REQUEST FOR QUOTATION for conducting: Drug substance methodology and production

Transcription

1 REQUEST FOR QUOTATION for conducting: Drug substance methodology and production Kraków, April 24 th, 2018 I. ORDERING PARTY: ORION BIOTECHNOLOGY POLAND SP. Z O.O. ul. Bobrzyńskiego 14, Kraków Tax Identification Number: The National Register of Economic Units: The National Court Register: II. SPECIFICATION OF THE SUBJECT OF THE ORDER: Orion Biotechnology Poland (formally K2 Biomedical) is seeking a Contract Manufacturing Organization to manufacture and vial Current Good Manufacturing Practice (cgmp) grade drug product for ongoing pharmaceutical and clinical trial activities. Orion Poland has recently partnered with the Mintaka Foundation who have previously developed a cgmp process for production of an HIV inhibitor 5P12-RANTES in Pichia yeast (Komagataella pastoris) and manufactured product through a partnership with the Biological Process Development Facility at the University of Nebraska (BPDF)( This process has been previously run twice at the 150 L scale. It is described in detail, together with a description of the analytical methods, in the manuscript attached in annex (Cerini et al., Protein Expr Purif March; 119: 1 10). Page left intentionally blank 1

2 Following a standard fermentation procedure, the key steps of the downstream purification process are described in the flow-chart below: Further details will be provided on request (both upstream and downstream processing) to ensure a thorough response to the proposal; all proper documentation (SOPs, batch records, etc.) will be made readily available upon the acceptance and selection of the tender. The overall scope of the CMO project will be to tech transfer the process developed by BPDF and use it to produce two further batches of 5P12-RANTES drug substance at a similar scale, one of which should be cgmp grade. The cgmp grade batch will be utilized to formulate and manufacture clinical drug product for intravenous administration within a Phase 1 clinical trial. The proposal associated with this tender should also include the costs of dispensing individual vials of 5P12-RANTES. Each vial should contain 100 mg of 5P12-RANTES. 1. Detailed description of the subject of the order: Procurement of the services for the company Orion Biotechnology Poland sp. z o.o. project concerning Development of a CCR5 antagonist for the treatment of solid tumors Reference: (Common Procurement Vocabulary - CPV , Research and experimental development services) 2. Purchaser does not allow submission of partial tender offers. III. CONDITIONS FOR PARTICIPATION IN THE PROCEEDINGS: 1. Excluded from the proceedings shall be those Contractors who are personally or equity related to the Ordering Party.* 2. Additional conditions for participation in the proceedings: not applicable 3. It is possible/not possible to make an offer for a part of an order. 2

3 4. It is possible/not possible to make a variant offer. IV. DEADLINE FOR ORDER COMPLETION Deadline for completion of the subject of the order: up to 24 months or shorter from fulfilment of the below conditions by Purchaser: 1. Receipt of subsidy from structural funds of the European Union within Competition 1 / / 2018 "Fast track" SMEs, Priority I: Support for conducting R & D works by enterprises, Submeasure Industrial research and. 2. NCBiR will not object against hiring Contractor. V. DESCRIPTION OF TENDER PREPARATION MODE Contractor should prepare the tender offer in English or Polish. The offer should have: Include the full name of a Contractor and contact details; Include date of the offer/submission date (In the absence of the date of issue on the tenders submitted by , date of receipt will be equivalent to the issue of the offer). Include price for order (without VAT/TAX). The Ordering Party accepts the tenders with prices given in different currency, however, for the purposes of comparison the tender price will be converted into PLN using current exchange rates at the time of tender (Average Exchange Rate Table of the National Bank of Poland (NBP): To avoid any doubts, the tender prices in PLN will be used only for comparing the tenders and for awarding scores; all settlements with the Contractor will be in the currency of the offer. Include Vendor s certification s and portfolio of highlighted experience in drug substance production programs set out in clause VII; Describe all additional elements required for tender; Estimated date of completion of the contract; RFQ expiration date specified at least 90 calendar days from the RFQ end date to enable Service Agreement finalization; Be legibly signed by the Contractor. A lack of any of the above-mentioned items may result in rejection of the tender for formal reasons. VI. PLACE AND DEADLINE FOR TENDER SUBMISSION 1. The tender should be sent by to: beata.b@orionbiotechnology.com, by post, by courier or delivered personally to the address by May 24 th, 2018 at 12:00PM: Orion Biotechnology Poland sp. z o.o. ul. Bobrzyńskiego 14, Kraków, POLAND 2. Tender evaluation shall be made on May 30 rd, 2018 and the results and choice of the most favorable tender will be announced on the website at and at 3. Tenders submitted after deadline shall not be examined. 4. Contractor may amend or withdraw the tender offer before the deadline. 5. In the course of examination and tenders evaluation Purchaser may request from Contractors explanations concerning the content of submitted tenders. 6. Enquiry for quotation has been placed on following websites: and VII. TENDER EVALUATION Purchaser shall evaluate valid tenders on the basis of the following criteria: Entry criteria/basic requirements (YES/NO): 1. Accuracy to requested subject of order (Section II). 3

