Request for proposal RFP 024534 - 2022/ABM/04/00011/0012/0013 - REFERENCE PRODUCTS

In connection with the co-financing of the projects entitled:

1. Project “Development, clinical confirmation of bioequivalence and implementation of a new generation combination ternary inhalation drug in the systematic therapy of COPD”, contract number 2022/ABM/04/00011 – 00
2. Project  “Development, clinical confirmation of bioequivalence and implementation of a new generation combination inhaled drug in the systematic therapy of COPD”, contract number 2022/ABM/04/00012 – 00
3. Project “Development, clinical confirmation of bioequivalence and implementation of a new generation complex inhaled drug in the systematic therapy of respiratory diseases Asthma and COPD”, contract number 2022/ABM/04/00013 – 00

financed by the State budget from the Medical Research Agency pursuant to § 8 of the co-financing agreement, Adamed Pharma S.A. invites to submit tenders for the below-defined service.

Subject of the Tender

1. Supply of reference products under the conditions described in this inquiry until the end of 2024 at the latest. Partial delivery allowed (under conditions in section Terms and methods of offer submission, point 5). Detailed list of products is presented in  Appendix_3. The quantities are forecast. The Contracting Authority reserves the right to change the quantities.
2. Place of delivery:
   Adamed Pharma S.A. (Pabianice)
   ul. Piłsudskiego 5
   95-200 Pabianice
3. The products offered under this tender must be brand new, not expired (expiration date not shorter than May 2025) and must be original manufacturer's products.
4. As a result of resolving the subject of the proceedings, the Contracting Authority will conclude an agreement with the selected Suppliers. The purpose of the proceedings is to determine the conditions regarding orders that may be implemented by the Contracting Authority during the term of the contract, in particular prices, delivery time and the scope of the ordered items. The Contracting Authority will purchase products from the selected Supplier only if the Contracting Authority needs to purchase them during the term of the contract. Deliveries will be carried out on the basis of orders placed according to the current needs of the Contracting Authority.
5. Supplementary orders may be submitted to the selected Tenderer only if they are consistent with the main purpose of this contract, with a value not exceeding 50% of the value of this contract.
6. Deliveries of the products of the order will be made at the Supplier's expense to the Contracting Authority seat. Deliveries must be made under controlled conditions in accordance with the product leaflet Appendix 7 – Statement of ensuring transport of reference products under controlled conditions in accordance with the product leaflet with data logger (own template).
   The orders will be placed by persons designated by the Contracting Authority. It is not required to sign the confirmation of delivery of the order. The person will confirm receipt electronically on the Adamed Purchasing Platform.
7. In a situation where the name of a specific product (brand) is used in the specification, the Ordering Party allows the submission of offers containing an equivalent product (brand) in relation to these items. The "equivalent" product (brand) should be understood as products with properties not worse than those indicated in the Inquiry. In order to confirm the quality of equivalent products (brands), the supplier shall attach to the offer relevant documents (quality specification, quality control certificate, certificate of analysis or other equivalent documents), which clearly show that the offered subject of the contract has the same or better parameters qualitative. Supplier is responsible of providing material which is equivalent with parameter mentioned in Appendix 3. The Supplier is obliged to prove that the deliveries it offers meet the requirements specified by the Ordering Party.

Conditions for participation in the proceedings

1. Orders cannot be awarded to entities affiliated personally or 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.

   5. being in a legal or factual relationship with the contractor that there is justified doubt as to their impartiality or independence in connection with the contract award procedure.

      In order to fulfill this condition a tenderer is obliged to submit with the offer signed statement of lack of connections (Appendix_1 to this request for proposal).

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).  

