October 4th, 2019

 

Update: The deadline for submitting the questions for the inquiry to 23th of October 2019, until 10:00 CET

Answers to your questions should be sent within 30th of October 2019, by the end of the day.

Request for proposal

RFP 14912 / PERFORMANCE OF THE PHARMACOKINETIC STUDIES:

A) PILOT BIOAVAILABILITY STUDY

B) PIVOTAL BIOEQUIVALENCE STUDY

C) DRUG-DRUG INTERACTION STUDY

 

In connection with obtaining the grant for the project “Development and implementation of an innovative combination drug in polytherapy of cardiovascular diseases together with comorbidities risk factors” (POIR.01.01.01-00-0188/18) under Sub-measure 1.1.1. of the Operational Programme Smart Growth 2014-2020, acting on the basis of Article 12 grant agreement, Adamed Pharma S.A. invites to submit tenders for the below-defined service.

Object of the contract:

Conducting the pilot bioavailability study, pivotal bioequivalence study and drug-drug interaction study (DDI), for the new formulation of the fixed-dose combination (FDC) product containing well known active compounds, used for the treatment of hypertension and lipid metabolism disorders (hypercholesterolaemia, dyslipidaemia).

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

The company stipulates that disclosure of the full details concerning the subject 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.

Activities included in the service:

1) The service should cover the realization of the clinical, bioanalytical, PK and statistical part of the studies, as well as data management, medical writing, reporting and project management. The offers should not include the study monitoring and insurance policy.

2) The following pharmacokinetic study should be performed:

A) Pilot bioavailability study

Randomized, 3-period, cross-over pilot biovailability study with 24 healthy subjects after a single dose administration in fasting conditions.

Purpose:

Assessment of the bioavailability as well as safety and tolerability of two fixed-dose combination test formulations versus reference monocomponents taken simultaneously based on pharmacokinetic parameters calculated from the plasma concentrations of the active substances after single drug administration to the healthy subjects in fasting state. Selection of the one optimal test formulation to the pivotal bioequivalence study.

Investigational products:

- Test formulations: fixed-dose combination products (bilayer tablets) containing two different active substances in given strengths. Two test formulations differing in composition will be tested in the pilot study.

- Reference products: the names of the reference products will be disclosed after signing of confidentiality agreement (Appendix 1).

Study conduct:

- only the healthy subjects of Caucasian race should be enrolled in the study due to differences in pharmacokinetics observed in other ethnic groups;

- the tenderer is required to submit the principle study assumptions i.e. the main inclusion/exclusion criteria, detailed sampling schedule, the number of blood samples and calculated pharmacokinetic parameters in the Study Synopsis form (Appendix 4, the form will be disclosed after signing of confidentiality agreement).

B) Pivotal bioequivalence study

Randomized, 2-period, cross-over bioequivalence study with healthy subjects after a single dose administration in fasting conditions.

 Purpose:

Assessment of the bioavailability as well as safety and tolerability of fixed-dose combination test formulation versus reference monocomponents taken simultaneously based on pharmacokinetic parameters calculated from the plasma concentrations of the active substances after single drug administration to the healthy subjects in fasting state. Study results should be referred to the bioequivalence acceptance range 80.00-125.00%.

Investigational products:

- Test formulation: fixed-dose combination product (bilayer tablet) containing two different active substances in given strengths. Only one test formulation will be examined in the pivotal study.

- Reference products: the names of the reference products will be disclosed after signing of confidentiality agreement (Appendix 1).

Study conduct:

- only the healthy subjects of Caucasian race should be enrolled in the study due to differences in pharmacokinetics observed in other ethnic groups;

- the tenderer should propose the samples size based on intra-subject variability (ISCV%) data available in literature or in-house data;

- statistical approach used for the sample size calculation i.e. ISCV%, T/R, Power, α should be presented in the Study Synopsis form (Appendix 4, the form will be disclosed after signing of confidentiality agreement);

- assumptions used to calculate samples size in the pivotal study may change after obtaining of the pilot study results;

- the tenderer is required to submit the principle study assumptions i.e. the main inclusion/exclusion criteria, detailed sampling schedule, the number of blood samples and calculated pharmacokinetic parameters in the Study Synopsis form (Appendix 4, the form will be disclosed after signing of confidentiality agreement).

