsy results obtained under
the former Alere-BRNI diagnostic trial program, in order for BRNI to perform the Services set forth in this paragraph. The study
design will be implemented in accordance with the terms of Attachment C-1 to this SOW Agreement, which is incorporated herein
and made a part hereof. It is the goal of this Agreement that BRNI deliver a commercially-marketable AD diagnostic product in twelve
months from the date of execution of an agreement with Johns Hopkins University (“JHU”) as set forth herein. It is
understood and agreed, however, that in order to meet this goal, it will be necessary to obtain additional samples pursuant to
an agreement with JHU, as set forth in Attachment D, which is incorporated herein and made a part hereof. The contract with
JHU shall require NTRP to provide funding to JHU for the following: a) a statistician who will design and implement a validation
trial, including therein a futility analysis trial, as set forth in Attachment C-1, b) obtaining, by purchase, the number of clinical
diagnoses and skin samples from JHU which, combined with the Alere diagnoses and samples, will provide a sufficient number for
the futility analysis trial and, c) purchase from JHU additional diagnoses, autopsies, and samples necessary to complete the validation
trial provided that the futility analysis trial does not indicate that further sample analysis will not result in achieving statistically
significant differences between the groups (see Attachment C-1) with 90% sensitivity and specificity. It is further understood
and agreed by the parties that part c of the JHU contract shall not become operative until NTRP is able to secure at least five
million dollars ($5,000,000) in additional funding. In the event NTRP does not proceed with part c of the JHU contract by June
30, 2015, then NTRP hereby agrees that the BRNI AD Diagnostic test is no longer a part of the Licensed Technology under the TLSA
and all rights to it shall revert to BRNI. In the event either, as a result of the futility analysis or, if conducted, the full
validation trial, the BRNI AD Diagnostic test fails to achieve a high confidence level of statistical validity, the parties understand
and agree that the obligation to develop a commercially-marketable AD diagnostic product may not be satisfied and, if so, shall
not be considered a breach of this SOW Agreement or the TLSA by BRNI or NTRP and shall not be cause for any reduction in the payments
from NTRP to BRNI as set forth in Paragraph 2 hereof.

 

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		9.	BRNI agrees, as owner of FDA-approved open label IND 71,276, that, to the extent permitted by applicable
law, it will transfer to NTRP all of BRNI’s rights and regulatory obligations therefor, provided, however, that BRNI shall
retain the responsibility for regulatory obligations related to the compassionate use expanded access trials. BRNI also agrees
to provide the FDA with the letter attached hereto and made a part hereof as Attachment E. It is understood and agreed by
the parties that Attachment E is intended to provide NTRP with the right to reference the IND in connection with NTRP’s application
to the FDA for orphan drug designation for treatment of Niemann Pick disease with bryostatin and in connection with NTRP’s
development program of Fragile X disease. Furthermore, should NTRP wish to transfer such rights and obligations to a Third Party
in connection with an assignment of the TLSA pursuant to Paragraph 13.1 thereof and, subject to BRNI’s consent which shall
not be commercially unreasonably withheld, BRNI will promptly take all appropriate action to effectuate such transfer to the assignee.
Notwithstanding the foregoing, the parties understand and agree that BRNI’s rights under Section 3.1 and 3.2 of the TLSA
apply to NTRP’s drug development for Fragile X disease using the Licensed Technology. For the avoidance of doubt, ownership
of the aforesaid IND shall remain with BRNI and, in the event of any termination of the TLSA, the transfer provided herein to NTRP
shall terminate.

 

		10.	Consistent with the provisions of Paragraph 5 hereof, BRNI agrees to conduct initial research on
the application of its PKC epsilon platform (including activation thereof) to treat Fragile X disease. This initial or Phase I
research is described in Attachment F, which is attached hereto and made a part hereof, and the payments set forth in Paragraph
2 above shall satisfy any and all of NTRP’s obligations to BRNI for its work pursuant to this Paragraph 10. It is understood
and agreed that additional, or Phase II, Services on Fragile X, if requested by NTRP, shall be the subject of an additional SOW
between NTRP and BRNI pursuant to Paragraph 3.1 of the TLSA.

