OPTION AGREEMENT
BETWEEN
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
AND
VYSIS, INC.
FOR
THE GLASS CHROMOSOME
UC CASE NOS. 95-095 AND 95-097
TABLE OF CONTENTS
ARTICLE NO. TITLE PAGE
----------- ----- ----
RECITALS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1. DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2. OPTION FOR EXCLUSIVE LICENSE. . . . . . . . . . . . . . . . . . . . 10
3. OPTION FEE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4. EXERCISE OF THE OPTION. . . . . . . . . . . . . . . . . . . . . . . 13
5. TERMS TO BE NEGOTIATED. . . . . . . . . . . . . . . . . . . . . . . 14
6. PROGRESS REPORTS. . . . . . . . . . . . . . . . . . . . . . . . . . 18
7. PATENT PROSECUTION AND MAINTENANCE. . . . . . . . . . . . . . . . . 18
8. LIFE OF THE AGREEMENT . . . . . . . . . . . . . . . . . . . . . . . 21
9. TERMINATION BY THE REGENTS. . . . . . . . . . . . . . . . . . . . . 22
10. TERMINATION BY OPTIONEE . . . . . . . . . . . . . . . . . . . . . . 22
11. DISPOSITION OF PRODUCT(S) ON HAND UPON TERMINATION. . . . . . . . . 23
12. USE OF NAMES AND TRADEMARKS . . . . . . . . . . . . . . . . . . . . 23
13. REPRESENTATIONS AND WARRANTS. . . . . . . . . . . . . . . . . . . . 24
14. INDEMNIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . 25
15. NOTICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
16. ASSIGNABILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
17. LATE PAYMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
18. WAIVER. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
19. GOVERNING LAWS. . . . . . . . . . . . . . . . . . . . . . . . . . . 28
20. CONFIDENTIALITY . . . . . . . . . . . . . . . . . . . . . . . . . . 28
21. SUPPLY OF THE BIOLOGICAL MATERIALS. . . . . . . . . . . . . . . . . 30
22. MAINTENANCE OF THE BIOLOGICAL MATERIALS . . . . . . . . . . . . . . 31
23. MISCELLANEOUS . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
OPTION AGREEMENT
FOR
THE GLASS CHROMOSOME
THIS OPTION AGREEMENT ("Agreement") is made and is effective this 3rd day
of April 1996, by and between THE REGENTS OF THE UNIVERSITY OF CALIFORNIA, a
California corporation having its statewide administrative offices at 000
Xxxxxxxx Xxxxx, 00xx Xxxxx, Xxxxxxx, Xxxxxxxxxx 00000-0000 ("The Regents"), and
VYSIS, INC., an Illinois corporation, having a principal place of business at
0000 Xxxxxxxxx Xxxxx, Xxxxxxx Xxxxx, Xxxxxxxx 00000 ("Optionee").
RECITALS
WHEREAS, certain inventions, generally characterized as a method for
comparing copy number of nucleic acid sequences where the target nucleic acid is
bound to a solid surface and a high density array fabrication and readout method
for a fiber-optic biosensor ("Invention"), were made in the course of research
at the University of California, San Francisco (UCSF) in the Division of
Molecular Cytometry under the direction of Xxx X. Xxxx and Xxxxxx Xxxxxx
("Principal Investigators") and at Medical Research Council (MRC), London,
England, by Xxxxx Xxxxxxxxx and are covered by Patent Rights as defined below;
WHEREAS, The Regents owns an undivided interest in U.S. Patent No.
4,468,464 entitled "Process and Composition for Biologically Functional
Molecular Chimeras" by X. Xxxxx, et al. and issued August 28, 1984, U.S. Patent
No.
4,740,470 entitled "Biologically Functional Molecular Chimeras" by X. Xxxxx, et
al. and issued April 26, 1988, and U.S. Patent No. 4,237,224 entitled "Process
and Composition for Biologically Functional Molecular Chimeras" by X. Xxxxx, et
al. and issued December 2, 1980, which patents may prevent the practice of
Invention(s) claimed in Patent Rights contained in Paragraph 1.5 of this
Agreement;
WHEREAS, if it is necessary for Optionee to be licensed under the
aforementioned U.S. Patent No. 4,468,464, U.S. Patent 4,740,470, or U.S. Patent
No. 4,237,224 to practice the Invention claimed in Patent Rights, then Optionee
shall obtain the necessary licenses from Stanford University; in no case do the
rights and options granted to Optionee under the terms of this Agreement cover
U.S. Patent No. 4,468,464, U.S. Patent No. 4,740,470, or U.S. Patent No.
4,237,224;
WHEREAS, The Regents and MRC entered into an Interinstitutional Agreement
(UC Control No. 95-28-1729) effective April 12, 1995, that grants to The Regents
the right to exclusively manage the Patent Rights contained in Subparagraphs
1.5a and 1.5b and administer their licensure for commercial development of
Products claimed therein;
WHEREAS, the research conducted at UCSF under which the Invention was made
was funded in part by the U.S. Department of Health and Human Services (DHHS);
WHEREAS, under 35 USC Section 200-212, The Regents may elect to retain
title to any invention (including the Invention) made by it under U.S.
Government funding;
WHEREAS, if The Regents elects to retain title to the Invention, then the
law requires that The Regents grant to the U.S. Government a nontransferable,
paid-up,
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nonexclusive, irrevocable license to use the Invention by or on behalf of the
U.S. Government throughout the world;
WHEREAS, The Regents and Optionee entered into a Research Agreement
entitled "Research Agreement for the Development of Molecular Cytogenetics"
dated July 1, 1994, to provide funding by Optionee to the Principal
Investigators at UCSF to perform research in the detection and treatment of
disease related to chromosome abnormalities ("Research Agreement");
WHEREAS, the Research Agreement has been amended to include the conduct of
research related to the Invention to be performed thereunder;
WHEREAS, under the terms of the amended Research Agreement, Optionee may
elect to include patent applications and resulting patents claiming inventions
arising in the conduct of work performed thereunder in this Agreement;
WHEREAS, The Regents and Optionee entered into a CRADA (defined below) to
provide funding by Optionee, which funding is partially provided under a NIST
grant, to the Principal Investigators at the Xxxxxxxx Berkeley Laboratory (LBL)
to perform research for detecting and mapping genetic abnormalities associated
with various diseases;
WHEREAS, LBL is managed by The Regents for the United States Department of
Energy (DOE) under Xxxxxxxx Xx. XX-XX00-00XX00000;
WHEREAS, pursuant to the terms of CRADA, Optionee may elect to retain title
to inventions made by The Regents in the course of work performed under the
CRADA;
WHEREAS, if Optionee elects to retain title to the inventions, Optionee is
3
required to grant to the U.S. Government a nontransferable, paid-up, non-
exclusive, irrevocable license to use the inventions by or on behalf of the U.S.
