Exhibit 10.8
LICENSE AGREEMENT
between
Nordmark Arzneimittel GmbH & Co. KG
Pinnauallee 4
25436 Uetersen
Germany
— hereinafter referred to asLicensor —
and
Eurand S.p.A.
Via Martin Luther King, 13
20060 Pessano con Bornago - Milano
Italy
— hereinafter referred to asLicensee—
(both parties referred to as theParties,
the License Agreement referred to as theAgreement)
Relating to Pancreatin (API) Documentation
PREAMBLE
| 1. | Whereas,Licensormanufactures active pharmaceutical ingredients (hereinafter collectively referred to asAPI) and medicinal products and possesses the necessary manufacturing authorization issued by the competent German authorities. |
| 2. | Whereas,Licensor is specialized and has accumulated comprehensive experience and know-how in the manufacture of theAPI pancreatin, - hereinafter referred to asPancreatin (Pancreatinproduced byLicensorwill hereinafter be referred to asN-Pancreatin). |
| 3. | Whereas,Licenseemanufactures medicinal products and sells them to third parties, and possesses, among other things, certain manufacturing authorizations issued by the competent Italian authorities. |
| 4. | Whereas,Licensee manufactures medicinal products containingPancreatin and sells them to third parties worldwide. For the manufacture of those medicinal products,Licensee usesPancreatin produced by third parties and/orN-Pancreatin. Medicinal products manufactured byLicensee usingN-Pancreatin will hereinafter be referred to asDrug Product. |
| [*] | Confidential treatment requested. |
| 5. | Whereas,Licenseeplans to apply either directly or indirectly for a marketing authorization for theDrug Productin the USA, Europe and other markets and - upon registration - to distribute directly or indirectly theDrug Productin the USA, Europe and any other markets. |
| 6. | Whereas, thePartiesas of July 13th/21st, 2003, have concluded a contract, - hereinafter referred to asContract,which is an agreement for the nonexclusive supply byLicensortoLicenseeofN-Pancreatin. |
| 7. | Whereas, thePartiesas of January 3rd, 2006, have concluded a cooperation agreement, - hereinafter referred to asCooperation Agreement,under whichLicensorhad an obligation to supply documentation to regulatory authorities. For a variety of reasons, thePartieselected to enter into thisAgreementwithout prejudice toLicensee’srights under theCooperation Agreement. |
| 8. | Whereas, thePartiesas of January 3rd, 2006, have concluded a supply contract, - hereinafter referred to asSupply Contract, which is an agreement for the non-exclusive supply byLicensortoLicenseeofN-Pancreatinthat shall come into force from the date of the marketing authorization approval, - hereinafter referred to as theEffective Date, of theDrug Productin the USA. On theEffective DatetheSupply Contractwill replace theContract. |
| 9. | Whereas,Licensee is the marketing authorization holder forDrug Productsmarketed in Germany as described inAnnex Irecital 1, - hereinafter referred to as theGerman Products. |
| 10. | Whereas, as a consequence of the re-registration process in Germany (“Nachzulassung”) deficiency letters have been issued by the competent German authority BfArM toLicenseeconcerning theGerman Productsthat contain questions thatLicenseehas to answer; and to answer these questionsLicensee has requested the assistance ofLicensor. |
| 11. | Whereas,Licenseehas applied and/or will apply directly or indirectly for further marketing authorizations forDrug Product, - hereinafter referred to asFurther Drug Products; in the countries in the European Union and other countries in which theDocumentationmay be useful, - hereinafter referred to asTerritories. |
| 12. | Whereas,Licenseeplans to conduct clinical trials using investigational medicinal products containingN-Pancreatin,hereinafter referred to asClinical Trials,as described inAnnex I,recital 3. |
| 13. | Whereas,Licensor has carried out extensive work on the characterization ofN-Pancreatinand virus validation as well as on the description and validation of the manufacturing process. This know-how has been documented in accordance with the applicable guidelines on the testing of medicinal products (hereinafter calledArzneimittelprufrichtlinien) and complies with the Common Technical Document Format (CTD-Format) (Annex I of directive 2001/83/EC of the European Parliament and of the Council on the Community Code relating to medicinal products for human use, as |
| [*] | Confidential treatment requested. |
| amended), in Module 2 and Module 3 (parts 3.1, 3.2.S and 3.2.A related toN-Pancreatin).Such documentation is specifically identified inAnnex II- hereinafter referred to as theDocumentationand may contain Confidential Information andLicensorhas not yet revealed such Confidential Information to theLicensee. |
