As a result of obtaining a grant for project no. POIR.01.01.01-00-1025/17 “Development of a cancer medicine in a reduced dose using modern technologies” submitted under Activities 1.1.1 of the Intelligent Development Operational Programme 2014-2020, acting on the basis of Article 13 of the financial project support contract, Adamed Pharma S.A. invites to submit tenders for the below-defined service.
I. Object of the contract
Conductingpharmacokinetic studies for the new formulation containing known active compound, used for the treatment of prostate cancer.
Contracting Authority (Study Sponsor): 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; contractors with whom such agreement has been concluded are obligated to present it, to receive full details of this request of proposal) which is attached to this inquiry (Appendix no. 1).
Activities included in the service:
1. The service should the cover the realization of the clinical, bioanalytical, pharmacokinetic (PK) and statistical part of the study, as well as data management, medical writing, reporting and project management. The offers should not include the study monitoring and insurance policy.
2. A threepharmacokinetic studies should be performed:
2.1) Pilot pharmacokinetic study 1:
- Assessment of the bioavailabilityof active substance from new formulations with the same strength but different composition.
- Evaluation of the pharmacokinetics of active substance in blood plasma after a single dose administration under fasting conditions.
- Assessment of safety and tolerability of test formulation.
- Based on the obtained pharmacokinetic data to give recommendation ondetermination which formulation is the best for future studies.
b) Study design: Randomized, 3 period, 3 way crossover study in healthy subjects, after a single dose administration under fasting conditions.
c) Investigational products:
- Test product: twosolid form formulation at one strength but with different composition administered orally.
- Reference product: film coated tabletat one strength administered orally.
2.2) Pilot pharmacokinetic study 2:
- Assessment of the bioavailability of active substance in thesame threeformulations but at three different strength.
- Evaluation of the pharmacokinetics of active substance in blood plasma after a single dose administration under fasting conditions.
- Assessment of safety and tolerability of test formulations.
- Based on the obtained pharmacokinetic data to give recommendation on determination which dose is optimal for future bioavailability studies.
b) Study design: Randomized, 4 period, 4 way crossover study in healthy subjects, after a single dose administration under fasting conditions.
c) Investigational products:
- Test product: threesolid form formulations with the same composition at three different strengthadministered orally.
- Reference product: film coated tablet at one strength administered orally.
2.3) Pivotal pharmacokinetic study 1:
- Assessment of the bioavailability of active substance inthe solid formulation.Study results should be referred to the bioequivalence acceptance range 80.00-125.00%.
- Assessment of safety and tolerability of test formulation.
- Evaluation of the pharmacokinetics of active substance in blood plasma after a single dose administration in fasting conditions.
b) Study design: Randomized, replicate, 4 period, 2 way crossover study in healthy subjects, after a single dose administration under fasting conditions.
c) Investigational products:
- Test product: solid form formulation at one strength administered orally.
- Reference product: film coated tablet at one strength administered orally.
3. The Sponsor propose number of blood samples for all studies (Appendix no. 4, it will be disclosed after signing confidentiality agreement).The Tenderer should propose the sampling scheme (Appendix no. 4).
4. The Tenderer should propose pharmacokinetic parameters, calculated on the basis of the plasma concentration of the active substance,which are adequate and sufficient for the purpose of the study. The Tenderer should complete proposal in the attached Study Synopsis (Appendix no. 4).
5. For the pilot and pivotal studies, the Sponsor specified the number of subjects in the attached Synopsis (Appendix no. 4).The samples size in the pivotal study may change after obtaining of the pilot study results.
6. Contracts concerning of the realization of the studies will be signed successively before the commencement of each subsequent study. The contract for each study between the Sponsor and the Supplier must cover the entire service provided. Contracts for part of services will not be accepted.
7. Contracts concerning of the realization of eachstudy will be signedwith maintaining the proposed conditions presented in current tender procedure.
8. The study should be designed, planned, performed and documented according to the:
a) ICH-GCP (R2) guideline,
b) Directive 2001/20/EC,2001/83/EC and 2005/28/EC,
c) with the principles enunciated in the World Medical Association Declaration of Helsinki (Fortaleza, Brazil, October 2013),
d) Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1/Corr**, 20 January 2010),
e) principles of GLP.
9. Realization of pivotal study 1 (submission of study documentation to the Ethics Committee(EC) and Competent Authority (CA)) should start after obtaining of preliminary results of pilot study 2. Realization of pilot study 2 (submission of study documentation to the Ethics Committee and Competent Authority) should start after obtaining of preliminary results of pilot study 1.
