Request for proposal RFP - 026005 – ACTIVE SUBSTANCE

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. 
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.
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.

financed by the State budget from the Medical Research Agency pursuant to § 8 sec. 2 point 2 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 Active Substances in 2025 and 2026 under the conditions set out in this request for proposals. A detailed list of subjects is presented in Appendix 2 (EN_Annex_2_RFP-026005 Requirements_Substancje_Active).
2. The Ordering Party reserves the right to choose three suppliers.
3. The maximum - total amount of active substances (API) ordered from all selected Suppliers is 1500 g, and each of the Bidders may submit an offer for the amount up to 500 g (in 2-3 deliveries) of active substances.
4. The maximum  - total amount of active substance standard relevant for active substance from all selected Suppliers is 150 mg, and each of the Bidder may submit and offer for the amount up to 50 mg (in 1-2 deliveries).
5. The maximum  - amount of each relevant Impurities standards (indicated by Supplier) related with API analysis from all selected Suppliers is 150 mg, and each of the Bidder may submit and offer for the amount up to 50 mg of each (in 1-2 deliveries) Impurity standard.
6. As a result of the settlement of the subject of the proceedings, the Ordering Party shall conclude an agreement with selected Suppliers. The purpose of the procedure is to determine the conditions for orders that may be implemented by the Ordering Party during the term of the contract, in particular prices, delivery time and the scope of ordered items. Under the contract, the Ordering Party does not undertake to purchase a specific number of products from the selected Supplier. The Purchaser shall purchase products from the selected Supplier only if the Purchaser needs to purchase them during the term of the contract. Deliveries will be made on the basis of placed orders according to the current needs of the Ordering Party.
7. In offer should be included the cost of transportation. Place of delivery: 
   Adamed Pharma S.A., Pieńków,
   St. Mariana Adamkiewicza 6A,
   05-152 Czosnów, Poland
   or
   Adamed Pharma S.A.
   St. Marszałka Józefa Piłsudskiego 5,
   95-200 Pabianice, Poland
8. 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. 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. 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. 4 to this RFP).  
3. 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_026005 _Company name 
2. Deadline for submitting Offer is 7th of February 2025 at 23:59 CET. The deadline may change, all Suppliers will be informed by e-mail from the Procurement System.  
   Questions should be submitted using the sheet Appendix_3 _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. 
3. Any Supplier may submit only one offer.  
4. The offer should be prepared on the excel spreadsheet which constitutes Appendix to this offer: Appendix_2_026005_Proposal CompanyName. If Appendix 2 is not filled out, the offer will not be considered.  
5. Only offers that meet all the Parameters marked in Appendix No. 2 with the description: "Critical" will be considered. Offers without completed Annex_2, including the fulfillment of the parameter (yes / no) will not be considered.
6. Offer along with the required attachments, may be submitted by e-mail address: Tadas.Zimkus[at]adamed.com.
7. In addition, the Bidder may also prepare an offer in his own preferable format and uploaded into the system.
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), delivery time (time required for delivery in days).  
10.  If the prices in the offer are expressed in a currency other than PLN, they will be converted using the average NBP exchange rate on the day of publication of the tender. If on the day of publication of this procurement notice, the NBP average exchange rate table is not published; the rate from the last average exchange rate table published before the day of publication of the procurement notice will be used.  
11. In the case of another currency than PLN/EUR/USD, the average NBP exchange rate from the last day of submitting offers will be accepted for conversion. 
12.  Please attach filled 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 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”.

Selection criteria and method of evaluation of submitted offers

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/USD), the weight criterion - 85%, shall include all the associated costs. 

   2. Lead Time (days), the weight criterion – 15%, (declared time needed for one delivery, expressed in days from provided purchase order) of the overall assessment. If different deadlines or time intervals are given, the longest declared deadline will be considered the completion date

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:  :

4. Criteria	Weight criterion[%]	Method of evaluation in accordance with the formula
   Unit Price	85%	net unit price of the lowest offer / net price of tested offer x 100 x 85% = number of points [total calculation for each of the items specified in the cost estimate]
   Lead time	15%	The shortest lead time of the one deliver/lead time of one tested offer x 100 x 15% = number of points

5. 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.  

6. 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. Information on the results of the procedure will be sent by the Contracting Authority to each Tenderer who submitted his offer and will be published on the Adamed Pharma website www.adamed.com.pl.

General provisions

1. The contracting authority reserves the right to cancel the procedure at any stage without giving any reason.
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 Ordering Party reserves the right to reject offers that are inconsistent with the content and subject of the request for quotation (including, depending on the scope of the request for quotation, the number of items/services offered, the scope of delivery/service, delivery/service completion dates) without the need to request the Bidder to provide explanations or submit appropriate supplements.  
9. The Bidder's withdrawal from concluding the agreement in the event of notifying the contractor of the selection of its offer may be the basis for the Ordering Party's claims, including for damage incurred (related to, among others, delays resulting from the need to select another contractor). In such additions, the provisions of the Civil Code shall apply accordingly. In connection with the above, the Ordering Party requests the submission of well-considered offers, consistent with all expected terms of the order, taking into account the indicated predictable deadlines for its completion.
10. 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.  
11. The Contracting Authority allows negotiations of the contract terms and conditions with the bidder.  
12. 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  
13. 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 documentation resulting from unforeseeable reasons, 
    2. financial constraints on the part of the Ordering Party resulting in the need to limit the scope of works included in the offer. 

Cooperation and communication in the course of preparing responses 

1. The title of each correspondence should include the number of the procedure: RFP_026005_Company name.
2. Any questions should be submitted by e-mail: [Tadas.Zimkus(at)adamed.com], (Appendix 3).
3. The person authorized to contact the bidders (Monday-Friday between 09:00-17:00 CET) is   [Tadas.Zimkus(at)adamed.com].

Appendix No 1  (download)

Appendix No 2  (download)

Appendix No 3  (download)

Appendix No 4  (download)

Appendix No 5  (download)