CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND
EXCHANGE ACT OF 1934, AS AMENDED.
EXHIBIT 10.17
DEVELOPMENT, MANUFCTURING AND
MARKETING AGREEMENT
DEVELOPMENT, MANUFACTURING AND MARKETING AGREEMENT
THIS AGREEMENT ("AGREEMENT") between XXXXXX HEALTHCARE CORPORATION, a
Delaware corporation ("BAXTER") with principal offices at Xxx Xxxxxx Xxxxxxx,
Xxxxxxxxx, Xxxxxxxx 00000, and STERITECH, INC., a California corporation
("STERITECH") with principal offices at 0000 Xxxxxxxx Xxxxx, Xxxxxxx, Xxxxxxxxxx
00000, is effective as of the tenth day of December, 1993 ("EFFECTIVE DATE").
1. BACKGROUND.
1.1 Steritech has substantial knowledge and expertise in the area of
decontamination of pathogens in blood products using photoactive compounds.
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 photoactive compounds for use in the inactivation of pathogens
in human platelet concentrate.
1.3 Concurrently with the execution and delivery of this Agreement,
Baxter is executing and delivering a Stock Purchase Agreement dated the date of
this Agreement with respect to the purchase of Series C Preferred Stock of
Steritech for a purchase price of $1,000,000.
2. DEFINITION OF TERMS.
The words appearing in capitalized form throughout this Agreement shall
have the meanings assigned to them in this Section 2.
ADDITIONAL COST OF GOODS shall mean that portion of the Cost of Goods
as (defined below) that exceeds the Anticipated Cost of Goods (defined below).
ANTICIPATED COST OF GOODS shall mean [ * ] or Xxxxxx'x Cost of Goods
for the Inactivation Package and [ * ] for Steritech's Cost of Goods for the
Steritech Compound.
BAXTER shall mean Xxxxxx Healthcare Corporation and its affiliates,
including, but not limited to, divisions and subsidiaries, and also including
its parent company, Xxxxxx International Inc. and its affiliates, including, but
not limited to, divisions and subsidiaries. A company shall be considered an
affiliate if it is at least forty percent (40%) owned or controlled by Xxxxxx
Healthcare Corporation or Xxxxxx International Inc.
BAXTER BENCHMARKS shall mean the accomplishments set forth on Schedule
A of this Agreement, to be accomplished by Baxter.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
2.
BAXTER KNOW-HOW shall mean unpatented inventions, data, processes,
compositions, techniques and other technical information proprietary to Baxter
relating to the Field and the System including, methods for manufacture or use
of a System or portion thereof.
BAXTER PATENTS shall mean 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.
BAXTER LICENSED KNOW-HOW shall mean all Baxter Know-How in existence as
of the Effective Date or created or acquired during the term of the Cooperative
Development Work, but not after December 31, 1998 unless such Know-How is used
in a System that is sold pursuant to this Agreement or the parties shall
otherwise agree in writing.
BAXTER LICENSED PATENTS shall mean all Baxter Patents in existence as
of the Effective Date of this Agreement or created and reduced to practice or
acquired during the term of the Cooperative Development Work, but not after
December 31, 1998 unless such Patent is used in a System that is sold under this
Agreement or the parties shall otherwise agree in writing.
BENCHMARKS shall mean Steritech Benchmarks and Baxter Benchmarks.
BULK FORM shall mean Steritech Compounds which are not packaged in
single dosage final form.
COOPERATIVE DEVELOPMENT WORK shall mean the Cooperative Development
Work described at Section 3 herein.
COST OF GOODS for any item shall mean the full cost of manufacture of
such item as determined by generally accepted cost accounting procedures, except
that such costs shall NOT include general corporate allocations or other
allocations which are not directly related to manufacture of the item and shall
NOT include amortization of development expenditures.
EUROPE shall mean Austria, the Benelux countries, Denmark, Finland,
France, Germany, Ireland, Italy, Norway, Spain, Sweden, Switzerland, and the
United Kingdom.
FDA shall mean the United States Food and Drug Administration.
THE FIELD shall mean the EX VIVO photochemical inactivation of viruses,
bacteria and parasites in human platelet concentrated for transfusion in
platelet-specific (but not multiple blood component) inactivation systems.
INACTIVATION PACKAGE shall mean the package containing the psoralen as
well as the delivery system.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
3.
INITIAL BUDGET shall mean the budget attached as Schedule B hereto.
INSTRUMENT shall mean the instrument to be developed under the
Cooperative Development Work that will provide illumination as required for
photochemical inactivation and may include associated data tracking systems.
INTERCONTINENTAL shall mean any country not included in the definition
of Europe and North America and excluding Japan.
JOINT PATENTS shall mean all United States and foreign patent
applications and patents claiming an invention conceived jointly by employees
and/or agents of both Steritech and Baxter, including any continuations,
divisions, reissues, re-examinations and all foreign counterparts thereof. A
schedule listing such applications and patents shall be appended to this
Agreement during its term and amended from time to time. Ownership of an
invention 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. As of the Effective Date, no Joint Patents exist.
MANAGEMENT BOARD shall mean the Management Board created pursuant to
Section 3.5 hereof.
MARKET LAUNCH of the 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.
NET SALES shall mean
(a) in the case the Inactivation Package is sold as a
stand-alone item, the amount invoiced by Xxxxxx and Xxxxxx affiliates for sales,
leases, or licenses of Inactivation Packages, 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 on shipment from Baxter to end users, and
(b) In the case in which the Inactivation Package is sold as
an integral part of a set with other collection and/or storage items, the Value
Added attributable to the Inactivation Package multiplied by the number of such
sets shipped to third parties by Xxxxxx and Xxxxxx affiliates. The Value Added
shall mean the amount by which the addition of the Inactivation Package to such
set increases the price of such set to ultimate purchasers or users in
comparison to a set that does not contain such inactivation package.
For the purpose of clause (a) of this definition:
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
4.
(i) Any Inactivation Package bundled (whether or
not invoiced separately) and sold at a discount with other products for
whatever reason, including a special promotional offer, or other than a bona
fide arms length transaction exclusively for money, or upon any use of such
Inactivation Package for purposes which do not result in a disposal of such
products in consideration of sales revenue customary of use, 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 Inactivation
Packages. (ii) 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 in its sole discretion recommends
the distributor to charge to its end customers (which may vary from territory
to territory).
In computing Net Sales of Inactivation Packages, no deduction from
invoice price or Value Added shall be made with respect to the costs of the
Instruments or with respect to any rental surcharge for Instruments. 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.
NORTH AMERICA shall mean the United States and Canada.
PATENT ROYALTY PAYMENT means a patent royalty payment made to a third
party for manufacture, use or sale of a System or portion thereof.
PREMIUM shall mean the Net Sales price minus Additional Cost of Goods.
PRODUCT MARKET in a given country shall mean the anticipated annual
market (expressed in number of Inactivation Packages) for Baxter systems for
decontamination of platelets in such country as determined by Baxter reasonably
and in good faith at the time of Regulatory Approval in such country, provided
that for each country in North America and Europe such market shall be not less
than the [ * ] in that country. Baxter shall notify Steritech of such
determination within sixty days after Regulatory Approval in such country.
