EXHIBIT 10.3
HARDWARE AND DISPOSABLES
SUPPLY AGREEMENT
This HARDWARE AND DISPOSABLES SUPPLY AGREEMENT ("Agreement"), dated as of
December 17, 1997, is entered into by and between Xxxxxx Healthcare Corporation,
a Delaware corporation having a place of business at 0000 Xxxx Xxxx Xxxx,
Xxxxxxxxx, Xxxxxxxx 00000 ("Baxter"), and BIT ACQUISITION CORP., a Delaware
corporation having a place of business at Nine Parker, Xxxxxx, Xxxxxxxxxx 00000
("Newco").
RECITALS
X. Xxxxxx and VIMRx Pharmaceuticals Inc., a Delaware corporation
("VIMRx"), have agreed to enter into a strategic alliance in the ex vivo cell
therapies business and have formed Newco for that purpose, pursuant to that
certain Asset Purchase Agreement dated as of October 10, 1997, by and among
Baxter, Newco and VIMRx (the "Acquisition Agreement").
B. Pursuant to the Acquisition Agreement, Baxter has transferred to Newco
certain Isolex(R) and Maxsep(R) Technology (as that capitalized term is defined
below) as well as other IT Assets relating to Isolex(R) and Maxsep(R) Products
(as those capitalized terms are defined below).
C. Pursuant to the Acquisition Agreement, Baxter and Newco have entered
into that certain sublicense of even date herewith relating to CD34+ cell
population and related antibody and method patents licensed from Becton,
Xxxxxxxxx and Company to Baxter (the "First BD Sublicense"); that certain
sublicense of even date herewith relating to B cell antibodies licensed from
Becton, Xxxxxxxxx and Company to Baxter (the "Second BD Sublicense"); that
certain sublicense of even date herewith relating to breast cancer antibodies
licensed from Cetus Oncology Corporation, d/b/a Chiron Therapeutics, to Baxter
(the "Chiron Sublicense"); and that certain sublicense of even date herewith
relating to B cells licensed from Xxxx. Xxxxx Xxxxxx to Xxxxxx Deutschland GmbH
(the "Dorken Sublicense") (the First BD Sublicense, the Second BD Sublicense,
the Chiron Sublicense and the Dorken Sublicense are collectively referred to
herein as the "Sublicense Agreements") pursuant to which Baxter has granted to
Newco licenses to the Licensed Technology (as that capitalized term is defined
in each of the Sublicense Agreements) as described therein.
X. Xxxxxx has agreed pursuant to the terms of that certain Hardware and
Disposables Manufacturing Agreement of even date herewith (the "Hardware and
Disposables Manufacturing Agreement"), to manufacture for Newco certain
Isolex(R) and Maxsep(R) Products (as that capitalized term is defined in the
Hardware and Disposables Manufacturing Agreement); and Baxter has
agreed to manufacture certain prototype products for the research market
pursuant to the terms of that certain Services Agreement of even date herewith
(the "Services Agreement").
X. Xxxxxx has agreed, pursuant to the terms of that certain Antibody
Manufacturing and Storage Agreement of even date herewith (the "Antibody
Manufacturing and Storage Agreement") to manufacture for Newco certain
Antibodies, Reagents and Reagent Kits (as those capitalized terms are defined in
the Antibody Manufacturing and Storage Agreement) which are utilized in
connection with the Isolex(R) and Maxsep(R) Products.
F. Newco desires that Baxter supply to Newco certain products utilized in
connection with, and other components of, the Isolex(R) and Maxsep(R) Products
as described herein and subject to the terms hereof and Baxter is willing to
supply to Newco certain products utilized in connection with, and other
components of, the Isolex(R) and Maxsep(R) Products as described herein and
subject to the terms hereof.
AGREEMENT
NOW, THEREFORE, in consideration of the premises and the mutual covenants
contained herein, Baxter and Newco hereby agree as follows:
1. DEFINITIONS.
1.1 Terms Defined in Preamble and Recitals: As used herein, all
capitalized terms defined in the Preamble and Recitals of this Agreement shall
bear the meanings ascribed to such terms as set forth therein.
1.2 Other Terms: As used herein, the following capitalized terms shall
have the following meanings:
A. "Affiliate" of a party shall mean any entity (i) which
directly or indirectly through one or more intermediaries Controls, is
Controlled by or is under common Control with, the party or (ii) fifty
percent (50%) or more of the voting capital stock (or in the case of an
entity which is not a corporation, fifty percent (50%) or more of the
equity interest) of which is beneficially owned or held by a party or any
of such party's Subsidiaries. The term "Control" means the possession,
directly or indirectly, of the power to direct or cause the direction of
the management and policies of an entity (other than a natural person),
whether through the ownership of voting capital stock, by contract or
otherwise.
B. "Baxter Products" means the products of Baxter identified on
Schedule 1 attached hereto (but not including the Spinning Membrane), as
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currently produced by Baxter, including improvements, revisions or
refinements of such products and such new products as are currently under
development, are in research, or have been identified as proposed new
products as indicated on Schedule 1, or as Baxter may otherwise agree to
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develop pursuant to this Agreement or the Services Agreement, in each case
as consistent with the nature of the Baxter Products existing at the date
of this Agreement for use in connection with the Isolex(R) and Maxsep(R)
Products and with Xxxxxx'x legal obligations and technological capabilities
(including, without limitation, regulatory requirements applicable to
Baxter) during the Term of this Agreement.
C. "Baxter Products Components" means components of Baxter
Products which may be assembled into Baxter Products and/or extruded sheet
stock which may be manufactured into Baxter Products, all as identified on
Schedule 2 attached hereto.
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D. "Device History Record" shall have the meaning ascribed to it
by the regulations of the FDA, as may be amended or changed from time to
time.
E. "Ex Vivo Cell Processing" shall mean the active selection, and
any subsequent modification, genetic alteration, activation and/or
expansion, of nucleated cells outside the body for therapeutic purposes
such as cellular therapy or gene therapy. For the purpose of this
definition, "active selection" shall mean processing involving the action
of a biological component, such as an antibody or modified antibody, a
lectin, or a ligand, to selectively and specifically bind to a particular
molecule on the surface of the cells to be selected so as to confer
specificity or selectivity for such cells in the cell selection process.
F. "FDA" means the United States Food and Drug Administration.
G. "FDA-Regulated Non-Baxter Component" shall mean any component
of a Supplied Product which is manufactured by a third party for or on
behalf of Baxter and which is either (a) deemed, under applicable law and
FDA regulations, to be "intended for use" in an FDA-regulated product or
(b) manufactured at any FDA-registered establishment.
H. "Fenwal" means the Fenwal Division of Baxter.
I. "Field of Distribution" shall have the meaning ascribed to
such capitalized term in the Marketing, Sales & Distribution Agreement.
J. "Forms FDA-483" shall have the meaning ascribed to that term
by FDA policy, as may be amended or changed from time to time.
K. "Fully Loaded Cost" means, for either party, such party's cost
of manufacturing, performing or acquiring any items or services, in
accordance with generally accepted accounting principles, consistently
applied ("GAAP"), and, with respect to each party, in accordance with such
party's normal accounting policies, all consistently applied, including any
royalties payable by such party in connection with manufacturing,
performing or acquiring any items or services (and in the case of Baxter,
including the royalties payable under the XxXxxxxxxx License), but
excluding, in the case of Xxxxxx'x Fully Loaded Cost, any royalty
obligations of Baxter that are paid or reimbursed by Newco pursuant to the
Sublicense Agreements. Fully Loaded Cost shall not include general
corporate allocations or other allocations which are not directly related
to the manufacture, performance or acquisition of the item or service,
however designated. A charge for the cost of funding the party's working
capital needs for such manufacture, performance or acquisition of items or
services, including capital expenditures for facilities and/or equipment
and capitalized manufacturing costs, will be included in Fully Loaded Cost,
which charge will be made at the interest rate paid by Baxter on its then
most recent issuance of commercial paper; provided, however, that no charge
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shall be made for any cost of, or the cost of funding, any changes in the
site of
manufacturing of the Baxter Products or Baxter Products Components. In the
event any item is acquired or any service is provided for a party from or
by an Affiliate of such party, the cost of acquiring such items or services
shall be deemed to mean such Affiliate's actual cost of manufacturing,
performing or acquiring such items or services in accordance with the
principles set forth in this definition of "Fully Loaded Cost". Current
costs of developing any items or services shall be included in Fully Loaded
Cost, but in no event shall any historic development costs be included in
Fully Loaded Cost.
L. "Isolex(R) and Maxsep(R) Products" shall have the meaning
ascribed to that term in the Hardware and Disposables Manufacturing
Agreement.
M. "Isolex(R) and Maxsep(R) Technology" means automated systems
for positive and negative immunomagnetic cell selection.
N. "Isolex(R) Products" means all Isolex(R) and Maxsep(R)
Products except Maxsep(R) instruments, Maxsep(R) disposables and Isolex(R)
disposables.
O. "IT Assets" means those Assets set forth in Schedule 2.1(A) of
the Acquisition Agreement that consist of personal property currently
utilized by Baxter solely in connection with manufacturing the Isolex(R)
and Maxsep(R) Products, including equipment, molds and tools.
P. "Manufacturing Facility" means any production site selected by
Baxter or a third party subcontractor of Baxter for manufacture of the
Supplied Products.
Q. "Marketing, Sales and Distribution Agreement " means the
Marketing, Sales and Distribution Agreement by and between Baxter and Newco
of even date herewith.
