DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT
CONFIDENTIAL
TREATMENT - Asterisked material has been omitted and filed separately with
the
Securities and Exchange Commission pursuant to a request for confidential
treatment.
This
Development, Manufacturing and Supply Agreement (the “Agreement”), dated this
28th
day of
April, 2006, is made between Cure Therapeutics, Inc. ("CTI"), and Hercon
Laboratories Corporation, a Delaware corporation ("Hercon").
RECITALS
A.
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CTI
owns or has licensed certain patented technology (US Patent # * and
# *,
Applications # * and # * and PCT Application # *), relating to the
use of
* to treat overuse * (as defined below, the “Clinical Trial
Products”).
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B.
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Hercon
will perform development and related manufacturing services for CTI
leading to the manufacture of Clinical Trial
Products.
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In
consideration of the foregoing premises, and the mutual covenants and
obligations set forth herein, CTI and Hercon hereby agree as
follows:
ARTICLE
1
DEFINITIONS
1.1
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“Affiliate”
shall mean, with respect to any party, any person or entity which,
directly or indirectly through one or more intermediaries, controls,
is
controlled by, or is under common control with, such party. A person
or
entity shall be deemed to control a corporation (or other entity)
if such
person or entity possesses, directly or indirectly, the power to
direct or
cause the direction of the management and policies of such corporation
(or
other entity) whether through the ownership of voting securities,
by
contract or otherwise.
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1.2
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“Nitroglycerin
Adhesive Mixture”
shall mean the adhesive mixture containing nitroglycerin as the active
ingredient sourced from a third party base
supplier.
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1.3
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“Clinical
Trial Products”
shall mean the formulations, and only such formulations as supplied
by
CTI, of Nitroglycerin Adhesive Mixture in such strengths as shall
provide
for delivery of * mg/hour to * mg/hour of GTN (glyceryl trinitrate)
(and
such other delivery strengths as the Parties may agree upon in writing)
in
patch form for transdermal administration to meet the Product
Specifications.
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1.4
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“Product
Specifications”
shall mean the specifications for the Clinical Trial Products as
shall be
mutually agreed between the parties in writing and attached as Exhibit
A
hereto, and shall include (as applicable) statements of pharmaceutical
manufacturing, filling, storage and quality control procedures, and
labeling and packaging specifications (as such may be revised from
time to
time in accordance with the terms of this Agreement by written agreement
executed by the parties).
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1.5
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“Confidential
Information”
shall mean, with respect to a party, all information of any kind
whatsoever (including without limitation, the Intellectual Property,
data,
compilations, formulae, models, patent disclosures, procedures, processes,
projections, protocols, results of experimentation and testing,
specifications, strategies and techniques), and all tangible and
intangible embodiments thereof of any kind whatsoever (including
without
limitation, apparatus, compositions, documents, drawings, machinery,
patent applications, records and reports), which is disclosed by
such
party to the other party and is marked, identified as or otherwise
acknowledged in written or tangible form to be confidential at the
time of
disclosure to the other party. Notwithstanding the foregoing, Confidential
Information of a party shall not include information which the other
party
can establish by written documentation (a) to have been publicly
known
prior to disclosure of such information by the disclosing party to
the
other party, (b) to have become publicly known, without fault on
the part
of the other party, subsequent to disclosure of such information
by the
disclosing party to the other party, (c) to have been received by
the
other party at any time from a source, other than the disclosing
party,
rightfully having possession of and the right to disclose such
information, (d) to have been otherwise known by the other party
prior to
disclosure of such information by the disclosing party to the other
party,
or (e) to have been independently developed by employees or agents
of the
other party without the use of such information disclosed by the
disclosing party to the other
party.
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1.6
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“Drug
Master File”
shall mean the Drug Master File for manufacturing the active
pharmaceutical ingredient or other raw materials used in the Clinical
Trial Products, filed with the FDA, and the equivalent filing with
any
other country, as same may be amended from time to
time.
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1.7
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“FDA”
shall mean the United States Food and Drug Administration, and any
successor agency thereto.
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1.8
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“GMP”
shall mean current Good Manufacturing Practices promulgated by the
FDA,
and their equivalent promulgated by the governing health authority
of any
other country in which the Clinical Trial Products manufactured by
Hercon
under this Agreement are to be sold by CTI, as the same may be amended
from time to time.
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1.9
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“Intellectual
Property”
shall mean rights, including, without limitation, any licensed rights,
existing as of the date hereof and as may be developed hereafter
in and to
all confidential or proprietary information, trade secrets, patent
rights,
technology, know-how, developments, improvements, techniques, data,
methods, processes, instructions, formulae, recipes, drawings and
specifications necessary to manufacture and supply the Clinical Trial
Products hereunder.
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1.10
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“Label”,
“Labeled”
or “Labeling”
shall mean (i) all labels and other written, printed or graphic matter
upon the Clinical Trial Products or upon any container or wrapper
utilized
with the Clinical Trial Products, or (ii) any written material
accompanying the Clinical Trial Products, including, without limitation,
package inserts.
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2
1.11
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“Limited
Warranty”
shall have the meaning defined in Section 4.4(c)
hereof.
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1.12
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“Packaging”
shall mean all primary containers, cartons, shipping cases or any
other
like matter used in packaging or accompanying the Clinical Trial
Products.
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1.13
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“Parties”
shall mean CTI and Hercon and their respective successors and assigns.
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1.14
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“Person”
shall mean 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.
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1.15
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“Product
NDA”
shall mean the New Drug Application relating to the Clinical Trial
Products as may be filed with the FDA by CTI, and any supplements
thereto.
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1.16
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“Regulatory
Dossiers”
shall mean all registrations, permits, licenses, authorizations,
approvals, presentations, notifications or filings (together with
all
applications therefor), if any, which are filed with or granted by
the
governing health authority of any country, including the FDA, and
which
are required to develop, make, use, sell, import or export the Clinical
Trial Products, other than the Drug Master
File.
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1.17
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“Territory”
shall mean the United States of America (including all of its states,
Puerto Rico, the District of Columbia, and all territories, dependencies,
and possessions of the United States) and such additional countries
as may
be added from time to time by mutual written agreement of the parties
hereto.
