In this task, you're given a passage that represents a legal contract or clause between multiple parties. Your job is to write questions that ask the basic details corresponding to the legal contracts or clauses. Avoid questions that can be answered correctly without actually understanding the paragraph, and which might have multiple answers. The answer to each question should be unambiguous.

Input: Consider Input: Exhibit 10.6   MediWound Ltd.   and   Challenge Bioproducts Corporation Ltd.            Supply Agreement — As amended on February 28, 2010

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.





  SUPPLY AGREEMENT   This Supply Agreement (Agreement) was made and entered into as of the 11 day of January, 2001 by and between MediWound Ltd., a corporation organized and existing under the laws of Israel (hereinafter referred to as MediWound) and Challenge Bioproducts Corporation Ltd., a corporation organized and existing under the laws of the Republic of China (hereinafter referred to as CBC) and amended by the parties on February 28, 2010 (Amendment Effective Date).   WITNESSETH: THAT   Whereas MediWound and CBC have originally entered into this Agreement on the date stated above (copy of which shall be attached hereto as Exhibit A); and   Whereas, the parties hereto have agreed to amend and add certain terms and conditions to this Agreement as of the Amendment Effective Date, all as set forth and marked herein; and   Whereas, CBC has invented and developed methods, processes and equipment to manufacture, and produce Bromelain SP (as such term is defined below), specially processed for transformation into a Bromelain-based pharmaceutical product derived from pineapple stems, known as Debridase (the Product); and   Whereas, subject to the going into effect of a License Agreement dated September 27, 2000 between MediWound and Mark Klein (respectively, the Klein Agreement and Klein) as amended on June 19, 2007, MediWound shall have an exclusive license under patents and other intellectual property, to develop, use, manufacture, market and sell the Product for burn treatment in humans; and   Whereas, MediWound desires to utilize Bromelain SP in the development and commercialization of the Product and to subsequently purchase Bromelain SP in bulk form to make and have made Product and pharmaceutical preparations thereof; and   Whereas, CBC is willing to supply Bromelain SP to MediWound for such purpose on the terms and conditions set forth hereunder.   NOW THEREFORE IN CONSIDERATION OF THE MUTUAL PROMISES AND COVENANTS SET FORTH HEREIN IT IS HEREBY AGREED AS FOLLOWS:

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   2





  1. Definitions   Terms defined in this Section 1 and elsewhere, parenthetically, in this Agreement, shall have the same meaning throughout this Agreement.   1.1 Affiliate means any firm, person or company which controls, is controlled by or is under common control with a party to this Agreement and for the purpose of this definition the term control means the possession, directly or indirectly of the power to direct or cause the direction of the management and policies of such firm, person or company whether through the ownership of voting securities, by contract or otherwise or the ownership either directly or indirectly of 20% (twenty percent) or more of the voting securities of such firm, person or company.   1.2 Approval means the grant of all necessary governmental and regulatory approvals required for the marketing, distribution and sale of a pharmaceutical product in any particular country, by a Regulatory Authority, and approvals required for pricing and reimbursements (if appropriate).   1.3 Bromelain SP means material derived from pineapple stems, [having the specification as presented in exhibit 1.13] presently manufactured by CBC at the Facility by a special process and used as a raw material in the production of the Product.   1.4 Conditions Precedent means the cumulative conditions listed in Section 2.1.   1.5 Effective Date shall have the meaning ascribed to such term in Section 2.2.   1.6 Facility means CBC's production facility in Tou-Liu City, Yun-Lin Hsien, Taiwan, R.O.C.   1.7 FDA means the Food and Drug Administration of the United States Government or any successor thereto.   1.8 Klein means Mr. Mark C. Klein.   1.9 LR means either or both of L.R. R & D Ltd. and/or Professor Lior Rosenberg.   1.10 Major Country means the USA, and the major European and Asian countries listed in Exhibit 1.10 attached hereto.   1.11 MOU means the Memorandum of Understanding of January 18, 2000 between MediWound (as assignee of Clal Biotechnology Industries Ltd.), Klein and CBC.   1.12 Regulatory Authority means the FDA or similar governmental or other agency in any country having authority to grant Approval.   1.13 Specifications means the specifications for Bromelain SP set forth as Exhibit 1.13 hereto, as the same may be amended with the consent of both parties hereto, it being agreed that no amendment may be made thereto or refused which would

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   3





  render Product incapable of application on humans or the use, supply or sale thereof in breach of any regulations.   1.14 Sub-Contractor means any firm or company whose services are retained by MediWound to transform Bromelain SP into Product and to package, label and deliver pharmaceutical preparations of the Product in finished form to MediWound and its sub- licensees. All references to MediWound under Sections 3.1, 5, 6 and 7.1 shall be construed as being inclusive of Sub- Contractors, unless the context dictates otherwise.   1.15 Technical Information means that information in use at the Facility during the term of this Agreement, relating to the manufacture of Bromelain SP meeting the Specifications, in bulk, as more comprehensively described in Section 1.15 of the TT Agreement.   1.16 TT Agreement means the Technology Transfer Agreement dated January 11, 2001 between the parties hereto, whereby CBC undertakes to transfer the Technical Information to MediWound.   2. Conditions Precedent   2.1 Conditions Precedent to the provisions of this Agreement becoming effective shall be all of the following:   2.1.1 Execution of a License Agreement between MediWound and LR whereby MediWound shall license certain Product-related know-how from LR; and   2.1.2 Execution of the TT Agreement.   2.2 The date upon which MediWound shall have acknowledged in writing to CBC that the Conditions Precedent have all been met shall be the Effective Date. Where the Conditions Precedent have not been met by January 31, 2001, for any reason whatsoever, then this Agreement and the MOU shall be deemed terminated as of that date with no further liability of either party, except for the obligation of confidentiality, as set forth in the MOU.   3. Grant of Rights   3.1 As from and subject to the Effective Date, and subject to the terms and conditions of this Agreement, CBC shall supply Bromelain SP to MediWound and MediWound shall acquire Bromelain SP from CBC, for transformation into the Product.   3.2 MediWound's rights as per Section 3.1 will be exclusive in the sense that CBC shall not nor shall permit any Affiliate or third party to manufacture, use, supply

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   4





  or sell Bromelain SP for utilization as an ingredient of any product which directly or indirectly competes with the Product.   4. Financial Provisions   4.1 In consideration for CBC's undertaking to supply Bromelain SP to MediWound and other obligations of CBC pursuant to this Agreement, MediWound has paid to CBC US$ [***] (US Dollars [***]) within 3 (three) business days of the Effective Date.   4.2 Payments for supply of Bromelain SP by CBC to MediWound as of the Amendment Effective Date shall be made in accordance with the following provisions:   4.2.1 The price of [***] Kg of an accepted batch of Bromelain SP (by MediWound pursuant to Section 6.4) shall be in accordance with the price per annual quantity table in Exhibit 4.2 attached hereto. The price used for invoicing during the year shall be based on the quantity in the Annual Forecast. At the end of each year the parties shall recalculate the amounts to be paid pursuant to the actual quantities purchased throughout the passing year and adjust the payments accordingly (for example: if the actual quantity purchased during the past year was higher than the Annual Forecast and such higher quantity should have been invoiced as per a lower price per Kg of Bromelain SP in accordance with price per annual quantity table in Exhibit 4.2, CBC shall recalculate the invoices for the past year as per the actual price that should have been invoiced and credit MediWound for the balance within [***] days accordingly. If the actual quantity purchased during the past year was lower than the Annual Forecast and such lower quantity should have been invoiced as per a higher price per Kg of Bromelain SP in accordance with price per annual quantity table in Exhibit 4.2, CBC shall recalculate the invoices for the past year as per the actual price that should have been invoiced and invoice MediWound for the balance within [***] days accordingly).   4.2.2 CBC may increase the prices only pursuant to an increase in its cost of manufacturing of the Bromelain SP. Any such increase shall be subject to MediWound's pre-approval, and no increase shall be executed more often than once every [***] months and any changes thereto shall be in-line with current market prices for Bromelain manufacturing except that (i) there is a change of cost of manufacturing of Bromelain SP due to a change requested by regulatory agency and confirmed by MediWound; and (ii) the Taiwan official Wholesale Price Index varies over [***]% within [***] months. When such exceptional situations arise, an increase

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   5





  of price shall be considered by MediWound at CBC's written request without the limit of no more often than once every [***] months.   4.2.3 MediWound shall make payment for each Bromelain SP batch that was supplied by CBC on a [***] days basis as of the date of delivery of the applicable batch at MediWound, provided that MediWound has provided CBC with an Acceptance Batch Notice for such purchased batch pursuant to Section 6.4. Payment for each purchase batch shall be effected by MediWound by swift to a bank account designated by CBC, or by other requested method as agreed between the parties. MediWound shall make down payment of USD[***]/kg for the [***]% of the amount of Annual Forecast before Dec.31 of the respective year for the insurance of components and materials and maintenance of manufacture and supply capacity of the requested [***]% of the next calendar year's Annual Forecast. The down payment will be then deducted respectively as every shipment is made to MediWound and listed in CBC's Invoice to MediWound.   4.2.4 Payment shall be made directly to CBC for payment for each order of Bromelain SP or, at CBC's written request, to Golden Life International Co., Ltd. on CBC's behalf, for payments other than any order of Bromelain SP (Payee); provided however, that any such payment to the Payee shall be considered as valid payment to CBC (as if made directly to CBC) in accordance with this Agreement, and that so long as such payment is made in accordance with CBC's said request, CBC shall have no claims or demands against MediWound for non-payment or in any other respect whatsoever in this regard. CBC solely shall be responsible to ensure that payment by MediWound to the Payee pursuant to CBC's request does not violate any applicable laws and regulations. Any tax implications due to payment to the Payee in accordance with CBC's request shall be borne by CBC. For avoidance of doubt, it is clarified that the Payee shall not be considered as a third party beneficiary under this Agreement and shall not have any rights to enforce payment or any other rights of CBC under this Agreement.   4.2.5 Invoices shall only be issued upon delivery of the Bromelain SP batch which shall take place only after CBC's quality control department has completed its testing and authorized delivery to MediWound, and MediWound's quality control department has provided CBC with an Acceptance Sample Notice for that batch and that the batch itself can be delivered.

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   6





  4.2.6 The consideration to be paid pursuant to this Agreement is final and inclusive of all taxes and/or duties, of whatsoever nature. If applicable laws require the withholding of taxes, MediWound will deduct the taxes from the related payment otherwise due to CBC, and such taxes shall be paid to the proper taxing authority. For avoidance of doubt, payments will be made only after receiving exemption from tax deduction approval from the tax authority in Israel. Delay in payment as a result of not receiving such exemption will not constitute late payment or breach hereunder.   5. Manufacture of Bromelain SP   5.1 Without derogating from CBC's representations and warranties herein, CBC and MediWound shall work together in order to enable the CBC facility to accomplish all required standards, related to the manufacturing, packaging and delivering of Bromelain SP in accordance with the Specifications, GACP (Good Agricultural and Collection Practice) and cGMP (Current Good Manufacturing Practice) standards, ISO 22000 and all other applicable laws and regulations. For such purpose, and without derogating from other terms herein, CBC shall permit MediWound, and/or a consultant on MediWound's behalf, to access and inspect the CBC facility and advise MediWound and/or CBC on such actions to be taken for accomplishing such compliance. Such mutual regulatory preparations shall begin no later than the finalization of MediWound's current phase III clinical trial.   CBC warrants and represents that all Bromelain SP shall be manufactured and supplied in compliance with the Specifications, quality control methods and test methods, all applicable SOP's and all applicable laws, and in accordance with GACP, cGMP, including the relevant guidelines, policies, codes, requirements, regulations, approvals and/or standards from time to time promulgated or issued by any relevant governmental and/or regulatory authority which relate to the manufacture of the Bromelain SP to be used for the production of a pharmaceutical agent as the Product.   CBC warrants further that CBC has, and will for the duration of this Agreement retain, all applicable regulatory approvals required for the carrying out of its obligations hereunder, including without limitation the manufacturing, packaging and supply of the Bromelain SP.   5.2 All manufacturing, packaging and labeling activities done at CBC will be performed according to the pre-approved batch records. If CBC wishes to make changes to the Specifications, the production and/or packaging batch records, the SOPs related to the Bromelain SP, or the design of the manufacturing process or any other change during production which would effect the quality of the