PROJECT COMMITTEE shall mean a committee consisting of two (2)
representatives from each party whose purpose is to oversee, coordinate and
manage the Cooperative Development Work to ensure that a coordinated plan exists
to take the System from conception through to commercialization. Each party will
nominate one of its representatives on the Project Committee as the party's
"Leader," subject to approval by the other party.
PROOF OF PRINCIPLES shall mean that tests have been conducted
demonstrating to Xxxxxx'x scientific satisfaction the inactivation of pathogens
and a reasonable level of preservation of cellular or protein function.
REGULATORY APPROVAL shall mean (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.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
5.
REVENUE SHARING FORMULA shall mean the relative percentage interest of
Baxter and Steritech as set forth in Section 7 hereof.
REVENUE SHARING PAYMENTS shall mean the payments that Steritech is
entitled to receive pursuant to Section 7.
SPECIFICATIONS FOR STERITECH COMPOUND shall mean the performance, cost,
quality and reliability requirements which the Project Committee and Management
Board agree must be met by a Steritech Compound for such Steritech Compound to
be acceptable for commercial implementation under Section 5.3. The Project
Committee and 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.
STERITECH shall mean 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 if it is at least
forty percent (40%) owned or controlled by Steritech.
STERITECH COMPOUND shall mean any and all psoralen 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 shall mean unpatented inventions, data, processes,
compositions, techniques and other technical information relating to the Field
proprietary to Steritech relating to the System, including methods for
manufacture or use of, Steritech Compounds and Systems or portions thereof.
STERITECH LICENSED KNOW-HOW shall mean all Steritech Know-How in
existence as of the Effective Date or created or acquired during the term of the
Cooperative Development Work, but not after December 31, 1998 unless the parties
shall otherwise agree in writing.
STERITECH PATENTS shall mean all United States and foreign patent
applications and patents relating to the Field having claims reading on
Steritech Compounds or compositions or 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 and claiming
an invention conceived solely by employees and/or licensors, agents of
Steritech, prior to the Effective Date, or during the term of Cooperative
Development Work, including any continuations, divisions, reissues,
re-examinations and foreign counterparts thereof. Steritech Patents in existence
as of the Effective Date are listed in the Attached Schedule B. Schedule B shall
be amended from time to time to include Steritech Patents as to applications
filed and patents issued during the term of this Agreement and forthwith
provided to Baxter.
STERITECH LICENSED PATENTS shall mean all Steritech Patents in
existence as of the effective date of this Agreement or created and reduced to
practice or acquired during the term of
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
the Cooperative Development Work, but not after December 31, 1998 unless the
parties shall otherwise agree in writing.
STERITECH MILESTONES shall mean the accomplishments set forth in
Section 4.0 of this Agreement, to be accomplished by Steritech.
SYSTEM shall mean a product developed pursuant to the Cooperative
Development Work for use in the Field, incorporating the instrument, associated
computer software, disposables or other components and also incorporating or
employing one or more Steritech Compounds.
SYSTEM SPECIFICATIONS shall mean the performance, cost, quality and
reliability requirements as the Project Committee and, 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 until the date the
System obtains Regulatory Approval in the United States, Europe (C.E. Xxxx) and
Japan, Baxter and Steritech shall work together to develop and obtain Regulatory
Approval of a System for use in the Field ("Cooperative Development Work").
3.2 BAXTER BENCHMARKS. Baxter shall develop the Instrument and
disposables for the System and attempt to achieve the Baxter Benchmarks by the
dates set forth for each Benchmark on Schedule A.
3.3 STERITECH BENCHMARKS. Steritech shall attempt to achieve the
Steritech Benchmarks by the dates set forth for each Benchmark on Schedule C.
3.4 PROJECT COMMITTEE. Steritech and Baxter will appoint a Project
Committee under the definition of such term in Article 2. The Project Committee
will meet at mutually acceptable times to review the Cooperative Development
Work.
3.5 MANAGEMENT BOARD. Steritech and Baxter will appoint a six (6)
person Management Board consisting of two (2) senior executives designated by
each company and each company's Leader from the Project Committee. The purpose
of the Management Board will be to facilitate the overall relationship of the
parties under this Agreement. System Specifications recommended by the Project
Committee shall not be deemed finalized until they are unanimously approved by
the Management Board. The Management Board shall meet from time to time as
appropriate, but no less frequently than two (2) times during each calendar
year, which meetings shall be in June and December, alternating between the
offices of the parties, unless the parties shall agree otherwise. The Management
Board shall review expenditures at least once during each calendar year. All
decisions of the Management Board shall be made by unanimous vote, with Baxter
and Steritech each having one vote regardless of the number of representatives
attending any meeting, in good faith, and considering the interests of both
parties.
3.6 REVIEW OF BUDGET, BENCHMARKS, ETC. The Benchmarks, budget and a
timetable will be reviewed by the Project Committee and Management Board from
time to time during the
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
7.
Cooperative Development Work with the intent that the parties move expeditiously
and effectively toward commercialization of the System. The Initial Budget is
attached hereto as Schedule D and is deemed approved by the Management Board. No
revision shall be made to the budget without unanimous approval of the
Management Board.
3.7 EXCHANGE OF INFORMATION. During the term of the Cooperative
Development Work, the parties shall exchange all information developed pursuant
to the Cooperative Development Work including the exchange of Baxter Know-How
and Steritech Know-How relating to the Field. The exchange shall occur pursuant
to Section 12.
3.8 EXPENDITURES. It is a principal goal of the parties that Baxter and
Steritech make approximately the same financial contribution to the Cooperative
Development Work.
3.8.1 Each party shall maintain detailed records which
accurately identify costs and expenses incurred and paid in connection with the
Cooperative Development Work. Each party shall submit this information to the
Management Board as of the 15th day of November or May for the prior six (6)
months 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 based upon actual employee salaries and fringe
benefits and variable expenses and directly applicable overhead allocations,
however, for Baxter expenses will include, to the extent applicable, any
internal corporate charge-backs. Only the reported actual cash outlays and
expenses which are previously unanimously approved by the Management Board as
part of the budget established and approved under Section 3.6 shall be
considered as actual cash outlays and expenses incurred by the parties in
connection with the Cooperative Development Work.
3.8.2 Each party will be responsible for all costs with
respect to participation of its own staff on the Management Board and the
Project Committee during the Cooperative Development Work, including travel
expenses for meetings and participation on the Management Board or Project
Committee. The goal of equality in expenditures shall be disregarded with
respect to these costs, and these costs shall not be subject to cost sharing.
3.9 PAYMENT SCHEDULE.
3.9.1 On December 13, 1993, Baxter will make a payment of
three million dollars ($3,000,000.00) to Steritech in consideration of the
rights given under this Agreement to Baxter to Steritech Patents and Steritech
Know-How. Additionally, on December 13, 1993, Baxter will also make to Steritech
a research and development payment for future developments in the amount of one
million seven hundred thousand dollars ($ 1,700,000.00).
3.9.2 Baxter will make development payments to Steritech,
except as provided in Section 3.9.3, to Steritech on the first business day for
the indicated months for each of the following years:
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
8.
