Attached files
| file | filename |
|---|---|
| 10-K/A - Apyx Medical Corp | v167911_10ka.htm |
| EX-31.1 - Apyx Medical Corp | v167911_ex31-1.htm |
| EX-32.2 - Apyx Medical Corp | v167911_ex32-2.htm |
| EX-10.2 - Apyx Medical Corp | v167911_ex10-2.htm |
| EX-32.1 - Apyx Medical Corp | v167911_ex32-1.htm |
| EX-31.2 - Apyx Medical Corp | v167911_ex31-2.htm |
| EX-10.13 - Apyx Medical Corp | v167911_ex10-13.htm |
| EX-10.14 - Apyx Medical Corp | v167911_ex10-14.htm |
|
Corporation
|
DISTRIBUTION
AGREEMENT
|
Article
I.
This
Distribution Agreement ("Agreement") is made as of October 6, 2006 ("Effective
Date") by and between Boston Scientific Corporation, One Boston Scientific
Place, Natick, MA 01760 ("Buyer"), and Bovie Medical Corporation, 7100 30th
Avenue-North, St. Petersburg, FL 33710 ("Seller") for the purpose of
purchase, sale and delivery of Products (as defined in Section 1.1) in
accordance with this Agreement. Buyer and Seller are herein referred
to collectively as “Parties” and individually as a “Party.”
MAILING
ADDRESSES AND FAX NUMBERS FOR NOTICES, ETC. UNDER AGREEMENT
|
Seller:
Bovie
Medical Corporation
7100
30th
Avenue North
St.
Petersburg, FL 33710
Attn: Moshe
Citronowicz, COO
Fax: (727)
344-3876
|
with copy to:
Bovie
Medical Corporation
7100
30th
Avenue North
St.
Petersburg, FL 33710
Attn:
General Counsel
Fax: (727)
344-3876
|
|
Buyer:
Boston
Scientific Corporation
One
Boston Scientific Way
Marlborough,
Massachusetts 01752-1242
Attn: President,
Oncology
Fax: (508)
683-5693
|
with copy to:
Boston
Scientific Corporation
One
Boston Scientific Place
Natick,
Massachusetts 01760-1537
Attn: General
Counsel
Fax: (508)
650-8956
|
NOW, THEREFORE, for good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties hereto hereby agree as follows:
1. Purchase and
Sale.
1.1 Products. For
purposes of this Agreement, “Product” shall mean the
medical resection device having a sintered tip, manufactured by Seller, as more
particularly described in the Specifications (defined below) attached hereto as
Exhibit A. Additional products, together with specifications and
pricing therefor, may be added to this Agreement by mutual agreement of the
Parties in accordance herewith.
1.2 Exclusivity. Seller
will manufacture, offer and sell on an exclusive, worldwide basis Products to
and for Buyer during the term of this Agreement. Seller shall not
offer or sell to any third party or for itself or its Affiliates or have made,
offered or sold on its behalf the Products. Buyer shall purchase the
minimum quantity of Products, as described in Sections 1.3(b) and 1.3(f),
below. For purposes of this Agreement, "Affiliate" means, as to
either Party, any other person or entity that, directly or indirectly, controls,
is under common control with, or is controlled by, that Party. For purposes of
this definition, "control" (including, with its correlative meanings, the terms
"controlled by" and "under common control with"), as used with respect to any
person or entity, shall mean direct or indirect ownership of more than 50% of
the stock or (partnership) shares of such person or entity.
1.3 Ordering.
(a) Buyer
shall place all orders with Seller for Products under this Agreement on Buyer’s
form of purchase order. A copy of Buyer’s current purchase order form is
attached hereto as Exhibit B and is made a part hereof. All Buyer
purchase orders shall set forth the Specifications (including relevant revision
level), quantities, and delivery schedule, and shall state such additional terms
and conditions as Buyer may deem appropriate. If a Buyer purchase
order conflicts with this Agreement as to Specifications, terms or conditions,
the Specifications, terms and conditions of this Agreement shall
control. No other terms or conditions (including those on Buyer’s
purchase order) and no modification, alteration or amendment of this Agreement
shall be binding on the Seller unless accepted in writing, in advance, by an
authorized officer of Seller.
(b) Buyer
will deliver to Seller an initial binding purchase order for two hundred (200)
units for the first three (3) calendar months of Product (the “Initial Purchase
Order”). Buyer shall deliver such Initial Purchase Order to
Seller with a mutually agreed lead-time prior to the first Product delivery date
set forth on that Initial Purchase Order. The first calendar month of
the Initial Purchase Order will be deemed to be the month in which the Initial
Purchase Order is placed. From time to time, Buyer may also place
additional purchase orders for Product. “Contract Year” means the
one-year period beginning on the Product Launch Date and ending on the 12-month
anniversary thereof, and each successive one-year period thereafter, during the
term of this Agreement. Notwithstanding anything herein to the
contrary, Buyer shall purchase a minimum
of ** ** units of Product
during the
first ** ** Contract
Years of the term of this Agreement as follows: during the first Contract Year,
a minimum
of ** ** units
in order quantities of at least 200 (as the Initial Purchase
Order), ** ** respectively;
and during the second Contract Year, a minimum of the difference
between ** ** and
the actual number of units purchased
by ** ** ** ** units. The
quantity of Product ordered by Buyer prior to the Product Launch Date (if any),
subject to the minimum per-order quantities set forth above, shall accrue to
the ** ** unit
minimum purchase requirement for
the ** ** Contract
Years. “Product
Launch Date” means the date the Seller ships to Buyer Product for
commercial resale (subject to all required regulatory approvals), but no later
than ninety (90) days after mutual execution of the design transfer document
required under applicable law; provided, however, that Seller
timely ships Product to Buyer in accordance with the Initial Purchase
Order.
(c) Within
five (5) Business Days after receipt of a purchase order from Buyer, Seller
shall acknowledge receipt and confirm whether the order can be supplied within
the delivery dates set forth therein. Unless Seller advises Buyer to
the contrary, in writing and within five (5) Business Days of the date Seller
receives Buyer’s sent purchase order, Seller shall be conclusively presumed to
have accepted the Specifications, quantities, due dates, and other terms of such
purchase order. For purposes of this Agreement a “Business Day” means any day,
other than Saturday, Sunday, or a legal holiday in Massachusetts or
Florida.
(d) Due
dates on the purchase orders are the dates that the Products must be received at
Buyer’s facility indicated on that purchase order. Orders arriving up to three
(3) Business Days early or three (3) Business Days late will be considered on
time. As soon as it becomes apparent to Seller that it cannot meet a
due date on a purchase order, Seller shall notify Buyer in writing of the
expected delivery delay.
(e) Seller
shall invoice Buyer and Buyer shall pay all shipping, insurance and related
charges. Seller shall pay premium freight charges in excess of normal
shipping charges to ensure timely deliver of Products ordered pursuant to a
purchase order if Seller is responsible for a delay in shipment unexcused by
Force Majeure (as set forth in Section 7.3).
(f) In
the first two (2) Contract Years, Buyer shall purchase at least the minimum
quantity of Product as set forth in Section 1.3(b), above, at the unit transfer
price set forth in Exhibit E (Transfer Pricing) for that
period. Thereafter, during each of the next three (3) Contract Years
during the term of this Agreement, if Buyer orders any Product, Buyer shall
issue a binding purchase order for a minimum
of ** ** units
of Product, with a minimum per-shipment quantity of not less
than ** ** units,
for delivery during the subsequent 12-month period.
“Pricing Period” means the six
(6) month period beginning on the commencement date of the first Contract Year,
and each successive six (6) month period thereafter during the term of this
Agreement.
As set
forth in Exhibit E, for Products purchased during Contract Years one (1) and two
(2), the price per unit of Product purchased during such twenty-four (24) month
period shall be ** **
for the first ** ** units
purchased, and
(b) ** ** for all
Product above the
first ** ** purchased
(whether purchased in Contract
Year ** **).
The
initial pricing set forth in Exhibit E is based on the Specifications Revision
“A-1,” as set forth in Exhibit A. Seller reserves the right to amend
the pricing in Exhibit E for the Product in accordance with changes to the
Specifications requested by Buyer; provided, that (i) Seller will provide Buyer
advance notice of any such price change, (ii) Seller will implement such changes
to the Specifications and amend such pricing, only upon Seller’s receipt of the
Buyer’s Oncology division’s president’s written approval thereof.
During
each of Contract Years three (3) through five (5), for each Pricing Period,
Buyer will initially pay the Product transfer price (set forth in Exhibit E)
that corresponds to the forecasted quantity of Products to be ordered for that
Pricing Period as set forth in the twelve (12)-month rolling forecast delivered
by Buyer in accordance with Section 1.6 of the Agreement on the last day of the
second month immediately preceding the commencement of such Pricing
Period. Within thirty (30) days following the end of each of Pricing
Period during Contract Years three (3) through five (5), the Parties will
compare the total amount actually paid for Products by Buyer during that Pricing
Period with the total amount which should have been paid based upon the actual
purchases of Products in such Pricing Period using the applicable Product prices
set forth in Exhibit E, as amended. Any difference will be paid to
the appropriate Party within forty-five (45) days following the end of the
applicable Pricing Period.
(g) Buyer
shall timely place and Seller shall timely fulfill binding purchase orders as
required under this Agreement. However, if (i) Seller is unable to
fulfill such binding purchase orders, (ii) Product is recalled as permitted
under Section 3.11 (Product Recalls), or (iii) Buyer rejects or returns all or
any part of a shipment of Product as permitted under Section 3.4 (Product
Acceptance) or 3.12 (Product Returns), as applicable, Seller shall suspend
Buyer’s minimum purchase obligations set forth in this Section 1.3 until fifteen
(15) business days after either (x) Seller is able to fulfill such binding
purchase orders, or (y) Seller satisfies its applicable obligations under
Section 3.4, 3.11, or 3.12.
1.4 Shipping; Freight
Terms. Subject to the terms set forth in Section 1.3, above,
Seller shall deliver Products that meet the Specifications in accordance with
the quantities, timing and shipping destination specified in Buyer’s purchase
orders utilizing Buyer’s appointed carriers and Buyer’s contracted
rates. Seller shall deliver all Products to Buyer free and clear of
all liens and encumbrances or other defects in title. All Products
shall be shipped F.O.B. St. Petersburg, FL.
1.5 Inventory;
Scheduling.
(a) Except
as expressly set forth herein, during the term of this Agreement, Buyer shall
purchase its Product requirements exclusively from Seller (including Products
required for engineering, testing, and clinical trials, if any) and from no
other manufacturer, person or entity, including, without limitation, any
division or Affiliate of Buyer.
