Document:

Exhibit 10.4

 

PATENT PURCHASE AGREEMENT (the “Agreement”)

 

Between

 

MEDIWOUND LTD.

 

a limited liability company incorporated under the laws of Israel, of 42 Hayarkon

 

Street, Yavne 81227, Israel

 

(“MediWound”)

 

and

 

L.R. R & D Ltd.

 

Omer 84965, Israel

 

(“LR”)

 

(together, the “Parties”)

 

 

WHEREAS, LR represented to MediWound that it owns all rights in and to certain Patents (defined below) which Patent refers to LR’s multipurpose dynamic occlusive dressing including without limitation an adhesive barrier; and

 

WHEREAS, LR wishes to sell to MediWound its entire right, title and interest in such Patents, the causes of action to sue for infringement thereof, and any other legal rights entitled by the original owner of the Patents under the law; and

 

WHEREAS, MediWound wishes to purchase such Patents free and clear of any restrictions, liens, claims or encumbrances;

 

NOW THEREFORE, in consideration for the mutual covenants contained herein and other good and valuable consideration, the sufficiency of which is hereby acknowledged, the parties hereto have agreed as follows:

 

1.                                      PREAMBLE, ANNEXES, SCHEDULES AND INTERPRETATION

 

1.1                               The Preamble and Annexes and Schedules hereto form an integral part of this Agreement.

 

1.2                               In this Agreement the terms below shall bear the meanings assigned to them below, unless specifically stated otherwise:

 

1.2.1                     “Affiliate” shall mean, with respect to any party hereto, any person, organization or entity directly or indirectly controlling, controlled by or under common control with, such party.  For purposes of this definition only, “control” of another person, organization or entity shall mean the ability, directly or indirectly, to direct the activities of the relevant entity, and shall include, without limitation (i) ownership or direct control of fifty percent (50%) or more of the outstanding voting stock or other ownership interest of the other organization or entity, or (ii) direct or indirect possession, of the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the organization or other entity;

 

1.2.2                     “Closing Date” means the date on which LR satisfies its delivery obligations under section 3.2.

 

1.2.3                     “Cover” or “Covered” shall mean, with respect to a product, that in the absence of ownership of or a license granted under, a Valid Claim included in such Patent right, the manufacture, development, commercialization, use, sale, import, or offer for sale, as applicable, of such product would infringe such Valid Claim in the country where such activity occurs.

 

1.2.4                     “CSO” shall bear the meaning ascribed thereto in Section 4.7 hereto.

 

1.2.5                     “Intellectual Property Rights” shall mean all intangible legal rights, titles and interests, evidenced by or embodied in: (i) all inventions, patents, provisionals, patent applications (whether pending or not), and patent disclosures together with all reissuances, continuations, continuations in part, revisions, extensions, and reexaminations thereof; (ii) all trademarks, service marks, copyrights, designs, trade styles, logos, trade dress, and corporate names, including all goodwill associated therewith; (iii) any work of authorship, regardless of copyrightability, all compilations, all copyrights (including the droit morale); (iv) all Know How, Confidential Information (as defined below) and proprietary processes, licenses; and (v) all derivative works of the above and all other

 

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proprietary rights and any other intellectual property rights of any kind and nature however designated and however recognized in any country or jurisdiction worldwide.

 

1.2.6                     “Know-How” shall mean all and any tangible or intangible expertise, inventions, discoveries, documents, materials, compounds, compositions, substances, methods, processes, techniques, know-how, technology, data, information, discoveries and other results of whatsoever nature, and any other works of authorship, copyrights, trade secrets, and all derivatives, modification and improvements thereof.  Or other proprietary intellectual or industrial rights directly or indirectly deriving therefrom.

 

1.2.7                     “Product” shall mean any product, in any formulation, dosage, material, design, structure, assembly and form, intended for human pharmaceutical use for the treatment of all indications in all therapeutic areas, the development, manufacture or sale of which would infringe any Valid Claim in any of the Patents.

 

1.2.8                     “Patents” shall mean (a) all patents and patent applications listed in Schedule 1.2.8 hereto; (b) all reissues, reexaminations, continuations, parents, continuations-in-part, divisionals and extensions (collectively “related cases”) of such patents and patent applications; (c) patents or patent applications (i) to which any or all of the foregoing directly or indirectly claims priority, (ii) for which any or all of the foregoing directly or indirectly forms a basis for priority, and/or (iii) that directly or indirectly incorporate by reference any or all of the foregoing or are directly or indirectly incorporated by reference by any of the foregoing; (d) all related cases (whether pending, issued, abandoned or filed after the Effective Date) and foreign counterparts to any or all of the foregoing, including without limitation utility models, design patents, certificates of invention and equivalent rights worldwide, and (e) the know-how, inventions, discoveries and improvements described or claimed in any or all of the foregoing.

 

1.2.9                     “Valid Claim” shall mean a claim of any issued, unexpired patent that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, and that has not been disclaimed or admitted to be invalid or unenforceable through reissue, reexamination, disclaimer, or otherwise.

 

1.3                               In this Agreement, words importing the singular shall include the plural and vice-versa and words importing any gender shall include all other genders and references to persons shall include partnerships, corporations and unincorporated associations.

 

1.4                               In the event of any discrepancy between the terms of this Agreement and any of the Annexes hereto, the terms of this Agreement shall prevail.

 

2.                                      TRANSFER OF PATENTS

 

2.1                               Patent Assignment.  LR hereby sells, assigns, transfers and conveys to MediWound all right, title and interest it has in and to the Patents, including without limitation, any and all legal rights entitled by the original owner of the Patents and all rights of LR to sue for past, present and future infringement, to collect royalties under such Patents, to prosecute all existing Patents worldwide, to apply for additional Patents worldwide and to have Patents issue in the name of MediWound.

 

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2.2                               Assignment of Causes of Action.  LR hereby sells, assigns, transfers and conveys to MediWound all right, title and interest it has in and to all causes of action and enforcement rights, whether known, unknown, currently pending, filed, or otherwise, for the Patents, including without limitation all rights to pursue damages, injunctive relief and other remedies for past, current and future infringement of the Patents.

 

3.                                      Delivery

 

3.1                               Executed Assignment.  LR shall execute an Assignment attached hereto as Exhibit B suitable for filing, independently of this Agreement, with the USPTO and other patent offices worldwide.

 

3.2                               Delivery on Effective Date.  On or within five (5) business days of the Effective Date (the “Closing Date”), LR shall send, via Federal reliable overnight and trackable delivery service, to MediWound, the executed original of the Assignment along with all files and original documents owned or controlled by LR or its agents or attorneys regarding the Patents including, without limitation, (i) all Letters Patents, (ii) assignments for the Patents, (iii) documents and materials evidencing dates of invention, (iv) prosecution history files for all issued, pending and abandoned Patents, (v) its own files regarding the issued Patents, and (vi) a current electronic copy of a docketing report for the Patents accurately setting forth to the best of LRs knowledge any and all dates relevant to the prosecution or maintenance of the Patents, including, without limitation, information relating to deadlines, payments and filings for the Patents, and the names, business addresses, email addresses, and phone numbers of all prosecution counsel and agents.  It is agreed and acknowledged that LR may comply with the provisions of this section 3.2 by providing the above to MediWound’s designated patent attorney and providing MediWound with written confirmation signed by LR’s CEO that it had done so in which case Delivery will not be completed until MediWound acknowledges receipt in writing.

