EXCLUSIVE LICENSE AND BAILMENT AGREEMENT BETWEEN
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XXXXXXX XXXXX UNIVERSITY AND BIOPULSE, INC.
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1 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
2 BYU Grant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
3 Licensee Grant . . . . . . . . . . . . . . . . . . . . . . . . . . .5
4 Exclusive Use . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
5 Performance Requirements. . . . . . . . . . . . . . . . . . . . . . .6
6 Antibody and Antigen Production . . . . . . . . . . . . . . . . . . .7
7 License Fees and Royalties. . . . . . . . . . . . . . . . . . . . . .7
8 Reports, Records, Penalties and Interest. . . . . . . . . . . . . . .8
9 Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . .9
10 Separate Service Agreement. . . . . . . . . . . . . . . . . . . . . 10
11 Export Controls . . . . . . . . . . . . . . . . . . . . . . . . . . 10
12 Patent Marking and Copyright Notice . . . . . . . . . . . . . . . . 11
13 Patent Prosecution and Maintenance . . . . . . . . . . . . . . . . 11
14 Infringement. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
15 Warranty and Limitation of Remedy . . . . . . . . . . . . . . . . . 13
16 Product Liability and General Indemnification . . . . . . . . . . . 14
17 Term and Termination. . . . . . . . . . . . . . . . . . . . . . . . 14
18 Negotiations, Mediation and Arbitration . . . . . . . . . . . . . . 16
19 Licensee Assignment . . . . . . . . . . . . . . . . . . . . . . . . 17
20 Non Use of BYU Name . . . . . . . . . . . . . . . . . . . . . . . . 17
21 Publication . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
22 Payment, Notices and Other Communications . . . . . . . . . . . . . 17
23 Miscellaneous Provisions. . . . . . . . . . . . . . . . . . . . . . 18
EXCLUSIVE LICENSE AND BAILMENT AGREEMENT
XXXXXXX XXXXX UNIVERSITY
This Agreement, effective Dec. 1, 2000, is entered into between Xxxxxxx
Young University, a Utah non-profit corporation and educational institution
with its principal campus and place of business located at Xxxxx, Xxxx
00000 (referred to in this Agreement as "BYU"), and Biopulse, Inc., a
Nevada corporation with its principal place of business located at Xxxxx
Xxxxxx, Xxxx 00000 (referred to in this Agreement as "LICENSEE").
RECITALS
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1. BYU is the sole owner of certain intellectual property rights known as
"Thymidine Kinase Isoenzyme Diagnostics" and has the right to grant
licenses with respect to these rights, and is the sole owner of certain
biological materials known as "Thymidine Kinase Hybridomas" and has the
right to grant a bailment for use of these materials.
A. BYU is an institution of higher education and is not in the
business of commercially developing ideas, inventions, biological
materials, or other types of intellectual property, but it does desire to
have Thymidine Kinase Isoenzyme Diagnostics and Thymidine Kinase
Hybridomas available to the public and is willing to enter into a license
and bailment agreement for this purpose.
B. LICENSEE has represented to BYU that LICENSEE has the technical
and commercial ability, and the technical, financial and other resources
necessary to develop and sell products or services based upon Thymidine Kinase
Isoenzyme Diagnostics and Thymidine Kinase Hybridomas.
C. LICENSEE desires to obtain a license to Thymidine Kinase Isoenzyme
Diagnostics and a bailment for the use of Thymidine Kinase Hybridomas upon the
terms and conditions of this Agreement.
In consideration of the promises and mutual covenants contained in
this Agreement the parties agree as follows:
TERMS OF AGREEMENT
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1 Definitions
For the purposes of this Agreement, the following terms, words and
phrases shall have the meaning ascribed to them in this Section.
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1.1 "ADJUSTED GROSS SALES" shall mean LICENSEE's gross receipts or
the fair market monetary equivalent value of consideration received for
LICENSED PRODUCTS or PROCESSES, including product or process IMPROVEMENTS,
sold, leased, licensed or otherwise transferred by LICENSEE, a SUBLICENSEE
or as otherwise authorized by the express written concent of BYU to a third
party, less qualifying costs directly attributable to such sale, lease,
license or transfer actually allowed and borne by LICENSEE or a
SUBLICENSEE. Such qualifying costs shall be limited to the costs of the
following:
A. Trade or quantity discounts actually allowed and taken in
such amounts as are customary in the trade;
B. Sales, import and export duties and/or use and excise taxes
directly imposed with reference to particular sales;
C. Outbound transportation expenses prepaid or allowed; and
D. Amounts allowed or credited by reason of timely rejections
or returns.
No deductions shall be made for commissions paid to individuals,
whether they be regularly employed by LICENSEE or by independent sales
agents, or for the cost of collections. For purposes of calculating
"ADJUSTED GROSS SALES" a LICENSED PRODUCT or PROCESS shall be considered
sold, leased, licensed or transferred when billed, invoiced, shipped, paid
for or transferred, whichever event occurs first.
1.2 "AFFILIATE" shall mean any person or entity owned or controlled
directly or indirectly by LICENSEE or any person or other entity controlled
by, controlling, or under common control with LICENSEE. The term "control"
means possession, direct or indirect, of the powers to direct or cause the
direction of the management and policies of a person or entity; whether
through ownership, voting securities, beneficial interests; by contract; by
agreement; or otherwise.
1.3 "BIOLOGICAL MATERIAL" shall mean the original cell culture lines
referred to in this agreement as "Thymidine Kinase Hybridomas" specifically
identified and delimited on Exhibit "A", which is attached to this
Agreement and by reference is incorporated and made part of this Agreement,
plus the progeny descendant from the original cell culture lines, and any
modifications or derivatives created by LICENSEE such as a functional sub-
unit or an expression product of the original cell culture lines
1.4 "END USER" means any person or entity to which LICENSED PRODUCTS
or LICENSED PROCESSES are sold or licensed for personal or business use and
not for the purpose of licensing or selling to other persons or entities.
1.5 "IMPROVEMENT(S)" means any invention, idea, trade secret,
know-how or derivative work which is directly related to or which includes
any portion of or utilizes any portion of the LICENSED TECHNOLOGY,
LICENSED PRODUCTS or LICENSED PROCESSES, whether or not patentable,
copyrightable, or otherwise protectable as intellectual property which is
subsequently acquired or developed by LICENSEE during the term of this
Agreement.
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1.6 "LICENSED PROCESS(ES)" means and includes any process, procedure,
technique, method or service the use or practice of which incorporates or
makes use of any part of the LICENSED TECHNOLOGY, BIOLOGICAL MATERIAL or
IMPROVEMENTS.
1.7 "LICENSED PRODUCT(S)" means and includes any product or
IMPROVEMENTS which are developed, or enhanced in whole or in part by
LICENSEE, the production, manufacture, sale, lease, license, transfer or
use of which incorporates or makes use of any part of or is derived from
the use of the LICENSED TECHNOLOGY, BIOLOGICAL MATERIAL or IMPROVEMENTS.
In the event such a product forms an integral part or component of a larger
product, such larger product shall be considered a "LICENSED PRODUCT," for
purposes of this Agreement.
1.8 "LICENSED TECHNOLOGY" means and includes all of BYU's technology
and intellectual property, patented or unpatented, referred to in this
Agreement as Thymidine Kinase Isoenzyme Diagnostics and related
enhancements generated at BYU as specifically identified and limited on
Exhibit "B", which is attached to this Agreement and by reference is
incorporated and made part of this Agreement.
1.9 "LICENSEE" is Biopulse, Inc. and its AFFILIATES, and any other
person or entity that becomes a successor in interest to, purchases, merges
with, assumes control of, or becomes an assignee of LICENSEE.