| 14. | Whereas, according to EMEA Monthly Report July 12th, 2006, EMEA 2226291/2006, page 22,Pancreatinshould be considered as a biosimilar. Therefore the delimitation between an open part and a closed part of the Drug Master File, - hereinafter referred to asDMF, and of the Active Substance Master Files, - hereinafter referred to asASMF - does not apply any longer in the European Community (EC) and both theDMFand theASMFhave to be revealed toLicensee. Consequently, the protection ofLicensor’sconfidential information related toN-Pancreatinwhich was formerly laid down in the closed part of theDocumentationin the EC is not possible any more. |
| 15. | Whereas,Licensee wishes to obtain certainDocumentationto answer to the BfArM all related questions in the re-registration procedure for theGerman Products, to support marketing authorizations; to answer all questions in the deficiency letters for theFurther Drug Productsand to assemble the required documentation related toN-Pancreatinfor the approval by the local competent authorities to conductClinical Trials. |
| 16. | Whereas,Licensor is prepared to place under the conditions laid down in thisAgreementatLicensee’sdisposal theDocumentationto support the aforementioned purposes. |
Now, therefore, thePartiesagree as follows:
Art. 1
Subject of Agreement
| 1.1 | Licensorwill prepare and place theDocumentation at Licensee’sdisposal for the sole purpose of obtaining, supporting, or maintaining marketing authorization for theDrug Product. Licensoris obliged to provide the final version of theDocumentationtoLicenseeby 12 May 2008, but will use its best effort to enableLicenseeto answer to the BfArM all related question in the re-registration procedure for theGerman Products, to support marketing authorizations; to answer all questions in the deficiency letters for theFurther Drug Productsand to assemble the required documentation related toN-Pancreatinfor the approval by local competent authorities to conductClinical Trialsimmediately after execution of thisAgreement. Subject to the terms and conditions of Section 2.10,Licensorwill provide additional documentation required by regulatory authorities in any country in the European Union and any country in Europe (as geographic area) to the extent such country will accept comparable documentation as may be required by regulatory authorities in the European Union, and will use commercially reasonable efforts to provide additional documentation requested by regulatory authorities in other jurisdictions. |
| [*] | Confidential treatment requested. |
-Art. 2
Grant of License
| 2.1 | Licensor grantsLicensee a non-exclusive license to use theDocumentation for the application and the maintenance of marketing authorizations for theDrug Product, and further to use theDocumentation to assemble the required documentation related toN-Pancreatin for the approval to conductClinical Trials using investigational medicinal products containingN-Pancreatin as legally necessary and as required by the local competent authorities. |
| 2.2 | ShouldLicensee wish to grant any sublicenses to use theDocumentation to a third party, - hereinafter referred to asSublicensee - in order to apply for or maintain a marketing authorization for theDrug Product or in order to conductClinical Trials, it shall (1) provide the third party’s name and the intendedTerritory toLicensor in writing, and (2) Licensor shall provide written consent to such sublicense within ten (10) working days, except in the event that such third party is (a) a manufacturer and/or supplier ofPancreatin or (b) an affiliate of a manufacturer and/or supplier ofPancreatin. Explicitly, a sublicense for the use of theDocumentation will not be granted to the company[*], - hereinafter referred to as[*] - or an affiliate of[*] All of this provided, however, thatLicensee ensures in writing that suchSublicensee shall comply with the same confidentiality obligations as imposed onLicensee pursuant to thisAgreement and will not have the rights to further sublicense theDocumentation. The names of theSublicensees and sublicensee candidates shall be deemedLicensee’s Confidential Information and shall only be used byLicensor for the sole purpose of determining whether the sublicensee meets the requisite criteria. Notwithstanding the foregoing provision of this Section,Licensee may grant a sublicense to the customers named in Annex I hereto. |
| 2.3 | ShouldLicensee or an approvedSublicensee intend to use theDocumentation forDrug Products orTerritories other than as mentioned inAnnex I,Licensee shall informLicensor by providingLicensor with an updated version ofAnnex I, recital 1 and 2, in which marketing authorization applicant/holder andTerritories are added, at least one month prior to the planned use of theDocumentation. |
