***CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTION.
DEVELOPMENT AND SUPPLY
AGREEMENT
THIS AGREEMENT is between Medical Components,
Inc. a Pennsylvania corporation, located at 1499 Delp Drive,
Harleysville, PA 19438 (“Medcomp”) and VeriChip
Corporation, a Delaware corporation, located at 1690 South Congress
Avenue, Suite 200, Delray, FL 33445
(“VeriChip”).
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A.
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Medcomp is engaged in the
development, manufacture and sale of various medical devices,
including venous catheters and infusion ports.
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B.
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The
parties have agreed that VeriChip will seek development and
manufacture of an 8mm RFID Microchip similar to its current 12mm
RFID Microchip, as described on Exhibit A (the
“Product”) for sale to Medcomp in accordance with the
specifications, delivery schedules and other requirements
referenced in this Agreement.
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C.
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Medcomp wishes to purchase the
Product from VeriChip for implantation into Medcomp’s
vascular access product lines.
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D.
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The
parties now desire to enter into an arrangement whereby VeriChip
will develop, manufacture and sell the Product and Medcomp will buy
the Product for implantation into vascular access medical devices
on an exclusive basis.
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NOW, THEREFORE, intending to be legally bound, the parties
hereto agree as follows:
ARTICLE IA — DEVELOPMENT OF
THE PRODUCT
Section 1A.01 Development
Efforts. Medcomp and
VeriChip acknowledge that they will cooperate in the development of
the Product and agree that all prior and future joint development
efforts with respect to the Product shall be governed by the terms
of this Agreement. Medcomp and VeriChip agree that, during the term
of this Agreement, they will cooperate and expend reasonable
efforts to jointly develop the Product in a manner which permits
the effective use of the Product. Such joint development efforts
may include testing, development of prototypes, development and/or
refinement of specifications for the Product (the
“Specifications”) manufacturing processes and other
research efforts. Medcomp shall be responsible for obtaining any
necessary regulatory approvals for use of the Product. Medcomp and
VeriChip agree to jointly conduct studies, tests, research and
other procedures designed to develop the Product and improve the
Product. Each party shall assist and coordinate with the other,
make its technical personnel and facilities required to perform
such research and development available to the other and use its
best efforts to successfully complete the development of the
Product.
*** CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTION.
Section 1A.02 Development Plan.
As soon as possible following the
signing of this Agreement, VeriChip will begin development of the
Product. VeriChip shall provide Medcomp with a complete and
operational prototype of the Product as well as the design history
file for the prototype of the Product within ninety (90) days
of the commencement of this Agreement. If VeriChip fails to meet
this ninety (90) day deadline, Medcomp may terminate this
Agreement provided however, that the ninety (90) day deadline
may be extended by written agreement.
Section 1A.03 Development Costs and
Expenses. Subject to
Section 1A.07, each party shall be responsible for payment of
all of its own direct costs and expenses for personnel and
facilities relating to the development of the prototype and the
Product.
Section 1A.04 Specifications and Standards
for the Product. Upon
completion of the development of the prototype of the Product, such
that the parties agree the same is feasible for manufacture and
sale, they shall discuss and agree upon the Specifications. The
Specifications shall, when adopted, be consistent with
Exhibit A, be reduced to writing, be signed by authorized
individuals from Medcomp and VeriChip, and by reference be
incorporated herein provided, however, that the Specifications may
be amended at any time by the written agreement of the
parties.
Section 1A.05 Property Rights.
Medcomp acknowledges and agrees that
VeriChip owns and/or has the right to use and shall retain all of
the right, title and interest in and to all of the patents,
trademarks, trade names, inventions, copyrights, know-how, trade
secrets and other intellectual property rights relating to the
design, assembly, manufacture, operation and/or service of its RFID
Microchips and the Product. The use by Medcomp of any of these
property rights is authorized only for the purposes set forth in
this Agreement and upon expiration of termination of this Agreement
for any reason such authorization shall cease.
