SMLOUVA O KLINICKÉM HODNOCENÍ CLINICAL TRIAL AGREEMENT
SMLOUVA O KLINICKÉM HODNOCENÍ |
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PPD Investigator Services LLC jednající svým vlastním jménem a oprávněnou provádět klinické zkoušky pro společnost Pfizer Inc. (dále jen „Zadavatel“ nebo „Pfizer“) se sídlem na adrese 000 Xxxxx Xxxxx Xx, Xxxxxxxxxx, XX 00000, XXX a daňovým identifikačním číslem: 00-0000000
(dále jen „CRO“)
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PPD Investigator Services LLC acting in its own name and authorized to perform clinical trials for Pfizer Inc. (hereinafter referred to as “Sponsor” or “Pfizer”) whose registered office is at 000 Xxxxx Xxxxx Xx, Xxxxxxxxxx, XX 00000, XXX and Tax identification number: 00-0000000
(hereinafter referred to as “CRO”)
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Fakultní nemocnicí Olomouc se sídlem na adrese Xxxxxxxxxxx 000/0, 000 00 Xxxxxxx, Xxxxx republika jednající prostřednictvím xxxx. XXXx. Xxxxxx Xxxxxxx, Ph.D. IČO: 00098892 DIČ: CZ00098892
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Fakultní nemocnice Olomouc with place of business at Xxxxxxxxxxx 000/0, 000 00 Xxxxxxx, Xxxxx Xxxxxxxx xxxxxxxxxxx by xxxx. XXXx. Xxxxx Xxxxxx, Ph.D. Company ID no.: 00098892 Tax ID no.: CZ00098892
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(dále jen „Centrum“)
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(hereinafter referred to as the “Center”)
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xxxx. XXXx. Xxxxxxxxxx Xxxxxxxxxx, Ph.D. trvalým bydlištěm na adrese Xxxxxxxxxx 000, Xxxxxx Xxxxxxx, Xxxxx republika Datum narození: 6. března 1965
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xxxx. XXXx. Xxxxxxxx Xxxxxxxx, Ph.D. with permanent address at Xxxxxxxxxx 000, Xxxxxx Xxxxxxx, Xxxxx Xxxxxxxx Date of Birth: 6th March1965
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(dále jen „Hlavní zkoušející”)
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(hereinafter referred to as the “Principal Investigator”)
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(Centrum a Hlavní zkoušející dále společně označováni jako „Smluvní partneři”)
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(the Center and the Principal Investigator hereinafter collectively referred to as the “Contracting Partners”)
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uzavřená níže uvedeného dne, měsíce a roku podle ustanovení § 1746 odst. 2 zákona č. 89/2012 Sb., občanský zákoník, ve znění pozdějších předpisů (dále jen „občanský zákoník“), (dále jen „Smlouva“):
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entered into on this day, month and year pursuant to Section 1746 (2) of Act no. 89/2012 of Coll., the Civil Code, as amended (hereinafter referred to as the “Civil Code”) (hereinafter referred to as the “Agreement”)
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Preambule
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Preamble |
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VZHLEDEM K TOMU, ŽE Zadavatel požádal Smluvní partnery, aby provedli klinické hodnocení s hodnoceným léčivým přípravkem PONSEGROMAB (dále jen „Hodnocený lék Zadavatele“) s názvem „DVOJITĚ ZASLEPENÁ, RANDOMIZOVANÁ, PLACEBEM KONTROLOVANÁ STUDIE FÁZE 2 HODNOTÍCÍ ÚČINNOST, BEZPEČNOST A SNÁŠENLIVOST PONSEGROMABU U PACIENTŮ S KARCINOMEM, KACHEXIÍ A ZVÝŠENÝMI KONCENTRACEMI GDF-15, PO KTERÉ NÁSLEDUJE VOLITELNÉ OTEVŘENÉ OBDOBÍ LÉČBY” (dále jen „Studie“), které je blíže popsáno v protokolu č. C3651003, který bude Smluvním partnerům předán Zadavatelem a který může být čas od času Zadavatelem jednostranně doplňován (dále jen jako „Protokol“).
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WHEREAS, the Sponsor asked the Contracting Partners to conduct a clinical trial involving the study drug PONSEGROMAB (hereinafter called the “Sponsor Drug”) named “A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PONSEGROMAB IN PATIENTS WITH CANCER, CACHEXIA, AND ELEVATED CONCENTRATIONS OF GDF-15, FOLLOWED BY AN OPTIONAL OPEN-LABEL TREATMENT PERIOD” (hereinafter referred to as the “Study”) as described in more detail in protocol no. C3651003 which will be provided to the Contracting Partners by the Sponsor and which may be from time to time unilaterally updated by the Sponsor (hereinafter referred to as the “Protocol”).
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VZHLEDEM K TOMU, ŽE Smluvní partneři disponují znalostmi, zkušenostmi a zdroji nezbytnými k provedení Studie, dle jejich nejlepšího vědomí mají přístup k požadovanému počtu subjektů hodnocení dle kritérií pro zařazení nebo vyřazení, jak jsou stanoveny v Protokolu, a jsou ochotni Studii provést,
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WHEREAS, the Contracting Partners possess knowledge, experience and resources necessary for conducting the Study, have - to the best of their knowledge - access to the required number of trial subjects based on the inclusion or exclusion criteria as laid down in the Protocol and are willing to conduct the Study.
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PROTO se smluvní strany (dále jen „strany“ nebo „smluvní strany“) dohodly následovně:
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THEREFORE, the parties (hereinafter referred to as the “Parties” or the “Contracting Parties”) have agreed as follows:
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Čl. 1 – Předmět Smlouvy
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Article 1 – Subject of the Agreement
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Čl. 2 – Povinnosti Smluvních partnerů
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Article 2 – Obligations of the Contracting Partners
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2.1 The Contracting Partners shall conduct and document the Study in a diligent and efficient manner in strict compliance with (a) the Protocol; and (b) the terms and conditions of this Agreement; and (c) the ethical principles of the Declaration of Helsinki; and (d) the ICH Harmonized Tripartite Guideline for Good Clinical Practice as amended from time to time as well as generally accepted standards of Good Clinical Practice; and (e) all applicable legal regulations; and (f) all orders and directives of competent public administration authorities and ethics committees, if any. The Center shall provide adequate resources and facilities for the performance of the Study.
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2.2 The Study at the Center shall be conducted under the supervision of the Principal Investigator who shall be responsible for due course of the Study. The Principal Investigator is the responsible head of the group of investigators in case the Study is conducted at the Center by several investigators (such additional investigators hereinafter referred to as “Investigators”). The Principal Investigator is responsible for the well-being of the trial subjects participating in the Study in terms of professional medical services provided.
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2.4 The Center shall allow and the Principal Investigator shall ensure that the Investigators and other persons involved with the Study (hereinafter referred to as “Study Team Members”) comply with the terms and conditions of this Agreement. The Center shall ensure through the Principal Investigator that original and new Study Team Members are appropriately trained, qualified and educated, in particular that they participate in all training sessions regarding the Study, including any good clinical practice training required and organized by the Sponsor (Study Team Members, who have a good clinical practice certificate that is not older than two years as of the first day of the Study, are not required to participate in good clinical practice training). The Sponsor and/or CRO shall have the right to reject specific Study Team Members, if the Sponsor and/or CRO deems them not appropriately educated and/or qualified. Study Team Members are employees of the Center. Study Team Members and the Principal Investigator shall attend trainings organized for them by the Sponsor and/or CRO in connection with the Study, and the Center shall allow such persons to attend. At the request of the Principal Investigator and the Center, there are also separate agreements in place with Study Team Members to facilitate direct payment to Study Team Members (see Section 4.1 below). |
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2.5 The Center shall make it possible for the Principal Investigator, Investigators and Study Team Members, as required, to participate in Investigators’ meetings and teleconferences held in the course of the Study to the extent requested by the Sponsor and/or CRO.
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2.6 Any subcontracting of any of the Center’s obligations under this Agreement to a third party requires the prior written consent of the Sponsor and/or CRO. Granting of such consent shall be within the Sponsor and/or CRO’s sole discretion. In the case that such consent is granted, the Center shall:
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2.6.1 make sure that such subcontractors observe the terms and conditions (a) that are relevant to the nature of requested services and similar to the terms and conditions of this Agreement, including – without limitation - the timelines for fulfilling obligations, (b) based on which the third party shall assign all rights with regard to the results of its performance/the Study to the Center or the Sponsor and (c) based on which the third party shall allow the Sponsor and/or CRO or third parties contracted by the Sponsor and/or CRO and competent regulatory authorities to perform audits and inspections at such a third party’ site, whereas this shall not limit the Center’s obligations with respect to audits and inspections; and
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2.6.2 be responsible for due performance of all delegated or subcontracted duties.
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2.7 The Contracting Partners agree to make maximum efforts to enroll three (3) trial subjects in the Study in accordance with the inclusion requirements and timelines set forth in the Protocol. The current timelines for conducting the Study are as follows:
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2.13 The Principal Investigator agrees to immediately answer any questions of the Sponsor or persons authorized by the Sponsor regarding adverse event documentation. This includes - but is not limited to - active follow-up monitoring and clarification of relevant inconsistencies in adverse event and pregnancy reports. For the purposes of adverse event and pregnancy reporting, the Contracting Partners must use the forms provided by the Sponsor, if applicable.
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2.14 During and after completion of the Study, the Contracting Partners shall submit to the Sponsor all documents received from authorities, ethics committee/s, and/or competent regulatory authorities regarding any consent or authorization or safety- related communication with respect to the Study within 24 hours following their receipt,
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2.15 Sponsor or CRO will arrange for the Center to receive sufficient quantities of the Sponsor Drug to conduct the Study. Unless otherwise indicated in Appendix 1, Sponsor or CRO will also arrange for the Center to receive any other Protocol-required drugs (e.g. placebo, comparator drug, concomitant drug). Any other Protocol-required drug that Sponsor or CRO provides or covers the cost of is, together with the Sponsor Drug, considered “Study Drugs”. The Contracting Partners agree to use the Study Drugs exclusively for the purposes of conducting the Study and only as specified in the Protocol. The Contracting Partners are responsible for the proper receipt, use, handling, storage and keeping detailed and accurate records of handling of the Study Drugs in the course of the Study pursuant to the requirements of good clinical practice, good pharmacy practice and Protocol. The Contracting Partners agree to return any unused Study Drugs or properly liquidate any unused Study Drugs, provided that the Sponsor requested such liquidation (at the expense of the Sponsor), and properly document such liquidation. The Contracting Partners shall immediately liquidate any unfinished or unused Study Drugs administered by infusion immediately after its preparation or modification.