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   7





  Bromelain SP or of the Product and/or otherwise would effect the Bromelain SP in any way or which might effect the regulatory approvals of the Product, then CBC shall (i) notify MediWound in writing at least 6 months in advance regarding such proposed changes, and (ii) represent that such change will not adversely effect the quality of the Bromelain SP or of the Product in any way, and (iii) not make such changes without MediWound's prior written approval, and (iv) will assure that such change will not delay or in any way effect any open orders for Bromelain SP.   5.3 MediWound shall participate and support the upgrade of the Facility and the generation of documentation for submission to the relevant Regulatory Authorities, all as may be determined to be necessary and appropriate, by independent regulatory consultants, designated by mutual consent. Such participation and support shall be in the form of an investment made by MediWound in the CBC facility, not to exceed $[***] (US Dollars [***]).   5.4 CBC undertakes to keep all records reasonably required by MediWound relating to the manufacture, quality control and testing of Bromelain SP. Such records shall include, but not be limited to, all records required by applicable laws and regulations, of the territories in which the Product is marketed and sold. MediWound (itself or through anyone on its behalf) or any relevant regulatory authority shall have the right to audit any such records and/or the relevant facilities of CBC (or any facilities of any CBC third party or subcontractor involved in the manufacture, quality control and/or supply of the Bromelain SP) with reasonable prior notice, during regular business hours, including the right to ask CBC to provide any relevant documents. CBC shall inform MediWound of any announced regulatory inspections that directly involve the Bromelain SP or the Product within 48 hours of the notification to CBC of such an inspection.   5.5 During the term of this Agreement, CBC shall make available to MediWound any and all information and data which it generates or which comes into its possession relating to any improvements in the manufacture and supply of the Bromelain SP. CBC shall, throughout the term of this Agreement, assist MediWound in all respects with regard to regulatory submission including but not limited to providing any information, data or documents in its possession. If any regulatory agency requests any changes to the Specifications or the manufacturing process, (including but not limited to any changes as a result of an audit performed) CBC shall (i) inform MediWound in advance and in writing of the changes needed to be made, and (ii) promptly advise MediWound as to any lead-time changes or other terms which may result therefrom, and (iii) make such changes, in coordination with MediWound as soon as possible.

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   8





  5.6 Sampling and Testing Procedures   5.6.1 The sampling procedures of incoming raw materials, packaging materials, in process control and released Bromelain SP shall be agreed between CBC and MediWound and conducted by CBC as per CBC's signed SOP as approved by MediWound.   5.6.2 MediWound and CBC will jointly agree and update from time to time as applicable the incoming raw materials, in-process and release testing methods applicable to the Bromelain SP.   5.6.3 CBC will test each batch of Bromelain SP for conformance with the batch Specifications, and for each batch of the Bromelain SP supplied by CBC, CBC will provide a certificate of analysis signed and dated by the responsible person at CBC, who has released the batch.   5.6.4 For each batch provided, CBC shall provide to MediWound a copy of the batch production and packaging execution records and shall retain such original records for one (1) year beyond the shelf-life of the Bromelain SP unless required by MediWound or under applicable laws and regulations to maintain the records for a longer period of time.   5.7 Quality Assurance — Investigations   5.7.1 Any deviation from the production process during the manufacture thereof shall be explained and documented in batch records. Any deviation that may impact on the safety/quality of the Bromelain SP or the Products and on other related issues will be investigated by CBC, and communicated to MediWound within 48 hours from the time of discovery. Following the investigation, the relevant corrective actions shall be taken and implemented.   5.7.2 CBC shall perform an out-of-specifications investigation in respect of batches that do not meet the batch Specifications.   5.7.3 Each investigation shall be reviewed by a CBC designated quality representative, and will follow the procedures recommended by regulatory agencies and as set out in relevant CBC SOP's. All completed investigation reports and other written documentation relating to all investigations shall be provided to MediWound and shall be included in the applicable released and executed batch records. Any corrective actions shall be discussed and agreed by the parties before being executed by CBC.

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   9





  5.8 Quality Complaints; Recall   5.8.1 MediWound and CBC shall notify each other immediately by an e-mail, of any information concerning the quality and/or malfunction of the Bromelain SP. The parties will investigate all complaints, and shall respond in accordance with mutually agreed SOP's. Both parties shall comply with requirements of all regulatory authorities in dealing with complaints. MediWound shall have the right to determine whether any adverse event should be reported to any applicable regulatory authority. All quality assurance and/or quality complaints shall be handled in accordance with this section above.   5.8.2 In the event that CBC has any reason to believe that the Bromelain SP or one or more Products should be recalled or withdrawn from distribution, CBC shall immediately notify MediWound in writing. In such event MediWound shall, at MediWound's sole discretion, determine whether to recall or withdraw the Product from the market.   5.8.3 If a recall of the Product is due to CBC or the Bromelain SP, then the recall shall be conducted by MediWound at CBC's expense, and CBC shall replace such Bromelain SP at no charge to MediWound or shall provide MediWound with a credit or refund of same, at MediWound's election.   5.9 Storage   CBC shall store, in accordance with the applicable CBC SOP, free of charge, Bromelain SP batches at its premises in appropriate storage conditions, for up to ninety (90) days from the day of the Acceptance Sample Notice for the respective batch or longer if CBC was unable to deliver such batch to MediWound earlier following the Acceptance Sample Notice. The Bromelain SP shelf life and designated packaging shall be in accordance with CBC SOP and subject to the supportive results of a proper stability study.   5.10 Retention of Samples   CBC shall retain samples of Bromelain SP stored at their original package from each batch for the duration of the Products' shelf- life and for a period of one (1) additional year thereafter, in quantities sufficient to enable the performance of two (2) CBC's full release tests in accordance with the CBC's release specifications and release methods.   6. Supply of Bromelain SP   6.1 MediWound undertakes to purchase, and CBC undertakes to furnish, supply and deliver Bromelain SP to MediWound, in bulk, on the terms and conditions hereinafter set forth.

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   10

  6.2 MediWound shall furnish CBC with a non-binding forecast of its anticipated annual requirements of Bromeline SP by no later than November 1 of each year (Annual Forecast), for the next calendar year. Notwithstanding the foregoing, the first forecast for the calendar year that commenced on January 1, 2001, was furnished by MediWound to CBC by March 15, 2001. MediWound undertakes to order at least [***]% of the Annual Forecast per each year.   CBC shall maintain, at all times, manufacture and supply capacity of at least [***]% of the Annual Forecast and shall maintain, in coordination with MediWound, inventory of Bromelain SP at its premises of (i) at least [***]% of the applicable Annual Forecast; and (ii) all Bromelain SP components and materials (the BSP Components and Materials) needed for the manufacture and supply of the Bromelain SP such that CBC can guarantee continuous supply of the Bromelain SP in accordance with MediWound's complete Annual Forecasts. In addition, the inventory of the BSP Components and Materials shall not be less than needed to manufacture [***] months stock of Bromelain SP (compared to the open purchase orders and the applicable Annual Forecast) or longer (respectively) for BSP Components and Materials having a lead time of more than [***] months. CBC shall provide MediWound with quarterly inventory and production reports for Bromelain SP and BSP Components and Materials.   Purchase orders issued by MediWound to CBC for quantities within the [***]% of the Annual Forecast shall be binding upon CBC and shall be deemed accepted upon delivery of the purchase order to CBC. Such purchase orders shall be supplied on the date specified in the applicable purchase order provided that the lead time in any purchase order shall be at least [***] days as of the purchase order's date.   Purchase orders issued by MediWound to CBC during a certain year for quantities exceeding [***]% of the applicable Annual Forecast shall be binding upon CBC, except that with respect to any amounts exceeding [***]% of the applicable Annual Forecast, CBC's obligation to provide such exceeding quantities shall be based on best efforts and CBC shall have an extended lead time for delivery as shall be agreed upon by the parties on a case by case basis. CBC shall confirm in writing, within 5 days of its acceptance of such exceeding purchase order, and shall state the anticipated delivery date for the exceeding amounts.   Without derogating from CBC's obligations under this Agreement, in the event that CBC is unable to supply all the Bromelain SP covered under any purchase order on the dates specified in the applicable supply plans, CBC shall promptly notify MediWound in writing in a separate notice to MediWound of such delay or noncompliance. In such event, and without prejudice to any other





remedies

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   11





  available to MediWound, CBC shall use its best efforts to fully comply with the purchase order as soon as possible.   6.3 CBC shall be responsible to prepare the shipment of Bromelain SP in accordance with a shipment SOP. Such shipment SOP shall comply with the regulatory requirements as well as specify the documents that should accompany any shipment (i.e. pro forma invoice, value for customs, specific declaration, and specific requirement for investigational products). CBC shall provide MediWound with copies of documents and reports with respect to each shipment of Bromelain SP, for quality assurance, quality control and regulatory purposes.   6.4 Prior to delivery of each batch of Bromelain SP, CBC shall submit a batch sample to MediWound for inspection and approval. MediWound shall have the right, for a period of [***] days following receipt, to reject any Bromelain SP sample which:   6.4.1 fails to comply with MediWound's purchase order; or   6.4.2 fails to comply with the sample incoming inspection Specifications.   Within the said [***] days, MediWound shall notify CBC of either: (i) its approval and acceptance of such batch sample (Acceptance Sample Notice); or (ii) its rejection of the batch sample in which case MediWound shall detail the reason(s) for the rejection of any such Bromelain SP sample. In the event of rejection by MediWound, CBC shall deliver complying Bromelain SP sample to MediWound within [***] days of rejection, free of cost (including transportation, duty, handling and insurance costs). For clarification purposes, MediWound's Acceptance Sample Notice in accordance with this section above shall in no event derogate from CBC's responsibilities hereunder.   After CBC receives MediWound's Acceptance Sample Notice, CBC shall deliver the corresponding batch to MediWound for inspection and approval. MediWound shall have the right, for a period of [***] days following receipt, to reject any Bromelain SP batch which:   6.4.3 fails to comply with MediWound's purchase order; or   6.4.4 fails to comply with the batch incoming inspection Specifications.   Within the said [***] days, MediWound shall notify CBC of either: (i) its approval and acceptance of such batch (Acceptance Batch Notice); or (ii) its rejection of the batch in which case MediWound shall detail the reason(s) for the rejection of any such Bromelain SP batch. In the event of rejection by MediWound, at CBC's request and expense, MediWound shall return any such Bromelain SP batch to CBC and CBC shall deliver complying Bromelain SP

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   12





  batch to MediWound within [***] days of rejection, free of cost (including transportation, duty, handling and insurance costs). For clarification purposes, MediWound's Acceptance Batch Notice in accordance with this section above shall in no event derogate from CBC's responsibilities hereunder.   6.5 If there is a dispute between the parties as to whether any Bromelain SP sample or batch complies with the sample or batch Specifications respectively and/or with the quality requirements set forth herein and/or under the law, then, without derogating from MediWound's remedies under this Agreement or at law, such dispute shall be resolved by mutual investigation of the parties which shall be conducted in good faith. If the parties are still unable to resolve such dispute, an independent, mutually agreed third party shall be retained as a consultant to review batch records and related documentation. Such consultant's determination in respect of the conformity of a sample or batch shall be binding upon the parties. The non-prevailing party shall bear the costs of consultant's services as well as for the production of the batch and corrective actions. If appropriate, pursuant to such investigation and/or consultant's determination, CBC shall replace the non-complying Bromelain SP within 30 (thirty) days thereafter, free of cost (including transportation, duty, handling and insurance costs).   6.6 CBC, at its own cost, shall obtain and shall cause to remain in effect, such licenses, permits, approval and consents as may be required for its performance hereunder, including, without limitation, export of Bromelain SP from the Republic of China.   7. Liability and Indemnity   7.1 CBC shall defend and assume responsibility for any suit, claim or other action by a third party alleging that MediWound's use of Bromelain SP infringes any patents or other rights of such third party.   7.2 MediWound shall be solely responsible for the commercialization of the Product, e.g. the completion of development, final formulation, the conduct of clinical trials (as necessary), labeling and packaging, as well as the due preparation and submission of all documentation required for the prosecution of registration and Approval of the Product in each of the countries in the Territory. MediWound shall assume all liabilities arising from the development, commercialization, use, offer for sale, sale or supply by, through or on behalf of MediWound or its Affiliates, of the Product (and related materials).   7A. Insurance   In order to provide insurance coverage for CBC responsibilities, obligations and undertakings as set out under this Agreement and/or as required under any law with

