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EXHIBIT 10.18
DEVELOPMENT AND LICENSE AGREEMENT
THIS AGREEMENT, is effective as of the 28th day of January, 1997, by
and between XXXXXXX & XXXXXXX MEDICAL, INC., a New Jersey corporation having an
office at 0000 Xxxxxxx Xxxxxxxxx, Xxxxxxxxx, Xxxxx 00000-0000 (hereinafter
"JJMI") and BIO-PLEXUS, INC., a corporation of the State of Connecticut having
an office at 000 Xxxxxx Xxxx, Xxxxxxx, Xxxxxxxxxxx 00000 (hereinafter
"BIO-PLEXUS").
W I T N E S S E T H:
WHEREAS, BIO-PLEXUS is the owner of certain patent rights and know-how
related to safety needles, and in particular, to developments described in U.S.
Patents listed on Exhibit A, certain other patent applications and continuing
development activities relating to safety devices for needles and sharpened
cannulae;
WHEREAS, JJMI wishes to fund and desires that BIO-PLEXUS undertake a
development project concerning such safety devices; and
WHEREAS, BIO-PLEXUS desires that such developments and inventions be
made available to the commercial markets, and in particular, to the Field (as
defined below); and
WHEREAS, JJMI desires to develop and bring to market products which
utilize such inventions related to the Field and to obtain an exclusive,
worldwide license to such inventions, patents and pending patent applications
for the Field;
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NOW, THEREFORE, in consideration of the premises and mutual covenants
herein contained, the parties hereto agree as follows:
ARTICLE 1 - DEFINITIONS
Where used in this Agreement, the following terms shall have the
meanings attributed to them herein:
1.1 The term "Affiliate" shall mean any company or other legal entity,
other than JJMI, in whatever country organized, controlling, controlled by, or
under common control with JJMI. The term "control" means the possession, direct
or indirect, of the power to direct or cause the direction of the management and
policies of an entity, whether through the ownership of voting securities, by
contract, or otherwise, and the term "entity" includes an individual,
corporation or other entity.
1.2 The term "Field" shall mean short peripheral intravenous catheters,
(three inches or less in length) including sideport peripheral catheters. Items
intended to be sold as blood collection needles, syringe needles, winged
infusion needles (butterflies), midline catheters, central and radial arterial
catheters, and Peripherally Inserted Central Catheter (PICC) introducers are
excluded from the Field.
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1.3 The term "Technical Information" shall mean patents, patent
applications, inventions, know-how, and other proprietary rights within the
Field or resulting from the performance of the Development Program and owned,
licensed by or controlled wholly or partially by BIO-PLEXUS.
1.4 The term "Licensed Patent Rights" shall mean
(i) that portion of Technical Information which comprises all
patents and applications for patents filed in any country
containing one or more claims to any invention within the
Field including, but not limited to, those patents listed on
Exhibit A; and
(ii) all patent applications filed in any country which claim the
benefit of the filing date of any of the patents or
applications listed on Exhibit A including all continuing,
divisional, and renewal applications thereof, all parent
applications, all patents which may be granted thereon, and
all reissues, re-examinations and extensions thereof.
1.5 The term "Licensed Products" shall mean any product within the
Field which would, but for the licenses granted herein,
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infringe any Valid Claim of an issued patent included in Licensed Patent Rights.
1.6 The term "Valid Claim" shall mean a claim of an issued patent which
has not lapsed or become abandoned and which claim has not been declared invalid
or unenforceable by an unappealed or unappealable decision or judgment of a
court of competent jurisdiction.
ARTICLE 2 - RESEARCH AND DEVELOPMENT
2.1 During the term of this Agreement, BIO-PLEXUS shall use its best
efforts to develop intravenous catheter Safety Needle Assemblies ("SNAs") to
JJMI specifications (attached in Exhibit B) for marketing by JJMI within the
Field ("Development Program"). BIO-PLEXUS shall develop such SNAs according to
the development plan attached hereto as Exhibit B. During the Development
Program the JJMI specifications may be modified by mutual written consent.
2.2 BIO-PLEXUS shall develop SNAs for two (2) IV catheter hub
configurations. The first SNAs developed shall be compatible with a hub
configuration for a straight plastic hub. A second configuration SNAs may
optionally be required by JJMI for a winged, metal hubbed or side port catheter.
