EXHIBIT 10.43
TECHNOLOGY LICENSE AGREEMENT
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THIS TECHNOLOGY LICENSE AGREEMENT (the "Agreement") is entered into as
of this 23rd day of September, 1998, by and between Biocontrol Technology, Inc.,
a Pennsylvania corporation with principal offices at 000 Xxxxxx Xxxxxxx Xxxx,
Xxxxxxx, Xxxxxxxxxxxx 00000 ("BICO"), and Luther Medical Products, Inc., a
California corporation with principal offices at 00000 Xxxxxxxx Xxxx, Xxxxxx,
Xxxxxxxxxx 00000 ("Luther").
R E C I T A L S:
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1. BICO owns technology in the field of implantable vascular access
medical devices as more fully set forth in Exhibit "A" hereof (the
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"Technology").
2. BICO has certain know how, background data, manufacturing, quality
assurance and regulatory documents and approvals, techniques, records,
expertise, protocols, devices and other confidential information which may be
useful in the design, development, manufacture, marketing, use and sale of
products utilizing the Technology as more fully set forth in Exhibit "B" hereof
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(the "Know-How").
3. Luther desires to use under license the Technology and the
Know-How, and to develop the Technology for its own use in the manufacture and
marketing of medical devices.
4. It is the intention of the parties hereto to allow Luther to gain
rapid entry into the market for implantable vascular access medical devices by
making a clone of BICO's theraPORT/(R)/ implantable vascular access system and
lines of products thereto, including model number(s) 1001, 1002, 1011, 1012,
1601, and 1602.
5. Luther desires for BICO to use its best efforts to ensure that
Luther is capable of an early market entry into the field of implantable
vascular access medical devices and BICO has so agreed to use its best efforts
in that regard.
6. BICO has agreed to assist Luther's efforts to enter into the field
of implantable vascular access medical devices by providing Luther with full and
free access to all of BICO's design, manufacturing, quality assurance, and
regulatory affairs documents that exist at September 23, 1998, relating solely
to the technology described in Exhibit A.
7. The parties previously executed a Proprietary Information
Agreement (the "Information Agreement") in anticipation of the execution of this
Agreement and a Distributorship Agreement (the "Distribution Agreement"). The
parties agree that any provisions of the Information Agreement that conflict
with the provisions hereof or of the Distribution Agreement shall be terminated
hereby.
8. BICO desires to grant to Luther an irrevocable, non-exclusive
license to use the Technology and the Know-How and Luther desires to obtain use
of the Technology and Know-How from BICO for a one-time cash consideration.
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NOW, THEREFORE, in consideration of the covenants and agreements
herein contained, and for other good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the parties hereto agree as
follows:
ARTICLE I
GRANT OF LICENSE FOR THE TECHNOLOGY AND KNOW-HOW
1.1 Subject to Luther's fulfillment of its obligations in this
Agreement, BICO hereby grants to Luther (a) an irrevocable, non-exclusive right
and non-transferable license (other than as set forth in Section 6.1, below) to
use the Technology and the Know-How for design, development, manufacture, and
sale of Luther's products; and (b) to Luther, and all purchasers and users of
Luther's products using the Technology and Know-How, a grant of immunity from
suit by BICO with respect thereto.
Luther recognizes that the Technology and Know-How furnished by BICO
pursuant to the terms of this Agreement may include proprietary and secret
information of BICO which would not otherwise be available to Luther. Luther
therefore agrees to receive such confidential Technology and Know-How only for
the performance of this Agreement. However, BICO recognizes that, in the
manufacture, sale and servicing of products, technical information must be given
to persons not under the control of Luther and such required information may
include confidential information derived from the Technology and Know-How, and
BICO expressly agrees and assents to the dissemination of all information
necessary for the proper manufacture and servicing of Luther's products.
1.2 Contemporaneously with the execution of this Agreement, BICO will
make available to Luther at BICO's principal offices, the Technology and
Know-How.
1.3 Luther shall use its best efforts to preserve and protect the
Technology and the Know-How at its own cost and expense. Luther will be
responsible for and will bear all its ongoing expenses in connection with the
development of the Technology and Know-How and carrying out of Luther's
operations.
1.4 While it is expected that the Technology and the Know-How will
enable Luther to develop commercially acceptable products, it is understood that
BICO does not warrant or guarantee that such results will be obtained.
1.5 No license or right is granted by implication or otherwise with
respect to any matter except as specifically set forth herein.
1.6 The use and disclosure of the Technology and the Know-How, or of
any technical information acquired pursuant to this Agreement in the exercise of
the rights granted by this Agreement, shall be subject to the export, assets and
financial control regulations of the United States of America including, without
limitation, restrictions under regulations of the United States that may be
applicable to direct or indirect re-exportation of such Technology and Know-How,
or the technical information or equipment, products or services directly
produced by use of such Technology and Know-How.