R. "Master Scheduling System" shall mean the computerized master
scheduling system currently used by Baxter in connection with the
production of the Supplied Products, as such system may be changed by
Baxter from time to time.
S. "XxXxxxxxxx License" means that certain Patent License and
Assignment Agreement, dated June 6, 1986, by and among Travenol
Laboratories, Inc., Hemascience Laboratories, Inc., and Xxxxxxx X.
XxXxxxxxxx, as amended from time to time.
T. "MDR" shall mean Medical Device Reports, as such term is
defined by the regulations of the FDA, as may be amended or changed from
time to time.
U. "Non-Compete Agreement" means the Non-Competition and
Confidentiality Agreement, by and among Baxter VIMRx, and Newco of even
date herewith.
V. "PMA Post-Approval Requirements" shall have the meaning
ascribed to them by the regulations and policy of the FDA, as the same may
be amended or changed from time to time.
W. "Product Field" means the treatment, mitigation or prophylaxis
of diseases, including research into such activities, through Ex Vivo Cell
Processing.
X. "Quality Manual" shall mean the quality manual currently used
in connection with the production of the Supplied Products, as such manual
may be changed from time to time.
Y. "Quality System Regulation" ("QSR") shall have the meaning
ascribed to it by the regulations of the FDA, as the same may be amended or
changed from time to time.
Z. "Regulatory Approval" means (1) in the United States, approval
from the FDA and any other United States governmental authority (or agency
or other political subdivision thereof) necessary for Newco to have the
right to market, sell or distribute the Isolex(R) and Maxsep(R) Products in
the United States to the public at large for use in the Product Field
(including the Field of Distribution), and (2) outside the United States,
an analogous order by a non-U.S. governmental authority (or agency or other
political subdivision thereof) necessary for Newco to have the right to
market, sell or distribute, and the right to be paid or
reimbursed for, the Isolex(R) and Maxsep(R) Products in a country (other
than the United States) to the public at large for use in the Product Field
(including the Field of Distribution).
AA. "Section 305 Hearing" shall have the meaning ascribed
to it by the Federal Food, Drug, and Cosmetic Act (the "Act") and
implementing regulations of the FDA, as may be amended or changed from time
to time.
BB. "Spinning Membrane" means the products of Baxter
described on Schedule 3 attached hereto, utilized in connection with one or
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more of the Isolex(R) and Maxsep(R) Products, and manufactured, used and
sold by Baxter subject to the XxXxxxxxxx License.
CC. "Standard Operating Procedure System" shall mean the
standard operating procedures used in connection with the production of the
Supplied Products, as such procedures may be changed from time to time.
DD. "Subcontractor" shall mean a third party who produces
and/or supplies Baxter Products or Spinning Membrane, or any FDA-Regulated
Non-Baxter Component of a Baxter Product or Spinning Membrane to or on
behalf of Baxter under contract.
EE. "Subsidiary" means, as to any party, any corporation of
which more than fifty percent (50%) of the outstanding capital stock having
ordinary voting power to elect a majority of the board of directors of such
corporation (irrespective of whether or not at the time stock of any other
class or classes of such corporation shall have or might have voting power
by reason of the happening of any contingency) is at the time directly or
indirectly owned by the party, by one or more of its subsidiaries, or by
the party and one or more of its subsidiaries.
FF. "Supplied Products" means the Baxter Products, the
Baxter Products Components and the Spinning Membrane and/or any components
of the Baxter Products and the Spinning Membrane.
GG. "Value Improvement Process" shall mean the Value
Improvement Management System currently used in connection with the
production of the Supplied Products, as such system may be changed from
time to time.
HH. "Warning Letter" shall have the meaning ascribed to it
by FDA policy, as the same may be amended or changed from time to time.
2. TERM.
2.1 Term: With respect to each of the Supplied Products except
the Harvester System, the Solution Transfer Pump and the Cell Wash Sets, the
term of this Agreement (the "Term"), unless earlier terminated pursuant to
Section 25 below, shall be eleven (11) years from the date hereof. If Newco and
Baxter are unable to agree upon the terms for extension or renewal of this
Agreement after good faith negotiation, then at the expiration of the Term
hereof, at Xxxxxx'x option, with respect to each Supplied Product either (A)
Baxter will continue to supply such Supplied Product under the then current
terms and conditions of this Agreement; or (B)(i) Baxter will transfer to Newco
or provide Newco with an exclusive, worldwide, royalty-free, perpetual license
or sublicense (subject in the case of a sublicense, to any applicable license
terms) to make, have made, use and sell such Supplied Product in connection with
Ex Vivo Cell Processing under all of the intellectual property (including
without limitation, patents, patent applications, copyrights, know-how and
confidential and proprietary information) owned or used by Baxter as required
for the manufacture of such Supplied Product, which license will be subject to
any then existing licenses or sublicenses of such technology, and (ii) Baxter
will transfer to Newco, or otherwise provide access to and the rights to
reference, any applicable FDA device master file.
2.2 Certain Products: With respect to each of the Harvester
System, the Solution Transfer Pump and the Cell Wash Sets, the Term, unless
earlier terminated pursuant to Section 24 below, shall be five (5) years from
the date hereof. At the end of such five (5) year term, (i) Baxter will grant
to Newco an exclusive, worldwide, royalty-free, perpetual license to make, have
made, use and sell the Harvester System, the Solution Transfer Pump and the Cell
Wash Sets in connection with Ex Vivo Cell Processing under all of the
intellectual property (including without limitation, patents, patent
applications, copyrights, know-how and confidential and proprietary information)
owned or used by Baxter as required for the manufacture of the Harvester System,
the Solution Transfer Pump and the Cell Wash Sets, which license will be subject
to any then existing licenses or sublicenses of such technology, (ii) Baxter
will transfer to Newco, or otherwise provide access to and the rights to
reference, any applicable FDA device master file, and (iii) Baxter will assist
in the transfer of the manufacture of the Harvester System, the Solution
Transfer Pump and the Cell Wash Sets to a third party manufacturer selected by
Newco in the manner described in clauses (i) through (iii) of Section 3.2B and
Section 3.2C, below.
2.3 Licenses: Licenses granted by Baxter to Newco pursuant to
this Section 2 shall not be assignable and sublicenses may not be granted
thereunder, except (i) any such license may be assigned in the event of an
acquisition or transfer of substantially all of the Ex Vivo Cell Processing
business of Newco to a third party; (ii) Newco may grant a sublicense under any
such license to an Affiliate of Newco that is owned by Baxter and VIMRx in
substantially the same proportions as Newco is owned; and (iii) Newco may grant
a sublicense under any such license to a third party manufacturer in connection
with the manufacturing for Newco of any Supplied Product, provided that such
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assignee, licensee or third party manufacturer has agreed to be bound by the
terms of that certain Non-Competition and Confidentiality Agreement of even date
herewith, by and among Baxter, VIMRx and Newco, in the same manner as Newco is
bound.
3. SUPPLY.
3.1 Baxter to Supply: During the Term, Baxter shall supply to
Newco the Supplied Products solely in conjunction with the manufacture, use and
sale of the Isolex(R) and Maxsep(R) Products, any substituted versions of such
products and any new products developed by Newco in connection with Ex Vivo Cell
Processing, subject to the terms and conditions contained in this Agreement.
Newco shall have the exclusive worldwide royalty-free right during the Term to
distribute the Supplied Products in connection with Ex Vivo Cell Processing,
provided that (a) the Spinning Membrane may only be sold by or on behalf of
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Newco as part of an Isolex(R) disposable kit for use in Ex Vivo Cell Processing;
(b) the Spinning Membrane subassembly may only be sold by or on behalf of Newco
as a spare part for replacement of such subassembly in one or more of the
Isolex(R) Products sold by Newco (or, prior to the date hereof, sold by Baxter)
for use in Ex Vivo Cell Processing; and (c) Newco's distribution rights
hereunder are subject to Xxxxxx'x right to distribute the Supplied Products
pursuant to the Marketing, Sales and Distribution Agreement.
3.2 Alternate Products or Manufacturers: All Supplied Products
shall be finished goods; provided, however, that:
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A. In the event Baxter elects to discontinue manufacturing any
specific Baxter Product or Products altogether and provides Newco with six
months' written notice of such discontinuation, Baxter shall instead
provide to Newco the Baxter Products Components which may be assembled or
manufactured by Newco or a third party manufacturer chosen by Newco, into
products having the same specifications as such Baxter Product(s)
("Alternate
Products") under an exclusive, worldwide, royalty-free license to make,
have made, use and sell such Alternate Products solely in connection with
Ex Vivo Cell Processing, on terms mutually agreeable to the parties (but
not including a license to any of Xxxxxx'x trademarks, trade names, logos
or service marks or to any of Xxxxxx'x copyrights). Baxter may only make
such an election to discontinue manufacturing any Baxter Products pursuant
to this Section 3.2A effective after three (3) years from the date hereof
and Baxter hereby agrees that in the event it makes such an election, (i)
it will provide Newco or Newco's third party manufacturer, at Xxxxxx'x sole
expense, with such support, assistance and manufacturing know-how as shall
be required by Newco to effect an orderly transition and (ii) it will
continue to manufacture and supply such Baxter Products until Newco or
Newco's third party manufacturer is ready, willing and able to satisfy the
demand for such Baxter products.