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2.2.1 JJMI may request additional SNAs for peripheral IV catheter
(3 inches or less) in the future. Development costs to be determined by mutual
consent. Unit volume generated by such future developments shall be included
under the licenses granted in this Agreement at the same royalty rates and
aggregated with volumes under this Agreement for royalty determination under
Exhibit C.
2.3 Each hub configuration shall be represented by approximately ten
(10) product codes which will be dependent upon gauge size and needle length.
2.4 BIO-PLEXUS shall be responsible for delivery of SNAs complying with
specifications supplied by JJMI for use in providing clinical data necessary for
submission for relevant regulatory approval. JJMI shall be responsible for
obtaining all regulatory approvals necessary for the free marketing of the
Licensed Products sold by JJMI. BIO-PLEXUS shall, at JJMI expense, assist and
cooperate with JJMI in all regulatory submissions and activities as requested by
JJMI. This includes preparation of all applications to the United States Food
and Drug Administration, whether by application for premarket approval or 510K
notification, or otherwise. BIO-PLEXUS shall have the right to apply for
regulatory approval in its own name, at its sole expense.
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ARTICLE 3 - FUNDING OF DEVELOPMENT
3.1 Payment - JJMI shall pay BIO-PLEXUS a total of Two Million Nine
Hundred Thousand Dollars ($2,900,000) upon execution of this Agreement, for
consideration of the following:
a) One Million Five Hundred Thousand Dollars ($1,500,000) in
consideration of the exclusive patent license granted herein
and the SNA research and development efforts completed by
BIO-PLEXUS through the date of this Agreement;
b) One Million Four Hundred Thousand Dollars ($1,400,000) for
complete consideration for the obligation of BIO-PLEXUS to
carry out and complete the Development Program. BIO-PLEXUS
shall continue work to complete the Development Program beyond
such payment above, at its sole cost and expense.
3.2 JJMI will separately fund expenditures on Initial Capital Equipment
related to development of intravenous catheter SNAs pursuant to this Agreement.
("Initial Capital Equipment" shall mean equipment sufficient to produce at a
capacity of twelve million (12,000,000) units of SNAs per year). JJMI will own
the Initial Capital Equipment (product machinery, molds, fixtures, etc.)
regardless of the physical location of the equipment. It is also contemplated
that BIO-PLEXUS may retrofit certain capital equipment, already owned by
BIO-PLEXUS, as part of the Development
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Program. Title to such equipment shall be transferred to JJMI at an agreed
amount not to exceed BIO-PLEXUS' book value for the equipment as determined
using generally accepted accounting principles consistently applied (i.e., full
depreciation). Expenditures for Initial Capital Equipment relating to the SNAs
shall not exceed $1.8 million. It is contemplated by the parties that the entire
Development Program will be completed within one (1) year of execution. Delays
due to FDA review times are not included in this one (1) year duration
expectation.
ARTICLE 4 - RESEARCH REPORTS AND OVERSIGHT
4.1 BIO-PLEXUS shall furnish to JJMI written monthly informal reports
on the progress of the Development Program.
4.2 Key Contact - The parties shall each name a key contact through
which day-to-day contact and decision-making may be made and to facilitate
communication between the parties. JJMI will make reasonable effort to timely
respond to all questions and requests from BIO-PLEXUS. The JJMI key contact
shall have access to the researchers and laboratories performing the Development
Program with reasonable notice to and consent of BIO-PLEXUS.
ARTICLE 5 - PROPRIETARY INFORMATION
All proprietary information of any party to this Agreement disclosed to
another party in connection with the Development
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Program and identified in writing and marked by the disclosing party as
confidential will be treated by the receiving party and its employees as
confidential throughout the term of this Agreement and for an additional five
(5) years. The above-mentioned obligation of confidentiality shall not apply to
information which:
(i) at the time of the disclosure was known to the receiving party
as evidenced by written records and was not previously subject
to any obligation of confidentiality; or
(ii) was generally available to the public or was otherwise part of
the public domain at the time of its disclosure; or
(iii) becomes generally available to the public or otherwise part of
the public domain after its disclosure other than through an
act of omission or commission of the receiving party in breach
of this Agreement; or
(iv) becomes known to the receiving party by disclosure of a third
party under no obligation of confidentiality to the disclosing
party.
