Request for proposal RFP - 025689 STABILITY STUDY OF PROTEIN IN AN INFUSION SYSTEM

In connection with the project „Clinical trial of the first phase (Ia/Ib) of a fusion protein with a dual anticancer mechanism”, financed from Medical Research Agency (nr. 2022/ABM/05/00006-00) operating under §8 of the subsidy agreement, Adamed Pharma S.A.  invites you to submit offers for the execution of the below defined subject of the contract.

Study Sponsor (Contracting Authority): Adamed Pharma S.A.

Object of the Contract

The purpose of this Agreement is to conduct a protein stability study in an infusion bag. Stability testing is to be performed in accordance with ICH guidelines and the client's detailed protocol.

All results and deviations are to be properly documented in the final report. The stability tests will follow a program mutually agreed upon between Adamed Pharma S.A. and the Provider, using the methods specified as stability methods in Appendix A, Table 1. Due to the nature of the work, all detailed information can only be provided to the Provider after signing a confidentiality agreement.

The study includes preparation of a dilution of the medicinal product in saline solution within selected infusion kits and testing the product's stability within a time frame established by the Sponsor (up to a maximum of 24 hours). A detailed study plan will be provided to the Provider upon signing the service agreement.

The ordered service comprises the following elements:

1. Transport of the Test Material from the production site (Lithuania) to the analytical laboratory under controlled conditions at -80°C ±10°C.
2. Preparation of the Infusion Set: Preparation of the test protein dilution in sterile saline for intravenous injection, and stability testing in accordance with the methods described in Appendix A, Table 1.
3. Scope of Stability Testing includes:
   • Package A:
     ​50 ml sterile syringe and simulated patient administration via syringe pump – 1 variants.
   • Package B:
     Two types of sterile infusion bags with volumes between 50-500 ml and simulated patient administration via infusion pump – 1 variant + 1 variants optionally
     Detailed information about selected infusion kits will be made available to the Provider upon signing the service agreement.
4. A final report containing a detailed description of the tests performed, the results obtained, and the final conclusions.
5. All of the above-mentioned tasks should be itemized separately in the offer.
6. From the perspective of research efficiency and the economic rationale for conducting the commissioned R&D work, dividing the order into parts is not justified. As a result, partial offers are not permitted. Offers that cover only selected tasks are also not allowed.
7. It is permissible to subcontract tasks or elements of tasks to external entities, with the Ordering Party’s consent, provided they meet all requirements described for the contractor in Appendix 3 (the Provider’s obligations include providing documents confirming that external entities have met the requirements at the stage of service implementation in order to obtain the Ordering Party's consent).
8.  Place of delivery of the results of the completed tasks: Adamed Pharma SA, Pieńków, Mariana Adamkiewicza 6A, 05-152 Czosnów.

Deliverabiles:

• Stability testing documentation prepared (Package A and B);
• Protein samples tested according to the specified testing panel;
• Raw data presented;
• QC/QA review of the results performed;
• Certificate of Testing (COT) issued;
• A final report containing a detailed description of the tests performed, the results obtained, and the final conclusions.

The research will be carried out in the time period: 02.01.2025 - 30.04.2025, according to details schedule that will be provided to the selected Contractor.

The Ordering Party reserves the right to resign from some of the tests that are the subject of the procedure, taking into account the project needs and/or results of previous tests.

