Exhibit 10.4

 

FINAL

Supply Agreement

 

This Supply Agreement (the “Agreement”) is made, effective as of June 9, 2020
(the “Effective Date”) by and between BryoLogyx Inc. (“BryoLogyx”) and
Neurotrope Bioscience, Inc. (“Neurotrope”), each of Neurotrope and BryoLogyx
being referred to herein individually as a “Party” and collectively as the
“Parties,” with respect to the supply by BryoLogyx to Neurotrope of cGMP
synthetic bryostatin-1 under the terms and conditions set forth herein.

 

BACKGROUND

 

A.Neurotrope is a clinical-stage biotech company leveraging bryostatin-1 and its
analogues to discover and develop targeted therapeutics for neurodegenerative
diseases and developmental disorders, and is a party to that certain Cooperative
Research And Development Agreement with the U.S. Department of Health and Human
Services, as represented by National Cancer Institute of the NIH dated January
29, 2019 (the “CRADA”) under which Neurotrope would study bryostatin-1 in its
application to cancer therapy using Neurotrope’s inventory of naturally derived
bryostatin-1.

 

B.BryoLogyx is a clinical-stage biotech company currently dedicated to
developing drugs to enhance the response rates and treatment durability of
cancer immunotherapies, and has developed a method of manufacturing synthetic
bryostatin-1 pursuant to the process invented by Dr. Paul Wender at Stanford
University (“the Wender Process”). Stanford University owns the rights to the
Wender Process and has licensed BryoLogyx to use, and manufacture for its use,
the Wender Process for the development of drugs for cancer treatments.

 

C.Neurotrope is also licensed by Stanford University to use the Wender Process
for the treatment of neurological or neurodegenerative diseases.

 

D.The Parties have entered into that certain Transfer Agreement of even date
herewith pursuant to which Neurotrope will transfer the CRADA to BryoLogyx, and
will assign Neurotrope’s IND PIND140578 to BryoLogyx, all in furtherance of
BryoLogyx’s own clinical development program, in exchange for a revenue share.

 

E.Neurotrope would like to source synthetic bryostatin-1 from BryoLogyx, and
BryoLogyx is willing to supply such material to Neurotrope, all as set forth in
more detail herein.

 

F.It is the intent and agreement of the Parties that this Agreement and the
above referenced Transfer Agreement together constitute the entire agreement of
the Parties with respect to the matters governed thereby.

 

1.             Definitions and Interpretation

 

1.1               Definitions. The terms in this Agreement with initial letters
capitalized, whether used in the singular or the plural, will have the meaning
for such relevant term set forth below or, if not listed below, the meaning
designated elsewhere in this Agreement.

 

(a)    “Additional Order” has the meaning set forth therefor in Section 2.4
hereof.

 

(b)    “API” means cGMP synthetic bryostatin-1 as an active pharmaceutical
ingredient to be used in a drug product, and meeting the Specifications, and
named in the Quality Agreement.

 

(c)    “Applicable Requirements” means (a) all requirements of the Quality
Agreement, (b) the Useful Life requirement (which condition will not apply to
the Initial Order), and (c) all applicable international, supranational,
multinational, federal, regional, state, provincial and local laws, ordinances,
rules and regulations of any governmental authority that apply to API or the
Processing of API or this Agreement, including (i) all applicable laws,
ordinances, rules and regulations of the jurisdiction where the Facility is
located; (ii) cGMP; (iii) Regulatory Agencies’ regulations and guidelines; and
(iv) those pertaining to workplace health and safety, all as may be amended from
time to time.

 

 

 

BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

(d)    ““bryostatin-1” means a macrocyclic lactone and a potent activator of
protein kinase C (PKC) either isolated from the bryozoan Bugula Neritina or
chemically synthesized.

 

(e)    “business day” means a day on which national banks in the United States
are open in New York, New York.

 

(f)     “cGMP” means those practices in the manufacture of pharmaceutical
products that are recognized as current good manufacturing practice regulations
and guidelines as described and promulgated by Regulatory Authorities including
(i) the FDA in accordance with FDA regulations guidelines and other
administrative interpretations, and, without limitation, (ii) the then-current
International Council on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) Q7 Good Manufacturing
Practice Guidance for Active Pharmaceutical Ingredients as adopted by the
relevant Regulatory Authority in the subject jurisdiction, and (iii) The
European Union’s Eudralex Volume 4,
Part II (independent of the Annexes) where it is in direct agreement with ICH
Q7, all as updated, amended, and revised from time to time.

 

(g)    “COGS” means BryoLogyx’s fully-burdened cost of all direct materials and
labor and
fully-allocated manufacturing overhead directly attributable to the cost of
process development and validation and the Processing of API for Neurotrope
hereunder, calculated in accordance with US GAAP, consistently applied;
provided, that manufacturing overhead will not include allocation of idle
capacity.

 

(h)    “Confidential Information” will have the meaning set forth in Section 8
hereof.