Government throughout the world;
WHEREAS, under the terms of Paragraphs 2.7 and 2.8 herein, Optionee will
assign title to The Regents to any and all patent applications claiming
inventions made by it under the CRADA and Optionee may elect to include such
patent applications and resulting patents claiming the inventions in this
Agreement;
WHEREAS, Optionee is desirous of acquiring exclusive licenses to any and
all of Patent Rights covering the Invention and any inventions arising in the
conduct of work performed under the Research Agreement and the CRADA, subject to
rights granted by to the U.S. Government as hereinafter described;
WHEREAS, the Invention has utility for the identification of differences in
gene dosage or expression among all populations for the study and detection of
disease, and the Optionee has an interest in obtaining rights to pursue the
evaluation of commercial development of the Invention; and
WHEREAS, The Regents desires to grant such rights to Optionee in order that
the Invention and any related inventions made under the Research Agreement and
the CRADA be developed and utilized to the fullest extent so that the benefits
can be enjoyed by the general public.
The parties agree as follows:
4
1. DEFINITIONS
As used in this Agreement, the following terms shall have the meaning set
forth below:
1.1 "Derived Product(s)" means any product containing (a) a plasmid, a
protein structure, a cDNA clone, a promoter, a gene or a chimeric gene, or
fragments thereof and their sequences derived from or comprising the biological
materials that are provided to Optionee by The Regents or any product identified
through the use of such biological materials, even if such product is
subsequently modified after its original identification; (b) any protein
structure produced or encoded by the biological materials; or (c) a compound
(substantially similar or identical to a compound in (a) or (b) above), produced
by chemical synthesis or by any other method which could not have been produced
but for the use of the biological materials; or (d) any nucleic acid-based
biosensor that employs protocols or concepts for its manufacture or use that are
provided to Optionee by The Regents that may comprise a solid support, methods
of DNA deposition or attachment, processes for DNA preparation for
hybridization, hybridization, signal detection, analysis, or any other feature
of the nucleic acid-based biosensor. Derived Products do not include Patent
Products and Unprotected Products.
1.2 "Research Agreement" means the agreement entitled "Research Agreement
for the Development of Molecular Cytogenetics" between The Regents and Optionee
dated July 1, 1994, for the conduct of research, and any extensions or renewals
thereof, and incorporated herein by reference. In the event of any
inconsistencies between the Research Agreement and this Agreement, the terms of
5
this Agreement shall control.
1.3 "CRADA" means the cooperative research and development agreement
entitled "Xxxxxxxxx-Xxxxxx (15 USC 3710) Cooperative Research and Development
Agreement (No. BG95-046/00)" between The Regents and Optionee for the conduct
of research, and any extensions or renewals thereof, and incorporated herein by
reference. In the event of any inconsistencies between the CRADA and this
Agreement, the terms of this Agreement shall control.
1.4 "Research Information" means technical data, processes, methods,
inventions, compositions-of-matter, and biological materials, nucleic acid-based
biosensors, equipment, instruments, apparatuses, devices, articles of
manufacture or component parts(s) thereof developed under or resulting from the
performance of research under the Research Agreement or the CRADA and
improvements thereof, except for improvements on new subject matter not funded
by Optionee. There shall be no transfer of the physical possession of
equipment, instruments, apparatuses, devices, articles of manufacture or
component part(s) thereof (except biological materials and nucleic acid-based
biosensors) comprising Research Information.
1.5 "Patent Rights" means all U.S. patents and patent applications and
foreign patents and patent applications assigned to The Regents and requested
under Paragraph 7.3 infra, including any reissues, extensions, substitutions,
continuations, divisions and continuations-in-part (only to the extent, however,
that claims in the continuations-in-part are entitled to the priority filing
date of the parent patent application) based on and including any subject matter
claimed in or covered by any of the following:
6
(1.5a) USSN 08/448,043 entitled "High Density Array Fabrication and
Read Out Method for a Fiber Optic Biosensor" filed May 23,
1995, by Xxx X. Xxxx and Xxxxxx Xxxxxx, who assigned to The
Regents, and Xxxxx Xxxxxxxxx, who assigned to MRC;
(1.5b) USSN 08/353,018 entitled "Comparative Fluorescence
Hybridization to Nucleic Acid Arrays" filed December 9,
1994, by Xxx X. Xxxx and Xxxxxx Xxxxxx, who assigned to The
Regents, and Xxxxx Xxxxxxxxx, who assigned to MRC; and
(1.5c) Any future patent rights to subject matter claimed in or
covered by a patent application(s) covering any inventions
elected by Optionee under the provisions of Article VIII of
the Research Agreement or Paragraphs 2.7 and 2.8 of this
Agreement.
1.6 "Patent Products" means (a) any kit, composition of matter, material,
or product; (b) any kit, composition of matter, material, or product to be used
in a manner requiring the performance of the Patent Method, or any kit,
composition of matter, material, or product produced by the Patent Method, or
(c) the practice of the Patent Method itself to the extent the manufacture, use,
or sale of (a), (b), or (c) immediately above falls within the scope of one or
more claims of Patent Rights during the term of the patent grant, in countries
in which such claim or claims have issued and have not expired, been abandoned,
disclaimed, or found invalid or unenforceable.
1.7 "Unprotected Products" means (a) any kit, composition of matter,
material, or product; (b) any kit, composition of matter, material, or product
to be used in a manner requiring the performance of the Unprotected Method, or
any kit, composition of matter, material, or product produced by the Unprotected
Method, or (c) the practice of the Unprotected Method itself to the extent the
manufacture, use, or sale of (a), (b), or (c) immediately above falls within the
scope of one or more
7
pending claims within Patent Rights during the period and in such countries in
which such claim or claims have not issued, and have not expired, been
abandoned, disclaimed, or found invalid or unenforceable, such period not to
exceed five (5) years from the date in which the subject matter is first
introduced in a patent application in each country that such patent application
is filed.
1.8 "Patent Method" means any process or method the use or practice of
which would constitute in a particular country, but for the license granted to
the Optionee pursuant to this Agreement, an infringement of an unexpired claim
of a patent within Patent Rights in that country in which the Patent Method is
used or practiced.
1.9 "Unprotected Method" means any process or method the use or practice
of which would constitute in a particular country, but for the license granted
to the Optionee pursuant to this Agreement an infringement of any unabandoned,
pending claim of a patent application within Patent Rights if such patent
application in that country in which the Unprotected Method is used or practiced
had issued.
1.10 "Product(s)" means Patent Products, Unprotected Products, and Derived
Products.
1.11 "Method" means Patent Method and Unprotected Method.
1.12 "Research Product" means any Product sold to the research market for
experimental use only and not approved for marketing by a regulatory agency of
the country in which it is sold.
1.13 "Clinical Product" means any Product sold to the clinical market for
the diagnosis, prognosis or treatment of disease that requires marketing
approval from a
8
regulatory agency, by way of example, an NDA, PMA, or 510K from an appropriate
regulatory agency of the country in which such Product is sold including by way
of example, the United States Food and Drug Administration.
