EXHIBIT 10.1
THIS VERSION HAS BEEN MODIFIED TO OMIT CERTAIN
CONFIDENTIAL INFORMATION OF VISION-SCIENCES, INC., WHICH HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED. THE PLACES IN THE DOCUMENT WHERE INFORMATION HAS
BEEN OMITTED ARE MARKED WITH [*].
EXCLUSIVE DISTRIBUTION
AGREEMENT
This Exclusive Distribution
Agreement (the “Agreement”) is made as of this 29th day
of December, 2004 (the “Effective Date”) by and between
Vision-Sciences, Inc. , a Delaware corporation (the
“Company”), and Medtronic USA, Inc ., a
Minnesota corporation (“MDT”, and collectively with the
Company, the “Parties”).
WHEREAS, the Company is engaged in
developing, manufacturing and marketing medical devices for use in
urology and related applications; and
WHEREAS, the Company wishes to
appoint MDT, and MDT wishes to accept its appointment as, the
exclusive distributor of the Products (as defined below) in the
Field (as defined below), all in accordance with the terms and
conditions of this Agreement.
NOW, THEREFORE, in consideration of
the mutual covenants and agreements hereinafter set forth, and for
other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the Parties agree as
follows:
1.
DEFINITIONS
1.1
“Affiliate” means, in
respect of any specified Person, any other Person which, but only
for so long as such other Person, directly or indirectly, controls,
is controlled by, or is under common control with, such specified
Person. The term “control” means the possession,
directly or indirectly, of the power to direct or cause the
direction of the management or policies of a Person, through the
ownership of voting securities or other equity interests, and the
terms “controlled” and “common control”
shall have correlative meanings.
1.2
“Field” means the field
of urology including urogynecology.
1.3
“Intellectual Property”
means all rights to patents, software, copyrights, trademarks,
trade secrets, know-how, concepts, designs, techniques, formulae,
inventions, trade names, labels, trade dress, literature, programs,
advertising material or other documents, materials or
information.
1.4
“MDT Appointee” means an
entity other than an Affiliate of MDT appointed by MDT, with
Company’s consent, which shall not be unreasonably withheld,
to perform one or more of MDT’s duties or functions pursuant
to this Agreement.
1.5
“Person” means any
natural person or any corporation, partnership, limited liability
company, business association, joint venture or other
entity.
1.6
“Products” means the
product or product groups listed on Annex A attached to and made a
part of this Agreement, improvements and replacements for those
products, and such other product or product groups as shall be
added to Annex A pursuant to Section 2.4, provided that Products
shall only include products that are directed to applications
within the Field and that are labeled and intended for use within
the Field.
1.7
“Territory” means the
United States of America and Canada.
2.
APPOINTMENT OF DISTRIBUTOR;
PRODUCTS
2.1
The Company hereby grants MDT the
exclusive right, effective as of the Effective Date, to distribute,
sell, advertise, promote and market the Products solely to
customers practicing within the Field and for use within the Field
and solely to persons and entities that are within the Territory
and for use within the Territory. MDT hereby accepts such
appointment.
2.2
(a)
Except as otherwise permitted under
this Agreement and unless and until this Agreement or the
exclusivity provisions hereof shall have been terminated in the
manner provided herein, the Company agrees not to: (i) distribute,
market or sell the Products to any Person other than MDT, (ii)
authorize any other Person other than MDT to distribute, market or
sell the Products or (iii) enter into any agreement or arrangement
for the private labeling of any of the Products or any product that
is identical or substantially similar in form or function to any of
the Products, in each case of clauses (i) through (iii) above
within the Territory and for use or sale within the Territory and
for applications within the Field. The Company reserves the
right to promote the technology underlying Products, the use and
application of Products and the Company’s role in developing
and manufacturing Products, both within and outside the Territory
and Field. It is agreed that the Company shall coordinate
with MDT in advance of any promotion or other publicity of the
Products within the Territory and for use or application within the
Field.
(b)
Without prejudice to any other
remedy of the Company hereunder, upon the failure of MDT to perform
its obligations under Section 3.1 below with respect to any
Product, which failure is not cured within thirty (30) days of
notice thereof to MDT by the Company, the Company shall not be
restricted from distributing, marketing or selling, or authorizing
any Person other than MDT to distribute, market or sell such
Products within the Territory and for use or sale within the
Territory and for applications within the Field. Upon the
taking of such action by the Company, MDT shall be released of any
future Quota obligations as provided later herein.