| 2.4 | ShouldLicensee or an approvedSublicensee intend to use theDocumentation forClinical Trials other than as mentioned inAnnex I,Licensee shall informLicensor by providingLicensor with an updated version ofAnnex I, recital 3, in which the clinical research organization, hereinafter referred to asCRO - andTerritories are added, at least one month prior to the planned use of theDocumentation. |
| 2.5 | If theDocumentation can be filed as a part of the confidential or closed part of aDMF,Licensor shall file suchDMF as manufacturer ofN-Pancreatin pursuant to the terms and conditions of theCooperation Agreement. |
| 2.6 | Licensee shall not use theDocumentation to support applications for medicinal products containingPancreatin other than theDrug Product (in particular or medicinal products containingPancreatin not manufactured byLicensor) nor make it wholly or partly accessible to third parties, except as permitted herein. For purposes of clarity and notwithstanding the foregoing, theParties acknowledge and agree thatLicensee may have, subject to applicable laws, other suppliers ofPancreatin and theDocumentation may be part of a regulatory dossier held byLicensee orSublicensee that supportsPancreatin containing drug products other than theDrug Product, provided however that Section 1.4 of theCooperation Agreement is unaffected. For purposes of clarity and notwithstanding the foregoing,Licensee acknowledges to buy at least 50 % of its requirements ofPancreatin (in accordance with the relevant terms and conditions in theCooperation Agreement) for such aPancreatin containing drug products fromLicensor. |
| [*] | Confidential treatment requested. |
| 2.7 | Affiliates of theLicensee are not considered third parties for the purposes of thisAgreement. For the purposes of thisAgreement: (a) one company is affiliated with another company if one of them is the subsidiary of the other or both are subsidiaries of the same company or each of them is controlled by the same person; and if two companies are affiliated with the same company at the same time, they are deemed to be affiliated with each other; (b) a company is a subsidiary of another company if (i) it is controlled by that other company; or if it is controlled by that other company and one or more company each of which is controlled by that other company; or if it is controlled by two or more companies each of which is controlled by that other company; or (ii) it is a subsidiary of a company that is a subsidiary of that other company. “Control” means the ability to direct the affairs of another whether by way of contract, ownership of shares or otherwise howsoever. |
| 2.8 | Licensor has drawn up theDocumentation to the best of its knowledge taking into account the current state of the art. Except to the extent resulting from gross negligence or willful misconduct,Licensor shall not be responsible for any damages thatLicensee may suffer as a result of any defects of theDocumentation, but shall be responsible to promptly correct suchDocumentation if and when such a defect is discovered and brought to its attention. Provided that suchDocumentation is found to be satisfactory by the competent authorities then theLicensee’s payment obligations described under Article 3 shall remain unaffected, except the costs involved for the elimination of defects are economically unacceptable toLicensor, in which case theLicensor will reimburse theLicensee in accordance with the proportional economic impact of the failure to provide suchDocumentation in such countries, e.g., the potential turnover of the failed registration will be compared to the total turnover generated by the countries where the registration will be obtained; the incidence as percent will be calculated and applied as proportional fee reimbursement. |
| 2.9 | Licensor shall not introduce any change having a regulatory impact to theDocumentation, and in the event a change is required and subject to Article 3, before implementing such a changeLicensor will (1) carefully evaluate the regulatory implications of the change considering the requirements of each country, (2) generate the supporting documentation in the appropriate format, including the update of theDocumentation, (3) notifyLicensee who will proceed, directly or throughSublicensee, to obtain the regulatory approval, and (4) implement the change only upon receiving feedback of the obtained approvals. In the event that such change is required by any competent authority, thenLicensor will (1) promptly notifyLicensee; (2) work withLicensee to carefully evaluate the regulatory implications of the change considering the requirements of each country, and (3) implement that change in a manner that harmonizes with the requirements of other countries in the Territory. In the event that any information, data or results pertaining toN-Pancreatin are generated or emerge from third parties and theDocumentation should change or otherwise require updating,Licensor will promptly so adviseLicensee and update theDocumentation and make it available toLicensee within the established regulatory deadline and in full cooperation withLicensee. |
