DEVELOPMENT AGREEMENT Made and entered into on the ____ day of January 31, 2006 Between - Neuro-Hitech Pharmaceuticals, Inc. Formerly: Marco Hi-Tech JV Ltd of 369 One Penn Plaza New York. NY 10019 (hereinafter called "Hi-Tech") and Org Syn Laboratory,...
Made
and
entered into on the ____ day
of
January 31, 2006
Between
-
Neuro-Hitech
Pharmaceuticals, Inc.
Formerly:
Marco Hi-Tech JV Ltd
of
000
Xxx Xxxx Xxxxx
Xxx
Xxxx.
XX 00000
(hereinafter
called "Hi-Tech")
and
Org
Syn Laboratory, Inc.
Of
0000
Xxxx Xxxxxxxx Xxxx Xxxxx,
Xxxxxxx,
Xxxxxxxx 00000
(hereinafter
called "OrgSyn")
SUBJECT
Hi-Tech
agrees to engage OrgSyn Laboratory, Inc. for the development of
Synthetic Huperzine
A (hereinafter referred to as "the Product") for
the
US and Wordwide market
(hereinafter referred to as the "Hi-Tech Territory"). Org-syn
agrees to develop the Product exclusively for Hi-Tech.
1.
|
COMPENSATION
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1.1.
|
In
return for the development work specified in Attachment A, Hi-Tech
agrees
to pay fees in
US Dollars as per the Summary Table of Attachment A. It
is agreed and understood by both
sides that this agreement covers execution of work specified in
the scope of work (see
Attachment A).
|
Orgsyn
will raise an invoice for the amount due in accordance with
Summary Table upon receipt
of Deliverables and Hi-Tech shall make the payment of the said invoice
amount within 45
days
from the date of invoice as per the details mentioned in the said
invoice. All above payments
will be exclusive of taxes.
Per
summery table, start-up funds will be invoiced immediately upon signatures
of
the
present development
agreement. Work will commence upon payment of the invoice
for the start-up funds.
2.
|
DUTIES
OF
ORGSYN
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2.1
|
OrgSyn
shall be responsible for managing the development work and performing
all activities
necessary to provide Hi-Tech with all the information it
requires to file the Chemistry
Manufacturing and Controls (CMC) Section of an NDA for the Product
with the
FDA. Orgsyn will address all questions and deficiencies related
to
its part in the CMC
section of the NDA within a reasonable
time.
|
The
duties of ORGSYN shall include:
2.2
|
Synthetic
process of Huperzine A shall be developed by Orgsyn as per the
scope
of work outlined in Attachment A
provided.
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2.3
|
Source
raw materials for the product.
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1
2.4
|
Establish
specifications and test methods for the raw materials. For pharmacopeal
monographs
materials, the USP monograph should be used, and other tests should
be
included as appropriate. All non-pharmacopeal substances must have
a
current active
DMF within the FDA and the DMF specifications are to be used. For
the API
and
related substances the assay should be validated by the
OrgSyn.
|
2.5
|
Manage
and supervise the production of scale up batches of the
Product.
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2.6
|
During
the development period, prepare and submit to Hi-Tech monthly progress
reports, based on an mutually agreed
schedule.
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2.7
|
Assemble
all relevant chemistry manufacturing and controls data (except
for those
directly related to the submission batches that will be produced
by
Hi-Tech) necessary for the
submission.
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2.8
|
Provide
CMC section of the pharmaceutical development report for submission
purposes.
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2.9
|
Provide
in a timely manner responses to all US FDA issues, questions and
comments
following screening and/or review of chemistry manufacturing data
including additional tests or development work that will be
requested.
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2.10
|
Validate
all analytical methods that require validation. These methods include
all
assay tests for the active and its related
substances.
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2.11
|
OrgSyn
will be responsible for the purity of chemicals used in the
synthesis.
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2.12
|
If
required, OrgSyn will work with outside analytical lab to develop
validayed analytical methods such as HPLC, OrgSyn will use the
method and,
in turn, determine whether our drug substance meets the purity
criteria,
and then OrgSyn submits the drug substance to the analytical laboratory
for an independent confirmation of the purity and then
releases.
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3.
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COORDINATION
|
Orgsyn
and Hi-Tech shall appoint co-ordination committee for smooth working of the
development
project and to monitor development work at every stage. The said committee
shall periodically inspect the report of the development, identify problems
and
deficiencies, if any, and rectify the said defects or deficiencies at every
stage.
4.
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TERMS
AND TERMINATION
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4.1
|
This
Agreement shall continue in effect until the end of the development
program, unless terminated earlier pursuant to this
Section.