1.14 "Affiliate(s)" of a party means any entity which, directly or
indirectly, controls such party, is controlled by such party or is under common
control with such party ("control" for these purposes being defined as the
actual, present capacity to elect a majority of the directors of such affiliate,
or if not, the capacity to elect the members that control fifty percent (50%) of
the outstanding stock or other voting rights entitled to elect directors)
provided, however, that in any country where the local law shall not permit
foreign equity participation of a majority, then an "Affiliate" shall include
any company in which the Licensee shall own or control, directly or indirectly,
the maximum percentage of such outstanding stock or voting rights permitted by
local law. Each reference to Optionee herein shall be meant to include its
Affiliates.
1.15 "Joint Venture" means any separate entity established pursuant to an
agreement between a third party and Optionee to constitute a vehicle for a joint
venture, which separate entity manufacture, uses, purchases, sells, or acquires
a Product from Optionee. Each reference to Optionee herein shall be meant to
include its Joint Ventures.
1.16 "License Agreement" means any agreement entered into by The Regents
and Optionee that grants Optionee the exclusive right to make, use, sell, offer
for sale, or import Products claimed in Patent Rights.
9
2. OPTION FOR EXCLUSIVE LICENSE
2.1 Subject to the limitations set forth in this Agreement and subject to
the licenses granted to the U.S. Government set forth in Paragraphs 2.6 and 13.2
infra, The Regents hereby grants to Optionee under the Patent Rights, a royalty-
free right to practice the Method and a royalty-free right to make and use the
Products for their development, test, and evaluation in determining the interest
by Optionee in exercising the option.
2.2 Subject to the limitations set forth in this Agreement and subject to
the licenses granted to the U.S. Government set forth in Paragraphs 2.6 and 13.2
infra, The Regents hereby grants to Optionee a time-limited exclusive right to
negotiate in good faith the terms of the License Agreement.
2.3 During the period this Agreement is in effect, The Regents will not
license Patent Rights to any other party or negotiate with respect to a license
with any other party other than the U.S. Government, and will not otherwise
encumber the Patent Rights in a manner inconsistent with the provisions of this
Agreement.
2.4 This Agreement does not constitute a license to make, have made, or
use Products or a license to practice the Method except for the sole purpose of
conducting an evaluation and developing Products to determine the interest by
Optionee in exercising its option. The right to sell Products is excluded from
this Agreement. Optionee will not attempt to sell, donate, abandon, or
otherwise transfer Products to any third party, except for the transfer of
Products for the sole purpose of conducting an evaluation and developing the
Products.
2.5 The rights granted to Optionee hereunder shall be subject to the
rights
10
of the U.S. Government including those set forth in 35 U.S.C. 200-212.
2.6 Nothing in this Agreement shall be deemed to limit the right of The
Regents to publish and use technical data from any research performed by The
Regents, Research Information, and Patent Rights relating to the Invention and
inventions specified under Subparagraph 1.5 and to make and use Products,
Methods, and associated technology for educational and research purposes.
2.7 The Regents will provide the Optionee with a copy of any manuscript
or abstract disclosing data or information comprising CRADA Research Information
prior to submission to any third party other than the U.S. Government not less
that fifteen (15) days after submission of such disclosure for the purpose of
obtaining comments on possible patentable subject matter, and The Regents will
withhold publication for up to sixty (60) days following disclosure to Optionee
for the purpose of filing a patent application. A request by Optionee for a
delay in publication to file a patent application shall be considered an
election by Optionee to include such patent application in this Agreement under
the provisions of Paragraph 2.8 infra. Optionee shall have the right to use the
technical reports, data and information comprising Research Information
delivered hereunder to Optionee by The Regents.
2.8 The Regents shall promptly disclose to Optionee any invention
conceived and reduced to practice in the performance of research conducted under
the CRADA. Optionee shall notify The Regents in writing of any and all
inventions or potentially patentable subject matter for which it desires to be
included in this Agreement and shall request The Regents to file patent
applications claiming such inventions or covering such potentially patentable
subject matter within sixty (60) days from the
11
date of disclosure of the invention or potentially patentable subject matter to
Optionee by The Regents. Optionee will promptly assign such patent applications
to The Regents at the time to be selected by Optionee but not later than four
(4) years from the effective date recited on page one of this Agreement. In the
event Optionee elects not to request The Regents to file a patent application,
such subject matter shall be deemed Research Information. If, however, The
Regents subsequently elects to file patent applications claiming the invention
or covering the potentially patentable subject matter, then Optionee will
promptly assign such patent applications to The Regents and The Regents shall be
free to grant licenses to others to such patent applications and resulting
patents without further obligation to Optionee, and Optionee shall have no
rights or licenses thereunder. Failure by Optionee to notify The Regents of its
request to file a patent application shall be deemed to be an election by
Optionee not to secure a license to that invention or potentially patentable
subject matter, and such invention or potentially patentably subject matter
shall no longer be subject to this Agreement. If any joint inventions are made
by employees of Optionee and The Regents in the performance of research under
the CRADA, then Optionee will assign to The Regents an undivided interest in the
patent applications claiming the joint inventions at a time to be selected by
Optionee but not later than four (4) years from the effective date recited on
page one of this Agreement, and the undivided interest owned by The Regents in
patent applications and resulting patents claiming such joint inventions shall
be disposed of in accordance with the terms of this Agreement. Optionee shall
own an undivided interest in the patent applications claiming such joint
inventions.
12
2.9 The Regents shall reasonably cooperate with Optionee in the subject
area of the Principal Investigators to aid Optionee in meeting its obligations
to NIST.
3. OPTION FEE
3.1 As consideration for all the rights granted to Optionee in the patent
applications contained in Subparagraphs 1.5a and 1.5b, Optionee shall pay to The
Regents an option fee of Thirty Thousand Dollars ($30,000) to be paid in two
equal installments of Fifteen Thousand Dollars ($15,000) each at the following
times:
(3.1a) $15,000 to be paid by Optionee to The Regents within thirty
(30) days of execution of this Agreement by both parties;
and
(3.1b) $15,000 to be paid by Optionee to The Regents on or before
June 30, 1996.
3.2 As further consideration for all the rights granted to Optionee
herein, Optionee shall pay to The Regents an option fee of Fifteen Thousand
Dollars ($15,000) for each U.S. patent application elected by Optionee to be
included in Patent Rights under Subparagraph 1.5c of this Agreement. The
Fifteen Thousand Dollar ($15,000) fee for each U.S. patent application shall be
paid to The Regents at the time Optionee requests that The Regents file the
patent application.
3.3 These fees are nonrefundable, noncreditable, and not an advance
against any fees or reimbursement of patent costs due The Regents under the
terms of this Agreement or fees, royalties, or reimbursement for any patent
costs due The Regents under the terms of the License Agreement.
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4. EXERCISE OF THE OPTION
4.1 If Optionee elects to exercise its rights to enter negotiations to
determine the terms of the License Agreement, then Optionee shall notify The
Regents in writing pursuant to Article 15 (NOTICES) prior to the expiration of
this Agreement. Failure of Optionee to so notify The Regents of its election
hereunder shall be deemed to be an election by Optionee not to secure a license.