| 2.10 | In the event that a competent authority requires additional documentation (other than that set forth inAnnex II), thePartiesshall promptly meet and discuss the feasibility of developing such additional documentation. In the event that such documentation is (1) required by regulatory authorities in any country in the European Union and any country in Europe (as geographic area) to the extent such country will accept comparable documentation as may be required by regulatory authorities in the European Union or (2) in the event that it is required by a regulatory authority outside of those countries and generating such documentation is commercially feasible; then thePartieswill develop a plan to effectuate the development of such documentation.Licensorshall make available qualified and knowledgeable personnel to implement the plan, provided thatLicensorwill only make its personnel available for up to one hundred (100) hours per year without additional charge, and for further activities at an hourly rate of 156,25 €. |
| [*] | Confidential treatment requested. |
Art. 3
Costs and Payment Conditions
| 3.1 | In consideration for the grant of license to use theDocumentationfor the application and the maintenance of marketing authorizations for theDrug Product, and to use theDocumentationto assemble the required documentation related toN-Pancreatinfor the approval to conductClinical Trialsusing investigational medicinal product containingN-Pancreatinas legally necessary and as required by the local competent authorities as defined in Art. 2,Licenseeshall pay a license fee of €[*] (plus VAT), fifty percent (50%) of which it shall pay within 30 days following receipt for theDocumentationbyLicenseeand the remaining fifty percent (50%) shall be paid within 30 days from the date the re-registration of the German marketing authorization (n° 6012523.00.00, ref. to Annex 1) has been granted, provided however, in the event that the marketing authorization is withdrawn based on the failure of theDocumentation,Licensorwill repay the amounts in accordance with Section 2.8. |
| 3.2 | Licensor’scosts caused to supplement theDocumentation shall be determined in accordance with Section 2.10 and 3.3 |
| 3.3 | In the event thatLicensee(directly or indirectly) requests documentation thatLicensorhas or is developing to support, obtain or maintain marketing authorization forDrug Productor related toN-Pancreatinfor the approval to conductClinical Trialsusing investigational medicinal product containingN-Pancreatinfor third party customers,Licensorwill proportionally divide the cost for developing such documentation between the third party customers andLicensee. |
Art. 4
Claim for Damages
| 4.1 | In caseLicensee shall not comply with the obligations according to Section 2.2 or 2.3,Licensee shall indemnifyLicensor for the damage resulting therefrom. |
Art. 5
Confidentiality
| 5.1 | Licensee shall keep theDocumentation and the content of thisAgreement strictly confidential, and take all the necessary measures to protect this information against disclosure to third parties, except as permitted herein. |
| 5.2 | Licensorshall keep the information set forth inAnnex I(and related documentation) and the content of thisAgreementconfidential, and take all the necessary measures to protect this information against disclosure to third parties, except as permitted herein. |
| [*] | Confidential treatment requested. |
| 5.3 | The Parties shall make this information accessible only to those persons who are directly entrusted with the performance of thisAgreement. TheParties shall oblige these persons accordingly to maintain confidentiality. |
| 5.4 | The restriction of use and confidentiality obligation shall not apply to such information that can be reasonably documented to show that it: |
| (a) | has been known by or available to the receiving party or the public when signing thisAgreement, |
| (b) | is published or otherwise becomes part of the public domain through no fault of the receiving party |
| (c) | was in the possession of the receiving party at the time of the disclosure and was not acquired directly or indirectly from the disclosing party, |
| (d) | was disclosed to the receiving party by a third party who has the right to disclose it; or |
| (e) | must be disclosed to the competent authorities because of legal requirements. |
The restriction of use and confidentiality obligation survives the term of thisAgreement.