1.10 "SUBLICENSEE" is any person or entity including value added
retailers or other individuals or entities, which are licensed pursuant to
this Agreement by LICENSEE with rights to the LICENSED TECHNOLOGY to market
to END USERS LICENSED PRODUCTS or LICENSED PROCESSES which are developed,
enhanced, improved or manufactured by said person or entity.
1.11 "TERRITORY" is all of the world subject to an existing option
agreement between BYU and E. Excel Laboratories, Inc. which covers rights
in the countries of Japan, China, Taiwan, Korea, Malaysia, Indonesia,
Philippines and Singapore.
2 BYU Grant
2.1 Subject to the provisions of Section 2.6, BYU hereby grants
LICENSEE an exclusive right and license to utilize the LICENSED TECHNOLOGY
(i) to develop LICENSED PRODUCTS, LICENSED PROCESSES, and IMPROVEMENTS,
(ii) to manufacture, sell, lease and otherwise transfer in vitro serum
diagnostic LICENSED PRODUCTS and other LICENSED PRODUCTS, LICENSED
PROCESSES, and IMPROVEMENTS, and (iii) to practice LICENSED PROCESSES
within the TERRITORY as authorized in this Agreement until such time as
this Agreement expires or is terminated. This grant will extend to the
manufacture, sale, lease, transfer or other disposition of LICENSED
PRODUCTS or LICENSED PROCESSES within the TERRITORY through an AFFILIATE or
through LICENSEE's use of any retail outlet or distributor and shall
authorize any END USERS' use of the LICENSED PRODUCTS and LICENSED
PROCESSES sold or transferred by LICENSEE or its AFFILIATES, retail outlets
or distributors.
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2.2 Subject to the provisions of Section 2.6, BYU hereby grants
LICENSEE exclusive bailment rights to utilize BYU's BIOLOGICAL MATERIAL (i)
to produce antigens and monoclonal antibodies for use in in vitro
diagnostic LICENSED PRODUCTS and LICENSED PROCESSES , (ii) to develop
LICENSED PRODUCTS, LICENSED PROCESSES and IMPROVEMENTS, (iii) to
manufacture, sell, lease and otherwise transfer LICENSED PRODUCTS and
IMPROVEMENTS, and (iv) to practice LICENSED PROCESSES within the TERRITORY
as authorized in this Agreement until such time as this Agreement expires
or is terminated. This grant will extend to the manufacture, sale, lease,
transfer or other disposition of LICENSED PRODUCTS or LICENSED PROCESSES
within the TERRITORY through an AFFILIATE or through LICENSEE's use of any
retail outlet or distributor and shall authorize any END USERS' use of the
LICENSED PRODUCTS and LICENSED PROCESSES sold or transferred by LICENSEE or
its AFFILIATES, retail outlets or distributors.
2.3 The grants provided under this Agreement shall specifically
include the right for LICENSEE to grant sublicenses to the LICENSED
TECHNOLOGY to SUBLICENSEES. All sublicenses granted by LICENSEE shall be
subject to the terms and conditions of this Agreement and the sublicense
agreement shall have an express provision to this effect. No sublicense
shall relieve LICENSEE of any of its obligations under this Agreement.
Sublicenses under this Agreement shall be structured to guarantee the
payment of royalties to BYU in an amount at least equal to the amount of
royalties which BYU would have received from LICENSEE had LICENSEE made,
sold, leased, or otherwise transferred the LICENSED PRODUCTS or LICENSED
PROCESS(ES) authorized in the sublicense. LICENSEE agrees to forward to
BYU a fully executed copy of each sublicense agreement within thirty (30)
days upon written request from BYU, and to act as a fiduciary to protect
BYU's interests in the sublicense and to collect and transmit to BYU all
royalties due.
2.4 LICENSEE hereby agrees that the title to the BIOLOGICAL MATERIAL
remains with BYU, and LICENSEE agrees, notwithstanding any contrary rights
stipulated, implied or inferred from this Agreement, to not transfer BYU's
BIOLOGICAL MATERIAL to any third party for any purpose without BYU's
express written permission, which permission BYU may withhold at its sole
discretion. LICENSEE may, however, with BYU's permission, transfer BYU's
BIOLOGICAL MATERIAL to a SUBLICENSEE or to another third party to produce a
product (e.g., monoclonal antibodies) for LICENSEE under a contract which
preserves all of BYU's rights set forth in this Agreement, including title
to the BIOLOGICAL MATERIAL. Furthermore, LICENSEE hereby agrees and will
require any SUBLICENSEE or third party which receives BIOLOGICAL MATERIAL
as authorized in this section, to label all storage containers containing
the BIOLOGICAL MATERIAL as being owned by BYU.
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2.5 Nothing in this Agreement shall be considered as granting any
rights, express or implied, in BYU's patents, patent applications,
inventions, methods, technical, confidential or proprietary information,
expertise, know-how, trade secrets or knowledge not specifically licensed
in this Agreement, and all rights not expressly granted by this Agreement
to LICENSEE are expressly reserved by BYU. The license granted by this
Agreement shall not be construed to confer any rights upon LICENSEE by
implication, estoppel or otherwise as to any existing, new or derivative
technology not specifically licensed by this Agreement. The reservation of
rights described in this Section is intended to be broadly construed and
not to be limited by the definitions set forth in this Agreement.
2.6 Notwithstanding the exclusive license granted pursuant to this
Agreement, BYU shall have the right to make, have made or use the LICENSED
TECHNOLOGY, LICENSED PRODUCTS, LICENSED PROCESSES and IMPROVEMENTS for
continuing research and non-commercial academic uses without cost.
Moreover, LICENSEE shall provide BYU with a reasonable number of its serum
ELISA diagnostic kits and any other related kits free of charge for use in
BYU's research program.
3. Licensee Grant
LICENSEE hereby grants to BYU all of LICENSEE's right, title and
interest to any IMPROVEMENTS to the LICENSED TECHNOLOGY which are
incorporated into the LICENSED PRODUCTS or LICENSED PROCESSES of any kind
or description created or developed by LICENSEE or its SUBLICENSEES. This
grant shall be absolute and irrevocable, shall survive the termination of
this Agreement and is intended to entitle BYU to use said IMPROVEMENTS for
its academic purposes as more fully described in Section of this
Agreement, to entitle BYU to license the LICENSED TECHNOLOGY and
IMPROVEMENTS to third parties subsequent to termination of this Agreement
and to entitle BYU to collect royalties.
4 Exclusive Use
4.1 Licensee shall use only the LICENSED TECHNOLOGY and IMPROVEMENTS
subject of this License Agreement for the purpose of marketing or
commercializing Thymidine Kinase Isoenzyme Diagnostics or related
technology and LICENSEE shall be expressly prohibited from using, selling
or commercializing any other alternative functionally inferior or
equivalent technology which is not subject of this Agreement for such
purpose without the express written consent of BYU, which shall not be
unreasonably withheld, and being subject to the provisions of Section 4.2
of this Agreement.
4.2 In the event LICENSEE believes that its use or substitution of
any alternative functionally inferior or equivalent technology not subject
of this Agreement would be in its best business interests, it may request
the written consent of BYU to use such substitute technology provided that
the royalty provisions of this Agreement shall extend to LICENSEE'S use of
any technology which performs any functions substantially equivalent to the
LICENSED TECHNOLOGY and IMPROVEMENTS subject of this License Agreement.
5
4.3 The restrictions described in this Section 4 "Exclusive Use"
shall not apply to LICENSEE'S use of collateral technology or intellectual
property which interfaces with or operates in conjunction with or
independently from the LICENSED TECHNOLOGY and IMPROVEMENTS but which does
not perform a function substantially equivalent to the LICENSED TECHNOLOGY
or IMPROVEMENTS.