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ARTICLE 6 - OWNERSHIP OF TECHNICAL INFORMATION
6.1 Each party shall own title to all technical information created
solely by it, its employees and/or contractors after the Effective Date of this
Agreement, except as provided in Paragraph 6.2 below. BIO-PLEXUS warrants that
it and its employees have entered into agreements wherein its employees have
agreed to assign their rights in and to all inventions, as well as all patents
and patent applications directed to such inventions, resulting from their
employment with BIO-PLEXUS to BIO-PLEXUS. Furthermore, BIO-PLEXUS warrants that
it has caused or will cause all additional BIO-PLEXUS employees, or personnel
performing work pursuant to the Development Program to execute similar
agreements with respect to the rights in and to all inventions, as well as all
patents and patent applications directed to such inventions, resulting from
their association with BIO-PLEXUS and warrants that it will enforce such
agreements to ensure that BIO-PLEXUS has perfected its title to the Technical
Information.
6.2 JJMI and BIO-PLEXUS will jointly own title to any and all technical
information first conceived jointly or discovered jointly by JJMI's employees
and BIO-PLEXUS's employees or personnel during the performance of the
Development Program.
6.3 Anything to the contrary notwithstanding, JJMI or its authorized
designees shall own the full right, title and interest
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in and to any government approvals, associated government files or licenses
related to making, using and selling Licensed Products within the Field to the
full extent possible under the law of each appropriate country. BIO-PLEXUS may,
at its sole expense and discretion, obtain regulatory approvals for Licensed
Products in its own name.
6.4 BIO-PLEXUS warrants that it is the owner of all patents and patent
applications included in Licensed Patent Rights.
ARTICLE 7 - LICENSE
7.1 BIO-PLEXUS agrees to grant and hereby does grant to JJMI, and any
Affiliate designated in writing by JJMI, an exclusive, worldwide license, with
the right to sublicense others, under the Technical Information within the Field
to make, have made, use and sell Licensed Products within the Field. JJMI may
grant sublicenses to unaffiliated third parties only after receiving the
approval of BIO-PLEXUS such approval not to be unreasonably withheld, and if
given, not delayed more than fifteen (15) days.
7.2 JJMI shall pay BIO-PLEXUS a royalty on Unit Sales of JJMI, its
Affiliates, and sublicensees, according to "Exhibit C" attached hereto. A "Unit
Sale" shall mean the sale of a Licensed Product to an unaffiliated third party.
To the extent the royalties due do not exceed the minimum royalties set forth in
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Exhibit C, JJMI shall pay the difference between the royalties due and the
minimum royalties as described below.
7.3 No royalty shall be payable on sales of any Licensed Product
between JJMI and any Affiliate or sublicensee, and only one (1) royalty shall be
payable hereunder with respect to the sale of any one (l) Licensed Product.
7.4 JJMI's obligation to pay royalties with respect to sale of Licensed
Product shall terminate upon expiration of the last to expire issued patent
included in Licensed Patent Rights covering such Licensed Product. Thereafter,
JJMI, its Affiliates and sublicensees shall have a paid-up, non-exclusive,
royalty-free license to make, have made, use and sell such Licensed Product.
7.5 JJMI shall keep accurate books and records of sales of Licensed
Products and of all payments due BIO-PLEXUS hereunder. JJMI shall deliver to
BIO-PLEXUS written reports of Unit Sales of Licensed Products during the
preceding calendar quarter, on or before the thirtieth (30th) day following the
end of each calendar quarter. Such reports shall include a calculation of the
royalties due and be accompanied by payment of the monies due. For avoidance of
doubt calendar quarter means each of the three calendar month periods ending on
March 31, June 30, September 30 and December 31 respectively. If JJMI is
reasonably unable to determine the actual
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royalties due by the thirtieth (30th) day following a calendar quarter, then it
may make a good faith estimated payment by the thirtieth (30th) day, followed by
an actual report with any necessary additional payment by the sixtieth (60th)
day. If the estimated payment exceeds the actual amount due then the difference
between the estimated payment and the actual amount due shall be a credit
against the next payment due from JJMI to BIO-PLEXUS. If the minimum royalty
called for in Section 7.2 is due, then the payment for the fourth quarter shall
include an amount sufficient to bring total royalties for the calendar year to
the minimum royalty amount.