(b) Buyer
shall provide Seller with firm purchase orders for Products in accordance with
the procedures and requirements set forth in Section 1.3; provided, however, that Buyer
shall have the right, exercisable only one (1) time per any three (3) month
period, up to five (5) Business Days prior to the date of shipment, and with the
prior written consent of Seller, which shall not be unreasonably withheld, to
issue binding, written change orders to delay up
to ** ** of
the quantity of Products on such purchase orders by no more than sixty (60)
calendar days from their originally scheduled shipment date. Buyer agrees to
accept partial shipments of Products from Seller should it, for any commercially
reasonable reason, become necessary to ship in advance of Seller’s ability to
complete each order. Seller shall make all commercially reasonable efforts to
comply with any revisions to a purchase order consistent with the provisions of
this Agreement.
(c) Seller
shall maintain its production capacity with respect to finished products and raw
materials
at ** ** Percent ** **
of all undelivered Product quantities on open purchase orders for the
then-current month. Seller will immediately notify Buyer in the event of any
material obsolescence, supply shortage, or other interruption or potential
interruption, in supply of any Products, or component or sub-assembly thereof,
as soon as Seller becomes aware of such.
(d) Within
the mutually agreed lead-time for the Initial Purchase Order set forth in
Section 1.3(b), above, Seller shall accumulate a finished goods inventory of
Products to be held in reserve equal to the average monthly quantity, based on
the Initial Purchase Order. Thereafter, for each subsequent month,
Seller will hold in inventory an amount of finished Products equal to the
average monthly quantity of the then-current Binding Forecast (defined
below). All Products held in inventory pursuant to this Section shall
be referred to herein as “Shelf
Inventory.” Seller may only deplete Shelf Inventory when
Buyer’s orders exceed the applicable Binding Forecast. Seller will at
all times throughout the term of this Agreement maintain the agreed upon Shelf
Inventory level, except that Seller will replace any units taken from Shelf
Inventory in accordance with previous sentence within thirty (30) days of the
date Seller takes such units from Shelf Inventory.
1.6 Estimates of
Requirements.
(a)
At the same time Buyer issues its Initial Purchase Order, and by the last day of
each calendar month thereafter, Buyer shall deliver to Seller a written,
twelve-month rolling forecast of Buyer's requirements for
Products. The first three (3) months of each such twelve-month
rolling forecast shall be binding upon Buyer (the “Binding Forecast”) and the
remaining nine (9) months of each such forecast will be non-binding and subject
to adjustment. Seller shall, no later than twenty-five (25) days after receipt
of each twelve-month rolling forecast delivered pursuant to this Section, notify
Buyer of any prospective problems of which Seller is aware that might prevent
Seller from meeting Buyer’s
forecasted requirements or estimated delivery dates. In the event
Seller so notifies Buyer of any issues in meeting quantities, Seller shall state
in writing the quantity of Products it estimates it can deliver and Buyer shall
only be required to purchase such revised quantity.
(b) In
addition to the forecasts delivered pursuant to Section 1.6(a), above, Buyer
will create a non-binding twelve-month forecast for Products, the first month of
which will be the month this Agreement is signed and delivered and which will be
attached hereto as Exhibit C. For the avoidance of doubt, Exhibit C
is being delivered for planning purposes only and no portion of Exhibit C will
be binding on either Party hereto.
(c)
Seller and Buyer agree to cooperate with each other and work jointly to
establish and maintain a smooth and efficient timetable for the manufacture and
supply of Products to Buyer hereunder. Seller shall use commercially reasonable
efforts to supply Buyer with all of its Product requirements, including, but not
limited to, the use of commercially reasonable efforts to accommodate "Rush"
orders from Buyer; provided, however, Seller shall
not be in breach of this Agreement for any failure or delay to supply quantities
of Products which exceed the Binding Forecast for the then-current month by more
than ** ** percent ** **.
1.7
Materials Requirements
Process.
(a) Seller
will deliver to Buyer a list of all components with lead times greater than
twelve ** ** weeks
(“Long Lead Time
Components”) upon the Parties’ mutual finalizations of and approvals for,
the Product requirements, Specifications, design, and bill of materials, which
list shall be set forth as Exhibit D and attached hereto. Seller
shall use its best efforts to reduce and minimize the number of Long Lead Time
Components. Seller shall use reasonable efforts to update the list of
Long Lead Time Components every quarter and to present an updated list of Long
Lead Time Components to Buyer. Each revised list of Long Lead Time
Components shall be deemed an amendment to Exhibit D. In the event
that Seller fails to present an updated list of Long Lead Time Components, (i)
the Parties shall continue to rely on the preceding list (as updated in writing
by the Parties) and (ii) Buyer will accept responsibility for Long Lead Time
Components ordered outside the lead times set forth in the list provided that
Seller can demonstrate to Buyer’s reasonable satisfaction that such components
were ordered in accordance with the then-current vendor lead times. (Buyer
acknowledges that lead times constantly change and the Seller might not always
be able to present Buyer with a current list of Long Lead Time
Components.)
(b) Buyer
shall be financially liable for all Long Lead Time Components when ordered in
accordance with this Section 1.7 if Buyer terminates this Agreement without
cause or Seller terminates this Agreement pursuant to Section 7.1(a) or
(d). Seller shall otherwise be financially liable for all Long Lead
Time Components. Specifically, Buyer’s component liability
for Long Lead Time Components shall be equal to Seller’s delivered cost
(delivered cost is the cost paid by Seller for the components, net of all
credits and discounts, plus a materials margin equal
to ** ** of
all components ordered in support of any Binding Forecast. At Buyer’s
request, Seller shall use commercially reasonable efforts to minimize Buyer’s
component liability by attempting to return components to the vendor; provided, however,
that Seller shall not be obligated to attempt to return to a vendor
components that are, in the aggregate, worth less
than ** **
Dollars ** **.
2. Pricing; Payment; Continuous
Improvement.
2.1 Pricing;
Escalation. Prices for the Products are set forth in Exhibit E
attached hereto, and include packaging (as set forth in the then-applicable
Specifications) and taxes. Subject to the provisions of Section
1.3(f), such prices shall be fixed for the
initial ** ** Contract
Year period of this Agreement. Thereafter, Seller may adjust prices
for each successive Contract Year period of this Agreement, according to the
annual Producer Price Index for Finished Goods (“PPIFG”) or its replacement if
so identified by the publisher, published by the United States Department of
Labor, Bureau of Labor Statistics (“BLS”); provided, that such
increases or decreases will be capped
at ** **
Percent ** ** of the
previous Contract Year’s Product transfer price. Such PPIFG shall not
be seasonally adjusted. The frequency for periodic adjustments hereunder shall
be annual, using the first publication of the annual value in the month
following the anniversary month of each successive Contract Year period of this
Agreement. The adjustments shall be calculated using the “simple
percentage method” as set forth by the BLS. Such PPIFG-based price
changes shall be in addition to price changes (if any) permitted under Section
1.3(f).
2.2 Payment. Payment
will be due forty five (45) days from Buyer’s receipt of Seller’s invoice,
except to the extent Buyer in good faith disputes each
invoice. Seller shall invoice Buyer at the time of shipment of the
applicable Product and as otherwise provided for hereunder.
2.3 Continuous
Improvement; Seller Performance Business Reviews. During the
term of this Agreement, Seller shall use commercially reasonable efforts
(including reasonable engineering support) to improve and enhance Product
design, quality, performance and manufacturing
processes (collectively, “Improvements”)
so as to maintain or increase the competitive advantage of the Products as
compared to similar products in the marketplace. Improvements may
result from Seller’s own initiative (“Bovie
Improvements”) or the request or suggestion of Buyer (“BSC
Improvements”) but, if a proposed BSC Improvement or Bovie Improvement
changes the Specifications or requirements of a purchase order the proposed
Improvement must be approved in writing by Buyer prior to implementation as
described in Section 3.1 hereof. Buyer shall pay Seller for waste or
remanufacturing of raw materials, work-in-progress, intermediate sub-assemblies
and finished goods inventory, which are rendered unusable by said BSC
Improvements or any other changes approved by Buyer (collectively, “Waste
Reimbursement”); provided, however, Buyer shall not be responsible for
Waste Reimbursements for Bovie Improvements. BSC Improvements
approved in accordance with this Section 2.3 and Section 3.1 hereof shall be
promptly incorporated into the Specifications and Products in accordance
herewith. In order to establish an effective system to identify and
achieve productivity and quality objectives, BSC Improvements and Bovie
Improvements, Seller shall submit a productivity report to key administrators
designated by Buyer on a mutually agreeable basis. Seller’s and
Buyer’s representatives will meet as reasonably requested by Buyer for the
specific purpose of driving mutual productivity and quality
objectives.
2.4 Tooling and Capital
Equipment. In addition to the price for each Product set forth
on Exhibit
E, ** ** shall ** ** Seller
the actual cost, net of all third party credits and discounts, plus a fifteen
percent (15%) management fee (“Management Fee”), of tooling, machining, molding,
and other capital expenditures necessary or appropriate for the manufacturing of
Product and that are purchased solely for use in connection with manufacturing
Product (collectively, “Manufacturing
Equipment”). Buyer will not be responsible for paying for any
Manufacturing Equipment unless Buyer approves the purchase of such Manufacturing
Equipment in writing in advance of purchase. Payment for
Manufacturing Equipment will be due in accordance with Section 2.2. Seller will
use Manufacturing Equipment solely in connection with the manufacturing of
Products for Buyer. Buyer will at all times have title to and own all
Manufacturing Equipment. Seller shall not take any action that would
cause a lien or other encumbrance to be placed on any Manufacturing Equipment.
At all times while the Manufacturing Equipment is in Seller’s custody and
control, Seller will maintain adequate levels of loss insurance to cover loss or
damage to the Manufacturing Equipment.
2.5 Payment of Start-up
Fee. Upon the execution of this Agreement, Buyer shall pay
Seller
a ** ** start-up
fee of ** **
Dollars ** ** (“Start-up Fee”), which is in
addition to any other payments from Buyer due hereunder.
3. Quality
Assurance; Recordkeeping; Notification. The
following obligations of Seller set forth in Sections 3.1 through 3.10 shall be
collectively referred to throughout this Agreement as the "QA
Standards".
