Request for proposal RFP 15818 – Monitoring of the pharmacokinetic study after multiple dose administration

As a result of obtaining a grant for project no. POIR.01.01.01-00-1346/15 submitted under Activities 1.1. ‘B+R 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 Article 13 of the financial support contract, Adamed Pharma S.A. invites to submit tenders for the below-defined service.

Subject of the Tender:

Monitoring of the pharmacokinetic study after multiple dose administration, 2 –period, cross-over, under fed conditionsin 30 healthy subjects.

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

The company stipulates that disclosure of the full details concerning the study will be done after signing of confidentiality agreement (in case of contractors with whom such agreement have not yet been concluded) which is attached to this inquiry – Appendix 1.

I. The following activities shall be conducted:

1. To perform the study monitoring in accordance to the requirements of ICH GCP.

2. To prepare written report after each visit.

3. To provide 100% source data verification (CRF vs SD), 100% of review of ICF, 100% review of AE and verification of the investigational product’s accountability at Centre.

4. During the offer preparation and calculation of the monitoring visits number an experience of the Supplier shall be used to select the most suitable monitoring scheme, which should ensure: review of screening documentation, verification of compliance with inclusion/exclusion criteria, monitoring on selected dosing days, review of dosing compliance and compliance with sampling schedule, check of the queries,  verification of AE reporting, verification of IMP dispensing and accountability.

The offer should be presented in the following scenario:

 the offer should take into account 9 visits, based on Sponsor’s assumptions: site initiation visit (1 visit), inclusion/exclusion criteria check visit (1 visit), monitoring during the selected dosing days (4 visits), in-between dosing days monitoring (2 visit) and close-out visit (1 visit);

  Suppliers may present their own proposal, adjusted to the specifics of the study and experience with documentation of Quinta Analytica s.r.o. clinical center (if such experience exists).

Quotations to the offer should be included in Appendix 2.

5. The collection of the copies of documents for Sponsor’s TMF will be required during the visits.

Timeframe for the implementation of services:

1. The offer shall take into account the following assumptions:

a) Study dates:

Site initiation visit:

Immediately after EC/SUKL approvals, before the start of the subjects’ screening.

Estimated date: around 20 April 2020.

Period 1

IMP dosing (Day 1):

Planned date: 02 May 2020.

IMP dosing (Day 2):

Planned date: 03 May 2020.

IMP dosing (Day 3):

Planned date: 04 May 2020.

Period 2

IMP dosing (Day 1):

Planned date: 16 May 2020.

IMP dosing (Day 2):

 Planned date: 17 May 2020.

IMP dosing (Day 3):

Planned date: 18 May 2020.

- Close-out visit:

Probablyin the firsthalf of July 2020, after all CRFs are completed and queries resolved.

b) As the dosingswill be also performed during the week-ends, the Monitor’s availability during the weekend has to be taken into consideration.

II. Conditions for participation in the proceedings:

1. Orders cannot be awarded to entities affiliated personally of 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 Contracting Party activities associated with the preparation and the procedure for selecting Suppliers and Supplier, in particular by:

1.1. participation in the company as a partner or partnership,

1.2. owning at least 10% of the shares,

1.3. the functions of a member of the supervisory or management, proxy,

1.4. 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 send with the offer signed statements about the lack of connections (Appendix 3).

2. This offer is addressed to entities (CROs) having experience in the monitoring of pharmacokinetic studies (Phase I) and having possibility to perform monitoring in the specified clinical centre in the presented timelines.A tenderer is obliged to send an appropriate statementconfirming that this criterion has been met (Appendix 4).

