REQUEST FOR PROPOSAL RFP 021565 – GLP HERG INHIBITION ASSAY IN IN VITRO CONDITIONS

In connection with obtaining from the National Centre for Research and Development a grant for the project "Clinical development of an innovative anti-cancer drug using the mechanism of  reactivation of p53 protein" (project no. MAZOWSZE/0012/19) under R&D programme "Ścieżka dla Mazowsza", acting on the basis of Article 10 of the financial project support contract, Adamed Pharma S.A. invites to submit tenders for the below-defined service.

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

Subject of the Tender:

The subject of the contract is to perform hERG inhibition study under GLP conditions.

1. The Order contains below stated elements:

   1. Manual Patch Clamp assay in HEK293 or CHO-K1 cells

   2. At least 4 concentrations of test article allowing to determine IC50 in at least 5 cells.

   3. At least 2 concentrations of Positive control tested on at least 3 cells

   4. Vehicle tested on at least 3 cells

   5. Experiments in physiological (37*C) or ambient temperature

   6. Assays and analytical quantification of dose-formulation samples under GLP conditions which will fulfill ICH S7B guideline requirements

   7. Report on the above-mentioned studies in paper and electronic version, containing at least the test article calculated IC50 values (if possible) and % of hERG inhibition.

   8. LC-MS/MS method development and validation with report

2. Place of delivery: Adamed Pharma SA, Pieńków, Mariana Adamkiewicza 6A, 05-152 Czosnów.

3. It is allowed to introduce small changes by Contracting Authority in the order regarding scope of experiments, however the order will not extend the frames of this request for proposal.

4. All above mentioned tasks should be priced accordingly to Appendix 1 in the offer.

5. Time limit for completion: till 30.09.2022.

Conditions for participation in the proceedings:

1. Orders cannot be awarded to entities affiliated personally of financially with the Contracting Authority. Through financial or personal connection we understand the interactions between the Contracting Authority or persons authorized to enter into commitments on behalf of the Contracting Authority or persons performing on behalf of the Purchaser activities associated with the preparation and the procedure for selecting Suppliers and Supplier, in particular by:
   1. participation in the company as a partner or partnership,
   2. owning at least 10% of the shares,
   3. the functions of a member of the supervisory or management, proxy,
   4. remaining married in consanguinity or affinity in a straight line, second-degree consanguinity or affinity of the second degree in the collateral line or by adoption or guardianship.
      In order to fulfill this condition a tenderer is obliged to send with the offer signed statements about the lack of connections (Appendix 2 to this RFP).
2. The offer is addressed to entities having an experience in realization of similar services. Experience should be demonstrated by submission of appropriate documents.
   1. The contractor must have at least 3 years documented experience in studies on pharmaceuticals in scope of hERG inhibition studies and possess relevant equipment to perform the studies. The experience the tenderer should present in the offer (e.g. statement or references or CV of staff members).

3. The Bidder must present a signed Confidentiality Statement (Appendix 3) with the Contracting Authority. If the Bidder has previously signed a confidentiality agreement with the Contracting Authority, he may submit this agreement.

Terms and methods of offer submission 

1. The title of each correspondence should include the number of the procedure

   RFP 021565–- Company name

   Deadline for submitting Offer is 31-03-2022 at 23:59 CET. The deadline may change, all Suppliers will be informed by e-mail from the Procurement System. 

   Questions of the inquiry may be submitted on the website to the Adamed Procurement System at https://supplier.ariba.com or by e-mail: aleksandra.stojak(at)adamed.com, in the form of a completed Appendix 4.

   Late submission of questions may result in lack of time to provide the required answer. In order to ensure equal access to information to all Tenderers participating in the proceedings, questions and answers (with hiding the author's questions) will be sent to all Tenderers.

2. Any Supplier may submit only one offer. 

3. Partial bids are not allowed. 

4. The offer should be prepared on the excel spreadsheet which constitutes Appendix 1 to this offer: Appendix_1_Proposal [Company]. If Appendix 1 is not filled out, the offer will not be considered. 

5. Offer along with the required attachments, may be submitted to the Adamed Procurement System at https://supplier.ariba.comor by e-mail: aleksandra.stojak(at)adamed.com. 

6. In addition, the Bidder may also prepare an offer in his own preferable format and uploaded into the system. 

7. Access to the Procurement System SAP Ariba Sourcing the Supplier obtains through the registration to verify the existence of the company. Basic information such as country, tax identification number, postal code, contact details, etc. should be provided. 

8. Supplier's Offer should be comprehensive in Polish or English, electronically. 

9. The offer should include at least the following information: supplier name, address, TAX / registry number, bid inquiry number, date of proposal, price net (PLN/EUR/USD/GBP), delivery time (time required for delivery in days), payment terms.

