AMENDED AND RESTATED SUPPLY AND DEVELOPMENT AGREEMENT
Exhibit
10.1
AMENDED AND RESTATED SUPPLY AND DEVELOPMENT AGREEMENT
This Amended and Restated Supply and Development Agreement (“Agreement”) is made as of
the 28th day of January, 2011 (“Effective Date”), by and between LifeCell Corporation, a
Delaware corporation (“LifeCell”), and Xxxxxx Medical Technology Inc., a Delaware
corporation (“Distributor”). This Agreement replaces and supersedes in its entirety the
Supply and Development Agreement, as amended, dated April 1, 2002, by and between LifeCell and
Distributor. Capitalized terms used in this Agreement have the meanings given to them in Section
18.1 or elsewhere in this Agreement.
Witnesseth:
WHEREAS, LifeCell is engaged in the business of, among other things, processing tissue using
its proprietary AlloDerm® process and marketing and selling tissue processing services to health
care providers;
WHEREAS, Distributor is engaged in the business of, among other things, distributing products
and services to health care providers;
WHEREAS, the parties desire that LifeCell engage Distributor to distribute Products to
Customers and that Distributor distribute Products to Customers on the terms and conditions
hereinafter set forth;
NOW, THEREFORE, in consideration of the foregoing, the mutual covenants contained herein and
other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged,
and intending to be legally bound, the parties hereto hereby agree as follows:
1. Distribution of the Products.
1.1 Appointment. LifeCell hereby appoints Distributor as its exclusive authorized distributor of the
Products to Customers in the Sales Territory for use within the Sales Territory in accordance with
the provisions of this Agreement. Distributor hereby accepts such appointment and agrees to use
all commercially reasonable efforts to develop and exploit the market and to solicit sales and
obtain orders for the purchase of Products for which its appointment as distributor is effective
and for use within the jurisdiction in the Sales Territory for which such appointment then is
effective. Distributor acknowledges that nothing contained in this Agreement grants Distributor
the exclusive, non-exclusive, or any other right whatsoever to sell or distribute Products to
persons in the Sales Territory that are not Customers and Distributor hereby agrees that it will
sell Products to Customers only in the Sales Territory, which Customers, to the best knowledge of
Distributor, after due inquiry, will use Products sold to them on or before June 30, 2011, only in
the Sales Territory for orthopedic applications and podiatric wound applications and Products sold
to them after June 30, 2011, only in the Sales Territory for orthopedic applications. LifeCell
hereby expressly retains all distribution and other rights in connection with the Products and
Processed Tissue not specifically granted to Distributor under this Agreement.
2. Distributor’s Duties.
2.1 Distributor’s Duties. Distributor’s duties hereunder shall include:
(a) promoting and selling the Products to Customers in the Sales Territory through
Distributor’s trained field sales representatives;
(b) regularly and diligently soliciting Product orders from present and potential Customers
within the Sales Territory for use within the Sales Territory;
(c) supporting, developing, administering, monitoring and participating in Market Development
Programs in accordance with Section 5;
(d) consulting with and furnishing information to LifeCell concerning Customers’ requirements
and other matters that may affect Product sales in the Sales Territory;
(e) not giving any warranties in favor of Customers or proposed Customers beyond those
contained in Section 4.9 hereof;
(f) being responsible for reporting to LifeCell all information in Distributor’s possession or
of which Distributor is aware, upon reasonable request by LifeCell to enable LifeCell to ensure
that the Products meet all applicable laws, rules and regulations relating to health, safety,
labeling and the like;
(g) refraining from any act or practice that (i) reasonably might tend to diminish or inhibit
Product sales or in any way adversely reflect upon LifeCell, provided, however, except as limited
by subsection (i) below, nothing contained herein shall restrict Distributor from developing or
otherwise acquiring rights to or selling (1) synthetic derived graft containment products, or (2)
xenograft tissue products, provided, however, that if xenograft tissue products exceed [***]% of
Distributor’s sales of graft containment products, Lifecell at its option may change the Agreement
to non-exclusive, and if xenograft tissue products exceed [***]% of Distributor’s sales of graft
containment products, Lifecell at its option may terminate the Agreement; or (ii) constitutes a
violation of applicable law;
(h) refraining from promoting, soliciting or otherwise participating in the sale of human
derived soft tissue graft containment products that directly compete with the Products, in North
America during the Term, and solely if this Agreement is terminated by LifeCell due to a material
and intentional breach by Distributor hereof which is not remedied within applicable cure periods
for [***] after such termination of this Agreement (and the foregoing shall survive such
termination of this Agreement for a period of [***], if applicable); provided, however, that
Distributor may develop a human-derived dermal product offering (which may not be commercialized
during the Term), subject to Distributor providing LifeCell with written notice upon initiation of
human clinical studies and trials to obtain clinical validation of the human-derived dermal
product;
(i) subsequent to June 30, 2011, refraining from promoting, soliciting or otherwise
participating in the sale of human and non-human derived soft tissue graft containment products in
the field of wound care treatment, including, without limitation, the care and treatment of acute,
surgical, and chronic wounds, such as, by non-limiting example, diabetic foot ulcers, venous leg
ulcers, and pressure ulcers, except that Distributor may promote, solicit or otherwise participate
in the sale of current or future products based on Distributor’s [***] currently marketed under the name “Biotape” (the “WMT Porcine Platform”) to
the hospital market, provided that Distributor will not, and will not permit, authorize, or license
any third party to, begin commercial sales of any new products based on the WMT Porcine Platform
(i.e. products not sold by Distributor as of the Effective Date) that are specifically indicated
for wound care applications to the hospital market prior to the second anniversary of the Effective
Date (the “Exclusion Period”). For the avoidance of doubt, the hospital market shall not include
the post acute wound care market, including, without limitation, wound care facilities, outpatient
facilities, or ambulatory surgical centers.
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(j) refraining from changing Product or Processed Tissue labels or containers, repackaging the
Products or Processed Tissue, or otherwise presenting or marketing the Products in competition with
or as similar substitute items for other products of LifeCell sold in the Sales Territory;
(k) furnishing to LifeCell for prior review and approval copies of all proposed Marketing
Materials in accordance with Section 9.5 and refraining from or discontinuing the use of any
Marketing Materials which in the reasonable opinion of LifeCell are false or misleading or may
subject LifeCell to liability;
(l) providing to LifeCell Updated Product Forecasts during the Term in accordance with Section
4.8;
(m) providing to LifeCell, on or before the fifteenth day of each month, a report of sales of
the Products in the immediately preceding month in the United States and, if applicable, on or
before the fifteenth day of each month immediately following each Sales Quarter, a report of sales
of Products in the immediately preceding Sales Quarter to each country other than the United States
in the Sales Territory, with each report listing the total dollar amount of sales and total number
of Units.
(n) refraining from (i) acting in any manner that could expose LifeCell to any liability
beyond such exposure as is inherent in connection with introducing a product, such as the Products,
into the market and Sales Territory as is contemplated by this Agreement and (ii) pledging or
purporting to pledge LifeCell’s credit;
(o) informing LifeCell of any infringements of its patents, trademarks and other proprietary
rights known to Distributor and using commercially reasonable efforts to assist LifeCell in the
safeguarding of such legal rights at LifeCell’s sole expense;
(p) not disputing the right of LifeCell to its trademarks;
(q) not marketing the Products (i) for sale, delivery or use outside the Sales Territory,
unless otherwise agreed in writing in advance with LifeCell, (ii) for sale inside the Sales
Territory if, to Distributor’s knowledge, after reasonable inquiry, the Products are ultimately
destined for delivery or use outside the Sales Territory, unless otherwise agreed in writing in
advance by LifeCell, or (iii) for sale, delivery or use, inside or outside the Sales Territory, to
persons that are not Customers, unless otherwise agreed in writing in advance by LifeCell;
(r) not marketing, promoting, soliciting, or, directly or indirectly, knowingly selling the
Product or allowing the Product to be sold for use in any application other than orthopedic
applications, other than during the period commencing on the Effective Date through June 30, 2011
(the “Wind Down Period”), when Distributor may market and sell the Product for orthopedic
applications, on an exclusive basis, and podiatric wound care applications, on a non-exclusive
basis;
(s) immediately upon expiration of the Wind Down Period, returning to LifeCell all Products
intended to be sold for podiatric wound care applications (i.e. unsold [***] Sheet Products and all
Micronized Products), for which Distributor shall receive a credit in the amount equal to [***] paid for such products, but not to exceed [***] Distributor’s average
monthly unit volume sales of such products over the [***] period immediately preceding the
repurchase date, to be applied against future Product purchases;
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(t) complying, at its sole expense and prior to any sale of Products in the Sales Territory,
with all laws, rules and regulations applicable to the performance of its duties under this
Agreement and to the operation of this Agreement, including the filing of all documents and
obtaining of all permits, authorizations and the like required by the laws of all the jurisdictions
in the Sales Territory, and providing to LifeCell promptly upon LifeCell’s request, reasonable
evidence of such compliance;
(u) securing and maintaining insurance, including product liability insurance, of at least
$3 million in accordance with Section 2.2;
(v) paying any and all expenses of and incidental to the distributorship obligations hereunder
incurred by the Distributor, including without limitation, costs and expenses associated with
Marketing Materials; salaries, commissions and benefits of Distributor’s employees and agents, as
applicable; taxes, imposts, charges and assessments levied by any appropriate governmental or
jurisdictional authority in connection with the purchase and sale of Products in the Sales
Territory; and
(w) supporting and participating in Clinical Development Programs in accordance with Section
5.
2.2 Insurance. Distributor shall maintain, during the Term, Comprehensive or Commercial General
Liability insurance, which shall include without limitation, broad form liability and products
liability coverage with minimum limits of three million dollars ($ 3,000,000). per occurrence/aggregate. Distributor shall
furnish LifeCell with such insurance certificates prior to the delivery of Products hereunder and
during the Term as LifeCell may require.
