EXHIBIT 10.1
HARDWARE AND DISPOSABLES
MANUFACTURING AGREEMENT
This HARDWARE AND DISPOSABLES MANUFACTURING 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 Subicense, 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 to manufacture for Newco certain antibodies, reagents
and reagent kits which are components of or used in connection with certain of
the Isolex(R) and Maxsep(R) Products (as such capitalized term is defined below)
pursuant to the terms of that certain Antibody Manufacturing and Storage
Agreement of even date herewith (the "Antibody Manufacturing and Storage
Agreement") and 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 also has agreed to supply to Newco certain other products and
components which are utilized in connection with the Isolex(R) and Maxsep(R)
Products, pursuant to the terms of that certain Hardware and Disposables Supply
Agreement of even date herewith (the "Hardware and Disposables Supply
Agreement").
F. Newco desires that Baxter manufacture for Newco the Isolex(R) and
Maxsep(R) Products as described herein and subject to the terms hereof and
Baxter is willing to manufacture for Newco certain 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. "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.
2
C. "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.
D. "FDA" means the United States Food and Drug Administration.
E. "FDA-Regulated Non-Baxter Component" shall mean any component
of a Manufactured 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.
F. "Fenwal" means the Fenwal Division of Baxter.
G. "Field of Distribution" shall bear 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 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
royalties payable by such party in connection with manufacturing,
performing or acquiring any items or services, 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
3
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 cost of, or the cost of funding any, changes in the
site of manufacturing any Manufactured Products. 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.
J. "Isolex(R) and Maxsep(R) Products" means, individually and
collectively, the products listed on Schedule 1 attached hereto, which
----------
Schedule 1 includes Isolex(R) and Maxsep(R) instruments and Isolex(R) and
----------
Maxsep(R) disposable sets (other than those products or components to be
acquired by Newco from third parties or manufactured or supplied by Baxter
under the Hardware and Disposables Supply Agreement or the Antibody
Manufacturing and Storage Agreement), in each case as currently produced by
Baxter utilizing the Isolex(R) and Maxsep(R) Technology, and such new
products as are currently under development, are in research, or have been
identified as proposed new products as indicated in Schedule 1, or as
----------
Baxter may otherwise agree to develop pursuant to the Services Agreement,
in each case as consistent with the nature of the Isolex(R) and Maxsep(R)
Products existing at the date of this Agreement and with Xxxxxx'x legal
obligations and technological capabilities (including, without limitation,
regulatory requirements applicable to Baxter) during the Term of this
Agreement.
4
K. "Isolex(R) and Maxsep(R) Technology" means automated systems
for positive and negative immunomagnetic cell selection.
L. "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 and
Maxsep(R) Products, including equipment, molds and tools.
M. "Manufactured Products" means all Isolex(R) and Maxsep(R)
Products and/or any components thereof, other than those products or
components to be acquired by Newco from third parties or manufactured or
supplied by Baxter under the Hardware and Disposables Supply Agreement, the
Antibody Manufacturing and Storage Agreement, or the Services Agreement.
N. "Manufacturing Facility" means any production site selected by
Baxter or a third party subcontractor of Baxter for manufacture of the
Manufactured Products.
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 the Isolex(R) and Maxsep(R) Products, as such system may be
changed by Baxter from time to time.
Q. "MDR" shall mean Medical Device Reports, as such term is
defined by the rules and regulations of the FDA, as may be amended or
changed from time to time.
R. "Non-Compete Agreement" means the Non-Competition and
Confidentiality Agreement by and among Baxter, VIMRx and Newco of even date
herewith.
S. "Post-Market Approval ("PMA") Post-Approval Requirements"
shall have the meaning ascribed to it by the regulations and policy of the
FDA, as may be amended or changed from time to time.
5
T. "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.
U. "Quality Manual" shall mean the quality manual currently used
in connection with the production of the Isolex(R) and Maxsep(R) Products
or components thereof, as such manual may be changed from time to time.
