NONEXCLUSIVE DISTRIBUTION AGREEMENT
THIS AGREEMENT is made and entered into as of November 15, 1996,
(The "Effective Date"), by and between POLYMEDICA INDUSTRIES, INC., a
Massachusetts corporation, having its principal offices at 00 Xxxxx
Xxxxxx, Xxxxxx, XX 00000 ( Manufacturer ) and XXXXXXXXXX LABORATORIES,
INC. a Texas corporation having its principal offices at 0000 Xxxxxx
Xxxx Xxxx, Xxxxxx, XX 00000 ( Distributor ).
WITNESSETH:
In consideration of the mutual covenants and conditions herein
contained, and intending to be legally bound hereby, the parties
mutually agree as follows:
1. Products and Territory
(a) Manufacturer hereby appoints Distributor as a distributor
for the products listed in Exhibit A hereto (the "Products") during the
term of this Agreement for the purposes of reselling the Products to the
professional healthcare marketplace, so long as those purchasers are
located in the United States of America and any other mutually agreed
upon geographic territories added hereunder from time to time in
writing (the "Territory").
(b) Manufacturer reserves the right to appoint additional
distributors in the Territory and shall itself be free to sell Products
directly to purchasers in the Territory.
(c) Distributor shall refrain from establishing or maintaining
any branch, warehouse or distribution facility for Products outside the
Territory. Distributor shall not engage in any advertising or
promotional activities relating to the Products directed primarily to
customers located outside the Territory. Distributor shall not solicit
orders from any prospective purchaser located outside the Territory. If
Distributor receives an order for Products from a prospective purchaser
located outside the Territory, Distribution shall refer that order to
Manufacturer.
(d) Distributor may appoint a secondary or subdistributor to
sell the Products in the Territory so long as: (i) such secondary or
subdistributor confirms in writing to Manufacturer that it will comply
with all of Distributor s obligations under this Agreement; and (ii)
Manufacturer approves such secondary or subdistributor.
2. Ordering, Prices and Payment
(a) At the earliest possible date, Distributor shall provide
Manufacturer with non-binding estimates of its orders of Products for
the next six (6) months on a rolling basis. Such forecasts shall be
stated on a monthly basis. Once a month is forecasted, such forecasted
amount may be increased or decreased by twenty-five percent (25%) before
a firm order for that month is placed pursuant to Section 2(b) below.
(b) Distributor (unless otherwise agreed in writing from time to
time) shall furnish Manufacturer with firm orders in writing for
Products not later than three (3) months prior to the required date for
receipt of the shipment of such Products. Firm orders for each calendar
month shall be no less than seventy-five percent (75%) and no greater
than one hundred twenty-five (125%) of the estimate contained in the
forecast for such calendar month provided in accordance with Section
2(a) above.
(c) Distributor shall order Products from Manufacturer by
submitting a written purchase order identifying the Products ordered and
requested delivery date(s). Said delivery dates must be within nine
months of the date of receipt of the written purchase order.
Manufacturer always undertakes to maintain a capacity to enable
Manufacturer to meet one hundred twenty-five percent (125%) of
Distributor s estimated requirements of the Products provided in
accordance with Section 2(a) above.
(d) If a purchase order is accepted in accordance with Section
2(c) above, the prices for Products covered by such purchase order shall
be Manufacturer s net distributor prices F.O.B. Golden, Colorado, USA
which are in effect on the date of the order. The initial price for
each Product under this Agreement is set out in Exhibit B hereto. Such
prices are F.O.B. Golden, Colorado, USA. Manufacturer shall review the
initial price for each Product on an annual basis, starting at the
beginning of the 1998 calendar year, and the parties may mutually agree
in writing to change the price for each Product once during each
calendar year, starting with the 1998 calendar year provided, however,
no price increase shall exceed five percent (5%). Any such change shall
become effective sixty (60) days after Distributor's receipt of notice
thereof; provided however, that no price change shall affect purchase
orders offered by Distributor and received by Manufacturer prior to the
date such price change becomes effective.
(e) Distributor shall be free to establish its own pricing for
Products which it sells.
