Exhibit 10.28
SUPPLY AND DEVELOPMENT AGREEMENT
     This Supply and Development Agreement (“Agreement’) is made as of the 1st
day of April, 2002, by and between LifeCell Corporation, a Delaware corporation
(“LifeCell”), and Wright Medical Technology Inc., a Delaware corporation
(“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 the Products only in the Sales Territory. 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.

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     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, 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;
          (i) refraining from promoting, soliciting or otherwise participating
in the sale of human or non-human derived soft tissue graft containment products
that directly compete with the Products, except for synthetic and xenograft
containment products, in North America during the Term and for one (1) year
after the termination of this Agreement due to a breach by Distributor. This
obligation shall survive termination of this Agreement for a period of one
(1) year, as applicable;
          (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;
 

[***]   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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          (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;
          (1) 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) 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;
          (s) securing and maintaining insurance, including product liability
insurance, of at least $3 million in accordance with Section 2.2;
          (t) paying any and all expenses of and incidental to the
distributorship

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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
          (u) 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;
          (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;
          (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
priorty or

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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 orthopaedic applications
exclusively to Distributor;
          (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; and
          (k) not disputing the right of Distributor to its trademarks.
     4. Terms and Conditions of Sale.
     4.1 Minimum Purchase Requirements; No Put Backs.
          (a) During the Term, Distributor shall purchase from LifeCell the
number of Units of Products in the Sizes (as set forth in the Initial Product
Forecast or Updated Product Forecast, as applicable) for sale to Customers in
the Sales Territory in accordance with (i) Schedule III annexed hereto (the
“Initial Product Forecast”) and the Updated Product Forecast, as applicable, and
(ii) the Delivery Schedule to be annexed hereto as Schedule IV, as it may be
revised in accordance with Section 4.8(b). In the event that any Customer seeks
to order Products from Distributor in a size not set forth on Schedule III (a
“Different Sized Product”), LifeCell and Distributor shall use commercially
reasonable efforts to reach agreement on the procedure and price applicable to
the sale and delivery of such Different Sized Product to such Customer.
          (b) In the event that Distributor purchases from LifeCell less than
the Minimum Purchase Requirements of Products in any Sales Quarter, as
determined in accordance with Section 4.1(a), Distributor shall have the option
to (i) pay to LifeCell an amount equal to any deficiency in the amount that
LifeCell would have received under Section 4.1(a) if Distributor had achieved
the Minimum Purchase Requirements for that Sales Quarter compared to the amounts
that LifeCell actually received from Distributor for that Sales Quarter or
(ii) within thirty (30) days after the end of that Sales Quarter, order the
amount of Products equal to the deficiency amount, provided, however, that
Distributor’s choice of option (ii) shall be deemed only to permit Distributor
to not be in breach of its Minimum Purchase Requirements for the Sales Quarter
in which the deficiency existed and provided, further, that nothing contained in
this Section 4.1(b) shall alter the Minimum Purchase Requirements for any Sales
Quarter. In the event that Distributor does not either (y) make payment in full
of any such deficiency or (z) order the amount of Products equal to the
deficiency amount on or before the 30th day after the end of the applicable
Sales Quarter, at any time thereafter, Distributor may, in its sole and absolute
discretion, (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.

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          (c) In the event that LifeCell is unable during any Sales Quarters to
furnish Distributor with the Minimum Purchase Requirements of Products in
accordance with Section 4.1(a), the obligation of Distributor to comply with
such Minimum Purchase Requirements for such consecutive Sales Quarters shall be
waived by LifeCell and the parties shall enter into good faith negotiations for
the purpose of determining and making reasonable amendments to the Minimum
Purchase Requirements for any future Sales Quarters arising from LifeCell’s
failure to furnish Distributor with such Minimum Purchase Requirements of
Product. Furthermore, in the event LifeCell is unable during any two consecutive
Sales Quarters to furnish Distributor with the Minimum Purchase Requirements of
the Products, LifeCell shall cooperate with Distributor in every way possible to
find an alternative supplier.
          (d) Except as otherwise provided in Section 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 Products to Distributor at the
prices set forth in the Transfer Price List attached to this Agreement as
Schedule I, as it may be changed by LifeCell, in its sole discretion, from time
to time, to reflect cost increases associated with processing Processed Tissue
(“Transfer Prices”), provided, however, that in no event shall LifeCell increase
the Transfer Prices (i) effective more than once in any Sales Year or (ii) by
more than [***] percent [***] 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 more than [***] percent [***] in any Sales Year
only if the costs associated with processing Processed Tissue increases by more
than [***] percent [***] in any Sales Year. In such an event LifeCell may
increase the Transfer Price above [***] percent [***] 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.
 

[***]   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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     4.3 Royalty. The Distributor will pay LifeCell a Royalty on sale of the
Products to Customers according to the percentages that are designated for the
applicable tranche of annual gross sales as set forth in the Royalty Payout List
(“Royalty”) attached to this Agreement as Schedule I. Gross Sales shall mean the
the total revenue recognized from sale of the Product to Customers.
     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
Royalty for sale of the Product to Customers by cash within 45 days following
each month occuring during the Term of this Agreement. Interest at the lesser of
the per annum rate of eighteen percent (18%) 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 Royalties, 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. 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 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,

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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, 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
II 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) Annexed hereto as Schedule III is the Distributor’s initial
forecast for the Interim Term (the “Initial Product Forecast”). The parties
agree that the forecasts for the Interim Term will not be binding, rather they
will serve as a baseline. Beginning January 1, 2003, the Updated Product
Forecast, provided to LifeCell for the fourth quarter of 2002 through the third
quarter of 2003 (the October 1, 2002 forecast), and all subsequent forecasts
will be binding. An additional condition to the scheduled Minimum Purchase
Requirements becoming effective shall be the validation of preclinical efficacy
and clinical evaluation is performed and concluded. Except as modified by any
valid Updated Product Forecast as provided in this Section 4.8(a), the Initial
Product Forecast is not binding on LifeCell and Distributor. Distributor shall
prepare and deliver to LifeCell, no later than the first day of every Sales
Quarter during the Term, beginning April 1, 2002, an updated rolling forecast
for the following twelve (12) month period in the format of the Initial Product
Forecast (each an “Updated Product Forecast”). In no event shall any Updated
Product Forecast provide for the purchase of a lesser number of Units of
Products in the Sizes than as set forth in the Initial Product Forecast or
applicable prior Updated Product Forecast unless agreed upon in writing by both
parties. Each Updated Product Forecast is subject to LifeCell’s express written
approval unless the Number of Units of Products in any of the Sizes is increased
by less than five percent (5%). In the event that either (i) an Updated Product
Forecast complies with the percentage requirement set forth in the immediately
preceding sentence, or (ii) 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 binding on LifeCell and
Distributor.