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1.18
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“Process”
or “Processing”
shall mean the act of manufacturing, handling, storing, analyzing,
testing, filling, finishing, packaging, inspecting, labeling and
preparing
for shipment of Clinical Trial Products by Hercon pursuant to this
Agreement and shall include, without limitation, optimization of
the
formulation of or process by which the Clinical Trial Products are
made.
Processing shall also include all tasks and services set forth on
Exhibit
B hereto.
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ARTICLE
2
OBLIGATIONS
2.1
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Obligations
of Hercon.
Hercon shall perform all Processing, including all tasks and services
set
forth on Exhibit B hereto, in accordance with this Agreement. Without
limiting the generality of the foregoing, Hercon’s obligations shall
include the following:
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(a)
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Regulatory
Compliance.
Promptly upon execution of this Agreement, Hercon shall apply for
or
extend, and throughout the term of this Agreement Hercon shall maintain
and remain in compliance with, all Regulatory Dossiers required in
the
Territory for Hercon’s Processing of the Clinical Trial Products
hereunder, including all necessary licenses, permits and approvals
required by the FDA and/or other regulatory agencies in connection
with
the manufacture, filling, packaging, storage, and shipment of the
Clinical
Trial Products.
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3
(b)
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Reporting.
Hercon shall keep CTI fully informed of the status of the Processing
of
the Clinical Trial Products including providing written reports at
reasonable frequencies to CTI upon request, stating in reasonable
detail
all efforts made and in process, and all significant progress achieved
and
material difficulties encountered in the Processing of the Clinical
Trial
Products since the last such report. In addition, verbal reporting
can be
regularized, such as every week or every other week, upon CTI’s request.
Hercon shall (i) provide CTI with access to all technical information
employed in or arising out of Hercon’s Processing of the Clinical Trial
Products; and (ii) provide such other information concerning the
Processing of Clinical Trial Products as CTI shall reasonably request.
Hercon will designate a primary project contact with respect to the
Clinical Trial Products throughout the performance of the Processing
of
the Clinical Trial Products pursuant to this Section 2.1 to answer
any
reasonable questions from CTI.
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(c)
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Generation
and Maintenance of Data and Records for Product NDA Filing and as
Required
by Law.
Hercon shall be responsible for generation and maintenance of all
product
manufacturing related data required for the filing by CTI of the
Product
NDA with the FDA, including, without limitation, data relating to
product
specifications, analytical methods, stability data, process validation
and
manufacturing processes and instructions. Upon the reasonable request
of
CTI, Hercon promptly shall provide CTI with such information, samples
and
technical assistance, and otherwise cooperate with CTI, in connection
with
the preparation, prosecution and maintenance of the Product NDA.
In
addition, Hercon shall maintain, for a period of at least three (3)
years
from the manufacturing date or longer if required under applicable
laws or
regulations, complete, true and accurate books, records, test and
laboratory data, reports and all other information relating to the
services performed by Hercon under this Agreement, including technical
records pertaining to the methods, facilities and equipment used
for
Processing of Clinical Trial Products, in accordance with all applicable
laws and regulations.
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2.2 |
Milestone
Payments to Hercon.
Subject to the achievement of the applicable milestones provided
in
Section 3.1, in consideration of technology transfer review, formulation
optimization and scale-up work, Clinical Trial Products manufacture
and
other services to be performed by Hercon under this Agreement, CTI
shall
pay Hercon the milestone payments set forth in Section 3.1, provided
the
scope of the project with respect to the clinical supplies outlined
in
Exhibit C does not change.
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2.3
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Funding
of the Safety and Efficacy Studies by CTI. CTI
shall, at its own cost and expense, engage a contract research
organization to conduct the safety and efficacy studies of Clinical
Trial
Products. In the event that the study fails to demonstrate the safety
or
the efficacy of the Clinical Trial Products, then CTI shall have
the right
to terminate this Agreement as provided in Section
11.2.
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4
2.4
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Filing
of a Product NDA.
Subject to Hercon’s assistance as set forth in Section 2.1 above, CTI
shall, at its own cost and expense, prepare, file and prosecute the
Product NDA with the FDA.
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ARTICLE
3
MILESTONE
PAYMENTS; PRICE AND PAYMENT TERMS
3.1
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Milestone
Payments.
For
the services rendered to CTI by Hercon under this
Agreement, CTI shall remit to Hercon the following milestone payments:
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MILESTONE
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PAYMENT
AMOUNT
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1
A. 5
days after the Execution of this Agreement
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$*
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1
B. The
latest date of completion of all of the following: Completion of
conversion to Hercon methodology, order components, dedicated tooling,
drawings, documentation records, testing/release; Completion of analytical
validation; and Completion of full scale-up, including non-GMP run
and
testing, and commencement of informal stability testing
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$*
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Subtotal
for Stage 1
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$*
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2
A. Initiation
of clinical trial batch manufacture
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$*
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2
B. Completion
of Phase 2 dose-ranging study clinical trial batch manufacture, completion
of testing/release, commencement of stability testing
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$*
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2
C. Completion
of 3 months accelerated and non-accelerated stability testing, with
2 year
room temperature testing ongoing
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$*
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Subtotal
for Stage 2
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$*
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3
A. Initiation
of clinical trial batch manufacture
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$*
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3
B. Completion
of Phase 3 pivotal study clinical trial batch manufacture, completion
of
testing/release, commencement of stability testing
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$*
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Subtotal
for Stage 3
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$*
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TOTAL
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$*
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Milestone
payments reflect the total cost of Nitroglycerin Adhesive Mixture,
materials and effort to complete Processing of the Clinical Trial
Products. Hercon recognizes that unexpected difficulties may arise
during
any stage of this work, and guarantees and agrees that the milestone
payments will never exceed the payments specified in Section
3.1.
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Each
of
the above-referenced milestone payments shall only be payable once no later
than
thirty (30) days from the date of invoices therefor issued to CTI by Hercon,
with the exception of milestone 1 A above, which shall be payable once, no
later
than five (5) days from the date of the execution of this Agreement. A more
detailed description of each milestone is set forth on Exhibit B hereto. Hercon
shall not issue any invoice prior to the achievement of the applicable milestone
above and the receipt of the milestone payments is expressly conditioned on
Hercon providing CTI with such invoices and with all necessary documentation
and
data requested by CTI in order to determine the achievement of any such
milestone.