2.3
MDT shall have the right to perform
its obligations and exercise its rights under this Agreement
through either Medtronic, Inc. or one or more Affiliates of MDT
that are, directly or indirectly, wholly owned subsidiaries of
Medtronic, Inc., and to appoint agents to market and sell the
Products solely to customers practicing within the Field and for
use within the Field and solely to persons and entities that are
within the Territory and for use within the Territory. MDT
shall have the right to appoint subdistributors to perform
MDT’s obligations hereunder in such local markets where MDT
does not currently maintain a direct sales force. All such
agents and subdistributors shall be party to agreements
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with MDT containing terms and conditions that
are consistent with the terms of this Agreement, including, without
limitation, those provisions relating to the marketing and sale of
Products, the protection of the Company’s confidential
information, trademarks and intellectual property rights and the
termination of this Agreement.
2.4
(a)
If the Company develops new products
for use and application within the Field and within the Territory
(“New Products”) then the Company and MDT shall, for a
period of 90 days prior to any commercial sale or launch of such
New Product within the Field and within the Territory, negotiate
exclusively and in good faith the reasonable terms and conditions
for adding such New Products to Annex A. If the Parties are
unable to agree on the terms and conditions of sale of such New
Products, including a minimum purchase commitment therefor during
the first twelve-month period following such commercial launch (the
“Initial New Product Quota”), then the Company shall be
free to market, distribute and sell such New Products either alone
or through one or more distributors. If the New Product is of
a substitute nature with respect to an existing Product and
otherwise directly competes in the market with any of the Products
(a “Substitute Product”), any minimum purchase
commitment agreed to with respect to such Product shall
automatically be reduced, on a dollar-for-dollar basis, by the
sales of such Substitute Product by the Company (or persons
appointed by the Company other than MDT) over the same
period. The Company shall report such sales of Substitute
Products to MDT for purposes of the adjustment to the minimum
purchase commitments of MDT.
(b)
If MDT wishes for the Company to
develop and manufacture a New Product outside of the
Company’s planned product-development process, the Company
will, upon MDT’s request and within a reasonable timeframe,
provide to MDT a quote for the Company’s development and
manufacturing of such New Product. MDT shall promptly notify
the Company of its decision whether to request that the Company
develop such New Product and the Parties shall negotiate in good
faith the terms and conditions for adding the New Product to this
Agreement, including the terms for the payment of the quoted costs
for such development and manufacturing. Nothing in this
Agreement shall be deemed to require the Company to undertake any
particular product development project and the Company shall have
no liability for any failure to develop New Products either on its
own initiative or pursuant to any request of MDT, except for such
liabilities and obligations set forth in any definitive agreement
or amendment to this Agreement setting forth the terms and
conditions for the development, marketing and sale of such New
Products.
3.
MDT’S DUTIES
3.1
MDT agrees to:
(a)
Use its commercially reasonable best
efforts, comparable in nature to efforts used by MDT to market,
promote, sell and support its other urological diagnostic products,
to market, promote, distribute, sell and support the Products on a
continuing basis throughout the term of this Agreement and
throughout the entire Territory. MDT’s obligation to
market the Products under this Agreement shall require MDT, among
other things, to: (i) conduct periodic promotions and obtain usual
and customary market feedback (but without the requirement of MDT
to undertake or requisition any formal studies from third parties)
with respect to the Products, (ii) maintain an adequate urinary
diagnostic or other comparable sales force to market and sell the
Products, (iii) utilize its existing training facilities
and
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programs to present the Products,
(iv) maintain adequate levels of Product inventory, (v) provide
incentives to its sales force for promoting and selling the
Products that are as favorable as those for promoting and selling
MDT’s other diagnostic products in the Field, and (vi)
include the Products in its promotional materials and on its
website, at trade shows, congresses and similar conferences, and at
sales and training courses and programs for MDT sales and marketing
personnel.
(b)
Carry out the marketing, promotion
and sale of the Products in the Territory efficiently and in an
orderly and regulated manner.
(c)
Refrain from selling or promoting in
the Territory products that are directly competitive with the
Products, and from marketing or promoting the Products in the
Territory in a manner that is inferior to the manner in which MDT
markets and promotes its other urological diagnostic products in
the Territory. By way of example, no products currently
marketed and sold by MDT in the Territory and within the Field as
of the date of this Agreement are directly competitive with the
Products within the meaning of this Section 3.1(c).
