**Exhibit 10.19**
**MANUFACTURING AND DISTRIBUTION AGREEMENT**
     **THIS MANUFACTURING AND DISTRIBUTION AGREEMENT**(the “Agreement”) is madeand entered into as of the 2nd day of September, 2004, by and betweenUroplasty, Inc., 2718 Summer Street N.E., Minneapolis, Minnesota 55413(“Uroplasty”), and CL Medical SAS, 28, av Général de Gaulle 69110 Ste Foy LèsLyon, France (“CL”).
**R E C I T A L S :**
     **WHEREAS**, Uroplasty manufactures and currently markets outside of theUnited States a family of injectable implant products used for soft-tissueaugmentation for specific indications in urology, urogynecology, colon andrectal, otolaryngology and plastic surgery markets;
     **WHEREAS**, Uroplasty plans to make a Premarket Approval Submission to theFDA for marketing of its Macroplastique*®*Implants within the United States fortreating female SUI;
     **WHEREAS**, CL has developed a tension-free vaginal tape for the treatment offemale SUI, currently being marketed in Europe under the brand name “I-Stop”(the “CL Product”);
     **WHEREAS**, subject to FDA regulatory approvals, Uroplasty desires to marketthe CL Product in the United States and purchase its requirements of the CLProduct from CL, and CL desires to manufacture the CL Product for Uroplasty andmake it the exclusive distributor of the CL Product in the United States;**THEREFORE, IT IS AGREED AS FOLLOWS**:
1. **Exclusive Distributorship and Manufacturing Arrangements**. During the termof this Agreement, CL appoints Uroplasty as CL’s exclusive distributor in theUnited States of the CL Product. In return, Uroplasty agrees during the termof this Agreement to purchase its entire requirements of CL Product componentsfrom CL, as further detailed below.
     To the extent required, CL hereby grants Uroplasty an exclusive right andlicense to make, use and sell the CL Product and to the use of the “I-Stop”tradename and logo, in the United States, during the term of this Agreement.
2. **CL’s Responsibilities**. During the term of this Agreement, CL will:
     (a) **Regulatory Assistance**. Use its best efforts to assist Uroplasty inobtaining and maintaining FDA 510(k) regulatory approval for the marketing ofthe CL Product in the United States, including by sharing (without cost) alltechnical files including but not limited to preclinical testing, design files,clinical, manufacturing, marketing and other data in CL’s possession orotherwise available to it relating to the CL Product and regulatory approvals,and by providing (without cost) sample products for testing;
     (b) **Regulatory Compliance**. Supply Uroplasty with (i) worldwide regulatorystatus changes relative to the CL Product market clearances, (ii) worldwideclinical adverse event experience (including investigational notes) and (iii)assistance as Uroplasty requests to investigate and resolve CL Productcomplaints and/or clinical adverse events.
     (c) **Component Supply**. Supply Uroplasty in a timely manner with its entirerequirements, in bulk and not sterilized, the stainless steel needles with thehandles, the tape and packaging components that are used to assemble the CLProduct, as further detailed below (the “CL Product Components”), all asmanufactured in accordance with ISO 13485 standards and European Directives.
     (d) **Marketing Assistance**. Use its best efforts to assist Uroplasty in themarketing of the CL Product by sharing (without cost) all of CL’s current andfuture marketing materials, including product photographs and graphics, I-Stoptrademark logos and designs, brochures and website designs and information.
3. **Uroplasty’s Responsibilities**. During the term of this Agreement, Uroplastywill:
     (a) **Regulatory Compliance**. Manage all U.S. regulatory affairs, includingby using its best efforts to obtain and maintain FDA 510(k) regulatory approvalfor the marketing of the CL Product in the United States and for the use ofproduct brochures and instructions and by keeping CL apprised of all U.S.clinical adverse events.
     (b) **Product Assembly**. Establish its own manufacturing facility for (oroutsource to a third party) the assembly of the final CL Product using the CLProduct Components and the sterilization, packaging and English labeling of
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the finished CL Product (including the translation of CL’s French languagematerials into English), all in accordance with ISO 13485 standards and FDAgood manufacturing practices; and
     (c) **Marketing**. Use its best efforts to market and sell the CL Product inthe United States at such prices, and on such terms, as Uroplasty shalldetermine in its sole discretion, and aid CL in obtaining a U.S. trademark forthe “I-Stop” product brand.
4. **Product Delivery**. As to CL Product Components for which Uroplasty placesits purchase order, CL shall deliver such CL Product Components (in accordancewith the specifications described on Exhibit A) to Uroplasty, at its offices inMinneapolis Minnesota or at such other location, as Uroplasty shall specify,not later than 60 days after the effective date of the related purchase order.
5. **Product Pricing and Payment**. Exhibit B is a schedule of CL’s pricing inU.S. dollars to Uroplasty for CL Product Components. Uroplasty will pay 30% ofthe purchase price for CL Product Components, in U.S. dollars, at the timeUroplasty places its purchase order. As to products that Uroplasty does notreject for defects, Uroplasty shall pay CL, in U.S. dollars, the remaining 70%balance net 60 days after receipt.
