Request for proposal RFP - 024313 - BIOANALITYCAL METHOD DEVELOPMENT, DETERMINATION OF AD-O51.4 AND ANTI-DRUG ANTIBODY LEVEL IN SERUM OF PATIENTS ENROLLED IN THE CLINICAL TRIAL (GLP STANDARD)- Update no 3 - additional questions and answers (update of attachment no 5)

In connection with the project „ Clinical trial of the first phase (Ia/Ib) of a fusion protein with a dual anticancer mechanism”, financed from Medical Research Agency (nr. 2022/ABM/05/00006-00)  operating under §8 of the subsidy agreement, Adamed Pharma S.A.  invites you to submit offers for the execution of the below defined subject of the contract.

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

Object of the Contract

The object of the Contract is:

• Development and validation of the LC-MS/MS bioanalytical method compliant with EMA / FDA guidelines for the determination of fusion protein in human serum, completed with a validation report. Lower detection limit not higher than 10 ng/ml is required.
• Determination of the fusion protein level in patient samples during a clinical trial (pharmacokinetic analysis) using previously developed LC-MS/MS method in the good laboratory practice (GLP) standard. The service shall be completed with an appropriate analytical report. Number of samples for the analysis is max. 600.
• Transfer and validation of a bioanalytical method (ELISA) detecting anti-drug antibodies (ADA) in serum from patients. The methods was previously established in non-GLP standard based on monkey and rat biological material. Method validation shall be performed in accordance with EMA/FDA guidelines and completed with an appropriate validation report.
• Transfer and validation of a method determining ADA neutralizing potential in serum samples from patients. The methods was previously established in non-GLP standard based on monkey and rat biological material. Method validation shall be performed in accordance with EMA/FDA guidelines and completed with an appropriate validation report.
• Analysis of patient serum samples from clinical trial in order to detect ADA according to the developed ELISA method in the GLP standard. The analysis shall be completed with an appropriate analytical report. Number of samples for the analysis is max. 200.
• Determination of ADA neutralizing potential in serum samples from patients, if present. The analysis shall be performed in accordance with the method developed in the GLP standard completed with an appropriate analytical report.
• Pharmacokinetic reports (final and partial after each clinical phase Ia and Ib) containing results and statistical analysis (CTD module 5 format)
• Partial pharmacokinetic reports for selected groups of patients containing results, calculated pharmacokinetic parameters, and statistical analysis (max. 20 reports).

The Ordering Party does not allow the submission of partial offers, i.e. for one, several or all of the above-mentioned tests. The research will be carried out in the time period from 01/04/2024 to 29/11/2028

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. 2 to this RFP).  
3. The offer is addressed to bidders who have experience in providing similar services and have a certificate of the necessary quality standards of GLP work. Experience should be demonstrated by attaching a declaration of meeting these criteria which constitutes Appendix 3:

• the facility must have at least 2 years of experience in performing bioanalytical and pharmacokinetic service according to GLP standards
• the facility have a qualified key employees involved in clinical projects of innovative drugs. In particular a project team whose employees have experience in:
  • work related to the analysis of molecules using high-performance liquid chromatography (HPLC) or liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) or ELISA in a certified laboratory (min. 3 years)
  • development and validation of analytical methods (LS-MS/MS, ELISA), their transfer, optimization, and validation in accordance with EMA/FDA guidelines (min. 3 years)
  • analysis of patient samples for determination of biological molecules level in patient serum during a clinical trial (pharmacokinetic analysis) (min. 2 years)
  • analysis of patient samples detecting  ADA (min. 2 years)
• the facility must have all resources necessary to provide bioanalytical testing services in the GLP standard (GLP certificate)
• the facility must use a quality management and control system to ensure compliance with all regulatory requirements.

The Ordering Party reserves the right to ask the Bidder to submit additional documents and explanations confirming the information contained in the declaration (Appendix No. 3).

Proposal preparation

1. Each correspondence should include the number of the procedure in the subject line:
   RFP 024313 - BIOANALITYCAL METHOD DEVELOPMENT, DETERMINATION OF AD-O51.4 AND ANTI-DRUG ANTIBODY LEVEL IN SERUM OF PATIENTS ENROLLED IN THE CLINICAL TRIAL (GLP STANDARD)- Company name / Name
2. Deadline for submitting offer is 26.03.2024 at 23:59. The date may change, about which all Suppliers will be informed.
3. The offer with all appendices can be placed on Adamed Procurement Platform SAP Ariba Network at https://supplier.ariba.com.
4. Each Tenderer may submit only one offer.
5. The Proposal should be prepared in Polish or English.
6. Prices in the offer should be net prices in polish zloty (PLN), euro (EUR) or American dollar (USD).
   If the prices in the offer are expressed in EUR, they will be converted using the 4.6371 PLN / EURexchange rate, in accordance with the Announcement of the President of the Public Procurement Office of December 3, 2023 on the current EU thresholds, their equivalent in PLN, the zloty equivalent of amounts expressed in euro and the average exchange rate of the zloty in relation to the euro constituting the basis for converting the value of public contracts or contests.
7. The offer should contain at least the following information: Company name, address, TAX/registry number or ID number, number of the inquiry, net price, currency, payment terms (in days) and required appendices.
8. The cost estimate should be prepared in a spreadsheet file, attached as Appendix no. 4 to this request for proposal: Appendix_4_RFP_024313_Cost_Proposal_[CompanyName/Name]. In addition, the Bidder may prepare the bid in its own format. Bids without a completed Attachment No. 4 will not be considered.
9. Offer period validity should be not less than 90 days (from the end of submission deadline).
10. It is allowed to award selected Contractor supplementary contracts in accordance with basic contract subject, in the amount not exceeding 50% of basic contract value. 
11. The Tenderer bears all costs related to offer preparations. Contracting Authority (Adamed Pharma) does not provide reimbursement of costs of participation in this procedure.
12. Partial offers are not allowed.