Conditions for participation in the proceedings

1. The contract may not be awarded to entities related to the Ordering Party personally or by capital. Capital or personal ties are understood as interrelationships between the Ordering Party and the Supplier or persons authorized to incur liabilities on behalf of the Ordering Party or persons performing on behalf of the Ordering Party activities related to the preparation and conduct of the Supplier selection procedure, consisting in particular of:
   1. participating in the company as a partner in a civil partnership or partnership,
   2. owning at least 10% of shares of stocks,
   3. acting as a member of the supervisory or management body, proxy, proxy,
   4. remaining in a marriage, relationship of kinship or affinity in a straight line, kinship of the second degree or affinity in the lateral line or in relation to adoption, care or guardianship.
      In order to meet this condition, the supplier is obliged to send, together with the offer, a signed Statement of the lack of connections (Appendix No. 1 to this RFP).
2. Orders cannot be awarded to:
   1. a Contractor referred to art. 7 sec. 1 indicated in lists specified in Regulation no 765/2006 and Regulation no 269/2014 or entered in list on basis of a decision on entry in the list deciding on application of measure referred to article 1 point 3 of the Act of April 13, 2022 on special solutions in field of counteracting supporting aggression against Ukraine (Polish Journal of Laws no 835).
   2. a Contractor whose beneficial owner within meaning of the Act of 1 March 2018 on counteracting money laundering and financing terrorism (Polish Journal of Laws no 593 and 655) is a person indicated in lists specified in Regulation 765/2006 and the Regulation 269/2014 or entered on  list or being such a beneficial owner from February 24, 2022, provided that it was entered on list on the basis of a decision on entry in the list determining application of measure referred to in art. 1 point 3 of the Act of April 13, 2022 on special solutions in field of counteracting supporting aggression against Ukraine (Polish Journal of Laws no 835);
   3. a Contractor whose parent undertaking or subsidiary entity within the meaning of Art. 3 sec. 1 point 37 and 39 of the Accounting Act of 29 September 1994 (Polish Journal of Laws no 217, 2105 and 2106) is an entity indicated in the lists specified in Regulation 765/2006 and Regulation 269/2014 or entered on the list or being such a parent undertaking from February 24, 2022, provided that it was entered on list on the basis of a decision on entry in list determining application of measure referred to in art. 1 point 3 of the Act of April 13, 2022 on special solutions in field of counteracting supporting aggression against Ukraine (Polish Journal of Laws no 835).
      In order to fulfill this condition a Tenderer is obliged to send with the offer signed statement (Appendix No. 2 to this RFP).  
3. The offer is addressed to bidders who have experience in providing similar services and have a certificate of the necessary quality standards. Experience should be demonstrated by attaching a declaration of meeting these criteria which constitutes Appendix 3 and demonstrating the necessary resources in accordance with Appendix No. 6:
   1. The facility must have broad expertise in conducting the studies described in Section I of this request for proposal, confirmed by at least 5 years of operation as a CMO in the market for the aforementioned analyses.
   2. The ability to perform the specified studies within the timeframes: 02.01.2025 - 30.04.2025, in accordance with the detailed study plan provided by the Client to the selected Contractor.
   3. At least 5 years of experience in contract manufacturing and analytics of drug substances (DS) for clinical and commercial studies in compliance with cGMP standards.
   4. At least 5 years of experience in contract manufacturing and analytics of drug products (DP) for clinical and commercial studies in compliance with cGMP standards.
   5. Possession of the necessary infrastructure and personnel resources to perform or subcontract analytical methods listed in Appendix A, Table 1.
   6. Possession of the necessary infrastructure and personnel resources to store samples under controlled conditions at -80°C ±10°C in compliance with cGMP standards.
   7. A current GMP certificate for DS manufacturing and analytics.
   8. A current GMP certificate for DP manufacturing and analytics.
   9. Necessary resources to carry out all listed activities. The bidder should provide a list with descriptions of the equipment and personnel. (Appendix No. 6)
   10. Validated testing methods as specified in Appendix A, Table 1.
   11.  The Ordering Party should employ a quality management system as well as an auditing and quality control system to ensure compliance with relevant regulations.

The Ordering Party reserves the right to ask the Bidder to submit additional documents and explanations confirming the information contained in the declaration (Appendix No. 3).