 

3.3                               Continued Prosecution.  LR shall diligently continue to prosecute the Patents through the Closing Date, shall pay (subject to section 5.1.1 below) any maintenance fees, annuities and the like for which the fee is payable (e.g., the fee payment window opens) on or prior to the Closing Date even if the surcharge date or final deadline for payment of such fee would be after the Closing Date, and shall notify MediWound in writing separate from any other disclosures made hereunder of any relevant due dates related to prosecution, filing or maintenance of the Patents that will occur within thirty (30) days after the Closing Date.

 

3.4                               Cooperation After Closing Date.  LR further covenants and agrees that after the Closing Date, it will upon request, and without further consideration, execute and deliver to MediWound any other documents and materials, and take any further actions (including ensuring the cooperation of the named inventors), that MediWound reasonably believes are necessary for MediWound to perfect its title, or otherwise enforce its rights, in the Patents anywhere in the world.

 

4.                                      RESEARCH

 

4.1                               Research.  MediWound shall have the right, at any time, to require that LR perform certain research with respect to the Products in accordance with a protocol, budget and payment schedule to be agreed upon between the Parties in good faith and attached hereto at a later date as Annex B (the “Research Protocol”, the “Research Budget” and the “Research Payment Schedule”, respectively), and such research shall be funded by MediWound (the “Research”).

 

4.2                               Duration of Research.  The duration of the Research shall be as set forth in the Research Protocol, and any extension to the Research must be approved in writing by MediWound and LR.

 

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However, in the event of delay caused by LR, MediWound shall have the right to extend the Research without LR’s prior written consent, the cost of which extension shall be deemed to already be included in the Research Budget.

 

4.3                               Changes.  Any change in the Research Budget and/or Research Protocol and/or the Research Payment Schedule will require MediWound’s prior written approval.  It is clarified that ongoing financing will be subject to the actual conduct of the Research and progress of the Research, as measured by successful achievement of the defined milestones to be set forth in Annex B hereto at a later date.  LR is obligated to complete the Research within the Research Budget as set forth in Annex B hereto, and MediWound shall not make any further payments for the completion of the Research.  In the event of early termination of the Research by MediWound, MediWound shall cover all costs directly relating to the Research, already incurred under this Agreement and committed to under the Research Budget that cannot be refunded, including any commitments already entered into by LR in good faith prior to its receipt of notice of termination, which cannot be refunded or terminated.

 

4.4                               Research Budget.  The Research Budget (in the event that MediWound shall exercise its option to have LR perform the Research) will be provided as set forth in Annex B.  Each payment will be made within thirty (30) days after the last day of the month in which the invoice was received from LR.  In any event MediWound shall not pay any amounts which exceed the actual expenses as reported by LR during the Research and if, in retrospect, MediWound has paid amounts which exceed the actual expenses, then LR shall refund such amounts to MediWound at the end of the performance of the Research, as applicable.

 

4.5                               Research Report.  Not later than sixty (60) days after the end of the Research, LR shall provide to MediWound a report summarizing the Research (the “Research Report”).

 

4.6                               Information.  After receipt by MediWound of the Research Report, if MediWound wishes to receive further information from LR, then LR will provide, within a reasonable time, such additional information and all information relating to the Research will be available for MediWound’s review if MediWound so requests.

 

4.7                               Reports.  For the avoidance of any doubt, it is clarified that MediWound may from time to time request that updates regarding the Research be provided, in addition to periodic progress reports which LR shall provide MediWound at the end of each quarter regarding the Research.  MediWound shall also be provided, on a regular basis, with reports, including, without limitation, financial reports in the format required by the Office of the Chief Scientist (“CSO”) which MediWound may be required to provide to the CSO in order to obtain CSO support for the Research, in addition to the periodic progress reports.

 

4.8                               Approvals.  LR shall obtain or procure all necessary approvals and consents necessary for the performance of the Research, and shall be exclusively obligated for the performance of the Research in accordance with all applicable laws.

 

4.9                               All Intellectual Property Rights evidenced by or embodied in: (i) rights that MediWound had utilized, possessed or otherwise had rights to, prior to the execution of this Agreement, and derivative works thereof; and (ii) all rights transferred and assigned to MediWound pursuant to this Agreement and any derivatives and or development and/or improvements thereof; and (iii) any invention, and Know How created, generated, made, conceived, developed or reduced to practice either by MediWound and/or LR, in the course of performing the Research, and any and all intellectual property right deriving therefrom, and any regulatory applications made and

 

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received in connection therewith, shall be owned solely by MediWound (“MediWound IP”).  If by operation of law any part of the MediWound IP, is not deemed owned in its entirety by MediWound automatically upon its creation, then LR hereby irrevocably grants and assigns to MediWound all rights, title and interest it may have in and to the MediWound IP produced.  LR agrees to consider the MediWound IP as Confidential Information.  LR hereby agrees at MediWound’s expense to provide all reasonable assistance to obtain for MediWound, legal protections for the MediWound intellectual property rights relating to the assignable intellectual property rights as set forth in this Agreement.  To this end, LR will execute, verify and deliver any documents and will perform such other acts (including appearances as a witness) as MediWound may reasonably request for use in applying for, obtaining, perfecting, evidencing, sustaining and enforcing such assignable Intellectual Property Rights and effecting the assignment thereof.

 

4.10                        LR shall indemnify and hold MediWound, its affiliates, and the officers, directors and employees and consultants of each of them, harmless from any and all liability, including liability for death or personal injury and reasonable attorney’s fees, which (i) results from willful misconduct of LR in performance of the Research and/or (ii) results from any infringement of third party intellectual property rights and/or unauthorized use of any third party confidential information in connection with and/or in the performance of the Research.

 

5.                                      MILESTONE PAYMENTS

 

5.1                               Milestone Payments.  In consideration for the transfer and assignment of all rights and title to the Patents, MediWound shall make the following milestone payments to LR, upon achievement of the relevant milestones (each, a “Milestone”) (the “Milestone Payments”):

 

5.1.1                     Subject to receipt of all documents reasonably required by MediWound detailing all out of pocket expenses incurred by LR in filing and obtaining the Patents.  Upon the Closing Date MediWound will reimburse LR for such out of pocket expenses estimated in the amount of 133,505 NIS + VAT or in an higher amount if additional such out of pocket expenses were incurred by LR up to the Closing Date all as listed in Schedule 5.2 of this agreement.  The Parties agree that this amount represents the full and complete reimbursement of all expenses incurred by LR in obtaining the Patents and all rights thereto.

 

5.1.2                     Upon the Closing Date - $50, 000 USD (fifty thousand US dollars);

 

5.1.3                     For every 12 months as of the Closing Date and as long as all claims of patent number W098/053778 are Valid Claims in the US and/or in any EPC member country, a payment of $30,000 USD (thirty thousand US dollars); in the event that at any time during a 12 month period, any claim becomes invalid in the US and/or in any EPC member country the amount of payment for such specific 12 months period shall be prorated from the beginning of such 12 months period until of the occurrence of such event (e.g. if the 12 months period began on October 01, 2016 and any claim becomes invalid in the US and/or in any of the EPC member countries on 01, January 2017, the 30,000 USD payment due to LR for the 12 months period of October 2016-2017 shall be prorated accordingly and shall be equal to 30,000/4 = 7,500 USD).