3.1 Changes. Seller
shall not make any changes to its documentation, shipping, manufacturing process
(including vendors) or manufacturing location, pertaining to any Product, to any
Product (including materials, packaging, labeling and Directions for Use) or to
the Specifications unless approved by Buyer in writing in advance. All such
changes shall be submitted to Buyer no later than sixty (60) days prior to
Seller’s proposed date of implementation for such change. If a
proposed change is approved by Buyer in writing in its sole discretion, Seller
shall be responsible for properly communicating and implementing such change,
including with respect to any of Seller’s vendors. Seller shall
notify Buyer in writing and must receive approval by Buyer prior to any (a) use
of any nonconforming material in the manufacture of any Product, (b)
implementation of any Seller-authorized temporary deviation that could
affect the production, interconnectivity, sterility, or handling of any Product,
or (c) implementation of any Seller-initiated corrective action that could
affect the safety or efficacy of any Product. Without limiting any
other of Seller’s obligations hereunder, Seller will assume full responsibility
and costs for any product development activities necessary to remedy any
non-conformance in Products (with respect to quantity, Specifications,
requirements and delivery dates), including costs to implement such changes on
all units in the field and in inventory. Notwithstanding
anything in this Agreement to the contrary, Buyer shall pay Seller for Waste
Reimbursements, as set forth in Section 2.3 above.
3.2 Seller’s
Vendors. At Buyer’s request, Buyer will perform a quality
system assessment of the vendors who provide Seller with raw
components/materials, sub-assemblies or contract services for
Products. All such vendors who provide Seller with such
materials and services as of the Effective Date are set forth on Exhibit F
attached hereto, which Exhibit F will be amended from time to time as Seller’s
vendors change. Buyer shall confirm in writing to Seller no later
than thirty (30) days after the Effective Date (and no later than thirty (30)
days after the date of any amendment to Exhibit F) the vendors listed on Exhibit
F with which Buyer’s Oncology Business (defined below) has a pre-existing
relationship (collectively, “Buyer’s
Vendors”). Seller agrees to assist Buyer in arranging visits
and inspection of the plants at which Seller’s vendors manufacture any
component/material, sub-assembly or service for any Product. Seller
shall not change the outsourcing of any sub-component of any Product unless
approved in writing in advance by Buyer in accordance with Section 3.1
hereof. In addition, Seller shall obtain Buyer’s prior written
approval, which Buyer shall not unreasonably withhold, with respect to each
supplier, including a new supplier or a change to an existing supplier, of any
material, component, sub-assembly or service relating to any Product as
described in Section 3.1 hereof. For avoidance of doubt, Seller shall
not incorporate into any Product any material, component or sub-assembly
purchased from a third-party supplier, or permit any third party to perform
services relating to a Product, unless approved in writing in advance by Buyer
in accordance with Section 3.1 hereof. Buyer agrees, on behalf of its
Oncology Business, not to contract directly with any vendors listed on Exhibit
F, as amended, who supply Seller with Product components, for components of the
Product for sale by Buyer’s Oncology Business during, and for a period of two
(2) years after any termination or expiration of, this Agreement for any reason
except as set forth in the next sentence; provided that this
restriction in no way applies to or otherwise limits Buyer’s right to contract
directly with (a) Mott Corporation (“Mott”), (b) Buyer’s Vendors,
or (c) any vendor that Buyer introduces to Seller, and further, except as
permitted in subclauses (a), (b) and (c) of this sentence, Buyer’s Oncology
Business will not accept via intra-company transfer or otherwise such Product
components purchased by Buyer or its Affiliates from Seller’s vendors listed on
Exhibit F, as amended. Notwithstanding the foregoing, such
restriction on Buyer’s Oncology Business’ contracting with Seller’s vendors as
set forth in the preceding sentence shall not apply in the event Seller breaches
this Agreement and Buyer terminates therefor pursuant to Sections 7.1(a),
7.1(b)(i), or 7.4, hereof. Seller agrees that, at such time as the
Parties mutually execute the design transfer document referenced in Section
1.3(b), Seller will enter into, and during the balance of the term of this
Agreement, will maintain, a written supplier agreement with Mott for the supply
of the sintered tip incorporated into the Product, and a written understanding
with Mott whereby Buyer would be able to visit and inspect Mott upon reasonable
notice; provided, that Seller
agrees that it will not at any time during and for a period of five (5) years
after any termination or expiration of this Agreement for any reason enter into
an exclusive supply arrangement or any other agreement or arrangement with Mott
that would limit Mott’s ability to sell or otherwise provide any components or
products to Buyer or its Affiliates. As used herein, “Buyer’s
Oncology Business” means that part of Buyer’s business primarily responsible for
Buyer’s oncological business.
3.3 Product
Conformity. Seller will manufacture Products in accordance
with the then-current (a) Specifications, (b) applicable regulations relating to
the current Good Manufacturing Practices (as defined by the Food, Drug and
Cosmetic Act, as amended) and similar protocols (“cGMP”), (c) the United States
Food and Drug Administration (“FDA”) quality system
regulations (“QSR”),
including master device and lot history records, ISO 13485 requirements,
ISO14971 requirements, MDD requirements and CMDCAS requirements, and (d) other
pertinent rules and regulations of FDA and similar regulatory bodies in other
applicable jurisdictions set forth in the Specifications, as
amended. In the event that Seller is required or deems it desirable
to obtain ISO Quality System Certification, Seller shall promptly notify Buyer
in writing of Seller’s selection (or change in registrar) for obtaining ISO
Quality System Certification. Seller shall maintain a current Declaration of
Conformity status with EU Notified Bodies per MDD requirements when Buyer is
distributing in European markets. During the term of this Agreement,
Seller will maintain or cause to be maintained the Product manufacturing
facility’s registration as a certified medical device manufacturing facility and
will maintain such facility registration with all applicable regulatory bodies
or cause such facility to be maintained such that the facility would pass an
audit for compliance with cGMP and QSR. Seller shall maintain ongoing
quality assurance and testing policies sufficient to satisfy its obligations
under this Agreement, and Seller's standard quality assurance
policies. Any non-conformance in Product, material or process which
Seller wishes to use “as is” or rework will require prior written approval from
Buyer. Seller will assume full responsibility and its
costs for any product development activities necessary to remedy any
non-conformance in Products arising exclusively from defects in Product design,
manufacture or materials, or from deviation from quality standards (but not in any way from
Product claims, which are the sole
responsibility of Buyer), which non-conformance is not approved by Buyer
in accordance with the requirements of the preceding sentence. Seller shall be
responsible for obtaining and maintaining any required regulatory filings and
registrations set forth in the Specifications, as amended, including ISO
registration (“CE Mark”)
and 510(k) filings with the FDA (collectively, the “Regulatory Filings”) for the
Products under Seller’s notified body or through other applicable Regulatory
Authorities (defined below and set forth in the Specifications, as amended);
provided, that
Buyer will have the right to review any Regulatory Filings and provide comments
on such filings (which Seller will consider in good faith) before they are
submitted by Seller; and further, provided, that Buyer
will at all times upon notice to Seller have the right to make any Regulatory
Filings with Regulatory Authorities outside of the United States in Buyer’s name
and Seller will provide Buyer with access to all documents necessary or
appropriate for Buyer to make such Regulatory Filings and with authorization to
use such documents and the information contained therein to make Regulatory
Filings as the distributor of Products. Upon termination or expiration of this
Agreement, Buyer may purchase from Seller physical and legal ownership of all
Regulatory Filings for the Product, including all documents and communications
to and from the pertinent Regulatory Authorities. Products will bear Seller’s
regulatory registration mark(s), including Seller’s CE
Mark. As used in this Agreement, “Regulatory Authority” means
any national supra-national, foreign, regional, state or local regulatory
agency, department, bureau, notified body, commission, council or other
governmental entity, including FDA, as set forth in the Specifications, as
amended.
3.4 Product
Acceptance. Each shipment of Product from Seller to Buyer
shall be inspected by Seller prior to shipment and shall contain such quality
control certificates reasonably requested by Buyer certifying, among other
things, that the Products are in conformity with Specifications. All
Products are subject to final inspection and acceptance at Buyer within thirty
(30) Business Days of delivery. Buyer shall notify Seller within
thirty (30) Business Days of delivery of any apparent defective material or
workmanship or non-conformity of any Product to the Specifications or applicable
purchase order. If Buyer fails to notify Seller within thirty
(30) Business Days of delivery of an apparent defect, Buyer will be
deemed to have accepted the Product; provided, that the
warranty contained in Section 8 hereof shall survive such
acceptance. Without prejudice to any other right or remedy of Buyer,
in case any Product is defective in material or workmanship or otherwise not in
conformity with the Specifications or the requirements of Buyer’s purchase
order, Buyer will have the right to reject it; provided, however, that Buyer
shall notify Seller of any rejection hereunder, and the basis for it, in
writing, within the thirty (30) Business Day timeframe set forth
above. Any Product that has been rejected must be replaced by and at
the expense of Seller promptly after notice. Buyer will return all
rejected Products to Seller at Seller’s expense. Seller
shall investigate the cause for the rejection and provide to Buyer in writing
all proposed corrective actions associated with the cause for
rejection. From time to time during the term of this Agreement, Buyer
may also request final inspection testing results from Seller, in addition to
the quality control certificates, as evidence that the supplied Product meets
Specifications. Seller will timely and fully respond to all such
requests.
3.5 Complaints and Corrective
Action.
(a) As
used in this Section:
(1) “Complaint” means any written,
electronic or oral communication, that alleges deficiencies related to the
identity, quality, durability, reliability, safety, effectiveness or performance
of a Product after it is released for distribution (marketed).
(2) “Complaint Investigation” means
a documented process for determining the root cause (or the most probable cause)
of a Complaint.
(3) “Medical Device Report” or
“MDR” means a report
filed with FDA to communicate an event when Seller or Buyer becomes aware (as
such phrase is defined in 21 CFR 803.3(c)) of information that reasonably
suggests that one of its marketed Products:
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(i)
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May
have caused or contributed to a death, Serious Injury or serious
deterioration in the state of health of a user or patient;
or
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(ii)
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Has
malfunctioned (see definition of Reportable Malfunction in 21
CFR 803.3 (n)) and that the Product or a similar device
marketed by the manufacturer or importer would be likely to cause or
contribute to a death or Serious Injury of a user or patient if the
malfunction were to recur.
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(4) “Medical Device Vigilance
Report” or “MDV”
means the official notification provided to regulatory authorities outside of
the United States of adverse events deemed reportable pursuant to the local laws
and/or regulations.
(5) “Serious Injury” means an
injury or illness that:
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(i)
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Is
life threatening (i.e. when continued use of the device is likely to have
resulted in the death of a patient or when a patient was at substantial
risk of dying at the time of the adverse event);
or
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(ii)
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Results
in permanent impairment or damage to a body structure or body function, or
necessitates medical or surgical intervention to preclude permanent
impairment or permanent damage to a body structure or body
function.
