Exhibit 10.87
[CONFIDENTIAL TREATMENT REQUESTED]
[Certain confidential information has been omitted from the Agreement and filed
separately with the Securities and Exchange Commission pursuant to a request by
Registrant for confidential treatment pursuant to Rule 24b-2. The omitted
confidential information has been identified by the following statement:
"CONFIDENTIAL TREATMENT REQUESTED".]
ROYALTY PROJECTS AGREEMENT
This Agreement is entered into as of January 4, 1995 by and between CIBA CORNING
DIAGNOSTICS CORP., a Delaware corporation having its principal place of business
at 00 Xxxxx Xxxxxx, Xxxxxxxx, XX 00000 X.X.X. (hereinafter "CCD"), and CIBA-
GEIGY Limited, a Swiss corporation having its principal place of business at
Xxxxxxxxxxxxxx 000, XX-0000 Xxxxx, Xxxxxxxxxxx (hereinafter Ciba).
WHEREAS, Ciba's Corporate Research Units ("CRU") conduct research projects
determined to have strategic benefit to Ciba;
WHEREAS, CCD wishes to evaluate such projects in order to identify whether they
have strategic potential for its own business in Diagnostics (as such term is
defined in Article 1.3 of this Agreement) and to obtain rights to exploit
results of such projects against compensation to Ciba in the form of royalties
and/or fees;
WHEREAS, Ciba is willing to make available results of certain projects for
exploitation in the field of Diagnostics by CCD against compensation in the form
of royalties and/or fees, under certain general conditions and project-specific
agreements, such projects being referred to herein as "Royalty Projects";
NOW, THEREFORE, in consideration of the premises and covenants, terms and
conditions set forth herein, Ciba and CCD agree as follows:
1. SCOPE OF THE AGREEMENT; DEFINITIONS
1.1 This Agreement governs the general procedures and terms to be applied
for Royalty Projects to be conducted by CRU for use by CCD in
Diagnostics upon mutual agreement by the two parties from time to time.
1.2 Projects started prior to January 4, 1995 and agreed by the parties
during the Steering Committee Meeting of April 27, 1995 to be continued
shall be considered Royalty Projects. These projects and their
agreed-upon specific terms are described in Attachments A and B to this
Agreement. Costs incurred by Ciba for such Royalty Projects prior to
January 4, 1995 shall be considered as having been remunerated by the
acquisition of CCD by Chiron Corporation.
1.3 As used in this Agreement
(a) "Affiliate(s)" shall mean a corporation or any other business
entity, in whatever country organized, which, directly or
indirectly, controls, is controlled by or is under common control
with Ciba or CCD, as the case may be. For this purpose, control
shall mean the ownership of 50% or more of the issued share
capital or the legal power to direct or cause the direction of the
general management and policies of the party in question. In the
case of CCD, "Affiliates" shall also include Ciba Corning
Diagnostics de Mexico S.A., so long as CCD continues to own at
least 49% of the voting stock of that corporation.
(b) "CCD License Option" shall have the meaning specified in Article
4.4 hereof.
(c) "Designated Country" means Germany, France, Italy, the United
Kingdom of Great Britain and Northern Ireland, Japan or the
United States of America.
(d) "Diagnostics" shall mean the development, manufacture, use and
sale of processes, materials, supplies and equipment for the
diagnosis of human and veterinary health.
(e) "License Maintenance Fee" means the fee payable by CCD in
accordance with Article 5.6.
(f) "Licensed Patents" means any and all letters patent, by whatever
country issued, now or hereafter issued to Ciba and licensed to
CCD in accordance with the provisions of this Agreement.
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(g) "Net Sales" shall mean the gross sales of Royalty Products by
CCD, its Affiliates or sublicensees to third parties, less
trade, cash or volume discounts, returns and allowances,
charges for freight handling and transportation, sales and use
taxes and other similar taxes incurred, and royalties payable
by CCD or such Affiliate or sublicensee to third parties with
respect to such products, as determined in accordance with
CCD's standard accounting methods and recognized accounting
principles. Where a Royalty Product is sold in combination
with a product which is not a Royalty Product, Net Sales shall
include only the revenues allocable to the Royalty Product as
determined in accordance with CCD's standard accounting
methods and recognized accounting principles. Where a product
consists of a combination of different groups of components,
each used for the measurement of a different analyte, the
components for measurement of each particular analyte shall be
considered as a separate product in determining whether such
components constitute a Royalty Product, and the revenue
attributable to such a group of components shall be determined
by dividing the revenue for the entire product by the number
of different analytes which can be measured thereby. Where a
Royalty Product is used by CCD or one of its Affiliates or
sublicensees to provide a service to a third party, the Net
Sales attributable to such Royalty Product shall be determined
based on the amount that would have been charged for sale of a
similar volume of such Royalty Product to a non-affiliated
third party in an arms'-length transaction.
(h) "Royalty Product" shall mean either a "Patent-Protected Royalty
Product" or an "Unprotected Royalty Product."
"Patent-Protected Royalty Product" shall mean a product the
sale or use of which is covered by a valid claim of an
unexpired Licensed Patent. "Unprotected Royalty Product"
means a product the sale or use of which would be covered by a
valid claim of an
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unexpired Licensed Patent if such product were sold or used in a
Designated Country, but which is not covered by a valid
claim of a Licensed Patent in the country in which such
product is actually sold or in the country in which such
product is actually used.
(i) "Strategic Exit Fee" shall mean, as to any Royalty Project, the
amount specified in Attachment B hereto as the fee to be paid
to Ciba by CCD if CCD, after exercising the CCD License Option
with respect to such Royalty Project, abandons development of
the technology resulting from such Royalty Project prior to
commercial launch of a product incorporating such technology,
for reasons other than lack of technical success.
(j) "Technical Exit Fee" shall mean, as to any Royalty Project, the
amount specified in Attachment B hereto as the fee to be
paid to Ciba by CCD if CCD, after exercising the CCD License
Option with respect to such Royalty Project, abandons
development of the technology resulting from such Royalty
Project prior to commercial launch of a product incorporating
such technology, due to lack of technical success in such
development.
(k) "Technology Delivery Date" shall have the meaning specified in
Article 5.1 hereof.
(l) "Technology Transfer Criteria" shall mean, as to any Royalty
Project, the technical criteria specified in Attachment A
hereto to be satisfied through Ciba's research program prior
to transfer of the technology resulting from such Royalty
Project to CCD for further development into commercial
products.
(m) "Technology Transfer Date" shall mean, as to any Royalty
Project, the date established as such pursuant to Article 5.2
hereof.
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2. IDENTIFICATION OF ROYALTY PROJECTS
2.1 Ciba shall inform CCD periodically (at least once a year) in the form
of an overview (in writing) about CRU projects and technology possibly
of strategic interest to CCD.
2.2 CCD likewise shall inform Ciba periodically (at least once a year,
preferably during the project management meetings provided for in
Article 3.2 hereof) in the form of an overview (in writing) about its
projects, technology, and technical problems which CCD considers
possibly relevant for CRU projects and of interest to Ciba.
2.3 In order to understand each other's positions, the parties shall meet
to discuss the projects contained in the overviews and to exchange
opinions on technology of mutual interest. In preparation for such
meetings, documentation and data in sufficient detail shall be
exchanged at least three weeks before the meetings. Minutes,
including recommendations regarding Royalty Projects, shall be written
and approved by the parties within three weeks after the meetings.
2.4 If a CRU project is of interest to CCD and Ciba is willing to consider
CCD's objectives to be included into the framework of such project,
the parties shall negotiate in good faith with respect to the terms on
which such project could become a Royalty Project under this
Agreement. In such cases, the parties shall endeavor to agree within
three months on the specific details for such project to be included
in Attachments A and B. The specific details shall include: research
objectives, scope of applications, expected Technology Transfer Date,
present status and technical milestones, project management structure,
Technology Transfer Criteria, intellectual property of each party to
be made available for use in the Royalty Project and third party
intellectual property to be acquired (to the extent need for such
intellectual property is known to either part), amounts of the
Strategic Exit Fee and the Technical Exit Fee and the royalty rates
applicable to products resulting from such Royalty Project.
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2.5 In case Ciba is not willing to consider a project to become a Royalty
Project, CCD may propose such project to become a Project under the
CRU Research-Funding Agreement of even date herewith.
2.6 Both parties shall inform each other in writing, as promptly as may be
reasonably practicable, on projects and technologies of potential
mutual interest outside of the periodic information procedure provided
for in Articles 2.1 through 2.3, in order not to lose time for the
exploitation of the potential of such projects and technologies.
3. PROJECT MANAGEMENT
3.1 Ciba shall perform its research work for Royalty Projects in such a
manner as to give due consideration to CCD's interests.
3.2 Ciba shall inform CCD periodically (at least twice a year) during
project management meetings on the progress and status of the Royalty
Projects. Ciba shall also inform CCD in writing, without delay, about
changes needed in Royalty Projects which may be necessary due to
scientific reasons or other unexpected circumstances. The parties
shall discuss and agree on any changes needed in Attachment A during
the course of the Royalty Projects.
3.3 Ciba shall inform CCD in writing as promptly as is practicable about
contemplated strategic redirection of Ciba's interest in such projects
which may have an impact on CCD's interest in having a project remain
a Royalty Project as well as about the contemplated termination of a
Royalty Project. Work for CCD's purposes under a Royalty Project
shall continue, however, for at least six (6) months after Ciba has
decided and informed CCD in writing of such decision to redirect or
terminate such project.
3.4 In cases where a Royalty Project has been redirected by Ciba, CCD
shall have the option either to terminate such a project as a Royalty
Project or to propose amendments to Attachments A and B for such
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redirected project to continue as a Royalty Project. The parties
shall negotiate in good faith with respect to any such proposed
amendments and shall endeavor to reach agreement thereon within three
(3) months. If the parties are unable to reach agreement on such
amendments, such project shall terminate as a Royalty Project at the
end of the six-month period specified in Article 3.3.
3.5 CCD shall inform Ciba in writing as promptly as is practicable if CCD
wishes at any time to terminate a Royalty Project.
3.6 CCD may request a re-direction of a Royalty Project. In such cases
the parties will negotiate in good faith revised Attachments A and B
with respect to such Royalty Project. Unless new terms shall be
negotiated within three (3) months, the Royalty Project in question
shall be terminated.
