**Exhibit10.9****Option and Distribution Agreement**This Option and Distribution Agreement (“Agreement”) is made as of September 20, 2002 betweenSutura, Inc. (“Supplier”) a California corporation, having its principal place of business at17080 Newhope Street, Fountain Valley, CA 92708 and Getz Bros. & Co., Inc. (“Distributor”) aDelaware corporation, located at 225 West Washington Street, Suite 1900, Chicago, IL 60606.In consideration of the mutual promises contained herein, Supplier and Distributor agree asfollows:**1.** **Definitions:**(a) “Products” means those products listed in Exhibit A attached hereto, as thatExhibit may be amended to include any and all new products manufactured or distributed bySupplier within the field of vascular closure and also to exclude those products as may bediscontinued by Supplier.(b) “Territory” means Japan.(c) “Promissory Note” means the Convertible Promissory Note dated September 20, 2002between the parties and attached hereto as Exhibit B.**1A. Distribution Option**  (a) *Distribution Option:*Distributor shall have an exclusive option to enter into anexclusive distribution agreement with Supplier for the Products in Japan. The terms of thedistribution agreement for Japan shall be as set forth in this Agreement. Distributor’sright to exercise such option shall expire at 11:59 p.m., Chicago time, on March 31, 2004.The term of such distribution agreement shall commence thirty (30) days after the date onwhich Distributor gives notice to Supplier that it is exercising its option. The pricesat which Distributor buys Products from Supplier hereunder shall be as agreed between theparties subject to the provisions hereof and provided that such pricing shall be suchthat Distributor can earn a minimum gross profit (as defined in Section 3(b) below) of atleast forty (40) percent of the existing reimbursement price published periodically by theJapanese Ministry of Health, Labor and Welfare (herein “MHLW”).(b) *Convertible Note:*Upon execution of this Agreement Distributor shall pay to Supplierone million dollars ($1,000,000) in exchange for the Promissory Note. Upon exercise of theDistribution Option provided in subsection (a) above, the Promissory Note shall beconverted into an advance payment (“Advanced Payment”) for Products fully creditableagainst Distributor’s future purchases of Products. In the event Distributor elects notto exercise the Distribution Option, Supplier agrees to repay Distributor as provided inthe Promissory Note.
 

 
**2.** **Appointment and Authority of Distributor:**(a) *Appointment:*Subject to the terms and conditions of this Agreement, uponDistributor’s exercise of its option under Section 1A above, Supplier hereby appointsDistributor, and Distributor accepts that appointment, as Supplier’s exclusive distributorof the Products in the Territory.(b) *Independent Contractors:*Distributor and Supplier are independent contractorsand are engaged in the operation of their own businesses. Neither party is to be consideredthe agent of the other party for any purpose whatsoever, and neither party has anyauthority to enter into any contracts or assume any obligations for the other party or makeany warranties or representations on behalf or the other party unless agreed to in writingby the other party.**3.** **Obligations of Distributor:**(a) *Registration and Marketing of Products:*Distributor agrees, at its expense, touse its best efforts to investigate, obtain government approval for, promote, anddistribute the Products, in the Territory upon execution of this Agreement, using generallythe same channels and methods, exercising the same diligence and adhering to the samestandards which it employs for other medical application products sold by Distributor, aswell as any of Distributor’s own products. In addition, Distributor agrees to pursueregulatory approval and reimbursement for Supplier’s Products in the Territory inaccordance with the local laws and regulations, provided that Supplier provides therequired data and information to comply with the MHLW.(b) *Minimum Performance Levels:*Distributor agrees to purchase the number of units ofProducts per calendar year during the term of this Agreement (beginning with the first dateof promoted sales of Products by Distributor in the Territory) as agreed between theparties; provided, however, that such minimum performance levels shall be appropriatelyadjusted by Supplier and Distributor if: (i) one or more events of force majeure affectDistributor’s ability to meet such, levels; (ii) Supplier is unable or refuses to sellProducts to Distributor when Distributor orders them; (iii) Products are deletedfrom this Agreement, (iv) Product registrations are delayed or denied by local governingagencies through no fault of Distributor, (v) Supplier is unable or refuses to supplyreasonable data or information to comply with local governing agencies, (vi) approval forProduct reimbursement is delayed or denied by local governing agencies, or (vii) Productreimbursement levels established by government regulatory authorities in the Territory donot allow Distributor to realize a minimum gross profit (defined as revenues from sales ofProducts less Product costs, as well as taxes and shipping expenses incurred in connectiontherewith) of
 