(d)
Refrain from making any oral or
written statements or representations that vary from the
specifications, instructions, warranties or representations given
or made in this Agreement by the Company to MDT with respect to
Products.
(e)
Not modify, adulterate, misbrand,
alter or remove labels from Products.
(f)
Promptly refer to the Company any
inquiry (other than a purchase order or potential purchase order
originating within the Territory) from the public, any governmental
authority, any trade association or any news media, publication or
reporter concerning the Products or the Company.
(g)
Except as may be required by
applicable law or regulation, or as may reasonably be required for
the proper handling of Product quality issues from time to time,
not take any action detrimental to the reputation or goodwill of
the Products and/or the Company.
(h)
Not commence or initiate, or cause
to be commenced or initiated, any engineering, research,
development or other technical activities on any of the Products or
otherwise utilizing the Company’s intellectual property
without the prior written consent of the Company.
(i)
Consistent with established industry
standards and applicable laws, not pay or make gift of value,
directly or indirectly, to any officer, employee or agent of a
political party, government or administrative or governmental
agency or to any candidate for public office, for the purpose of
obtaining or retaining business related to the Products.
3.2
MDT will comply, and will cause the
MDT Appointees and all agents and subdistributors appointed by it
to comply, in all material respects with all applicable federal,
state and local laws, rules, regulations and orders of all
governmental authorities affecting the sale and distribution of the
Products, as they are presently in effect and as they may be
revised or supplemented from time to time.
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3.3
MDT will adhere, and will cause the
MDT Appointee and all agents and subdistributors appointed by it to
adhere, to good and sound business practices and carry out its
duties under this Agreement according to the highest standards of
professional business conduct.
3.4
Any and all marketing, promotional,
sales and administrative costs, including any costs associated with
MDT’s and its invitees’ (other than the Company)
attendance at or participation in trade shows, congresses or
similar conferences, shall be borne by MDT at its own
expense.
4.
COMPANY’S COVENANTS AND
DUTIES
4.1
The Company agrees to:
(a)
Inventory and ship Products upon
order and request of MDT and in accordance with MDT’s
instructions.
(b)
Regularly inform MDT about available
displays, literature and other promotional and advertising
material, as the Company deems suitable for MDT in marketing
Products for use in the Field. The Company shall, upon
MDT’s reasonable request, deliver such available artwork,
pictures, graphic design files and other promotional and
advertising materials. Such deliveries will be free of
charge, except for freight and insurance. MDT is encouraged
and allowed to issue, at its own expense, any materials related to
the Products, provided that MDT shall obtain written approval from
the Company for each such item prior to issuance, which approval
from the Company shall not be unreasonably withheld or
delayed.
(c)
Label Products in accordance with
this Agreement.
(d)
Staff and maintain a service and
repair facility for the purpose of repairing and/or replacing
Products that are within or outside of their warranty period.
MDT shall advise the Company of Products requiring repair or
replacement and shall forward such Products to the Company’s
designated facility, but only after obtaining from the Company a
return authorization approval pursuant to customary return
procedures established from time to time by the Company. The
Company’s current return authorization procedures are as set
forth on Annex B hereto, and the Parties shall cooperate in good
faith to make such changes to such procedures from time to time as
may be reasonable and appropriate. The Company shall use
reasonable efforts to inspect the Products and make necessary
repairs or replacement, as appropriate, at its facilities and
return the repaired or replacement Product to MDT, or MDT’s
customer, as may be mutually agreed by both Parties, within fifteen
(15) business days of receipt of repair authorization from MDT, but
in no event later than thirty (30) business days following receipt
of such repair authorization. For Products repaired and/or
replaced that are within their warranty scope and period, the
Company shall bear all costs and expenses relating to servicing
such Products (including, without limitation, shipping and handling
costs from the Company to MDT or MDT’s customer, as the case
may be). For Products repaired that are outside their
warranty scope or period, the Company shall charge MDT its standard
time and materials rate, plus shipping and
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handling. MDT shall purchase,
and the Company shall maintain, a pool of Products which shall be
used as temporary replacements for Products pending repair.
MDT shall instruct the Company from time to time to ship such
replacement Products to MDT’s customers, and to receive
returned replacement Products from MDT’s customers once
repaired Products have been shipped to such customers. MDT
shall reimburse the Company for all direct reconditioning, repair
and shipping expenses associated with the maintenance of such
loaner pool of Products, other than expenses which are otherwise
covered by the applicable Product warranty.
