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EXHIBIT 10.51
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT PURSUANT
TO RULE 24b-2 UNDER THE SECURITIES AND EXCHANGE ACT OF 1934 AS AMENDED. THE
CONFIDENTIAL PORTIONS HAVE BEEN DELETED AND FILED SEPARATELY WITH THE UNITED
STATES SECURITIES AND EXCHANGE COMMISSION TOGETHER WITH A CONFIDENTIAL TREATMENT
REQUEST. DELETED LANGUAGE IS SHOWN BY [DELETED].
DEVELOPMENT AND MANUFACTURING AND
DISTRIBUTION AGREEMENT
This Development and Manufacturing and Distribution Agreement (this
"Agreement") is entered into as of the 19th day of December, 2000, by and
between Bio-Plexus, Inc., a Connecticut corporation ("BPI"), and Fresenius
Medical Care Holdings, Inc. (d/b/a Fresenius Medical Care North America), a New
York corporation ("FMC").
WHEREAS, BPI owns technology related to Extracorporeal Therapy Needles
(defined below) covered by BPI's patented PUNCTUR-GUARD(R) technology;
WHEREAS, BPI and FMC wish to develop such needles ("Phase 1") and FMC
wishes to manufacture, market and distribute such needles ("Phase 2"); and
WHEREAS, FMC desires to acquire and BPI wishes to grant an exclusive
worldwide license to manufacture, have manufactured, use, sell, have sold or
offer for sale such needles utilized in dialysis applications covered by BPI's
patented PUNCTUR-GUARD(R) technology;
NOW, THEREFORE, in consideration of the mutual agreements made herein
and other good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, the parties, intending to be legally bound, agree as
follows:
ARTICLE I. DEVELOPMENT PLAN.
Section 1.1. Development Plan. BPI and FMC shall cooperatively
produce a development plan ("the Development Plan"), relating to the development
of Extracorporeal Therapy Needles, as defined in Section 5.1(e), within the
Field of Use, as defined in Section 5.1(f), based on BPI's patented
PUNCTUR-GUARD(R) technology. The target goal cost to BPI to be set forth in the
Development Plan is [DELETED]. In the calculation of the engineering and other
expenses set forth in the Development Plan, BPI workers shall be charged at
[DELETED] per hour, and BPI direct incurred expenses, plus [DELETED] of such
expenses, shall be charged. The Development Plan shall be completed and jointly
approved by FMC and BPI within thirty days after the date of this Agreement.
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ARTICLE II. PURCHASE OF STOCK.
Section 2.1. Stock. Upon the delivery by FMC to BPI of written
approval of the Development Plan, FMC shall pay BPI in cash or by certified
check for [DELETED] newly issued shares of common stock, no par value (the
"Common Stock") of BPI. The total purchase price shall be [DELETED] (based on
the closing price of such shares on the NASDAQ market on the day before the date
of this Agreement of $0.78 per share). FMC agrees that the shares being
purchased pursuant to this Agreement are being acquired for its own account for
investment and not with a view to the distribution thereof. FMC may not sell or
otherwise dispose of such shares until the earlier of the Commercial Launch (as
defined below) of the Extracorporeal Therapy Needles or six months after FMC
delivers notice to BPI of FMC's decision not to proceed with Phase 2. In no
event may FMC transfer the shares prior to one year after FMC's payment of the
consideration therefor, and then only in compliance with the then applicable
rules and regulations applicable to such transfer pursuant to the Securities Act
of 1933, as amended (the "Securities Act"). FMC represents and warrants that it
is an "accredited investor" within the meaning of Rule 501(a) under the
Securities Act. All certificates evidencing the shares shall include the
following legend:
The securities represented by this Certificate were originally issued
on ___________, 2000, and have not been registered under the Securities
Act of 1933, as amended (the "Act"), and may not be sold or otherwise
disposed of except pursuant to an effective registration statement
under the Act and applicable state securities laws or an applicable
exemption to registration requirements of such laws. The transfer of
the securities represented by this Certificate is subject to a
Development and Manufacturing and Distribution Agreement, dated
December 19, 2000, as amended from time to time, between the issuer and
Fresenius Medical Care Holdings, Inc. The issuer reserves the right to
refuse to transfer such securities until the conditions of such
agreement have been fulfilled with respect to such transfer.
Simultaneously with the payment by FMC for such shares, FMC shall pay BPI, in
cash or by certified check, [DELETED] as a license fee.
Section 2.2. Proceeds. The proceeds acquired by BPI for the
shares sold pursuant to this Agreement and the license fees referred to in
Section 2.1 and this Section 2.2 shall be used to complete Phase 1. If the total
engineering and other costs incurred by BPI in Phase 1 exceed [DELETED], FMC
shall pay for additional costs (not to exceed an additional [DELETED]) in cash
or by certified check. If FMC makes such an additional payment it shall receive
newly issued shares of Common Stock. The number of shares to be issued to FMC
shall be determined by dividing the additional payment by the per share price
set forth in Section 2.1, rounded to the nearest whole share; provided that the
maximum number of shares issuable under this Section 2.2 is [DELETED]. To the
extent that the payment for additional costs by FMC exceeds the price of such
[DELETED] shares, the excess shall constitute an additional license fee. If
either FMC or BPI believes that the total Phase 1 costs will exceed [DELETED],
they shall meet to determine the reason for the cost overrun and how best to
proceed.
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ARTICLE III. PHASE 1.
Section 3.1. Xxxxx 0. Xxxxx 1 shall begin immediately after
the investment contemplated by Section 2.1. The goal of Phase 1 shall be to
construct [DELETED] fully functional Extracorporeal Therapy Needles. The
Extracorporeal Therapy Needles shall be used by FMC solely for purposes of
clinical or preference and functional evaluations and shall generally conform in
concept, design and function to the prototype dialysis needles previously
constructed by BPI and evaluated by FMC. In Phase 1, in accordance with the
development plan:
(a) BPI and FMC shall jointly establish product performance
requirements (for example, back-eye configuration, clamp, wing or body color,
needle shaft lengths and diameters and blunting member lengths and diameters).
(b) BPI shall prepare applicable drawings and cause single or
multiple cavity prototype molds for custom, injection-molded components to be
constructed.
(c) BPI and FMC shall test a sample (sufficiently large to
ensure statistical relevancy) of the Extracorporeal Therapy Needles for the
product performance characteristics (with special attention paid to flow,
sharpness, tensile strength, hemoloysis and ease of use) comparable to
Extracorporeal Therapy Needles currently available in the market.
(d) FMC shall supply tubing, clamps, xxxxx, caps and sheaths
for Phase 1 devices.