(f) Distributor hereby agrees: (i) to assist Manufacturer in
obtaining any required licenses or permits required by Manufacturer by
supplying such documentation or information as may be reasonably
requested by Manufacturer; (ii) to comply with all governmental decrees,
statutes, rules and regulations; (iii) to maintain the necessary records
to comply with such decrees, statutes, rules and regulations; (iv) not
to export any Products except in compliance with such decrees, statutes,
rules and regulations; (v) to obtain all governmental approvals and
licenses necessary to import the Products into any country in the
Territory; and (vi) not to sell, transfer or otherwise dispose of
Products in violation of the export laws of the United States. Each
party agrees to indemnify and hold harmless the other party from any and
all fines damages, losses, costs and expenses (including reasonable
attorneys fees) incurred by such other party as a result of any breach
of this Section 2(f) by the indemnifying party.
(g) Unless Distributor requests otherwise, all Products ordered
by Distributor shall be packed for shipment and storage in accordance
with Manufacturer's standard commercial practices and laws, rules and
regulations applicable in the Territory. It is Distributor's
obligations to notify Manufacturer of any special packaging requirements
(which shall be at Distributor's expense) and Manufacturer shall adhere
to all packaging, labeling and inserts instructions requested by
Distributor as a result of any laws, rules and regulations applicable in
the Territory. Distributor shall provide any required film work and art
work at its expense. Manufacturer shall deliver Products into the
possession of a common carrier designated by Distributor no later than
the date specified for such delivery on the relevant purchase order for
such Products; provided, however, that if Distributor does not designate
such carrier at least ten (10) days prior to such specified date, then
Manufacturer may designate such carrier on Distributor s behalf. Risk
of loss and damage to a Product shall pass to Distributor upon the
delivery of such Products to the common carrier designated hereunder.
(h) All amounts due and payable with respect to a Product
delivered by Manufacturer in accordance with Section 2(g) hereof shall
be paid in full within 45 days after the end of the calendar month in
which the invoice is received or dated with a 2% discount if paid within
30 days. All such amounts shall be paid against invoice in U.S. dollars
by wire transfer or check to such bank or account as Manufacturer may
from time to time designate in writing. All costs incurred in
connection with such wire transfer shall be the responsibility of
Distributor.
(i) Whenever any amount under Sections 2 or 3 hereof is due on a
day which is not a day on which banks in Denver, Colorado are open for
business (a Business Day ), such amount shall be paid on the next such
Business Day. Amounts hereunder shall be considered to be paid as of
the day on which funds are received by Manufacturer s designated bank.
(j) All amounts due and owing to Manufacturer under Sections 2
or 3 hereof but not paid by Distributor on the due date thereof shall
bear interest at the rate of the lesser of either: (i) one percent (1%)
per month; or (ii) the maximum lawful interest rate permitted under
applicable law. Such interest shall accrue on the balance of unpaid
amounts from time to time outstanding from the date on which portions of
such amounts become due and owing until payment thereof in full.
3. Other Obligations of Distributor
(a) Distributor shall maintain an adequate stock of Products so
as to render prompt and adequate service to the users of the Products in
the Territory.
(b) Each party to this Agreement shall report to the other party
with respect to all complaints received concerning the Products. For
any complaint likely to cause a risk to patient health, such complaint
shall be reported to the other party with urgency, but in no event more
than forty-eight (48) hours after receipt thereof. Where possible, the
reporting party shall provide copies of each complaint when reporting to
the other party in accordance with this Section 3(e).
4. Obligations of Manufacturer
(a) Manufacturer hereby agrees to provide to Distributor with
each shipment of Products, a certificate of conformity. Such
certificate shall state that such Products satisfy the agreed upon
specifications for such Products.
(b) To have any required licenses or permits, such as a valid
510(k) for Products it delivers to Distributor.
(c) Subject to Section 2(g) only deliver Product with
Distributor packaging labeling insert and artwork requirements.
The manufacturer shall print or label the Product ordered by
the Distributor in the manner designated by the Distributor from time to
time in accordance with FDA requirements. If the Distributor designates
substantial changes to the form of label initially designated by the
Distributor as set forth in Exhibit A for the Product then the
Distributor shall reimburse the Manufacturer for its out-of-pocket costs
in making such changes.