 

5.2                              Currency.  In calculating Net Sales, all amounts shall be expressed in US Dollars and any amount received in a currency other than US Dollars shall be translated into US Dollars, in

 

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accordance with the conversion rate existing in the United States (as reported in the Wall Street Journal) on the date of actual payment.

 

6.                                      REPORTS;  PAYMENTS

 

6.1                               Payment Terms.  Amounts payable to LR in terms of Section 5.1.3 shall be paid to LR no later than 60 (sixty) days after the end of each calendar year, commencing with the first calendar year after the Closing Date.

 

6.2                               Wire Transfer.  Each payment due to LR hereunder shall be paid by wire transfer of funds to LR’s account number 10-922-063400/99, or as otherwise designated by LR, from time to time, at least sixty (60) days before the relevant payment is due.

 

6.3                               Taxes.  If applicable laws require that taxes be withheld from any amounts due to LR under this Agreement, MediWound shall (a) deduct these taxes from the remittable amount, (b) pay the taxes to the proper taxing authority, and (c) deliver to LR a statement including the amount of tax withheld and justification therefor, and such other information as may be necessary for tax credit purposes.  For the avoidance of doubt, the Milestone Payment shall be reduced by any withholding or similar taxes applicable to such payment, such that the actual maximum payment by MediWound shall not exceed the amounts or the rates provided in this Agreement.

 

6.4                               Records.  MediWound shall maintain complete and accurate records of any amounts payable to LR in relation to such Products and which records shall contain information to reasonably permit LR to confirm the accuracy of any payments to LR under this Agreement, provided that in any event such records shall not be required to be any more detailed than those which MediWound generally maintain in their ordinary course of business.  MediWound shall retain each record for at least three (3) years, during which time LR shall have the right, not more than once per calendar year at its expense, to cause an independent, certified public accountant to inspect such records during normal business hours for the sole purpose of verifying any reports and payments delivered under this Agreement.  Such accountant shall not disclose to LR any information other than information relating to the accuracy of reports and payments delivered under this Agreement.  The Parties shall reconcile any underpayment or overpayment within thirty (30) days after the accountant delivers the results of the audit.  In the event that any audit performed under this Section reveals an underpayment in excess of five percent (5%) in any calendar year, the audited party shall bear the full cost of such audit.  LR may exercise its rights under this Section only once every year and only with reasonable prior notice to MediWound, and subject to prior coordination.  Any such audit shall be made during MediWound’s normal business hours and shall not unreasonably interfere with the business of MediWound and shall be completed within a reasonable time.

 

7.                                      REPRESENTATIONS AND WARRANTIES

 

LR hereby represents and warrants to MediWound that:

 

7.1                               Authority.  LR has the right and authority to enter into this Agreement and to carry out its obligations hereunder and requires no third party consent, approval, and/or other authorization to enter into this Agreement and to carry out its obligations hereunder, including, without limitation, the sell, transfer, convey and assignment of the Patents to MediWound.

 

7.2                               Title and Contest.  LR has good and marketable exclusive title to the Patents, including without limitation all rights, title, and interest in the Patents and the right to sue for past, present and

 

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future infringement thereof.  LR has obtained and properly recorded previously executed assignments for the Patents as necessary to fully perfect LR’s rights and title therein in accordance with governing law and regulations in each respective jurisdiction.  The Patents are free and clear of all liens, mortgages, security interests or other encumbrances, and restrictions on transfer.  There are no actions, suits, investigations, communications, correspondence, claims or proceedings threatened, pending or in progress relating in any way to the Patents.

 

7.3                               Existing Licenses.  No rights or licenses have been granted or retained under the Patents, including without limitation any rights or licenses granted or retained by LR, any prior owners, the inventors or any other third parties.

 

7.4                               Restrictions on Rights - Standards.  MediWound will not be subject to any covenant not to sue or similar restrictions on its enforcement or enjoyment of the Patents as a result of the transaction contemplated in this Agreement, or any prior transaction related to the Patents.  LR has not made any commitments to any standards or other organization regarding licensing or not asserting the Patents, and is not otherwise obligated to license or refrain from asserting the Patents.

 

7.5                               Enforcement.  LR has not put a third party on notice of actual or potential infringement of any of the Patents or considered enforcement action(s) with respect to any of the Patents.

 

7.6                               Patent Office Proceedings.  None of the Patents have been or are currently involved in any reexamination, reissue, interference proceeding, or any similar proceeding and that no such proceedings are pending or threatened.

 

7.7                               Fees.  All maintenance fees, annuities, and the like due on the Patents have been timely paid.

 

7.8                               Validity and Enforceability.  The Patents have never been found invalid or unenforceable for any reason in any administrative, arbitration, judicial or other proceeding.

 

7.9                               Patent Indemnification.  Without derogating from the provisions of Section 7 below, in the event that a third party files a claim of action against MediWound in a court of law arguing that the exploitation of the Patents or any part thereof infringes upon any intellectual property rights of such third party (the “IP Claim”), then MediWound may decide, by providing written notice to LR (the “Escrow Notice”), that any amounts due from MediWound to LR under this Agreement (“LR’s Consideration”) shall be transferred by MediWound to an escrow account to be maintained by a reputable escrow agent mutually and reasonably acceptable to both Parties (the “Escrow Agent” and the “Escrow Account”).  In the event that MediWound shall have provided LR with the Escrow Notice and an Escrow Agent has been nominated, MediWound shall be entitled to continue transferring any and all of LR’s Consideration to the Escrow Account, until the earlier of (i) such time as the aggregate LR’s Consideration transferred to the Escrow Account shall be equal to the amount claimed under the IP Claim plus any expenses and costs of MediWound reasonably incurred in connection therewith (including, reasonable attorney’s fees) or, (ii) a Determinative Decision (as defined below).  In the event that the Parties, within seven (7) days, have not agreed on the identity of an Escrow Agent, then the Parties shall nominate a Sole Arbitrator.  Notwithstanding the foregoing, in the event that one of the remedies requested under such IP Claim is the enjoinment of MediWound from exercising any or all of its rights with respect to the Patents and/or any Products, then MediWound shall be entitled to transfer LR’s Consideration to the Escrow Account until such time as a Determinative Decision has been made.  In the event that the effect of any Determinative Decision is to enjoin MediWound from selling Products then all amounts in the Escrow Account shall be transferred to MediWound.

 

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In the event that MediWound is required to make any payments to a third party pursuant to a Determinative Decision, MediWound shall be entitled to receive from the Escrow Account an amount equal to the payment MediWound is required to make to such third party plus any cost and expenses of MediWound reasonably incurred in connection therewith (including, reasonable attorney’s fees) (collectively, the “Reimbursable Amount”) and the balance of the amounts in the Escrow Account shall be transferred to LR.  In the event that the amounts, if any, in the Escrow Account are insufficient to cover the Reimbursable Amount, MediWound shall be entitled to deduct the balance of the Reimbursable Amount from any future LR’s Consideration due to the LR following the date of the Determinative Decision.