(e) FMC shall be responsible for seeking all regulatory
approvals necessary for the free marketing of the Extracorporeal Therapy Needles
and will commence these efforts during Phase 1. BPI shall assist and cooperate
with FMC in all regulatory submissions and activities as requested by FMC.
(f) FMC shall use the Extracorporeal Therapy Needles solely
for the purposes of human clinical or preference and functional tests and
evaluations. BPI shall assist and cooperate with FMC in all such tests and
evaluations, and FMC shall allow at least one representative from BPI on its
premises on reasonable notice and during regular business hours to observe all
such tests and evaluations. FMC shall furnish reasonable notice to BPI of all
such tests and evaluations.
Phase 1 will be complete upon BPI's delivery to FMC of the last of the [DELETED]
fully functional Extracorporeal Therapy Needles ("Phase 1 Completion"). The
parties intend to achieve the goals of Phase 1 within six months after the date
of this Agreement.
ARTICLE IV. PHASE 2.
Section 4.1. Option. Upon Phase 1 Completion, FMC shall have
the right, at its sole discretion, by written notice to BPI, to exercise an
option to acquire the rights described in
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Section 5.2 of this Agreement. The decision concerning whether to exercise such
option and proceed with Phase 2 shall be made by FMC on or before 120 days after
Phase 1 Completion, and will determine the start of Phase 2. If BPI does not
receive written notice from FMC during this 120 day period exercising its
option, such option will expire.
Section 4.2. Assistance. BPI shall provide mutually agreed upon
reasonable and customary assistance to FMC in design, sourcing, engineering,
product configuration, etc. to enable FMC to set-up a production facility for
the Extracorporeal Therapy Needles for a period of one year following
commencement of Phase 2. FMC shall pay BPI for this assistance at the rate of
[DELETED] per hour for each worker involved plus [DELETED] of BPI's direct
incurred expenses. After such period, if further ongoing support is requested of
BPI by FMC, they will seek to negotiate a mutually acceptable program and
compensation rate.
Section 4.3. Components. BPI shall cooperate with FMC in its
component sourcing and make available to FMC a current list of supply/OEM
vendors who are currently, or could potentially, provide components necessary
for the manufacture of the Extracorporeal Therapy Needles.
ARTICLE V. INTELLECTUAL PROPERTY.
Section 5.1. Certain Definitions. For purposes of this Agreement:
(a) "Affiliate" means an entity in which FMC owns or controls at
least 51% of the voting interest.
(b) "BPI Improvements" means all improvements, enhancements,
modifications and variations of a Licensed Product, whether or not patented or
patentable, generated solely or jointly by BPI or an employee or employees of
BPI.
(c) "Commercial Launch" is the first anniversary of the exercise
by FMC of its option under Section 4.1.
(d) "Extracorporeal Circulation Therapy" means the diversion of
blood or other bodily fluids through a circuit located outside the body but
continuous with the bodily circulation. Current examples include renal
hemodialysis or peritoneal dialysis or other forms of liver or pancreatic
dialysis.
(e) "Extracorporeal Therapy Needles" are defined as medical-grade
metal needles, for Extracorporeal Circulation Therapy (of blood or other
fluids), having a diameter of 13 gauge through 18 gauge (as defined by the
American Society of Testing and Materials, Standard Specifications for Stainless
Steel Needle Tubing, A908-91 ((Reapproved 1998),Table 3, Sizes and Tolerances)
and shall specifically exclude the following:
(i) Needles for blood collection or transfusion sets, defined as
needles which are packaged, together with pre-attached tubing and bag or bags,
which are used
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for the collection or administration of donor blood from or to patients,
typically using a 16-gauge diameter needle, and
(ii) Introducer needles, defined as needles that are temporarily
inserted into a vein or artery specifically to provide a conduit for the
insertion of another device, such as IV catheters, peripherally inserted central
catheters or guidewires.
(f) "Field of Use" means the use of Extracorporeal Therapy
Needles for Extracorporeal Circulation Therapy.
(g) "FMC Improvements" means all improvements, enhancements,
modifications and variations of a Licensed Product, whether or not patented or
patentable, generated solely or jointly by FMC or an employee or employees of
FMC.
(h) "Joint Improvements" means all improvements, enhancements,
modifications and variations, of a Licensed Product, whether or not patented or
patentable, generated jointly by BPI and FMC or employees of both FMC and BPI.
(i) "Licensed Know-How" means current and future technology;
know-how; trade secrets; equipment and component plans, specifications and
prototypes; processes; methods of use; methods of manufacturing; production
information; marketing and sales information; and business plans -- in all cases
in connection with Extracorporeal Therapy Needles with blunting technology
utilized in the Field of Use.
(j) "Licensed Patents" means all current and future patents owned
or licensed by BPI related to Extracorporeal Therapy Needles with blunting
technology utilized in the Field of Use. A list of current United States patents
is attached as Exhibit A.
(k) "Licensed Products" means all Extracorporeal Therapy Needles
with blunting technology utilized in the Field of Use, which incorporate the
Licensed Technology.
(l) "Licensed Technology" means the Licensed Patents and the
Licensed Know-How.
(m) "Licensed Trademarks" means all current and future trademarks
and/or service marks owned or licensed by BPI and utilized in marketing Licensed
Products. A list of current marks registered in the United States Patent and
Trademark Office is attached as Exhibit B.
(n) "Minimum Royalty" means [DELETED] in Year 1, [DELETED] in
Year 2, [DELETED] in Year 3, [DELETED] in Year 4, [DELETED] in Year 5, and
[DELETED] in Year 6 and subsequent years.
(o) "Year 1" shall commence the first day of the first calendar
quarter following the Commercial Launch. "Year 2" shall commence one year after
the commencement
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of Year 1, "Year 3" two years after the commencement of Year 1, "Year 4" three
years after the commencement of Year 1, "Year 5" four years after the
commencement of Year 1 and "Year 6" five years after the commencement of Year 1.
Section 5.2. Grants of Licenses. Upon the exercise of the option
set forth in Section 4.1:
(a) BPI grants to FMC an exclusive, worldwide license under the
Licensed Patents, to manufacture, have manufactured, use, sell, have sold, or
offer for sale Licensed Products in the Field of Use in countries where the
Licensed Patents are effective, subject to the terms of this Agreement. BPI
specifically reserves to itself and excludes from this license grant all rights
outside of the Field of Use.
(b) BPI grants to FMC an exclusive, worldwide license to utilize
BPI's PUNCTUR-GUARD(R) trademark and the other Licensed Trademarks used in
connection with the Licensed Products in the marketing and sale of Licensed
Products in the Field of Use, subject to the terms of this Agreement. FMC will
use BPI's PUNCTUR-GUARD(R) trademark on the device packaging, advertising and
literature, unless BPI authorizes FMC to utilize another Licensed Trademark. The
manner of use of the trademark shall be submitted for approval by BPI in advance
of use to insure the legal use of the trademark; such approval shall not be
unreasonably withheld.
