EXHIBIT 10.2
ANTIBODY MANUFACTURING AND STORAGE AGREEMENT
This ANTIBODY MANUFACTURING AND STORAGE AGREEMENT (the "Agreement"), dated
as of December 17, 1997 by and between Baxter Healthcare Corporation, a Delaware
corporation having a place of business at 1627 Lake Cook Road, Deerfield
Illinois 60015 ("Baxter") and BIT ACQUISITION CORP., a Delaware corporation
having a place of business at Nine Parker, Irvine, California 92618 ("Newco").
RECITALS
A. Baxter 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 an Asset Purchase
Agreement dated as of October 10, 1997 by and among Baxter, VIMRx and Newco (the
"Acquisition Agreement");
B. Baxter has agreed to manufacture for Newco certain Isolex(R) and
Maxsep(R) Products pursuant to the terms of that certain Hardware and
Disposables Manufacturing Agreement (the "Hardware and Disposables Manufacturing
Agreement"), to supply to Newco certain other products and components pursuant
to that certain Hardware and Disposables Supply Agreement (the "Hardware and
Disposables Supply Agreement") each between Baxter and Newco and each of even
date herewith (collectively, the "Hardware and Disposables Agreements") and 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");
C. 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).
D. 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,
Dickenson and Company to Baxter (the "First BD Sublicense"); that certain
sublicense of even date herewith relating to B cell antibodies licensed from
Becton, Dickenson 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 Prof. Bernd Dorken to Baxter 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.
E. Baxter currently manufactures certain Antibodies (as such capitalized
terms is defined below) which are components of the Isolex(R) and Maxsep(R)
Products, and certain Reagents and Reagent Kits (as those capitalized terms are
defined below) used in connection with the Isolex(R) and Maxsep(R) Products, and
is willing to continue to manufacture such Antibodies, Reagents and Reagent Kits
for Newco; and
F. Newco desires that Baxter manufacture for Newco such Antibodies,
Reagents and Reagent Kits as described herein and subject to the terms hereof
and Baxter is willing to manufacture such Antibodies, Reagents and Reagent Kits.
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 herein.
1.2 Terms Not Herein Defined. As used herein, all terms not defined
herein shall have the meanings ascribed to them in the Hardware and Disposables
Agreements.
1.3 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 the party or any of such party's
Subsidiaries. The term "Control" shall mean 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. "Antibodies" shall mean the antibodies specified in Schedule I
attached hereto and such other antibodies as Baxter may
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agree to produce, pursuant to Section 4 hereof, from time to time in
connection with the Isolex(R) and Maxsep(R) Products.
C. "Cell Lines" shall mean the cell lines specified in Schedule 2
attached hereto.
D. "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.
E. "FDA" shall mean the United States Food and Drug
Administration.
F. "FDA-Regulated Non-Baxter Component" shall mean any component
of a Reagent Kit 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.
G. "Field of Distribution" shall have the meaning ascribed to
such capitalized term in the Marketing, Sales & Distribution Agreement.
H. "Form FDA-483" shall have the meaning ascribed to it by FDA
policy, as the same may be amended or changed from time to time.
I. "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
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royalties payable by such party in connection with manufacturing,
performing or acquiring any items or services, but excluding in the case of
Baxter's 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 shall be made for any
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cost of, or the cost of funding any, changes in the site of manufacturing
any of the Antibodies, Reagents or Reagent Kits, except as expressly
provided in this Agreement. 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". Development costs will be included in
Fully Loaded Cost only to the extent such development costs consist of
costs for evaluating candidate cell lines and for producing pilot or
clinical scale lots of antibodies.
J. "Hyland" shall mean the Hyland Division of Baxter.
K. "Isolex(R) and Maxsep(R) Products" shall have the meaning
ascribed to such term in the Hardware and Disposables Manufacturing
Agreement.
L. "Isolex(R) and Maxsep(R) Technology" means automated systems
for positive and negative immunomagnetic cell selection.
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M. "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.
N. "Manufacturing Facility" means any production site selected by
Baxter or a Subcontractor of Baxter for manufacture of the Antibodies,
Reagents or Reagent Kits.
O. "Marketing, Sales & Distribution Agreement" means the
Marketing, Sales & Distribution Agreement by and between Baxter and Newco
of even date herewith.
P. "Master Scheduling System" shall mean the computerized master
scheduling system currently used by Baxter in connection with the
production of Antibodies, as such system may be changed by Baxter from time
to time.
Q. "Non-Compete Agreement" means the Non-Competition and
Confidentiality Agreement, by and among Baxter, VIMRx and Newco of even
date herewith.
R. "Product Field" means use of the Isolex(R) and Maxsep(R)
Technology in the treatment, mitigation or prophylaxis of diseases,
including research into such activities, through Ex Vivo Cell Processing.
S. "Quality Manual" shall mean the quality manual currently used
in connection with the production of the Antibodies, Reagents or Reagent
Kits, as such manual may be changed from time to time.
T. "Quality System Regulation" ("QSR") shall have the meaning
ascribed to it by the rules and regulations of the FDA, as may be amended
or changed from time to time.
U. "Reagents" means the reagents specified in Schedule 1 attached
hereto and such other reagents as Baxter may agree to produce, pursuant to
Section 4 hereof, from time to time in connection with the Isolex(R) and
Maxsep(R) Products.
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V. "Reagent Kits" means the reagent kits specified in Schedule 1
attached hereto and/or any components thereof and such other reagent kits
as Baxter may agree to produce, pursuant to Section 4 hereof, from time to
time in connection with the Isolex(R) and Maxsep(R) Products.
W. "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 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).
X. "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.
Y. "Standard Operating Procedure System" shall mean the standard
operating procedures used in connection with the production of Antibodies,
as such procedures may be changed from time to time.
Z. "Subcontractor" means a third party who produces and/or
supplies an Antibody, Reagent or reagent kit (but not the separate
components thereof), or any FDA-Regulated Non-Baxter Component thereof, to
or on behalf of Baxter under contract.
AA. "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
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(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.
