Exhibit 10.25
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CELL SOLUTIONS, LLC., a XXXX corporation (“CS”); |
BETWEEN: |
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AND:
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CYTOCORE, INC., a Delaware corporation (“CytoCore”). |
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DATED:
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August XX, 0000. |
RECITALS:
A. CS has developed and/or owns the rights to a cell preservation medium
(“Preservative”) and the methods (“Methods”), supplies (“Supplies”) and instrumentation
(“Instruments”) used in preparing cells suspended in the Preservative for use in cytological
evaluations.
B. CytoCore is engaged in the business of developing and commercializing products for
the screening and/or diagnosis of cancers and other diseases of the female reproductive
system.
C. CytoCore desires to Manufacture and sell “Kits” comprising the SoftPAP® cervical cell
collection device and the Preservative.
AGREEMENT:
In consideration of the foregoing Recitals, which are by this reference incorporated
in this Supply Agreement (this “Agreement”), and in consideration of the mutual promises,
representations, warranties and covenants set forth below, the parties agree as follows:
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1. |
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DEFINITIONS. When used in this Agreement, the following terms have the meanings set
forth below: |
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1.1 |
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“Preservative” means the Synermed general cytology preservative. |
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1.2 |
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“Methods” means procedures and processes for the preparation of suspensions of
cells in Preservative and for the preparation of specimens for evaluation from said cell
suspensions. |
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1.3 |
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“Supplies” means ancillary reagents and materials used in the preparation of
specimens for evaluation. |
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1.4 |
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“Instrument” means a machine that performs the function of preparing a specimen for
evaluation from a suspension of cells in the Preservative. |
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1.5 |
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“Kit” means a package or unit of sale that contains a SoftPAP® cervical cell
collection device and Synermed Preservative. |
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1.6 |
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“End User” means a physician, nurse, nurse practitioner, midwife or other person or
entity that is may legally collect cervical cytology specimens for the purpose of cervical
cancer screening. |
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1.7 |
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“Distribution Channels” means: (a) sales to physicians; (b) sales to hospitals,
clinics and other medical facilities; (c) sales to laboratories; and (d) sales to
distributors for use in (a) and (b) above. |
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1.8 |
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“Territory” means all countries of the world. |
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2.1. |
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CS grants to CytoCore the non-exclusive right to incorporate the Synermed
Preservative in its kits and to manufacture, use, market, sell, have sold, and
distribute Kits as defined in 1.5 above in the Territory, whether directly or
contractually through independent agents or distributors, to End Users. |
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2.1.1 |
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CytoCore may sublicense the rights identified in Section 2.1 to a
third party in those jurisdictions where such a sublicense is permitted or
required. |
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2.2 |
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CS grants to CytoCore the non-exclusive right to manufacture, use, market, sell,
have sold, and distribute Kits, whether directly or contractually through
independent agents or distributors, to laboratories that provide or sell cervical
cell collection devices and preservatives to End Users. |
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2.3 |
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CytoCore grants to CS the non-exclusive right to use, market, sell, have sold,
and distribute Kits, whether directly or contractually through independent agents or
distributors, to laboratories that provide or sell cervical cell collection devices
and preservatives to End Users. |
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2.4 |
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Neither Party grants to the other Party any rights other than those enumerated
above in any product or technology owned, invented or discovered by the Party,
whether past, present or future. |
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2.5 |
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Neither Party grants to the other the right to use trademarks, copyrights or
similar property of the Party except as may be mutually agreed upon from time to
time for the marking of packages and other manufacturing operations intended for
the exclusive use by CytoCore. CS will xxxx the Products, packaging and
packaging inserts with patent markings appropriate to reflect the Patents and as
otherwise directed by CytoCore. |
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3.1 |
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CS will provide CytoCore with Preservative to be incorporated into Kits |
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3.1.1 |
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The Preservative and its associated price schedule will be
entered into Schedule 1 of this Agreement. If CS agrees to provide
additional products to CytoCore, the Parties will amend Schedule 1 to
include such products and their associated price schedules. |
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3.1.2 |
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Except as mutually agreed on a case-by-case basis, CS will
manufacture, package and label the Preservative for CytoCore on a private
label basis. |
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3.1.3 |
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CytoCore will be responsible for the labeling applied by
CS to private label Preservative. |
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3.1.3.1 |
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The Parties will mutually determine whether CytoCore will, at its
cost and expense, provide to CS the physical labels required for the private
labeling of the Preservative or will provide to CS the artwork necessary to
allow CS to manufacture or procure said labels. |
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3.1.3.2 |