Section 1A.06 Product Development
Fee. Medcomp will pay
VeriChip a fee to cover its costs relating to completion of the
development of the Product in an agreed amount of ***. Medcomp will
make this payment in two equal installments of *** each, with the
first installment due within ten (10) days of the commencement
of this Agreement and the second installment due within forty (40)
days of the commencement of this Agreement. Should VeriChip fail to
meet the ninety (90) day deadline set forth in
Section 1A.02 above, or such extended deadline as is agreed to
by the parties, and Medcomp terminates this Agreement as a result,
VeriChip shall, within ten (10) days of the termination of
this Agreement, repay to Medcomp the Product development fee set
forth above.
Section 1A.07 Tooling.
All tooling unique to the production
of the Product (the “Tooling”) shall be the sole
property of VeriChip. VeriChip shall be responsible for the routine
maintenance and repairs of the Tooling.
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*** CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTION.
ARTICLE I. SUPPLY OF
PRODUCTS
Section 1.01 Supply of
Product.
(a) VeriChip agrees to sell the Product
exclusively to Medcomp during the Term of this Agreement, and
agrees that it shall not manufacture or sell the Product, or any
product using or incorporating the same, or substantially similar
technology, to any other manufacturer, seller or distributor of
vascular access products. Notwithstanding the foregoing, VeriChip
may use or sell a product substantially equivalent to the Product
so long as such use or sale is not in connection with vascular
access products (that compete with Medcomp, directly or
indirectly). VeriChip agrees that it will seek a similar
exclusivity from the manufacturer of the Product. In the event
VeriChip becomes insolvent or otherwise ceases operations during
the term of this Agreement, and has no successor which is bound by
the terms of this Agreement, Medcomp shall be able to maintain said
exclusivity with the manufacturer of the Product. Medcomp agrees
during the Initial Term of this Agreement, that it will purchase
not less than the following number of Products (the “Minimum
Purchase Requirements”): (i) *** in the first Product
Purchase Year, (ii) *** in the second Product Purchase Year, (iii)
*** in the third Product Purchase Year, (iv) *** in the fourth
Product Purchase Year and (v) *** in the fifth Product Purchase
Year. For the purpose of this Agreement, the “Product
Purchase Years” are the five (5) respective consecutive
twelve (12) month periods beginning on the date of the last to
occur of the following: (i) the Product being ready for
production; or (ii) 510k approval of the Product. In the event
Medcomp fails to meet the Minimum Purchase Requirements for a
Product Purchase Year, Medcomp shall, within thirty (30) days
of written demand from VeriChip, make a payment to VeriChip equal
to *** times the number of Products by which Medcomp failed to meet
the Minimum Purchase Requirement for the Product Purchase Year at
issue. Medcomp shall be released from the Minimum Purchase
Requirements should the FDA issue a recall of the Product, for more
than thirty (30) days.
(b) Medcomp’s original order for the
Product shall be submitted within ten (10) days of 510k
approval of the Product and Medcomp shall order the Product on a
quarterly basis thereafter. All orders for the Product shall be in
writing and shall specify (i) the number of units of each of
the Product to be purchased (in accordance with the terms and
conditions of the Agreement) and (ii) the destination to which
the Product is to be shipped. With each order of the Product,
Medcomp shall also provide a forecast of the number of Products it
will be purchasing for the next six (6) months. VeriChip will
deliver no less than ninety percent (90%) of the first order for
Products within eight (8) weeks of full production commencing.
Thereafter, VeriChip agrees to deliver no less than ninety percent
(90%) of the Products ordered by Medcomp within less than thirty
(30) days of the order date provided that the number of
Products (i) does not exceed one-hundred twenty percent (120%)
of the immediately previous order or, (ii) alone, or in
conjunction with the immediately previous order, does not exceed
the then current six (6) month forecast of Medcomp. If the
number of Products ordered (i) does exceed one-hundred twenty
percent (120%) of the immediately previous order or,
(ii) alone, or in conjunction with the immediately previous
order, exceeds the then current six (6) month forecast of
Medcomp, VeriChip agrees to deliver no less than ninety percent
(90%) ordered within sixty (60) days of the order date.
VeriChip shall be permitted a thirty (30) day cure period for
any missed delivery deadline. VeriChip shall not be liable for any
consequential damages as result of a failure to meet delivery
deadlines. Medcomp shall be released from the Minimum Purchase
Requirements of any particular year if its inability to meet the
minimum purchase requirements of that particular year was due to
VeriChip’s inability to make delivery pursuant to the
schedule set forth above.
