Document:

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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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 28th 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.

 

 

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.

 

1Exhibit 10.7

 

MediWound Ltd.

 

42 Hayarkon St.
 Industrial Zone Yavne, 81227 Israel
 Tel:                           +972 8 9324010
 Fax:                       +972 8 9324011

 

June 19, 2007

 

	
Mr. Mark Christian Klein
    	
E-mail:[***]
    
	
[***]
    	
cc:[***]
    
	
[***]
    	
By E-mail & Prepaid Airmail
    

 

Re:                                                     Amendment to License Agreement dated September 27, 2000
  Between Mr. Mark Christian Klein and MediWound Ltd.

 

Dear Mr. Klein,

 

Further to our meeting in New York, which took place on June 10, 2007, please find below a summary of said meeting:

 

1.                                      MediWound Ltd. (“MediWound”) reconfirms its commitment to send Mr. Mark Christian Klein (“Klein”) annual written reports as per section 7.6 of the above captioned license agreement (the “License Agreement”; copy attached hereto).

 

2.                                      In order to expedite delivery of Products to patients, to assist MediWound in attracting further financing, and to afford MediWound flexibility in its commercial development of Products, Klein wishes in good faith to waive his right to negotiate for new or additional compensation not contemplated in the Agreement in exchange for manufacturing rights desired by MediWound. Klein hereby confirms that the exclusive license Klein granted MediWound in the License Agreement is also for the purpose of manufacturing and having manufactured the Product (as defined in the License Agreement).  Accordingly, Sections 3.1 and 8.3 of the License Agreement shall be deemed amended, as follows:

 

Section 3.1:

 

“Without derogating from the provisions of Section 3.2 below, Klein hereby grants to MediWound with effect from the Effective Date, subject

 

*** 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.

 

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to the terms of this Agreement, an exclusive license under and using the Intellectual Property and Improvements for the purpose of developing, using, manufacturing, having manufactured, marketing, supplying and selling the Product in the Territory, with the right to sub- license”.

 

Section 8.3:

 

“MediWound shall purchase Bromelain from CBC and/or other sources pursuant to the CBC Agreement and shall be entitled to make and have made Product and pharmaceutical preparations thereof either by itself or through Sub-Contractors. Should Mediwound desire to acquire manufacturing rights to the Product, Klein shall negotiate with Mediwound in good faith for granting of such rights to Mediwound”.

 

3.                                      Without derogating from MediWound’s undertaking under the amended Section 8.1 of the Agreement (as set out below), MediWound, at its own discretion, will make reasonable commercial efforts to successfully conclude a pilot scale manufacturing and validation of 5 (five) consecutive batches of Product (the “Pilot Scale”), by the end of 2007.

 

4.                                      MediWound will pay Klein the amount of US$ 75,000 (US Dollars Seventy Five Thousand) which represents the second milestone payment, by December 31, 2007, regardless of the Pilot Scale.  Therefore, Section 4.1.2 of the License Agreement is hereby deemed amended, as follows:

 

“US$ 75,000 (US Dollars Seventy Five Thousand) by December 31, 2007. within 30 (thirty) days of successful pilot scale manufacturing and validation of 5 (five) consecutive batches of Product;

 

5.                                      The third milestone payment will be divided into two installments of US$ 75,000 each, as described below, and Section 4.1.3 is hereby deemed amended accordingly:

 

a)                                     “US$ 150,000  75,000 (US Dollars Seventy Five Thousand One Hundred and Fifty Thousand) upon the earlier to occur of (i) within 30 (thirty) days following the consummation of the Initial Closing as defined in that certain Share Purchase Agreement to be entered into during 2007 by and among MediWound and certain investors, or (ii) September 1, 2007; US$ 75,000 (US

 

*** 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.

 

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Dollars Seventy Five Thousand) after the completion Initiation  of a Pivotal Clinical Trial

 

6.                                      Section 8.1 is hereby deemed amended, as follows:

 

“During the term of this Agreement, MediWound shall use its best efforts to diligently develop, manufacture and commercially market finished pharmaceutical Products. Without limiting the generality of the foregoing, Mediwound shall fund the Development Plan in adherence with the milestones and time schedule set forth therein, without the participation of Klein”.

 

A failure by MediWound to meet Development Milestones will not entitle Klein to terminate the Agreement and/or receive the funds referred to in Section 15.4.2 of the License Agreement.  For the avoidance of doubt, this amendment in no way affects Klein’s right to terminate the Agreement for breach as set out in Section 15.1.

 

Accordingly, Sections 1.35, 15.2.4 and 15.4 as well as Exhibits 1.9 and 1.10 of the License Agreement are hereby deemed deleted.

 

7.                                      For the sake of clarity, Section 5.4 shall be amended as follows:

 

“5.4                         Upon cumulative Net Sales reaching $100,000,000 (US Dollars One Hundred Million), regardless of the countries in which such Net Sales occurred and whether there is or was at any time a Valid Claim in any such country, Mediwound shall pay Klein a lump sum of $1,500,000 (US Dollars One Million Five Hundred Thousand), as a one-time success fee, in addition to any other amounts due to Klein pursuant to this Agreement.”

 

8.                                      MediWound hereby reaffirms its commitment to pay Klein all payments to which he is entitled under the Agreement as amended.  MediWound will pay Klein royalties as set out in the Agreement in respect of any Product and will not claim or allege that a Product is not developed by using the Technology solely in order to avoid or reduce its payment obligations under the Agreement.

 

9.                                      Klein hereby waives any claim and/or contention raised in his letter of June 8, 2006, and/or related to the matters resolved herein except for a claim and/or contention in connection with MediWound’s breach of any of its obligations under this Amendment Letter.

 

*** 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.

 

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10.                               The Agreement shall be modified only as expressly specified above and all the other terms and conditions of the Agreement shall remain unchanged and in full force and effect.  For the avoidance of doubt, it is agreed that the amendments above shall be incorporated into the Agreement and shall constitute an integral part thereof.