3. LifeCell’s Duties.
3.1 LifeCell’s Duties. LifeCell’s duties hereunder shall include:
(a) providing Distributor with specimens of its existing promotional materials and marketing
brochures and copies of relevant documents either in its possession or commercially reasonably
obtainable by LifeCell relating to regulatory approvals;
(b) providing Distributor such reasonable assistance, as shall be determined mutually by
LifeCell and Distributor, to be appropriate to support Distributor’s promotional and advertising
activities within the Sales Territory, including LifeCell sending one LifeCell employee or
consultant knowledgeable about the Products to no more than three (3) significant industry trade
shows each Sales Year and to conduct two (2) training sessions concerning the Products each Sales
Year;
(c) referring to Distributor all orders and inquiries from Customers relating to the sale of
Products within the Sales Territory; provided, however, that LifeCell shall not have the duty to
refer orders and inquiries relating to podiatric wound care applications during the Wind Down
Period;
(d) supporting and participating in Clinical Development Programs in accordance with Section
5;
(e) including Distributor as an additional insured on LifeCell’s product liability insurance
policy;
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(f) securing
and maintaining product liability insurance of at least $3 million;
(g) supplying Distributor with Product in accordance with the Delivery Schedule. Furthermore,
Lifecell agrees that delivery of Product to Distributor is not, and will not be incumbered by any
contract, or other agreement in which priority or preferential delivery, obligations are offered to
any other party, distributor or dealer of Lifecell products or services;
(h) maintaining the Intellectual Property related to the Product;
(i) limiting the use of the Product for orthopedic applications exclusively to Distributor,
and limiting the use of the Product to Distributor for podiatric wound applications, on a
non-exclusive basis, during the Wind Down Period. Without limiting the generality of the
foregoing, LifeCell will not, at any time during the term of this Agreement, directly or indirectly
(i) knowingly sell or distribute the Product, or permit the Product to be sold or distributed, for
use in any orthopedic application, (ii) appoint, engage or authorize any other person or entity to
act as a seller or distributor of the Product for use in any orthopedic application or as its
representative or agent in connection with the sale or distribution of any Products for use in any
orthopedic application, or (iii) pay any commissions or other compensation to any person or entity
for or in connection with the sale or distribution of the Product for use in any orthopedic
application;
(j) refraining from (i) acting in any manner that could expose Distributor to any liability
beyond such exposure as is inherent in connection with introducing a product, such as the Products,
into the market and Sales Territory as is contemplated by this Agreement and (ii) pledging or
purporting to pledge Distributor’s credit;
(k) not disputing the right of Distributor to its trademarks;
(l) granting Distributor exclusive distribution rights in the orthopedic field and on the
terms and conditions set forth in this Agreement to any next generation human tissue products
commercialized by LifeCell that the parties mutually agree are both commercially viable and
clinically appropriate for orthopedic applications (which agreement shall not be unreasonably
withheld or delayed by LifeCell). No later than [***] of Distributor’s commercialization of a next generation human tissue product, the parties shall
determine the increase in annual Product sales reasonably attributable to such next generation
human tissue product during the previous [***] (net of any cannibalization of prior
generation Product sales), and make a [***] increase in the Minimum Annual Payment [***] in an amount proportionate to such net increase. Thereafter, no later
than February 28 of each calendar year during the Term, the parties shall analyze and discuss
whether a further increase in the Minimum Annual Payment is appropriate based on increases in
annual Product sales achieved during the prior periods which are attributable to next generation
human tissue products. For purposes of this Section, a “next generation human tissue product”
shall mean a new acellular, [***], human dermal sheet product offering commercialized by LifeCell
(other than an Enhanced Sheet Product). LifeCell will provide Distributor with written notice of
any next generation human tissue product that is both commercially viable and clinically
appropriate for orthopedic applications prior to commercializing any such application outside the
orthopedic field of use, and will cooperate with Distributor in the evaluation, development and
commercialization of such applications in the orthopedic market. Any such next generation human
tissue product shall be added to the definition of “Product” hereunder upon the granting to
Distributor of exclusive distribution rights in the
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orthopedic field with respect thereto pursuant to the provisions of this paragraph. All product
development and implementation costs associated with the
commercialization of the next genertion
human tissue product in the orthopedic field shall be borne by Distributor, including, without
limitation, labeling costs, SKU sizes, and thickness preparation. Notwithstanding the foregoing,
any future products resulting from changes to enhance, improve, or modify the Sheet Products, for
the orthopedic field, that combine the Sheet Products with [***], or other
[***] are hereafter referred to as “Enhanced Sheet Products” and
shall not be considered next generation human tissue products hereunder. Distributor has not been
granted any rights with respect to any Enhanced Sheet Products under this Agreement, but LifeCell
may elect under separate terms and conditions to enter into an agreement with Distributor to
develop, commercialize or use one or more Enhanced Sheet Products. In no event shall LifeCell
enter into any agreement with a third party to commercialize any Enhanced Sheet Product without
first providing Distributor the opportunity to accept or refuse such an agreement offered on equal
terms and conditions, which acceptance or refusal shall be provided in writing [***] after
written notice is sent from LifeCell describing in reasonable detail the subject Enhanced Sheet
Product and the terms and conditions of the proposed agreement with such third party with respect
to the commercialization thereof. LifeCell will promptly provide the Distributor with any and all
data and information relating to such Enhanced Sheet Product that Distributor may reasonably
request to facilitate its assessment of the viability of such product for orthopedic applications.
Failure by Distributor to provide written acceptance [***] shall be deemed a
rejection of the right to commercialize the Enhanced Sheet Product;
(m) cooperating with Distributor on the evaluation and potential development of any specific
project ideas, new product configurations, or potential additional indications in the orthopedic
field that are communicated to LifeCell by Distributor; provided the business case for each of
foregoing is reasonably acceptable to both parties (which acceptance shall not be unreasonably
withheld or delayed by LifeCell). All product development and implementation costs associated with
the commercialization of the foregoing in the orthopedic field shall be borne by Distributor,
including, without limitation, labeling costs, SKU sizes, and thickness preparation. Further, no
later than [***] of Distributor’s commercialization of a new project
idea, configuration or indication in the orthopedic field, the parties shall determine the increase
in annual Product sales reasonably attributable to such project idea, configuration and/or
indication during the previous [***] (net of any cannibalization of prior generation
Product sales), and make a [***] increase the Minimum Annual Payment [***] in an amount proportionate to such net increase. Thereafter, no later than February 28 of
each calendar year during the Term, the parties shall analyze and discuss whether a further
increase in the Minimum Annual Payment is appropriate based on increases in annual Product sales
achieved during the prior periods which are attributable to such project idea, configuration and/or
indication; and
(n) within forty-five (45) days following the end of the Wind Down Period, repurchasing
Distributor’s remaining inventory of [***] Sheet Product and Micronized Product from Distributor at
a price equal to [***], not to exceed [***] Distributor’s average monthly unit volume sales of such products [***] period
immediately preceding the repurchase date.
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4. Terms and Conditions of Sale.
4.1 Minimum Annual Product Sales.
(a) During the Term, Distributor is required to achieve Minimum Annual Product Sales. The
total United States dollar-value amount of sales of all Products to Customers that are recognized
by Distributor as revenue pursuant to United States Generally Accepted Accounting Principles during
any given calendar year period, beginning with the year ending December 31, 2004, are hereafter
referred to, respectively, as “Annual Product Sales”. Minimum Annual Product Sales for the
calendar years ending December 31, 2004 and 2005 are $[***] and $[***] respectively, per year.
Within thirty (30) days after completion of the calendar year ending December 31, 2006, and within
thirty (30) days following the completion of each calendar year through 2010, Distributor shall
calculate the compound annual growth rate of its Annual Product Sales for the most
recently-completed two year period (hereafter referred to as the “Two Year CAGR”) pursuant to the
following formula:
Two Year CAGR = (v(Ac/ Ac-2) ) — 1
Wherein; Ac = Annual Product Sales during the most recently completed calendar
year;
Ac-2 = Annual Product Sales during the calendar year two years prior to the most
recently-completed calendar year, and;
√ = the square root of a number;
As an example, if Ac equals $1,000,000 and Ac-2 equals $800,000, then
the 2010 Two Year CAGR computes to equal .1180, or 11.80%. As a further example, if Ac
equals $1,000,000 and Ac-2 equals $1,200,000, then the Two Year CAGR, equals -.0871, or
negative 8.71%.
In any calendar year during the period from the calendar year ending December 31, 2006 through
the calendar year ending December 31, 2010, if the Distributor achieves a Two Year CAGR of less
than [***], as determined in accordance with this Section 4.1(a) (the “Pre-2011 Minimum Annual
Product Sales”), the Distributor shall pay to LifeCell an amount equal to the difference between
(i) the Revenue Share Amount that LifeCell would have received pursuant to Section 4.3 if
Distributor had achieved the Pre-2011 Minimum Annual Product Sales, and (ii) the amount actually
earned by LifeCell pursuant to Section 4.3 (the “Pre-2011 Catch-up Amount”). The pre-2011 Catch-up
Amount shall be due and payable by Distributor within thirty (30) days following Distributor’s
determination of the pre-2011 Two Year CAGR pursuant to the second sentence of this Section.
(b) Beginning in the calendar year ending December 31, 2011, or any calendar year thereafter,
if Distributor’s Annual Product Sales are less than $[***] (the “Minimum Annual Product Sales”),
Distributor shall, within sixty (60) days following the completion of that respective period,
provide LifeCell with a plan for improving Distributor’s sales of Products to Customers. LifeCell
at its sole and absolute discretion, shall thereafter be entitled to change Distributor’s status as
exclusive distributor of Products in the Sales Territory to non-exclusive distributor of Products,
unless Distributor pays to LifeCell, within ninety (90) days following the completion of that
respective period, a “Catch-up Amount” equal to any difference between (x) the Revenue
Share Amount that LifeCell would have received pursuant to Section 4.3 if Distributor had achieved
the Minimum Annual Product Sales for that respective period and (y) the amount actually earned by
LifeCell pursuant to Section 4.3.
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(c) In the event that Distributor In the event that Distributor achieves a Two Year CAGR of
less than negative [***] for any period consisting of two consecutive calendar years during the
Term prior to December 31, 2010, as determined in accordance with Section 4.1(a), or Annual Product
Sales of less than $[***] in any calendar year during the Term after December 31, 2010 (the
“Terminable Minimum Annual Product Sales”) Distributor shall, within sixty (60) days following the
completion of that respective period, provide LifeCell with a plan for improving Distributor’s
sales of Products to Customers. LifeCell at its sole and absolute discretion, shall thereafter be
entitled to terminate this agreement, unless Distributor pays to LifeCell, within ninety (90) days
following the completion of that respective period, a “Termination Catch-up Amount” equal
to any difference between (x) the Revenue Share Amount that LifeCell would have received pursuant
to Section 4.3 if Distributor had achieved the Terminable Minimum Annual Product Sales for that
respective period and (y) the amount actually earned by LifeCell pursuant to Section 4.3 plus any
previous Catch-up Amounts and Termination Catch-up Amounts paid during that respective period.
(d) With respect to any calendar year during the Term, in the event that LifeCell is unable to
furnish Distributor, for any reason, with the Number of Units of each respective Product and Sizes
as established in Updated Product Forecasts pursuant to Section 4.8(a), or should LifeCell, for any
reason including a force majeure event, decline to accept an Updated Product Forecast wherein the
Number of Units of each respective Product and Sizes requested by Distributor falls within the
allowable percentage increase provisions established in Section 4.8(a), for purposes of calculating
the Minimum Annual Product Sales, the Distributor shall be allowed to include in its calculations
of the Minimum Annual Product Sales and Terminable Minimum Annual Product Sales, a sales amount
representative of what would have been derived from the number of units that LifeCell was unable to
furnish. For purposes of that period’s calculation, Distributor will be deemed to have achieved
those Product Sales. Additionally, should LifeCell’s inability to meet Distributor requests for
any of the Products be prolonged for more than twelve (12) months, Distributor shall be deemed to
have achieved the Minimum Annual Product Sales criteria set forth in Section 4.1(b) for the periods
in which the prolonged supply constraint occurred. Except as otherwise provided in Section 4.3,
4.9(b), 4.12 and 7.4, Distributor shall have no right and LifeCell shall have no obligation to
accept returns from Distributor of Products.
(e) LifeCell, at its expense, shall have the right upon no less than five (5) days advance
written notice to Distributor and no more often than one (1) time per year, to have an independent
consultant chosen by LifeCell, inspect and audit Distributor’s books and records reasonably
necessary or desirable to determine Distributor’s compliance with its obligations under this
Agreement. Such audit shall not be limited to the fiscal year in which the audit is performed.
Any audit performed pursuant to LifeCell’s right to audit shall be at LifeCell’s expense. This
Section 4.1(e) shall survive any expiration or termination of this Agreement for a period of two
years.
4.2 Transfer Price. LifeCell shall supply Sheet Products to Distributor at the price of [***] per
square centimeter of Product and, until the expiration of the Wind Down Period, LifeCell shall
supply Micronized Products to Distributor at prices consisting of [***] for the current one cubic
centimeter size and [***] for the current two cubic centimeter size (hereinafter such price of the
respective Products is referred to as the “Transfer Price”); provided, however, that in no
event shall LifeCell increase the respective Transfer Prices (i) effective more than once in any
Sales Year and/or (ii) by more than [***] in any Sales Year. LifeCell shall use commercially
reasonable efforts to provide ninety (90) days prior written notice to Distributor of any increase
in Transfer Prices and inform Distributor of such potential increases on or before November 15 of
each Sales Year, LifeCell may increase the Transfer Price by
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more than [***] in any Sales Year only if the costs associated with processing Processed Tissue
increases by more than [***] in any Sales Year. In such an event LifeCell may increase the
Transfer Price above [***] and up to the increase in costs associated with processing Processed
Tissue. In the event that LifeCell increases Transfer Prices by more than [***]% in any Sales
Year, Distributor may terminate this Agreement upon thirty (30) days written notice to LifeCell by
providing such written notice to LifeCell within sixty (60) days after receiving LifeCell’s
Transfer Price increase notice.