3. This offer is addressed to entities confirming conduct of their work in accordance with GCP requirements and having introduced quality system (SOPs). The Supplier is obliged to send a relevant statementconfirming that this criterion has been met.The offer should document the essential knowledge and experience as well as the tenderer's ability to provide the required services in accordance with all RFP requirements. To confirm this, the tenderer should send information on the company's history, quality assurance system and describe its experience in monitoring pharmacokinetic studies (Phase I) – (Appendix 5)

4. The monitors involved by the tender in the performance of the contract subject should:

a) have at least 2 years of experience in monitoring of pharmacokinetic studies,

b) be properly trained,

c) should possess the scientific and / or clinical knowledge necessary for the proper monitoring of pharmacokinetic studies, and

d) should be fluent in spoken and written English and Czech language, level of knowledge: very good

Monitor qualifications should be documented by enclosing to the offer the CV of monitors involved in the performance of the subject of the contract (Appendix 6).

5. It is permitted to award the selected Bidder with supplementary orders, which are in line with the subject of this master contract, amounting to 50% of this order.

III. Terms and methods of offer submission

1. The title of each correspondence should include the number of the procedure

RFP 15818 – MONITORING OF THE PHARMACOKINETIC STUDY AFTER MULTIPLE DOSE ADMINISTRATION - Company name

2. Deadline for submitting Offeris 17th of March 2020 at 23:59 CET. The deadline for Answers submission may change, all Suppliers will be informed by e-mail.

3. Questions of the inquiry:

The deadline for submitting the questions for the inquiry to 13th of March 2020, until 10:00 CET

Answers to your questions should be sent within 16th of March 2020, by the end of the day.

Questions should be submitted in the form of a completed Appendix7.

In order to ensure equal access to information to all Tenderers participating in the proceedings, questions and answers (with hiding the author's questions) will be sent to all Tenderers

4. Any Supplier may submit only one offer.

5. Partial bids are not allowed.

6. The offer should be prepared on the excel spreadsheet which constitutes Appendix 2 to this offer. If Appendix 2 is not filled out, the offer will not be considered.

7. Offer along with the required attachments, must be submitted to the Adamed Procurement System at https://service.ariba.com/Sourcing.aw or by e-mail: aleksandra.stojak@adamed.com

8. In addition, the Bidder may also prepare an offer in his own preferable format and uploaded into the system.

9. Supplier's Offer should be comprehensive in Polish or English, electronically.

10. The offer should include at least the following information: supplier name and address, bid inquiry number, price (PLN/EUR/USD), delivery date (time required for delivery in days), date of payment.

11. If the prices in the offer are expressed in EUR, they will be converted using the exchange rate of 4,2693 PLN / EUR, in accordance with the Ordinance of the Prime Minister of 18 December 2019 on the average exchange rate of the Polish zloty against the euro as the basis for conversion of the value of public contracts.

12. In the case of another currency, the average NBP exchange rate from the last day of submitting offers will be accepted for conversion.

13. Please attach filled out Appendices No. 1-6– please use the attached checklist to confirm that all required documents will be delivered (Appendix 8)

14. Tenders submitted after the deadline will not be considered.

15. The Supplier before time-limit for receipt of tenders is entitled:

16. to withdraw the offer by written notification by e-mail indicated for the submission of tenders,

16.1. to change the offer – notification of the changes must be submitted by the same rules as the submitted offer, appropriately marked with the note "CHANGING THE OFFER".

IV. Selection criteria and evaluation methods:

1. The Contracting Authority is entitled to reject the tender submitted by the Supplier who does not meet the conditions for participation in the proceedings, or if the offer is incomplete or incompatible with this request.

2. The Contracting Authority is entitled to reject the tender submitted by the Supplier if it has been documented that the tenderer, when performing the clinical trial monitoring service, did not comply with ICH-GCP or legal provisions regulating the performance of this activity or is an untrusted supplier, which was previously stated by the Sponsor - Adamed or Affiliate (for example in case of infringement of any confidentiality restrictions in the past or events of contract breach or timelines omission or poor quality of service). The obligation to prove of the above facts lies with the Purchaser. The proof provided by the Purchaserundermines having the level of qualification, competence and reliability required for proper performance of the contract, which is tantamount to a negative assessment of the Tenderer's ability to perform the contract properly and reliably under the conditions set out in the request for proposal.