 

For the purposes of this Section 6.9, a “Determinative Decision” shall mean a final (non-appealable decision) rendered by a court of competent jurisdiction.

 

8.                                      INDEMNITY

 

8.1                               LR Indemnification.  LR shall indemnify and hold MediWound, its Affiliates, and the officers, directors and employees and consultants of each of them, harmless from any and all liability, including liability for death or personal injury and reasonable attorney’s fees, which (i) results from willful misconduct of LR in performance of this Agreement and/or (ii) results from any infringement of third party intellectual property rights in connection with and/or relating to the Patents and/or (iii) any breach of LR’s representations and warranties hereunder.

 

8.2                               General.  As soon as reasonably possible after an indemnified party becomes aware of any potential liability hereunder, such party shall deliver written notice to the indemnifying party, stating the nature of the potential liability; provided, however, that the failure to give such notification shall not affect the indemnification provided hereunder except to the extent the indemnifying party shall have been actually prejudiced as a result of such failure.  The indemnifying party shall have the right to assume the defense of any suit or claim related to the liability if it has assumed responsibility for the suit or claim in writing; provided, however, if in the reasonable judgment of the indemnified party, such suit or claim involves an issue or matter which could have a materially adverse effect on the business, operations or assets of the indemnified party, the indemnified party may waive its rights to indemnity under this Agreement and control the defense or settlement thereof, but in no event shall any such waiver be construed as a waiver of any indemnification rights such indemnified party may have at law or in equity.  In the defense of any claim or litigation, the indemnifying party shall not, except with the prior written consent of the other Party, enter into a settlement which does not include as an unconditional term thereof the giving by the claimant or plaintiff to such other Party a complete release from all liability in respect of such claim or litigation.

 

If the indemnifying party defends the suit or claim, the indemnified party may participate in (but not control) the defense thereof at its sole cost and expense; provided, however, that the indemnifying party shall pay the reasonable fees and costs of any separate counsel to the extent such representation is due to a conflict of interest between the Parties.

 

9.                                      CONFIDENTIALITY

 

9.1                               Confidential Information.  Each party hereto (the “Recipient”) undertakes to treat and maintain, and to ensure that their Representatives (defined below) shall treat and maintain, in strict confidence and secrecy any information whether oral, visual or in written form disclosed by the other party (the “Discloser”) under this Agreement, except if such information is proprietary to the Recipient or is owned by the Recipient, whether under the terms of this Agreement or otherwise, regarding the existence or contents of this Agreement (the “Confidential

 

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Information”).  The Recipient shall not disclose, publish, or disseminate in any manner, any of the Discloser’s Confidential Information to a third party other than those of its Representatives with a need to know for the purpose of exercising the rights granted to the Recipient under this Agreement and performing its obligations hereunder (the “Purpose”).  In addition, the Recipient undertakes to treat and maintain (and to ensure that its Representatives treat and maintain) in strict confidence and secrecy and to prevent any unauthorized use, disclosure, publication, or dissemination of the Discloser’s Confidential Information, except for the Purpose.  The Recipient undertakes not to disclose all or any of the Discloser’s Confidential Information to any person or body whatsoever, except that disclosure which may be made to their Representatives to the extent reasonably necessary for the Purpose and provided that such Representative is bound by confidentiality obligations, either by a separate agreement or by the terms of such Representative’s employment and/or other agreement with the Recipient.  Each party shall assume full responsibility for breaches of this Agreement by its Representatives.

 

9.2                               Confidentiality Obligations.  The Recipient shall:

 

(i)                                     safeguard and keep secret all the Discloser’s Confidential Information, and will not directly or indirectly disclose to any third party the Discloser’s Confidential Information without written permission of the Discloser;

 

(ii)                                  in performing its duties and obligations hereunder, use at least the same degree of care as it does with respect to its own confidential information of like importance but, in any event, at least reasonable care; and

 

(iii)                               promptly notify the Discloser of disclosure of Discloser’s Confidential Information (or any part thereof) in compliance with any legal requirement, prior to such disclosure having been made to the extent possible, and in such event to disclose the minimum amount of information required for the purpose of the said legal requirement and/or cooperate with the Discloser in connection with the Discloser’s efforts to seek a protective order or other appropriate remedy to prevent such disclosure.  Notwithstanding the foregoing, either Party may disclose Confidential Information of the other Party if such Party is required to make such disclosure by applicable law, regulation or legal process, including by Israeli securities laws, the rules or regulations of the United States Securities and Exchange Commission (the “SEC”) or any similar regulatory agency in a country other than the United States or of any stock exchange, including the Tel Aviv Stock Exchange, in which event such Party shall provide prior notice of such intended disclosure to such other Party, if possible under the circumstances, and shall disclose only such Confidential Information of the other Party as is required to be disclosed.  If this Agreement shall be included in any report, statement or other document filed by either Party or an Affiliate of either Party pursuant to the preceding sentence, such Party shall use, or shall cause its Affiliate, as the case may be, to use, reasonable efforts to obtain confidential treatment from the SEC, similar regulatory agency or stock exchange of any financial information or other information of a competitive or confidential nature, and shall include in such confidentiality request such provisions of this Agreement as may be reasonably requested by the other Party.

 

9.3                               Carve-outs.  The undertakings and obligations under Sections 8.1 and 8.2 above shall not apply to any part of the Confidential Information which:

 

(i)                                     the Recipient establishes by its written records to the Discloser’s satisfaction was Confidential Information known to the Recipient prior to disclosure by the Discloser;

 

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(ii)                                  was generally available to the public prior to disclosure by the Recipient;

 

(iii)                               is disclosed to Recipient by a third party who is not bound by any confidentiality obligation, having a legal right to make such disclosure;

 

(iv)                              has become through no act or failure to act on the part of the Recipient public information or generally available to the public;

 

(v)                                 was independently developed by the Recipient, except in the event that such independently developed Confidential Information is considered to be Confidential Information of MediWound.

 

9.4                               Equitable Relief.  Each Party hereto acknowledges that the other party’s Confidential Information is of special and unique significance to them and that any unauthorized disclosure or use of such other party’s Confidential Information could cause irreparable harm and significant injury to the other party that may be difficult to ascertain.  Accordingly, any breach of this Agreement may entitle the aggrieved party in addition to any other right or remedy that it may have available to it by law or in equity, to remedies of injunction, performance and other relief, including recourse in a court of law.

 

9.5                               Each party agrees to inform the other party of any breach or threatened breach of the provisions hereof by its Representatives.

 

9.6                               Duration.  The provisions relating to confidentiality in this Section 8 shall remain in effect (a) during the term of this Agreement and (b) for a period of seven (7) years thereafter.

 

9.7                               “Representatives” shall mean employees, officers, agents, subcontractors, consultants, investors and/or any other person or entity acting on a party’s behalf, individually or collectively and which shall be exposed to Confidential Information.

 

9.8                               For the avoidance of doubt, any time or other limitations with respect to the confidentiality undertakings included herein, shall not be construed as derogating from or limiting any intellectual property rights of the Parties hereto.