(d) Deliver no Product that has a remaining shelf life of less
than two years.
5. Relationship of the Parties
(a) Distributor shall be considered to be an independent
contractor. The relationship between Manufacturer and Distributor shall
not be construed to be that of employer and employee, nor to constitute
a partnership, joint venture or agency of any kind.
(b) Distributor shall pay all of its expenses, including without
limitation all travel, lodging and entertainment expenses, incurred in
connection with its services hereunder. Manufacturer shall not
reimburse Distributor for any of those expenses.
(c) Distributor shall have no right to enter into any contracts
or commitments in the name of, or on behalf of, Manufacturer, or to bind
Manufacturer in any respect whatsoever. In addition, Distributor shall
not obligate or purport to obligate Manufacturer by issuing or making
any affirmations, representations, warranties or guaranties with respect
to Products to any third party, other than the warranties described in
Exhibit B attached hereto and made a part hereof.
6. Minimum Purchase Requirements
(a) Distributor shall purchase a sufficient amount of Products
from Manufacturer so as to meet or exceed 100,000 units per purchase
order.
For the purposes of Section 2(d) above, (i) a purchase of
Products within a specified time period shall mean Distributor
submitting a firm order to Manufacturer for such Products; (ii) a unit
of Products; and (ii) a "unit" of Products shall mean an amount of
Product equal to a 4 ins. by 4 ins. swatch. For example, a Product
measuring 8 ins. by 8 ins. shall count as four (4) units.
7. Liability
(a) Product Warranties. Manufacturer warrants that the
Products, as delivered to the Distributor, shall (i) conform to the
product purchase specification attached hereto as Exhibit A; and (ii) be
manufactured and stored before delivery in accordance with all
applicable regulatory requirements.
(b) Correction of Non-Conformity. Should any failure to conform
with the warranties set out in Section 9(a) appear within (1) month from
the date of delivery of the Product (whether discovered by Distributor
or their customers), and if given written notice by Distributor to
Manufacture within thirty (30) days from the date of the discovery,
Manufacturer shall correct such nonconformity, at its option, by
(i) replacement of the nonconforming Product; or
(ii) refund of the purchase price of the nonconforming
Product.
(c) Limitation of Warranties. The warranties shall not apply to
any Product which
(i) has been tampered with or otherwise altered;
(ii) has been subjected to alteration, misuse, negligence
or accident; or
(iii) has been stored, handled or used in a manner contrary
to applicable laws or other governmental requirements or
Manufacturer's instructions.
(d) DISCLAIMER. THE FOREGOING WARRANTIES IN THIS SECTION 7 ARE
EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES OF QUALITY AND
PERFORMANCE, WRITTEN, ORAL OR IMPLIED, AND ALL OTHER WARRANTIES
INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE ARE HEREBY DISCLAIMED BY MANUFACTURER, ITS AFFILIATES
AND THEIR SUBCONTRACTORS.
(e) Exclusive Remedy. Except as provided in Section 8(a) below,
correction of non-conformities in the manner and for the period of time
provided in Section 7(b) above shall be Distributor's exclusive remedy
and shall constitute fulfillment of all liabilities of Manufacturer, its
Affiliates and their subcontractors (including any liability for direct,
indirect, special, incidental or consequential damages), whether in
warranty, contract, tort (including, but not limited to, negligence,
failure to warn or failure to test), strict liability, or otherwise with
respect to any non-conformance of or defect or deficiency in the
Product.
8. Indemnifications and Insurance
(a) Indemnification of Distributor. Manufacturer shall
indemnify and hold Distributor and its Affiliates, directors, officers
and employees harmless from and against any and all loss, liability,
damage, expense and cost (including, without limitation, reasonable
attorney s fees and other costs of defense) arising out of legally
justified claims under Section 7, section 12, item 12(k) or from a third
party in respect of personal injuries to customers or users to the
extent caused by a defective Product, excluding, however, all such
losses, liabilities, damages, expenses and costs to the extent caused by
any act or omission of Distributor, its Affiliates or sub-distributors
or any failure by them to comply with their obligations under this
Agreement.