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          (b) Within ten (10) days after the Effective Date, LifeCell and
Distributor shall use best efforts to reach mutual agreement on a product
delivery schedule (the “Delivery Schedule”) which shall be annexed to this
Agreement as Schedule IV. The Delivery Schedule may be amended from time to time
by mutual agreement of the parties, subject to any increase in number of Units
of Products in the Sizes as set forth in a valid Updated Product Forecast.
          (c) Purchase orders for the shipment of the number of Units of
Products in the Sizes, issued in conformance with the Initial Product Forecast
or the Updated Product Forecast, as applicable, and the Delivery Schedule, as
revised in accordance with this Agreement, shall be binding on LifeCell and
Distributor, except as otherwise provided herein. Orders issued for the number
of Units of Products in the Sizes, in excess of the Initial Product Forecast or
Updated Product Forecast for any Sales Quarter, as applicable, subject to the
Delivery Schedule, shall be deemed accepted only up to the applicable Initial
Product Forecast or Updated Product Forecast for that Sales Quarter. Orders for
a quantity of Units of Products in the Sizes greater than the current Product
Specifications shall be subject to LifeCell’s written approval and acceptance.
          (d) Distributor agrees to submit to and cause to be received by
LifeCell, on or before the last day of the applicable Sales Quarter in
accordance with Section 4.1(a) at LifeCell’s address set forth in Section 15,
written purchase orders for the purchase of a quantity of Units of Products in
the Sizes necessary to satisfy the Minimum Purchase Requirements for that Sales
Quarter. Except as otherwise set forth herein, all such purchase orders are
subject to approval and acceptance by LifeCell. Distributor shall not cancel or
reschedule any purchase order within twenty (20) days of the scheduled shipment
date for the Products. Printed 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.

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          (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 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 [***]. This
limitation of liability shall apply regardless of the cause of action under
which those damages are sought. The parties acknowledge that absent this
 

[***]   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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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 one hundred twenty (120) days 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 twelve (12) months 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 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
finaldecisions 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 and during
such time the Minimum Purchase Requirements shall be waived.
     5. Market Development Programs. LifeCell and Distributor shall review the
implementation and administration of market development and regulatory
strategies, priorities,

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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 is effective as of April 1, 2002 (the “ Effective
Date”) and, unless earlier terminated, shall remain in force until 11:59 p.m.,
Eastern United States time, on January 1, 2007 (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, including without
limitation, revisions to the Minimum Purchase Requirements. 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 Distributor without
LifeCell’s prior written consent, (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 or
(6) a change in the control of Distributor reasonably unacceptable to LifeCell
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 Distributor shall have failed to
cure such breach within 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 4.1(b), 4.4, 4.9(b) and 16.2.
     7.4 Permitted Activities. Distributor agrees that upon termination of this

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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 at the Transfer Prices 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 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)

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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.
     7.7 Survival. Except as otherwise expressly set forth herein, the
obligations of the parties under Sections 2.1(j), 4.1(e), 4.4, 4.7, 4.9(e), 7.4,
8.1, 9, 12, 14, 17, 19, 20 and 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.
     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”).

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     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 non-exclusive, 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 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

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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, One Millennium Way, Branchburg, NJ 08876) 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-17-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,

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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 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

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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.
          (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

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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.
     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.

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     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   Wright Medical Technology, Inc.
 
  One Millennium Way   5677 Airline Road
 
  Branchburg, NJ 08876   Arlington, TN 38002
 
  Attn: Paul Thomas, President   Attn: President
 
  Telephone: 908-947-1102   Telephone: 901-867-4361
 
  Facsimile: 908-947-1081   Facsimile: 901-867-4332
 
       
 
  With a copy to:  
 
       
 
  Lowenstein Sandler, PC   Wright Medical Technology, Inc.
 
  50 Division Street   5677 Airline Road
 
  Somerville, NJ 08876   Arlington, TN 38002
 
  Attn: Steven B. Fuerst, Esq.   Attn: General Counsel
 
  Telephone: 908-526-2204   Telephone: 901-867-4743
 
  Facsimile: 908-526-2205   Facsimile: 901-867-4398

     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 at the Transfer Price.
     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

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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 pasties 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 haring 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 having
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

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the date when institution of legal or equitable proceedings based on such Claim
or the matter would be barred by applicable statutes of limitation.
     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) “Claim” shall have the meaning given to such term in Section 17.1.
          (f) “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.
          (g) “Commercial Arbitration Rules” shall have the meaning given to
such term in Section 17.1.
          (h) “Complaint” shall have the meaning given to such term in
Section 8.1.
          (i) “Confidential Information” shall have the meaning given to such
term in Section 14.1.
          (j) “Customer” means health care provider who or that performs
orthopaedic surgery procedures including, but not limited to, the spine, trauma,
oncology, extremities and joint replacement.
          (k) “Damages” shall have the meaning given to such term in
Section 12.1.