 

(i)     “Defect” or “Defective” means a unit of API that does not conform to the
Specifications or was not Processed in accordance with Applicable Requirements
or does not meet the Useful Life, provided that such Useful Life requirement in
order for API to not be Defective will apply only to Additional Orders and not
to the Initial Order.

 

(j)     “Deficiency Notice” means a written notice from Neurotrope to BryoLogyx
claiming a Defect with respect to API, and/or shortages in the amount of
delivered API, and describing in reasonable detail such Defect or shortage.

 

(k)    “Dollar” or “$” means the lawful currency of the United States.

 

(l)     “FDA” means the U.S. Food and Drug Administration, or any successor
agency thereto having jurisdiction over the manufacture of the API.

 

(m)  “Initial Order” has the meaning therefor set forth in Section 2.2 hereof.

 

(n)    “Intellectual Property” means any right or protection existing from time
to time in a specific jurisdiction, whether registered or not, under any patent
law or other invention or discovery law, copyright law, trade-secret law,
trademark law or trade name law, and includes legislation by competent
governmental authorities and judicial decisions under common law or equity.

 

(o)    “Person” means an individual, corporation, partnership, limited liability
company, trust, business trust, association, joint stock company, joint venture,
pool, syndicate, sole proprietorship, unincorporated organization, governmental
authority or any other form of entity not specifically listed herein.

 

(p)       “Processing” means all steps and activities to be performed for the
manufacture, storage and delivery of API for supply by BryoLogyx to Neurotrope
pursuant to this Agreement.

 

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BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

(q)       “Quality Agreement” means a separate written agreement that has been
entered into between BryoLogyx and BryoLogyx’s contract manufacturer for the API
that describes the quality assurance and technical requirements for Processing,
a copy of which will be provided to Neurotrope as promptly as possible when the
Quality Agreement has been updated for the cGMP synthetic processing of
bryostatin-1, which Quality Agreement, when so furnished, will be deemed
confidential and will thus be subject to the confidentiality provisions of
Section 8 hereof.

 

(r)        “Regulatory Agency” means any national, federal, state or local or
other regulatory agency, department, bureau or other governmental entity
(including the FDA) which is responsible for issuing approvals, licenses,
registrations or authorizations necessary for the manufacture, import,
distribution, sale and use of API.

 

(s)     “Specifications” means the specifications for API as set forth in
Exhibit A attached hereto and incorporated herein by reference, as such Exhibit
may be amended from time to time by the Parties in writing in accordance with
the terms of this Agreement.

 

(t)     “Supply Period” means the period of time commencing with the date of
cGMP certification and Neurotrope’s acceptance of the initial production run of
synthetic bryostatin-1 produced by BryoLogyx under a license to BryoLogyx from
Stanford University, and ending upon the earlier of (i) the fifth (5th) annual
anniversary of the date of completion by Neurotrope of Phase 3clinical trials
using API, provided that Neurotrope will promptly inform BryoLogyx in writing of
the date of completion of such Phase 3 clinical trials, or (ii) such earlier or
later date as is agreed by the Parties in writing in accordance with the terms
of this Agreement.

 

(u)    “Term” means the Supply Period.

 

(v)    “Third Party” means any Person other than Neurotrope or BryoLogyx.

 

(w)  “UNCISG” means the United Nations Convention on Contracts for the
International Sale of Goods, as in effect from time to time.

 

(x)    “Unit Price” Means the price per gram of API which is equal to COGS of
such gram of API plus 15%, in each case calculated as at the time of production
of the API requested by Neurotrope under the Initial Order or under the relevant
Additional Order.

 

(y)    “Useful Life” means the time period within which API will remain stable
after the date of BryoLogyx’s release of the relevant lot of API to Neurotrope,
which BryoLogyx expects to be at least twenty-four (24) months, with the Parties
acknowledging, however, that the Useful Life of API is not known or confirmed as
at the Effective Date and thus will not be an applicable requirement as to API
in the Initial Order, provided, however, that BryoLogyx will use its
commercially diligent efforts, in working with its contract manufacturer of API,
to determine and confirm Useful Life for API, and will promptly communicate such
confirmed Useful Life to Neurotrope in writing as soon as it is confirmed to
BryoLogyx, and such confirmed Useful Life thereafter will be applicable to
determining whether API in an Additional Order is Defective or meets the
Applicable Requirements.

 

1.2               Interpretation. The captions and headings to this Agreement
are for convenience only, and are to be of no force or effect in construing or
interpreting any of the provisions of this Agreement. Unless specified to the
contrary, references to Sections will refer to the particular Sections of or to
this Agreement. Unless the context otherwise clearly requires, whenever used in
this Agreement: (a) the words “include” or “including” will be construed as
incorporating, also, “but not limited to” or “without limitation;” (b) the word
“day,” “quarter” or “year” (and derivatives thereof, e.g., “quarterly”) means a
calendar day, calendar quarter or calendar year unless otherwise specified (and
“annual” or “annually” refer to a calendar year); (c) the word “notice” means
notice in writing (whether or not specifically stated) and will include notices,
consents, approvals and other written communications contemplated under this
Agreement; (d) the word “hereof,” “herein,” “hereby” and derivative or similar
word refers to this Agreement; (e) the word “or” has its inclusive meaning
identified with the phrase “and/or;” (f) provisions that require that a Party or
the Parties “agree,” “consent” or “approve” or the like will require that such
agreement, consent or approval be specific and in writing, whether by written
agreement, letter or otherwise; (g) words of any gender include the other
gender; and (h) words using the singular or plural number also include the
plural or singular number, respectively.