3. Selection criteria:

Net price (PLN/EUR/USD), the weight criterion - 100%, shall include all the associated costs.

If different dates or time periods are given, the longest declared will be considered as the Delivery time.

4. The Contracting Authority shall evaluate offers based on the result of the accumulated number of points calculated on the basis of above criteria and scores:

5.

Criteria

Weightcriterion [%]

Method of evaluation in accordance with the formula

Price

100%

net price of the lowest offer/net price of tested offer x 100 = number of points,

6. The amounts of points for each criterion after summing up will be the final number of points awarded by each tender. As the most advantageous offer will be considered that which obtains the highest number of points.

7. The results of the mathematical calculations carried out in the evaluation of tenders are rounded to the second decimal place. In case of equal scores for at least two offers the Contracting Authority will make the final choice of the offer more favorable when it comes to the impact on the environment (including the number of laboratory animals planned to use). For this purpose, the Contracting Authority shall have the right to call the Suppliers, whose tenders have obtained the highest final points, to complete the offer by giving indicated by the Contracting Authority information about an impact of the offer on the environment. The deadline to complete the offer will be determined by the Contracting Authority, but it cannot be less than 3 working days from receipt of the request.

V. The choice of Supplier and way of announcing:

1. The Contracting Authority will select the most advantageous offer on the basis of the selection criteria defined in this request for proposal.

2. The Contracting Authority will inform about the results of this request for proposal, on website www.adamed.com.pl, on website https://bazakonkurencyjnosci.funduszeeuropejskie.gov.pl/and will send to each Supplier which has submitted its offer.

VI. Significant agreement conditions

1. “IP Rights” means all intangible, intellectual, proprietary and industrial property rights and all intangible embodiments thereof wherever located with respect to the particular R&D, including without limitation, (i) all trade-marks, trade names, slogans, domain names, URLs or logos; (ii) all copyrights, moral rights and other rights in works of authorship; (iii) all patents and patent applications, industrial designs, patentable ideas, inventions and innovations; (iv) all know-how and trade secrets; and (v) all registrations, applications, renewals, extensions, continuations, divisions or reissues thereof now or hereafter in force (including any rights in any of the foregoing); (vi) all results of research, i.e. data and reports, samples and chemical or biological products;

2. “Contracting Authority Own IP” means all intangible, intellectual, proprietary and industrial property rights and all intangible embodiments thereof wherever located which are the possession of the Contracting Authority and are furnished to the Supplier by the Contracting Authority in connection with the Supplier’s prosecution of R&D hereunder, including without limitation, (i) all trade-marks, trade names, slogans, domain names, URLs or logos; (ii) all copyrights, moral rights and other rights in works of authorship; (iii) all patents and patent applications, industrial designs, patentable ideas, inventions and innovations; (iv) all know-how and trade secrets; and (v) all registrations, applications, renewals, extensions, continuations, divisions or reissues thereof now or hereafter in force (including any rights in any of the foregoing); (vi) all results, data and reports;

3. “ConfidentialInformation” means all information disclosed by one Party to the other, regardless of the form of disclosure (except anything that is expressly designated as non-confidential), and will include without limitation (i) all information relating to research, development, technologies, markets, products, patents, inventions, procedures, methods, designs, data, programs and improvements; and (ii) the terms and existence of the Agreement and the relationship of the Parties to one another; but will not include any information that:

a) is or becomes public domain through no fault or act of the receiving Party;

b) was independently developed by the receiving Party without the use of or reliance on the disclosing Party’s Confidential Information;

c) was provided to the receiving Party under no duty of confidentiality to the disclosing Party; or

d) s required to be disclosed by applicable law, provided, however, that prompt prior notice thereof will be given to the Party whose Confidential Information is to be disclosed and the receiving Party uses reasonable efforts to obtain a protective order limiting the further use or disclosure of such information.