4.2 Within thirty (30) days after notification by Optionee to The Regents
pursuant to Paragraph 4.1 immediately above, Optionee shall specify in writing
those particular patent applications, patents, and territories for which it
desires a license from The Regents and those in which it has no interest. Such
notification shall include a copy of a Plan of Commercialization covering the
specific Product(s) to be made, used, or sold by Optionee. "Plan of
Commercialization" means a reasonably detailed plan containing information
regarding, but not limited to, a development plan outlining specific performance
milestones and timetable for the commercial development of a Product and its
introduction to the market place, projected sales for the Product, the date of
the anticipated first commercial sale of a Product, projected costs and profits
for such Product, and other terms commonly included in business plans. Failure
of Optionee to provide a Plan of Commercialization to The Regents within sixty
(60) days of the notice date shall be deemed to be an election by Optionee not
to secure a license.
5. TERMS TO BE NEGOTIATED
5.1 If Optionee exercises its rights to patent applications and patents
under Article 4 (EXERCISE OF THE OPTION), then Optionee and The Regents will
thereafter
14
negotiate in good faith to determine the following provisions covering each such
Product to be included in the terms of the License Agreement:
(5.1a) the cash amount of the license issue fee for each Product
licensed hereunder to be paid to The Regents; the cash
amount of the license issue fee shall reflect the value of
the Product and shall be based on information contained in
the Plan of Commercialization for that Product;
(5.1bi) a royalty rate of four percent (4%) based on the net sales
(sales less customary allowances) of Research Products,
provided that Optionee shall not be charged a royalty rate
greater than four percent (4%) for Research Products whether
or not such royalty rate is due under the License Agreement
to any other license agreement between Optionee and The
Regents;
(5.1bii) a negotiated royalty rate based on the net sales (sales less
customary allowances) of Derived Products not covered by
Patent Rights. The negotiated royalty rate for such Derived
Products will be based on the competitive advantage of the
contributions provided by The Regents for the Derived
Products;
(5.1biii) a negotiated royalty rate based on the net sales (sales less
customary allowances) for Clinical Products. The negotiated
royalty rate shall be based on the profitability of each
Clinical Product calculated in accordance with the
information contained in the Plan of Commercialization;
(5.1c) minimum annual royalty payments to be paid to The Regents
for each Product; these minimum annual royalties shall be
paid to The Regents and shall be based on a percentage of
the anticipated income due The Regents from royalty income
based on the anticipated net sales of a Product; a U.S.
dollar amount comprising the minimum annual royalties shall
be paid to The Regents on dates established by the parties
during the good-faith negotiation in which market
introduction is expected for a Product; the minimum annual
royalties shall be paid to The Regents in the negotiated
amounts and at the negotiated times whether or not a Product
is available for sale in any country;
(5.1d) diligence provisions in the form of specific performance
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milestones representing technical and regulatory
achievements needed to be attained in order to commercialize
each Product elected hereunder and the corresponding date
each such milestone will be met by Optionee; the negotiation
establishing each specific performance milestone and the
corresponding date it will be met will be based on
information provided in the Plan of Commercialization for
each Product;
5.2 If Optionee and The Regents are unsuccessful in establishing terms and
conditions covering each Product or Method in accordance with the provisions of
Subparagraphs 5.1a through 5.1d supra, then either party may refer any
controversy or claim arising out of or relating to this Article 5 (TERMS TO BE
NEGOTIATED) binding arbitration by so notifying the other party in writing in
accordance with the provisions of Article 15 (NOTICES) stating the nature of the
dispute to be resolved.
5.3 Within fifteen (15) business days following such notice three
arbitrators shall be selected by the following process:
(5.4a) Each party shall designate one individual, not an employee,
director, paid consultant, or shareholder of the party, to
serve as an arbitrator; and
(5.4b) These two arbitrators shall select a third individual, who
shall be an attorney experienced in arbitration proceedings,
to serve as the third arbitrator and to preside in
resolution of the dispute. The third arbitrator shall not
be an employee, director, or shareholder of either party.
5.5 Promptly after selection of the three arbitrators, the arbitrators
shall meet with the parties at which time the parties shall each present in
writing the issue to be resolved and a proposed ruling on it. Such writing
shall be served on the other party in advance and be limited to no more than
twenty (20) pages.
5.6 The following general provisions shall apply to the arbitration
proceeding:
16
(5.6a) No later than thirty (30) days after the appointment of the
third arbitrator, the arbitrators shall set a date for a
hearing to resolve the issue identified by the parties. The
hearing shall take place no later than one hundred twenty
(120) days from the original notice requesting arbitration;
(5.6b) The arbitrators shall permit the taking of not more than one
(1) deposition by each party, and shall permit, subject to
the provisions of a mutually agreeable protective order, the
production of only those documents immediately and directly
bearing on the issue or issues subject to arbitration and
only to the extent necessary for the convenience and use of
the arbitrators, and shall not require or permit any other
discovery by any means, including, but not limited to,
depositions interrogatories or production of documents;
(5.6c) No later than ten (10) business days prior to the hearing,
each party may submit a single written brief or memorandum
in support of its position which may be no more than twenty
(20) pages. Each party shall be entitled to no more than
three (3) hours of hearing to present testimony or
documentary evidence. Such time limitation shall include
any direct, cross, or rebuttal testimony, but such time
limitation shall only be charged against the party
conducting such direct, cross or rebuttal testimony. It
shall be the responsibility of the arbitrators to determine
whether each party has had the three (3) hours to which it
is entitled or may, upon good cause shown, have additional
time to present its case;
(5.6d) Each party shall have the right to be represented by
counsel. The arbitrators shall have sole discretion with
regard to the admissibility of evidence. Admissibility will
be decided by two-thirds vote; and
(5.6e) Within fifteen (15) days of the conclusion of the hearing,
each party must submit a proposal finding to the
arbitrators.
5.7 The arbitrators shall rule on the disputed issue within thirty (30)
days following the completion of the testimony of both parties. Such ruling
shall adopt in their entirety the proposed findings of one of the parties on the
disputed issue, or the arbitrators shall propose alternative findings. The
issue shall be resolved upon two-
17
thirds vote of the arbitrators.
5.8 Arbitration shall take place in the location of choice of the party
who has not requested arbitration, but such location shall be in the state of
California.
5.9 The arbitrators shall be paid reasonable fees plus expenses, which
shall be shared equally between The Regents and Optionee.
5.10 The decision of the arbitrators shall be enforceable, but not
appealable, in any court of competent jurisdiction.
6. PROGRESS REPORTS
6.1 Beginning February 28, 1996, and annually thereafter, Optionee shall
submit to The Regents a progress report covering the activities of Optionee
related to the development and testing of Products covered by this Agreement.