(e)
Subject to Section 6, incorporate
any modifications and improvements that the Company makes to any of
its products into the Products if so desired by MDT and make the
changed Products immediately available to MDT. If MDT
requests that the Company make modifications or improvements to the
Products, such changes shall be made only if mutually agreed to by
the Company and MDT (including, without limitation, concerning any
change to price charged by the Company to MDT). If the
Parties are unable to agree on any such Product modification which
is reasonably necessary to ensure product safety, MDT may suspend
its distribution of the Product(s) affected, and MDT’s
minimum purchase commitment hereunder shall be tolled, until such
time as the Parties resolve such dispute as provided for
herein.
(f)
Provide adequate training to
MDT’s product managers and sales representatives on an
as-needed and reasonable basis to enable MDT to promote the sale of
the Product. The Company shall provide a minimum of ten (10)
days of training per year, as and when reasonably requested by
MDT. Such training will be conducted at MDT’s
facilities, or another location mutually agreed upon by both
Parties, and will be provided without charge to MDT, except for the
reimbursement of reasonable out-of-pocket expenses of the Company
incurred for training in excess of ten (10) days during the first
year following the date hereof, and in excess of five (5) days per
year thereafter. In addition, the Company will provide to MDT
Product updates and service bulletins as they become available, at
no additional cost to MDT.
(g)
Consistent with established industry
standards and applicable laws, not pay or make gift of value,
directly or indirectly, to any officer, employee or agent of a
political party, government or administrative or governmental
agency or to any candidate for public office, for the purpose of
obtaining or retaining business related to the Products.
(h)
Provide MDT with its written
specifications for each of the Products.
(i)
Except as may be required by
applicable law or regulation, or as may reasonably be required for
the proper handling of Product quality issues from time to time,
not take any action detrimental to the reputation or goodwill of
the Products and/or MDT.
4.2
The Company shall provide MDT with
all technical and clinical information related to and necessary for
the sale of the Products that the Company has in its possession
without any requirement of the Company to produce or requisition
any formal studies, data or information. The Company shall be
entitled to withhold any information that the Company determines,
in its sole discretion, constitutes
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trade secrets of the Company.
4.3
The Company reserves the right to
change a Product or its specifications without payment of
compensation to MDT, so long as such changes do not affect the
efficacy, safety, form, fit or function of the Product or require
regulatory approval or amendment. If such changes do affect
the efficacy, safety, form, fit or function of a particular
Product, or require regulatory approval or amendment, the Company
shall not be entitled to make such change without the prior written
consent of MDT, which consent shall not be unreasonably withheld or
delayed. The Company shall provide MDT with ninety (90)
days’ advance notice of any changes of Products to the extent
possible.
4.4
The Company will adhere to good and
sound business practices and will carry out its duties under this
Agreement according to the highest standards of professional
business conduct.
5.
ORDERING, SUPPLY, PRICE AND
PAYMENT
5.1
Minimum Purchase
Commitments .
(a)
Within thirty (30) days following
the Effective Date, MDT shall issue to the Company a purchase order
(the “Initial Order”) for the period from the Effective
Date until March 31, 2006 (the “Initial Period”),
providing for MDT to purchase pursuant to such purchase order
during the Initial Period no fewer than [*] of the
Company’s Slide-On™ EndoSheath® System for the
CST-2000, [*] with the Company’s catalog No.
08-2101(hereinafter, the “Basic Cysto Sheath”) and no
fewer than [*] of the Company’s flexible Cystoscope
(catalog No. 08-2201) (the “CST-2000”) at the prices
set forth on Annex A (the “Initial Quota”).
References in this Section 5.1 to “individual
units” of a Product refer to a single unit of such Product
and do not refer to a single package that may contain one or more
single units that are packaged and sold together under one catalog
number. MDT shall be obligated to purchase the Products
during the Initial Period according to the delivery schedule set
forth on Annex C. The minimum purchase requirements of this
Section 5.1 shall only apply to and be satisfied by sales of
Products for use and sale within the United States, and shall not
apply to or be satisfied by sales of Products for use and sales in
Canada.
