Request for proposal RFP 024461 - CONSULTANCY IN TOXICOLOGY INCLUDING PREPARATION OF IMPD/IB REGULATORY DOCUMENTATION

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)  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

1. The offer should include consultancy for a biotechnological drug candidate to be used in Phase I clinical trial in oncological indications, in period 2024 - 2028.
   The tasks would consist of:
   • Consultation of preclinical data/reports, especially in the fields of toxicology, hepatotoxicity and immunotoxicology
   • Support in a preparation of IMPD/IB, including gap fill analysis, review, supplementation and writing of integrated summaries and predicted effect in human
   • Translation of preclinical data into the clinic. Assessment of the patient's risk of potential adverse reactions
   • Preparing answers to the Agency's questions during the clinical trial application

The detailed list of activities is described in Appendix No. 7.

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. acting as a member of the supervisory or management body, proxy, 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 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).  
3. The offer is addressed to bidders who have:
   • toxicologist certification awarded by professional organizations such as the American Board of Toxicology (ABT) or The Academy of Applied Environmental Studies (AAES) or other equally important. Have higher medical education, PhD, and experience in oncology.
   • experience in preparation/consultation of IND/IMPD/IB documentation for oncological products for FIH applications – at least 3 submissions
   • experience in medical writing – at least 2 years
   • experience in consulting toxicology of biologics, especially in immunotoxicity, hepatotoxicity, and translation of preclinical results to patient risk- at least 3 years of experience.
   • Experience in supporting regulatory submissions writing, reviewing and supplementing regulatory documentation for IND/IMPD and contact with a regulatory Agency – at least 3 years

A written declaration of the experience covering the abovementioned requirements should be submitted with an offer as Appendix no. 3, along with the sent scan of the toxicologist's certificate and CV.

4.Each submitted CV should include the following clause:

I agree to the processing of personal data provided in this document by Adamed Pharma S.A. for realising the offer evaluation process submitted in the RFP 024461 pursuant to the Personal Data Protection Act of 10 May 2018 (Journal of Laws 2018, item 1000) and in agreement with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

Terms and methods of offer submission

1. Each correspondence should include the number of the procedure in the subject line:
   RFP 024461- CONSULTANCY IN TOXICOLOGY INCLUDING PREPARATION OF IMPD/IB REGULATORY DOCUMENTATION   - Company name / Name
2. Deadline for submitting offer is 22.02.2024 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_024461_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 per working - hour (PLN/EUR/USD), criterion weight – 100 % of the overall score
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
   Net price for an hour	100%	net price of the lowest offer/net price of tested offer x 100 x % = number of 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.3. The Bidder would be selected based on the highest experience in preparation of IMPD/IND documentations/submissions (measured as number of applications).

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 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 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. 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)

Appendix No 7  (download)

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

SAP Ariba Network registration (download)