 

 

	
 
    	
 
    	
Yours Sincerely,
    
	
 
    	
 
    	
/s/Gal Cohen
    
	
 
    	
 
    	
Gal Cohen, CEO
    
	
 
    	
 
    	
MediWound Ltd.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
/s/Ofer Gonen
    
	
 
    	
 
    	
Ofer Gonen, Director
    
	
 
    	
 
    	
MediWound Ltd.
    
	
 
    	
 
    	
 
    
	
Accepted and Agreed:
    	
 
    	
 
    
	
/s/ Mark Klein
    	
 
    	
 
    
	
Mr. Mark Christian Klein
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Date: 6/14/07
    	
 
    	
 
    

 

*** 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.

 

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DATED 27 September, 2000

 

Mark Klein

 

and

 

Mediwound Ltd.

 

 

License Agreement

 

 

Baratz, Gilat, Bar-Nathan & Co., Advocates & Notaries
 Amot Mishpat Bldg., 8 Shaul Hamelech Blvd., Tel-Avlv 64733 ISRAEL
 Tel:  972-3-6938787; Fax 972-3-6960986
 E-mail:  bgb@bgb-law.co.il

 

 

*** 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.

 

 

LICENSE AGREEMENT

 

This License Agreement (“Agreement”) is made and entered into as the 27th day of September, 2000 by and between Mr. Mark Christian Klein, bearer of U.S. passport number [***] (hereinafter referred to as “Klein”) and Mediwound Ltd., a corporation organized and existing under the laws of Israel (hereinafter referred to as “Mediwound”).

 

WITNESSETH:  THAT

 

Whereas, Klein is the owner of certain patents and proprietary information and know-how relating to a pharmaceutical product known as debridase, based on Bromelain (as such term is defined below), which product may be used for debriding bums and other wounds; and

 

Whereas, Mediwound desires to obtain an exclusive license under the patents and proprietary information and know-how belonging to Klein relating to the product referred to in the recital above to manufacture, develop and market a product for debriding bums and other wounds in humans.

 

NOW THEREFORE IN CONSIDERATION OF THE MUTUAL PROMISES AND COVENANTS SET FORTH HEREIN IT IS HEREBY AGREED AS FOLLOWS:

 

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’’ mean 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

 

*** 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.

 

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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” means the raw material derived from pineapple sterns and specially processed for the Product, presently manufactured by CBC at its facility in the Republic of China, having the specifications set forth in Exhibit 1.3.

 

1.4                               “CBC” means Challenge Bioproducts Corporation Ltd., a corporation organized and operating in the Republic of China.

 

1.5                               “CBC Agreement” means an Agreement to be entered into between Mediwound and CBC whereby Mediwound shall acquire the Bromelain required to manufacture Product from CBC.

 

1.6                               “Commercial Delivery” means the sale of the Product to a Customer, excluding sales for experimental or test market purposes.

 

1.7                               “Conditions Precedent” means the cumulative conditions listed in Section 2.1.

 

1.8                               “Customer” means any third party, other than an Affiliate, to whom Mediwound or its Affiliates supply Product.

 

1.9                               “Development Milestones” means the milestones to be met by Mediwound in the course of development of the Product, as set forth in Exhibit 1.9.

 

1.10                        “Development Plan” means the development program directed towards the development and registration of the Product, as set out in Exhibit 1.10.

 

*** 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.

 

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1.11                        “Effective Date” shall have the meaning ascribed to such term in Section 2.2.

 

1.12                        “FDA” means the Food and Drug Administration of the United States Government.

 

1.13                        “Field” means the treatment of all forms of burns and other wounds in humans by way of debriding with debridase or other products derived using the Technology;

 

1.14                        “Improvement” means any new composition or formulation of Product or any new application of, or presentation or configuration of the Product including combinations with any dressing, vehicle or any medical devise, having application or potential application in the Field or any additional indication, conceived, developed or otherwise acquired by Klein and/or his Affiliates during the term of this Agreement.

 

1.15                        “IND” means the document named US FDA IND no. 18,579 filed by Klein or a company controlled by Klein, with the FDA.

 

1.16                        “Initiation” means the first dosing of a patient in a clinical trial;

 

1.17                        “Intellectual Property” means the Technology and the Patents.

 

1.18                        “LR” means either or both of L.R. R & D Ltd. and/or Professor Lior Rosenberg.

 

1.19                        “LR Agreement” means a License Agreement between Mediwound and LR whereby Mediwound shall licensee certain Product-related know-how from LR.

 

*** 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.

 

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1.20                        “Lump Sum Revenues” means all gross payments which Mediwound or its Affiliate actually receive from a Sub-Licensee in consideration for a sub-license of any of the rights granted to Mediwound hereunder, in the form of lump sum license fees or milestone payments, other than payments made as a reimbursement of or contribution to expenditure incurred or to be incurred by Mediwound or its Affiliate on the development of Product.

 

1.21                        “Major Country” means each of the USA, Canada, England, France, Germany, Italy, Spain and Japan.

 

1.22                        “MOU” means the Memorandum of Understanding of January 18, 2000 between Mediwound (as assignee of Clal Biotechnology Industries Ltd.), Klein and CBC.

 

1.23                        “Net Sales” means the net selling price for Product established in bona fide, arms length transactions between Mediwound or its Affiliates and Customers, after deducting (i) any quantity, quality and customary trade discounts; (ii) packing, transportation and insurance charged to the Customer; (iii) import, export, excise and sales taxes and custom duties; and (iv) credit for returns, allowances, or trades.

 

1.24                        “Other Royalties” means all running royalties which Mediwound or its Affiliate actually receive from a Sub-Licensee on a Sub-Licensee’s sales of Product.

 

1.25                        “Patents” means the patents listed in Exhibit 1.25 and any patents that issue thereupon and all divisions, additions, continuations, continuations-in-part, reissues, supplementary, protection certificates and extensions thereof.

 

1.26                        “Pivotal Clinical Trial” means a clinical trial approved and defined by a Regulatory Authority in a Major Country as such.

 

1.27                        “Product” means any Bromelain-based pharmaceutical product developed by using the Technology, in any pharmaceutical form, configuration and presentation, and any improvement thereof, for wound debridement or other indications.

 

*** 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.

 

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1.28                        “Revenues’’ means Lump Sum Revenues and Other Royalties.