BB. "Supplied Products" means those products supplied by
Baxter to Newco under the terms of the Hardware and Disposables Supply
Agreement.
CC. "Value Improvement Process" shall mean the Value
Improvement Management System currently used in connection with the
production of Antibodies, as such system may be changed from time to time.
DD. "Warning Letter" shall have the meaning ascribed to it by FDA policy, as
the same may be amended or changed from time to time.
EE. "Term" shall mean, individually and collectively, the
term of this Agreement as provided in Section 2.
2. TERM. The term of this Agreement shall be five (5) years from
the date hereof.
3. CELL LINES.
3.1 Grant: Newco hereby grants Baxter the non-exclusive right
to use the Cell Lines during the Term to produce Antibodies pursuant to the
terms of this Agreement for Newco's use and sale.
3.2 Cell Pro Litigation: In the event that Baxter requires use
of the Cell Lines to meet Baxter's performance of certain obligations relating
to the CellPro Litigation as set forth in Section 8 of that certain License
Agreement of even date herewith with respect to the First BD License Agreement
(as defined therein), Newco agrees to make such Cell Lines available to Baxter
for such use.
3.3 Care of Cell Lines: Baxter shall have no right to retain
possession of master cell banks or otherwise use the Cell Lines except as set
forth in Section 3.1 and 3.2 hereof. Baxter shall at all times endeavor to keep
the Cell Lines secure and safe from loss and damage in such manner as Baxter
shall determine in accordance with the Standard Operating
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Procedures System. Upon transferring any portion of a master or working cell
bank to Newco, or to Newco's designee, at Newco's request, Baxter shall conduct
viability testing prior to shipment of such master or working cell bank and
shall retain reports of such testing for Newco's inspection. Newco shall assume
full responsibility for shipping such master or working cell banks and all such
shipments shall be FOB the facilities where such master or working cell banks
are kept by Baxter.
4. MANUFACTURING. During the Term, Baxter shall manufacture for
Newco those Antibodies, Reagents and Reagent Kits specified in Schedule 1
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hereto. In the event Baxter elects to discontinue producing any specific
Antibody altogether and provides Newco with twenty-four (24) months' written
notice of such discontinuation, Baxter shall then supply to Newco the master
cell bank for the Cell Line relating to such discontinued Antibody. Baxter may
make such an election to discontinue producing any Antibody pursuant to this
Section 4 effective only after the date that is three (3) years after the date
of this Agreement; and Baxter hereby agrees that in the event that it makes such
an election, it will, at Newco's expense, for a period of twenty-four (24)
months make all reasonable efforts to provide Newco or Newco's third party
manufacturer with such support, assistance and manufacturing know-how as shall
be required by Newco to effect an orderly transition. Notwithstanding the
foregoing, nothing contained in this Agreement shall prevent Newco from having
antibodies, reagents or reagent kits with the same specifications as the
Antibodies, Reagents, and Reagent Kits produced by Newco or third parties on
behalf of Newco. Nothing herein contained shall oblige Baxter to continue
producing or Newco to continue purchasing Antibodies, Reagents or Reagent Kits
if such production is reasonably believed by Newco or by Baxter, as the case may
be, to violate any applicable law or license or if the Antibodies, Reagents, or
Reagent Kits produced 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 Antibody, Reagent or Reagent Kit, as the case may be, into
compliance or to prevent such infringement, and Baxter will continue to produce
after a finding of infringement if Newco or Baxter reaches an agreement with the
third party which permits future production without infringement. In the event
that Baxter, in its sole discretion, agrees to manufacture for Newco any
additional antibodies, reagents or reagent kits and Baxter and Newco enter into
a separate written agreement on mutually agreeable terms (including price) with
respect to the terms of such production, then Baxter will produce such
additional antibodies, reagents or reagent kits as the two parties may so agree,
and such additional antibodies, reagents or reagent kits will be treated for all
purposes of this Agreement as Antibodies, Reagents or Reagent Kits, as the case
may be.
5. USE OF IT ASSETS. During the Term, Newco shall provide to Baxter
the use and possession of (at Baxter's Manufacturing Facilities described in
Section 8.1 below), but not title to, those IT Assets (including the master cell
banks containing the Cell Lines) which are required by, or may be useful for,
Baxter in producing the Antibodies pursuant to this Agreement, as set forth on
Schedule 3 attached hereto.
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6. TRADEMARK LICENSE AND LABEL COPY.
6.1 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
Antibodies 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 mark, logo or
material is to be used in connection with the Antibodies, 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 mark, 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.
6.2 Label Copy: Newco shall provide all labeling, product
inserts and packaging for the Antibodies provided that Baxter has reviewed and
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approved in writing each use or display on such labels, inserts or packaging of
any trademark, trade name, service mark or logo used or owned by Baxter, other
than any trademark, trade name, service mark or logo licensed to Baxter pursuant
to Section 6.1 of this Agreement. If a trademark, trade name, service mark or
logo owned or used by Baxter or its parent corporation, other than any
trademark, trade name, service mark or logo licensed to Baxter pursuant to
Section 6.1 of this Agreement, is to be used in connection with the Antibodies
(except to the extent such use is mandatory in connection with the labeling
requirements of applicable law) Newco shall obtain prior written authorization
from Baxter (which authorization may be withheld by Baxter in its sole
discretion) for such use and for all subsequent changes to the art work, labels,
inserts or packaging for the Antibodies that incorporate such a Baxter
trademark, trade name, service mark or logo. Each use of such a Baxter
trademark, trade name, service mark or logo shall inure to the benefit of Baxter
and its parent company. Should any such use vest in Newco any rights in a
trademark, trade name, service mark or logo used by Baxter, other than any
trademark, trade name, service mark or logo licensed to Baxter pursuant to
Section 6.1 of this Agreement, Newco shall transfer such rights to Baxter or its
designee upon the request of Baxter. Except as provided in this Agreement,
Newco shall not use any trademark, trade name, service mark or logo claimed by
Baxter or any confusingly similar trademark, trade name, service mark or logo
during or after the Term of this Agreement.