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   13





  respect to the manufacturing of Bromelain SP, CBC undertakes, at its sole cost and expense, to take out and maintain an All risk insurance against loss of and destruction or damage to the Facility (including fire, theft and vandalism, etc.), third party liability insurance, product liability insurance for the Bromelain SP and employers liability insurance.   Without prejudice to the above, CBC shall maintain, or shall cause to be maintained with respect to itself and each of its Affiliates, such types and levels of insurance (including, without limitation, third party and product liability insurance), as are customary in the pharmaceutical or manufacturing industry to provide coverage for their activities contemplated hereby. Upon request of MediWound, CBC shall keep MediWound informed of the general parameters of its liability insurance program and any proposed substantive changes therein. Upon request, CBC shall furnish MediWound certification of insurance (and/or true copies of policies) showing the above coverage, signed by an authorized agent of the insurance company, certifying that liability assumed under this Agreement is fully insured without exception, and providing for at least thirty (30) days prior written notice.   7B. Limitation of Consequential Damages   EXCEPT FOR BREACH OF CONFIDENTIALITY OBLIGATION HEREUNDER, AND TO THE EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION LOSS OF USE, DATA OR LOST PROFITS, EVEN IF IT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, WHETHER UNDER THIS AGREEMENT, IN TORT OR OTHERWISE.   8. Confidentiality   8.1 CBC and MediWound undertake to each other to keep, and shall procure that their respective Affiliates, employees, directors, officers, consultants and contractors (including those of any Affiliate) shall keep, confidential all information received from each other during or in anticipation of this Agreement however obtained and in whatever form (the Confidential Information). For clarification purposes, any information, materials and know-how related to the Product and/or provided by MediWound in connection with this Agreement including any related intellectual property rights, shall be owned solely by MediWound and shall constitute MediWound's Confidential Information which may be used by CBC solely for the purpose of manufacturing and supply of Bromelain SP to MediWound. Confidential Information shall not include the following:

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   14





  8.1.1 information which at the time of disclosure by one party to the other is in the public domain;   8.1.2 information which after disclosure by one party to the other becomes part of the public domain by publication except by breach of this Agreement;   8.1.3 information which the receiving party can establish by competent proof was already in its possession at the time of its receipt and was not acquired directly or indirectly from the other party; and   8.1.4 information received from third parties who were lawfully entitled to disclose such information.   8.2 Any Confidential Information received from the other party shall not be disclosed or used for any purpose other than as provided or anticipated under this Agreement.   8.3 The confidentiality and non-use obligations contained in this Agreement shall continue for the duration of this Agreement and for a period of 5 (five) years after termination or expiry of this Agreement, provided however that any Confidential Information with respect to the Product, including without limiting, such information with respect to intellectual property rights in connection with and/or related to the Products shall remain confidential in perpetuity.   8.4 The provisions of this Section 8 shall in no event prevent MediWound from disclosing any Technical Information to Regulatory Authorities or other governmental agencies in support of any application for regulatory approvals of the Product or any amendments thereof or in general whenever required to disclose such information under any applicable law or regulation. MediWound shall make reasonable efforts to notify CBC of its intention and the identity of the intended recipient as soon as reasonably practicable and if possible, prior to the date of disclosure.   9. Duration   This Agreement shall come into force on the Effective Date and the amendments herein shall be in effect as of the Amendment Effective Date. This Agreement as amended shall continue in force until terminated in accordance with the provisions of Section 10.   10. Termination   10.1 MediWound may terminate this Agreement at any time, by 6 (six) months prior notice in writing.

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   15





  10.2 CBC may terminate this Agreement by no less than 24 (twenty four) months notice given in writing by CBC to MediWound, or such greater period as may be reasonable for MediWound to establish an alternative source of manufacture of Bromelain SP and/or to acquire sufficient inventory of Bromelain SP for a 24 (twenty four) months period.   10.3 In the event of any breach of this Agreement at any time, if the breach complained of shall not be corrected by the breaching party within 90 (ninety) days of the other party's notice, either party hereto may, at its option:   10.3.1 by giving 90 (ninety) days written notice, specifying the breach complained of, terminate this Agreement, and the party asserted to be in breach shall have the right to treat the alleged breach as a dispute under Section 15; or   10.3.2 regard the breach and any failure to cure as the basis for a dispute and proceed to dispute resolution under Section 15 and such legal or equitable remedy as shall be applicable.   11. Effects of Termination   11.1 Upon termination of this Agreement, the parties shall abide by and uphold any and all rights or obligations accrued or existing as of the termination date, including, without limitation with respect to outstanding orders for Bromelain SP placed hereunder.   11.2 Any rights or remedies of either party arising from any breach of this Agreement shall continue to be enforceable after termination of this Agreement, unless previously waived in writing.   12. Assignment   12.1 Subject to Section 12.2, neither party shall assign its rights or obligations hereunder, in whole or in part, except with the prior written consent of the other party, except to a party acquiring all of the business of the assigning party to which this Agreement relates. Prior to any such permitted assignment the party wishing to effect the transaction shall procure that the third party concerned covenants directly with the other party to this Agreement to comply with the provisions of this Agreement, which shall be binding on it as the successor and assign of such party.   12.2 MediWound may assign all of its rights and obligations under this Agreement or perform some or all of its obligations under this Agreement through its Affiliates and Sub-Contractors, provided that MediWound shall remain solely responsible for and be guarantor of the performance by its Affiliates and Sub-Contractors and

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   16





  procure that its Affiliates and Sub-Contractors comply fully with the provision of this Agreement in connection with such performance.   13. Miscellaneous   13.1 Failure or delay by either party in exercising or enforcing any right or remedy under this Agreement in whole or in part shall not be deemed a waiver thereof or prevent the subsequent exercise of that or any other rights or remedy.   13.2 CBC and its employees and MediWound and its employees shall at all times be considered as independent contractors of each other, and at no time or under any circumstances shall they be considered employees, representatives, partners or agents of each other.   13.3 This Agreement shall constitute the entire agreement and understanding of the parties relating to the subject matter of this Agreement and supersede all prior oral or written agreements, understandings or arrangements between them relating to such subject, except for the TT Agreement. The MOU shall be deemed so superseded by this Agreement only upon the Effective Date.   13.4 Other than as explicitly amended and marked herein, all applicable terms and conditions of the Agreement as originally executed by the parties shall remain without change and shall continue to be binding and in full force and effect. No change or addition may be made to this Agreement except in writing signed by the duly authorized representatives of both parties.   13.5 The provisions intended by their nature to survive the termination or expiration of this Agreement shall so survive including without limiting Sections 1, 3.2, 5.1, 5.2, 5.4, 5.8, 5.10, 7, 7A, 7B, 8, 11, 13 (as amended), 14 and 15.   Without derogating from the foregoing, it is clarified that the restriction with respect to MediWound's intellectual property and CBC's obligations under the TT Agreement as well as MediWound's exclusive rights under this Agreement (as amended) shall continue to apply and survive the termination or expiration of the Agreement.   14. Notices   14.1 Any notice or other document given under this Agreement shall be in writing in the English language and shall be given by hand or sent by prepaid airmail, by facsimile transmission or electronic mail to the address of the receiving party as set out below unless a different address, facsimile number or e-mail address has been notified to the other in writing for this purpose.   14.2 MediWound's address for service of notices and other documents shall be:-

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   17





  MediWound Ltd. 42 Hayarkon St., 81227 Yavne Israel Tel: +972 8 932 4010 Fax: +972 8 932 4011 E-Mail: [***]   14.3 CBC's address for service of notices and other documents shall be:-   Challenge Bioproducts Corporation, Ltd. 17 Tou-Kong 12 Rd., Tou-Liu City, Yun-Lin Hsien, Taiwan, R.O.C., (CBC) Facsimile: +55-5572-045 E-Mail: [***]   15. Governing Law and Disputes   15.1 This Agreement is made under and subject to the provision of the substantive laws of the State of New York, without giving effect to its conflict of law rules.   15.2 Any disputes relating to this Agreement of whatever nature that cannot be resolved by negotiation between the parties shall be referred for final resolution to arbitration in New York City by 3 (three) Arbitrators under the Rules of the American Arbitration Association. The arbitration proceedings shall be conducted in English. The decision of the arbitrators shall be final and binding upon the parties and their legal successors. The arbitrators may at their discretion, provide for discovery by the parties not to exceed 4 (four) months from the date of notice of arbitration and the arbitrators shall notify the parties of their decision in writing within 30 (thirty) days of the completion of the final hearing. The arbitrators may at their discretion award costs and expenses in respect of the arbitration.   15.3 The parties submit to the exclusive jurisdiction of the courts of the State of New York.

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   18

  IN WITNESS WHEREOF, the parties, each by its duly authorized signatory, have caused this Agreement to be executed as of the date first above- mentioned.

  /s/ Gal Cohen



  /s/ Ching-Kuan Lin

  MediWound Ltd.



  Challenge Bioproducts Corporation Ltd.

  By:   Gal Cohen



  By: Ching-Kuan Lin

  Its:   Chief Executive Officer



  Its: President



  MediWound Ltd.



  Challenge Bioproducts Co., Ltd.

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   19





  List of Exhibits   Exhibit 1.13 - Current Bromelain SP Specifications   Exhibit 4.2 - Price list per annual quantity   Exhibit A - a copy of this Supply Agreement as originally signed on 11/1/2001

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   20





  Exhibit 1.13 — Current Bromelain SP Specifications   [***]

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.





  Exhibit 4.2 — Price list per annual quantity



MediWound Ltd. 42 Hayarkon Street, Yavne, Israel Tel: 972-8-9324010 www.mediwound.com





  Supply Agreement as amended on Feb 28  2010.   Exhibit 4.2 — Price list per annual quantity   The price of [***]Kg of released BSP below an annual ordered quantity of [***] Kg shall be USD[***]/Kg [***].   The price of [***]Kg of released BSP above an annual ordered quantity of [***] Kg shall be between USD[***]/Kg [***], as jointly agreed and set between CBC and MW, once the forecasted annual ordered quantity exceeds [***] Kg of released BSP.   Challenge Bioproducts Corporation Ltd:                 Date: 2011.10.12





            Signature:   /s/ Ching-Kuan Lin





                MediWound Ltd.





            Date:







            Signature:   /s/ Gal Cohen





  Chief Executive Officer





  MediWound, Ltd.







*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.

th





  Exhibit A - a copy of this Supply Agreement as originally signed on 11/1/2001   [Omitted: Agreement no longer in effect]

*** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.   1

Output: Highlight the parts (if any) of this contract related to Insurance that should be reviewed by a lawyer. Details: Is there a requirement for insurance that must be maintained by one party for the benefit of the counterparty?


Input: Consider Input: EXHIBIT 10.8

DISTRIBUTOR AGREEMENT         Tripath Technology, Inc. 3900 Freedom Circle Suite # 200 Santa Clara, CA 95054 Tel: (408) 567-3000 Fax: (408) 567-3003

This Agreement is effective 7/1/98 (Effective Date) between Tripath Technology, Inc. (Tripath), and

Uniquest Corporation 780 Montague Expressway Suite 406 Santa Jose, CA 95131

Tripath and Distributor intend to establish Distributor as a non-exclusive Distributor for Tripath products in the following designated Territory, subject to the terms and conditions of this Agreement.

Korea

1. Products

1.1 Products means the Tripath semiconductor products identified by Tripath in writing from time to time.

1.2 Tripath may discontinue manufacture or sale, or otherwise treat as obsolete, any or all of the Products covered by this Agreement upon thirty days written notice.

