Request for proposal RFP - 026653 - DEVELOPMENT AND VALIDATION OF NEUTRALIZING ANTIBODY ASSAYS FOR THE ASSESSMENT OF ANTI-DRUG ANTIBODY ACTIVITY AGAINST A BIOLOGIC THERAPY

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

General information on a test molecule is supplemented in Appendix 7.

The subject of the contract is as follows:

Task 1

The objective of Task 1 is to develop and validate a Cell-based assay (CBA) to determine the presence of neutralizing antibodies (NAb) in human serum against the test molecule, affecting its apoptotic activity mediated by the TRAIL domain.

Assay: measurement of the test molecule’s cytotoxic activity, preferentially MTT assay

General scope of work:

1. Development of analytical method
   1. Cell line selection
      ​The cell line must be able to cover two potential scenarios in response to ADA appearance:
      • Decreased activity of the test molecule and
      • Increased activity of the test molecule due to ADA crosslinking
        ​Preferentially A549, HEPG2 or SK-Mes-1 cell line shall be considered. The sponsor does not cover the cost of cell line license therefore needs to be included in the offer.
   2. Optimization of the assay conditions
   3. Selection of positive controls for each scenario to be tested. The sponsor does not cover the supply of appropriate antibody neutralizing TRAIL-derived activity. The cost of development or purchase of such need to be included in the offer.
   4. Deliverables: Quarterly intermediate reports and a summary final report
2. Validation of the analytical method
   1. The validation of the method must be performed according to the EMA/FDA bioanalytical guidelines
   2. Deliverables: Final validation report including a method protocol
3. Long-term stability up to 12 months, not more than 3 time points
   1. Deliverables: partial (after each time point tested) and final report for long term stability.

Task 2

The objective of Task 2 is to develop and validate a non-cell-based assay to determine the presence of neutralizing antibodies (NAb) in human serum against the test molecule, which may interfere with its binding to VEGFR.

Assay: measurement of the test molecule’s binding to VEGFR, preferentially SPR method

General scope of work:

1. Development of analytical method
   1. Optimization of the assay conditions
   2. Selection of positive controls. The sponsor does not cover the supply of appropriate antibody neutralizing binding of the molecule to VEGFR, nor the relevant peptide. The cost of development or purchase of such need to be included in the offer.
   3. Deliverables: Quarterly intermediate reports and a summary final report
2. Validation of the analytical method
   1. The validation of the method must be performed according to the EMA/FDA bioanalytical guidelines
   2. Deliverables: Final validation report including a method protocol
3. Long-term stability up to 12 months, not more than 3 time points
   1. Deliverables: partial (after each time point tested) and final report for long term stability.

Quarterly updates on the development progress are required and shall be documented in the form of intermediate reports.

The final validation reports for all tasks shall be finalized before the end of 2026.

The Ordering Party does not permit the submission of partial tenders, i.e., tenders covering only selected tasks.

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 or 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.
   5. being in such a legal or factual relationship with the contractor that there is a justified doubt as to their impartiality or independence in connection with the procurement procedure.
      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 crit
   1. This offer is addressed to entities with proven experience in providing similar services. The required experience shall be demonstrated by submitting a declaration of compliance with the requirements specified below, constituting Appendix No. 3 to this Request for Proposal.
   2. A minimum of three (3) years of documented experience in the development and validation of both cell-based and non-cell-based assays for the determination of neutralizing antibody (NAb) activity in the context of oncological therapies
   3. Demonstrated capability to handle and process human serum samples originating from clinical studies
   4. Demonstrated capability to handle complex biologics (e.g. multifunctional and multidomain molecules) and mechanism-specific neutralization assays.

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

Proposal preparation  

1. Each correspondence should include the number of the procedure in the subject line:
   RFP 026653 - DEVELOPMENT AND VALIDATION OF NEUTRALIZING ANTIBODY ASSAYS FOR THE ASSESSMENT OF ANTI-DRUG ANTIBODY ACTIVITY AGAINST A BIOLOGIC THERAPY - Company name / Name
2. Deadline for submitting offer is 24.07.2025 at 23:59. The date may change, about which all Suppliers will be informed.
3. The offer should contain at least the following information: Company name, address, VAT/registry number, number of the inquiry, net price, currency, payment terms (in days) and required appendices.
4. 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.
5. The cost estimate should be prepared in a spreadsheet file, attached as Appendix no. 4 to this request for proposal: Appendix_4_RFP_026653_Cost proposal. In addition, the Bidder may prepare the bid in its own format. Bids without a completed Attachment No. 4 will not be considered.
6. Questions should be submitted via the Adamed Procurement Platform SAP Ariba Network or sent via e-mail to: aleksandra.stojak@adamed.com, using the sheet Appendix no. 5. The Ordering Party reserves the right not to provide a response in the event that the question(s) are submitted within two days prior to the end of the tender procedure. 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.
7. All required annexes, declarations, and documents must be attached to the offer. The Ordering Party also includes with the request a completed and signed checklist (Appendix No. 6), which will serve to confirm whether all required documents have been submitted.
8. 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: aleksandra.stojak@adamed.com.
9. Each Tenderer may submit only one offer
10. The Ordering Party does not allow partial offers
11. The Proposal should be prepared in Polish or English
12. Tenders submitted after the deadline will not be considered.
13. The Supplier before time-limit for receipt of tenders is entitled to:
14. Withdraw the offer by submitting a written notification in the manner describes for submitting offers,
15. 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 [%]	Assessment method according to the formula
   Net price	100%	net price of the lowest offer / net price of the examined offer x 100 x 100% = number of points Refers to the sum of the component items indicated 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 the event that at least two offers receive the same score, the decisive criterion shall be the net price for the performance of the required services. 

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 seamlessly with purchasing platform https://supplier.ariba.com. The user should have at least the following technical capabilities:
   1. PC or Mac with a 1GHz processor or faster and a minimum of 512 MB RAM,
   2. permanent access to the Internet with a guaranteed bandwidth of not less than 1Mb / s,
   3. Internet browser in the latest version. IE 9.0+ or Mozilla Firefox or Chrome 24+ 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 Bidder's withdrawal from the conclusion of the contract upon notification of the contractor about the selection of their offer may serve as a basis for the Ordering Party's claims, including those related to the damages incurred (such as delays resulting from the necessity to choose another contractor). In such cases, the provisions of the Civil Code shall apply accordingly. Therefore, the Ordering Party requests that thoughtful offers be submitted, in compliance with all the expected conditions of the order, taking into account the indicated foreseeable deadlines for its execution.
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 does not undertake to purchase a specific number of services from the selected Supplier. The Ordering Party will order services from the selected Supplier only if a need for such services arises in the Ordering Party during the contract period. Services will be provided on the basis of orders placed according to the Ordering Party's current needs.
12. 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. the necessity or technical and economic justification for the use of equivalent materials and equipment
    3. the necessity to implement equivalent solutions resulting from technological or operational conditions
    4. financial limitations of Ordering Party resulting in limiting the scope of contracted activities
    5. in the event of an unforeseen necessity, not anticipated at the tender stage, to carry out additional services/analyses due to their scientific nature and the resulting complexity that is difficult to predict, the Parties allow for the possibility of extending the execution deadline. Any extension of the deadline requires prior written approval from the Sponsor.

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: aleksandra.stojak@adamed.com, using an Excel file - Appendix No 5.
2. The list of required documents is available in Appendix No. 6
3. The person authorized to contact the Suppliers on Monday-Friday from 09:00 am to 05:00 pm is  Aleksandra Stojak: [aleksandra.stojak@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)

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

SAP Ariba Network registration (download)