 

10.                               PUBLICATIONS

 

10.1                        During the term of this Agreement and for seven (7) years thereafter, any publication of the Know-How related to the Patents and/or the Products (provided such is not in the public domain) shall be subject to the prior written consent of MediWound.

 

11.                               LIMITATION OF LIABILITY

 

11.1                        LIMITATION ON CONSEQUENTIAL DAMAGES.  EXCEPT IN THE CASE OF FRAUD, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR LOSS OF PROFITS, OR ANY SPECIAL, CONSEQUENTIAL OR INCIDENTAL DAMAGES, HOWEVER CAUSED, KNOWN OR UNKNOWN, ANTICIPATED OR UNANTICIPATED, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.  THE PARTIES ACKNOWLEDGE THAT THESE LIMITATIONS ON POTENTIAL DAMAGES WERE AN ESSENTIAL ELEMENT IN SETTING CONSIDERATION UNDER THIS AGREEMENT.

 

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11.2                        LIMITATION OF LIABILITY.  EXCEPT IN THE CASE OF FRAUD, WITHOUT WAIVING ANY OTHER RIGHTS OF THE PARTIES, INCLUDING ANY RIGHT TO SEEK SPECIFIC PERFORMANCE OR SEEK OTHER EQUITABLE RELIEF, NEITHER PARTY’S TOTAL LIABILITY (INCLUDING PAYMENT OBLIGATIONS) UNDER THIS AGREEMENT SHALL EXCEED THE PAYMENT AMOUNTS ACTUALLY MADE AS OF THE DATE OF FILING OF ANY SUIT OR CLAIM BY EITHER PARTY UNDER THIS AGREEMENT PURSUANT TO SECTIONS 4, AND IF NO PAYMENTS HAVE BEEN MADE AND/OR NO ROYALTY PAYMENTS ARE DUE THEN THE AMOUNT DUE PURSUANT TO SECTION 4.1.  THE PARTIES ACKNOWLEDGE THAT THESE LIMITATIONS ON POTENTIAL LIABILITIES WERE AN ESSENTIAL ELEMENT IN SETTING CONSIDERATION UNDER THIS AGREEMENT.

 

12.                               TERM AND TERMINATION

 

12.1                        Term.  This Agreement shall be effective from the date of signature of the last signing party to the Agreement (the “Effective Date”) and shall continue in full force and effect, unless earlier terminated, in accordance with this Section 11.

 

12.2                        Termination Rights.  Without derogating from any other remedies that either Party hereto may have under the terms of this Agreement or at law, each Party hereto shall have the right to terminate this Agreement forthwith upon the occurrence of any of the following:

 

(i)                                     the material breach by the other Party hereto of its obligations hereunder, and such other Party’s failure to remedy such breach within sixty (60) days after being requested in writing to do so (or, if such default cannot be cured within such sixty (60) day period, if the breaching Party has not commenced and diligently continued actions to cure such default); or

 

(ii)                                  the other party’s liquidation, whether voluntarily or otherwise, or its entering into any arrangement with its creditors.

 

12.3                        Survival.  In the event of termination of this Agreement, (a) all financial obligations owed as of the Effective Date of such termination shall remain in effect, including such obligations that have accrued, but have not been invoiced, as of such Effective Date, and (b) the obligations set forth in, and all other terms, provisions, representations, rights and obligations contained in this Agreement that by their express terms survive expiration or termination of this Agreement, shall survive and all other terms, provisions, representations, rights and obligations contained in this Agreement shall terminate.

 

12.4                        Without derogating from the aforementioned, the following provisions of this Agreement shall survive the termination or expiration hereof: 2,4.9,4.10,5,6,7.9,8,9,11,13,14,15.

 

13.                               NOTICES

 

Any payment, notice or other written communication required or permitted to be made or given may be made or given by either Party by facsimile; by first-class mail, postage prepaid; or by air courier to the mailing address or facsimile numbers set as below:

 

	
If to MediWound Ltd.:
    
	
Attention:
    	
 CEO
    
	
Telephone:
    	
 972-8-932-4010
    

 

12

 

	
Facsimile:  
    	
972-8-932-4011
    
	
Address:  
    	
42 Hayarkon   St., 81227 Yavne Israel
    
	
 
    	
 
    
	
If to LR:
    
	
 
    	
 
    
	
Attention:  
    	
Prof. Lior   Rosenberg
    
	
Telephone:  
    	
08-6469922
    
	
Facsimile:  
    	
08-6460478
    
	
Address:  
    	
13 Hardof St.,   Omer 84965, Israel
    

 

or to such other addresses or facsimile numbers as either Party shall designate by notice, similarly given, to the other Party.  Notices or written communications shall be deemed to have been sufficiently made or given: (i) immediately, upon receipt, (ii) if mailed, seven (7) days after being dispatched by mail, postage prepaid; (iii) if by air courier, three (3) days after delivery to the air courier company; (iv) if by facsimile with confirmed transmission, within three (3) days of transmission; or (v) in any event, upon actual receipt.

 

14.                               GOVERNING LAW AND DISPUTE RESOLUTION

 

This Agreement shall be governed and interpreted according to the laws of the State of Israel.  Any dispute arising from this Agreement shall be resolved through the Courts of Tel Aviv/Jaffa, Israel, and by no other court or jurisdiction.  The validity and claim construction of any Patent shall be governed by and construed in accordance with the laws in the applicable country where such Patent issued.

 

15.                               MISCELLANEOUS

 

15.1                        The headings in this Agreement are intended solely for convenience or reference and shall be given no effect in the interpretation of this Agreement.

 

15.2                        This Agreement (including the Annexes attached hereto), with respect to its subject matter supersedes all prior agreements, arrangements, dealings or writings between the Parties.  This Agreement may not be varied except in writing signed by the Parties’ authorized representatives.

 

15.3                        This Agreement may be executed in any number of counterparts (including counterparts transmitted by fax), each of which shall be deemed to be an original, but all of which taken together shall be deemed to constitute one and the same instrument.

 

15.4                        The rights and obligations of MediWound under this Agreement shall inure to its successors and assigns.  MediWound shall be entitled, at any time, to assign this Agreement to an Affiliate of MediWound, provided MediWound shall guarantee performance of any and all financial liabilities hereunder by such transferee.  The rights of LR under this Agreement shall not be assignable in whole or in part, without MediWound’s prior written approval, which will not be unreasonably withheld.  Notwithstanding the foregoing, in case such third party is a competitor of MediWound (as determined by MediWound at MediWound’s sole discretion) then LR shall return to MediWound and/or its transferee any Confidential Information relating to MediWound and/or the Product.

 

15.5                       No waiver of a breach or default hereunder shall be considered valid unless in writing and signed by the Party giving such waiver and no such waiver shall be deemed a waiver of any subsequent breach or default of the same or similar nature.  No failure by any party hereto to take any action against any breach of this Agreement or default by another party hereto shall constitute a waiver

 

13

 

of the former party’s rights to enforce any provision of this Agreement or to take action against such breach or default or any subsequent breach or default by such other party.

 

15.6                        Should any part or provision of this Agreement be held unenforceable or in conflict with the applicable laws or regulations of any applicable jurisdiction, the invalid or unenforceable part or provision shall, provided that it does not go the essence of this Agreement, be replaced with a revision which accomplishes, to the extent possible, the original commercial purpose of such part or provision in a valid and enforceable manner, and the balance of this Agreement shall remain in full force and effect and binding upon the Parties hereto.

