Request for Bids No. 01/WPD107/2020

Request for Bids No. 01/WPD107/2020

August 7, 2020

Request for Bids No. 01/WPD107/2020

Project Title:

Development of an innovative drug candidate for the treatment  of solid tumor metastasis to the lungs

Status: Unresolved, 11^th September 2020

In the contract award procedure no bid has been received.

Contract object:

The contract object is a research service, involving the synthesis of an active pharmaceutical ingredient (API) which is a doxorubicin analog for the purpose of the planned research and development work and for clinical trial, as well as preparation of documentation compliant with the EU GMP regulations for this active pharmaceutical ingredient (API).

The goal od the RFP is implementation of the project under working title: "Development of an innovative drug candidate for the treatment  of solid tumor metastasis to the lungs” applying for funding in the competition "Fast track" under the Smart Growth Operational Program 2014-2020, Priority I Support for R&D work by enterprises, Measure 1.1 R&D projects of enterprises, Sub-measure 1.1.1 Industrial research and development works carried out by enterprises, Competition No. 6/1.1.1/2020.

Bid submission term:

8^th September 2020, 11.59p.m. CET

Bid submission method: by email to the Awarding Entity’s address:

oferty@wpdpharmaceuticals.com

Announcement category: Services

Place of the order implementation: dolnośląskie

City: Wrocław

Contact object description:

The scope of the service has been presented in the form of two (2) task Packages:

1. Package No 1 – Synthesis of the key intermediate material – which is an intermediate necessary for API synthesis, in accordance with cGMP guidelines and QA release for the purpose of API synthesis;
2. Package No 2 – Synthesis of the active pharmaceuticals ingredient (API), which is a small molecular weight cytotoxic compound – a doxorubicin analog (High potent API), with the use of the key intermediate, in cGMP standard with preparation of complete regulatory documentation necessary for the active pharmaceutical ingredient and the analytical standards in adequate format.

CPV Code: 73110000-6

CPV Code Name: Research service

Order delivery date:

The Term for the delivery of the order shall remain valid for:

• for Package 1 - up to 12 weeks, starting from the date of informing the Contractor by the Awarding Entity about signing the contract for project financing;

• for Package 2 – up to 12 months, starting from the date of delivery of the key intermediate material prepared in Package No. 1, with complete documentation.

Deadline and manner of contract execution:

The Awarding Entity plans to sign the conditional agreement with the selected Contractor within a maximum of 60 days from the date of the submission of the bids. This deadline may change in the event of the extension of the period of being bound by the bid.

The deadline for contract execution shall start:

1. For Package No. 1 – after informing the Contractor by the Awarding Entity about signing the contract for project financing,
2. For Package No.2 – after transfer to the Contractor by the Awarding Entity the key intermediate material produced in the Package No. 1

and expire upon final approval of the delivery and acceptance protocol for each of the Package and providing the Awarding Entity complete documentation developed as a part of the contract (including submitting to the electronic database provided by the Awarding Entity) and with no objections as to the performance of the Contract.

The Awarding Entity shall pay for each task package or stage of the order, confirmed by the Awarding Entity with the delivery and acceptance protocol, within 30 days from the date of receipt of the correct invoice. The value of the invoice submitted for payment will correspond to the value of the contract.

The invoice will be submitted after approval and signing the delivery and acceptance protocol, which confirms the correct implementation of each stage of the contract by the Awarding Entity.

Appendices:

Request for Bids No. 01/WPD107/2020

Appendix No. 1. Bid Form

Appendix No. 2. Declaration of compliance with the requirements

Appendix No. 3. Declaration of no capital or personal links

Appendix No. 4. List of services

Appendix No. 5. List of persons dedicated to perform the service

Appendix No. 6. Declaration of the Qualified Person

Appendix No. 7. NDA template

Appendix No. 8. Important provisions of the contract - template

Participation terms:

In the contract award procedure may participate Contractors who:

1. have the necessary knowledge and experience and have technical potential and people capable to perform the object of the order or present a written commitment of other entities to provide technical potential and persons capable to perform the object of the order, such as:

• for Package No 1:
• The Awarding Entity requires the Contractor to have documented experience in the provision of services consisting on the synthesis of low-molecular weight organic compounds for the third parties, in particular experience in carrying out multi-stage (at least two-stage) synthesis of the low-molecular weight organic compounds and optimization of the process. To confirm the above, it will be necessary for the Contractor to demonstrate duly completed at least (2) two contracts involving, in particular, a multi-stage (at least two-stage) synthesis and process optimization of the production of the low-molecular weight organic compounds;
• In terms of staff resources, the Awarding Entity requires the Contractor to have at his disposal or to engage persons with appropriate qualifications and experience for the execution of the contract, including at least (2) two persons with specialized education (pharmacy, chemistry or related fields, i.e. medicine, biological sciences), experienced in conducting organic synthesis and technologies for the production of active substances, as well as the development and validation of analytical methods and conducting analysis;
• In terms of technical potential, the Awarding Entity requires the Contractor to have appropriate technical facility dedicated to the synthesis of the low-molecular weight  organic compounds in septic conditions and to have certificate of the European GMP standards for the production of the organic compounds and have other required by law documents for the production, analysis and storage of the organic compounds, such as valid authorization for manufacturing of the low-molecular weight organic compounds, issued by the Main Pharmaceutical Inspectorate (for Poland) or other office appropriate for the country of residence of the Contractor.
• for Package No 2:
• The Awarding Entity requires the Contractor to have documented experience in the provision of services consisting of the synthesis of the low-molecular weight cytotoxic organic compounds (high potent API) in accordance with the GMP standard, intended for clinical trials for the third parties, in particular experience in conducting multi-stage (at least two-stage) synthesis of cytotoxic organic compounds and process optimization. To confirm the above, it will be necessary for the Contractor to demonstrate duly completed at least two (2) orders involving, in particular, multi-stage (at least two-stage) synthesis of the low-molecular weight organic cytotoxic compounds with high potency (high potent APIs) in the GMP standard, intended for clinical trials;
• The Awarding Entity requires the Contractor to have documented experience in development of documentation for active pharmaceuticals ingredients, in accordance with European GMP standards, including ASMF documentation, in particular module 3.S.2;
• In terms of staff potential, the Awarding Entity requires Contractors to have and engage to perform the contract persons with appropriate qualification and experience, including at least (2) persons with a specialized education in medicine, biotechnology, chemistry pharmacy or other related fields (e.g. biological science) having adequate knowledge and experience in the synthesis of cytotoxic organic compounds as well as in regulatory requirements and manufacturing standards for cytotoxic active pharmaceutical ingredients (including high potent APIs), and in development and validation of analytical methods and conducting analysis, as well as in preparation of registration documentation for active pharmaceutical ingredients consistent with the regulatory requirements applicable in the European Union, including EU GMP standards;
• In terms of technical potential, the Awarding Entity requires Contractor to have appropriate technical facility dedicated to the production of cytotoxic organic compounds as API (including high potent API) in septic conditions and to have certificate of the European GMP standards for the production of the cytotoxic organic compounds and have other required by law documents for the production, analysis and storage of the cytotoxic organic compounds, such as valid authorization for manufacturing of the cytotoxic organic compounds, issued by the Main Pharmaceutical Inspectorate (for Poland) or other office appropriate for the country of residence of the Contractor.
• are in financial and economic situation that will allow the contract object to be performed;
• are not excluded from the contract award procedure.

Contractors, in order to confirm the fulfillment of the condition for participation in the contract award procedure, shall submit the declarations and documents indicated below:

1. The “Bid Form” completed in accordance with the specimen and signed by the Contractor, which constitutes Appendix 1 to the Request for Bids;
2. Declaration of the compliance with the requirements indicated in Section VI, paragraph 1 of the Request for Bids, which constitutes Appendix 2 to the Request for Bids;
3.  Declaration of no capital or personal links, which constitutes Appendix 3 to the Request for Bids: “Declaration of no capital or personal links;
4. List of of services provided in accordance with the specimen indicated in paragraph 1, point 1) a, b, which includes:

• Contract object (name of the service),
• Scope and the purpose (i.e. type of the compound, the amount produced, types of documents prepared),
• Names of the entities for which the orders have been completed (or the country of origin, if providing name of the entity is not possible),
• Order delivery date, which constitutes Appendix 4 to the Request for Bids: “List of the deliveries”;

