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Supply Agreement

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 This Supply Agreement involves

WRIGHT MEDICAL GROUP INC | LifeCell Corporation | Wright Medical Technology Inc

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Title: SUPPLY AND DEVELOPMENT AGREEMENT
Governing Law: Delaware     Date: 2/22/2010
Industry: Medical Equipment and Supplies     Law Firm: Lowenstein Sandler     Sector: Healthcare

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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  

     

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Indicates portions of this exhibit that have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment.

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limitation, LifeCell would not have been able to agree to provide the Products or perform its other obligations hereunder for the consideration and on the terms and conditions set forth in this Agreement.      4.10 Processed Tissue Changes. LifeCell reserves the right at any time to make changes in the Processed Tissue provided, however, that LifeCell shall use commercially reasonable efforts to provide one hundred twenty (120) days prior written notice to Distributor of any such changes. Distributor agrees that LifeCell shall have no liability to Distributor by reason of any Processed Tissue change.      4.11 Processed Tissue Shelf Life. LifeCell covenants that the shelf life of any Processed Tissue delivered to Distributor during the Term shall have a shelf life of no less than twelve (12) months as of the date of shipment from LifeCell.      4.12 Product Recalls.           (a) Responsibility for Recall. In the event any Product(s) must be recalled or LifeCell reasonably determines that it is prudent to have any Product(s) recalled from the channel of distribution by reason of failure to meet any requirements of law or otherwise, Distributor shall have the sole responsibility to effect the recall. LifeCell is solely responsible for finaldecisions concerning the recall of Products in the United States, and the destruction and/or reconditioning of recalled Products. In addition, LifeCell is solely responsible for all communications with Regulatory Agencies concerning Product recalls in the United States. For recall of Product outside the United States, the parties agree to work cooperatively regarding communication with the Regulatory Agencies to effect the recall. Any costs and expenses incurred by either party in connection with a recall of Products shall be borne by the party whose acts or omissions caused or resulted in the necessity for such recall. LifeCell shall use commercially diligent efforts to cooperate with Distributor in implementing any such recalls to the extent such cooperation is necessary to effect the recall.           (b) Responsibility for Reimbursement. In the event the recall results from or is caused by an act or omission by Distributor, Distributor shall reimburse LifeCell for any costs and/or expenses reasonably expended by LifeCell as a consequence of the recall. Without limiting the general nature of the foregoing, Distributor shall bear the cost of any Products involved in such recall. In the event the recall results from or is caused by an act or omission by LifeCell, LifeCell shall reimburse Distributor for any costs and/or expenses reasonably expended by Distributor as a consequence of the recall. Without limiting the general nature of the foregoing, LifeCell will provide replacement Products for recalled Products and for any Products that cannot be shipped due to the condition requiring the recall within 120 days, and if this does not occur, Distributor shall have the right to terminate this Agreement and during such time the Minimum Purchase Requirements shall be waived.       5. Market Development Programs. LifeCell and Distributor shall review the implementation and administration of market development and regulatory strategies, priorities,