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CS will provide CytoCore with the specifications necessary for
CytoCore to procure the labels or prepare the label artwork. |
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3.1.3.3 |
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CytoCore is and shall be the copyright owner or licensee of all
designs and artwork used in connection with packaging for the
Product. To the extent third-party trademarks or other rights are
necessary for certain customers, CytoCore represents that it has
or will have obtained the right from such third parties for
CytoCore the right to use such trademarks or other rights solely
for such purpose. |
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3.1.3.4 |
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All product inserts must be pre-approved by CytoCore and be in
full compliance with all labeling laws in each jurisdiction in
which Products are distributed. |
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3.1.3.5 |
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CytoCore shall be responsible for all advertising and the
contents thereof related to the SoftPAP® collector and to the
Kits. |
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3.1.4 |
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The Parties recognize that the laws, regulations,
customs and/or practices pertaining to product labeling may differ
between countries and that different labels may therefore be required in
various countries. |
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3.1.4.1 |
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CytoCore shall be responsible for determining the labeling
requirements for each country and for providing |
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CS with labels and/or label artwork that conforms to
these requirements. |
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3.1.5 |
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CytoCore may manufacture Kits containing cytology
preservative other than the Synermed preservative specified in this
Agreement, so long as such preservative is not a copy of the Synermed
Preservative. |
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3.1.6 |
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CytoCore shall be responsible for assembling the Kits |
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3.1.7 |
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CS will provide to CytoCore copies of the Instructions for
Use, Material Safety Data Sheet (MSDS) and similar documents related to
the safety and proper use of the Preservative |
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4.0 |
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ORDERING AND ORDER FULFILLMENT |
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4.1 |
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Prior to the first business day of each calendar quarter CytoCore will
provide CS with a non-binding forecast of its anticipated requirements for
Preservative during each of the following three calendar quarters. |
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4.2 |
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CytoCore will issue Purchase Orders for the Preservative to CS. Each
Purchase Order will identify the Preservative, quantity and pricing in accordance
with Schedule 1 and shall additionally specify the packaging and labeling to be
applied to this Preservative. |
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4.3 |
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CS will deliver such orders to CytoCore “Free Carrier” (FCA, INCOTERMS
2000) the designated CS manufacturing facility unless other delivery
arrangements are agreed to between the Parties. |
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4.4 |
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Unless otherwise specified on the Purchase Order, CS will ship the
Preservative in accordance with its standard practices. |
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4.5 |
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CytoCore shall be responsible for all shipping charges. |
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4.6 |
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Shipping times will be mutually and reasonably agreed upon by the Parties,
and based on the size of the order and type of shipping. Notwithstanding the
foregoing, all orders will be shipped within 60 days of receipt of purchase order,
unless otherwise agreed so long as the total quantity of Preservative ordered for
delivery within a calendar quarter does not exceed the corresponding
forecast quantity by more than ten (10) percent. |
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4.7 |
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All Preservative delivered to CytoCore will have at least eighteen (18)
months of expiration dating remaining as of the date of delivery to CytoCore. |
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5.1 |
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Manufacturing Obligations. CS shall have the Preservative
manufactured in compliance with its specifications and in compliance with Quality |
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System Regulation (“QSR”) requirements set forth in 21 CFR Part 820 or
foreign equivalent thereof and in conformance with the requirements of ISO
13485 or any foreign equivalent thereof applicable to the Products. |
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5.1.1 |
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CS or its manufacturer shall maintain current
establishment registration and product listings, as specified in 21 CFR
Part 807 and shall maintain its current ISO 13485 registration. |
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5.1.2 |
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CS will provide evidence of its or its manufacturers’ as
applicable FDA and ISO 13485 registrations to CytoCore. |
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5.1.3 |
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CS will notify CytoCore of any changes in its or its
manufacturers’ FDA and/or ISO 13485 registrations and in its product
listings for the Preservative |
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5.2 |
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CS will provide CytoCore notice of any changes to the specifications and/or
formulation of the Preservative sufficiently in advance of implementation
of the change to permit CytoCore to validate the revised Preservative in its
applications. |
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5.2.1 |
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CS will provide CytoCore with samples of the revised
Preservative for validation at no charge. |
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5.2.2 |
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CS shall be responsible for making any regulatory
submissions and/or obtaining any relevant regulatory clearances,
registrations or approvals that pertain solely to the Preservative at its
discretion. CytoCore shall be responsible for making any
regulatory submissions and/or obtaining any relevant regulatory