 
forty (40) percent based on existing Supplier pricing. If Distributor and Supplier do notagree on acceptable minimum performance levels for any given year prior to the commencementof such year, Supplier shall have the right to terminate the Agreement; provided, however,the percentage increase in minimum performance levels for any year will not be greater thanseven (7) percent over the previous year’s minimum performance level unless mutually agreedupon.(c) *Reports:*Distributor agrees to submit regular reports to Supplier on a quarterly basis(unless otherwise agreed) accurately describing sales of the Products by Distributor for theprevious period (including prices, unit sales, and other information as may be reasonablyrequested by Supplier from time to time).(d) *ProductComplaints:*Distributor agrees to report to Supplier all available informationconcerning any product complaints that it is aware of. This information will bereported in order to assist Supplier in monitoring the quality and safety of its Products,and to allow Supplier to meet its reporting obligations under the United States MedicalDevice Reporting regulations (21 CFR 803.24) and Medical Device Vigilance Guidelines.Information concerning product complaints may be reported to the Supplier in eitherverbally or in writing. A “product complaint’ is any written or oral expression ofdissatisfaction as to the identity, quality, durability, reliability, safety, effectiveness,or performance of a Product. Product complaints associated with a death or serious injury,or a malfunction that could reasonably be expected to result in a death or serious injury ifthe malfunction recurs, will be reported to Supplier immediately upon Distributor’sknowledge of that information.(e) *Prohibited Sales:*Distributor agrees not to sell, and agrees to use reasonableefforts to ensure that Distributor’s subdistributors, agents and customers do notsell or use, any of the Products outside the Territory.(f) *Product Presentation:*Distributor agrees to present the Products fairly to potentialcustomers, not to disparage the Products, any Product trademarks or Supplier and to do allthings reasonable to promote the reputation of the Products and the value of any Producttrademarks.(g) *Non-Compete:*Upon Distributor’s exercise of its option under Section 1A above,Distributor agrees not to license, manufacture, sell, or distribute any product, whichcompetes with Supplier’s Products. Notwithstanding, Distributor reserves the right todistribute percutaneous closer devices manufactured by Perclose, Inc.(an AbbottLaboratories company) in the Territory until Distributor sells any remaining inventory,provided however, Distributor sells any remaining inventory within ninety (90) days from thedate set forth in Section 1A above.**4.** **Obligations of Supplier:**
 

 
(a) *Requirements of Distributor:*Supplier agrees to supply Distributor’srequirements for the Products in the Territory consistent with Distributor’s non-bindingforecasts of its expected requirements for the Products. If Supplier believes it will notbe able to satisfy Distributor’s requirements for the Products, it must promptly notifyDistributor, specifying the reasons for and duration of the expected delay and its durationat the time Product order is placed.(b) *Registration and Marketing Support:*To assist Distributor in registering and marketingthe Products in the Territory, Supplier agrees to:(i) Provide Distributor with materials necessary to obtain health registrations.Supplier will supply to Distributor the required quantity of samples, at a priceequal to Supplier’s cost of goods, to obtain registration approval.(ii) Provide Distributor with information on marketing and promotional plans ofSupplier for the Products as well as copies of marketing advertising, sales,technical training manuals, and available audiovisual teaching and marketing aidesand promotional literature concerning the Products.(iii) Provide Distributor with certain certificates of analysis concerning theProducts purchased by Distributor, certificates of free sale, trademarkauthorizations and any other documents which Distributor may require forregistration purposes.**5.** **Trademark Licenser:**Supplier grants to Distributor the right and license to use Supplier’strademarks and any trademark registrations which Supplier obtains and designates for theProducts in the Territory, but only in connection with sales of the Products purchased fromSupplier in the Territory. This trademark license shall continue in effect for eachjurisdiction in the Territory only while Distributor retains its distribution rights in eachjurisdiction. Distributor agrees not to remove or obscure any Product label affixed bySupplier.**6.** **Terms and Conditions of Sale:**(a) *Terms of Orders:*All purchases of the Products by Distributor from Supplier duringthe term of this Agreement will be subject to the terms and conditions of this Agreement.(b) *Packaging:*All quantities of the Products purchased from Supplier by Distributor willbe in the form of labeled, standard unit packages and in a form and formulation consistentwith the Products sold by Supplier for use in the United States, unless otherwise agreed bySupplier and Distributor in writing.
 