January July
1994 $ 1,235,164
1995 $ 692,169 $ 692,169
1996 $ 803,370 $ 803,370
1997 $ 204,316 $ 204,316
3.9.3 With respect to the payments under Section 3.9.2, at any
time there are delays in achievement of any Benchmark that justify a deferral of
funding of amounts that were budgeted for prepayment of outside contract
expenses for the next six month period (see Schedule E attached), Baxter may
defer such payment with respect to such outside expenses (but not with respect
to Steritech budgeted internal expenses) until such Benchmark is reached or the
Management Board determines that progress is otherwise satisfactory.
3.9.4 Unless otherwise agreed between the parties, all
development payments under Section 3.9 and all Steritech Milestone payments
under Article 4.0 hereof shall be paid on or before the due date by wire
transfer to the bank account of Steritech specified in writing by Steritech to
Baxter.
3.10 TESTING AND REGULATORY EXPENSES.
3.10.1 TESTING EXPENSES. Expenses incurred in connection with
any testing whose primary function is marketing of the System, rather than for
developing or obtaining Regulatory Approval of the System, shall be borne solely
by Baxter and shall not be considered expenses subject to cost sharing.
3.10.2 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 will be paid by the parties pursuant to the Cooperative
Development Work budget.
3.11 BUDGET CONTINGENCIES. If a Benchmark is not completed within the
budget for such Benchmark, upon the recommendation of the Project Committee, and
subject to the approval of the Management Board, the Management Board shall set
a new budget for completion of such Benchmark. Unless the Management Committee
shall determine otherwise, Steritech and Baxter will each fund one-half of the
amount needed to complete such Benchmark. Steritech shall not be obligated to
fund more than twelve and one-half (12.5) million dollars in the aggregate under
this Agreement. To the extent that budget over-runs could obligate Steritech to
spend more than twelve and one-half (12.5) million dollars, the Management
Committee can modify the time lines and budget items to allow Baxter, if it
desires, to fund budget over-runs that would obligate Steritech to spend more
that twelve and one-half (12.5) million dollars. To the extent Baxter pays more
than Steritech in budget over-runs, Baxter can recoup 50% of the difference
("Excess Payment") plus its cost of debt capital plus 8% per annum (collectively
not to exceed 20%) for the Excess Payment from the Revenue Sharing Payments due
Steritech.
3.12 RECONCILIATION OF EXPENDITURES FOLLOWING REGULATORY APPROVAL.
Within sixty (60) days following Regulatory Approval in the United States, the
Management Board will
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
9.
determine whether the actual cash outlays and expenses incurred by Steritech and
Baxter and approved by the Management Board up to such Regulatory Approval are
equal. If they are not equal, the party incurring fewer expenses shall make a
cash payment to the other party equal to one-half (1/2) the difference between
the parties' expenses up to such Regulatory Approval, except to the extent that
the Management Board shall previously have determined that particular expenses
shall be borne in a different ratio. The payment shall be made in cash within
sixty (60) days following the determination by the Management Board.
3.13 RECONCILIATION OF EXPENDITURES PRIOR TO REGULATORY APPROVAL. If
the parties jointly decide that they will both cease Cooperative Development
Work prior to Regulatory Approval in the United States, then within sixty (60)
days following the joint decision, the Management Board will determine whether
the actual cash outlays and expenses incurred by Steritech and Baxter and
approved by the Management Board up to the date of such decision for the System
are equal. If they are not equal, the party incurring fewer expenses shall make
a cash payment to the other party equal to one-half (1/2) the difference between
the parties' expenses up to that date, except to the extent that the Management
Board shall previously have determined that particular expenses shall be borne
in a different ratio. The payment shall be made in cash within sixty (60) days
following the determination by the Management Board.
3.14 FUNDING CONTINGENCY. Subject to the rights of Baxter under Section
13 and Section 17 hereof, if Steritech anticipates that for any reason it will
be unable to reasonably provide its share of the development funding for any
period, and shall provide to Baxter ninety (90) days written notice of such
anticipated funding shortfall, Baxter may, at its sole discretion, provide to
Steritech amounts sufficient to bridge such funding shortfall. To the extent
such payment shortfall is not otherwise reconciled as provided in this
Agreement, Baxter will be entitled to recoup such amounts plus Xxxxxx'x cost of
debt capital plus eight (8) percent per annum (collectively not to exceed 20%)
by deducting Revenue Sharing Payments otherwise due to Steritech in each
calendar quarter until such amounts and interest have been recouped.
4. MILESTONE PAYMENTS.
4.1 GENERAL. In furtherance of the research and development efforts
conducted by Steritech with respect to the System, Baxter shall make the
payments to Steritech specified below. These payments are to be used. solely for
the development of the System.
4.2 FUNDING. Baxter shall make the following payments to Steritech
during the term of the Agreement:
$200,000 Milestone and budget agreement (Previously paid)
$300,000 On December 13, 1993
$500,000 Upon IND toxicology initiation (Milestone A)
$750,000 Upon initiation of Phase I Clinical Trials (Milestone B)
$750,000 Upon initiation of Phase II Clinical Trials (Milestone C)
These payments shall not be subject to cost sharing.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
10.
Baxter shall pay Steritech $300,000 on December 13, 1993 to fund the
achievement of Milestone A, as set forth above. Thereafter, Baxter shall make
payments to Steritech to fund the achievement of additional research steps:
$500,000 toward the achievement of Milestone B, payable upon completion of
Milestone A, $750,000 toward the achievement of Milestone C, payable upon
completion of Milestone B, and $750,000 toward the achievement of additional
research efforts upon completion of Milestone C.
5. SUPPLY OF STERITECH COMPOUND AND SYSTEM MANUFACTURING.
5.1 BAXTER RESPONSIBILITIES. Subject to this Section 5, all aspects of
and costs related to scale-up, production, marketing and distribution of the
System, but not including the compound, shall be the responsibility of Baxter.
5.2 INSTRUMENT PRODUCTION. Baxter shall, at its own expense, tool and
scale up the production model of the Instrument. Baxter shall be responsible for
production and manufacture of the Instrument and associated software of the
System.
5.3 SYSTEM SPECIFICATIONS. Xxxxxx'x manufacture of each System shall be
in accordance with Systems Specifications as finally approved in writing by the
Project Committee and Management Board. Any change in Systems Specifications
must be approved in writing by the Management Board.
5.4 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 photoactive
compounds for use in the Field from Steritech. Steritech Compounds shall meet
the Specifications for Steritech Compounds as finally approved in writing by the
Project Committee and Management Board. Any change in specifications for
Steritech Compounds must be approved in writing by the Management Board.
5.5 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
Xxxxxx in Steritech's obtaining such alternate source to the extent commercially
reasonable.
5.6 FAILURE OF STERITECH TO MEET XXXXXX REQUIREMENTS. In the event that
Steritech cannot meet Xxxxxx'x requirements for Steritech Compound, Xxxxxx shall
be free to obtain Steritech Compound from a third party. Steritech agrees to
provide to the third party that Xxxxxx selects with the necessary information
and Steritech Know-How to allow the third party to make the Steritech Compound.
The monies Xxxxxx expends in obtaining Steritech Compound from a third party
shall be reimbursed to Xxxxxx and therefore treated as an Additional Cost of
Goods to Xxxxxx.