C) Drug-drug interaction study (DDI)

Randomized, 3-period, cross-over drug-drug interaction study with healthy subjects after a single dose administration in fasting conditions.

Purpose:

Indication of existence or non-existence of potential pharmacokinetic interactions and assessment of the safety and tolerability of the reference products administered individually and concurrently on the basis of PK parameters calculated from plasma concentrations of the active substances after single dose administration to healthy subjects in fasting conditions. The study results should be referred to the standard acceptance criteria used in bioequivalence studies 80.00-125.00% to establish of the presence or absence of the pharmacokinetic interactions.

Investigational products:

- Reference products given to the subjects as individual monocomponents or concomitantly. The names of the reference products will be disclosed after signing of confidentiality agreement (Appendix 1).

Study conduct:

- only the healthy subjects of Caucasian race should be enrolled in the study due to differences in pharmacokinetics observed in other ethnic groups;

- the tenderer should propose the samples size based on intra-subject variability (ISCV%) data available in literature or in-house data;

- statistical approach used for the sample size calculation i.e. ISCV%, T/R, Power, α should be presented in the Study Synopsis form (Appendix 4, the form will be disclosed after signing of confidentiality agreement);

- assumptions used to calculate samples size in the DDI study may change after obtaining of the pivotal study results;

- the tenderer is required to submit the principle study assumptions i.e. the main inclusion/exclusion criteria, detailed sampling schedule, the number of blood samples and calculated pharmacokinetic parameters in the Study Synopsis form (Appendix 4, the form will be disclosed after signing of confidentiality agreement).

3) Contracts concerning of the realization of the studies will be signed successively before the commencement of each subsequent study. Realization of the pivotal study (section B) will depend on the pilot study results (section A). Whereas realization of the DDI study (section C) will depend on the pivotal study results (section B).

4) Realization of the pivotal study (section B) should start (from the submission of study documentation to the EC and the Competent Authority) after obtaining of preliminary results of the pilot study (section A). Realization of the DDI study (section C) should start (from the submission of study documentation to the EC and the Competent Authority) after obtaining of preliminary results of the pivotal study (section B). Pivotal and DDI study commencement should be no later than within 2 months after obtaining of preliminary results of the pilot study and pivotal study, respectively.

5) The Sponsor reserves the right to cancel the section B and section C, in case the PK results for the test formulation are not satisfactory for the Sponsor.

6) Contracts concerning of the realization of the pilot, pivotal and DDI study will be signed with maintaining the proposed conditions presented in current tender procedure.

7) The study should be designed, planned, performed and documented according to the ICH-GCP guidelines, in accordance with Directive 2001/20/EC, 2001/83/EC and 2005/28/EC, with the principles enunciated in the World Medical Association Declaration of Helsinki (Fortaleza, Brazil, October 2013), and with current European Union guidelines, in particular with Guideline on the clinical development of fixed combination medicinal products (EMA/CHMP/158268/2017, 23 March 2017), the Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1/Corr**, 20 January 2010), Guideline on the investigation of drug interactions (CPMP/EWP/560/95/Rev. 1 Corr. 2**, 21 June 2012) and principles of GLP.

8) The analytical method should be developed and validated in accordance with the current guidelines, in particular with Guideline on Bioanalytical Method Validation (EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2**, 21 July 2011).

9) Supplier should prepare the design and documentation (including Study Protocol, ICF, CRF, etc.) of the above study.

10) Supplier should represent Sponsor in competent authorities and EC and obtain the legal approvals for the study.

11) Supplier should conduct internal audits of documentation and processes during the study execution.

12) Supplier should prepare the Clinical Study Report in accordance with the Note for Guidance on Structure and Content of Clinical Study Reports (CPMP/ICH/137/95, July 1996).

