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Contract No: DSTLX- 1000078175 NON-CLINICAL

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Contract No: DSTLX- 1000078175 NON-CLINICAL Contract No: DSTLX- 1000078175 NON-CLINICAL DRUG INTERACTION AND TOXICITY STUDIES (FOx) Contractor: Information Redacted CONTRACTS-IN-CONFIDENCE Contract NO: Defence Science and Technology DSTLX- 1000078175 Laboratory, Porton Down SCHEDULE OF REQUIREMENTS FOR Issued on: NON-CLINICAL DRUG INTERACTION Previous Contract No 17 January 2013 AND TOXICITY STUDIES (FOx) (Renewal Cts Only) Table I – Requirements PRICE ITEM NO DESCRIPTION QTY £ (VAT EX) Objective 1 Dstl has a requirement to undertake a programme of Safety Studies using a three-drug combination to support Clinical Studies and a UK Marketing Authorisation Application. The activities described in the attached Statement of Work will form part of these Safety Studies. There is an additional requirement to support the licensure of intravenous administration of HI-6 DMS alone. 2 Tasks The Contractor shall undertake the tasks as detailed in the Statement of Requirements at Annex A and the Information Redacted Technical Proposal (option 2) attached at Annex B. In the event of task conflict or contradiction, for the purposes of this Contract, the accepted Information Redacted Technical Proposal (option 2) will be used as the method statement. Deliverables 3 Full Rights versions of the following reports: For each Study listed above, a QA Audited Draft Report is required following completion of the experimental work The Draft report is to be up-lifted to a Final report to meet the final Milestone of each Study. Report – The Report shall describe the entire work performed under the Study in sufficient detail to explain comprehensively, the work undertaken and the results achieved to include, inter alia, all relevant technical details and details of any problems encountered. TOTAL PRICE (IN WORDS) TOTAL £1,449,650 One Million, Four Hundred and Forty Nine Thousand, Six Hundred and Fifty Pounds CONDITIONS OF CONTRACT - The Schedule of Requirements is integral to and subject to the attached Conditions of Contract. Table II – Packaging Requirements Adjustments* Item No Packaging specifications/special markings etc Qty £ N/A Commercial packaging appropriate for safe and N/A N/A secure transport in accordance with IATA regulations. * Note: to price per quantity shown in Table I Table III – Duration of Contract Start Finish Item No CONDITIONS OF CONTRACT This contract shall commence This Contract is subject to: immediately upon acceptance 17 February 2015 of the Offer (DEFORM10) Section 1 – General Conditions dated 17 January 2013 Section 2 – Special Conditions Section 3 – Annexes and Appendices CONTENTS 1. CONDITIONS OF CONTRACT Section 1 – General Conditions Section 2 – Special Conditions 1. HEADINGS 2. PERIOD OF CONTRACT 3. DATA PROTECTION ACT 4. ACCESS TO THE CONTRACTOR‟S PREMISES 5. PROGRESS REVIEWS AND REPORTS 6. QUALITY ASSURANCE AND CONTROL 7. PAYMENT [Stage Payment Plan To Be Agreed] 8. AMENDMENT TO CONTRACT 9. STATUS OF CONTRACT 10. SUB CONTRACTS 11. DELIVERY 12. DISCLOSURE OF INFORMATION 13. ISSUED PROPERTY 14. CONTRACTOR‟S RECORDS 15. INDEMNITY AND INSURANCE 16. PERFORMANCE 17. WARRANTIES 18. TRANSPARENCY Appendix to Contract – Addresses and Other Information Attachment 1 Statement of Requirement 1. Conditions of Contract Section 1 General Conditions DEFCON 68 (Edn 05/11) - Supply Of Data For Hazardous Articles, Materials And Substances DEFCON 92 (Edn 08/90) - Failure of Performance1 DEFCON 501 (Edn 04/04) - Definitions And Interpretations DEFCON 502 (Edn 06/08) - Specifications DEFCON 503 (Edn 07/05) - Amendments To Contract DEFCON 507 (Edn 10/98) - Delivery DEFCON 509 (Edn 09/97) - Recovery Of Sums Due DEFCON 513 (Edn 06/10) - Value Added Tax DEFCON 515 (Edn 10/04) - Bankruptcy And Insolvency DEFCON 516 (Edn 06/04) - Racial Discrimination DEFCON 518 (Edn 09/97) - Transfer2 DEFCON 520 (Edn 07/11) - Corrupt Gifts And Payments Of Commission DEFCON 521 (Edn 10/04) - Sub-Contracting To Supported Employment Enterprises DEFCON 523 (Edn 03/99) - Payment Of Bills Using The Bankers Automated Clearing Service (BACS) System DEFCON 524 (Edn 10/98) - Rejection DEFCON 525 (Edn 10/98) - Acceptance DEFCON 526 (Edn 08/02) - Notices DEFCON 527 (Edn 09/97) - Waiver 1 For the purposes of this contract DEFCON 92 shall apply to all services (excluding the supply of Articles) which the Contractor is required under the Contract to perform or to fulfil 2 Any request for a Transfer, which involves a change of Contractor name or entity (a “novation”), shall be forwarded to: Commercial Services Group - Defence Suppliers Service Ministry of Defence Maple 2B, #22 Abbey Wood Bristol BS34 8JH Copied to the Dstl Commercial Services Dept identified in the Contract DEFCON 528 (Edn 10/04) - Overseas Expenditure and Import Licences3 DEFCON 529 (Edn 09/97) - Law (English) DEFCON 529A (Edn 09/97) - Law (Scots) DEFCON 530 (Edn 07/04) - Dispute Resolution (English Law) DEFCON 530A (Edn 07/04) - Dispute Resolution (Scots Law) DEFCON 