22

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          (1) “Delivery Schedule” shall have the meaning given to such term in
Section 4.8(b).
          (m) “Different Sized Product” shall have the meaning given to such
term in Section 4.1(a).
          (n) “Distributor” shall have the meaning given to such term in the
preamble.
          (o) “Effective Date” shall have the meaning given to such term in
Section 6.
          (p) “FDA” shall have the meaning given to such term in Section 4.7.
          (q) “Initial Product Forecast” shall have the meaning given to such
term in Section 4.8(a).
          (r) “Initial Term” shall have the meaning given to such term in
Section 6.
          (s) “Intellectual Property” means United States and foreign patents
and patent applications, know-how, show-how, trade secrets, inventions,
discoveries and technical information, 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.
          (t) “Interim Term” shall mean the period from the Effective Date
through December 31, 2002.
          (u) “LifeCell” shall have the meaning given to such term in the
preamble.
          (v) “Market Development Programs” shall have the meaning given to such
term is Section 5.
          (w) “Marketing Materials” shall have the meaning given to such term in
Section 9.6.
          (x) “Minimum Purchase Requirements” means [***] of the quarterly
amounts set forth in the Initial Product Forecast or Updated Product Forecast,
as applicable, subject to the then current Delivery Schedule.
 

[***]   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

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          (y) “Notice Period” shall have the meaning given to such term in
Section 4.4.
          (z) “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).
          (aa) “Processed Tissue” means tissue processed by LifeCell in
accordance with its proprietary AlloDerm® process.
          (bb) “Products” means tissue processing services provided by LifeCell
in respect of Processed Tissue in the form of a sheet product for use as a bone
graft containment membrane in orthopedic surgery as further described in the
Product Specification as detailed in Schedule V which may be changed from time
to time by mutual agreement of the parties.
          (cc) “Proprietary Rights” shall have the meaning given to such term in
Section 10.
          (dd) “Recipient” shall have the meaning given to such term in
Section 14.1.
          (ee) “Renewal Notice” shall have the meaning given to such Term in
Section 6.
          (ff) “Renewal Term” means any and each additional one (1) year term of
this Agreement mutually agreed to by the parties.
          (gg) “Royalty” shall have the meaning given to such term in
Section 4.3.
          (hh) “Sales Quarter” means any three month period or shorter period,
as the case may be, occurring during the Term that commences on the Effective
Date and the first day of each calendar quarter thereafter, as the case may be,
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.
          (ii) “Sales Territory” means the United States, 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.
          (jj) “Sales Year” means any twelve (12) month or shorter period, as
the

24

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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.
          (kk) “Sizes” means the sizes in which the Products are offered for
sale as set forth in Schedule III.
          (ll) “Term” means the Initial Term and each Renewal Term, if any.
          (mm) “Trademarks” shall have the meaning given to such term in
Section 9.1.
          (nn) “Transfer Prices” shall have the meaning given to such term in
Section 4.2.
          (oo) “Units” means the number of Products to be purchased by
Distributor as set forth in Schedule III.
          (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.
          (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

25

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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.

26

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     22. Severability. Should any provision of this Agreement be held
unenforceable or invalid, then the parties hereto agree that such provision
shall be 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 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 stared 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.

27

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     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/ Paul Thomas         Name:   Paul Thomas         Title:  
President & CEO        WRIGHT MEDICAL TECHNOLOGY, INC.
      By:   /s/ F. Barry Bays         Name:   F. Barry Bays        Title:  
President & CEO     

Attachments:

      Schedule I —  Processed Tissue Transfer Price List and Royalty Payout List
Schedule II —  Processed Tissue Storage, Handling and Transportation
Specifications and Procedures Schedule III —  Initial Product Forecast
Schedule IV —  Delivery Schedule Schedule V —  Product Specification

28

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Schedule I
Transfer Price List
(As of March 1, 2002)

                  Catalog No.   Size   Thickness   Perforation   Transfer Price
 
               
 
  5 cm x 5 cm   [***]   1:1   [***]
 
               
 
  5 cm x 10 cm   [***]   1:1   [***]
 
               
 
  5 cm x 10 cm   [***]   1:1   [***]

Product Samples Not For Human Use (e.g. use by labs and workshops): Products
with a shelf life of less than three (3) months shall be provided to
Distributor, at its request, at a [***] discount off of the Transfer Price.
Distributor is responsible for ensuring that such Products are not for human use
by a Customer.
Product Samples for Human Use: Distributor shall be responsible for providing
Customers with “For Human Use” samples directly from Distributor’s inventory.
Royalty Pay Out

     
Annual Gross Sales Tranche
  Royalty %
 
   
[***]
  [***]
[***]
  [***]
[***]
  [***]

 

[***]   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.

29

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Schedule II
     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
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
Identification numbers’ of tissue’s
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
Tissue may be stored in a standard household refrigerator provided that this

30

--------------------------------------------------------------------------------

 

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.

31

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Schedule III
Initial Product Forecast
[***]
 

[***]   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.

 

--------------------------------------------------------------------------------

 

Schedule IV
Delivery Schedule
[TO BE INSERTED PURSUANT TO SECTION 4.8(b)]

 

--------------------------------------------------------------------------------

 

Schedule V
Product Specification
See the attached PRELIMINARY specification which is subject to final approval by
the parties.

 

--------------------------------------------------------------------------------

 

Wright Medical Technology
Issued   Document No.: PS02-0013
Rev.: 01

Product Specification for GraftJacketTM
Acellular Periosteum Replacement Scaffold
Effective Date: September 16, 2002
Revision Draft Date: September 11, 2002
Supersedes: PS02-0013 Rev. 00
Supersedes Date: July 29, 2002
Prepared by:
Kim Sevo Hughes
Project Engineer
Approved by:
Tiger Buford
Sr. Director, Bio-Orthopaedics Development
Sharon Seaton
Manager, Regulatory Compliance
Cary Hagen
Sr. Director, Marketing
Roger Brown
Sr. Director, Clinical & Regulatory Affairs
Michael Sheldon
Sr. Dir., International Marketing
Warren Haggard, Ph.D.
Vice President, Research
Document Release Section

          Dept/Function   Approver   Signature and Date
 
       
Documentation
  Sharon Seaton                                                              

  Proprietary Information
Do not copy or write on this document.   Page 1 of 5
Wright Medical Technology

 

--------------------------------------------------------------------------------

 

GraftJacketTMTM Acellular Periosteum Replacement Scaffold
Issued   Document No.: PS02-0013
Revision: 01

1.0   Objective       This specification describes the product requirements for
GraftJacketTM Acellular Periosteum Replacement Scaffold (manufactured by
LifeCell Corporation, Branchburg, NJ).