2. Appointment and Term

2.1 For the term of this Agreement, Tripath appoints Distributor as a non-exclusive distributor for the Products in the Territory, subject to Tripath's direct sales activities under Section 4.

2.2 Distributor will use best efforts to develop the local market and promote the sales of Products within the Territory. Distributor will not sell outside the Territory without Tripath's prior written permission, which will not be unreasonably withheld.

2.3 After one month's written notice, Tripath may in its discretion amend (i) the Products, and/or (ii) the Territory.

2.4 Tripath reserves the right to appoint other distributors in or out of the Territory who may sell into the Territory.

2.5 Distributor's appointment is for a term of one year from the Effective Date, renewable automatically unless terminated under Section 18

3. Distributor Responsibilities

3.1 Distributor will maintain an adequately trained sales organization, capable of fulfilling its obligation under Subsection 2.2.

3.2 Tripath will furnish technical and marketing information (such as sales aids and







Distributor Agreement

literature, data sheets, application notes, etc.) for the Products, and Distributor will maintain an organized and well stocked collection of such technical and marketing information for distribution to prospective customers.

3.3 Distributor will employ sufficient trained personnel (Application Engineers) to provide technical and marketing support for Tripath's Products. Distributor and Tripath will cooperate to ensure that the Application Engineers are and remain adequately trained and qualified.

3.4 Distributor will maintain a reasonable number of Demonstration Products (customer samples), with appropriate technical and marketing literature, available for demonstration by knowledgeable Distributor personnel, provided that Distributor must obtain prior approval by Tripath before any customer receives demonstration Products (customer samples).

3.5 Distributor has no authorization to make, and will not make, any guarantee or warranty with respect to any Product — all Product warranties are to be communicated to Customers directly by Tripath in writing. Distributor will make no representations as to quality, performance, capabilities, and the like except as are expressly authorized in writing by Tripath (such as in Tripath's standard, published specifications for a Product).

4. Other Product Lines

4.1 In appointing Distributor, Tripath is relying to a significant extent on Distributor's undertaking in Subsection 2.2.

4.2 Distributor will not carry any competitive products without Tripath's consent, which shall not be unreasonable.

5. Tripath Direct Sales Activity

5.1 Tripath may in its sole discretion, immediately upon written notice to Distributor, make direct sales to certain accounts in the Territory (Direct Sales Accounts), including accounts to which Distributor has made sales.

6. Pricing, credits, and allowances

6.1 Prices for Products will be as set forth in the then effective distributor price list (Distributor Price List) which will be furnished to Distributor from time to time. Any suggested resale prices shown in the Distributor Price List are to be considered as guidelines only.

6.2 The Distributor Price List may be changed without prior notice, and will be effective as of the effective date indicated. The amount and timing of such change will be exclusively at Tripath's discretion.

6.3 Orders for Products received and acknowledged by Tripath prior to a change in the Price List but shipped after the effective date of such change will be invoiced as follows: (a) in the case of a price decrease, the existing order backlog will be invoiced at the lower price, and (b) in the case of a price increase, the existing order backlog due for delivery within one month of the effective date of such change will be invoiced at the lower price. Outstanding written quotations will be held good for the same two-month period.

6.4 Distributor's inventory of any Product will be price protected for reductions in the price of such Product as follows: the lesser of Distributor's (a) entire inventory of the Product, or (b) previous one month's shipments of the Product from Tripath.

7. Purchase Orders and Payment

7.1 Distributor will maintain sufficient inventory of Products (but not less than one month's inventory without Tripath's approval) to provide prompt delivery to Distributor's customers, in furtherance of Distributor's undertaking in Subsection 2.2.

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Distributor Agreement

7.2 Distributor will purchase Products for resale to its customers in accordance with Tripath's then effective terms and conditions of sale set forth in the Tripath sales order acknowledgment (Sales Order Acknowledgment), and the pricing terms of the then effective Distributor Price List (including minimum order quantities). The terms and conditions of sale in the Sales Order Acknowledgment may be changed without prior notice, exclusively at Tripath's discretion.

7.3 No purchase order from Distributor is binding on Tripath until Tripath issues a Sales Order Acknowledgment to Distributor for such order, or makes a shipment against such order. Tripath will use commercially reasonable efforts to acknowledge Distributor purchase orders promptly.

7.4 Tripath will invoice Distributor for Products when Tripath ships such Products.

7.5 All credits will be handled as separate financial transactions from the original invoice, and will be evidenced by a written credit request submitted to Tripath. Distributor will not reduce any payment to Tripath to account for anticipated or unauthorized credits (except for short shipments and non-receipt of Products), either at the time of the payment of original invoice, or at the time of providing a credit request. Credit requests should be submitted by Distributor within one month after the date of Distributor's invoice for the related transactions.

7.6 Any credit request will be based on the price shown on the then current Distributor Price List, or the actual net price paid by Distributor for the Product, whichever is lower.

7.7 If Tripath notifies Distributor of any discrepancy in a credit request, Distributor has one month to resolve the discrepancy and pay the amount of the discrepancy.

7.8 No purchase orders for which a Sales Order Acknowledgment has been issued may be canceled or rescheduled within one month of the scheduled shipment date without Tripath's approval.

8. Special Pricing and Other Allowances

8.1 The provisions of this Section 8 will be applicable only to transactions on DPA (distributor price authorization) basis in which Distributor first obtains a DPA confirmation from Tripath.

8.2 Requests for special pricing and/or allowances will be submitted by Distributor to the appropriate Tripath sales office, and must be first approved in writing by that office.

8.3 Quotes for special pricing are good for one month, and must be backed by a Tripath quote number. Distributor will supply supporting documentation showing Products listed by part number, date of transaction, end customer name and address, and the appropriate special pricing details, not later than two weeks after shipment to the associated customer.

8.4 If Tripath has granted Distributor special pricing on a sale in which Distributor's customer has later returned the Product to Distributor, Distributor will reimburse Tripath for the amount of the DPA allowance within one month after such return.

8.5 Any debit memo submitted by Distributor for a DPA allowance will be based on the price shown on the then current Distributor Price List, or the actual net price paid by Distributor for the Product, whichever is lower.

9. Returns

9.1 Distributor may return Products only after receiving written authorization from Tripath. All authorized returns will be shipped by Distributor freight prepaid. Unauthorized returns may be reshipped to Distributor, freight collect.

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Distributor Agreement

9.2 Distributor may request stock rotation return of slow moving Products, which will be authorized by Tripath provided that: (a) the Product is contained in Tripath's then current Distributor Price List, (b) the Product is packaged as it was originally shipped, and (c) a purchase order for equal value accompanies the request for return. Such stock rotation returns will not exceed five percent (5%) of the dollar value of Distributor's previous six (6) months net purchase orders from Tripath.

9.3 Discontinued Product may be returned only with prior written authorization.

9.4 Credit will be allowed for returned Products based on the price actually paid by Distributor, less any prior DPAs, credits and other allowances.

9.5 If, in the reasonable opinion of Tripath, previously authorized returned Products have been used or damaged, a credit or replacement may be refused. Distributor will be notified within one month after receipt of Product by Tripath of any such Product Tripath is claiming to be used or damaged.

10. Limited Warranty

10.1 Tripath provides an end user limited warranty for retail Products, and one-year limited warranty for OEM products. The terms of the end user limited warranty are set forth in documentation provided with the retail Product.

10.2 For OEM Products, Tripath warrants that the Products will be free of manufacturing and workmanship defects for one year from the date of shipment by Distributor to a customer, or eighteen months from the date of shipment to Distributor, whichever is sooner.

10.3 If any OEM Products prove defective during this one year period as set forth in Section 10.2, Tripath will, at its option, either (a) repair or replace the Product with a new or reconditioned Product, (b) use reasonable efforts to provide Distributor with a correction of the defect, or (c) refund to Distributor the purchase price paid for the Product. Any Product replaced will become Tripath property.

10.4 Distributor must return the defective OEM Product pursuant to a return material authorization under Section 9.1 in the original shipping carton (or an equivalent protective carton), and pay the shipping and insurance charges. Distributor assumes the risk of loss or damage during shipment.

10.5 OEM Products that are defective as set forth in Section 10.2 as a result of improper handling, incorrect installation or other misuse, or as a result of accident, disaster, acts of God or other such events, as determined by Tripath in its reasonable discretion, are not covered by this limited warranty.

10.6 For OEM Products, Tripath provides only the warranties set forth in this limited one year limited warranty. For retail Products, Tripath provides to the end user only the warranties set forth in the applicable end user warranty. Any and all other warranties, either express, implied or statutory, including, without limitation, warranties of fitness for a particular purpose, or of merchantability, are hereby expressly excluded and disclaimed by Tripath.

11. Reports and Audits

11.1 Distributor will submit reports as may be reasonably requested by Tripath, including, without limitation, monthly reports of inventory on hand and sales relating to the Products. Sales data will include, without limitation, Product part number, quantity, resale price, special pricing, distributor invoice number, and customer name. Distributor will submit these reports electronically on a timely basis each month and in no case later than two weeks after the beginning of the month.

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Distributor Agreement

11.2 Tripath may have an authorized Tripath representative, at Tripath's cost, audit Distributor's records relating to sales and inventories of Products, including, without limitation, records pertaining to any claims submitted by Distributor for price protection, stock rotation, returned Products, ship from stock and debit, DPA allowances, and credit requests. Upon prior written notice, Distributor will provide reasonable access to such records during normal business hours at Distributor's office. Distributor agrees to maintain all such records for a minimum of three years.

12. Distributor's Financial Condition

12.1 Tripath may withhold shipments because of Distributor's general financial condition and/or conditions of Distributor's account with Tripath. Such withholding will be not construed as a breach of this Agreement.

12.2 Distributor will supply Tripath with credit data sufficient to establish Distributor's credit worthiness.

13. Advertising and Sales Promotion

13.1 Distributor's tradename may be used by Tripath in its advertisements, provided that such use is in proper form.

13.2 Distributor will be eligible to participate in Tripath distributor cooperative advertising programs designated by Tripath for the Territory. However, prior approval must be obtained in writing from Tripath before any expenditures of funds by Distributor are eligible for reimbursement.

14. Tripath Trademarks

14.1 Tripath grants to Distributor a non-exclusive license to use Tripath's trademarks, trade names and service marks only in connection with the Products and in the performance of Distributor's obligations under this Agreement. All such uses are subject to Tripath's prior review and consent, which will not be unreasonably withheld or delayed.

14.2 All use of Tripath trademarks and service marks will be in proper form, giving appropriate attribution to Tripath as the owner of the mark. Distributor will not undertake any use of a mark in a manner that might jeopardize Tripath's rights to use or register such mark, or Tripath's rights to prevent unauthorized use. Distributor will promptly notify Tripath of any acts of unfair competition or trade or service mark infringement, and reasonably cooperate with efforts to protect Tripath's rights.

14.3 All use of Tripath trade marks and service marks by Distributor will inure to the benefit of Tripath, and Distributor will reasonably cooperate, at Tripath's expense with Tripath's efforts to register or otherwise secure rights in such marks. Upon termination of this Agreement, Distributor will immediately cease all further use of Tripath's trademarks, trade names or service marks except as may be required in the sale of Products in inventory.

15. Relationship Between the Parties

15.1 Both Distributor and Tripath are independent contractors, and no agency or other joint relationship is created.

15.2 Neither party has any authority to act for and/or to bind the other in any way, or to represent that either is in any way responsible for the acts of the other.

16. Confidentiality

16.1 Confidential information (Information) of Tripath and/or Distributor will mean information that the disclosing party desires to protect against unauthorized use or disclosure, and which is furnished under this Agreement as follows: (a) written or other tangible information clearly marked with a notice, such as

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Distributor Agreement

CONFIDENTIAL; and (b) oral information that is identified at the time of disclosure as being confidential. Confidential Information will not include information that: (a) enters the public domain without a breach of this Agreement, (b) is known to the recipient prior to the time of disclosure, or is independently developed by the recipient without using any Information, or (c) is obtained from another source that the receiving party has no reasonable cause to believe is under any obligation of confidentiality with respect to Information.