6.2 The progress reports submitted under Paragraph 6.1 immediately above
shall include, but not be limited to, the following topics so that The Regents
may be able to determine the progress of the development of Products:
- summary of work completed
- key scientific discoveries
- summary of work in progress
7. PATENT PROSECUTION AND MAINTENANCE
7.1 The Regents will diligently prosecute and maintain the United States
and foreign patent applications and patents comprising Patent Rights using
counsel of its choice. The Regents shall promptly provide Optionee with copies
of all relevant
18
documentation so that Optionee may be currently and promptly informed and
apprised of the continuing prosecution, and may comment upon such documentation
sufficiently in advance of any initial deadline for filing a response, provided,
however, that if Optionee has not commented upon such documentation prior to the
initial deadline for filing a response with the relevant government patent
office, then The Regents will be free to respond appropriately without
consideration of comments or input by Optionee, if any. Both parties hereto
agree to keep this documentation in confidence in accordance with the provisions
of Article 20 (CONFIDENTIALITY) herein. The counsel of The Regents will take
instructions only from The Regents.
7.2 The Regents will use all reasonable efforts to amend any patent
application to include claims requested by the Optionee and required to protect
the Product contemplated to be sold or Method to be practiced under this
Agreement or the License Agreement.
7.3 The Regents will, at the request of Optionee, file, prosecute, and
maintain patent applications and patents covered by Patent Rights in foreign
countries if available. The Optionee must notify The Regents within seven (7)
months of the filing of the corresponding United States application of its
decision to request The Regents to file foreign counterpart patent applications.
This notice concerning foreign filing shall be in writing and must identify the
countries desired. The absence of such a notice from the Optionee to The
Regents within the seven (7)-month period will be considered an election by
Optionee not to request The Regents to secure foreign patent rights on behalf of
the Optionee. The Regents will have the right to file patent applications at
its own expense in any country Optionee has not included in its list of
19
desired countries, and such applications and resultant patents, if any, will not
be included in the rights granted under this Agreement. The Regents, however,
shall notify Optionee of such foreign countries in which The Regents filed
patent applications and in which Optionee elected not to secure foreign rights.
Subject to the availability of relevant rights, Optionee shall have the right
and option to include in this Agreement (if not already licensed exclusively to
a third party) those patent applications and patents issuing thereon filed in
countries not originally included in desired list of Optionee at any time up to
five (5) years from the filing date of such patent applications, provided,
however, that Optionee shall reimburse The Regents for any and all associated
patent costs in accordance with Paragraph 7.4 infra.
7.4 All past, present and future costs of preparing, filing, prosecuting
and maintaining all United States and foreign patent applications and patents
covered by Patent Rights in Paragraph 1.5 will be borne by Optionee. The costs
of all interferences and oppositions shall be considered prosecution expenses
and also shall be borne by Optionee. Optionee shall reimburse The Regents for
all costs and charges within thirty (30) days following receipt of an itemized
invoice from The Regents to which relevant law-firm xxxxxxxx shall be attached.
7.5 The obligation of Optionee to underwrite and to pay patent filing
costs and related costs, prosecution and maintenance costs will continue for
costs incurred until three (3) months after receipt by either party of a Notice
of Termination. Optionee will reimburse The Regents for all patent costs
incurred during the term of the Agreement and for three (3) months thereafter,
whether or not invoices for such costs are received during the three (3)-month
period after receipt of a Notice of
20
Termination. Optionee may, with respect to any particular patent application or
patent, terminate its obligations to the patent application or patent in any or
all designated countries upon three (3) months written notice to The Regents.
The Regents will use its best efforts to curtail the associated patent costs
after such a notice is received from Optionee. The Regents may continue
prosecution and/or maintenance of such application(s) or patents(s) at its sole
discretion and expense, provided, however, that Optionee will have no further
rights thereunder.
8. LIFE OF THE AGREEMENT
8.1 Unless otherwise terminated by operation of law or by acts of the
parties in accordance with the terms of this Agreement, this Agreement shall be
in force from the effective date recited on page one and shall remain in effect
for three (3) years thereafter, or if Optionee has exercised its rights under
Paragraph 4.1 with respect to any Product, this Agreement shall not terminate
until the effective date of the License Agreement covering such Product.
8.2 Any termination of this Agreement shall not affect the rights and
obligations set forth in the following Articles:
Article 7 Patent Prosecution and Maintenance
Article 11 Disposition of Product on Hand Upon Termination
Article 12 Use of Names and Trademarks
Article 14 Indemnification
Article 17 Late Payments
Article 20 Confidentiality
21
8.3 Any termination of this Agreement shall not relieve Optionee of its
obligation to pay any monies due or owing at the time of such termination and
shall not impair any accrued right of The Regents or Optionee.
9. TERMINATION BY THE REGENTS
9.1 If Optionee should violate or fail to perform any term or covenant of
this Agreement, then The Regents may give written notice of such default
("Notice of Default") to Optionee. If Optionee should fail to repair such
default within sixty (60) days of the effective date of such notice, then The
Regents shall have the right to terminate this Agreement and the rights herein
by a second written notice ("Notice of Termination") to Optionee. If a Notice
of Termination is sent to Optionee, then this Agreement shall automatically
terminate on the effective date of such notice. Such termination shall not
relieve Optionee of its obligation to pay any fees owing at the time of such
termination and shall not impair any accrued right of The Regents. These
notices shall be subject to Article 15 (NOTICES).
10. TERMINATION BY OPTIONEE
10.1 Optionee shall have the right at any time to terminate this Agreement
in whole or as to any portion of Patent Rights by giving notice in writing to
The Regents. Such notice of termination shall be subject to Article 15
(NOTICES) and termination of this Agreement shall be effective sixty (60) days
from the effective date of such notice.
10.2 Any termination pursuant to Paragraph 10.1 immediately above shall not
22
relieve Optionee of any obligation or liability accrued hereunder prior to such
termination or rescind anything done by Optionee or any payments made to The
Regents hereunder prior to the time such termination becomes effective, and such
termination shall not affect in any manner any rights of The Regents arising
under this Agreement prior to such termination.
11. DISPOSITION OF PRODUCT(S) ON HAND UPON TERMINATION
11.1 Upon termination of this Agreement or election by Optionee not to
include specific patent applications and patents issuing thereon in the License
Agreement, Optionee shall destroy or return to the Principal Investigators the
relevant Products in its possession within fifteen (15) days following the
effective date of its election to terminate the patent application or the
effective date of termination or expiration of this Agreement. Optionee shall
provide The Regents within thirty (30) days following said termination or
expiration date with written notice that the relevant Products have been
destroyed.
12. USE OF NAMES AND TRADEMARKS
12.1 Nothing contained in this Agreement shall be construed as conferring
any right to use in advertising, publicity, or other promotional activities any
name, trade name, trademark, or other designation of either party hereto by the
other (including contraction, abbreviation, or simulation of any of the
foregoing). Unless required by law, the use by Optionee of the name, "The
Regents of the University of California" or the name of any campus of the
University of California is expressly prohibited.
23
12.2 It is understood that The Regents shall be free to release to the
inventors and senior administrative officials employed by The Regents and MRC
the terms and conditions of this Agreement upon their request. If such release
is made, then The Regents shall request that such terms and conditions not be
disclosed to others. It is further understood that should a third party inquire
whether a license to Patent Rights is available, The Regents may disclose the
existence of this Agreement and the extent of the grant in Article 2 to such
third party, but shall not disclose the name of Optionee, except where The
Regents is required to release such information under either the California
Public Records Act or other applicable law.