2.0   Document Reference Summary

     
American Association of Tissue Banks (AATB) 21 CFR (Current Federal Regulation)
1270, 1271 G102-0163
  Standards of Tissue Banking Guidelines Human Tissue Intended for
Transplantation Package Challenge/Distribution Testing Procedure

3.0   Product Description

  3.   General Overview: GraftJacketTM 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
GraftJacketTM scaffold is used for the repair or replacement of damaged or
inadequate integumental tissue, such as periosteum.     3.3   Related Devices:
There are no related devices.

4.0   Proposed Size Offering

  4.1   GraftJacketTM will be [***] thick and have two size options with
approximate dimensions of 5 X 5 cm, approximately (2” X 2”) and 5 X 10 cm,
approximately (2” X 4”).     4.2   Each size will be provided for single patient
use in packaged, sealed containers.

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. Each sheet shall have an average thickness
ranging between [***].     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 conductive
to cellular and vascular infiltration.     5.6   Residual moisture of the
material shall be less than [***].     5.7   The product is supplied
freeze-dried.

  Proprietary Information
Do not copy or write on this document.   Page 2 of 5
Wright Medical Technology

 

[***]   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.

 

--------------------------------------------------------------------------------

 

GraftJacketTMTM Acellular Periosteum Replacement Scaffold
Issued   Document No.: PS02-0013
Revision: 01

5.0   Product Features and Functional Requirements (Continued)

  5.8   Functional requirements

      Fixation for GraftJacketTM shall be compatible with current surgical
techniques such as sutures, surgical tacks, etc.         Rehydrated product
shall be flexible and malleable for surgical manipulation.         If not
totally saturated, GraftJacketTM readily absorbs fluids such as saline, blood,
cells, or marrow.         GraftJacketTM shall resist tearing and deformation in
both wet and dry states.

6.0   Materials and Processes

  6.1   Manufacturing Processes

      Human dermal tissues from which GraftJacketTM 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.         GraftJacketTM shall
be certified to conform to the appropriate WMT material specification upon
receipt.

  6.2   Packaging

      GraftJacketTM shall be packaged with one piece of unattached, non-woven
backing that is clearly labeled to indicate that it must be removed. Removal
should occur after partial rehydration.         GraftJacketTM shall be packaged
in clean, heat-sealed peel pouches, freeze-dried, and sealed within a foil inert
atmosphere.         Labeling shall clearly indicate that the inner pouch and
contents are not sterile.

  6.3   Sterilization

      The tissues shall be prepared aseptically.

  6.3.   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 such as, but not limited to, cefoxitin, lincomycin,
polymyxin B, and vancomycin.

  Proprietary Information
Do not copy or write on this document.   Page 3 of 5
Wright Medical Technology

 

--------------------------------------------------------------------------------

 

GraftJacketTMTM Acellular Periosteum Replacement Scaffold
Issued   Document No.: PS02-0013
Revision: 01

7.0   Product Performance Specifications

  7.   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.        
GraftJacketTM 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.
        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, GraftJacketTM must be rehydrated. At least 200 ml of
rehydration fluid (sterile normal saline or sterile lactated Ringer’s solution)
must be used. GraftJacketTM, 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.     7.1.6   GraftJacketTM 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.     8.2  
Regulatory Clearance/Approvals

      GraftJacketTM is regulated by the FDA in accordance with 21 CFR, part 1270
& 1271 as human tissue for transplantation.

This product will be selectively registered outside the US by a joint
determination of International Marketing and Regulatory Affairs.

9.0   Production Launch and Distribution Logistics

  9.1   GraftJacketTM will be launched in the U.S. in the third quarter of 2002.
    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.

  Proprietary Information
Do not copy or write on this document.   Page 4 of 5
Wright Medical Technology

 

[***]   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.

 

--------------------------------------------------------------------------------

 

GraftJacketTM Acellular Periosteum Replacement Scaffold
Issued   Document No.: PS02-0013
Revision: 01

10.0   Production Costs

  10.   Material transfer costs are outlined in the Supply and Development
Agreement between LifeCell Corporation and Wright Medical Technology dated April
1, 2002 (5x10 cm [***] each, 5x5 cm [***]).

11.0   Document Changes

  Section 7.1.5   Replaced “100 ml” with “200 ml”; added “in a dish of 100 ml of
rehydration fluid” to the third sentence; added “in a separate dish of 100 ml of
rehydration fluid” to the fourth sentence

  Proprietary Information
Do not copy or write on this document.   Page 5 of 5
Wright Medical Technology

 

[***]   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.

 

--------------------------------------------------------------------------------

 