Terms and methods of offer submission

1. The title of each correspondence should include the number of the procedure
   RFP - 024534 - REFERENCE PRODUCTS
2. Deadline for submitting Offer is 19.02.2023 at 23:59 CET.
   The deadline may change, all Suppliers will be informed by e-mail from the Procurement System. 
3. Questions should be submitted using the sheet Appendix_4_Questions_[Company Name]. Questions will be answered until the end of the procedure. 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. In order to ensure equal access to information to all Bidders participating in the procedure, questions and answers (concealing the author of the questions) will be sent to all Bidders.
4. Any Supplier may submit only one offer. 
5. Partial bids are allowed, however offer may concern one, two, three or four selected items, and it is not possible to submit offers for delivery of individual products in the number of packages less than total amount per product in Appendix 3.
6. The offer should be prepared on the excel spreadsheet which constitutes Appendix to this offer: Appendix_3_RFP_024534_Offer [CompanyName]. If Appendix 3 is not filled out, the offer will not be considered. 
7. Offer along with the required attachments, may be submitted to the Adamed Procurement System at https://supplier.ariba.com.
8. 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. 
9. Supplier's Offer should be comprehensive in Polish or English, electronically. 
10. 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), delivery time (time required for delivery in days), amount of products, payment term (in days).
11. If the prices in the bid are expressed in a currency other than PLN, they will be converted using the average exchange rate of the National Bank of Poland (NBP) as of the date of publication of the tender. If the average exchange rate table of the National Bank of Poland is not published on the day of publication of this contract notice; the exchange rate from the last average exchange rate table published before the day of publication of the contract notice will be used. The Procuring Entity attaches a signed checklist (Attachment No. 5) to the request to confirm whether all required documents have been provided.
12. Please attach filled in and signed checklist to confirm that all required documents will be delivered (Appendix 5).
13. Tenders submitted after the deadline will not be considered. 
14. 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 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 (PLN/EUR), the weight criterion - 70%, shall include all the associated costs.
   2. Lead Time (in days), The term will be binding from the delivery of the invoice by the winning bidder If different terms or time frames are given, the longest declared term will be considered as the completion date - 20% of the total evaluation
   3. Certificate of Analysis (CoA) - 10% of the total score. A certification statement will not be considered equivalent to a certificate.
3. The contracting authority will evaluate the offers based on the result of the achieved number of points, calculated on the basis of the above-mentioned criteria and scoring:

   Criteria	Weight criterion[%]	Method of evaluation in accordance with the formula
   Price	70%	net price of the lowest offer/net price of tested offer x 100 x % = number of points
   Lead time	20%	net price of the lowest offer/net price of tested offer x 100 x % = number of points
   Certificate of Analysis (CoA)	10%	Number of certificates delivered x 100 x 10%. = number of points Not providing Certificate of Analysis (CoA) = 0 points.

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

5. The results of mathematical operations performed when evaluating the bids are rounded to two decimal places. In case of receiving equal points Bidders would be asked for submitting experience confirming documentation according to requirements stated in pt.2. The Bidder would be selected based on the highest experience in preparation of toxicology reports as well as toxicology studies on cynomolgus monkey.

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 about the results of the procedure will be published on the Adamed Pharma website www.adamed.com.pl and will be sent to each Supplier who submitted their offer.

Additional information about participation in the proceedings

1. The Request for Proposal is available on the Adamed Group Purchasing Platform at: https://supplier.ariba.com and on the website Adamed Pharma S.A.: https://www.adamed.com/.
2. The login and password needed to log in to the Purchasing Platform will be provided to Suppliers by the Operator via e-mail.
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 procedure will be repeated only if it is impossible to carry it out due to the fault of the Operator or the Contracting Authority. Technical problems on the part of the Suppliers will not affect the course of the proceedings.
5. Before starting the procedure, it is recommended to read the instructions for use of the Purchasing Platform attached to this procedure.
6. The start and end dates as well as the configuration of each stage of the procedure will be presented on the Purchasing Platform and may change, of which all interested Suppliers will be immediately notified by e-mail through the system.
7. During the proceedings, the contractor can use technical support by phone: +48 539 737 818 or in the application in the Help tab.

General provisions

1. The Contracting Authority required the offer to be valid for 90 days.
2. The Contracting Authority reserves the right to cancel the procedure at any stage without giving any reason.
3. 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.  
4. Submission of the application for registration in the process or tender is implies acceptance without reservation all the conditions of the proceedings. 
5. 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. 
6. In the process of evaluating Offers the Contracting Authority may seek information from the contractors concerning the content of their documents.  
7. If the application does not contain all the required elements, the Contracting Authority may in justified cases call the Supplier to complete it. 
8. 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. 
9. The Contracting Authority allows negotiations of the contract terms and conditions with the bidder. 
10. The Contracting Authority as a result of resolving the subject matter of the proceedings, will conclude an agreement with the selected Suppliers.
11. 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: 
    • necessary or justified changes in the documentation resulting from unforeseeable reasons,
    • financial constraints on the part of the Ordering Party resulting in the need to limit the scope of works included in the offer.
      Any changes and additions to the contract concluded with the selected Suppliers will be made in the form of written annexes to the contract signed by both parties, under pain of nullity.

Cooperation and communication in the course of preparing responses 

1. Any questions should be submitted using the SAP Ariba Sourcing or by e-mail: sylwia.adasiewicz@adamed.com (Appendix_4_RFP_024534_Questions).
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 07:00-15:00 CET) is sylwia.adasiewicz@adamed.com.

Appendix No 1  (download)

Appendix No 2  (download)

Appendix No 3  (download)

Appendix No 4  (download)

Appendix No 5  (download)