 

		11.	Consistent with the provisions of Paragraph 5 hereof, BRNI agrees to conduct initial research on
polyunsaturated fatty acid derivatives (“PUFA derivatives”) for the purpose of developing a commercially usable PKC
epsilon activator, and the payments set forth in Paragraph 2 above shall satisfy any and all of NTRP’s obligations to BRNI
for its work pursuant to this Paragraph 11. Phase I studies of PUFA derivatives for activation of PKC epsilon will consist of screening
at least five (5) of the most potent PUFA derivatives for their activation of five (5) principal PKC isozymes-namely alpha, epsilon,
gamma, beta, and delta isozymes. This screening will identify the most specific activators of PKC epsilon and will define the dose
response relationships for this activation. This screening will include purified isozymes that are available and/or antibodies
that are specific for these isozymes. In addition, the same screening will assay isozyme activation in at least one purified cell
culture system such as cultured rat hippocampal neurons or their equivalents, such as cultured human neurons, neuroblastoma cells,
etc. If requested by NTRP, further PUFA derivative studies or screenings not set forth herein shall constitute Phase II studies
and Services for such studies or screenings will require a new SOW pursuant to Paragraph 3.1 of the TLSA.

 

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		12.	Consistent with the provisions of Paragraph 5 hereof, BRNI agrees to provide assistance, advice
and other similar services to NTRP regarding NTRP’s analysis of bryologs, if requested by NTRP, pursuant to NTRP’s
agreement with Stanford University, for the purpose of developing a commercially usable PKC epsilon activator, and the payments
set forth in Paragraph 2 above shall satisfy any and all of NTRP’s obligations to BRNI for its Services pursuant to this
Paragraph 12. It is understood and agreed that Stanford University is performing the initial screening of its bryologs and BRNI
will be available to consult as stated above in this Paragraph 12. If requested by NTRP, Services relating to additional initial
screenings which may be performed by BRNI or Phase II screening of the bryologs by BRNI would require a new SOW pursuant to Paragraph
3.1 of the TLSA.

 

		13.	BRNI will transfer within three (3) business days of the execution of this SOW Agreement, to Bioconvergence
for secure storage, up to 90% (i.e. .8793 grams) of the bryostatin drug substance which BRNI received pursuant to the BRNI-NCI
MTA agreement (Amendment #1, Material Transfer Agreement #12-2-00083), and has remaining in its possession as of this date, together
with 609 bryostatin kits containing drug substance for non-human use. NTRP shall reimburse BRNI for all pre-approved costs and
expenses incurred by BRNI, if any, associated with the transfer, including shipment and insurance costs, of such drug substances
upon presentation to NTRP of invoices for such expenses. The Parties agree that the transferred bryostatin drug substance shall
remain subject to the requirements of the BRNI-NCI MTA, as amended, and further agree that no further transfer or use of the transferred
bryostatin to any other party shall occur without BRNI’s written consent in accordance with BRNI’s requirements under
the aforementioned MTA agreement; provided however, that BRNI hereby consents to the transfer of such bryostatin to the entities
listed on Attachment G, which is attached hereto and made a part hereof; and further provided that upon a request by NTRP
for any further transfers of such bryostatin, BRNI shall expeditiously make such request of NCI, as may be required under the MTA,
and BRNI shall use its best efforts to obtain such consent; and further provided that if NCI consents to a transfer in accordance
with BRNI’s requirements under the aforementioned MTA agreement, as stated above, then BRNI’s consent shall not be
unreasonably withheld. BRNI reserves the right to recall unused quantities of such drug substance from Bioconvergence if BRNI so
requires for pre-clinical or clinical studies to be conducted by BRNI and NTRP no longer has a need for the drug substance, in
which case NTRP shall arrange to ship such drug substance to BRNI at BRNI’s direction and at BRNI’s expense.

 

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		14.	If requested by NTRP and subject to a separate SOW, NTRP shall reimburse BRNI for Dr. Dan Alkon’s
time spent on services not reasonably related to this SOW Agreement.

 

		15.	BRNI hereby agrees to provide access, on a reasonable basis, by NTRP to BRNI’s intellectual
property counsel and shall make available, with counsel, all pertinent information in the possession of counsel regarding the licensed
Intellectual Property. For efficiency’s sake, NTRP’s and BRNI’s CEO’s shall contact such counsel together,
with others that they may invite to participate. Furthermore, BRNI agrees to provide promptly to NTRP a written disclosure of any
Invention in the Field conceived or reduced to practice. Also, BRNI shall keep NTRP reasonably informed of all patent related activity
with respect to the Intellectual Property in the Field and shall make office actions and responses thereto available to NTRP for
comment.