(b) Indemnification of Manufacturer. Distributor shall
indemnify and hold Manufacturer and its Affiliates, directors, officers
and employees harmless from and against any and all loss, liability,
damage, expense and cost (including without limitation, reasonable
attorney s fees and other costs of defense) to the extent arising out of
legally justified claims from a third party related to the Product
caused by any act or omission of Distributor, its Affiliates or sub-
distributors or any failure by them to comply with their obligations
under this Agreement.
(c) Defense of Actions. Each party indemnified hereunder (an
Indemnified Party ) will give the Indemnifying Party written notice of
any action or proceeding relating to any claim or loss for which
Indemnity is sought hereunder within ten (10) business days after any
such Indemnified Party shall have had actual notice thereof and the
Indemnifying Party, at its option, shall be entitled to participation in
or direct the defense or settlement of such action; provided the
Indemnifying Party employs counsel reasonably acceptable to the
Indemnified Party. The Indemnifying Party shall not be liable to the
Indemnified Party in respect of settlements effected by the Indemnified
Party without the written consent of the Indemnifying Party. In the
event that any Indemnifying Party shall undertake to compromise or
defend any action or proceeding, it shall promptly notify the
Indemnified Party of its intention to do so and the Indemnified Party
agrees to cooperate fully with the Indemnifying Party and its counsel in
any such compromise or defense.
(d) Insurances. The parties represent that they have and shall
maintain during the term hereof, and for three (3) years thereafter,
financial reserves and insurance with policy limits and coverage
reasonably adequate to cover all perils customarily protected against in
performing their respective obligations hereunder. Each party agrees to
provide the other party with a certificate of insurance upon the request
of the other party.
(e) Limitation of Liability. IN NO EVENT SHALL ANY PARTY OR ITS
AFFILIATES BE LIABLE TO THE OTHER PARTY FOR SPECIAL INDIRECT, INCIDENTAL
OR CONSEQUENTIAL DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT
(INCLUDING, BUT NOT LIMITED TO NEGLIGENCE, FAILURE TO WARN OR FAILURE TO
TEST), STRICT LIABILITY OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO,
LOSS OF PROFITS OR REVENUE, LOSS OF USE OF THE PRODUCT, DELAY OR CLAIMS
OF CUSTOMERS OF DISTRIBUTOR OR OTHER USERS OF THE PRODUCT.
9. Term and Termination
(a) Upon the occurrence of a material breach or default as to
any obligation hereunder by either party and the failure of the
breaching party to promptly pursue (within thirty (30) days after
receiving written notice thereof from the non-breaching party) a
reasonable remedy designed to cure (in the reasonable judgment of the
non-breaching party) such material breach or default, this Agreement may
be terminated by the non-breaching party by giving written notice of
termination to the breaching party, such termination being immediately
effective upon the giving of such notice of termination.
(b) Upon the filing of a petition in bankruptcy, insolvency or
reorganization against or by either party, or either party becoming
subject to a composition for creditors, whether by law or agreement, or
either party going into receivership or otherwise becoming insolvent
(such party hereinafter referred to as the insolvent party ), this
Agreement may be terminated by the other party by giving written notice
of termination to the insolvent party, such termination being
immediately effective upon the giving of such notice of termination.
(c) The term of this Agreement shall begin on the Effective
Date. Unless terminated earlier pursuant to the terms of Sections 9(a)
or 9(b) above, the term of this Agreement shall expire on the fifth
anniversary of the Effective Date.
(d) In the event of a termination pursuant to either of Sections
9(a) or 9(b) above or upon expiration of this Agreement pursuant to
Section 9(c) above, neither party shall have any obligation to the
terminated party, or to any employee of the terminated party, for
compensation or for damages of any kind, whether on account of the loss
by the terminated party or such employee of present or prospective
sales, investments, compensation or goodwill or otherwise, provided,
however, that this Section 9(d) is without prejudice to any rights the
terminated party may have in case of breach of this Agreement by the
terminating party. The terminated party, for itself and on behalf of
each of its employees, hereby waives any rights which may be granted to
it or them under the laws and regulations of the Territory or otherwise
which are not granted to it or them by this Agreement. The terminated
party hereby indemnifies and holds the terminating party harmless from
and against any and all claims, costs, damages and liabilities
whatsoever asserted by any employee, agent or representative of the
terminated party under any applicable termination, labor, social
security or other similar laws or regulations.