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2.16 The Center hereby agrees to ensure that the Study Drug is stored, prepared, inspected and distributed in compliance with the Protocol, the applicable law and all provisions of the LEK-12 guideline issued by the State Institute for Drug Control. The Contracting Partners shall not charge any trial subject or third party, such as a health insurance company, for the Study Drugs or for any services paid for by the Sponsor under this Agreement. |
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2.17 The Center agrees to appoint a sufficient number of representatives who meet qualification requirements for the position of a pharmacist pursuant to Act no. 95/2004 Coll., on conditions for acquisition and recognition of professional qualifications and specialized qualifications for physicians, dentists and pharmacists, as amended, or for pharmaceutical assistants pursuant to Act no. 96/2004 of Coll., on non-medical health professions, as amended. These representatives shall be responsible for handling the Study Drugs and for keeping related records and documentation. Immediately after the appointment of the representative(s), the Center shall notify the Sponsor in writing about the first and last name and contact details of such appointees. |
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2.18 The Principal Investigator agrees to draw the Study Drugs in compliance with the Protocol and in doses required for every visit of the trial subject.
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2.19 The Contracting Partners agree to report on the progress of the Study at the Center, including information about the enrolment of trial subjects, upon the Sponsor and/or CRO’s request.
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2.20 The Principal Investigator must collect data and enter them within 4 (four) calendar days of assessments being completed in the electronic case report forms (hereinafter referred to as “CRFs”) in accordance with the requirements set forth in the Protocol. The Principal Investigator agrees to regularly forward CRFs and any documentation required in the Protocol to the Sponsor and/or CRO so that the Sponsor and/or CRO could process them directly or through another entity on a continuous basis. In case of a delay with data entering for more than 10 working days, the Sponsor and/or CRO shall have the right by giving written notice to the Principal Investigator to stop the recruitment of trial subjects by the Principal Investigator until data entering is up to date. If this results in a delay with recruiting trial subjects, the Sponsor shall have the rights set forth in Article 12.4. Within 4 (four) working days of the last trial subject’s treatment, all outstanding CRFs must be entered and related documentation as well as unused paper CRFs, if applicable, must be forwarded to the Sponsor or destroyed upon the Sponsor and/or CRO’s request. The Contracting Partners agree to assist in promptly clarifying any questions concerning CRF data and to address and answer such questions within 10 (ten) business days of the query being issued. The Sponsor and/or CRO may request answers sooner than that due to key Study milestones, such as a clean database. Furthermore, the Contracting Partners agree to reasonably assist in preparing the overall Study report upon the Sponsor and/or CRO’s request. The Center shall ensure that CRFs shall not be available to any persons other than Study Team Members and the Principal Investigator and that access to CRFs, if they are in electronic form, shall be protected by user name and password.
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2.21 The Principal Investigator shall ensure that all CRFs submitted to the Sponsor and/or CRO are true, complete, correct and accurate and reflect the actual results of the Study. The Principal Investigator also agrees to provide the Sponsor and/or CRO with copies of all reports, including all updates and changes, that were requested by the ethics committee. |
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2.22 The Center shall keep all electronic and other documents, including without limitation, source documents and the Investigator’s files required by ICH guidelines and applicable laws regulating Study performance for period of twenty-five (25) years after the end of the Study. Study documentation must be kept in a suitable location and manner, and the Center must keep record of the location where Study documentation is stored to ensure that it is readily available upon the request of the Sponsor and/or CRO’s appointed representative, the ethics committee, an auditor or competent authorities. The Center must notify the Sponsor and/or CRO in the event that the Center plans to archive Study documentation outside of its own premises. |
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2.23 The Contracting Partners understand that the Sponsor and/or CRO or a third party on behalf of the Sponsor closely monitors the performance of the Study and regularly visits the Center. The Contracting Partners agree to appropriately support such monitoring activities, including without limitation, by providing the Sponsor and/or CRO’s appointed representative with access to the facilities and data as necessary and to cooperate with the Sponsor and/or CRO or the relevant third party in this regard. Upon request from CRO or Sponsor, Center will permit remote electronic access to Study records when available and permitted under applicable law. The Principal Investigator and Study Team Members must participate in personal discussions upon the request of the Sponsor and/or CRO. The Sponsor represents that the persons performing the monitoring or audit of the Study comply with the Decree no. no. 226/2008 Coll., On Good Clinical Practice and Detailed Conditions of Clinical Evaluation of Medicinal Products, as amended (hereinafter also referred to as Decree No. 226/2008 Coll.), are sufficiently qualified for their activities and that they will comply with all their applicable obligations under Decree no. no. 226/2008 Coll., during the performance of the monitoring or audit, inter alia, the obligation of confidentiality of all facts of which they learned in connection with the performance of monitoring or audit, to the extent determined by applicable law.
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2.24 The Sponsor and/or CRO and government authorities, such as for example the US Food and Drug Administration (the “FDA”) have the right to audit or inspect the Contracting Partners’ records, any and all other documentation and the facility relating to the Study at any time during the Study and/or for another 25 years after completion of the Study and without the Contracting Partners’ right to special payment. The Sponsor and/or CRO must announce such audit or inspection sufficiently in advance, provided that it is carried out by the Sponsor and/or CRO. The Contracting Partners must assist the Sponsor and/or CRO, its designated representatives or all government authorities in performing their tasks pursuant to the Protocol and take any and all reasonable actions requested by the Sponsor and/or CRO or government authorities to remedy deficiencies noted during an audit or inspection. |
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2.25 The Contracting Partners shall, during and after the Study, allow and support any inspections of responsible authorities without any right to special payment or reimbursement. The Contracting Partners must inform the Sponsor and/or CRO about any such inspection or the intent to conduct such inspection as soon as the Contracting Partners learn about it. The Contracting Partners shall allow the Sponsor and/or CRO to be present at any inspection conducted by authorities or similar institutions. Prior to responding to the findings of any such inspection, if any, the Contracting Partners must review and discuss such response with the Sponsor and/or CRO. The Contracting Partners shall promptly provide the Sponsor and/or CRO with copies of any findings or inspections of responsible authorities in relation to the Study. The Contracting Partners are bound by the obligations set forth in this provision provided that its fulfillment is not prohibited by applicable law or the competent authority.
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2.26 The Contracting Partners may not knowingly (having made reasonable enquiries) use the services, regardless of their volume, of any person prohibited to provide such services by the FDA or any other competent authority in the course of the Study. Furthermore, the Contracting Partners represent and warrant that, as far as they know (having made reasonable enquiries), neither they nor their employees, agents or representatives, who are involved in the Study, have been prohibited by the FDA or any other competent authority from performing the activities that are performed during the Study, nor that they are currently, to the best of their knowledge (having made reasonable enquires), the subject of proceedings concerning such prohibition by the FDA or any other authority, in particular on the basis of (i) United States 21 U.S.C. Section 335a and (ii) Title 21 Code of Federal Regulation, Section 312.70. During the Study and for a period of 3 years after its completion, the Contracting Partners agree to promptly notify the Sponsor and/or CRO about any such proceedings initiated against the Principal Investigator, the Center or its employees. Furthermore, the Contracting Partners represent and warrant that, as far as they know, they are not the subject of any past or current investigations, inquiries, warnings or enforcement decisions of public administration authorities that concern their conduct of clinical research that have not been disclosed to the Sponsor. The Contracting Partners shall notify the Sponsor about the fact described in the previous sentence without undue delay.
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2.27 In the event that the Principal Investigator terminates his or her employment at the Center, the Center shall inform the Sponsor and/or CRO as soon as it learns about it and shall propose a duly qualified person acting as a new principal investigator. The Sponsor and/or CRO shall have the right to object to such replacement. The Center shall make maximum efforts to require the new principal investigator to agree in writing to the terms and conditions stipulated in this Agreement. If the Center and the Sponsor and/or CRO are unable to agree on the new principal investigator or if the new principal investigator is unwilling to agree to the terms and conditions stipulated in this Agreement, the Sponsor and/or CRO shall have the right to terminate this Agreement in accordance with Article 12.5. The Center and the Principal Investigator must immediately inform the Sponsor and/or CRO in writing about any and all changes having an impact on the availability of resources and/or Study Team Members conducting the Study.
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2.28 The Contracting Partners agree to inform the Sponsor and/or CRO via assigned Study Monitor directly and immediately in the case that a trial subject participating in the Study announces or opines that his or her health has been damaged due to his or her participation in the Study and that he/she is therefore entitled to financial compensation. |
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2.29 The Contracting Partners agree to allow research organizations contracted by the Sponsor or any of its Affiliates to exercise any of the Sponsor’s rights and to perform any of the Sponsor’s obligations under this Agreement on behalf of the Sponsor, provided that they have authorization or a power of attorney to exercise the Sponsor’s rights and to perform the Sponsor’s obligations. The Contracting Partners agree to cooperate with such research organizations.
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2.30 The Contracting Partners undertake to provide medical services to trial subjects whose participation in the Study has not yet ended, in the case of a partial closure of the Study, as well as to subjects included in the post Study follow-up in compliance with ethics rules.
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2.31 In the case that the Center, the Principal Investigator or Study Team Members use in the course of the Study devices that require servicing, calibration or any other special care, the Center agrees to maintain such devices in due operational condition and to provide relevant documentation thereof to the Sponsor and/or CRO upon the request of the Sponsor and/or CRO.
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Čl. 3 – Povinnosti Zadavatele a/nebo CRO
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Article 3 – Obligations of the Sponsor and/or CRO
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3.1 The Sponsor and/or CRO’s contact persons regarding the Study are:
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monitor CRO
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CRO’s Monitor
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nebo kterékoli další osoby oznámené Hlavnímu zkoušejícímu.
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or any other person announced to the Principal Investigator.
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3.2 The Sponsor agrees to provide the Contracting Partners with the Study Drugs, necessary CRF templates, other information free of charge and in the quantity and frequency necessary for the proper performance of the Study.