(LIFECELL LOGO) [g22163g2216301.gif]
January 14, 2003
Wright Medical Technology Inc.
5677 Airline Road
Arlington, Tennessee 38002
Attention: Mr. F. Barry Bays, President and CEO
Dear Barry:
Reference is hereby made to the Supply and Development Agreement between
LifeCell Corporation (“LifeCell”) and Wright Medical Technology Inc. (“Wright”)
dated as of April 1, 2002 (“Supply Agreement”). Capitalized terms used in this
letter agreement that are not expressly defined herein shall have the meanings
specified in the Supply Agreement. In view of the desire of both parties to
expand the scope of the Product applications to which Wright shall serve as
exclusive authorized distributor, LifeCell and Wright have agreed to modify
certain provisions of the Supply Agreement, on the terms and conditions set
forth herein. In all other aspects, the Supply Agreement shall remain in full
force and effect.
1. Definition of “Products”. Section 18.1(bb) of the Supply Agreement is hereby
deleted and replaced in its entirety with the following:
(bb) “Products” means tissue processing services provided by LifeCell in respect
of Processed Tissue in the form of a sheet product for use as a containment
membrane in connection with a bone graft or torn rotator cuff repair in
orthopedic surgery as further described in the Product Specification as detailed
in Schedule V, which may be changed from time to time by mutual agreement of the
parties.
2. Schedules. Schedules I (Transfer Price List and Royalty Pay Out List), III
(Initial Product Forecast), IV (Delivery Schedule) and V (Product Specification)
of the Supply Agreement shall be discussed between the parties, and appropriate
amendments shall be negotiated in good faith to the extent warranted to reflect
the expanded scope of Products under the Supply Agreement, including any
provision for Different Sized Products, increases to the Updated Product
Forecast, changes to the Updated Delivery Schedule, or changes to the product
Specification .
3. Miscellaneous Provisions.
          (a) This letter agreement constitutes the entire agreement between
LifeCell and Wright regarding the subject matter hereof, there being no other
written, oral or other agreements or understandings between them with respect to
the subject matter hereof.
     
 
LifeCell Corporation One Millennium Way, Branchburg, NJ 08876 • Phone:
908.947.1100 • Fax: 908.947.1200 • www.lifecell.com

 

--------------------------------------------------------------------------------

 

          (b) The invalidity of any portion of this letter agreement shall not
affect the validity, force or effect of the remaining portions of this letter
agreement. If it is ever held that any provision hereunder is too broad to
permit enforcement of such provision to its fullest extent, such provision shall
be enforced to the maximum extent permitted by law.
          (c) This letter agreement may be executed in counterparts, each of
which shall be deemed an original and all of which together shall constitute one
and the same instrument. This letter agreement and all matters arising directly
or indirectly hereunder shall be governed by, and construed in accordance with,
Section 19 of the Supply Agreement.
If the foregoing accurately reflects our mutual understanding, please so
indicate by executing a counterpart of this letter agreement and returning it to
the undersigned.

            Very truly yours,

LIFECELL CORPORATION
      By:   /s/ Paul Thomas         Paul Thomas        President and CEO     

          ACCEPTED AND AGREED:

WRIGHT MEDICAL TECHNOLOGY INC.
      By:   /s/ F. Barry Bays         F. Barry Bays        President and CEO   
   

     
1/14/03
  Page 2

 

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(LIFECELL LOGO) [g22163g2216301.gif]
February 25, 2003
Wright Medical Technology Inc.
5677 Airline Road
Arlington, Tennessee 38002
Attention: Mr. F. Barry Bays, President and CEO
Dear Barry:
Reference is hereby made to the Supply and Development Agreement between
LifeCell Corporation (“LifeCell”) and Wright Medical Technology Inc. (“Wright”)
dated as of April 1, 2002 (“Supply Agreement”) as amended by the Letter
Agreement dated January 14, 2003. Capitalized terms used in this letter
agreement that are not expressly defined herein shall have the meanings
specified in the Supply Agreement. In view of the desire of both parties to
expand the scope of the Product applications to which Wright shall serve as
exclusive authorized distributor, LifeCell and Wright have agreed to modify
certain provisions of the Supply Agreement, on the terms and conditions set
forth herein. In all other aspects, the Supply Agreement shall remain in full
force and effect.
1. Definition of “Products”. Section 18.1(bb) of the Supply Agreement, as
amended, is hereby deleted and replaced in its entirety with the following:
(bb) “Products” means tissue processing services provided by LifeCell in respect
of Processed Tissue in the form of an acellular human dermal sheet product for
use in any and all orthopaedic surgical applications, with its use in [***], as
further described in the Product Specification as detailed in Schedule V, which
may be changed from time to time by mutual agreement of the parties. Provided,
however, that Wright shall not sell or distribute Products for any
non-orthopaedic application.
2. Miscellaneous Provisions.
(a) This letter agreement constitutes the entire agreement between LifeCell and
Wright regarding the subject matter hereof, there being no other written, oral
or other agreements or understandings between them with respect to the subject
matter hereof.
(b) The invalidity of any portion of this letter agreement shall not affect the
validity, force or effect of the remaining portions of this letter agreement. If
it is ever held that any provision hereunder is too broad to permit enforcement
of such provision to its fullest extent, such provision shall be enforced to the
maximum extent permitted by law.
 
LifeCell Corporation One Millennium Way, Branchburg, NJ 08876 • Phone:
908.947.1100 • Fax: 908.947.1200 • www.lifecell.com
 

[***]   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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(c) This letter agreement may be executed in counterparts, each of which shall
be deemed an original and all of which together shall constitute one and the
same instrument. This letter agreement and all matters arising directly or
indirectly hereunder shall be governed by, and construed in accordance with,
Section 19 of the Supply Agreement.
If the foregoing accurately reflects our mutual understanding, please so
indicate by executing a counterpart of this letter agreement and returning it to
the undersigned.

          Very truly yours,

LIFECELL CORPORATION
      By:   /s/ Paul Thomas         Paul Thomas        President and CEO       
ACCEPTED AND AGREED:

WRIGHT MEDICAL TECHNOLOGY INC.
      By:   /s/ F. Barry Bays         F. Barry Bays        President and CEO   
 

 

--------------------------------------------------------------------------------

 

         

(LIFECELL LOGO) [g22163g2216301.gif]
May 9, 2003
Mr. F. Barry Bays
President and CEO
Wright Medical Technology Inc.
5677 Airline Road
Arlington, Tennessee 38002
Dear Barry:
Reference is hereby made to the Supply and Development Agreement between
LifeCell Corporation (“LifeCell”) and Wright Medical Technology Inc. (Wright”)
dated as of April 1, 2002, as amended by letter agreement dated February 25,
2003 (“Supply Agreement”). Capitalized terms used in this letter agreement that
are not expressly defined herein shall have the meanings specified in the Supply
Agreement. In view of the desire of both parties to expand the geographic scope
of the territory to which Wright shall serve as exclusive authorized
distributor, LifeCell and Wright have agreed to modify the Supply Agreement, on
the terms and conditions set forth herein. In all other aspects, the Supply
Agreement shall remain in full force and effect.