5
ARTICLE
4
MANUFACTURING
CLINICAL TRIAL PRODUCTS
4.1
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Clinical
Trial Products Supply and Purchase Obligations.
CTI understands and agrees that Hercon does not warrant or commit
that the
Clinical Trial Products will receive applicable regulatory approval
or be
successfully marketed and commercialized. For the life of the patents
referenced in the Recitals to this Agreement, Hercon is precluded
from
manufacturing or supplying the Clinical Trial Products to any Person
other
than CTI or any licensee or transferee of CTI’s Intellectual
Property.
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4.2 |
Manufacturing
Practices.
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(a) |
Clinical
Trial Product Specifications.
Hercon shall manufacture, fill, assemble, warehouse and otherwise
Process
(except for labeling) the Clinical Trial Products in conformity with
the
Product Specifications and in accordance with all applicable laws
and
regulations, including the U.S. Federal Food, Drug and Cosmetic
Act,
21 U.S.C. §301 et
seq.
and regulations promulgated thereunder.
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(b)
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GMP.
Hercon shall manufacture the Clinical Trial Products in accordance
with
GMP. Hercon shall advise CTI in writing of any proposed process changes
that have regulatory implications prior to their implementation by
Hercon.
CTI shall have the right, at its sole expense, to audit Hercon for
compliance with GMP on reasonable notice during normal business hours
at
least once in each calendar year, and more often in CTI’s reasonable
discretion.
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(c)
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Nitroglycerin
Adhesive Mixture.
Hercon shall supply and use the Nitroglycerin Adhesive Mixture by
sourcing
such ingredient from the third party base supplier set forth in the
Product Specifications.
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(d)
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Certificates
of Analysis.
Hercon shall provide CTI with a certificate of analysis for each
shipment
of the Clinical Trial Products manufactured and supplied hereunder
based
upon a reference standard established by Hercon and reasonably acceptable
to CTI. Such certificate of analysis shall, at a minimum, list the
tests
performed by or on behalf of Hercon, test specifications and test
results.
In addition, a statement will be made that the Clinical Trial Products
were manufactured in accordance with
GMP(s).
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(e)
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Quality
Control Information.
Hercon shall perform quality control tests to ensure that the Clinical
Trial Products are produced in accordance with GMP and all applicable
laws
and regulations, including the U.S. Federal Food, Drug and Cosmetic
Act,
21 U.S.C. §301 et
seq.
and regulations promulgated thereunder, and
conform to the Product Specifications. Upon the written request of
CTI,
Hercon shall provide CTI with the results of such quality control
tests
and such other information, including other analytical and manufacturing
documentation, reasonably requested by CTI, regarding quality control
of
the Clinical Trial Products supplied hereunder. Hercon
shall notify CTI as soon as practicable after Hercon identifies any
manufacturing or testing deviations, and shall provide CTI with complete
records of any investigations, reports and the like pertaining to
such
deviations.
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6
(f)
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Packaging
Control.
In
addition to its obligations pursuant to Sections 4.2 (d) and (e),
Hercon
will evaluate and inspect each batch of Clinical Trial Products in
accordance with Packaging guidelines set forth in the Product
Specifications and will provide CTI with a Clinical Trial Products
lot
release.
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(g)
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Compliance
with Laws.
Hercon shall develop and manufacture all Clinical Trial Products
in
accordance with the Product Specifications. All Clinical Trial Products
shall be stored and packaged in accordance with the requirements
of all
applicable laws and the rules and regulations of the FDA or other
regulatory authority promulgated thereunder. Clinical Trial Products
shall, at the time of shipment and while in the custody and control
of
Hercon, not be adulterated, misbranded, misused, contaminated, tampered
with or otherwise altered, mishandled, or subjected to negligence
and
shall conform to the Product
Specifications.
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(h)
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Inspection.
CTI, or its designee, may, at its own expense, with prior reasonable
notice and during regular business hours, visit the facilities used
by
Hercon to manufacture, store or otherwise Process Clinical Trial
Products
to (i) review the Clinical Trial Products related records and the
facilities, (ii) inspect, observe and audit the Processing of Clinical
Trial Products, and (iii) examine the condition of the Clinical Trial
Products and materials used in the
Processing.
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(i)
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Sample
Retention.
Hercon shall retain samples of each batch of Clinical Trial Products
at
Hercon’s facility at no cost to CTI until the date that is three (3) years
after completion of Processing of each such batch (or for such longer
period as may be required by applicable regulatory authorities or
applicable laws or regulations).
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4.3 |
Labeling
and Packaging.
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(a)
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Labeling.
The Clinical Trial Products will be labeled by a third party provider
nominated by CTI. Hercon shall label corrugated cases and pain white
cartons in regards to the dose, however Hercon will not be required
to
provide full labeling required for clinical trial purposes. Other
than the
labeling described in 4.3(a), Hercon shall have no liability for
misbranding or otherwise arising out of or relating to the labeling
of the
Clinical Trial Products.
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(b)
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Packaging.
Hercon shall supply Packaging which includes, at a minimum, plain
white
packaging and plain white cartons packaged in corrugated cases. Hercon
shall supply Packaging for the Clinical Trial Products under this
Agreement and such Packaging shall be in accordance with the Product
Specifications as provided herein and all applicable laws and
regulations.
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7
4.4 |
Delivery
and Acceptance.
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(a)
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Delivery.
All Clinical Trial Products supplied under this Agreement shall be
shipped
F.O.B. Emigsville, PA in such quantities, on such dates, with such
carrier, to such designation, and in accordance with such other
requirements as are specified by CTI in the applicable purchase order.
CTI
shall pay all freight, insurance charges, taxes, import and export
duties,
inspection fees and/or other charges applicable to the sale and transport
of Clinical Trial Products purchased by CTI hereunder prior to delivery
thereof by Hercon to such CTI designated location. Title and risk
of loss
and damages to Clinical Trial Products purchased by CTI hereunder
shall
pass to CTI upon delivery to CTI’s designated carrier F.O.B. Hercon’s
facility in Emigsville, PA.