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 presented as the cost of preparing a full documentation package (criterion weight - 80% of the overall score), including all costs of the service provided

   2. Delivery time – 20% of the overall assessment

   Criteria	Weight criterion[%]	Method of evaluation in accordance with the formula
   Net price	80%	net price of the lowest offer/net price of the examined offer x 100 x 80% = number of points
   Delivery time [weeks]	20%	the shortest time / offer tested x 100 x 20% = number of points

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

4. The results of mathematical operations performed when evaluating the bids are rounded to two decimal places. In case of receiving equal points for at least two offers the net price of preparing the documentation package will be the decisive criterion.

Selection of the Contractor and manner of announcement:

1. The Ordering Party will select the most advantageous offer on the basis of the offer evaluation criteria specified in this inquiry.
2. The Ordering Party will inform about the results of this inquiry on the website  https://www.adamed.com/en/development-and-innovation/requests-for-proposals-and-tenders and will send them via SAP Ariba Platform to each Supplier who has submitted his offer.

Additional information about participation in the tender

1. Tender is available via the Adamed Group Purchasing Platform at: https://supplier.ariba.com and on website https://www.adamed.com/en/development-and-innovation/requests-for-proposals-and-tenders.
2. Username and password to log in to the Purchasing Platform will be sent to the Suppliers by the Operator by e-mail during registration.
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 tender procedure may be repeated only in case of inability to carry out by the Operator or the Employer. Technical problems on the side of Suppliers will have no impact on the course of the tenders.
5. Prior to the tender procedure, it is advisable to familiarize yourself with the operating instructions of the Purchase Platform attached to the tender.
6. The start and finish dates and configuration of each stage of the tender will be presented on the Purchase Platform and may change, all interested Suppliers will be notified by the system by e-mail.
7. Technical support during the procedure. During the procedure, the Suppliers can obtain technical support at: +48 539 737 818 or in the Platform in the Help tab.

General provisions

1.  The contracting authority reserves the right to cancel the procedure without giving any reason at any stage of the procedure.
2. In the event of cancellation of the procurement procedure, the contractors shall not be entitled to claim reimbursement of the costs of participation in the procedure.
3. By submitting an offer, you accept all terms and conditions of the procedure without any reservations.
4. Withdrawal by the Ordering Party from concluding the contract in the event of notifying the contractor about the selection of its offer, it may not be the basis for claims for the costs of participation in the procedure.
5. In the course of assessing the submitted applications, the Ordering Party may request the contractors to provide explanations regarding the content of the documents submitted by them.
6. If the offer does not contain all the required elements, the Ordering Party may, in justified cases, call the Contractor to supplement it.
7. The contracting authority reserves the right to record sound during technical meetings with suppliers. Sending the offer will be treated as giving consent to record the meetings.
8. The Ordering Party allows the contract terms to be negotiated with the Contractor to a limited extent.
9. The Ordering party will sign a contract with selected Contractor.
10. It is possible to place additional orders exclusively to the selected Bidder, if they align with the main objective of this agreement, with a value not exceeding 50% of the value of this order
11. The Ordering Party provides for 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 scope of service indicated in the offer / agreed scope, resulting from:

• justified and required changes in the project documentation that were impossible to predict at the time of contract execution
• Requirement for performing of equivalent activities based on scientific reasons
• Financial limitations of Ordering Party resulting in limiting the scope of contracted activities
• Changes in the project activities resulting from consultations carried out with regulatory agencies/offices
• 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.

Cooperation and communication in the course of preparing responses 

1. All questions related to the subject of this inquiry may be directed via email to: aleksandra.stojak@adamed.com, using an Excel file - Appendix No 5.
2. The list of required documents is available in Appendix No. 6.
3. The person authorized to contact the Suppliers on Monday-Friday from 08:00 am to 04:00 pm 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)

Appendix No 6  (download)

Creating an offer on the Portal SAP Ariba Network (download)

SAP Ariba Network registration (download)