 

1.29                        “Quarter” means a 3 (three) month period ending on the last day of March, June, September or December in any year.

 

1.30                        “Regulatory Authority” means the FDA or similar governmental or other agency in any country or region having authority to grant Approval.

 

1.31                        “Royalty Years” means consecutive 12 (twelve) month periods commencing as from the first Commercial Delivery to a Customer in a Major Country in the Territory.

 

1.32                        “Sub-Contractor” means any firm or company whose services are retained by Mediwound to transform Bromelain into Product and to package, label and deliver pharmaceutical preparations of the Product in finished form to Mediwound and its Sub-Licensees.

 

1.33                        “Sub-Licensee” means any person, firm or company sub-licensed by Mediwound under the Intellectual Property to practice any of the licenses granted hereunder.

 

1.34                        “Technology” means all technology, developments, creations, ideas, know-how, methods, documentation, written works, research, data and information of any kind pertaining to escharase or debridase or debridement technology, including, without limitation, any information relating to manufacture and use thereof and any technical regulatory, research, and clinical data relating thereto, that, in each case, are owned by Klein and/or his Affiliates or under his and/or their control on the Effective Date hereof identified in the documents referred to in Exhibit 1.34 and in the Patents, or under his and/or their control during the term hereof.

 

1.35                        “Target Date” means the target date set for the achievement of each Development Milestone, as specified in Exhibit 1.9.

 

*** 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.

 

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1.36                        “Territory” means the world.

 

1.37                        “Valid Claim” means a claim in any issued and unexpired Patent which has not been disallowed or held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through re-issue or disclaimer or otherwise.

 

2.                                      Conditions Precedent

 

2.1                               Conditions Precedent to the provisions of this Agreement becoming effective shall be all of the following:

 

2.1.1                     The successful conclusion by Mediwound of a technological, financial and legal due diligence review of the subject matter of this Agreement, as stipulated in the MOU;

 

2.1.2                     Execution of the LR Agreement;

 

2.1.3                     Execution of the CBC Agreement; and

 

2.1.4                     Approval of this Agreement and the agreements referred to in Sections 2.1.2 and 2.1.3 by the Board of Directors of Mediwound.

 

2.2                               The date upon which Mediwound shall have acknowledged in writing to Klein that the Condition Precedent have all been met shall be the “Effective Date”.  Where the Conditions Precedents have not be 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.                                      License

 

3.1                               Klein hereby grants to Mediwound with effect from the Effective Date subject to the terms of this Agreement, an exclusive license under and using the Intellectual Property and Improvements for 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.

 

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purpose of developing, using, marketing, supplying and selling the Product in the Territory, with the right to sub-license.

 

3.2                               Save as provided in the CBC Agreement or in Section 8.3 below, Klein shall not and shall not permit any Affiliate or third party to manufacture, use, supply or sell Product or use the Intellectual Property or Improvements.

 

3.3                               Within 7 (seven) days of the Effective Date, Klein shall furnish to Mediwound copies of all of the Patents and of the IND along with an assignment of his rights therein.

 

3.4                               Klein will make available to Mediwound for examination and copying all records, files and other written information pertaining to the Technology that are in Klein’s possession.  Following the Effective Date, upon request by Mediwound, at reasonably convenient times and with at least 72 (seventy-two) hours advance notice, Klein shall make such records, files and other information available to Mediwound at Klein’s premises for further examination and copying.

 

3.5                               As further Technology and Improvements come into the possession of Klein and/or his Affiliates, Klein shall forthwith notify Mediwound, and disclose the same to Mediwound at Mediwound’s request.

 

3.6                               Klein shall forthwith upon the written request of, Mediwound execute a formal license or or other documents which may be required in respect of the Patents so as to register the rights granted hereunder in any patent registry, as Mediwound may deem necessary and appropriate.

 

4.                                      Milestone Payments

 

4.1                               In consideration of the grant of the rights and licenses under this Agreement, Mediwound shall make the following payments to Klein:

 

4.1.1                     US$ 150,000 (US Dollars One Hundred and Fifty Thousand) within 7 (seven) days of the Effective Date.

 

4.1.2                     US$ 75,000 (US Dollars Seventy Five Thousand) within 30 (thirty) days of successful pilot scale manufacturing and validation of 5 (five) consecutive batches of Product;

 

*** 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.

 

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4.1.3                     US$ 150,000 (US Dollars One Hundred and Fifty Thousand) within 30 (thirty) days of Initiation of a Pivotal Clinical Trial;

 

4.1.4                     $ 125,000 (US Dollars One Hundred and Twenty Five) within 18 (months) of the Effective Date;

 

4.1.5                     $ 200,000 (US Dollars Two Hundred Thousand) within 30 (thirty) days of submission for Approval in a Major Country;

 

4.1.6                     US$ 250,000 (US Dollars Two Hundred and Fifty Thousand) within 30 (thirty) days of Approval of the use of the Product in a Major Country; and

 

4.1.7                     Running royalties, success fees and other payments in accordance with the provisions of Section 5 below.

 

4.2                               For the sake of clarity, it is hereby agreed that payments to be made pursuant to Sections 4.1.5 and Section 4.1.6 shall be due where the same are made or granted (as the case may be) in a Major Country or via the EMEA or CPMP or a similar kind of centralised procedure.

 

5.                                      Royalties and Success Fee

 

5.1                               In consideration for the grant of the licences set out in Section 3 and for the other benefits accruing to Mediwound under this Agreement in addition to the payments due to Klein pursuant to Section 4 above, Mediwound shall pay to Klein running royalties, success fees and other payments as provided in this Section 5.