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(b)
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Rejection
and Cure.
If
a shipment of Clinical Trial Products or any portion thereof (i)
fails to
conform to the applicable Product Specifications, (ii) was not Processed
in accordance with applicable laws or regulations or GMP, or (iii)
is
delivered with a material shortage or any overage of Clinical Trial
Products, then CTI shall have the right to reject such nonconforming
shipment of Clinical Trial Products or the nonconforming portion
thereof,
as the case may be. CTI shall give written notice to Hercon of its
rejection hereunder, within thirty (30) days after CTI’s receipt of such
shipment, specifying the grounds for such rejection; provided, however,
that in the event such defect is latent or was not obvious and could
not
be readily discovered from a physical inspection of the Clinical
Trial
Products shipment, CTI may give written notice to Hercon of its rejection
of such shipment within sixty (60) days after CTI's discovery of
such
non-conformance. The nonconforming shipment of Clinical Trial Products,
or
the nonconforming portion thereof, shall be held for Hercon’s disposition,
or shall be returned to Hercon, in each case at Hercon’s expense, as
directed by Hercon. Hercon shall use its commercially reasonable
efforts
to replace each nonconforming shipment of Clinical Trial Products,
or the
nonconforming portion thereof, with conforming Clinical Trial Products
as
soon as reasonably practicable after receipt of notice of rejection
thereof, and in any event shall do so within ninety (90) days after
the
receipt of replacement Nitroglycerin Adhesive Mixture which
shall be ordered no later than thirty (30) days after receipt of
notice of
rejection thereof.
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In
the
event of a dispute regarding any non-conforming Clinical Trial Products which
CTI and Hercon are unable to resolve, a sample of such Clinical Trial Products,
together with mutually agreed upon questions, shall be submitted by CTI to
an
independent laboratory reasonably acceptable to both parties for testing against
the Product Specifications, and the test results ("Test Results") obtained
by
such laboratory shall be final and binding upon the parties save for manifest
error on the face of the laboratory’s report. The outside testing laboratory
shall be required to enter into written undertakings of confidentiality at
least
as restrictive as those set forth herein. The fees and expenses of such
laboratory testing, and all additional shipping and transportation costs
incurred as a result of the dispute, shall be borne entirely by the party
against whom such laboratory findings are made. In the event the Test Results
indicate that the Clinical Trial Products in question do not conform to the
Product Specifications, Hercon shall replace such Clinical Trial Products with
conforming Clinical Trial Products in accordance with this Section.
8
Hercon
shall reimburse CTI for all reasonable out-of-pocket charges that CTI incurred
as a result of or relating to any nonconforming Clinical Trial Products,
including, without limitation, costs for shipping, disposal, storage or cover,
if applicable, of the nonconforming Clinical Trial Products.
(c)
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Warranty.
Hercon warrants that (a) Clinical Trial Products manufactured
hereunder shall conform with the Product Specifications; (b) Clinical
Trial Products shall be manufactured hereunder in accordance with
all
applicable laws and regulations, GMP and the Regulatory Dossiers;
(c) all
raw materials, including, without limitation, the Nitroglycerin Adhesive
Mixture, and all Clinical Trial Products will not be adulterated,
misbranded, misused, contaminated, tampered with or otherwise altered,
mishandled, or subjected to negligence while in the custody and control
of
Hercon or otherwise violate the rules and regulations of the FDA;
(d)
Hercon and its officers, directors, employees, Affiliates, contractors
and
agents have not been debarred or convicted of a crime which could
lead to
debarment, and Hercon will not use in any capacity the services of
any
Person debarred or convicted of a crime that could lead to debarment
under
Subsection 306(a) or (b) of the Generic Drug Enforcement Act of 1992,
and
neither Hercon nor its officers, directors, employees, Affiliates,
contractors or agents or other Person used by Hercon in any services
hereunder are or have been subject to any other penalty or sanction
by the
FDA; (e) Hercon will not transfer or supply any Clinical Trial Products
to
any Person other than CTI except as required by applicable law, regulation
or legal process; and (f) the Process shall not infringe the patent
rights
of any Person or constitute a misappropriation of the trade secrets
or
other intellectual property rights of any Person, except for any
such
infringement or misappropriation arising directly from Hercon’s use of
CTI’s Intellectual Property or any failure of CTI’s Intellectual Property
to be fully valid or to fully protect the Clinical Trial Products
from any
such claim of infringement or misappropriation (collectively, parts
(a),
(b) and (c) above comprise the “Limited Warranty”).
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ARTICLE
5
FURTHER
OBLIGATIONS OF THE PARTIES
5.1
|
Drug
Master File, Regulatory Dossiers.
Hercon shall provide CTI with such assistance as CTI shall reasonably
request to obtain a right of reference to the Drug Master File of
any
third-party supplier of the Nitroglycerin Adhesive Mixture and other
raw
materials for the Clinical Trial Products designated from time to
time by
CTI. The Product NDA and all Regulatory Dossiers shall be owned by
CTI and
Hercon shall have no rights
therein.
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9
5.2
|
Facility
Qualification.
In addition to Hercon’s responsibilities set forth hereunder, Hercon
shall, at no cost to CTI, take all such actions to qualify (and thereafter
to maintain qualification of) the facility (or facilities) at which
Hercon
Processes Clinical Trial Products hereunder, as required under applicable
law and regulations in the United States and each other country in
the
Territory, to enable CTI to obtain and maintain all applicable Regulatory
Dossiers for the Clinical Trial Products, including the Product NDA,
consistent with the requirements of the FDA and other applicable
regulatory authorities in the
Territory.
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5.3
|
Further
Obligations of Hercon.
During the term of this Agreement, Hercon
shall:
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5.3.1
|
At
its own expense, promptly respond to all reasonable inquiries from
CTI.
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5.3.2
|
Without
limiting the other provisions of this Agreement, use its commercially
reasonable efforts at all times to minimize the development
time.