7. CONTACTS/PLANNING COMMITTEE.
7.1 Administration: Administration of this Agreement will be
accomplished by the establishment of a "Production Operating Team." The
Production Operating Team will consist of representatives from each of Newco and
Baxter, who typically would include the individuals identified in Schedule 4, or
other persons of an appropriate level of authority and
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responsibility. Each party will select representatives and shall notify the
other party of such selections and any changes thereto. The Production
Operating Team 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. The
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
Baxter and Newco for service on the Production Operating Team, the
representatives of each party shall have, in the aggregate, a single vote in all
matters to be decided by the Production Operating Team. If, in the course of
conducting the activities contemplated in these Agreements, the 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 Manufacturing Oversight Committee.
7.2 Manufacturing Oversight Committees: The "Manufacturing
Oversight Committee" will consist of representatives from each of Newco and
Baxter and typically would consist of Newco's Director/Vice President,
Manufacturing and Logistics; Newco's Vice President, Global Marketing; and
Newco's Vice President, Business Development; Baxter's Vice President,
Monoclonal and Plasma Operations from Hyland; and/or such other representatives
as may be designated by Baxter and Newco. The Manufacturing Oversight Committee
will meet once a year or more often as necessary to carry out its
responsibilities hereunder, and shall review and approve the plans, programs and
recommendations prepared by the Production Operating Team. Regardless of the
number of representatives selected by each of Baxter and Newco for service on
the Manufacturing Oversight Committee, the representatives of each party shall
have, in the aggregate, a single vote in all matters to be decided by the
Manufacturing Oversight Committee. The Manufacturing Oversight Committee will
review and decide any matter in dispute referred to it by the Production
Operating Team. When the Manufacturing Oversight Committee cannot agree on the
resolution of any matter within its area of responsibility hereunder, it shall
promptly refer the matter to the Corporate Committee for resolution in
accordance with this Agreement.
7.3 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 Hyland, respectively. The
Corporate Committee will meet only as needed to resolve any dispute or otherwise
undecided matter referred to it by the Manufacturing Oversight Committee. 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.
7.4 Responsibilities: Newco and Baxter will cooperate to
identify their separate responsibilities hereunder, and will diligently execute
those responsibilities to assure a
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continuous, uninterrupted supply to the market for all Antibodies, Reagents and
Reagent Kits. 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 5. Whenever the need for functions and
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responsibilities not previously identified or assumed by either Newco or Baxter
becomes evident, the relevant Manufacturing Oversight Committee will assign such
functions or responsibilities.
8. PRODUCTION AND PRODUCTION SITES.
8.1 Production Sites: Baxter's and its Subcontractors'
production of the Antibodies, Reagents and Reagent Kits (including components
thereof) may be carried out at any of Baxter's or its Subcontractors'
Manufacturing Facilities, with the original Manufacturing Facilities selected by
Baxter and its Subcontractors as set forth on Schedule 6 attached hereto;
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provided that the cost of effecting any change of the Manufacturing Facilities
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from the original sites selected by Baxter, or of effecting any subsequent
change, shall not be included in Fully Loaded Cost, the new facilities meet any
applicable QSR and other regulatory requirements (or, in the case of a Baxter
Subcontractor, to Baxter's knowledge the new facilities meet any applicably QSR
and other regulatory requirements), and any change in facilities does not
require submission and approval of a Post-Marketing Approval ("PMA") supplement
or foreign marketing application by Newco. If Newco determines a PMA supplement
approval or foreign marketing authorization or approval is necessary, Baxter
(and/or its Subcontractor) and Newco shall agree to the allocation of costs
related to preparation and submission of the PMA supplement or foreign
application and Baxter or the relevant Subcontractor shall continue to supply
Newco from existing facilities, pending PMA supplement or foreign approval.
8.2 Closing of Munich Facility. Baxter and Newco acknowledge
that prior to the date of this Agreement, Baxter was manufacturing certain of
the Antibodies at a manufacturing facility in Munich, Germany (the "Munich
Facility"), and that Baxter intends to close such Munich Facility. Baxter will
bear all of the costs and expenses associated with closure of the Munich
Facility, and all of the costs and expenses of establishing and preparing
alternative facilities for the manufacture of the Antibodies previously
manufactured at the Munich Facility, provided, however, that such costs and
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expenses shall not include any costs and expenses of transferring any employee
previously employed at the Munich Facility to employment within the United
States. A charge for Baxter's costs and expenses of establishing and preparing
alternative facilities for the manufacture of the Antibodies previously
manufactured at the Munich Facility will be included in Baxter's Fully Loaded
Cost hereunder. During the term, Baxter will provide, at its Fully Loaded Cost
thereof, storage within Europe of the master cell bank of the T Cell antibody,
and will provide support, assistance and manufacturing know-how to effect an
orderly transition to manufacture of such antibody by a third-party manufacturer
in the same manner as set forth in Section 4 hereof with respect to
discontinuance of manufacturing of an Antibody.
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8.3 Production of Antibodies, Reagents and Reagent Kits: In
producing the Antibodies, Reagents and Reagent Kits Baxter and its
Subcontractors shall comply with all applicable QSR or applicable state or
foreign regulatory requirements except to the extent a relevant requirement has
been allocated to Newco under the Agreements between Newco and Baxter. More
specifically, as applicable, Baxter or its Subcontractor, as the case may be,
shall:
A. Expand and continuously passage the appropriate Cell Lines to
produce such Antibodies as requested by Newco;
B. 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 Antibodies, Reagents, and
Reagent Kits or as they shall be changed by Newco with
the prior written consent of Baxter or a Subcontractor
with respect to material changes (which consent shall
not be unreasonably withheld);
C. Perform the release function for each lot of Antibodies,
Reagents and Reagent Kits;
D. Prepare and maintain all appropriate records, and all
manufacturing records required for regulatory purposes, 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;
E. Maintain and comply with the quality system as described in
its current Quality Manual applicable to the Antibodies, Reagents or
Reagent Kits or as subsequently changed generally for all products of that
type manufactured by such manufacturer; and
F. Maintain and comply with its Standard Operating Procedure
System which is currently applicable to manufacturing Antibodies, Reagents
or Reagent Kits (relating to product manufacturing, testing and critical
engineering system monitoring and control, cleaning/sanitation, calibration
of equipment, preventative maintenance, employee training, pest control,
environmental control/monitoring,
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equipment/process validation, labeling/packaging control, failure
investigation, 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), as
such Standard Operating Procedure System may be amended by such
manufacturer from time to time.
