exv10w28






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.










10









 







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



12









 




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)



13









 




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”).



14









 





     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



15









 




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,



16









 




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



17









 




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



18









 




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.



19









 





     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



20









 




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



21









 




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









 








          (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









 








          (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









 







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









 






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









 







     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









 





     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












 





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









 








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









 





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.







 











 










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






 









 











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.










 









 







(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 	 	 



 









 






	 	 	 	 	 








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 	 	 



 









 






	 	 	 	 	 








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 	 	 
	 




 











 





	 	 	 
	

	 	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











 





[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	 	 






 









 







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