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of the Products (" Market Development Programs ") and Clinical Development Programs and activities and procedures related to the marketing and sales of Products.       6. Term. This Agreement is effective as of April 1, 2002 (the " Effective Date ") and, unless earlier terminated, shall remain in force until 11:59 p.m., Eastern United States time, on January 1, 2007 (the " Initial Term "). Not later than one hundred twenty (120) days prior to the expiration of the Initial Term or then current Renewal Term, each party shall provide written notice to the other party indicating its desire to renew this Agreement for a Renewal Term (the " Renewal Notice "). In the event that either party’s Renewal Notice indicates a desire to renew this Agreement for a Renewal Term, the parties shall arrange to meet, in person or telephonically, not later than ninety (90) days prior to the expiration of the Initial Term or then current Renewal Term, and shall negotiate in good faith concerning the renewal of this Agreement and any revisions to the terms and conditions to this Agreement, including without limitation, revisions to the Minimum Purchase Requirements. Unless otherwise extended by mutual agreement of the parties, in the event the parties have not agreed to renew this Agreement prior to September 30 of the last year of the Initial Term or then current Renewal Term, this Agreement shall terminate upon expiration of the Initial Term or then current Renewal Term, as the case may be. Each renewal to this Agreement, including any revisions to this Agreement agreed to between the parties, shall be memorialized in a written amendment to this Agreement executed by authorized representatives of each of the parties.       7. Termination.      7.1 Expiration. This Agreement shall terminate on the expiration of the Initial Term or then current Renewal Term, as applicable, unless the parties shall have agreed to a Renewal Term in accordance with Section 6.      7.2 LifeCell Option. This Agreement shall terminate, at the option of LifeCell, (i) immediately upon notice to Distributor in the event of (1) an attempted assignment or delegation of this Agreement by Distributor without LifeCell’s prior written consent, (2) an inability by Distributor to pay its debts as they become due, (3) the institution of any proceedings by or against Distributor for reorganization, bankruptcy or other relief under any insolvency or similar law, (4) an application for or the appointment of a receiver for Distributor, (5) dissolution of Distributor, whether voluntary or by law or (6) a change in the control of Distributor reasonably unacceptable to LifeCell or (ii) upon thirty (30) days written notice to Distributor in the event of a material breach by Distributor of any of the terms of this Agreement not otherwise described in clause (i) above, if Distributor shall have failed to cure such breach within 30 days of such notice.      7.3 Other. This Agreement also shall terminate in accordance with other Sections of this Agreement that permit or provide for such termination, including without limitation, Sections 4.1(b), 4.4, 4.9(b) and 16.2.      7.4 Permitted Activities. Distributor agrees that upon termination of this

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Agreement, LifeCell may, at its option, (i) ship Products to Distributor with respect to orders from Distributor duly accepted by LifeCell during the Term, for sale to and payment by Distributor in accordance with the terms of this Agreement (treating such terms for this limited purpose as being still in effect), and (ii) permit Distributor to sell Products in Distributor’s inventory on a non-exclusive basis, but otherwise subject to and in accordance with the terms of this Agreement (treating such terms for this limited purpose as being still in effect), until the earlier of such time as (1) all of Distributor’s then existing inventory of Products has been sold, or (2) the Products have reached their expiration date. Notwithstanding the foregoing, Distributor, at its option, may return to LifeCell the actual Products last delivered to Distributor in an amount equal to the amount of Products purchased by Distributor from LifeCell in the immediately preceding Sales Quarter, provided that those Products returned have a shelf life of no less than nine (9) months when received by LifeCell and meet the quality requirements applicable thereto, including without limitation, the requirements of Section 4.7 and Schedule II (the " Put-Back Amount "), and LifeCell shall refund to Distributor the dollar amount equal to the Transfer Prices paid by Distributor for the Sizes returned, multiplied by the number of Units thereof. In the event that Distributor, after the return to LifeCell of the Put-Back Amount, still retains Products in inventory, LifeCell, at its option, shall either purchase Distributor’s remaining inventory of Products at the Transfer Prices in effect at the time such Products were purchased by Distributor, provided that the Products to be repurchased by LifeCell have a shelf life of no less than nine (9) months when received by LifeCell and meet the quality requirements applicable thereto, including without limitation, the requirements of Section 4.7 and Schedule II, or permit Distributor to sell the Products in Distributor’s inventory on a non-exclusive basis for the greater of sixty (60) days after termination of this Agreement, or until all of Distributor’s then existing inventory of Products has been sold, or the Products have reached their expiration date.      7.5 Damages.           (a) Distributor shall not be entitled to and shall not claim or seek indemnification or any other form of damages or compensation from LifeCell by reason of termination of this Agreement pursuant to its terms or loss of its rights under this Agreement pursuant to such termination, nor shall it be entitled to seek compensation or damages on account of prospective profits or income after the termination date.           (b) LifeCell shall not be entitled to and shall not claim or seek indemnification or any other form of damages or compensation from Distributor by reason of termination of this Agreement pursuant to its terms or loss of its rights under this Agreement pursuant to such termination, nor shall it be entitled to seek compensation or damages on account of prospective profits or income after the termination date.      7.6 Distributor Option. This Agreement shall terminate, at the option of Distributor, (i) immediately upon notice to LifeCell in the event of (1) an attempted assignment or delegation of this Agreement by LifeCell without Distributor’s prior written consent, (2) an inability by LifeCell to pay its debts as they become due, (3) the institution of any proceedings by or against LifeCell for reorganization, bankruptcy or other relief under any insolvency or similar law, (4) an application for or the appointment of a receiver for LifeCell, (5)