5. In the scope of the possibility of involving people capable to perform the object of the order, in accordance with the requirements specified by the Awarding Entity, the Contractor shall present a list of persons together with their professional CVs, dedicated to perform the service, which constitutes Appendix 5 to the Request for Bids: “List of Persons”;
6. Written declaration of a Qualified Person dedicated by the Contractor to perform the service, confirming authorization to release active pharmaceutical ingredients within the European Union, together with an indication of the possibility of confirming the data provided in the statement by means of publicly available register or data made available by relevant offices, by providing the www address of the registry website or office or other reliable source, which constitutes Appendix 6 to the Request for Bids: “Statement of a Qualified Person”;
7. Documents (or certified true copies) confirming that the Contractor has an EU GMP certificate for the manufacturing of low-molecular weight cytotoxic organic compounds as API or equivalent, recognized by the European Union;
8. Other documents required by law (or certified true copies) related in particular to the production, analysis and storage of low-molecular weight cytotoxic organic compounds, including actual manufacturing authorization for the production of low-molecular weight cytotoxic organic compounds issued by the Main Pharmaceutical Inspectorate (for Poland) or other office  appropriate for the country of residence of the Contractor, recognized by the European Union, allowing confirmation of compliance with the requirements specified by the Awarding Entity in the description of the object of the order.
9. Submitted statements and documents should confirm that the conditions for the participation in the contract award procedure have been met for the date on the day of the deadline for the bid submission.
10. Assessment of compliance with the above conditions will be made in accordance with the formula “meets - does not meet”, based on information contained in the documents. The content of the attached documents must clearly show that the abovementioned conditions are met by the Contractor.
11. Failure to complete at least one of the above conditions will result in exclusion of the Contractor from the contract award procedure.
12. The bid of the excluded Contractor shall be considered rejected. Awarding Entity shall notify the Contractor about the exclusion, stating the justification for the exclusion.
13. The Awarding Entity reserves the right to verify the proper performance of the services referred in paragraph 1 point 1) by calling the selected Contractor to present at the stage of signing the contract documents confirming the proper performance of the services indicate in the bid.  As a proof that the order has been duly completed, the Awarding Entity shall consider references of other documents issued by the entity, for which the order has been completed, and in the event of objective reasons that such documents cannot be obtained, a statement of the Contractor.

Contract amendment terms:

The Ordering Party reserves the right to amend the provisions of the contract signed with the selected Contractor in the following cases:

1. changes to generally applicable legal regulations, in particular changes to tax law (e.g. the rates of goods and services tax), provided that the change has a direct impact on the performance of the contract object and may lead to the modification of only those contractual provisions it refers to;
2. changes to regulations concerning the implementation of the project as regards the manner of implementation or financing of tasks included in the Request for Bids, which have a direct impact on the performance of the contract with the Contractor and which may lead to the modification of those provisions of the contract that they refer to;
3. the opportunity to use more modern technical solutions which are more beneficial to the Ordering Party than those which existed at the time of signing the contract, provided that they do not increase the amount of the fee due to the Contractor;
4. changes concerning the execution of additional deliveries or services by the Contractor which were not included in the basic order, provided that they became essential for the delivery of the order and that the following conditions have been jointly met:

1. the Contractor must not be replaced for economic or technical reasons, in particular ones which concern the interchangeability or interoperability of equipment, services or installations ordered as part of the basic order;
2. a change of the Contractor would cause significant inconvenience or would drive up the cost for the Ordering Party;
3. the value of each subsequent change does not exceed 50% of the value of the order specified originally in the contract.

5. the change does not alter the nature of the contract and the following conditions are jointly met:

1. the need to amend the contract is due to circumstances which the Ordering Party, acting in good faith, could not have foreseen and
2. the value of the change does not exceed 50% of the value of the order specified originally in the contract;

6. The Contractor who was awarded the contract by the Ordering Party is to be replaced by a new contractor:

1. on the basis of contractual obligations, provided that they do not alter the nature of the contract,
2. as a result of a merger, division, transformation, bankruptcy, restructuring or acquisition of the existing contractor or its enterprise, provided that the new contractor meets the conditions for participation in the procedure, there are no grounds for its exclusion from the procedure and that the change does not entail any other significant amendments to the contract,
3. as a result of the Ordering Party taking over the Contractor’s obligations towards its subcontractors;