1.   Definition of “Sales Territory”. Section 18.1(ii) of the Supply Agreement
is hereby deleted and replaced in its entirety with the following:

          (ii) “Sales Territory” means the United States and Greece, 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.

2.   Miscellaneous Provisions.

          (a) This letter agreement constitutes the entire agreement between
LifeCell and Wright regarding the subject matter hereof, there being no other
written, oral or other agreements or understandings between them with respect to
the subject matter hereof.
          (b) The invalidity of any portion of this letter agreement shall not
affect the validity, force or effect of the remaining portions of this letter
agreement. If it is ever held that any provision hereunder is too broad to
permit enforcement of such provision to its fullest extent, such provision shall
be enforced to the maximum extent permitted by law.
          (c) This letter agreement may be executed in counterparts, each of
which shall be deemed an original and all of which together shall constitute one
and the same instrument. This letter agreement and all matters arising directly
or indirectly hereunder shall be governed by, and construed in accordance with,
Section 19 of the Supply Agreement.
05/09/03
 
LifeCell Corporation One Millennium Way, Branchburg, NJ 08876 • Phone:
908.947.1100 • Fax: 908.947.1200 • www.lifecell.com

 

--------------------------------------------------------------------------------

 

If the foregoing accurately reflects our mutual understanding, please so
indicate by executing a counterpart of this letter agreement and returning it to
the undersigned.

            Very truly yours,

LIFECELL CORPORATION
      By:   /s/ Paul Thomas         Paul Thomas        President and CEO     

          ACCEPTED AND AGREED:

WRIGHT MEDICAL TECHNOLOGY INC.
      By:   /s/ F. Barry Bays         F. Barry Bays        President and CEO   
 

 

--------------------------------------------------------------------------------

 

         

(LIFECELL LOGO) [g22163g2216301.gif]
July 18, 2003
Mr. F. Barry Bays
President and CEO
Wright Medical Technology Inc.
5677 Airline Road
Arlington, Tennessee 38002
Dear Barry:
Reference is hereby made to the Supply and Development Agreement between
LifeCell Corporation (“LifeCell”) and Wright Medical Technology Inc. (Wright”)
dated as of April 1, 2002 as amended by letters of agreement dated January 14,
2003, February 25, 2003 and May 9, 2003 (“Supply Agreement”). Capitalized terms
used in this letter agreement that are not expressly defined herein shall have
the meanings specified in the Supply Agreement. In view of the desire of both
parties to expand the geographic scope of the territory to which Wright shall
serve as exclusive authorized distributor, LifeCell and Wright have agreed to
modify the Supply Agreement, on the terms and conditions set forth herein. In
all other aspects, the Supply Agreement shall remain in full force and effect.

1.   Definition of “Sales Territory”. Section 18.1(ii) of the Supply Agreement
is hereby deleted and replaced in its entirety with the following:

          (ii) “Sales Territory” means the United States, Greece, Italy, and
South Africa 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.

2.   Definition of “Products”. Section 18.1(bb) of the Supply Agreement, as
amended, is hereby deleted and replaced in its entirety with the following:

(bb) “Products” means tissue-processing services provided by LifeCell in respect
of Processed Tissue in: (i) the form of an acellular dermal sheet product for
use in any and all orthopedic and podiatric surgical applications, with the
exception that its use [***]; and (ii) an acellular, micronized form,
specifically limited to use in the treatment of [***]. Products are further
described in the Product Specification as detailed hereto as Schedule V, which
may be changed from time to time by mutual agreement of the parties. Wright
agrees that it shall not sell or distribute Products for any non-orthopedic or
non-podiatric application, or as otherwise limited by or excluded in the
definition above.
Miscellaneous Provisions.
          (a) This letter agreement constitutes the entire agreement between
LifeCell and Wright regarding the subject matter hereof, there being no other
written, oral or other agreements or understandings between them with respect to
the subject matter hereof.
          b) The invalidity of any portion of this letter agreement shall not
affect the validity, force or effect of the remaining portions of this letter
agreement. If it is ever held that any provision hereunder is too broad to
07/18/03
 
LifeCell Corporation One Millennium Way, Branchburg, NJ 08876 • Phone:
908.947.1100 • Fax:
908.947.1200 • www.lifecell.com
 

[***]   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.

 

--------------------------------------------------------------------------------

 

permit enforcement of such provision to its fullest extent, such provision shall
be enforced to the maximum extent permitted by law.
          (c) This letter agreement may be executed in counterparts, each of
which shall be deemed an original and all of which together shall constitute one
and the same instrument. This letter agreement and all matters arising directly
or indirectly hereunder shall be governed by, and construed in accordance with,
Section 19 of the Supply Agreement.
If the foregoing accurately reflects our mutual understanding, please so
indicate by executing a counterpart of this letter agreement and returning it to
the undersigned.

            Very truly yours,

LIFECELL CORPORATION
      By:   /s/ Paul Thomas         Paul Thomas        President and CEO     

          ACCEPTED AND AGREED:

WRIGHT MEDICAL TECHNOLOGY INC.
      By:   /s/ F. Barry Bays         F. Barry Bays        President and CEO   
   

 

--------------------------------------------------------------------------------

 

     
(LIFECELL LOGO) [g22163g2216301.gif]
  Paul G. Thomas President, CEO, Chairman

March 4, 2004
Mr. F. Barry Bays
President and CEO
Wright Medical Technology Inc.
5677 Airline Road
Arlington, Tennessee 38002

  RE:    Amendment to Supply and Development Agreement between LifeCell
Corporation (“LifeCell”) and Wright Medical Technology, Inc.