X. Xxxxxx agrees to supply to Newco the Supplied Products listed
on Schedule 4 hereto, or, in Xxxxxx'x sole discretion, Baxter may license
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to Newco and Newco's third party manufacturer the right to produce any or
all of the Supplied Products listed on Schedule 4 under an exclusive,
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worldwide, royalty-free license to make, have made, use and sell such
Supplied Products solely in connection with Ex Vivo Cell Processing on
terms mutually agreeable to the parties; provided that such license shall
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not grant to Newco or Newco's third party manufacturer the right to make,
have made, use or sell such Supplied Products except to the extent
permitted in Section 3.1 above. Baxter may not elect to discontinue
manufacturing for Newco any of the Supplied Products listed on Schedule 4
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during the Term of this Agreement unless it has licensed to Newco the right
to produce such Supplied Product; provided, however, that Baxter may adjust
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the price for any of the Supplied Products listed on Schedule 4 at any time
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in accordance with the terms of Section 13.3 hereto. In the event that
Baxter elects to license to Newco and Newco's third party manufacturer the
right to produce any such Supplied Product, (i) Baxter will provide Newco
or Newco's third party manufacturer, at Xxxxxx'x sole expense, with such
support, assistance and
manufacturing know-how as shall be required by Newco to effect an orderly
transition, (ii) Baxter will transfer to Newco or Newco's third party
manufacturer, or otherwise provide access to and the rights to reference,
Xxxxxx'x FDA device master file, and (iii) Baxter will continue to
manufacture and supply Newco with Supplied Product until Newco or Newco's
third party manufacturer is ready, willing and able to satisfy the demand
for such Supplied Product.
C. In any case where Baxter is obligated to provide support,
assistance and manufacturing know-how and Baxter is obligated to continue
manufacturing until Newco or Newco's manufacturer is ready, willing and
able to satisfy the demand for such product, such Baxter obligations shall
continue only as long as Newco or any Newco third-party manufacturer
receiving such Baxter assistance is endeavoring in good faith to assume
manufacturing responsibilities and become ready, willing and able to
satisfy the demand for such product.
3.3 Acknowledgement: Newco acknowledges and understands that
Xxxxxx'x manufacturing and sale of the Spinning Membrane and any disposable sets
containing the Spinning Membrane is subject to the terms and conditions of, and
the limitations, if any, contained in, the XxXxxxxxxx License.
3.4 Violations: Nothing herein contained shall oblige Baxter to
continue supplying or Newco to continue purchasing any Supplied Product if such
supply or purchase is reasonably believed by Baxter or Newco, as the case may
be, to violate any applicable law, regulation, rule or license or if the
Supplied Products supplied infringe a third party's patent or other intellectual
property rights, provided that Baxter will cooperate with Newco, to the extent
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commercially feasible, to develop and implement such changes as may be necessary
to bring such Supplied Product into compliance or to prevent such infringement
and Baxter will continue to supply after a finding of infringement if Newco or
Baxter reaches an agreement with the third party which permits future production
without infringement.
4. CONTACTS/PLANNING COMMITTEE.
4.1 Administration: Administration of this Agreement will be
accomplished by the establishment of two "Production Operating Teams," to
include the Tampa Production Operating Team and Mountain Home Operating Team.
The Production Operating Teams will consist of representatives from each of
Newco and Baxter who typically would include
the individuals identified in Schedule 5, or other persons of an appropriate
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level of authority and responsibility. Each party will select representatives
and shall notify the other party of such selections and any changes thereto.
The Production Operating Teams will meet (in person or by teleconference) at
least once in each calendar quarter to review the progress of Newco and Baxter
in the execution of this Agreement and to develop, review and agree on specific
plans and programs designed to assure that Baxter can fulfill orders placed by
Newco. Each Production Operating Team will develop a process to agree upon
short-term and long-term forecasts, orders and production planning schedules and
to conduct any other business to discharge its responsibilities pursuant to the
provisions of this Agreement. Regardless of the number of representatives
selected by each of Newco and Baxter for service on either of the Production
Operating Teams, the representatives of each party shall have, in the aggregate,
a single vote in all matters to be decided by any Production Operating Team.
If, in the course of conducting the activities contemplated in these Agreements,
either Production Operating Team cannot resolve a matter of difference between
Baxter and Newco representatives, or cannot reach agreement on a matter within
its area of responsibility under the terms of this Agreement, the Production
Operating Team shall promptly refer the matter to the Corporate Committee.
4.2 Corporate Committee: The "Corporate Committee" will consist
of one representative each from VIMRx and Baxter, who ordinarily will be the
President and CEO of VIMRx and the President of Fenwal, respectively. The
Corporate Committee will meet only as needed to resolve any dispute or otherwise
undecided matter referred to it by the Production Operating Teams. If the
Corporate Committee cannot come to an agreement with respect to any matter, the
matter will be referred to arbitration as provided in this Agreement.
4.3 Responsibilities: Newco and Baxter will cooperate to
identify their separate responsibilities hereunder, and will diligently execute
those responsibilities to assure a continuous, uninterrupted supply to the
market for all Supplied Products. For guidance and illustrative purposes, a
list of the various responsibilities to be assumed by Newco and Baxter for
purposes of this Agreement are attached on Schedule 6. Whenever the need for
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functions and responsibilities not previously identified or assumed by either
Newco or Baxter becomes evident, the Production Operating Teams will assign such
functions or responsibilities.
5. TRADEMARK LICENSE AND LABEL COPY.
5.1 Trademark License: Newco hereby grants to Baxter and Baxter
accepts a non-exclusive royalty-free worldwide license to use Newco's
trademarks, trade names, service marks, corporate logos and copyrighted
materials solely in connection with the manufacture, use and sale of the
Supplied Products to or on behalf of Newco during the Term pursuant to the terms
of this Agreement, provided that Newco has reviewed and approved in writing each
use or display of such Newco trademarks, trade names, service marks, logos and
materials. If any such Newco trademark, trade name, service xxxx, logo or
material is to be used
in connection with the Supplied Products, Baxter shall obtain prior written
authorization from Newco (which authorization may be withheld by Newco in its
sole discretion) for such use and for all subsequent changes to any art work,
labels, inserts, advertising, packaging or marketing materials that incorporate
such Newco trademark, trade name, service xxxx, logo or materials. No other use
of Newco's trademarks, trade names, service marks, logos and copyrighted
materials is permitted during or after the Term of this Agreement. Except as
provided in this Agreement, Baxter shall not use any trademark, trade name,
service xxxx or logo claimed by Newco or any confusingly similar trademark,
trade name, service xxxx or logo, during or after the Term of this Agreement.
5.2 Label Copy: Newco shall provide all labeling, product
inserts and packaging for the Supplied Products, provided that Xxxxxx has
reviewed and approved in writing each use or display on such labels, inserts or
packaging of any trademark, trade name, service xxxx or logo used or owned by
Xxxxxx, other than any trademark, trade name, service xxxx or logo licensed to
Xxxxxx pursuant to Section 5.1 of this Agreement. Changes in Supplied Product
labeling requested by Newco and the cost of labeling made obsolete by such
changes will be paid for by Newco at Xxxxxx'x Fully Loaded Cost. If a
trademark, trade name, service xxxx or logo owned or used by Xxxxxx or its
parent corporation, other than any trademark, trade name, service xxxx or logo
licensed to Xxxxxx pursuant to Section 5.1 of this Agreement, is to be used in
connection with the Supplied Products (except to the extent such use is
mandatory in connection with the labeling requirements of applicable law) Newco
shall obtain prior written authorization from Xxxxxx (which authorization may be
withheld by Xxxxxx in its sole discretion) for such use and for all subsequent
changes to the art work, labels, inserts or packaging for the Supplied Products
that incorporate such a Xxxxxx trademark, trade name, service xxxx or logo.
Each use of such a Xxxxxx trademark, trade name, service xxxx or logo shall
inure to the benefit of Xxxxxx and its parent company. Should any such use vest
in Newco any rights in a trademark, trade name, service xxxx or logo used by
Xxxxxx, other than any trademark, trade name, service xxxx or logo licensed to
Xxxxxx pursuant to Section 5.1 of this Agreement, Newco shall transfer such
rights to Xxxxxx or its designee upon the request of Xxxxxx. Except as provided
in this Agreement, Newco shall not use any trademark, trade name, service xxxx
or logo claimed by Xxxxxx or any confusing similar trademark, trade name,
service xxxx or logo during or after the Term of this Agreement.
6. PRODUCTION.
6.1 Production of Supplied Products: In manufacturing the
Supplied Products, Xxxxxx and its Subcontractors shall comply with all
applicable QSR or applicable state or foreign regulatory requirements except to
the extent a relevant regulatory requirement has been allocated to Newco under
the Agreements between Xxxxxx and Newco. More specifically, as applicable,
Xxxxxx or its Subcontractor, as the case may be, shall:
A. Comply with all relevant materials, manufacturing and in-
process controls, label control and quality control specifications, product
drawings/blueprints and operating procedures which are applicable at the
time of manufacture to the manufacture of the Supplied Products thereof or
(except with respect to product specifications) as they shall be changed by
Xxxxxx or a Subcontractor with the prior written consent of Newco with
respect to material changes (which consent shall not be unreasonably
withheld);
B. Perform the release function for each lot of Supplied Product;
C. Prepare and maintain the Device History Record and any state,
local, or foreign equivalent thereof for each lot, including records of any
product retentions which may have been issued against the lot during the
manufacturing process, the action taken, and the disposition of the
retention;
D. Maintain and comply with the quality system as described in
its current Quality Manual applicable to the Supplied Products, or as
subsequently changed generally for all products of that type manufactured
by such manufacturer; and
E. Maintain and comply with its Standard Operating Procedure
System which is currently applicable to the Supplied Products (relating to
product manufacturing, testing and critical engineering system monitoring
and control, cleaning/sanitization, calibration of equipment, preventative
maintenance, employee training, pest control, environmental
control/monitoring, equipment/process validation, labeling/packaging
control, failure investigations, internal quality audits, handling of
customer calls and complaint forwarding, computer systems validation and
maintenance, product release, product/process change control and delegation
of authority), or as subsequently changed generally for all products of
that type manufactured by such manufacturer.
