Request for Bids No. 07/WPD104/2020
August 25, 2020
Request for Bids No. 07/WPD104/2020
New approach to glioblastoma treatment addressing the critical unmet medical need.
Contract object:The contract object is a research service, involving the production of an active pharmaceutical ingredient (API) which is a low-molecular weight cytotoxic organic compound, and investigational product (Product), for the purpose of the clinical trials.
Bid submission term:
28th September 2020, 11.59p.m. CET
Bid submission method: by email to the Awarding Entity’s address:
Announcement category: Services
Place of the order implementation: dolnośląskie
Contact object description:
The scope of the service has been presented in the form of two (2) task Packages:
- Package No 1 – Production of the active pharmaceuticals ingredient (API), which is a low molecular weight cytotoxic organic compound from the anthracycline family (berubicin) for the purpose of research and development work and clinical trials, including regulatory documentation compliant with the EU GMP for an active pharmaceuticals ingredient (API), and production of the lyophilized investigational product with documentation necessary for QP, release for the purpose of clinical trials;
- Package No 2 – QP release of the Product for the purpose of clinical trials along with the storage of the Product in accordance with the specification.
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 up to 6 months weeks, starting from the date of the contract execution;
• for Package 2 – up to up to 1 month, starting from the date of delivery of the Product along with the 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.Appendices:
In the contract award procedure may participate Contractors who:
- 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 (subcontractor or third party) to have documented experience in the provision of services consisting of the synthesis of low-molecular weight cytotoxic organic compounds in the GMP standard (including experience in the synthesis of compounds from the anthracycline family) and experience in production of drug products in GMP standard, including in particular sterile oncology products in lyophilized form or sterile formulations administered intravenously for research purposes, as well as experience in the development of documentation compliant with regulatory requirements for active substances. To confirm the above, it will be necessary for the Contractor to demonstrate duly completed at least (2) two contracts involving, in particular, the production of the low-molecular weight cytotoxic organic compounds in the GMP standard, including compounds from the group and the anthracyclines and the production of sterile oncology drug product for the proposals of clinical trials;
- In terms of staff resources, the Awarding Entity requires the Contractor (subcontractor or third party) 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, and production of oncology drug products and sterile manufacturing in GMP standard, as well as the performance of analysis and validation of analytical methods;
- In terms of technical potential, the Awarding Entity requires the Contractor (subcontractor or third party) to have appropriate technical facility dedicated to the production of cytotoxic active substances, in particular compounds from the anthracycline group and the production of sterile oncology products, also in the lyophilized form, and to have certificate of GMP standards for the production of cytotoxic organic compound and drug products, and to have other required by law documents for the production of the cytotoxic organic compounds and sterile oncology drug products, such as valid authorization for manufacturing, issued by the office appropriate for the country of residence of the Contractor, recognized in the European Union.
- for Package No 2:
- The Awarding Entity requires the Contractor (subcontractor or third party) to have documented experience in the QP release and developing of the regulatory documentation for the release of the products for clinical trials purposes and in labeling, storage and distribution of sterile oncology products. To confirm the above, it will be necessary for the Contractor to demonstrate duly completed at least two (2) orders involving, in particular, QP release, labeling and storage of the Investigational product for the purpose of clinical trials, in accordance with legal requirements and good practices;
- In terms of staff potential, the Awarding Entity requires Contractors (subcontractor or third party) 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 quality release of the products for clinical trials, including at least one (1) person authorized to release products for the purpose of clinical trial (Qualified Person, QP), in accordance with regulatory requirements in the European Union, including EU GMP standards;
- In terms of technical potential, the Awarding Entity requires Contractor (subcontractor or third party) to have appropriate technical facility dedicated to storing the investigational products for the purpose of clinical trials in controlled conditions compliant with the specification (in temp. -20 Celsius degrees), in accordance with the regulatory requirements applicable in the European Union and good practices.
- 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:
- The “Bid Form” completed in accordance with the specimen and signed by the Contractor, which constitutes Appendix 1 to the Request for Bids;
- 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;
- Declaration of no capital or personal links, which constitutes Appendix 3 to the Request for Bids: “Declaration of no capital or personal links;
- 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”;
- 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, dedicated to perform the service, which constitutes Appendix 5 to the Request for Bids: “List of Persons”;
- For the Package No. 2 additionally - 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”;
- Documents (or certified true copies) confirming that the Contractor (subcontractor or the third party) has GMP certificate, recognized by the European Union;
- Other documents required by law (or certified true copies) such as actual manufacturing authorization issued by the 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.
3. 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.
4. 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.
5. 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:
- 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;
- 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;
- 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;
- 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:
- 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;
- a change of the Contractor would cause significant inconvenience or would drive up the cost for the Ordering Party;
- the value of each subsequent change does not exceed 50% of the value of the order specified originally in the contract.