At least thirty days before selling any Licensed Products in a
country other than the United States of America, FMC will give BPI written
notice of its intent to do so in order that BPI may, at its sole discretion and
expense, pursue registration of the Licensed Trademarks in such country. The
trademark license granted herein will be extended to FMC to any foreign country
in which BPI applies for registration of the Licensed Trademarks, subject only
to the legal requirements of such foreign country to register and otherwise
protect the trademarks. FMC agrees, without charge or cost to BPI, to enter into
any registered user or like lawful agreement necessary or convenient in such
foreign country, and to make all lawful oaths and do all lawful acts reasonably
necessary to enable BPI to perfect its trademark rights in such foreign country.
If BPI elects not to pursue registration of the Licensed
Trademarks in such country, FMC shall have the right, but not the obligation, to
pursue such registration at FMC's cost. BPI agrees, without cost to FMC, to
enter into any registered user or like lawful agreement necessary or convenient
in such country, and to make all lawful oaths and do all lawful acts reasonably
necessary to enable FMC to perfect the trademark rights in such foreign country.
Title to any trademark application filed by FMC pursuant to this Section 5.2(b)
and to any related trademark shall be in BPI.
(c) BPI grants to FMC an exclusive, worldwide license to copy,
reproduce in any media and publicly display or perform, in connection with FMC's
marketing, sale and distribution of Licensed Products in accordance with this
Agreement, any and all copyrighted material pertaining to PUNCTUR-GUARD(R)
blunting technology and any other copyrighted material pertaining to the
Licensed Products, provided by BPI to FMC during the
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term of this Agreement. If FMC desires to modify, alter or prepare derivative
works from such materials, it shall present such modifications, alterations or
derivative works to BPI for its approval in advance of use or distribution for
any reason. FMC may not grant sublicenses to use BPI's copyrighted materials to
any third party, except that with BPI's consent (which may not be unreasonably
withheld). FMC may sublicense the copyrighted materials to subcontractors solely
for the purpose of assisting FMC to market and sell the Licensed Products
pursuant to this Agreement.
(d) BPI grants to FMC an exclusive, worldwide license under the
Licensed Know-How, to manufacture, have manufactured, use, sell, have sold, or
offer for sale Licensed Products in the Field of Use, subject to the terms of
this Agreement. BPI specifically reserves to itself and excludes from this
license grant (i) all rights outside of the Field of Use and (ii) the right to
use Licensed Know-How to manufacture, have manufactured, use, sell, have sold,
or offer for sale products other than Licensed Products in the Field of Use.
(e) FMC may not grant sublicenses to use any Licensed Technology
or Licensed Trademarks to any third party, except that with BPI's consent (which
may not be unreasonably withheld). FMC may disclose Licensed Technology to
subcontractors solely for the purpose of enabling such subcontractors to supply
to FMC such materials and services and manufactured parts necessary for FMC to
manufacture, market, sell or distribute Licensed Products. FMC shall obtain and
disclose to BPI written undertakings from each such subcontractor binding that
subcontractor to nondisclosure obligations at least as restrictive as those set
forth in Section 8.2 of this Agreement before FMC may directly or indirectly
disclose any Confidential Information to that subcontractor.
Section 5.3. Payments.
(a) In consideration of the grant of the licenses by BPI
hereunder, in addition to any license fees payable under Article II, FMC agrees
to pay royalties ("Royalties") to BPI in the amounts of: [DELETED] per Licensed
Product sold to an Affiliate and [DELETED] per Licensed Product sold to a party
that is not an Affiliate. For the purpose of the previous sentence, the term
"sold":
(i) includes, without limitation, the net transfer of devices to
parties that are not Affiliates (for example, independent hospitals,
distributors, group purchasing organizations, competitive dialysis centers) as
well as to Affiliates (for example, FMC dialysis centers);
(ii) does not include the sale or transfer of a Licensed Product
manufactured and transferred to an end user in a country where a Licensed Patent
has not been obtained; notwithstanding the foregoing, the Royalties in
connection with such sales or transfers (referred to in this Section 5.3(a)(ii))
shall be [DELETED] per Licensed Product sold to an Affiliate and [DELETED] per
Licensed Product sold to a party that is not an Affiliate; and
(iii) does not include devices transferred at no cost to the
receiving party and utilized for marketing; provided, however, that the number
of no-charge samples exempted from the royalty payments may not exceed [DELETED]
units in any year.
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(b) The Royalty payments shall be paid within thirty days
following the end of each calendar quarter. If the total of all quarterly
Royalty payments do not exceed the Minimum Royalty for a year, then the
difference shall be paid by FMC to BPI (subject to Section 5.3 (c)) within 60
days of the end of the year, including any Agreement extensions.
(c) In the event that FMC notifies BPI in writing that it will no
longer make the Minimum Royalty payments required above, then BPI may elect, by
written notice to FMC, in its discretion within twelve months after such
notification from FMC to amend such licenses to be worldwide, non-exclusive
licenses. While the licenses set forth in Section 5.2 remain in effect or are
amended pursuant to this Section 5.3(c), the payment obligations set forth in
Section 5.3(a) shall remain in effect.
(d) For the calculation of Royalties due under this Agreement,
any amount due to BPI for a sale of a Licensed Product shall be included in the
calculation of Royalties payable to BPI when invoiced by FMC, when payment for
the Licensed Product is actually received by FMC, or when shipped, whichever
shall first occur.
(e) The parties acknowledge and agree that a part of the value of
the license granted to FMC pursuant to this Agreement consists in the lead time
FMC shall gain with respect to its ability to manufacture and market the
Licensed Products compared to nonlicensed manufacturers of competing products,
and that the payments required by this Agreement are at least in part in
consideration for that gained lead time, the value of which may extend beyond a
time when the Licensed Technology or a portion thereof has entered into the
public domain.
(f) The parties acknowledge and agree that (i) each Licensed
Product will constitute a single product that may be composed using one or more
of the various elements of the Licensed Technology; (ii) to facilitate the
administration of the licenses and to allow for the maximum flexibility to FMC,
the various elements of the Licensed Technology, when practiced in a Licensed
Product, shall not be valued separately, but rather will be treated as an
indivisible entity; and (iii) so long as any element of the Licensed Technology
or Licensed Trademarks upon which a royalty may properly be paid is used in
connection with the Licensed Product, the royalties set forth in this Agreement
shall be payable, notwithstanding that at some time or in some territory a
royalty may not properly be paid on some portion (but not all) of the Licensed
Technology and Licensed Trademarks and the royalty shall not be deemed to have
been collected with respect to such portion of the Licensed Technology or
Licensed Trademarks (subject to Section 5.3(c)(i)).