4. “Developed method” means any method developed as a result of R&D, including in particular, but not limited to support in preclinical development.

5. “Supplier’s Own Technical Information” means any technical information relating to the Supplier’s services performed hereunder including, but not limited to, the Supplier’s methods and materials used and created before the performance of R&D, and also includes all business, legal and financial information relating to the Supplier.

6. [Contract’s value] It is allowed to grant supplementary orders to the selected Bidder, only if are consistent with the primary purpose of this contract, in the amount not exceeding 50% of the value of this order.

The proposal/quotation shall include all the associated costs (e.g. raw materials, additional services, licenses etc.).

7. [Agreement] The Contracting Authority upon settlement of the subject of the proceedings will conclude anAgreement with selected suppliers (“The Agreement”). The aim of the procedure is to establish the terms governing contracts which may be implemented by the Purchaser during the term of the Agreement, in particular the price, delivery time and the extent of ordered items in the appropriate Project Order. Under the Agreement the Contracting Authority undertakes no obligation to purchase a certain quantity of products or services from the Supplier. The Contracting Authority will purchase products or services from the Supplier only when during the term of the Agreement, a need to acquire them will be created. Realization of deliveries will proceed on the basis of successively placed orders according to the current needs of the Purchaser.

8. “Service” The Contracting Authority employs the Supplier to prosecute, and provide the results arising therefrom, the particular R&D, as required by the Contracting Authority, to the Contracting Authority, along with all IP Rights arising therefrom.

9. “Third Party Performer” The Supplier may enter into particular service agreements with various Third Party Performers of R&D such that the particular R&D or a portion thereof required by the Contracting Authority may be performed by said Third Party Performers, provided that the Supplier shall be fully liable for the Third Party Performer’s actions or omissions as though for its own actions or omissions.

10. [Deliverables] Delivery of the order will be executed at the expense of the Supplier to the Contracting Authority, on whose behalf the order will consist of designated persons. It is not required to sign a confirmation order delivery. The person will make confirmation of receipt electronically using the Adamed Procurement System.

11. [Offer’s parameters] The Purchaser requires other important parameters of the offer:

11.1. Payment deadline: minimum 45 days;

11.2. The validity of the offer: 60 days;

11.3. The price guarantee: minimum 12 months from the contract date.

12. [Intellectual Property] Under the Agreement the Contracting Authority exclusively acquires from the Supplier or any Third Party Performer any rights to results, data, information, discoveries, technology or inventions created, generated, made, conceived, developed, or reduced to practice, as well as the accompanying documentation, including in particular, but not limited to intellectual property rights (full copyrights, including any derivative rights, industrial property rights or know-how and trade secrets) to Developed Methods and to accompanying documentation, as part of or in connection with the performanceR&D, once the IP Rights comes into existence. The Contracting Authority shall have the right to use such IP Rights for any and all purposes, and shall have the full, unrestricted right to assign, license or otherwise transfer any such IP Rights and the deliverables without any further payment to the Supplier. The remuneration for sale and assignment of the IP Rights is included in the amount that the Contracting Authority agrees to pay the Supplier as described in a specific Project Order.

IP Rights of the Supplier or the Third Party Performer, including industrial property and know-how, necessary to complete the Project Orders and created before the performance of the Agreement started (“Background IP”) applied during the performance of R&D activities, shall remain the property of the Supplier or the Third Party Performer. To the extent necessary for the Supplier to duly execute the Project Orders and for the Contracting Authority to use the possibilities arising from their execution, the Supplier or the Third Party Performer shall provide the Contracting Authority with relevant licenses and permits for the Background IP, in particular relevant licenses and permits for using methods developed as a result of Project Orders.