4.4 In the event this Agreement is terminated, LICENSEE, and its
officers, directors and key technical employees shall not for a period of
three (3) years thereafter use, develop, market or commercialize, directly
or indirectly, any alternative product which utilizes a functionally
equivalent technology to the technology subject of this Agreement.
5 Performance Requirements
LICENSEE shall during the term of this Agreement complete the
performance requirements of Paragraphs 5.1 to 5.3 by the dates specified.
LICENSEE shall notify BYU within thirty (30) days of the completion of each
requirement.
5.1 LICENSEE shall develop a serum ELISA diagnostic kit for the
detection of Thymidine Kinase-1 isoenzyme by December 31, 2001.
5.2 LICENSEE shall complete clinical trials to validate the clinical
usefulness of the in vitro serum diagnostic ELISA test by June 30, 2002.
5.3 LICENSEE shall submit applications for United States Food and
Drug Administration approval for the in vitro serum diagnostic ELISA test
by December 31, 2002, and shall vigorously pursue approval of the
application.
5.4 LICENSEE's failure to perform in accordance with Section 5 of the
Agreement to the reasonable satisfaction of BYU may be considered by BYU to
be a material breach of this Agreement. (See Section 17 for termination
procedure.)
6 LICENSE FEES AND ROYALTIES
In consideration of the license for the LICENSED TECHNOLOGY and the
bailment for the BIOLOGICAL MATERIAL granted under this Agreement, LICENSEE
shall pay to BYU, in the manner designated below until the Agreement shall
be terminated, as follows:
6.1 License Fee: A license issue fee in the amount of Eight Hundred
Thousand Dollars ($800,000) shall be paid upon the execution of this
Agreement. This license issue fee shall be non-refundable and may not be
credited toward the payment of any royalties or other consideration
required by this Agreement. Notwithstanding the foregoing, if a functional
Thymidine Kinase Isoenzyme ELISA diagnostic test cannot, after due
dilligence, be developed within the parameters of Paragraph 5.1, LICENSEE
may notify BYU of its inability to develop a functional test and terminate
the Agreement. Upon receipt of said notice, BYU shall refund to LICENSEE
Seven Hundred Thousand Dollars ($700,000) of the license issue fee.
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6.2 Earned Royalties: Earned royalties shall be paid quarterly in
the amount equal to seven percent (7.0 %) of the ADJUSTED GROSS SALES of
the LICENSED PRODUCTS, LICENSED PROCESSES or IMPROVEMENTS subject of this
Agreement used, leased, licensed, sold or otherwise transferred to an END
USER by or for LICENSEE or its AFFILIATES until the expiration of the last
valid claim of any patent included in the Licensed Technology.
In consideration for the bailment rights for the BIOLOGICAL MATERIAL,
after expiration of the last valid claim of any patent included in the
Licensed Technology, earned royalties shall be paid quarterly in the amount
equal to four percent (4.0 %) of the ADJUSTED GROSS SALES of the LICENSED
PRODUCTS, LICENSED PROCESSES or IMPROVEMENTS subject of this Agreement.
6.3 Minimum Royalties: An annual minimum royalty amount shall be
paid for each calendar year as identified on Table 1. In the event that
LICENSEE's earned royalty payments to BYU during any particular calendar
year shall fall below that sum indicated in Table 1, then LICENSEE shall
pay a minimum royalty to BYU with its last report of the year in the amount
indicated in Table 1 less any earned royalties paid for the calendar year.
Earned royalties for any given calendar year shall only be credited against
minimum royalties for that same calendar year.
TABLE 1
Calendar Year Minimum Royalty
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2003 $100,000
2004 $200,000
2005 and each year thereafter $400,000
6.4 Pass Through Royalties: A "pass through royalty" will be levied
on all license fees, royalties and any and all other consideration of any
kind or description received by LICENSEE or any AFFILIATE from any third
party which is not an AFFILIATE, distributor, retail outlet or END USER,
but which is granted a sublicense, is assigned rights or receives rights
from LICENSEE with respect to the LICENSED TECHNOLOGY or BIOLOGICAL
MATERIAL to make, use, sell, lease or otherwise transfer LICENSED PRODUCTS
or PROCESSES made or developed by the SUBLICENSEE, assignee or transferee
and which is not otherwise subject to the earned royalty provisions of this
Agreement. The pass through royalty shall be paid on all such license
fees, royalties or consideration, which shall specifically include, but not
be limited to, license issue fees, royalties, minimum royalties, equity
interests or other consideration in excess of earned royalties to which BYU
is entitled pursuant to Sections 2.3, 6.2 and 6.3 of this Agreement.
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A. The "pass through royalty" shall be fifty percent (50%) of
all applicable consideration subject to the pass through
royalty.
B. Pass through royalty payments shall be payable to BYU
quarterly in addition to and contemporaneously with earned
royalty payments. Such pass through royalty payments shall
be based on all consideration paid during the applicable
three months. Reporting of such consideration shall be made
following the same criteria set forth for earned royalty
payments in this Agreement. In no event shall BYU be
entitled to receive both an "earned royalty" and a "pass
through royalty" on the same transaction.
6.5 Any royalty amount due to BYU arising out of this Agreement shall
accrue at the time of use, sale, lease, license or transfer of the LICENSED
PRODUCT or LICENSED PROCESS and shall be deemed to be held in trust for
the benefit of BYU until actual payment of such amounts is made pursuant to
this Agreement.
7 REPORTS, RECORDS, PENALTIES AND INTEREST
7.1 LICENSEE shall keep and shall require all SUBLICENSEES,
AFFILIATES, and any other party responsible by the terms of this Agreement
to make payments to BYU to keep, at their own expense, accurate books of
account, using generally accepted accounting principles and practices,
detailing all data necessary to calculate and easily audit any payments due
to BYU under this Agreement. These books of account shall be kept at
LICENSEE's, AFFILIATE's or SUBLICENSEE's principal place of business.
These books and supporting data shall be open at all reasonable times, upon
ten (10) calendar days written notice, for a period of five (5) years
following the end of the calendar year to which they pertain, to the
inspection by BYU or its agents for the purpose of verifying LICENSEE's
royalty statements or other compliance with this Agreement. In the event
that any such inspection reveals any underpayment of royalties by LICENSEE,
LICENSEE shall immediately rectify such underpayment, reimburse BYU for the
cost of such inspection, and shall pay the penalty and interest amounts as
identified in Section 8.4 of this Agreement.
7.2 LICENSEE, within thirty (30) days after the last day of each full
calendar quarter subsequent to the effective date of this Agreement, shall
deliver to BYU an accurate written report summarizing in sufficient detail
to allow BYU to verify all payment amounts, the data used during the
preceding three-month period under this Agreement to calculate the payments
due to BYU during the applicable accounting period. These records and
reports shall include at least the following information for the accounting
period:
A. Calculation of ADJUSTED GROSS SALES itemized as to the
number and the identity of the LICENSED PRODUCTS or
PROCESSES sold.
B. All qualifying deductible costs claimed as offsets as
applicable.
C. Total royalties due broken down by applicable category.
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D. Pass through royalty amounts.
E. Names and address of all AFFILIATES and SUBLICENSEES and
full reports from them complying with the reporting
requirements of Section 8.2 A-D.
7.3 With each such report submitted, LICENSEE shall pay to BYU all
fees, royalties and all other amounts due, payable and arising pursuant to
this Agreement. If no amounts shall be due, LICENSEE shall so report.
7.4 The remittance of all earned and pass through royalties payable
on ADJUSTED GROSS SALES outside the United States will be payable to BYU in
United States Dollars at the official rate of exchange (as published in the
Wall Street Journal) of the currency of the country from which the
royalties are payable for the closing rate for the last business day of the
calendar quarter in which the royalties are payable.