Art. 6
Term and Termination
| 6.1 | ThisAgreement shall be deemed effective after signature by bothParties and remains in force for the term of theContract and any renewal or extension thereof. It shall also remain in force for the duration of theSupply Contract or any new agreement concerningN-Pancreatin entered into between theParties in order to amend, restate or replace theContract. |
| 6.2 | Licensor shall have the right to terminate thisAgreement upon a 30 days written notice to theLicensee if the latter delay in payment pursuant to Art. 3 exceeds 6 months and such payment is not made within such 30 days after written notice of the same. |
| 6.3 | If theContract is not renewed, extended or replaced by theSupply Contract or any new agreement between theParties concerningN-Pancreatin, thisAgreement shall terminate. |
| 6.4 | Upon termination of thisAgreement pursuant to Section 6.1, 6.2 or 6.3,Licensee shall as soon as reasonably practicable cease using theDocumentation; provided any sublicense agreements entered into pursuant to Article 2 would be, atSublicencee’s discretion, transitioned to a license directly between theSublicensee and theLicensor for theDocumentation. |
| 6.5 | Within four weeks after termination of thisAgreementpursuant to Section 6.2 or 6.3,Licenseeshall return toLicensortheDocumentationand destroy or irretrievably delete |
| [*] | Confidential treatment requested. |
| all copies of theDocumentation (including electronic copies) that it may have in its possession. Provided however, it may maintain one copy for legal archival purposes and any copies provided toSublicenses and filed to the authorities. TheLicenseeshall informLicensor in writing that it complied with this obligation. |
| 6.6 | EitherParty (the “Non-breaching Party”) may, without prejudice to any other remedies available to it at law or in equity, terminate thisAgreement in the event the otherParty (the “Breaching Party”) shall have materially breached or defaulted in the performance of any of its material obligations hereunder, and such default shall have continued for forty-five (45) days after written notice thereof was provided to theBreaching Party by theNon-breaching Party (or, if such default cannot be cured within such forty-five (45) day period, if theBreaching Party does not commence and diligently continue actions to cure such default during such forty-five (45) day period). Any such termination shall become effective at the end of such forty-five (45) day period unless theBreaching Party has cured any such breach or default prior to the expiration of such forty-five (45) day period (or, if such default cannot be cured within such forty-five (45) day period, if theBreaching Party has commenced and diligently continued actions to cure such default). For the purposes of thisAgreement, the following shall constitute a per se material breach: |
| (i) | except as may be approved byLicensor, if theLicensee knowingly provides theDocumentationto a manufacturer and/or supplier ofPancreatin; |
| (ii) | in case of insolvency of eitherPartyor if either Party should file a declaration of bankruptcy or enter into any arrangement or composition with their creditors or go into liquidation whether voluntarily or compulsory or if the otherParty should generally assign its claims to his creditors. |
Art. 7
Final Provisions
| 7.1 | Amendments. No amendment or modification of the terms of thisAgreement shall be binding on eitherParty unless in writing and signed by bothParties. |
| 7.2 | Relationship of the Parties. EachPartyshall bear its own costs incurred in the performance of its obligations hereunder without charge or expense to the other except as expressly provided in thisAgreement. NeitherParty shall have any responsibility for the hiring, termination or compensation of the otherParty’s employees or for any employee benefits of such employee. No employee or representative of aParty shall have any authority to bind or obligate the otherParty to thisAgreementfor any sum or in any manner whatsoever, or to create or impose any contractual or other liability on the other Partywithout suchParty’s approval. For all purposes, and notwithstanding any other provision of thisAgreementto the contrary,Licensee’slegal relationship under thisAgreementtoLicensorshall be that of independent contractor. ThisAgreementis not a partnership agreement and nothing in thisAgreementshall be construed to establish a relationship of co-partners or joint venturers between theParties. |
| [*] | Confidential treatment requested. |
| 7.3 | Assignment. This Agreement may not be assigned by eitherParty without the prior consent of the otherParty; provided, however, that eachParty may assign thisAgreement, in whole or in part, to any of its affiliates; and provided further, that eachParty may assign thisAgreement to a successor, which is not aPancreatin manufacturer, to all or substantially all of its assets whether by merger, sale of stock, sale of assets or other similar transaction. ThisAgreement shall be binding upon, and subject to the terms of the foregoing sentence, inure to the benefit of theParties hereto, their permitted successors, legal representatives and assigns. |
| 7.4 | Notices. All demands, notices, consents, approvals, reports, requests and other communications hereunder must be in writing and will be deemed to have been duly given only if delivered personally, by facsimile with confirmation of receipt, by mail (first class, postage prepaid), or by overnight delivery using a globally-recognized carrier, to thePartiesat the following addresses: |
| If to LICENSOR: | Nordmark Arzneimittel GmbH & Co. KG | |
| Pinnaualle 4 | ||
| 25436 Uetersen | ||
| Germany | ||
| Attn: Head of Sales & Marketing | ||
| If to LICENSEE: | Eurand S.p.A. | |
| Via Martin Luther King, 13 | ||
| 20060 Pessano con Bornago | ||
| Milan, Italy | ||
| Attn: General Counsel | ||
or to such other address as the addressee shall have last furnished in writing in accordance with this provision to the addressor. All notices shall be deemed effective upon receipt by the addressee.