(b)
If MDT fails to purchase, during
each successive 12-month period following the Initial Period (each
such period, a “Quota Period”), the minimum dollar
amounts of Products (the “Quota”), at the prices set
forth on Annex A, which minimum dollar amounts shall be negotiated
in good faith between the Parties hereto ninety (90) days prior to
the expiration of the Initial Period or any successive Quota
Period, as applicable, then the Company shall have the right and
option, in its sole discretion, to (x) terminate the exclusivity of
this Agreement upon written notice to MDT or (y) terminate this
Agreement upon written notice to MDT. Upon the taking of any
such action by the Company, MDT shall be released of any future
Quota obligations. If the Parties are unable to agree on the
Quota for any Quota Period at least forty five (45) days prior to
the scheduled start of such Quota Period, then the Quota for such
Quota Period shall be:
(i)
For the first Quota Period following
the Initial Period, [*] of the greater of the Initial Quota
or MDT’s Product sales during the Initial Period;
and
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(ii)
For the second Quota Period
following the Initial Period, [*] of the greater of the
Quota for or MDT’s Product sales during the first Quota
Period following the Initial Period; and
(iii)
For each successive Quota Period,
[*] of the greater of the Quota for or MDT’s Product
sales during the immediately previous Quota Period.
(c)
Following the Initial Period (and
without derogating from the Quota otherwise set for any Quota
Period), MDT shall purchase no fewer than [*] of the Basic
Cysto Sheath and no fewer than [*] of the CST-2000 during
each calendar quarter.
(d)
If MDT fails to purchase (i) during
the first 12-month period following the earlier of the first
commercial sale or launch of any New Product that MDT has agreed to
carry and on which the Company and MDT have agreed upon an Initial
New Product Quota as set forth in Section 2.4 (the “Initial
New Product Period”), no less, in terms of dollars, of such
New Product than set forth in the Initial New Product Quota, and
(ii) during each 12-month period following the Initial New Product
Period (each such period, a “New Product Quota
Period”), such dollar amounts of the New Product as shall be
negotiated in good faith between the Parties (the “New
Product Quota”) ninety (90) days prior to the expiration of
the Initial New Product Period or successive New Product Quota
Period, as applicable, then the Company shall have the right and
option, in its sole discretion, to (x) terminate the exclusivity of
this Agreement upon written notice to MDT or (y) terminate this
Agreement upon written notice to MDT. Upon the taking of any
such action by the Company, MDT shall be released of any future New
Product Quota obligations. If the Parties are unable to agree
on the New Product Quota for any New Product Quota Period at least
forty five (45) days prior to the scheduled start of such New
Product Quota Period, then the New Product Quota for such New
Product Quota Period shall be [*] of the greater of the New
Product Quota for or MDT’s New Product sales during the
immediately previous New Product Quota Period (or during the
Initial New Product Period, for the first New Product Quota Period
following the Initial New Product Period).
5.2
MDT shall provide to the Company, on
a monthly basis, a rolling [*] forecast of Products it
expects to purchase. The first [*] months of the first
such forecast shall represent, and be accompanied by, a firm
commitment purchase order for Products stated therein, and the
[*] month of each such successive forecast (provided that
such [*] month is within the Term) shall represent, and be
accompanied by, a firm commitment purchase order for the Products
stated therein. MDT will deliver to the Company, on a
bi-weekly basis, a schedule indicating the on-hand inventory of the
Products located in the United States. The Company shall at
all times maintain inventory levels reasonably adequate to meet its
obligations under Section 4.1(a). The Company shall use its
commercially reasonable best efforts to maintain on hand at all
times spare Product inventory of equal to the monthly average of
MDT’s orders therefor in the then-previous [*]
months. MDT’s minimum purchase commitments hereunder
shall be tolled for any period during which the Company is unable
to ship Products in accordance with its obligations under Section
4.1(a) (including in connection with the Initial Order).
MDT’s minimum purchase commitments hereunder with respect to
any New Products shall be tolled for any period during which the
Company is unable to ship such New Products in accordance with its
obligations under Section 4.1(a) or any period during which the
Company has not received necessary regulatory approvals as set
forth in Section 11.2.
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5.3
Upon shipment, the Company shall
promptly invoice MDT in U.S. Dollars. Payment for Products
shall be in U.S. Dollars and is due [*] from shipment of the
Product by the Company; provided that MDT shall be entitled to a
[*] discount on any amounts paid and received by the Company
within [*] . Late payments will be assigned a monthly
service fee equal to [*] of the amount due. Persistent
failure to pay invoices when due shall constitute a material breach
of this Agreement. MDT shall pay all invoices in full
according to the stated terms. The Company will issue credits
for any rejected Product pursuant to Section 5.7 below that MDT may
use to reduce payment of future invoices.