7.5 Where royalties are due for ADJUSTED GROSS SALES in a country
where by reason of currency regulations of any kind or taxes of any kind it
is impossible to make royalty payments for that country's sales, said
royalties shall be deposited in whatever currency is allowable for the
benefit or credit of BYU in any accredited bank in that country as shall be
acceptable to BYU.
7.6 A penalty will be assessed in an amount equal to three percent
(3%) of any payment due to BYU arising out of this Agreement if the payment
is made more than thirty (30) days late. Interest will accrue from the
thirtieth day after the payment was due at a rate of eighteen percent (18%)
per annum and the interest payment shall be due and payable every thirty
(30) days thereafter. Any unpaid interest or penalty shall be compounded
monthly at the rate of eighteen percent (18%) per annum.
7.7 LICENSEE shall cause an independent auditor to deliver to BYU a
certified report which shall verify the accuracy of the quarterly reports
required in Section 8 on or before ninety (90) days after end of
LICENSEE's first full fiscal year following the effective date of this
Agreement and each year thereafter.
7.8 All amounts payable to BYU under this Agreement shall be paid
without any deduction or set-off whatsoever, and are exclusive of all
taxes, levies, or similar government charges, however designated, including
penalties and interest ("taxes") imposed by any jurisdiction, including but
not limited to those taxes based on gross revenue, payments under this
Agreement, or otherwise. If any such taxes are required to be withheld,
LICENSEE shall pay an amount such that the net amount after withholding of
taxes shall equal the amount that would have been otherwise payable under
this Agreement. LICENSEE agrees to pay all taxes which are properly
payable or to provide BYU with a certificate of exemption, acceptable to
the appropriate taxing authority, with respect to any unpaid taxes.
LICENSEE will provide BYU with official tax receipts or other acceptable
evidence of the payment of any tax required to be withheld on behalf of BYU
pursuant to this Agreement, and will provide reasonable assistance as may
be requested by BYU in order to permit it to claim U.S. foreign tax
credits.
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8 Confidentiality
8.1 LICENSEE agrees, that as LICENSEE receives material provided by
BYU which is marked as confidential, or is verbally so designated and
confirmed in writing by BYU within thirty (30) days of the receipt of the
materials by LICENSEE, or which LICENSEE would at the time of disclosure
reasonably understand under the circumstances to be considered by BYU to be
confidential, LICENSEE shall take reasonable precautions to protect such
material and to preserve its confidential, proprietary or trade secret
status during the term of this Agreement and for a period of five (5) years
after termination of this Agreement.
8.2 In determining whether or not information is confidential, the
burden of proof shall be upon LICENSEE to establish by competent proof and
by preponderance of the evidence that such information to be
nonconfidential was:
A. Already known to LICENSEE at the time of disclosure by BYU,
or
B. Was generally available to the public or otherwise part of
the public domain at the time of its disclosure to LICENSEE,
or
C. Became generally available to the public or otherwise part
of the public domain after its disclosure and other than
through any act or omission of LICENSEE in breach of this
Agreement, or
D. Was subsequently, lawfully disclosed to LICENSEE by a third
party.
8.3 LICENSEE may disclose BYU's confidential information only to the
extent it is authorized in writing to do so by BYU and such disclosure is
reasonably necessary to further the objectives of this Agreement.
8.4 All of LICENSEE's and SUBLICENSEE's employees and independent
contractors with access to BYU's confidential information shall be bound in
writing, copies of which shall be retained by LICENSEE and submitted to BYU
upon request of BYU, to make no unauthorized use or disclosure of the
confidential information. The form of the writing to be signed is
described on attached Exhibit "C", which is incorporated by reference into
this Agreement.
8.5 LICENSEE agrees that a breach of its obligation to protect BYU's
confidential information shall cause immediate and irreparable harm to BYU
which cannot be adequately compensated by monetary damages. Accordingly,
any breach or threatened breach of confidentiality shall entitle BYU to
preliminary and permanent injunctive relief in addition to such remedies as
may be otherwise available to BYU.
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9 SEPARATE SERVICE AGREEMENT
If BYU shall agree to supply technical and engineering services beyond
those reasonably required to effectively transfer to LICENSEE the LICENSED
TECHNOLOGY licensed herein, LICENSEE shall reimburse BYU for its expenses
incurred in furnishing such technical and engineering services pursuant to
the terms and conditions of a separate written agreement.
10 EXPORT CONTROLS
It is understood that the LICENSED TECHNOLOGY may be subject to United
States laws and regulations controlling the export of technical data,
laboratory prototypes and other commodities (including the Arms Export
Control Act, as amended, and the Export Administration Act of 1979), and
LICENSEE's obligations under this Agreement may be contingent upon
compliance with applicable United States export laws and regulations. The
transfer of certain technical data and commodities may require a license
from the cognizant agent of the United States Government and/or written
assurances by LICENSEE that LICENSEE shall not export data or commodities
to certain foreign countries without prior approval of such agency. BYU
neither represents that a license shall not be required nor that, if
required, it shall be issued. LICENSEE shall observe and obey all export
laws in countries in which it shall do business.
11 PATENT MARKING NOTICE
LICENSEE agrees to xxxx the LICENSED PRODUCTS sold in the United
States with all applicable United States patent numbers and notices. All
LICENSED PRODUCTS shipped to or sold in other countries shall be marked in
such a manner as to conform with the patent laws and practice of the
country of manufacture or sale.
12 PATENT PROSECUTION AND MAINTENANCE
12.1 BYU shall use its best efforts to apply for, seek prompt
issuance of, and maintain during the term of this Agreement any patent
and/or copyright rights to properly patentable or copyrightable
INTELLECTUAL PROPERTY set forth in Exhibit B or to any residuals,
derivatives, enhancements and modifications. BYU shall diligently
prosecute, file, perfect and maintain all such patent or copyright rights,
patents or applications utilizing legal counsel of its choice. LICENSEE
shall cooperate with BYU in such prosecution, filing and maintenance.
12.2 Payment of all fees and costs relating to the filing,
prosecution, perfection and maintenance of the patent and copyright rights,
both domestic and foreign, shall be reimbursed by LICENSEE to BYU, as such
fees and costs are incurred after the date of this Agreement.
11
12.3 LICENSEE SHALL HAVE NO CLAIM OR DAMAGES AGAINST BYU, ITS
PERSONNEL, TRUSTEES OR STUDENTS FOR FAILURE TO PERFORM ITS OBLIGATIONS
PURSUANT TO SECTION 13 OF THIS AGREEMENT, AND SHALL NOT CONSIDER BYU'S
FAILURE TO SO PERFORM A BREACH OF THIS AGREEMENT.
13 INFRINGEMENT
13.1 LICENSEE shall inform BYU promptly in writing of any alleged
infringement or misuse of the intellectual property rights subject of this
Agreement by a third party and of any available evidence of such
infringement or misuse.
13.2 During the term of this Agreement, BYU shall have the right, but
shall not be obligated, to prosecute at its own expense any infringements
or misuse and, in furtherance of such right, LICENSEE agrees that BYU may
require LICENSEE to participate as a party plaintiff in any such suit,
without expense to LICENSEE. The total cost of any such infringement
action commenced solely by BYU shall be paid by BYU and BYU shall be
entitled to retain any recovery or damages arising from the infringement or
misuse.
13.3 If within sixty (60) days after having been notified of any
alleged misuse or infringement, BYU does not intend on prosecuting an
infringement action, BYU shall notify LICENSEE of its intention not to
bring suit. In such event only, LICENSEE shall have the right, at its own
expense, to prosecute a suit to remedy the infringement or misuse of the
intellectual property rights subject of this Agreement. LICENSEE may, for
such purposes, use the name of BYU as party plaintiff. However, the right
to bring an infringement action shall remain only for so long as this
Agreement remains in effect. No settlement, consent judgment or other
voluntary final disposition of the suit may be entered into without the
express written consent of BYU, which consent shall not be unreasonably
withheld. LICENSEE shall indemnify BYU against any order or settlement for
costs or attorneys' fees that may be made against BYU in such proceedings
prosecuted by LICENSEE.