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3.3 The Study Drugs shall be delivered to the following address:
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Lékárna FNOL Fakultní nemocnice Olomouc Zdravotníků 248/7 779 00 Olomouc Česká republika
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Lékárna FNOL Fakultní nemocnice Olomouc Zdravotníků 248/7 779 00 Olomouc Česká republika
3.4 The Study Drugs, necessary CRF templates and other information required for the performance of the Study and provided to the Center are and shall remain the Sponsor’s property. The Sponsor declares that all conditions stipulated in applicable laws regulating the production (import) of the provided Study Drugs and the distribution of the Study Drugs to the Center have been met.
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3.5 The Sponsor and/or CRO agree to provide the Principal Investigator with new information regarding the safety of the Sponsor Drug without undue delay. |
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3.6 The Sponsor and/or CRO agrees to provide the necessary equipment and/or devices to the Contracting Partners for the conduct of the Study as specified in the Loan Agreement between the Parties for the exclusive use thereof in the Study, of which Contracting partners shall keep written records, the extent and terms of provision being defined in the Loan Agreement. The Contracting Partners shall return the equipment to the Sponsor upon completion of the Study.
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Čl. 4 – Odměna
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Article 4 – Remuneration
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Hlavní zkoušející a další Zkoušející jsou sami zodpovědní za řádné zdanění svých příjmů.
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The Principal Investigator and Investigators are themselves responsible for the taxation of their income.
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Banka: Česká národní banka, a.s. Kód banky: 0710 Majitel účtu: Fakultní nemocnice Olomouc IBAN: CZ44 0710 0000 0000 3633 4811 SWIFT: CNBACZPP Číslo účtu: 36334811/0710 Variabilní symbol: číslo faktury Specifický symbol: C3651003
Faktury musí být zasílány k proplacení dle instrukcí uvedených v Příloze č. 1. Odměny a náhrady dle této Smlouvy a přílohy č. 1 (s výjimkou odměn a náhrad, u kterých je splatnost zvlášť upravena v příloze č. 1 Smlouvy) budou Centru a Hlavnímu zkoušejícímu uhrazeny takto: Zpětně za bezprostředně uplynulé a dosud nefakturované období vždy každého kalendářního čtvrtletí Studie si Smluvní partneři společně se Zadavatelem a/nebo CRO vzájemně písemně nebo formou e-mailu odsouhlasí přehled počtu, druhu a jim odpovídající hodnoty jednotlivých úkonů provedených Hlavním zkoušejícím a/nebo ostatními Členy studijního týmu, jež mají být dle této Smlouvy Zadavatelem a/nebo CRO hrazeny (tzv. návrh faktury), zaslaný osobou pověřenou Zadavatelem a/nebo CRO. Tento přehled musí být zpracován zvlášť pro každý subjekt Studie a musí zahrnovat položkové vyúčtování všech návštěv, vyšetření a dalších služeb provedených v příslušném kalendářním čtvrtletí. Na základě vzájemného odsouhlasení návrhu faktury vystaví Centrum fakturu na odměnu a případné náhrady, jež je v souladu s touto Smlouvou oprávněno fakturovat, kterou doručí Zadavateli a/nebo CRO. Zadavatel a/nebo CRO zaplatí Centru na základě řádně vystavené a doručené faktury příslušnou odměnu a případné oprávněně fakturované náhrady za období, pro něž byl předmětný návrh faktury dle tohoto článku odsouhlasen.
V případě, že Zadavatel a/nebo CRO nezašle Centru výše uvedený přehled (návrh faktury) k odsouhlasení ve lhůtě 30 dnů ode dne ukončení kalendářního čtvrtletí, zašle Centrum Zadavateli a/nebo CRO písemnou výzvu a pokud Zadavatel a/nebo CRO nezašle uvedený přehled (návrh faktury) ani ve lhůtě 30 dnů od doručení takové výzvy, je Centrum oprávněno vystavit fakturu a Zadavatel a/nebo CRO je povinen uhradit Centru odměnu a náhrady za všechny fakturované úkony provedené v období kalendářního čtvrtletí Hlavním zkoušejícím a/nebo ostatními Členy studijního týmu.
V případě, že Centrum zjistí, že jsou v přehledu (návrhu faktury) nedostatky, tyto oznámí bez zbytečného odkladu Zadavateli a/nebo CRO, který je povinen je odstranit. Má-li Zadavatel a/nebo CRO zato, že v přehledu (návrhu faktury) žádné nedostatky nejsou, sdělí toto Centru. Centrum a Zadavatel a/nebo CRO jsou následně povinni si navzájem poskytnout součinnost nezbytnou k odstranění případných rozporů. Neposkytnutí součinnosti se považuje za nepodstatné porušení Smlouvy.
Neodstraní-li Zadavatel a/nebo CRO nedostatky v přehledu (návrhu faktury) ani ve lhůtě 45 dnů ode dne doručení oznámení dle předchozího odstavce, nebo v téže lhůtě nesdělí Centru, že v přehledu (návrhu faktury) žádné nedostatky nespatřuje, platí, že rozhodný pro vystavení faktury je přehled (návrh faktury) ve znění připomínek Centra, na základě kterého je Centrum oprávněno vystavit fakturu a Zadavatel a/nebo CRO je povinen odměnu a náhrady za fakturované úkony provedené v období kalendářního čtvrtletí Hlavním zkoušejícím a/nebo ostatními Členy studijního týmu Centru uhradit.
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Bank: Česká národní bank, a.s. Bank code: 0710 Account holder: Fakultní nemocnice Olomouc IBAN: CZ44 0710 0000 0000 3633 4811 SWIFT: CNBACZPP Account No.: 36334811/0710 Reference no.: invoice number Specific no.: C3651003
Invoices must be submitted according to terms stipulated in Appendix 1. Any remuneration and reimbursement based on this Agreement and Appendix 1 (except for remuneration and reimbursement, the due date of which is specified separately in Appendix 1 to the Agreement) shall be paid to the Center and the Principal Investigator in the following manner: retroactively for the past and not yet invoiced period of each calendar quarter of the Study, the Contracting Partners and the Sponsor and/or CRO shall approve in writing or by e-mail an overview of the number, type and value of individual activities, which were performed by the Principal Investigator and/or other Study Team Members and which are to be paid by the Sponsor and/or CRO based on this Agreement (i.e. draft invoice), sent by a person authorized by the Sponsor and/or CRO. Every overview must be prepared separately for each trial subject and must include an itemized list of all visits, examinations and other services provided in the relevant calendar quarter. Based on the mutually approved draft invoice, the Center shall issue an invoice for remuneration and potential reimbursement that the Center is entitled to charge pursuant to this Agreement and shall send it to the Sponsor and/or CRO. Based on the duly issued and delivered invoice, the Sponsor and/or CRO shall pay the Center the relevant remuneration and potential justified reimbursement for the period for which the draft invoice has been approved pursuant to this article.
In the case that the Sponsor and/or CRO does not send the Center the aforesaid overview (draft invoice) for approval within 30 days of the end of the calendar quarter, the Center shall send the Sponsor and/or CRO a written reminder and if the Sponsor and/or CRO does not send the aforesaid overview (draft invoice) within 30 days of receipt of the reminder, the Center shall have the right to issue an invoice and the Sponsor and/or CRO shall pay the Center the remuneration and reimbursement for all invoiced activities performed during the calendar quarter by the Principal Investigator and/or other Study Team Members.
The Center must immediately report any potential deficiencies in the overview (draft invoice) to the Sponsor and/or CRO, and the Sponsor and/or CRO must remedy such deficiencies. In the case that the Sponsor and/or CRO believes that the overview (draft invoice) has no deficiencies, the Sponsor and/or CRO shall announce it to the Center. The Center and the Sponsor and/or CRO must then cooperate as necessary to rectify such discrepancies. Failure to cooperate shall be considered a minor breach of this Agreement.
In the case that the Sponsor and/or CRO fails to remedy deficiencies in the overview (draft invoice), or fails to inform the Center that the Sponsor and/or CRO believes that the overview (draft invoice) has no deficiencies, within 45 days of announcement based on the previous paragraph, the Center shall use its version of the overview (draft invoice), based on which the Center shall issue an invoice and the Sponsor and/or CRO shall have to pay the remuneration and reimbursement for invoiced activities performed during the calendar quarter by the Principal Investigator and/or other Study Team Members.
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4.4 The Sponsor and/or CRO has the right to retain up to 10% of the remuneration for the calendar quarter (hereinafter referred to as the “Retainer”). The Sponsor and/or CRO agrees to pay the Center the Retainer after all relevant CRFs were submitted, all questions concerning CRF data were answered and all incorrect or incomplete data in the database were rectified. Retainer shall not apply to start-up fees, laboratory certificate fees and Trial Subject reimbursement.
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4.5 Unless otherwise stated in this Agreement, no amounts specified in this Agreement and its Appendices include VAT. In the case that any payment for services is subject to VAT, the Sponsor and/or CRO shall pay the relevant VAT amount stipulated in legal regulations effective as of the date of taxable supply based on the relevant tax document (invoice) that shall meet the requirements laid down in applicable legal regulations. The Center shall be responsible for paying any other tax with respect to the payments made based on this Agreement.
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4.6 The Contracting Partners understand that the Sponsor and/or CRO may disclose on the website www.transparentnispoluprace.cz owned and operated by the Association of Innovative Pharmaceutical Industry any payment and any transfer of value relating to research and development, i.e. (1) payments made by Sponsor and/or CRO under this Agreement and (2) any cost of accommodation, refreshments and travel of the Contracting Partners, which Sponsor and/or CRO covers under this Agreement and (3) any congress registration or participation fees or similar fees, which Sponsor and/or CRO covers under this Agreement, all this in an anonymized way, i.e. on aggregated level. This information may also be disclosed as a part of this Agreement in the Agreements Register pursuant Act No. 340/2015 Coll., on the agreements register (hereinafter referred to as the “Agreements Register Act”). Notwithstanding the aforementioned, the Sponsor and/or CRO may also disclose any transfer of value under this Agreement. The Contracting Parties have agreed that this Agreement shall be disclosed exclusively in the scope and redacted form agreed between Sponsor and/or CRO and Center.
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4.7 Payments to trial subjects shall be made by the Center in compliance with this Agreement and the Protocol. |
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Čl. 5 – Práva k výsledkům
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Article 5 – Rights to Results
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5.1 The Sponsor shall own the exclusive rights to all results, data, findings, discoveries, inventions and specifications, whether patentable or not, that were originated, conceived, derived, produced, discovered, invented or otherwise made by the Center, the Principal Investigator and/or Study Team Members in connection with conducting the Study (hereinafter referred to as “Results“). The Contracting Partners hereby assign all of their proprietary rights to Results to the Sponsor in advance and the Sponsor accepts such assigned rights. The royalty fee for this assignment is already included in the remuneration of the Contracting Partners under Article 4 hereof. The Contracting Partners shall not acquire any rights to Results by performing this Agreement.