V. "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.
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 the
Isolex(R) and Maxsep(R) Products, as such procedures may be changed from
time to time.
Z. "Subcontractor" means a third party who produces and/or
supplies any of the Isolex(R) and Maxsep(R) Products or any FDA-Regulated
Non-Baxter Component of a Manufactured Product to or on behalf of Baxter
under contract.
6
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 (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. "Term" shall mean, individually and collectively, the
term of this Agreement as provided in Section 2.
DD. "Value Improvement Process" shall mean the Value
Improvement Management System currently used in connection with the
production of the Isolex(R) and Maxsep(R) Products, as such system may be
changed from time to time.
EE. "Warning Letter" shall have the meaning ascribed to it
by FDA policy, as may be amended or changed from time to time.
2. TERM. The term of this Agreement shall be five (5) years from
the date hereof. After the expiration of twelve (12) months following the date
of this Agreement, Baxter and Newco shall commence to negotiate in good faith a
renewal as well as the prices to be paid during such renewal for the
Manufactured Products produced hereunder.
3. MANUFACTURING. During the Term, Baxter shall manufacture for
Newco the Manufactured Products, and shall complete the manufacturing and
assembly of the Isolex(R) and Maxsep(R) instruments and disposable sets using
components to be acquired by Newco from third parties or supplied by Baxter
under the Hardware and Disposables Supply Agreement and the Antibody
Manufacturing and Storage Agreement, for use and sale in the Product Field,
subject to the terms and conditions contained in this Agreement. In
manufacturing such Manufactured Products, Baxter will produce finished goods.
Nothing contained in this Agreement shall prevent Newco from having products
with the same specifications as the Manufactured Products manufactured by Newco
or third parties on behalf of Newco. Nothing herein contained shall oblige
Baxter to continue producing or Newco to continue purchasing any Manufactured
Product if such production is reasonably believed by Baxter or by Newco, as the
case may be, to violate any applicable law, regulation, rule or license or if
the Manufactured Products produced infringe
7
a third party's patent or other intellectual property rights, provided that
--------
Baxter will cooperate with Newco, to the extent commercially feasible, to
develop and implement such changes as may be necessary to bring a Manufactured
Product into compliance or to prevent such infringement, and Baxter will
continue to produce after a finding of infringement if Newco reaches an
agreement with the third party which permits future production without
infringement. Proposed new products identified on Schedule 1 as Isolex(R) and
Maxsep(R) Products and manufactured by Baxter pursuant to the Services Agreement
shall become Manufactured Products and shall be manufactured by Baxter hereunder
in the event that, and at such time as, their specifications become sufficiently
fixed to permit standardized production at commercial levels. In the event that
Baxter, in its sole discretion, agrees to manufacture for Newco any other
instruments, disposable sets or other products (other than proposed new products
identified on Schedule 1 as Isolex(R) and Maxsep(R) Products agreed to be
manufactured as Manufactured Products hereunder), and Baxter and Newco enter
into a separate written agreement on mutually agreeable terms (including price)
with respect to such manufacturing, then Baxter will manufacture such additional
products as the two parties may so agree, and such additional products will be
treated for all purposes of this Agreement as Manufactured Products.
4. MANUFACTURING LICENSE AND USE OF IT ASSETS.
4.1 Manufacturing License: Newco hereby grants to Xxxxxx and
Xxxxxx accepts, a non-exclusive, royalty-free worldwide license, under the
Isolex(R) and Maxsep(R) Technology, to make, have made, use and sell the
Manufactured Products to or on behalf of Newco during the Term pursuant to the
terms of this Agreement.
4.2 Use of IT Assets: During the Term, Newco shall provide to
Baxter the use and possession of (at Xxxxxx'x Manufacturing Facilities described
in Section 7.1 below), but not title to, those IT Assets (including equipment,
molds or tools) which are required by, or may be useful for, Baxter in
manufacturing the Manufactured Products pursuant to this Agreement, as set forth
on Schedule 2 attached hereto.