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4.2
|
Either
party shall have the right to terminate this Agreement immediately
upon
written notice to the other party if: (i) a petition is filed by
or
against the other party in bankruptcy, for the appointment of a
receiver,
or in reorganization under the provisions of any applicable bankruptcy
law; or (ii) the other party makes any assignment for the benefit
of
creditors.
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4.3
|
Either
party shall have the right to terminate this Agreement immediately
upon
written notice to the other party if the other party is in material
breach
of any of the terms of this agreement and fails to remedy such
breach
within ninety days after written notice of such
breach.
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2
4.4
|
Hi-Tech
shall have the right to terminate this Agreement upon written notice
to
Org-Syn
if OrgSyn fails to achieve any Milestone as set up in Attachment
A within
60 days
of
the deadlines above or on mutually agreed upon time
lines.
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5.
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PROPRIETORY
RIGHT TO DEVELOPMENT DATA
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5.1
|
Hi-Tech
will have ownership rights in the Hi-Tech Territory to the data
generated
by OrgSyn. OrgSyn agrees to assist in obtaining patents for Hi-Tech
for
the data generated
by OrgSyn.
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6.
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CONFIDENTIALITY
|
Each
party will hold proprietary information and will not, without the prior written
consent
of the other (or as expressly provided for in this Agreement), use or disclose
it
in
whole or in part to any Person other than for the purposes set forth in this
Agreement
for a period ending five (5) years following expiration or termination of
this
Agreement.
Each party will be entitled to disclose any such Confidential Information
to
such
of its Affiliates, professional advisers, directors, managers, officers and
employees
who are directly concerned with this Agreement and its implementation
and
whose
knowledge of such information in the opinion of the disclosing party is
necessary
for these purposes. Each party will use its reasonable efforts to ensure
that
each
individual to whom such a disclosure is made adheres to the terms of this
undertaking
as if he or she were a party hereto. Each party may disclose such Confidential
Information to the extent such disclosure is required by law; provided,
however,
that
the
disclosing party shall (to the extent permitted) give the other party prior
notice of such required disclosure and cooperate with such other party in
order
that
such
other party may seek a protective order or relief to prevent or limit the
Confidential
Information required to be disclosed; provided,
further, that
the
disclosing party
shall only disclose that portion of the Confidential Information that such
party
is advised
by its legal counsel is required to be disclosed by law and shall seek
assurances
that such Confidential Information will be maintained in confidentiality
by the
receiving party. For purposes of this Agreement, the existence of this Agreement
and
its
terms and conditions shall deemed Confidential Information of each
Party.
7.
|
REPRESENTATIONS
AND WARANTIES
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7.1
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Mutual
Representations and Warranties of Hi-Tech and
UNIQUE
|
Each
of
Hi-Tech and OrgSyn hereby represents and warrants to the other party as
follows:
(a)
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Organization. Such
party is duly organized, validly existing and in good standing
under the laws of the jurisdiction of incorporation or organization.
Such
party has the requisite legal and corporate power and authority
to
conduct
its business as presently being conducted and as proposed to be
conducted
by it and is duly qualified to do business in those jurisdictions
where
its ownership of property or the conduct of its business
requires.
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(b)
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Authority. Such
party has all requisite legal and corporate power and authority
to enter into this Agreement and to perform the services contemplated
hereunder (including, in the case of Hi-Tech, the manufacture of
the Product). All corporate actions on the part of such party,
the boards
of director
or managers, or similar governing body of such party (i) the
authorization, execution, delivery and performance by such party
of this
Agreement,
and (ii) the consummation of the transactions contemplated
hereby,
have been duly taken.
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3
(c)
|
Binding
Obligation. This
Agreement is a legally valid and binding obligation of
such party, enforceable against such party in accordance with its
terms
(except
in all cases as such enforceability may be limited by applicable
bankruptcy,
insolvency, reorganization, moratorium, or similar laws affecting
the
enforcement of creditors' rights generally and except that the
availability of
the equitable remedy of specific performance or injunctive relief
is
subject to
the discretion of the court before which any proceeding may be
brought).
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(d)
|
No
Conflicts. None
of the execution and delivery of this
Agreement,
the consummation
of the transactions provided for herein or contemplated hereby,
or the fulfillment by such party of the terms hereof or thereof,
will
(with
or without notice or passage of time or both) (i) conflict with
or result
in a breach
of any provision of the certificate or articles of incorporation
or
formation,
by-laws, statutes, operating agreement or other governing documents
of such party, (ii) result in a default, constitute a default under,
give
rise to any right of termination, cancellation or acceleration,
or require
any
consent or approval (other than approvals that have heretofore
been
obtained)
of any governmental authority or under any of the terms, conditions
or
provisions of any material note, bond, mortgage, indenture, loan,
arrangement,
license, agreement, lease or other instrument or
obligation
to which
such party is a party or by which its assets may be bound, or (iii)
violate
any law or regulation applicable to such party or any of its
assets.