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5.8 The Sponsor provides the Contracting Partners with a non-exclusive license with no right to sub-license to use Study data for internal non-commercial research and educational purposes, subject to confidentiality and publication terms specified in this Agreement. Such license does not allow for granting any sub-licenses.
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Čl. 6 – Zachovávání důvěrnosti
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Article 6 – Confidentiality
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6.2 The confidentiality obligation shall not apply to any information which the Contracting Partners have the right to publish Confidential Information in accordance with Article 7.
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6.3 The term Confidential Information, as used in this Agreement, does not apply to data and information where the Contracting Partners can prove that such data and information (i) were already in possession of the Center or the Principal Investigator without the confidentiality obligation at the time of their disclosure to them by or on behalf of the Sponsor and/or CRO or any of its Affiliates, (ii) are or become a part of public information by means other than by an act or omission on the part of the Center or the Principal Investigator, (iii) were legally acquired by the Center or the Principal Investigator from a third party not bound to the Sponsor and/or CRO or its Affiliates by an explicit or implied confidentiality obligation or (iv) were created independently by the Center or the Principal Investigator without reference to Confidential Information or its use.
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6.4 Furthermore, the Contracting Partners may disclose Confidential Information to the extent required by law or an enforceable court order, provided, however, that the Contracting Partners shall give the Sponsor and/or CRO reasonable advance notice and shall cooperate with the Sponsor and/or CRO to seek a protective order or any other appropriate remedy upon the request of the Sponsor and/or CRO. The Contracting Partners agree to make maximum reasonable efforts to ensure confidential treatment of any Confidential Information that shall be disclosed.
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6.5 This confidentiality obligation and the prohibition to use Confidential Information as specified in this Agreement shall remain in effect even after this Agreement is terminated.
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6.6 The Contracting Partners agree to liquidate and delete any Confidential Information in their possession or to return it to the Sponsor and/or CRO upon the request of the Sponsor and/or CRO.
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6.7 All pre-existing agreements regarding the confidentiality obligation with regard to the Study shall be superseded by this Agreement and only with regard to the Study. |
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Čl. 7 – Publikování, tiskové zprávy a veřejná oznámení
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Article 7 – Publication, Press Releases and Public Announcements
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7.1 The Sponsor acknowledges the interest of the Contracting Partners in the non-commercial scientific publication of Study results, regardless of whether the outcome of the Study is positive or negative. Considering the Sponsor’s reasonable interests, the Contracting Partners agree to comply with the following publication obligations and terms:
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7.1.7 The Contracting Partners agree to include in every Publication information that the creation of data was sponsored and financially supported by the Sponsor as well as information about their involvement in the Study and their benefits from the Study. Authorship and acknowledgements for scientific publications should be consistent with the Uniform Requirements for Manuscripts issued by the International Committee of Medical Journal Editors (ICMJE). |
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7.2 The obligations set forth in Article 7.1 shall remain in effect for another fifteen (15) years after early termination or expiration of this Agreement.
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7.3 The Sponsor may publish Results of the Study in any manner it deems appropriate, both during, and following termination of this Agreement; the Sponsor may also post information about the Study and Results on the Internet, e.g. on www.ClinicalTrials.gov (register posting) and on websites for results posting, on the Sponsor’s company website (register and results posting) and in any other database required by laws in accordance with applicable standards regarding scope, form and content.
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7.4 The Contracting Partners agree not to publish any press release or any other public announcements about the Study, results of the Study and/or the Sponsor Drug without the Sponsor's prior written consent, except for publicly available information.
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7.5 The name of the Sponsor and/or CRO may not be used in any advertising or any other material of the Contracting Partners without the Sponsor and/or CRO's prior written authorization. In accordance with its internal procedures and relevant legal regulations, the Center reserves the right to publish the name of the Sponsor and the Protocol number on its website without the prior Sponsor consent. In such case, the Sponsor and/or CRO will be informed of the publication without delay.
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Čl. 8 – Odpovědnost a odškodnění
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Article 8 – Liability and Indemnity
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8.4 The Contracting Partners shall not be entitled to indemnification under Article 8.2 and the Sponsor shall not provide indemnification, with the exception of Paragraph 8.4.3, if the Contracting Partners breach any of the following obligations and such breach has a negative impact on the possibility of successful defense against the lodged claim:
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8.4.2 The Contracting Partners must cooperate and require its employees to cooperate, with the Sponsor and its attorneys and insurers in the defense of such a claim or lawsuit; and |
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Čl. 9 – Pojištění
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Article 9 – Insurance |
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Čl. 10 – Ochrana a zpřístupnění osobních údajů
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Article 10 – Personal Data Protection and Disclosure
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10.1. Před zařazením Subjektů hodnocení do Studie je Zkoušející povinen Subjektům hodnocení předat formulář souhlasu Subjektů se zpracováním osobních údajů vypracovaný Zadavatelem. Zadavatel odpovídá za to, že formulář souhlasu Subjektů se zpracováním osobních údajů splňuje veškeré náležitosti zejména podle čl. 7, 13 a 14 nařízení GDPR a platných národních právních předpisů o ochraně osobních údajů vztahujících se k souhlasům se zpracováním osobních údajů, a že tedy umožňuje v souladu s platnou právní úpravou Centru jako zpracovateli pro Zadavatele ve stanoveném rozsahu a ke stanovenému účelu zpracovávat osobní údaje subjektu údajů včetně jejich předávání do zemí, kde úroveň jejich ochrany nemusí být tak vyspělá jako v zemích EU.
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10.4 The Contracting Partners agree to inform the Sponsor in writing about any breach of personal data protection provisions without undue delay; however, no later than two (2) days following such breach. |
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10.5 The Contracting Partners and the Sponsor and/or CRO agree to adhere to applicable personal data protection laws, especially Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), the law regulating personal data processing and relevant guidelines of the State Institute for Drugs Control, in particular guideline KLH-22, if applicable. |
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Čl. 11 – Trvání Smlouvy
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Article 11 – Term of the Agreement
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Čl. 12 – Ukončení
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Article 12 – Termination
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12.1 Notwithstanding any other termination right set forth in this Agreement or in the applicable generally binding legal regulations, the Sponsor and/or CRO reserves the right to terminate this Agreement at any time without cause based on thirty-day notice. Immediately upon receipt of the notice based on any provision of this Agreement, the Center and the Principal Investigator agree to (i) cease recruiting and enrolling trial subjects in the Study, (ii) cease all procedures to the extent medically permissible on trial subjects already enrolled in the Study and (iii) refrain as much as possible from incurring additional costs and expenses. In the case that the Center or the Sponsor and/or CRO announces that the thirty-day notice does not provide enough time to evaluate risks for enrolled trial subjects who receive the Sponsor Drug, the Contracting Parties shall cooperate so that the treatment of the trial subjects with the Sponsor Drug would be safely terminated during a mutually agreed period of time; however, the Sponsor shall not be required to provide the Sponsor Drug based on this Agreement for an unreasonable period of time.
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12.4 In the case that the Sponsor and/or CRO reasonably believes that the Contracting Partners shall be unable to start recruitment or to fulfil their recruitment obligations by the agreed deadline, the Sponsor and/or CRO shall have the right, by sending written notice to the Contracting Partners, to (a) decrease with immediate effect the number of trial subjects to be recruited; or (b) extend the recruitment deadline; or (c) terminate this Agreement. According to (c), the Sponsor and/or CRO may terminate this Agreement with immediate effect, provided that the Sponsor and/or CRO informed the Contracting Partners about their delay with recruiting trial subjects in writing beforehand and asked them to remedy this delay within an additional reasonable time-limit and the Contracting Partners failed to remedy this delay within such additional reasonable time-limit.
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12.5 In the case that the Sponsor and/or CRO does not approve a new Principal Investigator pursuant to Article 2.27 or a new Principal Investigator does not accept in writing the obligations under this Agreement, the Sponsor and/or CRO may terminate this Agreement as of the day of delivery of the termination notice to the Center. In the case that the Principal Investigator and the Sponsor and/or CRO wish to continue to cooperate with regard to the Study in another medical facility, the Center agrees to cooperate with transferring relevant data, information and materials that are not owned by the Center to such a medical facility.
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12.7 The Sponsor and/or CRO must pay all outstanding amounts for the services properly provided by the Contracting Partners based on this Agreement and all reasonably incurred costs, as of the day of receipt of the notice or, in the case that this Agreement is terminated pursuant to Article 12.1, as of the last day of the termination period or, in the case that this Agreement is terminated pursuant to Article 12.3, as of the day of receipt of the final rejection. In the case that the Center provably received higher payments than the payments due according to the work actually performed based on this Agreement, the Center shall refund the balance to the Sponsor and/or CRO without undue delay.
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12.8 Upon termination of this Agreement, the Contracting Partners shall return to the Sponsor and/or CRO all unused materials and items provided to the Contracting Partners in relation to the Study within thirty (30) working days of the day of termination of this Agreement.
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Čl. 13 – Různá ustanovení
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Article 13 – Miscellaneous
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13.6 Each Contracting Party shall act as an independent entity and shall not be construed for any purposes as a partner, agent, employee or representative to the other Contracting Party.
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13.7 CRO may freely assign any or all of its rights and delegate any or all of its duties under this Agreement to Sponsor on written notice to Contracting Parties. CRO (or Sponsor, following assignment and delegation by CRO) may also freely delegate and assign Study-related duties and rights to an external provider upon advance notice to Contracting Parties, and may freely delegate or assign its Study-related duties or rights to any Sponsor affiliate. CRO may not otherwise assign its rights or delegate its duties under this Agreement without written permission from the affected party. If CRO or Sponsor delegates or subcontracts any duties, CRO or Sponsor remains responsible to Contracting Parties, for the performance of those duties. If CRO assigns all of CRO's rights and duties under this Agreement, in accordance with the terms herein, to another service provider, that service provider will become responsible for performance of all duties. Save for the foregoing, neither Party may assign its rights or obligations under this Agreement, in whole or in part, to a third party without the prior written consent of the other Parties. This Agreement is binding for all Parties as well as their legal successors and parties to which the rights and obligations of the Contracting Parties shall be assigned in compliance with this Article. |
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13.8 The invalidity or unenforceability of a particular provision of this Agreement shall not prejudice the validity of the remaining provisions. The Contracting Parties agree to replace the invalid or unenforceable provision with a valid or enforceable provision that shall correspond as much as possible to the intent of the Parties at the time they entered into this Agreement. If there is any discrepancy or conflict between the terms contained in the Protocol and this Agreement, the Protocol shall govern and control with regards to the scientific and clinical aspects of the conduct of the Study, and the Agreement shall govern and control with respect to all other matters.