5. TRADEMARK LICENSE AND LABEL COPY.
5.1 Trademark License: Newco hereby grants to Xxxxxx and Xxxxxx
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
Manufactured 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 Manufactured
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
8
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 Manufactured Products, provided that Baxter 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
Baxter, other than any trademark, trade name, service xxxx or logo licensed to
Baxter pursuant to Section 5.1 of this Agreement. If a trademark, trade name,
service xxxx or logo owned or used by Baxter or its parent corporation, other
than any trademark, trade name, service xxxx or logo licensed to Baxter pursuant
Section 5.1 of this Agreement, is to be used in connection with the Manufactured
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 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 Manufactured Products that incorporate such
a Baxter trademark, trade name, service xxxx or logo. Each use of such a Baxter
trademark, trade name, service xxxx 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 xxxx or logo used by Baxter, other than any
trademark, trade name, service xxxx or logo licensed to Baxter pursuant to
Section 5.1 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 xxxx or logo claimed by Baxter
or any confusingly similar trademark, trade name, service xxxx or logo during or
after the Term of this Agreement.
6. ADMINISTRATION
6.1 Production Operating Teams: Administration of this
Agreement will be accomplished by the establishment of three "Production
Operating Teams," to include the Xxxxxx Production Operating Team, the Tampa
Production Operating Team and the Mountain Home Production 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
--------
3, or other persons of an appropriate 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 any 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
9
Production Operating Team. If, in the course of conducting the activities
contemplated in these Agreements, any 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 for resolution in accordance with this
Agreement.
6.2 Manufacturing Oversight Committee: 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; Newco's
Vice President, Business Development; Xxxxxx'x Vice President, Monoclonal and
Plasma Operations from Xxxxxx; Xxxxxx'x Renal Division Plant Manager, Tampa; and
Xxxxxx'x Renal Division Plant Manager, Mountain Home, or such other personnel as
may be designated by Newco and Baxter, respectively. 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 Teams. The
Manufacturing Oversight Committee will review and decide any matter in dispute
referred to it by a Production Operating Team. Regardless of the number of
representatives selected by each of Newco and Baxter 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. 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.
6.3 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 Fenwal, 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 agreement with respect to any matter, the
matter will be referred to arbitration as provided in this Agreement.
6.4 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 Manufactured Products. For guidance and illustrative purposes, a
list of the various functional responsibilities to be performed by Newco and
Baxter for purposes of this Agreement are attached as Schedule 4. Whenever the
----------
need for functions and responsibilities not previously identified or assumed by
either Newco or Baxter becomes evident, the relevant Manufacturing Oversight
Committee will assign such functions or responsibilities.
7. PRODUCTION AND PRODUCTION SITES.
7.1 Production Sites: Xxxxxx'x and its Subcontractors'
manufacture of the Manufactured Products (and components thereof) may be carried
out at any Manufacturing
10
Facility, with the original Manufacturing Facilities selected by Baxter and its
Subcontractors set forth on Schedule 5 attached hereto, provided that the cost
---------- --------
of effecting any change of the Manufacturing Facilities from the original sites
selected, or of effecting any subsequent change, shall not be included in the
Fully Loaded Cost, the new facilities meet any applicable QSR and other
regulatory requirements (or, in the case of a Baxter Subcontractor, to Xxxxxx'x
knowledge the new facilities meet any applicable QSR and other regulatory
requirements), and any change in facilities does not require submission and
approval of a 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 other application and Baxter or the relevant Subcontractor shall
continue to use and supply Newco from existing facilities, pending PMA
supplement or foreign approval.
7.2 Production of Manufactured Products: In manufacturing the
Manufactured Products, 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, Xxxxxx'x
or a Subcontractor's QSR responsibilities, include but are not limited to:
A. Complying 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 production to the manufacture of the Manufactured Products or as
they are 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).