16.2 The recipient of Information will treat it as proprietary and confidential, safeguarding the Information at least as carefully as it would its own confidential information, and will use all reasonable efforts to prevent any unauthorized use or disclosure, including restricting access to the Information within its organization and ensuring that its employees comply with this Agreement. A receiving party will not disclose any information to any third party without prior written consent. Either party learning of any unauthorized use or disclosure of any Information will promptly notify the other party, and will reasonably cooperate with efforts to protect such Information.

16.3 The recipient of information will use it only in the furtherance of the business relationship established by this Agreement, and for no other purpose without prior written consent. All Information will remain the property of the disclosing party, and will be returned or destroyed upon written request.

16.4 The confidentiality obligations in this Agreement will be binding during the Agreement and for a period of three years after any termination or non-renewal of the Agreement.

16.5 Neither party will disclose the existence or terms of this Agreement without prior written consent.

17. Export Control

17.1 Distributor will not engage in exporting activities within the Territory without the prior written approval of Tripath, and the United States Government if such approval is necessary. Nothing in this Subsection is meant to authorize Distributor shipments outside the Territory.

17.2 Distributor understands that the Products and Tripath confidential information are restricted by the United States Government from export to certain countries, and Distributor agrees that it will not sell or license Products or transfer Tripath confidential information in any way will violate any of the export control laws or regulations of the United States.

18. Term and Termination

18.1 The terms of this Agreement shall be one year from the effective date and will be automatically renewed on each anniversary of the effective date, for a renewal term of one year unless either party provides written notification of its intention not to renew this Agreement at least one month prior to the expiration of the initial or any renewal terms. Tripath will honor all orders acknowledged prior to the effective date of any such termination by nonrenewable.

18.2 Tripath or Distributor may terminate this Agreement for any reason with thirty days written notice.

18.3 Either party may terminate this Agreement immediately if the other party becomes insolvent, or takes any steps to make an arrangement with its creditors, or has a receiver appointed.

18.4 If Tripath terminates pursuant to Subsection 18.1 or 18.2, or if Distributor terminates pursuant to Subsection 18.3, Tripath will purchase and Distributor will resell to Tripath Distributor's inventory of Products (excluding

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Distributor Agreement

discontinued and demonstration Products) which Tripath determines to be undamaged and in good condition (including, at Tripath's option on-site inspection). The price for such inventory will be the price actually paid by the Distributor, less any prior credit or allowances.

18.5 If Distributor terminates pursuant to Subsection 18.1 or 18.2, or if Tripath terminates pursuant to Subsection 18.3, Tripath may, at its option, purchase and Distributor will resell to Tripath all or part of Distributor's inventory at the price set forth in Subsection 18.4, less a ten percent restocking charge.

18.6 On termination of this Agreement for whatever cause, Distributor will immediately (a) cease to engage in marketing and distribution activities as Tripath's official distributor, and (b) cease representing in any manner that it is a distributor of Tripath Products in the Territory.

18.7 All obligations of Distributor to make payments under this Agreement will survive any termination of this Agreement for whatever cause, along with the following provisions: Section 10 (Limited Warranty), Section 11 (Reports and Audits), Section 16 (Confidentiality), Section 17 (Export Control), Section 19 (Intellectual Property Indemnity), and Subsection 21.6 (Governing Law), and Subsection 21.7 (Arbitration).

19. Intellectual property indemnity

19.1 Indemnification. Distributor agrees that Tripath has the right to, and Tripath agrees that it will at its expense, defend or at its option settle any claim, suit, proceeding, or other action brought against Distributor or its customer for infringement of any United States copyright, trademark or other United States intellectual property right related to the Products or their use, subject to the limitations set forth in this Section. Tripath will have sole control of any such action or settlement negotiations (Tripath will not be liable for any costs or expenses incurred without its prior written authorization), and Tripath will pay any final judgment entered against Distributor or its customer based on such infringement. Tripath at its sole option will be relieved of the foregoing obligations unless Distributor or its customer notifies Tripath promptly in writing of such action and gives Tripath full information and assistance to settle and/or defend any such action. If it is adjudicated that a Product infringes, or if the sale or use of a Product is, as a result, enjoined, then Tripath will, at its option and expense either: (i) procure for Distributor and its customers the right to sell or use the Product; or (ii) replace the Product with other suitable Product; or (iii) suitably modify the Product to be noninfringing; or (iv) if none of the foregoing are commercially reasonable, as determined by Tripath, accept return of the affected Products and refund Distributor's aggregate payments for such Products, less a reasonable sum for use and/or damage, if any.

19.2 Limitation. Notwithstanding the provisions of Section 19.1, Tripath assumes no liability for, and Distributor agrees to indemnify Tripath to the same extent as Tripath's indemnity under Section 19.1 for: (i) any infringements covering completed equipment or any assembly, circuit, combination, or method in which any of the Products may be used but not covering such Products standing alone; or (ii) any trademark infringements involving any marking or branding not applied by Tripath or involving any marking or branding applied at the request of Distributor; or (iii) any modification of the Products unless such modification was made by Tripath.

19.3 Entire Liability. The foregoing provisions of this section 19 state the entire liability and obligations of Tripath and the exclusive remedy of Distributor and its customers, with respect to any actual or alleged intellectual property infringement by the Products.

20. Limitation of Liability

20.1 Neither Tripath nor Distributor will be liable for any incidental or consequential

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Distributor Agreement

damages (including, without limitation, damages for loss of business profits, business interruption, loss of business information, or other pecuniary loss) arising out of this Agreement, even if advised of the possibility of such damages.

21. General

21.1 Assignment. This Agreement is not assignable by Distributor without prior written consent of Tripath, which will not be unreasonably withheld. Tripath is free to assign this contract without Distributor's consent.

21.2 Modifications. This Agreement may be modified only in writing signed by an officer of each party.

21.3 Headings. The headings of the several Sections are inserted for convenience of reference only, and are not intended to be part of nor to affect the meaning or interpretation of this Agreement.

21.4 Notices. All notices under this Agreement will be sent by receipted courier (e.g., U.P.S.).

21.5 Non-Waiver. The failure of either party to enforce at any time any of the provisions of this Agreement will not be construed as a waiver of the right of such party to subsequently enforce any such provisions or a waiver of the provision itself.

21.6 Governing Law. This Agreement will be governed by the laws of California, without reference to conflicts of laws.

21.7 Arbitration. Any dispute or claim arising out of this Agreement will be referred to and resolved by the International Chamber of Commerce (ICC) in accordance with the ICC Arbitration Rules. The venue for such arbitration will be Santa Clara County, California, USA.

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Distributor Agreement

This Agreement supersedes all proposals, oral or written, all negotiations, or discussions between or among the parties relating to this Agreement, and all past course of dealing or industry custom. This Agreement takes precedence over the terms of any Tripath or Distributor order or sales documentation, including the Tripath Sales Order Acknowledgment.

TRIPATH CORPORATION   DISTRIBUTOR             By: /s/ EVERETT ROACH   By: /s/ CHARLES LIM             Name: Everett Roach   Name: Charles Lim             Title: Vice President, World Wide Sales   Title: President             Date: 7/1/98   Date: 7/7/98

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Output: Highlight the parts (if any) of this contract related to Warranty Duration that should be reviewed by a lawyer. Details: What is the duration of any  warranty against defects or errors in technology, products, or services  provided under the contract?


Input: Consider Input: Exhibit 10.19 CONFIDENTIAL TREATMENT REQUESTED Certain portions of this document have been omitted pursuant to a request for Confidential Treatment and, where applicable, have been marked with [***] to indicate where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.

MANUFACTURING AND SUPPLY AGREEMENT

This Manufacturing and Supply Agreement (this Agreement) is entered into as of the Effective Date (as defined below) by and between (1) Apollo Endosurgery, Delaware corporation having offices at 1120 S Capital of Texas Highway #300, Austin, TX 78746 (APOLLO), and (2) Establishment Labs, S.A a corporation organized under the laws of Costa Rica and having a principal place of business at Coyol Free Zone, B15, Alajuela, 20113, Costa Rica (ESTABLISHMENT). APOLLO and ESTABLISHMENT shall hereinafter be individually referred to as a Party and collectively as the Parties.

RECITALS

A. APOLLO is engaged in the research and development, manufacture, distribution and marketing of certain medical devices.

B. ESTABLISHMENT is engaged in the contract manufacturing and packaging of certain medical device products.

C. APOLLO desires that ESTABLISHMENT be the manufacturer and supplier of the product(s) outlined on Exhibit A of this Agreement (Product) for APOLLO.

D. APOLLO and ESTABLISHMENT desire to enter into this Agreement governing the supply of the Product upon the terms and conditions contained herein.

AGREEMENT

NOW THEREFORE, in consideration of the covenants contained herein, the above recitals, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:

1. DEFINITIONS

1.1Affiliates of a Party shall mean any corporation or other business entity controlling, controlled by, or under common control with such Party.

1.2Certificate of Conformance or COC shall mean a document prepared by ESTABLISHMENT containing at a minimum: product name, Lot (defined below) number, lot quantity and a statement indicating compliance to all product specifications. Each COC shall be signature approved by ESTABLISHMENT's Quality Assurance department.

1.3Control (including controlling, controlled by and under common control with of any party, corporation, or other business entity) shall mean the direct or indirect ownership of at least fifty percent (50%) of the voting or income interest in such party, corporation, or other business entity, respectively.

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1.4Current Good Manufacturing Practices (abbreviated GMPs or cGMPs) shall mean, a) for any period during the Term during which ESTABLISHMENT has received FDA certification, the standards established by the United States Food and Drug Administration (the FDA) for current Good Manufacturing Practices, as specified in FDA 21 C.F.R. §820 Quality Systems Regulations (or its successor provisions); and b) ISO 13485 Medical Devices - Quality Management Systems and other sections so designated by the title Good Manufacturing Practices; and c) as applicable to each respective Product to be manufactured and/or supplied by ESTABLISHMENT.

1.5Effective Date shall mean December 5, 2014.

1.6Facilities shall mean ESTABLISHMENT's manufacturing facilities at Coyol Free Zone, B15, Alajuela, 20113, Costa Rica.

1.7Lead Time shall mean the time period that begins on the day ESTABLISHMENT receives a Purchase Order (defined below) for Product from APOLLO and ends on the day ESTABLISHMENT is required to deliver the Product to APOLLO.

1.8Lot shall mean a defined quantity of starting material, packaging material or product processed in one process or series of processes so that it could be expected to be homogeneous.

1.9Product shall mean the product(s) to be manufactured and supplied by ESTABLISHMENT to APOLLO under Purchase Order(s) issued under this Agreement and as more specifically detailed in Exhibit A attached hereto.

1.10 Purchase Order shall mean a written purchase order issued to ESTABLISHMENT by APOLLO for the purchase of Product under this Agreement.

1.11Span of Control shall mean all operational activities that are necessary to occur at ESTABLISHMENT and component suppliers, if any, that are related to the procurement and manufacture of the Product.

1.12 Specifications shall mean the Product specifications provided to ESTABLISHMENT by APOLLO. The Specifications shall include all necessary test protocols, packaging and labeling specifications, bills of materials and other documentation required to describe, control, and assure the quality of the manufacture of the Product.

1.13 WIP shall mean Work In Progress.

2. TERM AND TERMINATION

2.1Term. This Agreement shall commence on the Effective Date and shall be valid for a period of five (5) years with automatic renewal of one year thereafter until terminated

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by either party with one (1) year written notice prior to the expiration of the initial period or any extension period thereof.

2.2Termination.

(a) Either Party may terminate this Agreement (i) for material breach upon one hundred and twenty (120) days written notice specifying the nature of the breach, if such breach has not been substantially cured within the one hundred twenty (120) day period, or (ii) if the other Party shall formally declare bankruptcy, insolvency, reorganization, liquidation, or receivership; or is named in an action for bankruptcy, insolvency, reorganization, liquidation, or receivership proceedings, and fails to remove itself from such proceedings within ten (90) days from the date of institution of such proceedings.

