Request for proposal RFP - 026746 - PREPARATION AND PRINTING OF LABELS FOR THE IMP PRODUCT IN A PHASE I CLINICAL TRIAL

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.

Subject of Order

Successive printing of labels for the labeling process of the IMP investigational product for the purposes of conducting the Clinical Trial at the Research Centers in the period: Q3 2025 – Q4 2026.

The subject of the contract is:

Printing of labels for the clinical trial according to a specific design provided by the Sponsor, suitable for use at low temperatures, i.e., down to -90°C, both for labeling and for long-term storage.

The Ordering Party will commission the production of labels depending on demand, i.e., from 50 to 200 labels per order. A total of up to 2,600 direct labels and 260 collective labels during the contract period.

The customer plans up to 10 partial orders.

Label templates:

1. Collective label:
   Shape: rectangular/white
   Height: 65.00 mm
   Length: 65.00 mm
   Material: PP-Film white gloss/white/for permanent use on glass
2. Direct/Multilayer Peel-Off Label:
   Shape: Rectangular
   Height: 20.00 mm
   Length: 210.00 mm
   Peel-Off Part Size:
   Height 20 mm / Length 30 mm
   Material: White gloss PP film for permanent use on glass, containing data in accordance with GMP requirements and the Customer's approved design

The Ordering Party provides four direct label templates.

The Supplier may utilize subcontractors to perform all or part of the services presented in this Request for Proposals. The Supplier is obligated to enter into appropriate agreements with subcontractors. Where a catalog number appears, it serves as a supporting source for the Supplier regarding the equivalent element.

Framework duration of the service: Q3 2025 – Q4 2026. These dates may change depending on the progress of the clinical trial.

As a result of the tender, the Contracting Authority will enter into an agreement with the selected Supplier. The purpose of the tender is to establish the terms and conditions for orders that may be fulfilled by the Contracting Authority during the contract period, in particular, prices and delivery times. Under the agreement, the Contracting Authority does not commit to purchasing a specific quantity of products from the selected Supplier. The Ordering Party will purchase products/order services from the selected Supplier only if the Ordering Party needs to purchase/provide them during the term of the contract.

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 a company as a partner in a civil partnership or partnership,
   2. owning at least 10% of the shares,
   3. serving as a member of a supervisory or management body, a proxy, or an attorney-in-fact,
   4. being married, in a direct lineal consanguinity or affinity relationship, a second-degree consanguinity or a second-degree collateral relationship, or a relationship of adoption, guardianship, or guardianship.
      To meet this requirement, the Bidder must submit a signed Declaration of No Affiliation (Appendix 1) with their bid.
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 meet this condition, the Supplier is required to submit a signed sanctions declaration (Appendix 2) to this request for proposals along with the offer.

3. The offer is addressed to entities:

   Able to print the above-mentioned materials within a maximum of 14 days of placing the order. To meet this requirement, the supplier must submit a signed declaration (Appendix 3 to this request for proposals) along with the offer.

Method of preparing the offer 

1. Each correspondence should include the tender number in the subject line:
   RFP 026746 Preparation and printing of labels for the IMP product in a clinical trial as part of a Phase I study - name of the bidder
2. Bids must be submitted by 20/08/2025, 11:59 PM CET. This deadline is subject to change, and all Suppliers will be notified accordingly.
3. Questions can be submitted by email to: magdalena.leszczyńska-wiloch@adamed.pl only in the form of a completed Appendix 4.
4. The Ordering Party reserves the right not to respond if the question(s) are submitted within two days before the end of the procedure.
   To ensure equal access to information for all Bidders participating in the procedure, questions and answers (with the author's name hidden) will be sent to all Bidders.
5. The bid should include the following information: name, address, and Tax Identification Number of the Bidder, request for proposal number, net price (EUR or PLN) and payment date, and scope of activity.
6. The Supplier should submit a cost estimate using the Ordering Party's template (Appendix 5). This cost estimate should include all costs of providing the service.
7. The offer must be accompanied by all required attachments, declarations, and documents. The Contracting Authority also encloses a completed and signed checklist (Appendix 6) to the request for quotation, which will confirm that all required documents have been submitted.
8. The offer, along with the required attachments, should be submitted to: magdalena.leszczynska-wiloch@adamed.com
9. Each supplier may submit only one offer.
10. The Contracting Authority does not allow partial offers. The bidder must ensure the provision of all required services, ensuring the efficient organization and implementation of the clinical trial.
11. The offer should be prepared in Polish or English.
12.  Prices in the offer should be net prices in Polish zloty (PLN) or euro (EUR).
13. If prices in the offer are expressed in a currency other than PLN, they will be converted using the average NBP exchange rate on the date of the tender announcement. If the NBP average exchange rate table is not published on the date of this procurement announcement; the exchange rate from the last table of average exchange rates published before the date of publication of the contract notice will be used.
14. Tenders submitted after the deadline will not be considered.
    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”.