B. Performing the release function for each lot of Manufactured
Product.
C. Preparing and maintaining the Device Master Record and Device
History Record or state, local or foreign equivalent for each Manufactured
Product, including records of any product retentions which may have been
issued against a lot during the manufacturing process, the action taken,
and the disposition of the retention.
D. Maintaining and complying with the quality system as described
in its current Quality Manual applicable to the Manufactured Products, or
as subsequently changed generally for all products of that type
manufactured by such manufacturer.
11
E. Maintaining and complying with its Standard Operating
Procedure System which is currently applicable to the Manufactured 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 and 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.
Baxter or a Baxter Subcontractor may change the product specifications for any
Manufactured Product only with the prior written consent of Newco, which consent
shall not be unreasonably withheld. If Baxter 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 which may
affect the PMA or state, local or foreign regulatory approval of any
Manufactured Product or that requires any 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 given hereunder by Xxxxxx or its
Subcontractor, as the case may be. In the event that Newco objects to a
proposed change because it would require a PMA supplemental approval or state,
local or foreign marketing authorization or approval or for any other reason,
Xxxxxx or its Subcontractor will continue to provide the Manufactured Products
without any change in product specifications, provided that if Newco objects to
-------------
the change because it determines a PMA supplemental approval or state, local or
foreign marketing application or approval would be necessary, Xxxxxx or its
Subcontractor may prepare and bear the cost of the PMA supplement or other
foreign application which Newco will file with the FDA or other appropriate
authority. In such a case, modified Manufactured Products may be provided upon
PMA supplement or state, local or foreign approval or when otherwise consistent
with the FDA or other applicable regulations.
7.3 Materials and Services: Xxxxxx and its Subcontractors shall
purchase all materials and services required to manufacture the Manufactured
Products (the cost of which will be reimbursed by Newco as part of Fully Loaded
Cost). Xxxxxx and its Subcontractors may change suppliers of materials or
services without the prior consent of Newco, provided that (i) there is no
--------
material increase in the price of the Manufactured Products to Newco, (ii) a PMA
supplemental approval or state, local or foreign marketing authorization or
approval for any of the Manufactured Products is not necessary, and (iii) the
production of the Manufactured Products otherwise conforms to the terms of this
Agreement (including Sections 7.2 and 12.1).
12
7.4 Title to Specifications: The specifications, product
drawings/blueprints and procedures that relate solely to the Manufactured
Products (and components thereof) referred to in Section 7.2A, other than any
such specifications, drawings/blueprints or procedures that relate solely to
those products or components to be supplied by Xxxxxx under the Hardware and
Disposables Supply Agreement, are and shall remain the property of Newco. Newco
shall provide copies of such documents to Xxxxxx or a relevant Subcontractor in
quantities sufficient to permit Xxxxxx or the Subcontractor to carry out its
obligations hereunder. Specifications, product drawings/blueprints and
procedures that were not transferred to Newco as part of the IT Assets and that
relate both to the Manufactured Products (and components thereof) and to other
Xxxxxx products are and shall remain the property of Xxxxxx or any relevant
subcontractor. Xxxxxx and its Subcontractors shall provide copies of such
documents to Newco in quantities sufficient to permit Newco to manufacture, or
have manufactured on its behalf, products with the same specifications as the
Manufactured Products.
8. CHANGE OF PRODUCTION SITES/OUTSOURCING MANUFACTURE. After
consultation with the Manufacturing Oversight Committee and after written notice
to Newco (but without the requirement of prior consent), Xxxxxx or a Xxxxxx
Subcontractor may change the current production site of any Manufactured Product
and Xxxxxx may outsource the production of any Manufactured Product, provided
--------
that (i) there is no material increase in the price of the Manufactured Products
to Newco, (ii) a PMA supplemental approval or state, local or foreign marketing
authorization or approval is not required, (iii) Newco's rights to any IT Assets
are not materially adversely affected thereby, and (iv) the manufacturing of the
Manufactured Products otherwise conforms to the terms of this Agreement with
respect to Manufactured Products (including Sections 7.2 and 12), or Xxxxxx
causes a relevant third party to comply with the terms of this Agreement in
connection with outsourced manufacturing of a Manufactured Product, as the case
may be. Newco and Xxxxxx agree that nothing contained in this Agreement shall
require Xxxxxx or a Subcontractor to change, or to open any new or additional
Manufacturing Facilities, apart from any upgrades in its Manufacturing
Facilities that Xxxxxx or a Subcontractor may make in order to meet the
specifications for production of the Manufactured Products applicable at any
time and any changes as may be necessary to enable Xxxxxx or a Subcontractor to
satisfy its obligations hereunder to deliver Manufactured Products to Newco.
Both Newco and Xxxxxx acknowledge and agree that the production of certain
components of the Manufactured Products is currently outsourced by Xxxxxx to
manufacturers other than Xxxxxx. 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 supplement
approval 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 supplement or other
application. New production sites, outsourcing and facility upgrades shall not
be utilized relative to Manufactured Products, pending PMA supplement or foreign
approval, unless consistent with FDA and other applicable regulations.
9. FACILITY ACCESS AND AUDITS.
13
9.1 Facility Access: During the Term, Xxxxxx and its Subcontractors
shall permit Newco access to all areas of the Manufacturing Facilities in which
the Manufactured 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.
9.2 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 a Xxxxxx Subcontractor wishes not to disclose to
Newco ("Restricted Information"), then on the written
14
demand of Xxxxxx 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, 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 the 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 Xxxxxx or such
subcontractor. The aggregate number of audits of Xxxxxx'x books and records
conducted under this Agreement and the Sublicense Agreements, the Antibody
Manufacturing and Storage Agreement, the Services Agreement, the Marketing,
Sales and Distribution Agreement and the Hardware and Disposables Supply
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 a Manufacturing Facility receives a Form FDA-483
during 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.
9.3 Xxxxxx Subcontractors: Newco's rights to facility access
and to audit books and records pursuant to this Section 9, process validation
pursuant to Section 10 below, and certain regulatory compliance matters pursuant
to Sections 12.1(D), (E), (F), (G), (H), (I) and (J) below are, in the case of
Xxxxxx'x 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 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 Manufactured Products as provided in this Section 9, Section 10
below and Sections 12.1(D), (E), (F), (G) (H), (I) and (J) below.
10. 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 Manufactured Products. Such review
shall be arranged by the Production Operating Teams.
11. REGULATORY RESPONSIBILITY. Except as allocated to Xxxxxx or its
Subcontractors as a QSR obligation or otherwise under the agreements between
Xxxxxx and Newco, Newco will obtain Regulatory Approval for, and shall maintain
all regulatory files on, every Manufactured Product (except Supplied Products)
manufactured by Xxxxxx or a Subcontractor exclusively for Newco.
12. COMPLIANCE WITH REGULATORY REQUIREMENTS.
12.1 Xxxxxx Responsibilities: Notwithstanding any provision of
Section 11 hereof to the contrary, Xxxxxx shall and, as applicable, shall
require any Subcontractor to:
15
A. Appropriately register its manufacturing establishments with
the FDA and other regulatory agencies when required.
B. Maintain its required IS0 and EN certification for each
Manufacturing Facility and comply with all European Union and other foreign
regulatory requirements, as applicable.
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 Xxxxxx and Newco.
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 Manufactured Products (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 Manufactured Products). 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
inspection visit, and responses thereto (which copies may be redacted to
the extent necessary to protect confidential information unrelated to the
Manufactured Products, provided that such redaction does not prevent Newco
from discerning any information that is related to the Manufactured
Products). Newco shall also be apprised as soon as possible of the time and
place of any FDA "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 Manufactured Product, provided that, in the discretion of
--------
Xxxxxx'x or its Subcontractor's 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 or "untitled"
16
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 Manufactured Products.
F. Communicate to Newco product complaints received relating to
the Manufactured Products 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
Manufactured Products 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 or
FDA policy, related to the Manufactured Products 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 Post-Approval Requirements related to the
Manufactured Products. 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 Manufactured Products as
Newco shall reasonably request.
12.2 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 relating to the Manufactured Products, except such files as are agreed
to be maintained by Xxxxxx or a Xxxxxx third party sub-contractor pursuant
to the other Agreements between Newco and Xxxxxx.
17
B. Provide Xxxxxx with copy for all labeling related to the
Manufactured Products, which labeling shall comply with the Act and with
FDA and any relevant state or local regulatory 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 Manufactured Products, and shall
notify Xxxxxx of complaints regarding Manufactured Products.
D. File with FDA medical device reports under 21 C.F.R. Part 803
regarding the Manufactured Products.
E. Administer all 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
Manufactured Products.
F. Register with the FDA as a specifications developer and
register with other authorities, as applicable.
G. List the Manufactured Products with the FDA or other
authorities, as necessary.
H. Comply with any PMA Post-Approval Requirements applicable to
the Manufactured Products.
I. Respond in a timely manner, after consultation with Xxxxxx or
a relevant Xxxxxx 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
the Manufactured Products.
J. Provide Xxxxxx with reasonable access to and a copy of such
portions of Newco's regulatory files relating to the Manufactured Products
as Xxxxxx shall reasonably request.
18
K. Comply with all European Union and other foreign regulatory
requirements, as applicable to the Manufactured Products.
12.3 Regulatory Actions: In the event that Newco takes a
regulatory action relative to any Manufactured Product (or component thereof)
and such action is due solely to Xxxxxx'x or its Subcontractor's failure to
produce the Manufactured Product (or component) in accordance with its
responsibilities under Sections 7.2, 8 or 12 of this Agreement, then Xxxxxx
shall pay or reimburse Newco for all out-of-pocket costs and expenses incurred
by Newco in connection with such action, including expenses or obligations to
third parties, the cost of notifying customers, costs associated with the return
of Manufactured Products (or components thereof) by customers, and costs related
to otherwise addressing, handling or correcting the Manufactured Products (or
components thereof). In the event that such action is due in part to Xxxxxx'x
or its Subcontractor's failure to manufacture the Manufactured Product (or
component) 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
shall be determined in binding arbitration pursuant to Section 32 of this
Agreement to be attributable to Xxxxxx'x failure. For purposes of this
paragraph, "regulatory action" means 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.
13. ACTIVITY PLANNING/FORECASTS AND ORDERS.
13.1 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 Manufactured Products during each of the next eighteen
(18) months, using 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 (2) 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 (18) months in such eighteen month
forecast may not vary from 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.
13.2 Production Schedule: Based on the forecasts and orders
received by Xxxxxx from Newco, Xxxxxx shall develop and maintain detailed
production schedules for the Manufactured Products which shall be presented for
review by the Production Operating Teams at least quarterly.