3.7 In case Ciba's work on a Royalty Project is terminated before the
Technology Transfer Date, CCD - at its option - may request to acquire
rights to the technology and know-how so far developed by Ciba for use
in Diagnostics. In such a case the parties will negotiate in good
faith the terms for such grant of rights, taking into account (a) the
original terms of this Agreement applicable to such Royalty Project
upon completion by Ciba of all work necessary to satisfy the
Technology Transfer Criteria and (b) an appropriate reduction of CCD's
cost to take into account the stage of completion of such Royalty
Project at the time of termination of Ciba's work and the work
remaining to satisfy the Technology Transfer Criteria. CCD may
thereafter complete the project by itself or propose a project under
the CRU Research Funding Agreement. Ciba shall not unreasonably refuse
to continue technical support for a terminated Royalty Project on a
funded basis under the CRU Research Funding Agreement for such period
as may be reasonably necessary for CCD to develop internal resources
to take over such work.
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4. TREATMENT OF INTELLECTUAL PROPERTY RIGHTS
4.1 Any and all intellectual property, including, but not limited to,
patents, trade secrets and copyrights, that has been, is or will be
generated, developed or created by Ciba within the scope of Royalty
Projects shall be the property of Ciba, provided that any invention
made jointly by one or more employees of Ciba and one or more
employees of CCD shall be the joint property of Ciba and CCD.
4.2 Subject to any licenses granted under Article 3.7 or Article 4.4, Ciba
shall be free to exploit any and all intellectual property as
described under Article 4.1 for its own businesses.
4.3 Intellectual property rights, whether protected by patent or not, that
are now or hereafter jointly owned by CCD and Ciba shall be freely
used by either co-owner, unless the parties hereafter agree that one
party's rights to a specified invention shall be exclusive in a
specified field or fields. Royalties and license fees received by
either party from the licensing of jointly-owned patents to third
parties shall be shared equally between the parties.
4.4 Ciba grants CCD an option for a license (the "CCD License Option") to
all Ciba intellectual property, whether patented or not, which shall
be granted for exclusive worldwide use (unless a non-exclusive license
is agreed to at the start of such Royalty Project), with the right to
grant sublicenses, in Diagnostics, within the scope of each Royalty
Project set forth in Attachment A, including without limitation the
patents and patent applications described in Attachment A. For each
Royalty Project the terms of such license shall be as set, forth in
Attachment B and the other provisions of this Agreement. The CCD
License Option for each Royalty Project shall remain valid for twelve
(12) months after the Technology Transfer Date for such Royalty
Project.
4.5 If CCD intends to distribute a Royalty Product for veterinary health
through a third party, Ciba shall have the right of first negotiation
to
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distribute such product, for a period of six months after receipt of
notice from CCD of CCD's wish to negotiate a distribution agreement
for such product.
4.6 In case CCD does not exercise the CCD License Option with respect to a
Royalty Project, Ciba shall be free to exploit its intellectual
property resulting from such Royalty Project for commercialization in
Diagnostics. In such a case Ciba will remunerate CCD out of income
from the commercialization of the Royalty Project in Diagnostics for
relevant contributions made by CCD in guiding the direction of Ciba's
research for the Royalty Project. The parties will negotiate in good
faith such remuneration prior to commercialization by Ciba or their
sublicensees. In addition, if after the Technology Delivery Date with
respect to a Royalty Project, CCD invents any improvements to the Ciba
technology resulting from such Royalty Project, upon CCD's failure to
exercise the CCD License Option CCD shall grant Ciba a non-exclusive
license to practice such CCD inventions, with the right to grant
sublicenses in connection with commercialization of the Ciba
technology by a third party. If Ciba or an affiliate commercializes
the technology resulting from such Royalty Project and makes use of
the CCD inventions, CCD shall be paid a reasonable royalty to be
negotiated by the parties in good faith. If Ciba licenses its
technology resulting from such Royalty Project together with CCD
inventions to a third party upon terms more favorable to Ciba than the
terms set forth in Attachment B with respect to such Royalty Project,
Ciba's revenue resulting from the difference between such improved
terms and the terms as set forth in Attachment B shall be shared
equally between Ciba and CCD. Except as expressly provided in this
Article 4.6, nothing herein shall require CCD to grant to Ciba a
license under any CCD intellectual property in the field of
Diagnostics.
4.7 Ciba shall have the exclusive right and obligation:
(a) to file at its cost and expense applications for letters patent
on any patentable inventions made by Ciba in carrying out Royalty
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Projects, including their use in Diagnostics, in the United
States of America and in each other PCT country in which CCD has
an Affiliate, distributor or sales representative. Ciba shall
consult with CCD regarding additional countries in which such
patent applications should be filed. Should CCD wish to include
additional countries where Ciba does not intend to file, CCD
shall have the option to have assigned the patent rights in such
countries and to file at its cost and expense patent applications
in such countries.
(b) to prosecute its pending and new patent applications and to
respond to oppositions filed by third parties against the grant
of letters patent for such applications.
(c) to maintain in force its letters patent by duly filing all
necessary papers and paying the fees required by the patent
laws of the particular country in which such letters patent
were granted.
Ciba shall notify CCD in a timely manner of any decision to abandon a
pending patent application or an issued patent licensed to CCD
hereunder or for which CCD has an option for a license hereunder.
Thereafter, CCD shall have the option to have assigned the respective
patent rights and, at its cost and expense, to continue to prosecute
patent applications or to keep the issued patents in force. Ciba
shall have a non-exclusive, royalty-free license, with sublicensing
rights, in fields of use other than Diagnostics, under all patents
filed by or assigned to CCD hereunder.
4.8 In cases where Ciba's intellectual property within the scope of a
Royalty Project is licensed from a third party, Ciba shall undertake
commercially reasonable efforts - as within its usual conduct of
business - to secure sublicensing rights to CCD for use of such
intellectual property in Diagnostics or to assist CCD in obtaining a
direct license to such intellectual property for use in Diagnostics.
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4.9 It is understood that within the scope of a Royalty Project, Ciba
shall make available to CCD for use in Diagnostics intellectual
property, whether patented or not, which was generated or acquired by
Ciba's CRU whether before or after the start of this Agreement or of
any Royalty Project, provided that if Ciba is prohibited from making
any such intellectual property available to CCD by any agreement with
a third party entered into before the identification of such
intellectual property as being needed by CCD hereunder, Ciba shall be
required only to use commercially reasonable efforts to obtain the
consent of such third party to the grant of a license to CCD.
Intellectual property developed or acquired by a division or
functional unit of Ciba independently of Ciba's CRU and without use of
the results of any Royalty Project ("Ciba Non-CRU Intellectual
Property") after January 4, 1995 may not be available for use by CCD
hereunder if the management of the division or functional unit which
developed or acquired such intellectual property determines that the
financial or strategic business interests of such division or
functional unit will be materially harmed by the inclusion of such
intellectual property in the license hereunder. Ciba represents that
the management of CRU is not aware at the date hereof of any Ciba
Non-CRU Intellectual Property which is likely to be needed by CCD in
connection with a Royalty Project, and Ciba agrees to notify CCD
within thirty (30) days of the management of CRU becoming aware of any
Ciba Non-CRU Intellectual Property that is relevant to the
commercialization in Diagnostics of the results of a Royalty Project.
The royalties specified in Attachment B hereto shall be the sole
compensation to Ciba for the use by CCD of any and all Ciba
intellectual property in connection with products resulting from a
Royalty Project and shall be in lieu of, and not in addition to, any
royalties payable under the 1985 Research Agreement.
4.10 CCD shall grant Ciba a first right of negotiation, prior to CCD
negotiating a license with any third party other than an Affiliate, to
obtain a worldwide non-exclusive license, with no right to sublicense,
for use outside Diagnostics of patented and non-patented intellectual
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property related to Royalty Projects contributed or generated by CCD
prior to or during the time that Ciba is actively involved in a
Royalty Project and needed by Ciba in order to develop, make, have
made, use and sell non-Diagnostics products incorporating Ciba's
technology resulting from such Royalty Project, against an adequate
royalty rate to be negotiated in good faith, provided that if CCD is
prohibited from making any such intellectual property available to
Ciba by any agreement with a third party entered into before the
identification of such intellectual property as being needed by Ciba
hereunder, CCD shall be required only to use commercially reasonable
efforts to obtain the consent of such third party to the grant of a
license to Ciba.
4.11 In cases where CCD's intellectual property needed by Ciba for use in
commercializing non-Diagnostics products resulting from Royalty
Projects is licensed from a third party, CCD shall undertake
commercially reasonable efforts - as within its usual conduct of
business - to secure sublicensing rights to Ciba for use of such
intellectual property outside Diagnostics or to assist Ciba in
obtaining a direct license to such intellectual property for use
outside Diagnostics.
5. TECHNOLOGY TRANSFER AND COMMERCIALIZATION OF THE TECHNOLOGY
5.1 When Ciba believes that the Technology Transfer Criteria have been met
for any Royalty Project, Ciba shall so advise CCD in writing, and
shall deliver to CCD with such notice all relevant documentation
giving evidence of such fact, together with all information and
materials resulting from such Royalty Project which are necessary for
CCD to evaluate and further develop the technology resulting from such
Royalty Project, the date of such delivery being referred to herein as
the Technology Delivery Date.
5.2 At the latest within two (2) months after the Technology Delivery
Date, CCD shall notify Ciba in writing whether or not CCD agrees that
the Technology Transfer Criteria are met. In case CCD is of the
opinion that the Technology Transfer Criteria are not met, such notice
shall be
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accompanied by CCD's statement in writing on the rationale for its
opinion and its position regarding whether the Royalty Project should
be continued or terminated. If CCD agrees that the Technology
Transfer Criteria have been met, the date of CCD's notice shall be the
Technology Transfer Date.
5.3 If CCD is of the opinion that the Technology Transfer Criteria with
respect to a Royalty Project have not been met, Ciba at its option may
either agree to continue the research phase (in which case the parties
shall agree on the scope of the additional research work needed and
the provisions of Articles 5.1 and 5.2 shall be applicable upon
completion thereof) or inform CCD in writing that Ciba will terminate
the Royalty Project (in which case Article 3.7 shall be applicable).