7.6 The parties hereto have contemplated entering into an associated
Supply Agreement. In order to maintain its exclusivity under the present
Development & License Agreement, JJMI will purchase minimum quantities as
outlined in the associated Supply Agreement. If JJMI does not purchase the
amounts indicated as minimum amounts in the associated Supply Agreement, and if
JJMI is not otherwise relieved of its respective purchase obligation pursuant to
the associated Supply Agreement, then JJMI may elect to either i) purchase the
indicated minimum unit requirements (and pay the associated royalty) or ii) pay
to BIO-PLEXUS the royalty required by this Agreement and manufacturing profit on
the difference of actual units ordered and the minimum purchase requirements.
For purposes of this section, the royalty payable on
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the difference between the actual units ordered and the minimum purchase
requirements shall be ten cents ($0.10) per unit as determined by Exhibit "D".
If, JJMI is, for any reason relieved from its minimum purchase requirements
under the associated Supply Agreement, then the minimum royalties due from JJMI
in order to maintain exclusivity under the present Development & License
Agreement shall be determined by applying the royalty rate of Exhibit "D" to the
minimum purchase requirements that would have applied under the associated
Supply Agreement had JJMI not been relieved of its minimum purchase requirement.
If, for any given calendar year, JJMI does not elect to purchase the minimum
requirements and does not elect to pay the associated royalties and
manufacturing profits on the difference of actual units ordered and the minimum
purchase requirements, then the license may, at BIO-PLEXUS' discretion, be
cancelled upon sixty (60) days notice.
7.7 If the associated Supply Agreement referred to in 7.6 is terminated
or BIO-PLEXUS is unwilling or unable to supply the quantities required by JJMI
under the Supply Agreement then JJMI may manufacture for itself or have product
manufactured by others under this License Agreement. If JJMI elects to
manufacture SNAs for itself or have others manufacture SNAs for it then JJMI may
maintain the exclusivity under the present Development and License Agreement by
paying at least a minimum royalty equivalent to the royalty required under this
agreement payable on the indicated
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minimum unit requirements in the associated Supply Agreement if the actual
royalties do not meet or exceed such minimum royalty amount. Such minimum
royalties shall be payable at the end of the calendar year and actual royalties
paid for Unit Sales occurring during the year shall be fully credited against
such minimum royalties. If the minimum royalties exceed the amount of actual
royalties paid on Unit Sales of the calendar year then JJMI shall pay an
additional amount equal to the difference between the minimum royalties due and
the actual royalties paid for the given calendar year. If the royalties for a
given calendar year exceed the minimum royalties required for that calendar year
then no additional payment shall be made. If for any given calendar year, in
which JJMI is manufacturing for itself, the royalties due do not equal or exceed
the minimum royalties and JJMI elects not to make the additional payment to
bring the royalty payments made up to the amount of the minimum royalties then
the license may, at BIO-PLEXUS' discretion, be cancelled upon sixty (60) days
notice.
7.8 BIO-PLEXUS agrees that the initial payment set forth in Section 3.1
above, and the royalties due under this Agreement on the minimum purchase
requirements in the associated Supply Agreement provided in 7.6 and 7.7 above
are full consideration for the exclusive licenses granted herein. Therefore,
JJMI makes no representation or warranty that it will market the Licensed
Products covered by this Agreement, or, if JJMI does market any of
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the Licensed Products, that such Licensed Products shall be the exclusive means
by which JJMI will participate in this Field. Furthermore, all business
decisions including, without limitation, the design, manufacture, sale, price
and promotion of Licensed Products after the Development Program covered by this
Agreement and the decision whether to sell a particular product within the
Licensed Products shall be within the sole discretion of JJMI. BIO-PLEXUS and
JJMI further agree that such one time payments and royalties payments are in
lieu of any obligation of best efforts or any level or standard of efforts to be
used by JJMI in the marketing of Licensed Products. JJMI will provide, during
the first three (3) years after commercial launch (as defined in Exhibit 2 to
the associated Supply Agreement) marketing plans for Licensed Products.
Marketing plans will indicate scheduled promotional activities related to the
Licensed Products.