Proposal preparation

1. Each correspondence should include the number of the procedure in the subject line:
   RFP 025689 Stability study of protein in an infusion system.- Company name / Name
2. Deadline for submitting offer is 11.12.2024 at 23:59. The date may change, about which all Suppliers will be informed.
3. Questions should be submitted via the Adamed Procurement Platform SAP Ariba Network or via e-mail: elzbieta.joziak@adamed.com, using the sheet Appendix_no. 5. Late submission of questions from the point of view of the closing date of the procedure may result in a lack of time to provide the required answer. Questions should be submitted until 06.12.2024. In order to ensure equal access to information to all Tenderers participating in the procedure, questions and answers (concealing the author of the questions) will be sent to all Tenderers and published on the Ordering Party’s website. The date may change, about which all Suppliers will be informed via email from the Adamed Procurement Platform SAP Ariba Network.
4. The cost estimate should be prepared in a spreadsheet file, attached as Appendix no. 4 to this request for proposal: Appendix_4_RFP_025689 Cost_Proposal_CompanyName/Name. In addition, the Bidder may prepare the bid in its own format. Bids without a completed Attachment No. 4 will not be considered.
5. The offer with all appendices can be placed on Adamed Procurement Platform SAP Ariba Network at https://supplier.ariba.com or sent via e-mail to:  elzbieta.joziak@adamed.com.
6. In addition, the Tenderer may prepare the bid in its own format.
7. The supplier gains the access to the Procurement Platform through a registration and company verification process. to complete this, basic information must be provided such as country, VAT number, postal code, contact details , etc.
8. Each Tenderer may submit only one offer.
9. The Ordering Party does not allow partial offers.
10. The Proposal should be prepared in Polish or English.
11. Prices in the offer should be net prices in polish zloty (PLN), euro (EUR),American dollar (USD) or Great Britain pounds (GBP).
    If prices in offer are expressed in a currency other than PLN, will be converted using the average exchange rate of the National Bank of Poland as of the date of publication of the tender. If the table of average NBP exchange rates is not published on the date of publication the exchange rate from the last table of average exchange rates published before the date of publication of the contract notice will be used.
12. The offer should contain at least the following information: Company name, address, , number of the inquiry, net price, currency, payment terms (in days) and required appendices.
13. Tenders submitted after the deadline will not be considered.
14. The Supplier before time-limit for receipt of tenders is entitled to:
    1. Withdraw the offer by submitting a written notification in the manner describes for submitting offers,
    2. Change the offer – notification of the changes must be submitted by the same rules as the submitted offer, appropriately marked with the note “CHANGING THE OFFER”.

Selection criteria and method of evaluation of submitted offers

1. The Ordering Party has the right to reject an offer submitted by a Supplier that does not meet the conditions for participation in the procedure or if the offer is incomplete or inconsistent with this inquiry.

2. Criteria for selecting offers:

   1. Net price presented as the cost of performing individual parts of the service package (criterion weight - 100% of the overall score), including all costs of the service provided

3. The Ordering Party shall evaluate offers based on the results of accumulated number of points calculated on the basis of above criteria and scores:

4. Criteria	Weight criterion[%]	Method of evaluation in accordance with the formula
   Net price - individual items indicated in the cost estimate	100%	net price of the lowest offer / net price of the examined offer x 100 x 100% = number of points [total calculation for each of the items specified in the cost estimate]

5. The Ordering Party reserves the right to negotiate proposals with all the Bidders. Negotiations may have several consecutive  rounds  with the  possibility  to  invite  the Bidders  to  submit  the updated quotation after each round of negotiations. 

6. The offer with the highest final number of points will be considered the most advantageous.

7. The results of mathematical operations performed when evaluating the bids are rounded to two decimal places. In case of equal scores for at least two offers the Ordering Party will make the final choice of the offer more favorable when it comes to the impact on the environment (including the number of laboratory animals planned to use). For this purpose, the Ordering Party shall have the right to call the Suppliers, whose tenders have obtained the highest final points, to complete the offer by giving indicated by the Ordering Party information about an impact of the offer on the environment. The deadline to complete the offer will be determined by the Ordering Party, but it cannot be less than 3 working days from receipt of the request. 

Selection of the Contractor and manner of announcement:

1. The Ordering Party will select the most advantageous offer on the basis of the offer evaluation criteria specified in this inquiry.
2. The Ordering Party will inform about the results of this inquiry on the website  https://www.adamed.com/en/development-and-innovation/requests-for-proposals-and-tenders and will send them via SAP Ariba Platform to each Supplier who has submitted his offer.