 

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BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

2.             Supply of API by BryoLogyx to Neurotrope

 

2.1               Sole Source. Commencing on the date upon which cGMP
certification from its contract manufacturer is obtained by BryoLogyx for
production of API provided such date is not later than March 31, 2021 (or such
later date as the Parties may agree in writing) and thereafter during the Term,
and as so long as BryoLogyx is able to supply API to Neurotrope in accordance
with the terms of this Agreement and meeting Neurotrope’s volume requirements,
the Applicable Requirements, and the Specifications, BryoLogyx will be the
exclusive supplier to Neurotrope, even as to Neurotrope itself, of API.

 

2.2               Initial Order. The execution and delivery by the parties of
this Agreement constitutes Neurotrope’s firm order for the purchase by
Neurotrope and BryoLogyx of a total of one (1) gram of API (the “Initial
Order”).

 

2.3               Delivery Of The Initial Order. The Initial Order will be
shipped by BryoLogyx to Neurotrope within sixty (60) days after the date upon
which cGMP certification is obtained by BryoLogyx for production of API.
BryoLogyx will notify Neurotrope promptly in writing of the date that such cGMP
approval is obtained. Such delivery will be made by BryoLogyx to such location
in the United States as Neurotrope informs BryoLogyx in writing within thirty
(30) days after the Effective Date.

 

2.4               Additional Orders By Neurotrope For API; Delivery Of
Additional Orders. Any orders by Neurotrope for API beyond the Initial Order
(each an “Additional Order”) must be (a) in writing, (b) for not less than one
(1) gram of API unless otherwise agreed in writing by BryoLogyx in accepting the
relevant Additional Order and (c) placed by Neurotrope with BryoLogyx at least
six (6) months lead time before the delivery date of such Additional Order
desired by Neurotrope, or such shorter period of time as BryoLogyx may agree in
writing with Neurotrope, and provided that as the manufacturing process for API
is further developed after the Effective Date the Parties will discuss with each
other in good faith any potential shortening in such lead time that may be
appropriate and any such changes agreed to will be in writing as an amendment to
this Agreement. Delivery of each Additional Order will be made by BryoLogyx in
accordance with the terms of the Additional Order to the location to which the
Initial Order was delivered, or to such location in the United States as
Neurotrope informs BryoLogyx in writing when placing the Additional Order.

 

2.5               Shipment; Title And Risk Of Loss Or Damage; Acceptance;
Deficiency Notice;
Latent Defect.

 

(a)                Shipment. Shipment to Neurotrope of the Initial Order and of
Additional Orders will be made using appropriate packaging and an appropriate
carrier and delivery method as determined in each case by Neurotrope. 

 

(b)                Title and Risk of Loss or Damage. BryoLogyx will, as to the
Initial Order and as to Additional Orders, retain title to, and will carry the
risk of loss or of damage to, API until such API is loaded onto the carrier
specified by Neurotrope. Title and risk of loss or of damage to API will, as to
the Initial Order and as to Additional Orders, transfer to Neurotrope upon being
loaded on the carrier. 

 

(c)                Acceptance; Deficiency Notice; Latent Defect. Neurotrope will
be deemed to have accepted the Initial Order, and will be deemed to have
accepted any Additional Orders unless it has sent to BryoLogyx a Deficiency
Notice with respect to the relevant shipment of API within thirty (30) days
after Neurotrope’s receipt of such API. If a Defect in API could not reasonably
be discovered by Neurotrope within such thirty (30) day period (a “Latent
Defect”), then Neurotrope will have the right to reject such API within ten (10)
business days after discovering the Latent Defect during the intended useable
life of API, provided Neurotrope has given written notice, in commercially
reasonable detail as to such Latent Defect, to BryoLogyx within such 10 business
day period. Without limiting other remedies available to Neurotrope, BryoLogyx
will, at its sole cost and expense, make up the shortage or replace the rejected
API, as applicable, by delivering replacement API to Neurotrope within thirty
(30) days at no extra charge to Neurotrope. Neurotrope’s actual or deemed
acceptance of API will not be construed as limiting any remedies given
Neurotrope at law or under this Agreement. Subject to the provisions of this
Section 2.5, Neurotrope has the right to reject and return, at the expense of
BryoLogyx and for full credit, any portion of any shipment of API which deviates
from the Specifications or cGMP, without invalidating the remainder of the
order. If BryoLogyx does not agree with Neurotrope’s determination that API is
Defective, then the Parties will designate an independent testing laboratory to
determine whether the API is Defective, the findings of which will be binding on
the Parties, absent manifest error. All costs and expenses of such laboratory
testing will be borne by the Party whose position is determined to have been in
error, or if the laboratory cannot place the cause of the rejection or defect
noticed, then all costs and expenses of such laboratory testing will be borne by
the Parties equally. All rejected API will be disposed of pursuant to Applicable
Requirements. BryoLogyx will not subcontract, transfer or delegate its
performance under this Agreement without Neurotrope’s prior written consent.