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5.3.3
|
Furnish
or otherwise make available to CTI current copies of all issued master
batch records, procedures, specifications and methods and standard
operating procedures related to the Clinical Trial Products that
are
material to regulatory filings and submit to CTI prior to implementation
any and all proposed changes to the same that are material to regulatory
filings.
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5.3.4
|
Furnish
or otherwise make available to CTI prior to implementation any proposed
manufacturing changes related to the Clinical Trial Products which
may
affect regulatory status, such as suppliers of raw material used
in the
Clinical Trial Products, containers, Packaging, Labeling, Product
Specifications, manufacturing process, testing or the facilities
which are
related to the manufacturing of Clinical Trial Products. Notwithstanding
anything to the contrary herein, no change in the Product Specifications,
manufacturing processes, test methods, or other documentation or
procedures relating to Processing of Clinical Trial Products shall
be
implemented by Hercon unless and until the Parties have executed
a written
agreement documenting such change.
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5.3.5
|
Promptly
notify CTI in writing of any comments, responses or notices received
from
the FDA, or other applicable regulatory authorities, which relate
to or
may impact the Clinical Trial Products or the manufacture of the
Clinical
Trial Products. Without limiting the foregoing, Hercon
shall advise CTI no later than the next day that is not a Saturday,
Sunday
or federal or state holiday if an authorized agent of any regulatory
authority plans to visit Hercon’s facility, and makes an inquiry regarding
Hercon’s
Processing of Clinical Trial Products or regarding any part of
the
facility that is used in Processing of Clinical Trial Products. CTI
shall
have the right to be present at any visit relating to the Clinical
Trial
Products and to review in advance and comment on any response by
Hercon to
the communication or investigation relating to Clinical Trial Products.
Hercon shall provide to CTI copies of any Form 483s or equivalent
documents delivered by such regulatory authority as a result of such
visit
and, at its own cost, obtain and maintain any and all Federal and
state
regulations and/or licenses with respect to Hercon's manufacture
of the
Clinical Trial Products.
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10
5.3.6
|
Provide
ongoing technical product support with respect to the Clinical Trial
Products.
|
ARTICLE
6
REPRESENTATIONS
AND WARRANTIES
6.1
|
Representations
and Warranties.
Each party hereby represents and warrants to the other party as
follows:
|
(a)
|
Corporate
Existence.
Such party is a corporation duly organized, validly existing and
in good
standing under the laws of the jurisdiction in which it is
incorporated.
|
(b)
|
Authorization
and Enforcement of Obligations.
Such party (a) has the corporate power and authority and the legal
right
to enter into this Agreement and to perform its obligations hereunder,
and
(b) has taken all necessary corporate action on its part to authorize
the
execution and delivery of this Agreement and the performance of its
obligations hereunder. This Agreement has been duly executed and
delivered
on behalf of such party, and constitutes a legal, valid, binding
obligation, enforceable against such party in accordance with its
terms.
|
(c)
|
Consents.
All necessary consents, approvals and authorizations of and notices
to all
governmental authorities and other Persons required to be obtained
or
provided by such party in connection with its performance of this
Agreement have been obtained or
provided.
|
(d)
|
No
Conflict.
The execution and delivery of this Agreement and the performance
of such
party’s obligations hereunder (a) do not conflict with or violate any
requirement of applicable laws or regulations, and (b) do not conflict
with, or constitute a default under, any contractual obligation of
such
party.
|
ARTICLE
7
INDEMNIFICATION;
INSURANCE
7.1
|
Hercon’s
Indemnity Obligations.
Hercon shall defend, indemnify and hold harmless CTI, its Affiliates
and
their respective successors and permitted assigns (and the respective
officers, directors, stockholders, partners and employees of each)
from
and against any and all losses, liabilities, claims, actions, proceedings,
damages and expenses (including without limitation reasonable attorneys’
fees and expenses) (herein “Damages”) relating to or arising from (a)
Hercon's performance of or failure to perform its obligations under
this
Agreement, including, without limitation, all data and other information
provided to CTI for use in the preparation and filing of the Product
NDA,
(b) any breach by Hercon or its Affiliates, subcontractors or agents
of
this Agreement, (c) the negligence or willful misconduct of any officers,
directors, partners or employees of Hercon or its Affiliates,
subcontractors or agents, or (d) any claims of infringement or
misappropriation relating to any intellectual property used by Hercon
(expressly excluding CTI’s Intellectual Property) in the fulfillment of
its obligations under this Agreement, including, without limitation,
any
modifications to CTI’s Intellectual Property without CTI's prior written
consent.
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11
CTI’s
Indemnity Obligations.
CTI
shall defend, indemnify and hold harmless Hercon, its Affiliates and their
respective successors and permitted assigns (and the respective officers,
directors, stockholders, partners and employees of each) from and against
any
and all Damages relating to or arising from (a) CTI's performance of or failure
to perform its obligations under this Agreement, including, without limitation,
all data and other information provided for use in the preparation and filing
of
the Product NDA, (b) any breach by CTI or its Affiliates, subcontractors
or
agents of this Agreement, (c) the negligence or willful misconduct of any
officers, directors, stockholders, partners or employees of CTI or its
Affiliates, subcontractors or agents, or (d) any third party claims of
infringement or misappropriation relating to any CTI Intellectual Property
used
by Hercon in the fulfillment of its obligations under this
Agreement.
7.2
|
Procedure.
A
party (the indemnitee) that intends to claim indemnification under
this
Article 7 shall notify the other party (the “indemnitor”) promptly in
writing of any action, claim or liability in respect of which the
indemnitee believes it is entitled to claim indemnification, provided
that
the failure to give timely notice to the indemnitor shall not release
the
indemnitor from any liability to the indemnitee except to the extent
the
indemnitor is prejudiced thereby. The indemnitor shall have the right,
by
written notice to the indemnitee, to assume the defense of any such
action
or claim within the fifteen (15) day period after the indemnitor’s receipt
of notice of any action or claim with counsel of the indemnitor’s choice
and at the sole cost of the indemnitor. If the indemnitor so assumes
such
defense, the indemnitee may participate therein through counsel of
its
choice, but at the sole cost of the indemnitee. The party not assuming
the
defense of any such claim shall render all reasonable assistance
to the
party assuming such defense, and all reasonable out-of-pocket costs
of
such assistance shall be for the account of the indemnitor. No such
claim
shall be settled other than by the party defending the same, and
then only
with the consent of the other party which shall not be unreasonably
withheld; provided that the indemnitee shall have no obligation to
consent
to any settlement of any such action or claim which imposes on the
indemnitee any liability or obligation which cannot be assumed and
performed in full by the indemnitor, and the indemnitee shall have
no
right to withhold its consent to any settlement of any such action
or
claim if the settlement involves only the payment of money by the
indemnitor or its insurer.
|
7.3
|
Insurance.