 

15.7                        Nothing contained in this Agreement shall be construed to place the Parties in a relationship of partners or parties to a joint venture or to constitute either party an agent, employee or a legal representative of the other party and neither party shall have power or authority to act on behalf of the other party or to bind the other party in any manner whatsoever.

 

15.8                        Without derogating from the provisions of Section 4 above, VAT will be added, where applicable, to all payments to be made hereunder and shall be paid against proper invoices.  Any payments made herein are final and inclusive of all taxes and/or duties, of whatsoever nature, which are now or may hereafter be imposed with regard to the transaction, and/or this document or any document related to this document.

 

15.9                        Each party agrees to execute, acknowledge and deliver such further documents and instruments and do any other acts, from time to time, as may be reasonably necessary, to effectuate the purposes of this Agreement.

 

15.10                 None of the provisions of this Agreement shall be enforceable by, any person who is not a party to this Agreement.

 

15.11                 The remedies afforded to any of the Parties hereto, whether hereunder, or under applicable law or otherwise, shall be cumulative in nature and not alternative.

 

14

 

IN WITNESS WHEREOF, each of the Parties has executed this Agreement and the Annexes hereto as of the date below.

 

	
MEDIWOUND
    	
 
    	
LR
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
signature
    	
/s/ Gal Cohen
    	
 
    	
signature
    	
/s/ Prof. Lior   Rosenberg
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
name
    	
Gal Cohen
    	
 
    	
name
    	
Prof. Lior   Rosenberg
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
designation
    	
Chief   Executive Officer, MediWound Ltd.
    	
 
    	
designation
    	
CEO, L. R.   R & D Ltd.
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
signature
    	
 
    	
 
    	
signature
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
name
    	
 
    	
 
    	
name
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
designation
    	
 
    	
 
    	
designation
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
24 November,   2010
    	
 
    	
Date:  
    	
24/11/2010,   2010
    

 

15

 

Schedule 1.2.8

 

Patent Rights

 

16

 

CONFIDENTIAL

 

Patent Family Report

 

File No.: MWD/002                                      Assignee:                                           L.R.R.& D LTD           Priority:  Israel          26/May/1997

 

Title :              A MULTIPURPOSE DYNAMIC OCCLUSIVE DRESSING

 

Abstract:                                            Occlusive dressing system, which comprises an endless, elongated, flexible, adhesive barrier, adapted to be arranged in a closed configuration, whereby to bound and define a surface area, and an impermeable sealing film adapted to overlie said surface area and to isolate it from the environment, when superimposed to said barrier arranged in said configuration, said barrier forming a gas-tight seal with sealing film when the two are applied to and pressed against one another.  A spreading mechanism that allows a single person to spread the sealing film over the occluding barrier and to detach the film from the main roll and ports (inlet and outlet) that can be placed across the barrier or the occluding film.

 

	
Country
    	
 
    	
Application No.
    	
 
    	
Filing Date
    	
 
    	
Patent No.\
   Pub. No.
    	
 
    	
Issue Date\
   Pub. Date
    	
 
    	
Status
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Europe
    	
 
    	
98921714.6
    	
 
    	
25/May/1998
    	
 
    	
1014905
    	
 
    	
02/May/2003
    	
 
    	
granted
    
	
France
    	
 
    	
98921714.6
    	
 
    	
25/May/1998
    	
 
    	
1014905
    	
 
    	
02/May/2003
    	
 
    	
granted
    
	
Germany
    	
 
    	
98921714.6
    	
 
    	
25/May/1998
    	
 
    	
DE 69814106
    	
 
    	
02/M ay/2003
    	
 
    	
granted
    
	
Israel
    	
 
    	
120910
    	
 
    	
26/May/1997
    	
 
    	
120910
    	
 
    	
05/Apr/2004
    	
 
    	
granted
    
	
Italy
    	
 
    	
98921714.6
    	
 
    	
25/May/1998
    	
 
    	
1014905
    	
 
    	
02/May/2003
    	
 
    	
granted
    
	
PCT
    	
 
    	
PCT/IL98/00238
    	
 
    	
25/May/1998
    	
 
    	
WO 98/053778
    	
 
    	
03/Dec/1998
    	
 
    	
expired
    
	
UK
    	
 
    	
98921714.6
    	
 
    	
25/May/1998
    	
 
    	
1014905
    	
 
    	
02/May/2003
    	
 
    	
granted
    
	
USA
    	
 
    	
09/424499
    	
 
    	
25/May/1998
    	
 
    	
7183454
    	
 
    	
27/Feb/2007
    	
 
    	
granted
    

 

17

 

Exhibit A

 

ASSIGNMENT

 

For good and valuable consideration, the receipt of which is hereby acknowledged, L.R. R & D Ltd, a corporation having a primary place of business at Orner 84965, Israel (“Assignor”), does hereby sell, assign, transfer and convey unto MediWound Ltd. with an office at 42 Hayarkon Street, Yavne 81227, Israel (“Assignee”) or its designees, all of Assignor’s entire right, title and interest in and to (a) all patents and patent applications listed below; (b) all reissues, reexaminations, continuations, parents, continuations-in-part, divisionals and extensions (collectively “related cases”) of such patents and patent applications; (c) patents or patent applications (i) to which any or all of the foregoing directly or indirectly claims priority, (ii) for which any or all of the foregoing directly or indirectly forms a basis for priority, and/or (iii) that directly or indirectly incorporate by reference any or all of the foregoing or are directly or indirectly incorporated by reference by any of the foregoing; (d) all related cases (whether pending, issued, abandoned or filed in the future) and foreign counterparts to any or all of the foregoing, including without limitation utility models design patents, certificates of invention and equivalent rights worldwide; and (e) the inventions, discoveries and improvements described or claimed in any or all patent and patent applications as detailed in the patent report attached hereto as annex 1 to this Assignment letter( collectively “Patent Rights”).

 

In addition, Assignor agrees to and hereby does sell, assign, transfer and convey unto Assignee all rights (i) in and to causes of action and enforcement rights for the Patent Rights including all rights to pursue damages, injunctive relief and other remedies for past, present and future infringement of the Patent Rights, (ii) the right to apply (or continue prosecution) in any and all countries of the world for patents, design patents, utility models, certificates of invention or other governmental grants for the Patent Rights, including without limitation under the Paris Convention for the Protection of Industrial Property, the International Patent Cooperation Treaty, or any other convention, treaty, agreement or understanding, and (iii) the rights, if any, to revive prosecution of any abandoned Patent Rights.

 

Assignor also hereby authorizes the respective patent office or governmental agency in each jurisdiction to issue any and all patents or certificates of invention or equivalent which may be granted upon any of the Patent Rights in the name of Assignee, as the assignee to the entire interest therein.

 

The terms and conditions of this Assignment shall inure to the benefit of Assignee, its successors, assigns and other legal representatives, and shall be binding upon Assignor, its successor, assigns and other legal representatives.

 

IN WITNESS WHEREOF this Assignment of Patent Rights is executed at

 

on

 

	
ASSIGNOR
    
	
 
    
	
By:
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Title:
    	
 
    	
 
    

 

(Signature MUST be notarized)

 

18Exhibit 10.6

 

MediWound Ltd.