| 7.5 | Severability. In the event of the invalidity of any provisions of thisAgreementor if thisAgreementcontains any gaps, thePartiesagree that such invalidity or gap shall not affect the validity of the remaining provisions of |
| [*] | Confidential treatment requested. |
| thisAgreement. TheParties will replace an invalid provision or fill any gap with valid provisions which most closely approximate the purpose and economic effect of the invalid provision or, in case of a gap, theParties’ presumed intentions. In the event that the terms and conditions of thisAgreement are materially altered as a result of the preceding sentences, theParties shall renegotiate the terms and conditions of thisAgreement in order to resolve any inequities. Nothing in this Agreement shall be interpreted so as to require eitherParty to violate any applicable laws. |
| 7.6 | Headings. The headings used in thisAgreementhave been inserted for convenience of reference only and do not define or limit the provisions hereof. |
| 7.7 | Waivers. Any term or condition of thisAgreementmay be waived at any time by thePartythat is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of thePartywaiving such term or condition. No waiver by anyPartyof any term or condition of thisAgreement, in any one or more instances, shall be deemed to be or construed as a waiver of the same or any other term or condition of thisAgreement on any future occasion. Except as expressly set forth in thisAgreement, all rights and remedies available to aParty, whether under thisAgreementor afforded by law or otherwise, will be cumulative and not in the alternative to any other rights or remedies that may be available to suchParty. |
| 7.8 | Entire Agreement.ThisAgreement(including the exhibits and schedules hereto) constitute the entire agreement between theParties, and supersede all previous agreements and understandings between theParties, whether written or oral, with respect to the within subject matter. |
| 7.9 | Third Party Beneficiaries. None of the provisions of thisAgreementshall be for the benefit of or enforceable by any third party, including any creditor of eitherParty. No such third party shall obtain any right under any provision of thisAgreementor shall by reasons of any such provision make any claim in respect of any debt, liability or obligation (or otherwise) against eitherParty. |
| 7.10 | Applicable Law. ThisAgreement is construed and will be governed by German law. |
| 7.11 | Dispute Resolution. Any dispute relating to thisAgreementshall be resolved in accordance with the dispute resolution procedure set forth inAnnex III. |
| [*] | Confidential treatment requested. |
| 7.12 | Counterparts. ThisAgreementmay be executed in any two counterparts, each of which, when executed, shall be deemed to be an original and both of which together shall constitute one and the same document; and such counterparts may be delivered to the otherPartyby facsimile. |
Milan,
Eurand S.p.A. | Uetersen
Nordmark Arzneimittel GmbH & Co. KG | |||
/s/ Gearoid M. Faherty | /s/ P. Tonne | |||
| Mr. Gearoid M. FAHERTY | Dr. P. Tonne | |||
| President and CEO | President | |||
| Date: 14th April 2008 | Date: 10 April 2008 | |||
| [*] | Confidential treatment requested. |
ANNEX I
Drug Products and Territories
1. German Products
Name | Marketing Authorization applicant/holder | Registration N°. | Territories | |||||
1. | Pankreatin Mikro- Eurand 20.000 | Eurand* | 6012523.00.00 | Germany | ||||
2. | Pangrol® 10000 | Berlin Chemie**§ | 6663835.00.00 | Germany | ||||
3. | Pangrol® 25000 | Berlin Chemie**§ | 3000917.00.00 | Germany |
2. Further Products
Name | Marketing Authorization applicant/holder | Registration N°. | Territories | |||||
| 1. | Pankreolan 10000 | Zentiva** | To be defined | |||||
| 2. | Pankrezym 25000 | Zentiva** | To be defined | |||||
| 3. | Pangrol® 10000 | Berlin Chemie**§ | To be defined | |||||
| 4. | Pangrol® 25000 | Berlin Chemie**§ | To be defined | |||||