5.4 Within one year from the Technology Transfer Date with respect to a
Royalty Project, CCD shall exercise the CCD License Option by written
notice to Ciba. If CCD does not so exercise the CCD License Option
for a Royalty Project within such period, CCD shall have no further
rights under this Agreement with respect to the Ciba intellectual
property developed in the course of such Royalty Project.
5.5 From and after the exercise of the CCD License Option with respect to
a Royalty Project, CCD shall report yearly to Ciba on the progress of
CCD's development program with respect to the technology resulting
from such Royalty Project. At the time of exercise of the CCD License
Option, CCD shall notify Ciba of the planned date for commercial
launch of the product or products to be developed. At the conclusion
of Stage II of the development plan, as defined in CCD's internal
procedure designated the "Innovation Process" as in effect on the date
hereof and which typically should occur within twenty-four months
after the Technology Transfer Date, CCD shall notify Ciba in writing
of any change in the planned commercial launch date. Thereafter, the
planned commercial launch date may be revised as reasonably necessary
due to technical difficulty in the development program.
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5.6 If CCD fails to launch a commercial product using technology resulting
from a Royalty Project by the planned launch date notified to Ciba at
the end of Stage II of CCD's, development plan, as revised in
accordance with the provisions of Article 5.5, CCD shall pay to Ciba,
on each anniversary of such planned launch date until the actual
commercial launch, the License Maintenance Fee specified in Attachment
B with respect to such Royalty Project. Such License Maintenance Fee
shall be fully creditable against royalties thereafter becoming due
with respect to Royalty Products resulting from such Royalty Project,
provided that such credit shall not be applied to more than fifty
percent (50%) of any installment of such royalties.
5.7 If, after CCD has exercised the CCD License Option with respect to a
Royalty Project, CCD ceases to pursue development of a commercial
product using the technology resulting from such Royalty Project, CCD
shall pay to Ciba (a) if such cessation is the result of a lack of
technical success in development, the Technical Exit Fee specified in
Attachment B for such Royalty Project, or (b) if such cessation is for
any other reason, the Strategic Exit Fee specified in Attachment B for
such Royalty Project, and in either case CCD's license with respect to
the technology resulting from such Royalty Project shall continue. If
at any time CCD or a CCD Affiliate or sublicensee launches a
commercial product using technology resulting from a Royalty Project
with respect to which a Strategic Exit Fee or Technical Exit Fee has
been paid, such fee shall be refunded.
5.8 Notwithstanding the provisions of Article 5.7, if in connection with
any Royalty Project, Ciba has not obtained patent protection in a
Designated Country for the products under development by CCD, or if
CCD has been unable to obtain a license to necessary third party
technology on commercially reasonable terms, or if Ciba has been
unable to obtain a consent of a third party required to license
necessary Ciba technology to CCD or a consent of a Ciba division's or
functional unit's management to license Ciba Non-CRU Intellectual
Property to
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CCD, no Strategic Exit Fee or Technical Exit Fee shall be payable by
CCD in the event of cessation of its development program.
6. PAYMENT OF ROYALTIES
6.1 CCD shall pay to Ciba a royalty on the Net Sales of Royalty Products
sold to third parties by CCD and its Affiliates and sublicensees or
used by CCD and its Affiliates and sublicensees in providing services
to third parties. The royalty rate shall be agreed upon by the
parties for each specific Royalty Project before its initiation in
accordance with Article 2.4 and shall for Unprotected Royalty Products
be fifty percent (50%) of the rate agreed upon for Patent-Protected
Royalty Products. If so agreed by the parties at the start of a
Royalty Project, for specific Royalty Projects, CCD shall have a
non-exclusive license, with the right to grant sublicenses, at a lower
royalty rate than would apply to an exclusive license, such lower rate
to be specified in the relevant Attachment B.
6.2 The royalties agreed upon under this Agreement for each Royalty
Project shall be payable in each country as follows:
(a) with respect to sales in each country with patent protection, for
the duration of the relevant patent(s), and
(b) with respect to sales in any country of the world without patent
protection, for a duration of seven (7) years from the day of the
first commercial introduction of any Unprotected Royalty Product
resulting from such Royalty Project.
6.3 After the first commercial sale of a Royalty Product resulting from a
Royalty Project, CCD shall deliver to Ciba, within sixty (60) days
after the end of each of CCD's fiscal half-years, a written statement
of the amount of royalties due hereunder for such period, by product,
and shall make payment of such royalties in United States Dollars. If
any amount used in the calculation of royalties is denominated in a
currency
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other than United States Dollars, such amount shall be translated into
United States Dollars in accordance with a method generally recognized
and consistently used by CCD in the preparation of its audited
financial statements. If governmental regulations prevent remittance
from a foreign country with respect to sales made in that country, the
obligation under this Agreement to pay royalties in respect of sales
in that country shall be suspended (but royalties shall continue to
accrue) until such remittances are possible, and Ciba shall have the
right, upon giving notice to CCD, to receive payment in that country
in the local currency.
6.4 Ciba shall have the right to have an independent certified public
accountant, to which CCD has no reasonable objection, inspect during
ordinary business hours relevant books and records of account of CCD,
its Affiliates and sublicensees to determine whether appropriate
accounting and payment have been made to Ciba, such inspection to be
made within one year after the end of the fiscal year to which such
books and records relate. Said independent certified public
accountant shall treat as confidential all information received in
connection with such inspection, and shall disclose to Ciba only
whether there has been a royalty underpayment and, if so, the amount
thereof. The fees and expenses of such accountant performing such
verification shall be borne by Ciba, unless such audit shows an
underpayment of seven and one-half percent (7 1/2%) or more. In the
case of any sublicense by CCD to any of its Affiliates or third
parties, CCD shall be responsible to Ciba for the adherence by such
Affiliates and sublicensees to the same obligations as those that
apply to CCD under this Agreement. CCD shall keep Ciba informed as to
the identity of each Affiliate and third party so sublicensed.
6.5 In case new applications in Diagnostics of the technology arising from
a Royalty Project become possible, which applications could not be
identified at the initiation of such Royalty Projects, the parties
will agree in good faith on the royalty rates for such applications.
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7. LIABILITY
CCD shall hold Ciba and its Affiliates and their officers and employees
harmless from and against any and all liability, costs, assessments, fines,
claims, actions, damages and expenses (including attorney's fees and costs
of investigation), including without limitation all product liability
claims and damages, arising in relation to the development, manufacture,
sublicense, use or sale by CCD of products incorporating the technology
resulting from a Royalty Project for use in Diagnostics, provided that
nothing herein shall require CCD to indemnify any party against such
liability, claims, etc., arising out of the gross negligence or willful
misconduct of such party, and provided, further, that any party seeking
indemnification hereunder shall promptly notify CCD of any claim for which
indemnification may be sought, shall permit CCD to assume the defense of
such claim with counsel of CCD's choice and shall cooperate as reasonably
requested by CCD in such defense.
8. INFRINGEMENT OF PATENT RIGHTS OF THIRD PARTIES
8.1 Ciba makes no representation or warranty that the practice of the
technology or manufacture, sale or use of the products resulting from
the Royalty Projects in Diagnostics, whether patented or not, does not
or will not infringe the rights of any third party.
8.2 In the event that a third party shall assert that the practice of any
of the technology or sale or use of any of the products resulting from
a Royalty Project for use in Diagnostics infringes any right of such
third party, the party having the knowledge thereof shall forthwith
give notice to the other. CCD shall have the exclusive right to
defend or otherwise dispose of such claim, provided that CCD shall
consult with Ciba regarding such defense or disposition. CCD shall be
entitled to offset fifty (50) percent of all reasonable defense costs
and all reasonable amounts paid in settlement of such claim, including
license fees and royalties under an appropriate license agreement
entered into with the third party in connection with such settlement,
or paid as damages
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for which CCD is held liable, against future royalties payable to Ciba
under this Agreement.
8.3 The License Maintenance Fees provided for in Article 5.6 hereof shall
not be payable with respect to any Royalty Project during any period
when CCD is prevented from practicing the technology arising from such
Royalty Project by reason of a claimed infringement of the rights of a
third party, and the due date of the first License Maintenance Fee
with respect to any Royalty Project shall be deferred to the extent of
any delay in CCD's product development plans arising from such claimed
infringement. If a claim of infringement affects only some of the
applications of such technology, the parties hereto shall negotiate in
good faith with respect to an appropriate reduction in the amount of
the License Maintenance Fee. If CCD abandons the development of the
technology arising out of a Royalty Project because of inability to
obtain a license under third party rights necessary to the success of
such development, no Strategic Exit Fee or Technical Exit Fee shall be
payable to Ciba as a result of such abandonment.
9. INFRINGEMENT OF PATENT RIGHTS BY THIRD PARTIES
In the event either party becomes aware that a third party is infringing
any patented intellectual property related to technology or products
resulting from a Royalty Project for use in Diagnostics, the parties shall
confer as to the manner in which they will proceed with respect to such
infringement. Ciba shall have the exclusive right to commence and
prosecute an action for patent infringement against such infringing party
(provided that Ciba shall consult with CCD with respect to such
commencement and prosecution), except that CCD shall have the right to
commence and prosecute a counterclaim in any suit defended by CCD pursuant
to Article 8 hereof (provided that CCD shall consult with Ciba with respect
to such commencement and prosecution). If Ciba undertakes such action or
CCD asserts such counterclaim, any damages recovered first shall be applied
to reimburse such party all expenses of such action not otherwise
reimbursed and next shall be paid to Ciba and CCD in proportion to
18
their actual damages upon which such recovery was based. If Ciba fails to
commence action to prevent such infringement within ninety (90) days after
learning of the facts constituting such infringement, or if Ciba agrees to
settle any such action on a basis which would allow such infringement to
continue, then CCD shall cease to be obligated to pay royalties in respect
of any product or service incorporating technology or products resulting
from a Royalty Project until such infringement shall have ceased.
10. CONFIDENTIALITY
10.1 Ciba and CCD agree that they will each treat as strictly confidential
any and all proprietary information and data disclosed by the other
party in connection with the subject matter of this Agreement or
resulting from their activities hereunder (the "Information") and they
will not use such Information or disclose such Information to any
third party without the prior written consent of the other party,
except as may be required or permitted in the performance of this
Agreement or by applicable law.