Timeframe for the implementation of services:

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

    PILOT BIOAVAILABILITY STUDY

  • availability of simplified IMPD/certificates of analysis required for obtaining the legal approvals for the pilot study: by November 30th, 2019
  • submission of the documentation of the pilot study to regulatory authority and EC: by December 31rst, 2019
  • deadline for the availability of the preliminary PK results for the pilot study: by May 29th , 2020

    PIVOTAL BIOEQUIVALENCE STUDY

  • availability of simplified IMPD/certificates of analysis required for obtaining the legal approvals for the pivotal study: by June 30th, 2020
  • submission of the documentation of the pivotal study to regulatory authority and EC: by July 31rst, 2020
  • deadline for the availability of the preliminary PK results for the pivotal study: by December 31rst , 2020

     DRUG-DRUG INTERACTION  STUDY (DDI)

  • submission of the documentation of the DDI study to regulatory authority and EC: by February 26th, 2021
  • deadline for the availability of the preliminary PK results for the DDI study: August, 31rst 2021

Terms of contract:

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 Purchaser activities associated with the preparation and the procedure for selecting Suppliers and Supplier, in particular by:

a) participation in the company as a partner or partnership,

b) owning at least 10% of the shares,

c) the functions of a member of the supervisory or management, proxy,

d) 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.

e) In order to meet this condition, the Supplier is obliged to send with the offer signed declaration (Appendix 2 to the offer).

2) This offer is addressed to entities:

a) having certificates confirming conduct of their work in accordance with GCP and GLP requirements or list of the positive GCP and GLP of EU inspections with short summary of the outcome (number of the findings and their category). Certificates or list should be sent with offer (Appendix 5);

b) positive inspection history of the European regulatory authorities with lack of the critical findings within last 4 years. It should be proved by the presented list of the inspections with short summary of the outcome (number of the findings and their category). List should be sent with offer (Appendix 6);

c) having the necessary knowledge and at least 5 years of experience in PK studies (including interaction studies). CV of the Principal Investigator, CV of Bioanalytical Laboratory Director and CV of Pharmacokinetic/Statistician should be sent; (Appendix 7)

d) having capability to supply the required services in accordance to all RFP requirements. To prove it, Supplier shall send: company’s organigram and information on the facility (at least including information on the number of beds, number and type of the personnel and list of clinical and bioanalytical equipment) (Appendix 8);

e) having developed and validated analytical method or declaring possibility to develop and validate analytical method of tested substances determination in plasma. The tenderer is obliged to send a relevant statement and provide the time (in weeks) needed to develop and/or validate analytical method (Appendix 9);

f) having capability to recruit male and female subjects to both clinical studies in roughly equal proportions. The tenderer is obliged to send a relevant statement (Appendix 10);

g) Declaring conducting of above mention study in accordance with current European Law and EMA guidelines. The tenderer is obliged to send a relevant statement (Appendix 11);

h) The tenderer is obliged to have an insurance policy and submit documentation confirming the validity of the insurance (Appendix 12).

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

Offer preparation:

  1. The title of each correspondence should include the number of the procedure RFP 14912 - Company Name
  2. Contracting Authority does not accept partial offers.
  3. Offers should be received by 8th of November 2019, 11:59 p.m.
  4. Questions of the inquiry:

The deadline for submitting the questions for the inquiry to 23th of October 2019, until 10:00 CET

Answers to your questions should be sent within 30th of October 2019, by the end of the day.

Questions should be submitted in the form of a completed Appendix No. 13.

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

  1. Any Bidder may submit only one offer.
  2. The Contracting Authority does not accept partial offers.
  3. The offer should be include following information: the Bidder name and address, request for proposal number, net price (EUR) and payment terms, scope of the service activities, proposed study design. The Tenderer should provide the detailed timeframes for study realization, specifying an estimated time required for obtaining of authority/EC approvals, timelines for analytical method development and validation, proposed dosing dates and the date of providing of preliminary results. The cost as well as the timelines are important in selection of the most advantageous offer.
  4. The offer should be prepared on the excel spreadsheet, which constitutes an Appendix 3 to this offer:

In addition, the Supplier may prepare the offer in its format. If Appendix 3 is not filled in, the offer will not be taken into consideration.