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1.7 No right is granted by this Agreement to use any registered or
unregistered trademark or trade name of BICO other than the registered or
unregistered trademarks or trade names of BICO's theraPORT/(R)/ product line as
granted in the parties' Distributorship Agreement of even date herewith. In
addition to the above, Luther, for its internal purposes, may continue to use
any such trademarks or trade names of BICO as were on any materials provided by
BICO to Luther in connection with the technology transfer contemplated by this
Agreement. The intent of this provision, and this limited grant in respect of
such technology transfer, is to remove any requirement for Luther to redraft any
of such documents, all of which may be retained by Luther indefinitely.
1.8 The parties agree that their respective rights, duties, and
obligations hereunder and under the Distribution Agreement shall supersede any
rights, duties, and obligations granted or undertaken pursuant to the
Information Agreement. Any provisions of the Information Agreement that
conflict with the provisions hereof or of the Distribution Agreement are hereby
terminated.
ARTICLE II
PAYMENT BY LUTHER
2.1 In consideration for the grant of license for use of the
Technology and Know-How to Luther by XXXX, Xxxxxx agrees to pay BICO cash
consideration of $50,000 upon execution and performance of this Agreement.
ARTICLE III
REPRESENTATIONS AND WARRANTIES OF XXXXXX
Xxxxxx represents and warrants to BICO as follows:
3.1 Luther is a corporation duly organized, validly existing and in
good standing under the laws of the State of California.
3.2 The execution and delivery by Luther of this Agreement and the
entering into of all transactions contemplated hereby have been duly authorized
by appropriate corporation action lawful under the laws of the State of
California.
3.3 This Agreement constitutes valid and legally binding obligations
of Luther, enforceable in accordance with its terms.
3.4 Neither the execution, nor the performance of Luther's
obligations under this Agreement will result in the breach of the terms of or a
default under any instrument, agreement, contract, order, judgment, law,
regulation or rule to which Luther is subject or the Articles of Incorporation
or Bylaws of Luther.
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ARTICLE IV
REPRESENTATIONS AND WARRANTIES OF BICO
BICO represents and warrants to Luther as follows:
4.1 BICO is a corporation duly organized, validly existing and in
good standing under the laws of the State of Pennsylvania.
4.2 The execution and delivery by BICO of this Agreement and the
performance of the transactions contemplated hereby have been duly authorized by
all appropriate corporate action, lawful under the laws of the State of
Pennsylvania.
4.3 This Agreement constitutes valid and legally binding obligations
of BICO, enforceable in accordance with its terms.
4.4 Neither the execution and delivery nor the performance of the
terms and conditions of this Agreement will result in a breach of the terms of
or a default under any instrument, agreement, contract, order, judgment, law,
regulation or rule to which BICO is subject or the Articles of Incorporation or
Bylaws of BICO.
4.5 BICO is the owner of the entire right, title, and interest in and
to the Technology and Know-How and there are no outstanding assignments, grants,
licenses, encumbrances, obligations, or agreements, written or oral, express or
implied, inconsistent with this Agreement. To the best knowledge of BICO, after
due inquiry, there are no material claims, disputes, actions, proceedings, or
investigations of any nature pending or threatened against or involving the
Technology, or the Know-How, or BICO's rights thereto.
4.6 There are no known defects in the drawings, designs, technical
information, or specifications furnished hereunder as part of the Technology or
Know-How.
4.7 Luther will suffer from no inability to manufacture its products
to any given specifications furnished hereunder as part of the Technology or
Know-How.
4.8 Neither the Technology nor the Know-How infringes any third
party's rights, including United States patent rights.
4.9 There is no pending or threatened claim or litigation contesting
BICO's rights with respect to the Technology or the Know-How.
ARTICLE V
DOMINATING OR CONFLICTING RIGHTS
5.1 BICO agrees to indemnify and hold harmless Luther, its officers,
directors, and agents, against claims of unrelated persons asserting United
States patent or copyright infringement or unfair competition arising from
Luther's license and use of the Technology and Know-How and all liability or
loss, including reasonable attorneys' fees stemming therefrom.
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Any changes or additions made to the Technology by Luther shall not be subject
to the indemnification rights set forth herein.
ARTICLE VI
NO SUBLICENSING OF RIGHTS
6.1 Luther believes that all of the BICO technology to be transferred
by BICO to Luther in accordance with this Agreement is already in the public
domain and that the value thereof is that it is organized in such a manner that
will allow Luther to make a rapid entry to the port market. Both parties to
this Agreement recognize that it is the intention of Luther initially to produce
a product that is substantially identical, e.g., a clone, to the BICO products
referenced in Recital 4, above. The parties also recognize that, shortly
following the execution of this Agreement, Luther may (i) produce products that
utilize both the Technology and Luther-developed or otherwise acquired
technology and (ii) continue to develop its product range by the addition of
further Luther-developed or otherwise acquired technology.