10.2 Each party agrees that it will take all reasonable precautions to
ensure that it or any of its employees receiving such Information
disclosed pursuant to this Agreement will maintain the confidentiality
thereof.
10.3 Both parties agree that Information may be disclosed either orally or
in writing. When disclosed in writing, Information will be
identified, labelled and stamped as confidential. When disclosed
orally, such Information will first be identified as confidential at
the time of oral disclosure, with subsequent confirmation in writing
within thirty (30) days after such disclosure.
10.4 It is agreed, however, that such Information:
(a) which at the time of disclosure is published by a third party or
is otherwise in the public domain;
19
(b) which after disclosure becomes part of the public domain
otherwise than through a breach of this Agreement by the receiving
party;
(c) which was known to the receiving party prior to receipt from the
disclosing party, provided that such prior knowledge can be
adequately substantiated by documentary evidence antedating the
disclosure by the other party;
(d) which is disclosed to the receiving party by a third party (other
than employees or agents of either party) who, in making such
Information available to the receiving party, is not in violation
of any obligation of confidentiality to the disclosing party
under this Agreement;
(e) which is shown by competent written evidence to be independently
developed by the receiving party; or
(f) which the receiving party is required to divulge either by a
court of law or in order to comply with any applicable law or
regulation (after providing the disclosing party with reasonable
notice of such requirement to divulge and with an opportunity to
obtain a protective order),
shall not be subject to the provisions of this Agreement.
10.5 Ciba recognizes the legitimate interest of CCD to publish its
Information in the field of Diagnostics. On the other hand, CCD
recognizes Ciba's interest that publications be made and lectures be
given only to the extent that it has reasonably safeguarded the
Information proprietary to Ciba through patent protection or otherwise
so that third parties cannot make commercial and/or industrial use of
Ciba's findings. For this purpose, CCD shall ensure that Ciba shall
have the opportunity to comment in advance on any publication or oral
presentation in public including disclosure of any Information of Ciba
relating to technology/products resulting from a Royalty Project and
20
that no such publication or presentation shall be made by CCD without
Ciba's prior written consent. Ciba shall not unreasonably withhold or
delay its consent to such publication or presentation. CCD shall
submit to Ciba sixty (60) days in advance its request for such
publication or presentation.
11. MATERIAL TRANSFER
From time to time in connection with the activities contemplated by this
Agreement, each party may transfer to the other samples of proprietary
materials developed by the providing party. Except as otherwise expressly
provided herein or in any applicable license or supply agreement between
the parties, such materials and any materials derived therefrom a) shall
remain the property of the providing party, b) shall be used only for
purposes specified at the time such materials are provided, c) shall not be
transferred to any third party without the consent of the party by whom
such materials were provided, and d) shall be destroyed or returned to the
providing party upon request by the providing party. Unless otherwise
agreed in writing with respect to particular materials, the providing party
shall have a non-exclusive, royalty-free license to any inventions made by
the other party through use of the providing party's proprietary materials,
subject to the provisions of this Agreement.
12. TERM OF AGREEMENT
12.1 Subject to the provisions of Article 3, each party shall have the
right to terminate this Agreement upon six (6) months prior written
notice.
12.2 In the event of a termination of this Agreement, all licenses, options
and rights of negotiation granted hereunder with respect to Royalty
Projects agreed upon during the term hereof shall continue upon and
subject to the terms of this Agreement.
21
13. LIMITATION OF ASSIGNMENT
This Agreement is personal in nature and neither of the parties shall,
without the consent of the other, assign or transfer its rights or
obligations hereunder to another company or person, except as herein
expressly provided or permitted, except that (a) either party may transfer
all or any portion of its rights and obligations to any of its Affiliates
which shall agree to be bound by the provisions hereof relating to the
assigned rights or obligations, in which event the assigning party shall
continue to be responsible for the performance by such Affiliate of its
obligations hereunder, and (b) CCD's rights hereunder with respect to
Royalty Projects which have been terminated or for which Ciba has proposed
that the Technology Transfer Criteria have been satisfied shall be
assignable to a successor to substantially the whole of one of its lines of
business. In the event that Ciba wishes to transfer the responsibility for
conducting the research phase of a Royalty Project to one of its
Affiliates, Ciba will first consult with CCD regarding the possible impact
of such transfer on the timely completion of the Royalty Project. If CCD
believes that CCD itself would be better able to complete such Royalty
Project than the Ciba Affiliate to whom Ciba proposes to transfer the
Project, Ciba will permit CCD to take over completion of the Royalty
Project, and the parties will negotiate in good faith with respect to the
terms on which Ciba will transfer to CCD the rights in Diagnostics to the
work already completed by Ciba, in accordance with the provisions of
Article 3.7. Subject to the foregoing provisions of this Section, this
Agreement shall be binding upon and inure to the benefit of the parties
hereto and their respective successors and assignees.
14. ENTIRE AGREEMENT; MODIFICATION AND WAIVER
This Agreement is the entire agreement between the parties with respect to
the subject matter hereof and supersedes any prior negotiations and
agreements, provided that all licenses granted by either party to the other
under the 1985 Research Agreement remain in effect. This Agreement may not
be modified or amended in any way except by mutual written agreement of the
parties. The failure of either party to enforce any provision hereof, or
any right hereunder, shall not be construed as a waiver of such provision
or right.
22
15. GOVERNING LAW; JURISDICTION
This Agreement shall be governed by, and construed in accordance with, the
laws of the State of Delaware applicable to contracts executed and to be
fully performed in that State. All actions and proceedings arising out of
or relating to this Agreement shall be brought by the parties and heard and
determined only in a Delaware state court or a federal court sitting in
that State and the parties hereto consent to jurisdiction before and waive
any objections to the jurisdiction of any such court.
16. WAIVER OF JURY TRIAL
Each of the parties of this agreement hereby irrevocably waives all right
to trial by jury in any action, proceeding or counterclaim (whether based
on contract, tort, or otherwise) arising out of or relating to this
Agreement or the actions of any of them in the negotiation, administration,
performance and enforcement hereof.
IN WITNESS WHEREOF, the parties have executed this Agreement or caused their
duly authorized representatives to execute this Agreement as of the date first
above written.
CIBA CORNING DIAGNOSTICS CIBA-GEIGY Limited
CORP.
By: /s/ Xxxxxxx X. Xxxx By: /s/ X. Xxxxxx
--------------------------------- --------------------
Xxxxxxx X. Xxxx, Ph.D. Xxxx. X. Xxxxxx
Senior Vice President, Research Head, CRU
& Development
and
By: /s/ X. Xxxxxx
--------------------
Xx. X. Xxxxxx
Legal Counsel, CRU
Attachment A Royalty Projects
Attachment B Financial Terms
23
Royalty Projects to be included in Attachments A and B
1. [Confidential Treatment Requested] For [Confidential Treatment Requested]
2. [Confidential Treatment Requested] for [Confidential Treatment Requested]
3. [Confidential Treatment Requested] for [Confidential Treatment Requested]
4. [Confidential Treatment Requested] Systems for [Confidential Treatment
Requested]
Attachment 1 Confidential
(Royalty Project Agreement) [Confidential Treatment Requested] for
[Confidential Treatment Requested]
Title: [Confidential Treatment Requested] Royalty Project for Ciba
for [Confidential Treatment Requested] Corning Diagnostics
[Confidential Treatment Requested]
(cf. Attachments A2 & A3 for other uses of
[Confidential Treatment Requested]
Status November 1995
Approved by:
Project Management:
__________________ ______________ CCD: [Confidential Treatment Requested]
SVP, R&D, CCD Head CRU, Ciba
30.11.95 30.11.95 Ciba: [Confidential Treatment Requested]
Working basis agreed upon: Exclusive
Objective
- Develop expertise and demonstrate feasibility of concepts in the field of
analytical methods based on [Confidential Treatment Requested] recognition,
advanced [Confidential Treatment Requested] detection schemes and
[Confidential Treatment Requested] handling systems.
- Develop and explore functional models of such systems with respect to human
diagnostics. Characterize performance range using [Confidential Treatment
Requested] representing the following criteria: Assay sensitivity, dynamic
range, suitability for low molecular weight analytes, assay format.
Expected Technology Transfer Date: [Confidential Treatment Requested]
Present Status
Patents:
- Method for the detection of [Confidential Treatment Requested] in the
[Confidential Treatment Requested] field of a [Confidential Treatment
Requested] Application [Confidential Treatment Requested] contract)
- Method for using an [Confidential Treatment Requested] for the detection
of [Confidential Treatment Requested] in the [Confidential Treatment
Requested] field of a [Confidential Treatment Requested] Priority:
[Confidential Treatment Requested] Application [Confidential Treatment
Requested] contract)
- Patent application filed for [Confidential Treatment Requested] comprising
one or more [Confidential Treatment Requested] used for [Confidential
Treatment Requested] contract)
- Method for detection of [Confidential Treatment Requested] in the
[Confidential Treatment Requested] field using [Confidential Treatment
Requested] for the [Confidential Treatment Requested] detection of several
[Confidential Treatment Requested] Ciba)
- [Confidential Treatment Requested] for [Confidential Treatment Requested] of
[Confidential Treatment Requested] substances [Confidential Treatment
Requested] Ciba)
- [Confidential Treatment Requested] (Ciba; in preparation)
- Principle design of [Confidential Treatment Requested] configuration for a
[Confidential Treatment Requested] system [Confidential Treatment Requested]
contract; in preparation by [Confidential Treatment Requested]
Present Status continued
Further know-how
- A [Confidential Treatment Requested] system has been developed and applied
in showing advantages under realistic conditions compared to routinely used
[Confidential Treatment Requested] such as: [Confidential Treatment
Requested] information available, high precision and improved sample
handling. Without loss in performance, the same [Confidential Treatment
Requested] could be used for up to [Confidential Treatment Requested]
measurements.
- [Confidential Treatment Requested] of [Confidential Treatment Requested]
has been demonstrated. The obtained [Confidential Treatment Requested]
performed exceptionally well and no loss of performance was observed even
after [Confidential Treatment Requested] measurement and regeneration
cycles.
- The immobilization of [Confidential Treatment Requested] on [Confidential
Treatment Requested] demonstrated the possibility to [Confidential
Treatment Requested] on [Confidential Treatment Requested]. With model
systems, the [Confidential Treatment Requested] could be reduced remarkably
compared to conventional [Confidential Treatment Requested].
