REQUEST FOR PROPOSAL RFP –  023690 – 2022/ABM/04/00011/0012/0013 - TENDER FOR TRAINING INHALER - Update no 1 - new dedaline for submitting offers

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.
   
   Study Sponsor (Contracting Authority): Adamed Pharma S.A.
   
   On order, the execution of which was carried out until 25.05.2023 together:
   • The Inhaler Training Device is used for coaching patients to use their DPI (Dry Powder Inhalers). The device measures peak inspiratory flow rate, and can simulate the resistance characteristics of the specific inhaler of a patient. The patient can then be trained to inhale at a flow rate known to be suitable for their personal inhaler There are six resistance groups, five of which relate to dry powder inhalers (DPIs) and one of which to pressurised metered dose inhalers (pMDIs). Quantity – 31.
   • Disposable One-way valve inspiratory mouthpieces help reduce risk of cross-infection to protect patient and equipment from contamination by preventing blowback. Quantity – 200.
     
     Contracting Authority allows the submission of offers containing an equivalent product in terms of the description of the subject and the necessary requirements listed in the attachment to the order offer. In the "product description" column, Contracting Authority will specify the scope of equivalence, i.e. features / parameters or indicate the catalog number on the basis of which the Bidder is able to determine whether he has a product equivalent to the one specified. An "equivalent" product should be understood as goods with properties not worse than those indicated in the Request for Proposal. 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) – Appendix 8, in which it is beyond any doubt that the offered subject of the contract has the same or better parameters qualitative. All risk related to proving "equivalence" rests with the Supplier. The Supplier is obliged to prove that the deliveries it offers meet the requirements specified by Contracting Authority.
     
     Place of delivery:
     Adamed Pharma S.A. (Pabianice)
     ul. Piłsudskiego 5
     95-200 Pabianice
2. The products offered under this tender must be brand new, not expired (expiration date not shorter than Q1.2024) and must be original manufacturer's products.

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 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).
      These requirements should be confirmed in the form of statements constituting obligatory attachments to the offer. Contracting Authority will reject the offers (as offers which do not meet requirements for participation in the tender) to which the above documents are not attached.
3. At the stage of submitting bids, Contracting Authority requires a statement on the expiry date of the products not shorter than Q1 2024 according to own template (Appendix 6) and a statement on ensuring transport in accordance with the device manual according to own template (Appendix 7).
4. 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.

Terms and methods of offer submission 

1. The title of each correspondence should include the number of the procedure
   RFP – 023690 – 2022/ABM/04/00011/0012/0013 - TENDER FOR TRAINING INHALER_Company name
   
   Deadline for submitting Offer 08.05.2023 at 23:59 CET.
   
   Questions should be submitted using the sheet Appendix_5_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.
   The deadline may change, all Suppliers will be informed by e-mail and information published on the Adamed Pharma website www.adamed.com.pl.
2. Any Supplier may submit only one offer. 
3. Contracting Authority will not allow the submission of partial tenders
4. The offer should be prepared on the excel spreadsheet which constitutes Appendix to this offer: Appendix_3_023690_Offer_[CompanyName]. If Appendix 3 is not filled out, the offer will not be considered. 
5. Offer along with the required attachments, may be submitted by sending e-mail to sylwia.adasiewicz(at)adamed.com.
6. Supplier's Offer should be comprehensive in Polish or English, electronically. 
7. 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).
8. 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
9. Please attach filled and signed checklist to confirm that all required documents will be delivered (Appendix 4) 
10. Tenders submitted after the deadline will not be considered. 
11. 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". 

V. 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 unit price (PLN/EUR), the weight criterion - 80%, shall include all the associated costs.

   2. Lead Time (days), the weight criterion – 20%, time from the order to the transfer of documentation or material

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
   Unit price	80%	net price of the lowest offer / net price of tested offer x 100 x 80%= number of points
   Lead time (days)	20%	net price of the lowest offer/net price of tested offer x 100 x 20% = 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 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.

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.  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:
    1. 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.
    2. 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, under pain of nullity.

Cooperation and communication in the course of preparing responses

1. Any questions should be submitted by e-mail: sylwia.adasiewicz(at)adamed.com (Appendix 5).
2. Answers will be provided to all the participants via e-mail.  
3. The person authorized to contact the bidders (Monday-Friday between 07:00-15:00 CET) is sylwia.adasiewicz(at)adamed.com.

Appendix No 1  (download)

Appendix No 2  (download)

Appendix No 3  (download)

Appendix No 4  (download)

Appendix No 5  (download)