Dear Barry:
Reference is hereby made to the Supply and Development Agreement between
LifeCell Corporation (“LifeCell”) and Wright Medical Technology, Inc. (“Wright”
or “Distributor”) dated April 1, 2002, as amended by letter agreements dated
January 14, 2003, February 25, 2003, May 9, 2003 and July 18, 2003 (collectively
the “Supply Agreement”). Capitalized terms used in this letter agreement that
are not expressly defined herein shall have the meanings specified in the Supply
Agreement. In view of the desire of both parties to extend the term of the
Supply Agreement and to modify certain terms of the Supply Agreement, LifeCell
and Wright agree to amend the Supply Agreement, on the terms and conditions set
forth herein, effective as of April 1, 2004. In all other aspects, the Supply
Agreement shall remain in full force and effect.
1. Schedules I, III and IV of the Supply Agreement are hereby deleted and
removed and are not replaced unless specified otherwise herein. Additionally,
definitions set forth in Sections 18.1 (1), (x) and (gg) of the Supply Agreement
are hereby deleted and removed and are not replaced.
2. Definition of “Customer.” Section 18.1(j) of the Supply Agreement is hereby
deleted and is replaced in its entirety with the following:
          (j) “Customer” means health care provider who or that performs
podiatric procedures or orthopaedic surgery procedures including, but not
limited to, the spine, trauma, oncology, extremities and joint replacement.
3. Definition of “Products.” Section 18.1(bb) of the Supply Agreement, as
amended, is hereby deleted and is replaced in its entirety with the following:
          (bb) “Products” means all tissue-processing services provided during
the term of this Agreement by LifeCell in respect of Processed Tissue in the
form of (i) LifeCell’s current acellular dermal sheet product for use in any and
all orthopedic and podiatric surgical applications, with the exception [***]
(“Sheet Products”) [***]
 
LifeCell Corporation One Millennium Way, Branchburg, NJ 08876 • Phone:
908.947.1100 •
Fax: 908.947.1200 • pthomas@lifecell.com
 

[***]   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.

--------------------------------------------------------------------------------

 

 

(“Micronized Products”). Products are further described in the Product
Specification as detailed hereto as Schedule V, which may be changed to include
additional Products, as they are developed by LifeCell and made available to
Wright by mutual agreement of the parties. Wright agrees that it shall not sell
or distribute Products for any non-orthopedic or non-podiatric application, or
as otherwise limited by or excluded in the definition above. Any future products
resulting from changes to enhance, improve, or modify the Sheet Products, for
the above fields of use, that combine the Sheet Products with growth factors,
stem cells, or other biological response modifiers are hereafter referred to as
“Enhanced Sheet Products”. 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 Product.
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.
4.Definition of “Sizes.” Section 18.1(kk) of the Supply Agreement, as amended,
is hereby deleted and is replaced in its entirety with the following:
          (kk) “Sizes” means the sizes in which the Products are offered for
sale as first set forth in the Initial Product Forecast and subsequently, as
updated and amended in the most current Updated Product Forecast.
5. Definition of “Units.” Section 18.1(oo) of the Supply Agreement, as amended,
is hereby deleted and is replaced in its entirety with the following:
          (oo) “Units” means the number of Products to be purchased by
Distributor for a respective Sales Quarter as first set forth in the Initial
Product Forecast and subsequently, as updated and amended in the most current
Updated Product Forecast.
6. Minimum Purchase Requirements; No Put Backs. The Section heading and
Sections 4.1 (a), (b), (c) and (d) of the Supply Agreement are hereby deleted
and replaced in their entirety with the following:
          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 $6,000,000
and $6,600,000, 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 thereafter throughout the Term,
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:

--------------------------------------------------------------------------------

 

3

Two Year CAGR = (Ö(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;
 
   
Ö=
  the square root of a number;

As an example, if Ac equals $1,000,000 and Ac-2 equals $800,000, then the 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%.
          (b) In the event that Distributor’s Annual Product Sales are less than
$6,000,000 but greater than $4,800,000 in the calendar year ending December 31,
2004, or less than $6,600,000 but greater than $5,280,000 in the calendar year
ending December 31, 2005, or Distributor achieves a Two Year CAGR of less than
10.00% (0.1000) for any period consisting of two consecutive calendar years
during the Term as determined in accordance with Section 4.1(a), (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 plus any previous Catch-up
Amounts paid during that respective period.
          (c) In the event that Distributor achieves Annual Product Sales less
than $4,800,000 in the calendar year ending December 31, 2004, or less than
$5,280,000 in the calendar year ending December 31, 2005, or a Two Year CAGR of
less than negative 10.00% (-0.1000) for any period consisting of two consecutive
calendar years during the Term as determined in accordance with Section 4.1(a),
(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 the Initial
Product Forecast and updated in subsequent 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

--------------------------------------------------------------------------------

 

4

requested by Distributor falls within the allowable percentage increase
provisions established in Section 4.8(a), for purposes of calculating the
minimun Annual Product Sales, the Distributor shall be allowed to include in its
calculations of the Minimum Annual Sales and the Minimum Terminable Annual
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 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.
7. Transfer Price. The first sentence of Section 4.2 of the Supply Agreement is
hereby deleted and replaced in its entirety with the following:
          LifeCell shall supply Sheet Products to Distributor at the price of
[***] per square centimeter of Product and 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
these prices of the Products is referred to for each as their respective
“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.
8. Royalty. Section 4.3 of the Supply Agreement is hereby deleted and replaced
in its entirety with the following:
          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 Wright to the Customers for
such Products (“Revenue Share Amount”), less the Transfer Price previously paid
by Wright 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 Wright shall not be entitled
to any credit against other Product Revenue Share Payments in past or future
Sales Quarters. (For example, if Wright 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 [***].) Wright 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.
9. Forecasts; Deliveries; Orders. Sections 4.8 (a), (b), (c) and (d) of the
Supply Agreement are hereby deleted and replaced in their entirety with the
following:
          (a) Within ten (10) days following the execution of this amendment,
Distributor shall provide to LifeCell its initial forecast for the year ending
December 31, 2004, prepared in a manner that
 

[***]   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.