Xxxxxx or a Xxxxxx Subcontractor may change the product specifications for any
Supplied Product only with the prior written consent of Newco, which consent
shall not be unreasonably withheld.
If Xxxxxx or its Subcontractor proposes to make a material change in product
specifications (including in design, materials or suppliers), it shall give
Newco not less than six months' prior notice of any such change (including,
without limitation, any change that may affect the Post-Marketing Approval
("PMA") or state, local or foreign regulatory approval of any Supplied Product
or of any Isolex(R) and Maxsep(R) Products which utilize such Supplied Product,
or that requires regulatory review). If any such change is unacceptable to
Newco (in its reasonable discretion), Newco shall give Xxxxxx and, if
applicable, the Subcontractor notice of its objection within thirty (30) days
after receipt of the notice provided hereunder by Xxxxxx or its Subcontractor as
the case may be. In the event that Newco objects to a proposed change, Xxxxxx
will continue to provide the Supplied Products without any change in product
specifications. If Newco objects to such a change because it determines a
Regulatory Approval is required for the Supplied Product or for any product of
Newco that incorporates a Supplied Product as a component thereof, Xxxxxx or its
Subcontractor, as the case may be, may prepare and pay the cost of application
for such Regulatory Approval with the appropriate regulatory authority, and
Xxxxxx or its Subcontractor may supply the changed Supplied Product upon
obtaining Regulatory Approval and satisfying any other applicable regulatory
requirements.
6.2 Materials and Services: Newco shall not have any right of
prior approval with respect to changes of suppliers or materials relating to
Supplied Products, except to the extent that such changes affect any Supplied
Product's specifications, whereupon Newco shall have the right to review and
approve or object to such changes pursuant to Section 6.1 above (and the rights
of the parties in connection therewith shall be governed by Section 6.1 above).
7. CHANGE OF PRODUCTION SITES / OUTSOURCING MANUFACTURE. After
consultation with the Production Operating Teams and written notice to Newco
(but without the requirement of prior consent) Xxxxxx or a Xxxxxx Subcontractor
may change the current production site of any Supplied Products (or any
component thereof) and Xxxxxx may outsource the production of any Supplied
Products provided that (i) there is no material increase in the price of the
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Supplied Products to Newco, (ii) A PMA supplemental approval or foreign
marketing authorization or approval for any Supplied Product or any of the
Isolex(R) and Maxsep(R) Products which utilize such Supplied Product is not
required, and (iii) the manufacturing of the Supplied Products otherwise
conforms to the terms of this Agreement or Xxxxxx causes a relevant third party
to comply with the terms of this Agreement in connection with outsourced
manufacturing of the Supplied Products, as the case may be. Newco and Xxxxxx
agree that nothing contained in this Agreement shall require Xxxxxx or a
Subcontractor to change, or open any new or additional, Manufacturing
Facilities, apart from any upgrades in its Manufacturing Facilities that Xxxxxx
or a Subcontractor may, in its sole discretion, make in order to meet the
specifications for production of the Supplied Products applicable at any time
and any change as may be necessary to enable Xxxxxx or a Subcontractor to
satisfy its obligations hereunder to deliver Supplied Products to Newco. With
respect to production site changes, new outsourcing, and facility upgrades,
Xxxxxx or a Subcontractor shall provide Newco with sufficient advance notice to
allow Newco to comply with any applicable regulatory requirements. If Newco
determines a PMA supplemental approval or
state, local or foreign marketing authorization or approval is necessary, Xxxxxx
(and/or its Subcontractor) and Newco shall agree to the allocation of costs
related to preparation and submission of the PMA supplemental or other
application. New production sites, outsourcing and facility upgrades shall not
be utilized for supply to Newco, pending PMA supplement or foreign approval,
unless consistent with FDA and other applicable regulations.
8. FACILITY ACCESS AND AUDITS.
8.1 Facility Access: During the Term, Xxxxxx and its
Subcontractors shall permit Newco access solely to those areas of the
Manufacturing Facilities in which the Supplied Products are manufactured, upon
reasonable prior notice and scheduling by Newco during normal business hours,
for the examination of production or quality records or to perform QSR audits.
Newco's access to such Manufacturing Facilities shall be coordinated through the
Production Operating Teams.
8.2 Audit: Newco may audit Xxxxxx'x and Xxxxxx Subcontractors'
books and records for the purpose of determining compliance with the terms of
this Agreement. Newco may use independent outside auditors (who may participate
fully in such audit). In the event that an audit is proposed with respect to
information which Xxxxxx or such Subcontractor wishes not to disclose to Newco
("Restricted Information"), then on the written demand of Xxxxxx or such
Subcontractor, the individuals conducting the audit with respect to the
Restricted Information will be limited to the independent auditors of Newco. In
such event, Xxxxxx or such Subcontractor shall pay the costs of the independent
auditors conducting such audit, but only with respect to that portion of the
audit relating to the Restricted Information. Such independent auditors shall
enter into an agreement with the relevant parties on terms that are agreeable to
such parties, under which such independent auditors shall agree to maintain the
confidentiality of the information obtained during the course of such audit and
establishing what information such auditors will be permitted to disclose in
reporting the results of any audit of Restricted Information to Newco. Any such
audit shall be conducted during regular business hours in a manner that does not
interfere unreasonably with the operations of Xxxxxx or a Subcontractor. The
aggregate number of audits of Xxxxxx'x or its Subcontractor's books and records
conducted under this Agreement and the Sublicense Agreements, the Hardware and
Disposables Manufacturing Agreement, the Antibody Manufacturing and Storage
Agreement, the Services Agreement and the Marketing, Sales and Distribution
Agreement shall not exceed one (1) per facility in any twelve (12) month period
unless the next preceding audit disclosed a failure to conform to the terms of
any such Agreement or unless the facility received a Form FDA-483 in the twelve
(12) months following any audit. Subject to the foregoing limitations, any such
audit shall be conducted when requested by notice given not less than thirty
(30) days prior to the commencement of the audit.
8.3 Xxxxxx Subcontractors: Newco's rights to facility access
and to audit books and records pursuant to this Section 8, process validation
pursuant to Section 9 below, and certain regulatory compliance matters pursuant
to Sections 11.1(D), (E), (G), (H), (I) and (J)
below, are, in the case of Xxxxxx Subcontractors, subject to the limits on
Xxxxxx'x rights under its agreements with such Subcontractors. Xxxxxx will use
its best efforts, without the requirement of the payment of money, to cause all
of its Subcontractors to permit facility access, the right to audit books and
records, process validation, and certain regulatory compliance matters as set
forth herein with respect to the Supplied Products as provided in this Section
8, Xxxxxxx 0 xxxxx xxx Xxxxxxxx 00.0(X), (X), (X), (X), (X) and (J) below.
9. PROCESS VALIDATION. During the Term, at Newco's request, Xxxxxx
and its Subcontractors shall permit Newco to review production validation
protocols and results with respect to the Supplied Products. Such reviews shall
be arranged by the Production Operating Teams.
10. REGULATORY RESPONSIBILITY.
10.1 Regulatory files: Except with respect to regulatory files and
records needed only or additionally by Newco to meet its PMA holder obligations,
Xxxxxx and its third party subcontractors will maintain all regulatory files on
all Supplied Products and every component thereof.
10.2 Newco Responsibility: Notwithstanding the provisions of Section
10.1 or Section 11.1L hereof, Newco shall prepare, obtain approval of and hold
all applications, notifications, submissions and regulatory files required by
the FDA and the Act, or by state or foreign authorities and laws, relating to
any Supplied Product manufactured by Xxxxxx solely for or on behalf of Newco,
provided that Xxxxxx and any Xxxxxx Subcontractor manufacturing such Supplied
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Product shall provide Newco with access to and the right to reference any
relevant device master file held by Xxxxxx or any such Subcontractor.
11. COMPLIANCE WITH REGULATORY REQUIREMENTS.
11.1 Xxxxxx Responsibilities: Notwithstanding any provision of
Section 10 hereof to the contrary, Xxxxxx shall, and, as applicable, shall
require any Subcontractor to:
A. Appropriately register its manufacturing establishments with
the FDA and other regulatory agencies when required and list Supplied
Products as necessary with the FDA and other regulatory agencies.
B. Maintain existing IS0 and EN certification for each
Manufacturing Facility, and comply with all European Union and other
foreign regulatory requirements as applicable.
C. As applicable, comply with the QSR requirements and other
relevant regulations issued by the FDA, state, local or other regulatory
authorities and in effect from time to time.
D. When practicable, permit Newco to send a representative to
attend, or when such attendance is not permitted or practicable, provide
Newco with periodic progress reports on every visit to a relevant
Manufacturing Facility by the FDA or other regulatory agency which affects
or concerns a Supplied Product (such reports to be given as frequently as
reasonably possible, but not more often than once in each 24-hour period,
during that portion of the visit which directly affects or concerns a
Supplied Product. Newco shall be provided with a copy of any Form FDA-483,
Establishment Inspection Report and/or Warning or "untitled" Letter
generated as a result of an FDA visit, or any equivalent foreign, state or
local document generated as a result of an inspectional visit, and
responses thereto (which copies may be redacted to the extent necessary to
protect confidential information unrelated to the Supplied Products,
provided that such redaction does not prevent Newco from discerning any
information that is related to the Supplied Products. Newco shall also be
apprised as soon as possible of the time and place of any "close out"
meeting at the end of an FDA or other agency visit and allowed to attend
the meeting when the meeting directly affects or concerns any Supplied
Product provided that in the discretion of Xxxxxx'x or its Subcontractor's
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regulatory professionals, the presence of a Newco representative would not
prejudice Xxxxxx'x or its Subcontractor's interests.