The parties recognize that, within three years following the execution
of this Agreement, it will be impossible to identify which elements of Luther's
technology were the subject of the license under this Agreement. Therefore, for
such three-year period, neither this Agreement nor any other rights herein
granted to Luther by BICO shall be the subject of any sublicense by Luther
without the prior written consent of BICO. Any purported assignment in
violation of this Section 6.1 shall be null, void and of no effect whatsoever.
Luther shall not have the right to sell, license, or otherwise grant rights to
third parties in the Technology and the Know-How, except in respect of
manufacturing for, or sales on behalf of, Luther. This prohibition against such
sales, sublicensing, or other granting of rights to third parties shall not
apply in the event of a business combination transaction involving Luther or the
sale of all, or substantially all, of its assets.
ARTICLE VII
COOPERATION
7.1 Luther, at its expense, shall be allowed full and free access
during reasonable business hours to view the operations and manufacturing
processes of BICO that utilize the Technology and Know-How. During such periods,
BICO shall demonstrate to Xxxxxx XXXX'x manufacturing process in action, or in
simulated action, in order to identify additional Know-How information for
Luther.
7.2 BICO shall provide to Luther on such schedule as Luther shall
require access to all documents and Know-How that BICO believes to be relevant
to enable Luther to manufacture and market a clone of the products. Such access
shall include, but not be limited to, BICO's relevant 510Ks, device master
records, device history records, design dossiers, technical files, validation
protocols, validation reports, vendor lists, bills of materials, and purchasing
information. The foregoing list is not intended to be a complete listing of the
relevant information that Luther may require that BICO provide to complete a
successful transfer of the Technology and Know-How in order to allow Luther to
manufacture and market such products. BICO shall
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promptly provide to Luther copies of all documents and Know-How as Luther may
request. Luther shall be permitted to make notes on any Know-How that Luther
identifies, in its sole discretion, as relevant.
7.3 BICO shall cooperate with Luther in soliciting continuous
cooperation from and providing access to BICO's vendors and suppliers, and BICO
shall specifically notify same that each is permitted to supply materials,
components, services, or other items of value to Luther on terms equally as
favorable as those provided to BICO.
7.4 During the three-year period following the date of this
Agreement, BICO shall make available to its vendors and suppliers specifically
for Luther's benefit all of BICO's tooling and all related process information
as necessary for vendors and suppliers to supply and service Luther's design and
manufacturing requirements.
7.5 BICO shall provide reasonable support, cooperation, and technical
assistance necessary to ensure that Luther's products utilizing the Technology
and Know-How are capable of an early market entry.
7.6 BICO shall make available to Luther all current employee and
consultant contact information, as required by Luther to enable it to contact
such individuals for assistance in support of the transactions contemplated by
this Agreement and shall permit Luther to communicate with such individuals in
order to maximize Luther's potential use of the Technology and Know-How. In the
event Xxxxxx xxxxx it necessary to contact BICO's past employees and BICO deems
it appropriate to do so due to some inability to address a specific matter
pertaining to the Technology and Know-How, BICO shall communicate its approval
of the release of confidential or potentially confidential information by said
individuals to Luther, and if necessary, provide each affected individual a
written waiver of confidentiality.
ARTICLE VIII
CONFIDENTIALITY
8.1 Each party undertakes to use its best efforts to ensure that any
and all information regarding the Technology and Know-How, and any information
regarding the business or business prospects of the other party and its
customers obtained by such party or its employees, shall be kept strictly
confidential, shall not be disclosed to third parties, and shall not be used by
either party for any purpose whatsoever other than that party's performance
under this Agreement without the express written permission of the other party.
ARTICLE IX
NOTICE
9.1 All notices hereunder shall be in writing and shall be deemed
received and effective five calendar days after being sent by registered or
certified mail, postage prepaid, return receipt requested, or one calendar day
after being sent by an overnight courier, fees prepaid or by confirmed facsimile
transmission. All notices, requests, or demands shall be sent to the following
addresses:
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To BICO:
Biocontrol Technology, Inc.
000 Xxxxxx Xxxxxxx Xxxx
Xxxxxxx, Xxxxxxxxxxxx 00000
Facsimile: (000) 000-0000
Attention: President
To Luther:
Luther Medical Products, Inc.
00000 Xxxxxxxx Xxxx
Xxxxxx, Xxxxxxxxxx 00000-0000
facsimile: (000) 000-0000
Attention: Xx. Xxxxx Xxxxx
Either party shall notify the other of any change of address or
facsimile number, in the manner set forth in this Article.