--------------------------------------------------------------------------------

 

5

forecasts Distributor’s expected purchases of Number of Units of each respective
Product and Sizes by month throughout 2004 (the “Initial Product Forecast”).
Thereafter, no later than the first day of every future Sales Quarter during the
Term, Distributor shall provide to LifeCell an updated rolling forecast for the
following twelve (12) month period in the format of the Initial Product Forecast
(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.
          (b) The Number of Units of Products specified for the first Sales
Quarter of the Initial Product Forecast and for the first Sales Quarter of each
subsequently-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
forth 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 purchase 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.

--------------------------------------------------------------------------------

 

6

10.6 Term. The first sentence of Section 6 of the Supply Agreement is hereby
deleted and replaced in its entirety with the following:
          6. Term. This Agreement, as amended shall be effective as of
January 1, 2004 (the “Effective Date”) 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, 2013 (“the
Initial Term”).
11. Termination.Sections 7.2 and 7.3 of the Supply Agreement are hereby deleted
and replaced in their entirety with the following:
          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 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 or
(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 (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 Distributor shall have failed to cure such a breach within
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 4.1(c), 4.4, 4.9(b) and 16.2.
12. Miscellaneous Provisions.

  (a)   This letter agreement constitutes the entire agreement between LifeCell
and Wright regarding the subject matter hereof, there being no other written,
oral or other agreements or understandings between them with respect to the
subject matter hereof.     (b)   The invalidity of any portion of this letter
agreement shall not affect the validity, force or effect of the remaining
portions of this letter agreement. If it is ever held that any provision
hereunder is too broad to permit enforcement of such provision to its fullest
extent, such provision shall be enforced to the maximum extent permitted by law.
    (c)   This letter agreement may be executed in counterparts, each of which
shall be deemed an original and all of which together shall constitute one and
the same instrument. This letter agreement and all matters arising directly or
indirectly hereunder shall be governed by, and construed in accordance with,
Section 19 of the Supply Agreement.

--------------------------------------------------------------------------------

 

7

If the forgoing accurately reflects our mutual understanding, please so indicate
by executing and returning a counterpart of this letter agreement.

            Very truly yours,

LIFECELL CORPORATION
      BY:   /s/ Paul Thomas         Paul G. Thomas        President and CEO     

          ACCEPTED AND AGREED:

WRIGHT MEDICAL TECHNOLOGY, INC.
      By:   /s/ F. Barry Bays         F. Barry Bays        President and CEO   
   

     
CC:
  J. Bakewell — Wright Medical Technology, Inc.
 
  J. Harper — LifeCell Corporation
 
  S. Sobieski — LifeCell Corporation

8

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[Wright Medical Technology, Inc. logo]
John K. Bakewell
Executive Vice-President, Chief
Financial Officer
Direct Dial (901) 867-4527
E-mail jbakewell@wmt.com
April 22, 2005
Mr. Paul G. Thomas,
President, CEO, Chairman
LifeCell Corporation
One Millennium Way
Brandenburg, NJ 08876

    Re: Amendment to Supply and Development Agreement

Dear Paul:
          Reference is hereby made to the Supply and Development Agreement
between LifeCell Corporation (“LifeCell”) and Wright Medical Technology, Inc.
(“Wright” or “Distributor”) dated April 1, 2002, as amended by letter agreements
dated January 14, 2003, February 25, 2003, May 9, 2003, July 18, 2003 and
March 4, 2004 (collectively the “Supply Agreement”). Capitalized terms used in
this letter agreement that are not expressly defined herein shall have the
meanings specified in the Supply Agreement. In view of the desire of both
parties to expand the geographic scope of the territory to which Wright shall
serve as exclusive authorized distributor, LifeCell and Wright agree to amend
the Supply Agreement, on the terms and conditions set forth herein, effective as
of March 15, 2005. In all other aspects, the Supply Agreement shall remain in
full force and effect.
          Definition of “Sales Territory”. Section 18.1(ii) of the Supply
Agreement is hereby deleted and replaced in its entirety with the following:
“(ii) “Sales Territory” means the United States, Greece, Italy, South Africa,
Canada, and 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 shall be lost if Distributor fails to sell the Product in
such additional countries or jurisdictions within 18 months of LifeCell’s
reasonable request.”

             
headquarters
           
Wright Medical Technology, Inc.
  5677 Airline Road   Arlington, TN 38002          901.867.9971 phone  
www.wmt.com

             
international subsidiaries
           
011.32.2.378.3905 Belgium
  905.826.1600 Canada   011.33.1.45.13.24.40 France   011.49.4161.745130 Germany
011.39.0250.678.227 Italy
  011.81.3.3538.0474 Japan   011.44.1483.721.404 UK    

 

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Miscellaneous Provisions.
          (a) This letter agreement constitutes the entire agreement between
LifeCell and Wright regarding the subject matter hereof, there being no other
written, oral or other agreements or understandings between them with respect to
the subject matter hereof.
          (b) The invalidity of any portion of this letter agreement shall not
affect the validity, force or effect of the remaining portions of this letter
agreement. If it is ever held that any provision hereunder is too broad to
permit enforcement of such provision to its fullest extent, such provision shall
be enforced to the maximum extent permitted by law.
          ( c) This letter agreement may be executed in counterparts, each of
which shall be deemed an original and all of which together shall constitute one
and the same instrument. This letter agreement and all matters arising directly
or indirectly hereunder shall be governed by, and construed in accordance with,
Section 19 of the Supply Agreement.
          If the foregoing accurately reflects our mutual understanding, please
so indicate by executing and returning a counterpart of this letter agreement.

            Sincerely,

WRIGHT MEDICAL TECHNOLOGY, INC.
      /s/ John K. Bakewell       John K. Bakewell      Executive Vice-President,
Chief Financial Officer     

          JKB/bb

Approved and accepted by:

LifeCell Corporation
      By:   /s/ Steven T. Sobieski