E. Respond in a timely manner, after consultation with Newco, to
any Form FDA-483, Warning Letter or Section 305 Notice, and any other
notices or letters received from the FDA, a state or local regulatory
authority, or an analogous regulatory authority outside the United States,
which relate to the Supplied Products.
F. Be responsible for handling product complaints and maintenance
of complaint files and records related to its Supplied Products.
G. Provide to Newco copies of product complaints received
relating to Supplied Products which were used in conjunction with the
Isolex(R) and Maxsep products or other Newco-owned products.
H. Maintain and store production records relating to the Supplied
Products as required by its record retention policy and its Standard
Operating Procedure System, as amended from time to time.
I. With cooperation from Newco, as mutually agreed by the
parties, administer mandatory notifications, repairs, replacements, and
refunds, safety alerts, "cease distribution and notification" and mandatory
recall actions, voluntary recalls, market withdrawals and stock recoveries,
and device removals and corrections, as defined or understood under law or
FDA policy, and related and analogous actions involving the Supplied
Products. Newco's cooperation shall be at Xxxxxx'x or its Subcontractor's
expense, subject to the provisions of Section 11.3 below.
J. Cooperate with Newco, as mutually agreed by the parties, in
connection with Newco's compliance with PMA and other post-approval
requirements, such cooperation to be at Newco's expense, subject to the
provisions of Section 10.3 below.
K. Prepare and file with FDA, under 21 C.F.R. Part 803, MDRs
related to Supplied Products it manufactures.
L. Prepare, obtain approval of, and hold all applications,
notifications, submissions and regulatory files required by FDA and the
Act, or by state or foreign authorities and laws, relating to its Supplied
Products, except as described in Section 10 above.
M. Comply with any PMA Post-Approval Requirements or other post-
approval regulatory requirements or special controls applicable to its
Supplied Products.
11.2 Newco Responsibilities: Newco shall:
A. Forward product complaints received on Supplied Products to
Xxxxxx or the relevant Xxxxxx Subcontractor.
B. Cooperate, as mutually agreed by the parties, in Xxxxxx'x or a
Xxxxxx Subcontractor's administration of mandatory notifications, repairs,
replacements and refunds, safety alerts, "cease distribution and
notification" and mandatory recall actions, voluntary recalls, market
withdrawals and stock recoveries, and device removals and corrections, as
defined or understood under law or FDA policy, or related or analogous
actions involving the Supplied Products.
C. Comply with distributor medical device reporting (MDR)
responsibilities as set forth in 21 C.F.R. Part 804 relating to Supplied
Products, to the extent required by law.
D. Comply with European Union and any other foreign regulatory
requirements, as applicable.
11.3 Regulatory Actions: In the event that Newco takes a
regulatory action relative to any Supplied Product or any Newco product
containing any Supplied Product manufactured for or supplied to it by Xxxxxx or
a Xxxxxx Subcontractor and such action is due solely to Xxxxxx'x or its
Subcontractor's failure to manufacture the Supplied Product in accordance with
its responsibilities under Sections 6.1, 7 or 11.1 of this Agreement, then
Xxxxxx shall pay or reimburse Newco for all out-of-pocket costs and expenses
incurred by Newco due to such action, including expenses or obligations to third
parties, the cost of notifying customers, costs associated with the return by
customers of Supplied Products or Newco products containing any Supplied
Products, and costs related to otherwise addressing, handling or correcting the
Supplied Products. In the event that such action is due in part to Xxxxxx'x or
its Subcontractor's failure to manufacture the Supplied Product in accordance
with its responsibilities under this Agreement, Xxxxxx shall pay or reimburse
Newco for such part of Newco's out-of-pocket costs and expenses as shall be
agreed by the parties or by the Corporate Committee, or as determined in binding
arbitration pursuant to Section 30 of this Agreement. For purposes of this
paragraph, "regulatory actions" mean mandatory notifications, repairs,
replacements and refunds, safety alerts, "cease distribution and notification"
and mandatory recall actions, voluntary recalls, market withdrawals and stock
recoveries, and device removals and corrections, as defined or understood under
law or FDA policy, and related or analogous actions.
12. ACTIVITY PLANNING / FORECASTS AND ORDERS.
12.1 Forecasts: Prior to the beginning of each calendar month during
the Term, Newco shall give Xxxxxx a forecast of the orders Newco expects to
place with Xxxxxx for Supplied Products during each of the next eighteen (18)
months, using the data supplied to Newco by Xxxxxx from the Master Scheduling
System currently employed by Xxxxxx and reviewed by the appropriate Production
Operating Teams. The forecast for the first two months contained in such
eighteen month forecast shall constitute firm orders. The forecast for the
first of the eighteen (18) months in such eighteen month forecast must be the
same as the forecast for the second month in the previous eighteen month
forecast; and the forecast for the second of the eighteen months in such
eighteen month forecast may not increase the number of orders shown in the
forecast for such month in the previous eighteen month forecast by more than
[Confidential Information Omitted], without the prior consent of Xxxxxx after
consultation with each of the Production Operating Teams. The eighteen month
forecast for the eighteen month period beginning on the date hereof, was
delivered to Xxxxxx on the date hereof.
12.2 Production Schedule: Based on the forecasts and orders
received by Xxxxxx from Newco, Xxxxxx shall develop and maintain detailed
production schedules for the Supplied Products, which shall be presented for
review by the Production Operating Teams at least quarterly.
12.3 Production in Excess of Orders: If Xxxxxx'x actual
production of Supplied Products which are manufactured specifically for Newco
exceeds Newco's firm orders, Newco shall purchase such excess, up to
[Confidential Information Omitted] above Newco's firm orders, provided that
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Newco's firm orders for the next month shall be reduced by such excess unless
Newco requests that such reduction not be made.
12.4 Production Below Amount of Orders: If, due to the fault or
error of Xxxxxx or a third-party supplier or subcontractor of Xxxxxx, subject to
the provisions of Section 25 of this Agreement, Xxxxxx fails to deliver Supplied
Products in the quantities specified in Newco's firm orders, Xxxxxx shall take
action as may be necessary to cure such failure as rapidly as is commercially
reasonable, including without limitation, the actions specified with respect to
various fill rates as follows:
A. If production for any month is [Confidential Information
Omitted] of Newco's firm orders or lower, Xxxxxx shall (i) increase its
production in the next following month as reasonably necessary to satisfy
both the unfilled orders and the firm orders for such next following month,
and (ii) pay air freight and other extraordinary shipping costs reasonably
necessary to deliver the delayed Supplied Products to Newco or Newco's
product manufacturer until Xxxxxx has brought production into compliance
with firm orders. Increased production under this Section 11.4(A) shall not
be subject to
the limits on variance of orders set forth in Section 12.1. The
[Confidential Information Omitted] fill rate commitment established
pursuant to this Section may be adjusted by the parties during the Term
hereof as may be appropriate to reflect actual manufacturing experience.
B. If production for any month is [Confidential Information
Omitted] of Newco's firm orders (as increased by the number of unfilled
orders, if any, carried over from the previous month) or lower, or if
production for any three consecutive months is [Confidential Information
Omitted] of Newco's firm orders (as increased by the number of unfilled
orders, if any, carried over from the previous month) or lower, Xxxxxx
shall (i) take the remedial measures set forth in Section 12.4(A), (ii)
promptly prepare and present to the Production Operating Teams a plan for
restoring compliance with firm orders, and (iii) promptly implement such
measures to restore compliance with firm orders as are directed by the
Production Operating Teams, including without limitation, changing or
allocating additional manufacturing resources.
C. If, after the first twelve (12) months of the Term, production
for any three consecutive months is [Confidential Information Omitted] of
Newco's firm orders (as increased by the number of unfilled orders, if any,
carried over from the previous month) or lower, or if production for any
six consecutive months is [Confidential Information Omitted] of Newco's
firm orders (as increased by the number of unfilled orders, if any, carried
over from the previous month) or lower, Xxxxxx shall, at Newco's option,
(i) take the remedial measures set forth in Section 12.4(B) or (ii) (x) in
the case of the Supplied Products other than those listed on Schedule 7,
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assist Newco to transfer all manufacturing of the Supplied Products to a
third party alternative manufacturer selected by Newco, with such
assistance to include without limitation licensing or sub-licensing Newco
and Newco's third-party manufacturer to make use and sell the Supplied
Products in connection with Ex Vivo Cell Processing under any patent or
other rights necessary to the manufacture and sale of the Supplied
Products; transfer such inventory, raw materials, work in process, IT
Assets, specifications, drawings/blueprints, copy of regulatory files, and
such other property owned by
Newco or owned by Xxxxxx and previously charged to Newco as part of Fully
Loaded Cost; transfer all information and technical know-how concerning
Xxxxxx manufacturing processes required for the production of the Supplied
Products; transfer or provide all necessary access to and rights to
reference any device master file concerning manufacture of the Supplied
Products; provide the services of technical personnel as needed to effect
such transfers of information and technical know-how; and continue to
manufacture the Supplied Products during the transition to an alternative
manufacturer until such alternative manufacturer is ready, willing and able
to meet market demand for the Supplied Products; provided that Newco and
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such alternative manufacturer are making good faith efforts to effectuate
the transition and to enable such alternative manufacturer to meet market
demand for the Supplied Products; or (y) in the case of any of the Supplied
Products listed on Schedule 7, allocate for sale to Newco hereunder such
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portion of Xxxxxx'x total aggregate production of such Supplied Product
(whether or not produced pursuant to this Agreement) as is equal to the
aggregate number of unfilled Newco orders for such Supplied Product divided
by the aggregate number of all unfilled orders for such Supplied Product
held by Xxxxxx. Any third party alternative manufacturer selected by Newco
must (a) agree to be bound, to the same extent that Newco is bound, by the
provisions of the Non-Competition Agreement, and (b) be approved by the
Corporate Committee.