Hercon shall obtain, at its expense, property, commercial and liability
insurance covering its obligations hereunder, in each case in amounts
appropriate to the conduct of its business. Without limiting the
foregoing, Hercon shall use reasonable efforts to obtain and maintain
in
force at all times during the term of this Agreement third party
liability
insurance in reasonably prudent amounts in respect of the risks of
which
it is providing indemnity hereunder, with a reputable insurance carrier
or
by self-insurance. Hercon shall make available to CTI, at CTI’s request,
evidence of its maintenance of insurance in satisfaction of its
obligations under this Section 7.3.
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12
ARTICLE
8
RELATIONSHIP
BETWEEN THE PARTIES
8.1
|
Independent
Contractor.
The relationship between Hercon and CTI is solely that of buyer and
seller, it being understood that each party is acting as an independent
contractor for its own account and this Agreement does not establish
a
joint venture, agency, partnership or employer/employee relationship
between the parties. Neither party shall have authority to conclude
contracts or otherwise to act for or bind the other party in any
manner,
whatsoever, as agent or otherwise. Any and all contracts and agreements
entered into by either party shall be for that party’s sole account and
risk and shall not bind the other party in any
respect.
|
ARTICLE
9
CONFIDENTIALITY
AND PUBLIC DISCLOSURE
9.1
|
Mutual
Confidentiality.
Except as may be required to obtain government approval to manufacture,
sell or use the Clinical Trial Products, Hercon and CTI will treat
as
confidential the Confidential Information, and will take all necessary
precautions to assure the confidentiality of such information. Each
party
agrees to return to the other upon the expiration or termination
of this
Agreement all Confidential Information acquired from the other except
as
to such information it may be required to retain under applicable
law or
regulation, and except for one copy of such information to be retained
by
the other party’s legal department or legal counsel. Neither party shall,
during the period of this Agreement and for five (5) years thereafter,
without the express prior written consent of the other party use
or
disclose any such Confidential Information for any purpose other
than to
carry out its obligations hereunder. Both parties, prior to disclosure
of
such Confidential Information to any employee, consultant or advisor
shall
ensure that such person is bound in writing to observe the confidentiality
provisions of this Agreement. The obligations of confidentiality
shall not
apply to information that Hercon or CTI is required by law or regulation
to disclose, provided however that the disclosing party shall so
notify
the other party in writing in advance of such required disclosure
and
shall cooperate with the other party on reasonable measures to protect
the
confidentiality of the information.
|
9.2
|
Public
Disclosure.
No announcement, news release, public statement, publication, or
presentation relating to the existence of this Agreement, the subject
matter hereof, or either party’s performance hereunder will be made
without the other party’s prior written approval, which approval shall not
be unreasonably withheld. The parties agree that they will use reasonable
efforts to agree on the text, and to coordinate the release, of a
press
release relating to the existence of this Agreement so that such
initial
announcement or press release by each is made contemporaneously.
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13
9.3
|
Remedies.
Because of the unique nature of the Confidential Information, the
receiving party acknowledges and agrees that the disclosing party
may
suffer irreparable injury if the receiving party fails to comply
with the
obligations set forth in this Article 9, and that monetary damages
may be
inadequate to compensate the disclosing party for such breach.
Accordingly, the receiving party agrees that, in addition to any
other
remedies available at law, in equity or otherwise, the disclosing
party
will be entitled to seek injunctive relief and/or specific performance,
without the requirement of posting a bond or proving actual damages,
to
enforce the terms, or prevent or remedy the violation, of this Article
9.
This provision shall not constitute a waiver by either party of any
rights
to damages or other remedies which it may have pursuant to this Agreement
or otherwise.
|
ARTICLE
10
INVENTIONS
AND WORK PRODUCT
10.1
|
Inventions.
Hercon shall disclose in writing to CTI any invention, development,
information or idea, whether patentable or not, made or conceived
by
Hercon or any of its employees or consultants, in the course of performing
or that arise out of the performance of Hercon’s obligations hereunder,
including those relating solely to the Clinical Trial Products, Processing
of Clinical Trial Products or relating solely to or arising solely
from
the Confidential Information or Intellectual Property of CTI
(collectively, the “Inventions”). Hercon shall make such disclosure to CTI
promptly after the conception or reduction to practice of any Inventions.
All Inventions shall be the sole and exclusive property of CTI and
Hercon
hereby expressly and irrevocably conveys and assigns, and shall cause
its
Affiliates and its and their employees and agents, as applicable,
to so
convey and assign, to CTI any and all rights, title and interest
they may
have in and to such Inventions. Assignment and transfer of all such
Inventions shall occur instantly and automatically upon the development,
making, conception or reduction to practice of such Inventions and
shall
not require any further deeds or documents to be exchanged between
the
Parties; provided, however, that upon CTI’s request, Hercon shall execute,
acknowledge and deliver, and shall cause its employees and consultants
to
execute, acknowledge and deliver, all applications, assignments and
other
instruments which CTI (or its nominee) shall deem reasonably necessary
to
apply for, obtain, protect, perfect or enforce CTI’s ownership of all
rights, title, and interest in the Inventions, including as necessary
to
apply for and obtain invention rights, patents, patent applications,
letters patent, copyrights and reissues thereof (“Rights”) in the United
States and foreign countries. Hercon shall execute, acknowledge and
deliver, and shall cause its employees and consultants to execute,
acknowledge and deliver, all such further papers as CTI may reasonably
request to enable CTI (or its nominee) to publish or protect Inventions
and render such further assistance as CTI may reasonably request
in the
prosecution of Rights and in any patent office proceeding or litigation
involving Inventions. All Intellectual Property and know-how regardless
of
origin associated with the Clinical Trial Products shall be the sole
and
exclusive property of CTI and any inventions shall be duly assigned
to
CTI.
|
10.2
|
Injunctive
Relief.