 
(c) *Price and Payment:*The prices for the Products to Distributor are set forth in ExhibitA attached hereto. The prices are valid for a minimum period of twelve (12) months, unlessmutually agreed otherwise in writing. Ninety (90) days advance written notification isrequired for price increases by Supplier.(d) *Resale Price:*Distributor may resell Products at any price that Distributor in its solediscretion determines.(e) *Expenses:*All expenses for importation, promotion, sales and distribution, as well asDistributor’s administrative and overhead expenses, will be borne solely by Distributor.(f) *Credit:*Distributor assumes all credit and other risks involved in its sales underthis Agreement. All collection expenses on sales made by Distributor will be atDistributor’s expenses.(g) *Payment Terms:*Basic payment terms are net sixty (60) days.**7.** **Product Warranty; Insurance:**Supplier warrants that all Products: (a) will conform with allspecifications and descriptions thereof provided by Supplier, (b) will be free of defects inmaterial, workmanship, and design, (c) will be of merchantable quality, suitable for thepurposes for which they are intended to be used, and (d) will comply with all applicable lawsand regulations. Supplier will have the right to exchange or accept existing inventory ifProducts do not meet requirements (a) to (d). All warranties shall survive any inspection,delivery, acceptance, or payment. Supplier will provide, when requested by Distributor,certification that to the best of its knowledge it is in compliance with U.S. laws, statutes,rules, regulations, and relevant orders relating to the manufacture, use, distribution, andsale of each Product. Distributor will use its best efforts to afford the Supplier thereasonable opportunity to inspect the allegedly defective Product at the location of its useor storage. Distributor will, or will cause, upon request and in accordance with Supplier’sinstruction, return of any defective Product to Supplier at Supplier’s cost. Any replacementof Products may be made by substitution upon mutual agreement.Supplier shall maintain in full force, and shall continue to maintain in full force forthe term of this Agreement and five years thereafter, public and products liabilityinsurance, naming Distributor as an additional insured, against bodily injury, death orproperty damage in any way arising out of the design, manufacture, sale, distribution, oruse of any Product in an amount of not less than US$5,000,000 per occurrence and annuallyin the aggregate. Said liability insurance shall: (a) be written by an insurance company licensed to do business inthe Territory, reasonably satisfactory to Distributor;
 

 
 (b) include (i) products liability coverage insuring all of the Productscovered by this Agreement, as amended, and (ii) contractual liability coverageinsuring the indemnification provisions of this Agreement;  (c) include a duty to defend and cover legal and defense costs aswell as indemnity costs;  (d) include a separation of interests or cross liability clausesuch that the policy will respond on behalf of Distributor as if a separatepolicy had been issued, except for the policy limits;  (e) include the Territory within the territory covered by theinsurance policy.Supplier shall furnish Distributor with a copy of the insurance policy or a Certificate ofInsurance evidencing such insurance upon request of Distributor, provided that Suppliershall provide such policy or such certificate upon execution of this Agreement and atleast annually thereafter. Said policy, or said certificate shall provide that theinsurance evidenced thereby, shall not be canceled, terminated or materially reduced incoverage without at least thirty days prior written notice to Distributor. Failure tomaintain the required insurance shall constitute a material breach of this Agreement.**8.** **Indemnification:**(a) Supplier agrees to indemnify Distributor and defend its employees, agents,representatives, and subdistributors harmless from and against, and to assume all costsand expenses (including attorney’s fees) for;(i) claims or suits for bodily injury, including death, or property damagearising out of the design, manufacture, sale, distribution, resale, or useof any Product;(ii) any product recalls or replacements, whether required or recommendedby any government or other authority or organization or otherwise deemedappropriate by Supplier and Distributor; or(iii) any product liability claims arising from the Product Warrantyprovided by Supplier in Section 7,except if such injury, damage, cost, or expense is caused by the sole negligence ofDistributor.
 