ARTICLE X
DISPUTE RESOLUTION
10.1 Arbitration. Any dispute between the parties regarding the
terms and conditions of this Agreement or the interpretation or enforcement
thereof (the "Arbitration Proceeding") shall be determined by binding
arbitration before the American Arbitration Association in accordance with its
rules for commercial arbitration.
10.2 Venue. If BICO commences an Arbitration Proceeding, it shall be
held at the offices of the American Arbitration Association in Orange County,
California. If Luther commences an Arbitration Proceeding, it shall be held at
the offices of the American Arbitration Association in Pittsburgh, Pennsylvania.
10.3 Governing Law. If BICO commences an Arbitration Proceeding,
this Agreement shall be governed by the laws of the State of California, without
regard for choice of laws provisions. If Luther commences an Arbitration
Proceeding, this Agreement shall be governed by the laws of the State of
Pennsylvania, without regard for choice of laws provisions.
ARTICLE XI
MISCELLANEOUS
11.1 Written Amendment. This Agreement may only be modified or
amended in writing and signed by the parties hereto or their duly authorized
representatives or agents.
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11.2 Waiver. No claim or right arising out of a breach of this
Agreement may be discharged in whole or in part by a waiver or renunciation of
the claim or right unless the waiver or renunciation is supported by
consideration and is in writing signed by the aggrieved party.
11.3 Continuing Cooperation. Each party hereto shall upon the
written request of another, promptly execute, acknowledge and deliver to such
parties such additional documents and/or instruments, and take such other steps,
as such party may reasonable require to evidence, maintain and/or effectuate the
intent of this Agreement and/or any and all of the rights granted to such party
hereunder.
11.4 Assignment. No right or interest in this Agreement shall be
assigned by either party without the written consent of the other, and no
delegation of any material duty or material obligation, or of the performance of
any material duty or material obligation, owed by either party shall be made
without the written permission of the other.
11.5 Successors. This Agreement and all of its provisions and
obligations shall be binding upon and inure to the benefit of the parties and
their heirs, successors, and assigns.
11.6 Complete Agreement. This writing is intended by the parties to
be a final expression of their agreement and is intended also as a complete and
exclusive statement of the terms of their agreement. No course of prior
dealings between the parties and no usage of the trade shall be relevant to
supplement or explain any term used in this Agreement. Acceptance or
acquiescence in a course of performance rendered under this Agreement shall not
be relevant to determine the meaning of this Agreement even if the accepting or
acquiescing party has knowledge of the nature of the performance and opportunity
for objection.
11.7 Severability. If any provision or provisions herein are held to
be invalid, illegal or unenforceable by a body of competent jurisdiction, the
validity, legality and enforceability of the remaining provisions shall not in
any way be affected or impaired thereby.
11.8 Force Majeure. If the performance of this Agreement or of any
obligation hereunder, except the making of payments, is prevented, restricted or
interfered with by reason of fire or other casualty or accident, strikes or
labor disputes, inability to procure power or supplies, war or other violence,
any law, order proclamation, regulation, ordinance, demand or requirement of any
governmental agency or any other act or condition whatsoever beyond the
reasonable control of a party hereto, the party so affected, upon giving prompt
notice to the other party, shall be excused from such performance to the extent
of such prevention, restriction or interference provided that such party shall
use its best efforts to avoid or remove such causes for non-performance and
shall continue performance hereunder with the utmost dispatch as and when such
causes have been removed.
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the date first above written.
BIOCONTROL TECHNOLOGY, INC. LUTHER MEDICAL PRODUCTS, INC.
By: /s/ Xxxxx X. Xxxxx By: /s/ Xxxxx Xxxxx
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Name (Print): Xxxxx X. Xxxxx Xxxxx Xxxxx, President
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By: /s/ Xxxxx X. Xxxxxx By: /s/ Xxxxxx X. Xxxxxx
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Name (Print): Xxxxx X. Xxxxxx Name (Print): Xxxxxx X. Xxxxxx
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TECHNOLOGY LICENSE AGREEMENT
Exhibit A
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The Technology is all proprietary and intellectual information and
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property relating to BICO's theraPORT/(R)/ implantable vascular access system
and lines of products thereto, including model number(s) 1001, 1002, 1011, 1012,
1601, and 1602.
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XXXX-XXXXXX
TECHNOLOGY LICENSE AGREEMENT
Exhibit B
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The Know-How includes, but is not limited to, all background data,
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manufacturing, quality assurance and regulatory documents and approvals,
techniques, records, expertise, protocols, devices and other confidential
information which may be useful in the design, development, manufacture,
marketing, use and sale of BICO's theraPORT/(R)/ product line together with
copies of all 510K documents, device master records, device history records,
design dossiers, technical files, validation protocols, validation reports,
vendor lists, all bills of materials and purchasing information, designs,
specifications, research notes, other technical data, and patent information,
and all records and books of account relating to all prior activities of BICO in
connection with the development of the theraPORT/(R)/ product line.
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