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(b) Buyer
will be the initial contact for all Complaints from its
customers. Buyer may require Seller to perform Complaint
Investigations related to the manufacturing, Seller’s design, or packaging of
Products in order to investigate the cause of any such Complaints and to
determine any required corrective actions. In connection with every
Complaint Investigation, Seller will perform a lot history or device history
review of the affected Product. If the Complaint is accompanied by or
followed by return of the subject Product to Buyer, Buyer will return to Seller
the Product that is the subject of the Complaint; provided, Buyer may
at its option perform an initial evaluation of the returned Product to determine
the root cause of failure. Seller will maintain records of all such
Complaint Investigations as required by cGMP and other applicable rules and
regulations of any Regulatory Authority. No later than fifteen (15) business
days after Seller’s receipt of a written request from Buyer to perform a
Complaint Investigation including receipt of the allegedly defective Product
(unless such Product is unavailable), Seller will provide Buyer with an initial
report of such Complaint Investigation, and no later than thirty (30) days after
Seller’s receipt of a written request from Buyer to perform a Complaint
Investigation including receipt of the allegedly defective Product (unless such
Product is unavailable), Seller shall perform and provide to Buyer a written
report of such Complaint Investigation, including a complete investigation that
contains a root cause analysis and corrective action recommendations. In the
event of an MDR or MDV, Buyer may require Seller to expedite the Complaint
Investigation in order to comply with any applicable regulatory filing
requirements of any Regulatory Authority.
(c) Seller
will be responsible for filing all required Complaint reports (including MDRs
and/or MDVs) with the appropriate Regulatory Authorities. In any
event, Buyer retains the right to file all required Complaint reports, including
MDR and MDV reports; provided, however, that Buyer
shall immediate notify Seller, in writing, of its intention to file such
reports.
(d) Seller
will maintain a cross-reference from Seller’s Complaint response to Buyer’s
associated Complaint file numbers. Seller will complete all corrective
actions, including any corrective actions identified in a response to Buyer
pursuant to this Section 3.5 or any corrective actions reasonably requested by
Buyer, within a mutually agreed upon timeframe, and upon request of Buyer,
provide written evidence of such completion.
3.6 Inspection;
Access. Buyer shall have the right to have employees and other
representatives of Buyer (including external auditors and representatives of
Buyer’s notified body) present at any plant or production facility relating to
or used in connection with the manufacturing of Product during normal business
hours to conduct an initial and periodic inspections of such facilities and
manufacturing procedures for compliance with ISO, cGMP and QSR, and the
Specifications and to inspect Seller’s inventory of Products, work-in-process,
raw materials to be used for Products, production records, design history file,
quality manuals, regulatory dossiers and such other matters as may be pertinent
to proper quality assurance of Products to be delivered
hereunder. Buyer agrees to give Seller a minimum of two (2) Business
Days’ prior notice of any such inspection
“for cause” and ten (10) Business Days’ prior notice for any other
inspection. Seller shall immediately use its best efforts to take
such action as is required to correct any deficiencies identified by Buyer or
its representatives relating to the production of any Product. Seller
is not currently a party to, and shall not enter into, any third-party
manufacturing agreement relating to any Product that does not grant to Buyer and
its representatives, as third-party beneficiaries, rights to inspect the plant
or plants at which Product components or materials are manufactured on the terms
set forth in this Section. Seller further agrees to use its best
efforts to provide such documentation or conduct such analyses as Buyer or its
representatives may reasonably request in connection with any regulatory
submission or audit hereunder. In accordance with applicable laws and
regulations governing regulatory inspections, Seller shall permit authorized
representatives of relevant regulatory authorities, including FDA, to inspect
any plant and production facilities relating to or used in connection with the
manufacture of any Product.
3.7 Records. For
the longer of seven (7) years after delivery to Buyer of each Product, or such
longer period as may be required by cGMP and other applicable rules and
regulations of any Regulatory Authority or by law, Seller shall: (a)
maintain traceability records for each Product, including the manufacture date
and lot number of each unit of Product and each component and material
comprising the Product; (b) maintain records subject to 21 CFR 820 Subpart M
(such as the Device Master Record, quality system record and Complaint files);
and (c) provide Buyer a copy of such records without charge upon Buyer’s
request. Upon
termination or expiration of this Agreement, such records shall be placed in
escrow on terms mutually agreed to by the Parties.
3.8 Required
Notification. Each Party hereto shall immediately notify the
other Party by fax, with confirming notice by Overnight Delivery, as soon as a
Party becomes aware of any: (a) defect or condition which renders or
may render any Product ineffective or dangerous; (b) Product that is not in
compliance with the Specifications (including manufacturing process, labeling or
packaging) or other QA Standards; (c) breach by either Party of the terms of
this Agreement; (d) regulatory, FDA or ISO inspections or other communications
with regulatory, FDA or ISO authorities related to a Product or that would in
any way impact the Product or either Party’s performance hereunder; or (e)
infringement by any party of intellectual property rights applicable to the
Product. Without limiting the generality of the foregoing, each Party
will notify the other Party immediately if it becomes aware of any death or
bodily injury caused by a Product (or suspected to be caused by a Product) or
any malfunction of a Product.
3.9 EEO
Laws. Seller acknowledges that Buyer is an equal employment
opportunity/affirmative action employer subject to Executive Order 11246, the
Vietnam Era Veterans Readjustment Assistance Act, Section 503 of the Vocational
Rehabilitation Act, and their implementing regulations (collectively, "EEO Laws"). Seller
may be governed by these laws and implementing regulations which are
incorporated into this Agreement by reference. By acceptance of this
Agreement, Seller certifies that it complies and will continue to comply with
all applicable EEO Laws, and it shall not discriminate on the basis of race,
age, color, religion, gender, sexual orientation, disability, veteran status,
national origin or any other characteristic protected by federal, state or local
law.
3.10 Quality
Plan. Seller and Buyer
shall establish a quality plan which will define the quality practices, the
resources and the activities relevant to Products that are designed and/or
manufactured for Buyer. This plan will define how the quality
requirements will be met and will be approved in writing by both
Parties.
3.11 Product
Recalls.
(a) If,
in the judgment of Seller or Buyer, any Product defect or any government action
requires a recall of, or the issuance of an advisory letter regarding, any
Product, either Party shall undertake such recall or issue such advisory letter
only after notification to and consultation with the other
Party. Each Party shall notify the other Party
within ** ** Business
Days of becoming aware (as such phrase is defined in 21 CFR 803)
of any issue that could lead to a field action related to the
Products. The Parties shall endeavor to reach an agreement prior to
making any recall or issuing any advisory letter regarding the manner, text and
timing of any publicity to be given in such matters in time to comply with any
applicable legal or regulatory requirements, but such agreement will not be a
precondition to any action that either Party deems necessary to protect users of
Products or to comply with any applicable governmental orders or
mandates. The Parties agree to provide reasonable assistance to one
another in the event of any recall or issuance of any advisory
letter. Notwithstanding anything in this Agreement to the contrary,
Buyer shall have the right to manage any Product recall.
(b) In
the event of a recall of Product, Seller shall correct any deficiency relating
to its manufacturing, packaging, testing, labeling, storing or handling of
Product, if applicable, or cause the vendor of any material, component, or
sub-assembly incorporated into Product to do likewise with respect to such
material, component, or sub-assembly, and shall, at Seller’s option, either (i)
at its cost replace each unit of Product recalled (including units held in
inventory by Buyer or its customers) with a corrected Product within a
reasonable period of time, or (ii) refund the Buyer’s purchase price
thereof. Seller shall promptly pay or reimburse Buyer for its costs
and expenses (i.e., shipping, quality control testing, and notification)
incurred by Buyer as a result of any recall or advisory letter; provided, however, that if the
recall is related to requirements or Specifications (i.e., materials, design or
process changes, and Product claims) originating with Buyer, then Buyer will pay
the costs and expenses incurred for such recall.
3.12 Product
Returns. Seller shall accept returns of Product shipped by
Seller if: (a) the request to return such Product is received
within ** ** Business
Days of invoice date (or, if later, the date that shipment is received); (b) the
Product is returned in new condition, salable and in its original packaging, and
(c) the reason for the return is directly related to defective product
quality. Nothing express or implied in this Section 3.12 shall be
deemed to modify or diminish the right of Buyer to reject Products in accordance
with the provisions of Section 3.4 or limit the warranty for Products set forth
in Section 8.
3.13 Compliance with
Laws. Seller will comply with all applicable laws and
regulations of the Regulatory Authorities set forth in the Specification, as
amended, pertaining to the testing, manufacture, labeling or packaging of
Products or pertaining to performance by Seller of its obligations under this
Agreement, including the maintenance of ongoing quality assurance and testing
procedures to comply with applicable regulatory requirements. Without
limiting the generality of the foregoing, Seller will (a) report to every
applicable Regulatory Authority within any relevant time periods all events that
are required to be reported (including any death or serious bodily injury caused
by a Product); and (b) deliver, within the permitted time periods, all annual or
other periodic reports required to be delivered to every applicable Regulatory
Authority. Seller represents and warrants that it is the legal
manufacturer of the Product.
3.14 Product Specifications;
Packaging and Labeling. All Products delivered by Seller
hereunder shall be in full compliance with the Specifications therefor and shall
be ready for end-user sale, including all packaging, labeling,
instructions-for-use and sterilization set forth therein, as
amended. All Products shall be labeled (including bar coding/UPN
numbers) in accordance with the work instructions, procedures and label
text/graphics specified in writing from time to time by Buyer and mutually
approved by Buyer and Seller. Buyer shall give Seller at least thirty (30) days
advance written notice of any change to its labeling procedures prior to the
date when such changes are to take affect. Notwithstanding anything
in this Agreement to the contrary, Buyer shall pay Seller for Waste
Reimbursements, as set forth in Section 2.3 above. All Products will be marked
to make it clear that they have been manufactured by Seller and are being
distributed by Buyer. Buyer may include Product as a component in any
kit or collection of products. Buyer maintains the right to
over-label Products as it deems necessary or appropriate in accordance with work
instructions, procedures, and label text/graphics, which are mutually approved
by both Parties hereto. Seller is not responsible for any
over-labeling or any consequences thereof. As used in
this Agreement, “Specifications” for the
Product means the specifications set forth on Exhibit A, as revised from time to
time pursuant to the next sentence, and as provided by Seller and approved by
Buyer, including the part number, revision level, controlled drawing, and
packaging and sterilization instructions for the Product and all requirements of
any applicable laws and regulations of the Regulatory Authorities, specified
therein. The Parties understand that the Specifications may need to
be revised from time to time up to the Product Launch Date. Each
version (each, a “Revision Level”) of the Specifications will be labeled with a
Revision Level number (“Revision Level Number”), starting with “A-1,” and
continuing sequentially with “A-2,” “A-3,” etc., and each revision of the
Specifications will be so labeled and attached to this
Agreement. Each subsequent Revision Level will replace and supersede
all former Revision Levels for all purposes hereunder, except with respect to
Article 4 of this Agreement. Attached to this Agreement as Exhibit A
as of the Effective Date is Revision Level “A-1.”
4. Confidential Information;
Intellectual Property.