- For model systems, a significant simplification of [Confidential Treatment
Requested] has been achieved using two approaches: a) [Confidential
Treatment Requested] systems comprising [Confidential Treatment Requested]
and [Confidential Treatment Requested] b) [Confidential Treatment
Requested] using [Confidential Treatment Requested] to generate
[Confidential Treatment Requested].
- Thorough theoretical and practical understanding of [Confidential Treatment
Requested] from the former project [Confidential Treatment Requested] has
been successfully transferred to [Confidential Treatment Requested] based
[Confidential Treatment Requested] detection schemes.
- [Confidential Treatment Requested] Technology: A [Confidential Treatment
Requested] including [Confidential Treatment Requested] and [Confidential
Treatment Requested] techniques under clean room conditions as well as
[Confidential Treatment Requested] and [Confidential Treatment Requested]
characterization methods have been established and applied to thorough
characterization. First results are available in [Confidential Treatment
Requested] and [Confidential Treatment Requested] production.
- Expertise in development of complex [Confidential Treatment Requested]
based on [Confidential Treatment Requested]
Milestones (to be updated twice a year)
Version agreed upon in Meeting of [Confidential Completion Responsible
Treatment Requested]
6 Months milestones
- Finalize the set of selected [Confidential [Confidential [Confidential
Treatment Requested] Treatment Treatment
Requested] Requested]
- Fix the relevant precision data for the [Confidential [Confidential
above assays for [Confidential Treatment Treatment Treatment
Requested] criteria Requested] Requested]
- Provide SOP and source for [Confidential [Confidential [Confidential
Treatment Requested] materials for the Treatment Treatment
above assays Requested] Requested]
- Reevaluate [Confidential Treatment [Confidential [Confidential
Requested] situation on [Confidential Treatment Treatment
Treatment Requested] and [Confidential Requested] Requested]
Treatment Requested]
- Clarify relations to external partners [Confidential [Confidential
with respect to short-term [Confidential Treatment Treatment
Treatment Requested] supply and long term Requested] Requested]
contracts.
- Develop system concepts regarding [Confidential [Confidential
[Confidential Treatment Requested] and Treatment Treatment
[Confidential Treatment Requested] and Requested] Requested]
[Confidential Treatment Requested]
- Design first [Confidential Treatment [Confidential [Confidential
Requested] system Treatment Treatment
Requested] Requested]
- Decide on [Confidential Treatment [Confidential [Confidential
Requested] for
[Confidential Treatment Requested] Treatment Treatment
Requested] Requested]
- Transfer of [Confidential Treatment [Confidential [Confidential
Requested] from CCD to Ciba completed Treatment Treatment
Requested] Requested]
- [Confidential Treatment Requested] [Confidential [Confidential
on [Confidential Treatment Requested] Treatment Treatment
for [Confidential Treatment Requested] Requested] Requested]
Long term milestones
- Develop the product concept [Confidential [Confidential
Treatment Treatment
Requested] Requested]
- Decision on [Confidential [Confidential [Confidential
Treatment Requested] Treatment Treatment
material & [Confidential Requested] Requested]
Treatment Requested]
[Confidential Treatment
Requested] and
[Confidential Treatment
Requested] configuration
[Confidential Treatment
Requested]
- Transfer of all [Confidential Treatment [Confidential [Confidential
Requested] from CCD to Ciba completed Treatment Treatment
Requested] Requested]
- Decide on [Confidential Treatment [Confidential [Confidential
Requested] Treatment Treatment
Requested] Requested]
- [Confidential Treatment Requested] & [Confidential [Confidential
[Confidential Treatment Requested] for Treatment Treatment
first [Confidential Treatment Requested] Requested] Requested]
available
- Sample [Confidential Treatment [Confidential [Confidential
Requested] for [Confidential Treatment Treatment
Treatment Requested] available Requested] Requested]
- Decision on [Confidential Treatment [Confidential [Confidential
Requested] Treatment Treatment
Requested] Requested]
- [Confidential Treatment Requested] on [Confidential [Confidential
[Confidential Treatment Requested] Treatment Treatment
developed/compared with specs. Requested] Requested]
- Design [Confidential Treatment Requested] [Confidential [Confidential
Treatment Treatment
Requested] Requested]
- Build [Confidential Treatment Requested] [Confidential [Confidential
Treatment Treatment
Requested] Requested]
- Transfer of [Confidential Treatment [Confidential [Confidential
Requested] procedures Treatment Treatment
Requested] Requested]
- [Confidential Treatment Requested] [Confidential [Confidential
developed and tested for specs on Treatment Treatment
[Confidential Treatment Requested] Requested] Requested]
Ciba: [Confidential Treatment Requested]
[Confidential Treatment Requested]
CCD [Confidential Treatment Requested]
Intellectual property from outside of the Royalty Project to be made available:
Ciba: [Confidential Treatment Requested]
CCD: [Confidential Treatment Requested]
Third party: [Confidential Treatment Requested]
Management
Project Management Meetings twice a year.
Technology Transfer Criteria (Article 5.1)
- A [Confidential Treatment Requested] will have been set-up which is capable
of demonstrating assay performance under stable and reproducible
conditions. It will include the [Confidential Treatment Requested] and
[Confidential Treatment Requested] design, a [Confidential Treatment
Requested] system, the [Confidential Treatment Requested] system for
[Confidential Treatment Requested] and [Confidential Treatment Requested]
and [Confidential Treatment Requested]. It is understood, that the main
purpose of the [Confidential Treatment Requested] will be to demonstrate
functionality and the main purpose of the [Confidential Treatment
Requested] to demonstrate assay performance. Costly and voluminous
components, evidently not suitable for CCD's commercial use will not be
applied. single source materials and chemicals are to be identified.
- Performance will be demonstrated using the assays and specifications listed
below. Multifactorial design experiments will be applied in order to
confirm the specs to be fulfilled.
- Performance to specs will be shown for the [Confidential Treatment
Requested] jointly as part of the transfer process at least twice.
- [Confidential Treatment Requested] are discussed in the biannual meetings
and [Confidential
Treatment Requested] are included in the overhead slide collections.
- Documentation will be prepared to allow a skilled CCD technician to
reproduce the system and its performance in-house or to run a [Confidential
Treatment Requested] system physically transferred to CCD. Documentation
will include the accumulated experience about common failure modes and
reliability problems encountered during the research phase as related to
[Confidential Treatment Requested] and [Confidential Treatment Requested].
SPECIFICATIONS
1. Calibration [Confidential Treatment Requested] i.e. to run
[Confidential Treatment Requested]
2. Sample size [Confidential Treatment Requested] per
[Confidential Treatment Requested]
3. Mode of operation [Confidential Treatment Requested] or
[Confidential Treatment Requested] to be
fixed by the fall meeting [Confidential
Treatment Requested]
4. Assays per chip [Confidential Treatment Requested]
5. Time to result [Confidential Treatment Requested] min.
preferred)
6. Samples [Confidential Treatment Requested] (will be
[Confidential Treatment Requested] for final
product at CCD).
7. Assay sensitivity [Confidential Treatment Requested]
demonstrated with [Confidential Treatment
Requested]
8. Dynamic range [Confidential Treatment Requested]
demonstrated with [Confidential Treatment
Requested]
9. Assay format [Confidential Treatment Requested] and
[Confidential Treatment Requested]
10. Low MW analyte Demonstrated with [Confidential Treatment
Requested]
11. Selectivity [Confidential Treatment Requested] to be
decided in [Confidential Treatment Requested]
12. Precision/Reproducibility To be defined by [Confidential Treatment
Requested] after consulting with [Confidential
Treatment Requested]
13. Experimental control [Confidential Treatment Requested] of all
software system components/Menu for complete assays
* This spec must be feasibly reachable after development but need not be
demonstrated with the [Confidential Treatment Requested]
** Reference assays fulfilling requirements of enclosed assay performance
chart will be developed and provided by Chiron Diagnostics as agreed
(see milestones).
Title: [Confidential Treatment Requested] Royalty Project for Ciba
for [Confidential Treatment Requested] Corning Diagnostics
[Confidential Treatment Requested]
(cf. Attachments A2 & A3 for other uses of
[Confidential Treatment Requested]
Status November 1995
Approved by:
Project Management:
. . . . . . . . . . . . . . . CCD: [Confidential Treatment Requested]
SVP, R&D, Chiron Head CRU, Ciba
15.12.95 15.12.95 Ciba: [Confidential Treatment Requested]
Working basis agreed upon: Exclusive
Objective
- Based on expertise acquired under program A1, demonstrate feasibility of
concepts in the field of [Confidential Treatment Requested] of
[Confidential Treatment Requested] advanced [Confidential Treatment
Requested] schemes and [Confidential Treatment Requested] systems, with
special attention to [Confidential Treatment Requested] system
[Confidential Treatment Requested].
- Investigate alternative [Confidential Treatment Requested] concepts based
on [Confidential Treatment Requested] interactions for clinical
diagnostics. Consider new achievements in [Confidential Treatment
Requested] diagnostics [Confidential Treatment Requested]
- Develop and explore functional models of an [Confidential Treatment
Requested] for the simultaneous analysis of [Confidential Treatment
Requested] (Immuno). Potential usages include: [Confidential Treatment
Requested] Detection & [Confidential Treatment Requested] and [Confidential
Treatment Requested] Detection & [Confidential Treatment Requested].