(g) The use of Joint Improvements shall be royalty free to either
FMC or BPI. Both BPI and FMC must agree to any license that may be granted for
any patent jointly owned.
(h) If FMC obtains a patent pursuant to Section 5.5(a) and/or a
trademark pursuant to Section 5.2(b), FMC may credit all of FMC's expenses in
obtaining such patent and/or trademark against Royalties that would otherwise be
due on sales in the country in which the patent and/or trademark were obtained.
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(i) If a court determines that BPI owes FMC any amount under
Section 8.1(b), FMC may credit such amount against Royalties that would
otherwise be due; provided that such credit shall not exceed 50% of the
Royalties due BPI in any year except to the extent that the indebtedness is
based on Section 8.1(b)(v), in which case FMC may credit such amount against
100% of the Royalties due BPI in any given year. The balance of any indebtedness
under Section 8.1(b) after giving effect to the foregoing set-off rights in a
given year may be carried forward to be set-off against Royalties due BPI in
future years in accordance with this Section 5.3(i) until the indebtedness is
satisfied.
(j) FMC's obligation to pay Royalties with respect to the sale of
a Licensed Product shall terminate upon expiration of the last to expire issued
patent included in the Licensed Patents covering such Licensed Product.
Thereafter, FMC and sublicensees shall have a paid-up, non-exclusive,
royalty-free license to manufacture, have manufactured, use, sell, have sold, or
offer for sale such Licensed Product.
(k) Any sum required under United States tax laws, or the tax
laws of any other country, to be withheld by FMC from Royalties shall be
promptly paid by FMC to the appropriate tax authorities, and FMC shall furnish
BPI with official tax receipts or other appropriate evidence issued by the
appropriate tax authorities sufficient to enable BPI to support a claim for
income tax credit in respect to any sum so withheld.
Section 5.4. Reports; Records.
(a) FMC shall, at all times during the term of this Agreement in
which Royalties are accruing, cause true and accurate books of account and
records of all manufacture, uses and sales of Licensed Products, to be kept in
such detail as to enable BPI to ascertain whether Royalties reported and paid
hereunder are accurate. All such books and records shall be open to inspection
and audit by a duly authorized representative of BPI acceptable to FMC upon
reasonable notice and during regular business hours, upon executing an
appropriate confidentiality agreement, for the sole purpose of verifying the
Royalties payable as provided for in this Agreement for the two preceding years;
provided, however, that no more that one such inspection and/or audit shall be
permitted during any calendar year, and FMC shall disclose to BPI only
information relating solely to the accuracy of the Royalty report and the
Royalty payments made in accordance with this Agreement.
(b) FMC shall render written reports to BPI within thirty days
following each twelve-month period in which Royalties are due hereunder, showing
the amount of Royalties due thereon and all information used to make the Royalty
calculation.
Section 5.5. Prosecution and Ownership of Patents and
Improvements.
(a) BPI owns all rights to the Licensed Technology, including all
drawings, specifications, models and all other materials used in the development
of the Extracorporeal Therapy Needles, and all BPI Improvements regardless of
whether or not BPI chooses to apply for a United States or foreign patent or
other protection.
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If BPI elects not to apply for a United States or foreign patent
protection relating to the Licensed Technology or BPI Improvements, FMC shall
have the right, but not the obligation, to file applications for such protection
at FMC's cost. BPI agrees, without cost to FMC, to execute such documents and do
all lawful acts reasonably necessary to enable FMC to perfect any such
applications and obtain issuance of patents thereon. Title to any patent
application filed by FMC pursuant to this Section 5.5(a) and to any patent which
issues thereon shall initially be in FMC. If and when the expenses of FMC in
connection with such applications are all credited against Royalties pursuant to
Section 5.3(h), FMC shall assign any such patent to BPI at no cost to BPI. In
addition, if BPI elects, in its sole discretion, to pay FMC the out-of-pocket
costs incurred by FMC in connection with FMC's obtaining a patent on a BPI
Improvement, less any amount of such costs previously credited pursuant to
Section 5.3(h), FMC shall assign any such patent to BPI.
Notwithstanding the foregoing, if FMC has furnished a notice
pursuant to Section 5.3(c) or, beginning in Year 2, if FMC has not paid or been
credited with all Minimum Royalties that have become due for previous years, FMC
shall not have any rights under this Section 5.5(a).
(b) FMC shall own all rights in and to any FMC Improvements.
(c) FMC shall have the sole discretion to decide whether or not
to pursue patent protection for any FMC Improvement.
(d) FMC and BPI shall jointly own and pursue patent protection
for any Joint Improvement, except as provided in this Section 5.5(d). The
out-of-pocket costs of obtaining any joint patent shall be shared equally,
unless a party elects by written notice to the other to bear a specified
percentage of the out-of-pocket costs (less than 50% but more than 20%), in
which case such electing party shall receive such specified percentage of the
benefits of the joint patent. If one party chooses not to apply for a United
States or foreign patent or other protection in respect of any Joint
Improvement, the other party shall be entitled to file a patent application or
patent applications for such protection at its sole cost. Both parties agree to
execute such documents as are required to perfect any such patent applications
and obtain issuance of patents thereon. Title to any patent application paid for
by one party and to any patent which issues thereon shall be in the paying
party.
(e) BPI shall not institute a suit or join as a co-plaintiff any
suit alleging that FMC's actions in compliance with this Agreement constitute
patent infringement of the Licensed Patents.
Section 5.6. Ownership of Approvals. Except for the Licensed
Patents and the Licensed Trademarks and except as otherwise provided in this
Agreement, FMC or its authorized designees shall own the full right, title, and
interest in and to any government approvals, associated government files or
licenses related to making, using and selling Licensed Products in the Field of
Use to the full extent possible under the law of each appropriate country.
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Section 5.7. Infringement by Third Parties.
(a) BPI may assert claims of infringement of and to enforce the
Licensed Patents and Licensed Trademarks against any third party infringer or
alleged infringer or misappropriator, including the right to bring actions in
equity or in law in its name at BPI's sole expense, through counsel of its
choice, but has no obligation to do so. FMC agrees to cooperate fully in any
such action. Any recovery of money by judgment or settlement in connection with
such claims shall be paid to BPI. BPI may not grant licenses in the Licensed
Technology and Licensed Trademarks that would interfere with or impair the
rights provided by this Agreement to any such third party in settlement of any
claim of infringement.