5.7 UPGRADES. During the term of this Agreement, Steritech will
cooperate with Xxxxxx in making adjustments to the System to meet changing
market needs, provided such activities do not require material expense on the
part of Steritech, such as initiation of new toxicology or clinical trials.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
11.
6. MARKETING AND DISTRIBUTION RIGHTS: LOSS OR RETENTION OF EXCLUSIVE
DISTRIBUTION RIGHTS.
6.1 EXCLUSIVE RIGHT TO MARKET. Xxxxxx shall have the exclusive
right to and shall market and distribute the System directly through its
distributors throughout the world pursuant to the terms of this Agreement.
6.2 SALES PERFORMANCE REQUIREMENTS.
6.2.1 For the purpose of determining whether Xxxxxx may retain
exclusive distribution rights to each System in a country, Xxxxxx'x sales
performance shall be evaluated annually over a twelve (12) month period on a
country-by-country basis commencing with the twelve (12) month period beginning
on the first day of the first calendar quarter following the third anniversary
of the Market Launch of a System in a Country ("Evaluation Period").
6.2.2 In order to retain exclusive distribution rights to the
System in a given country, the number of Inactivation Packages sold by Xxxxxx in
that country during the Evaluation Period must represent for the first year of
the Evaluation Period [ * ] of the Product Market, for the second year of the
Evaluation Period [ * ] of the Product Market and for every year after the
second year of the Evaluation Period [ * ] of the Product Market, except for
countries that fall within the definition of Intercontinental where Xxxxxx'x
obligations shall be only [ * ] of Product Market for the first year of the
Evaluation Period, [ * ] of Product Market for the second year of the Evaluation
Period, and [ * ] of Product Market for every year thereafter. These percentages
assume that during such period there are not competitive systems in the country
that represent at least [ * ] for an Intercontinental country, of the Product
Market. If there are competitive systems in such country and the competitive
system(s) represent at least [ * ] for [ * ] or [ * ] for an Intercontinental
country, of the anticipated share of the Product Market then Xxxxxx is obligated
only to sell an amount that is equal to the [ * ]. If more than one competitive
system exists in a country then Xxxxxx'x obligations are reduced by the [ * ].
6.2.3 Within ninety (90) days following each Evaluation
Period, Xxxxxx shall provide Steritech with a writer report in sufficient detail
to facilitate Steritech's evaluation of whether Xxxxxx'x sales comply with the
performance criteria in Section 6.2.2. Xxxxxx shall permit an independent
certified public accountant designated by Steritech and approved by Xxxxxx to
audit Xxxxxx'x records solely for the purpose of verifying the accuracy of
Xxxxxx'x reports, provided such accountant agrees to execute a confidentiality
agreement reasonably satisfactory to Xxxxxx. The cost of such audit shall be the
sole expense of Steritech unless Xxxxxx'x report differs from the accountant's
report in Xxxxxx'x favor by ten percent (10%) or more, in which case, Xxxxxx
shall pay the entire expense of such audit.
6.2.4 If Xxxxxx fails to meet the criteria set forth in
Section 6.2.2 in a particular country, on ninety (90) days written notice to
Xxxxxx, Steritech may convert Xxxxxx'x exclusive distribution rights with
respect to that System in that country to non-exclusive distribution rights for
that System in that country. In such event, Xxxxxx hereby grants Steritech a
non-exclusive license bearing a royalty of [ * ] of Steritech's Net Sales. under
Xxxxxx Patents and Know-How to make, have made and use, and sell Systems in the
Field in such country terminating upon expiration of the last to expire of the
Xxxxxx Patents. Upon Steritech's request, Xxxxxx shall, if it
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
12.
has the present capability, manufacture or have manufactured and sell Systems
and/or components thereof to Steritech at a price equal to [ * ] of Xxxxxx'x
actual fully loaded cost of goods. Steritech shall not have the right to
distribute Systems through a third party manufacturer or distributor of blood
packs or automated blood collection systems unless specific approval from
Xxxxxx is obtained.
6.2.5 FAILURE TO MARKET. in addition to the rights set forth
in Section 6.2.3 above, in the event that, following Regulatory Approval in a
country, Xxxxxx shall not undertake, or shall cease, active marketing and
distribution of the System in a country for a period of 12 months Steritech may
by notice to Xxxxxx market and distribute, on a nonexclusive basis, Systems in
that country and Steritech shall have a royalty-free license with respect to
Xxxxxx'x Patents and Know-How to make, have made and use, and sell Systems in
such country. Steritech shall not have the right to distribute Systems through a
third party manufacturer or distributor of blood packs or automated blood
collection systems unless specific approval from Xxxxxx is obtained.
6.2.6 Notwithstanding the provisions of Sections 6.2.1 through
6.2.6, the parties agree that Steritech's right to convert Xxxxxx'x rights shall
be suspended if any failure of Xxxxxx to meet the criteria set forth in Section
6.2.2-6 during any Evaluation Period results from recall or withdrawal of
government approval or a delay in manufacturing or sales beyond the reasonable
control and occurring without the fault of Xxxxxx, as a result of which it would
be commercially infeasible for any entity to achieve the requirements of Section
6.2.2-6. This right shall be suspended only for the duration of the event that
precluded Xxxxxx from meeting the Section 6.2.2-6 criteria.
6.3 MEETINGS CONCERNING MARKETING. During those periods when Xxxxxx is
the exclusive distributor of the System in a Region, the parties will meet from
time to time to discuss 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 Xxxxxx. However,
Xxxxxx will consult with Steritech prior to any pricing decision that will cause
the Premium to be less than [ * ].
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 7.2, 13, and 17, no later than forty-five (45) days after the first and
all subsequent calendar quarters following the Market Launch of the System,
Xxxxxx shall pay to Steritech a sum equal to twenty-six percent (26%) of the
Premium during such calendar quarter ("Revenue Sharing Payments"). 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 at Concord, California in U.S. dollars
converted from such currency using the closing spot exchange rate between the
two currencies quoted in the Wall Street Journal (or, if not available, such
other mutually agreeable financial publication of international circulation) in
effect on the last business day of the calendar quarter to which the payment
relates.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
13.
7.2 EXCEPTION TO REVENUE SHARING PAYMENTS OF 7.1. It the Premium for
the Inactivation Package is $50.00 to $58.00, then Steritech shall receive as
its sole Revenue Sharing Payment $14.25 for each Inactivation Package sold at
that Premium. If the Premium for the Inactivation Package is $40.00 to $49.99,
then Steritech shall receive 28% of the Premium for each Inactivation Package
sold at that Premium. In no event shall Steritech receive less than $8.50 per
Inactivation Package sold or more than $20.00 for each Inactivation Package
sold, unless the United States consumer price index (CPI) in any year exceeds
the 1993 CPI by 50% or more in which case the $320.00 figure shall increase
$5.00 for each 50% above the 1993 CPI.
7.3 ADJUSTMENTS TO REVENUE SHARING PAYMENTS. To the extent that
Xxxxxx'x or Steritech's Cost of Goods exceeds the Anticipated Cost of Goods, the
Additional Cost of Goods per Inactivation Package will be provided to the
appropriate party and deducted from Net Sales to determine the Premium.
8. PATENTS, KNOW-HOW, LICENSE GRANTS.
8.1 STERITECH SOLE OWNERSHIP. Steritech shall own all Steritech Patents
and Steritech Know-How.