 

and

 

Challenge Bioproducts Corporation Ltd.

 

	
 
    
	
Supply Agreement   — As amended on February 28, 2010
    
	
 
    

 

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

 

 

SUPPLY AGREEMENT

 

This Supply Agreement (“Agreement”) was made and entered into as of the 11 day of January, 2001 by and between MediWound Ltd., a corporation organized and existing under the laws of Israel (hereinafter referred to as “MediWound”) and Challenge Bioproducts Corporation Ltd., a corporation organized and existing under the laws of the Republic of China (hereinafter referred to as “CBC”) and amended by the parties on February 28, 2010 (“Amendment Effective Date”).

 

WITNESSETH: THAT

 

Whereas MediWound and CBC have originally entered into this Agreement on the date stated above (copy of which shall be attached hereto as Exhibit A); and

 

Whereas, the parties hereto have agreed to amend and add certain terms and conditions to this Agreement as of the Amendment Effective Date, all as set forth and marked herein; and

 

Whereas, CBC has invented and developed methods, processes and equipment to manufacture, and produce Bromelain SP (as such term is defined below), specially processed for transformation into a Bromelain-based pharmaceutical product derived from pineapple stems, known as Debridase (the “Product”); and

 

Whereas, subject to the going into effect of a License Agreement dated September 27, 2000 between MediWound and Mark Klein (respectively, the “Klein Agreement” and “Klein”) as amended on June 19, 2007, MediWound shall have an exclusive license under patents and other intellectual property, to develop, use, manufacture, market and sell the Product for burn treatment in humans; and

 

Whereas, MediWound desires to utilize Bromelain SP in the development and commercialization of the Product and to subsequently purchase Bromelain SP in bulk form to make and have made Product and pharmaceutical preparations thereof; and

 

Whereas, CBC is willing to supply Bromelain SP to MediWound for such purpose on the terms and conditions set forth hereunder.

 

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

 

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

 

2

 

1.                                      Definitions

 

Terms defined in this Section 1 and elsewhere, parenthetically, in this Agreement, shall have the same meaning throughout this Agreement.

 

1.1                               “Affiliate” means any firm, person or company which controls, is controlled by or is under common control with a party to this Agreement and for the purpose of this definition the term “control” means the possession, directly or indirectly of the power to direct or cause the direction of the management and policies of such firm, person or company whether through the ownership of voting securities, by contract or otherwise or the ownership either directly or indirectly of 20% (twenty percent) or more of the voting securities of such firm, person or company.

 

1.2                               “Approval” means the grant of all necessary governmental and regulatory approvals required for the marketing, distribution and sale of a pharmaceutical product in any particular country, by a Regulatory Authority, and approvals required for pricing and reimbursements (if appropriate).

 

1.3                               “Bromelain SP” means material derived from pineapple stems, [having the specification as presented in exhibit 1.13] presently manufactured by CBC at the Facility by a special process and used as a raw material in the production of the Product.

 

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

 

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

 

1.6                               “Facility” means CBC’s production facility in Tou-Liu City, Yun-Lin Hsien, Taiwan, R.O.C.

 

1.7                               “FDA” means the Food and Drug Administration of the United States Government or any successor thereto.

 

1.8                               “Klein” means Mr. Mark C. Klein.

 

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

 

1.10                        “Major Country” means the USA, and the major European and Asian countries listed in Exhibit 1.10 attached hereto.

 

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

 

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

 

1.13                        “Specifications” means the specifications for Bromelain SP set forth as Exhibit 1.13 hereto, as the same may be amended with the consent of both parties hereto, it being agreed that no amendment may be made thereto or refused which would

 

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

 

3

 

render Product incapable of application on humans or the use, supply or sale thereof in breach of any regulations.

 

1.14                        “Sub-Contractor” means any firm or company whose services are retained by MediWound to transform Bromelain SP into Product and to package, label and deliver pharmaceutical preparations of the Product in finished form to MediWound and its sub-licensees. All references to “MediWound” under Sections 3.1, 5, 6 and 7.1 shall be construed as being inclusive of Sub-Contractors, unless the context dictates otherwise.

 

1.15                        “Technical Information” means that information in use at the Facility during the term of this Agreement, relating to the manufacture of Bromelain SP meeting the Specifications, in bulk, as more comprehensively described in Section 1.15 of the TT Agreement.

 

1.16                        “TT Agreement” means the Technology Transfer Agreement dated January 11, 2001 between the parties hereto, whereby CBC undertakes to transfer the Technical Information to MediWound.

 

2.                                      Conditions Precedent

 

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

 

2.1.1                     Execution of a License Agreement between MediWound and LR whereby MediWound shall license certain Product-related know-how from LR; and

 

2.1.2                     Execution of the TT Agreement.

 

2.2                               The date upon which MediWound shall have acknowledged in writing to CBC that the Conditions Precedent have all been met shall be the “Effective Date”. Where the Conditions Precedent have not been met by January 31, 2001, for any reason whatsoever, then this Agreement and the MOU shall be deemed terminated as of that date with no further liability of either party, except for the obligation of confidentiality, as set forth in the MOU.

 

3.                                      Grant of Rights

 

3.1                               As from and subject to the Effective Date, and subject to the terms and conditions of this Agreement, CBC shall supply Bromelain SP to MediWound and MediWound shall acquire Bromelain SP from CBC, for transformation into the Product.

 

3.2                               MediWound’s rights as per Section 3.1 will be exclusive in the sense that CBC shall not nor shall permit any Affiliate or third party to manufacture, use, supply

 

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

 

4

 

or sell Bromelain SP for utilization as an ingredient of any product which directly or indirectly competes with the Product.

 

4.                                      Financial Provisions

 

4.1                               In consideration for CBC’s undertaking to supply Bromelain SP to MediWound and other obligations of CBC pursuant to this Agreement, MediWound has paid to CBC US$ [***] (US Dollars [***]) within 3 (three) business days of the Effective Date.

 

4.2                               Payments for supply of Bromelain SP by CBC to MediWound as of the Amendment Effective Date shall be made in accordance with the following provisions:

 

4.2.1                     The price of [***] Kg of an accepted batch of Bromelain SP (by MediWound pursuant to Section 6.4) shall be in accordance with the price per annual quantity table in Exhibit 4.2 attached hereto. The price used for invoicing during the year shall be based on the quantity in the Annual Forecast. At the end of each year the parties shall recalculate the amounts to be paid pursuant to the actual quantities purchased throughout the passing year and adjust the payments accordingly (for example: if the actual quantity purchased during the past year was higher than the Annual Forecast and such higher quantity should have been invoiced as per a lower price per Kg of Bromelain SP in accordance with price per annual quantity table in Exhibit 4.2, CBC shall recalculate the invoices for the past year as per the actual price that should have been invoiced and credit MediWound for the balance within [***] days accordingly. If the actual quantity purchased during the past year was lower than the Annual Forecast and such lower quantity should have been invoiced as per a higher price per Kg of Bromelain SP in accordance with price per annual quantity table in Exhibit 4.2, CBC shall recalculate the invoices for the past year as per the actual price that should have been invoiced and invoice MediWound for the balance within [***] days accordingly).