- the change does not alter the nature of the contract and the following conditions are jointly met:
- the need to amend the contract is due to circumstances which the Ordering Party, acting in good faith, could not have foreseen and
- the value of the change does not exceed 50% of the value of the order specified originally in the contract;
- The Contractor who was awarded the contract by the Ordering Party is to be replaced by a new contractor:
- on the basis of contractual obligations, provided that they do not alter the nature of the contract,
- 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,
- as a result of the Ordering Party taking over the Contractor’s obligations towards its subcontractors;
- the change does not alter the nature of the contract and the total value of the change is less than the amounts specified in the provisions issued under Art. 11 paragraph 8 Public Procurement Law and at the same time it is less than 10% of the value of the order specified in the original contract;
- 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;
- the occurrence of a force majeure event;
- changing the dates of the contract 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 Contractor.
- reducing the amount of the Contractor's remuneration due to limitation or exclusion from the Employer's implementation of part of the subject of the contract,
- 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,
- changes in the persons responsible for contacts and supervision over the implementation of the Subject of the contract,
- changes in the company name, headquarters of the Parties to the Agreement, bank account numbers and other identification data.
2. 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 valid authorization , confirming compliance with the requirements.
Bid evaluation criteria and method.
- 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.
- The score for this criterion shall be calculated as follows:
Lowest bid price
Score granted to the evaluated offer =---------------------- x 100
Evaluated bid price
- The score will be expressed with the accuracy of up to two decimal places.
- As a result of the evaluation, according to the criterion indicated in the clause 1 above, the bid may receive the score of maximum 100 points.
- The most economic and best quality bid shall be the one which has not been excluded from the procedure and which receives the highest score during the evaluation.
- The price shall be given in Polish zlotys (PLN) or any currency other than PLN.
- The price must be expressed numerically with the accuracy of up to two decimal places and in words.
- The price must include all the costs of the contract including all fees and taxes (including goods and services).
- Any other costs which have been incurred by the Contractor while completing the order and have not been included in the bid price will not be additionally covered by the Awarding Entity.
- Bids submitted by the foreign Contractors participating in the contract award procedure, who under other regulations are not obligated to pay VAT in Poland, contain prices without VAT (0% VAT). Tax liability in the situation of acquiring goods or services from foreign entities rests with the Awarding Entity, in accordance with the provisions of the Value Added Tax Act. For the purpose of comparing the bids Awarding Entity will add to the bid price submitted by the foreign Contractors, the amount of VAT and custom duty (if applicable, for Contractors from outside the European Union), which are charged to the Awarding Entity for the performance of the contract.
- For the purpose of comparing the bids the bid price in a foreign currency will be converted into PLN using the average exchange rate given by the National Bank of Poland (NBP) valid for the day of the request for bids publication in the Competitiveness Base. Average exchange rate is available at the NBP official web site: http://www.nbp.pl.
- The prices stated in the bid shall remain valid throughout the entire period of its validity and shall be binding for the signed contract.
- When the two or more bids receive the same score, the Awarding Entity will select the best offer by the criterion of positive environmental impact. Positive environmental impact may be demonstrated by, for example:
- the use of solutions that reduce energy consumption during service performance or during the operation of the object of the contract,
- the use of solutions that reduce or eliminate the amount of waste generated during the service performance or during the operation of the object of the contract,
- the use of solutions that reduce the consumption of consumables during the service performance or during the operation of the object of the contract,
The Contractor may indicate and describe any number of solutions having a positive impact on the environment, indicating technical parameters that allow verification of the declared impact in comparison with standard solutions.
The bid may receive (1) one point for each solution indicated regarding positive environmental impact. If no solution is indicated or solution is indicated but without technical parameters allowing verification of the declared environmental impact in comparison with standard solutions, the bid will not receive a point.
13. The Awarding Entity shall award the contract to the Contractor whose bid received the highest score during the evaluation process.
Grounds for exclusion from the contract award procedure:
- Excluded from the contract award procedure shall be Contractors who:
- do not meet the conditions listed in Section VI;
- 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;
- submitted false information affecting the outcome of the contract award procedure.
- 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:
- participation in the company in the capacity of a partner in a civil law company or partnership;
- 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,
- holding the function of a member of a supervisory or management body, a commercial representative or an attorney;
- 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.
- 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. The Awarding Entity may exclude the Contractor from the contract award procedure at any stage.
Awarding Entity Name:
WPD Pharmaceuticals Sp. z o.o.
Żwirki i Wigury 101
02-089 Warszawa, Poland
Telephone Number: +48 515262381
Tax Number: 5252721500