clearances, registrations or approvals that pertain solely to Kits. . |
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5.2.3 |
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In the event that a change in the Preservative
specifications makes the Preservative unsuitable for CytoCore’s
use hereunder, CytoCore may terminate this Agreement in accordance with
Section 13.4.1.4 in its entirely or with respect to any country within the
Territory. |
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5.3 |
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CS will provide CytoCore with written certification that each lot of
Preservative supplied to CytoCore conforms to its specifications. |
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5.3.1 |
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All Preservative supplied to CytoCore shall be traceable
by lot number in accordance with the pertinent FDA regulations. |
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5.3.2 |
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CS or its manufacturer shall keep and maintain adequate
records of all quality control testing, instrumentation validation and
stability studies and, upon CytoCore’s reasonable request, shall provide
CytoCore with access to such records and the results of any testing. |
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5.4 |
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Force Majeure. CS will use its best efforts to fill accepted
orders as promptly as practicable, subject to unanticipated delays caused by
governmental orders, actions or requirements, transportation conditions,
inclement weather, labor or material shortage, strike, riot, terrorist act,
fire, natural disaster or other cause beyond CS’ control. In all cases, CS
will use its best efforts to advise CytoCore in advance of any inability to
make full and timely delivery of Products to CytoCore. Each party shall not
be liable for failure to perform hereunder due to governmental orders,
actions or requirements, transportation conditions, inclement weather, labor
or material shortage, strike, riot, terrorist act, fire, natural disaster or
other causes beyond such non-performing party’s reasonable control. |
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6.0 |
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PRODUCT PRICING AND PAYMENT. |
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6.1 |
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CS shall invoice CytoCore and CytoCore shall pay for the quantities of
Product delivered by CS pursuant to this Agreement, at the purchase prices set
forth in the attached Schedule 1. |
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6.2 |
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Payment terms shall be Net 30 days. |
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6.3 |
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Shipping costs, duties and fees shall the responsibility of CytoCore. |
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6.4 |
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No adjustment in a Purchase Price shall be permitted during the initial
annual period following CytoCore’s first order. Thereafter, but not more than
once during any calendar year, the Parties may agree to amend the pricing given
in Schedule 1. |
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6.5 |
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Title to ordered Products will pass to CytoCore upon the later of tender
of delivery. Risk of loss will pass to CytoCore upon delivery to the shipper. |
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7.0 |
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REGULATORY CLEARANCES AND APPROVALS. |
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7.1 |
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CytoCore shall be solely responsible for pursuing, obtaining and
maintaining each regulatory clearance required for CytoCore’s sale of the Kits to
be distributed and sold within the Territory, and for fulfilling the obligations
as the holder of such clearances. |
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7.1.1 |
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CS will provide CytoCore with such technical
information and data pertaining to the Preservative as is determined to
be required to support such applications for regulatory clearance of
the Kits to the extent that such information does not compromise CS
trade secrets. |
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7.2 |
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CS shall be solely responsible for pursuing, obtaining and maintaining
each regulatory clearance required for the sale of the Preservative to be
distributed and sold within the Territory, and for fulfilling the obligations as
the holder of such clearances.. |
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7.3 |
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The Parties may agree to collaborate or coordinate efforts on the design,
execution and/or evaluation of studies intended to obtain data to support
regulatory filings. |
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7.4 |
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CS will provide CytoCore with the names and contact information of any
authorized representatives who possess copies of the Technical File for the
Preservative in accordance with the applicable laws and regulations. |
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8.0 |
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SALES AND DISTRIBUTION |
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8.1 |
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Each Party will establish and maintain its own network of
distribution partners and sales representatives within the Territory. |
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8.1.1 |
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CytoCore distributors will primarily provide Kits to End
Users, but may provide Kits to laboratories in such cases where the
laboratory provides its customers with cervical cell collection devices
and cytology preservative. |
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8.1.2 |
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CS distributors will primarily provide Preservative and/or
Supplies to laboratories, but may provide Kits to End Users in such areas
within the Territory where CytoCore does not have a distributor. |
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8.1.3 |
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In sales territories where only one of the Parties has
engaged a distributor and, if warranted by the circumstances, the Parties
may agree that the Party that has engaged the distributor may sell the
products of the other Party through that distributor. |
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8.1.4 |
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Where practical the Parties will align their respective
sales territories such that they coincide geographically. |
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8.1.5 |
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Each Party will introduce the other Party to its existing