The provisions of this Section 12.4 shall not apply to Supplied
Products manufactured for use in clinical trials. Except with respect to
Supplied Products manufactured for use in clinical trials (as to which Section
12.4 does not apply), the provisions of Section 12.4 shall be the sole remedy
available to Newco in the event that Xxxxxx fails to satisfy Newco's firm orders
made pursuant to this Section 12, provided that Xxxxxx is endeavoring in good
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faith to satisfy its obligations to Newco in accordance with the terms of this
Agreement, including without limitation, this Section 12.4.
12.5 Transition Period: Xxxxxx and Newco acknowledge that during
the first twelve (12) months of the Term of this Agreement, it may not be
commercially feasible for Xxxxxx (a) to immediately strictly comply with the
labeling, product inserts and packaging requirements of Section 5 of this
Agreement by changing the label copy, product inserts and packaging for Supplied
Products to include Newco's label copy, product inserts, packaging,
trademarks, trade names, service marks, logos or materials or (b) to fulfill the
production rate requirements of Sections 12.4A through 12.4C, inclusive, of this
Agreement. Accordingly, Xxxxxx and Newco agree that during the first twelve
(12) months of the Term of this Agreement, Xxxxxx will use its commercially
reasonable best efforts to achieve full compliance with (a) the labeling,
product inserts and packaging requirement of Section 5 of this Agreement and (b)
the production rate requirements of Section 12.4A of this Agreement but shall
not be deemed to be in breach of Sections 5 or 12.4 of this Agreement during
such twelve (12) month period unless Xxxxxx fails to comply with this Section
12.5. Any dispute between Xxxxxx and Newco relating to Xxxxxx'x non-compliance
with this Section 12.5 shall be referred to the Production Operating Teams for
resolution pursuant to Section 4.1 of this Agreement. The fill rate commitment
percentages established pursuant to this Section may be adjusted by the parties
during the Term hereof as may be appropriate to reflect actual manufacturing
experience; and shall be so adjusted to reflect actual manufacturing experience
in the case of the Harvester System, Solution Transfer Pump and Cell Wash Sets,
provided that Xxxxxx is endeavoring in good faith to satisfy Newco's orders and
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the production schedules established pursuant to Section 12.1 and 12.2 hereof.
12.6 Long Range Forecasts: The parties shall cooperate in good
faith in providing other, longer range, forecasts, which shall be useful in
budget planning for the parties.
13. INVENTORY. Xxxxxx shall retain title to all raw materials and
work in process relating to the Supplied Products.
14. PRICING, BILLING AND PAYMENT.
14.1 Fully Loaded Cost: During the first three (3) full years of
the Term, the prices to Newco for Supplied Products shall be Xxxxxx'x Fully
Loaded Cost for such Supplied Products.
14.2 Fully Loaded Cost Plus: After the expiration of the first three
(3) full years of the Term, the prices for Supplied Products during the next two
(2) full years of the Term shall be Xxxxxx'x Fully Loaded Cost for such Supplied
Products plus [Confidential Information Omitted] of such Fully Loaded Cost
(unless Xxxxxx and Newco otherwise agree in writing to a different price). After
the expiration of the first five (5) full years of the Term, the prices for
Supplied Products during the remainder of the Term shall be Xxxxxx'x fully
Loaded Cost for such Supplied Products plus [Confidential Information Omitted]
of such Fully Loaded Cost (unless Xxxxxx and Newco agree in writing to a
different price).
14.3 [Confidential Information Omitted]
14.4 Price Adjustments: The prices for Supplied Products
shall be adjusted as of January 1 of each year of the Term, through Xxxxxx'x
annual internal budgeting process, based on forecast changes in volume pursuant
to the forecasting process set forth in Section 12, anticipated changes in
materials prices and anticipated cost reductions resulting from Xxxxxx'x Value
Improvement Process. The overall intent of the parties is that the Supplied
Products shall be transferred at the prices described in Sections 14.1 as
adjusted for future changes in Xxxxxx'x costs of production (taking into account
Section 14.4 hereof).
14.5 Unanticipated Volume, Materials Price or Overhead Changes:
Cost variances shall be paid by or credited to the parties during the course of
a calendar year based on unanticipated volume, materials price or overhead
changes, as follows:
A. Cost variances based on volume changes shall be made only when
firm orders exceed or are less than forecast activity by [Confidential
Information Omitted] or more (excluding any increases attributable to
earlier failures to supply firm orders) and shall cover only the difference
between [Confidential Information Omitted] of the budgeted activity and the
variance from budgeted activity. The adjustment will be based on
[Confidential Information Omitted] of Xxxxxx'x standard overhead
attributable to the difference from the planned volume.
B. Cost variances based on materials price changes shall be made
only when actual prices for total materials costs differ from those
anticipated in the budgeting process by more than [Confidential Information
Omitted]. The adjustment shall cover only the difference between
[Confidential Information Omitted] of total budgeted materials cost and the
variance from budgeted activity.
C. Cost variances based on overhead cost changes caused by
conditions, other than those described in 14.4(A) or 14.4(B) above, beyond
Xxxxxx'x control, shall be shared pro rata (based on changes in total plant
overhead) by the parties or as they shall otherwise agree.
D. Adjustments pursuant to this Section 14.4 will be determined
as of the end of each calendar quarter (on a year to date basis) and
reflected as an amount due and payable (or a credit receivable) spread
ratably over the following three months.
E. All pricing adjustments will be reviewed, but not for
approval, by the Production Operating Teams and any dispute concerning such
adjustments will be referred to the Corporate Committee.
14.6 Spare Parts: During the Term hereof, Xxxxxx shall
manufacture and make available for purchase by Newco spare parts for the repair
of the Supplied Products and Newco products incorporating the Supplied Products.
Newco's purchases of such spare parts shall be subject to the pricing, billing
and payment provisions of this Section 14. Notwithstanding the foregoing,
Xxxxxx shall maintain a stock of spare parts to satisfy its obligations under
service contracts entered into by Xxxxxx with purchasers of the Isolex(R) and
Maxsep(R) Products, there shall be no charge to Newco for such spare parts
manufactured by or at the direction of Xxxxxx for the purpose of satisfying such
Xxxxxx obligations, and Xxxxxx shall be entitled to retain all revenues from
such service contracts and from the sale of such spare parts pursuant to such
service contracts.
14.7 Billing and Payment: Xxxxxx shall xxxx Newco as of the end
of each calendar month for Supplied Products shipped during the month and
current development costs under Section 14.3. Newco shall pay such invoices
within sixty (60) days of Newco's receipt thereof.
15. FOREIGN CURRENCY CONVERSION. Where calculations of Xxxxxx'x
Fully Loaded Cost relate to a currency other than United States dollars, all
such calculations shall be calculated pursuant to Xxxxxx'x then current
accounting policies and practices.
16. WITHHOLDING TAXES. Where required to do so by applicable law,
Newco shall withhold taxes required to be paid to a taxing authority on account
of any payments to Xxxxxx hereunder, and Newco shall furnish Xxxxxx with
satisfactory evidence of such withholding and payment in order to permit Xxxxxx
to obtain a tax credit or other relief as may be available under the applicable
law. Newco shall cooperate with Xxxxxx in obtaining exemption from withholding
taxes where available under applicable law.
17. INTEREST ON OVERDUE PAYMENTS. Interest shall accrue and be
payable on all overdue payments owing by a party under this Agreement from the
date due at the rate of [Confidential Information Omitted] per month (or the
highest rate allowed by law, if lower), compounded annually, until fully paid
(including full payment of such interest).
18. DELIVERY. All shipments of Supplied Products shall be FOB the
manufacturing facilities where such Supplied Products are manufactured by or on
behalf of Xxxxxx. Except as specified in Section 12.4 above, all freight,
insurance, and other delivery costs (and any customs duties) shall be paid by
Newco.
19. TITLE. Title to all Supplied Products shall pass to Newco (or
Newco's designated distributor) when the products are placed on Newco's truck or
Newco's designated carrier (or Newco's designated distributor's truck or
designated carrier) at Xxxxxx'x Manufacturing Facility or when Supplied Products
distributed by Xxxxxx pursuant to the Marketing, Sales and Distribution
Agreement are placed in Xxxxxx'x designated finished goods inventory.
20. WARRANTIES.
20.1 Warranty: Xxxxxx warrants to Newco that the Supplied
Products delivered to or at the direction of Newco hereunder (i) will have been
manufactured in accordance with the applicable specifications, procedures and
product drawings/blueprints and all applicable laws (including the Act) and (ii)
will not be adulterated or misbranded within the meaning of the Act as a result
of acts of or omissions by Xxxxxx, and (iii) are free from defects in
workmanship. Notwithstanding the foregoing, Xxxxxx shall not be liable to Newco
under subpart (ii) above as a result of any labels supplied by or affixed to
such Supplied Products by Newco. This warranty shall be continuing and shall be
binding on Xxxxxx and its permitted successors and assigns and shall inure to
the benefit of Newco and its permitted successors and assigns. WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE NOT GIVEN BY XXXXXX AND
ANY SUCH IMPLIED WARRANTIES ARE SPECIFICALLY DISCLAIMED.