10. If the prices in the offer are expressed in EUR they will be converted using the exchange rate of 4,4536 PLN/EUR, in accordance with the Notice of the President of the Public Procurement Office of 3 December 2021 on the current EU thresholds, their PLN equivalent, PLN equivalent of amounts expressed in EUR and the average PLN / EUR exchange rate constituting the basis for converting the value of public contracts or design contests. 

    In the case of another currency than PLN or EUR, the average NBP exchange rate from the last day of submitting offers will be accepted for conversion

11. Please attach filled and signed checklist to confirm that all required documents will be delivered (Appendix 5) 

12. Tenders submitted after the deadline will not be considered. 

13. The Supplier before time-limit for receipt of tenders is entitled: 

    1. to withdraw the offer by written notification by e-mail indicated for the submission of tenders, 

    2. to 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 evaluation methods:

1. The Contracting Authority is entitled to reject the tender submitted by the Supplier who does not meet the conditions for participation in the proceedings, or if the offer is incomplete or incompatible with this request.
2. Selection criteria:
   1. Net price (PLN/EUR/USD/GBP), the weight criterion - 60%, shall include all the associated costs.
   2. Delivery time (declared time needed for delivery in days) - 40% of the overall assessment. The delivery time should be calculated from the time of the Test Item receipt to the end of studies
      If you specify different terms or time intervals, the deadline will be considered the longest declared
3. The Contracting Authority shall evaluate offers based on the result of the accumulated number of points calculated on the basis of above criteria and scores:

   Criteria	Weight criterion [%]	Method of evaluation in accordance with the formula
   Price	60%	net price of the lowest offer/net price of tested offer x 100 x 60% = number of points
   Delivery date	40%	the shortest time to the completion of a study/ offer tested x 100 x 40% = number of points

    

4. The amounts of points for each criterion after summing up will be the final number of points awarded by each tender. As the most advantageous offer will be considered that which obtains the highest number of points. 

5. The results of the mathematical calculations carried out in the evaluation of tenders are rounded to the second decimal place. In case of equal scores for at least two offers the Contracting Authority 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 Contracting Authority 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 Contracting Authority information about an impact of the offer on the environment. The deadline to complete the offer will be determined by the Contracting Authority, but it cannot be less than 3 working days from receipt of the request. 

The choice of Supplier and way of announcing:

1. The Contracting Authority will select the most advantageous offer on the basis of the selection criteria defined in this request for proposal.
2. Information on the results of the procedure will be sent by the Contracting Authority to each Tenderer who submitted his offer.
3. The Contracting Authority will inform about the results of this request for proposal on website https://bazakonkurencyjnosci.funduszeeuropejskie.gov.pl/and will send to each Supplier which has submitted its offer

General provisions

1. The contracting authority reserves the right to cancel the procedure at any stage without giving any reason.

2. In the case of cancellation of the contract the Suppliers are not entitled to claim for reimbursement of the costs of participation in the proceedings.  

3. Submission of the application for registration in the process or tender is implies acceptance without reservation all the conditions of the proceedings. 

4. Withdrawal by the Contracting Authority from the conclusion of the contract after the notification the Supplier about the selecting the offer, cannot be the basis for claims of incurred costs of participation in the proceedings. 

5. In the process of evaluating Offers the Contracting Authority may seek information from the contractors concerning the content of their documents.  

6. If the application does not contain all the required elements, the Contracting Authority may in justified cases call the Supplier to complete it. 

7. The Contracting Authority reserves the right to record sound during technical meetings with suppliers. Submission of the offer will be treated as giving consent to the recording of the meeting. 

8. The Contracting Authority allows negotiations of the contract terms and conditions with the bidder. 

9. The Contracting Authority reserves the right to negotiate the proposal with the bidder, whose bid has the highest number of points, especially when the price offered by the bidder exceeds the budget intended by the Contracting Authority to perform the order. Negotiations may have several  consecutive  rounds  with  the  possibility  to  invite  bidder  to  submit  the updated quotation after each round of negotiations 

10. Terms of contract change: The contracting authority envisages 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 indicated scope of works specified in the offer: 

    1. Necessary or justified changes in the design documentation resulting from unforeseeable reasons, 

    2. The necessity or the technical-economic appropriateness of the use of equivalent materials and equipment, 

    3. The necessity to make equivalent solutions resulting from technological or utility conditions, 

    4. Financial constraints on the part of the Contracting Authority which cause the necessity to limit the scope of works included in the offer, 

    5. Necessary or justified changes in the delivery time and conditions of the contract subject resulting from unforeseeable reasons 

       Any changes and additions to the contract concluded with the selected Supplier will be made in the form of written annexes to the contract signed by both parties, under rigor of invalidity. 

Cooperation and communication in the course of preparing responses

1. Any questions should be submitted using the SAP Ariba Sourcing or by e-mail: Aleksandra.Stojak(at)adamed.com (Appendix 4)

2. Answers will be provided to all the participants via Procurement System SAP Ariba Sourcing.  

3. The person authorized to contact the bidders (Monday-Friday between 08:00-16:00 CET) 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)