Hercon acknowledges and agrees that, because of the unique and
extraordinary nature of the development obligations, any breach or
threatened breach of the provisions of Section 10.1 hereof would
cause
irreparable injury and incalculable harm to CTI and CTI shall,
accordingly, be entitled to injunctive and other equitable relief
for such
breach or threatened breach, without the requirement of posting a
bond or
proving actual damages, and that resort by CTI to xxx for injunctive
or
other equitable relief shall not be deemed to waive or to limit in
any
respect any other right or remedy which CTI may have with respect
to such
breach or threatened breach. The parties agree that in the event
of any
action, suit or proceeding at law or in equity brought to enforce
the
covenants contained in Section 10.1 hereof, or to obtain money damages
for
breach thereof, the party prevailing in any such action, suit or
proceeding shall be entitled upon demand to reimbursement from the
other
party for all expenses (including, without limitation, reasonable
attorney’s fee and disbursements) incurred in connection
therewith.
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14
ARTICLE
11
TERM
AND TERMINATION
11.1
|
Term.
Unless terminated earlier pursuant to Section 11.2 below, the term of
this Agreement (the “Term”) shall expire two (2) years from the date of
this Agreement.
|
11.2 |
Termination.
|
By
Either party or Both Parties.
(i)
|
This
Agreement may be terminated immediately upon mutual written consent
of
both Parties upon mutually accepted terms;
or
|
(ii)
|
Either
party shall have the right to terminate this Agreement upon giving
written
notice of termination to the other party, after the breach of any
material
provision of this Agreement by the other party if the other party
has not
cured such breach within thirty (30) days after receipt of written
notice
thereof from the non-breaching party;
or
|
By
CTI.
(i) |
CTI
shall have the right to terminate this Agreement at any time for
any
reason upon giving written notice of termination to
Hercon.
|
11.3 Rights
and Remedies Upon Expiration or Termination.
Upon
the
expiration of the Term or the termination of this Agreement pursuant to Section
11.2 hereof: (a) Hercon's obligations to develop the Clinical Trial Products
for
CTI and CTI's obligations under this Agreement shall terminate; (b) Hercon
shall
promptly deliver to CTI all manufactured Clinical Trial Products in its
possession or control; (c) CTI shall pay to Hercon all unpaid milestone payments
for which the corresponding milestones have been met at the date of termination
as provided in Section 3.1 and Exhibit B; (d) all Confidential Information,
including, without limitation, the Intellectual Property belonging to the
disclosing party will remain the sole and exclusive property of the disclosing
party and shall be returned to the disclosing party as provided in Section
9.1;
(e) all data obtained through Hercon’s performance of its services under this
Agreement, including, without limitation, any and all test data, clinical study
results, regulatory filings, reports, records and materials in Hercon's
possession or control which are specifically exclusive to the manufacture of
the
Clinical Trial Products, and any intellectual property developed by Hercon
relating exclusively to the Clinical Trial Products (which, as provided in
Section 10.2 is and shall be the property of CTI), shall be promptly transferred
to CTI by Hercon at CTI’s expense; and (f) any and all Clinical Trial Products
paid for by CTI, that are in Hercon’s possession at the date of termination
shall be promptly delivered to CTI; (g) the confidentiality obligations of
the
parties shall survive for the term specified in Section 9.1; and (h) the
indemnity obligations of the parties shall survive termination for the period
determined by the applicable statute of limitations relating to the claim for
which indemnification is sought. Any and all payment obligations of the parties
to one another accruing prior to termination shall survive termination and
if
significant progress has been made by Hercon toward the next milestone, CTI
shall be obligated to make a pro-rated payment based on time, effort or another
equitable arrangement as agreed upon by Hercon and CTI.
15
Upon
termination of this Agreement pursuant to Section 11.2, Hercon shall, for a
period up to three months after such termination, transfer to CTI (or its
designee) all unique manufacturing technology and know-how related specifically
solely to the process of manufacturing Clinical Trials Products (“Technology
Transfer”).
A
Technology Transfer shall include at least the following activities: (a) Hercon
shall make available all pertinent know-how, technical data, and other
information and documentation necessary or useful to Process the Clinical Trial
Products in accordance with this Agreement and to support regulatory filings
for
the Clinical Trial Products; (b) Hercon shall provide training sessions and
reasonable assistance and cooperation at manufacturing site(s) designated by
CTI
in order to enable CTI or its designee to Process Clinical Trial Products;
and
(c) Hercon shall allow CTI or its designee reasonable access to Hercon’s
facility at reasonable times on business days for any reasonable purpose
connected with such Technology Transfer. Should this Agreement be terminated
as
a result of Hercon’s default or breach, such Technology Transfer shall be
provided at Hercon’s sole cost and expense; otherwise, Hercon may invoice and
CTI shall pay for such Technology Transfer at Hercon’s then-current and
reasonable rates.
ARTICLE
12
NON-COMPETE
Hercon
shall not perform any services similar to the services provided by Hercon
hereunder or related to Intellectual Property for any other Person with a
product utilizing nitric oxide to treat musculoskeletal disease, painful
conditions or vascular disease where such services would constitute or
contribute to competition with CTI’s business as it relates to the Clinical
Trial Products, unless Hercon obtains prior written approval from CTI to provide
such other services.
16
ARTICLE
13
MISCELLANEOUS
13.1
|
Notices.
All notices or other communications given pursuant hereto by one
party
hereto to the other party shall be in writing and deemed given (a)
when
delivered by messenger, (b) when sent by fax, (with receipt confirmed),
(c) when received by the addressee, if sent by Express Mail, Federal
Express or other express delivery service (receipt requested), or
(d) five
days after being mailed in the U.S., first-class postage prepaid,
registered or certified, in each case to the appropriate addresses
and fax
numbers set forth below (or to such other addresses and fax numbers
as a
party may designate as to itself by notice to the other
party):
|
If
to
CTI, to it at:
Cure
Therapeutics, Inc.