 
(b) Supplier agrees to further indemnify, defend, and hold Distributor, and its employees,agents, representatives, and subdistributors, harmless from and against, and shall assumeall costs and expenses (including attorney’s fees) for any claim that any Product infringesor violates any patent, copyright, trademark, trade name, trade secret, or otherintellectual property right.(c) Supplier and Distributor each agree to indemnify and hold the other harmless from andagainst any and all claims made by any person or entity arising out of the processing,marketing, distribution, and sale of the Products, where and to the extent damages arealleged to have been caused by the fault of the indemnifying party or its employees oragents.**9.** **Confidential Information:**Each party agrees to keep confidential and not to publish orotherwise divulge or use for its own benefit or for the benefit of any third party anyinformation of a proprietary nature furnished to it by the other party without the priorwritten approval of the disclosing party, except as required by law or court order or asnecessary for the marketing of the Products. The confidential information includes (but is notlimited to) information concerning Products, proposed products, marketing plans, methods ofmanufacture, customers and any other information or materials in whatever form. Thisobligation does not extend to information which: (i) is already known by recipient at the timeof its disclosure to recipient; (ii) is publicly available or later becomes publicly availablethrough no fault of the recipient; or (iii) is disclosed to recipient by a third party havingno similar confidentiality obligation. This obligation shall terminate two years aftertermination of this Agreement. **10.** **Term and Termination:**(a)* Term and Renewal:*The initial term of Distributor’s distribution rights hereundershall commence on the date set forth in Section 1A above and will continue in force untilfive (5) years after the first date of promoted sales of the Products by Distributor in theTerritory. The parties will be required to give notice to the other of its intention toterminate this Agreement at least six (6) months prior to the expiration of the initialterm hereof or of any renewal term.(b)* Termination of Agreement:*Either party may at its option, terminate this Agreement atany time by giving to the other party not less than sixty (60) days prior written notice,as applicable, if: (i) the other party at any time commits a material breach of any of itsobligations hereunder and fails to correct any breach during such 60-day notice period;(ii) Distributor is unable to secure regulatory approval by the MHLW for the Productswithin eighteen months of the first date of this Agreement or; iii) there is a “change ofcontrol” (defined herein as a change in the beneficial ownership of fifty (50) percent ofthe voting capital stock) of Supplier or Distributor or any of its majority ownedsubsidiaries or affiliates. This agreement also may be terminated by either party if theother party becomes
 

 
insolvent, makes or seeks to make an arrangement with or an assignment for the benefit ofcreditors, or if proceedings in voluntary or involuntary bankruptcy are instituted by, onbehalf of or against such other party, or if a receiver or trustee of the other party’sproperty is appointed.(c)* Termination of Agreement for Noncompliance with Minimum Performance Levels:*If the Distributor fails to purchase the required minimum number of units ofProducts during any calendar year during the term of this Agreement, Supplier may, ifDistributor fails to cure such failure within six (6) months after receipt of notice thereoffrom Supplier, terminate this Agreement upon terms and conditions to be agreed upon betweenthe parties.(d)* Effect of Termination of Agreement:*Upon termination or expiration of the Agreement,Distributor agrees to promptly assign or otherwise transfer to Supplier or its designees allof Distributor’s rights, title and interest to registrations, regulatory approvals, licensesand/or pending applications for Supplier’s Products in Japan. Once Distributor hasexercised its option under Section 1A hereunder, upon termination of this Agreement Suppliermay elect to (i) buy back all inventory on hand within sixty (60) days at Distributor’s“fully loaded cost” (defined as total cost incurred to import, register and warehouse theProducts, plus product promotion expenses) to Distributor or (ii) allow the Distributor, andDistributor shall be authorized, to continue to sell the remaining inventory; provided, thatin no event shall Distributor be required to continue to sell or distribute Productsafter the termination of the Agreement. In addition, Distributor agrees to deliverto Supplier or destroy, upon request, all Product materials supplied by Supplier and allProduct marketing materials of any kind. Distributor agrees to promptly assign or otherwisetransfer to Supplier or its designees all of Distributor’s rights, title and interest toregistrations, regulatory approvals, licenses and/or pending applications for Supplier’sProducts. If Distributor has not exercised the option in Section 1A above, Supplieragrees to repay Distributor as provided in the Promissory Note. If Distributor has exercisedthe option in Section 1A above, Supplier agrees to repay any remaining balance of theAdvanced Payment. The obligations of Supplier and Distributor pursuant to Sections 7(Product Warranties), 8 (Indemnification), 9 (Confidential Information), 10 (Term andTermination) and 11 (General Provisions) of this Agreement will survive any termination ofthis Agreement. Nothing herein will limit any remedies which a party may have for theother’s default, except as expressly provided herein, Neither party shall be liable to theother for any damage in connection with that party’s termination of this Agreement bynotice.**11.** **General Provisions:**(a)* Governing Law:*This Agreement is to be governed by and interpreted in accordancewith the laws of the State of California, without regard to its rules on conflicts oflaws.
 