20.2 Xxxxxx Indemnity: Subject to Section 26 below, Xxxxxx agrees
to indemnify Newco and hold it harmless from any liability, loss, expense, cost,
claim or judgement arising out of any claim for property damage, personal injury
or death which is caused by Xxxxxx'x (or its Subcontractor's) failure to
manufacture the Supplied Products in accordance with the designs,
specifications, procedures and product drawings/blueprints, with the law,
regulations, rules, orders and notices, and with the quality system and Standard
Operating Procedure System described in Section 6.1 and Section 11.1 above, and
which are applicable to Xxxxxx or such Subcontractor thereunder, as the case may
be. At Xxxxxx'x expense, Newco shall cooperate fully with Xxxxxx in defending
or otherwise resolving any such claim. Xxxxxx shall have full control of any
litigation brought against Newco with respect to any claim that is indemnifiable
by Xxxxxx hereunder, but Newco may, at its expense, also be represented by its
own counsel in any such litigation.
21. INSURANCE.
21.1 Xxxxxx Insurance: During the Term, Xxxxxx shall procure and
maintain, through self-insurance or a combination of self-insurance and
commercially placed insurance, comprehensive general liability insurance
covering each occurrence of bodily injury and property damage in the amount of
not less than [Confidential Information Omitted] combined single limit including
coverage for product and completed operations, blanket contractual liability and
vendor's liability. Xxxxxx shall, within sixty (60) days of the date of this
Agreement, furnish a certificate of insurance to Newco evidencing the foregoing
coverages and limits and thereafter shall give at least thirty (30) days prior
notice to Newco of any termination, expiration without renewal, or material
change to such insurance, coverage or limits.
21.2 Newco Insurance: During the Term, Newco shall procure and
maintain, through self-insurance or a combination of self-insurance and
commercially placed
insurance, comprehensive general liability insurance covering each occurrence of
bodily injury and property damage in the amount of not less than [Confidential
Information Omitted] combined single limit including coverage for product and
completed operations, blanket contractual liability and vendor's liability.
Newco shall, within sixty (60) days of the date of this Agreement, furnish a
certificate of insurance to Xxxxxx evidencing the foregoing coverages and limits
and thereafter shall give at least thirty (30) days prior notice to Xxxxxx of
any termination, expiration without renewal, or material change to such
insurance, coverage or limits.
22. DISCONTINUANCE OF PRODUCT LINE. If Newco wishes to discontinue a
product or product line which includes any Supplied Product (subject to Newco's
obligations under the Marketing, Sales & Distribution Agreement), Newco shall
give Xxxxxx six (6) months' prior written notice thereof and the parties will
negotiate appropriate closure conditions which provide for recovery by Xxxxxx of
the related overhead costs, any related investment (including any dedicated or
additional equipment purchased by Xxxxxx exclusively to support the discontinued
product line) and related out-of-pocket expenses.
23. INDEMNIFICATION FOR PATENT INFRINGEMENT.
23.1 Xxxxxx Indemnification: Xxxxxx shall defend, indemnify and
hold Newco harmless with respect to any liability, loss or damage incurred by
Newco with respect to any claim of patent, trade name, trademark or copyright
infringement or misuse with respect to any current commercial Supplied Product.
At Xxxxxx'x expense, Newco shall cooperate fully with Xxxxxx in defending or
otherwise resolving any such charges of infringement or misuse. Xxxxxx shall
have full control of any litigation brought against Newco alleging such
infringement or misuse, but Newco may, at its expense, also be represented by
its own counsel in any such litigation.
23.2 Newco Indemnification: Newco shall defend, indemnify and
hold Xxxxxx harmless with respect to any liability incurred by Xxxxxx as a
result of activities under this Agreement with respect to any claim of patent,
trade name, trademark or copyright infringement or misuse (i) with respect to
any Isolex(R) and Maxsep(R) Products, reagent kits or other products which are
not being manufactured or supplied by Xxxxxx (or its Subcontractor) for or to
Newco under this Agreement or an agreement having the same date as this
Agreement (or an extension or renewal thereof); or (ii) arising from any
modification to product designs, specifications, procedures or product
drawings/blueprints made by Newco subsequent to its acquisition thereof from
Xxxxxx. At Newco's expense, Xxxxxx shall cooperate fully with Newco in
defending or otherwise resolving any such charges of infringement or misuse.
Newco shall have full control of any litigation brought against Xxxxxx alleging
such infringement or misuse, but Xxxxxx may at its own expense also be
represented by its own counsel in any such litigation.
24. TERMINATION.
24.1 Expiration: This Agreement, and any licenses granted
hereunder, shall terminate upon the earlier to occur of the expiration of the
Term or a termination pursuant to Section 24.2 below.
24.2 Early Termination: A non-breaching party may terminate this
Agreement, and may terminate any licenses granted by such party hereunder, if
any of the following events (each is herein referred to as a "Material Breach")
occur:
A. A party fails to pay any amount owing under this Agreement, on
the date(s) specified for such payment and such failure shall continue for
sixty (60) days after written notice of such failure by the other party to
this Agreement;
B. A party shall default in the performance of or compliance with
any covenant contained in this Agreement or the Non-Compete Agreement
(other than a failure to make a payment described in Section 24.2(A) above)
which shall continue uncured beyond the applicable grace period therefor,
or if a party shall default in the performance of or compliance with any
covenant in the Marketing, Sales and Distribution Agreement and such
default results in termination of such Marketing, Sales and Distribution
Agreement; or the Marketing, Sales and Distribution Agreement is rejected
in the course of the bankruptcy of the non-terminating party;
C. A receiver, conservator, custodian, liquidator or trustee of a
party or of all or any of the property of a party, is appointed by court
order and such order remains in effect for more than ninety (90) days; or
an order for relief is entered under the federal bankruptcy laws with
respect to a party; or any of the material property of a party is
sequestered by court order and such order remains in effect for more than
ninety (90) days; or a petition is filed against a party under the
bankruptcy, reorganization, arrangement, insolvency, readjustment of debt,
dissolution or liquidation law of any jurisdiction, whether now or
hereafter in effect, and is not dismissed within ninety (90) days after
such filing;
D. A party files a petition in voluntary bankruptcy or seeking
relief under any provision of any bankruptcy, reorganization, arrangement,
insolvency, readjustment of debt, dissolution or liquidation law of any
jurisdiction, whether now or hereafter in effect, or consents to the filing
of any petition against it under any such law; or
E. A party makes an assignment for the benefit of its creditors,
or admits in writing its inability to pay its debts generally as they
become due, or consents to the appointment of a receiver, conservator,
custodian, liquidator or trustee of the party, or of all or any part of its
property.
25. FORCE MAJEURE. Neither party to this Agreement shall be liable
for delay or failure in the performance of any of its obligations hereunder if
such delay or failure is due to causes beyond its reasonable control, including
acts of God, fires, earthquakes, strikes and labor disputes, acts of war, civil
unrest or intervention of any governmental authority, but any such delay or
failure shall be remedied by such party as soon as is reasonably possible.
26. LIMITATION OF LIABILITY. IN NO EVENT, WHETHER AS A RESULT OF
BREACH OF CONTRACT, TORT LIABILITY (INCLUDING NEGLIGENCE), OR OTHERWISE, SHALL
EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, PUNITIVE, EXEMPLARY
OR LIQUIDATED DAMAGES.
27. FOREIGN GOVERNMENT APPROVAL OR REGISTRATION. If this Agreement
or any associated transaction is required by the law of any nation to be either
approved or registered with any governmental authority, or any agency or
political subdivision thereof, Xxxxxx shall assume all legal obligations to do
so.
28. EXPORT CONTROL. Xxxxxx shall observe all applicable United
States and foreign laws with respect to the transfer of all Supplied Products to
or on behalf of Newco between nations, countries or other sovereign states.
29. NOTICES. All notices required under this Agreement shall be in
writing, and all such notices and other written communications (including
product orders and invoices) shall be delivered either by hand, by a nationally
recognized overnight delivery service (with delivery charges prepaid), by first
class, registered or certified United States mail (postage prepaid), or by
facsimile transmission (provided that in the case of facsimile transmission, a
confirmation copy of the notice shall be delivered by hand, by a nationally
recognized overnight delivery service (with delivery charges prepaid), or by
first class, registered or certified United States mail
(postage prepaid) within two (2) days of facsimile transmission), addressed to
each party as follows:
If to Xxxxxx, such notices shall be delivered to:
President
Xxxxxx Biotech Group
with a copy to:
General Counsel
Xxxxxx Healthcare Corporation
If to Xxxxxx, other written communications shall be delivered to:
President
Venture Management
Xxxxxx Biotech Group
with a copy to:
Associate General Counsel
Xxxxxx Healthcare Corporation
If to Newco, such notices shall be delivered to:
President
BIT Acquisition Corp.
with a copy to:
Xxxxxxx Xxxxxx & Green, P.C.
000 Xxxx Xxxxxx
Xxx Xxxx, XX 00000
Attn: Xxxxxx X. Xxxxxxxxxx, Esq.