8.4 Materials and Services: Baxter and its Subcontractors shall
purchase all materials and services required to produce the Antibodies, Reagents
and Reagent Kits (the cost of which will be reimbursed by Newco as part of Fully
Loaded Cost). Baxter and its Subcontractors may change suppliers of materials
or services without the prior consent of Newco, provided that (i) there is no
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material increase in the price of the Antibodies, Reagents and Reagent Kits to
Newco, (ii) a PMA supplemental approval or foreign marketing authorization or
approval for any Antibody, Reagent or Reagent Kit or for any product
incorporating any of the Antibodies, Reagents or Reagent Kits as a component
thereof is not necessary, and (iii) the production of the Antibodies, Reagents
and Reagent Kits otherwise conforms to the terms of this Agreement (including
Sections 8.3 and 12.2)
8.5 Title to Cell Lines and Records: Baxter acknowledges that
the Cell Lines, and all documents and records relating to the history and
Regulatory Approval of the Cell Lines, including without limitation regulatory
files maintained by Baxter pursuant to its obligations under Sections 8.3 and
12.2 hereof, are and shall remain the property of Newco or of the relevant
third-party licensor of certain of the Cell Lines, as the case may be. Baxter
will provide Newco with copies of all relevant documents, records and regulatory
files promptly upon Newco's request.
9. CHANGE OF PRODUCTION SITES/OUT SOURCING MANUFACTURE. After
consultation with the Manufacturing Oversight Committee and after written notice
to Newco (but without the requirement of prior consent), Baxter or a
Subcontractor of Baxter may change the current production site of any of the
Antibodies, Reagents or Reagent Kits or outsource the production of any of the
Antibodies, Reagents or Reagent Kits; provided that (i) there is no material
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increase in the price of the Antibodies, Reagents and Reagent Kits to Newco,
(ii) a PMA supplemental approval or foreign marketing authorization or approval
for any Antibody, Reagent or Reagent Kit or for any product incorporating any of
the Antibodies, Reagents or Reagent Kits as a component thereof is not
necessary, (iii) Newco's rights to any IT Assets (including but not limited to
the Cell Lines) are not materially adversely affected thereby, and (iv) the
production of the Antibodies, Reagents and Reagent Kits otherwise conforms to
the terms of this Agreement (including Sections 8.3 and 12.2) or Baxter causes a
relevant third party to comply with the terms of this Agreement in connection
with outsourced production of the Antibodies, Reagents or Reagent Kits, as the
case may be. Newco and Baxter agree that nothing contained in this Agreement
shall require Baxter or a Subcontractor to change, or open any new or
additional,
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Manufacturing Facilities, apart from any upgrades in its Manufacturing
Facilities that Baxter or a Subcontractor may, in its sole discretion, make in
order to meet the specifications for production of the Antibodies, Reagents or
Reagent Kits applicable at any time and any changes as may be necessary to
enable Baxter or a Subcontractor to satisfy its obligations hereunder to deliver
Antibodies, Reagents or Reagent Kits to Newco. With respect to production site
changes, new outsourcing and facilities upgrades, Baxter or its Subcontractor
will 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, Baxter (and/or its Subcontractor) and Newco shall agree to the
allocation of costs related to preparation and submission of the PMA supplement
or other application. New production sites, outsourcing and facility upgrades
shall not be utilized relative to Antibodies, Reagents or Reagent Kits pending
PMA supplemental or other approval, unless consistent with FDA and other
applicable regulations.
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10. FACILITY ACCESS AND AUDITS.
10.1 Facility Access: During the Term, Baxter and any Baxter
Subcontractor shall permit Newco access to all areas of the Manufacturing
Facilities, 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
arranged by and coordinated through the Production Operating Team.
10.2 Audits: Newco may audit Baxter's and Baxter 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 Baxter or its Subcontractor does not wish to disclose to Newco
(the "Restricted Information"), then on the written demand of Baxter or such
Subcontractor, the individuals conducting the audit with respect to the
Restricted Information will be limited to Newco's independent auditors. In such
event, Baxter 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. Any such audit
shall be conducted during regular business hours in a manner that does not
interfere unreasonably with the operations of Baxter or its Subcontractor. The
aggregate number of audits of Baxter's or its Subcontractor's books and records
conducted under the provisions of this Agreement; the Sublicense Agreements; the
Hardware and Disposables Manufacturing Agreement; the Hardware and Disposables
Supply Agreement; the Marketing, Sales and Distribution Agreement, and the
Services 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 Manufacturing Facility receives 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.
10.3 Baxter Subcontractors: Newco's rights to facility access
and to audit books and records pursuant to this Section 10, process validation
pursuant to Section 11 below, and Newco's rights to participation and co-
operation in certain regulatory compliance matters pursuant to Sections 12.2(D),
(E), (F), (G), (H), (I) and (J) below are, in the case of Baxter's
Subcontractors, subject to the limits on Baxter's rights under its agreements
with such Subcontractors. Baxter will use its best efforts, without the
requirement of payment of money, to cause all of its Subcontractors to permit
facility access, the right to audit books and records, process validation, and
Newco's rights to participation and cooperation in regulatory compliance
15
matters as set forth herein with respect to the Antibodies, Reagents and Reagent
Kits as provided in this Section 10, Section 11 below and Sections 12.2(D), (E),
(F), (G), (H), (I) and (J) below.
11. PROCESS VALIDATION. During the Term, at Newco's request, Baxter
and its Subcontractors shall permit Newco to review production validation
protocols and results with respect the Antibodies, Reagents and Reagent Kits.