and potential distribution partners. The Parties may engage the same or
different distributors within any sales territory and may engage
additional distributors. |
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8.1.6 |
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The Parties will coordinate their marketing, promotional,
sales and distribution activities within the sales territories and may
agree to jointly market, sell and/or jointly distribute products within
selected sales territories. |
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8.1.7 |
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The Parties agree that if one Party receives a sales lead
or order for products sold by the other Party, the Party receiving the
sales lead or order will refer the customer to the other Party. |
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9.0 |
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CUSTOMER SERVICE, TRAINING AND COMPLAINTS. |
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9.1 |
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CytoCore shall furnish technical service, assistance and support
arising out of sales of Kits by or on behalf of CytoCore. |
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9.2 |
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CS shall furnish technical service, assistance and support arising out of
sales of the Preservative. |
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9.3 |
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CytoCore agrees to require that its distributors be trained in the use of
the Preservative and associated Methods and Supplies. CS agrees to provide this
training to CytoCore and to make such training available to distributors of
CytoCore Kits. |
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9.4 |
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CytoCore will provide CS with copies of all inquiries, complaints and
requests pertaining to the Preservative in a timely manner. CytoCore shall be
responsible for the investigation of any complaints arising from the sale or use
of Kits. CS shall support CytoCore in such investigations. |
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9.5 |
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CytoCore shall be responsible for compliance with the medical device
reporting (“MDR”) requirements of the FDA, as specified in 21 CFR Part 803 and
foreign counterparts thereto, and corrections or removal requirements, as
specified in 21 CFR Part 806 and foreign counterparts thereto, as such
requirements pertain to the SoftPAP® collector and Kits. |
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9.5.1 |
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CS and CytoCore agree that if either Party should discover
or become aware of any fact, condition, circumstance or event (whether
actual or potential) concerning or related to the Preservative,
the Kits, or the Methods, Supplies and/or Instruments associated with the
Preservative which may reasonably require recall, correction or
removal, such party shall promptly communicate such fact,
condition, circumstance or event to the other Party within 48 hours. In
the event any governmental entity or regulatory body requests that a
Product be recalled, or the Parties agree, after consultation with each
other, that a Product should be recalled or removed, the parties shall
take all appropriate remedial actions with respect to such recall or
withdrawal of the Product. |
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9.5.2 |
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CytoCore will take the lead in the reporting,
investigation and resolution of adverse events associated with the
SoftPAP® collector and CS will take the lead in the reporting,
investigation and resolution of adverse events associated with the
Preservative or its associated Methods, Supplies and/or Instruments. |
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10.1 |
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CS warrants that Preservative delivered to CytoCore will conform
to all Specifications in effect at the time of manufacture and that for a
period of one (1) year from the date of delivery to CytoCore the
Preservative will be free of defects in material and workmanship |
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10.2 |
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CS shall at its sole expense replace any Preservative that is
determined not to conform to the applicable Specifications or to be
defective in materials or workmanship |
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EXCEPT AS EXPRESSLY SET FORTH ABOVE, CS DISCLAIMS ANY WARRANTY, EXPRESS OR
IMPLIED, WITH RESPECT TO (A) THE MERCHANTABILITY OF CS PRODUCTS, (B) THE
FITNESS OF CS PRODUCTS FOR ANY PARTICULAR PURPOSE OR USE, AND (C) ANY
COURSE OF DEALING, COURSE OF PERFROMANCE, OR USAGE OF TRADE |
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11.0 |
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INDEMNITY AND LIMITATION OF LIABILITY |
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11.1 |
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CytoCore shall indemnify, defend and hold CS and its Affiliates and
the officers, directors, employees, agents and independent contractors of each
of them harmless from and against any and all claims, demands, actions, suits,
losses, damages, liabilities, settlement amounts, costs or expenses (including
reasonable attorneys’ fees and costs) (collectively, “Claims”) arising out of
or relating to: (a) CytoCore’s breach of this Agreement; or (b) CytoCore’s
gross negligence or willful misconduct or (c) any products liability claims
relating to CytoCore products excluding the Preservative provided by CS
hereunder. |
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11.2 |
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CS shall indemnify, defend and hold CytoCore, its Affiliates and
the officers, directors, employees, agents and independent contractors of each
of them harmless from and against any and all Claims arising out of or
relating to: (a) CS’ breach of this Agreement; or (b) CS’ gross negligence or
willful misconduct; or (c) defects attributable solely to CS products. |
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11.3 |
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The party seeking indemnification (the “Indemnified Party”) will
give prompt written notice of any Claim of which the Indemnified Party is
aware to the other party (the “Indemnifying Party”); provided, however, that
the failure by an Indemnified Party to give such notice will not relieve the
Indemnifying Party of its obligations under this Section 15, except to the
extent that the failure results in the failure of actual notice and the
Indemnifying Party is damaged as a result. The Indemnified Party will allow
the Indemnifying Party to direct the defense and settlement of any such Claim,
with counsel of the Indemnifying Party’s choosing, and will provide the
Indemnifying Party, at the Indemnifying Party’s expense, with information and
assistance reasonably necessary for the defense and settlement of the Claim.