 

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BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

2.6               Certain Limitations And Further Conditions. The fulfillment by
BryoLogyx of the Initial Order and of any Additional Orders will be subject to
the following conditions in each case:

 

(a)       Cancellation; Reduction. Neurotrope may not cancel or reduce the
amount of API in the Initial Order nor may it cancel or reduce the amount of API
in any Additional Order, unless in each case such cancellation or reduction is
agreed to in writing by BryoLogyx (such agreement not to be unreasonably
withheld).

 

(b)       Conditions For Supply Of API To Neurotrope For Commercial Sale.
BryoLogyx’s obligations hereunder to supply API to Neurotrope for commercial
sale will be subject to (i) BryoLogyx having achieved such regulatory approvals,
if any, as may be required with respect to commercial sale of API, and (ii)
BryoLogyx having established for itself a commercial-level manufacturing and
supply process therefor.

 

2.7               Certain Further Limitations On Neurotrope As To Marketing,
Offer To Sell Or Selling API. During the period of time during the Term in which
Neurotrope is using API for its clinical research and clinical trials,
Neurotrope will not market, offer to sell or sell API to any Third Party without
the prior written consent of BryoLogyx, and during the remainder of the Term
with respect to commercial sales by Neurotrope, Neurotrope will not market,
offer to sell or sell API as a standalone product by itself, but will only
market, offer to sell or sell API as a component of a drug product in a licensed
clinical application.

 

2.8               Changes to Specifications. If either BryoLogyx or Neurotrope
believes that any Applicable Requirement requires a change to the
Specifications, the Party believing that such change is required will promptly
notify the other Party in writing thereof, in commercially reasonable detail and
thereafter the Parties will in good faith discuss such proposed change to the
Specifications. If BryoLogyx and Neurotrope are unable to reach written
agreement regarding whether, and to what extent, an amendment to the
Specifications is required, then such dispute will be resolved pursuant to
Section 9 of this Agreement.

 

2.9               Records. BryoLogyx will maintain complete and accurate records
developed in the course of its performance under this Agreement and will
maintain such records for the period of time required by Applicable
Requirements, and will make such records available to the FDA and other
applicable regulatory bodies. With the direct participation of BryoLogyx,
Neurotrope may (a) review, but may not make copies of, API manufacturing and
testing records, and may (b) audit and manufacturing facilities, all to the
extent that BryoLogyx has such rights pursuant to the Quality Agreement.
BryoLogyx will, upon the written request of Neurotrope therefor, make available
to the FDA and other applicable regulatory bodies, solely for use by reference
in Neurotrope’s regulatory filings, the CMC section of BryoLogyx’s IND with
respect to the API, and the manufacturer’s Drug Master File, and such other CMC
provisions of BryoLogyx’s IND as are reasonably required in support of
Neurotrope’s regulatory filings.

 

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BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

2.10           Exclusivity. During the term hereof, BryoLogyx will not, directly
or indirectly, including by authorization, license or permission, either itself
or on behalf of or with another person or entity, research, develop, distribute,
commercialize, manufacture, license, sell, or supply synthetic bryostatin-1 to
any party other than Neurotrope as a pharmaceutical ingredient to be used in the
diagnosis, treatment or prevention of neurological or neurodegenerative disease
to the extent governed by the License Agreement between Stanford University and
Neurotrope with respect to the field of use rights granted therein to Neurotrope
for the use of synthetic bryostatin-1 in neurological or neurodegenerative
disease.

 

3.            PRICING; FREIGHT CHARGES; SALES TAXES; INSURANCE; INVOICING;
PAYMENT

 

3.1               Pricing. Neurotrope will pay to BryoLogyx, in cash, for API
ordered by Neurotrope and delivered by BryoLogyx pursuant to this Agreement at
the Unit Price.

 

3.2               Freight Charges; Sales Taxes; Insurance. Neurotrope will pay
freight charges for delivery of API order hereunder to Neurotrope, and any
applicable sales taxes required by law to be charged by BryoLogyx. The cost of
any insurance desired by Neurotrope with respect to any shipment of API
hereunder will be borne by Neurotrope, and Neurotrope will arrange for any such
insurance that it so desires.