  1. The offer should include all required Appendices, i.e. Appendix 1-12 - please use the attached checklist (Appendix 14) to confirm that all required documents will be delivered.
  2. The offer should be prepared in English or Polish.
  3. Prices in the offer should be expressed as net prices in Polish zlotych (PL) or Euro (EUR).
  4. If the prices in the offer are expressed in EUR, they will be converted using the exchange rate of 4,3117 PLN / EUR, in accordance with the Ordinance of the Prime Minister of 28 December 2017.
  5. Offer along with the required attachments, must be submitted by e-mail: aleksandra.stojak(at)adamed.com.
  6. The offers submitted after the deadline shall not be taken into consideration.
  7. Prior to the offer submission deadline, the Bidder has the right to:

- withdraw the offer by submitting a notification in writing in the manner described for the offer submission,

- change the offer - a notification of the changes made must be submitted in the same manner as the offer and be -labelled ‘CHANGE TO THE OFFER’.

Selection criteria and method of assessing submitted offers:

  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. Formal compliance, the degree of compliance with the RFP requirements.
  3. Possibility of realization of service within the above presented timeframes.
  4. Selection criteria:

- net price (weight criterion - 70%);

- timelines (in weeks) counted from the availability of simplified IMPD/certificates of analysis required for obtaining the legal approvals for the pilot study to the preliminary PK results of the DDI study (weight criterion - 20%);

- timelines (in weeks) for development and validation of analytical method (weight criterion - 10%).

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:

 

Criteria

Weight criterion [%]

Method of evaluation in accordance with the formula 

Price

70%

net price of the offer with the lowest price/net price tested offer x 100 x70 % = number of points

Timelines

(weeks)

20%

timelines (in weeks) of the offer with the shortest timelines/ time (in weeks) of the tested offer x 100 x 20 % = number of points

Timelines – development and validation of analytical method

(weeks)

10%

timelines (in weeks) of the offer with the shortest timelines/ time (in weeks) of the tested offer x 100 x 10 % = number of points

 

  1. As the most advantageous offer will be considered that which obtains the highest number of points.
  2. The results of the mathematical calculations carried out in the evaluation of tenders are rounded to the second decimal place.

Offeror selection and the manner of notification:

  1. The Sponsor shall select the best offer based on the offer evaluation criteria specified in this call for offers.
  2. The Sponsor shall post information concerning the outcome of the procedure on the on www.adamed.com.pl, https://bazakonkurencyjnosci.funduszeeuropejskie.gov.pl websites and send it to each Bidder who submitted an offer.

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 bidder exceeds 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.

 

Cooperation and communication

  1. The person authorized to contact the bidders (Monday-Friday between 09:00-17:00) is Aleksandra Stojak [Aleksandra.Stojak(at)adamed.coml]

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. Confidential Information” 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) is 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. “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.

5. “Agreement” The Contracting Authority upon settlement of the subject of the proceedings will conclude an Agreement 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.

6. “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.

7. “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.

8. [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.

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

9.1. Payment deadline: minimum 45 days;

9.2. The validity of the offer: 90 days;

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

10. [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 performance R&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.

  1. [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.

  1. [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.
  2. [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.
  3. [Audit] The Contracting Authority reserves the right to audit the Supplier before the conclusion of the contract or in the course of its duration.
  4. [Penalty clause] The Supplier shall pay penalty clauses:

15.1. 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,

15.2. due to improper execution of the contract,

15.3. 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.

  1. [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.
  2. [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.
  3. [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.
  4. [Effective date] The Agreement will commence on (a) the Effective Date (date of the last signature) and shall expire on 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.
  5. [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.

Appendix 1 (download)

Appendix 2 (download)

Appendix 3 (download)

Appendix 11 (download)

Appendix 13 (download)

Appendix 14 (download)