Expected Technology Transfer Date: [Confidential Treatment Requested]
Present Status
Patents:
- Method for the detection of [Confidential Treatment Requested] in the
[Confidential Treatment Requested] field of a [Confidential Treatment
Requested] Application [Confidential Treatment Requested] contract)
Attachment A2 Confidential Page
(Royalty Project Agreement)
[Confidential Treatment Requested] for [Confidential Treatment Requested]
- Method for using an [Confidential Treatment Requested] for the detection
of [Confidential Treatment Requested] in the [Confidential Treatment
Requested] field of a [Confidential Treatment Requested]; Priority
[Confidential Treatment Requested] Application [Confidential Treatment
Requested] contract)
- Patent application filed for [Confidential Treatment Requested] comprising
one or more [Confidential Treatment Requested] used for [Confidential
Treatment Requested] contract)
- Method for detection of [Confidential Treatment Requested] in the
[Confidential Treatment Requested] field using [Confidential Treatment
Requested] for the [Confidential Treatment Requested] detection of several
[Confidential Treatment Requested] Ciba)
Patents continued
[Confidential Treatment Requested] for [Confidential Treatment Requested] of
[Confidential Treatment Requested] substances [Confidential Treatment
Requested] Ciba)
- [Confidential Treatment Requested] (Ciba; in preparation)
- Principle design of [Confidential Treatment Requested] configuration for a
[Confidential Treatment Requested] system [Confidential Treatment Requested]
contract; in prepartion by [Confidential Treatment Requested]
Further know-how
- A [Confidential Treatment Requested] system has been developed and applied,
showing advantages under realistic conditions compared to routinely used
[Confidential Treatment Requested] such as:[Confidential Treatment
Requested] information available, high precision and improved sample
handling. Without loss in performance, the same [Confidential Treatment
Requested] could be used for up to [Confidential Treatment Requested]
measurements.
- A detection limit of [Confidential Treatment Requested] moles [Confidential
Treatment Requested] labeled [Confidential Treatment Requested] of
[Confidential Treatment Requested] binding to protein [Confidential
Treatment Requested] on a [Confidential Treatment Requested] has been
achieved.
- The principle feasibility of simultaneous assays on [Confidential Treatment
Requested] areas [Confidential Treatment Requested] has been demonstrated in
model [Confidential Treatment Requested] assay for [Confidential Treatment
Requested].
- A first [Confidential Treatment Requested] system will be developed in the
module [Confidential Treatment Requested] for [Confidential Treatment
Requested] of the Ciba/CCD royalty project (Appendix A-1).
Attachment A2 Confidential Page
(Royalty Project Agreement)
[Confidential Treatment Requested] for [Confidential Treatment Requested]
- For model systems, a significant simplification of [Confidential Treatment
Requested] has been achieved using two approaches: a) [Confidential
Treatment Requested] systems comprising [Confidential Treatment Requested]
and [Confidential Treatment Requested] b) [Confidential Treatment Requested]
using [Confidential Treatment Requested] to generate [Confidential Treatment
Requested].
- [Confidential Treatment Requested] Technology: A [Confidential Treatment
Requested] including [Confidential Treatment Requested] and [Confidential
Treatment Requested] techniques under clean room conditions, as well as
[Confidential Treatment Requested] and [Confidential Treatment Requested]
characterization methods have been established and applied to thorough
characterization. First results are available in [Confidential Treatment
Requested] and [Confidential Treatment Requested] production
Milestones (to be updated end of 1997)
Proposed Completion Responsible
Milestones of Attachment A1 achieved [Confidential
Treatment
Requested]
Development and evaluation of novel [Confidential
[Confidential Treatment Requested] Treatment
concepts for [Confidential Treatment Requested]
Requested] and spacially [Confidential
Treatment Requested]
Minimum [Confidential Treatment Requested]
for model assay determined
Relation between [Confidential Treatment
Requested] and [Confidential Treatment
Requested] between individual [Confidential
Treatment Requested] investigated
Test of different assay formats for [Confidential
[Confidential Treatment Requested] Treatment
Requested]
Concept for selection of [Confidential
Treatment Requested] for a sample
[Confidential Treatment Requested] and
[Confidential Treatment Requested] or
different [Confidential Treatment
Requested] developed
Structured [Confidential Treatment Requested] [Confidential
Attachment A2 Confidential Page
(Royalty Project Agreement)
[Confidential Treatment Requested] for [Confidential Treatment Requested]
optimized Treatment
Requested]
Transfer [Confidential Treatment Requested]
and [Confidential Treatment Requested]
developed and tested against [Confidential
Treatment Requested] on [Confidential
Treatment Requested] [Confidential Treatment
Requested]
Intellectual property from outside of the Royalty Project to be
made available:
Ciba: [Confidential Treatment Requested]
CCD: [Confidential Treatment Requested]
Third party: [Confidential Treatment Requested]
Management
Project Management Meetings twice a year.
Technology Transfer Criteria (Article 5.1)
Specifications will be re-examined at the end of [Confidential Treatment
Requested]. Significant changes to the specs will be accepted through
[Confidential Treatment Requested]. Only modest to small changes will be
accepted in [Confidential Treatment Requested].
- A [Confidential Treatment Requested] will have been set-up which is capable
of demonstrating throughput and assay performance under stable and
reproducible conditions. It will include the [Confidential Treatment
Requested] and [Confidential Treatment Requested], a [Confidential Treatment
Requested] system, the [Confidential Treatment Requested] system for
[Confidential Treatment Requested] and detection and experimental control
[Confidential Treatment Requested]. It is understood, that the main purpose
of the [Confidential Treatment Requested] will be to demonstrate
functionality and the main purpose of the [Confidential Treatment Requested]
to demonstrate assay performance. Costly and voluminous components,
evidently not suitable for CCD's commercial use will not be applied.
- Performance will be demonstrated using the assays and specifications listed
below.
Documentation will be prepared to allow a skilled CCD technician to reproduce
the system and its performance in-house or to run a [Confidential Treatment
Requested] physically transferred to CCD. Documentation will include the
accumulated experience about common failure modes and reliability problems
encountered during the research phase as related to instrumentation and
[Confidential Treatment Requested]
Prototypes/Boundary Assays [Confidential Treatment Requested] or
-------------------------- [Confidential Treatment Requested]
Specifications
--------------
Attachment A2 Confidential Page
(Royalty Project Agreement)
[Confidential Treatment Requested] for [Confidential Treatment Requested]
1. Mode of operation [Confidential Treatment Requested] use
2. Multiplexity Up to [Confidential Treatment Requested]
per [Confidential Treatment Requested]
Processing of up to [Confidential
Treatment Requested]
3. Temperature [Confidential Treatment Requested]
temperature [Confidential Treatment
Requested]
4. Sample size/OED [Confidential Treatment Requested]
5. Time to first results [Confidential Treatment Requested]
6. Samples [Confidential Treatment Requested]
7. Assay sensitivity [Confidential Treatment Requested]
molecules/Analyte (Input) demonstrated
with [Confidential Treatment Requested]
8. Dynamic range [Confidential Treatment Requested]
detection up to [Confidential Treatment
Requested] required: [Confidential
Treatment Requested] with integrated
dilution (e.g. [Confidential Treatment
Requested] demonstrated with
[Confidential Treatment Requested]
9. Assay format [Confidential Treatment Requested]
10. Fluidics [Confidential Treatment Requested] sample
distribution
* This spec must be feasible reachable after development but need not be
demonstrated with the [Confidential Treatment Requested]
** Antibodies or antigens from prototype or marketed assays will be made
available by Chiron Diagnostics when ever possible in support of the
project milestones. In case of unavailability alternate assays will be
negotiated.
Attachment A3 Confidential Page
(Royalty Project Agreement)
[Confidential Treatment Requested] for [Confidential Treatment Requested]
Title: [Confidential Treatment Requested] Royal Project for Ciba Corning
for [Confidential Treatment Requested] Diagnostics
(cf Attachments A1 & A2 for other uses of
[Confidential Treatment Requested]
Status December 1995
--------------------------------------------------------------------------------
Approved by:
Project Management:
CCD: [Confidential Treatment Requested]
Ciba: [Confidential Treatment Requested]
___________________ ___________________
SVP, R&D, CC Head CRU, Ciba
3.1.96 3.1.96
Working basis agreed upon: EXCLUSIVE
OBJECTIVE
- Develop expertise and demonstrate feasibility of concepts in the field of
[Confidential Treatment Requested] methods based on [Confidential Treatment
Requested] recognition, advanced [Confidential Treatment Requested]
detection schemes and [Confidential Treatment Requested] systems that are
adequate for achieving [Confidential Treatment Requested] limits.
- To build a basis for very high [Confidential Treatment Requested] and
[Confidential Treatment Requested] for screening of [Confidential Treatment
Requested] panels to be delt with in a follow-up Royalty Project.
- Develop and explore functional models of an [Confidential Treatment
Requested] for the simultaneous analysis of [Confidential Treatment
Requested]. Potential usages include: [Confidential Treatment Requested]
detection and [Confidential Treatment Requested] quantification for the
[Confidential Treatment Requested] and the [Confidential Treatment
Requested] panel.
EXPECTED TECHNOLOGY TRANSFER DATE: [Confidential Treatment Requested]
PRESENT STATUS
Patents:
--------
- Method for the detection of [Confidential Treatment Requested] in the
[Confidential Treatment Requested] field of a [Confidential Treatment
Requested]. Application
Attachment A3 Confidential Page
(Royalty Project Agreement)
[Confidential Treatment Requested] for [Confidential Treatment Requested]
[Confidential Treatment Requested] contract).
Method for using an [Confidential Treatment Requested] for the detection of
[Confidential Treatment Requested] in the [Confidential Treatment Requested]
field of a [Confidential Treatment Requested]. Priority: Application
[Confidential Treatment Requested] contract).
- Patent application filed for [Confidential Treatment Requested], comprising
one or more [Confidential Treatment Requested] used for [Confidential
Treatment Requested] contract).
- Method for detection of [Confidential Treatment Requested] in the
[Confidential Treatment Requested] field using [Confidential Treatment
Requested] for the [Confidential Treatment Requested] detection of several
[Confidential Treatment Requested] Ciba.
- [Confidential Treatment Requested] for [Confidential Treatment Requested] of
[Confidential Treatment Requested] substances [Confidential Treatment
Requested] Ciba).
Patents continued
- [Confidential Treatment Requested] (Ciba; in preparation)
- Principle design of [Confidential Treatment Requested] configuration for a
[Confidential Treatment Requested] system [Confidential Treatment Requested]
contract; in preparation by [Confidential Treatment Requested].
Further know-how:
- The principle feasibility of [Confidential Treatment Requested] assays on
[Confidential Treatment Requested] areas [Confidential Treatment Requested]
has been demonstrated in model affinity [Confidential Treatment Requested]
and [Confidential Treatment Requested] assays [Confidential Treatment
Requested] of [Confidential Treatment Requested] with complementary,
[Confidential Treatment Requested] labeled strand).
- A first [Confidential Treatment Requested] system will be developed in the
module [Confidential Treatment Requested] for [Confidential Treatment
Requested] of the Ciba/CCD royalty project (Appendix A1).