 

5.2                               Mediwound shall pay to Klein royalties on the Net Sales of Product sold by Mediwound and its Affiliates in any country in the Territory, calculated as follows, subject to the provisions of Section 5.3:

 

5.1.1                     3% (three percent) in respect of cumulative Net Sales of up to $ 50,000,000 (US Dollars Fifty Million):

 

5.1.2                     4% (four percent) in respect of cumulative Net Sales of between $ 50,000,000 (US Dollars Fifty Million) and $ 100,000,000 (US-Dollars One Hundred Million):

 

5.1.3                     5% (five percent) in respect of cumulative Net Sales which exceed $ 100,000,000 (US Dollars One Hundred Million)

 

By way of illustration, if cumulative Net Sales during the first calendar quarter of the first Royalty Year reach $ 40,000,000 (US

 

*** 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.

 

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Dollars Forty Million) and if in the second calendar quarter cumulative Net Sales (inclusive of sales during the first and second quarters) reach $ 70,000,000 (US Dollars Seventy Million), and provided that all of the Products were sold to countries in which there are Valid Claims, the royalty rate payable during the first calendar quarter would be 3% (three percent) and the royalty rates payable during the second calendar quarter would be calculated at 3% (three percent) with respect to the first $ 10,000,000 (US Dollar Ten Million) in Net Sale during the second quarter and 4% (four percent) of the next $ 20,00,000 (US Dollars Twenty Million) in Net Sales during the second quarter.

 

5.3                               All of the royalty rates set forth in Section 5.2 shall be reduced by 50% (fifty percent) in respect of Net Sales of Product in any country in the Territory where sales of Product are not subject to a Valid Claim.  By way of illustration as to royalties payable pursuant to Section 5.2.1 above, until such time as cumulative Net Sales reach $ 50,000,000 (US Dollars Fifty Million), Klein shall; be entitled to royalties at a rate of 1.5% (one and a half percent) in respect of Net Sales of Product to countries in which there are no Valid Claims and 3% (three percent) in respect of Net Sales of Product to countries in which there are Valid Claims.

 

5.4                               Upon cumulative Net Sales reaching $ 100,000,000 (US Dollars One Hundred Million), Mediwound shall pay Klein a lump sum of $ 1,500,000 (US Dollars One Million Five Hundred Thousand), as a one-time success fee, in addition to any other amounts due to Klein pursuant to this Agreement.

 

5.5                               The royalties and success fees which may be payable pursuant to Sections 5.1 through 5.4 above shall be payable in respect of sales of Product in the Territory until the expiration of 15 (fifteen) Royalty Years, starting from the first Commercial Delivery in a Major County it being understood and agreed, however, that Klein shall be entitled to such payments in respect of sales of Product in each Major Country, for not less than 10 (ten) Royalty Years starting from the first Commercial Delivery in such Major.

 

5.6                               Royalties and success fees due under Sections 5.1 through 5.4 above shall be payable within 45 (forty-five) days of the end of each Quarter in respect of Net Sales collected by Mediwound during such Quarter.

 

5.7                               Where Mediwound collects Lump Sum Revenues, then Klein shall be entitled to receive 2% (two percent) of all Lump Sum Revenues up to the first $ 1,000,000 (US Dollars One Million) paid to

 

*** 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.

 

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Mediwound as Lump Sum Revenues and 4% (four percent) of all Lump Sum Revenues paid to Mediwound in excess of such sum.

 

5.8                               Where Mediwound collects Other Royalties, then Klein shall be entitled to receive 20% (twenty percent) of such payments where received in respect of sales of Products in a country in which there is a Valid Claim and 10% (ten percent) in respect of sales of Products in any other country.

 

5.9                               Payments due to Klein as per Sections 5.7 and 5.8 above will-be made, pro rata, within 45 (forty-five) days of collection of the underlying payments by Mediwound.

 

6.                                      Payment Terms

 

6.1                               All sums due under this Agreement shall be made:-

 

6.1.1                     in United States Dollars to the credit of a bank account to be designated in writing by Klein.  If the Product is sold or supplied by Mediwound or its Affiliates or Revenues are collected in a currency other than United States Dollars Net Sales or Revenues (as the case may be) shall first be determined in the currency in which such Product was sold or supplied or Revenues were collected and then converted into equivalent United States Dollars at the middle market rate of such foreign currency as quoted by the Wall Street Journal as at the close of business of the last business day of the Quarter with respect to which the payment is made;

 

6.1.2                     in full without deduction of income or other taxes, charges and/or duties that may be imposed except insofar as Mediwound is required to deduct the same to comply with relevant laws.  In the event that Mediwound is required to make any such deduction it shall promptly provide Klein with a certificate or other documentary evidence sufficient to enable Klein to support a claim for a tax credit in respect of any amount so withheld;

 

6.1.3                     by the due date for payment as provided in this Agreement failing which Klein may without prejudice to any other right or remedy available to Klein under this Agreement, charge a late payment fee equal to the interest compounded daily at the lesser of the prime rate as published by the Wall Street Journal plus 5 (five) percentage points per annum or the maximum rate allowed under applicable law.

 

*** 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.

 

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7.                                      Records And Reports

 

7.1                               Mediwound and its Affiliates shall keep at their normal place of business detailed, accurate and up to date records and books of account showing the quantity and value of the Product supplied and Net Sales and Revenues collected by Mediwound and its Affiliates with respect to each country within the Territory and being sufficient to ascertain the royalties and other payments payable during the term of this Agreement and for 2 (two) years thereafter.

 

7.2                               Having been given 10 (ten) or more days notice by Klein, Mediwound shall make such records and books available for inspection, in sufficient detail to enable Klein to determine the amounts due from Mediwound pursuant to this Agreement, at its premises at all reasonable times during business hours not more than twice in any calendar year by Klein or an independent auditor appointed by Klein for the purpose of verifying the accuracy of any statement or report given by Mediwound to Klein and/or the amount of royalties due and other payments due hereunder and any such representatives making such inspection shall be entitled to take copies or extracts from the records and books of account of Mediwound and its Affiliates.

 

7.3                               Klein and his independent auditor appointed under Section 7.2 above shall maintain all such information and materials in strict confidence.

 

7.4                               Klein shall be solely responsible for his costs in making such inspections unless there is an inaccuracy that is greater than 5 (five) percent on any royalty statement in which event Mediwound shall forthwith pay to Klein the costs in making the relevant inspections and in any event, make up any deficiency.