13.4 In the event that LICENSEE shall undertake the enforcement of
intellectual property rights by litigation, LICENSEE may withhold up to 50%
of any royalty payment otherwise due BYU and apply the same toward
reimbursement of a cumulative maximum of fifty percent (50%) of its
reasonable and paid outside attorneys fees, court costs and fees of expert
witnesses. Any recovery of damages by LICENSEE for such suit shall be
applied first to satisfaction of any unreimbursed litigation expenses and
legal fees of LICENSEE relating to the suit and next toward reimbursement
of BYU for any royalties withheld and outside costs incurred in support of
LICENSEE's action. The balance remaining from any such recovery shall be
divided equally between LICENSEE and BYU.
13.5 In the event that a declaratory judgment or other action
alleging unlawful infringement of any intellectual property rights of a
third party is brought against LICENSEE, BYU, at its sole option, shall
have the right within thirty (30) days after the commencement of such
action to intervene and assume the sole defense of the action at its own
expense. Should BYU elect not to defend, LICENSEE shall have the right to
defend the suit at its sole expense.
12
13.6 If a third party is successful in prevailing against LICENSEE in
an adjudicated lawsuit demonstrating that the LICENSED TECHNOLOGY as
delivered to LICENSEE by BYU unlawfully infringed upon such third party's
intellectual property rights, LICENSEE shall be entitled to offset against
future earned royalties the full amount of LICENSEE's court costs, attorney
fees and damages awarded.
13.7 In any infringement suit, the other party shall, at the request
and expense of the party initiating the suit, cooperate in all respects
and, to the extent possible, make its employees reasonably available to
testify when requested and make available relevant records, papers,
information, samples, specimens, and the like.
14 WARRANTY AND LIMITATION OF REMEDY
14.1 BYU represents and warrants that to the best of its knowledge it
is the owner of the entire right, title, and interest in and to and has the
sole right to grant bailments and licenses under this Agreement to the
BIOLOGICAL MATERIAL and the LICENSED TECHNOLOGY as described on Exhibits
"A" and "B"respectively. BYU makes no warranty or representation with
respect to the application of the BIOLOGICAL MATERIAL or LICENSED
TECHNOLOGY to any particular purpose.
14.2 BYU makes no representation that the manufacture, use, lease, or
sale of the LICENSED TECHNOLOGY will not infringe a patent granted to
others, other than to state that it knows of no such patent or other
proprietary interests which would be so infringed.
14.3 Each party represents and warrants to the other that it has all
of the requisite power and authority to enter into this Agreement and to
perform each and every term, provision and obligation of this Agreement and
that neither the execution nor delivery of this Agreement will conflict
with or result in a breach of the terms, provisions or obligations of, or
constitute a default pursuant to any other Agreement or instrument under
which each party is obligated.
14.4 ALL WARRANTIES MADE IN THIS AGREEMENT ARE EXCLUSIVE AND IN LIEU
OF ALL OTHER WARRANTIES EXPRESS AND IMPLIED, INCLUDING BUT NOT LIMITED TO,
THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE, OR ANY OTHER WARRANTY WHETHER EXPRESS OR IMPLIED.
14.5 BYU will not be liable for any loss of profits or for any claim
or demand against LICENSEE by any other party. BYU's liability, if any,
for any damages to LICENSEE shall not exceed in any event the total earned
royalties which have been paid by LICENSEE to BYU during the term of this
Agreement. IN NO EVENT WILL BYU BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL
DAMAGES EVEN IF BYU HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
No action, regardless of form, arising out of the transaction subject of
this Agreement may be brought against BYU more than one year after the
cause of action is discovered.
13
15 PRODUCT LIABILITY AND GENERAL INDEMNIFICATION
15.1 BYU does not warrant the effectiveness or operation of any of
the LICENSED PRODUCTS or LICENSED PROCESSES and the parties to this
Agreement agree and understand that BYU shall have no liability to an END
USER. LICENSEE, therefore, agrees to hold BYU harmless and indemnify BYU,
its trustees, officers, employees and agents from and against any and all
litigation, claims, damages or actions (including reasonable attorneys'
fees) that may be instituted against BYU arising out of LICENSEE's
marketing, distribution, sale, production, manufacture, lease, consumption
or advertisement of the LICENSED TECHNOLOGY, LICENSED PRODUCTS or LICENSED
PROCESSES or arising from any obligation of LICENSEE under this Agreement,
including, but not limited to, claims resulting from any alleged type of
defect in the LICENSED PRODUCTS or LICENSED PROCESSES or damages allegedly
caused by any breach of contract by LICENSEE, its AFFILIATES or
SUBLICENSEES or the use or misuse of the LICENSED PRODUCTS and LICENSED
PROCESSES, notwithstanding any third-party allegation that their claims,
injuries or damages were proximately caused in part or wholly by BYU's
negligence. In the event BYU is sued as a party defendant or otherwise
pursuant to claims identified in this Section as being subject to
indemnification, LICENSEE agrees to defend BYU at LICENSEE's sole expense
in such action. Should any award or decree be made against BYU, it shall
be the obligation of LICENSEE to (a) appeal the decision and pay if the
appeal is lost or (b) pay such award or make any settlement as may be
warranted before or after the decision on appeal. BYU may, at its own
option, conduct its own defense in such actions and all expenses and
attorneys' fees for such defense shall be paid by LICENSEE.
15.2 LICENSEE shall immediately notify BYU of any litigation in which
it, its officers or its directors, agents or employees may be involved if
there is a reasonable possibility that this Agreement or BYU will be
affected and afford BYU reasonable cooperation should BYU elect to make its
own defense.
16 TERM AND TERMINATION
16.1 Subject to earlier termination in accordance with this Section
16, this Agreement shall commence on the effective date of this Agreement
and remain in force for a period of five (5) years. This Agreement may be
extended for additional periods of five (5) years upon notification from
LICENSEE to BYU.
16.2 The Agreement may be terminated without prior notice by BYU at
its election in the event of the occurrence of any one of the following
circumstances:
A. In the event LICENSEE is placed in the hands of a receiver
or makes a general assignment for the benefit of creditors;
or
14
B. In the event that substantial assets of LICENSEE or its
successor-in-interest are seized or attached in conjunction
with any action brought against it by a third party
creditor.
16.3 This Agreement may be terminated effective upon thirty (30) days
written notice from BYU and the failure of LICENSEE to cure any breach or
default prior to the expiration of the thirty (30) day notice period in any
of the following circumstances:
A. In the event LICENSEE becomes insolvent or shall cease to
carry on its business in the normal course; or
B. In the event there is a transfer or sale of LICENSEE's
business purporting to transfer or assign this Agreement or
LICENSED TECHNOLOGY without the prior express written
consent of BYU; or
C. Disclosure of confidential information in violation of the
confidentiality provisions of this agreement; or
D. In the event that BYU reasonably determines that LICENSEE
does not have the financial ability to perform the terms of
this Agreement.
16.4 In the case of breach or default arising from LICENSEE's failure
to pay BYU royalties or other costs or expenses pursuant to the Agreement
when due and payable, failure to complete the performance requirements of
Section 5 of this Agreement or from any other material breach or default of
this Agreement other than those described in Section 16.3 and Section 16.2,
BYU shall have the right to terminate this Agreement upon thirty (30) days
notice to LICENSEE. Termination shall become effective upon the failure of
LICENSEE to cure such breach or default.