(b) If FMC reasonably believes that a third party's actions
infringe on the Licensed Technology or Licensed Trademarks in a manner that
jeopardizes FMC's exclusive license rights in the Field of Use, the parties are
required to confer in good faith about the perceived infringement. If BPI elects
not to seek an injunction or other appropriate remedy, FMC shall have the right,
but not the obligation, to assert claims of infringement of and to enforce the
Licensed Technology and Licensed Trademarks against any such third party
infringer or alleged infringer, including the right to bring actions in equity
or in law, and the right to appeal adverse decisions regarding infringement,
validity or enforceability of the Licensed Technology or Licensed Trademarks
through counsel of its own choice, at its own expense. BPI agrees to cooperate
fully in any such action.
Any recovery of money by judgment or settlement in connection
with such claims shall be paid to FMC.
If BPI and FMC jointly participate in asserting claims of
infringement of and enforcing the Licensed Technology or Licensed Trademarks,
BPI and FMC shall each pay one-half of the out-of-pocket costs involved, unless
a party elects by written notice to the other to bear a specified percentage of
the out-of-pocket costs (less than 50% but more than 20%). Any recovery of money
by judgment or settlement in connection with such claims shall be divided
equally between BPI and FMC, unless an election is made pursuant to the previous
sentence, in which case the electing party shall receive such specified
percentage of any such recovery.
(c) Each party shall notify the other party in writing within
thirty days after the date of its first knowledge of any activities of
infringement or misappropriation of a Licensed Patent or Licensed Trademark by a
third party.
(d) FMC agrees to xxxx all labels for Licensed Products with the
applicable numbers of the Licensed Patents in the manner required by law to give
notice to potential infringers of the patent status of the Licensed Products.
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Section 5.8. Preservation of Intellectual Property.
(a) BPI shall use commercially reasonable efforts to preserve
each Licensed Patent by timely paying all fees and filing all papers required to
maintain the Licensed Patent in force in the country which issued the Licensed
Patent.
(b) BPI shall use commercially reasonable efforts to preserve
each Licensed Trademark by timely paying all fees and filing all papers required
to maintain the registration of any Licensed Trademark in force in the country
which issued the registration.
Section 5.9. Certain Agreements Concerning Trademarks. In order
to insure the integrity of and avoid misuse of the Licensed Trademarks, the
parties agree as follows:
(a) BPI and FMC shall jointly approve in writing the product
specifications ("Product Specifications") defining the performance requirements
of the Licensed Products, and all significant revisions thereto, and such
approval shall be a condition precedent to FMC's sale or offer to sell any
Licensed Products under the Licensed Trademarks.
(b) FMC shall manufacture and have manufactured the Licensed
Products in conformity, in all material respects, with Section 501 of the Food,
Drug, and Cosmetic Act and all applicable standards adopted or promulgated under
such Section 501 and shall manufacture or have manufactured the Licensed
Products in conformity, in all material respects, with all state and foreign
laws and regulations requiring medical devices such as the Licensed Products
which are manufactured or sold in the applicable jurisdiction to be safe for use
as manufactured (collectively, the "Standards"). If FMC breaches the first
sentence of this Section 5.9(b) and does not cure a breach within the time
allowed by applicable laws and governmental rules and regulations after such
notice, or within 90 days after such notice, whichever time is greater, BPI
shall have the right to terminate this Agreement. Within the time allowed by
applicable laws and governmental rules and regulations after a notice of a
breach of the Standards, FMC shall cease distributing or selling Licensed
Products unless and until both parties mutually determine that those Licensed
Products would not cause a breach of the Standards. In addition, if the breach
is a direct result of the marketing or advertising of the Licensed Products,
then within the time allowed by applicable laws and governmental rules and
regulations after such notice, FMC shall cease marketing or advertising Licensed
Products unless and until both parties mutually determine that those Licensed
Products would not cause a breach of the Standards.
(c) BPI shall have the right to review and inspect, at a
reasonable time and with reasonable notice, Licensed Products and those elements
of FMC's production operations pertaining to the manufacture of the Licensed
Products in order to ascertain that the Product Specifications of the Licensed
Products acceptable to BPI are maintained. If BPI determines in its reasonable
judgment that the Product Specifications are not being materially maintained,
BPI shall provide the particulars of the material defect or defects in writing
to FMC. BPI shall have the right to terminate this Agreement 90 days after BPI
furnishes such written notice to FMC, if FMC does not cure the defect or defects
during such 90 days. Notwithstanding the foregoing, within a reasonable time
after such notice, FMC shall cease distributing or selling
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Licensed Products unless and until both parties mutually determine that those
Licensed Products would not cause a breach of this Section 5.9(c). In addition,
if the breach is a direct result of the marketing or advertising of the Licensed
Products, then within a reasonable time after such notice, FMC shall cease
marketing or advertising Licensed Products unless and until both parties
mutually determine that those Licensed Products would not cause a breach of this
Section 5.9(c).
ARTICLE VI. CERTAIN REPRESENTATIONS, WARRANTIES AND AGREEMENTS.
Section 6.1. Both Parties. Each of the parties hereto represents
and warrants to the other as follows:
(a) Such party is a corporation validly existing and in good
standing under the laws of the jurisdiction of its incorporation and has the
full corporate power and authority to enter into and perform this Agreement.
(b) The execution, delivery, and performance of this Agreement by
such party have been duly authorized by all necessary corporate action on the
part of such party, and this Agreement constitutes the valid and binding
obligation of such party, enforceable against it in accordance with its terms,
except to the extent enforceability may be limited by bankruptcy, insolvency,
reorganization, moratorium, or other similar laws affecting the enforcement of
creditors' rights in general and subject to general principles of equity
(regardless of whether enforceability is considered in a proceeding at law or in
equity).
(c) The execution, delivery, and performance of this Agreement by
such party will not: (i) violate or conflict with the certificate of
incorporation or by-laws of such party; (ii) conflict with, or result in the
breach, termination or acceleration of, or constitute a default under, any
material lease, agreement, commitment, or other instrument to which such party
is a party or by which it or its properties are bound; or (iii) to the best
knowledge of such party, constitute a violation of any law, regulation, order,
writ, judgment, injunction or decree applicable to such party or any of its
properties, or require any governmental consent or approval, other than the
approval of the Food and Drug Administration and similar agencies in foreign
countries.
(d) There is no judicial or administrative action, proceeding or
investigation pending or, to the best knowledge of such party, threatened that
questions the validity of this Agreement or of any action taken or to be taken
by such party in connection with this Agreement. There is no litigation,
proceeding or governmental investigation pending or, to the best knowledge of
such party, threatened, or any order, injunction or decree outstanding against
such party that, if adversely determined, would have a materially adverse effect
upon such party's ability to perform its obligations hereunder.