 

7.5                               Mediwound shall send to Klein at the same time as each royalty payment is made under Section 5 above a statement signed by Mediwound’s Chief Financial Officer setting out the quantity of Product sold, the calculations of Net Sales and Revenues collected during the Quarter to which the royalty payment is applicable and totals, by country per month.  The statement shall show the total Net Sales and Revenues expressed both in local currency and in United States Dollars, showing the conversion rates used.

 

7.6                               Within 30 (thirty) days of the end of each calendar year during the term of this Agreement, Mediwound will prepare and submit to

 

*** 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.

 

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Klein a written report describing Mediwounds activities with respect to development of Products, regulatory applications and approvals with respect to the Products and commercialization of the Products.

 

8.                                      Development and Manufacturing

 

8.1                               During the term of this Agreement, Mediwound shall use its best efforts to develop and commercially market finished pharmaceutical Products.  Without limiting the generality of the foregoing, Mediwound shall fund the Development Plan in adherence with the milestones and time schedule set forth therein, without the participation of Klein.

 

8.2                               Mediwound shall be responsible for applying for and prosecuting applications for Approvals, in all countries in the Territory and shall be responsible for the maintenance of all such Approvals.  All Approvals shall be applied for in Mediwound’s name.

 

8.3                               Mediwound shall purchase Bromelain from CBC and/or other sources pursuant to the CBC Agreement and shall be entitled to make and have made Product and pharmaceutical preparations thereof through Sub-Contractors.  Should Mediwound desire to acquire manufacturing rights to the Product, Klein shall negotiate with Mediwound in good faith for the granting of such rights to Mediwound.

 

9.                                      Mediwound’s Launch and Marketing Efforts

 

9.1                               All business decisions, including but not limited to, pricing, reimbursement, package design, sales and promotional activities relating to the Product, shall be within the sole discretion of Mediwound.

 

9.2                               Mediwound and its Affiliates as the case may be, shall be solely responsible for the preparation of scientific literature and promotional material relating to the Product in accordance with its normal business practices and quality standards.

 

9.3                               Mediwound shall use reasonable efforts to promote, market and launch the Product in each Major Country as soon as practicable after obtaining the requisite Approval in such Major Country Mediwound will invest reasonable efforts to promote, market and launch the Product in other countries in the Territory, on the basis of sound commercial considerations.

 

*** 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.

 

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9.4                               Mediwound shall promptly inform Klein of the date of launch and first Commercial Delivery of Product in each of the Major Countries.

 

10.                               Patents; Infringement

 

10.1                        Mediwound shall at its own cost and expense prosecute any patent applications within the Patents, and use reasonable efforts to obtain patents thereon, to defend and maintain any such Patents and to pursue new patents and other forms of intellectual property protecting the Technology.

 

10.2                        Infringement of Third Party Rights

 

10.2.1              If the manufacture, use or sale of Product using the Intellectual Property constitutes an infringement of the rights of a third party in a country of the Territory, each party shall, as soon as it becomes aware of such infringement, notify the other party thereof in writing giving in the same notice full details known to it of the rights of such third party and the extent of any potential infringement.

 

10.2.2              In the event that Mediwound negotiates a license from such third party then Mediwound shall be entitled to credit up to 50% (fifty percent) of any actual license fees or royalties paid by Mediwound under any license negotiated with such third party against royalties, milestone and other payments due to Klein under this Agreement in respect of the countries covered by such third party rights only.

 

10.2.3              If Mediwound decides to defend a suit or claim referred to in Section 10.2.1 above then Mediwound shall have the right to deduct from the royalties otherwise payable to Klein under Section 5 be in respect of countries covered by such third party rights on sales of the allegedly infringing Products up to 50% (fifty percent) of its reasonable legal and experts’ fees in defending such suit or claim as well as 50% (fifty percent) of any amounts so awarded to a third party.

 

10.3                        Infringement of the Intellectual Property

 

10.3.1              In the event that either party becomes aware of any infringement or suspected infringement of the Intellectual Property or misuse of the Technology then it shall promptly give notice to the other 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.

 

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10.3.2              Mediwound may at its own discretion take such action that it may consider necessary and appropriate to terminate or prevent such infringement or misuse.  Mediwound shall be entitled to retain all damages and other sums, so attained by it except for an amount equal to a 20% (twenty percent) royalty thereon as if the same were Other Royalties, after deduction of 50% (fifty percent) of Mediwound’s reasonable legal fees, experts fees and other expenses incurred in prosecuting such claim.

 

11.                               Technical Assistance

 

11.1                        During the first 2 (two) years commencing from the Effective Date, Klein shall, at the request of Mediwound after prior coordination and reasonable notice in advance, render technical support and assistance to Mediwound in connection with the activities described in Sections 8 and 10 of this Agreement, over a number of days not to exceed 20 (twenty) per year, in the aggregate.

 

11.2                        Klein shall bear his own overheads in rendering such assistance, but Mediwound shall, promptly against Klein’s invoice therefor, pay Klein $ 1,000 (US Dollars One Thousand) per day and reimburse Klein with his direct travel, lodging, food and other related out-of-pocket expenses approved in writing, in advance.

 

11.3                        Klein shall provide all reasonable assistance to Mediwound (including but not limited to the use of his name in or being joined as a party to the proceedings) at the request of Mediwound, in connection with any action taken by Mediwound pursuant to the provisions of Section 10.  Klein shall collaborate with legal counsel appointed by Mediwound in connection with any action taken by Mediwound pursuant to Section 10.3, the fees and other expenses of which shall be borne by Mediwound.  Without derogating from Mediwound’s undertakings pursuant to Section 11.2 above, Mediwound shall indemnify Klein against all and any costs, expenses, losses, damages or compensation awarded against or incurred by Klein as a result of such action being taken.

