Exhibit 10.1 TURN-KEY CONTRACT FOR DESIGN AND
CONSTRUCTION OF PLANT FOR MEDICAL PRODUCTS Drawn up and signed on the August 2, 2006 Between: OMRIX BIOPHARMACEUTICALS LTD.
Private company no. 51 - 216605 - 9
Address: Blood Services Building, P.O.B. 888, Tel Hashomer, Kiryat Ono, 55100
Tel: 03 - 5316535, Fax: 03 - 5350265
(hereinafter: the " Client" ) of the first part And: S&A DESIGN AND CONSTRUCTION LTD.
Private company no. 51 - 24102 - 18
Of 4 Hasadna' ot Street, Herzliya Pituach, 64728
Tel: 9716111, Fax: 09 - 9716112
(hereinafter: the " Contractor" ) of the second part
TABLE OF CONTENTS Introduction
Chapter A - General
Sections 1- 7
Definitions Headings Contract Documents Contractor' s Declarations and Obligations Client' s Declarations Duties and Powers of the Supervisor Assignment of Contract Chapter B - Time Schedule and Efficiency Incentives
Sections 8- 9
Time Schedule Advancement/ Efficiency Incentives and fines for delay Chapter C - Detailed Design of the Project
Sections 10-11
Detailed Design and Intellectual Property Rights Supervision of Purchasing Equipment and Bringing It To Site Chapter D - The Construction of the New Plant
Sections 12-14
The Construction of the New Plant Completion Certificates for the Works Cleaning the Site of the Works Chapter E - Supervision
Sections 15-16
Supervision on Behalf of the Contractor Safety in Performance of the Works Chapter F - General Undertakings
Sections 17-19
Provisions of the Law Permits, Licenses and Approvals Harm to the Public' s Convenience and to Property
Chapter G - Employees
Sections 20-21
Provision of Personnel By the Contractor Employees' Conditions and Welfare Chapter H - Equipment, Materials and Work
Sections 22-24
Provision of Equipment, Facilities and Materials Quality of the Materials and Work, and Testing Samples Removal of Waste Materials and Demolition of Rejected Work Chapter I - Consideration and Terms of Payment
Sections 25-26
Consideration (Contract Fee) Terms of Payment Chapter J - Performance and Maintenance Guarantees
Sections 27-29
Guarantee for Performance of the Contract Guarantee for the Warranty Period General Provisions Regarding the Guarantees Chapter K - Changes, Additions and Deletions
Sections 30-34
Changes Evaluation of Changes Payments for Daily Work Measurement of Quantities in the Performance of Changes and/or Additions Extension for Completion of Performance of the Works Chapter L - Maintenance, Repairs, Service (Maintenance)
Sections 35-36
Maintenance, Repairs and Completion Certificate Maintenance and Repairs for Computer System Chapter M - Training
Sections 37
Training
Chapter N - Relations Between the Contractor and Various Entities
Sections 38-40
Relations with the Contractor, the Owners of the Site of the Works and Other Tenants Relations Between the Contractor and Other Contractors Relations Between the Contractor, Consultants and Other Service Providers Chapter O - Damages and Insurance
Sections 41-49
Contractor' s Liability for Damage On Site Damages to Person or Property Damages to Third Party Damages to Employees Indemnification Insurance Chapter P- Breaches and Remedies
Sections 50-54
Fundamental Breaches No Right to Cancel Performance instead of the Breaching Party Removal of the Contractor Disputes Chapter Q - Miscellaneous
Sections 55-57
Secrecy Rights Termination of Contract Jurisdiction Independent Contractor Offsetting Modifications and Waivers Attorneys' Fees Notices
INTRODUCTION WHEREAS: The Client is a company which deals in research and development, production and marketing of various medical preparations that are manufactured from plasma produced from human blood (hereinafter: the " Products" ); AND WHEREAS: The Client wishes to design and construct in Har Hotzvim in Jerusalem a new plant for the manufacture of the Products, which plant shall comply with Current Good Manufacturing Practices (cGMP) as determined from time to time by the various regulatory authorities in Israel (the Israeli Ministry of Health), Europe (the European Agency for the Evaluation of Medicinal Products - the EMEA), USA (Food and Drug Administration of the USA - the FDA) and Canada (Health Canada) and also with the requirements of any competent authority in Israel, Europe, the USA and Canada (hereinafter: the " New Plant" ); AND WHEREAS: The Client wishes to order the performance of the design and construction works for the New Plant pursuant to the provisions of this Contract, the general terms and the other documents attached to this Contract as an integral part hereof; AND WHEREAS: The Contractor engages, inter alia, in the design and construction of medical plants, and also in the provision of warranty and service during the warranty period for projects of the type of the Project as defined below; AND WHEREAS: The Contractor declares that it possesses the qualifications, reliability, the professional, technical, organizational and financial know-how, and that it has the personnel, the means, the know-how and the experience for the purpose of the performance of its undertakings pursuant to the Contract, at the professional level and pursuant to the time schedule as set forth in the Contract, and that it wishes to perform the Project in its entirety, under its total responsibility, as a turn-key project, including the detailed design of the New Plant, the characterization, examination and testing of the