Such review shall be arranged by the Production Operating Team.
12. COMPLIANCE WITH REGULATORY REQUIREMENTS.
12.1 Newco Responsibilities: Newco shall:
A. Prepare, obtain approval of, and hold all applications, notifications,
submissions and regulatory files required by the FDA and the Act or state,
local or foreign authorities and laws relating to all products which
incorporate the Antibodies, Reagents or Reagent Kits as a component
thereof, except such files and records as are agreed to be maintained by
Baxter or a Baxter third party sub-contractor pursuant to other Agreements
between Newco and Baxter.
B. Provide Baxter with copy for all labeling relating to all
products which incorporate the Antibodies, Reagents and Reagent Kits as a
component thereof, which labeling shall comply with FDA and any relevant
state or local requirements, as well as with all applicable foreign
regulatory requirements.
C. Be responsible for handling product complaints and
maintenance of complaint files and records related to products which
incorporate the Antibodies, Reagents or Reagent Kits as a component
thereof, and notify Baxter of complaints regarding Antibodies,
Reagents and Reagent Kits.
D. File with FDA medical device reports (MDRs) under 21 C.F.R.
part 803 regarding products which incorporate the Antibodies, Reagents or
Reagent Kits as a component thereof.
E. Administer all mandatory notifications, repairs, replacements
and refunds, safety alerts, "cease distribution and notification" and
mandatory recall actions, voluntary
16
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 by any applicable state, local or foreign regulatory
authorities involving products which incorporate the Antibodies, any
applicable state, local or foreign regulatory authorities Reagents or
Reagent Kits as a component thereof.
F. Register with the FDA as a specifications developer and
register with any applicable state, local or foreign regulatory
authorities.
G. List with the FDA and state, local or foreign authorities, as
necessary, those products which incorporate the Antibodies, Reagents or
Reagent Kits as a component thereof.
H. Comply with any PMA Post-Approval Requirements or any other
post-approval requirements applicable to products which incorporate the
Antibodies, Reagents, or Reagent Kits as a component thereof.
I. Respond in a timely manner, after consultation with Baxter or
a relevant Baxter third party sub-contractor, to any Form FDA-483, Warning
Letter or Section 305 Notice received, 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
products which incorporate the Antibodies, Reagents or Reagent Kits as a
component thereof.
J. Comply with all European Union and other foreign regulatory
requirements, as applicable to products which incorporate the Antibodies,
Reagents or Reagent Kits as a component thereof.
K. Provide Baxter with reasonable access to and a copy of such
portions of Newco's regulatory files relating to the Antibodies, Reagents
and Reagent Kits as Baxter shall reasonably request.
12.2 Baxter Responsibilities: Baxter shall; and, as applicable,
shall require any Subcontractor to;
17
A. Appropriately register its manufacturing establishments with the FDA and
other regulatory agencies as required;
B. Maintain required ISO and EN certification for each
Manufacturing Facility, and comply with all EU and other applicable foreign
regulatory requirements.
C. Comply with the QSR requirements and other relevant
regulations issued by the FDA, state, local or other regulatory agencies
and in effect from time to time, except to the extent that a QSR or other
regulatory obligation has been allocated to Newco under the Agreements
between Newco and Baxter.
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 the manufacture of the Antibodies Reagents or Reagent Kits
(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 any Antibody, Reagent or Reagent
Kit). Newco shall be provided with a copy of any Form FDA-483,
Establishment Inspection Report (EIR 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 Antibodies, Reagents or
Reagent Kits, provided that such redaction does not prevent Newco from
--------
discerning any information that is related to the Antibodies, Reagents or
Reagent Kits. 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 be allowed to attend the meeting when the meeting directly
affects or concerns any Antibody, Reagent or Reagent Kit, provided that, in
--------
the discretion of Baxter's or its Subcontractor's regulatory professionals,
the
18
presence of a Newco representative would not prejudice Baxter's or its
Subcontractor's interests.
E. Respond, in a timely manner, after consultation with Newco, to
any Form FDA-483, Warning or "untitled" Letter or Section 305 Notice
received, 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 Antibodies, Reagents or Reagent Kit.
F. Communicate and forward to Newco product complaints received
relating to the Antibodies, Reagents or Reagent Kits and cooperate, as
mutually agreed by the parties, with Newco in the resolution of such
product complaints.
G. Maintain and store production records relating to the
manufacture of Antibodies, Reagents and Reagent Kits as required by its
record retention policy, as amended from time to time.
H. Cooperate with Newco, as mutually agreed by the parties, in
connection with 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 and
FDA policy, or related and analogous actions related to the Antibodies,
Reagents or Reagent Kits produced for Newco. Such cooperation shall be at
Newco's expense, subject to the provisions of Section 12.3 below.
I. Cooperate with Newco in Newco's preparation and filing of MDRs
and compliance with PMA and other post-approval requirements regarding
products which incorporate the Antibodies, Reagents or Reagent Kits as a
component thereof. Such cooperation shall be at Newco's expense, subject
to the provisions of Section 12.3 below.
J. Provide Newco with reasonable access to and a copy of such
portions of its regulatory files relating to the Antibodies,
19
Reagents and Reagent Kits as Newco shall reasonably request.
12.3 Regulatory Actions: In the event that Newco takes a
regulatory action relative to any of its products which contain or use
Antibodies, Reagents or Reagent Kits produced by Baxter or a Baxter
Subcontractor pursuant to this Agreement (the "Newco Products") or relative to a
Newco Product component, and such action is due solely to Baxter's failure or
its sub-contractor's failure to produce the Newco Products in accordance with
its responsibilities under Sections 8.3, 9 or 12.2 of this Agreement, then
Baxter 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 of
Newco Products by customers, and costs related to otherwise addressing, handling
or correcting Newco Products. In the event that such action is due in part to
Baxter's or its sub-contractor's failure to manufacture any Newco Product in
accordance with its responsibilities under this Agreement, Baxter 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 shall be
determined in binding arbitration pursuant to Section 32 of this Agreement. For
purposes of this paragraph, "regulatory action" means mandatory notification,
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.