16.5 Upon termination of this Agreement, for any reason, the parties
shall not be released from any obligation that has matured prior to the
effective date of the termination. LICENSEE may, however, after the
effective date of such termination, sell all LICENSED PRODUCTS and complete
LICENSED PROCESSES in its inventory or in process as of the time of such
termination, provided that LICENSEE shall pay to BYU the royalties and
other consideration on these products as required by this Agreement and
shall submit the reports as required.
16.6 Upon the termination of this Agreement, any SUBLICENSEE which
has not breached in any material way its sublicense agreement may be
granted the right to receive a license directly from BYU, at BYU's sole
discretion, granting license rights to the LICENSED TECHNOLOGY.
16.7 Upon the termination of this Agreement, LICENSEE shall return to
BYU all of BYU's BIOLOGICAL MATERIAL; and all equipment, enhancements and
all other materials, documents and information as may have been provided by
BYU pursuant to this Agreement, which contain information which is
confidential or proprietary to BYU and shall grant back to BYU all of
LICENSEE's right, title and interest to all IMPROVEMENTS, with applicable
documentation, made by LICENSEE in relation to the LICENSED TECHNOLOGY.
15
16.8 Nothing herein shall be construed to limit BYU's legal or
equitable remedies in the event of a default by LICENSEE and/or subsequent
termination of this Agreement by BYU.
17 NEGOTIATIONS, MEDIATION AND ARBITRATION
17.1 With respect to any and all claims, disputes or controversies
arising out of the performance of or in connection with this Agreement,
except with respect to enforcement of the LICENSEE's obligations to pay
royalties and fees for which BYU may seek any legal or equitable remedy
available through a court of competent jurisdiction, the parties agree to
attempt in good faith to resolve those claims, disputes or controversies by
negotiations between the parties. In the event either party believes the
negotiation discussions are likely not to result in settlement, the parties
must, in good faith, participate in mediation sessions with a professional
mediator to be mutually selected by the parties and the expense of which is
to be paid fifty percent (50%) by each party. In the event, after one or
more mediation sessions, either party believes the mediation process is not
likely to resolve the dispute by mutual agreement, the dispute shall be
resolved by final and binding arbitration in Provo, Utah. Each party shall
choose one arbitrator and these two arbitrators shall in turn select a
third arbitrator, which three arbitrators shall constitute the arbitration
panel. The arbitrators shall have no power to add to, subtract from or
modify any of the terms or conditions of this Agreement. Any award
rendered in such arbitration may be enforced by either party in either the
courts of the State of Utah or in the United States District Court for the
District of Utah in which jurisdiction for such purposes BYU and LICENSEE
hereby irrevocably consent and submit. The arbitration proceedings shall
be conducted in all matters not specifically identified in this Agreement
pursuant to the rules of the American Arbitration Association, unless
otherwise expressly agreed in writing by the parties. Each party shall
bear its own costs.
17.2 Claims, disputes or controversies concerning the validity,
construction or effect of any patent subject of this License Agreement
shall be resolved in any court having competent jurisdiction.
17.3 In the event in any arbitration proceeding any issue shall arise
concerning the validity, construction or effect of any patent licensed, the
arbitrator shall assume the validity of all claims as set forth in the
patent. Except with reference to a prior determination by a court of
competent jurisdiction, neither party shall raise any issue concerning the
validity, construction or effect of any patent licensed under this
Agreement in any arbitration proceeding, in any proceeding to enforce the
arbitration award or in any proceeding arising out of such arbitration
award.
16
17.4 Nothing in this Section shall be construed to waive any rights
of timely performance of any obligation existing under the Agreement.
18 LICENSEE ASSIGNMENT
Neither this Agreement nor the LICENSED TECHNOLOGY is assignable by
LICENSEE without the express written consent of BYU, which shall not be
unreasonably withheld. Any attempt to make such an assignment without BYU's
written consent may be voided at the election of BYU. LICENSEE agrees
that in the event BYU elects to void an unauthorized assignment that BYU
will have suffered immediate and irreparable damage and shall be entitled
to immediate injunctive relief. In the event BYU does not elect to void an
unauthorized assignment, LICENSEE agrees that the assignee will be treated
in all respects as an AFFILIATE for purposes of this Agreement. Nothing in
this provision may be construed to preclude BYU from initiating an
independent action against the assignee of the unauthorized assignment or
to otherwise pursue other legal or equitable remedies against LICENSEE, the
assignee or both.
19 NON USE OF BYU NAME
LICENSEE shall not use the name of Xxxxxxx Xxxxx University nor of any
of its employees, nor any adaptation thereof, in any advertisement,
promotion or sales literature without the express prior written consent
from BYU in each case, except that LICENSEE may state that it is licensed
by BYU.
20 PUBLICATION
BYU shall have the right to publish any academic paper, article or
learned treatise and make public disclosure at professional meetings or
seminars regarding any portion of the LICENSED TECHNOLOGY which has been or
may be invented, conceived or developed by BYU.
21 PAYMENT, NOTICES AND OTHER COMMUNICATIONS
Any payment, notice or other communication pursuant to this Agreement
shall be sufficiently made or given on the date of mailing if sent by
certified first-class mail, postage prepaid, addressed to the receiving
party at its address designated below or such address as shall be
designated by written notice given to the other party.
BYU: Technology Transfer Office
A-285 ASB
Xxxxxxx Young University
X.X. Xxx 00000
Xxxxx, Xxxx 00000-0000
(000) 000-0000
17
LICENSEE: BioPulse International, Inc.
00000 Xxxxx Xxxxxx Xxxxxxx, Xxxxx 000
Xxxxx Xxxxxx, Xxxx 00000
(000) 000-0000
22 MISCELLANEOUS PROVISIONS
22.1 Independence of Parties. BYU and LICENSEE are independent
parties engaged in independent business and neither party nor any
respective agent or employee of either party shall be regarded as an agent
or an employee of the other. Nothing in this Agreement shall be construed
as reserving to either party the right to control the other in the conduct
of its business, nor shall either party have the authority to make any
promise, guarantee, warranty or reservation which will create any
obligation or liability whether express or implied on behalf of the other.
22.2 Attorneys' Fees. In the event a suit or an arbitration
proceeding is commenced to construe or enforce any provision of this
Agreement, the prevailing party, in addition to all other amounts to which
such party may be entitled, shall be paid by the other party a reasonable
sum for attorneys' fees, expert witness fees and reasonable costs related
to the dispute resolution.
22.3 Waiver. No waiver by either party, whether express or implied,
of any provisions of this Agreement or of any breach or default of either
party, shall constitute a continuing waiver of such provision or a wavier
of any other provisions of this Agreement.
22.4 Governing Law. This Agreement shall be interpreted and
construed in accordance with the laws of the State of Utah. Venue for any
legal disputes shall be in Utah County, Utah.
22.5 Partial Invalidity. Should any Section or any part of a Section
of this Agreement be held unenforceable or in conflict with the law of any
jurisdiction, the validity of the remaining Sections and Subsections shall
not be affected by the invalidity of any other part of the Agreement.
22.6 Force Majeure. Neither party to this Agreement shall be in
default because of a delay or failure to perform which is not the result of
the defaulting party's intentional or negligent acts or omissions, but
results from causes beyond the reasonable control of such party such as
acts of God, civil disobedience and war.
22.7 Entire Agreement. This Agreement constitutes the entire
Agreement and understanding between the parties and supersedes all prior
agreements and understandings with respect to the LICENSED TECHNOLOGY,
whether written or oral. No modification or claimed waiver of any of the
provisions of this Agreement shall be valid unless in writing and signed by
authorized representatives of the party against whom such modification or
wavier was sought to be enforced.
18
22.8 Binding Effect. This License Agreement shall be binding upon
and shall inure to the benefit of the successors, assigns and legal
representatives of the parties.
22.9 Headings. The paragraph and subparagraph headings contained in
this Agreement are for convenience and reference only. They are not
intended to define and limit the scope of the provisions of this Agreement.