| 5. | Nutrizym 10 | E Merck Ltd** | PL 0493/0157 | UK | ||||
| 6. | Nutrizym 22 | E Merck Ltd** | PL 0493/0158 | UK | ||||
| 7. | Nutrizym 10,000 | E Merck Ltd** | PA 54/64/2 | Ire | ||||
| 8. | Nutrizym 22,000 | E Merck Ltd** | PA 54/64/3 | Ire | ||||
| 9 | Pancrease HL capsules | Janssen Cilag Ltd** | UK NL |
| [*] | Confidential treatment requested. |
3. Clinical trials
Trial Number | CRO | Territories | ||||
| * | Ratiopharm’s MA transfer toLicenseeon January 11 2008 |
| ** | Sublicensee |
| § | Berlin Chemie has already obtained the Documentation directly from the Licensor and all requests relevant to Drug Substances will be managed accordingly by Berlin Chemie. |
| [*] | Confidential treatment requested. |
ANNEX II
Documentation
| 3.1 | Module 3 Table of Contents | |
| 3.23 | Body of Data | |
| 3.2.S | Drug Substance | |
| 3.2.S.1 | General Information | |
| 3.2.S.1.1 | Nomenclature | |
| 3.2.S.1.2 | Structure | |
| 3.2.S.1.3 | General Properties | |
| 3.2.S.2 | Manufacture | |
| 3.2.S.2.1 | Manufacturer(s) | |
| 3.2.S.2.2 | Description of Manufacturing Process and Process Controls | |
| 3.2.S.2.3 | Control of Materials | |
| 3.2.S.2.4 | Controls of Critical Steps and Intermediates | |
| 3.2.S.2.5 | Process Validation and/or evaluation | |
| 3.2.S.2.6 | Manufacturing Process Development | |
| 3.2.S.3 | Characterization | |
| 3.2.S.3.1 | Elucidation of Structure and Other Characteristics | |
| 3.2.S.3.2 | Impurities | |
| 3.2.S.4 | Control of Drug Substance | |
| 3.2.S.4.1 | Specification | |
| 3.2.S.4.2* | Analytical Procedures | |
| 3.2.S.4.2.1 | Analytical Procedures - Overview | |
| 3.2.S.4.2.2 | Identification Enzymatic Activity | |
| 3.2.S.4.2.3 | Lipolytic Activity Assay, Ph. Eur. | |
| 3.2.S.4.2.4 | Amylolytic Activity Assay, Ph. Eur. | |
| 3.2.S.4.2.5 | Assay for Total Proteolytic Activity, Ph. Eur. | |
| 3.2.S.4.2.6 | 2-Propanol / GC Identification and Assay | |
| 3.2.S.4.2.7 | §35 LMBG K 48.00 1 (Aflatoxins determination) | |
| 3.2.S.4.2.8 | §35 LMBG K 15.03 1 (Ochratoxin A determination) | |
| 3.2.S.4.2.9 | §35 LMBG 00.00 19/1 (Heavy Metals determination) | |
| 3.2.S.4.2.10 | DIN EN ISO 17294-2 (Heavy Metals ICP-MS determination) |
| [*] | Confidential treatment requested. |
| 3.2.S.4.2.11 | §35 LMBG 00.00 19/4 (Mercury determination) | |
| 3.2.S.4.2.12 | EU Directive 20021691EC (Dioxins determination) | |
| 3.2.S.4.2.13 | §35 LMBG 00.00 34 (Pesticides determination) | |
| 3.2.S.4.3 | Validation of Analytical Procedures | |
| 3.2.S.4.3.1 | Validation of Analytical Procedures - Overview | |
| 3.2. S.4.3.2 | Identification Enzymatic Activity | |
| 3.2.S.4.3.3 | Assay for Lipolytic Activity, Ph. Eur. | |
| 3.2.S.4.3.4 | Assay Amylolytic Activity, Ph. Eur. | |
| 3.2.S.4.3.5 | Assay Total Proteolytic Activity, Ph. Eur. | |
| 3.2.S.4.3.6 | Test on Purity Assay 2-Propanol / GC | |
| 3.2.S.4.4 | Batch Analyses | |
| 3.2.S.4.5 | Justification of Specification | |
| 3.2.S.5 | Reference Standards or Materials | |
| 3.2.S.6 | Container Closure System | |
| 3.2.S.7 | Stability | |
| 3.2.S.7.1 | Stability Summary and Conclusions | |
| 3.2.S.7.2 | Post-approval Stability Protocol and Stability Commitment | |
| 3.2.S.7.3 | Stability Data | |
| 3.2.A | Appendices | |
| 3.2.A.1 | Facilities and Equipment | |
| 3.2.A.1.1 | Facilities and Equipment Report - Drug Substance | |
| 3.2.A.2 | Adventitious Agents Safety Evaluation | |
| 3.2.A.2.1 | Adventitious Agents Safety Evaluation Report - Viral Safety | |
| * | The Section 3.2.S.4.2 contains only tests which are not referred to as PHEURI-2 and PHEUR3-1 in Annex IV: “Reference Document: 3.2.S.4.1.1 Specification Pancreas Powder Ph. Eur.”. |
| [*] | Confidential treatment requested. |
I
| Module 2.3 Table of Contents | ||
| 2.3.S | Drug Substance | |
| 2.3.S.1 | General Information | |
| 2.3.S.2 | Manufacture | |
| 2.3.S.3 | Characterisation | |
| 2.3.S.4 | Control of Drug Substance | |
| 2.3.S.5 | Reference Standards or Materials | |
| 2.3.S.6 | Container Closure System | |
| 2.3.S.7 | Stability | |