 

3.3               Invoicing; Payment. BryoLogyx will invoice Neurotrope upon
shipment of API to Neurotrope. Each invoice will set out the quantity of API
which is the subject of the invoice, the Unit Price, and freight/delivery
charges and applicable sales tax amounts. Neurotrope will pay all invoices in
accordance the payment method will be specified by BryoLogyx in the relevant
invoice, wire transfer to such account and routing instructions as will be set
forth in such invoice, with wiring or other transmission fees to be paid by
Neurotrope, or by check payable to BryoLogyx be sent to the address as indicated
by BryoLogyx in such invoice. Neurotrope will pay all invoiced amounts that are
not in good faith disputed by Neurotrope, within thirty (30) days after
Neurotrope’s receipt of the relevant invoice. The Parties will discuss and
finalize in good faith promptly any amounts invoiced by BryoLogyx to Neurotrope
that are disputed in all good faith by Neurotrope.

 

4.             REGULATORY AGENCY COMMUNICATIONS

 

Each Party will notify the other immediately in writing, in commercially
reasonable detail, if the notifying Party receives any communication from or on
behalf of a Regulatory Agency with respect to API, including without limitation
any notice of any deficiencies noted or otherwise referenced by any Regulatory
Agency with respect to API and/or its manufacture or with respect to any drug
product manufactured from or incorporating API. Reference is hereby made to the
provisions of Section 2.9 hereof, with respect to the availability to FDA and
other applicable regulatory bodies solely for use by reference in Neurotrope’s
regulatory filings the CMC section of BryoLogyx’s IND with respect to the API,
and the manufacturer’s Drug Master File, and such other CMC provisions of
BryoLogyx’s IND, as are reasonably required in support of Neurotrope’s
regulatory filings.

 

5.             Representations and Warranties

 

5.1               General. Each Party represents and warrants to the other Party
that:

 

(a)          Authority. The representing Party has all corporate or other
authority to perform this Agreement and this Agreement has been duly executed
and delivered and constitutes such Party's legal, valid and binding obligation
enforceable against it in accordance with its terms subject, as to enforcement,
to bankruptcy, insolvency, reorganization and other laws of general
applicability relating to or affecting creditors' rights and to the availability
of particular remedies under general equity principles;

 

(b)          No Action or Proceeding. The representing Party is not involved in
any action or proceeding and has not received notice of any threatened action or
proceeding that would jeopardize its performance under this Agreement;

 

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BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

(c)          The execution, delivery and performance by the representing Party
of this Agreement and its compliance with the terms hereof, does not and will
not conflict with or result in a breach of any term of, or constitute a default
under (i) any agreement or instrument binding or affecting it or its property;
(ii) its charter documents or bylaws; or (iii) any order, writ, injunction or
decree of any court or governmental authority entered against it or by which any
of its property is bound;

 

(d)          The representing Party has obtained any consent, approval or
authorization of, or notice, declaration, filing or registration with, any
governmental or regulatory authority required for the execution, delivery and
performance of this Agreement by such Party, and the execution, delivery and
performance of this Agreement will not violate any law, rule or regulation
applicable to such Party; and

 

(e)          Approvals. The representing Party has obtained all necessary
corporate approvals to enter into and execute this Agreement and to perform such
Party’s obligations hereunder.

 

5.2               Additional Representation by BryoLogyx. In addition to its
representations under Section 5.1 hereof, BryoLogyx further represents and
warrants to Neurotrope that BryoLogyx’ method of manufacturing synthetic
bryostatin-1 results in a product that is equivalent in all analytical respects
to natural bryostatin-1 as supplied by the NCI and that each unit of API at the
time of delivery to Neurotrope will conform to the Specifications, be free from
Defects, fit for such products intended use, properly packaged and labeled to
the extent required by law, and be delivered free from any encumbrances.
BryoLogyx represents and certifies that all persons engaged by it to perform
work relating to this Agreement have never been and are not currently debarred
pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335(a), as
amended, or any similar state law or regulation, excluded by the Office of
Inspector General pursuant to 42 U.S.C. § 1320a-7, et seq. or any state agency
from participation in any Federal or state health care program or otherwise
disqualified or restricted by the FDA pursuant to 21 C.F.R. 312.70 or any other
regulatory authority.

 

5.3               Disclaimer. EXCEPT AS PROVIDED IN THIS SECTION 5, NEITHER
PARTY MAKES ANY WARRANTIES, whether EXPRESS, IMPLIED, or STATUTORY, WITH RESPECT
TO THE SUBJECT MATTER HEREOF AND EACH PARTY EXPRESSLY DISCLAIMS ANY SUCH
ADDITIONAL WARRANTIES.

 

6.             Term and Termination

 

6.1               Term. The Term of this Agreement will commence on the
Effective Date and will continue in full force and effect for the Supply Period
unless earlier terminated as provided herein (the “Term”).