IN WITNESS WHEREOF, the parties have entered into this Agreement and
it is effective this ______ day of ______________, 200___.
XXXXXXX XXXXX UNIVERSITY
----------------------------------------- -----------------
By: Xxxx X. Xxxxxx Date
Associate Academic Vice President
LICENSEE
----------------------------------------- -----------------
By: Date
Title:
----------------------------------
TT-4088
December 20, 2000
19
EXHIBIT "A"
BIOLOGICAL MATERIAL
THYMIDINE KINASE HYBRIDOMAS
The BIOLOGICAL MATERIAL known as "Thymidine Kinase Hybridomas"
consists of the following hybridoma cell line clones which produce
anti-thymidine kinase monoclonal antibodies, including:
1. The cell cultures which were deposited with the American Type
Culture Collection in connection with filing the application for U.S.
Patent Number 5,698,409:
a. KORG-1
b. KORG-2
c. KORG-5
2. All cell culture lines existing in the laboratory of Xx. Xxx
X'Xxxxx on the effective date of this Agreement which would fall
within the scope of the claims of U.S. Patent Number 5,698,409. The
following clones are perceived to be the most useful and will be
delivered upon execution of the Agreement:
a. 14F2G - IgG
b. 3G4 - IgM
c. 2E2 -IgM
d. 3F9-IgM
e. 8D12- IgM
3. All cell culture lines which may be developed under the direction
of Xx. Xxx X'Xxxxx in the future which would fall within the scope of
the claims of U.S. Patent Number 5,698,409.
DESCRIPTION OF MONOCLONAL ANTIBODIES
Purification of the monoclonals.
TK1 was purified using gel filtration and ion exchange from Raji cell
extract. Mice were immunized at least three times using purified TK1
antigen.. The immune response to TK1 was assayed by ELISA with pure TK1.
Mice with the highest antiserum titer in the previous boosts received an
ultimate injection of 20 g of antigen by spleenic injection and were
sacrificed 3 days later. Immune spleen cells were fused with SP2/0-Ag
myeloma cells. Hybridomas surviving HAT selection were screened by ELISA
and further screened by TK1 activity inhibition assay. Positive monoclonal
clones were subcloned at least three times. After several fusions and
cloning, seven stable hybrodoma cell lines against TK1 were successfully
produced. Clone # 2 was isotyped and found to be IgG1 and clone # 5 was
IgM. Positive IgG cell lines were named 14F2 IgG and 5G11. Positive IgM
cell lines were named 3G4, 2E2, 3F9, 8D12, and 14F2 IgM.
20
Using direct ELISA immunoblotting the IgG Mabs were confirmed highly
specific to human TK1. These results were further confirmed using TK1
activity inhibition assay, and immunohistochemistry. IgM Mabs were
confirmed highly specific to human TK1 by direct ELISA and TK1 activity
inhibition assay. Also linear correlations were obtained between TK1
concentrations and O.D. value at 450 nm in the sandwich ELISA (IgG coating
and IgM chasing). The results of direct ELISA provided excellent
correlations with the TK radioassay using serum samples.
1. Direct ELISA
Supernatant from hybridoma cells was used as test sample and
supernatant from SP2 (fusion partners) was used as the blank The TK source
was purified TK1 from Raji cells. All of these supernatant were positive
(over two times O.D. value more than the blank O.D. value at 450 nm).
IgG: Blank 14F2 IgG 5G11
O.D. value 0.482 1.668 1.163
IgM: Blank 2E2 3F9 3G4 8D12 14F2 IgM
O.D. value: 0.370 >2.5 >2.5 >2.5 >2.5 >2.5
These results were then confirmed using western blot.
2. Western Blotting (using 14F2 IgG)
Lane: 1 2 3 4 5
Marker Pure TK1 Raji extract Hela extract Serum
3. TK1 activity inhibition assay
Mab's were collected from the supernatant of hybridoma cells. Control
supernatant was collected in a similar manner from SP2 cells. TK extract
was then combined with supernatant from hybridoma cells (containing the
anti-TK1 antibodies) in ratios of 1:1, 1:4, 1:16, 1:32, and 1:64 to make
120 l samples. Controls were made according to the same ratios using TK
extract and supernatant from SP2 cells. The results show the test sample
TK1 activity expressed as a percentage of the control sample TK1 activity.
21
4. Immunohistology (using 14F2 IgG and 5G11)
Serum starved (24hrs) TK-6 cells had low TK1 level (0.1532 + 0.0423
CPM/cell), but, high level in growing cells after serum addition (14 hr)
(1.1154 + 0.3580). Using the Mab' s it was possible to demonstrate that
proliferating TK-6 cells (High in TK1) were clearly stained but not resting
cells (Low TK1).
5. Sandwich assay
30 g 14F2 IgG or 5G11 was coated into xxxxx. After washing, 3% BSA
was used to block. Then, pure TK1 was added into xxxxx in different
concentrations and incubated. After washing, chasing IgM Mabs (2E2, 3F9,
or 3G4) were added into xxxxx to incubate. After washing, anti-mouse IgM
antibodies conjugated with HRP were added into the xxxxx to incubate. After
washing, TMB was added to develop the color. Finally, after 0X X0XX0 to
stop color development, O.D. values were measured at 450 nm.
6. Correlation between TK assay and ELISA in serum samples
Serum samples diluted in PBS to a final concentration of 200 g/ml
were coated into xxxxx to incubate. After washing, 3% BSA was added into
each well to block. After washing, anti-TK1 Mab (14F2 IgG 20 g/ml) was
added into xxxxx to incubate. After washing, anti-mouse IgG antibodies
conjugated with HRP was added into xxxxx to incubate. After washing, TMB
was added to develop color. Finally, after 0X X0XX0 to stop color
development, O.D. values were measured at 450 nm.
TK1 activities were also detected by TK assay.
22
Serum Starved, Non-Growing Cells
Picture included on paper copy
Actively Growing and Dividing Cells
Picture included on paper copy
23
EXHIBIT "B"
LICENSED TECHNOLOGY
THYMIDINE KINASE ISOENZYME DIAGNOSTICS
The LICENSED TECHNOLOGY includes U.S. patent number 5,698,409,
"Monoclonal Antibodies to Thymidine Kinase-1 and Uses in Diagnostic and
Therapeutic Applications" all foreign counterparts thereof (including but
not limited to Australian patent number 675,872, "Monoclonal Antibodies to
Thymidine Kinase Isozymes" and patent applications pending in Canada and
the European Patent Office), as well as all continuations, continuations-
in-part, divisions and renewals thereof, all patents which may be granted
thereon, and all reissues, reexaminations, extensions, patents of addition,
improvement patents and patents of importation thereof; and trade secrets;
and know-how which trade secrets and know-how are in existence upon the
effective date of the Agreement.
TT-4088
24
EXHIBIT "C"
NON-DISCLOSURE OF CONFIDENTIAL INFORMATION AGREEMENT
This Agreement is entered into between __________________________, a
_______________ corporation with its principal place of business located at
_______________________________________________________________________
(referred to in this Agreement as "Licensee") and
______________________________________, an employee or contractor of
Licensee (referred to in this Agreement as "Disclosee").
Licensee and Disclosee agree that they are voluntarily entering into
this Agreement for the express benefit of Xxxxxxx Xxxxx University, a Utah
nonprofit corporation and educational institution with its principal campus
and place of business located at Xxxxx, Xxxx 00000 (referred to in this
Agreement as "BYU") and further agree to abide by the terms of this
Agreement as follows:
RECITALS
--------
1. BYU is the sole owner of certain intellectual property rights
known as _____________________________________________________ and has
entered into an Exclusive License Agreement (referred to in this Agreement
as the "License Agreement") with Licensee to allow for its development and
commercialization.