 

		16.	NTRP hereby represents that it is engaged in efforts to raise additional capital for NTRP and hereby
agrees that any such capital raised shall constitute B Round Financing, within the meaning of Paragraph 4.3 of the TLSA, and therefore
NTRP further agrees to pay to BRNI 5 % of the amount raised as an advance payment of future Royalty payable under Paragraph 4.5
of the TLSA.

 

		17.	NTRP hereby agrees that this SOW shall also serve as an agreement between NTRP and BRNI whereby
Dr. Dan Alkon will advise and consult with NTRP regarding NTRP’s contract with Mt. Sinai Hospital for the use of bryostatin
in the treatment of Neimann Pick disease. NTRP hereby agrees to pay BRNI twenty thousand dollars ($20,000) in quarterly payments
in the twelve months from the date of this Agreement. For clarity, the payment set forth herein is in addition to the payments
set forth in paragraph 2 hereof.

 

		18.	For the avoidance of doubt, this SOW Agreement shall not (i) act to waive other rights or remedies
available to BRNI under the TLSA, including, but not limited to, the provisions of Paragraphs 3.1 and 3.2 of the TLSA following
the date hereof, (ii) affect either Party’s rights or obligations under the TLSA, or (iii) act to modify the terms or conditions
of the TLSA in any way.

 

		19.	The parties agree that the following paragraphs of this SOW shall survive the expiration of this
SOW and shall remain in effect for the term of the TLSA: paragraphs 5, 9, 13, 15, 16, and this paragraph 19. The parties further
agree that paragraph 17 shall expire twelve months from the date of this Agreement, and paragraph 8 shall expire as set forth therein.

 

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Dated: February 4, 2015
and effective as of October 1, 2014

 

	Neurotrope Bioscience, Inc.	 	Blanchette Rockefeller Neurosciences Institute
	 	 	 	 	 
	By:	/s/ Charles S. Ramat	 	By:	/s/ William S. Singer
	 	 	 	 	 
	Name: 	Charles S. Ramat	 	Name: 	William S. Singer
	 	 	 	 	 
	Title:	President and Chief Executive Officer	 	Title:	President

 

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Attachment A List
of Current Clinical Advisory Board Members

 

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Attachment B AD Therapeutic
Support Services

 

		1.	BRNI to participate in the design, protocols, trial implementation, site identification, FDA regulations, and interpretation
of results of the clinical trials for the BRNI therapeutic drug platform for AD. NTRP, shall have the final decision rights in
all aspects of clinical trial design, implementation, and interpretation for its commercialization, subject to BRNI’ s rights
under Paragraphs 3.1 and 3.2 of the TLSA.

 

		2.	BRNI will measure PKC epsilon in the blood samples obtained from the compassionate use/expanded access trial patients. It is
understood and agreed by NTRP and BRNI that this SOW Agreement does not include the measurements set forth in this paragraph for
clinical trial patients. It is further understood and agreed if NTRP requests that BRNI perform such measurements for clinical
trial patients, such Services would require a new Statement of Work between NTRP and BRNI pursuant to the TLSA. BRNI will conduct
pre-clinical studies on the dose-response relationship for Bryostatin in normal rodent species. Associated measurements to determine
activation, downregulation, and synthesis of PKC epsilon in plasma will be included, as possible. NTRP shall have the right to
review and approve all protocols prior to the commencement of these studies. It is understood and agreed between NTRP and BRNI
that this SOW Agreement does not include studies referenced in this paragraph on Alzheimer’s transgenic mice. It is also
understood that this SOW does not include measurements to quantify the relationships among doses, plasma levels, and brain levels
of bryostatin and PKC epsilon for in vivo normal and/or transgenic rodent studies. It is further understood and agreed that, if
requested by NTRP, Services to perform such studies on normal and/or Alzheimer’s transgenic mice would require a new Statement
of Work between NTRP and BRNI pursuant to the TLSA.

