Statement of Work Agreement dated February 4, 2015, and effective as of October 1, 2014, between Neurotrope Bioscience, Inc. and BRNI

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

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

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.

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

Attachment A List of Current Clinical Advisory Board Members

Attachment B AD Therapeutic Support Services

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:

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.

Attachment C-1

AD Dx Biomarkers - General Study Design

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.

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.

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 ###-###-####

with a copy to the undersigned.

Sincerely,

Shana Phares, CEO

Cc: Dr. Warren Wasiewski

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.

Attachment G List of Current Recipients of Bryostatin

MPI Research

BioReliance Inc.

Intertek Pharmaceutical Services, Inc.

ViTrax

ChanTest Corp.