If to Newco, other written communications shall be delivered to:
President
BIT Acquisition Corp.
with a copy to:
Vice President
BIT Acquisition Corp.
or such other address as any such party may designate in writing and delivered
to the other party hereto pursuant to this Section 29. All such notices or
other written communications shall be deemed to have been received by the
addressee if delivered by: hand or by a nationally recognized overnight delivery
service (with delivery charges prepaid) at the time of delivery; by first class,
registered or certified United States mail (postage prepaid), three (3) business
days after delivery thereof to the United States Postal Service; or by facsimile
transmission, at the time of transmission.
30. DISPUTE RESOLUTION.
30.1 Provisional Remedies: The procedures specified in this
Section 30 shall be the sole and exclusive procedures for the resolution of
disputes between the parties arising out of or relating to this Agreement;
provided, however, that a party, without prejudice to these procedures, may seek
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a preliminary injunction or other provisional relief if, in its sole judgement,
such action is deemed necessary to avoid irreparable damage or to preserve the
status quo. During such action, the parties will continue to participate in
good faith in the procedures specified in this Section 30.
30.2 Negotiations Between Executives: The parties will attempt in
good faith to resolve any claim or controversy arising out of or relating to the
execution, interpretation or performance of this Agreement (including the
validity, scope and enforceability of the provisions contained in this Section
30) promptly by negotiations under the procedures set forth in Section 4
concerning referral of disputes to the Corporate Committee.
30.3 Arbitration: In the event that any dispute arising out of
or relating to this Agreement or its breach, termination or validity has not
been resolved after good faith negotiation pursuant to the procedures of Section
30.2, such dispute shall upon written notice by either party to the other, be
finally settled by arbitration administered by the Center for Public Resources
in accordance with the provisions of its Commercial Arbitration Rules and the
United Stated Federal Arbitration Act, as modified below:
A. The arbitration shall be heard by a panel of three (3)
independent and impartial arbitrators all of whom shall be selected from a
list of neutral arbitrators supplied by the Center for Public Resources.
From such list, each of Xxxxxx and Newco shall select one (1) arbitrator,
and the arbitrators
so selected shall select a third. The panel shall designate one (1) among
them to serve as chair.
B. The arbitration proceedings shall be conducted in Los Angeles
County or Orange County in the State of California.
C. Any party may seek interim or provisional remedies under the
Federal Rules of Civil Procedure and the United States Federal Arbitration
Act as necessary to protect the rights or property of the party pending the
decision of the arbitrators.
D. The parties shall allow and participate in limited discovery
for the production of documents and taking of depositions, which shall be
conducted in accordance with the Commercial Arbitration Rules of the Center
for Public Resources. All discovery shall be completed within sixty (60)
days following the filing of the answer or other responsive pleading.
Unresolved discovery disputes shall be brought to the attention of the
chair of the arbitration panel and may be disposed of by the chair.
E. Each party shall have up to fifty (50) hours to present
evidence and argument in a hearing before the panel of arbitrators,
provided that the chair of the panel of arbitrators may establish such
longer times for presentations as the chair deems appropriate.
F. The arbitration award shall be rendered by the arbitrators
within fifteen (15) business days after conclusion of the hearing of the
matter, shall be in writing and shall specify the factual and legal basis
for the award. Judgment thereon may be entered in any court having
jurisdiction thereof.
G. The arbitrators are empowered to order money damages in
compensation for a party's actual damages, specific performance or other
appropriate relief to cure a breach; provided, however, that the
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arbitrators will have no authority to award special, punitive or exemplary
damages, or other money damages that are not measured by the prevailing
party's actual damages.
30.4 Performance During Dispute: Each party is required to continue to
perform its obligations under this Agreement pending final resolution of any
dispute arising out of or relating to this Agreement, unless to do so would be
commercially impossible or impractical under the circumstances.
31. CHOICE OF LAW AND JURISDICTION. This Agreement shall be governed
by and construed in accordance with the internal laws of the state of Delaware,
without application of conflicts of law principles, and, subject to Section 30
above, each party hereby submits to the jurisdiction and venue of any state or
federal court in the State of Delaware. To the extent permissible by law, each
of the parties hereby waives, releases and agrees not to assert, and agrees to
cause its Affiliates to waive, release and not assert, any rights such party or
its Affiliates may have under any foreign law or regulation that would be
inconsistent with the terms of this Agreement as governed by Delaware law.
32. PROVISIONS CONTRARY TO LAW / SEVERABILITY. In performing this
Agreement, the parties hereto shall comply with all applicable laws. Nothing in
this Agreement shall be construed so as to require the violation of any law, and
wherever there is any conflict between any provision of this Agreement and any
applicable law, the applicable law shall prevail. In the event any provision of
this Agreement conflicts with any applicable law or is otherwise determined by
an arbitrator or court having valid jurisdiction thereof to be unenforceable,
the affected provision of this Agreement shall be deemed to have been modified
to the extent necessary so as not to conflict with the applicable law or to be
unenforceable or, if such modification is not possible, such provision shall be
deemed to have been deleted herefrom, without affecting, impairing or
invalidating the remaining provisions of this Agreement.
33. ENTIRE AGREEMENT. This Agreement, together with any exhibits or
schedules attached hereto, constitutes the entire agreement between the parties
as to the subject matter hereof, and all prior negotiations, representations,
agreements and understandings are merged into, extinguished by and completely
expressed by this Agreement.
34. WAIVERS AND MODIFICATIONS. The failure of any party to insist on
the performance of any obligation hereunder shall not be deemed to be a waiver
of such obligation. Waiver of any breach of any provision hereof shall not be
deemed to be a waiver of any other breach of such provision or any other
provision. No waiver, modification, release or amendment of any obligation
under or provision of this Agreement shall be valid or effective unless in
writing signed by the party to be bound by such waiver, modification, release or
amendment.
35. NO OTHER LICENSES. Except as permitted by Section 19 of this
Agreement, or as may otherwise be agreed to by the parties in writing, neither
party shall use the name of the other party in any promotional materials or
advertising without the prior written consent of the other party. Except as
provided in Section 3.2(B) and Section 12.4(C) hereof, nothing in this Agreement
shall grant to either party any right to the other party's intellectual
property, including
patents, patent applications, technology, know-how, inventions, copyrights,
trademarks, service marks, logos or trade names ("Intellectual Property").
Neither party shall at any time assert any claim to any goodwill, reputation or
ownership of the other party's Intellectual Property and all uses of a Party's
Intellectual Property shall inure to the benefit of that party.
36. ASSIGNMENT. Newco may assign its rights and obligations under
this Agreement to any Affiliate without the prior written consent of Xxxxxx,
provided that such Affiliate is owned, directly or indirectly, by Xxxxxx and
--------
VIMRx in substantially the same proportions as Newco is owned. Xxxxxx may
assign its rights and obligations hereunder to any Affiliate of Xxxxxx without
prior notice to or consent of Newco. No assignment by Xxxxxx or by Newco, or by
any permitted assignee, shall be effective unless and until the assignee shall
have agreed to become bound by the provisions of the Non-Compete Agreement to
the same extent and in the same manner as Xxxxxx (in the case of a Xxxxxx
assignee) or Newco (in the case of a Newco assignee) is bound. No party may
assign any of its rights or obligations under this Agreement unless and to the
extent expressly permitted by this Section 36. Subject to the foregoing, this
Agreement shall inure to the benefit of and be binding on the parties' permitted
successors and assigns.
37. INDEPENDENT PARTIES. By virtue of this Agreement, neither party
constitutes the other as its agent (except as may other-wise be expressly
provided herein), partner, joint venture, or legal representative and neither
party has express or implied authority to bind the other in any manner
whatsoever.
38. COUNTERPARTS. This Agreement may be executed in any number of
counterparts with the same effect as if all parties had signed the same
document. All such counterparts shall be deemed an original, shall be construed
together, and shall constitute one and the same instrument.
39. RULES OF CONSTRUCTION. In this Agreement, unless a clear
contrary intention appears:
A. The singular number includes the plural number and vice versa;
B. Reference to any party includes such party's permitted
successors and assigns;
C. Reference to any gender includes the other gender;
D. Reference to any Section, Exhibit or Schedule means such
section of this Agreement, exhibit to this Agreement or schedule to this
Agreement, as the case may be, and
references in any section or definition to any clause means such clause of
such section or definition;
E. "Herein," "hereunder," "hereof," "hereto," and words of
Similar import shall be deemed references to this Agreement as a whole and
not to any particular section or other provision of this Agreement;
F. "Including" (and with the correlative meaning "include") means
including without limiting the generality of any description preceding such
term;
G. Relative to the determination of any period of time, "from"
means "from and including", "to" means "to but excluding" and "through"
means "through and including "
H. Reference to any law (including statutes and ordinances) means
such law as amended, modified, codified or reenacted, in whole or in part,
and in effect from time to time, including rules and regulations
promulgated thereunder-,
I. Accounting terms used herein shall have the meanings
historically attributed to them by Xxxxxx International Inc., a Delaware
corporation, and its subsidiaries prior to the date hereof,
J. In the event of any conflict between any of the provisions of
the body of this Agreement and any exhibit or schedule hereto, the
provisions of the body of this Agreement shall control;
K. The headings contained in this Agreement have been inserted
for convenience of reference only, and are not to be used in construing
this Agreement; and
L. Any rule of construction or interpretation which might
otherwise require this Agreement to be construed or interpreted against
either party shall not apply to any construction or interpretation hereof
[THE REMAINDER OF THIS PAGE IS INTENTIONALLY LEFT BLANK.]
IN WITNESS WHEREOF, the parties have duly executed this Agreement as of the
date set forth above.
XXXXXX HEALTHCARE CORPORATION
By:____________________________
Name:
Title:
BIT ACQUISITION CORP.
By:____________________________
Name:
Title:
