Development, Manufacturing and Marketing Agreement - Baxter Healthcare Corp. and Steritech Inc.
DEVELOPMENT, MANUFACTURING
AND
MARKETING AGREEMENT
BETWEEN
BAXTER HEALTHCARE CORPORATION
AND
STERITECH, INC.
APRIL 1, 1996
<PAGE> 2
TABLE OF CONTENTS
PAGE
1. BACKGROUND.................................................................... 1
2. DEFINITION OF TERMS........................................................... 1
3. COOPERATIVE DEVELOPMENT WORK.................................................. 9
3.1 Period; Objective.................................................... 9
3.2 Management Board..................................................... 9
(a) Constitution................................................ 9
(b) Project Committees.......................................... 9
(c) Voting...................................................... 10
(d) Disputes.................................................... 10
3.3 Review Of Budget, Benchmarks; Approved Projects...................... 11
(a) The Red Cell Project........................................ 11
(b) The Fresh Frozen Plasma Project............................. 12
(c) Other Projects.............................................. 13
3.4 Exchange Of Information.............................................. 13
3.5 Cost Sharing......................................................... 13
3.6 Testing And Regulatory Expenses...................................... 14
(a) Testing Expenses............................................ 14
(b) Regulatory Expenses......................................... 14
3.7 Budget Contingencies................................................. 15
(a) Exceeding Initial Budget.................................... 15
(b) Reconciliation Of Expenditures.............................. 15
3.8 Baxter Participation In 1996......................................... 15
4. EQUITY PURCHASE............................................................... 15
4.1 Baxter Purchase Of Equity In Steritech............................... 15
4.2 Option To Purchase Equity In Steritech............................... 19
4.3 Standstill By Baxter................................................. 20
i.
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TABLE OF CONTENTS
(CONTINUED)
PAGE
5. SUPPLY OF STERITECH COMPOUND AND SYSTEM MANUFACTURING......................... 23
5.1 Steritech Responsibilities........................................... 23
5.2 Baxter Responsibilities.............................................. 23
5.3 Instrument Production................................................ 23
5.4 System Specifications................................................ 23
5.5 Steritech Specifications............................................. 23
5.6 Source Of Supply..................................................... 23
5.7 Failure Of Steritech To Meet Baxter Requirements..................... 23
5.8 System Improvements.................................................. 23
6. MARKETING AND DISTRIBUTION RIGHTS: EXCLUSIVE DISTRIBUTION RIGHTS............. 24
6.1 Commercialization.................................................... 24
6.2 Meetings Concerning Marketing........................................ 24
6.3 Reserved Right To Compete............................................ 24
6.4 Competing Products................................................... 24
6.5 Commencement, Cessation Of Marketing................................. 24
6.6 Achievement Of Market Share.......................................... 25
6.7 Supply Of Baxter Goods............................................... 25
6.8 Requalification...................................................... 25
6.9 Management Board Access To And Review Of Marketing And
Distribution Information............................................. 26
7. REVENUE SHARING............................................................... 26
7.1 Revenue Sharing Payments............................................. 26
7.2 Baxter Sourcing Steritech Compounds.................................. 26
7.3 Steritech As Seller Of Systems....................................... 26
7.4 Licensing............................................................ 27
7.5 Distributor Sales.................................................... 27
8. PATENTS, KNOW-HOW, LICENSE GRANTS............................................. 27
8.1 Steritech Sole Ownership............................................. 27
8.2 Baxter Sole Ownership................................................ 27
8.3 Joint Patents........................................................ 27
8.4 License.............................................................. 28
8.5 Steritech Rights..................................................... 28
ii.
<PAGE> 4
TABLE OF CONTENTS
(CONTINUED)
PAGE
(a) Decontaminated Products..................................... 28
(b) Other....................................................... 29
8.6 Cross-License........................................................ 29
8.7 Excluded Products.................................................... 29
8.8 Notice Of Sole Rights................................................ 29
8.9 Other Agreements..................................................... 30
8.10 Regulatory Files..................................................... 30
8.11 Rights Under Government-Sponsored Research........................... 30
9. PROSECUTION OF PATENT RIGHTS.................................................. 30
9.1 Steritech Patents.................................................... 30
9.2 Baxter Patents....................................................... 30
9.3 Joint Patents........................................................ 30
9.4 Prior Art; Review And Comment........................................ 30
9.5 Election Not To Pay Expenses......................................... 31
10. TRADEMARKS.................................................................... 31
10.1 Baxter Trademarks.................................................... 31
10.2 Steritech Trademarks................................................. 31
11. CONFIDENTIAL INFORMATION...................................................... 31
11.1 Confidentiality Agreement............................................ 31
11.2 Use Of Consultants................................................... 32
12. CESSATION OF COOPERATIVE DEVELOPMENT WORK..................................... 32
12.1 Cessation............................................................ 32
12.2 Cessation Payment.................................................... 33
13. REPORTS....................................................................... 33
13.1 Quarterly Sales Reports.............................................. 33
13.2 Cost Of Goods/Base Revenue........................................... 34
iii.
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TABLE OF CONTENTS
(CONTINUED)
PAGE
14. BOOKS AND RECORDS............................................................. 34
14.1 Records.............................................................. 34
14.2 Retention............................................................ 34
14.3 Interest............................................................. 34
15. TERM.......................................................................... 34
16. BREACH........................................................................ 35
16.1 Material Breach...................................................... 35
16.2 Rights On Termination................................................ 35
17. REPRESENTATIONS AND INDEMNITIES............................................... 35
17.1 Steritech Representations............................................ 35
17.2 Steritech Indemnification -- Representations And Warranties.......... 36
17.3 Steritech Indemnification -- Products................................ 36
17.4 Insurance............................................................ 36
17.5 Baxter Representations............................................... 36
17.6 Baxter Indemnification -- Representations And Warranties............. 37
17.7 Baxter Indemnification-Products...................................... 37
17.8 Baxter Insurance..................................................... 37
18. INFRINGEMENT.................................................................. 38
18.1 Defense Of Third Party Infringement Suits............................ 38
18.2 Third Party Patent Expenses.......................................... 38
18.3 Suits For Infringement By Others..................................... 38
19. GENERAL....................................................................... 39
19.1 Entire Agreement..................................................... 39
19.2 Relationship Of Parties.............................................. 39
19.3 Senior Baxter Contact................................................ 39
19.4 Senior Steritech Contact............................................. 39
19.5 Severability......................................................... 39
19.6 Force Majeure........................................................ 39
19.7 Notices.............................................................. 40
iv.
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TABLE OF CONTENTS
(CONTINUED)
PAGE
19.8 Binding.............................................................. 40
19.9 Governing Law........................................................ 40
19.10 Venue................................................................ 40
19.11 Disbursements........................................................ 41
Schedule A Red Cell Budget and Tasks
Schedule B FFP Budget and Tasks
Schedule C Phase II Platelet Interim Determination Criteria
Schedule D Plasma Derivatives Letter
Schedule E Confidentiality Agreement
Schedule F Baxter Participation 1996
Schedule G Stock Purchase Agreement
v.
<PAGE> 7
DEVELOPMENT, MANUFACTURING
AND MARKETING AGREEMENT
THIS AGREEMENT ("Agreement") between BAXTER HEALTHCARE CORPORATION, a
Delaware corporation ("Baxter") with principal offices at One Baxter Parkway,
Deerfield, Illinois 60015, and STERITECH, INC., a California corporation
("Steritech") with principal offices at 2525 Stanwell Drive, Concord, California
94520, is effective as of the 1st day of April, 1996 ("Effective Date").
1. BACKGROUND.
1.1 Steritech has substantial knowledge and expertise in the area of
inactivation of pathogens for the decontamination of blood products. Baxter has
substantial knowledge and expertise in the research, development, manufacture
and distribution of healthcare products including those relating to the
collection, preservation, processing, manipulation, storage and treatment of
blood and blood components.
1.2 The parties are interested in the development and commercialization
of products and/or systems which provide a customer with instrumentation,
disposables and compounds for use in ex-vivo inactivation of pathogens for the
decontamination of all human blood cells, Protein Preparations and human blood
components intended for human use.
2. DEFINITION OF TERMS.
The words appearing in capitalized form throughout this Agreement shall
have the meanings assigned to them in this Section 2.
APPROVED DISTRIBUTOR means any company, other than a company (or any of
its affiliates) that manufactures blood collection products or any distributor
of blood collection products identified in a letter from Baxter to Steritech of
even date with this Agreement. For the purposes of this definition, an
"affiliate" of a company shall mean an entity controlling, controlled by, or
under common control with such company. "Control" for the purposes of this
definition shall mean fifty percent (50%) ownership.
ALE has the meaning set forth in that certain letter dated March 14,
1996 from Kathryn P. Wilke of Steritech to Joseph B. Barrett of Baxter.
BASE REVENUE means for any Integrated Inactivation Set as of any
measurement date the average net sales price (computed using the same
adjustments as provided in paragraphs (a) and (b) of the definition of NET
SALES) of a comparable set without an Inactivation Package ("Base Set") during
the three full calendar months preceding such date, and in the case of each new
Integrated Inactivation Set, during the three full months preceding the first
sale of such Integrated Inactivation Set ("Initial Base Revenue"). Base Revenue
shall be adjusted, with
1.
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respect to the sales of each Integrated Inactivation Set in each quarter
commencing with the first full calendar quarter after its first sale, to
(a) an amount equal to the average net sales price (computed
using the same adjustments as provided in paragraphs (a) and (b) of the
definition of NET SALES) of a comparable Base Set during three full calendar
months preceding the first day of such calendar quarter, if there exists
throughout such period a large blood collection market for such comparable Base
Set, or
(b) if there does not exist throughout such period a large
blood collection market for such Base Set, an amount equal to:
(w) which bears the same ratio to (x) the average Net
Sales price for such Integrated Inactivation Set in such quarter
as the ratio of (y) the Base Revenue for such Base
Set during the most recent three full month period in which there
continuously existed a large clinical market for such Base Set to (z)
the average Net Sales price for such Integrated Inactivation Set during
such three full month period (or shorter period since first sale of
such Integrated Inactivation Set).
Baxter shall provide to Steritech information supporting such average net sales
price within sixty (60) days after the last day of the first calendar quarter in
which the first sale of each Integrated Inactivation Set occurs and sixty (60)
days after the last day of each calendar quarter thereafter. For the purposes of
this definition, a "large blood collection market" shall be deemed to exist for
any Base Set in any three-month period if Baxter has sales of such Base Set into
the blood collection (for transfusion) market of at least twenty-five percent
(25%) of the number of units of such Base Set that were sold in the three-month
period immediately preceding the first sale of the comparable Integrated
Inactivation Set. Baxter shall provide to Steritech within sixty (60) days after
the last day of each calendar quarter information for each such Base Set
evidencing whether or not there exists a large clinical market.
BASE SET has the meaning set forth in the definition of Base Revenue.
BAXTER means Baxter Healthcare Corporation and its affiliates,
including, but not limited to, divisions and subsidiaries, and also including
its parent company, Baxter International Inc. and its affiliates, including, but
not limited to, divisions and subsidiaries. A company shall be considered an
affiliate of Baxter if it is at least forty percent (40%) owned or controlled by
Baxter Healthcare Corporation or Baxter International Inc.
BAXTER KNOW-HOW means unpatented inventions, data, processes,
compositions, techniques and other technical information proprietary to Baxter,
which is solely owned by Baxter or which Baxter has the right to control the use
of, relating to the Field and any Systems including methods for manufacture or
use of Systems or portion thereof.
2.
<PAGE> 9
BAXTER LICENSED KNOW-HOW means all Baxter Know-How in existence as of
the Effective Date or created or acquired during the term of the Cooperative
Development Work.
BAXTER LICENSED PATENTS means all Baxter Patents in existence as of the
Effective Date of this Agreement, or claiming an invention conceived or
discovery made, or which are acquired, during the term of the Cooperative
Development Work.
BAXTER NONCASH CONTRIBUTION shall be deemed to be [*] million for
the Red Cell Project, [*] million for the FFP Project and such amount as the
parties may agree for any other Project, provided that if the parties do not so
agree, the Baxter Noncash Contribution for such Project shall be one-half of the
Initial Budget for the total Project, the amount of the Baxter Noncash
Contribution in each case being subject to adjustment as provided herein.
BAXTER PATENTS means all United States and foreign patent applications
and patents that relate to the Field and have claims reading on a System or
portion thereof or methods for manufacture or use thereof, owned by Baxter or
licensed to Baxter with the right to sublicense and claiming an invention
conceived solely by employees and/or agents and/or licensors of Baxter both
prior to the Effective Date and during the term of this Agreement pursuant to
the Cooperative Development Work, including any continuations, divisions,
reissues, re-examinations and all foreign counterparts thereof.
BULK FORM means Steritech Compounds which are not packaged in final
form.
COOPERATIVE DEVELOPMENT WORK means the Cooperative Development Work
defined in Section 3.1 of this Agreement.
COST OF GOODS means, for either party, such party's [*] such items, in
accordance with generally accepted accounting principles, consistently applied
("GAAP") and in accordance with Baxter's normal accounting policies, all
consistently applied. Cost of Goods shall not include [*] which are not directly
related to [*] and shall not include [*] or expenses falling under the category
designated by Baxter "other costs of sales" or similar category, however
designated, unless otherwise agreed by the Management Board. Capital
expenditures for facilities and/or equipment and capitalized manufacturing
start-up costs will be amortized and included in Cost of Goods In the event any
item is acquired by a party from an affiliate of such party, [*] shall be deemed
to mean such affiliate's [*].
COST OF GOODS/BASE REVENUE for Steritech means Steritech's Cost of
Goods. For Baxter COST OF GOODS/BASE REVENUE means:
(a) in the case in which the Inactivation Package is sold as a
stand-alone item, Baxter's Cost of Goods, or
*[Confidential Treatment Requested]
3.
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(b) in the case in which the Inactivation Package is sold as a
part of an Integrated Inactivation Set in any calendar year, the greater of (i)
Baxter's Cost of Goods for the Integrated Inactivation Set plus a percentage of
Baxter's Base Revenue equal to the percentage applied to Net Sales in such
calendar year under the definition of Marketing and Administrative Expenses (for
marketing and administration expenses associated with Base Revenue), or (ii)
Baxter's Base Revenue PLUS Baxter's Cost of Goods for the Inactivation Package.
DISTRIBUTOR PORTION means, for any Inactivation Package or Integrated
Inactivation Set sold through a distributor, the amount by which Net Sales price
therefrom exceeds the revenues from the sale of such items to the Distributor.
EUROPE means any of the countries within the definition of Europe, as
such term is defined in the Platelet Agreement.
EXCLUDED PRODUCT has the meaning provided in Section 8.7 of this
Agreement.
FDA means the United States Food and Drug Administration.
THE FIELD means the use of [*] in each case that are obtained from [*]
. The Field includes [*] for [*]. The Field does not include, however, any [*]
to make, enable, or improve the [*]. The preceding sentence is not intended,
however, to exclude (a) the use of such [*] falling within the clauses (i),
(ii) or (iii) above, or (b) the [*] falling within clauses (i), (ii) or (iii)
above, in which the [*]. (Steritech reserves all rights to [*] in which the
intended use of the [*].) The Field also excludes [*].
FINAL PROJECT TOTAL BUDGET means the total cost and expense of
developing a System up to and including obtaining Regulatory Approval to market
the System in the countries in which the Management Board determines that
Regulatory Approval should be sought and any other items of cost or expense that
this Agreement expressly requires to be included in Final Project Total Budget.
In the event either party, to the extent permitted under Section 3.6(b) of this
Agreement, elects not to share in the costs of Regulatory Approval of a Project
in a particular country, the Final Project Total Budget shall be adjusted solely
as to such country by adding to the overall Final Project Total Budget the
amount of the incremental expenditures incurred by the party bearing the costs
of Regulatory Approval in such country and such party's cash contribution to the
Project solely as to such country will be increased by adding the amount of such
expenditures to such party's overall cash contribution to the Project.
*[Confidential Treatment Requested]
4.
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INACTIVATION PACKAGE means the package containing the Steritech
Compound as well as the delivery system (consisting of all disposables and
compound removal device, if any, associated with a System).
INITIAL BUDGET means the budget first approved by the Management Board
for developing a particular Project to Regulatory Approval, which for the
Initial Budget for the Red Cell Project means Regulatory Approval in the United
States and Europe, and for the Initial Budget for the Fresh Frozen Plasma
Project means Regulatory Approval in the United States.
INSTRUMENT means an instrument or instruments to be developed or
adapted under the Cooperative Development Work and may include associated data
tracking systems.
INTEGRATED INACTIVATION SET means an integrated set containing an
Inactivation Package and other collection or storage items.
JOINT PATENTS means all United States and foreign patent applications
and patents claiming an invention conceived or discovery made jointly by
employees and/or agents of both Steritech and Baxter, including any reissues,
re-examinations and all foreign counterparts thereof. Ownership of an invention
or discovery shall conclusively be considered "joint" when one or more employees
or agents from Baxter and one or more employees or agents from Steritech must be
indicated as co-inventors under United States patent laws on a patent
application for the invention.
MANAGEMENT BOARD means the Management Board created pursuant to Section
3.2 hereof.
MARKET LAUNCH of a System in a given country is deemed to be the
earlier of (1) the date of first commercial sale following Regulatory Approval
for sale of the System in that particular country or (2) the ninetieth (90th)
day following Regulatory Approval for commercial sale of that System in that
country.
MARKETING AND ADMINISTRATIVE EXPENSES for a party in any calendar year
is that percentage of such party's Net Sales (minus Base Revenue in the case of
sales of Integrated Inactivation Sets) for costs incurred in marketing, selling
and administering the Systems, established as follows:
AGGREGATE NET SALES PERCENTAGE APPLIED
OF SUCH PARTY TO ALL NET SALES IN
IN SUCH CALENDAR YEAR SUCH CALENDAR YEAR
--------------------- -------------------
Under [*] [*]
[*] up to [*] [*]
[*] up to [*] [*]
Over [*] [*]
*[Confidential Treatment Requested]
5.
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(All dollar amounts in this definition are expressed in U.S. dollars, converted
from foreign currencies in accordance with Section 7.1 hereof). For the purpose
of determining Premium for the first three quarterly Revenue Sharing Payments
for any calendar year, the percentage used as set forth above to compute a
party's Marketing and Administrative Expenses will be based on the party's bona
fide forecast of Net Sales in such calendar year used for its internal
management purposes (which information will be provided to the Management
Board). If actual aggregate annual Net Sales vary from such projections to an
extent that would cause a change in the applicable percentage rate for such
calendar year, such first three quarterly Revenue Sharing Payments will be
appropriately adjusted retroactively in the final Revenue Sharing Payment for
such calendar year (i.e., the First Revenue Sharing Payment date in the
following calendar year) and additional payments will be made to the receiving
party, or amounts reimbursed from the receiving party, to yield the actual
Revenue Sharing Payment to which the receiving party is entitled based on the
level of actual Net Sales in such calendar year.
NET SALES means
(a) in the case of the Inactivation Package sold as a
stand-alone item or as part of an Integrated Inactivation Set, the amount
invoiced by Baxter for sales, leases, or licenses of the stand-alone
Inactivation Package or Integrated Inactivation Set, less credits or allowances,
if any, for rejections or returns, customary trade discounts actually given,
less customs and duties paid; less separately invoiced and actually incurred
taxes and other governmental charges that are imposed directly on or measured by
the sale, transfer, transportation, delivery or use of an Inactivation Package;
and less freight paid by Baxter on shipment from Baxter to end users.
(b) In the event any Inactivation Package or Integrated
Inactivation Set is bundled (whether or not invoiced separately) and sold at a
discount with other products for whatever reason, including a special
promotional offer, or in the event of any transaction other than a bona fide
arms length transaction exclusively for money, or upon any use of such
Inactivation Package or Integrated Inactivation Set for purposes which do not
result in customary sales revenue, such sale or other disposal or use shall be
(unless the parties agree otherwise) deemed to constitute a sale at the then
current average selling price for the Inactivation Package or Integrated
Inactivation Set, as the case may be.
(c) In the case of sales by Baxter to a distributor, the Net
Sales shall be computed on the distributor's invoice price to the ultimate
purchaser or user. In the event that Baxter is not able to determine the price
charged by a distributor to the ultimate purchaser or user, such price shall be
the recommended price which Baxter, at the direction of the Management Board,
recommends the distributor to charge to its end customers (which may vary from
territory to territory).
(d) In the event Baxter, in accordance with policies
established by the Management Board, supplies Instruments to end users without
charge in return for an increased price of Inactivation Packages to such end
users, Baxter may deduct from Net Sales received from such end users the
depreciation of cost of such Instruments. In the event such Instruments
6.
<PAGE> 13
are also used in connection with products supplied by Baxter other than the
Inactivation Packages or Integrated Inactivation Sets developed under this
Agreement, then the amount of such depreciation to be deducted in any quarter
from Net Sales shall be limited to that portion of the depreciation reasonably
allocable to the use of the Instruments in connection with Inactivation Packages
and Integrated Inactivation Sets, in accordance with policies established by the
Management Board.
(e) In the event that the ultimate purchaser or end user is
assessed a charge on a per-inactivation or other usage basis, the amount of such
charge shall be included in Net Sales.
(f) If the term "Net Sales" is used in reference to Systems
sold by Steritech, the word "Baxter" in this definition shall be deemed to mean
"Steritech".
NONCASH CONTRIBUTION means the Baxter Noncash Contribution and/or the
Steritech Noncash Contribution, as the context requires.
PATENT ROYALTY PAYMENT means a patent royalty payment made to a third
party for manufacture, use or sale of a System or portion thereof.
PLATELET AGREEMENT means that certain Development, Manufacturing and
Marketing Agreement between the parties dated as of December 10, 1993.
PREMIUM means the Net Sales price of an Inactivation Package or
Integrated Inactivation Set minus each Party's Cost of Goods/Base Revenue in the
Inactivation Package or Integrated Inactivation Set, and minus Marketing and
Administrative Expenses.
PROJECT means the Cooperative Development Work performed by the Parties
to develop, obtain Regulatory Approval of, and market a System for a specific
application within the Field.
PROTEIN PREPARATIONS shall mean all blood derived products in which the
therapeutic component is a protein, such as coagulation factors.
REGULATORY APPROVAL means (1) in the United States, approval from the
FDA for marketing and promotion of the System, or (2) outside of the United
States, an analogous order by a non-U.S. governmental agency which requires
regulatory approval prior to marketing and promotion of a System in such
non-U.S. country.
REVENUE SHARING FORMULA means the relative percentage interest of
Baxter and Steritech as set forth in Section 7 hereof.
REVENUE SHARING PAYMENTS has the meaning set forth in Section 7.1
hereof.
SPECIFICATIONS FOR STERITECH COMPOUND means the performance, quality
and reliability requirements which the Project Committee and Management Board
agree must be met by a
7.
<PAGE> 14
Steritech Compound for such Steritech Compound to be acceptable for commercial
implementation under Section 6. The Management Board shall prepare written
specifications for Steritech Compound. Such specifications shall include a
provision that Steritech Compound be made according to Good Manufacturing
Practices in a facility licensed by the FDA or (if Steritech shall elect to
manufacture Steritech Compound outside the United States) other applicable
regulatory authority.
STAND-ALONE OR STAND-ALONE, in reference to an Inactivation Package,
means an Inactivation Package that is not integrated with other collection or
storage items, and which may take the form, for example, of a bag and tube set
that may be sterile docked, a syringe or ampule.
STERITECH means Steritech, Inc., a company organized under the laws of
California and its affiliates, including, but not limited to, divisions and
subsidiaries. A company shall be considered an affiliate of Steritech if it is
at least forty percent (40%) owned or controlled by Steritech.
STERITECH COMPOUND(S) means any and all psoralen compounds and anchor
linker effector ("ALE") compounds, developed by, licensed to, acquired by or
otherwise commercially accessible to Steritech prior to the Effective Date or in
the course of the Cooperative Development Work but does not include the psoralen
compound that at this time is designated by Steritech as [*].
STERITECH KNOW-HOW means unpatented inventions, data, processes,
compositions, techniques and other technical information proprietary to
Steritech, which is solely owned by Steritech or which Steritech has the right
to control the use of, relating to the Field and the System, including methods
for manufacture or use of Steritech Compounds and Systems or portions thereof.
STERITECH LICENSED KNOW-HOW means all Steritech Know-How in existence
as of the Effective Date or created or acquired during the term of the
Cooperative Development Work.
STERITECH LICENSED PATENTS means all Steritech Patents in existence as
of the effective date of this Agreement, or claiming an invention conceived or
discovery made, or which are acquired, during the term of the Cooperative
Development Work.
STERITECH NONCASH CONTRIBUTION shall be deemed to be [*] million for
the Red Cell Project, [*] million for the FFP Project and such amount as the
parties may agree for any other Project, provided that if the parties do not so
agree, the Steritech Noncash Contribution for such Project shall be one-half of
the Initial Budget for the total Project, the amount of the Steritech Noncash
Contribution in each case being subject to adjustment as provided herein.
STERITECH PATENTS means all United States and foreign patent
applications and patents that relate to the Field and have claims reading on
Steritech Compounds or compositions or
*[Confidential Treatment Requested]
8.
<PAGE> 15
formulations thereof, or otherwise reading on a System or portion thereof, or
methods for manufacture or use of such System or Steritech Compound owned by or
licensed to Steritech with the right to sublicense and claiming an invention
conceived solely by employees and/or agents and/or licensors of Steritech both
prior to the Effective Date and during the term of the Cooperative Development
Work, including any continuations, divisions, reissues, reexaminations and all
foreign counterparts thereof.
SYSTEM(S) means a product developed pursuant to the Cooperative
Development Work for use in the Field, incorporating one or more Steritech
Compounds, an Instrument, if any, and associated computer software, and any
disposables, delivery system or other components.
SYSTEM IMPROVEMENTS means those improvements of commercial Systems
approved by the Management Board. The Management Board shall approve and manage
a budget for all System Improvements (System Improvement Costs).
SYSTEM SPECIFICATIONS means the performance, cost, quality and
reliability requirements as the Management Board agree must be met by a System
in order for the System to be acceptable for marketing and distribution
hereunder.
3. COOPERATIVE DEVELOPMENT WORK.
3.1 PERIOD; OBJECTIVE. From the Effective Date, Baxter and Steritech
shall work together to develop and obtain Regulatory Approval for (the
"Cooperative Development Work") and thereafter market Systems in the Field. The
Management Board shall from time-to-time approve specific Projects for the
Steritech Compounds within the Field.
3.2 MANAGEMENT BOARD.
(a) CONSTITUTION. Steritech and Baxter will appoint a five (5)
person Management Board consisting of two (2) senior executives designated by
each company and one (1) independent member chosen by mutual agreement of the
Parties. The purpose of the Management Board will be to facilitate the overall
relationship of the parties under this Agreement and to manage the research,
development and marketing of Projects within the Field. System Specifications
recommended by the Parties shall not be deemed finalized until they are approved
by the Management Board. The Management Board shall meet from time to time as
appropriate, but no less frequently than four (4) times during each calendar
year, alternating between the offices of the parties, unless the parties shall
agree otherwise. The Management Board shall review and approve budgets, resource
allocations, Projects undertaken within the Field, sales and marketing plans and
expenditures.
(b) PROJECT COMMITTEES. To assist the Management Board in its
work, the Management Board may, from time-to-time, at its sole discretion,
create project committees, including Management Board and non-Management Board
members. A project committee shall only have that authority specifically granted
to it by the Management Board. A project
9.
<PAGE> 16
committee may be created to oversee a Project or a specific aspect or a Project.
However, a project committee shall never have the authority to disperse funds or
reimburse expenses.
(c) VOTING. All decisions of the Management Board shall be
made by majority vote or written consent, with Baxter and Steritech each having
one vote regardless of the number of representatives attending any meeting. The
independent member shall vote on all deadlocks of the Management Board; however,
the independent member shall not vote on matters pertaining to any dispute
concerning the parties' legal obligations to each other for disbursement of
funds or the reimbursement of expenses under any circumstances. In the event of
a deadlock that may be broken by the independent member, either Baxter or
Steritech may notify the other party and the independent member in writing of
the existence of such deadlock and provide to each the specific resolution that
such party proposes to be adopted by the Management Board. Each party will have
thirty (30) days from such notice to present its position to the independent
member, which shall include at least one meeting at which both parties and the
independent member are present. Either Baxter, Steritech or the independent
member may, by notice to the others, shorten such time period if such party
believes that urgent action is required on the matter at issue. The independent
member shall render his or her vote on such resolution as promptly as possible,
and in no event later than twenty (20) days after such time period. In the event
of a deadlock between the parties on a decision whether to discontinue
Cooperative Development Work on a Project or to reduce funding for a Project,
the independent member shall not break the deadlock and the Project will
continue without reduction of funding level, subject to the right of either
party to cease participation in such Project, as provided in Section 12 hereof.
Any compensation of the independent member shall be by mutual agreement of the
Parties and shall be subject to cost sharing. The independent member shall vote
on all matters in a manner that in the good faith judgment of the independent
member is in Baxter and Steritech's best interests as risk and revenue sharers
under this Agreement (i.e. in the same manner that a corporate director would
vote in the best interests of the shareholders of a corporation). Baxter and
Steritech will indemnify and hold harmless the independent member against any
claim arising from a decision made by the independent member, so long as such
decision was made in good faith. The independent member may be removed and/or
replaced by mutual written consent of Baxter and Steritech.
(d) DISPUTES. With regard to the disputes concerning the
parties' legal obligations to each other for disbursement of funds or
reimbursement of expenses, in the event of a deadlock of the Management Board on
these particular issues, if they are unable to reach agreement within thirty
(30) days of the onset of the deadlock, then the matter shall be finally settled
by arbitration, to be held in Chicago, Illinois, in accordance with the
Commercial Arbitration Rules of the American Arbitration Association ("AAA").
Any such dispute or controversy shall be arbitrated before one arbitrator,
acceptable to both parties. If the parties are unable to agree on an arbitrator,
one shall be selected in accordance with the rules of the AAA. The arbitrator's
decision shall be final and binding upon the parties. The parties shall be
entitled to full discovery in any such arbitration. Each party shall bear one
half of the cost of such arbitration, unless the arbitrator otherwise allocates
such costs. During the period of any arbitration, each party shall pay to the
other party any amounts that are or become due and owing to such other party,
other than amounts being contested in good faith in the arbitration.
10.
<PAGE> 17
In addition, in the event that there is a deadlock on any other issue within the
authority of the Management Board as to which the independent member would be
authorized to break the deadlock, and at that time there is not an independent
member (or for any reason the independent member does not break such deadlock),
either party may apply to the AAA to appoint an individual, in accordance with
the rules of the AAA who will act in the capacity of independent member solely
for the purpose of breaking such deadlock and resolving such issue. Prior to
making such application, a party will provide to the other party ten (10) days'
advance written notice of its intent to do so. During such ten (10) day period,
the parties will use their good faith best efforts to resolve such issue in a
meeting between the chief executive officer of Steritech and the highest ranking
officer of Baxter Biotech or comparable successor division or entity, or failing
such resolution, to agree upon appointment of an independent member. Each party
will in all cases cooperate in providing the independent member such information
as the independent member may request in considering any matter.
3.3 REVIEW OF BUDGET, BENCHMARKS; APPROVED PROJECTS. The benchmarks,
budget and timetable for all Projects will be reviewable by the Management Board
from time-to-time during the Cooperative Development Work with the intent that
the parties move expeditiously and effectively toward commercialization of any
System.
(a) THE RED CELL PROJECT. The Initial Budget for one Project
approved, as of the Effective Date of this Agreement, by the Management Board is
the Red Cell Project, attached hereto as Schedule A. Each party shall perform
the respective tasks set forth on Schedule A.
(i) All funding of the Red Cell Project shall be
provided by Steritech, until [*], except as provided in Subsection 3.3(a)(ii).
Steritech will use reasonable commercial development efforts to conduct such
program in 1996 in accordance with the budget for 1996 on Schedule A, including
expenditure of the amounts called for in such budget for 1996. Upon achievement
of the Platelet Milestone, Baxter shall participate in the Red Cell Project in
accordance with this Agreement, including without limitation the obligation to
share fifty percent (50%) of the costs and expenses of the Cooperative
Development Work incurred on or after January 1, 1997, and to market and sell
the Systems for Red Cells developed under this Agreement. Baxter shall pay to
Steritech on the later of (a) the date of achievement of the Platelet Milestone,
or (b) January 1, 1997, fifty percent (50%) of the amount (if any) expended by
Steritech under the Project budget from January 1, 1997 to the date of payment,
and shall also pay to Steritech on such date, and on the first day of each
calendar year thereafter, the amount by which Steritech's budgeted expenditures
under the then current Project budget for the then current calendar year
(including amounts budgeted to be expended by Steritech on outside expenses)
exceeds fifty percent (50%) of the budgeted expenditures for such period.
(ii) Notwithstanding Subsection 3(a)(i), in the event
that, for any reason, the Platelet Milestone is not achieved by September 30,
1997, then Baxter must provide notice of its commitment to participate ("Red
Cell Commitment Notice") in the Red Cell Project,
*[Confidential Treatment Requested]
11.
<PAGE> 18
and commence participation in accordance with the terms of this Agreement, by
October 31, 1997 or Baxter shall be deemed to have elected not to participate,
and decontamination systems for Red Cells will thereafter be deemed to be an
Excluded Product. Baxter shall pay to Steritech on the date of the Red Cell
Commitment Notice, fifty percent (50%) of the amount expended by Steritech under
the Project budget from January 1, 1997 to the date of payment, and shall also
pay to Steritech on such date, and on the first day of each calendar year
thereafter, the amount by which Steritech's budgeted expenditures under the then
current budget for the remainder of then current calendar year exceeds fifty
percent (50%) of the budgeted expenditures for such period. The Commitment
Notice shall evidence Baxter's obligation to participate in and share fifty
percent (50%) of the cost of the Cooperative Development Work on the Red Cell
Project from and after the date of such notice and to market and sell Systems
for Red Cells developed under this Agreement. Steritech's obligation to proceed
with such Cooperative Development Work will be contingent on the negotiation by
Baxter and Steritech of a revision of the equity purchase schedule under Section
4 hereof to provide funding for Steritech to support such Cooperative
Development Work. Nothing in this subsection should be construed as any
expectation that achievement of the Platelet Milestone will be delayed.
(b) THE FRESH FROZEN PLASMA PROJECT. The Initial Budget for
one project approved by the Management Board as of the Effective Date of this
Agreement is the Fresh Frozen Plasma Project, attached hereto as Schedule B.
Each Party shall perform the respective tasks set forth on Schedule B.
(i) All funding of the Fresh Frozen Plasma Project
shall be provided by Steritech, until [*], except as provided in Subsection
3.3(b)(ii). Steritech will use reasonable commercial development efforts to
conduct such program in 1996 in accordance with the budget for 1996 on Schedule
B, including expenditure of the amounts called for in such budget for 1996. Upon
achievement of the Platelet Milestone, Baxter shall participate in the Fresh
Frozen Plasma Project in accordance with this Agreement, including without
limitation the obligation to share fifty percent (50%) of the costs and expenses
of the Cooperative Development Work incurred on or after January 1, 1997, and to
market and sell the Systems for Fresh Frozen Plasma developed under this
Agreement. Baxter shall pay to Steritech on the later of (a) the date of
achievement of the Platelet Milestone, or (b) (i) January 1, 1997, fifty percent
(50%) of the amount (if any) expended by Steritech under the Project budget from
January 1, 1997 to the date of payment, and shall also pay to Steritech on such
date, and on the first day of each calendar year thereafter, the amount by which
Steritech's budgeted expenditures under the then current Project budget for the
then current calendar year (including amounts budgeted to be expended by
Steritech on outside expenses) exceeds fifty percent (50%) of the budgeted
expenditures for such period.
(ii) Notwithstanding Subsection 3(b)(i), in the event
that, for any reason, the Platelet Milestone is not achieved by September 30,
1997, then Baxter must provide notice of its commitment to participate ("FFP
Commitment Notice") in the Fresh Frozen Plasma Project, and commence
participation in accordance with the terms of this Agreement, by October 31,
1997 or Baxter shall be deemed to have elected not to participate, and
*[Confidential Treatment Requested]
12.
<PAGE> 19
decontamination systems for Fresh Frozen Plasma will thereafter be deemed to be
an Excluded Product. Baxter shall pay to Steritech on the date of the FFP
Commitment Notice, fifty percent (50%) of the amount expended by Steritech under
the Project budget from January 1, 1997 to the date of payment, and shall also
pay to Steritech on such date, and on the first day of each calendar year
thereafter, the amount by which Steritech's budgeted expenditures under the then
current budget for the remainder of then current calendar year exceeds fifty
percent (50%) of the budgeted expenditures for such period. The Commitment
Notice shall evidence Baxter's obligation to participate in and share fifty
percent (50%) of the cost of the Cooperative Development Work on the Fresh
Frozen Plasma Project from and after the date of such notice and to market and
sell Systems for Fresh Frozen Plasma developed under this Agreement. Steritech's
obligation to proceed with such Cooperative Development Work will be contingent
on the negotiation by Baxter and Steritech of a revision of the equity purchase
schedule under Section 4 hereof to provide funding for Steritech to support such
Cooperative Development Work. Nothing in this subsection should be construed as
any expectation that achievement of the Platelet Milestone will be delayed.
(c) OTHER PROJECTS. The budget for each other project shall be
approved by the Management Board. Baxter shall pay to Steritech upon the
approval of the Initial Budget for each such project, and upon each anniversary
of the date thereof, the amount by which Steritech's budgeted expenditures under
the then current budget for the succeeding twelve month period exceeds 50% of
the total then budgeted expenditures for such period.
3.4 EXCHANGE OF INFORMATION. During the term of the Cooperative
Development Work, the parties shall exchange all material information developed
pursuant to the Cooperative Development Work including the exchange of Baxter
Know-How and information concerning Baxter Patents and Steritech Know-How and
information concerning Steritech Patents relating to the Field. The exchange
shall occur pursuant to Section 11. The Systems shall embody and use such
Steritech Licensed Patents and Steritech Licensed Know-How and Baxter Licensed
Patents and Baxter Licensed Know-How as shall be determined by the Management
Board.
3.5 COST SHARING. Except as otherwise provided in this Agreement,
commencing January 1, 1997, Baxter will fund fifty percent (50%) and Steritech
will fund fifty percent (50%) of the Cooperative Development Work with respect
to each Project, and Steritech will fund one hundred percent (100%) of the cost
of the Cooperative Development Work, as set forth in the Initial Budget, with
respect to the Red Cell Project and the Fresh Frozen Plasma Project prior to
that date. Funding shall include all costs and expenses incurred in connection
with the Cooperative Development Work. These costs and expenses shall be shared
equally for each Project, fifty percent (50%) paid by Baxter and fifty percent
(50%) paid by Steritech. Cost and expenses shall include only those expenditures
made in accordance with Project budgets approved by the Management Board related
to, research, development, clinical trials, and Regulatory Approval and other
expenses that this Agreement expressly provides shall be subject to cost
sharing. In the event that the funding for the Cooperative Development Work for
any project is not shared equally commencing January 1, 1997, then (except as
otherwise provided in Section 12 or Section 16 hereof) the Revenue Sharing
Formula in Section 7.1 for such Project shall be adjusted such that the
percentage of Premium received by a party will equal the
13.
<PAGE> 20
percentage contributed by such party to the sum of (a) the cash contributed to
the Final Project Total Budget commencing January 1, 1997 (excluding carryovers
of 1996 expenditures, as provided below in this Section), plus (b) Noncash
Contribution to the Project. Nothing in this Section 3.5 shall be construed to
imply that prior to achievement of the Platelet Milestone Baxter shall have any
obligation to provide funds for Cooperative Development Work. Capital
expenditures for facilities and/or equipment and capitalized manufacturing
start-up costs will not be included in costs and expenses shared. Steritech
agrees to expend on the Red Cell Project and the Fresh Frozen Plasma Project the
respective amounts set forth on Schedules C and D for 1996; provided that if
such amounts cannot for any reason be spent in 1996, the unexpended amounts will
be carried over and expended in 1997 (without reducing Steritech's obligations
with respect to the 1997 budget).
(a) All expenses and costs incurred by the parties in
connection with the Cooperative Development Work commencing January 1, 1997
shall be subject to cost sharing pursuant to Section 3.5. Each party shall
maintain detailed records which accurately identify costs and expenses incurred
and paid in connection with the Cooperative Development Work for each specific
Project. Each party shall submit this information to the Management Board on the
on the last business day of February for the period ending December 31, and on
the last business day of August for the period ending June 30 (or such
alternative dates as the Management Board may establish) along with an estimate
of expenses to be incurred during the current six months. Expenses internally
generated because tasks are performed by a party's own staff will be accounted
for on a uniform average cost per full time equivalent basis.
(b) All costs with respect to participation on the Management
Board during the Cooperative Development Work, including travel expenses for
meetings and participation on the Management Board, shall be subject to cost
sharing.
3.6 TESTING AND REGULATORY EXPENSES.
(a) TESTING EXPENSES. All expenses incurred in connection with
any testing whose primary function is marketing of the System, rather than
developing the System or obtaining Regulatory Approval of the System, shall be
borne solely by Baxter and shall not be considered expenses subject to cost
sharing, unless the Management Board determines that such expenses should be
considered part of the Cooperative Development Work.
(b) REGULATORY EXPENSES. The Management Board shall determine
the countries in which Regulatory Approval will be sought and the timing of
seeking such Regulatory Approval. All expenses incurred to obtain Regulatory
Approval are expenses subject to cost sharing under Section 3.5 and shall be
part of the Final Project Total Budget; provided, however, that either party
may, by notice given to the other party within thirty (30) days after such
Management Board decision with respect to a particular country, elect to not
share in the costs of Regulatory Approval in not more than five (5) countries
outside of North America and Europe, which will result in an adjustment for each
such country of Final Project Total Budget (as further provided in the
definition of "Final Project Total Budget").
14.
<PAGE> 21
3.7 BUDGET CONTINGENCIES.
(a) EXCEEDING INITIAL BUDGET. If the Management Board
establishes a budget for a new Project, or determines that the budget for an
approved Project within the Field must be increased over the previously
established budget for the Project, then Baxter will fund fifty percent (50%)
and Steritech will fund fifty percent (50%) of the new Project budget or of any
increase in the previously approved budget. In the event of any new Project
budget or budget increase, however, either party may, by written notice to the
other party, elect to fund less than its full share (50%) of such new Project
budget or budget increase. In such an event, the funding party may, by written
notice to the non-funding party, elect to assume responsibility for the funding
of such unfunded amount, in which event (except as otherwise provided in Section
12 and Section 16 hereof) the Revenue Sharing Formula in Section 7.1 for such
Project will be adjusted such that the percentage of Premium to be received by a
party will equal the percentage contributed by such party to the sum of (i) the
cash contributed to Final Project Total Budget commencing January 1, 1997
(excluding 1996 carryovers as described in Section 3.5), plus (ii) total Noncash
Contribution to the Project.
(b) RECONCILIATION OF EXPENDITURES. Unless otherwise agreed,
the Management Board shall reconcile actual cash outlays and expenses approved
by the Management Board with respect to a Project on an annual basis such that
costs have been incurred in the proportion of fifty percent (50%) by Baxter and
fifty (50%) by Steritech, or such other ratio as is established pursuant to
Section 3.7(a). If they are not in such proportion, Steritech will make a cash
payment to Baxter, or Baxter will make a cash payment to Steritech, in order to
achieve such proportion. The payment shall be made in cash within thirty (30)
days following the determination by the Management Board.
3.8 BAXTER PARTICIPATION IN 1996. In calendar year 1996, Baxter will in
good faith provide non-incremental Baxter resources at no cost to Steritech to
support the program under the Cooperative Development Work. In addition, in such
calendar year Baxter will use good faith efforts to supply other resources to
Steritech at Steritech's request and at Steritech's expense from time to time on
a reasonable time and materials basis to carry out the activities set forth on
Schedule F. To the extent Baxter cannot supply such services with its existing
resources, Baxter and Steritech will consult in good faith concerning Baxter's
adding additional internal resources or using outside services to perform such
activities.
4. EQUITY PURCHASE.
4.1 BAXTER PURCHASE OF EQUITY IN STERITECH. Baxter shall purchase
equity in Steritech according to the following terms and schedule:
(a) Purchase six million dollars ($6,000,000.00 U.S.) of Series E
Preferred Stock in Steritech at fifteen dollars and
seventy-five cents ($15.75 U.S.) per share, Three Million
Dollars ($3,000,000 U.S.) of which will be purchased on April
1, 1996 and Three Million Dollars ($3,000,000 U.S.) will be
purchased on July 1, 1996.
15.
<PAGE> 22
(b) Purchase five million dollars ($5,000,000.00 U.S.) of
Steritech equity upon approval to commence a Phase II study in
the United States or Europe in the program under the Platelet
Agreement ("Tranche 2 Milestone") consisting of Common Stock
at a purchase price equal to open market plus twenty percent
(20%) if Steritech is publicly traded at the time of such
purchase, or if then privately held, Preferred Stock at the
[*] last private third-party financing round, provided that
this clause (ii) shall apply only if there has been a
third-party private financing round of [*] since the date of
the last equity purchase by Baxter pursuant to this Section
3.11. Such purchase will be consummated and the purchase price
paid not later than January 10, 1997, or within fifteen (15)
business days after such Tranche 2 Milestone, if later. As
used in this Section 4.1, "open market" means the average
closing price of the Steritech stock, as reported in the Wall
Street Journal, for the thirty (30) trading days (or lesser
number of trading days that Steritech stock is publicly
traded) prior to and including the trading day that is two (2)
trading days prior to the date the purchase is consummated. A
"trading day" is a day when the Steritech stock may be traded
on the relevant exchange or over the counter.
(c) Either purchase five million dollars ($5,000,000.00 U.S.) of
Steritech equity upon the completion of both Phase II Platelet
Interim Determination and filing of an IND with the F.D.A. to
begin a Phase I study under the Red Cell Project, or
comparable filing in Europe under such Project (the "Tranche 3
Milestone") or, at Steritech's election, purchase two million
dollars ($2,000,000 U.S.) of Steritech equity upon the
completion of the Phase II Platelet Interim Determination
("Tranche 3a Milestone") and purchase three million dollars
($3,000,000 U.S.) upon the approval of an IND by the F.D.A.
under the Red Cell Project or comparable approval in Europe
under such Project ("Tranche 3b Milestone") consisting of
Common Stock at a purchase price equal to open market price
plus twenty percent (20%) if Steritech is publicly traded at
the time of such purchase or, if then privately held,
Preferred Stock at the [*] last private third-party financing
round provided that this clause (ii) shall apply only if there
has been a third-party private financing round of [*] since
the date of the last equity purchase by Baxter pursuant to
this Section 3.11. Such purchase will be consummated and the
purchase price paid not later than January 10, 1998, or within
fifteen (15) days after such Tranche 3 Milestone, Tranche 3a
Milestone or Tranche 3b Milestone, as the case may be, if
later. The purchase price stated in clause (i) above, however,
shall be increased from [*] to [*] if both the Tranche 3a
Milestone and Tranche 3b Milestone are achieved by January 31,
1998. If a closing under this subparagraph 3(c) has previously
occurred at the [*] price, the price per share shall be
retroactively increased to [*], and Baxter shall promptly make
an additional payment to Steritech to
*[Confidential Treatment Requested]
16.
<PAGE> 23
yield an effective price of [*] per share on such purchase.
For the purposes of this Section, the "Phase II Platelet
Interim Determination" means a point in the Phase II clinical
trials under the Platelet Agreement at which Baxter and
Steritech determine that there is sufficient data to determine
that such Phase II trials are likely to have a successful
outcome pursuant to the criteria set forth on Schedule C to
this Agreement. The point in the Phase II trials at which such
determination shall be made shall be included as part of the
protocol agreed upon by Baxter and Steritech for the Phase II
trials. Baxter and Steritech shall make such determination in
good faith.
(d) Purchase five million dollars ($5,000,000.00 U.S.) of
Steritech equity upon (i) the approval by the F.D.A. to
commence a Phase II study in the United States or comparable
approval in Europe under the Red Cell Project, and (ii) the
approval of an NDA by the F.D.A. under the Platelet Agreement
or comparable approval in Europe under such Agreement
("Tranche 4 Milestone") consisting of Common Stock at a
purchase price equal to open market price plus twenty percent
(20%) if Steritech is publicly traded, at the time of such
purchase, or if then privately held, Preferred Stock at the
[*] last private third-party financing round provided that
clause (y) shall apply only if there has been a third-party
private financing round of [*] since the date of the last
equity purchase by Baxter pursuant to this Section 3.11. Such
purchase will be consummated and the purchase price paid not
later than January 10, 1999, or within fifteen (15) days after
such Tranche 4 Milestone, if later. The purchase price stated
in clause (x) above, however, shall be increased from [*] to
the following price per share if the events set forth in
clause (ii) above has occurred in both the U.S. and Europe on
or before the following dates:
DATE PRICE PER SHARE
January 31, 1999 $ [*]
June 30, 1999 $ [*]
or if the event set forth in clause (ii) above has occurred in
Europe on or before the following date:
September 30, 1998 $ [*]
If a closing under this subparagraph 3(d) has previously
occurred at the [*] price, the price per share shall be
retroactively increased to the applicable price per share set
forth in the above table, and Baxter shall promptly make an
additional payment to Steritech to yield such applicable price
per share on such purchase. Notwithstanding the foregoing,
Steritech may, in its discretion, elect to refrain from
selling equity to Baxter, or may elect to sell less than five
million
*[Confidential Treatment Requested]
17.
<PAGE> 24
dollars ($5,000,000) of equity to Baxter, pursuant to this
subsection (d). If, at the time the event set forth in clause
(ii) above has occurred, Steritech has not yet achieved the
event set forth in clause (i) above, then until completion of
the full Tranche 4 Milestone, in the event that Steritech
conducts a third-party equity financing round of at least five
million dollars ($5,000,000), then upon Steritech's written
request, Baxter will purchase in such round nineteen and
nine-tenths (19.9%) (but not exceeding $5,000,000 in purchase
price) of the shares being sold in such round on the same
terms and conditions as the other investors in such round. The
dollar amount purchased by Baxter in such round will reduce
the dollar amount required to be purchased under this
subsection (d) upon achievement of the Tranche 4 Milestone.
(e) The purchase prices set forth above in Subsections (c), (d)
and (e), excluding prices set by open market price, will be
appropriately adjusted for stock splits, stock dividends and
the like.
(f) The purchases of equity set forth above will be made in
accordance with an agreement substantially in the form of the
Preferred Stock Purchase Agreement in the form of Schedule G
to this Agreement, with appropriate changes to reflect share
price, class and series of stock being purchased and to make
accurate representations and warranties as of the date of the
subsequent equity purchases; such changes shall not affect the
equity purchase and sale obligations hereunder. While it is
anticipated that the parties will separately execute and
deliver such Stock Purchase Agreements and associated
documents for subsequent equity purchases, the obligation to
purchase and sell equity as set forth in this Section are
enforceable obligations upon the signing of this Agreement
irrespective of whether there is a separate execution and
delivery of such Stock Purchase Agreements and associated
documents. It is understood that from and after the date of
Steritech's initial public offering or other conversion of
Steritech's outstanding Preferred Stock to Common Stock, the
shares purchased hereunder will be shares of Steritech Common
Stock. Prior to such time, the shares purchased hereunder will
be shares of Steritech Preferred Stock. Steritech will use
reasonable efforts to provide Baxter fifteen (15) days prior
notice of the expected date of achievement of milestones under
subparagraphs (b), (c) and (d).
(g) Notwithstanding Subsections (b), (c) and (d) above, in the
event that any purchase of equity pursuant to such subsection
would cause Baxter to own in excess of twenty and one-tenth
percent (20.1%) of issued and outstanding capital stock of
Steritech, Steritech may limit such purchase of equity by
Baxter to a number of shares of capital stock that would cause
Baxter to own not more than twenty and one-tenth percent
(20.1%) of such issued and outstanding capital stock.
(h) Notwithstanding subsections (b), (c) and (d) above, in the
event that any purchase pursuant to such subsection would
cause Baxter to own in excess of nineteen and nine-tenths
percent (19.9%) of issued and outstanding capital stock of
Steritech,
18.
<PAGE> 25
Baxter may limit such purchase of equity to a number of shares
of capital stock that would cause Baxter to own not more than
nineteen and nine-tenths percent (19.9%) of the issued and
outstanding capital stock of Steritech; provided that in each
such instance, upon the written request of Steritech, Baxter
shall pay to Steritech as a research and development payment
an amount equal to the difference between five million dollars
($5,000,000 U.S.) and the dollar amount of capital stock being
purchased. Such research and development payment will be made
to Steritech on the date for consummation of purchase of such
capital stock. Unless Steritech notifies Baxter, as set forth
below, that Steritech elects to repay to Baxter the amount of
such research and development payment, such research and
development payment will be treated as if Baxter had made an
additional contribution of cash to the Final Project Total
Budget for the purposes of the fourth sentence of Section 3.5
(allocated among then ongoing Projects in proportion to the
size of the then approved budget for each Project). (Such
research and development payment shall not, however, change
the actual approved budget for any Project nor Steritech's
contribution thereto.) Steritech must notify Baxter in writing
at the time of such research and development payment whether
or not Steritech elects to repay to Baxter the amount of such
research and development payment. If Steritech notifies Baxter
that Steritech elects to repay such amount, Steritech will, if
such amount is not earlier repaid, pay to Baxter fifty percent
(50%) of the Revenue Sharing Payments received by Steritech
hereunder, until such amount is repaid. In the event that
Baxter makes any such research and development payment to
Steritech pursuant to this subsection (h), Steritech will
grant to Baxter a warrant to purchase capital stock of
Steritech on the following terms: (i) the exercise price will
be the price per share to Baxter established under subsection
(b), (c) or (d) above (i.e., the subsection applicable to the
then current Baxter equity purchase); (ii) the term of the
warrant shall extend until two (2) years following market
launch in the U.S. or Europe of the first product developed
under the Platelet Agreement, but not to exceed seven (7)
years from the date such research and development payment was
made, subject to earlier termination in the event of merger or
acquisition of Steritech; and (iii) the number of shares
subject to the warrant shall be equal to ten percent (10%)
times the amount of such research and development payment
divided by such exercise price. The number of shares subject
to the warrant will be appropriately adjusted from time to
time for stock splits, stock dividends and the like. Repayment
of the amount of the research and development payment will not
terminate the warrant.
4.2 OPTION TO PURCHASE EQUITY IN STERITECH. Steritech grants to Baxter
the following options to purchase equity in Steritech according to the following
terms and schedule:
(a) The Investors' Rights Agreement grants to Baxter the option to
participate in other non-public sale of equity in Steritech by
purchasing up to nineteen and nine-tenths percent (19.9%) of
the Equity Securities sold in such offering, as such term
19.
<PAGE> 26
is defined in and in accordance with the terms of the
Investors' Rights Agreement; and
(b) Steritech agrees that in the event of an initial public
offering of equity in Steritech, Baxter has the option of
acquiring nineteen and nine-tenths percent (19.9%) of the
shares offered to the public at the initial public offering
price, net of underwriter discount. The terms and conditions
of such a sale to Baxter shall be identical to those terms
sold to the public at the initial public offering; provided
that the shares will be subject the same to lock-up provisions
agreed to by officers, directors and major shareholders. Such
option shall be exercised as follows:
At such time as Steritech shall begin serious efforts toward
undertaking its initial public offering, Steritech will so
notify Baxter in writing. Steritech shall not have any
liability arising from any notice or alleged failure to give
timely notice under this Section, nor shall any dispute
concerning such notice in any way limit or delay Steritech's
ability to conduct its initial public offering or expend any
rights of Baxter.
In order to guarantee its participation in the offering Baxter
must provide notice to Steritech within fourteen (14) days
prior to the anticipated filing date of the registration
statement for the initial public offering, stating the
percentage of such offering, not exceeding nineteen and
nine-tenths percent (19.9%), that Baxter will commit to buy
(the "commitment notice") (Baxter may also specify a maximum
dollar amount of shares it will purchase, which may reduce the
percentage of the offering that Baxter would otherwise
receive.) In the event that Baxter is unable to provide such
commitment notice within such fourteen day period, but
notifies Steritech within such period that it is strongly
interested in participating in the offering, Steritech will
make all reasonable efforts to include Baxter in the offering
up to the limits specified above, provided that Steritech will
not, in such regard, be obligated to take any action that
would delay or otherwise interfere with the offering. In the
event the offering is withdrawn, the above procedure will be
reinstituted at the time Steritech elects to proceed with a
new offering. In the event that the registration statement
does not become effective within ninety (90) days after the
date of filing of the registration statement, Baxter may by
written notice give within seven (7) days thereafter, withdraw
its commitment notice.
4.3 STANDSTILL BY BAXTER. Baxter agrees that it will not at any time,
nor will it permit any of its Affiliates to, without the prior written consent
of Steritech:
(a)(i) acquire, directly or indirectly, by purchase or otherwise, of
record or beneficially, other than by the transactions set forth in Sections 4.1
and 4.2 of this Agreement, any securities of Steritech or rights or options to
acquire any securities from any holder of such securities if after such
acquisition (and giving effect to the exercise of any such
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rights or options) Baxter and its Affiliates would own capital stock of
Steritech having twenty and one-tenth percent (20.1%) or more of the voting
power of the outstanding capital stock of Steritech; provided, however, that
neither (1) the purchase of shares of Common Stock pursuant to Sections 4.1 or
4.2 of this Agreement or (2) subsequent reductions in the number of shares of
outstanding capital stock of Steritech (or rights or options therefor) shall be
deemed to have caused a violation of this Section 4.3(a);
(ii) To the extent Baxter and/or its Affiliates owns, beneficially
or of record, securities of Steritech constituting twenty and one-tenth percent
(20.1%) or more of the voting power of the outstanding capital stock of
Steritech and such securities include securities of Steritech other than those
purchased pursuant to Sections 4.1 or 4.2, Baxter and/or its Affiliates shall be
deemed to own "Prohibited Securities." Baxter agrees that neither it nor any of
its Affiliates shall (and neither it nor any of its Affiliates shall be entitled
to) vote any Prohibited Securities with respect to any matter subject to the
vote or written consent of Steritech's stockholders (provided, however, that the
foregoing shall not be deemed to limit Steritech's remedies in the event that
the excess securities were acquired in violation of this Section);
(iii) Baxter hereby covenants and agrees that it will provide
written notice to Steritech of any purchase, sale or other acquisition or
disposition, on the open market or in private transactions, by Baxter or any of
its Affiliates of any securities of Steritech (or if Baxter or such Affiliates
shall direct any third party to take any such actions on behalf of Baxter or
such Affiliates). Such notice shall be transmitted to Steritech by facsimile
(with telephonic notice) within three (3) business days after any such
transaction on the open market or within ten (10) business days after any such
private transaction, and shall specify the person or entity effecting the
transaction, the date of such transaction, the number of securities and the
price per security with respect to such transaction;
(b) solicit proxies with respect to any securities of Steritech under
any circumstances for change in the directors or management of Steritech or
relating to merger or acquisition of the Company or deposit any securities of
Steritech in a voting trust or subject them to a voting agreement or other
agreement of similar effect (other than subjecting shares owned by Baxter to a
revocable proxy);
(c) initiate, propose or otherwise solicit any stockholder for the
approval of one or more stockholder proposals at any time, or induce or attempt
to induce any other person to initiate any stockholder proposal for change in
the directors or management of Steritech or relating to merger or acquisition of
the Company; or
(d) take any action individually or jointly with any partnership,
limited partnership, syndicate, or other group or assist any other person,
corporation, entity or group in taking any action it could not take individually
under the terms of this Section 4.3.
The preceding provisions of this Section 4.3 shall terminate in the
event (i) any Person (defined below) or 13D Group (defined below) other than an
Affiliate of Baxter) shall have
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commenced a tender offer for a majority of the outstanding shares of Common
Stock (including any other outstanding voting securities) of Steritech or (ii)
Steritech's Board of Directors (the "Board") shall determine to (A) approve any
transaction set forth in clause (i) immediately preceding, (B) liquidate
Steritech or sell all or substantially all of the assets of Steritech to another
person, (C) approve a merger or consolidation of Steritech with any other person
that would result in the voting securities of Steritech outstanding immediately
prior thereto continuing to represent less than a majority of the combined
voting power of the voting securities of Steritech or such surviving entity
outstanding immediately after such merger or consolidation or (D) sell to any
person a majority of Steritech's outstanding voting securities. In the event of
any determination by the Board pursuant to the immediately preceding clause
(ii), Steritech shall notify Baxter at least 15 days prior to the final approval
of such transaction, and any such Board determination shall be conditioned upon
the notification by Steritech of Baxter in compliance with this sentence. For
purposes of this Section 4.3, a "13D Group" means any group formed for the
purpose of acquiring, holding, voting or disposing of securities of Steritech
that would be required under the Securities Exchange Act of 1934, as amended
(the "Exchange Act"), and the rules and regulations promulgated thereunder, to
file a statement on Schedule 13D with the (United States Securities Exchange
Commission) as a "Person" within the meaning of Section 13(d)(3) of the Exchange
Act if such group beneficially owned sufficient securities to require such a
filing. All of the provisions of this Section 4.3 shall be reinstated and shall
apply in full force according to their terms in the event that: (x) if the
preceding provisions of this Section 4.3 shall have terminated as a result of a
tender offer, such tender offer (as originally made or as extended or modified)
shall have terminated (without closing) prior to the commencement of a tender
offer by Baxter or any of its Affiliates that would have been permitted to be
made pursuant to the preceding provisions of this paragraph as a result of such
third-party tender offer, (y) any tender offer by Baxter or any of its
Affiliates (as originally made or as extended or modified) that was permitted to
be made pursuant to the preceding provisions of this paragraph shall have
terminated (without closing), or (z) if the preceding provisions of this Section
4.3 shall have terminated as a result of a Board determination referred to in
the preceding clause (ii), the Board shall have determined not to take any of
such actions (and no such transaction considered by the Board shall have closed)
prior to the commencement of a tender offer by Baxter or any of its Affiliates
that would have been permitted to be made pursuant to the preceding provisions
of this paragraph as a result of the initial Board determination referred to in
the preceding clause (ii), unless prior to such Board determination not to take
any of such actions, any of the events described in the preceding clause (i)
shall have occurred. Upon reinstatement of the provisions of this Section 4.3,
the preceding provisions of this paragraph shall continue to govern (including,
without limitation, those that provide for the termination of the preceding
provisions of this Section 4.3) in the event that any of the events described in
the preceding clauses (i) or (ii) shall occur. Upon the closing of any tender
offer for, or acquisition by Baxter or its Affiliates of, any securities of
Steritech or rights or options to acquire any such securities that would have
been prohibited by the preceding provisions of this Section 4.3 but for the
provisions of this paragraph, all provisions of this Section 4.3 shall
terminate.
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5. SUPPLY OF STERITECH COMPOUND AND SYSTEM MANUFACTURING.
5.1 STERITECH RESPONSIBILITIES. Steritech shall at all times use
commercially reasonable efforts to supply, or have supplied, Baxter's demand for
the Steritech Compounds used in each System. The Parties shall agree in good
faith upon a forecasting, order, supply and delivery mechanism for the Steritech
compounds.
5.2 BAXTER RESPONSIBILITIES. Baxter shall be responsible for all
aspects relating to scale-up, production, marketing and distribution of each
System, but not including manufacturing of the inactivation compound.
5.3 INSTRUMENT PRODUCTION. Baxter shall tool and scale up the
production model of any Instrument needed for each System. Baxter shall be
responsible for production and manufacture of the Instrument and associated
software of each System.
5.4 SYSTEM SPECIFICATIONS. Baxter's manufacture of each System shall be
in accordance with Systems Specifications as finally approved in writing by the
Management Board. Any change in Systems Specifications must be approved in
writing by the Management Board.
5.5 STERITECH SPECIFICATIONS. Steritech shall supply Steritech
Compounds in Bulk Form to Baxter to be used as a component of a System and
Baxter shall obtain Steritech Compounds to meet its requirements of inactivation
compounds for use in the Field from Steritech. Steritech Compounds shall meet
the Specifications for Steritech Compounds as finally approved in writing by the
Management Board. Any change in specifications for Steritech Compounds must be
approved in writing by the Management Board.
5.6 SOURCE OF SUPPLY. In the event Baxter recommends that Steritech
change Steritech's source of raw materials or Steritech Compound because of
actual or anticipated irregularity of supply, or failure to meet specifications
and a viable alternative source of supply is available, Steritech will support
Baxter in Steritech's obtaining such alternate source to the extent commercially
reasonable.
5.7 FAILURE OF STERITECH TO MEET BAXTER REQUIREMENTS. To the extent
that Steritech cannot meet Baxter's requirements for Steritech Compound, Baxter
shall be free to obtain Steritech Compound from a third party. Steritech agrees
to provide the third party that Baxter selects with the necessary information
and Steritech Know-How to allow the third party to make the Steritech Compound.
5.8 SYSTEM IMPROVEMENTS. During the term of this Agreement, as approved
by the Management Board, the Parties will cooperate in making improvements to
each System to meet changing market needs. The costs for such System
Improvements of Inactivation Packages shall be budgeted by the Management Board
and subject to cost sharing pursuant to Section 3.5 and shall be added to the
Final Project Total Budget.
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6. MARKETING AND DISTRIBUTION RIGHTS: EXCLUSIVE DISTRIBUTION RIGHTS.
6.1 COMMERCIALIZATION. Baxter shall use commercially reasonable efforts
to market and sell Systems developed under this Agreement in those countries of
the world in which the Management Board determines that such Systems should be
marketed and sold.
6.2 MEETINGS CONCERNING MARKETING. The Management Board shall meet from
time-to-time to discuss and approve marketing strategies in order to optimize
customer acceptance and effective promotion of the System. All final decisions
regarding System marketing, distribution and pricing shall be made by the
Management Board reasonably and in good faith. Baxter shall follow the
strategies established by the Management Board. In the event that any product is
sold by Baxter for a price less than the price established by the Management
Board for such product, for the purpose of computation of Net Sales, the product
will be deemed to be sold at the price established by the Management Board.
6.3 RESERVED RIGHT TO COMPETE. With the exception of psoralens or ALE
compounds, Baxter expressly reserves the right to research, develop and market
inactivation/decontamination products (expressly including
inactivation/decontamination products which compete indirectly or directly with
the Systems developed and marketed under this Agreement) which incorporate
technology owned or licensed by Baxter, and/or third parties to make, use and
sell such inactivation/decontamination products. Nothing herein shall be
interpreted to limit in any manner such right of Baxter. Baxter shall notify
Steritech in writing if Baxter commences development internally or with a third
party of a competing inactivation or decontamination product in a program in
which Baxter has budgeted at least one million dollars ($1,000,000) in any
twelve (12) month period of research and development expenses (or equity
investment), acquires marketing rights to a competing inactivation or
decontamination product or commences marketing of a competing inactivation or
decontamination product, or files an application for 510(k) or I.N.D., or
foreign equivalent, for such a competing product.
6.4 COMPETING PRODUCTS. In the event Baxter markets within a specific
country or territory an inactivation/decontamination product that competes
directly with a specific System developed under this Agreement, Baxter's rights
under this Agreement shall become co-exclusive with Steritech for the specific
System in that specific country or territory only, allowing Steritech to market,
sell and distribute the System itself within the specific country or territory
or, if Steritech chooses, through a single Approved Distributor (or Approved
Distributors, so long as only one Approved Distributor is appointed per
geographic region) within the specific country or territory. The sharing of
Premium shall be adjusted according to Section 7.3.
6.5 COMMENCEMENT, CESSATION OF MARKETING. If (a) according to the
Management Board, Baxter (through its own efforts or those of its distributors)
has not marketed a specific System within a specific country or territory
following Market Launch within a reasonable time, but not less than one year nor
more than three years from Market Launch, or (b) after commencement of marketing
of a specific System in a particular country or territory, Baxter shall cease
marketing (or be prevented from marketing by governmental action concerning
Baxter) of such System in such country or territory in the manner required under
this
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Agreement, Steritech shall have exclusive rights to market that specific System
in that specific country or territory only, allowing Steritech to market, sell
and distribute the System itself within the specific country or territory, or if
Steritech chooses, through an Approved Distributor (or Approved Distributors, so
long as only one Approved Distributor is appointed per geographic region) within
the specific country or territory. The sharing of Premium shall be adjusted
according to Section 7.3. If, according to the Management Board, Steritech
(through its own efforts or those of its distributors) has failed to gain a
sufficient market share for a particular System within a specific country or
territory within three (3) years after Steritech has obtained marketing rights
in such country or territory, or to gain or maintain sufficient market share in
such country at any time thereafter, or has ceased marketing of a Specific
System in any country or territory, Steritech's rights under this Agreement
shall become co-exclusive with Baxter for that specific System in that specific
country or territory, allowing Baxter to market, sell and distribute the System
itself within the specific country or territory or, if Baxter chooses, through a
single Approved Distributor (or Approved Distributors, so long as only one
Approved Distributor is appointed per geographic region) within the specific
country or territory.
6.6 ACHIEVEMENT OF MARKET SHARE. If, according to the Management Board,
Baxter (through its own efforts and those of its distributors) has not gained a
sufficient market share for a particular System within a specific country or
territory within three (3) years following Market Launch, or has not to gained
or maintained sufficient market share in such country at any time thereafter,
Baxter's rights under this Agreement shall become co-exclusive with Steritech
for that specific System in that specific country or territory, allowing
Steritech to market, sell and distribute the System itself within the specific
country or territory or, if Steritech chooses, through a single Approved
Distributor (or Approved Distributors, so long as only one Approved Distributor
is appointed per geographic region) within the specific country or territory.
The sharing of Premium shall be adjusted according to Section 7.3.
6.7 SUPPLY OF BAXTER GOODS. Baxter shall provide the necessary Baxter
disposables, Blood Pack Units(R), Instruments, or other components necessary for
Steritech, or Steritech's Approved Distributor, to sell Systems under Sections
6.4, 6.5 and 6.6. Steritech shall forecast its needs for such Baxter
disposables, apheresis kits, Blood Pack Unit(R), Instruments or other components
under Sections 6.4, 6.5 and 6.6. Baxter's Cost of Goods/Base Revenue under this
section shall be reimbursed under Section 7.3. Baxter shall not, however, be
obligated to develop, reconfigure, modify, qualify or seek Regulatory approval
for any disposables, apheresis kits, Blood Pack Units(R), Instruments or other
components supplied to Steritech or Steritech's Approved Distributor under this
Section.
6.8 REQUALIFICATION. In the event Steritech obtains marketing rights
under Section 6.5, 12 or 16, or in the event Baxter does not supply sufficient
goods under Section 6.7 to meet Steritech's needs (without limiting Baxter's
obligation to supply such goods) Steritech may, or may license third parties to,
make, have made, use, sell and have sold products using the Steritech Compounds
or under the Steritech Patents or Steritech Know-How, and under any patents or
know-how under which Steritech is licensed pursuant to Section 8.5(b) hereof,
for the use and in the particular country or countries for which Steritech has
marketing rights, provided
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that such products are qualified for regulatory approval on Steritech's or such
third party's own system.
6.9 MANAGEMENT BOARD ACCESS TO AND REVIEW OF MARKETING AND DISTRIBUTION
INFORMATION. A party marketing and distributing products under this Agreement
will provide to the Management Board all information in such party's possession
as the Management Board may reasonably require from time to time to review and
make decisions concerning marketing and distribution, including without
limitation breakdown and substantiation of any data provided pursuant to Section
13 of this Agreement. If the information requested of a party is information
that is not normally collected by the party, and requires substantial additional
expense of such party to collect and provide, such additional expense shall be
borne equally by the parties.
7. REVENUE SHARING.
7.1 REVENUE SHARING PAYMENTS. In consideration of the Cooperative
Development Work to be undertaken and other obligations set forth herein, the
parties agree to share Net Sales as follows: Subject to the provisions of
Sections 3.5, 3.7(a), 7.2, 7.3, 7.4, and 12, no later than sixty (60) days after
the first and all subsequent calendar quarters following the Market Launch of
the System, (a) Baxter shall pay to Steritech, with respect to Net Sales in such
calendar quarter, a sum equal to: (1) Steritech's Cost of Goods/Base Revenue;
and (2) fifty percent (50%) (or such other percentage is established pursuant to
Section 3.5 hereof) of the Premium during such calendar quarter ("Revenue
Sharing Payments"), and (b) Baxter shall retain for itself the balance of the
proceeds of Net Sales of Systems shipped during such Calendar Quarter. On each
such date a party that has received in such calendar quarter a royalty, license
fee or other consideration for licensing or sublicensing rights hereunder shall
pay to the other party the amount due to such party under Section 7.4. The
Revenue Sharing Payments due and payable hereunder shall be computed for each
calendar quarter in the currency in which the sale was made, but shall be
definitively discharged by payment to Steritech in U.S. dollars converted from
such currency using the average of spot rates for such currency for the last
business day of the second and third months of such quarter and of the first
month of the subsequent quarter, as quoted in the Wall Street Journal (or such
other mutually agreeable financial publication of international circulation or
rates published by Baxter's corporate treasury, if mutually agreed).
7.2 BAXTER SOURCING STERITECH COMPOUNDS. In the event Baxter sources
the Steritech compounds from an alternate source, Baxter shall retain for itself
the Cost of Goods/Base Revenue for the Steritech Compounds in the Systems
shipped during such calendar duration.
7.3 STERITECH AS SELLER OF SYSTEMS. In the event Steritech, or an
Approved Distributor appointed by Steritech, is the seller of the Systems under
Sections 6.4, 6.5 or 6.6, Steritech shall retain for itself its Cost of
Goods/Base Revenue, and the Marketing and Administrative Expenses, and pay to
Baxter, Baxter's Cost of Goods/Base Revenue and the percentage of Premium
received by each of the parties will equal the percentage contributed by such
party to the sum of (a) cash contributed to the final Project Total Budget, PLUS
(b) Noncash Contribution to the Project, provided that for the purposes of
computations under this Section, Baxter's Noncash Contribution shall be reduced
by (i) fifty percent (50%) if such sales are made
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pursuant to Section 6.4 or 6.6, or (ii) by seventy-five percent (75%) if such
sales are made pursuant to Section 6.5. In the event that Steritech purchases
any components from Baxter, as provided in Section 6.7, Baxter's share of the
Premium split shall be not less than fifty percent (50%) of Baxter's Cost of
Goods for such components.
7.4 LICENSING. In the event either Steritech (pursuant to Section 6.8
hereof) or Baxter (pursuant to Section 8.4 hereof) licenses or sublicenses a
third party to rights arising under this Agreement, all royalties, license fees
and other consideration received from such licensing or sublicensing (excluding
research or development payments) shall be shared by the parties according to
the percentage of the sum of (a) funding by each party in the Final Project
Total Budget (or such lesser amount as shall have been expended by Baxter and
Steritech to enable the parties to license or sublicense the rights hereunder
and to comply with their development obligations under the license or sublicense
agreement), plus (b) Noncash Contribution to such Project made by each party,
provided that for the purposes of this Section, Steritech's and Baxter's Noncash
Contributions will be equitably adjusted to reflect the relative contribution of
Steritech Patents and Steritech Know-How and Baxter Patents and Baxter Know-How
to the rights being licensed or sublicensed, but in all events Baxter's Noncash
Contribution shall be reduced by not less than seventy-five percent (75%).
Notwithstanding the foregoing, Steritech will not have any obligation to pay any
royalty, license fee or other consideration with respect to any licensing by
Steritech to third parties pursuant to the rights of Steritech under Section
8.5(a) of this Agreement.
7.5 DISTRIBUTOR SALES. In the event that either party sells
Inactivation Packages or Integrated Inactivation Sets through a distributor, Net
Sales shall be computed as set forth in paragraph (c) of the definition of Net
Sales, and the Distributor Portion will not diminish the Revenue Sharing Payment
receivable by the other party.
8. PATENTS, KNOW-HOW, LICENSE GRANTS.
8.1 STERITECH SOLE OWNERSHIP. Steritech shall own all Steritech Patents
and Steritech Know-How.
8.2 BAXTER SOLE OWNERSHIP. Baxter shall own all Baxter Patents and
Baxter Know-How.
8.3 JOINT PATENTS.
(a) Baxter shall own, and is hereby assigned, all Joint
Patents specifically reading on materials and configuration of blood bags and
associated tubes and connections, developed under this Agreement. Except as
provided in Section 8.3(b), Steritech shall own, and is hereby assigned, all
other Joint Patents, including without limitation Joint Patents reading on the
compounds, and methods of using or removing compounds, developed under this
Agreement.
(b) Steritech shall own, and is hereby assigned, all Joint
Patents specifically reading on the illumination device elements of Instruments
developed under this agreement,
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including hardware and software associated with the illumination device
elements. Baxter shall own, and is hereby assigned, all Joint Patents
specifically reading on all other elements of Instruments developed under this
Agreement.
(c) Within the Field the parties shall use any Joint Patents
solely for the development, sale or licensing of Systems pursuant to this
Agreement.
8.4 LICENSE.
Subject to the terms and conditions of this Agreement, for
Systems whose manufacture, use or sale is covered by a claim of a Steritech
Licensed Patent, or which use Steritech Licensed Know-How, Steritech hereby
grants Baxter an exclusive, paid-up, royalty free (except as provided herein)
license, with the right to sublicense (if such sublicense is approved in advance
by the Management Board), under Steritech Licensed Patents and Steritech
Licensed Know-How to make, have made, sell or have sold such Systems, and to use
such Systems solely for promotion and sale thereof, worldwide, solely for use in
the Field. Notwithstanding the foregoing, for any country or territory where
such marketing rights become co-exclusive or exclusive to Steritech pursuant to
Sections 6.4, 6.5 or 6.6 of the Agreement, such license shall automatically
become co-exclusive with Steritech, or the rights shall revert exclusively to
Steritech, as the case may be, for such country or territory. Except as set
forth herein in Section 5.7, such license shall exclude the right to make or
have made Steritech Compounds. As to Steritech Compounds, such license shall be
limited to the Steritech Compounds that are selected by the Management Board for
a specific Project within the Field. Notwithstanding anything in this Section or
elsewhere in this Agreement, Baxter shall not have any license or distribution
rights in or to any Steritech Patent or Steritech Know-How to the extent
relating to (a) the inactivation of bacteria, viruses, parasites or other
pathogens through use of compounds other than psoralens or ALE compounds, or (b)
the [*] inactivation system development at Steritech, or (c) use outside the
Field, except as provided in Section 8.6 of this Agreement.
8.5 STERITECH RIGHTS.
(a) DECONTAMINATED PRODUCTS. Baxter and Steritech have
previously entered into a letter agreement dated January 18, 1996 Re
Non-Exclusive License for Plasma Derivatives a copy of which is attached hereto
as Schedule D (the "Plasma Derivatives Letter"). Baxter and Steritech agree that
the terms of the Plasma Derivatives Letter, rather than this Agreement, shall
apply to all products in the Field where the product to be produced or sold is a
decontaminated blood cell, Protein Preparation, recombinant equivalent or blood
component or other product, rather than a System containing a disposable
Inactivation Package. The Plasma Derivatives letter will apply to such other
products to the same extent and in the same manner as if such other products
were expressly listed with plasma derivatives in the Plasma Derivatives Letter.
Accordingly, the license set forth in Section 8 is subject to the exclusive
right retained by Steritech in the Steritech Patents and Steritech Know-How to
inactivate pathogens in such products and license others to inactivate pathogens
in such products, including the right to make, have made, use and sell compounds
and other components applicable to such inactivation
*[Confidential Treatment Requested]
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process; provided that Steritech shall accord to Baxter the rights set forth in
the Plasma Derivatives letter.
(b) OTHER. The license to Baxter set forth above is subject to
the right retained by Steritech to grant licenses to third parties under
Steritech Patents and Steritech Know-How, and exercise other rights, as provided
in Section 6.8 of this Agreement. Baxter further grants to Steritech paid-up,
royalty-free (except as provided herein) license, with right to sublicense (a)
co-exclusive in the Field, to any Baxter Patents or Baxter Know-How developed in
the course of the Cooperative Development Work, and (b) non-exclusive in the
Field to any Baxter Patents or Baxter Know-How otherwise embodied or used within
a System; solely for the purposes of granting licenses and exercising other
rights pursuant to Section 6.8 or exercising Steritech's rights under Section 12
or 16 of this Agreement. The foregoing clause (b) shall exclude, however, any
Baxter proprietary materials or Baxter proprietary configuration of blood bags
and associated tubes and connections, or Baxter proprietary processes to
manufacture any of the same, unless Baxter shall consent in writing to license
of the same to Steritech.
8.6 CROSS-LICENSE. Steritech hereby grants to Baxter, and Baxter hereby
grants to Steritech, a worldwide, non-exclusive, paid-up, royalty-free license,
with right to sublicense, to make, have made, and use, sell or have sold,
outside the Field, products under any patents and know-how of the granting party
used or embodied in any Instrument or in any [*] developed under this
Agreement. In addition, Baxter hereby grants to Steritech a worldwide,
non-exclusive, paid-up, royalty-free (except as provided herein) license, with
right to sublicense, under the Baxter Patents and Baxter Know-How to make, have
made, and use, sell or have sold Instruments in connection with the exercise by
Steritech of any rights under Sections 6.4, 6.5, 6.6, 6.7, 6.8, 8.5 or 12 of
this Agreement in the event Baxter is unable to supply the same to Steritech at
a cost to Steritech equal to or less than the cost from an alternative supplier.
8.7 EXCLUDED PRODUCTS. The term Excluded Product means any product in
the Field that Baxter, in its sole discretion, specifically notifies Steritech
in writing that Baxter has no interest in developing and marketing. In the event
that Steritech proposes in writing a product for development under the
Cooperative Development Work, Baxter will consider such proposal in good faith
and will notify Steritech in writing if Baxter has no interest in developing and
marketing such product in the reasonably foreseeable future. Notwithstanding any
other provision of this Agreement, all rights and licenses hereunder as to any
Excluded Product shall revert to Steritech, including without limitation the
right to make, have made, and use, sell and have sold the Excluded Product.
Steritech shall not have any obligation to account to Baxter for any proceeds
from sale of any Excluded Product.
8.8 NOTICE OF SOLE RIGHTS. After the Effective Date of this Agreement,
a party asserting sole ownership of any patent rights or know-how in the Field
developed pursuant to the Cooperative Development Work shall provide reasonable
notice to the Management Board of its intention to seek patent protection or to
assert proprietary interest in such Know-How. The Management Board shall have
the right to a reasonable opportunity to review and comment on such assertions
prior to patent applications being filed.
*[Confidential Treatment Requested]
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8.9 OTHER AGREEMENTS. Steritech shall not terminate, alter or amend the
terms of the following agreements in a manner that would limit Steritech's or
Baxter's rights under this Agreement without the prior written approval of
Baxter: The Technology Transfer Agreement and the License Agreement between
Steritech and HRI Research, Inc. each dated December 13, 1991. Baxter shall
respond within thirty (30) days of receipt of written proposed changes to such
agreements. Baxter's approval of proposed changes shall not be unreasonably
withheld.
8.10 REGULATORY FILES. Baxter and Steritech shall each have full access
to all materials filed and correspondence with the FDA and other regulatory
agencies in connection with the Cooperative Development Work and each System,
and shall be entitled to use and rely on such materials with respect to any
regulatory approvals for a product sought by either, whether or not such product
relates to this Agreement. In the event that product registration is in the name
of Baxter in any country and Steritech obtains marketing rights for such product
in such country, then Baxter will, at Steritech's expense, cause the product to
be co-registered in Steritech's name or take other steps so that Steritech may
market and sell the product under such registration.
8.11 RIGHTS UNDER GOVERNMENT-SPONSORED RESEARCH. Any licenses hereunder
to any "subject invention," if any, as defined in 35 U.S.C. Section 201, shall
be subject to the rights of the United States Government under 35 U.S.C.
Section, 200 et seq.
9. PROSECUTION OF PATENT RIGHTS.
9.1 STERITECH PATENTS. Steritech shall have the right but no obligation
to timely prepare, file, prosecute and maintain, under its exclusive control and
at its expense, Steritech Patents.
9.2 BAXTER PATENTS. Baxter shall have the right but no obligation to
timely prepare, file, prosecute and maintain, under its exclusive control and at
its expense, Baxter patents.
9.3 JOINT PATENTS. The party to whom a Joint Patent is assigned
pursuant to Section 8.3 hereof shall employ counsel for the purpose of timely
preparing, filing, prosecuting and maintaining the Joint Patents which are
assigned to such party pursuant to such Section 8.3. The other party shall have
the right to approve such counsel, which approval shall not be unreasonably
withheld. Whenever possible, the parties shall file internationally under the
Patent Cooperation Treaty and/or the European Patent Convention in order to
minimize expenses. The reasonable expenses of preparing, filing, prosecuting and
maintaining corresponding Joint Patents in the countries of the United States,
Australia, Canada, the United Kingdom, Germany, Belgium, France, Italy,
Netherlands, and Japan, and all other countries that are agreeable to Baxter and
Steritech, as evidenced in writing shall be borne equally. Unless such other
countries are agreed to by the parties in writing, such other country filings
shall not be made. Baxter shall pay such patent expenses and will deduct
Steritech's share of such expenses from Revenue Sharing Payments otherwise due
Steritech.
9.4 PRIOR ART; REVIEW AND COMMENT. Each party shall cooperate with the
other to ensure that all prior art that is pertinent to the examination of a
Joint Patent is brought to the
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attention of the other party. The parties to this Agreement shall have the right
to review and comment on substantive documents prepared in connection with the
preparation, filing, prosecution and maintenance of the Joint Patents prior to
the filing of such papers; however, such review and comment shall be performed
expeditiously so as not to negatively affect patent rights.
9.5 ELECTION NOT TO PAY EXPENSES. If either party elects for any reason
not to pay its share of the reasonable expenses for a particular Joint Patent,
then, at the option of the other party:
(a) the joint ownership of that nonpaying party under this
Agreement with respect to that particular patent application or patent shall
immediately terminate and the paying party shall exclusively own that particular
patent or patent application, without affecting the nonpaying party's rights
under all other patent applications and patents; or
(b) the application or patent shall be allowed to lapse.
In the event the paying party elects option (a) above, the nonpaying
party hereby agrees to execute documents necessary to transfer its interest in
such patent or patent application to the paying party.
10. TRADEMARKS.
10.1 BAXTER TRADEMARKS. Steritech shall make no use of any Baxter
trademark without the prior written approval by Baxter.
10.2 STERITECH TRADEMARKS. Baxter shall include the Steritech name and
mark (or successor name and mark) in a prominent manner on and on packaging,
literature and promotional material and advertising for the System unless Baxter
makes a good faith determination that the Steritech name cannot be used due to
third party rights. Baxter shall, to the extent practical, provide to Steritech
for review copies of all proposed uses of the Steritech name and mark and
references to Steritech. At Steritech's reasonable request, Baxter shall refer
to the Steritech Compounds by the Steritech trademark that Steritech indicates
is appropriate. Baxter shall include on material bearing such trademarks an
acknowledgment that such trademarks are the property of Steritech. If necessary
in any market to maintain Steritech's rights in the Steritech trademarks, Baxter
shall enter into a registered user agreement regulating its use of the Steritech
trademarks. Except as provided in this Section, no rights to Steritech
trademarks are hereby granted to Baxter.
11. CONFIDENTIAL INFORMATION.
11.1 CONFIDENTIALITY AGREEMENT. The use and disclosure of information
designated by either party as confidential shall be governed by the attached
Schedule E Confidentiality Agreement. The Schedule E Confidentiality Agreement
shall survive termination of this Agreement.
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11.2 USE OF CONSULTANTS. The parties contemplate that from time to time
during the term of this Agreement third party technical consultants may be
employed by either party in connection with the development of Steritech
Compounds or Systems. The parties agree that information designated as
confidential may be disclosed to such consultants provided that the other party
is given reasonable notice of the circumstances and nature of the intended
disclosure and that the disclosure is limited to information necessary to enable
the technical consultant to provide technical consulting services. The
consultant will be required to sign an agreement committing the consultant to
protect such confidential information.
12. CESSATION OF COOPERATIVE DEVELOPMENT WORK.
12.1 CESSATION. Either party may unilaterally cease all participation
on a specific approved Project or all Cooperative Development Work under this
Agreement upon ninety (90) days written notice of its intent. At any time
thereafter, the party who did not unilaterally cease participation in the
Cooperative Development Work shall have the right to proceed with the
independent development of such System at its own expense. Should a party so
proceed, the following terms and conditions shall apply:
(a) The Premium Sharing Formula in Section 7.1 will be
adjusted. The Premium shall be split between the
Parties based on the percentage of the sum of (i)
Final Project Total Budget funded by each Party, plus
(ii) Noncash Contributions to the Project made by
each party, adjusted as provided in clauses (b) and
(c) below. Such percentage being calculated as
follows: for purposes of this Section only, after the
cessation of funding by one Party, the funds provided
by the other Party thereafter to support the
Cooperative Development Work shall be considered
doubled when calculating the Final Project Total
Budget and the corresponding respective percentage
funded by each Party. All funds provided by either
Party prior to a Party's cessation shall be credited
but not doubled.
(b) In the event that Steritech unilaterally ceases all
participation, then at Baxter's election by written
notice, all marketing rights and licenses of
Steritech hereunder to the System(s) developed or
being developed under such Project, or under the
Development Work, as the case may be shall terminate,
and Baxter shall source the Steritech Compounds from
an alternative source with the cooperation of
Steritech, and the Revenue Sharing Formula in Section
7.1 will be adjusted under Sections 7.2 and 12.1(a);
(c) In the event that Baxter unilaterally ceases all
participation, then at Steritech's election by
written notice, all marketing rights and licenses of
Baxter to the System(s) developed or being developed
under such Project, or under the Cooperative
Development Work, as the case may be, shall terminate
and Steritech shall have exclusive rights to market,
sell and distribute such System throughout the world.
Baxter shall provide the
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necessary Baxter disposables, apheresis kits, Blood
Pack Units(R) or other components necessary for
Steritech, or Steritech's Approved Distributor to
sell Systems under Section 6.7. Revenue Sharing under
Section 7.1 shall be adjusted under Sections 7.3, 7.4
and 12.1(a).
12.2 CESSATION PAYMENT. In the event that either party gives notice of
unilateral cessation of participation on a specific approved Project or all
Cooperative Development Work under this Agreement, such party shall, not later
than twenty (20) days after the date of such notice, pay to the other party an
amount equal to [*] following the date of such cessation. Such cessation payment
need not be applied by the receiving party to continuation of work on such
Project or Cooperative Development Work. Neither party shall be entitled to give
notice of unilateral cessation of participation on the Red Cell Project or the
Fresh Frozen Plasma Project prior to January 1, 1998 or on any other Project
prior to two years after the approval of the Management Board to commence the
Project, provided, however, that either party shall have the right to give
notice of unilateral cessation of a Project prior to that date if such party
concludes, reasonably and in good faith, based on an unambiguous, unsuccessful
outcome in a critical test in the Project test protocol that there is no
reasonable likelihood that the Project will attain Regulatory Approval.
13. REPORTS.
13.1 QUARTERLY SALES REPORTS. Each quarterly payment made under Section
7 shall be accompanied by a full and accurate accounting of all Net Sales of
Systems by Baxter and Steritech, as the case may be, for the calendar quarter.
Each such report shall include at least the following information for each type
of System separately as to each of the following regions: U.S., Europe, Japan,
rest of world:
(a) The number of stand-alone Inactivation Packages and
Integrated Inactivation Sets sold to third parties by Baxter or Steritech, as
the case may be;
(b) The Net Sales, with a breakdown between Net Sales of
stand-alone Inactivation Packages and Integrated Inactivations Sets;
(c) Cost of Goods/Base Revenue with a breakdown between
stand-alone Inactivation Packages and Integrated Inactivation Sets;
(d) Computation of the Revenue Sharing Payment due to the
other party.
(e) Customer published price lists for Systems; and
(f) Any deductions from Revenue Sharing Payments.
*[Confidential Treatment Requested]
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Each report shall include the certification of the party making the report
attesting to the fact that the report is an accurate and complete accounting of
all information required hereunder.
To the extent Baxter is unable to provide any such information when due, Baxter
will provide to Steritech at such time Baxter's best estimates of such
information, and will provide actual information as soon as it is available,
provided, however, that Baxter will, in any event, provide reports when due of
actual Net Sales and Cost of Goods/Base Revenue.
13.2 COST OF GOODS/BASE REVENUE. To the extent not provided under
Section 13.1 above, each party will furnish quarterly reports to the other party
on such party's Cost of Goods/Base Revenue for components supplied by such
party.
14. BOOKS AND RECORDS.
14.1 RECORDS. Baxter and Steritech shall keep full and accurate books
of account containing all particulars that may be necessary for the purpose of
calculating all amounts owing to either party. Books of account maintained by
the parties shall be kept at their principal place of business. All such reports
and data shall be open for inspection on a confidential basis at all reasonable
times and either party may conduct at its own expense, once every year during
normal business hours through an independent certified public accountant, an
examination of the accounts contemplated above. If any audit shall show that the
selling party underpaid amounts due under this Agreement herein as to the period
subject of the audit, then the party which underpaid shall immediately pay to
the other any such deficiency with interest thereon in accordance with Section
14.3. If the underpayment shall exceed ten percent (10%) of the amount owed for
any calendar year, the party underpaying shall also reimburse the other for
costs related to such audit.
14.2 RETENTION. Books and records required to be maintained by the
parties hereunder shall be retained for at least two (2) years from the date of
the payment to which they pertain.
14.3 INTEREST. All payments due hereunder that are not paid when due
and payable hereunder shall bear interest at an annual rate equal to 4% (four
percent) above the U.S. dollar reference rate ("prime rate") charged from time
to time by Bank of America N.T. & S.A. from the date due until paid or at such
lower rate as shall be the maximum rate permitted by law.
15. TERM.
This Agreement shall continue so long as any System is being developed
or marketed under this Agreement, unless terminated earlier pursuant to Section
16.1, and provided that Cooperative Development Work may be earlier terminated
pursuant to Section 12.1. Further, upon expiration of the agreement, except as
otherwise provided herein, no Party shall be obligated to provide materials,
disposables, Blood Pack Units(R), apheresis kits, delivery systems, Instruments
and chemicals to the other Party. Upon termination of any Project by the
Management Board or by mutual consent, all licenses hereunder shall terminate
with respect to the subject matter of such Project (which shall not affect
licenses with respect to any other
34.
<PAGE> 41
Project). In the event that either party hereunder does not commence
participation, or ceases participation, in the Cooperative Development work for
the Red Blood Cell Project, other than pursuant to the proviso in the last
sentence of Section 12.2, all licenses of such party under this Agreement shall
terminate except such licenses as may be necessary or useful in connection with
other then ongoing approved Projects. Any license under Section 8.6 hereof,
however, shall survive any termination of this Agreement.
16. BREACH.
16.1 MATERIAL BREACH. Either party may terminate this Agreement for any
material breach by the other party sixty (60) days after providing the other
party with written details of the breach if the breach remains uncured at the
end of the sixty (60) day notice period. Notwithstanding the preceding sentence,
each party acknowledges that the ability of the other party to carry on the
Cooperative Development work will be substantially adversely affected in the
event that such party does not make payment when due to the other party.
Accordingly, in the event of the failure to make any payments that are due and
owing, or fund any equity purchase, a thirty (30) day notice period shall apply
in lieu of such sixty (60) day notice period in the preceding sentence.
16.2 RIGHTS ON TERMINATION. In the event of termination by either party
as provided in Section 16.1, without limiting any other rights or remedies, such
party shall have the rights provided for under Section 12 of the Agreement as if
the other party had unilaterally ceased participation in the Cooperative
Development Work.
17. REPRESENTATIONS AND INDEMNITIES.
17.1 STERITECH REPRESENTATIONS. Steritech represents and warrants that
as of the Effective Date:
(a) It has granted no prior license or assignment of rights
under the Steritech Patents in the Field.
(b) There are no foreign or United States administrative,
judicial or Patent and Trademark Office proceedings contesting the inventorship
or ownership of any Steritech Patent;
(c) Neither the execution and delivery of this Agreement, nor
the performance of the obligations of Steritech hereunder shall result in a
violation, breach or event of default (or any event or condition which with
notice or the passage of time or both would constitute an event of default) of
or with respect to any agreement, mortgage, indenture or order of any court of
competent jurisdiction binding upon Steritech or upon the property of Steritech;
(d) It is party to no contract materially adverse to the
obligations undertaken and rights granted in this Agreement;
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<PAGE> 42
(e) The execution of this Agreement and delivery to Baxter
does not conflict with the terms of any agreement to which Steritech is bound.
(f) The Technology Transfer Agreement and the License
Agreement between Steritech and HRI Research, Inc. each dated December 13, 1991
are in full force and effect and are binding and enforceable in accordance with
their terms.
(g) That Steritech has advised Baxter of any knowledge of any
third party patent or Know-How that might be infringed by the incorporation of
any Steritech Patent or Steritech Know-How likely to be embodied or used in a
System; and
(h) Steritech is unaware of any technology not licensed to
Baxter hereunder, that it believes would be necessary to optimally use the
Steritech Compound.
17.2 STERITECH INDEMNIFICATION -- REPRESENTATIONS AND WARRANTIES.
Steritech shall indemnify Baxter for any losses sustained or expenses incurred
by Baxter as a result of a breach by Steritech of any of the foregoing
representations and warranties.
17.3 STERITECH INDEMNIFICATION -- PRODUCTS. Steritech shall defend,
indemnify and hold Baxter harmless from and against any and all claims, damages,
liability, suits, actions and expenses, including reasonable attorney's fees, by
reason of liability imposed by law upon Baxter resulting from the sale of
Systems to the extent any such liability, expressly including, but not limited
to products liability, arises from the failure to conform to Specifications for
Steritech Compounds incorporated into Systems; provided that Baxter shall give
Steritech prompt written notice of such claim and Steritech shall have the right
to defend such claim (Baxter having the right to participate in any such defense
at Baxter's own expense).
17.4 INSURANCE. Steritech shall, at its own expense, establish and at
all times during the period from Market Launch until three (3) years after the
last delivery of a System under this Agreement products liability insurance in
an amount not less than $5,000,000 each occurrence combined single limit bodily
injury and property damage, provided that such insurance is available on
commercially reasonable terms. The insurance policy shall be endorsed to name
Baxter as an additional insured and to provide for written notification to
Baxter by the insurer not less than thirty (30) days prior to cancellation,
non-renewal or material change. A certificate of insurance evidencing compliance
with this section and referencing this Agreement shall be furnished to Baxter by
Steritech within ten (10) days of Market Launch.
17.5 BAXTER REPRESENTATIONS. Baxter represents and warrants to
Steritech that as of the Effective Date:
(a) It has granted no prior license or assignment of rights
under the Baxter Patents that would materially impair its ability to develop,
manufacture or sell Systems.
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<PAGE> 43
(b) There are no foreign or United States administrative,
judicial or Patent and Trademark Office proceedings contesting the inventorship
or ownership of any Baxter Patent that is likely to be embodied or used in a
System.
(c) neither the execution and deliver of this Agreement, nor
the performance of the obligations of Baxter hereunder shall result in a
violation, breach or event of default (or any event or condition which with
notice or the passage of time or both would constitute an event of default) of
or with respect to any agreement, mortgage, indenture, or order of any court of
competent jurisdiction binding upon Baxter or upon the property of Baxter.
(d) it is party to no contract materially adverse to the
obligations undertaken in this Agreement.
(e) The execution of this Agreement and delivery to Steritech
does not conflict with the terms of any agreement to which Baxter is bound.
(f) Baxter has no current agreements with other parties for
systems for the inactivation of pathogens in FFP or Red Cells.
(g) Baxter has advised Steritech of any knowledge of any third
party patent or know-how that might be infringed by the incorporation by Baxter
of any Baxter Patent or Baxter Know-How likely to be embodied or used in a
System.
(h) Baxter is unaware of any technology not licensed to Baxter
it believes would be necessary to optimally use the Baxter Patents or Baxter
Know-How in a System.
17.6 BAXTER INDEMNIFICATION -- REPRESENTATIONS AND WARRANTIES. Baxter
shall indemnify Steritech for losses sustained or expenses incurred by Steritech
as a result of a breach by Baxter of the foregoing representations and
warranties.
17.7 BAXTER INDEMNIFICATION-PRODUCTS. Baxter shall indemnify and hold
Steritech harmless from and against any and all claims, damages, liability,
suits actions and expenses, including reasonable attorney's fees, by reason of
liability imposed by law upon Steritech resulting from the sale of Systems to
the extent any such liability, including but not limited to product liability,
arises from the failure of components of Systems by Baxter, excluding
Instruments if manufactured by a third party (provided that Baxter shall
contractually require any third-party manufacturer to indemnify Steritech to the
full extent that Baxter is indemnified by such manufacturer), to conform to
specifications; provided that Steritech shall give Baxter prompt written notice
of such claim and Baxter shall have the right to defend such claim (Steritech
having the right to participate in such defense at its own expense).
17.8 BAXTER INSURANCE. In the event that the net worth of Baxter shall
at any time be reduced to less than $2 billion U.S., Baxter shall, at its own
expense, establish and at all times that such net worth is not maintained until
three (3) years after the last delivery of a System under this Agreement
maintain products liability insurance in an amount not less than $5,000,000
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<PAGE> 44
each occurrence combined single limit bodily injury and property damage,
provided that such insurance is available on commercially reasonable terms. The
insurance policy shall be endorsed to name Steritech as an additional insured
and to provide for written notification to Steritech by the insurer not less
than thirty (30) days prior to cancellation, non-renewal or material change. A
certificate of insurance evidencing compliance with this section and referencing
this Agreement shall be furnished to Steritech by Baxter within ten (10) days of
the date that Baxter becomes obligated to establish such insurance.
18. INFRINGEMENT.
18.1 DEFENSE OF THIRD PARTY INFRINGEMENT SUITS. In the event that a
third party shall sue either party alleging that the manufacture, use or sale of
a System, or any part thereof, infringes a patent of such third party, then the
Management Board shall have the option to control the defense of such suit. The
parties shall provide reasonable cooperation in the defense of such suit and
furnish all evidence in their control. All attorneys' fees as well as any
judgments, settlements, or damages payable with respect to such suit shall be
subject to cost sharing pursuant to Section 3.5 and shall be added to the Final
Project Total Budget. Neither party shall enter into any settlement that
materially affects the other party's rights or interests without such other
party's prior written consent, which consent shall not be unreasonably withheld.
18.2 THIRD PARTY PATENT EXPENSES. If the Management Board shall approve
the payment to a third-party of Patent Royalty Payments with respect to the sale
or use of a System or any portion thereof, then Baxter and Steritech shall bear
the Patent Royalty Payment under such license proportionately to the Revenue
Sharing Formula, and Baxter may deduct Steritech's share of such Patent Royalty
Payment from Revenue Sharing Payments due to Steritech.
18.3 SUITS FOR INFRINGEMENT BY OTHERS. In the event Baxter or Steritech
becomes aware of any actual or threatened infringement of the Steritech Licensed
Patents or the Steritech Licensed Know-How, or the Baxter Licensed Patents or
Baxter Licensed Know-How, that party shall promptly notify the Management Board
and the Management Board shall determine the most appropriate action to take.
All expenses for pursuing such suit shall be subject to cost sharing. Any award
in such suit shall be divided between the parties in proportion to the parties'
relative combined cash contributions and Noncash Contributions to the product or
process that is subject to the infringement.
In the event the accused product is not in competition with a System in the
Field,
(a) Steritech alone may, in its sole discretion and at its
expense, initiate and conduct an infringement action relating to alleged
infringement of Steritech Patents or Steritech Know-How and keep any settlement
or award which may be obtained.
(b) Baxter alone may, in its sole discretion and at its
expense, initiate and conduct an infringement action relating to alleged
infringement of Baxter Patents or Baxter Know-How and keep any settlement or
award which may be obtained.
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19. GENERAL.
19.1 ENTIRE AGREEMENT. (1) This Agreement and Schedules, (2) the
attached Schedule E Confidentiality Agreement of even date, (3) each stock
purchase agreement pursuant to Section 4.1 hereof, and (4) the Plasma
Derivatives Letter contain the entire agreement between the parties relating to
the subject matter hereof and all prior understandings, representations and
warranties between the parties are superseded; provided, however, that this
Agreement does not limit any agreement restricting disclosure or use of
confidential or proprietary information previously entered into between the
parties. None of the terms of this Agreement shall be deemed to be waived or
amended by either party unless such a waiver or amendment specifically
references this Agreement and is in writing signed by the party to be bound.
Nothing in this Agreement is intended to amend or modify the Platelet Agreement,
except that this Agreement supersedes Sections 8.7 and 8.8 of such agreement,
which provisions shall cease to be effective upon the execution and delivery of
this Agreement.
19.2 RELATIONSHIP OF PARTIES. Baxter acknowledges that it is not an
agent of Steritech and has no authority to speak for, represent, or obligate
Steritech in any way. Steritech acknowledges that it is not an agent of Baxter
and has no authority to speak for, represent, or obligate Baxter in any way.
This Agreement does not and shall not be deemed to create any relationship of a
joint venture or a partnership.
19.3 SENIOR BAXTER CONTACT. The senior Baxter contact of the purpose of
administering this Agreement is President, Fenwal, One Baxter Parkway,
Deerfield, Illinois 60015. At present, Kim Bush occupies this position.
19.4 SENIOR STERITECH CONTACT. The senior Steritech contact for the
purpose of administering this Agreement is the President of Steritech at the
address first above written. At present, Mr. Stephen T. Isaacs occupies this
position.
19.5 SEVERABILITY. The parties do not intend to violate any public
policy or statutory or common law. However, if any sentence, paragraph, clause
or combination of this Agreement is in violation of any law or is found to be
otherwise unenforceable by a court from which there is no appeal, or no appeal
is taken, such sentence, paragraph, clause, or combination of the same shall be
deleted and the remainder of this Agreement shall remain binding, provided that
such deletion does not alter the basic structure of this Agreement. In such
event, the parties shall renegotiate this Agreement in good faith, but should
such negotiations not result in a new agreement with ninety (90) days of the
initiation of such negotiations, then this Agreement may be terminated by either
party by thirty (30) days notice to the other.
19.6 FORCE MAJEURE. Any party shall be excused from the performance of
its obligations under this Agreement and shall not be liable for damages to the
other if such performance is prevented by circumstances beyond its effective
control. Such excuse from performance shall continue so long as the condition
responsible for such excuse continues and for a thirty (30) day period
thereafter. For the purposes of this Agreement, circumstances beyond the control
of a party which excuse that party from performance shall include, but shall
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not be limited to, acts of God, acts, regulations or laws of any government
including currency controls, war, civil commotion, commandeer, destruction of
facility or materials by fire, earthquake, storm or other casualty, labor
disturbances, judgment or injunction of any court, epidemic, and failure of
public utilities or common carrier.
19.7 NOTICES. All notices and demands required or permitted to be given
or made pursuant to this Agreement shall be in writing and shall be effective
when personally given or made or when placed in an envelope and deposited in the
United States mail postage prepaid, addressed as follows:
IF TO BAXTER: IF TO STERITECH, IN CARE OF:
General Counsel President and Chief Executive Officer
Baxter Healthcare Corporation Steritech, Inc.
One Baxter Parkway 2525 Stanwell Drive
Deerfield, Illinois 60015 Concord, California 94520
WITH A COPY TO: WITH A COPY TO:
Kim Bush
President, Fenwal Howard G. Ervin
Baxter Healthcare Corporation Cooley, Godward, Castro, Huddleson & Tatum
One Baxter Parkway One Maritime Plaza, 20th Floor
Deerfield, Illinois 60015 San Francisco, California 94111
or to such other address as to which either party may notify the other.
19.8 BINDING. This Agreement shall be binding upon and inure to the
benefit of the parties, their successors and assigns. This Agreement shall be
assignable: (i) by either party without the consent of the other to any
Affiliate of the party (an Affiliate being defined as any entity in which the
party or its parent owns or controls directly or indirectly, forty percent (40%)
or more of the voting securities); (ii) by either party with the written consent
of the other; (iii) by either party without the consent of the other in
connection with the purchase or other acquisition of substantially all the
assets of its business to which this Agreement relates; or (iv) by either party
in connection with a reincorporation under the laws of another state. Any
attempted assignment which does not comply with the terms of this Section shall
be void.
19.9 GOVERNING LAW. This Agreement is deemed to have been executed in
and shall be governed by and construed according to the laws of the State of
Illinois.
19.10 VENUE. In the event that Baxter files suit against Steritech, it
shall do so in, and hereby agrees to submit to, the jurisdiction of a court in
U.S. District Court, N.D. California. In the event that Steritech files suit
against Baxter, it shall do so in, and hereby agrees to submit to, the
jurisdiction of the U.S. District Court N.D, Illinois.
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19.11 DISBURSEMENTS. Unless otherwise agreed between the parties, all
disbursements from one party to another under this Agreement shall be paid on or
before the due date by wire transfer to the bank account specified in writing by
the party receiving the disbursement.
IN WITNESS WHEREOF, this Agreement is signed by duly authorized
representatives of each party as of the Effective Date.
BAXTER HEALTHCARE CORPORATION STERITECH, INC.