4.3 Revenue Share Payment. The Distributor shall, with respect to all Product sold to Customers during
a Sales Quarter, pay to LifeCell an amount equal to [***]% of the gross sales price invoiced by
Distributor to the Customers for such Products (“Revenue Share Amount”), less the Transfer
Price previously paid by Distributor to LifeCell for such Products (the net amount of the Revenue
Share Amount less the Transfer Price, hereafter, the “Revenue Share Payment”). In the
event that the Revenue Share Amount for Products sold during a respective Sales Quarter is less
than the Transfer Price of such Products, the Revenue Share Payment for such sold Products shall be
zero, and Distributor shall not be entitled to any credit against other Product Revenue Share
Payments in past or future Sales Quarters. (For example, if Distributor sells Products to
Customers during a Sales Quarter in an amount that totals $100,000.00, and the Transfer Price of
those Product units when purchased from LifeCell was $10,000.00, the Revenue Share Payment to be
paid to LifeCell upon sale of the Product is $[***], calculated as $[***] less the Product Transfer
Price of $10,000.00.) Distributor shall be entitled to a credit for any Revenue Share Payment made
for any unit of Product that is rejected or returned by a Customer.
4.4 Payment Terms. The Distributor shall (i) pay for the Products purchased hereunder by cash within
forty five (45) days of the later of the date of shipment or the invoice date for such Products and
(ii) pay the applicable Revenue Share Payment for sale of the Product to Customers by cash within
45 days following each month occurring during the Term of this Agreement. Interest at the lesser
of the per annum rate of [***] or the highest interest rate permitted under
applicable law shall accrue, and Distributor shall pay to LifeCell such interest on any amounts
owed to LifeCell for Products purchased and Revenue Share Payments, which amounts have not been
paid to LifeCell within forty five (45) days of the later of the date of shipment or the invoice
date for such Products with respect to payments for Products or within 45 days following the month
in which Revenue Share Payments are earned with respect to Revenue Share Payments. LifeCell, in
its sole discretion, may terminate this Agreement upon 30 days prior written notice of termination
(the “Notice Period”) to Distributor if any invoice (including invoices for interest accrued and
payable under the terms hereof) from LifeCell to Distributor remains unpaid for more than 45 days
from the later of the date of such invoice or the date of the related shipment and Distributor has
not paid such invoice, together with accrued unpaid interest thereon as provided herein, upon
expiration of the Notice Period. Notwithstanding the foregoing or anything to the contrary
contained in this Agreement, in the event that LifeCell provides written notice of non-payment to
Distributor pursuant to this Section 4.4 more than once in any Sales Year, LifeCell may
immediately, without the requirement of a Notice Period, either (i) change Distributor’s status as
exclusive distributor of Products in the Sales Territory to non-exclusive distributor of Products
or (ii) terminate this Agreement.
4.5 Delivery. All deliveries of Products by LifeCell to Distributor hereunder, unless otherwise agreed
to by LifeCell in writing, shall be made in accordance with the Delivery Schedule and shall be FOB LifeCell’s tissue processing facility. LifeCell agrees to use commercially reasonable efforts to
ship Products in accordance with the Delivery Schedule, but in no event more than ninety (90) days
after
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LifeCell’s receipt of Distributor’s purchase order, provided that LifeCell timely receives
Distributor’s purchase order issued in accordance with the terms of this Agreement. Distributor
agrees that its only right or remedy for LifeCell’s failure to deliver Products within 90 days of
receipt of Distributor’s applicable and compliant purchase order is as set forth in Section 4.1(c).
4.6 Regulatory Approval. LifeCell shall be responsible for securing all marketing and other regulatory
approvals and permits necessary or otherwise required in the United States and shall pay for all
costs associated therewith. In the event that the Sales Territory includes jurisdictions outside
of the United States, Distributor shall be responsible for securing all marketing and other
regulatory approvals and permits necessary or otherwise required in any jurisdiction in the Sales
Territory other than the United States in which Distributor intends to distribute Products or is
distributing Products, as the case may be, and shall pay for all costs associated therewith.
Distributor shall provide evidence of its securing all marketing and other regulatory approvals and
permits as set forth in this Section 4.6 promptly upon the request of LifeCell. Upon any
termination or expiration of this Agreement, to the extent transferable by law, Distributor shall
in its sole discretion have the option to enter good faith negotiations with LifeCell to sell
LifeCell all such marketing and other regulatory approvals and permits upon mutually satisfactory
terms and conditions.
4.7 Storage and Handling. Distributor agrees to store, handle and transport Processed Tissue and
adhere to all applicable record keeping requirements therefor, in strict accordance with all
applicable laws, rules and regulations, including without limitation, the guidelines of the United
States Food and Drug Administration (the “FDA”) and the American Association of Tissue Banks (the
“AATB”) and the specifications and procedures of LifeCell set forth in Schedule I attached to this
Agreement and made apart hereof, as it may be reasonably changed by LifeCell, in its sole
discretion, from time to time. LifeCell agrees to provide Distributor with such advance notice of
any such changes to Schedule II as is commercially reasonable. Upon reasonable notice and during
regular business hours, Distributor shall make available from time to time its storage, handling
and transport facilities for inspection at LifeCell’s expense by independent representatives
selected by LifeCell or qualified LifeCell employees to verify compliance with the applicable
provisions hereof. Distributor shall store Products and sell Products from inventory to Customers
in the Sales Territory on a First In First Out basis.
4.8 Forecasts; Deliveries; Orders.
(a) No later than the first day of every Sales Quarter during the Term, Distributor shall
provide to LifeCell an updated rolling forecast for the following twelve (12) month period in the
format typically provided by Distributor prior to the date of this amendment and restatement (each
an “Updated Product Forecast”). Each Updated Product Forecast is subject to LifeCell’s
express written approval unless either (i) the Number of Units of Products in any of the Sizes for
any of the first three Sales Quarters of that respective forecast have increased by less than ten
percent (10%), respectively, from their most recent previously-forecasted amounts, or (ii) the
Number of Units of Products in any of the Sizes for the newly-added fourth Sales Quarter of that
respective forecast exceed those of the forecast’s third Sales Quarter by less than ten percent
(10%). In the event that either (y) an Updated Product Forecast complies with the percentage
requirement set forth in the immediately preceding sentence, or (z) an Updated Product Forecast
that does not comply with such percentage requirement is otherwise approved in writing by LifeCell
pursuant to this Section 4.8(a), it shall be deemed as accepted by LifeCell and Distributor.
Promptly following the Effective Date, the parties will mutually agree on a separate Product
forecast for [***] Sheet Product and Micronized Product through the Wind Down Period
| [***] | Indicates portions of this exhibit that have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. |
-10-
reasonably calculated to allow for appropriate depletion of Distributor’s supply of [***] Sheet
Product and Micronized Product by the expiration of the Wind Down Period. Such forecast will be
adjusted by the parties on a monthly basis following the parties mutual review and consideration of
current inventory volumes and customer demand promptly at the end of each month of the Wind Down
Period.
(b) The Number of Units of Products specified for the first Sales Quarter of each accepted
Updated Product Forecast, (each a “First Quarter Commitment”), shall constitute binding
commitments on behalf of Distributor to purchase from LifeCell and LifeCell to deliver to
Distributor. The Number of Units of each respective Product and Sizes forecasted for the second,
third and fourth Sales Quarters of such product forecasts shall constitute non-binding projections
of anticipated future unit demand until such time, whether subsequently revised pursuant to Section
4.8(a) or left unchanged, each become the unit forecast for the first Sales Quarter of the latest
Updated Product Forecast.
(c) Purchase orders for the shipment of the number of Units of Products in the Sizes, issued
in conformance with each First Quarter Commitment shall be binding on LifeCell and Distributor,
except as otherwise provided herein. Purchase orders issued for the number of Units of Products in
the Sizes, in excess of the current First Quarter Commitment for the current Sales Quarter shall be
deemed accepted only up to the applicable First Quarter Commitment for that Sales Quarter unless
otherwise expressly acknowledged by LifeCell in writing.
(d) Distributor agrees to submit to and cause to be received by LifeCell, on or before the
last day of each applicable Sales Quarter in accordance with Section 4.1(a) at LifeCell’s address
set forth in Section 15, written purchases orders for the purchase of a quantity of Units of
Products in the Sizes necessary to at least satisfy the impending First Quarter Commitment for the
next Sales Quarter. Except as otherwise set forth herein, all purchase orders for Numbers of Units
of each respective Product and Sizes in excess of those specified in the current First Quarter
Commitment are subject to approval and written acceptance by LifeCell. Once issued, Distributor
shall not cancel or reschedule any purchase order within twenty (20) days of the scheduled shipment
date for the Products without express written consent from LifeCell. Hand written provisions on
any purchase orders submitted by or through Distributor shall be deemed deleted. Additional or
different terms inserted in this agreement or in any purchase order by either party, or deletions
thereto, whether by alterations, addenda, or otherwise, shall be of no force and effect, unless
mutually expressly agreed to by both parties in writing.
4.9 Warranty; Limitation of Liability.
(a) LifeCell represents and warrants that any Processed Tissue delivered by it to Distributor
hereunder will be, and will have been, obtained, processed, stored, handled and transported in
accordance with (i) all applicable legal requirements then in effect, including without limitation,
the regulations of the FDA and the United States Department of Health and Human Services (21 C.F.R.
Part 1270), (ii) the guidelines of the AATB, (iii) the license requirements of the states of New
York, California and Florida, and (iv) the procedures and specifications set forth on Schedule II.
Distributor agrees that the only remedies for failure of any Processed Tissue to comply with this
limited warranty shall be replacement of non-conforming Processed Tissue.
(b) The parties acknowledge and understand that, under the Federal Food, Drug, and Cosmetic
Act and regulations thereunder, FDA may consider the Processed Tissue or any Products to be medical
devices for the intended uses contemplated in this Agreement, rather than human tissue. The
parties understand, acknowledge and agree that LifeCell does not warrant that the Processed Tissue
| [***] | Indicates portions of this exhibit that have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. |
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or any Products currently meet or in the future will be able to meet medical device regulatory
requirements, including, without limitation, obtaining premarket approval. The parties further
understand, acknowledge and agree that the FDA’s imposition of medical device regulatory
requirements would be substantially more burdensome and costly than the FDA’s human tissue
requirements and that, among other things, the FDA could require that a party or the parties take
certain actions with respect to the Processed Tissue or Products regarding premarket approval,
commercial distribution and regulatory requirements that could have a material impact on the
distribution of Products as contemplated by the parties hereunder. In the event that the FDA
imposes medical device regulatory requirements on the Products or Processed Tissue, (i) Distributor
may cancel any pending purchase orders and/or return any inventory in Distributor’s possession in
exchange for a prompt refund by LifeCell to Distributor of the dollar amount equal to the Transfer
Prices paid by Distributor for the Sizes returned multiplied by the number of Units thereof, and
(ii) LifeCell or Distributor may terminate this Agreement upon fifteen (15) days advance written
notice to the other without incurring any further liability under this Agreement.
(c) In the event and to the extent that any of the actions contemplated by or performed in
connection with this Agreement constitutes the sale of goods by LifeCell, LIFECELL HEREBY DISCLAIMS
AND NEGATES ANY AND ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED WITH RESPECT TO THE PROCESSED
TISSUE, THE PRODUCTS OR ANY RIGHTS HEREUNDER TRANSFERRED, INCLUDING WITHOUT LIMITATION, ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
(d) Distributor covenants and agrees that it shall not make or provide to any Customer any
warranties, representations, specifications, or claims regarding the Processed Tissue or Products
in excess of or inconsistent with those described herein.