(b) In the event this Agreement is terminated for reasons other than material breach by ESTABLISHMENT, APOLLO shall pay ESTABLISHMENT for all work, material purchases, WIP and finished goods performed pursuant to any unfinished Purchase Order(s) prior to such termination in addition to reparation charges outlined on Exhibit A of this Agreement.

(c) In the event this Agreement is terminated for any reason, ESTABLISHMENT shall promptly cease performing any work not necessary for the orderly close out of the affected Purchase Order(s) or for the fulfillment of regulatory requirements.

(d) Within thirty (30) days following the termination of this Agreement, and upon receiving payment for any outstanding invoices for previously fulfilled Purchase Orders, ESTABLISHMENT shall deliver to APOLLO all data and materials provided by APOLLO to ESTABLISHMENT for the manufacturing and supply activities under the impacted Purchase Order(s). Within this same timeframe APOLLO shall provide ESTABLISHMENT any reasonable compensation relative to work, materials, and WIP purchased specifically to support APOLLO's Product. Termination of this Agreement, for any reason, shall not release either Party from liability which at said time has already incurred, nor affect in any way the survival of any rights, duties or obligations of either Party which are expressly stated elsewhere in this Agreement to survive termination. Without limiting the generality of the foregoing, the Parties agree that Sections 2.2 and Articles 6, 7, 8, 9, and 10 shall survive termination of this Agreement for any reason.

3. MANUFACTURE AND SUPPLY OF PRODUCT

3.1Performance Standards. ESTABLISHMENT shall manufacture the Product in accordance with the Specifications of this Agreement, and shall comply with all quality system requirement communicated by Apollo from time to time, ISO 13485:2012 and any applicable cGMPs and all other applicable local, United States or European regulations or laws in connection with the manufacture, testing, packaging, labeling, shipping, and handling of the Product.

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(a) ESTABLISHMENT shall be responsible for normal and daily maintenance of all consigned equipment provided by APOLLO, as described in Exhibit C. APOLLO will be responsible for all other repair and/or replacement costs relating to loaned or consigned equipment due to normal wear and use. Unless otherwise agreed upon in writing, at APOLLO's sole discretion, this equipment will be insured by APOLLO while located in ESTABLISHMENT's manufacturing plants.

3.2ESTABLISHMENT Representations. ESTABLISHMENT makes the following representations to APOLLO:

(a) ESTABLISHMENT is duly organized, validly existing and in good standing under the laws of Costa Rica. ESTABLISHMENT has all requisite power and authority to own, operate and lease its properties and to carry on its business as now conducted. ESTABLISHMENT has full corporate power and authority to execute, deliver and perform this Agreement; all corporate actions of ESTABLISHMENT necessary for such execution, delivery and performance have been duly taken; and this Agreement is a valid and binding obligation of ESTABLISHMENT.

ESTABLISHMENT shall perform all manufacturing, storage, handling, and testing of the Product(s) at the Facilities. ESTABLISHMENT warrants that the Facilities have been periodically inspected by its Notified Body's representatives and auditors and/or any other required government agency and are in good standing with said governmental agencies, are fully compliant with ISO 13485:2012 and that all employees working on the Product whose responsibilities involve work which must be performed under ISO 13485:2012 standards have been properly trained in the requirements of those standards. ESTABLISHMENT additionally warrants that the Facilities hold all necessary licenses and permits from applicable local, national, and European regulatory bodies, required for the manufacture and testing of the Product and that all such licenses and permits are in full force and effect.

(b) ESTABLISHMENT shall comply with all applicable export and import control laws and regulations.

3.3Suppliers. Except as otherwise agreed upon in writing ESTABLISHMENT assumes the responsibility for interacting with all chemical, component and packaging suppliers as required to deliver the Product in accordance with the applicable Purchase Order, including the Specifications, and this Agreement. Payment to the suppliers shall be handled directly by ESTABLISHMENT unless otherwise agreed upon in writing by APOLLO. ESTABLISHMENT shall not change its raw material, component or packaging materials without the prior written consent of APOLLO, which consent shall not be unreasonably withheld. With respect to the supply of the silicone raw materials for the shell and sheath product components, APOLLO shall acquire materials from a third party supplier and arrange for delivery to ESTABLISHMENT and ESTABLISHMENT shall be responsible for inspecting said components to ensure that they meet chemical, component and packaging specifications.

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4. PRICING AND PAYMENT; Fixtures and Tooling

4.1Product Prices. Pricing for the Product ordered per the terms of this Agreement is set forth in Exhibit A attached hereto. Any penalty for failure to purchase a designated quantity of product for a defined period, if any, shall be clearly described in Exhibit A or in a written amendment. Any future modification to pricing shall be mutually agreed upon and may be captured in a revised Exhibit A or a written amendment signed by both Parties.

4.2Payment Terms. Unless otherwise agreed to by ESTABLISHMENT in writing, ESTABLISHMENT shall invoice APOLLO for Product ordered at the time of shipment and APOLLO shall pay each invoice within thirty (30) days from date of invoice. Each invoice shall set forth, in U.S. Dollars, the applicable price for the shipment properly determined in accordance with the provisions of this Agreement. If APOLLO disputes any portion of an invoice received from ESTABLISHMENT the Parties shall use good faith efforts to reconcile the disputed amounts as soon as practicable. Invoices should be sent to the physical and email addresses as specified in writing by APOLLO in the applicable Purchase Order.

4.3Fixtures and Tooling. In addition, Apollo will pay as set forth in Exhibit A for certain fixtures and tooling to be set forth in Exhibit C, and Apollo will maintain all right, title and interest in and to such fixtures and tooling. During the Term, fixtures and tooling will be identified to Apollo and will be subject to the requirements for ESTABLISHMENT to maintain set forth as part of the Services in Exhibit A. The parties will amend Exhibit C from time to time in writing to set forth an accurate list of such fixtures and tooling. With respect to all tooling and fixtures purchased by Apollo in connection with the manufacture and supply of Product and provision of Services hereunder and listed on Exhibit C (which, in accordance with this Agreement, Apollo shall retain all right, title and interest in and to), for so long as ESTABLISHMENT maintains possession of such tooling and fixtures, Establishment will retain, maintain and use such fixtures and tooling in the ordinary course of business (normal wear and tear excepted) consistent with its handling of other tooling and fixtures and will use such tooling and fixtures only for manufacturing and supply of Product and provision of Services to APOLLO as provided in this Agreement.

5. FORECASTS, PURCHASE ORDERS AND DELIVERY

5.1Forecasts. APOLLO shall provide ESTABLISHMENT on a monthly basis a twelve (12) month rolling forecast to allow for visibility into expected future demands. APOLLO shall deliver to ESTABLISHMENT a forecast for anticipated monthly deliveries of Product to APOLLO over the subsequent four (4) calendar quarters (the Forecast). The Forecast is to be used by the Parties for planning purposes and is not a commitment by APOLLO to purchase the quantities of Products specified in such Forecast, except as described below.

The quantities of Product forecasted for the initial three (3) months of each updated rolling Forecast shall represent a binding obligation of Apollo to purchase from ESTABLISHMENT, and of ESTABLISHMENT to manufacture and supply to APOLLO, such quantities of Product.

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ESTABLISHMENT shall, at all times during the Term, maintain an inventory of raw materials and components sufficient to manufacture the binding obligations.

5.2Orders. APOLLO shall routinely provide ESTABLISHMENT Purchase Orders for Product demands. All Product ordered by APOLLO shall be in the form of a firm written Purchase Order. Each Purchase Order shall contain at a minimum, the following information: description of the Product and quantity ordered, price, freight carrier information, payment terms, delivery date, and Purchase Order number for billing purposes. The Parties shall cooperate to establish appropriate lead times for orders; requested delivery dates shall provide sufficient lead times for the products ordered.

5.3Delivery. Unless expressly provided otherwise in the applicable Purchase Order, shipping to APOLLO for the Product shall be Ex Works - ESTABLISHMENT (Incoterms 2010). The Product will be packaged and shipped per the Specifications and using a shipper and insurance coverage approved by APOLLO. In the event that any delivery of the Product is anticipated to be late, ESTABLISHMENT will promptly notify APOLLO of the circumstances for the delay and, upon request, ESTABLISHMENT will take reasonable steps to minimize the delay. At the request of APOLLO, ESTABLISHMENT will provide a written corrective action for the result of delays caused by events under the Span of Control of ESTABLISHMENT.

5.4Acceptance, Rejection, and Claims. APOLLO may inspect any or all shipments of Product to insure all specifications are met including proper labeling, packaging and count within thirty (30) business days of APOLLO's receipt of each shipment; however, any such inspection shall not relieve ESTABLISHMENT of any obligations or warranties under this Agreement. APOLLO has the right to reject, via written notification to ESTABLISHMENT within this thirty (30) day period, any or all of a shipment of Product that fails to satisfy any warranty in this Agreement and may reject all of a given Lot of Product if a statistical sample does not meet the Specifications. Upon confirmation of defective condition by ESTABLISHMENT and issuance of a return material authorization (RMA) number, APOLLO shall be entitled to the immediate return and replacement, free of charge, of any Product supplied by ESTABLISHMENT in breach of any warranty under this Agreement.

5.5Spoilage Due to Change or Obsolescence. APOLLO shall be responsible for any printed packaging components, purchased raw materials, work in progress or finished Product which becomes obsolete as a result of a specification or drawing change so long as the purchased raw materials did not exceed three months of APOLLO's forecast requirements and, upon Apollo's request, such raw materials, work in progress and finished Product are transferred to APOLLO

6. WARRANTIES

6.1Product Warranty. ESTABLISHMENT warrants that all Product supplied under this Agreement shall, when it leaves ESTABLISHMENT's possession and control, conform with the Specifications and shall be free from defects in materials and workmanship.

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ESTABLISHMENT further warrants that the Product shall be manufactured in accordance with applicable ISO 13485:2012 standards and with all applicable laws and regulations.

6.2Debarment. ESTABLISHMENT represents, warrants and covenants that no person or entity that will be involved in the performance of ESTABLISHMENT's obligations under this Agreement is under investigation by the FDA or other Regulatory Authority for debarment or is presently debarred by the FDA or other Regulatory Authority. In addition, ESTABLISHMENT represents and warrants that it has not engaged in any conduct or activity that could lead to any such debarment actions. If during the Term, ESTABLISHMENT or any person or entity that will be involved in the performance of ESTABLISHMENT's obligations under this Agreement (i) comes under investigation by the FDA for a debarment action, (ii) is debarred, or (iii) engages in any conduct or activity that could lead to debarment, ESTABLISHMENT shall notify APOLLO immediately after gaining knowledge of the situation.

6.3 Intellectual Property. ESTABLISHMENT represents, warrants and covenants to APOLLO that ESTABLISHMENT will not, in the course of performing obligations hereunder, infringe or misappropriate any intellectual property of any other person. APOLLO represents, warrants and covenants to ESTABLISHMENT that by complying with its obligations under this agreement APOLLO will not knowingly direct ESTABLISHMENT to incur any violation, infraction or misappropriation of any intellectual property of any other party.

6.4Training. ESTABLISHMENT represents, warrants and covenants to APOLLO that all of its employees and personnel that will be performing any work in connection with this Agreement will have the appropriate training and skill necessary to perform their job functions.

6.5No Conflicts. ESTABLISHMENT represents, warrants and covenants that it shall not enter into any agreement or arrangement with any other entity that would prevent or in any way negatively interfere with ESTABLISHMENT's ability to perform it obligations hereunder.

7. REGULATORY AND QUALITY

7.1Compliance. ESTABLISHMENT agrees that its work under this Agreement will be conducted in compliance with all applicable laws, rules and regulations, and with the standard of care customary in the industry. If requested by APOLLO, ESTABLISHMENT shall provide APOLLO with a certificate evidencing its accreditation by the appropriate accrediting body. Such accreditation shall remain in force during the term of this Agreement. ESTABLISHMENT agrees that all Product shipments to APOLLO shall be in accordance with APOLLO's instructions governing the shipment, labeling, and packaging of the Product.