8.2 XXXXXX SOLE OWNERSHIP. Xxxxxx shall own all Xxxxxx Patents and
Xxxxxx Know-How.
8.3 JOINT PATENTS. Steritech and Xxxxxx shall jointly own all Joint
Patents, provided that either party that shall exploit a Joint Patent outside
the Field shall pay to the other party a reasonable royalty of [ * ] of Net
Sales unless the Management Committee sets a different royalty rate with respect
to such exploitation. Joint Patents within the Field may be exploited by either
party only through the development, manufacture and sale of Systems under and in
accordance with the terms of this Agreement.
8.4 LICENSE TO XXXXXX. 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 Xxxxxx an exclusive, paid-up, royalty free (except as provided
herein) license under Steritech Licensed Patents and Steritech Licensed Know-How
to make, have made, and use, sell or have sold such Systems, solely with
Inactivation Packages pursuant to this Agreement worldwide, solely for use in
the Field. Notwithstanding the foregoing, for any period or country where such
marketing rights become nonexclusive pursuant to the Agreement, such license
shall automatically become nonexclusive for such period or in that country.
Except as set forth in Section 5.6, and 17.3, such license shall exclude the
right to make and have made Steritech Compounds. As to Steritech Compounds, such
license shall be limited to the Steritech Compound that is selected by the
Management Board to proceed with clinical trials and that is incorporated in the
System that receives Regulatory Approval, provided that if for technical or
other reasons the Management Board substitutes another Steritech Compound in
such process, such license shall cover such substituted Steritech Compound.
Notwithstanding anything in this Section or elsewhere in this Agreement, Xxxxxx
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 (b) the [ * ] inactivation system
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
14.
development at Steritech as further described on Schedule hereto, (c) synthetic
media, or (d) use outside the Field.
8.5 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.
8.6 OTHER AGREEMENTS. Steritech shall not terminate, alter or amend the
terms of the following agreements in a manner that would limit Steritech's or
Xxxxxx'x rights under this Agreement without the prior written approval of
Xxxxxx: the Technology Transfer Agreement and the License Agreement between
Steritech and HRI Research, Inc. each dated December 13, 1991.
Xxxxxx shall respond within thirty (30) days of receipt of written
proposed changes to such agreements. Xxxxxx'x approval of proposed changes shall
not be unreasonably withheld.
8.7 RIGHT OF FIRST REFUSAL. Steritech hereby grants Xxxxxx a right of
first refusal with respect to a development, manufacturing and
marketing
agreement for any technology Steritech, its employees, or agents may develop
during the term of the Cooperative Development Work relating to decontamination
of red blood cells, platelet rich plasma, or fresh frozen plasma (Technology).
Steritech and Xxxxxx shall negotiate in good faith for an exclusive license to
any such Technology. If the parties fail to reach agreement with respect to any
such Technology, Steritech may solicit other offers and engage in negotiations
with third parties with respect to that specific Technology. However, prior to
concluding any such Agreement with any third party, Steritech must offer Xxxxxx
the option to accept the proposed Agreement with respect to the Technology on
the terms agreed to with the third party. If not accepted in forty-five (45)
days of such offer in writing by Xxxxxx, Steritech will be free to enter into an
agreement with the third party on such terms. This right of first refusal shall
expire if Xxxxxx breaches this Agreement and does not cure the breach pursuant
to Section 17 or if Xxxxxx unilaterally ceases development work pursuant to
Section 13. 1.
8.8 RIGHT OF FIRST NEGOTIATION. In the event that Steritech, during the
term of the Cooperative Development Work, determines to pursue a corporate
partnership arrangement for the development, manufacturing and distribution of a
system (other than a system based on [ * ] for [ * ], Steritech will notify
Xxxxxx in writing. Xxxxxx will promptly notify Steritech (in no event later than
30 days after Steritech's notice) whether Xxxxxx intends to enter negotiations
for such an agreement. If so, Xxxxxx will have the exclusive right, for a period
of 120 days from the date of Steritech's notice, to negotiate with Steritech for
the right to fund development of, and to manufacture and distribute such system.
In the event that Xxxxxx and Steritech do not enter into a definitive
written agreement within such period, Xxxxxx will provide to Steritech prior to
the end of such period a precise definitive written statement of terms on which
Xxxxxx is willing to enter such an agreement (the "Xxxxxx Terms"). The Xxxxxx
Terms shall include up-front payments, development funding,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
15.
revenue sharing and any other material terms. Steritech may thereafter negotiate
with third parties for the development, manufacturing and marketing of the
system. Steritech may not, however, enter into such an agreement with any third
party on terms ("Third Party Terms") which, taken as a whole, are more favorable
to the third party than the Xxxxxx Terms unless Steritech shall have first
presented to Xxxxxx such Third Party Terms, or the form of definitive agreement
with the third party incorporating the Third Party Terms, and Xxxxxx shall not
have given to Steritech Xxxxxx'x unqualified commitment in writing to such
Third Party Terms or definitive agreement, as the case may be, within thirty
days thereafter. Third Party Terms shall not be considered more favorable than
the Xxxxxx Terms if they afford an equal or lower net present value (based on
reasonable projections) or materially lesser rights to the third party than the
Xxxxxx Terms. This right of first negotiation shall expire if Xxxxxx breaches
this Agreement and does not cure the breach pursuant to Section 17 or
unilaterally ceases the development work pursuant to Section 13. 1.
8.9 ADDITIONAL CONSIDERATION. In consideration of the Rights of First
Refusal and Negotiation, Xxxxxx will pay Steritech $1,000,000 upon Steritech
providing Xxxxxx with Proof of Principles of a red blood cell inactivation
system on or after January 1, 1995. Should the parties not enter into a
development, manufacturing, and
marketing agreement with respect to such red
blood cell inactivation system, Steritech will refund the $1,000,000 payment to
Xxxxxx within 120 days after written request by Xxxxxx.
8.10 SUBLICENSES. Neither Xxxxxx nor Steritech shall not have the right
to grant to any third party Sublicenses to the licenses granted above.
8.11 REGULATORY FILES. Xxxxxx 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 the 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.
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 XXXXXX PATENTS. Xxxxxx shall have the right but no obligation to
timely prepare, file, prosecute and maintain, under its exclusive control and at
its expense, Xxxxxx Patents.
9.3 JOINT PATENTS. Steritech and Xxxxxx shall employ mutually
acceptable counsel for the purpose of timely preparing, filing, prosecuting and
maintaining Joint Patents. 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 Xxxxxx and Steritech, as evidenced in writing shall be borne
equally. Unless such other countries are agreed to by the
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
16.
parties in writing, such other country filings shall not be made. Xxxxxx 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 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 XXXXXX TRADEMARKS. Steritech shall make no use of any Xxxxxx
trademark without the prior written approval of Xxxxxx.
10.2 STERITECH TRADEMARKS. Xxxxxx shall include the Steritech name and
xxxx in a prominent manner on and on packaging, literature and promotional
material and advertising for the System unless Xxxxxx makes a good faith
determination that the Steritech name cannot be used due to third party rights.