7.9 BIO-PLEXUS shall have the right to nominate an independent
accountant acceptable to and approved by JJMI who shall have access to JJMI and
its Affiliates' records during reasonable business hours, upon executing an
appropriate confidentiality agreement, for the purpose of verifying the royalty
payable as provided for in this Agreement for the two (2) preceding years, but
this right may not be exercised more than once in any year, and the accountant
shall disclose to BIO-PLEXUS only information relating
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solely to the accuracy of the royalty report and the royalty payments made in
accordance with this Agreement.
7.10 Royalty payments under this Agreement shall be made in United
States dollars.
7.11 Any sum required under United States tax laws, or the tax laws of
any other country, to be withheld by JJMI from payments shall be promptly paid
by JJMI to the appropriate tax authorities, and JJMI shall furnish BIO-PLEXUS
with official tax receipts or other appropriate evidence issued by the
appropriate tax authorities sufficient to enable BIO-PLEXUS to support a claim
for income tax credit in respect of any sum so withheld.
7.12 The parties recognize that JJMI desires the opportunity to have
the Field expanded to include all OTN ("Over-the-Needle") venous/arterial access
devices. BIO-PLEXUS agrees that prior to entering into any agreement licensing,
transferring or otherwise encumbering Technical Information for any
venous/arterial access devices including, but not limited to, midline catheters
with OTN introducers and OTN introducers for Peripherally Inserted Central
Catheters ("PICCs"), BIO-PLEXUS shall first negotiate with JJMI for a period of
ninety (90) days from BIO-PLEXUS' first documented written offer to JJMI. If the
parties do not enter into an agreement within such ninety (90) day period then
BIO-PLEXUS shall
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be free to enter into an agreement i) within one (1) year on only as broad terms
and on terms no more favorable to a third party than those contained in a final
offer to JJMI and ii) on any terms thereafter.
7.13 JJMI agrees to grant and hereby does grant to BIO-PLEXUS, a one
(l) year, nonexclusive, royalty-free, worldwide license to all patents, patent
applications, inventions, know-how, and other proprietary rights relating solely
to improvements to SNAs. This license shall begin upon the early termination of
this Agreement and extend for a time limited to one (1) year thereafter. After
such one (1) year term, BIO-PLEXUS' license hereunder shall terminate and cease
to exist.
7.14 The license granted by BIO-PLEXUS to JJMI hereunder, shall
immediately terminate and be of no further force or effect upon the early
termination of this Agreement.
ARTICLE 8 - PATENT FILINGS
8.1 BIO-PLEXUS shall promptly disclose to JJMI all Technical
Information. BIO-PLEXUS may elect to file and prosecute patent applications
directed to any Licensed Patent Right described in such written disclosures.
Such applications shall be filed and prosecuted utilizing patent counsel
selected by BIO-PLEXUS. Should BIO-PLEXUS elect not to file such patent
application or
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applications, JJMI may elect to file and prosecute such patent application or
applications in JJMI's name at JJMI's expense utilizing patent counsel selected
by JJMI.
8.2 With respect to all patent applications referred to above, and to
the extent the parties are able to do so, the parties shall provide each other
with reasonable opportunity to advise the other and shall cooperate with each
other in the prosecution of all patent applications.
ARTICLE 9 - INFRINGEMENT
9.1 In the event that there is infringement within the Field by a third
party of any patent licensed to JJMI hereunder, JJMI shall notify BIO-PLEXUS in
writing to that effect, including with such written notice, evidence
establishing a prima facie case of infringement by such third party. If, prior
to the expiration of one hundred twenty (120) days from the date of such notice,
BIO-PLEXUS overcomes the prima facie case of infringement, obtains a
discontinuance of such infringement or brings suit against the third party
infringer, then the obligation of JJMI to pay royalties under such Licensed
Patent shall continue unabated. BIO-PLEXUS shall bear the expenses of any suit
brought by it, shall retain all damages or other monies awarded or received in
settlement of such suit. JJMI will cooperate with BIO-PLEXUS in any such suit
and
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shall have the right to consult with BIO-PLEXUS and be represented by its own
counsel at its own expense.