19
13.3 Production in Excess of Orders: If Xxxxxx'x actual production of
Manufactured Products exceeds Newco's firm orders, Newco shall purchase such
excess, up to [Confidential Information Omitted] above Newco's firm orders,
provided that Newco's firm 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 Xxxxxx or a third-party supplier or subcontractor of Xxxxxx, and
subject to the provisions of Section 29 of this Agreement, Xxxxxx fails to
deliver Manufactured 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 delayed Manufactured Products to Newco's
customers until Xxxxxx has brought production into
compliance with firm orders. Increased production
required under this Section 13.4(A) shall not be
subject to the limits on variance of orders set forth
in Section 13.1. The [Confidential Information
Omitted]fill rate commitment established pursuant to
this Section 13.4(A) 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 13.4(A), (ii) promptly prepare and present
to the Production Operating Teams a plan for restoring
compliance 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
hereof, production for any three consecutive months is
[Confidential Information Omitted] of Newco's firm
orders (as increased by the number of unfilled
20
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, either (i)
take the remedial measures set forth in Section 13.4(B)
or (ii) assist Newco to transfer, at Xxxxxx'x sole
expense, all manufacturing of Manufactured Products to
a third party alternative manufacturer selected by
Newco, with such assistance to include without
limitation the transfer of such inventory, raw
materials, work in process, IT Assets, specifications,
drawings/blueprints, copy of the Device History Record,
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 production of the Manufactured
Products; provide the services of technical personnel
as needed to effect such transfers of information and
technical know-how; and continue to manufacture the
Manufactured Products during the transition to an
alternative manufacturer until such alternative
manufacturer is able to meet market demand for the
Manufactured Products, 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
Manufactured Products. 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 Xxxxxx, 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 Manufactured Products
manufactured for use in clinical trials. Except with respect to Manufactured
Products manufactured for use in clinical trials (as to which Section 13.4 does
not apply), the provisions of Section 13.4 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 13, provided that Xxxxxx 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.
13.5 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.
21
13.6 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 Section 13.4A through 13.4C, 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 requirements of Section 5 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 5 or 13.4 of this Agreement during such twelve (12)
month period unless Xxxxxx fails to comply with this Section 13.6. Any dispute
between Xxxxxx and Newco relating to Xxxxxx'x non-compliance with this Section
13.6 shall be referred to the Production Operating Teams for resolution pursuant
to Section 6.1 of this Agreement.
14. INVENTORY. Xxxxxx shall retain title to all raw materials and
work in process relating to the Manufactured Products, except that any of such
items relating solely to the Manufactured Products which become obsolete due to
action of Newco or regulatory requirements shall, at Xxxxxx'x 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 Manufactured Products shall be Xxxxxx'x Fully
Loaded Cost for such Manufactured Products.
15.2 Fully Loaded Cost Plus: After the expiration of the first
three (3) full years of the Term, the prices for Manufactured Products shall be
Xxxxxx'x Fully Loaded Cost for such Manufactured Products plus [Confidential
Information Omitted] of such Fully Loaded Cost (unless Xxxxxx and Newco
otherwise agree in writing to a different price).
15.3 Price Adjustments: The prices for Manufactured 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 13, 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 Manufactured
Products shall be transferred at the prices described in Sections 15.1 and 15.2,
as adjusted for future changes in Xxxxxx'x costs of production (taking into
account Section 15.4 hereof).
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:
22
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 Section 15.4(A) or 15.4(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 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, to the Corporate Committee.
15.5 Spare Parts: Xxxxxx shall manufacture and make available
for purchase by Newco spare parts for the repair of the Manufactured Products.
Newco's purchases of such spare parts shall be subject to the pricing, billing
and payment provisions of this Section 15. 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.
23
15.6 Billing and Payment: Xxxxxx shall xxxx Newco as of the end of
each calendar month for Manufactured Products shipped during the month. Newco
shall pay such invoices within sixty (60) days of Newco's receipt thereof.
16. 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.
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 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.
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] percent [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 Manufactured Products shall be FOB
the manufacturing facilities where such Manufactured Products are manufactured
by or on behalf of Xxxxxx. Except as specified in Section 13.4 above, all
freight, insurance, and other delivery costs (and any customs duties) shall be
paid by Newco.
20. TITLE. Title to all Manufactured Products shall pass to Newco
(or Newco's designated distributor) when the Manufactured 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
Manufactured Products distributed by Xxxxxx pursuant to the Marketing, Sales and
Distribution Agreement, of even date herewith, by and between Xxxxxx and Newco,
are placed in Xxxxxx'x designated finished goods inventory.
21. CHANGES IN LABELING. Changes in Manufactured 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.
22. WARRANTIES.
22.1 Warranty: Xxxxxx warrants to Newco that the Manufactured
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), (ii)
will not be adulterated or misbranded within the meaning of the Act as a result
of acts 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
24
result of any labels supplied by or affixed to such Manufactured 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.