(c) VeriChip agrees, during the Term, to
make its other products that are compatible with the Product
available to Medcomp on commercially reasonable terms.
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***CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTION.
Section 1.02 Pricing.
The standard purchase price for the
Product will be ***, provided, however, that if Medcomp places an
order within the first three (3) months of any Product
Purchase Year (i) for not less than *** units for delivery of
Product in that Product Purchase Year, the price for those Products
will be ***, or (ii) for not less than *** units for delivery
in that Product Purchase Year, the price of those Products will be
***. It is understood that all such pricing will be firm for the
Initial Tem.
Section 1.03 Delivery Terms.
Products will be shipped, FOB
Medcomp’s Harleysville, PA, facility. Payment for shipping
charges shall be Medcomp’s responsibility.
Section 1.04 Payment.
Notwithstanding the Product
Development Fee subject to Section 1A.06, unless otherwise agreed
by the parties in writing, payment shall be made by Medcomp
separately for each shipment of Products. Medcomp shall pay all
invoice amounts within thirty (30) days of the date of invoice
in U.S. dollars. Any invoices not paid within thirty (30) days
shall accrue interest at the rate of one and one-half percent
(1-1/2%) per month.
Section 1.05 Inability to
Supply. VeriChip expects
and intends to supply Medcomp with the Product in accordance with
the provisions of this Agreement. If VeriChip determines that it
will be unable to supply Medcomp with the Product in the desired
quantities for unanticipated reasons such as an Act of God or a
long-term shortage of materials, VeriChip shall give Medcomp prompt
notice of its inability to timely supply of the Product. If
VeriChip is unable to make timely deliveries of the Product for
unanticipated reasons such as set forth above, or by reason such as
war, civil commotion, embargo, strike or any other act which is
beyond the reasonable control of VeriChip, VeriChip shall be
excused from meeting said delivery deadlines provided, however,
that VeriChip shall continue performance hereunder with reasonable
dispatch whenever such causes are removed.
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ARTICLE II. —
REPRESENTATIONS, WARRANTIES AND COVENANTS
VeriChip
represents, warrants and covenants to Medcomp as
follows:
(a) This Agreement has been duly
authorized, executed and delivered by VeriChip and constitutes a
valid and binding obligation of VeriChip, enforceable in accordance
with its terms.
(b) This Agreement does not conflict with
any applicable law, rule or regulation to which VeriChip is
subject, or any agreement to which VeriChip is a party.
(c) VeriChip represents and warrants that
the Products, when sold to Medcomp, do not infringe or encroach
upon any party’s personal, contractual or proprietary rights,
including but not limited to, patents, trademarks, copyrights, or
trade secrets. VeriChip further represents and warrants that the
Products, when sold to Medcomp, (i) are merchantable, (ii) are
fit for the purposes for which they were sold, (iii) are free
from any and all defects in design, material and workmanship,
(iv) conform to the Specifications and Medcomp’s quality
standards (v) are fit and safe for use by Medcomp; and
(vi) shall have at least eighty percent (80%) of their shelf
life remaining when sold to Medcomp, and shall remain in full
compliance with the Specifications for the full shelf life period
of such Products; and (vii) shall be in compliance with all
applicable laws and regulations and all regulatory requirements of
the United States Food and Drug Administration (the “
FDA ”), or other appropriate regulatory authority
currently in effect, including without limitation the Federal Food,
Drug and Cosmetic Act, as amended from time to time (the “
Act ”), the FDA’s then current Good
Manufacturing Practices (“ cGMP ”). VeriChip
further represents and warrants that they will convey good
and merchantable title to Medcomp for the Products and that the
Products are free of any security interest or other lien or
encumbrance.
(d) No Products constituting or being a
part of any shipment hereunder shall at the time of any such
shipment be (i) adulterated or misbranded within the meaning
of the Act, or regulations promulgated thereunder, as such law or
regulation is constituted and in effect at the time of any such
shipment, or (ii) an article which may not, under the
provisions of Sections 404, 505 or 512 of the Act, be
introduced into interstate commerce.