4.1 Confidential
Information.
(a) "Confidential Information"
means all information disclosed by or on behalf of either Party hereto (a
“Disclosing Party”) to the other Party hereto (a “Receiving Party”), or any of
the Receiving Party’s employees, officers, directors, Affiliates,
subcontractors, agents, successors or assigns (collectively “Representatives” and together
with the Disclosing Party, the “Disclosing Group”), including
information (i) relating to the matters that are the subject of this
Agreement, including the terms, existence and nature of this
Agreement, (ii) all other information regarding the Disclosing
Party’s past, present or future research, technology, know-how, ideas, concepts,
designs, products, markets, customer information, computer programs, prototypes,
processes, machines, articles of manufacture, compositions of matter, business
plans and operations, technical information, drawings, specifications (including
Specifications), (iii) BSC Improvements or Bovie Improvements (as applicable),
and (iv) any knowledge or information developed by the Disclosing Party as a
result of work in connection with this Agreement that directly relates to the
Product, except information which is: (i) at the time of disclosure,
or thereafter becomes lawfully part of the public domain through no act or
omission by the Receiving Party; (ii) lawfully in the possession of Receiving
Party prior to disclosure by or on behalf of Disclosing Party, as shown by
written records; (iii) lawfully disclosed to the Receiving Party by a third
party which did not acquire the same under an obligation of confidentiality from
or through the Disclosing Group; or (iv) independently developed by the
Receiving Party without use of Confidential Information, as shown by written
records. If a Receiving Party believes in good faith that it is
required by law to disclose any Confidential Information, it shall provide
notice to the Disclosing Party, prior to making such disclosure so as to allow
Disclosing Party time to undertake legal or other action, to prevent such
disclosure or otherwise obtain confidential treatment of such
disclosure.
(b) A
Receiving Party shall not, without the prior consent of the Disclosing Party,
disclose any Confidential Information to anyone for any reason at any time or
use any Confidential Information for any purpose except as requested by the
Disclosing Party. The Receiving Party shall limit dissemination of
Confidential Information to only those Receiving Party Representatives having a
"need to know." A Receiving Party shall not, except as permitted
under this Agreement: (i) appropriate or use a Disclosing Party’s
Confidential Information in Receiving Party’s own manufacture of Products for
itself or for any third party or for any other purpose; or (ii) by virtue of
either this Agreement or its supply or purchase of Products, as applicable,
obtain any title to, or any interest or license in, any Confidential Information
of a Disclosing Party.
(c) Neither
Party shall issue a press release or other public announcement concerning this
Agreement (or any term sheet, bids, negotiations or other related information),
the transactions contemplated herein, or the relationship between the Parties
without the prior written approval of an authorized representative of the other
Party, which approval shall not be unreasonably withheld or
delayed.
(d) Neither
Party shall: (i) disclose to the other Party any confidential or
proprietary information belonging to any third party without the consent of such
party; or (ii) represent as being unrestricted any designs, plans, models,
samples, or other writings or products that the Disclosing Party knows or has
reason to know are covered by valid patent, copyright, trade secret, or other
form of intellectual property protection.
4.2 Buyer’s
Property. All tangible property
provided to Seller in connection with this Agreement, including: Product
requirements, drawings, standard operating protocols, quality testing and other
documentation, all samples, Buyer’s Confidential Information, all reports,
brochures, manuals, sales literature, all equipment and tooling, provided by
Buyer to test, manufacture or assemble the Products, and all Manufacturing
Equipment (collectively, “Buyer’s Property”) shall be
and remain the exclusive property of Buyer unless otherwise agreed in
writing. Seller shall: (a) keep and maintain in its
custody and subject to its control any Buyer’s Property that it receives or
develops during the term of this Agreement, for the sole benefit of Buyer; (b)
use Buyer’s Property solely in furtherance of fulfilling its obligations to
Buyer under this Agreement; and (c) return or surrender to Buyer all Buyer’s
Property within fifteen (15) days after termination or expiration of this
Agreement or otherwise upon written request by Buyer provided; however, such
return of Buyer’s Property does not interfere with Seller’s performance
hereunder.
4.3 Intellectual
Property.
(a) Buyer
and Seller acknowledge and agree that (i) the performance of engineering
services; and (ii) the development of designs, concepts, inventions, prototypes
and the like, and intellectual property relating thereto, by Seller prior to the
Effective Date, either solely or in cooperation with others including Buyer,
which relate solely to any medical device having a sintered, conductive metal
tip, are within the scope of this Agreement and the results of such services and
development are the exclusive property of Buyer and included within the
definition of BSC Intellectual Property provided in Section
4.3(b). Consideration for such services and development has been
accounted for in the price of the Products herein.
(b) Except
for Seller’s intellectual property related solely to electrosurgical generators
(e.g., RF energy generation, monitoring and control), (i) all intellectual
property, both domestic and foreign, including any and all tangible and
intangible trade secret rights, patents rights (including registrations,
applications, renewals, extensions, continuations, divisions, reexaminations and
reissues), processes, know-how, prototypes, Specifications, drawings, designs,
tools, industrial property rights, inventions, Improvements (excluding
manufacturing processes), developments or discoveries, conceived or made by
Buyer or Seller, whether patentable or not, related solely to any medical device
having a sintered, conductive metal tip, (ii) Buyer’s Confidential Information,
and (iii) Buyer’s Property (except Manufacturing Equipment) (collectively,
“BSC Intellectual
Property”), shall be the exclusive property of Buyer, and Seller shall
cooperate in assigning, and hereby does assign, all right, title, and interest
in and to such BSC Intellectual Property to Buyer. All copyrightable
works developed by Seller, either alone or with others, related to BSC
Intellectual Property, are “works made for hire” and are hereby assigned to and
shall belong exclusively to Buyer, and any and all copyright rights to such
works, including the right to copy or reproduce the works, create further
derivative works, file for copyright registration, and renew such rights, are
hereby assigned to, and shall be the exclusive property of, Buyer.
(c) Seller
agrees to cooperate with Buyer in the preparation, prosecution, filing and
maintenance of the BSC Intellectual Property during the term of this Agreement
and thereafter, and Buyer agrees to pay Seller reasonable compensation for such
cooperation.
(d) To
the extent there is jointly invented and jointly owned intellectual property,
each Party hereto agrees to cooperate with the other Party with the preparation,
prosecution, filing and maintenance of the intellectual property during the term
of this Agreement and thereafter beyond that provided by the
Agreement. Each Party agrees to pay the other Party reasonable
compensation for such cooperation beyond the term of this
Agreement.
(e) During
the term of this Agreement, and any extension thereof, Buyer hereby grants to
Seller a worldwide, royalty-free, non-exclusive license to use the BSC
Intellectual Property solely for the purpose of fulfilling its obligations
hereunder. No other license is granted by Buyer therein or in any
other of Buyer’s intellectual property. Buyer reserves to itself
exclusive ownership and rights in the BSC Intellectual Property, except to the
extent of the limited license granted in this section.
(f) Seller
agrees that there shall be no consideration provided by Buyer to Seller not
expressly contemplated in this Agreement for Seller’s manufacturing know-how and
other intellectual property used by Seller in the manufacture and delivery of
Product to Buyer.
4.4 Co-Branding
(a) All
labeling, packaging, materials for advertising and marketing, websites, and user
and technical documentation for Products (collectively, “Materials”) will be co-branded
with both the Boston Scientific and Bovie names (the “Co-Brand”). Unless
otherwise mutually agreed to by the Parties in writing, the Co-Brand shall be
present on all Materials in a size and format to be mutually agreed upon by the
Parties, but in all cases so that each name is prominent and reasonably legible
to the naked eye. The Parties will work in good faith to agree to one
or more standard Co-Brand templates for use on the Materials, which Templates
shall specify the acceptable visual characteristics of the Co-Brand for use on
Materials, and as long as one of these templates is used, Buyer may use the
Co-Brand without the further prior approval of Seller. Any deviation
from the template will require the prior written approval of Seller, which
approval shall not be unreasonably withheld.
(b) Buyer
will use Seller’s trademarks as adjectives and not as nouns or verbs, and not in
the plural or possessive form. In advertising and marketing
materials, Buyer shall distinguish Seller’s trademark from surrounding text by
using bold, italics or the appropriate visual tools, or by capitalization or the
use of quotation marks, and will use the proper trademark symbol in connection
with Seller’s trademarks.
(c) Seller
hereby grants to Buyer a fully paid-up, royalty free license to use Seller’s
trademarks solely in connection with the marketing, distribution, import,
export, use, offer to sell and sale of the Products.
(d) Seller
will take such actions as are reasonably necessary to prosecute and maintain its
trademarks and shall inform Buyer of any changes in or additions to any
trademark used in the Co-Brand materials.
(e) Except
as required under this Agreement, and as set forth in this Section 4.4
(Co-Branding), in no event will Seller be permitted to use Buyer’s trademarks
without the prior written consent of Buyer.
(f) Combining
the Parties’ trademarks is permitted only as mutually agreed to by the Parties
for purposes of the Co-Brand.
5. Insurance and
Indemnification.
5.1 Insurance. Seller shall:
(a) during the term of this Agreement, maintain commercial general liability
insurance, naming Buyer as additional insured and loss-payee; and (b)
immediately notify Buyer in writing of any change or cancellation relating to
such policy. Prior to execution of this Agreement, Seller shall
provide Buyer with a certificate of insurance evidencing such
insurance.
5.2 Indemnification.
(a) Seller
shall indemnify, defend and hold harmless Buyer and its Affiliates and their
respective directors, officers, employees and agents from and against any claim,
action, suit, demand, damage, expense or losses (including
reasonable attorneys’ fees) (collectively, "Claims") resulting from or in
any way relating to: (i) the gross negligence, intentional misconduct, or
violation of law by Seller or Seller Representatives in the performance of, or
its failure to perform, any of Seller’s obligations under this Agreement; (ii)
any material breach of Seller’s representations, warranties, covenants or
obligations under this Agreement, including Seller’s obligation to deliver
Product under this Agreement; or (iii) infringement or alleged infringement of
any third party intellectual property rights with respect to any Product
provided by Seller to Buyer hereunder to the extent that infringement is found
by a court of competent jurisdiction to result from the use or sale of a Bovie
Improvement or the incorporation of Bovie Intellectual Property into a
Product.
(b) Buyer
shall indemnify, defend and hold harmless Seller and its Affiliates and their
respective directors, officers, employees and agents from and against any Claims
resulting from or in any way relating to: (i) the gross negligence,
intentional misconduct, or violation of law by Buyer in the performance of, or
its failure to perform, any of Buyer’s obligations under this Agreement; (ii)
any material breach of Buyer’s representations, warranties, covenants or
obligations under this Agreement, or (iii) infringement or alleged infringement
of any third party intellectual property rights with respect to any BSC
Intellectual Property (including Specifications or requirements provided by
Buyer to Seller hereunder), except to the extent that infringement is found by a
court of competent jurisdiction to result from Buyer’s use, manufacture, offer
to sell, or sale of Bovie’s Intellectual Property or Bovie’s Improvements
incorporated into a Product.