22.2 Xxxxxx Indemnity: Subject to Section 28 below, Xxxxxx
agrees to indemnify Newco and hold it harmless from any liability, loss,
expense, cost, claim or judgment 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 Manufactured Products in accordance with the designs,
specifications, procedures and product drawings/blueprints, with the laws,
regulations, rules, orders and notices, or with the quality system and Standard
Operating Procedure System described in Section 7.2 and Section 12 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.
22.3 Newco Indemnity: Subject to Section 28 below, Newco agrees
to indemnify Xxxxxx and hold it harmless from 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 products, design,
specifications, procedures, product drawings/blueprints, label copy or resulting
from the use of the Manufactured Products; provided, however, that Newco will
-------- -------
have no liability to Xxxxxx 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
Xxxxxx 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, Xxxxxx shall
cooperate fully with Newco in defendng or otherwise resolving any such claim.
Newco shall have full control of any litigation brought against Xxxxxx with
respect to any claim that is indemnifiable by Newco hereunder; but Xxxxxx may,
at its expense, also be represented by its own counsel in any such litigation.
22.4 Indemnification for Infringement: Newco shall defend,
indemnify and hold Baxter 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
25
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 expense, also be represented
by its own counsel in any such litigation.
23. INSURANCE.
23.1 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] Dollars [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.
23.2 Newco Insurance: During the Term, Newco shall procure
andmaintain, 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] Dollars [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.
24. DISCONTINUANCE OF PRODUCT LINE. Subject to Section 25 below, if
Newco wishes to discontinue a product or product line which includes any
Manufactured 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 direct out-of-
pocket expenses.
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 Manufactured Products, 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
Discontinued Products in the Product Field or any sub-field thereof to a third
party, Xxxxxx 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 Xxxxxx of Newco's intention
to sell such right, Xxxxxx 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 Xxxxxx, bargaining
in good faith,
26
and documented in a written agreement, signed by authorized representatives of
both parties. If, after notice to Xxxxxx 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 Xxxxxx (a "New Offer"), then Newco must give Xxxxxx 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.
27
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; a party shall default in the performance of or compliance
with any covenant contained 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,
28
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 Manufactured Products then held by, or under
the control of, Xxxxxx pursuant to this Agreement and copies of any and all
other specifications, product drawings/blueprints and procedures required for
the manufacture of the Manufactured Products.
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 or intervention of any governmental authority, 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, Xxxxxx shall assume all legal obligations to do
so.
30. EXPORT CONTROL. Xxxxxx shall observe all applicable United
States and foreign laws with respect to the transfer of all Manufactured
Products 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
29
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
Xxxxxx Healthcare Corporation
If to Baxter, other written communications shall be delivered to:
President
Venture Management
Baxter 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
Attention: 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 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
30
thereof to the United States Postal Service; or by facsimile transmission, at
the time of transmission.
31
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
-------- -------
a preliminary injunction or other provisional relief if, in its sole judgment,
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 promptly 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), by negotiations under the procedures set forth in Section 6
concerning referral of disputes to the Corporate Committee.
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 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
32
(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
-------- -------
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
33
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.
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 4 or Section 5
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 manufacture of the Manufactured Products as set forth in
Sections 4 and 5 of this Agreement, and subject to Section 25 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
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 hereto
may assign any of its rights or obligations under this Agreement, unless and to
the extent expressly permitted by 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
34
venturer, 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.
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 Xxxxxx International Inc., a Delaware
corporation, and its subsidiaries prior to the date hereof;
35
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]
36
IN WITNESS WHEREOF, the parties have duly executed this Agreement as
of the date first set forth above.
XXXXXX HEALTHCARE CORPORATION
By:______________________________
Name:
Title:
BIT ACQUISITION CORP.
By:______________________________
Name:
Title:
37