If, after the expiration of said one hundred twenty (120) days from the
date of such notice, BIO-PLEXUS has not overcome the prima facie case of
infringement, obtained a discontinuance of infringement, or brought suit against
a third party infringer, then JJMI shall be relieved of all obligation to make
payment of further royalties under the patent being infringed until such time as
either the third party infringement has ceased or suit for infringement has been
filed by BIO-PLEXUS. In addition, JJMI shall have the right after such one
hundred twenty (120) day notice period, but not the obligation, to bring suit
against such infringer and join BIO-PLEXUS as a party plaintiff provided that
JJMI shall bear all expenses of such suit. BIO-PLEXUS will cooperate with JJMI
in any suit for infringement of the Licensed Patent brought by JJMI against a
third party and shall have the right to consult with JJMI and to participate in
and be represented by independent counsel in such litigation at its own expense.
JJMI shall incur no liability to BIO-PLEXUS as a consequence of such litigation
or any unfavorable decision resulting therefrom, including any decision holding
BIO-PLEXUS' patent invalid or unenforceable. Damages awarded or received in
settlement shall be paid to JJMI in satisfaction of all expenses of such suit;
any remainder shall be shared fifty percent (50%) to JJMI and fifty percent
(50%) to BIO-PLEXUS.
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9.2 BIO-PLEXUS warrants that it is presently aware of no patents or
patent applications owned by a third party which would present any issue of
infringement by reason of the manufacture, use or sale of the SNAs portion of
the Licensed Product. In the event JJMI is charged with such infringement by a
third party, JJMI shall have the right to defend against such charge of
infringement, and during the period in which such litigation is pending, JJMI
shall have the right to apply Fifty Percent (50%) of the royalties due
BIO-PLEXUS on sales of the allegedly infringing Licensed Product against its
litigation expenses. If, as a result of judgment in the litigation or settlement
with a third party, JJMI is required to pay royalties or other monies to such
third party, JJMI may thereafter deduct from the amount of royalties due
BIO-PLEXUS on Unit Sales of the Licensed Product charged to infringe, an amount
which is the lesser of all sums paid by JJMI to such third party, or Fifty
Percent (50%) of all royalty payments otherwise payable to BIO-PLEXUS on the
Unit Sales of such Licensed Product.
ARTICLE 10 - TERMINATION
10.1 The term of this Agreement shall extend from the above-effective
date until the expiration of the last to expire of all patents included in or
issuing from Licensed Patent Rights.
10.2 Upon any breach of or default under this Agreement by a party, the
other may terminate this Agreement by sixty (60) days'
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written notice to the party. Said notice shall become effective at the end of
such period unless during such period the party shall cure such breach or
default.
10.3 JJMI shall have the right to terminate this Agreement at any time
upon three hundred sixty-five (365) days' written notice to BIO-PLEXUS.
10.4 Failure to terminate this Agreement following breach or failure to
comply with this Agreement shall not constitute a waiver of the party's
defenses, rights or causes of action arising from such or any future breach or
noncompliance.
10.5 The provisions hereof relating to ownership of Technical
Information and confidentiality shall survive the termination of this Agreement.
ARTICLE 11 - NOTICE
11.1 Any notices given under this Agreement shall be in writing and
shall be deemed delivered when sent by First Class mail, postage prepaid,
addressed to the parties as follows (or at such other addresses as the parties
may notify each other in writing:
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To JJMI
Xxxxxxx & Xxxxxxx Medical, Inc.
0000 Xxxxxxx Xxxxxxxxx
Xxxxxxxxx, Xxxxx 00000-0000
Attention: President
With a copy to:
Xxxxxxx & Xxxxxxx
Xxx Xxxxxxx & Xxxxxxx Xxxxx
Xxx Xxxxxxxxx, Xxx Xxxxxx 00000
Attention: Chief Patent Counsel
To BIO-PLEXUS
Bio-Plexus, Inc.
000 Xxxxxx Xxxx
Xxxxxxx, Xxxxxxxxxxx 00000
ARTICLE 12 - GENERAL
12.1 Use of Name - No party to this Agreement shall employ or use the
name of the other party in any promotional materials or advertising without the
prior express written permission of such other party.
12.2 BIO-PLEXUS, for all purposes related to this Agreement, shall be
deemed-an independent contractor of JJMI, and nothing in this Agreement shall be
deemed to create a relationship of employment or agency, or to constitute
BIO-PLEXUS and JJMI as partners or joint venturers.