equipment, the systems and the components which the Client shall be required to purchase for the purpose of the performance of the Project (hereinafter: the " Equipment" ), the installation of the Equipment, the use thereof, the submission of operational and properly functioning production lines after the completion of the OQ/IQ process, all when the New Plant, after completion of the works pursuant to this Agreement, shall be fit and suitable for compliance with all the requirements of the standards and the binding instructions of the competent authorities, as stated above; AND WHEREAS: The Contractor has performed in the past for the Client a project of the expansion of the infrastructure and production system of the plant at which the Client currently manufactures part of the Products, and it has also submitted to the Client a proposal for performance of the Project and the works; AND WHEREAS: The Client wishes and has agreed, relying on the Contractor' s declarations and undertakings as set forth in this Contract and on the Contractor' s proposal, to deliver performance of the Project and the works to the Contractor, all in accordance with and subject to the terms of this Contract; The following has therefore been declared, stipulated and agreed between the Parties: Chapter A - General 1. Definitions In this Contract, the terms below shall have the meanings set forth beside each one of them, unless the context requires otherwise. " The Client" - Omrix Biopharmaceuticals Ltd., private company no. 51-216605-9. " The Contractor" - S&A Design and Construction Ltd ., private company no. 512410218. It is agreed that the Contractor may appoint sub-contractors on its behalf, provided that the responsibility shall remain with the Contractor.
" The Regulatory Requirements" - all of the requirements of the competent authorities in the European Union, Israel, the USA and Canada, the Israeli Ministry of Health, the EMEA and the FDA, and also the Current Good Manufacturing Practices (cGMP) presently in effect. " The Contract" / " this Contract" - this document, the general specification and all the documents and appendices attached hereto and/or which shall be attached hereto after the signing of this document, subject to their being signed by both parties. " The Project" - the project of the design and construction of a new plant which shall be used by the Client for the manufacture of the Products and which shall be located at the Site of the Works (as defined below), including its Equipment and systems and also all the works which shall be performed in connection with the New Plant until the completion of the acceptance tests, including IQ, OQ and PQ and the receipt of the completion certificate after the PQ process, all in accordance with the provisions of this Contract. " The New Plant" - as defined in the Preamble to this Contract. " The Works" (or " the Work" ) - all the works required for the purpose of completion of the Project, including the detailed design and the construction of the New Plant, the characterization, examination and testing of the Equipment, the installation of the Equipment and the preparation thereof for use, the development of the software, the set-up of the computer system and the installation of the software on the computer system, the submission of operational and properly functioning production lines which are operated by the computer system, without any failures, and which comply with all the requirements of the competent authorities in the European Union, in the USA and in Israel, including the EMEA and the FDA, all in accordance with the specifications and plans and in accordance with the provisions of the Contract, including any amendment, addition and/or modification which shall be required in writing by the supervisor and/or the Client in accordance with this Contract.
" The Equipment" - all the machines, the systems (including hardware, computer programs and other technological systems), the accessories, the components and the items due to comprise and form part of the New Plant, including those required for performance of the Works and completion of the Project, as shall be determined in accordance with the provisions of this Contract. " The Site of the Works" - the area leased by the Client from the company Har Hotzvim Assets Ltd., in Building B at Har Hotzvim in Jerusalem. " Project Manager" - Mr. Shlomo Sackstein, and should he be unable to perform his duties - an engineer with at least ten years of experience in the field of pharmaceuticals and in the management of similar projects, who shall be appointed by the Contractor after receipt of the Client' s prior, written approval. " The Supervisor" - Any person who shall be appointed from time to time by the Client for supervision of the performance of the Works or any part thereof by the Contractor and an immediate report of his appointment shall be made to the Contractor. " The Consultants" - technical consultants in the various professions and planners of the various systems in the Project, who shall be appointed by the Contractor from time to time and also any entities acting on their behalf and in their name. " The Engineer" - a registered, skilled and experienced engineer who shall be appointed and employed by the Contractor, at the Contractor' s expense, after receipt of the Client' s approval with regard to his identity, and who shall be present at the Site of the Works for the purpose of supervision of the performance of the Works. " Other Contractors" - various contractors (with the exception of the Contractor and its sub-contractors) which shall perform any works in the Project at the Client' s invitation, in the course of and during the performance of the Works by the Contractor, and whose work shall be coordinated a reasonable period of time in advance with the Contractor.