 

		3.	BRNI will conduct in vitro pre-clinical studies to determine the potency, specificity, and dose-response relationships for
PUFA Derivatives that are possible lead candidates for PKC activators in clinical trials. It is understood and agreed between NTRP
and BRNI that this SOW Agreement does not include in vivo studies on normal animals, Alzheimer’s transgenic mice, and other
pre-clinical models of neurologic disorders (such as stroke, Fragile X, etc.) except as provided in Attachment F. It is further
understood and agreed that if requested by NTRP, Services to perform such studies would require a new Statement of Work between
NTRP and BRNI pursuant to the TLSA. NTRP shall have the right to review and approve all protocols prior to the commencement of
these studies.

 

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Attachment C - Diagnostic
Support Services

 

BRNI and NTRP will, within the next thirty (30) days establish
the specifications for the diagnostic product that the Parties agree (i) must meet sensitivity and specificity confidence levels
at 90% to be commercially acceptable and (ii) be able to reproduce statistically significant separation between non-AD dementia
patients from AD patients. BRNI will conduct a prospective, double-blind validation trial for which all relevant data will be collected
in a virtual data room that will be established by BRNI. This virtual data room will also store primary and derived data produced
in the diagnostic laboratory (Rockville) in the past three years for the three AD Diagnostic Biomarkers. These past data are source
document verified (as will be the planned validation trial data), i.e. they are traceable to notebooks, cell lines, images etc.
All the files in Windows/Linux operating systems that we have used have a time stamp and history of accessing (See below). These
will be available for inspection by BRNI, NTRP, and their agents. BRNI will provide Services to use two BRNI Biomarkers (PKC epsilon
and Morphometrics) to assay all skin samples obtained for a Clinical Validation Trial (See Attachment B 1 below) to diagnose Alzheimer’s
Disease (AD) patients in discrimination from age-matched controls and non-AD dementias such as those due to Huntington’s
Chorea, Parkinson’s disease, and/or JakobCreuzfelt disease. BRNI will make these diagnostic measurements according to CLIA
standards.

 

BRNI will provide the following Services to implement two BRNI
Biomarker (PKC epsilon and Morphometrics). Assays on all skin samples obtained for a Clinical Validation Trial to diagnose Alzheimer’s
Disease (AD) patients:

 

		1.	Receiving and handling a sufficient number of skin samples, as determined by an independent statistician,
from clinical sites such as the Johns Hopkins University (JHU).

 

		2.	Purifying the skin samples to select and grow fibroblast cultures for the Biomarker analyses.

 

		3.	Growing the cultures to sufficient quantity and density for Assay measurements.

 

		4.	Measuring the PKC epsilon levels with and without A Beta oligomer applications.

 

		5.	Measuring the fibroblast network formation with and without A Beta oligomer applications.

 

		6.	Quantifying the above measures so as to distinguish AD patients from all other patients.

 

		7.	Blindly collecting the above data for submission to a 3rd party statistician to analyze,
codify, and unblind the final results, and

 

		8.	Providing the statistician the results of both biomarker assays to be combined for a final diagnosis.

 

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BRNI will work with NTRP to design the validation trial to be
sufficiently powered and validated so as to arrive at meaningful values for the sensitivity and specificity of diagnosing AD as
stated above.

 

As described above, the collected data will be securely encrypted
and stored in a virtual data room accessible only to carefully identified parties (particularly Neurotrope). Accounts and passwords
for clients will be set up for those granted access to the virtual room, most likely using Secure Shell (SSH) communication which
is encrypted - or its equivalent. Primary data files as well as results derived from all assays will be available. This will be
in a readable format in ASCII or Excel format or an equivalent such as the Statistical Analysis Software (SAS) format. All data
will be source document verified – i.e. every entry in the electronic database will be referenced to identifiable and retrievable
signed notebook pages for those data transcribed from notebooks or referable to entries derived from electronic data capture. Data
entries will have time and date stamps. Patient sample tracking logs will also be available for all trial participants. Similarly,
the diagnostic laboratory (Rockville) will provide the quality control, instrument calibration, SOPs, and other documentation that
are required for CLIA standards of laboratory practice.