7.2Quality Control. Establishment shall maintain and follow a quality control and testing program consistent with the Product Specifications, ISO 13485:2012, Applicable Laws and quality system requirements communicated in writing by APOLLO from time to time

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(the Quality Control Procedures). All Product supplied to APOLLO hereunder shall be manufactured in compliance with ISO 13485:2012 and all other applicable requirements of Regulatory Authorities, and in compliance with all other Applicable Laws (collectively, Regulatory Standards). At all times the Products shall be manufactured in an ISO Class 7 Clean Room, unless otherwise set forth in an amendment to this Agreement or the Exhibits hereto signed by both Parties.

7.3Records. Establishment shall keep complete, accurate and authentic accounts, notes, data and records pertaining to the manufacture, processing, testing, storage, and distribution of the Product, including without limitation master production and control records, in material compliance with applicable Regulatory Standards. Establishment shall use commercially reasonable efforts to maintain and store such records in a manner to prevent loss, theft or deterioration. Establishment shall retain such records for five (5) years following the date of manufacture, or such longer period of time if consistent with Regulatory Standards, and shall make available to Apollo copies of such records; and upon the expiration of such period, Establishment shall contact Apollo and give Apollo the option to have such quality control documentation transferred to Apollo or destroyed. Unless this Agreement is terminated by Apollo due to a Triggering Event, in which case APOLLO shall bear the following costs: (i) ESTABLISHMENT may charge APOLLO for ESTABLISHMENT actual, documented, reasonable labor expenses incurred by ESTABLISHMENT for transfer or destruction of such documents and (ii) in the event of transfer of documents all freight costs shall be borne by APOLLO.

7.4Product Complaints/Reports. The parties expect that APOLLO shall receive any complaint, claim or adverse reaction report regarding the Product. However (and except as otherwise noted below) in the event that ESTABLISHMENT receives any complaint, claim or adverse reaction report regarding any Product, including, but not limited to, notices from a competent Regulatory Authority regarding any regulatory non-compliance of a Product, upon notice, ESTABLISHMENT shall within a reasonable time frame provide APOLLO with all information related to such complaint, report, or notice and such additional information regarding the Product as may be reasonably requested. ESTABLISHMENT shall provide as much information as it has, to allow APOLLO comply with the competent Regulatory Authority requirements for complaint handling. If Product contains a defect which could or did cause death or serious bodily injury, ESTABLISHMENT shall immediately provide APOLLO with a complete description of all relevant details known to ESTABLISHMENT concerning any such incident, including but not limited to, a description of any defect and such other information which may be necessary to report to the competent Regulatory Authority or any Ministry of Health. APOLLO is responsible for filing any/all MDR Reports as required by the competent Regulatory Authority.

7.5Recalls. APOLLO shall have the right to reasonably declare any recall of, or field corrective action to, any Product supplied to APOLLO under this Agreement. ESTABLISHMENT agrees to cooperate with APOLLO in connection with any such recall inasmuch as related to its concern in the Product.

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7.6Government Inquiries. Without limiting the generality of Section 7.2, ESTABLISHMENT shall use its best efforts to:

(a) Respond fully and accurately to all inquiries directed to it by the competent Regulatory Authority or any government agency or regulatory body with respect to the manufacture and testing of the Product.

(b) Assist APOLLO in responding to inquiries directed to APOLLO by any competent Regulatory Authority or any government agency or regulatory body with respect to the manufacture and testing of the Product.

7.7 Inspection of Manufacturing Facilities.

(a) ESTABLISHMENT shall permit APOLLO and its agents, during business hours and upon notice to ESTABLISHMENT, to inspect the Facilities where the Product is manufactured, handled, stored or tested, as well as all processes relating to the manufacture, handling, storage, or testing of the Product, as well as all test records regarding the Product.

7.8ESTABLISHMENT warrants and agrees that it will correct within a reasonable amount of time from the date of notification, all deficiencies and/or non-conformances found during an APOLLO or any competent Regulatory Authority (regulatory body or agency) audit; and that it will take reasonable steps to correct such deficiencies and/or non-conformances or issue an approved plan, including a timetable, to correct all deficiencies and/or non-conformances within a reasonable time period.

7.9Control Testing. ESTABLISHMENT shall perform quality control testing in accordance with the Specifications for release of each Lot of Product to APOLLO. Quality control testing shall include testing associated with the production of the Product, including, but not limited to, incoming component and raw material testing, in process testing, and final release testing as agreed upon from time to time between APOLLO and ESTABLISHMENT.

7.10 Specifications and Change Control.

(a) The Specifications may not be changed without prior written approval by APOLLO.

(b) ESTABLISHMENT shall not make any changes to the manufacturing process, Facilities, or equipment used in the manufacture that affects the form, fit or function of the Product without APOLLO's prior written approval.

(c) APOLLO shall use commercially reasonable efforts to provide ESTABLISHMENT with sufficient written notice of any instructions or requirements of a government regulatory agency that may require a change of the Specifications. ESTABLISHMENT shall immediately notify APOLLO if any such changes in the Specifications

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shall render ESTABLISHMENT unable to supply the Product in accordance with the terms and conditions of this Agreement or if they would cause a delay in supply of the Product.

7.11Technical Assistance. ESTABLISHMENT shall provide APOLLO with certain technical support regarding the Product as reasonably requested by APOLLO, including, but not limited to, analytical test methods, manufacturing process development, and validation support. If there are charges associated with these services, a separate quote will be provided to APOLLO.

7.12 Quality Agreement. ESTABLISHMENT and APOLLO shall execute a written Quality Agreement between the Parties (the Regulatory Agreement). Upon execution, the Quality Agreement shall be attached hereto as Exhibit B and shall be incorporated herein. The Quality Agreement may be updated from time to time upon the mutual written agreement of the Parties. ESTABLISHMENTs agrees to comply with any reasonable requirements of APOLLO's quality system.

8. INDEMNIFICATION, LIMITATION OF LIABILITY AND INSURANCE

8.1 Indemnification by APOLLO. APOLLO agrees to indemnify, defend and hold harmless ESTABLISHMENT, its officers, agents, and employees from any and all liability, loss (including reasonable attorneys' fees) or damage they may suffer as the result of claims, demands, costs or judgments against them arising out of the negligence, recklessness or willful misconduct on the part of APOLLO, its officers, agents, employees, contractors or consultants in connection with this Agreement.

8.2 Indemnification by ESTABLISHMENT. ESTABLISHMENT agrees to indemnify, defend and hold harmless APOLLO, its officers, agents, and employees from any and all liability, loss (including reasonable attorneys' fees), or damage they may suffer as the result of claims, demands, costs or judgments against them arising out of:

(a) a failure by ESTABLISHMENT, its officers, agents, employees, contractors or consultants to adhere to the terms of a Purchase Order or written instructions received from APOLLO in accordance with this agreement;

(b) negligence, recklessness or willful misconduct on the part of ESTABLISHMENT, its officers, agents, employees, contractors or consultants; or

(c) a breach of any applicable local law or regulation or of this Agreement by ESTABLISHMENT, its officers, agents, employees, contractors or consultants in relation to the execution of this agreement.

8.3General Conditions of Indemnification. Each Party's agreement to indemnify, defend and hold the other harmless is conditioned on the indemnified Party (i) providing written notice to the indemnifying Party of any claim, demand or action arising out of the indemnified activities within thirty (30) days after the indemnified Party has knowledge of

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such claim, demand or action; (ii) permitting the indemnifying Party to assume full responsibility to investigate, prepare for and defend against any such claim or demand; (iii) assisting the indemnifying Party, at the indemnifying Party's reasonable expense, in the investigation of, preparation for and defense of any such claim or demand; and (iv) not compromising or settling such claim or demand without the indemnifying Party's written consent; provided, however, that the failure of the indemnified Party to undertake any of the foregoing actions shall not relieve the indemnifying Party of any obligation it may have under this Article 8, except to the extent that the indemnifying Party's ability to fulfill such obligation has been materially prejudiced thereby.

8.4Limitation of Liability. EXCEPT FOR BREACHES OR VIOLATIONS OF ARTICLE 9, OR INDEMNITY LIABILITIES ARISING UNDER THIS ARTICLE 8, OR CASES OF GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY CONSEQUENTIAL, INDIRECT, SPECIAL, INCIDENTAL OR PUNITIVE DAMAGES INCLUDING LOSS OF USE, REVENUES OR PROFITS, INTERRUPTION OF BUSINESS OR CLAIMS AGAINST EITHER PARTY OR ITS CUSTOMERS BY ANY THIRD PARTY, WHETHER SUCH CLAIM IS BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE, EVEN IF THE PARTY IS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

8.5 Insurance. ESTABLISHMENT, at its sole cost and expense, will maintain appropriate insurance including, but not limited to, Commercial General Liability Insurance with premises, operations coverage including Person Injury/Property Damage coverage, with limits of not less than $1,000,000 per occurrence. As of January 1, 2015, such insurance shall also have annual aggregate limits not less than $2,000,000. Evidence of insurance indicating such coverage will be delivered to APOLLO upon request. The evidence will (a) indicate that the policy will not change or terminate without at least fifteen (15) days prior written notice to APOLLO, (b) APOLLO shall be listed as an additional insured on the commercial general liability policy.

9. CONFIDENTIALITY

9.1Confidential Information. For purposes of this Agreement, Confidential Information shall mean all information relating to the subject matter of this Agreement (i) identified in written or oral format by the disclosing Party as confidential, trade secret or proprietary information and, if disclosed orally, summarized in written format within thirty (30) days of disclosure, or (ii) the receiving Party knows or has reason to know is confidential, trade secret or proprietary information of the disclosing Party. Notwithstanding the foregoing, Confidential Information shall not include any information which the receiving Party can show: (i) is now or subsequently becomes legally and publicly available without breach of this Agreement by the receiving Party, (ii) was rightfully in the possession of the receiving Party without any obligation of confidentiality prior to receiving it from the disclosing Party, (iii) was rightfully obtained by the receiving Party from a source other than the disclosing Party without

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any obligation of confidentiality, or (iv) was developed by or for the receiving Party independently and without reference to such information as shown by documentary evidence.

9.2Nondisclosure. Each Party agrees not to use the Confidential Information of the other Party for any purpose, including trading in the financial instruments of the other Party, except in its performance under this Agreement. In addition, the receiving Party shall treat and protect such Confidential Information in the same manner as it treats its own information of like character, but with not less than reasonable care. The receiving Party agrees to take appropriate measures by instruction and/or written agreement prior to disclosure of Confidential Information to its employees and contractors to prevent unauthorized use or disclosure. Confidential Information may be disclosed to the extent necessary to comply with an order of an administrative agency or court of competent jurisdiction provided, however, that the Party so required to disclose Confidential Information shall provide prior written notice thereof to the other Party in sufficient time to enable that Party to seek a protective order or otherwise prevent such disclosure. The receiving Party's confidentiality obligations under this Article 9 shall survive the termination of this Agreement, and shall remain binding on the Parties hereto until the earlier of a) the Confidential Information falls within one of the exceptions stated in Section 9.1 and b) five (5) years from the expiration or termination of the Agreement. Previously executed non-disclosure agreements between the Parties will remain in effect in conjunction with The Agreement until the termination dates specified in those agreements and any Confidential Information shall also be considered to be Confidential Information hereunder. Disclosure of Confidential Information under this Agreement will create no license, right, interest, or ownership in any such information in a receiving Party.

10. GENERAL PROVISIONS

10.1 Relationship Between the Parties. In fulfilling its obligations pursuant to this Agreement, each Party shall be acting as an independent contractor. Neither Party is granted any right or authority to assume or to create any obligation or responsibility, express or implied, on behalf of or in the name of the other Party.

10.2 Nonexclusivity. Nothing in this Agreement shall limit or restrict Apollo from establishing a second source for the manufacture of the Products.

10.3 No Third Party Beneficiaries. This Agreement is neither expressly nor impliedly made for the benefit of any party other than those executing it.

10.4 Severability. If, for any reason, any part of this Agreement or any Purchase Order is adjudicated invalid, unenforceable or illegal by a court of competent jurisdiction, such provision will be changed and interpreted to accomplish the objectives of such provision to the greatest extent possible under applicable law and the remaining provisions of this Agreement or Purchase Order (as the case may be) will continue in full force and effect.