By: /s/ Victor Schmitt By: /s/ Stephen T. Isaacs
__________________________________ _______________________________
Victor Schmitt Stephen T. Isaacs
Title: President, Venture Management Title: President
Date: April 1, 1996 Date: March 15, 1996
________________________________ _____________________________
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SCHEDULE A
RED CELL BUDGET AND TASKS
11 Pages
<PAGE> 49
RED CELL PROGRAM
Revised Budget
February 28, 1996
PROJECT
1996 1997 1998 1999 2000 2001 TOTAL
--------------- -------------- -------------- -------------- -------------- -------------- -------------
FTE $ FTE $ FTE $ FTE $ FTE $ FTE $
--------------- -------------- -------------- -------------- -------------- --------------
STERITECH R&D
Personnel......... [*] $ [*] [*] $ [*] [*] $ [*] [*] $ [*] [*] $ [*] [*] $[*] $ [*]
Out of Pocket..... $ [*] $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
Instrument........ $ [*] $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
BAXTER R&D
Personnel......... [*] $ [*] [*] $ [*] [*] $ [*] [*] $ [*] [*] $ [*] [*] $[*] $ [*]
Out of Pocket..... $ [*] $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
Instrument........ $ [*] $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
OUTSIDE
[*] $ [*] $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
[*] $ [*] $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
[*] $ [*] $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
[*] $ [*] $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
[*] $ [*] $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
------ ------ ------ ------ ------ ----- ------
TOTAL............. $ [*] $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
====== ====== ====== ====== ====== ==== =======
*[Confidential Treatment Requested]
<PAGE> 50
RED CELL BUDGET, 1996 PROJECTION: STERITECH R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- --------
Out of Pocket $ [*]
[*] [*] [*]
Instrument [*] $ [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Project Leader [*] [*]
========
[*]
Total $ [*]
--------
5 Year Budget (Revised 28 Feb 96)
*[Confidential Treatment Requested]
Page 2
<PAGE> 51
RED CELL BUDGET, 1996 PROJECTION: BAXTER R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- -------
Out of Pocket $ [*]
Instrument [*] [*]
[*] [*] [*]
[*] [*] [*]
Project Coordinator [*]
=======
[*]
TOTAL $ [*]
-------
RED CELL BUDGET, 1996 PROJECTION: OUTSIDE EXPENSES
CATEGORY EXPLANATION $
-------- ----------- ---------
[*] [*] $ [*]
[*] [*] $ [*]
[*] [*] $ [*]
=========
Total $ [*]
---------
5 Year Budget (Revised 28 Feb 96)
*[Confidential Treatment Requested]
Page 3
<PAGE> 52
RED CELL BUDGET, 1997 PROJECTION: STERITECH R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- --------
Out of Pocket $ [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Project Leader [*]
========
[*]
TOTAL $ [*]
--------
5 Year Budget (Revised 28 Feb 96)
*[Confidential Treatment Requested]
Page 4
<PAGE> 53
RED CELL BUDGET, 1997 PROJECTION: BAXTER R&D
CATEGORY EXPLANATION FTE/$
--------------------- ----------------------------------------- ----------
Out of Pocket $ [*]
Instrument [*] $ [*]
[*] [*] [*]
[*] [*] [*]
Instrument [*] [*]
[*] [*] [*]
Other Technical [*]
Project Leader [*]
==========
[*]
TOTAL $ [*]
----------
RED CELL BUDGET, 1997 PROJECTION: OUTSIDE EXPENSES
CATEGORY EXPLANATION $
--------------------- ----------------------------------------- ----------
[*] [*] $ [*]
[*] [*] [*]
[*] [*] [*]
==========
Total $ [*]
----------
5 Year Budget (Revised 28 Feb 96)
*[Confidential Treatment Requested]
Page 5
<PAGE> 54
RED CELL BUDGET, 1998 PROJECTION: STERITECH R&D
Category Explanation FTE/$
-------- ----------- --------
Out of Pocket $ [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Project Leader [*]
========
[*]
TOTAL $ [*]
--------
5 Year Budget (Revised 28 Feb 96)
*[Confidential Treatment Requested]
Page 6
<PAGE> 55
RED CELL BUDGET, 1998 PROJECTION: BAXTER R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- ----------
Out of Pocket $ [*]
Instrument [*] $ [*]
[*] [*] [*]
Instrument [*] [*]
[*] [*] [*]
Other Technical [*]
Project Leader [*]
==========
[*]
TOTAL $ [*]
----------
RED CELL BUDGET, 1998 PROJECTION: OUTSIDE EXPENSES
CATEGORY EXPLANATION FTE/$
-------- ----------- ----------
[*] [*] $ [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
==========
Total $ [*]
----------
5 Year Budget (Revised 28 Feb 96)
*[Confidential Treatment Requested]
Page 7
<PAGE> 56
RED CELL BUDGET, 1999 PROJECTION: STERITECH R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- --------
Out of Pocket $ [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Project Leader [*]
========
[*]
Total $ [*]
--------
5 Year Budget (Revised 28 Feb 96)
*[Confidential Treatment Requested]
Page 8
<PAGE> 57
RED CELL BUDGET, 1999 PROJECTION: BAXTER R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- --------
Out of Pocket $ [*]
Instrument [*] [*]
[*] [*] [*]
[*] [*] [*]
Project Leader [*]
========
[*]
TOTAL $ [*]
--------
RED CELL BUDGET, 1999 PROJECTION: OUTSIDE EXPENSES
CATEGORY EXPLANATION $
-------- ----------- ----------
[*] [*] $ [*]
[*] [*] $ [*]
[*] [*] $ [*]
[*] [*] $ [*]
==========
Total $ [*]
----------
5 Year Budget (Revised 28 Feb 96)
*[Confidential Treatment Requested]
Page 9
<PAGE> 58
RED CELL BUDGET, 2000 PROJECTION: STERITECH R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- -----
Out of Pocket $ [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Project Leader [*]
========
[*]
TOTAL $ [*]
--------
RED CELL BUDGET, 2000 PROJECTION: BAXTER R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- -----
Out of Pocket $ [*]
[*] [*] [*]
[*] [*] [*]
=======
[*]
TOTAL $ [*]
--------
5 Year Budget (Revised 28 Feb 96)
*[Confidential Treatment Requested]
Page 10
<PAGE> 59
RED CELL BUDGET, 2000 PROJECTION: OUTSIDE EXPENSES
CATEGORY EXPLANATION $
-------- ----------- -----
[*] [*] $ [*]
[*] [*] $ [*]
==========
Total $ [*]
----------
RED CELL BUDGET, 2001 PROJECTION: BAXTER R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- -----
Out of Pocket $ [*]
Instrument [*] $ [*]
Technical support [*] [*]
========
[*]
TOTAL $ [*]
--------
5 Year Budget (Revised 28 Feb 96)
*[Confidential Treatment Requested]
Page 11
<PAGE> 60
SCHEDULE B
FFP BUDGET AND TASKS
11 Pages
<PAGE> 61
FFP PROGRAM
Revised Budget
February 28, 1996
1996 1997 1998 1999 2000 PROJECT TOTAL
--------------- -------------- -------------- -------------- -------------- -------------
FTE $ FTE $ FTE $ FTE $ FTE $
--------------- -------------- -------------- -------------- -------------
STERITECH R&D
Personnel......... [*] $ [*] [*] $ [*] [*] $ [*] [*] $ [*] [*] $[*] $ [*]
Out of Pocket..... $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
$ [*]
BAXTER R&D
Personnel......... [*] $ [*] [*] $ [*] [*] $ [*] [*] $ [*] [*] $[*] $ [*]
Out of Pocket..... $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
Instrument........ $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
Outside
[*] $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
[*] $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
[*] $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
[*] $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
------ ------ ------ ------ ---- ------
TOTAL............. $ [*] $ [*] $ [*] $ [*] $[*] $ [*]
====== ====== ====== ====== ==== ======
*[Confidential Treatment Requested]
<PAGE> 62
FFP BUDGET, 1996 PROJECTION: STERITECH R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- -------
Out of Pocket [*] $ [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
=======
TOTAL $ [*]
-------
*[Confidential Treatment Requested]
Page 1
<PAGE> 63
FFP BUDGET, 1996 PROJECTION: BAXTER R&D
CATEGORY EXPLANATION FTE/$
--------------------- ----------------------------------------- --------
Out of Pocket [*] $ [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Project Leader [*] [*]
==========
TOTAL $ [*]
--------
FFP BUDGET, 1996 PROJECTION: OUTSIDE EXPENSES
CATEGORY EXPLANATION $
--------------------- ----------------------------------------- --------
[*] [*] $ [*]
[*] [*] [*]
========
TOTAL $ [*]
--------
*[Confidential Treatment Requested]
Page 2
<PAGE> 64
FFP BUDGET, 1997 PROJECTION: STERITECH R&D
CATEGORY EXPLANATION FTE/$
--------------------- ------------------------------------------- --------
Out of Pocket [*] $ [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Project Leader [*] [*]
========
$ [*]
--------
*[Confidential Treatment Requested]
Page 3
<PAGE> 65
FFP BUDGET, 1997 PROJECTION: BAXTER R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- -----
Out of Pocket [*]
[*] [*] $ [*]
[*] [*] $ [*]
[*] [*] $ [*]
Project Leader [*] $ [*]
$ [*]
========
TOTAL [*]
$ [*]
--------
CATEGORY EXPLANATION $
-------- ----------- ----------
[*] [*] $ [*]
[*] [*] $ [*]
[*] [*] $ [*]
==========
TOTAL $ [*]
----------
*[Confidential Treatment Requested]
Page 4
<PAGE> 66
FFP BUDGET, 1998 PROJECTION: STERITECH R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- -----
Out of Pocket [*] $ [*]
[*] [*] $ [*]
[*] [*] $ [*]
[*] [*] $ [*]
[*] [*] $ [*]
[*] [*] $ [*]
Project Leader [*] $ [*]
=======
TOTAL [*]
$ [*]
-------
*[Confidential Treatment Requested]
Page 5
<PAGE> 67
FFP, 1998 PROJECTION: BAXTER R&D
Category Explanation FTE/$
-------- ----------- -----
Out of Pocket [*] $ [*]
[*] [*] $ [*]
[*] [*] $ [*]
$ [*]
Project Leader [*] $ [*]
========
TOTAL [*]
$ [*]
--------
FFP BUDGET, 1998 PROJECTION: OUTSIDE EXPENSES
Category Explanation $
-------- ----------- -----
[*] [*] $ [*]
[*] [*] $ [*]
========
Total $ [*]
--------
*[Confidential Treatment Requested]
<PAGE> 68
FFP BUDGET, 1999 PROJECTION: STERITECH R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- -------
Out of Pocket [*] [*]
[*] [*] [*]
[*] [*] [*]
Project Leader [*] [*]
=======
TOTAL [*]
$ [*]
-------
*[Confidential Treatment Requested]
Page 7
<PAGE> 69
FFP, 1999 PROJECTION: BAXTER R&D
CATEGORY EXPLANATION FTE / $
-------- ----------- -------
Out of Pocket [*] $ [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Project Leader [*] [*]
=======
TOTAL [*]
$ [*}
-------
FFP BUDGET, 1999 PROJECTION: OUTSIDE EXPENSES
CATEGORY EXPLANATION $
-------- ----------- --------
[*] [*] [*]
========
Total $ [*]
--------
*[Confidential Treatment Requested]
Page 8
<PAGE> 70
FFP BUDGET, 2000 PROJECTION: STERITECH R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- -----
Out of Pocket [*] $ [*]
[*] [*] [*]
Project Leader [*] [*]
=======
TOTAL [*]
$ [*]
-------
*[Confidential Treatment Requested]
Page 9
<PAGE> 71
FFP, 2000 PROJECTION: BAXTER R&D
CATEGORY EXPLANATION FTE/$
-------- ----------- -----
[*] [*] [*]
[*] [*] [*]
Project Leader [*] [*]
=======
TOTAL [*]
[*]
--------
FFP BUDGET, 2000 PROJECTION: OUTSIDE EXPENSES
CATEGORY EXPLANATION [*]
-------- ----------- -----
[*] [*] [*]
======
Total [*]
------
*[Confidential Treatment Requested]
Page 10
<PAGE> 72
SCHEDULE C
[*] INTERIM DETERMINATION CRITERIA
The results of the [*] will be evaluated on an interim basis. [*] will be
evaluated. In accord with the [*], each will have received a [*] of the
specified [*] (should such [*] be specified in the [*].) [*] following [*] will
be compared. The definition of a successful outcome is defined as a [*] to the
mean reference product corrected count increments. [*] values shall be at least
[*].
*[Confidential Treatment Requested]
<PAGE> 73
SCHEDULE D
PLASMA DERIVATIVES LETTER
<PAGE> 74
[BAXTER HEALTHCARE CORPORATION LETTERHEAD]
Schedule D
January 18, 1996
Mr. Stephen T. Isaacs
President and CEO
Steritech, Inc.
2525 Stanwell Drive
Suite 300
Concord, CA 94520
Re: [*]
Dear Steve:
Thank you for your letter of December 26, 1995 discussing the rescission of your
Notice dated November 10, 1995. As we discussed on several occasions, Baxter is
[*]. It has always been the position of Baxter that the Steritech
decontamination technology would be [*]. With this in mind, this letter confirms
the agreement of Baxter and Steritech that:
(i) Steritech is entitled to negotiate and enter into agreements
with third parties for the development and/or licensing to such third parties
of [*], free of any rights of Baxter and without obligation to Baxter, except
as set forth in clause (ii) below.
(ii) In those cases where Steritech licenses [*] other than Baxter,
Steritech shall, at Baxter's written request, license such Steritech technology
to Baxter for such product on terms no less favorable than the terms received by
such other manufacturer.
Steritech will notify Baxter of the names of the third-party manufacturers with
whom Steritech is negotiating for licenses to Steritech's [*].
This letter agreement supersedes [*] of the Development, Manufacturing and
Marketing Agreement between Steritech and Baxter, dated as of December 10, 1993,
insofar as such section concerns [*]. (For the purposes of this letter, the term
[*] includes the term [*] used in such section.)
*[Confidential Treatment Requested]
<PAGE> 75
Mr. Stephen T. Isaacs
January 18, 1996
Page 2
Upon the execution and delivery by Steritech of this letter where indicated
below, the Notice dated November 10, 1996 is rescinded.
Sincerely,
/s/ Kim C. Bush
------------------
Kim C. Bush
President, Fenwal Division
Biotech Group
AGREED AS SET FORTH ABOVE
Steritech, Inc.
By: /s/ Stephen T. Isaacs
------------------------
Stephen T. Isaacs
President
<PAGE> 76
SCHEDULE E
CONFIDENTIALITY AGREEMENT
THIS AGREEMENT, made on March 18, 1996 with respect to the Development,
Manufacturing and Marketing Agreement ("Agreement") between Baxter and
Steritech dated as of April 1, 1996 between STERITECH, INC. ("Steritech"),
having a principal place of business at 2525 Stanwell Drive, Concord,
California and BAXTER HEALTHCARE CORPORATION ("Baxter"), a corporation having a
principal place of business at One Baxter Parkway, Deerfield, Illinois 60015,
to assure the protection and preservation of Proprietary Information disclosed
or to be disclosed or made available to each other in connection with the
Agreement.
WHEREAS, the parties have entered into a development, manufacturing and
marketing collaboration pursuant to the Agreement;
WHEREAS, the parties desire to assure the confidential status of the
information which may be disclosed to each other in connection with the
Agreement;
NOW THEREFORE, in reliance upon and in consideration of the following
undertakings, the parties agree as follows:
1. All information disclosed to the other party shall be deemed to be
"Proprietary Information." In particular, Proprietary Information shall be
deemed to include any information, process, technique, algorithm, program,
design, drawing, formula or test data relating to any research project, work in
progress, future development, engineering, manufacturing, marketing, servicing,
financing or personnel matter relating to the disclosing party, its present or
future products, sales, suppliers, clients, customers, employees, investors, or
business. Any Proprietary Information outside the scope of the Agreement shall
be identified by the disclosing party in writing and marked "Confidential" or
if such Proprietary Information is disclosed orally, within 30 days after such
disclosure the Proprietary Information shall be reduced to writing and marked
"Confidential" by the disclosing party and such writing forwarded to the
receiving party.
2. The term "Proprietary Information" shall not be deemed to include
information which: (i) is now, or hereafter becomes, through no act or failure
to act on the part of the receiving party, generally known or available; (ii)
is known by the receiving party at the time of receiving such information as
evidenced by its records; (iii) is furnished to the receiving party by a third
party whom the receiving party believes has a right to disclose such
information; (iv) is independently developed by the receiving party without any
breach of this Confidentiality Agreement; and (v) is the subject of a written
permission to disclose provided by the disclosing party.
3. Each party shall maintain in trust and confidence and not disclose
to any third party or use for any unauthorized purpose any Proprietary
Information received from the other
1.
<PAGE> 77
party. However, each party may disclose Proprietary Information to its
affiliates who are bound by this Agreement (affiliates include: any company
owning 40% or more of a party, or a subsidiary of the party, or a subsidiary of
a party owning 40% or more of the party). Each party may use such Proprietary
Information only to the extent required under the Agreement.
4. The responsibilities of the parties with respect to the Proprietary
Information are limited to using the same degree of care used to protect their
own Proprietary Information from unauthorized use or disclosure. Both parties
shall advise their employees or agents who might have access to such Proprietary
Information of the confidential nature thereof.
5. This Confidentiality Agreement shall continue in full force and
effect for so long as the parties continue to exchange Proprietary Information
under the Agreement. The termination of the Agreement shall not relieve either
party of the obligations imposed by this Confidentiality Agreement with respect
to Proprietary Information disclosed prior to the effective date of such
termination, which obligations shall survive the termination of the Agreement
for a period of two (2) years from the date of disclosure.
6. Each party hereby acknowledges and agrees that in the event of any
breach of this Confidentiality Agreement by the other party, including, without
limitation, the actual or threatened disclosure of a disclosing party's
Proprietary Information without the prior express written consent of the
disclosing party, the disclosing party will suffer an irreparable injury, such
that no remedy at law will afford it adequate protection against, or
appropriate compensation for, such injury. Accordingly, each party hereby
agrees that the other party shall be entitled to any injunctive relief as may
be granted by a court of competent jurisdiction.
AGREED TO: AGREED TO:
STERITECH, INC. BAXTER HEALTHCARE CORPORATION
By: Stephen T. Isaacs By: Kim Bush
President President, Fenwal Division
2.
<PAGE> 78
SCHEDULE F
BAXTER PARTICIPATION IN 1996
RED CELL ESTIMATED FTES
1. Consult on [*] [*]
2. Consult on [*] [*]
3. Consult on [*] [*]
FRESH FROZEN PLASMA
1. Consultants to review and comment on [*] TBD
2. [*] Baxter - I.V. Systems and/or Baxter Fenwal Europe [*]
will consult
3. Disposable/Device - Final phase development of a
disposable for use in toxicology and clinical trials.
Ongoing production of bags for use in [*]
work/toxicology trials/clinical trials [*]
4. [*] -- Development and validation of [*] [*]
*[Confidential Treatment Requested]
<PAGE> 79
SCHEDULE G
STOCK PURCHASE AGREEMENT
Reference is hereby made to Exhibit 10.14,
which is hereby incorporated herein by reference.