 

12.                               Representations and Warranties, Liability and Indemnity

 

12.1                        Klein represents and warrants that:

 

12.1.1              he is free to enter, into this Agreement in his own right and that there are no rights exercisable by or obligations owed to any third party, including, without limitation,

 

*** 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.

 

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Bioproducts Inc. which may prevent or restrict him from entering into this Agreement;

 

12.1.2              he is the absolute legal owner of the Intellectual Property, free and clear of all liens, charges and encumbrances,

 

12.1.3              he shall safely store at his office in Brunswick, Maine, and immediately disclose, allow access to, and furnish Mediwound with copies of, any of the documents which form part of the Intellectual Property, as requested by Mediwound from time to time;

 

12.1.4              so far as he is aware the Patents are or will be when granted valid and that the manufacture, use, sale, import or export of Product in the Field or for any other indication will not infringe the rights of any third party;

 

12.1.5              he has disclosed to Mediwound all information in his possession relating to the Product and in which the novelty, validity or sufficiency of the Patents and any claim made therein has been challenged or disallowed; and

 

12.1.6              there are no claims or actions by any third parties on the basis of which Klein has any reason to believe that Mediwound’s practice of the Intellectual Property will infringe any valid patent or constitute a misappropriation of trade secrets of others.

 

12.2                        Except as expressly set forth in Section 12.1, Klein makes no express or implied representation or warranty of any kind regarding the Technology or any Product, and the license of the Technology hereunder is “as is”.  Without limiting the generality of the foregoing, Klein makes no express or implied representation or warranty as to:

 

12.2.1              The validity or scope of any Patent right; and

 

12.2.2              The Technology being exploited without infringing intellectual property rights of third parties; or

 

12.2.3              The Technology being effective or free of defects.

 

12.3                        Except as provided in Section 12.8 below, in no event shall the liability of Klein in connection with this Agreement exceed the total amount actually paid to Klein by Mediwound under the terms of this Agreement.  Klein shall have no obligation to indemnify Mediwound in respect to any damages to the extent that such damages are reimbursed by insurance maintained by Mediwound

 

*** 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.

 

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or any other person, it being understood that Mediwound shall be obligated to seek reimbursement for losses covered by any such insurance.

 

12.4                        Mediwound represents and warrants that:

 

12.4.1              it has the legal power to enter into this Agreement; and

 

12.4.2              neither the execution nor the performance of this Agreement will result in any violation of any statute, regulation or judicial decree, or cause if to breach any contractual commitment by which it is bounds.

 

12.5                        Mediwound shall assume all liabilities arising from the development, testing use, offer for sale, sale or supply, by, through or on behalf of Mediwound or its Affiliates, of the Product (and related materials) in the Territory, including without limitation all claims based upon product liability laws, as of the Effective Date.

 

12.6                        Mediwound shall defend, indemnify and hold harmless Klein and his Affiliates from and against any and all claims, demands, losses, damages and/or expenses (including without limitation reasonable fees) arising from or in connection with any development, testing, manufacture, use, sale or supply by Mediwound or its Affiliates of the Product in the Territory.

 

12.7                        Mediwound shall exonerate, hold harmless, defend and indemnify Klein against any kind of claim or liability whatsoever arising out of any failure or alleged failure including, without limiting the generality of the foregoing, claims of participants in clinical trials, Customers, end-users, members of the public or of any government agency or employees’ claims as a result of any use of clinical trials or other studies with, and/or Mediwound’s practice of the Technology.

 

12.8                        Klein shall exonerate, hold harmless, defend and indemnify Mediwound against any kind of claim or liability whatsoever arising out of the development and/or testing of the Technology prior to the date hereof, including, without limitation, any liabilities, losses or damages whatsoever with respect to death or injury to any individual or damage to any property arising from clinical trials conducted by Klein alone or together with his Affiliates or associates prior to the Effective Date.

 

13.                               Confidential Information; Confidentiality; Non Competition

 

13.1                        Klein and Mediwound undertake to each other to keep, and shall procure that their respective Affiliates, employees, directors,

 

*** 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.

 

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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”) provided that Confidential Information shall not include the following:

 

13.1.1              information which at the time of disclosure by one party to the other is in the public domain;

 

13.1.2              information which after disclosure by one party to the other becomes part of the public domain by publication except by breach of this Agreement;

 

13.1.3              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

 

13.1.4              information received from third parties who were lawfully entitled to disclose such information.

 

13.2                        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.

 

13.3                        The confidentiality and non-use obligations contained in this Agreement shall continue for the duration of this Agreement and for a period of 10 (ten) years after termination or expiry of this Agreement.

 

13.4                        The provisions of this Section 13 shall in no event prevent Mediwound from disclosing any Technology to Regulatory Authorities or other governmental agencies, if required, in support of any application for regulatory approvals or any amendments thereof in accordance with the provisions of this Agreement or in general whenever required to disclose such information under any applicable law or regulation provided that Mediwound shall notify Klein of its intention and the identity of the intended recipient as soon as reasonably practicable prior to the date of disclosure.

 

13.5                        Mediwound shall enter into and maintain agreements with each of its employees, who have access to the Technology or the Improvements, under which each employee assigns and conveys to Mediwound all of his or her rights in all technology, and all proprietary rights therein, that derives from or is based upon the Technology, the Improvements or any Product.

 

*** 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.

 

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13.6                        In consideration of the mutual provisions contained in this Agreement, Mediwound and Klein each agree not to, directly or indirectly, own, operate, manage, finance, grant rights to, or otherwise assist, participate or engage in any business or effort to develop or market any bromelaine based debridement product other than the Products.  The foregoing restriction shall apply to the parties during the term of this Agreement.  If this Agreement is terminated by reason of the satisfaction in full of all of Mediwound’s obligations to make payments hereunder, the foregoing restriction shall continue to apply to Klein for a period of five (5) years following such termination.  If this Agreement is terminated for any reason other than that described in the preceding sentence, the foregoing restriction shall continue to apply to Mediwound for a period of five (5) years following termination.

 

14.                               Duration

 

This Agreement and the licenses granted Clause 3 shall come into force on the Effective Date and unless terminated earlier in accordance with the provisions of this Agreement, this cessation of all obligations to pay royalties under Clause 5 and thereafter Mediwound shall have a fully paid up royalty free license the Product.