(c) Each
Party’s obligations to the other Party under this Section 5.2 are conditioned
upon the Party seeking indemnification: (i) providing notice to the
indemnifying Party of any Claims promptly, but not later than thirty (30) days
after the Party knows of such Claim; (ii) permitting the indemnifying Party to
assume full responsibility for the defense of such Claim; (iii) assisting the
indemnifying Party in defense of such Claim; and (iv) not compromising or
settling any such Claim without the indemnifying Party’s prior
consent. Notwithstanding the foregoing, a Party's failure to give
the notice specified in Section 5(c)(i), or delay in giving such notice, shall
not affect such Party's right to indemnification under this Section 5.2 except
to the extent that the indemnifying Party has been prejudiced by such failure or
delay. In addition, the indemnifying Party may not settle a claim
without the indemnified Party’s consent unless such settlement includes a full
release or license for both past and future sales of Product at no additional
cost to the indemnified Party.
6. Remedies. Termination of this Agreement, or
the exercise of any other remedy, shall not be deemed to be an exclusive remedy
hereunder, and shall be in addition to any other remedies available at law or in
equity (including a Party’s right to obtain specific performance and other
equitable relief for other Party’s material breach).
7.
Term.
7.1 Term;
Termination. The initial
term of this Agreement shall commence on the Effective Date and expire on the
fifth (5th) 12-month anniversary of the Product Launch Date of the
Product. This Agreement will automatically renew for additional
one-year periods, unless notice of cancellation is delivered by either Party at
least one hundred and eighty (180) days prior to the end of the then current
term. Notwithstanding the above, this Agreement shall
terminate:
(a) subject
to Section 7.1(b), sixty (60) days after notice of a material breach from one
Party to the other, but only if such breach remains uncured at the end of such
60-day period; provided, however, that this
Agreement shall terminate immediately upon notice of breach to a Party if the
same or similar material breach was the subject of a previous notice of breach
pursuant to which a 60-day cure period was previously provided to such
Party;
(b) subject
to the Force Majeure provisions of Section 7.3, immediately upon notice from
Buyer if: (i) Seller does not satisfy Buyer’s binding purchase order
requirements for any two (2) consecutive months; (ii) Buyer determines in good
faith that Five Percent (5%) or more of any particular Product manufactured and
delivered to Buyer during a calendar month is defective, or does not meet the
Specifications for such Product, anytime after the first ninety (90) days of the
term of this Agreement; (iii) Buyer believes in good faith that Seller's quality
assurance policies do not comply with Section 3; or (iv) Buyer reasonably
determines that any material breach hereunder does or may negatively impact the
performance of any of Buyer’s Products, Buyer’s reputation, patient safety or
the safety of any other persons or the environment;
(c) in
accordance with Section 7.3 or 7.4 hereof;
(d) immediately
upon notice from a Party if the other Party has become the subject of voluntary
or involuntary bankruptcy, receivership, or insolvency proceedings;
(e) following
one hundred and twenty (120) days written notice from Buyer of its intent to
terminate for convenience;
(f) immediately
upon notice from Seller if Buyer fails to make payments to Seller in accordance
with the provisions of Section 2.2, above.
7.2 Fulfillment Upon
Termination. (a) Upon termination (except pursuant to Section
7.1(e), above) or expiration of this Agreement, Seller shall be obligated to
fulfill any then open binding purchase orders, and Buyer shall be obligated to
purchase (a) all Products on open binding purchase orders not yet purchased, and
(b) all then-existing Shelf Inventory; provided, however, that in no
event shall Buyer be required to purchase any Product (including work-in-process
or raw materials or Shelf Inventory) after any termination of this Agreement by
Buyer pursuant to Section 7.1(a), (b), (c) or (d) .
(b) Upon
termination pursuant to Section 7.1(e), above, in Contract Years One or Two, if
Buyer has not purchased the minimum quantity of Product units for Contract Years
One and Two, as set forth in Section 1.3, above, Buyer shall immediately
purchase or, at its election, pay for in cash the transfer price of the number
of Product units equal to the difference between Thirty-Five Hundred (3,500) and
the actual number of Product units purchased to that point in time by Buyer.
Upon termination pursuant to Section 7.1(e), above, after Contract Year Two,
Buyer shall be obligated to purchase (a) all Products on then open binding
purchase orders not yet purchased, and (b) all then-existing Shelf
Inventory.
7.3 Force
Majeure. If a Party’s performance is delayed because of war or
similar unrest, terrorism, fire, act of God or other similar cause that is
beyond its control and which such Party could not have reasonably prevented,
such delay in performance shall not be considered a breach of this Agreement;
provided, however that if such
delay continues for sixty (60) days or more, then: (a) the other
Party may upon notice cancel all or any portion of unfilled orders; and (b) that
other Party may immediately terminate this Agreement.
7.4 Failure to
Supply. If Seller fails to meet its binding supply obligations
under any binding purchase orders provided by Buyer pursuant to Section 1.3, and
such failure:
(a) remains
uncured for more
than ** **, then such
shortfall shall be sold to Buyer at a price discount
of ** ** percent ** **
and this discount will remain in effect for three (3) consecutive months after
the failure to supply has been cured; and
(b) results
in less than the specified number of Product units being delivered to Buyer for
any five (5) months, whether consecutive or not, at any time during the term of
this Agreement, then Buyer may terminate this Agreement immediately upon written
notice and initiate a manufacturing transfer pursuant to Section 7.5 hereof to
be completed by Seller at Seller’s expense.
7.5 Manufacturing
Transfer. In the event of any termination of this Agreement,
Seller shall physically transfer to Buyer, at Buyers expense, all of Buyer’s
Property held by Seller. Buyer may purchase from Seller, all tooling
developed by Seller and not previously charged to Seller.
8. Warranty.
In
addition to any other representations and warranties of Seller herein, Seller
represents and warrants to Buyer that all Products supplied to Buyer hereunder
shall: (a) conform to the Product Specifications, (b) be manufactured, labeled,
packaged and tested in accordance with the applicable regulatory approvals
therefor and the applicable laws and regulations relating to the manufacture,
labeling, packaging and testing of Products, and (c) be free from
defects in design, materials and workmanship. Seller shall provide
all end-users of all Products a limited warranty that reasonable care has been
used in the design and manufacture of the Products. If a Product does
not conform to the warranties set forth above, Seller will replace the Product,
issue Buyer a refund, or issue Buyer a credit toward future purchases, solely at
Seller’s discretion.
9. Miscellaneous.
9.1 Seller
is an independent contractor of Buyer, and neither Party has the power to bind
the other. Subject to the limitations of Force Majeure set forth in
Section 7.3, above, time is of the essence in performance
hereunder.
9.2 Neither
Party shall assign this Agreement or its obligations hereunder, whether
voluntarily or involuntarily, without the express prior written consent of the
other Party, except that either Party hereto may assign all of its rights and
obligations under this Agreement to any purchaser, directly or indirectly, of
(a) in the case of Seller, all or substantially all of Seller’s assets (or
stock), and (b) in the case of Buyer, all or substantially all of Buyer’s
Oncology Business assets (or stock), without the other Party’s
consent. Any permitted assignee hereunder is deemed to have assumed
the assignor’s performance obligations in favor of the non-assigning
Party.
9.3 This
Agreement is fully binding upon either Party’s successors and permitted
assigns.
9.4 All
requests, approvals, consents and notices must be in writing and will be
effective as of the date actually received and, unless otherwise specified in
this Agreement, shall be sent as follows: (i) certified mail - return receipt
requested; (ii) a nationally recognized overnight delivery service that
guarantees overnight delivery and requires the signature of recipient; or (iii)
facsimile, transmission confirmed; to the addresses and fax numbers indicated on
the first page of this Agreement; provided, however, that a copy
is also sent one of the foregoing methods of subsection (i) or (ii),
above
9.5 This
Agreement: (i) is governed by the laws of The State of New York,
without reference to its internal principles of conflicts of laws; (ii) together
with all Exhibits thereto (which are hereby incorporated into this Agreement) is
the entire and exclusive set of terms and conditions for transactions made with
respect to the Products; (iii) supersedes conflicting terms of purchase orders,
invoices or other documents issued under it; and (iv) may only be modified by a
writing signed by both Parties.
9.6 Headings
of the articles, sections and subsections of this Agreement, and the name of
this Agreement, are for reference purposes only and shall not limit or affect
the meaning or construction of the terms and conditions
hereof. Whenever the words “include”, “includes” or “including” are
used in this Agreement, they shall be deemed in each instance to be followed by
the words “without limitation.”
9.7 No
failure of either Party to enforce any right under this Agreement shall be
deemed a waiver thereof.
9.8 For
purposes of clarity, nothing in this Agreement shall restrict: as to Buyer, the
right to pursue alternative resection device technology or Dissimilar Devices
(defined below) from third parties or, as to Buyer or Seller, from
developing alternative resection device technology or Dissimilar Devices
internally or from selling any such Dissimilar Devices. As used herein, a
"Dissimilar Device" is a
medical device whose manufacture, use, importation, offer for sale, or sale,
would not, if performed by a party other than Buyer (or its licensee) infringe
BSC Intellectual Property.
9.9 All
obligations and rights which are by their nature continuing, including the
obligations contained in Sections 3.7 and 7.2 and Sections 4 through 6, and 8,
shall survive the expiration or termination of this Agreement.
[BALANCE
OF THIS PAGE INTENTIONALLY LEFT BLANK]
10. Additional Representations
and Warranties. Each Party hereby represents and warrants to
the other that: (a) the execution and delivery of and performance
under this Agreement by such Party does not, and will not, conflict with or
violate any other agreement or obligations with third parties or any
restrictions of any kind or any law to which it is bound or subject; and (b) it
has the unrestricted right to disclose any information it submits to the other
Party, free of all claims of third parties, and that such disclosures do not
breach or conflict with any confidentiality provisions of any agreement to which
it is a party.
Each Party hereto further hereby represents and warrants that (x) it owns
or has sufficient license and right to intellectual property used in connection
with or incorporated into the Product; and (y) the manufacture, use,
importation, offer for sale, and sale of the Product does not and will not
infringe the intellectual property rights of any third party.