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dissolution of LifeCell, whether voluntary or by law or (6) a change in the control of LifeCell reasonably unacceptable to Distributor or (ii) upon thirty (30) days written notice to LifeCell in the event of a material breach by LifeCell of any of the terms of this Agreement not otherwise described in clause (i) above, if LifeCell shall have failed to cure such breach within 30 days of such notice or (iii) upon 60 days prior written notice to LifeCell in the event that LifeCell changes any of the Products and such changes, in Distributor’s reasonable judgment, significantly and adversely affect Distributor.      7.7 Survival. Except as otherwise expressly set forth herein, the obligations of the parties under Sections 2.1(j), 4.1(e), 4.4, 4.7, 4.9(e), 7.4, 8.1, 9, 12, 14, 17, 19, 20 and 27 shall survive any expiration or termination of this Agreement forever.       8. Complaints and Regulatory Notices.      8.1 Complaints.           (a) In the event that LifeCell or Distributor at any time during the Term receives any written, electronic or oral communication that alleges deficiencies related to identity, quality, durability, reliability, safety, effectiveness or performance concerning the Products or Processed Tissue (individually or collectively, a "Complaint"), including notices from the FDA regarding any alleged regulatory non-compliance of such Products or Processed Tissue, or the marketing thereof, such party shall, within two (2) business days following receipt of notices relating to medical reports and within 2 business days following receipt of any notice relating to any other Complaint or such shorter period as may be required by applicable laws, rules or regulations, provide to the other party all information contained in such Complaint, report or notice and any additional information relating thereto as may reasonably be requested.           (b) In the event that any Complaint is received from a Customer, LifeCell and Distributor shall use their best efforts to reach mutual agreement concerning the handling and resolution of such customer Complaint. LifeCell shall be responsible for the timely review and analysis of each Complaint, to document its findings in connection therewith and, as LifeCell deems necessary, to take corrective action.      8.2 Regulatory Notice. Each of LifeCell and Distributor shall promptly but in no event more than five (5) days following the receipt thereof, notify the other party and provide to such party a copy or transcription, if available, of any materially adverse communication received from a regulatory agency relating to the Product or Processed Tissue, the marketing thereof or any related matter.       9. Trademarks.      9.1 Definition. Distributor acknowledges that LifeCell owns and shall continue to own all right, title and interest in and to the trademarks or trade names "AlloDerm," "LifeCell" and "AlloDerm Process" (the " Trademarks ").