 
(b)* Jurisdiction and Venue:*Each party submits to the exclusive jurisdiction of any state orfederal court located in Cook County, Illinois, U.S.A., over any suit, action or proceeding(“Action”) arising out of or relating to this Agreement or the relationship between the parties.Each party waives any objection to the venue of any Action brought in such court and any claim thatthe Action has been brought in an inconvenient forum. Each party agrees that a final judgment inany Action brought in such court shall be conclusive and binding upon it and may be enforced inany other courts to whose jurisdiction it may be subject.(c)* Dispute Resolution:*The parties agree to use their best efforts to resolve any claim or disputearising out of this Agreement through negotiation or, upon failure of such negotiations, throughsuch alternative dispute resolution (“ADR”) techniques as they may deem appropriate. However,nothing shall prohibit either party from terminating its participation in ADR if it believes thedispute is not suitable for ADR, or if ADR does not produce results satisfactory to it. If anyclaim or dispute is not resolved by negotiation or ADR, either party may, upon giving the otherparty at least fifteen (15) days prior written notice, initiate litigation to resolve the dispute.(d)* Entire Agreement:*This Agreement and subsequent agreements for the Territory represent theentire agreement and understanding of Supplier and Distributor with respect to distribution of theProducts, supersedes all previous agreements and understandings related thereto and may only beamended or modified in writing signed by authorized representatives of Distributor and Supplier.(e)* Assignment:*(i) Neither Supplier nor Distributor may assign any of its rights or obligationspursuant to this Agreement without the prior written consent of the other party, except toa successor to substantially all of the business of either party by merger, sale ofassets, or other form of reorganization and except that Distributor shall have the rightto assign all or part of this Agreement and the Promissory Note to Getz Bros. Co., Ltd.,in which case Distributor shall be released from any obligations hereunder with respect tothat part or parts of this Agreement and/or the Promissory Note which has been soassigned.(ii) Distributor may resell the Products to, and appoint as its subdistributor(s) withinthe Territory, any majority owned subsidiaries or affiliates of Distributor’s corporateparent. The appointment of any subdistributor is conditioned upon:
 

 
(A) Subdistributor expressly acknowledging that its SubdistributorAgreement with Distributor is subject to and subordinate in all respects tothe terms and conditions of this Agreement, and the Subdistributor furtheracknowledging that it is familiar with and will comply with all applicable termsof this Agreement: and(B) Distributor remaining directly responsible to Supplier for the due performanceof all obligations imposed on Distributor by this Agreement, including payment forall purchases of Product;(iii) Supplier agrees to accept orders for shipment of Products into theTerritory only from Distributor or any Subdistributor.(f) *Notices:*All notices under this Agreement must be in writing and will be deemed given if sentby facsimile, telex, telecopier, or telegram (except for legal process in each case), certified orregistered mail or commercial courier (return receipt or confirmation or delivery requested), orby personal delivery to the party to receive the notice or other communications called for by thisAgreement at the following addresses (or at another address for a party as specified by a party bylike notice);   **Supplier** **Distributor**Sutura, Inc. Getz Bros. & Co., Inc.17080 Newhope St. 225 W. Washington St., Suite 1900Fountain Valley, CA 92708 Chicago, IL 60606Attn: President & CEO Attn. President, Medical Group(g) *Non-Hire:*Without the prior written consent of the other party, neither party shall, duringthe term of this Agreement or for twelve months thereafter, either directly or indirectly, hire orotherwise engage, or cause, aid or assist any other person or entity (including its subsidiaries,parents or other affiliates) to hire or otherwise engage, any current or former employee of otherparty for a period of twelve months after the termination of such individual’s employmentrelationship with the other party. This provision shall survive the termination of this Agreement.(h) *Force Majeure:*Each of the parties hereto will be excused from its performance of itsobligations hereunder if the performance is prevented by force majeure, and that excuse willcontinue so long as the condition constituting that force majeure continues plus thirty days afterthe termination of the condition. For the purposes of this Agreement, “force majeure” is defined toinclude causes beyond the control of Distributor of Supplier, including without limitation acts ofGod, acts, regulations or laws of any government, war, civil commotion,
 

 
destruction of production facilities or materials by fire, earthquake or storm, labor disturbances,or medical epidemics.         **SUTURA, INC.**   **GETZ BROS. & CO., INC.**         By:     By:                          (printed name)   (printed name)         Title:     Title:           
 

 
**EXHIBIT A**Products are defined as vascular closure products including but not limited to all and any newproducts developed within the field of vascular closure during the course of the exclusivedistribution agreement. The initial Products are:   **Product** **Unit Price (USS)**SuperStitch 6F To be agreed upon by the parties subject to Section 1A above.SuperStitch 8F To be agreed upon by the parties subject to Section 1A above.KnotPusher 6F To be agreed upon by the parties subject to Section 1A above.