4 2. Documented, relevant company experience and successful track record in conducting similar drug substance production programs with any applicable certifications. 3. Documented, relevant company capabilities and infrastructure to fulfill project needs. 4. Program completion within Orion Biotechnology Poland s required timeframe. The entry criteria (1-4) must be met by the bidder; only in this case will be evaluated based on price criterion. Method of assessment: The ordering party will select the offer with the lowest price among the offers complying with the requirements of the proceedings. VIII. ADDITIONAL INFORMATION Purchaser shall sign a conditional agreement with a chosen contractor. The agreement shall become effective in case of completion of the following event: 1. Receipt of subsidy from structural funds of the European Union within Competition 1 / / 2018 "Fast track" SMEs, Priority I: Support for conducting R & D works by enterprises, Submeasure Industrial research and. 2. NCBiR will not object against hiring Contractor. Procurement of services will be done on the basis of: Operational Programme Intelligent Development , Priority Axis: Support of research and development (R&D) conduct by companies, Measures: Research and development (R&D) projects of companies, Sub-measures: Industrial research and development work performed by companies. IX. AGREEMENT CONCLUSION The tenderer whose tender is assessed the best shall be obliged to conclude an agreement with the Ordering Party within 14 calendar days of the date the draft agreement have been sent or immediately after the Ordering Party obtaining the consent from the National Research and Development Centre (if such approval is required). If the Contractor whose tender won evades from concluding the agreement the Ordering Party may choose the best tender from among the remaining tenders. X. ADDITIONAL INFORMATION 1. The Ordering Party reserves the right to change the content of this request. If the changes can affect the content of tenders submitted in the procedure, the Ordering Party shall extend the tender submission deadline. Any changes made shall be provided promptly to all tenderers to which the request was sent and shall be binding on them. 2. The Ordering Party allows the possibility of granting an order if all received quotations exceed the delivery time specified in the RFQ and extension of delivery time does not affect the proper conduct of the project research. The Ordering Party will choose supplier based on criterion specified above. 3. The Ordering Party reserves the right to cancel this procedure without providing reasons, change the number of products ordered in relation to the number specified in this RFQ, purchase one of parts/items and also to complete the procedure without choosing the winning tender. * Equity or personal relationship is understood as relations between the Ordering Party or individuals authorized to take commitments on behalf of the Ordering Party or those acting on behalf of the Ordering Party in order to prepare and implement the contractor selection procedure, and the Contractor, including in particular: 1) being a partner to civil law partnership or commercial law partnership; 2) holding at least 10% of shares; 4

5 3) being a member of a supervisory or management corporate body, a holder of general commercial power of attorney, an authorized representative; 4) being married to, being in direct consanguinity or affinity, second-degree consanguinity or affinity of the second degree collaterally or by adoption or guardianship. 5