In the event that the Indemnifying Party fails to assume the defense or
settlement of any such Claim within 30 days after receipt of notice of same
from the Indemnified Party, the Indemnified Party shall have the right to
undertake the defense, appeal or settlement of such Claim at the expense of
and for the account of the Indemnifying Party. An Indemnifying |
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Party will not be liable for any settlement of a Claim affected without its
reasonable written consent, nor will an Indemnifying Party settle any such
Claim without the reasonable written consent of the Indemnified Party. No
Indemnifying Party will consent to the entry of any judgment or enter into
any settlement that does not include as an unconditional term the giving by
the claimant or plaintiff to the Indemnified Party a release from all
liability with respect to the Claim. |
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11.4 |
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Limitation of Liability. EXCEPT AS RELATED TO
INDEMNIFICATION OBLIGATIONS HEREUNDER, NEITHER PARTY SHALL BE LIABLE TO THE
OTHER FOR CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY, OR
PUNITIVE DAMAGES, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF
SUCH DAMAGES |
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12.0 |
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INTELLECTUAL PROPERTY. |
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12.1 |
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CS will retain full ownership of the CS intellectual property which
underlies the Preservative and any other CS product.. |
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12.2 |
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CytoCore agrees not to “reverse engineer” any CS product
or manufacturer a similar substitute preservative product. |
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13.0 |
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TERM AND TERMINATION. |
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13.1 |
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This Agreement shall become effective when fully executed by both
parties. This Agreement shall have an initial term of three (3) years
(beginning on its execution), with automatic renewals of one (1) year each,
unless (a) terminated by either party, (b) one party gives notice of
termination at least 90 days prior to the end of the initial or any renewal
term, or (c) terminated as set forth below. |
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13.2 |
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Either Party may terminate this agreement for convenience by
providing ninety (90) day advance written notification of such termination to
the other Party. |
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13.3 |
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If a Party should fail to perform under this Agreement or should
violate any term of this Agreement, then the other Party may give written
notice of the default and, if the defaulting party fails to fully correct the
default within sixty (60) days, then the other party shall have the right to
terminate this Agreement. |
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13.4 |
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Either Party may terminate this agreement for cause upon notice and
failure to cure within sixty (60) days of notice under the following
conditions: |
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13.4.1 |
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CytoCore may terminate this Agreement for cause if: |
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13.4.1.1 |
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CS fails to timely supply Products in the amounts
ordered by CytoCore |
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13.4.1.2 |
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Defective Products are received more than twice in any year |
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13.4.1.3 |
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CS’s supply of the Products are enjoined by reason of alleged
infringement or found to be infringing and a non- infringing
substitute is not timely provided |
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13.4.1.4 |
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CS makes a change in a Product which makes the Product
unsuitable for use in one or more countries within the Territory |
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13.4.1.5 |
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CS does not maintain and make available to regulatory
authorities a Technical File for the Preservative as required to
maintain the CE marking of the Preservative or does not provide
technical information pertaining to the Preservative that CytoCore
is required to provide to regulatory authorities. |
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13.4.1.6 |
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CS is subject to a regulatory action that prevents CS from
legally supplying Preservative to CytoCore |
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13.4.2 |
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CS may terminate this Agreement for cause if: |
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13.4.2.1 |
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CytoCore fails to pay invoices in a timely manner |
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13.4.2.2 |
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CytoCore Kits and/or the SoftPAP collector are subject to a
regulatory action that prevents them from being legally sold in
the territory. |
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13.5 |
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Termination of this Agreement for any reason by either party
shall not relieve the parties of any obligations accrued prior to the
effective date of the termination |
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13.6 |
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Upon termination of this Agreement: |
(a) All rights, licenses and privileges granted to CytoCore under this
Agreement shall immediately cease and terminate, but any such
termination will not affect the rights and obligations of the parties
respecting remedies for breach of this Agreement;
(b) All obligations arising out of events prior to the effective
termination date, including without limitation orders previously accepted and
obligations to pay for delivered Products, shall be performed in accordance
with the terms and conditions of this Agreement;
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11 of 18 |
(c) If terminated by CS, CytoCore shall have the right to fulfill any
contract obligations for the sale of Kits that it may have upon its books
when termination notice was received by CytoCore. If, at the time of
termination, CytoCore does not have sufficient Preservative in inventory to
meet these contract obligations, CS shall supply CytoCore with sufficient
Preservative to meet these obligations under the then existing terms and
conditions. In addition, CytoCore has the right to sell unsold Preservative
in its inventory for a period of six (6) months after termination; and
(d) All sublicenses shall also be terminated by CytoCore unless otherwise
extended by CS.