7. the change does not alter the nature of the contract and the total value of the change is less than the amount specified under Art. 11 paragraph 8 Public Procurement Law, on which depends the obligation to submit notices to the European Union Publication office and at the same time it is less than 10% of the value of the order specified in the original contract;
8. there are discrepancies or ambiguities in the contract which cannot be eliminated in any different manner and the change will make it possible to eliminate such discrepancies and make the contract more precise in order to ensure its unambiguous interpretation by the parties;
9. the occurrence of a force majeure event;
10. changing the deadline of the contract execution in the event of external causes beyond the control of the Ordering Party or the Contractor resulting in the inability to meet the original deadlines arising from the Contract,
11. reducing the amount of the Contractor's remuneration due to limitation or exclusion of execution by the ordering Party part of the contract object, e.g. reducing the number of sites,
12. changes in the term of the Agreement in the event of a change in the date of implementation of the Project under which the Agreement is implemented,
14. changes in persons responsible for contacts and supervision over the implementation of the contract,
15. changes in the company name, headquarters of the Parties to the Agreement, bank account numbers and other identification data.

Change of the Timetable referred to in Article 2.2 does not constitute an amendment to the contract.

List of documents/declarations required from the Contractor:

Documents attached to this Bid (delete as appropriate):

Appendix No. 1. Power of attorney to represent the Contractor (if applicable)

Appendix No. 2.  Declaration of the Contractor

Appendix No. 3.  Declaration of no capital or personal links

Appendix No. 4. List of services

Appendix No. 5. List of persons dedicated to perform the service

Appendix No. 6. Declaration of the Qualified Person

Appendix No 7. Certificate of European GMP standard or other equivalent documents recognized by the European Union

Appendix No. 8. Any other documents required by law, such as authorization for cytotoxic organic compounds manufacturing, confirming compliance with the requirements described in the Request for Bids No. 01/WPD107/2020.

 

Bid evaluation criteria and method.

1. In selection the best offer the Awarding Entity shall evaluate the “Gross total price” criterion for the total gross prices of the Contract Object descripted in Section III(3) on the basis of the information supplied by the Contractor in the Bid Form.
2. The score for this criterion shall be calculated as follows:

                                                         Lowest bid price

Score granted to the evaluated offer =---------------------- x 100

                                                          Evaluated bid price

 

Grounds for exclusion from the contract award procedure:

1. Excluded from the contract award procedure shall be Contractors who:
   1. do not meet the conditions listed in Section VI;
   2. performed activities directly related to the preparation of the contract award procedure or used to prepare the bid with persons participating in these activities, unless the participation of these contractors does not hinder the fair competition;
   3. submitted false information affecting the outcome of the contract award procedure. 
2. Contractors who have capital or personal links to the Awarding Entity shall also be excluded from participation in the contract award procedure; capital or personal links shall be understood as mutual ties between the Contractor and the Awarding Entity or persons authorized to incur obligations on behalf of the Awarding Entity, or persons performing any activities related to the contractor selection procedure on behalf of the Awarding Entity; such links shall in particular include: 
   1. participation in the company in the capacity of a partner in a civil law company or partnership;
   2. ownership of at least 10% of shares or stock, provided that a lower threshold is not mandated under legal regulations or rules concerning the principles of implementation of the project covered by the Request for Bids,
   3. holding the function of a member of a supervisory or management body, a commercial representative or an attorney;
   4. being married to or having lineal consanguinity or direct affinity, collateral consanguinity or affinity to the second degree to, or being adopted by, or being under the guard or custody of such persons,

or any other relationships which may result in the conflict of interests while awarding the contract and in the violation of the competition principle. Should any capital or personal links be revealed between the Contractor and the Awarding Entity, the contract shall not be awarded to the Contractor.

3. In order to demonstrate the absence of premises referred to in the paragraph 2, being the basis for excluding the Contractor from participation in the contract award procedure, the Contractor is obligated to submit together with the Bid Form, completed in accordance with the specimen, which constitutes Appendix 1 to the Request for Bids, declaration of no capital or personal links, according to the specimen, which constitutes Appendix 3 to the Request for Bids: “Declaration of no capital or personal links”.
4. Failure to submit the declaration referred to in paragraph 3 will exclude the Contractor from the contract award procedure. Excluding the Contractor from the contract award procedure means rejection of the Bid submitted by the Contractor.
5. The Awarding Entity may exclude the Contractor from the contract award procedure at any stage.

 

Awarding Entity Name:

WPD Pharmaceuticals Sp. z o.o.

Address:

Żwirki i Wigury 101

02-089 Warszawa, Poland

Telephone Number: +48 515262381

Tax Number:  5252721500