(e) LifeCell will not be liable for indirect, incidental, special, consequential, punitive,
exemplary or multiple damages, including without limitation, any damages resulting from business
interruption, loss of use, loss of business, loss of revenue, or loss of profits, arising in
connection with this Agreement or LifeCell’s performance hereunder or of any other obligations
relating to this Agreement, even if LifeCell has been advised of the likelihood of those damages.
The aggregate liability of LifeCell to Distributor arising directly or indirectly out of this
Agreement shall not exceed an amount equal to the total of twelve
(12) full months of revenue actually received by LifeCell under
Section 4.1 during the twelve (12) months immediately preceding the
date on which notice of a claim for such liability arose. This limitation of liability shall
apply regardless of the cause of action under which those damages are sought. The parties
acknowledge that absent this limitation, LifeCell would not have been able to agree to provide the
Products or perform its other obligations hereunder for the consideration and on the terms and
conditions set forth in this Agreement.
4.10
Processed Tissue Changes. LifeCell reserves the right at any time to make changes in the Processed
Tissue provided, however, that LifeCell shall use commercially reasonable efforts to
provide [***] prior written notice to Distributor of any such changes. Distributor
agrees that LifeCell shall have no liability to Distributor by reason of any Processed Tissue
change.
4.11 Processed Tissue Shelf Life. LifeCell covenants that the shelf life of any Processed Tissue
delivered to Distributor during the Term shall have a shelf life of no less than [***] as of the date of shipment from LifeCell.
4.12 Product Recalls.
(a) Responsibility for Recall. In the event any Product(s) must be recalled or LifeCell
reasonably determines that it is prudent to have any Product(s) recalled from the channel of
distribution
| [***] | Indicates portions of this exhibit that have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. |
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by reason of failure to meet any requirements of law or otherwise, Distributor shall have the
sole responsibility to effect the recall. LifeCell is solely responsible for final decisions
concerning the recall of Products in the United States, and the destruction and/or reconditioning
of recalled Products. In addition, LifeCell is solely responsible for all communications with
Regulatory Agencies concerning Product recalls in the United States. For recall of Product outside
the United States, the parties agree to work cooperatively regarding communication with the
Regulatory Agencies to effect the recall. Any costs and expenses incurred by either party in
connection with a recall of Products shall be borne by the party whose acts or omissions caused or
resulted in the necessity for such recall. LifeCell shall use commercially diligent efforts to
cooperate with Distributor in implementing any such recalls to the extent such cooperation is
necessary to effect the recall.
(b) Responsibility for Reimbursement. In the event the recall results from or is caused by an
act or omission by Distributor, Distributor shall reimburse LifeCell for any costs and/or expenses
reasonably expended by LifeCell as a consequence of the recall. Without limiting the general
nature of the foregoing, Distributor shall bear the cost of any Products involved in such recall.
In the event the recall results from or is caused by an act or omission by LifeCell, LifeCell shall
reimburse Distributor for any costs and/or expenses reasonably expended by Distributor as a
consequence of the recall. Without limiting the general nature of the foregoing, LifeCell will
provide replacement Products for recalled Products and for any Products that cannot be shipped due
to the condition requiring the recall within 120 days, and if this does not occur, Distributor
shall have the right to terminate this Agreement.
5. Market Development Programs. LifeCell and Distributor shall review the implementation and
administration of market development and regulatory strategies, priorities, of the Products
(“Market Development Programs”) and Clinical Development Programs and activities and procedures
related to the marketing and sales of Products.
6. Term. This Agreement, as amended shall be effective as of April 1, 2004 and, unless earlier
terminated in accordance with the terms pursuant to Section 7, shall remain in force and effect
until 11:59 p.m., Eastern United States time, December 31, 2018 (the “Initial Term”). Not
later than one hundred twenty (120) days prior to the expiration of the Initial Term or then
current Renewal Term, each party shall provide written notice to the other party indicating its
desire to renew this Agreement for a Renewal Term (the “Renewal Notice”). In the event that either
party’s Renewal Notice indicates a desire to renew this Agreement for a Renewal Term, the parties
shall arrange to meet, in person or telephonically, not later than ninety (90) days prior to the
expiration of the Initial Term or then current Renewal Term, and shall negotiate in good faith
concerning the renewal of this Agreement and any revisions to the terms and conditions to this
Agreement. Unless otherwise extended by mutual agreement of the parties, in the event the parties
have not agreed to renew this Agreement prior to September 30 of the last year of the Initial Term
or then current Renewal Term, this Agreement shall terminate upon expiration of the Initial Term or
then current Renewal Term, as the case may be. Each renewal to this Agreement, including any
revisions to this Agreement agreed to between the parties, shall be memorialized in a written
amendment to this Agreement executed by authorized representatives of each of the parties.
7. Termination.
7.1 Expiration. This Agreement shall terminate on the expiration of the Initial Term or then current
Renewal Term, as applicable, unless the parties shall have agreed to a Renewal Term in accordance
with Section 6.
7.2 LifeCell Option. This agreement shall terminate, at the option of LifeCell, (i) immediately upon
notice to Distributor in the event of (1) an attempted assignment or delegation of this Agreement
by
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Distributor, without LifeCell’s prior written consent, to an entity that is neither controlled
by, nor controls
Distributor via an ownership interest of at least ninety percent (90%), (2) an inability by
Distributor to pay its debts as they become due, (3) the institution of any proceedings by or
against Distributor for reorganization, bankruptcy or other relief under any insolvency or similar
law, (4) an application for or the appointment of a receiver for Distributor (5) dissolution of
Distributor, whether voluntary or by law, unless dissolved into a an entity that is either
controlled by, or controls Distributor via an ownership interest of at least ninety percent (90%),
or (6) solely if LifeCell and KCI Medical Resources are then Affiliates, a material and
intentional breach by Distributor of Section 1B of that certain Trademark License Agreement by and
between Distributor and KCI Medical Resources, dated the Effective Date (the “KCI License
Agreement”) which is not remedied by Distributor within thirty (30) days after written notice
thereof specifying in reasonable detail the nature of the alleged breach, as determined by final
judgment of an arbitrator pursuant to Section 12 of the KCI License Agreement which is no longer
subject to appeal, and provided LifeCell first follows in good faith the dispute resolution
procedures set forth in Section 10D of the KCI License Agreement; or (ii) upon thirty (30) days
written notice to Distributor in the event of a material breach by Distributor of any of the terms
of this Agreement not otherwise described in clause (i) above, if such notice specifies in
reasonable detail the nature of the alleged breach and Distributor shall have failed to cure such a
breach within thirty (30) days of such notice.
7.3 Other. This Agreement also shall terminate in accordance with other Sections of this Agreement
that permit or provide for such termination, including, without limitation, Sections 4.4, 4.9(b)
and 16.2.
7.4 Permitted Activities. Distributor agrees that upon termination of this Agreement, LifeCell may, at
its option, (i) ship Products to Distributor with respect to orders from Distributor duly accepted
by LifeCell during the Term, for sale to and payment by Distributor in accordance with the terms of
this Agreement (treating such terms for this limited purpose as being still in effect), and (ii)
permit Distributor to sell Products in Distributor’s inventory on a non-exclusive basis, but
otherwise subject to and in accordance with the terms of this Agreement (treating such terms for
this limited purpose as being still in effect), until the earlier of such time as (1) all of
Distributor’s then existing inventory of Products has been sold, or (2) the Products have reached
their expiration date. Notwithstanding the foregoing, Distributor, at its option, may return to
LifeCell the actual Products last delivered to Distributor in an amount equal to the amount of
Products purchased by Distributor from LifeCell in the immediately preceding Sales Quarter,
provided that those Products returned have a shelf life of no less than nine (9) months when
received by LifeCell and meet the quality requirements applicable thereto, including without
limitation, the requirements of Section 4.7 and Schedule II (the “Put-Back Amount”), and LifeCell
shall refund to Distributor the dollar amount equal to the Transfer Prices paid by Distributor for
the Sizes returned, multiplied by the number of Units thereof. In the event that Distributor, after
the return to LifeCell of the Put-Back Amount, still retains Products in inventory, LifeCell, at
its option, shall either purchase Distributor’s remaining inventory of Products [***] in effect at the time such Products were purchased by Distributor, provided that the
Products to be repurchased by LifeCell have a shelf life of no less than nine (9) months when
received by LifeCell and meet the quality requirements applicable thereto, including without
limitation, the requirements of Section 4.7 and Schedule II, or permit Distributor to sell the
Products in Distributor’s inventory on a non-exclusive basis for the greater of sixty (60) days
after termination of this Agreement, or until all of Distributor’s then existing inventory of
Products has been sold, or the Products have reached their expiration date.
7.5 Damages.
(a) Distributor shall not be entitled to and shall not claim or seek indemnification or any
other form of damages or compensation from LifeCell by reason of termination of this Agreement
| [***] | Indicates portions of this exhibit that have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. |
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pursuant to its terms or loss of its rights under this Agreement pursuant to such termination, nor
shall it be entitled to seek compensation or damages on account of prospective profits or income after the
termination date.
(b) LifeCell shall not be entitled to and shall not claim or seek indemnification or any other
form of damages or compensation from Distributor by reason of termination of this Agreement
pursuant to its terms or loss of its rights under this Agreement pursuant to such termination, nor
shall it be entitled to seek compensation or damages on account of prospective profits or income
after the termination date.
7.6 Distributor Option. This Agreement shall terminate, at the option of Distributor, (i) immediately
upon notice to LifeCell in the event of (1) an attempted assignment or delegation of this Agreement
by LifeCell without Distributor’s prior written consent, (2) an inability by LifeCell to pay its
debts as they become due, (3) the institution of any proceedings by or against LifeCell for
reorganization, bankruptcy or other relief under any insolvency or similar law, (4) an application
for or the appointment of a receiver for LifeCell, (5) dissolution of LifeCell, whether voluntary
or by law or (6) a change in the control of LifeCell reasonably unacceptable to Distributor or (ii)
upon thirty (30) days written notice to LifeCell in the event of a material breach by LifeCell of
any of the terms of this Agreement not otherwise described in clause (i) above, if LifeCell shall
have failed to cure such breach within 30 days of such notice or (iii) upon 60 days prior written
notice to LifeCell in the event that LifeCell changes any of the Products and such changes, in
Distributor’s reasonable judgment, significantly and adversely affect Distributor. In addition to
the foregoing, Distributor shall have the right to terminate this Agreement at any time, for any
reason in its sole discretion, by giving LifeCell written notice of termination not less than
eighteen (18) months prior to the effective date of termination.
7.7 Survival. Except as otherwise expressly set forth herein, the obligations of the parties under
Sections, 4.1(d), 4.4, 4.7, 4.9, 4.12, 7.4, 8.1, 9, 10, 11, 12, 14, and 17 through 27 shall survive
any expiration or termination of this Agreement forever.
8. Complaints and Regulatory Notices.
8.1 Complaints.
(a) In the event that LifeCell or Distributor at any time during the Term receives any
written, electronic or oral communication that alleges deficiencies related to identity, quality,
durability, reliability, safety, effectiveness or performance concerning the Products or Processed
Tissue (individually or collectively, a “Complaint”), including notices from the FDA regarding any
alleged regulatory non-compliance of such Products or Processed Tissue, or the marketing thereof,
such party shall, within two (2) business days following receipt of notices relating to medical
reports and within 2 business days following receipt of any notice relating to any other Complaint
or such shorter period as may be required by applicable laws, rules or regulations, provide to the
other party all information contained in such Complaint, report or notice and any additional
information relating thereto as may reasonably be requested.
(b) In the event that any Complaint is received from a Customer, LifeCell and Distributor
shall use their best efforts to reach mutual agreement concerning the handling and resolution of
such customer Complaint. LifeCell shall be responsible for the timely review and analysis of each
Complaint, to document its findings in connection therewith and, as LifeCell deems necessary, to
take corrective action.