13. REPRESENTATIONS AND WARRANTS
13.1 Optionee represents and warrants the following:
(13.1a) Optionee shall fund research under and according to the
Research Agreement and CRADA, which research shall be under
the direction of the Principal Investigators.
13.2 The Regents represents and warrants the following:
(13.2a) Patent Rights were developed under funding provided in part
by the Department of Health and Human Services (DHHS);
(13.2b) pursuant to 35 USC 200-212, The Regents may elect to retain
title to any invention (including the Invention) made by it
under U.S. Government funding;
(13.2c) if The Regents elects to retain title to the Invention, The
Regents is required by law to grant to the U.S. Government a
nontransferable, paid-up, non-exclusive, irrevocable license
to use the Invention by or on behalf of the U.S. Government
throughout the world; and
(13.2d) The Regents elected to retain title to the portion of the
Invention claimed in the patent application contained in
24
Subparagraph 1.5a on October 14, 1994, and elected to retain
title to the portion of the Invention claimed in the patent
application contained in Subparagraph 1.5b on October 14,
1994, and accordingly, granted the required licenses to the
U.S. Government.
13.3 The Regents and MRC represent to the best of their knowledge and
accordingly warrant that:
(13.3a) Invention and inventions specified under Subparagraph 1.5
are provided WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR
IMPLIED. THE REGENTS AND MRC MAKE NO REPRESENTATION OR
WARRANTY THAT PRODUCTS OR METHOD WILL NOT INFRINGE ANY
PATENT OR OTHER PROPRIETARY RIGHT;
(13.3b) IN NO EVENT WILL THE REGENTS OR MRC BE LIABLE FOR ANY
INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM
EXERCISE OF THIS OPTION OR THE USE OF THE INVENTION OR
INVENTIONS SPECIFIED UNDER SUBPARAGRAPH 1.5, METHOD, OR
PRODUCTS.
(13.3c) Nothing in this Agreement shall be construed as a warranty
or representation by The Regents or MRC as to the validity,
enforceability, or scope of any of Patent Rights; a warranty
or representation that anything made, used, sold, or
otherwise disposed of under any rights granted in this
Agreement is or will be free from infringement of patents of
third parties; an obligation to bring or prosecute actions
or suits against third parties for patent infringement; or
conferring by implication, estoppel or otherwise any license
or rights under any patents of The Regents or MRC other than
Patent Rights as defined herein, regardless of whether such
patents are dominant or subordinate to Patent Rights
(specifically, The Regents does not grant to Optionee any
rights under U.S. Patent No. 4,468,464, U.S. Patent No.
4,237,224 and U.S. Patent No. 4,740,470 set forth in the
Recitals of this Agreement); or an obligation to furnish any
know-how that does not constitute Derived Products or
Research Information not provided under the Research
Agreement, CRADA, or Patent Rights.
25
14. INDEMNIFICATION
14.1 Optionee agrees to indemnify, hold harmless, and defend MRC and The
Regents, their officers, employees, and agents; the sponsors of the research
that led to the Invention and inventions specified under Subparagraph 1.5; the
inventors (and their employers) of any invention covered by any patents and
patent applications comprising Patent Rights, Method, and Products contemplated
hereunder against any and all claims, suits, losses, damage, costs, fees, and
expenses resulting from or arising out of anything performed under this
Agreement. Acts performed under the CRADA or the Research Agreement shall be
governed by the allocation of risk under Article XI of the Research Agreement
and applicable Articles of the CRADA.
15. NOTICES
15.1 Any payment, notice, or other communication required or permitted to
be given to either party hereto shall be in writing and shall be deemed to have
been properly given and to be effective (a) on the date of delivery if delivered
in person or (b) on the fourth day after mailing if mailed by first-class
certified mail, postage paid, to the respective address given below, or to such
other address as it shall designate by written notice given to the other party
as follows:
In the case of the Optionee: VYSIS, INC.
0000 Xxxxxxxxx Xxxxx
Xxxxxxx Xxxxx, Xxxxxxxx
Attention: Vice President, Technology and
Business Development
26
In the case of The Regents: THE REGENTS OF THE UNIVERSITY
OF CALIFORNIA
Office of Technology Transfer
0000 Xxxxxx Xxx Xxxxxxx, Xxxxx 000
Xxxxxxx, Xxxxxxxxxx 00000
Attention: Executive Director
16. ASSIGNABILITY
16.1 This Agreement is binding upon and shall inure to the benefit of the
parties hereto and their respective successors and assigns, provided, however,
this Agreement shall be personal to the Optionee and shall be assignable by the
Optionee only with the written consent of The Regents, except that Optionee may
freely assign this Agreement to an Affiliate or to a business entity that
acquires all or substantially all of the business or assets of the Optionee.
17. LATE PAYMENTS
17.1 In the event payments, fees, or patent prosecution costs are not
received by The Regents when due, Optionee shall pay to The Regents interest
charges at the rate of five percent (5%) plus the rate of interest which is
charged by the San Francisco Federal Reserve Bank to member banks twenty-five
(25) days prior to the date the payment was due. Such interest shall be
calculated from the date payment was due until actually received by The Regents.
Acceptance by The Regents of any late payment interest from Optionee under this
Paragraph 17.1 shall in no way affect the provision of Article 18 (WAIVER)
herein.
27
18. WAIVER
18.1 It is agreed that no waiver by either party hereto of any breach or
default of any of the covenants or agreements herein set forth shall be deemed a
waiver as to any subsequent and/or similar breach or default.
19. GOVERNING LAWS
19.1 THIS AGREEMENT SHALL BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH
THE LAWS OF THE STATE OF CALIFORNIA excluding any choice of law rules that would
direct the application of the laws of another jurisdiction, but the scope and
validity of any patent or patent application shall be governed by the applicable
laws of the country of such patent or patent application.
20. CONFIDENTIALITY
20.1 Optionee and The Regents respectively shall treat and maintain the
proprietary business, patent prosecution, software, engineering drawings,
process and technical information, and other proprietary information
("Proprietary Information") of the other party in confidence using at least the
same degree of care as that party uses to protect its own proprietary
information of a like nature for a period from the date of disclosure until five
(5) years after the date of termination of this Agreement, provided that all
Proprietary Information shall be labeled or marked confidential or as otherwise
similarly appropriate by the disclosing party, or if the Proprietary Information
is orally disclosed, then it shall be reduced to writing or some other
physically tangible form, marked and labeled as set forth above by the
disclosing party and delivered to
28
the receiving party within thirty (30) days of the oral disclosure as a record
of the disclosure and the confidential nature thereof. Notwithstanding the
foregoing, Optionee may disclose Proprietary Information to its employees,
agents, consultants, and contractors, or as is deemed necessary by Optionee for
any purpose set forth or relating to this Agreement, provided that any such
parties are bound by a like duty of confidentiality.