13. FORECASTS AND ORDERS
13.1 Forecasts: Newco shall supply to Baxter a rolling two year
forecast of its estimated requirements for all Antibodies, Reagents and Reagent
Kits on a quarterly basis. Such forecast shall state monthly estimated
requirements for each Antibody and for Reagents and Reagents Kits included in
the forecast, using data supplied by Baxter from Baxter's Master Planning
Schedule and reviewed by the appropriate Production Operating Teams. The two
year forecast for the two year period beginning on the date hereof was delivered
to Baxter on the date hereof.
13.2 Purchase Orders: Newco shall supply the following
information on a purchase order submitted to Baxter at least eight (8) months
before the requested delivery date:
A Number of units ordered of each Antibody, Reagent or
Reagent Kit; and
B. Requested delivery date of the Antibodies, Reagents and
Reagent Kits ordered in the purchase order.
20
13.3 Production in Excess of Orders: If Baxter's actual production of
Antibodies exceeds Newco's orders, Newco shall purchase such excess, up to
[Confidential Information Omitted] above Newco's orders; provided that Newco's
--------
orders for the next month shall be reduced by such excess unless Newco requests
that such reduction not be made.
13.4 Production Below Amount of Orders: If, due to the fault or
error of Baxter or a third-party supplier or sub-contractor of Baxter, and
subject to the provisions of Section 28 of this Agreement, Baxter fails to
deliver Antibodies in the quantities specified in Newco's orders, Baxter shall
take such 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, Baxter 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 delayed Antibodies to Newco or Newco's product manufacturer
until Baxter has brought production into compliance with firm orders. The
[Confidential Information Omitted] fill rate commitment established
pursuant to this Section 13.4A 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, Baxter
shall (i) take the remedial measures set forth in Section 13.4(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 of this
Agreement, 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
21
(6) 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, Baxter shall, at Newco's option,
either (i) take the remedial measures set forth in Section 13.4(B) or (ii)
assist Newco to transfer all manufacturing of Antibodies, Reagents and
Reagent Kits to a third party alternative manufacturer selected by Newco,
with such assistance to include without limitation the transfer of such
Cell Lines, master cell banks, inventory, raw materials, work in process,
IT Assets, specifications, drawings/blueprints, copy of regulatory files,
and such other property used in manufacturing the Antibodies, Reagents and
Reagent Kits hereunder and owned by Newco or by third-party licensors, or
owned by Baxter and previously charged to Newco as part of Fully Loaded
Cost; transfer all information and technical know-how concerning Baxter
manufacturing processes required for production of the Antibodies, Reagents
and Reagent Kits; provide the services of technical personnel as needed to
effect such transfers of information and technical know-how; and continue
to manufacture the Antibodies, Reagents and Reagent Kits during the
transition to an alternative manufacturer until such alternative
manufacturer is able to meet market demand for the Antibodies, Reagents and
Reagent Kits, provided that Newco and such alternative manufacturer are
making good faith efforts to effectuate the transition and to enable such
alternative manufacturer to meet market demand for the Antibodies, Reagents
and Reagent Kits. 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 that certain Non-Competition and Confidentiality
Agreement among Baxter, VIMRx and Newco of even date herewith, and (b) be
approved by the Corporate Committee.
The provisions of this Section 13.4 shall not apply to Antibodies, Reagents and
Reagent Kits manufactured for use in clinical trials. Except with respect to
Antibodies, Reagents and Reagent Kits manufactured for use in clinical trials
(as to which Section 13.4 does not apply), the provisions of this Section 13.4
shall be the sole remedy available to Newco in the event that Baxter fails to
satisfy Newco's firm orders made pursuant to this Section 13, provided that
Baxter is endeavoring in good faith to satisfy its obligations to Newco in
accordance with the terms of this Agreement, including without limitation, this
Section 13.4.
22
13.5 Transition Period: Baxter and Newco acknowledge that during the
first twelve (12) months of the Term of this Agreement, it may not be
commercially feasible for Baxter (a) to immediately strictly comply with the
labeling, product inserts and packaging requirements of Section 6 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 Section 13.4A through 13.4C, inclusive, of this Agreement.
Accordingly, Baxter and Newco agree that during the first twelve (12) months of
the Term of this Agreement, Baxter will use its commercially reasonable best
efforts to achieve full compliance with (a) the labeling, product inserts and
packaging requirements of Section 6 of this Agreement and (b) the production
rate requirements of Section 13.4A of this Agreement but shall not be deemed to
be in breach of Sections 6 or 13.4 of this Agreement during such twelve (12)
month period unless Baxter fails to comply with this Section 13.5. Any dispute
between Baxter and Newco relating to Baxter's non-compliance with this Section
13.5 shall be referred to the Production Operating Team for resolution pursuant
to Section 7.1 of this Agreement.
14. INVENTORY. Baxter shall retain title to all raw materials and
work in process relating to the Antibodies, Reagents and Reagent Kits, except
that any of such items relating solely to the Antibodies, Reagents and Reagent
Kits which become obsolete due to action of Newco or regulatory requirements
shall, at Baxter's option, be purchased by Newco pursuant to Section 15 below to
the extent they do not exceed ninety (90) days' normal usage, based on annual
budgeted volume.
15. PRICING, BILLING AND PAYMENT.
15.1 Fully Loaded Cost: During the first three (3) full years of
the Term, the prices to Newco for the Antibodies, Reagents and Reagent Kits
shall be Baxter's Fully Loaded Cost for such products.
15.2 Fully Loaded Cost Plus: After the expiration of the first
three (3) full years of the Term, the prices for Antibodies, Reagents and
Reagent Kits shall be Baxter's Fully Loaded Cost for such products plus
[Confidential Information Omitted] of such Fully Loaded Cost (unless Baxter and
Newco otherwise agree in writing to a different price).