531 (Edn 05/05) - Disclosure Of Information DEFCON 532A (Edn 06/10) - Protection of Personal Data (Where Personal Data is not being processed on behalf of the Authority) DEFCON 534 (Edn 06/97) - Prompt Payment (Sub-Contracts) DEFCON 537 (Edn 06/02) - Rights Of Third Parties DEFCON 538 (Edn 06/02) - Severability DEFCON 566 (Edn 02/11) - Change Of Control Of Contractor4 DEFCON 601 (Edn 10/04) - Redundant Materiel DEFCON 602B (Edn 12/06) - Quality Assurance (Without Deliverable Quality Plan) DEFCON 606 (Edn 10/97) - Change And Configuration Control Procedure DEFCON 608 (Edn 10/98) - Access And Facilities To Be Provided By The Contractor DEFCON 609 (Edn 10/98) - Contractor's Records DEFCON 611 (Edn 07/10) - Issued Property DEFCON 612 (Edn 10/98) - Loss Of Or Damage To The Articles DEFCON 621B (Edn 10/04) - Transport (If Contractor Is Responsible For Transport) DEFCON 625 (Edn 10/98) - Co-Operation on Expiry of Contract DEFCON 632 (Edn 02/07) - Third Party Intellectual Property - Rights And Restrictions DEFCON 646 (Edn 10/98) - Law And Jurisdiction (Foreign Suppliers) DEFCON 656 (Edn 03/06) - Break 3 The Contractor shall, within one month of acceptance of the Contract, notify the Commercial Services Department of details of any overseas sub-contract or order he has placed, or intends to place, in aid of the contract. Details to be provided are: Prime Contract Reference: Country Sub-Contract Placed/to be Placed: Name of Sub-Contractor/Supplier: Full Address: Value of Sub-Contract Order Applicable to Prime Contract: Date Placed/to be Placed: If no overseas orders are to be placed, the Contractor shall advise the Commercial Services Department to this effect in the same timescale. 4 Details of any changes are to be copied to the Commercial Services Department, address as in Box 1 of Appendix to Contract DEFCON 694 (Edn 02/12) - Accounting For Property Of The Authority DEFCON 703 (Edn 11/02) - Intellectual Property Rights – Vesting In The Authority Section 2 Special Conditions 1. HEADINGS In the following Terms and Conditions of Contract the relative ordering of conditions or the placing of information in Annexes is of no significance. All headings within these Terms and Conditions are generally for convenience only and shall not affect interpretation of the subsequent text or the Contract as a whole. All cross-references are for immediate ease of reference only and are not intended to be either complete or definitive. 2. PERIOD OF CONTRACT The Contract shall commence immediately upon acceptance of the Offer of Contract and shall continue until 17 February 2015. No work shall be carried out after this date without the prior written approval of the Authority, or his authorised Commercial representative. On acceptance of the Contract, all work carried out by the Contractor on the requirement prior to the Contract coming into force shall be deemed to have been carried out under the terms and conditions of the Contract. The Contract shall have deemed to have expired on the completion of all the Studies and on acceptance and payment of all the Deliverables listed in Table 1. 3. DATA PROTECTION ACT The Contractor warrants that all obligations under the Data Protection Act 1998, which arise in connection with this Contract will be adhered to. 4. ACCESS TO THE CONTRACTOR’S PREMISES For the purposes of this Contract in addition to the provisions of DEFCON 608 the following shall apply: The Chief Executive, Dstl, or his authorised representative, shall have the right of access to the premises where the work of the Contract is being undertaken, including those of any subcontractors, and to all information relevant to the Contract for the purpose of keeping in touch with the nature and progress of the work. 5. PROGRESS REVIEWS AND REPORTS For the purposes of this Contract in addition to the provisions of DEFCON 604 and DEFCON 642 the following shall apply: 5.1 Progress Reviews Progress Reviews will be held on a quarterly basis or as required by the Dstl Project Manager (as shown at Box 2 of the Appendix to Contract). The Contractor is to supply a Minutes Secretary and produce minutes of the meetings if necessary. The front page of any Minutes produced as a result of any Meeting between the Authority and the Contractor shall state: “Nothing in these Minutes shall be construed as giving authority to proceed on work beyond that provided in the Contract or vary the terms and conditions of the Contract.” 5.2 Reports The Contractor shall prepare and submit Reports in the manner stated below and in accordance with Clause 11 (Delivery) of this contract: Reports shall be signed on the Contractor‟s behalf by a person authorised to commit the Contractor. All Reports shall be to the requirements and acceptance of the Dstl Project Manager (as at Box 2 of the Appendix to Contract). The title page of all reports shall be annotated as follows: The investigation, which is the subject of this Report, was initiated by the Chief Executive, Dstl and was carried out under the terms of Contract No – [DSTLX- 1000078175].
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