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14.0 |
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REPRESENTATIONS AND WARRANTIES. |
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14.1 |
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Each of CS and CytoCore represents and warrants to the other that
it is not a party to any agreement or covenant with any other person, and
knows of no statute, law, ordinance, regulations, rule, order or decree of a
governmental authority, which prohibits or restricts it from entering into and
performing pursuant to this Agreement |
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14.2 |
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CS and CytoCore each represents and warrants that it is, and will
remain, in compliance with all applicable international, federal,
provincial, state and local laws, regulations and orders related to its
respective business and duties under this Agreement. CS specifically
represents and warrants that the Product shall, as of the date of shipment to
CytoCore or its customers, not be adulterated or misbranded within the meaning
of the U.S. Food, Drug, and Cosmetic Act, and any similar provisions of state
and local laws, regulations and orders, and shall comply with GMP requirements
for such products including but not limited to ISO 13485 and foreign
equivalents |
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14.3 |
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CS represents and warrants that: (a) CS and its manufacturer have
the right to enter into this Agreement; (b) all necessary actions, corporate
and otherwise, have been taken to authorize CS’ execution and delivery of this
Agreement and the same is the valid and binding obligation of CS; (c) all
licenses, consents and approvals necessary for CS to carry out all of the
transactions contemplated in this Agreement have been obtained; and (d) CS has
the experience and technical and physical capacity to fulfill its obligations
under this Agreement. |
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14.4 |
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CytoCore represents and warrants that: (a) CytoCore has the right
to enter into this Agreement; (b) all necessary actions, corporate and
otherwise, have been taken to authorize CytoCore’s execution and delivery of
this Agreement and the same is the valid and binding |
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obligation of CytoCore; (c) all licenses, consents and approvals necessary
for CytoCore to carry out all of the transactions contemplated in this
Agreement have been obtained; and (d) CytoCore has the experience and
technical and physical capacity to fulfill its obligations under this
Agreement |
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14.5 |
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CS represents and warrants that the Products will comply to the
specifications therefore and that such Products do not infringe any
proprietary right of any third party |
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14.6 |
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Each party or CS’ contract manufacturer shall, during the term of
this Agreement, at its sole cost and expense, obtain and keep in force a
policy of comprehensive general liability insurance with bodily injury,
death and property damage limits of at least $1,000,000 per occurrence and
$2,000,000 aggregate, including product liability coverage. On execution of
this Agreement, and on each anniversary of same, each party shall furnish a
certificate of insurance, in form reasonably acceptable to the other party,
evidencing such insurance and providing for 30 days’ prior written notice to
the other party of any cancellation, nonrenewal or change of such insurance
coverage. CellSolutions is currently working with its Manufacturer to secure
the extension of its product liability coverage to include the Products of
CellSolutions. It is expected that such coverage will be in place by
December 31, 2009. |
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15.1 |
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The term “Confidential Information” means: (a) the terms and
conditions of this Agreement; and (b) a party’s information, data, knowledge
and know-how (in whatever form and however communicated) relating directly or
indirectly to the disclosing party (or to its Affiliates or contractors), as
to its or their respective businesses, employees, operations, methods,
processes, trade secrets, plans, properties, products, markets or financial
positions) that is delivered or disclosed by such party, its Affiliate or any
of their respective officers, directors, partners, members, employees,
contractors, agents or shareholders to the other party in writing,
electronically, orally or through visual means, or that such party learns or
obtains aurally, through observation or analyses, interpretations,
compilations, studies or evaluations of such information, data, knowledge or
know-how; and (c) any information that would be reasonably deemed to be
confidential when considering the nature of such information and the
circumstances surrounding its disclosure. Without limiting the foregoing,
CytoCore acknowledges and agrees that the proprietary information and
technology comprising the components, design and makeup of the Products are
proprietary and trade secrets of CS and constitute Confidential Information.