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13.9 A unilateral waiver of a right or acquiescence or failure to claim a breach of any provision of this Agreement by either Contracting Party shall not establish a unilateral waiver of such right with respect to any subsequent breach of any provision of this Agreement.
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Centra: Fakultní nemocnice Olomouc Zdravotníků 248/7, 779 00 Olomouc Czech Republic K rukám: Gabriela Tichá Telefon: +420 588 443 829
Úkon učiněný vůči Centru se považuje za řádně učiněný i vůči Hlavnímu zkoušejícímu, resp. členům Studijního týmu.
CRO: PPD Czech Republic, s.r.o. Budějovická Alej Antala Staška 2027/79 140 00 Praha 4 Česká republika K rukám: monitora studie C3651003 Tel.: +420 233 081 000
Hlavní zkoušející: Prof. MUDr. Bohuslav Melichar, Ph.D. Přednosta onkologické kliniky Fakultní nemocnice Olomouc onkologická klinika Zdravotníků 248/7 779 00 Olomouc Czech Republic Tel.: +420 588 444 288 Fax.: +420 588 442 522 E-mail: bohuslav.melichar@fnol.cz
Zadavatele:
Pouze pro schvalování publikací: Shannon Lubaczewski Study Clinician (Studijní lékař) Pfizer 3200 Walnut Street Boulder, CO 80301 US Telefon: +1484.865.8735 Email: shannon.lubaczewski@pfizer.com
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13.10 Unless otherwise agreed in this Agreement, the Center’s contact person shall be:
Center: Fakultní nemocnice Olomouc Zdravotníků 248/7, 779 00 Olomouc Česká republika Attention: Gabriela Tichá Telephone: +420 588 443 829
All actions taken with respect to the Center shall be deemed as actions taken respect to the Principal Investigator or Study Team Members as well.
CRO: PPD Czech Republic, s.r.o. Budějovická Alej Antala Staška 2027/79 140 00 Praha 4 Czech Republic Attention: Study Monitor for C3651003 Telephone: +420 233 081 000
Principal Investigator: Prof. MUDr. Bohuslav Melichar, Ph.D. Head of Oncology Clinic Fakultní nemocnice Olomouc Oncology Clinic Zdravotníků 248/7 779 00 Olomouc Czech Republic Tel.: +420 588 444 288 Fax.: +420 588 442 522 E-mail: bohuslav.melichar@fnol.cz
Sponsor:
For Submission of Publications Only: Shannon Lubaczewski Study Clinician Pfizer 3200 Walnut Street Boulder, CO 80301 US Telephone: +1484.865.8735 Email: shannon.lubaczewski@pfizer.com
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13.11 The Contracting Parties have agreed that this Agreement may be changed, excluding the exception mentioned below, only through written consecutively numbered amendments signed by all Contracting Parties. The Contracting Parties are not obliged to execute an amendment to this Agreement in case of so-called minor changes in the Protocol. A minor change in the Protocol means a change in the Protocol that does not change the scope or manner of procedures (in particular examination) performed by the Contracting Partners as part of the Study and has no impact on remuneration for performing the Study or on any other prices specified in this Agreement. Minor changes in the Protocol shall come into effect on the day of their delivery to the Center.
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13.12 This Agreement is construed and governed by the Czech law, regardless of the provisions of its collision norms. The Contracting Parties have agreed that any dispute arising from this Agreement shall be decided by materially and locally competent courts of the Czech Republic.
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13.13 This Agreement has been drawn up in the Czech and English language, and the Contracting Parties consider both language versions to be equal; however, in case of any interpretation discrepancy between the individual versions, the Czech version shall prevail as agreed by the Contracting Parties.
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Čl. 14 – Přílohy |
Article 14 – Appendices |
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Následující přílohy tvoří nedílnou součást této Smlouvy, nestanoví-li tato Smlouva jinak:
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The following Appendices constitute an integral part of this Agreement, unless set forth otherwise herein: |
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Příloha č. 1: Finanční podmínky |
Appendix 1: Financial Terms |
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Příloha č. 2: Zpracování osobních údajů |
Appendix 2: Personal Data Processing |
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Příloha č. 3: Mezinárodní protiúplatkářské a protikorupční zásady |
Appendix 3: International Anti-Bribery& Corruption Principles |
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Příloha č. 4: Dodatečná ujednání a podmínky |
Appendix 4: Additional Terms and Conditions |
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Příloha č. 1 Finanční podmínky Pfizer Protokol č. C3651003 |
Appendix 1 Financial Terms Pfizer Protocol # C3651003
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PŘÍLOHA č. 2 |
APPENDIX 2 |
Zpracování osobních údajů |
Personal Data Processing
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Ochrana a zveřejňování osobních údajů |
Personal Data Protection and Disclosure
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1.1 Osobní údaje. „Osobní údaje“ mají význam stanovený platnými právními předpisy a zahrnují bez omezení jakékoli informace (bez ohledu na médium a samotné nebo v kombinaci s jinými dostupnými informacemi), které identifikují nebo se vztahují k identifikované nebo identifikovatelné fyzické osobě. Klíčem kódované nebo jinak pseudonymizované údaje se považují za osobní údaje, i když držitel těchto údajů nemá přístup ke klíči, který spojuje údaje s totožností jednotlivce. Osobní údaje shromážděné v souvislosti se Studií budou zahrnovat veškeré informace, které jsou zástupci zadavatele povinni předávat smluvním stranám, jakož i osobní údaje týkající se Hlavního zkoušejícího, spoluzkoušejících, Členů studijního týmu, třetích stran a subjektů hodnocení.
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1.1 Personal Data. “Personal Data” has the meaning given by applicable law and includes, without limitation, any information (regardless of the medium and whether alone or in combination with other available information) that identifies or relates to an identified or identifiable natural person. Key‑coded or otherwise pseudonymized data are considered Personal Data even if the holder of those data does not have access to the key that links the data to the identity of an individual. Personal data collected in association with the Study will include any information that Sponsor representatives are required to submit to the Contracting Parties, as well as Personal Data relating to the Principal Investigator, sub-investigators, Study Team Members, third parties, and trial subjects.
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1.2 Kontrola a dodržování předpisů. Centrum a Zadavatel jsou nezávislí správci údajů, pokud jde o zacházení s údaji o pacientech. Zadavatel se považuje za nezávislého správce, pokud jde o zpracování osobních údajů nahlášených Centrem Zadavateli podle Protokolu Studie a Smlouvy. Centrum je správcem osobních údajů shromážděných od subjektu hodnocení v souvislosti s léčbou subjektu hodnocení v souladu se standardní lékařskou péčí a povinnostmi dle platných právních předpisů. Centrum a Zadavatel budou dodržovat platné zákony o ochraně údajů, včetně implementace inventáře a příslušného bezpečnostního programu, jmenování pověřence pro ochranu údajů a plnění dohod o zpracování se zpracovateli, které jmenují. Centrum a Zadavatel budou odpovědní za jakékoli neplnění svých vlastních úkolů jakožto správci údajů, včetně jakéhokoli neplnění ze strany zpracovatele, kterého najali.
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1.2 Controllership and compliance. Center and Sponsor are independent data controllers with respect to the handling of patient data. Sponsor considers itself an independent controller with respect to its processing of personal data reported by Center to Sponsor pursuant to the Study Protocol and the Agreement. The Center remains the controller of personal data collected from the trial subject with respect to the treatment of the trial subject pursuant to medical standard of care and applicable legal obligations. Center and Sponsor will comply with data protection applicable law, including but not limited to the implementation of the inventory and an appropriate security program, the appointment of a data protection officer and the execution of processing agreements with the processors they respectively appoint. Center and Sponsor will be responsible for any noncompliance of its own tasks as data controller, including any noncompliance by a processor which it has engaged.
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1.3 Spolupráce. Strany budou spolupracovat a vzájemně si pomáhat v souvislosti s jakýmikoli posouzeními dopadů na ochranu údajů a / nebo regulačními konzultacemi, které mohou být požadovány v souvislosti se zpracováním údajů prováděným podle této smlouvy. Centrum neprodleně informuje Zadavatele o (i) veškerých oznámeních přijatých od orgánu pro ochranu údajů, která se vztahují ke Studii; a (ii) bezpečnostní incident související s osobními údaji udržovanými centrem na základě Smlouvy. Oznámení bude obsahovat dostatečné informace pro zadavatele k poskytnutí zpětné vazby Centru pouze jako zúčastněná strana, nikoli jako právní nebo regulační radu. Centrum určí, zda bude bezpečnostní incident považován za porušení zabezpečení dat, provede všechna požadovaná oznámení a provede veškerá nezbytná opatření k nápravě bezpečnostního incidentu a bude odpovědné za veškeré náklady a pokuty spojené s těmito oznámeními a nápravnými opatřeními.
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1.3 Cooperation. The parties will cooperate and assist each other with respect to any data protection impact assessments and/or regulatory consultations that may be required with respect to data processing carried out under the Agreement. Center will immediately notify Sponsor of (i) any notices received from a data protection authority that relate to the Study; and (ii) a security incident related to Personal Data maintained by Center under the Agreement. The notification will contain sufficient information for Sponsor to provide feedback, solely as an interested party and not as legal or regulatory advice, to Center. Center will determine if the security incident will be considered a data security breach and conduct all required notifications as well as perform all necessary actions to remediate the security incident and be responsible for all costs and penalties associated with these notifications and remedies.
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1.4 Práva subjektů účastnících se studie, jejichž údaje se zpracovávají. Centrum a Zadavatel souhlasí s tím, že mezi nimi bude Centrum nejlépe schopno spravovat žádosti o ochranu údajů od subjektů hodnocení a bude reagovat na žádosti subjektů hodnocení v souladu s platnými zákony. Centrum bude Zadavatele neprodleně informovat na adrese Research_dataprivacy@pfizer.com o každém odvolání jakéhokoli souhlasu se zpracováním údajů poskytnutým subjektem hodnocení. V rozsahu, ve kterém Centrum nebude schopno žádostem subjektů hodnocení vyhovět, Centrum bude kontaktovat Zadavatele a projedná řešení požadavku. Centrum bude odpověedné za předání řešení subjektu hodnocení.