- The [Confidential Treatment Requested] assay system was applied both on
[Confidential Treatment Requested] and on [Confidential Treatment
Requested]. From a [Confidential Treatment Requested] analysis of the
signals obtained at different concentrations, an
Attachment A3 Confidential Page
(Royalty Project Agreement)
[Confidential Treatment Requested] for [Confidential Treatment Requested]
expected detection limit in the [Confidential Treatment Requested] range was
calculated.
- A detection limit of [Confidential Treatment Requested] binding to
[Confidential Treatment Requested] on a [Confidential Treatment Requested]
has been achieved.
- Immobilization of [Confidential Treatment Requested] acting as [Confidential
Treatment Requested] was performed by [Confidential Treatment Requested]
synthesis and using the [Confidential Treatment Requested] system, both on
[Confidential Treatment Requested] and on [Confidential Treatment Requested]
as [Confidential Treatment Requested]. With [Confidential Treatment
Requested] more than [Confidential Treatment Requested] cycles could be
performed on [Confidential Treatment Requested] without loss of performance.
- For model systems, a significant simplification of [Confidential Treatment
Requested] handling has been achieved using two approaches: A) [Confidential
Treatment Requested] system comprising [Confidential Treatment Requested]
and [Confidential Treatment Requested] b) [Confidential Treatment
Requested] using [Confidential Treatment Requested] to generate
[Confidential Treatment Requested] as a [Confidential Treatment Requested].
- [Confidential Treatment Requested] Technology: A [Confidential Treatment
Requested] including [Confidential Treatment Requested] and [Confidential
Treatment Requested] techniques under clean room conditions, as well as
[Confidential Treatment Requested] and [Confidential Treatment Requested]
characterization methods have been established and applied to thorough
characterization. First results are available in [Confidential Treatment
Requested] and [Confidential Treatment Requested] production.
Milestones (to be updated end of 1997)
Proposed Completion Responsible
Analysis and investigation of current [Confidential
[Confidential Treatment Requested] Treatment
quantification assays on compatibility Requested]
with [Confidential Treatment
Requested] technology
Design and adaption of [Confidential
Treatment Requested] model assays for
the recognition and quantification of
[Confidential Treatment Requested] on
[Confidential Treatment Requested].
Evaluation of sensitivity improvement
by combining [Confidential Treatment
Requested] and [Confidential Treatment
Requested] technology.
Attachment A3 Confidential Page
(Royalty Project Agreement)
[Confidential Treatment Requested] for [Confidential Treatment Requested]
Development and evaluation of [Confidential [Confidential
Treatment Requested] concepts for high Treatment
throughput [Confidential Treatment Requested]
Requested]and [Confidential Treatment
Requested] and [Confidential Treatment
Requested] chemistry).
Minimum [Confidential Treatment Requested]
for model assay determined
Relation between [Confidential Treatment
Requested] and [Confidential Treatment
Requested] between individual
[Confidential Treatment Requested]
investigated.
Establish required technologies for spacially
[Confidential Treatment Requested].
Transfer [Confidential Treatment Requested]
Test of different assay formats for boundary assays.
Intellectual property from outside of the Royalty Project to be made available:
Ciba: [Confidential Treatment Requested]
CCD: [Confidential Treatment Requested]
Third party: [Confidential Treatment Requested] technology
(Chiron Corporation)
Above Amendment accepted:
April 15, 1996
____________ __________
MANAGEMENT
Project Management Meetings twice a year.
TECHNOLOGY TRANSFER CRITERIA (Article 5.1)
Specifications will be re-examined at the end of [Confidential Treatment
Requested]. Significant changes to the specs will be accepted through
[Confidential Treatment Requested]. Only modest to small changes will be
accepted in [Confidential Treatment Requested].
- A [Confidential Treatment Requested] system will have been set-up which is
capable of demonstrating throughput and assay performance under stable and
reproducible
Attachment A3 Confidential Page
(Royalty Project Agreement)
[Confidential Treatment Requested] for [Confidential Treatment Requested]
conditions. It will include the [Confidential Treatment Requested] and
[Confidential Treatment Requested], a [Confidential Treatment
Requested] delivery system, the [Confidential Treatment Requested] system
for [Confidential Treatment Requested] and detection and experimental
control [Confidential Treatment Requested]. It is understood, that the main
purpose of the [Confidential Treatment Requested] will be to demonstrate
functionality and the main purpose of the [Confidential Treatment Requested]
to demonstrate assay performance. Costly and voluminous components,
evidently not suitable for CCD's commercial use will not be applied.
- Performance will be demonstrated using the assays and specification listed
below. [Confidential Treatment Requested] design experiments will be
applied in order to confirm the specs to be fulfilled.
- Documentation will be prepared to allow a skilled CCD technician to
reproduce the system and its performance in-house or to run a
[Confidential Treatment Requested] system physically transferred to CCD.
Documentation will include the accumulated experience about common failure
modes and reliability problems encountered during the research phase as
related to instrumentation and sensor chemistry.
PROTOTYPES/BOUNDARY ASSAYS [Confidential Treatment Requested] Panel,
[Confidential Treatment Requested] for
[Confidential Treatment Requested] and
[Confidential TreatmentRequested]
Specifications
--------------
1. Mode of operation [Confidential Treatment Requested] use
2. Multiplexity Up to [Confidential Treatment Requested]
per [Confidential Treatment Requested]
3. Temperature [Confidential Treatment Requested]
temperature incubations [Confidential
Treatment Requested] phases during total
incubation time)
4. Sample size/OED [Confidential Treatment Requested]
of extracted sample
5. Time to first results Up to [Confidential Treatment Requested]
(May require change)
6. Samples [Confidential Treatment Requested] or
[Confidential Treatment Requested]
7. Assay sensitivity [Confidential Treatment Requested]
Analyte (Input)
8. Dynamic range Direct detection of up to [Confidential
Treatment Requested]
9. Fluidics [Confidential Treatment Requested] sample
distribution
PROTOTYPES/BOUNDARY ASSAYS [CONFIDENTIAL TREATMENT REQUESTED] (HIGH
SENSITIVITY PROTOTYPE) *
Attachment A3 Confidential Page
(Royalty Project Agreement) [Confidential Treatment Requested]
for[Confidential Treatment Requested]
PROTOTYPE)*
Specifications
--------------
1. Mode of operation [Confidential Treatment Requested] use
2. Multiplexity [Confidential Treatment Requested] per[Confidential
Treatment Requested]
3. Temperature [Confidential Treatment Requested] temperature
incubations
4. Sample size/OED [Confidential Treatment Requested] serum/plasma
5. Time to first results [Confidential Treatment Requested]
6. Samples [Confidential Treatment Requested]
7. Assay sensitivity [Confidential Treatment Requested] molecules
8. Dynamic range [Confidential Treatment Requested] (with integrated
dilution)
9. Fluidics [Confidential Treatment Requested]
* [Confidential Treatment Requested] and [Confidential Treatment
Requested] from prototype or marketed assays will be made available by
Chiron Diagnostics whenever possible in support of the project milestones.
In case of unavailability alternate assays will be negotiated.
Attachment A4 Confidential Page
(Royalty Project Agreement) [Confidential Treatment Requested]
for[Confidential Treatment Requested]
Title: [Confidential Treatment Royalty Project for Ciba
Requested] Systems for Corning Diagnostics
[Confidential Treatment Requested]
Status October 1995
-------------------------------------------------------------------------------
Approved by: Project Management:
CCD:
__________________ _________________
SVP, R&D, CCD Head CRU, Ciba Ciba:
15.12.95 15.12.95
Working basis agreed upon: Exclusive
OBJECTIVE
- Development of analytical systems for human diagnostics based on the
combination of novel [Confidential Treatment Requested] elements with
advanced [Confidential Treatment Requested] and [Confidential Treatment
Requested] systems.
- Development of novel or modified functional components [Confidential
Treatment Requested] host [Confidential Treatment Requested] for
[Confidential Treatment Requested] and [Confidential Treatment Requested]
for improved and patent Protected [Confidential Treatment Requested]
systems for [Confidential Treatment Requested].
