Request for proposal RFP - 025130 - IN VIVO ANTI-CANCER EFFICACY STUDY USING MATERIAL FROM DONORS - Update no 2: change of the deadline for submitting offers, change of the expected date of order, adding questions and answers in Annex 5

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 object of the Contract is:

• Creating model in immunocompromised mice (NOG or NSG strain) by engraftment of hCD34+ hematopoietic stem cells (different human donors) which develops stable multi-lineage human immunity (with T cells, B cells and NK cells, monocytes/macrophages) and by engraftment of human cancer cell line SW620 or SK-OV-3 (or another human cell line available and validated by the contractor, that meets the indication requirements)
• Anti-tumor efficacy study on the created model with intravenous administration of delivered molecules (6 administrations, every 3 days) – 48 mice in the experiment, 4 groups, 12 mice per group (with 4 different donors of hematopoietic stem cells (HSC) per group)
• Body weight measurement (every 3 days) and tumor volume measurement (every 2 days) during dosing (6 doses, every 3 days) and clinical observation of the animals (daily examination of the animals - recording clinical observations such as unusual behavior or mortality if any occurs)  up to final measurements and sacrificing .
• Confirmation of the presence of immune cells after engraftment of HSC in mice – before starting the experiment   (e.g. a certificate from the animal supplier – if the engraftment was performed outside the contractor’s laboratories) and also at the end of the experiment (in collected blood)
• Terminal blood collection (at the end of the experiment) and optional: blood collection during the study (max 2times). Shipping samples to Poland
• Optional: Necropsy
• Optional: Terminal tumor collection and determination of the presence of TILs and TAMs in tumors (e.g. IHC staining)
• Optional: Additional control group of animals in anti-tumor efficacy study (24 mice) without hCD34+ hematopoietic stem cells and with engrafted human cancer cell line (the experimental schedule as above)
• Final study report with experimental steps and methods, results, statistical analysis and graphs, conclusions

The Ordering Party does not allow the submission of partial offers, i.e. for one, several or all of the above-mentioned tests.

The research will be carried out in the time period from 01/07/2024 to 30/11/2024.

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:
   • the facility must have broad expertise and a track record in performing and completing such projects evidenced by at least 2 years of activity of CRO on the market in terms of this specific service (humanized mice models) the facility has qualified key employees. In particular a project team whose employees have experience in:
     • Preclinical oncology research,
     • in vivo models, humanized mice models
   • Collaboration with clients on selecting a particular model
   • In addition to the proof of experience with engrafting immune components, the facility should provide the proof of validation of certain cell lines inducing tumors
   • the facility must have all resources necessary to provide services the facility must use a quality management and control system to ensure compliance with all regulatory requirements, for example AAALAC accreditation issued by Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International Council. The copy of certificate should be provided by the Contractor.

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 025130 IN VIVO ANTI-CANCER EFFICACY STUDY USING MATERIAL FROM DONORS.

   Deadline for submitting offer is 14.06.2024 at 23:59. The date may change, about which all Suppliers will be informed.

2. The offer with all appendices can be placed on Adamed Procurement Platform SAP Ariba Network at https://supplier.ariba.com.
3. Each Tenderer may submit only one offer.
4. The Proposal should be prepared in Polish or English.
5. Prices in the offer should be net prices in polish zloty (PLN), euro (EUR), American dollar (USD) or

   Great Britain pound (GBP).
   If prices in the offer are expressed in a currency other than PLN, will be converted using the average NBP (Narodowy Bank Polski – the central bank of the Republic of Poland) exchange rate on 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 will be used.

6. The offer should contain at least the following information: Company name, address, TAX/registry number or ID number, number of the inquiry, net price, currency, payment terms (in days) and required appendices.
7. The cost estimate should be prepared in a spreadsheet file, attached as Appendix no. 4 to this request for proposal: Appendix_4_RFP_025130_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.
8. Offer period validity should be not less than 90 days (from the end of submission deadline).
9. The Tenderer bears all costs related to offer preparations. The Contracting Authority (Adamed Pharma) does not provide reimbursement of costs of participation in this procedure.
10. Partial offers are not allowed.

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

   Criteria	Weight criterion[%]	Method of evaluation in accordance with the formula
   Net price	100%	net price of the lowest offer / net price of the examined offer x 100 x 100% = number of points

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

4. The results of mathematical operations performed when evaluating the bids are rounded to two decimal places. In case of receiving equal points for at least two offers the net price of preparing the documentation package will be the decisive criterion.

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. The Ordering party will sign a contract with selected Contractor.
10. 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.
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:

• justified and required changes in the project documentation that were impossible to predict at the time of contract execution
• Requirement for performing of equivalent activities based on scientific reasons
• Financial limitations of Ordering Party resulting in limiting the scope of contracted activities
• Changes in the project activities resulting from consultations carried out with regulatory agencies/offices
• 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 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 08:00 am to 04:00 pm is: Aleksandra Stojak [aleksandra.stojak [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)

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

SAP Ariba Network registration (download)