 

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Attachment C-1

 

AD Dx Biomarkers - General Study Design

 

		1.	The execution of the validation study for the diagnostic product is dependent on the following: The validation study will include
2 biomarkers, the PKC e - ASPD assay and the morphometric aggregation assay- to accurately diagnose Alzheimer’s disease.
Overall sensitivity and specificity must be at 90% or greater to subsequently begin commercialization and marketing. It is anticipated
that the study, on initiation, will be 12 months in duration. The costs for BRNI’s Services as described herein shall be
covered by the payments provided in the SOW. The trial design shall include 1) clinical diagnoses, 2) autopsy validation of AD
and Non-AD dementias, 3) genetic identification of Non-AD dementia patients such as Huntington’s Chorea, Parkinson’s
Disease, and Tauopathies, and 4) Non-demented age-matched controls, i.e. patients identified by standard psychometric evaluations
not to be demented.

 

		2.	The determination of a sample size for both assays, ASPD stimulation assay and the morphometric assay, such that each has sufficient
power to establish a statistically significant difference between the groups to be studied, as agreed upon by the statistician,
Dr. Rick Thompson Johns Hopkins University (“JHU”), Warren Wasiewski, and Dan Alkon, and shall not to exceed 150.

 

		3.	The parties have agreed to use the statistician, Dr. Thompson, in consultation with Warren Wasiewski and Dan Alkon, to assist
in the formulation of the study design, including determination of a sample size for each of the three cohorts as described under
#4 below and determination of appropriate statistical analysis methodology for data analysis. If Dr. Thompson becomes unavailable
the parties will agree on a comparable substitute. Dr. Thompson’s total fee is estimated to be $20 - 30K and will be billed
to BRNI, but reimbursed by Neurotrope.

 

		4.	The study design must include the following:

 

		a.	Patient population for study:

		1.	Alzheimer’s dementia

		2.	Non-Alzheimer’s dementia

		3.	Age-matched controls

 

Agreement on primary and secondary end points is
to be determined and mutually agreed to by Neurotrope and BRNI, with Dr. Thompson’s guidance and with the objective of 90%
diagnostic sensitivity and specificity.

 

		b.	Identification of sources for sample acquisition, so it is clear that the study can be completed if initiated. These sources
will include the Alere, autopsy-validated dementia cases and JHU for age-matched controls, Alzheimer’s dementia patients,
and Non-Alzheimer’s dementia patients. Neurotrope will, within a reasonable time after the execution of this SOW, pay $150,000
to Alere, Inc. as specified in Paragraph 8 of the SOW Agreement to access the autopsy-validated results in the possession of Alere.
The Alere autopsy-validated patients may be included within the planned futility analysis outlined below. If the futility analysis,
as set forth in paragraph d, subparagraphs i through v, fails, indicating that further sample analysis will not result in achieving
statistically significant differences between the groups with 90% sensitivity and specificity, the study will be stopped. If the
study passes the futility analysis, the study will be completed with the required additional patients from JHU.

 

    	15

    	 

    

 

		c.	The study will be blinded and the blinding codes held by an independent, unblinded individual who has no other responsibility
for the study.

 

		d.	The study will include a futility analysis at a sample size agreed upon by Neurotrope, BRNI, and Dr. Thompson as sufficient
for a meaningful analysis. This futility analysis would include adequate numbers (determined by Dr. Thompson in consultation with
Warren Wasiewski and Dan Alkon) in each of the 3 cohorts listed under #4a above, based on initial review of the statistics. This
analysis will be in compliance with the following guidelines:

		i.	Stopping rules and adequate confidence intervals for futility will be established by Dr. Thompson, subject to agreement by
both parties.

 

		ii.	Fully developed and agreed to protocols prior to the onset of the validation trial, as well as the futility analysis, will
be completed and signed off by Neurotrope and BRNI prior to any work. These include:

		1.	A protocol or protocols for the lab evaluation of PKC e and the morphology assay.

 

		2.	A protocol that will be used for acquisition of skin samples as needed.

		iii.	The futility analysis will be performed by an independent external review board established by Neurotrope and BRNI.

 

		iv.	The independent external review board will consist of at least one neurologist with Alzheimer’s disease experience, one
statistician and one research scientist; and may include additional members.

		1.	No employees of BRNI, JHU or Neurotrope can participate on the external review board.

 

		2.	A charter defining the board’s charge will be developed and signed off by Neurotrope and BRNI.

 

		v.	The 3rd BRNI Biomarker (AD Index) would be used – on samples already collected – should the initial
futility analysis demonstrate statistically that the two tested Biomarkers, either separately or in combination, could not yield
90% sensitivity and specificity. This would entail no additional cost to Neurotrope and will be covered within the Rockville laboratory
budget (covered within the $200 K / month agreed upon).