(20.1a) Nothing contained herein shall in any way restrict or impair the
right of Optionee or The Regents to use, disclose, or otherwise
deal with any Proprietary Information:
i) that recipient can demonstrate by written records was previously
known to it; or
ii) that is now, or becomes in the future, public knowledge other
than through acts or omissions of recipient; or
iii) that is lawfully obtained without restrictions by recipient from
sources independent of the disclosing party; or
iv) that is required to be disclosed to a governmental entity or
agency in connection with seeking any governmental or regulatory
approval, or pursuant to the lawful requirement or request of a
governmental entity or agency; or
v) that is furnished to a third party by the recipient with similar
confidentiality restrictions imposed on such third party, as
evidenced in writing; or
vi) that The Regents is required to disclose pursuant to the
California Public Records Act or other applicable law.
If The Regents is required to disclose the Proprietary Information of Optionee
pursuant to Subparagraphs (iv) and (vi) above, The Regents shall give Optionee
ten (10) days notice prior to disclosure.
20.2 The Optionee and The Regents agree to destroy or return to the
29
disclosing party Proprietary Information received from the other in its
possession within fifteen (15) days following the effective date of termination
or expiration of this Agreement. However, each party may retain one copy of
Proprietary Information for archival purposes in nonworking files. Optionee
and The Regents agree to provide each other, within thirty (30) days following
termination, with a written notice that Proprietary Information has been
returned or destroyed. The parties agree that the Indemnification provisions
contained in Article 14 shall not apply to a breach by The Regents under this
Article 20.
21. SUPPLY OF THE BIOLOGICAL MATERIALS
21.1 The Regents will initially supply Optionee with viable samples of the
biological materials and nucleic acid-based biosensors comprising Research
Information (to the extent that such biological materials and nucleic acid-based
biosensors are in a form acceptable for transfer) within thirty (30) days upon
request from Optionee up until three (3) months after termination of the
Research Agreement and the CRADA. To the extent Optionee requires and requests
additional samples from The Regents during the term hereof, and The Regents has
such additional samples in its possession, The Regents will supply Optionee with
such additional samples. Optionee will pay the actual handling and shipping
costs for any additional samples provided.
30
22. MAINTENANCE OF THE BIOLOGICAL MATERIALS
22.1 The Regents will instruct the Principal Investigators that when
circulating replicable biological materials comprising Research Information
or Derived Products to third parties to do so under the terms and conditions
set forth in the Biological Material Transmission Letter attached hereto as
Appendix A. The Regents expressly reserves the right to transfer replicable
biological materials comprising Research Information as provided in this
Paragraph 22.1 to Universities and nonprofit, research organizations to the
extent that such transfer does not compete with Optionee. The Regents shall
inform Optionee of third party requests for biological materials and shall
provide Optionee with a copy of the fully executed copy of the Biological
Material Transmittal Letter. The Regents shall inform Optionee of comments,
suggestions, and information provided to The Regents by recipients of the
biological materials. Optionee shall not
31
interfere with the efforts of The Regents to bail these materials to third
parties.
22.2 The Optionee shall not transfer the replicable biological materials or
nucleic acid-based biosensors comprising Research Information that are not
freely available to others accept to Affiliates, Joint Ventures, sublicensees,
and potential sublicensees.
23. MISCELLANEOUS
23.1 The headings of the several sections are inserted for convenience of
reference only and are not intended to be a part of or to affect the meaning or
interpretation of this Agreement.
23.2 This Agreement will not be binding upon the parties until it has been
signed below on behalf of each party, in which event, it shall be effective as
of the date recited on page one.
23.3 No amendment or modification hereof shall be valid or binding upon the
parties unless made in writing and signed on behalf of each party.
23.4 This Agreement, the CRADA, secrecy agreements covering Patent Rights,
and the Research Agreement embody the entire understanding of the parties and
shall supersede all previous communications, representations, or understandings,
either oral or written, between the parties relating to the subject matter
hereof.
23.5 In case any of the provisions contained in this Agreement shall be
held to be invalid, illegal, or unenforceable in any respect, such invalidity,
illegality, or unenforceability shall not affect any other provisions hereof,
but this Agreement shall be construed as if such invalid or illegal or
unenforceable provisions had never been
32
contained herein.
IN WITNESS WHEREOF, both The Regents and Optionee have executed this
Agreement, in duplicate originals, by their respective officers hereunto duly
authorized, on the day and year hereinafter written.
VYSIS, INC. THE REGENTS OF THE UNIVERSITY
OF CALIFORNIA
By /s/ J. Xxxxxxxx Xxx By /s/ Xxxxxxx X. Xxxxxxxxx
--------------------------- -------------------------------------
(Signature) (Signature)
Name J. Xxxxxxxx Xxx Name Xxxxxxx X. Xxxxxxxxx
-------------------------- -----------------------------------
(Please Print)
Title: Vice President Title: Executive Director
------------------------ Research Administration
and Office of Technology Transfer
Date 28 March 1996 Date 4-3-96
-------------------------- -----------------------------------
[STAMP]
33
APPENDIX A - PAGE 1A
University of California/San Francisco
Instructions for Standard Letter Transmitting
Biological Materials to Universities and
Nonprofit Institutions
The attached letter is authorized for use by University of California
(Xxxxxxxx Berkeley Laboratory) Principal Investigators and Administrators ONLY
with Scientists at other UNIVERSITIES AND NONPROFIT RESEARCH INSTITUTIONS when
transmitting cell lines, plasmids and the like for non-commercial research
purposes.
1. Choose the appropriate form of university or nonprofit research
institution in paragraph 2.
2. Choose whether or not to include the phrase "our cooperative" in
paragraph 2.
3. Insert in paragraph 4 the amount of processing charge. If the
material is to be shipped at no charge, insert the words "no charge".
4. Send the letter IN DUPLICATE to the other scientists.
5. Do not send biological materials until you receive the duplicate copy
executed by both the scientist and the other institution.
6. Send a copy of the fully executed letter agreement to:
Xxxxxxx X. Xxxxxxxxx
Executive Director
Office of Technology Transfer
0000 Xxxxxx Xxx Xxxxxxx
Xxxxx 000
Xxxxxxx, XX 00000
7. Any changes in the wording of this standard letter must be reviewed by
the Executive Director of the Office of Technology Transfer before
acceptance.
Note: Do not use this letter for the exchange of living plants. A separate
"Testing Agreement for the Plant Varieties" is available for that purpose.