" The Specifications" - the technical specifications for the performance of the Works and/or any part thereof, which shall be prepared and approved in accordance with the provisions of this Contract, and which include (1) the User Requirements Specification (URS), which was prepared by the Client and (2) the New Plant Layout; and which are attached herewith respectively as Appendices B1 and B2 to this Contract, and including any modification and/or addition to the Specifications which shall be approved by the parties, in writing, as stated in this Contract. " The Program" - a computer program for the operation, management and control of the entire production system at the New Plant, which shall be developed in accordance with the Client' s requirements, as described in the URS document and in the detailed characterization. " The Infrastructure Programs" - Third party programs which are required for the application and operation of the computer system, in accordance with the provisions of this Agreement. " The Hardware" - servers, end-user computers and fixed-line and wireless data communications components, insofar as required for the application and operation of the Program and the Infrastructure Programs in accordance with the provisions of the detailed characterization. " Computer System" - the Program, the Infrastructure Programs and the Hardware. " The Detailed Characterization" - a detailed characterization for the Computer System, which shall be prepared in accordance with the provisions of this Agreement by the Contractor and which shall be approved by the Client, in writing, and in accordance with the provisions of section 10 below. " The Plans" or " the Detailed Design" - the detailed design of the New Plant, including all the performance plans, as shall be prepared by the Contractor and approved by the Client, in writing, and attached as Appendix D to the Contract, as an integral part thereof, and including any modification or addition to the Plans which shall be approved by the parties in accordance with the provisions of this Contract, in writing. " The Main Time Schedule" - the Main Time Schedule for
the performance of the Works, which is attached as Appendix E, and as shall be updated, if at all, from time to time, in accordance with the provisions of this Contract. " Date of Completion of the Works" - April 2 , 2008, and as shall be updated, if at all, from time to time, in accordance with the provisions of this Contract. " Foreman" - The foreman on behalf of the Contractor who shall be appointed in accordance with the provisions of section 2 of the Work Safety Regulations (Construction Work) 5748 - 1988, and under whose direct and continuous management the Works shall be performed. The appointment of the Foreman or the replacement thereof in the course of performance of the Project shall be coordinated in advance with the Client. " IQ Process" - (Instrumentation Qualification) - the process of examining the installation of each item of the Equipment or entire assemblies at the plant. " OQ Process" - (Operation Qualification) - the process of examining the operation of each item or entire assemblies at the plant, and of the production system in its entirety, including acceptance tests for the Computer System at the Site of the Works. " PQ Process" - (Performance Qualification) - the process which ascertains that the Equipment or assembly, the production system in its entirety and the Computer System are operating without failures, meet the performance requirements and comply with the functionality required thereof. 2. Headings The headings in this Contract have been inserted for convenience of reference only and no interpretive meaning shall be attributed thereto. 3. Contract Documents
3.1 The Preamble to this Contract, and its appendices and their attachments, form an integral part of the Contract and shall be deemed to be part of its terms, and without derogating from the generality of the definition of " This Contract" , in any place where the term Contract is mentioned, it shall also include the following documents, appendices and their attachments, and any document which shall be prepared in accordance with the provisions of this Agreement and which shall be approved by the parties in writing: 1. The Contract 2. Appendix A - Cancelled. 3. Appendix B(1) - User Requirements Specification (URS). 4. Appendix B(2) - New Plant Layout. 5. Appendix B(3) - Process-Flow Diagrams (PFD) and Block Diagrams. 6. Appendix D - The Detailed Design- shall be attached in the future. 7. Appendix E - The Main Time Schedule. 8. Appendix F - Special Technical Requirements. 9. Appendix G - The Lease Agreement and the Management Agreement. 10. Appendix H - Milestones for the Project. 11. Appendix I - Completion Certificate. 12. Appendix J - Cancelled. 13. Appendix K - Bill of Quantities. 14. Appendix L1 - The Autonomous Guarantee. 15. Appendix L2 - The Maintenance Guarantee. 16. Appendix M - The Change Control Form. 17. Appendix N - Service Level Agreement. 18. Appendix O - Training Appendix. 19. Appendix P - Confirmation of Obtaining Insurance by the Contractor. 23. Appendix Q - Procedure for Means of Fire Prevention. 24. Appendix R - Declaration of Confidentiality by the Contractor. 25. Appendix S - Documentation. 26. Appendix T - List of Main Equipment. 27. Appendix U- Draft of Bank Consent for Assignment of Rights.