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8.2 Regulatory Notice. Each of LifeCell and Distributor shall promptly but in no event more than five
(5) days following the receipt thereof, notify the other party and provide to such party a copy or
transcription, if available, of any materially adverse communication received from a regulatory
agency relating to the Product or Processed Tissue, the marketing thereof or any related matter.
9. Trademarks.
9.1 Definition. Distributor acknowledges that LifeCell owns and shall continue to own all right, title
and interest in and to the trademarks or trade names “AlloDerm,” “LifeCell” and “AlloDerm Process”
(the “Trademarks”).
9.2 Grant. LifeCell hereby grants to Distributor a non-exclusive license to use the Trademarks during
the Term solely in connection with Distributor’s marketing and sales of the Products to Customers
in the Sales Territory as provided herein and, in those jurisdictions in which Distributor has been
appointed an exclusive distributor pursuant to Section 1.1 and provided Distributor’s
distributorship status has not become nonexclusive, LifeCell agrees not to grant a license to any
other person to use the Trademarks during the Term in connection with marketing and sales of the
Products to Customers in the Sales Territory.
9.3 Distributor’s Trademarks. The parties acknowledge and agree that all right, title and interest in
and to any trademarks, service marks, trade names or brand names developed for the Product by the
Distributor hereunder shall reside solely with the Distributor. The parties further acknowledge
and agree that the use and display of the trademarks developed by the Distributor and/or LifeCell
Trademarks shall be authorized in advance by LifeCell. The Distributor will provide packaging
specifications, labeling and graphics to LifeCell for review and approval. The parties agree that
the Product package will include a statement, to be agreed upon by both parties, indicating
LifeCell as the manufacturer/technology provider.
9.4 Limitation of Grant. In performing its obligations hereunder, Distributor may use the Trademarks
only for display on packaging or images of the Products and Processed Tissue. All such use and
display shall be solely in connection with the promotion and solicitation of orders for the
Products to Customers in the Sales Territory and only in such fashion as has been expressly
authorized by LifeCell in advance of such use or display. Distributor acknowledges and agrees that
its use of the Trademarks shall at all times be as licensee for the account and benefit of
LifeCell. To the extent that any rights in and to any of the Trademarks are deemed to accrue to
Distributor pursuant to this Agreement, Distributor hereby assigns any and all such rights, at such
time as they may be deemed to accrue, to LifeCell.
9.5 Distributor Actions. Distributor shall not, at any time, do or cause to be done any act or thing
that (i) will in any way impair the rights of LifeCell in or to the Trademarks or their
registrations, (ii) may affect the validity of any of the Trademarks or (iii) may depreciate the
value of the Trademarks or their reputation. Except as otherwise specifically provided herein,
Distributor shall not, during the Term or thereafter, attach LifeCell’s title or right in and to
the Trademarks. Distributor shall, at LifeCell’s request and sole expense, provide all
commercially reasonable cooperation and assistance in connection with LifeCell’s efforts to
register, maintain, protect and defend the Trademarks and to prosecute any infringers with respect
to the Trademarks. LifeCell shall control all efforts to register, maintain, protect and defend
the Trademarks and to prosecute any infringers with respect to the Trademarks. Distributor agrees
to advise LifeCell promptly of any actual or potential infringement of the Trademarks on becoming
aware of such infringements. LifeCell shall have the sole right to determine if any action shall
be taken against any third party on account of any such infringements or imitations and Distributor
shall not institute any suit or take any action against any third party on account of any such
infringements or imitations without first
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obtaining LifeCell’s written consent to do so. Any
recovery as a result of such action shall belong solely to LifeCell, except to the extent that such
recovery represents damage to Distributor, in which event any specified recovery, net of all
expenses paid by LifeCell, including Distributor’s attorneys’ fees, if any, shall
be paid to Distributor, Distributor agrees and undertakes that its use of the Trademarks will be in
strict compliance with any and all applicable laws, rules and regulations, including trademark
laws, and that it will make such marking on the Product packaging or otherwise in connection
therewith as may be required by LifeCell in its sole discretion. Distributor shall use commercially
reasonable efforts to cooperate fully with LifeCell in preparing and causing to be recorded at
LifeCell’s expense such documents as may be necessary or desirable to evidence, protect and
implement the rights of LifeCell pursuant to this Section 9.
9.6 Pre-Publication Review of Marketing Materials. All Marketing Materials are expressly subject to
pre-publication review and approval with respect to, but not limited to, content, style,
appearance, composition, timing, and media. Prior to the distribution or publication of any
advertising, technical, sales or other materials containing any of LifeCell’s trademarks, service
marks or trade names, or referring to the Products or Processed Tissue (“Marketing Materials”),
Distributor shall provide one copy of proofs of such Marketing Materials to LifeCell for review and
approval (Attention: Vice-President, Marketing, LifeCell Corporation, Xxx Xxxxxxxxxx Xxx,
Xxxxxxxxxx, XX 00000) at least ten (10) days prior to the anticipated publication of such Marketing
Materials. LifeCell shall use commercially diligent efforts to provide feedback and/or approval (as
the case may be) to Distributor within five (5) days after LifeCell’s receipt of the applicable
Marketing Materials. Notwithstanding anything to the contrary contained herein, Distributor shall
not use, distribute or publish anything containing LifeCell’s trademarks, service marks or trade
names or referring to Products or Processed Tissue without the express prior written consent of
LifeCell.
9.7 Termination of Use of Trademark. Except as provided in Section 7.4, if for any reason Distributor
ceases to be the Distributor of the Products in the Sales Territory, Distributor’s right to use the
Trademarks shall terminate immediately upon depletion of existing inventory of Product. Except as
provided in Section 7.4, upon any termination of this Agreement, (i) any and all rights granted to
Distributor hereunder, together with any interest in and to the Trademarks and registrations
therefor which Distributor may be deemed to have acquired by virtue thereof or otherwise, shall
immediately cease and without further act or instrument be assigned to and revert to LifeCell, and
(ii) Distributor shall immediately terminate all further use of the Trademarks except as provided
herein. Thereafter, Distributor shall not recommence or continue using any of the Trademarks
without the prior written consent of LifeCell. In addition, Distributor will promptly execute any
instruments reasonably requested by LifeCell which LifeCell reasonably, in its sole discretion,
deems necessary, proper or appropriate to accomplish or confirm the foregoing. Any such
assignment, transfer or conveyance shall be without further consideration other than the mutual
agreement contained herein.
10. Proprietary Rights. To LifeCell’s knowledge, it owns or possesses, or has licenses or other
rights to use and license all patents, patent applications, patent disclosures and inventions,
patent licenses, trademarks, trade names, trade secrets, service marks, brand marks, brand names,
copyrights, copyright applications, inventions, technologies, know-how, formulae and processes
owned by or licensed to LifeCell (collectively, “Proprietary Rights”) necessary for it to comply
with its obligations under this Agreement without any conflict with or infringement of the rights
of any third party. To LifeCell’s knowledge, no claim has been asserted or threatened by any person
regarding the use or licensing of any of the Proprietary Rights by LifeCell or challenging or
questioning the validity, enforceability or effectiveness of any licenses or agreements relating to
Proprietary Rights or asserting any rights in such Proprietary Rights. To LifeCell’s knowledge,
the use by LifeCell of its Proprietary Rights does not violate
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or infringe the rights of any third
party. LifeCell is not aware of any third parties who are infringing or violating any of the
Proprietary Rights.
11. Independent Contractor. Distributor is an independent contractor and agrees not to represent
itself in any manner to any third party as a partner, agent, associate or employee of LifeCell. It
is expressly provided that this Agreement does not create a partnership, joint venture or any similar
business association or combination between the parties hereto. It is understood and agreed that
all contracts for the sale of Products to Customers will be between Distributor (or its permitted
sub-distributors) and Customers. Distributor shall have no authority to accept orders for Products
on behalf of LifeCell. Distributor does not have the power to bind LifeCell or to assume or create
any contract or other obligation on behalf of LifeCell.
12. Indemnity.
12.1 Distributor. Distributor shall indemnify and hold LifeCell harmless from any and all claims,
liabilities, judgments, losses, damages, costs and expenses, including without limitation,
reasonable attorneys’ fees and costs, (“Damages”) successfully asserted against LifeCell by any
person not a party to this Agreement which Damages result from any bodily injury, illness, death,
or property damage if Damages (i) arise out of any statement, representation, warranty or Marketing
Materials issued by Distributor which materially exceeds in scope or is different in meaning from
statements made by LifeCell in LifeCell’s own literature, or specifications or has been previously
approved by LifeCell or (ii) arises solely from the negligence or wrongful activity of Distributor.
12.2 LifeCell. LifeCell shall indemnify and hold Distributor harmless from any and all Damages by any
person or entity not a party to this Agreement which Damages result from any bodily injury,
illness, death, or property damage if such Damages arise from (i) a defect in any of the Processed
Tissue associated with any Products, (ii) a failure of any of the Processed Tissue associated with
any Products to meet LifeCell’s specifications, (iii) from the negligence or wrongful activity of
LifeCell or (iv) infringement of Proprietary Rights of third parties.
12.3 Settlements and Compromises. Neither the party having the right to indemnification nor the party
having the indemnification obligation under this Section 12 may settle or compromise any such
claim, suit, action or proceeding unless (i) the other party consents in writing (which consent may
not be unreasonably withheld) and (ii) the terms of that settlement or compromise release the other
party from any and all liability with respect to that claim.
12.4 Joint Actions. In the event any claim, suit, action or proceeding is asserted against both
LifeCell and Distributor, or one party to this Agreement joins the opposite party in any such
claim, suit, action or other proceeding, a party will be obligated to indemnify the opposite party
with respect to that matter only if, and in proportion to the extent that, such party is first
found to have been at fault with respect to that matter by a final, non-appealable judgment of a
court of law.
13. Compliance with Laws.
(a) Each of LifeCell and Distributor shall comply with, and be responsible for ensuring that
its employees and agents comply with, all applicable statutes, rules, regulations, orders and
by-laws of the federal government of the United States and any other jurisdiction in the Sales
Territory or any state and any agency, authority or political subdivision thereof.
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(b) Distributor agrees that neither it nor any of its officers, directors, employees or
representatives will, directly or indirectly, in connection with the solicitation of sales of the
Products to Customers in the Sales Territory:
(i) make any payment to any officer or employee of any government, or to any political
party or official thereof; where such payment either is unlawful under laws applicable
thereto, or would be unlawful under the Foreign Corrupt Practices Act of 1977, as amended,
of the United States of America, if Distributor, as the case may be, were a “domestic
concern”, within the meaning of such act;
(ii) make any payment to any person, if such payment constitutes an illegal bribe,
illegal kickback or other illegal payment under laws applicable thereto; or
(iii) commit, directly or indirectly, any other act or omission in violation in any
material respect of any applicable law, regulation, rule or custom having the effect of law.
14. Confidential Information.
14.1 Definition. LifeCell and Distributor may from time to time provide to the other party (each, a
“Recipient”) certain advice, technical information, know-how and other proprietary data and
information that they respectively own to aid each other in the performance of their respective
obligations under this Agreement. Inasmuch as various of these materials and advice (all of which
will be referred to herein as the “Confidential Information”) will contain confidential information
and/or trade secrets, it is hereby agreed that any Confidential Information which is disclosed by
one party to the other is valuable, proprietary property belonging to the party making such
disclosure, and the Recipient agrees that it will neither use nor disclose any Confidential
Information to any third party (except if necessary in the performance of its duties hereunder),
except with the prior written consent of the other party, provided, however, that any written
Confidential Information shall be marked “Confidential”.
14.2 Limitation. The Recipient agrees to make copies of that Confidential Information received by the
Recipient as is authorized by the other party and which is necessary to the performance of
Recipient’s obligations under this Agreement. Recipient also agrees to limit disclosure of the
Confidential Information to only those employees of Recipient with a need to know such Confidential
Information in connection with the performance of Recipient’s obligations under this Agreement.