Additional information about participation in the tender

1. Tender is available via the Adamed Group Purchasing Platform at: https://supplier.ariba.com and on website https://www.adamed.com/en/development-and-innovation/requests-for-proposals-and-tenders.
2. Username and password to log in to the Purchasing Platform will be sent to the Suppliers by the Operator by e-mail during registration.
3. Technical requirements. In order to work smoothly with the https://supplier.ariba.com Purchasing Platform, the user should have at least the following technical capabilities:
   • PC or MAC computer with a 1GHz or faster processor and at least 512 MB RAM,
   • permanent access to the Internet with a guaranteed bandwidth of not less than 1Mb/s,
   • Internet browser in the latest version. IE 9.0+ or Mozilla Firefox 24+ or Chrome 26+ or Safari 5+.
4. The tender procedure may be repeated only in case of inability to be carried out by the Operator or the Employer. Technical problems on the side of Suppliers will have no impact on the course of the tenders.
5. Prior to the tender procedure, it is advisable to familiarize yourself with the operating instructions of the Purchase Platform attached to the tender.
6. The start and finish dates and configuration of each stage of the tender will be presented on the Purchase Platform and may change, all interested Suppliers will be notified by the system by e-mail.
7. Technical support during the procedure. During the procedure, the Suppliers can obtain technical support at: +48 539 737 818 or in the Platform in the Help tab.

General provisions

1. The contracting authority reserves the right to cancel the procedure without giving any reason at any stage of the procedure.
2. In the event of cancellation of the procurement procedure, the contractors shall not be entitled to claim reimbursement of the costs of participation in the procedure.
3. By submitting an offer, you accept all terms and conditions of the procedure without any reservations.
4. Withdrawal by the Ordering Party from concluding the contract in the event of notifying the contractor about the selection of its offer, it may not be the basis for claims for the costs of participation in the procedure.
5. In the course of assessing the submitted applications, the Ordering Party may request the contractors to provide explanations regarding the content of the documents submitted by them.
6.  If the offer does not contain all the required elements, the Ordering Party may, in justified cases, call the Contractor to supplement it.
7. The contracting authority reserves the right to record sound during technical meetings with suppliers. Sending the offer will be treated as giving consent to record the meetings.
8.  The Ordering Party allows the contract terms to be negotiated with the Contractor to a limited extent.
9. It is possible to place additional orders exclusively to the selected Bidder, if they align with the main objective of this agreement, with a value not exceeding 50% of the value of this order.
10. The Ordering party will sign a contract with the selected Contractor.
11. The Ordering Party provides for the possibility of introducing significant changes to the contract concluded as a result of the conducted contract award procedure in relation to the content of the offer, on the basis of which the contractor was selected, in the event of the necessity to change the scope of service indicated in the offer / agreed scope, resulting from:
    1. Justified and required changes in the project documentation that were impossible to predict at the time of contract execution
    2. Requirement for performing of equivalent activities based on scientific reasons
    3. Financial limitations of Ordering Party resulting in limiting the scope of contracted activities
    4. Changes in the project activities resulting from consultations carried out with regulatory agencies/offices
    5. Any changes and additions to the contract concluded with the selected Contractor will be made in the form of written annexes to the contract signed by both parties.

Cooperation and communication in the course of preparing responses 

1. All questions related to the subject of this inquiry may be directed via the Adamed Group Purchasing Platform at: https://supplier.ariba.com or via email to: elzbieta.joziak@adamed.com, using an Excel file - Appendix No 5.
2. The list of required documents is available in Appendix No. 7
3. The person authorized to contact the Suppliers on Monday-Friday from 09:00 am to 05:00 pm is  Elżbieta Józiak: [elzbieta.joziak[at] adamed.com].

Appendix No 1  (download)

Appendix No 2  (download)

Appendix No 3  (download)

Appendix No 4  (download)

Appendix No 5  (download)

Appendix No 6  (download)

Appendix No 7  (download)

Appendix A  (download)

Creating an offer on the Portal SAP Ariba Network (download)

SAP Ariba Network registration (download)