REQUEST FOR PROPOSAL - UPDATE No 2 RFP 022896 – ANALYTICS AND FORMULATION OF mRNA WITH IMMUNOGENIC POTENTIAL

In connection with the co-financing of the project entitled „Development of novel mRNA/VLP-based vaccines against emerging zoonotic viral diseases” financed by the State budget from the Medical Research Agency (no. 2021 / ABM / 05 / 00001-00) as part of the Competition: Development of innovative therapeutic solutions using RNA technology, 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.

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

Subject of the Tender:

ANALYTICS AND FORMULATION OF mRNA WITH IMMUNOGENIC POTENTIAL

On order, the execution of which was carried out until December 31, 2024, how are the tasks:

1. mRNA formulation

• Selection of ingredients based on the maximum patent purity of the target formulation;
• Optimization of the LNP (Lipid Nanoparticels) composition in terms of alignment with the sequence and additional elements of the packaged mRNA;
• Optimization of LNP composition in terms of minimal polydispersion;

2. Analyzes of mRNA and the obtained mRNA + LNP formulation

• Development of mRNA quality analysis methods;
• Research on mRNA stability after packaging in LNP;
• Studies of the stability of LNP spheres with mRNA under various storage conditions
• Development of methods for testing the level of mRNA packing into LNP
• Development of a method for testing the degree of LNP dispersion after mRNA packing

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

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 5 to this RFP).

3. This offer is addressed to entities:

• having competent staff with appropriate education (biological or chemical and IT) and equipment enabling the performance of mRNA and mRNA analytical tests in LNP formulation, and preparation of a formulation ensuring mRNA stability).

• The entity must have a minimum of 2 years of experience in the commercial use of mRNA and its formulation and analysis,
  These requirements should be confirmed in the form of statements, references or CVs of the staff.

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 022896 – Company name

   Deadline for submitting Offer is 06-01-2023 at 23:59 CEST. 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_RFP_022896_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

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_2 RFP 022896_Proposal [Company]. If Appendix 2 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.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).
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 no 4) 
12. Tenders submitted after the deadline will not be considered. 
13. The Supplier, before the deadline for submitting proposals, has the right to:
    1. withdraw the offer by submitting a written notification in the same way which is described for the submission of offers,
    2. change the offer - notification about the introduction of changes must be submitted according to the same rules as the offer submitted, appropriately marked with the annotation "CHANGE OF 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 price (PLN/EUR/USD/GBP), the weight criterion - 90%, shall include all the associated costs.

   2. Lead Time (days), the weight criterion – 10%, 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	Wieght criterion[%]	Method of evaluation in accordance with the formula
   Price net	90%	net price of the lowest offer / net price of the examined offer x 100 x 90% = number of points
   Lead time	10%	net price of the lowest offer / net price of the examined offer x 100 x 10% = 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.

General provisions

1. The Contracting Authority requires that the offer be valid for at least 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 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 
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: 
    1. The necessity to make equivalent solutions resulting from technological or utility conditions, 
    2. Financial constraints on the part of the Contracting Authority which cause the necessity to limit the scope of works included in the offer, 

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 3)
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)

Supplier's instructions. Creating an offer on the Portal SAP Ariba Network (download)