Without limiting the foregoing, CS acknowledges and agrees that all
information submitted by CytoCore in support of regulatory approvals are the
Confidential Information of CytoCore. Each party xxxx |
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limit access to Confidential Information to only those of its employees, agents
and consultants having a need-to-know in connection with this Agreement and
will take reasonable steps to ensure no unauthorized person has access to the
Confidential Information. Each party will advise in writing its employees,
agents and consultants to whom disclosure of Confidential Information is made
of the obligations under this Agreement to protect the Confidential
Information. Each party will be liable for the unauthorized disclosure of
Confidential Information by its employees, agents and consultants |
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15.2 |
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Confidential Information shall not include information, data, knowledge
and know-how that, as shown by written records: (a) is known to the receiving
party prior to disclosure to or receipt by such party without breach of an
obligation of confidentiality; (b) is in the public domain prior to disclosure
to a party; (c) enters the public domain through no violation of this Agreement
after disclosure to such party; or (d) is independently developed by a party
without reliance in any way on Confidential Information |
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15.3 |
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Each party shall keep the Confidential Information communicated to it
by the other party confidential and shall not either itself use or disclose such
information or provisions to any third person without the prior written approval
of the other party in each instance, except that either party may disclose such
provisions to the extent required by law or other demand under lawful process,
provided the receiving party gives the disclosing party prompt notice prior to
such disclosure to allow the disclosing party to make a reasonable effort to
obtain a protective order or otherwise protect the confidentiality of such
information. Subject to the requirements of applicable securities laws and
regulations of applicable stock exchanges, neither CytoCore nor CS shall make
any news releases or any other public disclosure with respect to the
transactions contemplated by this Agreement without the prior written consent of
the other party, which consent may be withheld by such other party in its sole
discretion; provided, however, that the foregoing shall not prohibit the
disclosure of this Agreement, subject to customary written confidentiality
restrictions, to persons with whom either party intends to enter into a sale,
merger, capital raising or other similar strategic transaction. |
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15.4 |
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Either party aggrieved by breach or threatened breach of this Section
16 shall be entitled to bring an action to prevent, stop or otherwise obtain
redress, including specific performance, injunctive relief or other available
equitable remedy, without having to post bond or other undertaking therefor, and
without necessity of providing 60 days’ notice pursuant to Section 13.3 above |
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16.0 |
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SUBCONTRACTING AND ASSIGNMENT. |
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16.1 |
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Except as provided in this Agreement, neither Party may assign or
transfer this Agreement or any rights or duties under it, voluntarily or by
operation of law, without the prior written consent of the other Party. Any
attempted assignment or transfer not in compliance with this Agreement shall
be void and of no force or effect. A reorganization or merger with another
corporation or other person shall not itself, however, constitute a
prohibited assignment |
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16.2 |
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Notwithstanding Section 16.1 above, in the event of a merger, sale
of stock or assets or reorganization, either party hereto may sell and
transfer its entire rights and obligations under this Agreement to a third
party at any time without prior written consent of the other Party. |
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16.3 |
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Either Party may subcontract its obligations hereunder provided
that each Party is responsible for the actions of its subcontractors |
Any notice, under this Agreement shall be in writing and be deemed given upon
written receipt of delivery, delivered via overnight courier in each case
addressed to the following addresses:
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If to CS:
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Cell Solutions, LLC.
Attn: Xxxxx Xxxxxx
0000 Xxxxxxxxxx Xxxx Xxxxx, Xxx. 000
Xxxxxxxxxx, XX 00000
Fax 000-000-0000 |
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If to CytoCore:
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CytoCore, Inc.
Attn: Legal Counsel
000 Xxxxx Xxxxxxx Xx., Xxx. 000
Xxxxxxx, XX 00000
Fax (000) 000-0000 |
or to such other address as a party may provide by notice given in the same
manner.