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1.4 Rights of Data Subjects Participating in the Study. Center and Sponsor agree that, as between them, Center is best able to manage data protection requests from trial subjects and will will respond to trial subjects’ requests in accordance with applicable law. Center will promptly notify Sponsor at Research_dataprivacy@pfizer.com of any withdrawal of any consent to data processing provided by a trial subject. To the extent that the Center will not be able to resolve the trial subject requests, the Center will contact the Sponsor and will discuss a resolution of the request. The Centre shall be responsible for providing a resolution to a trial subject.
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1.5 Osobní údaje zaměstnanců Centra. Centrum potvrzuje, že obdrželo oznámení společnosti Pfizer o ochraně osobních údajů pro Zkoušející a pracovníky Studie – Evropská unie, Evropský hospodářský prostor a Švýcarsko.
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1.5 Personal Data of Center staff. Center acknowledges that it has received the Pfizer Privacy Notice for Investigators and Study Personnel – European Union, European Economic Area, and Switzerland.
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APPENDIX 3 / PŘÍLOHA č. 3
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PFIZER INTERNATIONAL ANTI-BRIBERY AND |
MEZINÁRODNÍ PROTIÚPLATKÁŘSKÉ A PROTIKORUPČNÍ ZÁSADY |
ANTI-CORRUPTION BUSINESS PRINCIPLES |
SPOLEČNOSTI PFIZER |
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Pfizer has a long-standing policy forbidding bribery and corruption in the conduct of our business in the United States or abroad. Pfizer is committed to performing business with integrity, and acting ethically and legally in accordance with all applicable laws and regulations. We expect the same commitment from the consultants, agents, representatives or other companies and individuals acting on our behalf (“Business Associates”), as well as those acting on behalf of Business Associates (e.g., subcontractors), in connection with work for Pfizer. |
Společnost Pfizer dlouhodobě prosazuje firemní politiku zakazující úplatky a korupci při obchodní činnosti ve Spojených státech i v zahraničí. Společnost Pfizer se zavázala vykonávat svou obchodní činnost bezúhonným, etickým a zákonným způsobem v souladu se všemi příslušnými zákony a nařízeními. Stejný závazek očekáváme od našich poradců, zmocněnců, zástupců nebo dalších společností či fyzických osob jednajících naším jménem (dále jen „Obchodních partnerů”), jakož i od osob jednajících jménem těchto Obchodních partner (např. subdodavatelů) v souvislosti s prací pro společnost Pfizer. |
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Bribery of Government Officials |
Uplácení úředních osob |
Most countries have laws that forbid making, offering or promising any payment or anything of value (directly or indirectly) to a Government Official when the payment is intended to influence an official act or decision to award or retain business. |
Ve většině států existují zákony zakazující (přímé či nepřímé) poskytování, nabízení nebo slibování jakýchkoli plateb nebo čehokoli hodnotného úředním osobám s úmyslem ovlivnit úřední úkony či rozhodnutí o získání či udržení určité obchodní příležitosti. |
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“Government Official” shall be broadly interpreted and means: |
Pojem „Úřední osoba“ je vykládán v širokém smyslu a zahrnuje: |
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(i) any elected or appointed Government official (e.g., a legislator or a member of a Government ministry); |
(i) jakoukoli volenou nebo jmenovanou úřední osobu (např. zákonodárce nebo úředníka ministerstva vlády); |
(ii) any employee or individual acting for or on behalf of a Government Official, agency, or enterprise performing a governmental function, or owned or controlled by, a Government (e.g., a healthcare professional employed by a Government hospital or researcher employed by a Government university); |
(ii) jakéhokoli zaměstnance nebo osobu jednající jménem nebo z pověření úřední osoby, úřadu vlády nebo podniku, který vykonává vládní funkci nebo který vlastní či řídí vláda (např. zdravotníka zaměstnaného ve státní nemocnici nebo výzkumného pracovníka zaměstnaného na státní univerzitě); |
(iii) any political party officer, candidate for public office, officer, or employee or individual acting for or on behalf of a political party or candidate for public office; |
(iii) jakéhokoli představitele politické strany, kandidáta na veřejnou funkci, úředníka, zaměstnance nebo osobu jednající jménem nebo z pověření politické strany nebo kandidáta na veřejnou funkci; |
(iv) any employee or individual acting for or on behalf of a public international organization; |
(iv) jakéhokoli zaměstnance nebo osobu jednající jménem nebo z pověření veřejné mezinárodní organizace; |
(v) any member of a royal family or member of the military; and |
(v) jakéhokoli člena královské rodiny nebo příslušníka armády; a |
(vi) any individual otherwise categorized as a Government Official under law. |
(vi) jakoukoli osobu jinak ze zákona považovanou za úřední osobu. |
“Government” means all levels and subdivisions of governments (i.e., local, regional, or national and administrative, legislative, or executive). |
Pojem „Vláda“ v tomto kontextu zahrnuje všechny úrovně a složky vlády (tj. orgány na místní, krajské i celostátní úrovni, a to správní, zákonodárné i výkonné). |
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Because this definition of “Government Official” is so broad, it is likely that Business Associates will interact with a Government Official in the ordinary course of their business on behalf of Pfizer. For example, doctors employed by Government-owned hospitals would be considered “Government Officials.” |
Vzhledem k širokému pojetí definice úřední osoby je pravděpodobné, že Obchodní partneři budou v rámci své obvyklé činnosti pro společnost Pfizer s úředními osobami běžně jednat. Například lékaři zaměstnaní ve státních nemocnicích se podle zásad společnosti Pfizer považují za Úřední osoby. |
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The U.S. Foreign Corrupt Practices Act (the “FCPA”) prohibits making, promising, or authorizing a payment or providing anything of value to a non-U.S. Government Official to improperly or corruptly influence that official to perform any governmental act or make a decision to assist a company in obtaining or retaining business, or to otherwise gain an improper advantage. The FCPA also prohibits a company or person from using another company or individual to engage in any such activities. As a U.S. company, Pfizer must comply with the FCPA and could be held liable as a result of acts committed anywhere in the world by a Business Associate. |
Americký zákon o zahraničních korupčních praktikách (dále jen „FCPA“) zakazuje poskytování, slibování nebo schvalování platby nebo poskytování čehokoli hodnotného zahraniční úřední osobě za účelem nepatřičného nebo korupčního ovlivnění jednání nebo rozhodování takovéto osoby s úmyslem pomoci společnosti získat nebo si udržet obchodní příležitost nebo získat jinou nepatřičnou výhodu. FCPA rovněž zakazuje společnostem či osobám využívat jiných společností nebo fyzických osob k provádění kterékoli z výše uvedených činností. Společnost Pfizer je jako americká společnost povinna dodržovat ustanovení FCPA a může nést právní odpovědnost za jednání, jehož se kdekoli na světě dopustí kterýkoli z jejích Obchodních partnerů. |
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Anti-Bribery and Anti-Corruption Principles Governing Interactions with Governments and Government Officials |
Protiúplatkářské a protikorupční zásady upravující vztahy s Vládami a Úředními osobami |
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Business Associates must communicate and abide by the following principles with regard to their interactions with Governments and Government Officials: |
Obchodní partneři jsou povinni sdělovat a dodržovat následující zásady týkající se jejich vztahů s Vládami a Úředními osobami: |
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• Business Associates, and those acting on their behalf in connection with work for Pfizer, may not directly or indirectly make, promise, or authorize the making of a corrupt payment or provide anything of value to any Government Official to induce that Government Official to perform any governmental act or make a decision to help Pfizer obtain or retain business. Business Associates, and those acting on their behalf in connection with work for Pfizer, may never make a payment or offer any item or benefit to a Government Official, regardless of value, as an improper incentive for such Government Official to approve, reimburse, prescribe, or purchase a Pfizer product, to influence the outcome of a clinical trial, or to otherwise benefit Pfizer’s business activities improperly. |
• Obchodní partneři a osoby jednající jejich jménem v souvislosti s prací pro společnost Pfizer nesmí přímo ani nepřímo poskytovat, slibovat nebo schvalovat provedení korupční platby nebo poskytování čehokoli hodnotného kterékoli Úřední osobě s úmyslem ji přimět, aby učinila určitý úkon nebo přijala určité rozhodnutí, které společnosti Pfizer pomůže získat nebo udržet si obchodní příležitost. Obchodní partneři a osoby jednající jejich jménem v souvislosti s prací pro společnost Pfizer nesmí nikdy poskytnout žádné Úřední osobě platbu nebo jí nabídnout jakýkoli předmět či výhodu (bez ohledu na jejich hodnotu) s úmyslem nepatřičně přimět Úřední osoby ke schválení, proplacení, předepsání nebo nákupu jakéhokoli přípravku společnosti Pfizer nebo ovlivnění výsledku klinického hodnocení nebo dosažení jakéhokoli jiného nepatřičného zvýhodnění obchodní činnosti společnosti Pfizer. |
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• In conducting their Pfizer-related activities, Business Associates, and those acting on their behalf in connection with work for Pfizer, must understand and comply with any local laws, regulations, or operating procedures (including requirements of Government entities such as Government-owned hospitals or research institutions) that impose limits, restrictions, or disclosure obligations on compensation, financial support, donations, or gifts that may be provided to Government Officials. If a Business Associate is uncertain as to the meaning or applicability of any identified limits, restrictions, or disclosure requirements with respect to interactions with Government Officials, that Business Associate should consult with his or her primary Pfizer contact before engaging in such interactions. |
• Obchodní partneři a osoby jednající jejich jménem v souvislosti s prací pro společnost Pfizer musí znát a dodržovat všechny místní zákony, nařízení nebo provozní postupy (včetně požadavků vládních subjektů, jako např. státních nemocnic nebo výzkumných ústavů), které stanoví limity, omezení nebo požadavky na zveřejnění odměn, finanční podpory, darů nebo dárkům, jež mohou být poskytovány Úředním osobám. Pokud si Obchodní partner není jistý významem nebo aplikovatelností kteréhokoli stanoveného limitu, omezení nebo požadavků na zvěřejnění v souvislosti s jednáním s Úředními osobami, měl by se před zahájením takového jednání obrátit na svou primární kontaktní osobu ve společnosti Pfizer. |