00
Xxxx
00xx Xxxxxx
Xxxxx
0X
Xxx
Xxxx,
XX 00000
Telephone:
000-000-0000
Fax:
000-000-0000
If
to
Hercon, to it at:
Hercon
Laboratories Corporation
000
Xxxxxxx Xxxxxxx Xxxx
Xxxxxxxxxx,
XX 00000
Telephone:
(000) 000-0000
Fax:
(000) 000-0000
13.2
|
Assignment.
Neither party shall, without the prior written consent of the other
party
(not to be unreasonably withheld or delayed), assign or transfer
this
Agreement to any Person, in whole or in part, provided that, each
party
may assign or transfer this Agreement to any Affiliate or to any
successor in interest (whether by merger, acquisition, asset purchase
or
otherwise) to all or substantially all of its business to which this
Agreement relates
without the prior written consent of the other party hereto. All
of the
terms and provisions of this Agreement shall be binding upon and
inure to
the benefit of and be enforceable by the parties hereto and their
respective permitted successors and
assigns.
|
13.3
|
Severability.
If any portion of this Agreement is held invalid by a court of competent
jurisdiction, such portion shall be deemed to be of no force and
effect
and this Agreement shall continue in full force and effect without
said
portion(s), consistent with the intent of the Parties at the time
of its
execution, provided however, if the deletion of such provision materially
impairs the commercial value of this Agreement to either party, the
parties shall attempt to renegotiate such provision in good
faith.
|
13.4
|
Entire
Agreement.
This Agreement and all Exhibits and Schedules attached hereto and
thereto
contain the sole and entire agreement and understanding of the parties
hereto and their respective Affiliates and representatives related
to the
subject matter hereof and supersede all oral or written agreements
concerning the subject matter made prior to the date of this Agreement.
|
13.5
|
Amendments,
Waivers.
This Agreement may not be amended, changed, modified or supplemented
orally, and no amendment, change, modification or supplement of this
Agreement shall be recognized nor have any effect, unless the writing
in
which it is set forth is signed by Hercon and CTI, nor shall any
waiver of
any of the provisions of this Agreement be effective unless in writing
and
signed by the party to be charged therewith. The failure of either
party
to enforce, at any time, or for any period of time, any provision
hereof
or the failure of either party to exercise any option herein shall
not be
construed as a waiver of such provision or option and shall in no
way
affect that party’s right to enforce such provision or exercise such
option. No waiver of any provision hereof shall be deemed to be,
or shall
constitute, a waiver of any other provision, or with respect to any
succeeding breach of the same
provision.
|
17
13.6
|
Governing
Law, Dispute Resolution.
This Agreement shall be governed by, and construed in accordance
with, the
laws of the State of Delaware and the United States, as though made
and to
be fully performed therein without regard to conflicts of laws and
principles thereof.
|
The
parties shall initially attempt in good faith to resolve any significant
controversy, claim, allegation of breach or dispute arising out of
or
relating to this Agreement (hereinafter collectively referred to
as a
“Dispute”) through negotiations between senior executives of CTI and
Hercon. If any Dispute is not resolved through such negotiations,
each
party irrevocably and unconditionally consents to the exclusive
jurisdiction of the courts of general jurisdiction of the State of
Delaware and the United States District Court for the District of
Delaware
for any action, suit or proceeding relating to a Dispute, and agrees
not
to commence any such action, suit or proceeding except in such courts.
Each Party further irrevocably and unconditionally waives any claim
that
such action, suit or proceeding has been brought in an inconvenient
forum
or should be brought in any other venue to which such party may be
entitled by virtue of domicile or
otherwise.
|
13.7
|
Singular
and Plural Forms.
The use herein of the singular form shall also denote the plural
form, and
the use herein of the plural form shall denote the singular form,
as in
each case the context may require.
|
13.8
|
Headings.
The headings contained in this Agreement are for convenience of reference
only and shall not constitute a part hereof or define, limit or otherwise
affect the meaning of any of the terms or provisions
hereof.
|
13.9
|
Counterparts.
This Agreement may be executed in one or more facsimile or original
counterparts, each of which shall be deemed an original, but all
of which,
when taken together, shall constitute one and the same
instrument.
|
13.10
|
Force
Majeure.
If either party is prevented from complying, either totally or in
part,
with any of the terms or provisions of this Agreement, by reason
of force
majeure, including, but not limited to, fire, flood, earthquake,
explosion, storm, war, rebellion, acts of God and/or other causes
or
externally induced casualty beyond its reasonable control and without
its
negligence, whether similar to the foregoing matters or not, then,
upon
written notice by the party liable to perform to the other party,
the
requirements of this Agreement or such of its provisions as may be
affected, and to the extent so affected, shall be suspended during
the
period of such disability; provided that the party asserting force
majeure
shall bear the burden of establishing the existence of such force
majeure
by clear and convincing evidence; and provided further, that the
party
prevented from complying shall use its best efforts to remove such
disability within thirty (30) days and shall continue performance
with the
utmost dispatch whenever such causes are removed and shall notify
the
other party of the event not more than five (5) days from the time
of the
event. When such circumstances arise, the parties shall discuss what,
if
any, modifications to the terms of this Agreement may be required
in order
to arrive at an equitable solution. Notwithstanding the foregoing,
in the
event that a material event of force majeure shall continue for a
period
of longer than sixty (60) days, then the party unaffected by such
event
may terminate this Agreement by not less than fifteen (15) days'
written
notice of termination to the other party; provided that, if the force
majeure event ceases within such fifteen day period, this Agreement
shall
remain in full force and effect.
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[Signatures
on Next Page]
18
IN
WITNESS WHEREOF, the parties have caused this Agreement to be executed by their
respective duly authorized officers as of the date first above
written.
CURE
THERAPEUTICS, INC.
By:
Name:
Title:
HERCON
LABORATORIES CORPORATION
By:
Name:
Title:
19
Exhibits
A, B and C have been omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential
treatment.
20