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     9.2 Grant. LifeCell hereby grants to Distributor a non-exclusive license to use the Trademarks during the Term solely in connection with Distributor’s marketing and sales of the Products to Customers in the Sales Territory as provided herein and, in those jurisdictions in which Distributor has been appointed an exclusive distributor pursuant to Section 1.1 and provided Distributor’s distributorship status has not become non-exclusive, LifeCell agrees not to grant a license to any other person to use the Trademarks during the Term in connection with marketing and sales of the Products to Customers in the Sales Territory.      9.3 Distributor’s Trademarks. The parties acknowledge and agree that all right, title and interest in and to any trademarks, service marks, trade names or brand names developed for the Product by the Distributor hereunder shall reside solely with the Distributor. The parties further acknowledge and agree that the use and display of the trademarks developed by the Distributor and/or LifeCell Trademarks shall be authorized in advance by LifeCell. The Distributor will provide packaging specifications, labeling and graphics to LifeCell for review and approval. The parties agree that the Product package will include a statement, to be agreed upon by both parties, indicating LifeCell as the manufacturer/technology provider.      9.4 Limitation of Grant. In performing its obligations hereunder, Distributor may use the Trademarks only for display on packaging or images of the Products and Processed Tissue. All such use and display shall be solely in connection with the promotion and solicitation of orders for the Products to Customers in the Sales Territory and only in such fashion as has been expressly authorized by LifeCell in advance of such use or display. Distributor acknowledges and agrees that its use of the Trademarks shall at all times be as licensee for the account and benefit of LifeCell. To the extent that any rights in and to any of the Trademarks are deemed to accrue to Distributor pursuant to this Agreement, Distributor hereby assigns any and all such rights, at such time as they may be deemed to accrue, to LifeCell.      9.5 Distributor Actions. Distributor shall not, at any time, do or cause to be done any act or thing that (i) will in any way impair the rights of LifeCell in or to the Trademarks or their registrations, (ii) may affect the validity of any of the Trademarks or (iii) may depreciate the value of the Trademarks or their reputation. Except as otherwise specifically provided herein, Distributor shall not, during the Term or thereafter, attach LifeCell’s title or right in and to the Trademarks. Distributor shall, at LifeCell’s request and sole expense, provide all commercially reasonable cooperation and assistance in connection with LifeCell’s efforts to register, maintain, protect and defend the Trademarks and to prosecute any infringers with respect to the Trademarks. LifeCell shall control all efforts to register, maintain, protect and defend the Trademarks and to prosecute any infringers with respect to the Trademarks. Distributor agrees to advise LifeCell promptly of any actual or potential infringement of the Trademarks on becoming aware of such infringements. LifeCell shall have the sole right to determine if any action shall be taken against any third party on account of any such infringements or imitations and Distributor shall not institute any suit or take any action against any third party on account of any such infringements or imitations without first obtaining LifeCell’s written consent to do so. Any recovery as a result of such action shall belong solely to LifeCell, except to the extent that such recovery represents damage to Distributor, in which event any specified recovery, net of all expenses paid by LifeCell, including Distributor’s attorneys’ fees, if any, shall be paid to