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• Business Associates, and those acting on their behalf in connection with work for Pfizer, are not permitted to offer facilitation payments. A “facilitation payment” is a nominal payment to a Government Official for the purpose of securing or expediting the performance of a routine, non-discretionary governmental action. Examples of facilitation payments include payments to expedite the processing of licenses, permits or visas for which all paperwork is in order. In the event that a Business Associate, or someone acting on their behalf in connection with work for Pfizer, receives or becomes aware of a request or demand for a facilitation payment or bribe in connection with work for Pfizer, the Business Associate shall report such request or demand promptly to his or her primary Pfizer contact before taking any further action. |
• Obchodní partneři a osoby jednající jejich jménem v souvislosti s prací pro společnost Pfizer nesmí nabízet odměny za urychlené vyřízení. „Odměnou za urychlené vyřízení“ se rozumí platby zanedbatelné částky Úředním osobám s cílem zajištění nebo urychlení rutinního úředního úkonu, ke kterému nemá rozhodovací pravomoci. Příkladem Odměny za urychlené vyřízení jsou platby za urychlené vyřízení licencí, povolení nebo víz, k nimž byly řádně doloženy veškeré potřebné podklady. Pokud Obchodní partner nebo osoba jednající jeho jménem v souvislosti s prací pro společnost Pfizer obdrží požadavek nebo se dozví o požadavku na Odměnu za urychlené vyřízení nebo úplatku v souvislosti s prací pro společnost Pfizer, je Obchodní partner povinen tuto skutečnost bezodkladně nahlásit své primární kontaktní osobě ve společnosti Pfizer předtím, než podnikne jakékoli další kroky. |
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Commercial Bribery |
Komerční úplatkářství |
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Bribery and corruption can also occur in non-Government, business to business relationships. Most countries have laws which prohibit offering, promising, giving, requesting, receiving, accepting, or agreeing to accept money or anything of value in exchange for an improper business advantage. Examples of prohibited conduct could include, but are not limited to, providing expensive gifts, lavish hospitality, kickbacks, or investment opportunities in order to improperly induce the purchase of goods or services. Pfizer colleagues are not permitted to offer, give, solicit or accept bribes, and we expect our Business Associates, and those acting on their behalf in connection with work for Pfizer, to abide by the same principles. |
K uplátkářství a korupci může docházet i mimo úřední styk, v obchodních vztazích mezi podniky. Ve většině států existují zákony zakazující nabízení, slibování, poskytování, požadování, přijímání nebo souhlas s přijímáním peněz nebo čekoholi hodnotného výměnou za poskytnutí nepatřičné obchodní výhody. Mezi příklady zakázaného jednání patří zejména poskytování drahých darů, okázalá pohostinnost, nezákonné provize nebo investiční příležitosti s cílem nepatřičně někoho přimět k nákupu zboží nebo služeb. Spolupracovníci společnosti Pfizer nesmí nabízet, poskytovat, požadovat nebo přijímat úplatky; společnost Pfizer očekává od svých Obchodních partnerů, jakož i od osob jednajících jejich jménem v souvislosti s prací pro společnost Pfizer, že budou dodržovat stejné zásady. |
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Anti-Bribery and Anti-Corruption Principles Governing Interactions with Private Parties and Pfizer Colleagues |
Protiúplatkářské a protikorupční zásady upravující vztahy se soukromými osobami a spolupracovníky společnosti Pfizer |
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Business Associates must communicate and abide by the following principles with regard to their interactions with private parties and Pfizer colleagues: |
Obchodní partneři jsou povinni sdělovat a dodržovat následující zásady týkající se jejich vztahů se soukromými osobami a spolupracovníky ve společnosti Pfizer: |
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• Business Associates, and those acting on their behalf in connection with work for Pfizer, may not directly or indirectly make, promise, or authorize a corrupt payment or provide anything of value to any person to influence that person to provide an unlawful business advantage for Pfizer. |
• Obchodní partneři a osoby jednající jejich jménem v souvislosti s prací pro společnost Pfizer nesmí přímo ani nepřímo provádět, slibovat nebo schvalovat provedení korupční platby nebo poskytnout cokoli hodnotného kterékoli osobě s cílem ji ovlivnit, aby poskytla společnosti Pfizer nezákonnou obchodní výhodu. |
• Business Associates, and those acting on their behalf in connection with work for Pfizer, may not directly or indirectly, solicit, agree to accept, or receive a payment or anything of value as an improper incentive in connection with their business activities performed for Pfizer. |
• Obchodní partneři a osoby jednající jejich jménem v souvislosti s prací pro společnost Pfizer nesmí přímo ani nepřímo požadovat, souhlasit s přijetím nebo přijímat platby nebo cokoli hodnotného jako nepatřičnou pobídku v souvislosti s jejich obchodní činností prováděnou pro společnost Pfizer. |
• Pfizer colleagues are not permitted to receive gifts, services, perks, entertainment, or other items of more than token or nominal monetary value from Business Associates, and those acting on their behalf in connection with work for Pfizer. Moreover, gifts of nominal value are only permitted if they are received on an infrequent basis and only at appropriate gift-giving occasions. |
• Spolupracovníci společnosti Pfizer nesmí od Obchodních partnerů a osob jednajících jejich jménem v souvislosti s prací pro společnost Pfizer přijímat žádné dary, služby, výhody, zábavu nebo jiné předměty s vyšší než symbolickou nebo zanedbatelnou peněžní hodnotou. Dary zanedbatelné hodnoty jsou dovoleny jen v případě, že jsou přijímány jen občas při vhodných příležitostech. |
Reporting Suspected or Actual Violations |
Ohlašování porušení nebo podezření na porušení |
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Business Associates, and those acting on their behalf in connection with work for Pfizer, are expected to raise concerns related to potential violations of these International Anti-Bribery and Anti-Corruption Principles or the law. Such reports can be made to a Business Associate’s primary point of contact at Pfizer, or if a Business Associate prefers, to Pfizer’s Compliance Group by e-mail at corporate.compliance@pfizer.com or by phone at 00-1-212-733-3026. |
Od Obchodních partnerů a osob jednajících jejich jménem v souvislosti s prací pro společnost Pfizer se očekává, že nahlásí své obavy ohledně možného porušení těchto mezinárodních protiúplatkářských a protikorupčních zásad nebo zákonů. Tato hlášení mohou být adresována primární kontaktní osobě Obchodního partnera ve společnosti Pfizer nebo, pokud to daný Obchodní partner upřednostňuje, oddělení Compliance společnosti Pfizer e-mailem na adresu corporate.compliance@pfizer.com nebo telefonicky na číslo 00-1-212-733-3026. |
PŘÍLOHA č. 4 |
APPENDIX 4
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DODATEČNÁ UJEDNÁNÍ A DODATEČNÉ PODMÍNKY
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ADDITIONAL TERMS AND CONDITIONS
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Článek 2 – Povinnosti Smluvních partnerů
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Article 2 – Obligations of the Contracting Partners
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2.32 Smluvní strany uznávají, že pokud je Hlavní zkoušející nebo jiný pracovník Studie povinen účastnit se schůzek zkoušejících pro tuto Studii, CRO zajistí a uhradí přímo cestu a ubytování a uhradí přiměřené náklady na stravu v souvislosti s těmito schůzkami, ale neposkytuje náhradu za takovou účast.
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2.32 The Contracting Parties accept that If Principal Investigator or other Study personnel are required to attend investigator meetings for this Study, CRO will arrange and pay directly for travel and accommodation and will cover the reasonable costs of meals in connection with those meetings but does not provide compensation for such attendance.
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2.33 Hlavní zkoušející zajistí přesné a včasné shromažďování, zaznamenávání a předkládání údajů ze Studie, včetně dodržování časových harmonogramů pro zadávání údajů stanovených v dokumentu CRF Požadavky na dodržení předpisů, který je Hlavnímu zkoušejícímu poskytován CRO nebo Zadavatelem.
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2.33 Principal Investigator will ensure accurate and timely collection, recording, and submission of Study data, including adhering to timelines for data entry set out in the CRF Completion Requirements document provided to Principal Investigator by CRO or Sponsor.
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2.34 Kromě ohlašovacích povinností uvedených v článku 2.12 budou Smluvní partneři okamžitě informovat Zadavatele o jakýchkoli naléhavých bezpečnostních opatřeních přijatých Hlavním zkoušejícím k ochraně subjektů hodnocení před bezprostředním nebezpečím.
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2.34 In addition to the reporting obligations detailed in Article 2.12, Contracting Partners will inform Sponsor immediately of any urgent safety measures taken by Principal Investigator to protect trial subjects against immediate hazard.
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2.35 Smluvní strany nebudou subjektu hodnocení ani plátci třetí strany účtovat za Hodnocené léky ani za žádné služby hrazené CRO nebo zadavatelem na základě této Smlouvy žádné poplatky.
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2.35 Contracting Parties will not charge a trial subject or third-party payer for Study Drugs or for any services reimbursed by CRO or Sponsor under this Agreement.
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2.36 Smluvní strany potvrzují, že neexistují žádné platné předpisy ani jiné povinnosti, které by jim zakazovaly provádět Studii a uzavřít tuto Smlouvu.
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2.36 The Contracting Parties confirm that there are no applicable regulations or other obligations that prohibit them from conducting the Study and entering into this Agreement.
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2.37 Pokud jde o dokumenty uložené v souladu s článkem 2.22, Centrum souhlasí s kontaktováním Zadavatele na adrese InvestigatorRecords@Pfizer.com před zničením jakýchkoli studijních záznamů a dále souhlasí s tím, aby zadavateli umožnilo zajistit, aby byly studijní záznamy v případě potřeby uchovány po delší dobu, a to na náklady Zadavatele, na základě ujednání, které chrání důvěrnost záznamů (např. zabezpečené externí úložiště). Centrum bude kontaktovat Zadavatele na konci doby pro archivaci, jak je uvedeno v článku 2.22 této Smlouvy, a sdělí Zadavateli, že záznamy zničí, pokud ho Zadavatel nebude do 60 dnů kontaktovat a informovat jinak. Pokud tak Zadavatel v uvedené lhůtě neučiní nebo nepodá další instrukce Centru ohledně archivace, je Centrum oprávněno přistoupit za předpokladu, že to nevylučují platné právní předpisy k likvidaci uchovávané dokumentace.