14.3 Remedies. In the event of breach or threatened breach by the Recipient or its employees of any of
the provisions of Sections 14.1 or 14.2, the other party shall be entitled to an injunction or
judicial order equivalent thereto restraining the Recipient or its employees from disclosing, in
whole or in part, such Confidential Information. Nothing herein shall be construed as prohibiting
the other party from pursuing any other remedies available to it for such breach or threatened
breach, including recovery of damages from the Recipient.
14.4 Termination. The Recipient agrees, either upon the termination of this Agreement or upon request,
to surrender to the other party all documentary material including Confidential Information, price
lists, catalogues, technical literature, sales literature, samples and any other documents, papers
or other properties of the other party, however previously supplied to the Recipient by the other
party, provided, however, that Distributor may retain a reasonable amount of Marketing Materials as
necessary to sell Products in accordance with Section 7.4. The Recipient may retain one (1) copy or
memorandum of said documentary materials for dispute resolution purposes only.
-19-
14.5 Survival. The obligations of the Recipient pursuant to this Section 14 shall continue in full
force and effect after the termination of this Agreement regardless of how or when this Agreement
is expires or is terminated.
14.6 Exclusions. Notwithstanding any other provision in this Section 14, the term “Confidential
Information” does not include information which (i) came into the Recipient’s possession prior to
execution of this Agreement, provided that such information is not known by the Recipient to be
subject to another confidentiality agreement with or other obligation of secrecy to the other
party, or (ii) becomes generally available to the public other than as a result of a disclosure by the Recipient
or any of the Recipient’s directors, officers, employees, agents or advisors, or (iii) becomes
available to the Recipient on a non-confidential basis from a source other than the other party or
the other party’s advisors, provided that such source is not bound by a confidentiality agreement
with or other obligation of secrecy to the other party.
15. Notices. Any notice, transmittal of documents, correspondence or other communication between the
parties to this Agreement required hereunder shall be in writing, addressed to the party to whom
sent and transmitted by certified mail, courier or by facsimile with signed written original to
follow by certified mail or courier. All such notices in compliance with this provision shall be
deemed received by the other party on the next business day after transmission. For purposes of
this Agreement, the addresses of the parties are as follows until changed by written notice from
the party desiring to change its address to the other party.
If to LifeCell:
|
If to Distributor: | |
LifeCell Corporation Xxx Xxxxxxxxxx Xxx Xxxxxxxxxx, XX 00000 Attn: President Telephone: 000-000-0000 Facsimile: 000-000-0000 |
Xxxxxx Medical Technology, Inc. 0000 Xxxxxxx Xxxx Xxxxxxxxx, XX 00000 Attn: President Telephone: 000-000-0000 Facsimile: 000-000-0000 |
|
With a copy to: |
||
LifeCell Corporation Xxx Xxxxxxxxxx Xxx Xxxxxxxxxx, XX 00000 Attn: Legal Department Telephone: 000-000-0000 Facsimile: 000-000-0000 |
Xxxxxx Medical Technology, Inc. 0000 Xxxxxxx Xxxx Xxxxxxxxx: XX 00000 Attn: General Counsel Telephone: 000-000-0000 Facsimile: 000-000-0000 |
16. Force Majeure.
16.1 Definition. Neither party hereto shall be responsible for any loss or damage to the other in the
event that it is unable to fulfill the whole or any part of its obligations hereunder, or is
prevented or delayed from fulfilling the same, due to war or hostilities (whether war be declared
or not), invasion, act of foreign enemies, rebellion, revolution, insurrection, military usurpation
of power, civil war or riot, strike, lockout, commotion, disorder, flood, tempest, earthquake, acts
or omissions of civil or military authority whether legitimate or not, or other causes beyond the
control of either party, including changes in laws or regulations relating to or affecting the
Processed Tissue or the Products and increase in costs of raw materials resulting in commercial
impracticability of selling Products [***].
| [***] | Indicates portions of this exhibit that have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. |
-20-
16.2 Consequences. Upon the occurrence of an event of force majeure, the party affected shall notify
the other party immediately. The rights and obligations of either party under this Agreement
affected by any such event of force majeure shall be suspended only for the duration and to the
extent of such event of force majeure, and once such event of force majeure ceases to exist, the
rights and obligations of the parties shall continue in full force. In the event that a condition
of force majeure sufficient to suspend a party’s obligations under this Agreement is continuing for
a period of ninety (90) days or more, either party may terminate this Agreement immediately upon
written notice to the other party.
17. Arbitration.
17.1 Agreement. Any dispute, controversy, claim or other matter in question between the parties hereto
arising out of or relating to this Agreement or any other document or instrument executed by the
parties hereto in connection with this Agreement contemplated in any of the foregoing, including
all issues of fact and law (for the purposes of this Section 17, the “Claim”), shall be settled by
arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration
Association (the “Commercial Arbitration Rules”), except as otherwise expressly set forth herein.
Without limiting the generality of the foregoing, “Claims” shall also include any dispute,
controversy, claim or other matter in question arising out of or related to this Agreement or any
document or instrument executed by the parties hereto in connection herewith, it being the purpose
and intent hereof to evidence the agreement of all the parties hereto to submit all Claims to
arbitration. Notice of demand for arbitration shall be filed in writing with all parties to this
Agreement as to whom the Claim is alleged and with the American Arbitration Association (the
“AAA”). The arbitration proceeding shall be conducted by one disinterested neutral arbitrator who
shall be appointed from a panel in accordance with the Commercial Arbitration Rules of the AAA;
provided, however, that if a neutral arbitrator cannot be selected and appointed by the parties to
the dispute from the first list of names submitted by the AAA, then the AAA shall submit to each
party to the dispute a second list of names of persons chosen from the panel, and if a neutral
disinterested arbitrator cannot be appointed for any reason from said second list, then the AAA
shall then be deemed authorized and directed to and shall select and appoint, on behalf of all
parties to the dispute, one disinterested neutral arbitrator (but in no event shall the AAA appoint
an arbitrator whose name has previously been rejected by the parties to the dispute). All persons
submitted as prospective arbitrators by the AAA shall be persons having substantial knowledge of
substantive commercial laws and the general issues in question for arbitration.
17.2 Proceedings. The arbitrator shall conduct the arbitration proceeding in the State of New Jersey if
the Distributor initiates the dispute and in Memphis, Tennessee if LifeCell initiates the dispute,
as provided hereinabove and in the Commercial Arbitration Rules. The arbitrator rendering the
judgment or award shall deliver a brief written opinion explaining such judgment or award and the
legal and factual reasons therefor. This agreement to arbitrate shall be specifically enforceable
under applicable law in any court having jurisdiction thereof. The award rendered by the
arbitrator shall be final, such judgment shall be entered upon it in accordance with applicable law
in a court hearing jurisdiction thereof and any such award or judgment shall be subject to appeal
in accordance with the same procedures and an the same legal basis as a final judgment of the trial
court in which such judgment is entered. The parties hereto agree to expedite and cooperate in
obtaining the entry of judgment with respect to such award. A demand for arbitration shall be made
within a reasonable time after the Claim or other matter in question has arisen. In no event shall
the demand for arbitration be made after the date when institution of legal or equitable
proceedings based on such Claim or the matter would be barred by applicable statutes of limitation.
-21-
18. Definitions and Construction.
18.1 Certain Definitions. Capitalized terms used in this Agreement, unless the context otherwise
requires, have the meanings specified in this Section 18.1 or in the part of this Agreement
referred to below.
(a) “AAA” shall have the meaning given to such term in Section 17.
(b) “AATB” shall have the meaning given to such term in Section 4.7.
(c) “Agreement” shall have the meaning given to such term in the preamble and shall for all
purposes include the Schedules and Exhibits hereto.
(d) “Agreement Matters” shall have the meaning given to such term in Section 19.
(e) “Affiliate” means, with respect to any specified person at any time, any person who is
directly or indirectly controlling, controlled by or under common control with such specified
person at such time.
(f) “Claim” shall have the meaning given to such term in Section 17.1.
(g) “Clinical Development Programs” means the conduct, in the United States and outside the
United States, as applicable, of preclinical and clinical activities and filing and prosecution of
regulatory applications in support of regulatory approval and regulatory classification in respect
of commercial introduction, marketing and sales of the Products.
(h) “Commercial Arbitration Rules” shall have the meaning given to such term in Section 17.1.
(i) “Complaint” shall have the meaning given to such term in Section 8.1.
(j) “Confidential Information” shall have the meaning given to such term in Section 14.1.
(k) “Customer” means health care provider who or that performs orthopedic surgery procedures
including, but not limited to, the spine, trauma, oncology, extremities and joint replacement, or,
until June 30, 2011, podiatric wound surgical procedures or other care or treatment of podiatric
wounds.
(l) “Damages” shall have the meaning given to such term in Section 12.1.
(m) “ “Distributor” shall have the meaning given to such term in the preamble.
(n) “Effective Date” shall have the meaning given to such term in the opening paragraph of
this Agreement.
(o) “FDA” shall have the meaning given to such term in Section 4.7.
(p) “Initial Term” shall have the meaning given to such term in Section 6.
(q) “Intellectual Property” means United States and foreign patents and patent applications,
know-how, show-how, trade secrets, inventions, discoveries and technical information,
-22-
including
without limitation, information embodied in drawings, designs, copyrights, copyright applications,
trademarks and trademark applications, service marks and service marks applications, material
specifications, processing instructions, formulas, equipment specifications, product
specifications, confidential data, computer software, electronic files, research notebooks,
invention disclosures, research and development reports and the like related thereto and all
amendments, modifications and improvements of any of the foregoing.
(r) “LifeCell” shall have the meaning given to such term in the preamble.
(s) “Market Development Programs” shall have the meaning given to such term is Section 5.
(t) “Marketing Materials” shall have the meaning given to such term in Section 9.6.
(u) “person” means any individual, corporation, partnership, joint venture, association,
limited liability company, joint stock company, trust, unincorporated organization or any federal,
state, local or other government (or agency or political subdivision thereof).
(v) “Processed Tissue” means tissue processed by LifeCell in accordance with its proprietary
AlloDerm® process.
(w) “Products” means all Processed Tissue provided during the Term in the form of (i)
LifeCell’s current human acellular [***] dermal sheet product for use in any and all orthopedic
surgical applications and, until the expiration of the Wind Down Period, LifeCell’s current human
acellular [***] and [***] sheet product in podiatric wound applications, with the exception that
the marketing of product by Distributor for use in [***] (“Sheet Products”), [***]; and
(ii) until June 30, 2011, LifeCell’s current acellular, micronized form, specifically limited to
use in [***] (“Micronized Products”). Products are further described in the Product Specification
as detailed hereto as Schedule II, which may be changed to include additional Products, as they are
developed by LifeCell and made available to Distributor in accordance with the provisions of this
Agreement or otherwise by mutual agreement of the parties. Distributor agrees that it shall not
sell or distribute Products for any non-orthopedic application, or as otherwise limited by or
excluded in the definition above, except that Distributor may sell or distribute the Product for
podiatric wound applications until the expiration of the Wind Down Period.
(x) “Proprietary Rights” shall have the meaning given to such term in Section 10.
(y) “Recipient” shall have the meaning given to such term in Section 14.1.
(z) “Renewal Notice” shall have the meaning given to such Term in Section 6.
(aa) “Renewal Term” means any and each additional one (1) year term of this Agreement mutually
agreed to by the parties.
(bb) “Revenue Share Payments” shall have the meaning given to such term in Section 4.3.
| [***] | Indicates portions of this exhibit that have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. |
-23-
(cc) “Sales Quarter” means any three month period or shorter period, as the case may be,
occurring during the Term that commences on the first day of each calendar quarter and terminates
on the earlier of the first day of the immediately following calendar quarter or on the date this
Agreement expires or is terminated.
(dd) “Sales Territory” means the United States, Greece, Italy, South Africa, Canada, and the
United Kingdom as well as any other country or jurisdiction which the parties mutually agree by
written amendment to this Agreement is to be included in the Sales Territory; provided, however,
that Distributor shall have the first option to exclusively distribute the Products in other
countries or jurisdictions which right shall be lost if Distributor fails to sell the Product in such
additional countries or jurisdictions within 18 months of LifeCell’s reasonable request.