Xxxxxx shall, to the extent practical, provide to Steritech for review copies of
all proposed uses of the Steritech name and xxxx and references to Steritech. At
Steritech's reasonable request, Xxxxxx shall refer to the Steritech Compounds by
the Steritech trademark that Steritech indicates is appropriate. Xxxxxx shall
include on material bearing such trademarks an acknowledgement that such
trademarks are the property of Steritech. If necessary in any market to maintain
Steritech's rights in the Steritech trademarks, Xxxxxx 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 Xxxxxx.
11. COMPETITIVE ACTIVITY.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
17.
11.1 RESTRICTIONS ON STERITECH. During the period when Xxxxxx has
exclusive rights to market a System in a country, Steritech shall not sell,
transfer or otherwise make available to any third party in that country the
Steritech Compounds for use in the Field.
11.2 RESTRICTION ON XXXXXX. Except as provided in Section 13.4.5
hereof, during the term of this Agreement, Xxxxxx shall not manufacture,
distribute or sell any systems that use chemicals or chemical agents for the
inactivation of pathogens in platelet concentrates other than the System.
12. CONFIDENTIAL INFORMATION.
12.1 CONFIDENTIALITY AGREEMENT. The use and disclosure of information
designated by either party as confidential shall be governed by the attached
Schedule F Confidentiality Agreement. The Schedule F Confidentiality Agreement
shall survive termination of this Agreement.
12.2 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 with both Steritech and Xxxxxx
setting forth the consultant's obligations with respect to confidential
information.
13. CESSATION OF COOPERATIVE DEVELOPMENT WORK.
13.1 CESSATION. After January 1, 1995, either party may unilaterally
cease all participation in all Cooperative Development Work 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 the System at its own
expense. Should a party so proceed, the following terms and conditions shall
apply.
13.2 STERITECH CONTINUING RIGHTS. In the event that Xxxxxx chooses to
exercise its rights pursuant to Section 13.1 above, and Steritech proceeds
independently of Xxxxxx to develop, manufacture or sell the System, then:
13.2.1 For Systems whose manufacture, use or sale is
covered by a claim of a Xxxxxx Patent or uses Xxxxxx Know-How, Xxxxxx hereby
grants Steritech a worldwide non-exclusive license under the Xxxxxx Patents
and Know-How to make, have made and use, sell or have sold such Systems in
the Field, terminating upon expiration of the last to expire of the Xxxxxx
Patents. The license shall bear a [ * ] Royalty to Xxxxxx an Steritech's Net
Sales of Systems in each country where a valid Xxxxxx Patent subsists and
would be infringed but for a license, otherwise the license shall be royalty
free. Only a single Patent Royalty shall be
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
18.
paid by Steritech and Xxxxxx an the sale of each System. Royalty Payments shall
be made within sixty (60) days of the end of each calendar quarter.
13.2.2 For a period of two (2) years following the Notice
Period or until twelve (12) months following the date on which Steritech
enters into a contract with a third party for manufacture of Systems,
whichever occurs earlier, upon Steritech's request, Xxxxxx shall manufacture
or have manufactured and sell Systems and/or components thereof to Steritech,
to the extent Xxxxxx has at the time the present capability including
manufacturing capability, at a price equal [ * ] of Xxxxxx'x actual fully
loaded cost of goods. This provision applies only to Systems which Xxxxxx had
received Regulatory Approval or Systems or components the development of
which had been substantially completed prior to the Notice Period.
13.2.3 Except for the Royalty provided for in Section 13.2.1,
Xxxxxx shall have no share in Net Sales from Steritech's sales of Systems made
pursuant to this Section 13.2.
13.2.4 Should Xxxxxx'x decision to exercise its rights
under 13.1 not be based on either: (i) Xxxxxx'x good faith determination that
the Steritech Compound does not comply with the specifications for Steritech
Compound, or (ii) Xxxxxx'x good faith determination that the marketplace no
longer will support an Inactivation Package, then Xxxxxx shall pay Steritech
a one time payment of [ * ] at the time it unilaterally ceases to participate
in the Cooperative Development Work.
13.3 XXXXXX CONTINUING RIGHTS. In the event that Steritech chooses its
rights under Section 13.1 above, Xxxxxx proceeds independently of Steritech to
develop, manufacture or sell the Systems, then:
13.3.1 The license grant under the Steritech Patents, and
Steritech Know-How shall become a worldwide non-exclusive license grant to
Xxxxxx, terminating upon expiration of the last to expire of the Steritech
Patents. This license shall bear a five percent (5%) Royalty to Steritech on
Xxxxxx'x Net Sales of Systems in each country where a valid Steritech Patent
subsists and would be infringed but for a license, otherwise the license shall
be Royalty free. Only a single Patent Royalty shall be paid by Xxxxxx to
Steritech on the sale of each System. Royalty Payments shall be made within
sixty (60) days of the end of each calendar quarter.
13.3.2 Xxxxxx will retain all distribution rights an exclusive
basis.
13.3.3 For a period of two (2) years following the Notice
Period or until twelve (12) months following the date on which Xxxxxx enters
into a contract with a third party for manufacture of Steritech Compound,
whichever occurs earlier, upon Xxxxxx'x request, Steritech shall manufacture or
have manufactured and sell Steritech Compound thereof to Xxxxxx, to the extent
Steritech has at the time the present capability including manufacturing
capability, at a price equal to [ * ] of Steritech's actual fully loaded cost of
goods.
13.3.4 Except for the Royalty provided for in Section 13.3.1,
Steritech shall have no share in Net Sales from Xxxxxx'x sale of Systems.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
19.
14. REPORTS.
14.1 QUARTERLY SALES REPORTS. Each quarterly payment made to Steritech
under Section 7 shall be accompanied by a full and accurate accounting of all
Net Sales of Products by Xxxxxx and Xxxxxx for the calendar year. Each such
report shall include at least the following information as to each country and
Region:
14.1.1 The number of Inactivation Packages sold to third
parties by Xxxxxx and Xxxxxx affiliates;
14.1.2 The Net Sales, with a breakdown between Net Sales
falling within clause (a) and clause (b) of the definition of such term of
Section 2 hereof;
14.1.3 Additional Cost of Goods (if applicable) together with
substantiation and breakdown thereof;
14.1.4 Xxxxxx'x computation of the Revenue Sharing Payment due
to Steritech; and
14.1.5 Price lists for Inactivation Packages, and for
disposable sets with and without Inactivation Packages, as then in effect. Each
report shall include the certification of the Controller of Xxxxxx attesting to
the fact that the report is an accurate and complete accounting of all
information required hereunder.
14.1.6 Any deductions from Revenue Sharing Payments.
15. BOOKS AND RECORDS.
15.1 RECORDS. Xxxxxx and each of its affiliates shall keep full and
accurate books of account containing all particulars that may be necessary for
the purpose of calculating all amounts owing to Steritech. Books of account
maintained by Xxxxxx and each of its affiliates shall be kept at the principal
place of business of Xxxxxx. All such reports and data shall be open for
inspection on a confidential basis at all reasonable times and Steritech may
conduct at its own expense, once every year during normal business hours through
an independent certified public accountant designated by Steritech and
reasonably acceptable to Baxter, an examination of the accounts contemplated
above. If any audit conducted an behalf of Steritech shall show that Baxter or
any of its affiliates underpaid the royalties due to Steritech under the
licenses herein as to the period subject of the audit, then Baxter shall
immediately pay to Steritech any such deficiency with interest thereon in
accordance with Section 15.3. If the underpayment shall exceed ten percent (10%)
of the amount owed for any calendar year, Baxter shall also reimburse Steritech
for costs related to such audit.