 

6.2               Termination for Cause. Either Party may terminate this
Agreement immediately (or in the case of events described in Section 6.2(a)
hereof, after the applicable cure period has elapsed) and without prior written
notice to the other Party, upon the happening of any of the following events of
default, provided that the terminating Party will provide written notice to the
other Party, after such termination, of such termination and of the effective
date thereof, and provided that any termination under this Section 6.2 will be
subject to the provisions of Section 6.4 hereof:

 

(a)                Material Uncured Breach. The other Party materially breaches
any obligation, warranty or representation hereunder of such Party (which will
include without limitation, the failure of the Neurotrope to pay any undisputed
monies when payable hereunder) and such breach is not cured within thirty (30)
days after written notice thereof from the non-breaching Party, setting forth
the nature of the alleged breach in commercially reasonable detail; or

 

(b)                Bankruptcy, Etc. The other Party makes a general assignment
for the benefit of its creditors, suspends business or commits any act amounting
to business failure, voluntarily assigns or transfers all or substantially all
of its property, files a voluntary petition or has an involuntary petition filed
against it seeking its reorganization, adjustment, liquidation, or dissolution
under any present or future law or regulation relating to bankruptcy, which
petition is not dismissed within 90 days, insolvency, relief of debtors or
protection of creditors, termination of legal entities, or has a receiver,
trustee, liquidator, assignee or custodian appointed for it.

 

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BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

(c)                cGMP. BryoLogyx is unable to obtain cGMP certification from
its contract manufacturer by March 31, 2021 and the Parties are unable to agree
in writing to a later date as set forth in Section 2.1.

 

6.3               Termination for Convenience. Until the date that Neurotrope
places its first Additional Order for commercial supply of API, Neurotrope may
not terminate this Agreement, other than for the reasons set forth in Section
6.2 hereof. After the date upon which Neurotrope places its first Additional
Order for commercial supply of API, either Party may terminate this Agreement
for any reason or no reason upon at least six (6) months’ prior written notice
to the other Party, subject to the provisions of Section 6.2 hereof. Any
termination under this Section 6.3 will be subject to the provisions of Section
6.4 hereof.

 

6.4               Effect of Termination.

 

(a)                Fulfillment Of Certain Obligations. Upon any termination of
this Agreement, both Parties will fully perform all of their obligations
hereunder that have accrued through the date of such termination.

 

(b)                Shipment Of API By BryoLogyx To Neurotrope. Upon the
effective date of termination of this Agreement by either party, then, unless
the Parties agree otherwise in writing, BryoLogyx will deliver to Neurotrope all
API in inventory or storage, with respect to the Initial Order and each
Additional Order, and Neurotrope will be required to pay for such API under the
terms for payment set forth in this Agreement.

 

(c)                Transition Assistance. If Neurotrope terminates this
Agreement pursuant to Section 6.2(b) hereof, then BryoLogyx will, at
Neurotrope’s written request, promptly and diligently work with AMRI (formerly
known as Albany Molecular Research Inc.; “AMRI”) to cause AMRI to provide API
directly to Neurotrope under such terms as set forth in the agreement between
BryoLogyx and AMRI until AMRI and Neurotrope enter into their own separate
written agreement for such supply, provided that Neurotrope will pay AMRI
directly for supply of API by AMRI to Neurotrope. BryoLogyx acknowledges that
time is of the essence in BryoLogyx’s performance of this Section 6.4(c) and
will use its commercially diligent efforts to facilitate the transition to AMRI
of API supply to Neurotrope.

 

6.5               Survival. Notwithstanding anything herein to the contrary,
termination of this Agreement by a Party will be without prejudice to other
remedies such Party may have at law or equity. Sections
1, 2.8, 4, 6.4, 6.5, 7, 8, 9 and 10 hereof, and all liabilities that accrue
during the Term, will survive expiration or termination of this Agreement and
will continue to be enforceable.

 

7.            Intellectual Property Rights

 

Each Party will retain, and no license or other right is granted to the other
Party with respect to, such first Party’s intellectual property rights, however
arising, including any intellectual property rights of the relevant Party which
may arise after the Effective Date, and including without limitation any such
intellectual property rights with respect to bryostatin in any form or
formulation, and further provided that the Parties do not intend to conduct with
each other during the Term any research and development activities related to
bryostatin in any form or formulation and that any such collaborative activities
will be the required to be set forth in and governed by a separate written
agreement between the Parties with respect thereto.

 

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BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

8.            Confidentiality

 

8.1               Confidentiality. The Parties are parties to that certain
Mutual Confidentiality Agreement dated as of April 13, 2018 (the “CDA”).
BryoLogyx and Neurotrope each acknowledge and agree that they have been and will
be in a confidential relationship to the other Party pursuant to this Agreement
and that each has gained and will gain knowledge that comprises valuable trade
secrets and other confidential information of the other Party, including
customer lists, other customer data and information, sales and marketing data
and information, technical data and information, Processing information,
Intellectual Property, and other data and information concerning API, including
the Specifications, or the Party’s respective businesses, all of which,
including without limitation the Quality Agreement as confidential information
of BryoLogyx, constitutes confidential information of the relevant Party under
the CDA, and the Parties’ use of such information will be governed by the CDA
and this Agreement.

 

8.2               Public Announcements. Neither Party will advertise, issue any
press release, post any image or make any other public statement, including
without limitation any disclosure requirements of Neurotrope under applicable
securities laws, regarding or relating to the Parties’ relationship pursuant to
this Agreement, including the terms and conditions of this Agreement, without
the other Party’s express prior written approval, which will not be unreasonably
or untimely withheld or denied.