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18.1 |
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Definition of Affiliate. The term “Affiliate” means any person
controlled by, under common control with or which controls a party to this
Agreement, control being defined as either having ownership of a majority of
the equity of such party generally eligible to elect a majority of the
governing body of such party, or the right by agreement or otherwise to
direct the actions of such party (including, without limitation as a general |
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partner of a partnership or as a managing member of a limited liability
company) |
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18.2 |
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Applicable Law. This Agreement shall be governed by and
construed in accordance with the laws and decisions of the state of Delaware,
without regard to the conflicts of law rules of such state |
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18.3 |
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Mediation. In the event of a dispute between the parties,
which cannot be resolved in the course of ordinary business, either party may
submit a written request for a meeting of senior executives to resolve such
dispute. In the event that such a request is submitted, the receiving party
shall make a senior executive available to discuss the matter within 10
business days. If the matter is not resolved by such meeting, either party
may send a written request that the dispute be submitted to mediation. Such
request shall include the names of at least three U.S.-based mediators or
mediation services, each of which must have appropriate professional training
and experience in business mediation. The parties shall work in good faith to
agree on a mediator within five business days of receipt of the request, and
the mediation shall be scheduled as soon as reasonably practicable, but in any
case within 30 days of receipt of the request. The mediation shall occur in
the principal office city of the request recipient. All costs of mediation
shall be borne equally by the parties. In the event that a mutually agreeable
resolution cannot be reached through mediation, either party may proceed to
use the courts or other legal methods to achieve resolution. Nothing in this
Section 19.3 shall be construed as preventing either party from using the
courts directly and immediately for injunctive relief pursuant to Section 16
in the event that imminent harm is threatened, or as preventing either party
from proceeding to litigation in the event that mediation is unsuccessful |
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18.4 |
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Further Assurance. Each party shall execute and deliver, at
the request of the other party, such further documents or instruments, and
shall perform such further acts, that may be reasonably required to fully
accomplish the intent of this Agreement |
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18.5 |
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Waiver of Breach. The waiver by either party of a breach of
any term or provision of this Agreement shall not be construed as a waiver of
any subsequent breach of the same or any other term or provision by either
party |
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18.6 |
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Modification. This Agreement may not be amended or modified
except in a writing executed by the parties |
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18.7 |
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Assignment. This Agreement shall be binding upon and
operate to the benefit of the parties and their successors and permitted
assigns |
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18.8 |
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Relationship of Parties. The relationship of the parties
under this Agreement is that of independent contractors. Nothing contained in
this |
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Agreement is intended or is to be construed so as to constitute the parties
as partners or joint venturers, or either party as an agent or employee of
the other. Neither party has any express or implied right under this
Agreement to assume or create any obligation on behalf of or in the name of
the other, or to bind the other party to any contract, agreement or
undertaking with any third party, and no conduct of the parties shall be
deemed to infer such right |
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18.9 |
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Severability. If any provision of this Agreement is
finally held to be invalid, illegal or unenforceable by a court or agency of
competent jurisdiction, that provision shall be severed or shall be modified
by the parties so as to be legally enforceable (and to the extent modified, it
shall be modified so as to reflect, to the extent possible, the intent of the
parties), and the validity, legality and enforceability of the remaining
provisions shall not be affected or impaired in any way |
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18.10 |
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Interpretation. Time is of the essence of this
Agreement in all particulars. All monetary figures are in U.S. Dollars. The
term “days” means calendar days. As the context may require in this Agreement,
the use of any gender (male, female or neuter) shall include any other gender,
and the singular shall include the plural and the plural the singular. The
word “person” includes individual, joint venture, partnership, limited
liability company, corporation, association, trust or any other entity or
organization. The captions heading the sections and subsections of this
Agreement are inserted for convenience of reference only, and are not to be
used to define, limit or describe the scope or intent of any term, provision,
section or subsection of this Agreement. Each Schedule described in and
attached to this Agreement is incorporated in it. This Agreement may be
executed in several counterparts, each of which shall be deemed an original
but all of which taken together shall constitute one and the same instrument |
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18.11 |
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Integration. THIS AGREEMENT CONTAINS THE FINAL AND
CONCLUSIVE AGREEMENT AND UNDERSTANDING OF THE PARTIES WITH RESPECT TO THE
SUBJECT MATTER OF IT, AND SUPERSEDES ALL PRIOR AND CONTEMPORANEOUS
AGREEMENTS, PROMISES, REPRESENTATIONS, AGREEMENTS OR UNDERSTANDINGS, ORAL OR
WRITTEN, BETWEEN THE PARTIES RELATING TO THE SUBJECT MATTER OF THIS
AGREEMENT, |
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18.12 |
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Survival. Sections 5.3, 9.5, 10, 11, 13-15, 16.1, 16.2,
17 AND 18 shall survive termination or expiration of this Agreement |
EXECUTED by the parties through their duly authorized representatives as of the date first
written above.
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| CELL SOLUTIONS, LLC. |
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CYTOCORE, INC. |
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By
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/s/ Xxxxx Xxxxxx
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By |
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/s/ Xxxxxx X. XxXxxxxxxx Xx. |
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Xxxxx Xxxxxx, Ph.D., CEO
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Xxxxxx X. XxXxxxxxxx Xx., CEO |
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