15.2 RETENTION. Books and records required to be maintained by Baxter
and its affiliates hereunder shall be retained for at least two (2) years from
the date of the royalty payment to which they pertain.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
20.
15.3 INTEREST. All payments due hereunder from Baxter that are not paid
to Steritech when due and payable hereunder shall bear interest at an annual
rate equal to 4% 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.
16. TERM. The term of this Agreement shall be for an initial period of fifteen
(15) years commencing with the Effective Date unless terminated earlier pursuant
to Section 13.1 or 17.1. Thereafter, the parties shall make good faith efforts
to negotiate a renewal thereafter for additional successive periods of three (3)
years unless either party provides the other with written notice of termination
no later than twelve (12) months prior to the conclusion of the initial term or
any subsequent renewal term.
17. BREACH.
17.1 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,
Baxter acknowledges that the ability of Steritech to carry on the Cooperative
Development work will be substantially adversely affected in the event that
Baxter does not make payment when due of development payments under Section 3
hereof or Milestone payments under Section 4 thereof. Accordingly, in the event
of the failure to make any of such payments that are due and owing a forty-five
(45) day notice period shall apply in lieu of such sixty (60) day notice period
in the preceding sentence. To the extent Steritech is in breach for failing to
fund its development efforts under this Agreement, Steritech will have one
hundred eighty (180) days, to cure such breach. If the breach remains uncured
after one hundred and eighty (180) days, Baxter can terminate the Agreement
pursuant to the procedure set forth above in this Section.
17.2 STERITECH RIGHTS. In the event of termination by Steritech as
provided in Section 17.1, without limiting any other rights or remedies,
Baxter shall immediately upon such termination pay to Steritech the amount of
[ * ] after the date of termination pursuant to Section 3.9 (as the same may
have been revised pursuant to budget modifications previously approved by the
Management Board) and the amount of [ * ], in each case whether or not then
earned, and any other amounts owing from Baxter to Steritech hereunder. In
addition, Steritech shall be entitled to all the rights in Section 13.2.1
through Section 13.2.4 on an exclusive basis, subject to the terms of such
sections.
17.3 BAXTER RIGHTS. In the event of termination by Baxter as provided
in Section 17.1, without limiting any other rights or remedies, Steritech shall
immediately upon such termination pay to Baxter any amounts then owing from
Steritech to Baxter hereunder. Additionally, Steritech shall return to Baxter
any monies paid by Baxter under Section 3.9 that have not been expended pursuant
to Cooperative Development Work as of the date of breach. In addition, Baxter
shall be entitled to all rights in Section 13.3.1 through 13.3.4 on an exclusive
basis.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
21.
18. REPRESENTATIONS IN INDEMNITIES
18.1 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;
(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 Steritech
Compound; 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.
18.2 STERITECH INDEMNIFICATION. 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.
18.3 BAXTER REPRESENTATIONS. Baxter represents and warrants to
Steritech that as of the Effective Date:
(a) 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 being upon Baxter or upon the property of Baxter.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
22.
(b) it is party to no contract materially adverse to the
obligations undertaken in this Agreement.
(c) Xxxxxx has no current agreements with other parties for
systems for the photo-inactivation of pathogens in platelet concentrates.
18.4 BAXTER INDEMNIFICATION. Baxter shall indemnify Steritech for
losses sustained or expenses incurred by Steritech as a result of a breach by
Baxter of either of the foregoing representations and warranties.
19. INDEMNIFICATION, LIABILITY, INFRINGEMENT.
19.1 DEFENSE OF THIRD PARTY INFRINGEMENT SUITS. In the event that a
third party shall xxx either party alleging that the manufacture, use or sale of
the System, or any part thereof, infringes a patent of such third party, then
the party sued shall promptly notify the other party in writing. The party sued
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 attorney's fees as well as any judgments,
settlements, or damages payable with respect to such suit shall be deducted from
the Net Sales and paid to the party incurring the expenses. 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.
19.2 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 the System or any portion thereof, then Baxter and Steritech shall
bear the Patent Royalty Payment under such license equally, and Baxter may
deduct Steritech's share of such Patent Royalty Payment from Revenue Sharing
Payments due to Steritech.
19.3 SUITS FOR INFRINGEMENT BY OTHERS. In the event Baxter or Steritech
becomes aware of any actual or threatened infringement the Steritech Licensed
Patents or the Steritech Licensed Know-How, that party shall promptly notify the
other and the parties shall discuss the most appropriate action to take. If the
infringing product competes with a System in the Field, Baxter shall have the
first right to bring, at its own expense, an infringement action against the
third party infringer. If Baxter does not bring such action within six (6)
months from date of notification, then Steritech may bring such action at its
own expense. The party not conducting such suit shall assist the other party
without expense to the party requesting assistance. The award in such suit shall
first be used to pay the expenses of such suit and any balance shall be divided
between the parties in proportion to the Revenue Sharing Payment.
In the event the accused product is not in competition with a System in
the Field, then
(a) Steritech alone may, in its sale 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.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
23.
(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.
20. GENERAL
20.1 ENTIRE AGREEMENT. The following three agreements 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 the confidential disclosure letter agreement
dated March 17, 1993 shall continue to govern the disclosures made thereunder.
(1) This Agreement, (2) the attached Schedule F Confidentiality Agreement of
even date, and (3) the Stock Purchase Agreement of even date. 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.
20.2 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.
20.3 SENIOR BAXTER CONTACT. The senior Baxter contact of the purpose of
administering this Agreement is the President of the Fenwal Division of Xxxxxx
Healthcare Corporation, Xxx Xxxxxx Xxxxxxx, Xxxxxxxxx, Xxxxxxxx 00000. At
present, Xx. Xxxxxxx Xxxxx occupies this position.
20.4 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, Xx. Xxxxxxx X. Xxxxxx occupies this
position.
20.5 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 within 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.
20.6 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 not
be
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
24.
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.
20.7 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
Xxxxxx Healthcare Corporation Steritech, Inc.
One Xxxxxx Parkway 0000 Xxxxxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxx 00000 Xxxxxxx, Xxxxxxxxxx 00000
WITH A COPY TO: WITH A COPY TO:
President, Fenwal Division Cooley, Godward, Xxxxxx, Xxxxxxxxx & Xxxxx
Xxxxxx Healthcare Corporation 0 Xxxxxxxx Xxxxx, 00xx Xxxxx
Xxx Xxxxxx Xxxxxxx Xxx Xxxxxxxxx, XX 00000
Xxxxxxxxx, Xxxxxxxx 00000 Attn: Xxxxxx Xxxxx
or to such other address as to which either party may notify the other.
20.8 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, 40% or more of the
voting securities); (ii) by either party with the written consent of the other;
or (iii) by either party without the consent of the other to the purchase of
substantially all the assets of its business to which this Agreement relates.
Any attempted assignment which does not comply with the terms of this Section
shall be void.
20.9 GOVERNING LAW. This Agreement is deemed to have been executed in
and shall be governed by and construed according to the law of the State of
Illinois.