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(g)
|
Consents
and Approvals. All
material consents, approvals, qualifications, orders
or authorizations of, filings with, or notices to any governmental
authority
or any other Person required in connection
with
such party's execution,
delivery or performance of (i) this Agreement, and (ii) the consummation
of any other transaction contemplated on the part
of
such party
hereby have been obtained, made or
given.
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(h)
|
No
Violation of Law; Permits. Orgsyn
and Hi Tech in USA are not in violation of
any law or regulation (nor is such party aware of any violation
of any law
or regulation
by any other Person), which violation could reasonably be expected
to adversely affect such party's performance of its obligations
hereunder
or the ability of the other party to realize the intended benefits
to
such
other party under this Agreement, and, except as otherwise contemplated
hereby, such party holds each of the licenses, permits, approvals
or authorizations necessary with respect to its current business
and
operations (and its rights and obligations contemplated hereby)
in
compliance
with all laws and regulations.
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8.
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INDEMNIFICATION
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Orgsyn
shall indemnify, defend, save and hold Hi-tech harmless from and against
all
claims
of
third parties brought in the United States and Worlwide and all associated
losses
to
the extent resulting from or arising out of any claim concerning the Products
development
or formulation. This indemnity clause shall survive termination or expiry
of
the
Agreement.
9.
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ARBITRATION
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9.1
|
All
claims, disputes and other matters arising in connection with this
Agreement or the performance
thereof, including but not limited to questions as to
whether
a mailer is governed
by this arbitration provision, shall be subject exclusively to
and finally
settled
under
the rules of conciliation and arbitration under the auspices of
the
AAA
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9.2
|
Reasonable
discovery and production of evidence shall be allowed in arbitration,
and
the
Parties agree to accept the decision of the Arbitrator regarding
discovery
and production of documents;
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4
9.4
|
The
costs and fees of the arbitration, including reasonable attorneys'
fees,
shall be allocated by the arbitrator or
arbitrators.
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9.5
|
The
award rendered in arbitration shall be final, and judgment may
be entered
in accordance with applicable law and in any court having jurisdiction
thereof. Notwithstanding the foregoing provisions, all rights
of
termination of this Agreement conferred upon either or both of
the Parties
hereto may be exercised by such Parties without first submitting
the
matter-tor arbitration.
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10.
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ENTIRE
AGREEMENT, AMENDMENTS
|
Subject
to all mutually agreed price lists and all modifications thereof made in
conformity
with the provisions hereunder, the present Agreement and all Exhibits and
Schedules
attached hereto, constitute the entire agreement between the Parties and
supersede
all prior agreements, letters of intent, understandings, agreements,
representations, warranties or other provisions, express or implied, relating
to
the subject
matter of the present Agreement, except as herein provided, and no amendment
or waiver of any provision thereof shall be binding on the Parties or either
of
them
unless consented to in writing by the Party against whom the amendment or
waiver
is
to be enforced.
11.
|
WAIVER
|
The
Parties hereto mutually covenant and agree that a waiver by either Party
of a
breach
of
any of the terms of this Agreement by the other Party shall not be deemed
a
waiver
of
any subsequent breach of the terms of this Agreement.
12.
|
SEVERABILITY
|
If
any
provision of the present Agreement should be determined by a tribunal of
competent
jurisdiction to be invalid, illegal or unenforceable in any respect, such
determination
shall not impair or affect the validity, legality or enforceability of the
remaining
provisions hereof, and each provision of the present Agreement is to be
considered separate, severable and distinct, except those which are an integral
part of
or are
otherwise clearly inseparable from such invalid or unenforceable part or
provision.
13.
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APPLICABLE
LAW
|
The
present Agreement shall be construed, interpreted and enforced in accordance
with,
and
respective rights and obligations of the Parties
shall
be
governed by, the laws
of
the State of New York and all proceedings shall be conducted in the first
instance
in New York City.
14.
|
RESTRICTED
RELATIONSHIP
|
Nothing
in this Agreement shall be deemed or construed to constitute between the
Parties
the relationship of principal and agent, nor to create any partnership, joint
venture
or other form of legal association of any nature whatsoever. Neither Party
is
hereby
constituted a legal representative of the other Party fo rany purpose
whatsoever;
and neither is granted any right or authority hereunder to assume or
create,
whether in writing or otherwise, any obligation or responsibility, express
or
implied,
or to make any representation, warranty or guarantee, or otherwise to act
in
any
manner in the name of the other Party.