 

9.           DISPUTE RESOLUTION.

 

Any claim arising out of or relating to this Agreement or the validity,
enforcement, or breach thereof, will be first referred by either Party, in
writing to the other Party, simultaneously to the President or Chief Executive
Officer the other Party, which individuals will promptly and in good faith
discuss and attempt to resolve such matter, including in such discussion the
possibility of mediation or arbitration, provided that if after such good faith
discussion the matter is not successfully resolved, each Party will have the
right to pursue such judicial remedy or remedies as are available to it.

 

10.         Miscellaneous

 

10.1           Limitation of Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE
FOR LOSS OF PROFITS, LOSS OF REVENUE OR INCOME, LOSS OF BUSINESS REPUTATION OR
OPPORTUNITY, OR OTHER INDIRECT, INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES
UNDER THIS AGREEMENT, EXCEPT FOR DAMAGES CAUSED BY (A) A BREACH OF SECTION 8
(CONFIDENTIALITY) HEREOF, OR (B) A PARTY’S GROSS NEGLIGENCE, MISCONDUCT OR
VIOLATION OF LAW, OR (C) BRYOLOGYX’S BREACH OF SECTION 2.10 HEREOF.

 

10.2           Governing Law. This Agreement and all actions arising out of or
in connection with this Agreement will be governed by and construed in
accordance with the laws of the State of California, without regard to the
conflict of laws provisions thereof or of any other state and provided that the
UNCISG will not apply to this Agreement.

 

10.3           Independent Contractors. The relationship between Neurotrope and
BryoLogyx hereunder will be that of independent contractors, and nothing in this
Agreement will be deemed to constitute a joint venture, partnership, agency or
employer/employee arrangement between the Parties. Neither Party will have any
authority or power to bind the other Party or to contract in the name of, or
make any representations or warranties, express or implied, on behalf of the
other Party, or otherwise create any liability against the other Party in any
way for any purpose.

 

10.4           Force Majeure. The Parties hereto will not be responsible for any
loss or breach due to delay in delivery or performance hereunder caused by
causes outside of such Party’s reasonable control which may include governmental
regulations, controls or directions, outbreak of a state of emergency,
hostilities, civil commotion, riots, epidemics, acts of God, other natural
casualties, fires, strikes, or walkouts or other similar unforeseeable cause or
causes not caused by the affected Party’s negligence. In the event that any
Party will be delayed in, or prevented from, performing its obligations under
this Agreement as a result of any of the foregoing, such Party will promptly
notify the other Party of such delay or cessation in performance. In the event
that such Party is unable to resume performance hereunder within sixty (60) days
after the date on which its performance was suspended, the other Party will have
the right to terminate this Agreement upon at least ten (10) days prior written
notice to the non-performing Party.

 

10.5           Assignment. Neither Party may assign this Agreement without the
prior written consent of the other Party, which consent will not be unreasonably
withheld, delayed or conditioned; provided, however, that each Party may assign
this Agreement without the consent of the other Party to a successor to all or
substantially all of such Party’s business or assets relating to this Agreement
whether by sale, amalgamation, merger, operation of law or otherwise. The Party
assigning this Agreement will notify the other Party in writing promptly (but in
no event more than ten (10) days) after such assignment, which notice will
include the name and address of the assignee, and provided that it will be a
condition of any such assignment that the assignee agrees in writing
specifically for the benefit of the non-assigning Party to fully assume and
discharge the remaining undischarged obligations of the assigning Party. Any
assignment in violation of this Section 10.5 will be null and void.

 

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BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

10.6           Counting Of Time. Whenever days are to be counted under this
Agreement, the first day will not be counted and the last day will be counted.

 

10.7           Notices. All notices, consents and other formal or legal
communications hereunder to any Party will be deemed to be sufficient if
contained in a written instrument delivered in person, including delivery by
recognized express courier, fees prepaid, or sent by electronic mail with
confirmed receipt (“email”) in each case addressed as set forth below such
Party’s signature below, or to such other address as may hereinafter be
designated in writing by the recipient to the sender pursuant to this Section
10.7. Notices hereunder may not be sent by facsimile or by mail. All such
notices, consents and communications will be deemed to have been received in the
case of personal delivery, including delivery by express courier, on the date of
such delivery, or in the case of email transmission, upon confirmation of
transmission.

 

10.8           No Waiver. No failure to delay on the part of either Party in
exercising any right or remedy hereunder will operate as a waiver thereof, nor
will any single or partial exercise of any such right or remedy preclude any
other or further exercise thereof or of any other right or remedy. No provision
of this Agreement may be waived except in a writing signed by the Party granting
such waiver.

 

10.9           Expenses. Each Party will, except as otherwise set forth
specifically in this Agreement bear such Party’s own fees and expenses incurred
with respect to the negotiation and execution of this Agreement and with respect
to the transactions contemplated hereby.