 

4.2.2                     CBC may increase the prices only pursuant to an increase in its cost of manufacturing of the Bromelain SP. Any such increase shall be subject to MediWound’s pre-approval, and no increase shall be executed more often than once every [***] months and any changes thereto shall be in-line with current market prices for Bromelain manufacturing except that (i) there is a change of cost of manufacturing of Bromelain SP due to a change requested by regulatory agency and confirmed by MediWound; and (ii) the Taiwan official Wholesale Price Index varies over [***]% within [***] months. When such exceptional situations arise, an increase

 

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

 

5

 

of price shall be considered by MediWound at CBC’s written request without the limit of no more often than once every [***] months.

 

4.2.3                     MediWound shall make payment for each Bromelain SP batch that was supplied by CBC on a [***] days basis as of the date of delivery of the applicable batch at MediWound, provided that MediWound has provided CBC with an Acceptance Batch Notice for such purchased batch pursuant to Section 6.4. Payment for each purchase batch shall be effected by MediWound by swift to a bank account designated by CBC, or by other requested method as agreed between the parties. MediWound shall make down payment of USD[***]/kg for the [***]% of the amount of Annual Forecast before Dec.31 of the respective year for the insurance of components and materials and maintenance of manufacture and supply capacity of the requested [***]% of the next calendar year’s Annual Forecast. The down payment will be then deducted respectively as every shipment is made to MediWound and listed in CBC’s Invoice to MediWound.

 

4.2.4                     Payment shall be made directly to CBC for payment for each order of Bromelain SP or, at CBC’s written request, to Golden Life International Co., Ltd. on CBC’s behalf, for payments other than any order of Bromelain SP (“Payee”); provided however, that any such payment to the Payee shall be considered as valid payment to CBC (as if made directly to CBC) in accordance with this Agreement, and that so long as such payment is made in accordance with CBC’s said request, CBC shall have no claims or demands against MediWound for non-payment or in any other respect whatsoever in this regard. CBC solely shall be responsible to ensure that payment by MediWound to the Payee pursuant to CBC’s request does not violate any applicable laws and regulations. Any tax implications due to payment to the Payee in accordance with CBC’s request shall be borne by CBC. For avoidance of doubt, it is clarified that the Payee shall not be considered as a third party beneficiary under this Agreement and shall not have any rights to enforce payment or any other rights of CBC under this Agreement.

 

4.2.5                     Invoices shall only be issued upon delivery of the Bromelain SP batch which shall take place only after CBC’s quality control department has completed its testing and authorized delivery to MediWound, and MediWound’s quality control department has provided CBC with an Acceptance Sample Notice for that batch and that the batch itself can be delivered.

 

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

 

6

 

4.2.6                     The consideration to be paid pursuant to this Agreement is final and inclusive of all taxes and/or duties, of whatsoever nature. If applicable laws require the withholding of taxes, MediWound will deduct the taxes from the related payment otherwise due to CBC, and such taxes shall be paid to the proper taxing authority. For avoidance of doubt, payments will be made only after receiving exemption from tax deduction approval from the tax authority in Israel. Delay in payment as a result of not receiving such exemption will not constitute late payment or breach hereunder.

 

5.                                      Manufacture of Bromelain SP

 

5.1                               Without derogating from CBC’s representations and warranties herein, CBC and MediWound shall work together in order to enable the CBC facility to accomplish all required standards, related to the manufacturing, packaging and delivering of Bromelain SP in accordance with the Specifications, GACP (Good Agricultural and Collection Practice) and cGMP (Current Good Manufacturing Practice) standards, ISO 22000 and all other applicable laws and regulations. For such purpose, and without derogating from other terms herein, CBC shall permit MediWound, and/or a consultant on MediWound’s behalf, to access and inspect the CBC facility and advise MediWound and/or CBC on such actions to be taken for accomplishing such compliance. Such mutual regulatory preparations shall begin no later than the finalization of MediWound’s current phase III clinical trial.

 

CBC warrants and represents that all Bromelain SP shall be manufactured and supplied in compliance with the Specifications, quality control methods and test methods, all applicable SOP’s and all applicable laws, and in accordance with GACP, cGMP, including the relevant guidelines, policies, codes, requirements, regulations, approvals and/or standards from time to time promulgated or issued by any relevant governmental and/or regulatory authority which relate to the manufacture of the Bromelain SP to be used for the production of a pharmaceutical agent as the Product.

 

CBC warrants further that CBC has, and will for the duration of this Agreement retain, all applicable regulatory approvals required for the carrying out of its obligations hereunder, including without limitation the manufacturing, packaging and supply of the Bromelain SP.

 

5.2                               All manufacturing, packaging and labeling activities done at CBC will be performed according to the pre-approved batch records. If CBC wishes to make changes to the Specifications, the production and/or packaging batch records, the SOPs related to the Bromelain SP, or the design of the manufacturing process or any other change during production which would effect the quality of the

 

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

 

7

 

Bromelain SP or of the Product and/or otherwise would effect the Bromelain SP in any way or which might effect the regulatory approvals of the Product, then CBC shall (i) notify MediWound in writing at least 6 months in advance regarding such proposed changes, and (ii) represent that such change will not adversely effect the quality of the Bromelain SP or of the Product in any way, and (iii) not make such changes without MediWound’s prior written approval, and (iv) will assure that such change will not delay or in any way effect any open orders for Bromelain SP.

 

5.3                               MediWound shall participate and support the upgrade of the Facility and the generation of documentation for submission to the relevant Regulatory Authorities, all as may be determined to be necessary and appropriate, by independent regulatory consultants, designated by mutual consent. Such participation and support shall be in the form of an investment made by MediWound in the CBC facility, not to exceed $[***] (US Dollars [***]).

 

5.4                               CBC undertakes to keep all records reasonably required by MediWound relating to the manufacture, quality control and testing of Bromelain SP. Such records shall include, but not be limited to, all records required by applicable laws and regulations, of the territories in which the Product is marketed and sold. MediWound (itself or through anyone on its behalf) or any relevant regulatory authority shall have the right to audit any such records and/or the relevant facilities of CBC (or any facilities of any CBC third party or subcontractor involved in the manufacture, quality control and/or supply of the Bromelain SP) with reasonable prior notice, during regular business hours, including the right to ask CBC to provide any relevant documents. CBC shall inform MediWound of any announced regulatory inspections that directly involve the Bromelain SP or the Product within 48 hours of the notification to CBC of such an inspection.

 

5.5                               During the term of this Agreement, CBC shall make available to MediWound any and all information and data which it generates or which comes into its possession relating to any improvements in the manufacture and supply of the Bromelain SP. CBC shall, throughout the term of this Agreement, assist MediWound in all respects with regard to regulatory submission including but not limited to providing any information, data or documents in its possession. If any regulatory agency requests any changes to the Specifications or the manufacturing process, (including but not limited to any changes as a result of an audit performed) CBC shall (i) inform MediWound in advance and in writing of the changes needed to be made, and (ii) promptly advise MediWound as to any lead-time changes or other terms which may result therefrom, and (iii) make such changes, in coordination with MediWound as soon as possible.

 

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

 

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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.

 

1

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