(e) Termination of this Agreement shall not affect the
obligation of Distributor to pay Manufacturer all amounts owing or to
become owing or to become owing as a result of Products delivered by
Manufacturer to the common carrier on or before the date of such
termination, as well as interest thereon to the extent any such amounts
are paid after the date they became or will become due pursuant to this
Agreement.
(f) Notwithstanding anything else in this Agreement to the
contrary, the parties agree that Section 7, 8, 9(d) and (e), 10, 11 and
12 shall survive the termination or expiration of this Agreement, as the
case may be.
10. Publicity
Distributor agrees that any publicity or advertising which shall
be released by it in which Manufacturer is identified in connection with
the Products shall be in accordance with the terms of this Agreement and
with any information or data which Manufacturer has furnished in
connection with this Agreement. Copies of all such publicity and
advertising shall be forwarded promptly to Manufacturer.
11. Confidentiality Maintained
(a) Each party agrees that the other party has a proprietary
interest in any information provided by the other party, whether in
connection with this Agreement or otherwise, whether in written or oral
form, which is (i) a trade secret, confidential or proprietary
information, (ii) not publicly known, and (iii) annotated by a legend,
stamp or other written identification as confidential or proprietary
information (hereinafter referred to as Proprietary Information ).
Each party shall disclose the Proprietary Information provided by the
other party only to those of its agents and employees to whom it is
necessary in order to properly carry out their duties as limited by the
terms and conditions hereof. Both during and after the term of this
Agreement, all disclosures by the party receiving Proprietary
Information to its agents and employees shall be held in strict
confidence by such agents and employees. During and after the term of
this Agreement, such receiving party, its agents and employees shall not
use the Proprietary Information for any purpose other than in connection
with discharging its duties in the Territory pursuant to this Agreement.
The receiving party shall, at its expense, return to the disclosing
party the Proprietary Information provided by such disclosing party as
soon as practicable after the termination or expiration of this
Agreement. During the term of this Agreement and thereafter, all such
Proprietary Information shall remain the exclusive property of the party
which provided it. This Section 11 shall also apply to any consultants
or subcontractors that the receiving party may engage in connection with
its obligations under this Agreement.
(b) Notwithstanding anything contained in this Agreement to the
contrary, each party shall not be liable for a disclosure of the
Proprietary Information of the other party if the information so
disclosed: (i) was in the public domain at the time of disclosure
without breach of this Agreement; or (ii) was known to or contained in
the records of receiving party from a source other than providing party
at the time of disclosure by providing party to receiving party and can
be so demonstrated; or (iii) was independently developed and is so
demonstrated promptly upon receipt of the documentation and technology
by receiving party; or (iv) becomes known to the receiving party from a
source other than providing party without breach of this Agreement by
receiving party and can be so demonstrated; or (v) was disclosed
pursuant to court order or as otherwise compelled by law.
12. Miscellaneous
(a) No modification or change may be made in this Agreement
except by written instrument duly signed by each party.
(b) This Agreement and the rights and obligations hereunder may
not be assigned, delegated or transferred by either party without the
prior written consent of the other party; provided, however, that the
other party s consent shall not be required with respect to any
assignment, delegation or transfer by a party to any affiliate of such
party. To the extent permitted by this Agreement, this Agreement shall
inure to the benefit of the permitted successors and assigns of both
parties.
(c) All notices given under this Agreement shall be in writing
and shall be addressed to the parties at their respective addresses set
forth above. Either party may change its address for purposes of this
Agreement by giving the other party written notice of its new address.
Any such notice if given or made by registered or recorded delivery
letter shall be deemed to have been received on the earlier of the date
actually received and the date three (3) calendar days after the same
was posted (and in proving such it shall be sufficient to prove that the
envelope containing the same was properly addressed and posted as
aforesaid) and if given or made by telecopy transmission shall be deemed
to have been received at the time of dispatch, unless such date of
deemed receipt is not a Business Day, in which case the date of deemed
receipt shall be the next such succeeding Business Day.