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2.37 With regard to documents stored in accordance with Article 2.22, Center agrees to contact Sponsor at InvestigatorRecords@Pfizer.com prior to destroying any Study records and further agrees to permit Sponsor to ensure that the Study records are retained for a longer period if necessary, at Sponsor’s expense, under an arrangement that protects the confidentiality of the records (e.g., secure off-site storage). Center will contact Sponsor at the end of the retention period as stated in Article 2.22 hereto, and tell Sponsor that it will destroy the records if it does not hear back from Sponsor within 60 days. If the Sponsor fails to do so within the given period or does not provide further archiving instructions, the Center is entitled, provided that this is not forbidden by the applicable law, to destroy the archived documents.
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2.38 Biologické vzorky. Pokud je to stanoveno v protokolu a dokumentu s informovaným souhlasem, Hlavní zkoušející může shromáždit a poskytnout CRO, Zadavateli nebo jím pověřenému zástupci biologické vzorky získané od subjektů hodnocení (např. krev, moč, tkáň, sliny atd.) K testování, které přímo nesouvisí s péčí o subjekt hodnocení nebo se sledováním bezpečnosti, jako je farmakokinetické, farmakogenomické testování nebo testování biomarkerů („biologické vzorky“). Biologické vzorky mohou zahrnovat osobní údaje subjektů hodnocení (jak je definováno níže)
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2.38 Biological Samples. If so specified in the Protocol and the informed consent document, Principal Investigator may collect and provide to CRO, Sponsor or their designee, biological samples obtained from trial subjects (e.g., blood, urine, tissue, saliva, etc) for testing that is not directly related to trial subject care or safety monitoring, such as pharmacokinetic, pharmacogenomic, or biomarker testing (“Biological Samples”). Biological Samples may include Personal Data (as defined below) of trial subjects.
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2.39 Elektronický archiv pracoviště Zkoušejícího. CRO nebo Zadavatel může požádat Centrum a Hlavního zkoušejícího, aby použili elektronický archiv souborů pracoviště Zkoušejícího specifikovaný CRO nebo Zadavatelem, nebo mohou schválit použití elektronického archivu pracoviště poskytovaného centrem (souhrnně „systém e-ISF“) k udržování archivu na pracovišti Zkoušejícího v Centru, který bude obsahovat studijní záznamy.
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2.39 Electronic Investigator Site File. CRO or Sponsor may request Center and Principal Investigator to use an electronic investigator site file binder solution specified by the CRO or Sponsor or may approve the use of an electronic site file binder solution provided by the Center (collectively “e-ISF Solution”) to maintain the investigator site file at the Center that includes Study records.
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Článek 5 – Práva na výsledky |
Article 5 – Rights to Results
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5.9 Smluvní strany zajistí, aby Členové studijního týmu přidělili všechna svá vlastnická práva k výsledkům uvedeným v článku 5.1 Zadavateli.
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5.9 The Contracting Parties will ensure that Study Team Members assign all of their proprietary rights to Results detailed in Article 5.1 to the Sponsor
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5.10 S výjimkou použití uvedeného v Protokolu Zadavatel neuděluje smluvním partnerům žádná výslovná ani předpokládaná práva na duševní vlastnictví na Hodnocený lék Zadavatele ani na jakékoli metody výroby nebo používání Hodnoceného léku Zadavatele.
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5.10 Except for, and limited to, the use specified in the Protocol, Sponsor grants Contracting Partners no express or implied intellectual property rights in the Sponsor Drug or in any methods of making or using the Sponsor Drug.
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Článek 6 – Zachovávání důvěrnosti |
Article 6 – Confidentiality
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6.8 Jakákoli data (jak jsou definována v článku 10.1), která Hlavní zkoušející nebo Centrum shromažďuje, zpracovává, ukládá, převádí nebo používá v souvislosti s prováděním a podáváním zpráv o studii, musí být pro účely této Smlouvy rovněž identifikována a považována za důvěrné informace a podléhají ustanovením článku 6. |
6.8 Any Data (as defined in Article 10.1) that Principal Investigator or Center collects, processes stores, transfers, or uses in connection with the conduct and reporting of the Study is also to be identified and treated as Confidential Information for purposes of this Agreement and subject to the provisions of Article 6.
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Článek 8 – Zákonná odpovědnost a odškodnění
8.5 Pokud bude vznesen jakýkoli nárok nebo žaloba, která spadá do odškodnění poskytnutého Zadavatelem v článku 8, smluvní partneři v rozsahu povoleném zákonem, na žádost Zadavatele a na náklady Zadavatele, souhlasí s tím, že Zadavateli poskytnou plnou součinnost a kontrolu v souvislosti s nárokem nebo soudním sporem s využitím právního zastoupení podle vlastního výběru.
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Article 8 – Liability and Indemnity
8.5 If any claim or lawsuit is received that falls within the indemnity given by the Sponsor in Article 8, the Contracting Partners agree to the extent permitted by law, on Sponsor’s request, and at Sponsor’s cost, agree to permit Sponsor to have full care and control of the claim or lawsuit using legal representation of its own choosing.
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Článek 10 – Ochrana a zveřejňování osobních údajů
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Article 10 - Personal Data Protection and Disclosure |
10.6 V zájmu transparentnosti vztahů se Zkoušejícími a studijními pracovišti nebo k zajištění souladu s platnými místními zákony může Zadavatel zveřejnit podporu, kterou poskytuje podle této Smlouvy. V takovém zveřejnění Zadavatelem může být identifikováno jak Centrum, tak Hlavní zkoušející, ale bude se jasně rozlišovat mezi platbami nebo jinými odměnami pro instituce a těmi, které se provádějí jednotlivcům.
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10.6 In the interest of transparency relating to its relationships with investigators and study sites or to ensure compliance with applicable local law, Sponsor may publicly disclose the support it provides under this Agreement. Such a disclosure by Sponsor may identify both the Center and the Principal Investigator but will clearly differentiate between payments or other transfers of value to institutions and those made to individuals.
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10.7 Zadavatel si vyhrazuje právo určit Hlavního zkoušejícího a Centrum v souvislosti se seznamem protokolu v databázi klinických hodnocení Národního ústavu zdraví ve Spojených státech (United States National Institutes of Health, NIH), jinými veřejně dostupnými výpisy probíhajících klinických studií nebo jinými službami či mechanismy pro nábor subjektů hodnocení.
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10.7 Sponsor reserves the right to identify the Principal Investigator and Center in association with a listing of the Protocol in the United States National Institutes of Health (NIH) Clinical Trials Data Bank, other publicly available listings of ongoing clinical trials, or other trial subject recruitment services or mechanisms
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Článek 12 – Ukončení |
Article 12 – Termination
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12.9 Pokud smluvní partneři nebudou dodržovat podmínky článku 13.3, Zadavatel může Studii okamžitě ukončit na základě písemného oznámení a neposkytne Centru žádnou další platbu podle této Smlouvy, bez ohledu na jakékoli aktivity, které smluvní partneři podnikli, nebo dohody třetích stran, jež smluvní partneři uzavřeli před ukončením Smlouvy.
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12.9 If Contracting Partners fail to comply with the terms of Article 13.3, Sponsor may terminate the Study immediately upon written notice and will not provide Center with any further payment under this Agreement, regardless of any activities that Contracting Partners have undertaken or third-party agreements that Contracting Partners entered into before termination.
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Článek 13 – Různé |
Article 13 – Miscellaneous
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13.14 Zadavatel je zamýšleným příjemcem této Smlouvy jako třetí strana a je oprávněn přímo vymáhat veškerá svá práva vyplývající z této smlouvy. Pokud třetí strana získá práva na Zadavatelův přípravek a Zadavatel převede sponzorství studie na třetí stranu, Zadavatel může volně převést některá nebo všechna svá práva a povinnosti podle této Smlouvy na nového zadavatele.
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13.14 Sponsor is an intended third-party beneficiary to this Agreement and is entitled to enforce directly any and all of its rights under it. If a third party acquires rights in the Sponsor Drug and Sponsor transfers sponsorship of the Study to the third party, Sponsor may freely transfer any or all of its rights and obligations under this Agreement to the new sponsor.
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13.15 Zveřejnění upravené smlouvy. Při nebo před uzavřením této Smlouvy poskytne CRO centru redigovanou verzi Smlouvy ve formátu PDF („Upravená smlouva“), přičemž odstranil veškeré informace, které dle rozumného úsudku CRO nebo Zadavatele představují obchodní tajemství CRO nebo Zadavatele. Do 5 dnů od přijetí Upravené smlouvy zveřejní Centrum Upravenou smlouvu v registru smluv vedeném Ministerstvem vnitra (dále jen „registr smluv“) v souladu se zákonem 340/2015 Sb. v registru smluv. Centrum poskytne CRO důkazy o zveřejnění Upravené smlouvy, jakmile to bude rozumně proveditelné. Pokud CRO neobdrží důkaz o zveřejnění Upravené smlouvy do 7 dnů od přijetí Upravené smlouvy Centrem, bude CRO nebo Zadavatel oprávněn zveřejnitUpravenou smlouvu v registru smluv. Strany berou na vědomí, že Smlouva není platná, dokud nebude zveřejněna v registru smluv, a souhlasí s tím, že nebudou zahájeny žádné smluvní aktivity související se Studií, dokud obě strany neobdrží potvrzení o tomto zveřejnění. Veškeré písemné změny provedené podle podmínek této Smlouvy budou upraveny a zveřejněny v souladu s postupem stanoveným v tomto článku.
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13.15 Publication of Redacted Agreement. On or before execution of this Agreement, CRO will provide Center with a redacted version of the Agreement in PDF format (“Redacted Agreement”), having removed any information which in CRO’s or Sponsor’s reasonable opinion constitutes a CRO or Sponsor trade secret. Within 5 days of receipt of the Redacted Agreement, Center will publish the Redacted Agreement in the contract registry maintained by the Ministry of the Interior (“Contract Registry”) in accordance with Act 340/2015 Coll. on Contract Registry. Center will provide CRO with evidence of publication of the Redacted Agreement as soon as is reasonably practicable. If CRO does not receive evidence of publication of the Redacted Agreement within 7 days of receipt of the Redacted Agreement by Center, CRO or Sponsor will be entitled to publish the Redacted Agreement in the Contract Registry. The parties acknowledge that the Agreement is not valid until published in the Contract Registry and agree that no contracted Study-related activities will commence until both parties are in receipt of confirmation of such publication. Any written amendments made pursuant to the terms of this Agreement shall be redacted and published in accordance with the procedure set out in this Article.
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C3651003_PI Prof. Melichar_Approved for signature_CS_BH/07Mar23