(e) No broker or finder has, as a representative of such party,
been employed by such party in connection with this Agreement.
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Section 6.2. BPI. BPI represents, warrants and agrees as follows:
(a) Upon issuance of shares pursuant to this Agreement, they will
be validly issued, fully paid and non-assessable. BPI has received all approvals
and consents required for the issuance of [DELETED] shares of Common Stock
pursuant to this Agreement.
(b) Appaloosa Management, L.P., as collateral agent ("Appaloosa")
has a perfected first priority security interest in and to, among other things,
the Licensed Technology, the Licensed Trademarks and all copyprightable
materials held or owned by BPI.
(c) Subject to Section 6.2(b), BPI is the owner of the entire
right, title and interest in the Licensed Patents and the inventions disclosed
therein. BPI has no knowledge of any information that would render a Licensed
Patent invalid or unenforceable. The practice of the inventions disclosed or
claimed in the Licensed Patents does not infringe or misappropriate any third
party rights, including copyrights, patent rights and trade secret rights.
(d) Subject to Section 6.2(b), BPI is the owner of the entire
right, title and interest in the Licensed Trademarks. BPI has no knowledge of
any information that would render a Licensed Trademark invalid or unenforceable.
The use of the marks disclosed or claimed in the Licensed Trademarks does not
infringe or misappropriate any third party rights, including copyrights and
trademark rights.
(e) Subject to Section 6.2(b), BPI is the owner of the entire
right, title and interest in the copyrights for all copyrightable material
provided to FMC. BPI has no knowledge of any information that would render any
such copyright invalid or unenforceable. The copyrightable material does not
infringe or misappropriate any third party rights, including copyrights, patent
rights and trade secret rights.
(f) Subject to Section 6.2(b), BPI is the owner of the entire
right, title and interest in the Licensed Know-How provided to FMC. The Licensed
Know-How does not infringe or misappropriate any third party rights, including
copyrights, patent rights and trade secret rights.
(g) Subject to Section 6.2(b), BPI and its employees have entered
into agreements wherein its employees have agreed to assign their rights in and
to all inventions, resulting from their employment with BPI to BPI. BPI has
caused or will cause all additional BPI employees performing work pursuant to
this Agreement to execute similar agreements with respect to the rights in and
to all inventions, as well as patents and patent applications directed to such
inventions, resulting from their association with BPI. BPI will enforce such
agreements to ensure that BPI has perfected its title to the Licensed Know-How.
(h) Subject to Section 6.2(b), the execution, delivery and
performance by FMC of this Agreement will not conflict with, or result in the
breach, termination or acceleration of, or constitute a default under, any
development, license, distribution or other similar agreement related to
PUNCTUR-GUARD(R) technology to which BPI is a party or by which it or its
properties are bound.
Section 6.3. Appaloosa.
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(a) Notwithstanding anything to the contrary contained herein,
FMC recognizes, acknowledges and agrees that pursuant to that certain Security
Agreement (the "Security Agreement") dated April 28, 2000, among BPI and
Appaloosa, and the other Transaction Documents (as such term is defined in that
certain Convertible Note Purchase Agreement as of April 28, 2000 among the
Company, the purchasers named therein and Appaloosa (the "Note Purchase
Agreement")), Appaloosa has a perfected first priority security interest in and
to, among other things, the Licensed Technology, the Licensed Trademarks and all
copyrightable material provided or to be provided to FMC hereunder.
(b) Appaloosa represents, acknowledges and agrees that, as of the
date of this Agreement, it has not received any written notice from BPI or any
other Person (as such term is defined in the Note Purchase Agreement) of the
occurrence of any Default (as such term is defined in the Note Purchase
Agreement) or Event of Default (as such term is defined in the Note Purchase
Agreement) under the Transaction Documents.
(c) Appaloosa acknowledges and agrees that the exercise of its
rights, powers and privileges pursuant to the Security Agreement shall not
result in the termination of this Agreement or disturb FMC's possession or use
of the Licensed Technology, the Licensed Trademarks and/or any copyrightable
material provided to it, in each case in accordance with the terms hereof;
provided that the foregoing shall not act to impair, diminish or affect the
rights of BPI to enforce any obligation of FMC hereunder or to take such action
as is available to BPI hereunder or under applicable law by reason of any
default or breach hereunder by FMC beyond the applicable periods of notice,
grace and cure provided for herein.
(d) To the extent that BPI is entitled to enforce any claim or
remedy against FMC or any other Person (as such term is defined in the Note
Purchase Agreement) in connection with this Agreement, the parties hereto agree
that, to the extent that BPI fails to enforce vigorously any such claim or
remedy, Appaloosa shall be subrogated to the rights of BPI against FMC or any
other Person (as such term is defined in the Note Purchase Agreement) with
respect to such claim or remedy.
ARTICLE VII. TERM AND TERMINATION.
Section 7.1. Termination. If Phase 1 is not completed within
twelve months after the date of this Agreement, unless the delay is caused by
FMC, FMC may, at its sole discretion, by notice to BPI, terminate this
Agreement, except for the provisions of Sections 8.1 and 8.2. If the option
provided in Section 4.1 is not exercised within the period set forth in Section
4.1, this Agreement shall terminate, except for the provisions of Sections 8.1
and 8.2. If such option is exercised, this Agreement shall terminate on the
seventh anniversary of the date of exercise of such option, unless extended by
written notice from FMC to BPI more than thirty days prior to the expiration of
the then current term of this Agreement. Each such extension shall be for a
period of one year and no more than three extensions may be elected by FMC
pursuant to such a notice. After a third extension, any additional extension
must be pursuant to the written agreement of FMC and BPI. If the option provided
in Section 4.1 is exercised, upon
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termination of this Agreement, Sections 5.4, 5.5, 5.6, 5.7 (as to litigation
commenced prior to such termination), 8.1 and 8.2 shall remain in effect.
Section 7.2. Default. Upon a breach of this Agreement by a
party, the other party, in addition to exercising all available remedies, may
terminate this Agreement on 90 days' notice to the breaching party. Such notice
shall be effective at the end of such period unless during such period the
breach is cured.
Section 7.3. Effect of Termination. Upon termination of this
Agreement, any license granted by BPI to FMC shall terminate and FMC shall cease
to make, sell and use the Licensed Products using the Licensed Technology and
Licensed Trademarks. FMC's obligation to pay Royalties under Section 5.3
relating to Licensed Products sold prior to termination shall remain in effect
after termination of this Agreement. Upon such termination, each party shall
immediately return or destroy all copies of Confidential Information of the
other party on any media. If a party destroys Confidential Information, such
party shall deliver a written certification of such destruction to the other
party. Upon termination, FMC and BPI shall be relieved of all obligations under
this Agreement, except as specifically provided in this Section and Section 7.1.