(d) None of the conditions or provisions of this Agreement shall
be held to have been waived by any act or knowledge on the part of
either party, except by an instrument in writing signed by a duly
authorized officer or representative of such party. Further, the waiver
by either party of any right hereunder or the failure to enforce at any
time any of the provisions of this Agreement, or any rights with respect
thereto, shall not be deemed to be a waiver of any other rights
hereunder or any breach or failure of performance of the other party.
(e) This Agreement shall be construed and governed according to
the laws of Massachusetts applicable to contracts made and to be fully
performed therein, excluding (i) the United Nations Convention on
Contracts for the International Sale of Goods; (ii) the 1974 Convention
on the Limitation Period in the International Sale of Goods (the 1974
Convention ), and (iii) the Protocol amending the 1974 Convention, done
at Vienna, April 11, 1980.
(f) Any dispute, controversy or claim arising out of or relating
to this Agreement or to a breach hereof, including its interpretation,
performance or termination, shall be finally resolved by arbitration.
The arbitration shall be conducted by three (3) arbitrators, one to be
appointed by Manufacturer, one to be appointed by Distributor and a
third being nominated by the two arbitrators so selected or, if they
cannot agree on a third arbitrator, by the American Arbitration
Association; provided, however, in the event any such dispute,
controversy or claim involves a claim of damages for $100,000 or less,
the arbitration shall be conducted by one (1) arbitrator appointed by
Manufacturer and Distributor or, if they cannot agree on an arbitrator,
by the American Arbitration Association. The arbitration shall be
conducted in English and in accordance with the rules of the American
Arbitration Association, which shall administer the arbitration and act
as appointing authority. The arbitration, including the rendering of
the award, shall take place in Denver, Colorado and shall be the
exclusive forum for resolving such dispute, controversy or claim. The
decision of the arbitrators shall be binding upon the parties hereto,
and the expense of the arbitration (including without limitation the
award of attorneys fees to the prevailing party) shall be paid as the
arbitrators determine. The decision of the arbitrators shall be
executory, and judgment thereon may be entered by any court of competent
jurisdiction. Not withstanding anything contained in this Section 12(g)
to the contrary, each party shall have the right to institute judicial
proceedings against the other party or anyone acting by, through or
under such other party, in order to enforce the instituting party s
rights hereunder through reformation of contract, specific performance,
injunction or similar equitable relief.
(g) No rights or licenses with respect to the Products or the
Trademarks are granted or deemed granted hereunder or in connection
herewith, other than those rights expressly granted in this Agreement.
(h) Taxes, now or hereafter imposed with respect to the
transactions contemplated hereunder (with the exception of income taxes
or other taxes imposed upon Manufacturer and measured by the gross or
net income of Manufacturer) shall be the responsibility of Distributor,
and if paid or required to be paid by Manufacturer, the amount thereof
shall be added to and become a part of the amounts payable by
Distributor hereunder.
(i) Distributor may not customize, modify or have customized or
modified any Product unless it obtains the prior written consent of
Manufacturer, which consent may be withheld in the sole discretion of
Manufacturer. Any unauthorized customizing or modification of any
Product by Distributor or any third party shall relieve Manufacturer
from any obligation it would otherwise have had with respect to such
Product under the warranties described.
(j) Neither Manufacturer nor Distributor shall be liable in
damages, or shall be subject to termination of this Agreement by the
other party, for any delay or default in performing any obligation
hereunder (other than a payment obligation) if that delay or default is
due to any cause beyond the reasonable control and without fault or
negligence of that party; provided that, in order to excuse its delay or
default hereunder, a party shall notify the other of the occurrence or
the cause, specifying the nature and particulars thereof and the
expected duration thereof; and provided, further, that within fifteen
(15) calendar days after the termination of such occurrence or cause,
such party shall give notice to the other party specifying the date of
termination thereof. All obligations of both parties shall return to
being in full force and effect upon the termination of such occurrence
or cause. For the purposes of this 12(i) a cause beyond the reasonable
control of a party shall include, without limiting the generality of
the phrase, any act of God, act of any government or other authority or
statutory undertaking, industrial dispute, fire, explosion, accident,
power failure, flood, riot or war (declared or undeclared).