ACCEPTANCE
OF AGREEMENT
By
signing below the undersigned acknowledge and accept all terms and conditions of
this Agreement.
|
SELLER: BOVIE MEDICAL
CORPORATION
|
BUYER: BOSTON SCIENTIFIC
CORPORATION
|
|||
|
By:
|
/S/ Moshe Citronowicz
|
By:
|
||
|
(Signature)
|
(Signature)
|
|||
|
Print
Name:
|
Moshe Citronowicz
|
Print
Name:
|
Dave
McClellan
|
|
|
Title:
|
Vice President/COO
|
Title:
|
President,
Oncology Division
|
|
|
Date
Signed:
|
10/06/06
|
Date
Signed:
|
||
|
By:
|
||||
|
(Signature)
|
||||
|
Print
Name:
|
Ghislain
Gackiere
|
|||
|
Title:
|
Finance
Director
|
|||
|
Date
Signed:
|
||||
EXHIBIT
A: PRODUCT AND PRODUCT SPECIFICATIONS
|
Author
Thomas
Feldhaus
|
Document
Number
|
Rev
Level
A-1
|
Page
1-12
|
|
|
Title: Product
Specification: Resection
Device
|
||||
EXHIBIT A
Version A-1 to Exhibit 10.12 – Redacted
BOVIE
–
Resection
Device
Product
Specifications
BOVIE MEDICAL
CORPORATION
CONFIDENTIAL
FOR INTERNAL USE
ONLY
BOVIE
MEDICAL CONFIDENTIAL
THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR. INFORMATION HEREIN IS CONFIDENTIAL. DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.
|
Author
Thomas
Feldhaus
|
Document
Number
|
Rev
Level
A-1
|
Page
2-12
|
|
|
Title: Product
Specification: Resection
Device
|
||||
Table of
Contents
|
1 INTRODUCTION
|
4
|
|
1.1 Purpose
|
4
|
|
1.2 Scope
|
4
|
|
2 APPLICABLE
DOCUMENTS
|
4
|
|
2.1 Standards
|
4
|
|
3.0
GENERAL DESCRIPTION
|
4
|
|
3.1
Concept Drawing
|
5
|
|
3.2
Application
|
5
|
|
3.2.1
Intended Use
|
5
|
|
3.2.2
Intended Users
|
6
|
|
3.3
Quality System Requirements
|
6
|
|
3.3.1
US Requirements
|
6
|
|
3.3.2
Canadian Requirements
|
6
|
|
3.3.3
European Classifications
|
7
|
|
3.3.4
Quality System Requirements
|
7
|
|
4 PRODUCT
DOCUMENT STRUCTURE
|
7
|
|
4.1 Project
Documentation
|
7
|
|
4.2 Model Number
Format
|
7
|
|
5 PRODUCT
REQUIREMENTS
|
8
|
|
5.1 Electrical and
Mechanical
|
8
|
|
5.1.1 Insulated
Handle
|
8
|
|
5.1.2 Shaft
and Electrode Tip
|
9
|
|
5.1.3 Shipping
and Handling
|
10
|
|
5.1.4 Sterilization
|
10
|
|
6 Protection
Against Hazards
|
10
|
|
7 Packaging
|
10
|
|
7.1 Labeling
|
10
|
|
7.2 Packaging
Configuration
|
11
|
|
7.3 Manufacturing
|
11
|
BOVIE
MEDICAL CONFIDENTIAL
THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR. INFORMATION HEREIN IS CONFIDENTIAL. DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.
|
Author
Thomas
Feldhaus
|
Document
Number
|
Rev
Level
A-1
|
Page
3-12
|
|
|
Title: Product
Specification: Resection
Device
|
||||
List
of Tables
|
Table
One – Standards
|
Page
4
|
|
Table
Two – Device Classifications
|
Page
6
|
|
Table
Three – Model Number Format
|
Page
7
|
|
List
of Figures
|
|
|
Figure
One – Concept Drawing
|
Page
5
|
BOVIE
MEDICAL CONFIDENTIAL
THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR. INFORMATION HEREIN IS CONFIDENTIAL. DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.
|
Author
Thomas
Feldhaus
|
Document
Number
|
Rev
Level
A-1
|
Page
4-12
|
|
|
Title: Product
Specification: Resection
Device
|
||||
|
1
|
INTRODUCTION
|
|
1.1
|
Purpose
|
This
Product Specification defines preliminary product requirements and constitutes a
part of the Design Inputs for the Resection Device Project for Boston Scientific
Corporation (“BSC”).
|
1.2
|
Scope
|
This
Product Specification sets forth the requirements, provided by BSC, for the
Resection Device, (the “Device”).
|
2
|
APPLICABLE
DOCUMENTS
|
The
following is a list of all documents and other sources of information referenced
in this Product Specification.
|
2.1
|
Standards
|
|
Standard
|
|
Version/Date
|
|
Description
|
|
21
CFR Part 820
|
Medical
Devices, Current Good Manufacturing Practices, Final Rule, Quality System
Regulation.
|
|||
|
HF-18
|
2001
|
AAMI/ANSI
Electrosurgical Devices
|
||
|
10993-1
|
3;
Date 8-1-03
|
AAMI/ANSI/ISO
Biological evaluation of medical devices – Part 1: Evaluation and
Testing
|
||
|
EN
980
|
2003
04/16/2003
|
Graphical
symbols for use in the labeling of medical devices
|
||
|
EN
ISO 14971
|
2000
AMD 1 2003
03/01/2003
|
Medical
devices – Application of risk management to risk management to medical
devices (ISO 14971:2000)
|
||
|
ISTA
2A 2006
|
2006
|
Performance
Test for Packaged-Products Weighing 150 lbs (68 kg) or
Less
|
Table 1 -
Applicable Standards for Medical Devices (US)
|
3.0
|
GENERAL
DESCRIPTION
|
The
Device is a sterile, single use electrosurgical device intended to be used in
conjunction with an electrosurgical generator for the delivery of radiofrequency
(“RF”) current and sterile saline for hemostatic sealing and coagulation of soft
tissue in accordance with instructions and user procedures provided by
BSC. The device is not intended for any other unspecified uses.
BOVIE
MEDICAL CONFIDENTIAL
THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR. INFORMATION HEREIN IS CONFIDENTIAL. DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.
|
Author
Thomas
Feldhaus
|
Document
Number
|
Rev
Level
A-1
|
Page
5-12
|
|
|
Title: Product
Specification: Resection
Device
|
||||
|
3.1
|
Concept
Drawing
|
Figure 1
|
3.2
|
Application
|
|
3.2.1
|
Intended
Use
|
The
Device is a sterile, single use electrosurgical device intended to be used in
conjunction with an electrosurgical generator for the delivery of radiofrequency
current and sterile saline for hemostatic sealing and coagulation of the soft
tissue in accordance with instructions and user procedures provided by BSC. The
device is not intended for any other unspecified uses.
BOVIE
MEDICAL CONFIDENTIAL
THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR. INFORMATION HEREIN IS CONFIDENTIAL. DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.
|
Author
Thomas
Feldhaus
|
Document
Number
|
Rev
Level
A-1
|
Page
6-12
|
|
|
Title: Product
Specification: Resection
Device
|
||||
|
3.2.2
|
Intended
Users
|
Users of
this Device will be healthcare professionals such as medical doctors and nurses,
who are qualified and trained in electrosurgical procedures.
|
3.3
|
Quality
System Requirements
|
The
Device has the following classifications for FDA, CMDR, and MDD
classification.
|
Device
|
US Classification
|
Canada
Classification
|
MDD
Classification
|
|||
|
Resection
Device
|
II
|
III
|
IIb
|
Table 2 -
Device Classifications
|
3.3.1
|
US
Requirements
|
To market
medical products, the Food and Drug Administration (FDA) must determine that a
medical device is substantially equivalent to similar marketed medical
devices. The Bovie Regulatory department intends to use the
dissecting sealer device manufactured by TissueLink as a predicate
device.
|
3.3.1.1
|
Classification
|
The
Device’s classification is Class II.
|
3.3.1.2
|
Safety
and Effectiveness
requirements
|
The
Device will meet electrical safety requirements (ANSI/AAMI
HF-18:2001).
|
3.3.1.3
|
Quality
System Requirements
|
Quality
system requirements are specified as part of 21 CFR Part 820, Quality System
Regulation.
|
3.3.2
|
Canadian
Requirements
|
To market
medical products in Canada, a license application must be presented to Health
Canada. Once the license application is approved, the medical product can be
labeled and made available for sale in the Canadian provinces.
|
3.3.2.1
|
Classification
|
Class
III
BOVIE
MEDICAL CONFIDENTIAL
THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR. INFORMATION HEREIN IS CONFIDENTIAL. DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.
|
Author
Thomas
Feldhaus
|
Document
Number
|
Rev
Level
A-1
|
Page
7-12
|
|
|
Title: Product
Specification: Resection
Device
|
||||
|
3.3.2.2
|
Safety
and Effectiveness
requirements
|
Safety
and effectiveness requirements closely correspond to the essential requirements
of the Medical Device Directive. A list of Health Canada recognized
standards has been issued as of April 11, 2002 in Policy on Recognition and Use
of Standards under Medical Device Regulations.
|
3.3.2.3
|
Quality
System Requirements
|
Health
Canada requires manufacturers of Class II, III and IV device to demonstrate that
their devices are manufactured in accordance with internationally recognized
standards. Demonstration of compliance with the quality system
requirements will be required at the time an application is made for a medical
device license.
|
3.3.3
|
European
Classifications
|
|
3.3.3.1
|
Classification
|
The
Device is classified IIb (Rule 9 ) in accordance with the Medical Devices
Directive Annex IX.
(Reference:
Guidelines for the Classification of Medical Devices – MEDDEV 2.4/1 Rev. 8, July
2001)
|
3.3.3.2
|
Conformance
Assessment Route
|
The
Device assessment route will be via Annex II (full quality assurance
system).
|
3.3.4
|
Quality
System
Requirements
|
Bovie
Medical Corporation (“Bovie”) has been certified to ISO13485
|
4
|
PRODUCT
DOCUMENT STRUCTURE
|
|
4.1
|
Project Documentation
|
Documents
will be in standard Bovie document format.
|
4.2
|
Model Number Format
|
The
following table lists the Device’s model number and corresponding product /
catalog code.
|
Catalog #
|
Comments
|
|
|
TBD
|
Laparoscopic Monopolar
Device
|
|
|
TBD
|
Open
Abdominal Monopolar
Device
|
Table
Three
BOVIE
MEDICAL CONFIDENTIAL
THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR. INFORMATION HEREIN IS CONFIDENTIAL. DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.
|
Author
Thomas
Feldhaus
|
Document
Number
|
Rev
Level
A-1
|
Page
8-12
|
|
|
Title: Product
Specification: Resection
Device
|
||||
|
5
|
PRODUCT
REQUIREMENTS
|
The
following section will describe requirements for the insulated handle and shaft
with electrode tip.
|
5.1
|
Electrical
and Mechanical
|
The
Device hardware is comprised of two (2) major components: (i) an Insulated
Handle and (ii) a Shaft with Electrode Tip. RF energy is passed through the
Insulated Handle through the Shaft to the Electrode Tip by a powered lead from
an electrosurgical generator.
|
5.1.1
|
Insulated
Handle
|
The
Insulated Handle encases the controlling mechanism for the flow of saline, and
activation and selection of the RF current for the Device.