 

		5.	Written monthly reports on study progress will be provided to Neurotrope from BRNI.

 

		6.	Neurotrope will have access to all raw data as requested and at the conclusion of the study.

 

    	16

    	 

    

 

		7.	BRNI and Dan Alkon will have overview responsibility for all diagnostic data collection, recording, and processing. Raw data
and processed data will then be transmitted to Dr. Thompson who will have ultimate responsibility for unblinding at the completion
of the study, final analysis, and reporting to Neurotrope and BRNI.

 

		8.	All laboratory procedures will be monitored by a CLIA consultant, at BRNI’s expense, who ensures compliance with CLIA
standards.

 

    	17

    	 

    

 

Attachment D

 

The NTRP/Johns Hopkins University Agreement for a clinical validation
trial shall:

 

(a)          Identify
and clinically diagnose Alzheimer’s patients and controls pursuant to the AD Dx Biomarkers- General Study Design as set forth
in Attachment C-1 hereof,

 

(b)          Obtain
and send punch biopsy skin samples to BRNI under blind conditions, and perform autopsies when possible on study patients,

 

(c)          Maintain,
blind, and transmit all study data to the designated statistician for analyses according to the study design pursuant to the AD
Dx Biomarkers General Study Design as set forth in Attachment C-1 hereof, and

 

(d)          Provide
for joint publication rights between BRNI, NTRP and JHU, with review and comment by NTRP, and further provide that required patent
filings would occur on any new intellectual property prior to publication without causing any unreasonable delays for publication.

 

    	18

    	 

    

 

Attachment E Letter
to FDA re: Right of Reference [BRNI Letterhead]

 

February 4, 2015

 

Billy Dunn, MD, Acting Director

Division of Neurology Products

U. S. Food and Drug Administration

10903 New Hampshire Avenue

Bld. 22, Suite 4200

Silver Spring, MD 20993

 

General Correspondence

Subject: Transfer of Rights and Obligations of IND 71,276

SN0008

 

Dear Dr. Dunn:

 

The purpose of this correspondence is to inform you that effective,
2/4/2015, the Blanchette Rockefeller Neuroscience Institute (hereinafter, BRNI) hereby transfers the rights and obligations of
IND 71,276 to Neurotrope BioScience, Inc., 50 Park Place, Suite 1401, Newark, New Jersey 07102 (hereinafter, Neurotrope) with respect
to all clinical trials being conducted or to be conducted by Neurotrope. BRNI is reserving all rights and obligations under the
IND with respect to all compassionate use/expanded access protocols that BRNI is supporting or may support in the future. BRNI
will provide Neurotrope with a copy of the original IND and all records pertaining to it. Neurotrope will assume all administrative,
maintenance and reporting responsibilities of the IND from the date of transfer for the clinical trials being conducted or to be
conducted by Neurotrope.

 

Future communications regarding the IND should be directed to:

 

Dr. Warren Wasiewski, Executive Vice President, Development
and

Chief Medical Officer

Neurotrope BioScience, Inc.

50 Park Place

Suite 1401

Newark, New Jersey 07102

973.242.0005

 

with a copy to the undersigned.

 

Sincerely,

 

Shana Phares, CEO

 

Cc: Dr. Warren Wasiewski

 

    	19

    	 

    

 

Attachment F Fragile
X

 

Phase I

 

Bryostatin 1 will be administered to mice with the Fragile X
gene during a critical period of the developing brain (2 - 4 weeks post-natal). All of the major pathologic markers of Fragile
X mental retardation will be assayed for wild-type, Fragile X mice, and age-matched controls with and without treatment with Bryostatin
1, as well as behavioral assessments. These markers will include synaptic morphology as measured by confocal microscopy, spatial
maze learning, and GSK-3 Beta levels.

 

    	20

    	 

    

 

Attachment G List
of Current Recipients of Bryostatin

 

MPI Research

 

BioReliance Inc.

 

Intertek Pharmaceutical Services, Inc.

 

ViTrax

 

ChanTest Corp.

 

    	21Exhibit 10.12

 

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:

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