15.3 Price Adjustments: The prices for Antibodies shall be
adjusted as of every January 1 of each year of any Term, through Baxter's annual
internal budgeting process, based on forecast changes in volume pursuant to the
forecasting process set forth in Section 13, anticipated changes in materials
prices and anticipated cost reductions resulting from Baxter's Value Improvement
Process. The overall intent of the parties is the Antibodies shall be
transferred at the prices described in Sections 15.1 and 15.2, as adjusted for
future changes in Baxter's costs of production (taking into account Section 15.4
hereof).
23
15.4 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 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 Baxter's 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 15.4(A) or 15.4(B) above, beyond
Baxter's 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 15.4 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 Manufacturing Oversight Committee and,
if necessary, the Corporate Committee.
15.5 Billing and Payment: Baxter shall bill Newco as of the end
of each calendar month for the Antibodies, Reagents and Reagent Kits shipped
during such month. Newco shall pay such invoices within sixty (60) days of
Newco's receipt thereof.
24
16. FOREIGN CURRENCY CONVERSION. Where calculations of Baxter's
Fully Loaded Cost relate to a currency other than United States dollars, all
such calculations shall be calculated pursuant to Baxter's then current
accounting policies and practices.
17. 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 Baxter hereunder, and Newco shall furnish Baxter with
satisfactory evidence of such withholding and payment in order to permit Baxter
to obtain a tax credit or other relief as may be available under the applicable
law. Newco shall cooperate with Baxter in obtaining exemption from withholding
taxes where available under applicable law.
18. 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).
19. DELIVERY. All shipments of Antibodies, Reagents and Reagent Kits
shall be FOB the manufacturing facilities where such products are manufactured
by or on behalf of Baxter. Except as specified in Section 13.4 above, all
freight, insurance, and other delivery costs (and any customs duties) shall be
paid by Newco. At the time of shipping the Antibodies, Baxter shall make
appropriate viability tests to demonstrate the specified activity of the
Antibodies prior to shipment. Newco shall bear the risk of loss for the
Antibodies or any loss of activity of the Antibodies during shipment.
20. TITLE. Title to all Antibodies shall pass to Newco (or Newco's
designated distributor) when the Antibodies are placed on Newco's truck or
Newco's designated carrier (or Newco's designated distributor's truck or
designated carrier) at Baxter's Manufacturing Facility or when products
distributed by Baxter pursuant to the Marketing, Sales and Distribution
Agreement, of even date herewith, by and between Baxter and Newco, are placed in
Baxter's designated finished goods inventory.
21. CHANGES IN LABELING. Changes in Antibodies, Reagents or Reagents
Kits labeling requested by Newco and the cost of labeling made obsolete by such
changes will be paid for by Newco at Baxter's Fully Loaded Cost.
22. WARRANTIES.
22.1 Warranty: Baxter warrants to Newco that the Antibodies,
Reagents and Reagent Kits delivered to or at the direction of Newco hereunder
(i) will have been manufactured in accordance with the applicable specifications
and procedures for the production of such Antibodies, Reagents and Reagent Kits,
and in accordance with all applicable laws (including the Act); (ii) will not be
adulterated or misbranded within the meaning of the Act as a
25
result of acts or omissions by Baxter; and (iii) are free from defects in
workmanship. Notwithstanding the foregoing, Baxter shall not be liable to Newco
under subpart (ii) above as a result of any labels supplied by or affixed to
such Antibodies, Reagents or Reagent Kits by Newco. This warranty shall be
continuing and shall be binding on Baxter 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 BAXTER AND ANY SUCH IMPLIED WARRANTIES ARE SPECIFICALLY DISCLAIMED.
22.2 Baxter Indemnity: Subject to Section 28 below, Baxter
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 Baxter's (or its Subcontractor's)
failure to manufacture the Antibodies, Reagents or Reagent Kits in accordance
with the specifications and procedures, and with the laws, regulations, rules,
orders and notices, and with the quality system and Standard Operating Procedure
System described in Sections 8.3 and 12.2 above and which are applicable to
Baxter or such Subcontractor thereunder, as the case may be. At Baxter's
expense, Newco shall cooperate fully with Baxter in defending or otherwise
resolving any such claim. Baxter shall have full control of any litigation
brought against Newco with respect to any claim that is indemnifiable by Baxter
hereunder; but Newco may, at its expense, also be represented by its own counsel
in any such litigation.
22.3 Newco Indemnity: Subject to Section 28 below, Newco agrees
to indemnify Baxter 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 defects in the products, design,
specifications, procedures, product drawings/blueprints, label copy or resulting
from the use of the Antibodies, Reagents or Reagent Kits; provided, however,
-------- -------
that Newco will have no liability to Baxter whatsoever with respect to any
liability, loss, expense, cost, claim or judgment arising out of any claim for
property damage, personal injury or death which is caused by defects in the
designs, specifications, procedures, or product drawings/blueprints acquired by
Newco from Baxter pursuant to the Acquisition Agreement, except defects in
modifications to such designs, specifications, procedures, or product
drawings/blueprints made by Newco subsequent to its acquisition thereof. At
Newco's expense, Baxter shall cooperate fully with Newco in defending or
otherwise resolving any such claim. Newco shall have full control of any
litigation brought against Baxter with respect to any claim that is
indemnifiable by Newco hereunder; but Baxter may, at its expense, also be
represented by its own counsel in such litigation.
22.4 Indemnification for Infringement: Newco shall defend,
indemnify and hold Baxter harmless with respect to any liability incurred by
Baxter 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 Antibodies, Reagents or Reagent Kits, any Isolex(R) or Maxsep(R)
Products, or other products which are not being manufactured or supplied by
Baxter
26
(or its third party subcontractor) for or to Newco under this Agreement or an
agreement having the same date as this Agreement (or an extension of 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 Baxter. At Newco's expense, Baxter
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 Baxter alleging such infringement or misuse, but
Baxter, may at its expense, also be represented by its own counsel in any such
litigation.
23. INSURANCE.
23.1 Baxter Insurance: During the Term, Baxter 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. Baxter 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.