(ee) “Sales Year” means any twelve (12) month or shorter period, as the case may be, occurring
during the Term that commences on the Effective Date or the anniversary of the Effective Date, as
the case may be, and terminates on the earlier of the date 12 months thereafter or on the date this
Agreement expires or is terminated.
(ff) “Sizes” means the sizes in which the Products are offered for sale as set forth in the
most current Updated Product Forecast.
(gg) “Term” means the Initial Term and each Renewal Term, if any.
(hh) “Trademarks” shall have the meaning given to such term in Section 9.1.
(ii) “Transfer Prices” shall have the meaning given to such term in Section 4.2.
(jj) “Units” means the number of Products to be purchased by Distributor for a respective
Sales Quarter as set forth in the most current Updated Product Forecast.
(kk) (pp) “Updated Product Forecast” shall have the meaning given to such term in Section
4.8(a).
18.2 Other Definitions. Other terms may be defined elsewhere in this Agreement and shall have the
meanings there indicated.
18.3 Gender, etc. Words used in this Agreement, regardless of the number or gender specifically used,
shall be deemed and construed to include any other number, singular or plural, and any other
gender, masculine, feminine or neuter, as the context shall require.
18.4 Certain Constructions. As used in this Agreement, unless expressly stated otherwise, references
to:
(a) (i) “include” and “including” mean “include, without limitation” and “including, without
limitation”, respectively, (ii) the words “hereof’, “herein” and “hereunder”, and similar words,
refer to this Agreement as a whole and not to any particular section, subsection, paragraph or
provision of this Agreement and (iii) “or” means “either or both”,
(b) Unless otherwise specified, all reference in this Agreement to sections, subsections,
paragraphs or schedules are deemed references to the corresponding sections, subsections,
paragraphs or schedules in this Agreement.
| [***] | Indicates portions of this exhibit that have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. |
-24-
(c) References to “days”, “months”, “quarters” and “years” in this Agreement, unless
otherwise specifically indicated, shall mean calendar days, months, quarters and years,
respectively,
18.5 Captions. The section, subsection and paragraph headings contained herein are for convenience of reference
only and shall not affect or control the construction or interpretation of any provision hereof.
19. Governing Law and Jurisdiction. The validity, interpretation, performance, and enforcement of
this Agreement and all matters arising directly and indirectly from this Agreement (collectively
“Agreement Matters”) shall be governed by the internal laws of the State of Delaware, without
regard to any conflicts or choice of law rules. The parties hereby irrevocably submit to the
exclusive personal jurisdiction of the State and Federal courts located in Delaware for the purpose
of any suit, action, proceeding or judgment which, directly or indirectly, arises out of any
Agreement Matters; provided that a party to this Agreement shall be entitled to enforce an order or
judgment of a Delaware court (or a federal appellate court of competent jurisdiction issuing the
same on appeal from a Delaware court) in any other court having jurisdiction over the other party
hereto. Each of the parties hereby irrevocably waives, to the fullest extent permitted by
applicable law, any objection that it may now or hereafter have to the laying of the venue of any
such proceeding brought in such a court and any claim that any such proceeding brought in such a
court has been brought in an inconvenient forum.
20. Public Announcements. Unless otherwise required by applicable laws, rules or regulations of any government, agency or
political subdivision thereof or the rules of any securities exchange or market on which such
party’s securities are listed, neither party shall issue a press release or make any public
announcement relating to this Agreement or the transactions contemplated hereby or subsequent
developments relating to the relationship of the parties hereto without first providing a copy of
such release or announcement to the other party and the prior consent of the other party, which
consent shall not be unreasonably withheld. In the case of any announcement required by applicable
laws, rules or regulations of any government, agency or political subdivision, thereof or the rules
of any securities exchange or market on which such party’s securities are listed, neither party
shall issue a press release or make any public announcement relating to this Agreement or the
transactions contemplated hereby or subsequent developments relating to the relationship of the
parties hereto without first providing a copy of such proposed announcement to the other party as
soon as practicable prior to the proposed release thereof.
21. Amendment; Remedies; Waiver. This Agreement may be amended, modified, superseded, canceled, renewed or extended, and its
terms and conditions may be waived, but only by a written instrument signed by the parties or, in
the case of a waiver, by the party waiving compliance. All remedies available to either party for
breach of this Agreement are cumulative and may be exercised concurrently or separately. Exercise
of any one remedy shall not be deemed an election of such remedy to the exclusion of other
remedies. No delay on the part of any party in exercising any right, power or privilege hereunder
shall operate as a waiver thereof, nor shall any waiver on the part of any party of any right,
power or privilege hereunder, nor any single or partial exercise of any right, power or privilege
hereunder, preclude any other or further exercise thereof or the exercise of any other right, power
or privilege which that party might otherwise have hereunder, or at law or in equity.
22. Severability. Should any provision of this Agreement be held unenforceable or invalid, then the parties hereto
agree that such provision shall he deemed modified to the extent necessary to render it lawful and
enforceable, or if such a modification is not possible without materially altering the intention of
the parties hereto, then such provision shall be severed herefrom. In such case the validity of
the
-25-
remaining provisions shall not be affected and this Agreement shall be construed as if such
provision were not contained herein.
23. Assignment. Other than as expressly set forth herein, neither party shall assign or subcontract the whole or
any part of this Agreement without the other party’s written consent.
24. Entire Agreement. All agreements and understandings between the parties relating to the purchase and distribution
of the Products in the Sales Territory are embodied in this Agreement. This Agreement supersedes
any previous agreements and understandings between the parties as to the subject matter hereof and
is entire in itself and not a part of any other agreement, and no promises, covenants, or
representations of any kind or nature other than those expressly stated herein have been made to
induce either party to enter into this Agreement. All other terms and conditions, whether express,
or implied by statute, common law, trade usage or custom are hereby excluded and extinguished.
25. Construction of Agreement. Both parties have participated fully in the preparation and revision of this Agreement. Any
rule of construction to the effect that ambiguities are to be resolved against the drafting party
shall not apply to the interpretation of this Agreement.
26. Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an
original and all of which together shall constitute one and the same instrument.
27. Further Assurances. Each party will do such further acts, including executing and delivering additional agreements
or instruments as the other may reasonably require, to consummate, evidence, confirm or give effect
to the agreements contained in this Agreement.
(Remainder of page intentionally left blank)
-26-
IN WITNESS WHEREOF, the parties hereto, by their duly authorized representatives, have
executed and delivered this Agreement as of the date first above written.
| LIFECELL CORPORATION |
||||
| By: | /s/ Xxxx Xxxxxxxx 1-28-11 | |||
| Name: | Xxxx Xxxxxxxx | |||
| Title: | President | |||
| XXXXXX MEDICAL TECHNOLOGY, INC |
||||
| By: | /s/ Xxxx X. Xxxxxx | |||
| Name: | Xxxx X. Xxxxxx | |||
| Title: | CEO | |||
Attachments:
| Schedule I — Processed Tissue Storage, Handling and Transportation Specifications and Procedures | |
| Schedule II — Product Specification |
-27-
Schedule I
Processed Tissue Storage, Handling and Transportation Specifications and Procedures
The following policies and procedures to be incorporated into Distributor’s existing protocols are
based on the Standards of the American Association of Tissue Banks (1998) and specifically address
the issue of “Tissue Distribution Intermediates” (Section M). Technical assistance is available
from LifeCell to facilitate the incorporation of these procedures.
Appropriate documentation is critical. Particular attention should be paid to the following areas:
Documentation of receipt of tissue
Lot/graft numbers
Expiration date
Received by
Date of receipt
Condition of packaging
Expiration date
Received by
Date of receipt
Condition of packaging
Documentation of storage conditions
Temperature monitoring
Documentation of distribution
Distributor shall maintain distribution records that permit the tracing of the Processed
Tissue to the consignee. Distribution records must include:
Date of order
Consignee name and address
Identification of person placing the order
Type and quantity of tissue ordered
Information regarding tissue shipped
Consignee name and address
Identification of person placing the order
Type and quantity of tissue ordered
Information regarding tissue shipped
Identification numbers of tissue’s
Expiration date of tissue Date of shipment
Mode of transportation
Name of Individual filling order
Expiration date of tissue Date of shipment
Mode of transportation
Name of Individual filling order
Documentation of final package inspection prior to distribution
Additional requirements:
Storage Equipment
Distributor must insure that all storage equipment (i.e., refrigerator(s)) is regularly maintained
(i.e. preventative maintenance program), calibrated, and monitored.
Monitoring of refrigerators may consist of the installation of a continuous temperature recording
device or a routine (once each working day) and documented check of temperature utilizing a
refrigerator thermometer. Acceptable temperature range for the storage of Processed Tissue is 1 -
10°C. Processed
-28-
Tissue may be stored in a standard household refrigerator provided that this temperature range can
be maintained.
Adverse Outcomes
All reports of complaints or adverse outcomes must be required to be forwarded immediately to
LifeCell.
Return of Tissue
All expired, returned, damaged, or otherwise compromised packages or grafts must be returned to
LifeCell.
Labels
Packages containing Processed Tissue cannot be relabeled. Existing labeling cannot be altered.
-29-
Schedule II
Product Specification
See attached.