(k) Each of Distributor and Manufacturer convenants that all of
its activities under or pursuant to this Agreement shall comply with all
applicable laws, rules and regulations, and neither is a party to any
agreement which would prevent the sale or purchase of the Products.
(l) If any provision of this Agreement is declared invalid or
unenforceable by a court having competent jurisdiction, it is mutually
agreed that this Agreement shall endure except for the part declared
invalid or unenforceable by order of such court. The parties shall
consult and use their best efforts to agree upon a valid and enforceable
provision which shall be a reasonable substitute for such invalid or
unenforceable provision in light of the intent of this Agreement.
(m) This Agreement may be executed in one or more counterparts,
each of which shall be deemed an original, but all of which together
shall constitute one and the same instrument.
(n) For the purposes of this Agreement, affiliates shall mean
all companies, natural persons, partnerships and other business entities
controlled by, under common control with or controlling either party to
this Agreement.
IN WITNESS WHEREOF, the parties hereto have signed this Agreement.
XXXXXXXXXX LABORATORIES, INC., as Distributor
By
Name: Xx. Xxxxxxx X. Xxxxxx
Title: President & CEO
POLYMEDICA INDUSTRIES INC., as Manufacturer
By
Name:
Title:
EXHIBIT A
POLYMEDICA
Product Purchase Specification
General Description:
The Product is a breathable, absorptive, self-adhesive dressing.
The Product has hydrophilic properties and is designed to manage
wound exudate by a combination of its absorption and evaporative
properties.
The dressings are constructed of three layers:
1) Layer one, a non-transparent pigmented (tan
coloration), hydrophilic polyurethane film;
2) Layer two, a hydrophilic, asymmetric, microporous,
open-cell polyurethane membrane; and
3) Layer three, a porous, acrylic, copolymer, pressure
sensitive adhesive.
The dressing is supplied on a release paper which is cut to
provide an easy peel facility (crack and peel). The dressing is
packaged in individual pouches. Pouched dressings are packaged
with an Instructions for Use leaflet in a carton. The dressings
packed in pouches, and cartons are gamma irradiated to produce
sterile product.
Product Properties:
Mechanical Properties:
Tensile Strength: >= 0.1 Kg/mm(2)
% Elongation: >= 100%
Moisture Vapor Transport Rate (MVTR):
Upright >= 1100 g/m(2)/24 hrs.
Ratio Inverted/Upright:
>= 2.0 g/m(2)/24 hrs.
Lot Code: To be a minimum of 1/8" high on pouch. All
letters and numerals must be legible
individually.
Expiration Date: Present and legible on pouch and carton.
Pouch Seal: Is complete and not over Product.
EXHIBIT A
POLYMEDICA
Product Purchase Specification
(Continued)
Sterility:
Packaged product is sterilized by gamma irradiation with a minimum
dose of 2.5 Mrads (25 Kgys) for a Sterility Assurance Xxxxx xx 0-
00 . Xxxxxxxxxx and release criteria to be those set forth in
the current Guideline for Gamma Radiation Sterilization :
Association for the Advancement of Medical Instrumentation (AAMI).
Indications For Use:
The Product is intended for use in the management of:
Venous stasis ulcers Partial-thickness wounds
Diabetic ulcers Superficial xxxxx
Pressure sores Abrasions and
lacerations
Donor sites Full-thickness wounds
The Product is not indicated for third degree xxxxx.
Product Dating:
Product packaging is individually stamped with an expiry code
which is 3 years from the date of manufacture.
Product Labeling:
Examples of initially designated labeling from Distributor is
attached.
EXHIBIT B
POLYMEDICA
Product Pricing
Nominal Size Price (xxxxxx)
------------ --------------
2" x 3" $ 0.71
4" x 4" $ 1.11
6" x 8" $ 3.85
All prices FOB, Golden, Colorado, USA