SCOPE OF APPLICATIONS/EXPECTED TECHNOLOGY TRANSFER DATES:
For [Confidential Treatment Requested] and [Confidential Treatment Requested]
[Confidential Treatment Requested] in [Confidential Treatment
Requested]
For [Confidential Treatment Requested] and [Confidential Treatment Requested]
[Confidential Treatment Requested]
[CONFIDENTIAL TREATMENT REQUESTED] MILESTONES
Refill [Confidential Treatment Requested] [Confidential Treatment Requested]
each for [Confidential Treatment Requested]
Medfield and Basel) and [Confidential [Confidential Treatment Requested]
Treatment Requested] for Basel [Confidential Treatment Requested]
Synthesize [Confidential Treatment [Confidential Treatment Requested]
Requested]
Attachment A4 Confidential Page
(Royalty Project Agreement) [Confidential Treatment Requested]
for[Confidential Treatment Requested]
[Confidential Treatment Requested]
[Confidential Treatment Requested] testing [Confidential Treatment Requested]
against specs [Confidential Treatment Requested]
[Confidential Treatment Requested] testing [Confidential Treatment Requested]
[Confidential Treatment Requested]
Evaluation of [Confidential Treatment [Confidential Treatment Requested]
Requested] completed [Confidential Treatment Requested]
List of [Confidential Treatment Requested] [Confidential Treatment Requested]
screened and documentation [Confidential Treatment Requested]
[Confidential Treatment Requested] [Confidential Treatment Requested]
inventory returned to [Confidential [Confidential Treatment Requested]
Treatment Requested]
[Confidential Treatment Requested] [Confidential Treatment Requested]
inventory shipped to [Confidential [Confidential Treatment Requested]
Treatment Requested]
Narrow approach from [Confidential [Confidential Treatment Requested]
Treatment Requested] [Confidential Treatment Requested]
Scale up of [Confidential Treatment [Confidential Treatment Requested]
Requested] for evaluations Treatment [Confidential Treatment Requested]
Requested]
Supply of [Confidential Treatment [Confidential Treatment Requested]
Requested] for evaluation [Confidential [Confidential Treatment Requested]
Treatment Requested]
Scale up for [Confidential Treatment [Confidential Treatment Requested]
Requested] and [Confidential Treatment [Confidential Treatment Requested]
Requested]
[CONFIDENTIAL TREATMENT REQUESTED] MILESTONES
Report on [Confidential Treatment [Confidential Treatment Requested]
Requested] study [Confidential Treatment Requested]
Report on study of [Confidential Treatment [Confidential Treatment Requested]
Requested] using [Confidential Treatment [Confidential Treatment Requested]
Requested]
Information and documentation for transfer [Confidential Treatment Requested]
identified [Confidential Treatment Requested]
Attachment A4 Confidential Page
(Royalty Project Agreement) [Confidential Treatment Requested]
for[Confidential Treatment Requested]
[Confidential Treatment Requested] confirmed [Confidential Treatment Requested]
[Confidential Treatment Requested]
[Confidential Treatment Requested] study [Confidential Treatment Requested]
[Confidential Treatment Requested] [Confidential Treatment Requested]
wrapped up
[Confidential Treatment Requested] [Confidential Treatment Requested]
formulation optimized [Confidential Treatment Requested]
[Confidential Treatment Requested] [Confidential Treatment Requested]
disclosure [Confidential Treatment Requested]
Decision on continuation of [Confidential [Confidential Treatment Requested]
Treatment Requested] [Confidential Treatment Requested]
Deliver [Confidential Treatment Requested] [Confidential Treatment Requested]
with [Confidential Treatment Requested] [Confidential Treatment Requested]
Scale up of [Confidential Treatment [Confidential Treatment Requested]
Requested] and [Confidential Treatment [Confidential Treatment Requested]
Requested]
[CONFIDENTIAL TREATMENT REQUESTED] MILESTONES
Deliver [Confidential Treatment Requested] [Confidential Treatment Requested]
[Confidential Treatment Requested]
Deliver [Confidential Treatment Requested] [Confidential Treatment Requested]
[Confidential Treatment Requested]
Deliver [Confidential Treatment Requested] [Confidential Treatment Requested]
[Confidential Treatment Requested]
Refill [Confidential Treatment Requested] [Confidential Treatment Requested]
containing [Confidential Treatment [Confidential Treatment Requested]
Requested] for Basel
Refill [Confidential Treatment Requested] [Confidential Treatment Requested]
containing [Confidential Treatment [Confidential Treatment Requested]
Requested] for Medfield
Deliver [Confidential Treatment Requested] [Confidential Treatment Requested]
to Medfield for [Confidential Treatment [Confidential Treatment Requested]
Requested] testing
Extensive [Confidential Treatment [Confidential Treatment Requested]
Requested] testing in [Confidential [Confidential Treatment Requested]
Treatment Requested]
Attachment A4 Confidential Page
(Royalty Project Agreement) [Confidential Treatment Requested]
for[Confidential Treatment Requested]
Report on [Confidential Treatment [Confidential Treatment Requested]
Requested] and [Confidential Treatment [Confidential Treatment Requested]
Requested]
Refill [Confidential Treatment [Confidential Treatment Requested]
Requested] with [Confidential Treatment [Confidential Treatment Requested]
Requested]
Comparative data on early response, [Confidential Treatment Requested]
[Confidential Treatment Requested] [Confidential Treatment Requested]
Decision on continuation of [Confidential [Confidential Treatment Requested]
Treatment Requested] [Confidential Treatment Requested]
Conclude [Confidential Treatment [Confidential Treatment Requested]
Requested] Support [Confidential Treatment Requested]
[Confidential Treatment Requested]
Milestones (Basel)
Deliver [Confidential Treatment [Confidential Treatment Requested]
Requested] for research [Confidential Treatment Requested]
Deliver [Confidential Treatment [Confidential Treatment Requested]
Requested] for research [Confidential Treatment Requested]
Deliver [Confidential Treatment [Confidential Treatment Requested]
Requested] with [Confidential Treatment [Confidential Treatment Requested]
Requested]
[Confidential Treatment Requested] [Confidential Treatment Requested]
(research quantity) [Confidential Treatment Requested]
Deliver [Confidential Treatment [Confidential Treatment Requested]
Requested] with [Confidential Treatment [Confidential Treatment Requested]
Requested]
[Confidential Treatment Requested] [Confidential Treatment Requested]
(research quantity) [Confidential Treatment Requested]
Report on [Confidential Treatment [Confidential Treatment Requested]
Requested] testing [Confidential Treatment Requested]
Deliver [Confidential Treatment [Confidential Treatment Requested]
Requested] with [Confidential Treatment [Confidential Treatment Requested]
Requested]
[Confidential Treatment Requested] [Confidential Treatment Requested]
(research quantity) [Confidential Treatment Requested]
Attachment A4 Confidential Page
(Royalty Project Agreement) [Confidential Treatment Requested]
for[Confidential Treatment Requested]
Transfer [Confidential Treatment [Confidential Treatment Requested]
Requested] [Confidential Treatment Requested]
Report on [Confidential Treatment [Confidential Treatment Requested]
Requested] testing [Confidential Treatment Requested]
Transfer [Confidential Treatment [Confidential Treatment Requested]
Requested] [Confidential Treatment Requested]
Deliver [Confidential Treatment [Confidential Treatment Requested]
Requested] with [Confidential Treatment [Confidential Treatment Requested]
Requested]
[Confidential Treatment Requested] [Confidential Treatment Requested]
development [Confidential Treatment Requested]
Deliver [Confidential Treatment [Confidential Treatment Requested]
Requested] with [Confidential Treatment [Confidential Treatment Requested]
Requested]
[Confidential Treatment Requested] ab) [Confidential Treatment Requested]
[Confidential Treatment Requested]
Deliver [Confidential Treatment [Confidential Treatment Requested]
Requested] with [Confidential Treatment [Confidential Treatment Requested]
Requested]
[Confidential Treatment Requested] [Confidential Treatment Requested]
or [Confidential Treatment [Confidential Treatment Requested]
Requested] development
Deliver [Confidential Treatment [Confidential Treatment Requested]
Requested] with [Confidential Treatment [Confidential Treatment Requested]
Requested]
[Confidential Treatment Requested] kilo lab [Confidential Treatment Requested]
[Confidential Treatment Requested]
Deliver [Confidential Treatment [Confidential Treatment Requested]
Requested] with [Confidential Treatment [Confidential Treatment Requested]
Requested]
[Confidential Treatment Requested] [Confidential Treatment Requested]
or [Confidential Treatment Requested] [Confidential Treatment Requested]
kilo lab
[Confidential Treatment Requested]
[Confidential Treatment Requested]
[Confidential Treatment Requested]
Attachment A4 Confidential Page
(Royalty Project Agreement) [Confidential Treatment Requested]
for[Confidential Treatment Requested]
Intellectual property from outside of the Royalty Project to be made available:
Ciba: (to be confirmed)
CCD: (to be confirmed)
Third party: (to be confirmed)
MANAGEMENT
PROJECT MANAGEMENT MEETINGS TWICE A YEAR.
TECHNOLOGY TRANSFER CRITERIA (ARTICLE 5.1)
1. SPECIFICATIONS
------------------
All analytes: According to [Confidential Treatment Requested]
[Confidential Treatment Requested] [Confidential Treatment Requested]
[Confidential Treatment Requested]
[Confidential Treatment Requested]
[Confidential Treatment Requested] [Confidential Treatment Requested]
[Confidential Treatment Requested]
[Confidential Treatment Requested]
[Confidential Treatment Requested] [Confidential Treatment Requested]
[Confidential Treatment Requested]
[Confidential Treatment Requested]
Response time: [Confidential Treatment Requested]
2. PROTOCOLS:
--------------
[Confidential Treatment Requested] performance testing in Basel will be done on
[Confidential Treatment Requested] system or the [Confidential Treatment
Requested] system in a [Confidential Treatment Requested] mode with
[Confidential Treatment Requested] sample solutions, QC materials from the
[Confidential Treatment Requested], according to [Confidential Treatment
Requested] protocol provided by CCD. All tests to be performed at [Confidential
Treatment Requested] on equilibrated [Confidential Treatment Requested] samples
will be tested as a challenge but not to demonstrate the specifications. The
initial response of the [Confidential Treatment Requested] will be investigated
and documented.
Attachment A4 Confidential Page
(Royalty Project Agreement) [Confidential Treatment Requested]
for[Confidential Treatment Requested]
3. DOCUMENTATION:
------------------
Performance will be demonstrated using the assays and specifications listed
above. Sufficient data will be compiled to allow an assessment of consistency.
Sufficient documentation will be prepared to allow a skilled CCD technician to
run the system and to reproduce the assays. Documentation will include the
accumulated experience about common failure modes and reliability problems
(including the stability of compounds, if tested) encountered during the
research phase as related to instrumentation and [Confidential Treatment
Requested] chemistry.
A materials list including the supplier, the purity and the available analysis
results will be provided for the critical materials of [Confidential Treatment
Requested] and [Confidential Treatment Requested] synthesis.
Ciba-Geigy/Ciba Corning Royalty Projects 3. Jan. 96
Attachment B
EXIT FEES AND ROYALTIES
(All numbers in MM CHF)
PROJECT OR APPLICATION FEES ROYALTY RATE *
---------------------- ---- --------------
Refer to Strategic Technical License Exclusive
Attachment Failure Fee Failure Fee Maintenance License
[Confidential Treatment Requested] A4 [Confidential [Confidential [Confidential [Confidential
Systems for [Confidential Treatment Treatment Treatment Treatment Treatment
Requested] Requested] Requested] Requested] Requested]
[Confidential Treatment Requested] for A1 [Confidential [Confidential [Confidential [Confidential
Treatment Treatment Treatment Treatment
Requested] Requested] Requested] Requested]
[Confidential Treatment Requested] for A2 [Confidential [Confidential [Confidential [Confidential
Treatment Treatment Treatment Treatment
Requested] Requested] Requested] Requested]
[Confidential Treatment Requested] for A3 [Confidential [Confidential [Confidential [Confidential
Treatment Treatment Treatment Treatment
Requested] Requested] Requested] Requested]
* For products that are within the scope of a patent issued in any Designated
Country but that are sold in countries where patents are pending or are not
filed, the royalty rate shall be [Confidential Treatment Requested] of the
rate specified in the table.
Approved by:
______________________________ _______________________________
SVP, R&D, CCD Head CRU, Ciba