ARTICLE VIII. GENERAL.
Section 8.1. Indemnification.
(a) Except to the extent arising from any breach by BPI of its
obligations to FMC under this Agreement, or any action or omission by BPI or any
of its agents, employees, representatives, successors or assigns, FMC shall
indemnify and hold harmless BPI against any and all costs, claims (including,
without limitation, claims of product liability), damages (but excluding
consequential damages), liabilities, litigation, fees and expenses (including,
without limitation, reasonable attorneys' fees and expenses) arising from (i)
any breach by FMC of any obligation or representation and warranty contained in
this Agreement, (ii) all claims alleging defects in design, material or
workmanship of, or arising from injury to persons or property caused by Licensed
Products developed, manufactured, marketed, sold or distributed by or on behalf
of FMC, except to the extent that such claims arise from the Licensed
Technology, (iii) any third party's claim of infringement of any patent or any
other proprietary rights arising from the development, manufacture, marketing,
sale or distribution of Licensed Products by or on behalf of FMC, except to the
extent that such claims arise from the Licensed Technology, or (iv) any
negligent or willful action or omission of FMC or any of its agents, employees,
representatives, successors or assigns in connection with the Extracorporeal
Therapy Needles.
Furthermore, FMC agrees to immediately assume the handling,
adjustment, and defense of any claim, allegation, petition, suit or action
covered by this Section 8.1(a); and BPI, without waiving any of its rights under
this Agreement, specifically reserves the right to participate, at its own
expense, in the handling, adjustment, and defense of any such claim, allegation,
petition, suit or action. BPI agrees to cooperate fully in any such action. BPI
may elect to retain its own counsel, at its expense.
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(b) Except to the extent arising from any breach by FMC of its
obligations to BPI under this Agreement, or any action or omission by FMC or any
of its agents, employees, representatives, successors or assigns, BPI shall
indemnify and hold harmless FMC against any and all costs, claims (including,
without limitation, claims of product liability), damages (but excluding
consequential damages), liabilities, litigation, fees and expenses (including,
without limitation, reasonable attorneys' fees and expenses) arising from (i)
any breach by BPI of any obligation or representation and warranty contained in
this Agreement, (ii) any injury to persons or property allegedly caused by BPI's
intentional misconduct or negligence related to Extracorporeal Therapy Needles
manufactured and sold by BPI before the commencement of Xxxxx 0, (xxx) any third
party's claim of infringement of any patent or any other proprietary rights
arising from the Licensed Technology or Licensed Trademarks, (iv) any negligent
or willful action or omission of BPI or any of its agents, employees,
representatives, successors or assigns in connection with the Extracorporeal
Therapy Needles, or (v) any breach of any agreement to which BPI is a party
which may grant rights relating to Extracorporeal Therapy Needles, unless the
breach results from actions of FMC in breach of this Agreement.
Furthermore, BPI agrees to immediately assume the handling,
adjustment, and defense of any claim, allegation, petition, suit, or action
covered by this Section 8.1(b); and FMC, without waiving any of its rights under
this Agreement, specifically reserves the right to participate, at its own
expense, in the handling, adjustment and defense of any such claim, allegation,
petition, suit or action. FMC agrees to cooperate fully in any such action. FMC
may elect to retain its own counsel, at its expense.
(c) No settlement of a claim, allegation, petition, suit or
action subject to this Section 8.1 shall be entered into without the prior
consent of the indemnifying party.
Section 8.2. Confidentiality.
(a) Confidential Information includes, but is not limited to,
technology; know-how; trade secrets; equipment; equipment and component plans,
specifications and prototypes; processes; methods of use; methods of
manufacturing; trademarks; assets and production information; marketing and
sales information; and business plans -- in all cases, related to a party
communicated to, supplied to or observed by the other party.
(b) Each party shall use at least the same degree of care, but no
less than a reasonable degree of care, to avoid unauthorized disclosure or use
of the other party's Confidential Information as it employs with respect to its
own Confidential Information of like importance.
(c) Neither party has any obligation with respect to any
Confidential Information which (i) was previously known by such party without
obligations of confidentiality; (ii) that party independently develops; (iii) is
or becomes publicly available without a breach of this Agreement by either
party; or (iv) is disclosed to it by a third person who is not required to
maintain its confidentiality. The party claiming any of the above exceptions has
the burden of proving its applicability.
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(d) Each party may disclose Confidential Information only to its
own officers, directors and employees and to its consultants and advisors who
reasonably need to know it. Each party, shall be responsible to the other for
any violation of this Agreement by its own officers, directors, employees,
consultants or advisors.
(e) Neither party may print or copy, in whole or in part, any
documents or other media containing any Confidential Information without the
prior written consent of the other party, other than copies for its officers,
directors, employees, consultants or advisors who are working on the matter
involved. Neither party may remove or deface any notice of copyright, trademark,
logo or other proprietary notice of the other party appearing on any original or
copy of the other's Confidential Information.
(f) Neither party may use the other party's Confidential
Information for competing with the other party or for any purpose not in
furtherance of the terms of this Agreement.
(g) Each party's Confidential Information shall remain its own
property. Upon the request of the other party, each party shall return all of
the other's Confidential Information, or destroy it and provide the other party
with written certification of such destruction, except for archival and backup
copies that are not readily available for use and business records required by
law to be retained.
(h) If either party becomes legally obligated to disclose any of
the other party's Confidential Information, the party subject to the obligation
shall notify the other party in writing promptly and shall cooperate with the
other party at the other party's expense in seeking a protective order or other
appropriate remedy.
(i) Each party agrees that in the event of a breach or threatened
breach by either party, including its officers, directors, employees,
consultants or advisors, of this Section 8.2, the non-breaching party will have
no adequate remedy in money damages and, accordingly, shall be entitled to seek
an injunction against such breach, in addition to any other legal or equitable
remedies available to it.
(j) If any Confidential Information originating in the United
States is authorized by this Agreement to be disclosed outside the United
States, the receiving party agrees to ensure that it or any materials derived
from it are not disclosed or communicated to any individual or entity in any
country to which the export of such information is prohibited by U.S. export
laws or regulations.