The Supplier and the Third Party Performer are not entitled to submit any applications in order to protect the IP rights, including, but not limited to patent applications and submissions concerning other exclusive rights.

The Supplier shall be liable towards the Contracting Authority for ensuring that neither Third Party Performer nor any other persons involved in the performance of the Agreement on the part of the Supplier shall claim from the Contracting Authority or other third parties any remuneration in respect of such participation, including, without limitation the remuneration in respect of the creation, use or assignment of IP Rights.

Excluding any IP rights to Developed Methods and to accompanying documentation, all IP Rights in and to (i) any of the Supplier’s Own Technical Information relating to the particular R&D, (ii) all know-how, trade secrets, methods and data related thereto, (iii) all improvements to and new uses of, and new techniques and methods used to apply the Supplier’s Own Technical Information relating to the particular R&D, developed during or resulting from the performance of the particular R&D, shall remain the exclusive property of the Supplier.

13. [Confidential Information] Neither Party shall disclose the other Party’s Confidential Information to any third party without such Party’s express prior written authorization. Each Party will only disclose the other Party’s Confidential Information to its directors, officers, or employees who have a direct need to obtain such Confidential Information to fulfill the Party’s obligations under the Agreement, and then, only to the extent necessary for such directors, officers, or employees to do so, always provided that the scope of such disclosure conforms with the scope of tasks assigned to such persons in connection with the Agreement and that such persons are informed by the Contracting Authority about the obligations resulting from the Agreement and obliged to abide by all confidential information obligations, including but not limited to keeping the Confidential Information strictly confidential and not using the Confidential Information in any manner other than permitted by the Agreement.

The Supplier undertakes to ensure that any service agreement entered in to with a Third Party Performer for the performance of certain R&D shall be accompanied by a non-disclosure agreement so as to protect Confidential Information.

14. [Order Acceptance Certificate] Within ten (10) business days from the Contracting Authority’s receipt of the report and any other deliverables ordered, the Parties shall sign an acceptance certificate.

15. [Inconsistencies or defects] If there are material inconsistencies or defects in the execution of the Services due to the sole fault of the Supplier, the Supplier shall be obligated to repeat the inconsistent Services at its own costs. Objections to test results must be made by the Contracting Authority to the Supplier within fourteen (14) business days after the Supplier receives the final Report and the Contracting Authority shall specify in reasonable detail material inconsistencies or defects. These works should be carried out without undue delay and the period for the collection of Materials stated in the relevant Project Order shall be extended accordingly. Subject to that the Supplier would not be able to re-perform the Services free of such inconsistencies, the Supplier shall refund the monies paid for such services if inconsistencies are found.

16. [Audit] The Contracting Authority reserves the right to audit the Supplier before the conclusion of the contract or in the course of its duration.

17. [Penalty clause] The Supplier shall pay penalty clauses:

17.1.  a delay in the delivery date of the order for each day of delay, if the delay is not the fault of the Contracting Authority,

17.2.  due to improper execution of the contract,

17.3.  due to incomplete execution of the contract.

The Supplier agrees to deduct the amount of liquidated damages directly at the payment of VAT invoice on delivery.

18. [Supplier’s indemnification] The Supplier will indemnify, defend, and hold the Contracting Authority harmless from and against any and all liability, losses (including reasonable attorneys’ fees) or damages they may suffer (including as a result of claims, demands, costs or judgments against them) from third party claims (collectively, “Losses”) that arise out of (a) the negligence or willful misconduct of The Supplier or any of its employees, consultants or subcontractors, including without limitation any Third Party Performer (b) the failure of the Supplier or any of its employees, consultants or subcontractors to comply with the Contracting Authority written instructions, or (c) the material breach of the Agreement or any Project Order by the Supplier, except to the extent that any such Losses are caused by (a) the negligence or willful misconduct of the Contracting Authority, (b) the Contracting Authority use of the IP Rights generated from the services of the Supplier, or (c) the material breach of the Agreement or any Project Order by the Supplier. 