5.4
Prices for the Products ordered by
MDT from the Company shall be as set forth in Annex A to this
Agreement.
5.5
All prices and charges for Products
are FOB designated Company facility. Title to Products
delivered hereunder and all risks of loss or damage thereto shall
pass to MDT upon shipment from the Company’s
facility.
5.6
The Company shall package Products
in accordance with good commercial practices and mutually agreed
specifications, and in a manner sufficient to withstand the rigors
of transportation.
5.7
MDT shall have the right, within
fifteen (15) days from receipt, to reject any Product that does not
meet the Company’s written specifications or any applicable
laws or regulations or that is otherwise defective consistent with
the FOB terms specified in Section 5.5 above and the warranties set
forth in Section 7.1(b) below. Any such rejection shall be
accomplished by a notice from MDT identifying and specifying, in
reasonable detail, the Product rejected and the reasons for
rejection. Any Product rejected by MDT shall be made
available, on reasonable notice and during normal business hours,
for inspection by the Company or its representatives in a manner
consistent with the Company’s return authorization procedures
established from time to time and as previously communicated to
MDT. The Company will repair or replace any rightfully
rejected Product free of charge and will indemnify MDT for
reasonable out-of-pocket expenses (including freight and customs
clearance, if any) incurred by MDT in connection with (a) shipment
of repaired or replacement Product to the same location and (b)
shipment of the nonconforming Product back to the Company (if so
requested by the Company and then pursuant to the Company’s
return authorization approval procedures). In the event of a
rejection of defective Product, the Company shall ship, at its sole
option, either repaired or replacement Product within seven (7)
days of its receipt of the rejected Product from MDT, or such
longer period of time as may be reasonable under the
circumstances. For purposes of clarification, the Company
shall either repair the rightfully rejected or returned Product
unit or replace such returned Product unit with a new Product unit,
but shall not replace any returned Product unit with another used
or repaired unit.
5.8
The Parties agree that MDT may
appoint, subject to the Company’s consent as specified in
Section 1.4, one or more MDT Appointees to conduct MDT’s
logistics and supply-chain activities in support of its obligations
hereunder. Such MDT Appointee’s activities under such
appointment may include procurement of Products, Product
inspections and shipping and receiving. MDT shall enter into
an agreement with each MDT Appointee governing the terms of such
appointment, containing terms and conditions that are consistent
with the terms of this Agreement, including, without limitation,
those provisions relating to the marketing and sale of Products,
the payment of invoices, the
9
protection of the Company’s confidential
information, trademarks and intellectual property rights and the
termination of this Agreement. MDT hereby unconditionally,
absolutely and irrevocably guarantees each MDT Appointee’s
full and prompt performance of and compliance with this
Agreement.
6.
REGULATORY; QUALITY
ASSURANCE
The Company agrees to comply in all material
respects with all applicable federal, state and local laws, rules,
regulations and orders of all governmental authorities affecting
the manufacture, labeling, inspection and sale of the Products, or
that otherwise bear upon Company’s performance hereunder, as
they are presently in effect and as they may be revised and/or
supplemented from time to time. The Company agrees to perform
current Product performance trending, take corrective actions and
preventative actions and devote appropriate resources for ongoing
quality management support. The Company represents and
warrants to MDT that the Products have been and shall be designed,
manufactured, labeled, packaged and sold to MDT in accordance with
the Company’s quality system, all applicable laws and
regulations of the United States and Canada, ISO 13485
certification or successor requirement(s), all other applicable
manufacturing requirements and the representations and warranties
set forth in this paragraph and in Section 13.2 of this
Agreement. The Company further represents and warrants to MDT
that the Company’s manufacturing and quality system is in
compliance with the Quality System Regulations promulgated by the
U.S. Food and Drug Administration (or any successor requirements)
and has been certified to be in compliance with the standards set
forth in ISO 13485. Once per year during the Initial Term (as
hereafter defined) of this Agreement or any renewal thereof, the
Company shall provide MDT’s or the applicable MDT
Appointee’s regulatory personnel reasonable access to the
facilities and records of the Company for the purpose of confirming
the Company’s and the Pro