Evaluation of submitted offers and selection criteria

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. Formal compliance with the requirements of the request for proposals.

3. Ability to deliver the service within the specified timeframe.

4. Criteria for selecting offers:

   1. Net price of the service (criterion weight – 100% of the overall score) for the performance of the evaluation procedures described in Appendix 5

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

6. Criteria	Weight [%]	Assessment method according to the formula
   Net price of the servis	100%	net price of the lowest offer / net price of the examined offer x 100 x 100% = number of points

7. The Contracting Authority reserves the right to negotiate offers with any Bidder. Negotiations may be conducted in several successive rounds, with the option of inviting the Bidder to submit an updated offer after each round.
8.  The offer with the highest final score will be deemed the most advantageous.
9. The results of mathematical calculations performed during the evaluation of offers will be rounded to two decimal places.

Bidder Selection and Announcement Procedure

1. The Contracting Authority will select the most advantageous bid based on the bid evaluation criteria specified in this Request for Proposals.
2. The Contracting Authority will post information on the results of the tender on its website https://www.adamed.com/rozwoj-i-innowacje/zapytania-ofertowe-i-przetargi and send it to each Bidder.

General provisions

1. The Ordering Party reserves the right to cancel or terminate the procurement procedure at any stage without providing a reason.
2. In the event of cancellation of the procurement procedure, contractors shall not be entitled to claim reimbursement of participation costs.
3. Submitting an application for registration in the procurement procedure or a bid constitutes unreserved acceptance of all terms and conditions of the procedure.
4. The Ordering Party reserves the right to reject bids that are inconsistent with the content and subject matter of the request for proposals (including, depending on the scope of the request for proposals, the number of items/services offered, the scope of delivery/service, and delivery/service completion dates) without the need to request the Bidder to provide clarification or submit appropriate supplements.
5. A Bidder's withdrawal from the contract after notifying the contractor of the selection of their bid may constitute grounds for the Ordering Party's claims, including for damages incurred (related, among other things, to delays resulting from the need to select another contractor). In such cases, the provisions of the Civil Code shall apply accordingly. Therefore, the Ordering Party requests the submission of well-considered bids that comply with all expected terms of the contract, taking into account the indicated expected completion dates.
6. The Ordering Party reserves the right to exclude from the proceedings a bidder who has refused to conclude the contract in another Adamed tender.
7. During the evaluation of submitted applications, the Ordering Party may request clarification from contractors regarding the content of the documents they have submitted.
8. If the application does not contain all the required elements, the Ordering Party may, in justified cases, request the Contractor to supplement it.
9. The Ordering Party reserves the right to audio record during technical meetings with suppliers. Submission of the bid will be deemed consent to the recording of such meetings.
10. The Ordering Party allows negotiations on the terms of the contract with the Contractor, to a limited extent.
11. 1Supplementary orders may be submitted to the selected Bidder only if they are consistent with the primary purpose of this contract, with a value not exceeding 50% of the value of this order.
12. The Ordering Party reserves the right to conduct an audit of the Bidder prior to signing the contract. If the audit results are unsatisfactory, the Ordering Party may withdraw from signing the contract. Unsatisfactory audit results will primarily be deemed to include a finding of non-fulfilment of the conditions specified in point III.2.
13. Conditions for amending the contract:
    The Contracting Authority anticipates the possibility of making significant amendments to the contract concluded as a result of the procurement procedure, in relation to the content of the offer based on which the contractor was selected, if it becomes necessary to amend the scope of services specified in the offer/agreed scope of services resulting from:
    1. The Sponsor may change the timeframe for conducting the study as specified in the request for proposals if the relevant authority and/or the relevant ethics committee does not issue consent and/or a positive opinion for conducting this clinical trial.
    2. Necessary or justified changes to the delivery date and conditions of the subject of the contract arising from unforeseeable reasons. Any amendments or additions to the contract concluded with the selected Contractor will be made in the form of written amendments to the contract signed by both parties, under pain of nullity.

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.

Appendix No 1  (download)

Appendix No 2  (download)

Appendix No 3  (download)

Appendix No 4  (download)

Appendix No 5  (download)

Appendix No 6  (download)