5
15.
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CLINICAL
STUDIES
|
15.1.
|
Hi-Tech
and
Orgsyn
will
work
jointly to monitor clinical bridge studies to show bioequivalence
to Natural Huperzine A as required by the US FDA for the marketing
approval
of the Product as an NDA.
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16.
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COUNTERPARTS
|
This
agreement may be executed in identical duplicate counterparts. Each identical
counterpart shall be deemed an original, but all of which together shall
constitute one and
the
same instrument.
17.
|
ENUREMENT
|
The
within Agreement shall enure to and be binding upon the parties hereto, their
successors
and assigns.
IN
WITNESS WHEREOF,
each of
the Parties hereto has caused this Agreement to be
duly
executed by its duly authorized representative.
Neuro
Hi-Tech Pharmaceuticals,
Inc.
|
OrgSyn
Laboratory, Inc.
|
|
/s/
Xxxxxx
Xxxxxxx
|
/s/
Xxxxxxxx X.
Xxxxxxxxx
|
|
Name:
Xxxxxx
Xxxxxxx
|
Name:
Xxxxxxxx X.
Xxxxxxxxx,
Ph.D.
|
|
Title:
President
|
Title:
President
&
CEO
|
|
Date:
|
Date:
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6
Attachment
A
The
project consists of three components
1.
|
GMP
Synthesis of 80-100 gs of Huperzine A Using the Racemic
Synthesis
Method
|
2.
|
Pre
GMP Synthesis and Analytical Work
|
3.
|
New
Asymmetric Synthesis
|
Each
will
be discussed individually in terms of cost (start up and balance), timelines
(start date and delivery date) and deliverables.
1. GMP
Synthesis of 80-100 gs of Huperzine A Using
the Racemic Synthesis
Method
We
will
synthesize 80-100 grams Huperzine A using the racemic synthesis. This will
be
done under GMP condition and the product will be suitable for clinical
trials.
The
cost
is $135,328.00 and 50% will be the start up amount, that is, $67,664.00
at signing the contract. The delivery date will be seven months from
signing the contract.
The
deliverable is 80-100gs of Huperzine A.
2. Pre-GMP
Synthesis and
Analytical Work
Concurrent
with the 80-100 gs GMP synthesis of task 1, above, we will be
developing
all that is required for the GMP synthesis. It is possible to do this
because
the non-GMP steps in the 80-100 gs synthesis of item 1 will be
initiated
concurrently with the development of GMP synthesis.
There
are
two components to this item. The first is the Master Batch Record synthesis.
The cost is $67,666.64 of which 50% start up funds are needed ($33,833.32)
at signing of the contract.
The
second component is the development of analytical methodology to support
the GMP synthesis. The cost is $43,550.00 of which 50% ($21,750.00)
is required at signing of contract.
The
deliverable is the Master Batch Record, the analytical data and a certificate
of
analysis for the GMP product. Both tasks will require 6 months.
3. New
Asymmetric Synthesis
We
will
devise a new asymmetric synthesis for Huperzine A. The cost is $173,000.00
with 50% on signing $86,500.00. The discrepancy between $185,000.00
(in the proposal) and $173,000.00 is that many of the chemicals
for the racemic synthesis can be used
in the
new
synthesis. Therefore,
we will not include an additional charge of $12,000.00 for chemicals.
We
will
need $86,500.00 for start up funds at the time of signing and 6 months
will be required.
The
deliverable is a new synthesis of Huperzine A which is
patentable.
SUMMARY TABLE
GOALS
|
TIMELINE
|
DELIVERABLES
|
COST
|
|
Start
Date
|
Delivery
Date
|
$
(US DOLLARS)
|
||
1. GMP
Synthesis
of
80-100 gs Of
Huperzine
A Using
the
Racemic
Synthesis
Method
|
Date
of
contract
signing
|
7
months from
contract
signing
|
80-100
gs of GMP
Huperzine
A
|
Start
up funds of
67,644.00
Balance
67,644.00
Total
135,328.00
|
2. Pre-GMP
Synthesis
and
Analytical
Work
|
Date
of
contract
signing
|
6
months from
contract
signing
|
Master
Batch
Record,
the
analytical
data and
a
certificate
of
analysis
for the
GMP
product.
|
Component
1
Start
up funds of
33,833.32
Balance
33,833.32
Total
67,666.64.
Component
2
Start
up funds of
21,750.00
Balance
21,750.00
Total
43,500.00
|
3. New
Asymmetric
Synthesis
|
Date
of
contract
signing
|
6
months from
contract
signing
|
New
synthesis of
Huperzine
A
|
Start
up funds of
86,500.00
Balance
86,500.00
Total
173,000.00
|