19. [The Contracting Authority’s indemnification] The Contracting Authority will indemnify, defend, and hold the Supplier harmless from and against any and all liability, losses (including reasonable attorneys’ fees) or damages they may suffer (including as a result of claims, demands, costs or judgments against them) from third party claims (collectively, “Losses”) that arise out of (a) the negligence or willful misconduct of the Contracting Authority or any of its employees, consultants or subcontractors, (b) a subject alleging injury/illness sustained as a result of the subject’s participation in the Contracting Authority clinical study involving the administration of the Contracting Authority drug, (c) the Contracting Authority use of IP generated from the services of the Supplier, or (d) the material breach of the Agreement or any Project Order by the Contracting Authority, except to the extent that any such Losses are caused by (a) the negligence or willful misconduct of the Supplier, including without limitation any Third Party Performer (b) the failure of the Supplier or any of its employees, consultants or subcontractors, including without limitation any Third Party Performer to comply with the Contracting Authority’s written instructions, or (c) the material breach of the Agreement or any Project Order by the Supplier, including without limitation any Third Party Performer.

20. [Offer’s costs] The Supplier carries all costs associated with preparing and submitting the offer. Contracting Authority does not provide for reimbursement of the costs of participation in the proceedings.

21. [Effective date] The Agreement will commence on (a) the Effective Date (date of the last signature) and shall expire on 31.12.2019 or (b) the completion of all Services under the last Project Order executed by the parties prior to 31.12.2019. The Term may be extended by mutual written agreement of the Parties.

22. [Governing law] Agreement may be construed and enforced in accordance with, and the rights of the parties shall be governed by, the laws of the Parties choice.

VII. General provisions

1. The Contracting Authority reserves the right to terminate the procedure at each stage without giving any reason.

2. In the case of cancellation of the contract the Suppliers are not entitled to claim for reimbursement of the costs of participation in the proceedings.

3. Submission of the application for registration in the process or tender is implies acceptance without reservation all the conditions of the proceedings.

4. Withdrawal by the Contracting Authority from the conclusion of the contract after the notification the Supplier about the selecting the offer, cannot be the basis for claims of incurred costs of participation in the proceedings.

5. In the process of evaluating Offers the Contracting Authority may seek information from the contractors concerning the content of their documents.

6. If the application does not contain all the required elements, the Contracting Authority may in justified cases call the Supplier to complete it.

7. The Contracting Authority reserves the right to record sound during technical meetings with suppliers. Submission of the offer will be treated as giving consent to the recording of the meeting.

8. The Contracting Authority allows negotiations of the contract terms and conditions with the bidder.

9. The Contracting Authority reserves the right to negotiate the proposal with the bidder, whose bid has the highest number of points, especially when the price offered by the bidderexceeds the budget intended by the Contracting Authority to perform the order. Negotiations may have several  consecutive  rounds  with  the  possibility  to  invite  bidder  to  submit  the updated quotation after each round of negotiations

10. Terms of contract change:The contracting authority envisages 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 indicated scope of works specified in the offer:

10.1. Necessary or justified changes in the design documentation resulting from unforeseeable reasons,

10.2. The necessity or the technical-economic appropriateness of the use of equivalent materials and equipment,

10.3. The necessity to make equivalent solutions resulting from technological or utility conditions,

10.4. Financial constraints on the part of the Contracting Authority which cause the necessity to limit the scope of works included in the offer,

10.5. Necessary or justified changes in the delivery time and conditions of the contract subject resulting from unforeseeable reasons

10.6. Any changes and additions to the contract concluded with the selected Supplier will be made in the form of written annexes to the contract signed by both parties, under rigor of invalidity.

VIII. Cooperation and communication

1.  The person authorized to contact the bidders (Monday-Friday between 08:00-16:00) is Aleksandra Stojak [aleksandra.stojak@adamed.com]