10. The Sponsor reserves the right to cancel the pilot study 2 and pivotal study 1 in case the PK results for the test formulation are not satisfactory for the Sponsor.
11. The analytical method should be 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).
12. Supplier should prepare study documentation (including Study Protocol, ICF, CRF and other required documents).
13. Supplier should represent Sponsor in EthicsCommittee and Competent Authorities and obtain the legal approvals for each study.
14. Supplier should maintain sufficient quality of the study and conduct internal audits of documentation and processes during the studies.
15. Supplier should prepare the Clinical Study Report for each study in accordance with the Note for Guidance on Structure and Content of Clinical Study Reports (CPMP/ICH/137/95, July 1996).
II. Timeframe for the implementation of services
1. The offer shall take into account the following assumptions:
1.1) Pilot pharmacokinetic study 1:
a) availability of simplified IMPD/certificates of analysis required for obtaining the legal approvals for the pilotstudy: by June 1st, 2020
b) deadline for the availability of the preliminaryPK results for the pilot study: by November 30th, 2020
1.2) Pilot pharmacokinetic study 2:
a) availability of simplified IMPD/certificates of analysis required for obtaining the legal approvals for the pilot study: by November 1st, 2021
b) deadline for the availability of the preliminaryPK results for the pilot study: by April 30th, 2022
1.3) Pivotal pharmacokinetic study 1:
a) availability of simplified IMPD/certificates of analysis required for obtaining the legal approvals for the pivotal study: by June 1st, 2022
b) deadline for the availability of the preliminaryPK results for the pivotal study: by January 31th, 2023
2. Contracting Authority may change timeframe for implementation of services after obtaining preliminary results for each study.
III. 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.
In order to meet this condition, the Tenderer is obliged to send with the offer signed declaration (Appendix no. 2).
2. This offer is addressed to entities:
a) Declaring conducting of above mention studies in accordance with current European Law and EMA guidelines. The Tenderer is obliged to send a relevant statement (Appendix no. 5).
b) Having capability to recruit male subjects, capable of using one of contraceptive methods, to all clinical studies. The Tenderer is obliged to send a relevant statement (Appendix no. 6).
c) Having certificatesconfirming conduct of their work in accordance with GCP and GLP requirementsorlist 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 the offer.
d) Having inspection history of the European regulatory authorities with lack of the critical findings in the last 4 years. List of the inspections with short summary of the outcome (number of the findings and their category) should be sent with the offer.
e) Having the necessary knowledge and at least 5 years of experience in pharmacokineticbioavailability studies.The Tenderer is obligated to sent relevant statement and list of conducted studies in the last 3 years.
f) Having the experienced staff capable of conducting the study. CV of the Principal Investigator, CV of BioanalyticalLaboratory Director and CV of Pharmacokinetic/Statistician should be sentwith the offer. CVs should include list of trainings which they took part in the last 3 years and confirm at least 3 years of experience in the filed of clinical or pharmacokinetic studies. The Principal Investigator must have actual GCP training.
g) Having capability to supply the required services in accordance to all RFP requirements. To prove it, Tenderershall send: company’s organigram and information on the facility (number of beds, number and qualification of the personnel and list of clinical and bioanalytical equipment).
h) Having validated analytical method ofactive substance determination inplasma. The Tenderer is obliged to send a relevant statement.
i) The Tenderer is obliged to have an insurance policy and submit documentation confirming the validity of the insurance.
3. The Supplier may use the services of subcontractors to perform all or part of the services presented in this request for proposal. The supplier is obliged to ensure that his subcontractors meet the requirements contained in this request for proposal. In order to confirm the qualifications of subcontractors, the Supplier must provide documents confirming their ability to perform the services entrusted to them as stated in point 2. Subcontractors must have a current GCP certificate or present the inspection history of relevant authorities in the field of GCP and GLP with a brief summary of their results (number and categories of findings). The Supplier is obliged to conclude an appropriate contract with subcontractors.
4. It is permitted to grant to the selected Tenderer supplementary orders, which are in line with the subject of this basic contract, amounting to 50% of this order.
IV. Offer preparation
1. The title of each correspondence should include the number of the procedure RFP 15662- Company Name
2. Offers should be received by March 23rd, 2020, 11:59 p.m. (CET).
Questions of the inquiry:
The deadline for submitting the questions for the inquiry to March 2nd, 2020, 11:59 p.m. (CET).
Answers to your questions should be sent within March 09th, 2020, 11:59 p.m. (CET).