 

10.10        Severability. If any Section, or portion thereof, of this Agreement
is held invalid by reason of any law, statute, or regulation existing now or in
the future in any jurisdiction by any court of competent authority or by a
legally enforceable directive of any governmental body, such section or portion
thereof will be validly reformed so as to approximate the intent of the Parties
as nearly as possible and, if unreformable, will be deemed divisible and deleted
with respect to such jurisdiction, but the Agreement will not otherwise be
affected.

 

10.11        Further Actions and Documents. Each Party will execute, acknowledge
and deliver all such further instruments, and to do all such further acts, as
may be reasonably necessary or appropriate to carry out the intent and purposes
of this Agreement.

 

10.12        Entire Agreement; Amendment. This Agreement, together with the CDA,
constitutes and contains the entire understanding and agreement of the Parties
respecting the subject matter hereof and cancels and supersedes any and all
prior and contemporaneous negotiations, correspondence, understandings and
agreements between the Parties, whether oral or written, regarding such subject
matter. If the terms of this Agreement conflict with any order, the terms of
this Agreement will control and prevail, and no terms, provisions or conditions
of any purchase order, invoice or other business form or written authorization
used unilaterally (as opposed to matters agreed to in writing by the Parties
together as provided herein) by either Party as to the matters governed by this
Agreement will have any effect on the rights, duties or obligations hereunder or
otherwise modify this Agreement. No agreement or understanding varying or
extending this Agreement will be binding upon either Party, and no amendment
hereto, will be valid unless set forth in a writing which specifically refers to
the Agreement and the relevant matter, and that is signed by duly authorized
officers or representatives of the respective Parties, and the provisions of the
Agreement not specifically amended thereby will remain in full force and effect.
Nothing in this Agreement removes or overrides any right of action by any Party
in respect of any fraudulent misrepresentation, fraudulent concealment or other
fraudulent action by the other Party. This Agreement binds the Parties’
successors and permitted assigns. In the event of a conflict between the terms
of this Agreement and the Quality Agreement, the terms of the Quality Agreement
will govern with respect to quality and technical terms, and the terms of this
Agreement will govern all other matters.

 

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BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

10.13        Construction; References. This Agreement has been negotiated by the
Parties and their respective counsel. This Agreement will be fairly interpreted
in accordance with its terms and without any strict construction in favor of or
against any Party, and any ambiguity will not be interpreted against the
drafting Party. References to “Sections” herein are to Sections hereof.

 

10.14        Counterparts. This Agreement may be executed in counterparts, each
of which will be deemed an original, but which together will constitute one and
the same instrument. Any signature page delivered by electronic image
transmission, including without limitation a PDF by email, will be binding to
the same extent as an original signature page.

 

[Signature page follows]

 

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BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

  

IN WITNESS WHEREOF, the Parties have caused their duly authorized
representatives to execute this Agreement.

 

Neurotrope bioscience, Inc. BRYOLOGYX INC.     By: /s/ Robert Weinstein By:  /s/
Thomas M. Loarie Robert Weinstein Thomas M. Loarie Chief Financial Officer Chief
Executive Officer Date signed:  June 9, 2020 Date signed:  June __, 2020

Address: Attention: CFO Address:  Attention:  CEO   1185 Avenue of the Americas
  2485 Holly Oak Drive   New York, NY 10036   Danville, CA 94506-2043   Email:
rweinstein@neurotropebioscience.com   Email:  tloarie@bryologyx.com

 

 

 

 

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BryoLogyx/Neurotrope—Bryostatin-1 Supply Agreement

 

EXHIBIT A

 

SPECIFICATIONS

 

[Note: These are initial specifications as at the Effective Date, and are to be
updated with completion of analytical method development to confirm final
specifications and provided that such updated specification will be set forth on
this Exhibit A at such time, as an automatic amendment of this Exhibit A.]

 

Test Description Acceptance Criteria   Physical description Visual Assessment
White to off-white   Identity 1H NMR Conforms to structure   HPLC Sample
retention time corresponds to  reference marker retention time (Ratio agreement
0.95 – 1.05)   Chemical Purity (% area) HPLC NLT 96.0%   Optical rotation
Polarimeter Report results     Potency (%w/w) Quantitative NMR 96-104%  
Individual and Total Related Substances (% area) HPLC
Specified  and  Unspecified Impurities: report   Total Impurities: NMT 4.0%  

Residual Solvents l

GC t-Butylmethylether: NMT 5000 ppm   Dicholoromethane: NMT 600 ppm  
Ethylacetate : NMT 5000 ppm   n-Heptane: NMT 5000 ppm   Methanol: NMT 3000 ppm  
Tetrahydrofuran: NMT 720 ppm   Toluene : NMT 890 ppm   Melting Point (°C) DSC
Report   Water Content (%) Karl Fisher Report results (%)   Microbial (cfu/g)
USP

Total Aerobic Microbial Count: NMT 103

Total Yeast and Mold Count: NMT 102

 

 

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