10.5 Notices. Any notice to be given under this Agreement must be in writing and delivered either in person, by any method of mail (postage prepaid) requiring return receipt,

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or by overnight courier, to the Party to be notified at its address(es) given below, or at any address such Party has previously designated by prior written notice to the other. Notice shall be presumptively deemed to be sufficiently given for all purposes upon the earlier of: (a) the date of actual receipt; (b) if mailed, three (3) calendar days after the date of postmark; or (c) if delivered by overnight courier, the next business day the overnight courier regularly makes deliveries.

If to ESTABLISHMENT: Establishment Labs S.A. Coyol Free Zone, B15, Alajuela 20113, Costa Rica Attention: Luis Gutierrez. General Counsel

If to APOLLO: Apollo Endosurgery, Inc. 1120 S. Capital of Texas Hwy, Suite 300 Austin, TX 78746 Attn: Brian Szymczak, Legal Dept.

10.6 Force Majeure. Each Party shall be excused from liability for the failure or delay in performance of any obligation under this Agreement by reason of any event beyond such Party's reasonable control, including, but not limited to, Acts of God, other natural forces or war. Such excuse from liability shall be effective only to the extent and duration of the event(s) causing the failure or delay in performance and provided that the Party seeking relief has not caused such event(s) to occur. Notice of a Party's failure or delay in performance due to force majeure must be given to the other Party within three (3) calendar days after its occurrence. All delivery dates under this Agreement that have been affected by force majeure shall be tolled for the duration of such force majeure.

10.7 Legal Fees. The prevailing Party in any litigation between the Parties relating to this Agreement may be awarded some or all of its reasonable attorneys' fees and court costs if the Court (in its reasonable discretion) finds that a non- prevailing party has not acted in good faith in the pursuit or defense of a claim hereunder, in addition to any other relief that it may be awarded.

10.8 Governing Law and Venue. Notwithstanding its place of execution or performance, this Agreement shall be governed by and construed in accordance with the laws of the State of Texas, irrespective of its laws regarding choice or conflict of laws. Any dispute arising under or relating to this Agreement shall be submitted for resolution to a state or federal court of competent jurisdiction in Austin, Texas, and the Parties hereby agree to submit to the jurisdiction and venue of such court.

10.9 Assignment. This Agreement is binding upon and inures to the benefit of the Parties to it, and to their successors and assigns. Neither Party shall have the right to assign this Agreement or any of its rights or obligations hereunder without the prior written consent of the other Party; provided, however, APOLLO may assign the Agreement to and may, without the

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prior consent of ESTABLISHMENT, assign all of its rights under this Agreement to (i) a parent or subsidiary of Apollo, (ii) a purchaser of all or substantially all the Apollo assets related to this Agreement, or (iii) a third party acquiring control of Apollo through a merger, acquisition, sale of assets or other corporate reorganization.

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IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the Effective Date.

ESTABLISHMENT LABS, SA Apollo Endosurgery, Inc. By: /s/ Juan Jose Chacon By: /s/ Todd Newton Name: Juan Jose Chacon Name: Todd Newton Title: CEO Title: CEO

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1. a. i. ii.

2. a. b. c.

3.

a. b. c. d.

• •

4. a. b. c.

5. a. b. c.

6. a. b. c.

EXHIBIT A

Product & Price Listing

Apollo BIB Sheath and Balloon Assembly Transition to E-LABS Rev.4

Transition Plan Milestones & Description Approximate Timeline Fee Notes

Project Launch Apollo to define component requirements (draft drawings) Onsite review of Allergan process in Costa Rica (1 trip). Agreement on specification/requirements Production to be performed in an ISO Class 7 Clean Room.

[***] [***] Agreement to be signed before project launch..

Proof of Process Obtain raw materials Prototype 1st mandrels/fixtures Deliver samples (10 pcs each) to Apollo (or Allergan) to agreed draft specification

[***] [***]

Requirements: -Drawings from Allergan for molds and tooling. -STL files from Allergan. -Materials standard specifications from Allergan. -Contact information of suppliers. -No cost for raw materials is included. -Tooling and Materials to be provided from Allergan.

Process Set Up & Scale Up (for initial annual volumes of up to 50,000 pcs/each) Define production mandrels/fixtures Measurement system process set up Manufacturing Documentation Process characterization & definition of process limits

Tooling (for annual volumes of 50,000 pcs/each) BIB Balloon Mandrels BIB Sheath Mandrels

[***] [***]

Completion is achieved when ready for first wet run.

E-Labs Process Validation Equipment qualification Measurement systems Apollo review of protocol

[***] [***]

No raw materials or equipment cost are considered.

First Articles / Validation (Apollo) Quantities to be determined by Apollo Deliver first articles to Apollo Transition project complete

[***] [***]

Patched BIB ballon with Sheath, including raw material.

Manufacture / Deliver BIB Components for Commercial Use Apollo receives approval from applicable government/regulatory agencies. Order quantities to be determined Anticipate first delivery by [***].

[***] [***]

Patched BIB ballon with Sheath, including raw material.

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• • • •

• • • •

• ◦ ◦ • • • •

• ◦ ◦ • • • •

Tooling & Other Program Requirements Unit Price Notes

Shell, BIB Sheath, DWG BSS Rev. 08 [***] Material: NuSil [***] Silicone Assumes NuSil MED 4-2014 [***], Xylene [***]/liter Bulk packaged in double poly bags and labeled Lead time: [***] weeks

For annual volumes between [***] See below

Shell, BIB Sheath, [***] and E-Labs Draws from Apollo Stock] Material: NuSil [***] Silicone Assumes NuSil MED [***]/kg, Xylene [***]/liter Bulk packaged in double poly bags and labeled Lead time: [***] weeks

For annual volumes between [***] See below

Budgetary pricing for higher volumes of Shell Bib Sheath, [***]

Note: This row should accommodate the two scenarios: Purchasing NuSil Material & Apollo Purchases NuSil Material and E-Labs Draws from Apollo Stock

Annual Volumes [***]

Annual [***]

See below

See below

Balloon Assembly, BIB (E/S), per [***] Includes Shell, BIB BB, [***] Material: NuSil [***] Assumes NuSil [***]kg, Xylene [***]/liter Includes Valve Ring, BIB produced [***] Includes Valve Cylinder Slit, [***] for [***] Bulk packaged in double poly bags and labeled Lead time: [***] weeks

For annual volumes between [***] See below

Balloon Assembly, BIB (E/S), per drawing 6870 Rev 10 [Apollo Purchases Nusil Material and E-Labs Draws from Apollo Stock] Includes Shell, BIB BB, [***] Material: NuSil [***] Silicone Assumes NuSil [***]/kg, Xylene [***]/liter Includes Valve Ring, BIB [***] Includes Valve Cylinder Slit, [***] for [***] each Bulk packaged in double poly bags and labeled Lead time: [***] weeks

For annual volumes between [***] See below

Budgetary pricing for higher volumes of BIB [***]

Annual Volumes [***] pieces

Annual [***]+ pieces

See below

See below

PRICES

TRANCHES BIB SYSTEM PRICING MATRIX [***] [***] [***] [***] BIB SYSTEM [***] [***] [***] [***] BIB SHELL [***] [***] [***] [***] BIB SHEATH [***] [***] [***] [***]

Conditions: • Prices have been calculated considering the information available to Establishment Labs on this date, subject to the requirements noted on each item. Prices may vary with further information. • Minimum yearly purchases of [***] units on each contract year. Five-year contract term is considered.

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• As discussed with client, the quote given is for the manufacture of both components; prices for individual components is for reference only. • No cost of equipment or molds is included in the pricing. Item 3, Tooling, does include the cost of specific tooling as requested, for reference. • Process set-up and validation is considered on as-is condition. No process modification is quoted at this stage. • Quality control and certificates included as detailed in Exhibit B • Product sold [***] • Item 3, Tooling includes ONLY: ◦ For BIB Balloon, each run consists of [***] ◦ For BIB Sheath each run consists of [***] ◦ Unit Prices of tools: ▪ BIB Balloon Mandrel [***] ▪ BIB Balloon Handle [***] ▪ BIB Sheath Mandrel [***] • Note: The Tooling price is incomplete, prices for the following were not requested and are not included: cutters, inserts, racks, carts and machines (sheath dipping, mixing, cutting, vulcanizing). • Invoicing during the first six months after deliver of First Article should be a minimum of [***]. Any difference will be paid by Apollo. • Payment Terms: ◦ Fee for project launch payable upon signing. ◦ Transition Plan payments: on milestone completion. ◦ Net 30 on product sales. • Projected timeline for First Articles / Validation is [***]. For every month Establishment comes in earlier than said date, [***] incentive payment will be paid to Establishment. • For clarity, for the period from the delivery date of the first Purchase Order (as described in Item 6(c) above) until the end of the Calendar Year in which such delivery date occurs, Company shall be required to order only [***] to be given the pricing on such Purchase Orders for [***] annual units for such Calendar Year. Thereafter, in subsequent Calendar Years, the annual volume minimums to be given volume pricing shall be as set forth above and shall be per Calendar Year. [NOTE: This is to bring the contract pricing into a calendar year basis after the first purchases.] • In the event of termination under section 2.2(b) no additional reparation charges have been agreed upon by the parties; any future agreed upon reparation charge or amount shall be binding only if adopted as an amendment to this Agreement.

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Exhibit B Regulatory Agreement

Establishment Labs Apollo BIB Balloon and Sheath Testing & Inspection Proposal

1. Manufacturing facility capabilities: • ISO Class 7 (ISO 14644-1:1999) - Certified clean room. • ISO 13485:2003 and ISO 9001:2008 Certified facility. • RDC#16:2013 Brazilian GMPs Approved facility. • SAP inventory levels remote consultation interface. Optional. 2. Certificate of raw material conformance as per specification for all supplier lots of silicone dispersions, valve ring, slit valve and silicone adhesive: • Incoming inspection testing, as applicable: ◦ Appearance, viscosity, Shore A durometer value, tear strength, refractive index, supplier certificate review, tack free time, tensile strength, and elongation. ◦ Verification of Slit Valve functionality at incoming receiving. • Pre-process testing and statistical analysis report to comply with mechanical properties of the shell: ◦ Shell thickness lot analysis. ◦ Shell elongation and break force. ◦ Tensile set. ◦ Lot viscosity and devol time process parameters definition. 3. Certificate of product conformance per lot, including: • Reference to Apollo/EL specifications drawing or Material Standard Specification. • EL Product Lot Number. • QTY description per lot. • Product Part Number and Description. • Raw Materials description with related documents including: ◦ Part number and supplier lot number. ◦ Supplier product certificates. • In process product testing controls, including: ◦ 100% shell and Sheath thickness report. ◦ 100% shell and Sheath visual inspection. ◦ 100% assembly visual inspection. ◦ Sampling testing for shell elongation and break force. ◦ Sampling testing for patch-joint. ◦ Sampling testing tensile strength. ◦ 100% leak test inspection of the balloon assembly. • DHR Review and QA approvals. • Other as required. 4. Process engineering: • Manufacturing procedures engineering change orders managing and execution. • Process parameters improvement and DMR's updating, if applicable. • Process data analysis.





• Process Control Plans that identify Procedures, tooling, critical process controls, inspection requirements, inspection frequency, and inspection equipment. 5. Digital back-up at Establishment Labs in accordance with Quality Standards of: • Raw material incoming inspection reports. • Pre-process testing reports. • DHRs for every lot number. • Lot processing parameters. • Clean room monitoring. • Equipment maintenance and calibration records. • Tensile tester testing raw data. 6. Validations: • All processes that cannot be verified need to be validated. 7. Quality System: • Must be updated to allow business as a contract manufacturer. • For Apollo product, updates should include but not limited to: customer related processes, customer audits, feedback, monitoring and measurement of product, management review, and analysis of non-conforming product.





Exhibit C

Fixtures and Tooling

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Output: Highlight the parts (if any) of this contract related to Insurance that should be reviewed by a lawyer. Details: Is there a requirement for insurance that must be maintained by one party for the benefit of the counterparty?