Questions should be submitted in the form of a completed Appendix No. 7.
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. Deadline for answers may change. All Tenderers will be informed via email about the change.
3. The offer should be include following information: the Tenderer name and address, request for proposal number, net price (EUR or PLN) 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, 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 no. 3 to this offerEN_Appendix_3_RFP_15662_Offer_CompanyName.xlsx
5. In addition, the Supplier may prepare the offer in its format. If Appendix no. 3 is not filled in, the offer will not be taken into consideration.
6. The offer should include all required Appendicesand documents - please use the attached checklist (Appendix no. 8) to confirm that all required documents will be delivered.
8. Any Tenderer may submit only one offer.
9. The Contracting Authority does not accept partial offers.
10. The offer should be prepared in English or Polish.
11. Prices in the offer should be expressed as net prices in Polish zlotych (PLN), Euro (EUR) or dollars (USD)
12. 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.
13. In the case of another currency, the average NBP exchange rate from the last day of submitting offers will be accepted for conversion.
14. The offers submitted after the deadline shall not be taken into consideration.
15. Prior to the offer submission deadline, the Bidder has the right to:
a) withdraw the offer by submitting a notification in writing in the manner described for the offer submission,
b) 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’.
V. Selection criteria and method of assessing submitted offers
1. The Contracting Authority is entitled to reject the tender submitted by the Tenderer 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(Section II).
4. Selection criteria:
a) net price (weight criterion –80%);
b) total timelines(in weeks)(weight criterion – 20%). The timelines of each study is counted separately from:
- theavailability of simplified IMPD/certificates of analysis forPilot pharmacokinetic study 1to the preliminary results of the Pilotpharmacokinetic study1.
- the availability of simplified IMPD/certificates of analysis for Pilot pharmacokinetic study 2 to the preliminary results of the Pilot pharmacokinetic study 2.
- the availability of simplified IMPD/certificates of analysis for Pivotal pharmacokinetic study 1 to the draft of the Clinical Study Report from the Pivotal pharmacokinetic study 1.
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:
|Method of evaluation in accordance with the formula|
|net price of theoffer with the lowest price/net price tested offer x 100 x 80 % = number of points|
|timelines (in weeks)of the offer with the shortest timelines/ time(in weeks) of the tested offerx 100 x 20 % = number of points|
5. As the most advantageous offer will be considered that which obtains the highest number of points.
6. The results of the mathematical calculations carried out in the evaluation of tenders are rounded to the second decimal place.
VI. Tenderer selection and the manner of notification
1. The Contracting Authorityshall select the best offer based on the offer evaluation criteria specified in this call for offers (Section V).
2. The Contracting Authorityshall post information concerning the outcome of the procedure on the,www.bazakonkurencyjnosci.gov.pl/publication/list/ website, www.adamed.com.pl website and send it to each Tenderer.
VII. General provisions
1. The Contracting Authority reserves the right to invalidated or 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 Tenderer.
9. The Contracting Authority reserves the right to negotiate the proposal with the Tenderer, 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:
a) Necessary or justified changes in the design documentation resulting from unforeseeable reasons,
b) The necessity or the technical-economic appropriateness of the use of equivalent materials and equipment,
c) The necessity to make equivalent solutions resulting from technological or utility conditions,
d) Financial constraints on the part of the Contracting Authority which cause the necessity to limit the scope of works included in the offer,
e) Necessary or justified changes in the delivery time and conditions of the contract subject resulting from unforeseeable reasons
f) 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. 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) 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:
a) Payment deadline: minimum 45 days;
b) The validity of the offer: 90 days;
c) 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.
11. [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.
12. [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.
13. [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.
14. [Audit] The Contracting Authority reserves the right to audit the Supplier before the conclusion of the contract or in the course of its duration.
15. [Penalty clause] The Supplier shall pay penalty clauses:
a) 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,
b) due to improper execution of the contract,
c) 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.
16. [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.
17. [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.
18. [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.
19. [Effective date] The Agreement will commence on (a) the Effective Date (date of the last signature) and shall expire on 30.09.2022 or (b) the completion of all Services under the last Project Order executed by the parties prior to 30.09.2022. The Term may be extended by mutual written agreement of the Parties.
20. [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.
IX. Additional information
a) Any questions related to the subject matter of this request should be submitted using SAP Ariba Sourcing System or directed to the address: email@example.com
b) Checklist is provided in Appendix No. 8.
c) The person authorized to contact the bidders (Monday-Friday between 09:00-17:00) is: Aleksandra Stojak [firstname.lastname@example.org]