20.10 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.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
25.
IN WITNESS WHEREOF, this Agreement is signed by duly authorized
representatives of each party as of the Effective Date.
STERITECH, INC. XXXXXX HEALTHCARE CORPORATION
By: /s/ Xxxxxxx X. Xxxxxx By: /s/ Xxxxxxx X. Xxxxxxxx
-------------------------- ---------------------------------
Xxxxxxx X. Xxxxxx Xxxxxxx X. Xxxxxxxx
Title: President Title: President Biotech
Date: December 11, 1993 Date: December 13, 1993
------------------------ -------------------------------
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
26.
SCHEDULE A
BAXTER BENCHMARKS
[ * ]
o Provide [ * ] studies that are modified to be suitable for [ * ].
o Technical Exchange of Information between Steritech and Baxter Nivelles.
o [ * ] engineering team in place.
o [ * ] survey in place.
o [ * ] from Steritech to Nivelles completed.
[ * ]
o [ * ] studies to define adequacy to [ * ] initiated.
o Define priority of [ * ].
o Provide [ * ] for backup [ * ] that are modified to be suitable for [ * ].
[ * ]
o Finalize design for [ * ] (based on marketing input/BB survey results).
o Finalize design for [ * ] (based on marketing input/BB survey results).
o [ * ] completed, [ * ] delivered.
[ * ]
o Provide [ * ] of the presumed [ * ].
[ * ]
o Provide [ * ] for validation studies of [ * ].
o Provide [ * ] for validation studies of [ * ].
o [ * ] to begin on [ * ].
[ * ]
o Provide [ * ] to Steritech for [ * ].
o Provide [ * ].
[ * ]
o Provide complete data on [ * ] provide relevant [ * ].
[ * ]
o Provide required number of [ * ].
[ * ]
o Finalize marketing and promotional/sales materials for [ * ].
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
SCHEDULE B
STERITECH PATENTS: UNITED STATES
NO. XXX./APP. NO. DATE TITLE
--- ------------- ---- -----
1 [ * ] [ * ] DEVICE AND METHOD FOR PHOTOINACTIVATION
2 [ * ] [ * ] ACTIVATION COMPOUNDS AND METHODS OF SYNTHESIS OF
ACTIVATION COMPOUNDS
3 [ * ] [ * ] COMPOUNDS FOR THE [ * ] IN BLOOD
4 [ * ] [ * ] METHODS FOR RENDERING AMPLIFIED NUCLEIC ACID
SUBSEQUENTLY UNAMPLIFIABLE
5 [ * ] [ * ] DEVIDE AND METHOD FOR PHOTOACTIVATION
6 [ * ] [ * ] DEVICE AND METHOD FOR PHOTOACTIVATION
7 [ * ] [ * ] DECONTAMINATING BLOOD COMPONENTS
8 [ * ] [ * ] DEVICE AND METHOD FOR PHOTOACTIVATION
9 [ * ] [ * ] METHOD FOR INHIBITING TEMPLATE DEPENDENT
ENZYMATIC SYNTHESIS
10 [ * ] [ * ] PHOTOCHEMICAL DECONTAMINATION TREATMENT OF WHOLE
BLOOD OR BLOOD COMPONENTS
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
FOREIGN
1 [ * ] [ * ] DECONTAMINATING BLOOD COMPONENTS
2 [ * ] [ * ] ACTIVATION COMPOUNDS AND METHODS FOR NUCLEIC
ACID STERILIZATION
3 [ * ] [ * ] ACTIVATION COMPOUNDS AND METHODS FOR NUCLEIC
ACID STERILIZATION
4 [ * ] [ * ] ACTIVATION COMPOUNDS AND METHODS FOR NUCLEIC
ACID STERILIZATION
5 [ * ] [ * ] ACTIVATION COMPOUNDS AND METHODS FOR NUCLEIC
ACID STERILIZATION
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
SCHEDULE C
SETRITECH BENCHMARKS
1. [ * ] PROGRAM INITIATED
(requires [ * ])
Date: [ * ]
2. INITIATION OF [ * ]
(requires [ * ])
Date: [ * ]
3. INITIATION OF [ * ]
(requires successful completion of [ * ])
Date: [ * ]
4. [ * ]
(requires successful completion of [ * ]).
Date: [ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
SCHEDULE X
XXXXXX/STERITECH JOINT PROGRAM BUDGET
1993 1994 1995 1996 1997 TOTAL
---------------------------------------------------------------------------------------------------------------------
STERITECH [ * ] [ * ] [ * ] [ * ] [ * ] [ * ]
---------------------------------------------------------------------------------------------------------------------
BAXTER [ * ] [ * ] [ * ] [ * ] [ * ] [ * ]
---------------------------------------------------------------------------------------------------------------------
OUTSIDE [ * ] [ * ] [ * ] [ * ] [ * ] [ * ]
---------------------------------------------------------------------------------------------------------------------
TOTAL [ * ] [ * ] [ * ] [ * ] [ * ] [ * ]
---------------------------------------------------------------------------------------------------------------------
STERITECH BAXTER
o NCE DISCOVERY & MFR o DEVICE
o PLATELET PHYSIOLOGY & VIROLOGY o DISPOSAL
o TOXICOLOGY
o CLINICAL TRIALS
o NCE REMOVAL
* (US DOLLARS IN THOUSANDS)
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
SCHEDULE E
Deferrable Outside Contract Expenses*
Six Month Period Total Contract Expense Maximum Deferrable Amt. (50%)
---------------- ---------------------- -----------------------------
7/1/94 - 12/31/94 [ * ] [ * ]
1/1/95 - 6/30/95 [ * ] [ * ]
7/1/95 - 12/31/95 [ * ] [ * ]
1/1/96 - 6/30/96 [ * ] [ * ]
7/1/96 - 12/31/96 [ * ] [ * ]
1/1/97 - 6/30/97 [ * ] [ * ]
7/1/97 - 12/31/97 [ * ] [ * ]
o Limited to the extent of deferral of prepayment of outside contract expenses
per contract Section 3.9.3.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
SCHEDULE F
CONFIDENTIALITY AGREEMENT
THIS AGREEMENT, made on the Effective Date of the Development,
Manufacturing and
Marketing Agreement ("Agreement") between Baxter and Steritech
to which this document is appended, is between Steritech, Inc. ("STERITECH"),
having a principal place of business at 0000 Xxxxxxxx Xxxxx, Xxxxxxx, Xxxxxxxxxx
and Xxxxxx Healthcare Corporation ("BAXTER"), a corporation having a principal
place of business at Xxx Xxxxxx Xxxxxxx, Xxxxxxxxx, Xxxxxxxx 00000, to assure
the protection and preservation of Proprietary Information 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 during 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 is
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 who 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 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 or the extent required under the
Agreement.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
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. The 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 acknowledged 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. XXXXXX HEALTHCARE CORPORATION
By: /s/ Xxxxxxx X. Xxxxxx By: /s/ Xxxxxxx X. Xxxxxxxx
------------------------------- ---------------------------------
Xxxxxxx X. Xxxxxx Xxxxxxx X. Xxxxxxxx
Title: President Title: President Biotech
Date: December 11, 1993 Date: December 13, 1993
----------------------------- -------------------------------
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