2. Disclosee is an employee or contractor employed by or doing work
for hire for Licensee.
3. Pursuant to the License Agreement, Licensee will receive material
and information from BYU which is confidential or proprietary to BYU and
Licensee has agreed with BYU to take reasonable precautions to preserve the
confidential or proprietary status of this material and information during
the term of the License Agreement and for a period of five (5) years after
termination of the License Agreement.
4. Licensee has also agreed with BYU that all of its employees and
independent contractors with access to BYU's confidential or proprietary
information will be bound in writing to make no unauthorized use or
disclosure of the confidential information. The purpose of this Agreement
is to affect compliance with Licensee's obligation to protect BYU's
confidential information.
25
1. Definitions
-----------
1.1 "Licensed Technology" means and includes all of BYU's technology
and intellectual property referred to in this Agreement as
____________________ and related enhancements generated at BYU or
improvements developed by Licensee as specifically identified on Exhibit
"C" to the License Agreement which exhibit is incorporated by reference and
made a part of this Agreement.
1.2 "Confidential Information" shall mean and include all material
and information provided by BYU to Licensee which is marked as
confidential, or is verbally so designated and confirmed in writing by BYU
within thirty (30) days of receipt of the materials or information by
Licensee, or which Licensee would at the time of disclosure reasonably
understand under the circumstances to be considered by BYU to be
confidential, proprietary or to constitute a trade secret.
2. Disclosure and Acknowledgment
-----------------------------
2.1 The parties acknowledge that, from time to time during the term
of the License Agreement between BYU and Licensee, it may be necessary for
Confidential Information to be disclosed by BYU to Licensee and from BYU or
Licensee to Disclosee. The parties acknowledge the provisions of this
Agreement are necessary to protect the confidentiality, value, and secrecy
of BYU's Confidential Information concerning the Licensed Technology and to
protect BYU's patent and ownership rights to the Licensed Technology.
2.2 Nothing in this Agreement shall be construed as conferring upon
Disclosee by implication, estoppel, or otherwise any right, title or
interest in, or any license under, any Licensed Technology, intellectual
property, patent or trade secret now or subsequently owned by BYU.
2.3 Disclosee agrees to take all precautions reasonably necessary to
maintain the confidential nature of the Confidential Information disclosed
to him or her by BYU or Licensee or otherwise obtained by him or her in
connection with any dealings with BYU or Licensee.
26
3. Use of Confidential Information
-------------------------------
Disclosee agrees as follows:
3.1 Not to use the Confidential Information on his or her own behalf
or on the behalf of others and to hold in trust for BYU the Confidential
Information and any related information, test data, and benefits which
arise during the course of employment or work for hire with Licensee.
3.2 Not to copy, duplicate or in any way record any Confidential
Information disclosed to him or her under the terms of this Agreement.
3.3 That all ideas, developments, inventions, or improvements
relating to the Confidential Information which are discovered by Disclosee
or which Disclosee and others conceive during the term of this Agreement
shall be promptly disclosed to Licensee and to BYU.
3.4 That all such ideas, developments or inventions shall be the
sole property of BYU and Licensee subject to the terms of the License
Agreement and to irrevocably assign, transfer and set over to BYU and
Licensee all rights, title and interest in and to all such ideas,
developments or inventions, regardless of whether they may or may not be
patentable, as directed by the License Agreement.
3.5 To execute, acknowledge and deliver any and all documents,
instruments and papers and to do any and all other things that may be
deemed to be reasonably necessary by BYU and/or Licensee to carry out the
provisions of Section 3 of this Agreement.
3.6 To render all reasonable assistance to BYU and Licensee in
preparing copyrights or patent applications and in protecting the rights of
BYU and/or Licensee and/or their designees in and to any matter which BYU
and/or Licensee desire to protect under any patent or copyright laws of
this or any other country.
3.7 In the event that BYU and/or Licensee is unable, after
reasonable effort, to secure Disclosee's signature on any document or
documents needed to apply for or prosecute any patent, copyright or other
right or protection relating to any idea or invention, whether because of
Disclosee's physical or mental incapacity or for any other reason whatever,
Disclosee hereby irrevocably designates and appoints BYU and its duly
authorized officers and agents as attorney-in-fact to act in Disclosee's
behalf and stead to execute and file any required documents, and to do all
other lawfully permitted acts to further prosecution and issuance of
patents, copyrights or other similar protections with the same legal force
and effect as if executed by Disclosee.
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4. Term and Termination
--------------------
4.1 Disclosee's obligation of confidence, nondisclosure and non-use
pursuant to this Agreement shall be effective for a period of the term of
the License Agreement and for a period of five (5) years after termination
of the License Agreement provided, however, that Disclosee shall have no
obligation of confidence, nondisclosure or non-use with respect to
information:
4.1.1 Already known to Disclosee at the time of the disclosure by BYU
to Licensee; or
4.1.2 Was generally available to the public or otherwise part of the
public domain at the time of disclosure from BYU to Licensee; or
4.1.3 Became generally available to the public or otherwise part of
the public domain after its disclosure and other than through any act or
omission of Licensee or Disclosee in breach of the License Agreement or of
this Agreement; or
4.1.4 Was subsequently and lawfully disclosed to Licensee or
Disclosee by a third party.
4.1.5 Notwithstanding the above subparts of Section 4 of this
Agreement, information shall not be considered to be generally known to the
public or in the trade if, in order to acquire such information from
publicly available sources, Disclosee used Confidential Information to
guide him or her in reviewing such sources or to select therefrom a series
of unconnected items which may be fit together to match the Confidential
Information first learned from BYU and/or Licensee.
4.2 Upon termination of the License Agreement or at the conclusion of
Disclosee's employment relationship with Licensee, or at any time upon
receiving written request from BYU or Licensee, Disclosee shall return all
Confidential Information as well as any and all blueprints, drawings,
diagrams, manuals, memoranda, notes, records, books, files, software, data,
instruments, paper or any other documents or things pertaining to the
Confidential Information and any copies, summaries or compilation of such.
5. Miscellaneous
-------------
5.1 In the event Disclosee is in breach of any of its obligations
pursuant to this Agreement, both BYU and Licensee shall have the right and
standing, in addition to any other remedies available to them at law or in
equity, to preliminary injunctive relief to enforce the obligation of
confidence hereunder until such time as a final adjudication by a court of
competent jurisdiction is secured.
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5.2 In the event a suit is commenced to enforce any obligations of
this Agreement, the prevailing party, in addition to any other amounts or
remedies to which it may be entitled, shall be paid by the non-prevailing
party a reasonable sum for attorneys fees and reasonable costs related to
the dispute resolution.
5.3 This Agreement is subject to and shall be interpreted under the
laws of the State of Utah and the venue for any dispute resolution shall be
in the State of Utah, County of Utah in the State District Court to which
jurisdiction the parties to this Agreement irrevocably consent.
5.4 The parties to this Agreement agree that this Agreement is made
and entered into for the benefit of BYU and that BYU is a third party
beneficiary to this Agreement and has standing to enforce the terms of this
Agreement and to avail itself of all other equitable and legal remedies
allowable by law as if it were a direct party to this Agreement.
5.6 This Agreement is divisible and separable so that if any
provision or provisions shall be held invalid, such holding shall not
impair the remaining provisions.
5.5 This Agreement constitutes the entire agreement and understanding
between the parties and supersedes all prior agreements and understandings
with respect to the subject matter, whether written or oral.
IN WITNESS WHEREOF, the parties have entered into this Agreement and
it is effective as of the __________ day of ____________________, 200__.
LICENSEE:
By:_________________________________
Its:_________________________________
Date:_______________________________
DISCLOSEE:
Name:______________________________
Date:_______________________________
TT-4088
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