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12.3 Representations and Warranties - Each party hereto acknowledges
and agrees:
(i) that no representation or promise not
expressly contained in this Agreement has
been made by the other party hereto or by
any of its agents, employees,
representatives or attorneys concerning the
subject matter of this Agreement;
(ii) that this Agreement is not being entered
into on the basis of or in reliance on, any
promise or representation, express or
implied, covering the subject matter hereof
other than those which are set forth
expressly in this Agreement; and
(iii) that each party has had the opportunity to
be represented by counsel of its own choice
in this matter, including during the
negotiations which preceded the execution of
this Agreement.
12.4 Each party warrants and represents that to the best of its
knowledge it has the full right and power to make the promises and grant the
licenses set forth in this Agreement, and that there
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are no outstanding agreements, assignments or encumbrances in existence
inconsistent with the provisions of this Agreement.
12.5 Force Majeure - No party shall be liable for any failure to
perform as required by this Agreement, to the extent such failure to perform is
caused by any reason beyond the party's control, or by reason of any of the
following: labor disturbances or disputes of any kind, accidents, failure of any
required governmental approval, civil disorders, acts of aggression, acts of
God, energy or other conservation measures, failure of utilities, mechanical
breakdowns, material shortages, disease, or similar occurrences.
12.6 Assignment - No party hereto shall assign this Agreement to any
other person without the prior written consent of the other party, and any
purported assignment without such consent shall be void, except that JJMI may
assign this Agreement to an Affiliate or to a legal entity acquiring all or
substantially all of JJMI's assets to which this Agreement relates, on the
condition that any successor to-or assignee of JJMI is and shall be bound by all
the terms, conditions and allegations under this Agreement, and that this
Agreement is and shall be incorporated into such assignment.
12.7 Severability - In the event that a court of competent jurisdiction
holds any provision of this Agreement to be invalid,
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such holding shall have no effect on the remaining provisions of this Agreement,
and they shall continue in full force and effect.
12.8 This Agreement contains the entire Agreement between the parties.
No amendments or modifications to this Agreement shall be effective unless made
in writing and signed by an authorized representative of both parties.
12.9 Governing Law - This Agreement shall be governed by and construed
in accordance with the laws of the State of New Jersey.
12.10 No party, except as required by law, shall originate any
publicity, news release, public disclosure or public announcement, written or
oral, whether to the public or press, stockholders or otherwise, relating to
this Agreement, including its existence, the subject matter to which it relates,
or any of its terms, to any amendment hereto or performances hereunder without
the express written permission of the other party, which permission will not be
unreasonably withheld. If a party intends to make an announcement concerning
this Agreement, it will give the other party thirty (30) days' (unless law
requires a shorter period) advance written notice of the text of the proposed
announcement so that the other party may have an opportunity to comment upon the
announcement.
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12.11 Any and all disputes between the parties relating in any way to
the entering into this Agreement and/or the validity, construction, meaning,
enforceability, or performance of this Agreement or any of its provisions, or
the intent of the parties in entering into this Agreement, or any of its
provisions, or any dispute relating to patent validity or infringement arising
under this Agreement shall be settled by arbitration. Such arbitration shall be
conducted at New York, New York in accordance with the rules then pertaining to
the American Arbitration Association with a sole arbitrator who shall be an
attorney experienced in patent licensing matters. Reasonable discovery as
determined by the arbitrator shall apply to the arbitration proceeding. The law
of the State of New Jersey shall apply to the arbitration proceedings. Judgment
upon the award rendered by the arbitrator may be entered in any court having
jurisdiction thereof.
12.12 Limitation of Damages - Neither party shall be responsible for
any indirect, speculative or consequential damages under this Agreement,
provided that product recall expenses required due to the fault of a party
hereto shall not be excluded damages.
12.13 Markings - Licensed Product sold by JJMI will make reference to
license from Bio-Plexus, Inc. and shall note the PUNCTUR-GUARD brand name to the
extent such is owned by BIO-PLEXUS.
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Such reference will be made on shelf packaging or related package insert. This
requirement does not apply to individual product put-ups.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement by
their duly authorized officers or representatives.
BIO-PLEXUS, INC. XXXXXXX & XXXXXXX MEDICAL, INC.
By: /s/ Xxxxxx X. Xxxxxx By: /s/ Xxx Xxxxxxx, M.D.
Title: Chairman / Treasurer Title: VP Market & Business Development
Worldwide
Date: 1/29/97 Date: 1-28-97
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