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Distributor. Distributor agrees and undertakes that its use of the Trademarks will be in strict compliance with any and all applicable laws, rules and regulations, including trademark laws, and that it will make such marking on the Product packaging or otherwise in connection therewith as may be required by LifeCell in its sole discretion. Distributor shall use commercially reasonable efforts to cooperate fully with LifeCell in preparing and causing to be recorded at LifeCell’s expense such documents as may be necessary or desirable to evidence, protect and implement the rights of LifeCell pursuant to this Section 9.      9.6 Pre-Publication Review of Marketing Materials. All Marketing Materials are expressly subject to pre-publication review and approval with respect to, but not limited to, content, style, appearance, composition, timing, and media. Prior to the distribution or publication of any advertising, technical, sales or other materials containing any of LifeCell’s trademarks, service marks or trade names, or referring to the Products or Processed Tissue (" Marketing Materials "), Distributor shall provide one copy of proofs of such Marketing Materials to LifeCell for review and approval (Attention: Vice-President, Marketing, LifeCell Corporation, One Millennium Way, Branchburg, NJ 08876) at least ten (10) days prior to the anticipated publication of such Marketing Materials. LifeCell shall use commercially diligent efforts to provide feedback and/or-17-approval (as the case may be) to Distributor within five (5) days after LifeCell’s receipt of the applicable Marketing Materials. Notwithstanding anything to the contrary contained herein, Distributor shall not use, distribute or publish anything containing LifeCell’s trademarks, service marks or trade names or referring to Products or Processed Tissue without the express prior written consent of LifeCell.      9.7 Termination of Use of Trademark. Except as provided in Section 7.4, if for any reason Distributor ceases to be the Distributor of the Products in the Sales Territory, Distributor’s right to use the Trademarks shall terminate immediately upon depletion of existing inventory of Product. Except as provided in Section 7.4, upon any termination of this Agreement, (i) any and all rights granted to Distributor hereunder, together with any interest in and to the Trademarks and registrations therefor which Distributor may be deemed to have acquired by virtue thereof or otherwise, shall immediately cease and without further act or instrument be assigned to and revert to LifeCell, and (ii) Distributor shall immediately terminate all further use of the Trademarks except as provided herein. Thereafter, Distributor shall not recommence or continue using any of the Trademarks without the prior written consent of LifeCell. In addition, Distributor will promptly execute any instruments reasonably requested by LifeCell which LifeCell reasonably, in its sole discretion, deems necessary, proper or appropriate to accomplish or confirm the foregoing. Any such assignment, transfer or conveyance shall be without further consideration other than the mutual agreement contained herein.       10. Proprietary Rights. To LifeCell’s knowledge, it owns or possesses, or has licenses or other rights to use and license all patents, patent applications, patent disclosures and inventions, patent licenses, trademarks, trade names, trade secrets, service marks, brand marks, brand names, copyrights, copyright applications, inventions, technologies, know-how,

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formulae and processes owned by or licensed to LifeCell (collectively, " Proprietary Rights ") necessary for it to comply with its obligations under this Agreement without any conflict with or infringement of the rights of any third party. To LifeCell’s knowledge, no claim has been asserted or threatened by any person regarding the use or licensing of any of the Proprietary Rights by LifeCell or challenging or questioning the validity, enforceability or effectiveness of any licenses or agreements relating to Proprietary Rights or asserting any rights in such Proprietary Rights. To LifeCell’s knowledge, the use by LifeCell of its Proprietary Rights does not violate or infringe the rights of any third party. LifeCell is not aware of any third parties who are infringing or violating any of the Proprietary Rights.       11. Independent Contractor. Distributor is an independent contractor and agrees not to represent itself in any manner to any third party as a partner, agent, associate or employee of LifeCell. It is expressly provided that this Agreement does not create a partnership, joint venture or any similar business association or combination between the parties hereto. It is understood and agreed that all contracts for the sale of Products to Customers will be between Distributor (or its permitted sub-distributors) and Customers. Distributor shall have no authority to accept orders for Products on behalf of LifeCell. Distributor does not have the power to bind LifeCell or to assume or create any contract or other obligation on behalf of LifeCell.       12. Indemnity.      12.1 Distributor. Distributor shall indemnify and hold LifeCell harmless from any and all claims, liabilities, judgments, losses, damages, costs and expenses, including without limitation, reasonable attorneys’ fees and costs, (" Damages ") successfully asserted against LifeCell by any person not a party to this Agreement which Damages result from any bodily injury, illness, death, or property damage if Damages (i) arise out of any statement, representation, warranty or Marketing Materials issued by Distributor which materially exceeds in scope or is different in meaning from statements made by LifeCell in LifeCell’s own literature, or specifications or has been previously approved by LifeCell or (ii) arises solely from the negligence or wrongful activity of Distributor.      12.2 LifeCell. LifeCell shall indemnify and hold Distributor harmless from any and all Damages by any person or entity not a party to this Agreement which Damages result from any bodily injury, illness, death, or property damage if such Damages arise from (i) a defect in any of the Processed Tissue associated with any Products, (ii) a failure of any of the Processed Tissue associated with any Products to meet LifeCell’s specifications,(iii) from the negligence or wrongful activity of LifeCell or (iv) infringement of Proprietary Rights of third parties..      12.3 Settlements and Compromises. Neither the party having the right to indemnification nor the party having the indemnification obligation under this Section 12 may settle or compromise any such claim, suit, action or proceeding unless (i) the other party consents in writing (which consent may not be unreasonably withheld) and (ii) the terms of that settlement or compromise release the other party from any and all liability with respect to that