34
APPENDIX A - PAGE 2A
SAMPLE LETTER FOR USE PRIOR TO TRANSMISSION OF BIOLOGICAL
MATERIALS TO INVESTIGATORS AT UNIVERSITIES OR NON-PROFIT
RESEARCH INSTITUTIONS
(date)
IN DUPLICATE
To:
______________________________
This is to (acknowledge receipt of your letter) (confirm our telephone
conversation) in which you requested certain research materials developed in
this laboratory be sent to you for scientific research purposes. The materials
concerned, which belong to The Regents of the University of California, Xxxxxxxx
Berkeley Laboratory are: _______________________________________________________
________________________________________________________________________________
While I cannot transfer ownership of these materials to you, I will be
pleased to permit your use of these materials within your (university) (Non-
Profit Research Institution) laboratory for (our cooperative) scientific
research. However, before forwarding them to you, I require your agreement that
the materials will be received by you only for use in (our cooperative work)
(scientific research), that you will bear all risk to you or any others
resulting from your use, and that you will not pass these materials, their
progeny or derivatives, on to any other party or use them for commercial
purposes without the express written consent of The Regents of the University of
California. You understand that no other right or license to these materials,
their progeny or derivatives, is granted or implied as a result of our
transmission of these materials to you.
These materials are to be used with caution and prudence in any
experimental work, since all of their characteristics are not known.
As you recognize, there is a processing cost to us involved in providing
these materials to you. We will xxxx you for our processing costs, which will
amount to $_________________________.
If you agree to accept these materials under the above conditions, please
sign the enclosed duplicate copy of this letter, then have it signed by an
authorized representative of your institution, and return it to me. Upon
receipt of that confirmation I will forward the material(s) to you.
35
APPENDIX A - PAGE 3A
(Note: other paragraphs discussing the relevant literature, the nature of the
work, hazards relating to materials to be sent etc. may be appropriate. These
will vary depending on the individual circumstances and the relationship between
the two parties previously established. Be sure to retain a signed copy when
received and send a photocopy of the completed agreement to the Executive
Director, University of California, Office of Technology Transfer, 0000 Xxxxxx
Xxx Xxxxxxx, Xxxxx 000, Xxxxxxx, XX 00000.)
UNIVERSITY OF CALIFORNIA
MATERIAL PROVIDED BY:
_________________________
Printed Name
_________________________
(Signature)
________________________
Date
ACCEPTED:
RECIPIENT RESEARCH INVESTIGATOR
_________________________
Printed Name
_________________________
(Signature)
_________________________
Date
00
XXXXXXXX X - PAGE 1B
The INVENTORS listed below understand and agree to abide by the terms and
conditions of Article 22 (MAINTENANCE OF THE BIOLOGICAL MATERIALS) of the Option
Agreement between The Regents of the University of California and Vysis, Inc.
effective July 1, 1995, and to instruct all relevant personnel working within
their laboratory to act accordingly. Said paragraph reads, in part, as follows:
22.1 The Regents agrees to instruct the Principal Investigators that when
circulating replicable biological materials comprising Research Information
or Derived Products to third parties to do so under the terms and
conditions set forth in the Biological Material Transmission Letter
attached hereto as Appendix A. The Regents expressly reserves the right to
transfer replicable biological materials comprising Research Information or
Derived Products as provided in this Paragraph 22.1 to Universities and
nonprofit, research organizations to the extent that such transfer does not
compete with Optionee. The Regents shall inform Optionee of third party
requests for biological materials and shall provide Optionee with a copy of
the fully-executed copy of the Biological Material Transmittal Letter. The
Regents shall inform Optionee of comments, suggestions, and information
provided The Regents by recipients of the biological materials. Optionee
shall not interfere with the efforts of The Regents to bail these materials
to third parties.
The Derived Product(s) are defined in said Agreement as follows:
1.1 "Derived Product(s)" means any product containing (a) a plasmid, a
protein structure, a cDNA clone, a promoter, a gene or a chimeric gene, or
fragments thereof and their sequences derived from or comprising the
biological materials that are provided to Optionee by The Regents or any
product identified through the use of such biological materials, even if
such product is subsequently modified after its original identification;
(b) any protein structure produced or encoded by the biological materials;
or (c) a compound (substantially similar or identical to a compound in (a)
or (b) above), produced by chemical synthesis or by any other method which
could not have been produced but for the use of the biological materials;
or (d) any nucleic acid-based biosensor that employs protocols or concepts
for its manufacture or use that are provided to Optionee by The Regents
that may comprise a solid support, methods of DNA deposition or attachment,
processes for DNA preparation for hybridization, hybridization, signal
detection, analysis, or any other feature of the nucleic acid-based
biosensor.
By: /s/ Xxxxxx Xxxxxx 7-31-95
--------------------------- ---------------------------------
Xxxxxx Xxxxxx Date
By: /s/ Xxx X. Xxxx 8/1/95
--------------------------- ---------------------------------
Xxx X. Xxxx Date
37
APPENDIX C - PAGE 1C
DIRECTOR APPROVAL OF COMMERCIAL RESTRICTIONS OF TANGIBLE
RESEARCH PRODUCTS
In May 1989, the University of California issued the GUIDELINES ON
UNIVERSITY-INDUSTRY RELATIONS ("Guidelines"). Guideline 10 entitled "Tangible
Research Products" requires that when the commercial availability of tangible
research products resulting from the conduct of research are restricted by a
license, approval must be obtained from the Director of Xxxxxxxx Berkeley
Laboratory (or his designee) where the research took place.
The attached Option entitled "The Glass Chromosome" ("Option") contains
provisions that restrict the tangible research products from transfer to
commercial competitors of Vysis, Inc., and requires that tangible research
products transferred for educational and research purposes be conveyed under a
biological material transfer agreement (Appendix A). In accordance with the
Guidelines, this Option permits the University to retain the discretion to
publish any results of research at any time and to disseminate the tangible
materials for educational and research purposes.
Director Shank of the University of California at Xxxxxxxx Berkeley
Laboratory approves of the provisions of the attached Option that restrict the
commercial availability of tangible research products.
Director Approval:
------------------------------------ ----------------------------------
Director Xxxxxxx X. Xxxxx Date
38
APPENDIX C - PAGE 1C
DIRECTOR APPROVAL OF COMMERCIAL RESTRICTIONS OF TANGIBLE
RESEARCH PRODUCTS
In May 1989, the University of California issued the GUIDELINES ON
UNIVERSITY-INDUSTRY RELATIONS ("Guidelines"). Guideline 10 entitled "Tangible
Research Products" requires that when the commercial availability of tangible
research products resulting from the conduct of research are restricted by a
license, approval must be obtained from the Director of Xxxxxxxx Berkeley
Laboratory (or his designee) where the research took place.
The attached Option entitled "The Glass Chromosome" ("Option") contains
provisions that restrict the tangible research products from transfer to
commercial competitors of Vysis, Inc., and requires that tangible research
products transferred for educational and research purposes be conveyed under a
biological material transfer agreement (Appendix A). In accordance with the
Guidelines, this Option permits the University to retain the discretion to
publish any results of research at any time and to disseminate the tangible
materials for educational and research purposes.
Director Shank of the University of California at Xxxxxxxx Berkeley
Laboratory approves of the provisions of the attached Option that restrict the
commercial availability of tangible research products.
Director Approval:
/s/ Xxx X. Xxxxxxxxxx 3 Aug 95
----------------------------------- ----------------------------------
Xxx X. Xxxxxxxxxx Date
Assoc. Laboratory Director, IGP
for Director Xxxxxxx X. Xxxxx
39
