Request for proposal no. RFP 024481– eCTD DOCUMENTATION AND SEND DATASET FOR BIOLOGICAL DRUG CANDIDATE

In connection with the project POIR.01.01.01-00-0220/20 entitled: “Preclinical and clinical development of recombinant fusion protein in targeted anti-cancer therapy” submitted under Activities 1.1. ‘R&D Enterprise Projects’, Sub-activities 1.1.1 ‘Industrial Research and Development Carried out by Enterprises’ of the Intelligent Development Operational Programme 2014-2020 acting on the basis of §12 of the project funding agreement, Adamed Pharma S.A. invites you to submit offers for the execution of the below defined subject of the contract.

The order will be awarded on the condition of receiving funding from the Project in the above-mentioned Program.

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

Object of the Contract:

The offer should include:

1. Preparation of eCTD documentation (ang. Electronic Common Technical Document) for a repeated-dose toxicology studies conducted in two species (rat and monkey)  required by Regulatory Agency as a part of a IMPD/IND with Appendices for a biotechnological drug candidate to be used in Phase I Clinical Trial. Documentation should be prepared  according to ICH M8 eCTD (v3.2.2, v4.0 and EWG/IWG) as well as U.S. FDA eCTD Guidance.
2. Development of  validated SEND data packages (Standard for Exchange of Nonclinical Data) for repeated-dose general toxicology conducted in monkey and rat. The tested substance was a fusion protein developed for oncologic indications. The study and report were conducted in compliant with GLP regulation.  Full report with raw date will be provided. The data packages should be compliant with U.S. FDA SEND requirements, as well as 21 CFR Part 11. All terms and translations should be used as specified by the U.S. FDA, and enables the creation of all domains required per SENDIGv3.0.and SENDIGv3.1.

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. 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.
   5. remaining with the contractor in such a legal or factual relationship that there is a reasonable doubt as to their impartiality or independence in connection with the procurement procedure.
      ​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).  

3. This offer is addressed to entities having an experience in realization of similar services. Experience should be demonstrated by submission of appropriate documents. A written declaration of the experience covering the below mentioned requirements should be submitted with an offer as Appendix No. 3

• The Tenderer  must have at least 3 years’ experience in preparation of toxicological report according to requirements  of IND/IMPD , as well as BLA/MAA application.  
• The contractor must have at least 3 years’ experience in studies on novel pharmaceuticals in the scope of ADME / PK, toxicology and legal regulations applicable in this scope, including experience in work with biological compounds in the field of oncology.
• The Tenderer should demonstrate that it has all resources to provide services in non-GLP and GLP regulatory toxicology studies.
• The Contractor should use a quality management system and the auditing system to ensure compliance with all required regulatory requirements.
• The Tenderer should demonstrate the experienced personnel involved in preclinical research and development projects of innovative drugs of the principle team members, in particular a Study Director and toxicologist with highlighted experience in the field of formal preclinical development and regulatory expertise on toxicology of at least 3 years, including at least five in GLP studies conducted.  
• The contractor must have at least 3 years’ experience in conducting at least 5 GLP-compliant toxicology studies in selected species – rat and cynomolgus monkey

The Ordering Party has a right to request documentation confirming information stated in the declaration of experience (Appendix No. 3).

Proposal preparation

1. Each correspondence should include the number of the procedure in the subject line:
   RFP 024481- eCTD DOCUMENTATION AND SEND DATASET - Company name
2. Deadline for submitting offer is 15.12.2023 at 23:59. The date may change, about which all Suppliers will be informed.
3. The offer with all appendices can be placed in 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).
7. If the prices in the offer are expressed in EUR, they will be converted using the 4.4536 PLN / EURexchange rate, in accordance with the Notice of the President of the Public Procurement Office of December 3, 2021 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.
8. 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, delivery time, payment terms (in days) and required appendices.
9. The cost estimate should be prepared in a spreadsheet file, attached as Appendix no. 4 to this request for proposal: Appendix_4_RFP_024481 _Cost proposal_[CompanyName]. In addition, the Bidder may prepare the bid in its own format. Bids without a completed Attachment No. 4 will not be considered.
10. Offer period validity should be not less than 90 days (from the end of submission deadline).
11. 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.  
12. The Tenderer bears all costs related to offer preparations. Contracting Authority (Adamed Pharma) does not provide reimbursement of costs of participation in this procedure.
13. 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 (criterion weight – 80 % of the overall score) as an overall cost of the service

   2. Delivery time  (in weeks) - 20% of the overall assessment.

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	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

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.2. The Bidder would be selected based on the highest experience in preparation of toxicology reports as well as toxicology studies on cynomolgus monkey.

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 seamlessly with purchasing platform https://supplier.ariba.com. The user should have at least the following technical capabilities:
   • PC or Mac with a 1GHz processor or faster and a minimum of 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 or Chrome 24+ 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 in 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 in Adamed Procurement Platform SAP Ariba Network at https://supplier.ariba.com, according to the enclosed instructions, using 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)

Ariba Supplier's user guide - Creating an offer on the Portal  (download)

Ariba_Supplier's user guide -Registration on Ariba Network  (download)