| Xxxxxx Medical Technology | Document No.: PS02-0013 | |
| Issued | Rev.: 07 |
Product Specification for GRAFTJACKET®
Regenerative Tissue Matrix
Regenerative Tissue Matrix
Revision Draft Date:
|
July 26, 2007 | |
Issue Date:
|
July 31, 2007 | |
Effective Date:
|
July 31, 2007 | |
Supersedes:
|
PS02-0013, Rev.: 06 | |
Supersedes Date:
|
January 25, 2007 |
Prepared by:
|
Xxxxx Xxxxxx, Product Development Engineering | |
Approved by:
|
Xxx Xxxxxxx, Biologics Development | |
| Xxxxxxx Xxxx, Material Engineering | ||
| Xxxxxx Xxxxxx, Industrial Engineering | ||
| Xxxx Xxx, Marketing | ||
| Xxxxx Xxxxx, Regulatory Affairs | ||
| Xxx Xxxxxxx, International Marketing | ||
| Xxxx Xxxx, Production Management | ||
| Xxx Xxxxx, Process Engineering | ||
| Xxxxxx Xxxxxxxx, Quality Assurance | ||
| Xxxxx Xxxxxxx, Quality Engineering | ||
| Xxxxx Xxxxxxx, Purchasing | ||
| Xxxx Xxxxx, Clinical | ||
| Xxxxxx Xxxxx, Sterilization Assurance | ||
| Xxxx Xxxxx, Packaging Engineering | ||
Document Release Section
| Dept/Function | Approver | Signature and Date | ||
Documentation
|
Xxxx Xxxxxx | /s/ Xxxx Xxxxxx 7-31-2007 |
|
Proprietary Information Do not copy or write on this document. |
Page 1 of 5 |
| Product Specification for GRAFTJACKET® Regenerative Tissue Matrix Issued |
Document No.: PS02-0013 Rev.: 07 |
| 1.0 | Objective | |
| This specification describes the product requirements for GRAFTJACKET® Regenerative Tissue Matrix (manufactured by LifeCell Corporation, Branchburg, NJ). | ||
| 2.0 | Document Reference Summary |
| • | American Association of Tissue Banks (AATB): Standards for Tissue Banking Guidelines | ||
| • | 21 CFR 1271, Subpart C — Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products | ||
| • | 21 CFR 1271, Subpart D — Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments. | ||
| • | G102-0163 Package Challenge/Distribution Testing Procedure |
| 3.0 | Product Description |
| 3.1 | General Overview: GRAFTJACKET® is human dermal tissue that has been processed to remove all epidermal and dermal cells while maintaining its biologic matrix. It is provided freeze-dried and must be rehydrated prior to use. Once rehydrated, the product may be sutured, folded, or easily trimmed with scissors or a scalpel in the operating room. | ||
| 3.2 | Intended Use: The GRAFTJACKET® matrix is used to provide supplement support, protection, and reinforcement of tendon and ligamentous tissue; to be used as a periosteal patch or covering; or for protection and support of bone and tendons in hand surgery. | ||
| 3.3 | Related Devices: There are no related devices. | ||
| 3.4 | Post-market Surveillance: Post-market surveillance will be investigated through complaint history, surgeon feedback, and/or clinical evaluations of both WMT and related competitor products. |
| 4.0 | Proposed Size Offering |
| 4.1 | GRAFTJACKET® matrix will have multiple size offerings ranging from 1 to 5 cm in width to 4 to 12 cm in length. | ||
| 4.2 | GRAFTJACKET® matrix may have specific size options with the approximate dimensions of 5 X 5 cm (approximately 2” X 2”), 5 X 10 cm (approximately 2” X 4”), 2 X 4 cm (approximately 0.8” X 1.6”), 4 X 7 cm (approximately 1.6” X 2.8”), and 1 X 12 cm (0.4” X 4.7”). | ||
| 4.3 | GRAFTJACKET® matrix will have different thicknesses ranging from 0.013” to 0.099”. | ||
| 4.4 | GRAFTJACKET® matrix may have different thickness ranges for specific size options: |
| 4.2.1 | The average sheet thickness for the standard GRAFTJACKET® matrix 5 X 5 cm, 4 X 7 cm, and 5 X 10 cm sizes may fall in the range of 0.035” to 0.060”. | ||
| 4.2.2 | The average sheet thickness for the thin GRAFTJACKET® matrix 2 X 4 cm size may fall in the range of 0.013” to 0.024”. | ||
| 4.2.3 | The average sheet thickness for the thick GRAFTJACKET® matrix 2 X 4 cm, 5 X 5 cm, and 4 X 7cm sizes may fall in the range of 0.040” to 0.070”. | ||
| 4.2.4 | The average sheet thickness for the ultra thick GRAFTJACKET® matrix 4 X 7 cm size may fall in the range of 0.071” to 0.099”. | ||
| 4.2.5 | The average sheet thickness for the long strip GRAFTJACKET® matrix 1 X 12 cm size may fall in the range of 0.050” to 0.075”. |
| 4.5 | Each size will be provided for single patient use in packaged, sealed containers. |
| Proprietary Information Do not copy or write on this document. |
Xxxxxx Medical Technology Page 2 of 5 |
| Product Specification for GRAFTJACKET® Regenerative Tissue Matrix Issued |
Document No.: PS02-0013 Rev.: 07 |
| 5.0 | Product Features and Functional Requirements |
| 5.1 | Product thickness shall be determined by LifeCell Corporation in the dry state per their standard procedure. | ||
| 5.2 | Product sheets shall be visibly uniform in appearance and white or buff colored. | ||
| 5.3 | The donor tissue shall be recovered in accordance with FDA regulations and AATB guidelines. Donor history and tissues shall be examined to rule out pathogenic contamination. | ||
| 5.4 | The material shall be processed to ensure there is no damage to the underlying matrix of the tissue. The patented LifeCell process shall remove epidermal and dermal cells, while preserving the collagen, elastin, blood vessel channels, and proteoglycan proteins. | ||
| 5.5 | Material shall be biocompatible and conducive to cellular and vascular infiltration. | ||
| 5.6 | Residual moisture of the material shall be less than ≤ 6%. | ||
| 5.7 | The product is supplied freeze-dried. | ||
| 5.8 | Functional requirements |
| 5.8.1 | Fixation for GRAFTJACKET® shall be compatible with current surgical techniques such as sutures, surgical tacks, etc. | ||
| 5.8.2 | Rehydrated product shall be flexible and malleable for surgical manipulation. | ||
| 5.8.3 | If not totally saturated, GRAFTJACKET® readily absorbs fluids such as saline, blood, cells, or marrow. | ||
| 5.8.4 | GRAFTJACKET® shall resist tearing and deformation in both wet and dry states. |
| 6.0 | Materials and Processes |
| 6.1 | Manufacturing Processes |
| 6.1.1 | Human dermal tissues from which GRAFTJACKET® is produced shall be procured in accordance with FDA regulations and AATB guidelines. | ||
| 6.1.2 | Dermal and epidermal cells shall be removed and the product freeze-dried by LifeCell Corporation per their patented processes. | ||
| 6.1.3 | GRAFTJACKET® shall be certified to conform to the appropriate WMT material specification upon receipt. |
| 6.2 | Packaging |
| 6.2.1 | GRAFTJACKET® shall be packaged with one piece of unattached, non-woven backing that is clearly labeled to indicate that it must be removed, except for size options less than 2 cm wide which will not have a backing (i.e., the long strip GRAFTJACKET® matrix, 1 X 12 cm). Removal should occur after partial rehydration. | ||
| 6.2.1 | GRAFTJACKET® shall be packaged in clean, heat-sealed peel pouches, freeze-dried, and sealed within a foil inert atmosphere. | ||
| 6.2.2 | Labeling shall clearly indicate that the inner pouch and contents are not sterile. |
| Proprietary Information Do not copy or write on this document. |
Xxxxxx Medical Technology Page 3 of 5 |
| Product Specification for GRAFTJACKET® Regenerative Tissue Matrix | Document No.: PS02-0013 | |
| Issued | Rev.: 07 |
| 6.0 | Materials and Processes (continued) |
| 6.3 | Sterilization |
| 6.3.1 | The tissues shall be prepared aseptically. |
| 6.3.1.1 | Product shall be aseptically prepared in a controlled area. | ||
| 6.3.1.2 | Representative samples of the final product tested from the donor lot must be free of bacterial and fungal pathogens using microbiological tissue cultures in accordance with AATB guidelines. | ||
| 6.3.1.3 | All processing shall be done in conjunction with antibiotics. Antibiotics utilized in transport or processing of the tissue are to appear on the final labeling. |
| 7.0 | Product Performance Specifications |
| 7.1 | Performance Requirements |
| 7.1.1 | Products must meet appropriate FDA regulations and AATB guidelines. | ||
| 7.1.2 | The aseptically prepared product shall have an expiration date of two years from the date of manufacture, clearly indicated on the package. | ||
| 7.1.3 | GRAFTJACKET® may be transported in ambient temperature, then refrigerated immediately on receipt to maximize the shelf life. Unopened product shall be stored under refrigeration at 1 to 10°C (34-50°F). Per the manufacturer, temperature fluctuations during shipping will not affect the product adversely. | ||
| 7.1.4 | Packaging components must pass the challenge/distribution test per the WMT document G102-0163, Package Challenge/Distribution Testing Procedure. | ||
| 7.1.5 | Prior to use, GRAFTJACKET® must be rehydrated. At least 200 ml of rehydration fluid (sterile normal saline or sterile lactated Ringer’s solution) must be used. GRAFTJACKET®, with backing, must be submerged for at least five minutes in a dish of 100 ml of rehydration fluid. After five minutes the backing must be removed, and the product submerged for an additional five minutes in a separate dish of 100 ml of rehydration fluid. When fully rehydrated, the product is soft and pliable throughout. | ||
| NOTE: Thicker grafts may take up to 30 minutes or longer to completely rehydrate. The ultra thick GRAFTJACKET® matrix may take up to 1 hour or longer to completely rehydrate. | |||
| 7.1.6 | GRAFTJACKET® shall be easily sutured without tearing. |
| 7.2 | Test Specifications | ||
| [***] |
| 8.0 | Clinical and Regulatory Plan |
| 8.1 | Clinical Evaluation Requirements | ||
| Clinical evaluation will be undertaken after commercialization as defined by the clinical & regulatory, research & development, marketing groups, and surgeon consultants. |
| Proprietary Information | Xxxxxx Medical Technology | |
| Do not copy or write on this document. | Page 4 of 5 |
| [***] | Indicates portions of this exhibit that have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. |
| Product Specification for GRAFTJACKET® Regenerative Tissue Matrix | Document No.: PS02-0013 | |
| Issued | Rev.: 07 |
| 8.0 | Clinical and Regulatory Plan (continued) |
| 8.2 | Regulatory Clearance/Approvals |
| 8.2.1 | GRAFTJACKET® is regulated by the FDA in accordance with 21 CFR, Part 1271, as human tissue for transplantation. | ||
| 8.2.2 | This product will be selectively registered outside the US by a joint determination of International Marketing, Regulatory Affairs, and LifeCell Corporation. |
| 9.0 | Production Launch and Distribution Logistics |
| 9.1 | GRAFTJACKET® Regenerative Tissue Matrix was launched in the U.S. in the third quarter of 2002. The thin GRAFTJACKET® Matrix 2 X 4 cm product was launched in the fourth quarter of 2003. The thick GRAFTJACKET® Matrix 4 x 7 cm product was distributed in the fourth quarter of 2003. The thick GRAFTJACKET® Matrix 2 x 4 cm was available in the first quarter of 2005. The thick GRAFTJACKET® Matrix 5 x 5 cm product was distributed in the first quarter of 2005. The ultra thick GRAFTJACKET® Matrix 4 x 7 cm product was launched in the second quarter of 2005. The thick GRAFTJACKET® Matrix 4 x 7 cm product was available in the first quarter 2007. The long strip GRAFTJACKET® Matrix 1 X 12 cm product will be launched in the fourth quarter of 2007. | ||
| 9.2 | Launch support materials will include brochures, surgical techniques, informational videos, press releases, etc. Product usage training will be conducted in regional training sessions. | ||
| 9.3 | This product will be selectively launched outside the US by a joint determination of International Marketing and Regulatory Affairs. |
| 10.0 | Production Costs |
| 10.1 | Material transfer costs are outlined in the effective Supply and Development Agreement between LifeCell Corporation and Xxxxxx Medical Technology. |
| 11.0 | Document Changes | |
| (02) Material Change | ||
| Approvals Added Xxxxxx Xxxxxxx and removed Xxxxxxx Xxxxxxxx. | ||
| Added new product size to the Product Specification. |
| Section 3.2 | Updated Intended for Use section per the current IFU. | ||
| Section 3.4 | Added post-market surveillance. | ||
| Section 4.0 | Broadly defined possible product sizes and thickness ranges. | ||
| Section 4.1 | Added new product size dimensions. | ||
| Section 4.2 | Added thickness range for new product size. | ||
| Section 5.1 | Deleted specific thickness specifications for specific products. This information is part of the Material Specification. | ||
| Section 5.6 | Updated a residual moisture content of 5% to £ 6%. | ||
| Section 6.2.1 | Indicated new product(s) may not have a non-woven backing. | ||
| Section 8.2.2 | Added “and LifeCell Corporation.” | ||
| Section 9.1 | Updated for previous launches and planned launch of new product size. |
| Proprietary Information | Xxxxxx Medical Technology | |
| Do not copy or write on this document. | Page 5 of 5 |
Document Distribution Summary Sheet
Document Contact |
Upon receipt of a new controlled document, put document into documentation book and shred obsolete document (when new document is a revision). Inform appropriate personnel of the revisions made, or of the new document. | |
Document No:
|
PS02-0013 | |
Revision:
|
07 | |
Issued Date:
|
July 31, 2007 | |
Document Title:
|
Product Specification for GRAFTJACKET® Regenerative Tissue Matrix |
Initial distribution of the document indicated above is to the following locations:
| Distribution Location | Code | Contact/Backup | ||||
Writer
|
DDF | Xxxxx Xxxxxx | ||||
C&RA
|
012 | Xxxxxxx Xxxxxx/Xxxxxx Xxxxx | ||||
R&D Hips and Knees
|
016 | Xxxxxxxx Xxxxxx | ||||
Bio. Development Lab
|
026 | Xxxxx Xxxxxx | ||||
Mat./Process Research
|
065 | Xxxxxxxx Xxxxxx | ||||