5.1.1.1
Insulated Handle and Power Cord Insulation Resistance
The
insulation of the Insulated Handle and Power Cord shall meet Requirements of
Section 4.2.5.4 Dielectric withstands of accessories ANSI/AAMI
HF-18:2001
5.1.1.2
Insulated Handle Ergonomics
The
Insulated Handle shall be designed for comfortable and efficient hand
operation. It will incorporate an over-mold to give the body an
elegant feel and soft touch.
5.1.1.3
Insulated Handle Electrical Cord
The
Insulated Handle Electrical Cord shall be approximately ten (10) feet in length
and incorporate a 3-prong electrical plug.
5.1.1.4
Insulated Handle Flow Control Mechanism
The
Device will have a flow control mechanism, either on the tubing or in the handle
itself so the flow can be regulated by the user within the sterile
field.
5.1.1.5
Insulated Handle Tubing Length
The
tubing length should be approximately seven (7) feet in length and incorporate
an I.V. spike on the end to attach directly to a hanging IV bag.
5.1.1.6
Insulated Handle Tubing Material
The
tubing material should be a material that will resist kinking but should not
have so strong a memory as to pull the probe off of the sterile
field.
5.1.1.7
Insulated Handle Activation Buttons
The Device should have a Cut and Coagulation Mode. “Cut”/”Coag”
buttons must be easy to operate.
BOVIE
MEDICAL CONFIDENTIAL
THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR. INFORMATION HEREIN IS CONFIDENTIAL. DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.
|
Author
Thomas
Feldhaus
|
Document
Number
|
Rev
Level
A-1
|
Page
9-12
|
|
|
Title: Product
Specification: Resection
Device
|
||||
5.1.1.8
Insulated Handle Compatibility
|
|
·
|
The
Insulated Handle should have compatibility with standard RF generators
used for electrocautery and standard grounding
pad.
|
|
|
·
|
The
Insulated Handle should have compatibility with standard 0.9% saline I.V.
bag.
|
|
5.1.2
|
Shaft
and Electrode Tip
|
The Shaft
and Electrode Tip provide the actual working portion of this
system.
5.1.2.1
Saline Flow Rate of Device
The
Saline flow rate prior to use will be
** **
5.1.2.2
Device (Shaft) Length
The
Device should be straight and have two (2) lengths: one for laparoscopic
monopolar procedures (approximately thirty-two (32) cm) and one for open
monopolar procedures (approximately fourteen (14) cm).
5.1.2.3
Shaft Configuration
The Shaft
will be hollow to allow for fluid to flow to the sintered stainless steel tip.
The inside diameter of the Shaft should be equal to the inside diameter of the
tubing that feeds fluid to the Shaft to minimize any flow restriction in the
fluid circuit.
5.1.2.4
Tip Material
The Tip
shall be made of ** **
.
5.1.2.5
Tip Strength
The
porous blade tip to shaft tensile bond strength (axial mode) must be greater
than ** **
after
being subjected to a full-power simulated use duty cycle.
The
porous blade tip to shaft bond strength in an flexural mode must be greater than
** **
. after being subjected to a full-power simulated use duty
cycle.
BOVIE
MEDICAL CONFIDENTIAL
THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR. INFORMATION HEREIN IS CONFIDENTIAL. DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.
|
Author
Thomas
Feldhaus
|
Document
Number
|
Rev
Level
A-1
|
Page
10-12
|
|
|
Title: Product
Specification: Resection
Device
|
||||
5.1.2.6
Tip performance
|
|
·
|
Bovie
will exert its best efforts to meet the design goal that tip cutting
performance be superior to competitive devices with respect to cutting
speed. Tip will have the ability to coagulate soft tissue when performed
in a suitable simulated use
environment.
|
|
5.1.3
|
Shipping
and Handling
|
4.1.3.1
Shipping Temperatures
Tropical
(Wet and Dry) Conditions and Winter (Frozen) Conditions per ISTA
2A.
4.1.3.2
Transportation Testing
The Final
Product Packaging Configuration for the Device shall meet the finished device
requirements after being subjected to Simulated Transportation Conditioning per
ISTA 2A.
|
5.1.4
|
Sterilization
|
5.1.4.1
Withstand 2x ETO Sterilization.
5.1.4.2
EN 550: 1994 – Sterilization of Medical Devices – Validation and routine control
of ethylene oxide sterilization.
5.1.4.3
AAMI/ANSI/ISO 11135 -1994 Medical Devices – Validation and routine control of
ethylene oxide sterilization.
|
6
|
Protection
Against Hazards
|
A
Hazard/Risk Analysis will be performed throughout the design
process. The Hazard/Risk Analysis will be documented and filed as
part of the design history file.
|
7
|
Packaging
|
|
7.1
|
Labeling
|
7.1.1
Package must be labeled in accordance with both BSC and Bovie Labeling
Standards.
7.1.2 BSC and Bovie branding, including mutually approved trademarks, will
be on the Handle and/or the shaft.
7.1.3 The Device is to have a three (3) year shelf life under normal storage
conditions.
BOVIE
MEDICAL CONFIDENTIAL
THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR. INFORMATION HEREIN IS CONFIDENTIAL. DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.
|
Author
Thomas
Feldhaus
|
Document
Number
|
Rev
Level
A-1
|
Page
11-12
|
|
|
Title: Product
Specification: Resection
Device
|
||||
|
7.2
|
Packaging Configuration
|
|
|
·
|
The
Tip and Shaft protector shall be included into the
Design.
|
|
|
·
|
The
Scratch Pad shall be packaged with the
Device.
|
|
|
·
|
The
Device will be packaged in a Sterile
Pouch.
|
|
7.3
|
Manufacturing
|
Final
assembly and packaging will be performed by Bovie.
BOVIE
MEDICAL CONFIDENTIAL
THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR. INFORMATION HEREIN IS CONFIDENTIAL. DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.
|
Author
Thomas
Feldhaus
|
Document
Number
|
Rev
Level
A-1
|
Page
12-12
|
|
|
Title: Product
Specification: Resection
Device
|
||||
APPROVALS
|
Author
|
|||
|
Thomas
Feldhaus
|
Date
|
||
|
Sales
& Marketing
|
|||
|
Rick
Pfahl
|
Date
|
||
|
Regulatory
|
|||
|
Rick
Kozloff
|
Date
|
||
|
Quality
|
|||
|
John
Woody
|
Date
|
||
|
Manufacturing
|
|||
|
Lillian
Eshem
|
Date
|
||
|
Engineering
|
|||
|
Fred
Baron
|
Date
|
BOVIE
MEDICAL CONFIDENTIAL
THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR. INFORMATION HEREIN IS CONFIDENTIAL. DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.
EXHIBIT
B: BUYER’S FORM OF PURCHASE ORDER
PURCHASE
ORDER
|
Boston
Scientific
Corporate
Headquarters
One
Boston Scientific Place
Natick,
MA 01760
USA
|
Page
1
Purchase
Order No.
6056307
|
||
|
This
number must appear on all invoices, packages and
correspondence
|
|||
|
Ship
to Address:
|
|||
|
Boston
Scientific
Corporate
Headquarters
One
Boston Scientific Place
Natick,
MA 01760
USA
|
|||
|
Bill
to Address:
|
|||
|
Boston
Scientific
Corporate
Headquarters
One
Boston Scientific Place
Natick,
MA 01760
USA
|
|||
|
Tax
Exemption No.
|
|||
|
Telephone:
|
5086478600
|
04-2695240
|
|
|
FAX:
|
5086479416
|
||
|
Date
Ordered:
|
FOB
|
Mode
of Transportation
|
|
|
9-28-2006
|
VNCR:
FOB: Ship Point - Collect
|
||
|
Buyer
No.
|
Confirm
To:
|
||
|
06B
NAT
|
John
Q. Public
|
||
|
Terms
of Payment
|
|||
|
Within
45 days Due net
|
|||
|
Item
|
Port
Number
|
Description
|
|||||
|
Quantity
|
UOM
|
Due
Date
|
Unit
Price
|
Taxable
|
Revision
Total
|
||
|
00010
|
(Test
Purchase Order)
|
||||||
|
1.00
EA
|
150.00/100
|
Y
|
0.00
|
||||
|
Balance
Due: 0.03
Item
Text:
***
Item Canceled ***
***
Item Canceled ***
|
|||||||
|
TOTAL
ORDER:
|
0.00
|
||||||
|
CURRENCY:
|
USD
|
||||||
|
Authorized
Signature
JOHN
SMITH
|
|||||||
|
BUYER
|
|||||||
No
changes or substitutions can be made to DSC specified components or he
processing of those components without prior notification and approval of the
purchasing department.
VENDOR
COPY
EXHIBIT
C: NON-BINDING 12-MONTH FORECAST
Surgical
Resection
|
Year
1
|
|||||||||||||||||||||||||
|
Month
1
|
Month
2
|
Month
3
|
Month
4
|
Month
5
|
Month
6
|
Month
7
|
Month
8
|
Month
9
|
Month
10
|
Month
11
|
Month
12
|
Totals
|
|||||||||||||
|
** **
|
** **
|
** **
|
** **
|
** **
|
** **
|
** **
|
** **
|
** **
|
** **
|
** **
|
** **
|
** **
|
** **
|
EXHIBIT
D: LONG LEAD TIME COMPONENTS
(To
be provided as set forth in Section 1.7(a))
EXHIBIT
E: TRANSFER PRICES
|
Units Purchased in Contract Years 1-2 (in
aggregate)
|
Price per Unit*
|
|
|
** **
|
** **
|
|
|
** **
|
** **
|
|
|
Units Purchased in Contract Years 3-5
(annually)
|
Price per Unit*
|
|
|
** **
|
** **
|
|
|
** **
|
** **
|
|
|
** **
|
** **
|
|
|
** **
|
** **
|
|
|
** **
|
** **
|
*Note:
use of this Exhibit, including the determination of applicable pricing, is
subject to the provisions of Section 1.3 of the Agreement.
EXHIBIT
F: SELLER’S VENDORS
The
following list is tentative as of the Effective Date, and Seller reserves the
right to amend this list upon finalization and approval of the Specifications
and Bill-of-Materials for the Product.
1.
** **
2. Mott
Corporation 84
Spring Lane, Farmington, CT 06032, 860-747-6333.
3. ** **