Section 8.3. Right of Last Opportunity. During the term of this
Agreement (as extended pursuant to Section 7.1), if BPI desires to enter into a
contract (the "Contract") relating to manufacture, use, sale, or offer for sale
of products that compete with Licensed Products, BPI shall negotiate all the
terms of the Contract with a person or entity (the "Third Party") and FMC will
have thirty days from the date it receives the Contract (or such other period of
time agreed to by the parties) to notify BPI in writing that it will enter into
the Contract, with such changes as may be negotiated between FMC and BPI in such
thirty-day period. If FMC does not elect to enter into the Contract, with any
such changes in such thirty-day period, BPI shall have the right
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to enter into the Contract (with no changes) with the Third Party within ten
days after such thirty-day period. If BPI does not enter into the Contract with
the Third Party in such ten-day period, any future Contracts shall be subject to
the terms of this Section 8.3.
Notwithstanding the foregoing, if FMC has furnished a notice
pursuant to Section 5.3(c) or, beginning in Year 2, if FMC has not paid or been
credited with all Minimum Royalties that have become due for previous years, FMC
shall not have any rights under this Section 8.3.
Section 8.4. Expenses. Unless otherwise agreed to by the parties,
and unless otherwise provided in this Agreement, each party shall bear its own
fees and expenses incurred with the transactions contemplated by this Agreement.
Section 8.5. Assignment. This Agreement shall inure to the
benefit of the parties and their respective successors and assigns; provided
that no party may assign its rights or obligations hereunder without the prior
consent of the other party. Notwithstanding the foregoing, FMC may assign its
rights and obligations to an Affiliate without the consent of BPI, provided that
such assignment shall not diminish the value to BPI of the transactions
contemplated herein.
Section 8.6. Entire Agreement. This Agreement constitutes the
entire agreement and understanding of the parties concerning the subject matter
hereof, and supersedes any other agreements or understandings, whether oral or
in writing.
Section 8.7. Governing Law. This Agreement shall be governed by
and construed in accordance with laws of the State of Connecticut, without
giving effect to any choice of law rule.
Section 8.8. Amendments; Waivers. This Agreement may not be
amended in any manner except by an instrument in writing signed by a duly
authorized representative of each of the parties. A waiver shall be effective
against a party only if it is in a writing signed by such party.
Section 8.9. No Waiver. No failure to exercise or delay in
exercising any right or remedy under this Agreement by either party shall
operate as a waiver thereof or of any right or remedy which such party may have
hereunder, nor shall any single or partial exercise of any such right or remedy
preclude any further exercise thereof or any right or remedy which such party
may have hereunder.
Section 8.10. Severability. If any provision or any portion of
any provision of this Agreement is adjudged to be invalid, illegal or
unenforceable, such provision or portion shall be deemed to be deleted from this
Agreement and the validity of the remainder of this Agreement shall remain
unaffected thereby.
Section 8.11. Notices. All notices or other communications
required or permitted to be furnished hereunder shall be delivered or sent by
overnight delivery service, postage prepaid, or facsimile to the other party at
its address set forth below or to such other
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address as may from time to time be furnished by a party to the other in
accordance with this Section 8.11:
(a) If to BPI:
President
Bio-Plexus, Inc.
000 Xxxxxxxxx Xxxx
Xxxxxx, XX 00000
and to:
Xxxxx Xxxxxx, Esq.
Paul, Hastings, Xxxxxxxx & Xxxxxx LLP
0000 Xxxxxxxxxx Xxxxxxxxx
Xxxxx Xxxxx
Xxxxxxxx, XX 00000-0000
(b) If to FMC:
Vice President, Strategic Business Development
Renal Products and Laboratory Services Group
Fresenius Medical Care, NA
00 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
and to:
General Counsel
Fresenius Medical Care, NA
00 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Section 8.12. Headings. The headings of this Agreement are
inserted for convenience of reference only and shall not affect the construction
or interpretation hereof.
Section 8.13. Survival. All representations and warranties
contained in this Agreement shall survive the execution and delivery of this
Agreement and the consummation of the transactions contemplated hereby,
regardless of any investigation made by any party.
Section 8.14. Counterparts. This Agreement may be executed
simultaneously in two or more counterparts, which need not contain signatures of
more than one party, but all such counterparts, taken together, shall constitute
one and the same Agreement.
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Section 8.15. Use of Name. Neither party shall employ or use the
name of the other party in any promotional materials or advertising without the
prior written permission of the other party.
Section 8.16. Nature of Relationship. Neither party is an agent,
joint venturer or partner of the other party.
Section 8.17. Force Majeure. Neither party shall be liable under
this Agreement for any failure of, or interruption or delay in, performance of a
provision of this Agreement to the extent that such failure, interruption or
delay is caused by Force Majeure. The party claiming any such failure,
interruption or delay shall promptly notify the other party of such failure,
interruption or delay. "Force Majeure" means:
(a) Any act of God, war, riot, fire, rupture, flood, strike,
injunction or governmental action or order,
(b) Any lockout or any other labor disturbance, or
(d) Any shortage or unavailability of any materials, supplies
or energy or unscheduled outage, or shut-down or other cause which is beyond the
reasonable control of the party relying on this Section 8.17.
Section 8.18. Adjustments. If there is any change in the
number of outstanding shares of Common Stock resulting from a stock dividend or
distribution, stock split, reverse stock split, recapitalization, exchange of
shares, merger, consolidation or reorganization, the number of shares issuable
under Section 2.2 shall be appropriately adjusted.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives as of the day and year first
above written.
BIO-PLEXUS, INC.
By: /s/ Xxxx X. Xxxx
______________________________
Xxxx X. Xxxx
President and CEO
FRESENIUS MEDICAL CARE HOLDINGS, INC.
By: /s/ Xxxxxx X. Xxxxxx, Xx.
_____________________________
Xxxxxx X. Xxxxxx, Xx.
President
Renal Products
Acknowledged and Sections 6.3(b) and 6.3(c) agreed to:
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APPALOOSA MANAGEMENT, L.P.,
as collateral agent
By: /s/ Xxxxx X. Xxxxx
__________________________________
Xxxxx X. Xxxxx
Vice President & Secretary
EXHIBIT A
UNITED STATES PATENTS
XXX. NO. TITLE
5,951,520 Self-blunting needle medical devices and methods of manufacture
thereof
4,828,547 Self-blunting needle assembly and device including the same
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00
XXXXXXX X
XXXXXX XXXXXX
REGISTERED TRADEMARKS
XXXX REGISTRATION NO.
BIO-PLEXUS 2033996
PUNCTUR-GUARD 1776391
DROP-IT 2025696
N/A (Design Only) 2136254
SAFEGUARDING THE FUTURE 2136255
OF HEALTHCARE WORKERS
UNITED STATES
TRADEMARK APPLICATIONS
XXXX SERIAL NO.
PUNCTUR-GUARD REVOLUTION 75721017