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claim.      12.4 Joint Actions. In the event any claim, suit, action or proceeding is asserted against both LifeCell and Distributor, or one party to this Agreement joins the opposite party in any such claim, suit, action or other proceeding, a party will be obligated to indemnify the opposite party with respect to that matter only if, and in proportion to the extent that, such party is first found to have been at fault with respect to that matter by a final, non-appealable judgment of a court of law.       13. Compliance with Laws.           (a) Each of LifeCell and Distributor shall comply with, and be responsible for ensuring that its employees and agents comply with, all applicable statutes, rules, regulations, orders and by-laws of the federal government of the United States and any other jurisdiction in the Sales Territory or any state and any agency, authority or political subdivision thereof.           (b) Distributor agrees that neither it nor any of its officers, directors, employees or representatives will, directly or indirectly, in connection with the solicitation of sales of the Products to Customers in the Sales Territory:      (i) make any payment to any officer or employee of any government, or to any political party or official thereof; where such payment either is unlawful under laws applicable thereto, or would be unlawful under the Foreign Corrupt Practices Act of 1977, as amended, of the United States of America, if Distributor, as the case may be, were a "domestic concern", within the meaning of such act;      (ii) make any payment to any person, if such payment constitutes an illegal bribe, illegal kickback or other illegal payment under laws applicable thereto; or      (iii) commit, directly or indirectly, any other act or omission in violation in any material respect of any applicable law, regulation, rule or custom having the effect of law.       14 . Confidential Information.      14.1 Definition. LifeCell and Distributor may from time to time provide to the other party (each, a " Recipient ") certain advice, technical information, know-how and other proprietary data and information that they respectively own to aid each other in the performance of their respective obligations under this Agreement. Inasmuch as various of these materials and advice (all of which will be referred to herein as the " Confidential Information ") will contain confidential information and/or trade secrets, it is hereby agreed that any Confidential Information which is disclosed by one party to the other is valuable, proprietary

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property belonging to the party making such disclosure, and the Recipient agrees that it will neither use nor disclose any Confidential Information to any third party (except if necessary in the performance of its duties hereunder), except with the prior written consent of the other party, provided, however, that any written Confidential Information shall be marked "Confidential".      14.2 Limitation. The Recipient agrees to make copies of that Confidential Information received by the Recipient as is authorized by the other party and which is necessary to the performance of Recipient’s obligations under this Agreement. Recipient also agrees to limit disclosure of the Confidential Information to only those employees of Recipient with a need to know such Confidential Information in connection with the performance of Recipient’s obligations under this Agreement.      14.3 Remedies. In the event of breach or threatened breach by the Recipient or its employees of any of the provisions of Sections 14.1 or 14.2, the other party shall be entitled to an injunction or judicial order equivalent thereto restraining the Recipient or its employees from disclosing, in whole or in part, such Confidential Information. Nothing herein shall be construed as prohibiting the other party from pursuing any other remedies available to it for such breach or threatened breach, including recovery of damages from the Recipient.      14.4 Termination. The Recipient agrees, either upon the termination of this Agreement or upon request, to surrender to the other party all documentary material including Confidential Information, price lists, catalogues, technical literature, sales literature, samples and any other documents, papers or other properties of the other party, however previously supplied to the Recipient by the other party, provided, however, that Distributor may retain a reasonable amount of Marketing Materials as necessary to sell Products in accordance with Section 7.4. The Recipient may re

       
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