3.2 In any event of an inconsistency between the provisions of this document and its appendices, the provisions of this document shall prevail, and in any event of an inconsistency between the documents and/or the various appendices attached to this document, the provisions shall prevail of whichever document, which was subsequently drawn up and signed by the parties. For the purpose of the performance of the Works, the order of priorities shall be as follows: Appendix F (Special Technical Requirements), and thereafter, User Requirements Specification (URS), Appendix B(1), and thereafter, in order, B(2) and B(3), Appendix K, Appendix D, Appendix E, in accordance with the last draft that shall be prepared and approved in accordance with the provisions of this Contract, and thereafter, the provisions of the Contract shall apply. 3.3 It is clarified that the omission of a requirement for performance in a later document shall not be deemed to be contradicting the earlier document in which the requirement appeared, which was subsequently omitted, unless the omission was expressly stated in the later document, from which it was omitted. 4. Contractor' s Declarations and Undertakings The Contractor hereby declares and undertakes, in addition to its declarations in the Preamble to this Contract and in any other place in the Contract, the following: 4.1 That it has visited the Site of the Works and the surrounding area, that it has examined the conditions of the area and all of the data required for the purpose of performance of the Works and also any other matter in connection with the performance of its undertakings in this Contract, and it has found that there is no factual, technical, contractual or other impediment to the fulfillment of its undertakings pursuant to this Contract, in full and on time. 4.2 That it is familiar with the standards in effect on the date of the signing of this Contract for the design and construction of the New Plant and that it is
aware that it is required to make a special effort to comply with all the standards and requirements of the relevant authorities in Israel and abroad, subject to and as set forth in this Agreement, and to ensure that upon completion of the Works and completion of the Project, the New Plant shall comply with all the Regulatory Requirements. For the avoidance of doubt, it is hereby clarified that the Contractor shall be responsible for keeping up-to-date, from time to time, with the changes that shall occur in the standardization and in the regulation after the date of the signing of this Contract, and to offer to the Client the changes required in the specifications, so as to comply with the updated requirements. At the Client' s request, the Contractor shall make the required changes and they shall be subject to the provisions of Chapter K of this Contract. It is clarified that the Contractor' s obligation for compliance with the Regulatory Requirements shall apply to all the systems of the Project which are included in the Detailed Design, however, the Contractor' s obligation shall not apply to the Regulatory Requirements relating to the quality and nature of the Products that shall be manufactured at the New Plant which have no connection to the systems of the Project. 4.3 That it is aware that any specification and/or engineering plan which shall be submitted for the Client' s inspection shall be deemed to have been submitted after being examined by the Contractor and being found to comply with all the standards and the Regulatory Requirements, whether this is stated in the document or not. 4.4 That it shall perform the Project while complying with the provisions of any law, including the work safety laws, the municipal by-laws, the environmental quality laws, the Israel Police, the Israel Electric Corporation and any other competent entity whose approval is required for the performance of the Works and/or for the operation of the New Plant as duly required.
4.5 That the Contractor is not aware of any legal impediment, which could prevent the performance of the Works and the completion of the Project in accordance with the provisions of this Contract. 4.6 That the Contractor possesses all the relevant information, from any entity, which is required for the purpose of performance of the Project and the Works and performance of its undertakings pursuant to this Contract, and that it is not relying on any representations of the Client, with the exception of the Client' s requirements as presented in this Agreement and in the appendices hereto, and as shall be updated from time to time in accordance with the provisions of the Agreement, and that it shall not require any additional information, except for such information as shall be required from time to time in a reasonable manner as the result of a change or addition of the Client in accordance with the provisions of this Contract. That stated in this section shall not derogate from the Client' s obligation to cooperate with the Contractor and to update the Contractor with details and information as required in order to perform the provisions of this Contract, insofar as such details and information are known to it. 4.7 That the items of Equipment, including any component and any item which shall be used in the performance of the Works and which shall be installed during the Project at the New Plant, unless otherwise agreed by the Client, in advance and in writing: (1) shall comply with any standard and with all the relevant Regulatory Requirements; (2) similar use was made thereof by the Contractor in similar (but not identical) projects for the performance of works of the type of the Works; (3) use shall not be made of the components before it has made inquiries and found that no cessation of production is planned with regard thereto, in the support and provision of maintenance services and in the supply of spare parts for the said components. Without derogating from that stated above, the Contractor undertakes that the Program shall operate on the Hardware, that all of the components of the Computer System shall operate in compatibility and in full integration between themselves in accordance with the requirements of the Detailed