23.2 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 Baxter evidencing the foregoing
coverages and limits and thereafter shall give at least thirty (30) days prior
notice to Baxter of any termination, expiration without renewal, or material
change to such insurance, coverage or limits.
24. DISCONTINUANCE OF PRODUCT LINE. Subject to Section 25 below, if
Newco wishes to discontinue a product or product line which includes any
Antibodies, Reagents or Reagent Kits (subject to Newco's obligations under the
Marketing, Sales & Distribution Agreement), Newco shall give Baxter six (6)
months' prior written notice thereof and the parties will negotiate appropriate
closure conditions which provide for recovery by Baxter of the related overhead
costs, any related investment (including any dedicated or additional equipment
purchased by Baxter exclusively to support the discontinued product line) and
related direct out-of-pocket expenses.
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25. RIGHT OF FIRST OFFER. In the event Newco elects to abandon
and/or discontinues substantially all efforts to develop or market (or to have
developed or marketed) the Antibodies, Reagents or Reagent Kits, or any of them
(the "Discontinued Products"), within the Product Field or any sub-field thereof
and Newco elects to sell Newco's right to make, have made, use and sell the
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Discontinued Products in the Product Field, or any sub-field thereof, to a third
party, Baxter shall have a right of first offer to obtain an exclusive worldwide
license to make, have made, use and sell, in such Product Field or sub-field,
those Discontinued Products. After Newco notifies Baxter of Newco's intention
to sell such right, Baxter will have sixty (60) days to respond to Newco and to
negotiate the material terms and conditions of such a license. The terms and
conditions of such a license shall be negotiated by Newco and Baxter, bargaining
in good faith, and documented in a written agreement, signed by authorized
representatives of both parties. If, after notice to Baxter and expiration of
sixty (60) days without completed negotiation of the material terms of a license
agreement, Newco desires to enter into an agreement with a third party on terms
and conditions that are less favorable to Newco than the terms and conditions
offered by or to Baxter (a "New Offer"), then Newco must give Baxter notice and
an additional thirty (30) days to respond to Newco's offer on substantially the
same terms and conditions as those of the New Offer. The culmination of any
transaction pursuant to this Section 25 is subject to the parties entering into
a definitive agreement on terms which are agreeable to each of the parties, in
their sole discretion.
26. TERMINATION.
26.1 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 26.2 below.
26.2 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 material covenant contained in this Agreement or the Non-Compete
Agreement (other than a failure to make a payment described in Section
26.2A 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 contained in the Marketing,
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Sales and Distribution Agreement and such default results in termination of
the 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.
26.3 Return of IT Assets: In addition to any other rights or
remedies the parties may have upon termination of this Agreement at law or in
equity, Baxter agrees that Baxter shall, upon termination and payment in full to
Baxter of any unpaid amounts due under this Agreement by Newco, deliver at
Newco's direction, and at Newco's sole risk of loss and expense, any and all IT
Assets, any and all other specifications, drawings/blueprints and other
documents relating solely to the Antibodies, Reagents or Reagent Kits then held
by, or under the control of, Baxter pursuant to this Agreement and copies of any
and all other specifications, product drawings/blueprints and procedures
required for the manufacture of the Antibodies, Reagents and Reagent Kits.
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27. 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, intervention of any governmental authority or cell death due to neither
party's actions, but any such delay or failure shall be remedied by such party
as soon as is reasonably possible.
28. 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.
29. 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, Baxter shall assume all legal obligations to do
so.
30. EXPORT CONTROL. Baxter shall observe all applicable United
States and foreign laws with respect to the transfer of all Antibodies, Reagents
and Reagent Kits to or on behalf of Newco between nations, countries or other
sovereign states.
31. 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 Baxter, such notices shall be delivered to:
President
Baxter Biotech Group
with a copy to:
General Counsel
Baxter Healthcare Corporation
If to Baxter, other written communications shall be delivered to:
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President
Venture Management
Baxter Biotech Group
with a copy to:
Associate General Counsel
Baxter Healthcare Corporation
If to Newco, such notices shall be delivered to:
President
BIT Acquisition Corp.
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with a copy to:
Epstein Becker & Green, P.C.
250 Park Avenue
New York, NY 10177
Attn: Lowell S. Lifschultz, 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 31. 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.
32. DISPUTE RESOLUTION.
32.1 Provisional Remedies: The procedures specified in this
Section 32 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 32.
32.2 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
32) promptly by negotiations under the procedures set forth in Section 7
concerning referral of disputes to the Corporate Committee.
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32.3 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
32.2, 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 Baxter 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
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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.
32.4 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.
33. 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 32
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.
34. 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.
35. 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.
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36. 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.
37. NO OTHER LICENSES. Except as permitted by Section 5 or Section 6
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
necessary for the production of the Antibodies, Reagents and Reagent Kits as set
forth in Section 5 and Section 6 of this Agreement, and subject to Section 26
above, 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.
38. ASSIGNMENT. Newco may assign its rights and obligations under
this Agreement to any Affiliate of Newco without the prior written consent of
Baxter, provided that such Affiliate is owned, directly or indirectly, by Baxter
and VIMRx in substantially the same properties as Newco is owned. Baxter may
assign its rights and obligations hereunder to any Affiliate of Baxter without
prior notice to or consent of Newco. No assignment by Baxter 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 Baxter (in the case of a Baxter
assignee) or Newco (in the case of a Newco assignee) is bound. No party hereto
may assign any of its rights or obligations under this Agreement, unless and to
the extent expressly permitted in this Section 38. Subject to the foregoing,
this Agreement shall inure to the benefit of and be binding on the parties'
permitted successors and assigns.
39. INDEPENDENT PARTIES. By virtue of this Agreement, neither party
constitutes the other as its agent (except as may otherwise 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.
40. 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.
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41. 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 Baxter 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;
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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.
IN WITNESS WHEREOF, the parties have duly executed this Agreement as
of the date first set forth above.
BAXTER HEALTHCARE CORPORATION
By:_________________________________
Name:
Title:
BIT ACQUISITION CORP.
By:_________________________________
Name:
Title:
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