 

15.                               Termination

 

15.1                        In the event of any breach of this Agreement at any time, if the breach complained of, shall be corrected by the breaching party within 60 (sixty) days of the other party’s notice, either party hereto may, without affecting its ability to recover amounts owed or enforcing any rights pursuant to this Agreement at its option:

 

15.1.1              by giving 60 (sixty) days written notice, specifying breach complained of, terminate this Agreement, and the licenses herein granted, and the party asserted to be in breach shall have the right to treat the alleged breach as a dispute under Section 21; or

 

15.1.2              regard the breach and any failure to cure as the basis for a dispute and proceed to dispute resolution under Section 21 and such legal or equitable remedy as shall be applicable.

 

15.2                        If any of the following shall occur:

 

*** 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.

 

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15.2.1              Mediwound shall file a voluntary petition in bankruptcy or for any other relief under any bankruptcy or insolvency statutes as may be amended from time to time or make an assignment for the benefit of its creditors; or

 

15.2.2              Mediwound shall have an order made or pass a resolution for winding up;

 

15.2.3              Mediwound shall be declared either an insolvent or bankrupt or if a receiver or trustee is appointed for part or all of the assets of Mediwound on behalf of any creditor or creditors, and the order, judgement or decree making such appointment shall not be vacated or set aside within 90 (ninety) days after the date hereof;

 

15.2.4              Subject to Section 15.4, any failure by Mediwound to meet a Development Milestone within 6 (six) months of the corresponding Target Date this Agreement, at the option of Klein, may be terminated by giving notice to Mediwound of such intention to terminate and on receipt of such notice this Agreement shall terminate.

 

15.3                        Where in the opinion of Mediwound the development or sale or supply of Product is no longer appropriate or cannot be undertaken by Mediwound for an Intellectual Property, technical or regulatory-related reason it may terminate this Agreement in its entirety by giving 6 (six) months written notice whereupon Mediwound and Klein shall be released of all obligations and for the liability hereunder with respect thereto, except for the provisions of Clause 15.6 which shall apply.

 

15.4                        Notwithstanding the provisions of Sections 15.2.4, if Mediwound shall be unable to meet a Development Milestone within 6 (six) months of the corresponding Target Date, Mediwound shall be given additional time to remedy the situation, upon the following conditions:

 

15.4.1              Mediwound shall continue to make diligent efforts to meet the Development Milestones, and

 

15.4.2              Mediwound shall pay Klein $ 25,000 (US Dollars Twenty-Five Thousand) for each calendar, quarter of delay, starting from the first calendar quarter that commences after expiration of the 6 (six) month grace period provided for above, up to a maximum of 3 (three) such calendar quarters.  Following the expiration of such 3 (three) calendar quarters the parties shall make an effort to

 

*** 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.

 

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negotiate a mutually acceptable basis for the continuance of their collaboration, failing which Klein shall be entitled to terminate this Agreement by written notice to Mediwound

 

For the avoidance, of any doubt, difficulties with Regulatory Authorities which are beyond Mediwound’s control shall be treated as “force majeure’’ events, and the provisions of Section 18 shall apply.

 

15.5                        Without derogating from any other remedies that may be applicable, termination of the license by Klein pursuant to Sections 15.1 or 15.2.4, for any reason other than a breach involving non-payment, shall not go into force or effect, or entitle Klein to restrain or prevent Mediwound from utilizing the Intellectual Property, until such time as a decision supporting the grounds for Klein’s decision to terminate, is issued by an arbitration appointed in accordance with the provisions of Section 21.

 

15.6                        Upon termination of this Agreement pursuant to any of the provisions of Sections 15.1, 15.2, 15.3 or 18:

 

15.6.1              The licenses granted under Section 3 shall terminate automatically.

 

15.6.1              Mediwound shall and shall procure that its Affiliates shall immediately stop all activities licensed hereunder, except that Mediwound and its Affiliates shall be permitted to offer for sale and sell and supply remaining stocks of Product in their possession at the date of termination or delivered thereafter as quickly as reasonably possible and complete deliveries on contracts in force at that date subject to the payment of royalties under and in accordance with the provisions of Sections 5 and 6.

 

15.6.2              Mediwound shall within 30 (thirty) days of the date of termination make all outstanding payments due to Klein.

 

15.6.3              Mediwound shall transfer to Klein and/or its designees all applications for Approvals and Approvals in its name.

 

15.6.4              Mediwound shall transfer to Klein and/or its designees all of the Technology and Product-related data as it reasonably may so that Klein can continue to develop and promote and ultimately deliver burn treatment products based on the Technology to patients unencumbered by any obligations to Mediwound.

 

*** 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.

 

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15.6.5              The provisions of this Section 15 and Sections 11, 12, 13, 17, 18, 20 and 21 shall continue in full force and effect following termination.

 

16.                               Publicity

 

Each of the parties hereto shall be entitled to make news releases and public announcements relating to the existence of this Agreement and the subject matter to which it relates.

 

17.                               Assignment

 

17.1                        Subject to Sections 17.2 and 17.3, 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.

 

17.2                        Mediwound may grant any sub-license of its rights or obligations thereunder without the prior written consent of Klein and shall notify Klein of the grant of any sub-license and provide Klein with a summary of the terms thereof as soon as reasonably practicable following such grant.  The grant of any sub-license by Mediwound shall not relieve Mediwound of any of its obligations hereunder and Mediwound shall incorporate within the terms of any such agreement rights and obligations consistent with the rights and obligations granted hereunder and including without limitation those as to confidentiality and Mediwound shall procure the performance of any sub-license by its Sub-Licensee.

 

17.3                        The parries may assign this Agreement or perform some or all of their obligations under this Agreement to and through their Affiliates provided that each party shall remain solely responsible for and be guarantor of the performance by its Affiliates and procure that its Affiliates comply fully with the provision of this Agreement in connection with such performance.

 

18.                               Force Majeure

 

If the implementation of this Agreement or of any obligation hereunder is delayed, prevented or restricted or interfered with by reason of (i) war arined conflict, embargoes, strikes, labor conflicts, riots, fires, floods, explosions, natural calamities, wreckage of material, delay or interruption

 

*** 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.

 

21

 

of transportation, any law of any government; or (ii) any other acts whatsoever, whether similar or dissimilar to those above enumerated beyond the reasonable control of a Party hereto, which shall make it impracticable, impossible or exorbitant for the Party concerned, from an industrial or commercial point of view to carry out its obligations, there shall be no breach or violation of this Agreement and the party so affected, upon giving prompt notice to the other shall not be liable for non-performance or delay in performance of its obligations, to the extent of such prevention, restriction or interference however that the party so affected shall use its best efforts to remove such cause of non-performance and that both parties resume performance hereunder with the utmost dispatch whenever such causes are removed Provided further that if the force majeure condition shall continue for 6 (six) consecutive months, either party may terminate this Agreement without incurring any further liability.