6. **Minimum Purchase Requirements**. Despite the above provisions, Uroplastyagrees during the term of this Agreement to purchase a minimum number of CLProduct Components as described on the attached Exhibit C.
7. **Intellectual Property Matters**. CL represents and warrants that the CLProduct Components, and Uroplasty’s assembly thereof and sale and marketing ofCL Products, do not and will not infringe the patent or other intellectualproperty rights of any third party. CL will indemnify and hold Uroplasty andits officers, directors, employees and agents harmless from any claim relatingthereto, including for all expenses and legal fees and costs.
8. **CL Product Warranty**. CL warrants that the CL Product Components will bemanufactured in accordance with ISO 13485 standards and the European Directiveand free of all defects. At Uroplasty’s option, CL will, at its sole cost andexpense, repair, replace or accept return for credit of any CL ProductComponents that Uroplasty determines not to meet product specifications andthis warranty.
9. **Non-competition by Uroplasty**. In consideration of the exclusivearrangements provided in this Agreement, Uroplasty agrees that, during the termof this Agreement and, if this Agreement expires pursuant to the openingparagraph of Section 11 upon the end of the initial or any successive termhereof, for three years after such expiration, it will not manufacture its own,or market any other party’s, tension-free vaginal tape product for thetreatment of female SUI.
10. **New or Improved CL Products**. As further consideration for this Agreement,if CL develops any improvements or modifications to the CL Product or the CLProduct Components during the term hereof, CL will provide such improvements ormodifications to Uroplasty without additional charge for use under thisAgreement as Uroplasty so determines in its discretion, subject to FDAregulatory approval. In addition, if CL develops any new medical devices orprocedures during the term hereof, it will offer Uroplasty the right of firstrefusal for the exclusive manufacturing, assembly and/or distribution rights asto such devices or procedures in the United States.
11. **Term and Termination**. The initial term of this Agreement runs through sixyears from the date of this Agreement. Uroplasty may renew this Agreement forsuccessive five-year terms upon written notice to CL given not later than sixmonths prior to the end of the initial or any successive term.
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     Despite the foregoing, this Agreement may terminate early as follows:
     (a) by mutual written agreement of the parties;
     (b) by either party upon written notice to the other of a material breachof this Agreement, but only if the other party does not cure the breach within30 days after receipt of such written notice;
     (c) by either party upon written notice to the other if the other party(i) files a bankruptcy or other similar petition relating to its debts (or hasan involuntary petition filed against it that is not dismissed within 30 days),(ii) becomes insolvent or (iii) makes an assignment for the benefit ofcreditors.
Upon any termination, Uroplasty may dispose of all CL Products and CL ProductComponents in its remaining inventory in the normal course of business.
12. **Confidentiality**. Each party agrees to keep confidential all proprietaryand confidential information (written and oral) concerning the other’sbusiness, financial, operational and acquisition plans and projections. Eachagrees to use this information only to further this Agreement. Neither partywill disclose any of this information to any person, firm or entity, except ona need-to-know basis to its respective employees, agents, attorneys andadvisors who agree to maintain the confidentiality of this information.
     A party is not responsible to keep confidential any information that (i)is or becomes public other than as a result of acts by or through such party,(ii) it can demonstrate is already known by such party at the time of theother’s disclosure, (iii) it independently obtains from a third party having noduty of confidentiality to the other, (iv) it independently develops withoutusing confidential information from the other or (v) it must disclose pursuantto applicable laws or court order. CL acknowledges that Uroplasty willdisclose regulatory and other data of CL to the FDA in connection with the510(k) application and that Uroplasty may file this Agreement with the U.S.Securities and Exchange Commission as part of Uroplasty’s periodic filings.
13. **Assignment**. This Agreement is binding upon, and will inure to the benefitof, the parties hereof and their respective permitted successors and assigns.Uroplasty may assign this Agreement to any person, firm or entity that acquiresall or substantially all of Uroplasty’s assets or acquires Uroplasty by stockacquisition or merger.
14. **Dispute Resolution**. All disputes arising out of or in connection with thisAgreement shall be finally settled under the Rules of Arbitration of theInternational Chamber of Commerce. The arbitration shall be before threearbitrators to be nominated by the International Chamber of Commerce. Onearbitrator shall be selected by each party and the third arbitrator (who shallbe the Chairperson) shall be selected by the first two arbitrators. Thearbitration shall be in English and held in Amsterdam, Netherlands (or in suchother place as the parties may agreed). This Agreement will be governed by thelaws of the Netherlands and specifically excludes the United States Conventionon Contracts of International Sales of Goods.
     **IN WITNESS WHEREOF**, the undersigned have hereunto affixed theirsignatures.         **Uroplasty, Inc.**   **CL Medical SAS**         By     By        Its     Its        
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