Characterization and the performance requirements which shall be defined therein. 4.8 The Contractor declares that it is aware that the Plant which is being planned and constructed pursuant to this Agreement is vital for the Client' s production system and that a delay in the performance of the Works and in the completion of the Project would prevent the Client from meeting the demand for the Products in the market and from exploiting the sales potential of the Products during the period of the delay, and also thereafter, and that a delay in the completion of the Project and/or in any material milestone in the Project would cause the Client serious damages, and it shall constitute a fundamental breach by the Contractor of its undertakings pursuant to the Contract. 4.9 That in the performance of the Works and/or in the Equipment and in any part thereof and in the use thereof, there shall be no breach of any third party rights; this undertaking does not apply to any intellectual property relating to the Client' s Products, its production methods or with regard to the land (which is the subject of the Site of the Works). 4.10 The Contractor declares that the Plans which are being provided to the Client and all the products of the Project which shall be prepared during and/or for the purpose of performance of the Works and completion of the Project, including the specifications and the Plans, shall be free of any third party right. 4.11 That it shall perform the Works at an excellent standard, with precision and extreme care, while making use of materials that are consistent with the Specifications. In cases where a binding standard is determined in law or in the relevant Regulatory Requirements, the Contractor shall perform the Works at a level which shall not be less than the binding standard, however, in the event that the level thereof was not defined for a material or for a particular component, out of a number of possible alternatives, the Contractor shall make use of the best materials.
4.12 It is aware that the Client is relying to a large extent on the Contractor' s professionalism and experience, in accordance with its declarations, including and in particular, in accordance with the definition of the Client' s requirements and the definition of the Project, so that the New Plant will meet the production targets and the standards as required by the Client and as set forth in the appendices to this Contract. 4.13 The Computer System shall be free from any time mechanism, encryption mechanism or any other mechanism which would cause the cessation of its activities in the future or which would require the use of a code or cipher for the purpose of the continued operation or the renewed operation of the Program, unless expressly required in the Detailed Characterization, and provided that the code and cipher and all the relevant operating instructions were delivered to the Client and the Client was given full and exhaustive training on how to operate these mechanisms, without requiring assistance from the Client. The aforesaid shall not apply with regard to third party programs, in respect of which the Contractor made undertakings as stated in section 10.7 below. 5. The Client' s Declarations The Client hereby declares that: 5.1 The Client is not aware of any legal impediment which could prevent the performance of the Works or the completion of the Project in accordance with the provisions of this Contract, subject to the Lease Agreement and the Management Agreement attached herewith as Appendix G. 5.2 The Client' s general requirements for the performance of the Works are as set forth in the appendices of this Contract, and upon the signing of the Detailed Characterization, the Detailed Characterization shall present the Client' s requirements subject to the provisions of the Contract, including Chapter K. 5.3 The Client shall allow the Contractor access to the Site of the Works in accordance with and subject to the provisions of Chapter G and it shall
ensure that the site of the performance of the Works shall be connected to the electricity, water and sewage infrastructures. The request for actual connection and the bureaucratic handling entailed therein shall be done by the Contractor for the Client, and the Client shall sign the documents required for this purpose. The costs of the connection to the infrastructures as stated and the current payment in respect thereof to the authorities shall be at the Client' s expense. 5.4 With the exception of officers on behalf of the Client, whose presence at the Site of the Works is required for the purpose of the performance of the Project, the Client shall not let people on its behalf enter the Site of the Works without coordination with the Supervisor and with the Contractor. 5.5 Should the performance of the Works or part thereof be contingent upon the receipt of a permit or license as duly required, the responsibility for receipt thereof shall lie with the Client. The Contractor shall act on the Client' s behalf in order to receive the required licenses, and the Client undertakes to cooperate with the Contractor and to bear the costs to third parties entailed therein. 6. Duties and Powers of the Supervisor 6.1 Should the Client so wish, and after it shall appoint a Supervisor, the performance of the Works - whether at the Site of the Works or at any other place where activities are conducted for the purpose of the performance of the Works - shall be subject to the Supervisor' s supervision, and the Contractor undertakes to perform the Works to the Supervisor' s satisfaction. The Supervisor and/or any entity appointed by him are entitled and authorized to examine the quality of the Works, the Equipment which has been ordered and/or which has been installed by the Contractor at the New Plant, the materials which the Contractor is using, and also the manner of the performance of the Contract and/or the Supervisor' s instructions by the Contractor. In ...
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