| 2.3.A | Appendices | |
| 2.3.A.1 | Facilities and Equipment | |
| 2.3.A.2 | Adventitious Agents Safety Evaluation |
| [*] | Confidential treatment requested. |
ANNEX III
Dispute Resolution Process
SELECTION OF ARBITRATORS. In the event that the Parties are unable to resolve a dispute within thirty (30) days after commencement of discussions between members of senior management, either party may submit the matter to binding arbitration in accordance with the procedures set forth in this Annex IlI. If a party intends to commence arbitration to resolve a dispute, such party shall provide written notice to the other party of such intention, and shall designate one arbitrator. Within ten (10) days of receipt of such notice, the other party shall designate in writing a second arbitrator. The two arbitrators so designated shall, within ten (10) days thereafter, designate a third arbitrator. The arbitrators so designated shall not be employees, consultants, officers, directors or shareholders of or otherwise associated with either party or an Affiliate of either party. Except as modified by the provisions of this Annex III, the arbitration shall be conducted in accordance with the then rules of commercial arbitration of and before the International Chamber of Commerce (ICC) in Zurich, Switzerland. The language of such arbitration shall be English and all notices and written submissions provided in such proceeding shall be in English.
WRITTEN PROPOSALS. Within thirty (30) days after the designation of the third arbitrator, the arbitrators and the Parties shall meet, at which time each party shall be required to set forth in writing the issues which need to be resolved and a proposed ruling on each such issue. Written submissions shall be limited to 30 pages of text (not including exhibits which may include copies of agreements, or extracts from books and records, but including testimony affidavits).
HEARING. The arbitrators shall set a date for a hearing, which shall be no later than thirty (30) days after the submission of written proposals, to discuss each of the issues identified by the Parties. Each party shall have the right to be represented by counsel. The arbitrators shall have sole discretion with regard to the admissibility of any evidence. Unless otherwise determined by unanimous agreement of the arbitrators the hearing shall be concluded in one (1) day unless the arbitrators conclude by majority vote that the hearing should be extended to avoid working an injustice to one of the parties.
RULING. The arbitrators shall use their best efforts to rule on each disputed issue within thirty (30) days after the completion of the hearings described in above. The arbitrators shall, by majority decision, select the ruling proposed by one of the Parties as the arbitrators’ ruling. The arbitrators’ ruling shall be, in the absence of fraud or manifest error, binding and conclusive upon both Parties and may be enforced in a court of competent jurisdiction. The arbitrators may not award punitive or exemplary damages.
ARBITRATION COSTS. The arbitrators shall be paid a reasonable fee plus expenses, which fees and expenses shall be paid as designated by the arbitrators or if the arbitrators do not so designate, such costs shall be shared equally by the parties.
| [*] | Confidential treatment requested. |
ANNEX IV
Reference Document: 3.2.S.4.1.1 Specification Pancreas Powder Ph.Eur.
PANCREAS POWDER (PH.EUR.) - NORDMARK ARZNEIMITTEL - Page : 1/3
| 3.2.S.4.1 | Specification | |
| 3.2.5.4.1.1 | Pancreas Powder Ph. Eur. | |
Test Parameter | Specification | Test Method |
[*]
| [*] | Confidential treatment requested. |
Nordmark
PANCREAS POWDER (PH.EUR.)-NORDMARK ARZNEIMITTEL - PO
2 13
Test Parameter | Specification | Test Method |
[*]
| [*] | Confidential treatment requested. |
Nordmark
PANCREAS POWDER (PH.EUR.) - NORDMARK ARZNEIMITTEL - PO
Pana: 313
Test Parameter | Specification | Test Method |
[*]
| [*] | Confidential treatment requested. |