(e) VeriChip agrees that it will attain the
manufacturing, processing and packaging of the Products only at
specified and approved facility(ies) (the “ Plant
”) and that part of such services may at any time be
subcontracted to a third party without prior written approval of
Medcomp.
(f) VeriChip shall not make any changes in
the Specifications or raw materials, purchased components,
packaging materials, labeling, formulations, quality control test
methods or manufacturing processes or manufacturing equipment, with
regard to the Product, without Medcomp’s prior written
agreement.
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(g) VeriChip owns or has the right to use
all copyright, trademarks, patents, and other intellectual property
rights to the intellectual property which they shall use to perform
their obligations hereunder.
(h) VeriChip shall provide to Medcomp all
documentation and information requested by Medcomp: (i) in
order to assist Medcomp in determining whether any delivery
complies fully with the Specifications and the requirements of this
Agreement (including VeriChip’s calculation of any price
adjustments, rebates, loss allowance, credits and/or most favored
nations status); (ii) in order to assist Medcomp in obtaining
any and all regulatory approvals necessary to market Medcomp’
products which contain the Product; or (iii) to enable Medcomp
to comply with any statutory or regulatory requirements, or with a
request by any governmental or regulatory authority.
(i) VeriChip agrees to work with the
manufacturer to assure the quality level of the Product through the
use of a formal quality assurance program (the “QA
Program”) reasonably acceptable to Medcomp. The QA program
shall require the manufacturer to prepare and maintain written
records sufficient to enable Medcomp to trace the build and
inspection history of the Product. VeriChip will require the
manufacturer to maintain such records for a period of five
(5) years after manufacture. Pursuant to the QA Program,
VeriChip shall require the manufacturer to place lot numbers and
date codes on all Products to enable the identification and
traceability of the Product. During the Term, and upon reasonable
notice, Medcomp shall have the right to reasonably audit the QA
program, at its expense, during regular business hours.
(ii) VeriChip shall require the
manufacturer to conduct and document final inspection and quality
control tests in accordance with reasonable Medcomp procedures on
the Products prior to shipment to verify that the Product meets and
conforms to the Specifications and the QA Program provided,
however, that if Medcomp requires a type of inspection or quality
control test involving equipment that is not currently owned by
manufacturer, that Medcomp shall be responsible for the cost of
obtaining such equipment.
(iii) Medcomp will, at its expense, and
upon reasonable notice to VeriChip and the manufacturer, have the
right to reasonably inspect manufacturer’s facilities to
ensure compliance with the terms and conditions of the QA Program.
Proprietary VeriChip or manufacturer’s manufacturing process
technology shall not be subject to any such inspection.
(iv) VeriChip shall cooperate with, and
provide assistance to, Medcomp with respect to customer complaints
and product recalls relating to the Product.
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(j) VeriChip shall immediately notify
Medcomp of any contact which the FDA or any other regulatory or
other governmental authority has with it concerning the Product or
its manufacturing facilities relating thereto, including, but not
limited to, cGMP’s, product registrations and safety and
efficacy claims. The parties shall consult with one another in an
effort to arrive at a mutually acceptable response; however, should
the parties not agree as to a response, Medcomp shall have total
discretion to respond appropriately to such regulatory or other
governmental authority.
(k) VeriChip shall inform Medcomp within
twenty-four (24) hours of any notification to VeriChip of any
site visits by the FDA, state or federal regulatory agencies or any
other governmental or regulatory agency, relating, directly or
indirectly, to the manufacture, storage, disposal and/or
transportation of the Product, and shall provide to Medcomp all
other materials related thereto or used in connection therewith.
VeriChip shall report in writing the results of the visit to
Medcomp within thirty (30) days of the occurrence thereof In
the event that any such governmental or regulatory agency finds
that VeriChip’s operation relating, directly or indirectly,
to the manufacture, storage, disposal and/or transportation of the
Product is deficient or unsatisfactory in any respect, VeriChip, as
is appropriate, shall cure all said deficiencies within the earlier
of ninety (90) days or such cure period as ordered by the
governmental or regulatory agency.
(l) VeriChip shall make available to
Medcomp all records and reports relating to the m
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