 

19.                               Miscellaneous

 

19.1                        The parties will execute and deliver any and all documents and instruments of all kinds, necessary or appropriate to carry this Agreement into effect

 

19.2                        If any provision of this Agreement is held to be invalid or inapplicable by a court of competent jurisdiction the remaining provisions will continue in full force and the parties will make such amendments to this Agreement by the addition or deletion of wording as appropriate to remove the invalid or unenforceable part of such provision but otherwise achieve to the maximum extent permissible the economic, legal and commercial objectives of the original provision.

 

19.3                        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

 

19.4                        The headings in this Agreement are for convenience only and shall not affect its interpretation References in the singular include the plural and vice versa References to Recitals, Sections and Exhibits are references to Recitals, Sections and Exhibits to this Agreement.

 

19.5                        Neither party shall act or describe itself as the agent of the other nor shall it make, or represent that it has authority to make any commitment on the other’s behalf.

 

19.6                        This Agreement shall constitute the entire agreement and understanding of the parties relating to the subject matter of this

 

*** 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.

 

22

 

Agreement and supersede all prior oral or written agreements, understandings or arrangements between them relating to such subject, except for the MOU, which shall be deemed superseded by this Agreement only upon the Effective Date.

 

19.7                        No change or addition may be made to this Agreement except in writing signed by the duly authorised representatives of both parties.

 

20.                               Notices

 

20.1                        Any notice or other document given under this Agreement shall 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.

 

20.2                        Each such notice or document shall:

 

20.2.1              if sent by hand, be deemed to have been given when delivered at the relevant address;

 

20.2.2              if sent by prepaid airmail, be deemed to have been given 10 (ten) days after posting; and

 

20.2.3              if sent by facsimile transmission or electronic mail, be deemed to have been given when transmitted provided that confirmatory copy of such facsimile or e-mail transmission shall have been sent by prepaid airmail within 24 (twenty-four) hours, of such transmission.

 

20.3                        Klein’s address for service of notices and other documents shall be:

 

[***]
 E-mail:  [***]

 

Copy to [***]
 [***]
 [***]

 

20.4                        Mediwound’s address for service notices and other documents shall be:

 

C/O Clal Biotechnology lndustries Ltd
 Atidim Tower, 16th Fl., Tel — Aviv
 Facsimile +972-3-765-0312
 E-mail:  ophirs@cii.il

 

*** 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.

 

23

 

Copy to Yael Baratz Adv
 Baratz, Gilat, Bar-Nathan & Co
 8 Shaul Hamelech Blvd
 Fax:  + 972-3-6960986
 E-mail:  yael@bgb-lse.vo.il

 

21.                               Governing Law and Disputes

 

21.1                        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.

 

21.2                        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) Arbitration 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.

 

21.3                        The parties submit to the exclusive jurisdiction of the courts of the State of New York.

 

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/Mark Klein
    	
 
    	
/s/illegible / /s/illegible
    
	
 
    	
 
    
	
Mark Klein
    	
Mediwound Ltd.
    
	
 
    	
 
    
	
By:
    	
By: illegible / illegible
    
	
 
    	
 
    
	
Its:
    	
Its: Chairman / Director
    

 

List of Exhibits

 

Exhibit 1.3 — Specifications (Bromelain)

Exhibit 1.9 — Development Milestones and Target Dates

Exhibit 1.10 — Development Plan

Exhibit 1.25 — Patents

Exhibit 1.34 — Technology

 

*** 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.

 

24

 

Exhibit 1.3

 

Base Powder Specification

 

CONFIDENTIAL INFORMATION:  PROPERTY OF CHALLENGE BIOPRODUCTS CO. LTD. ANY USE OR DISCLOSURE IS PROHIBITED WITHOUT EXPRESS WRITTEN CONSENT.

 

Description:

 

A Proteolytic enzyme derived from pineapple plants: [***]

 

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 1.09

 

[Omitted, Exhibit 1.09 was deleted by June 19, 2007 amendment]

 

*** 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 1.10 — Three Year Work Plan

 

[Omitted, Exhibit 1.10 was deleted by June 19, 2007 amendment]

 

*** 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 1.25 — Patents

 

	
Australia
    	
AU 676464B2, ( the 464B2 Patent),   examined and accepted, published March 13, 1997
    
	
 
    	
 
    
	
Europe
    	
EP618811B1, ( the 811B1 patent), granted   patent Published April 5, 2000
    
	
 
    	
 
    
	
Finland
    	
F1942603A the (603A application),   unexamined Published August 2, 1994
    
	
 
    	
 
    
	
Hungary
    	
HU21641B, the (641B patent), patent   specification, Published on April 28, 1998
    
	
 
    	
 
    
	
Israel
    	
IL103969a, (the 969A patent), accepted   application Open for Inspection, published January 10, 1997
    
	
 
    	
 
    
	
Japan
    	
JP08508635A (the 635A application)   unexamined Published September 17, 1996 (Exhibit C)
    
	
 
    	
 
    
	
USA
    	
US Patent No:  5, 830,739 issued November 3, 1998 (Exhibit   D)
    

 

PCT Application WO 93/1081

 

European Patent EP 617711B1

 

Japanese Application JP08508635A

 

*** 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 1.34 - Technology

 

1.                                      IND #18,579

 

2                                         Clinical data from 3M Corp’s 100 patient multi center trial (included in #1 and any raw data in my possession)

 

3                                         Toxicology data (Included in #1 and raw data)

 

4                                         Bioassay QA/QC techniques i use for definitive testing in my USDA approved lab.

 

5                                         Bioassay records & data in my possession

 

6.                                      Lot samples and corresponding production flow sheets.

 

*** 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.

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