Zpracování dat Sample Clauses

Zpracování dat. Each Party shall be responsible for its own processing of Personal Data and Quintiles shall ensure that any Personal Data relating to a Study Subject, Investigator and/or Study Staff, is collected, stored, used, disclosed and transferred in accordance with all applicable supranational and national privacy laws and with the informed consents that are or will be obtained from Study Subjects. Investigator shall be responsible for obtaining and providing Quintiles with written consent (in the form agreed with Quintiles) from each Study Staff for the collection, use and disclosure of their Personal Data. Každá smluvní strana nese odpovědnost za vlastní zpracovávání osobních údajů. Quintiles zajistí, aby byly osobní údaje Subjektů studie, Zkoušejícího a případně Studijního personálu shromažďovány, ukládány, využívány, sdělovány a předávány v souladu s platnými mezinárodními a národními předpisy o ochraně soukromí a v souladu s informovaným souhlasem, který byl nebo bude získán od Subjektů studie. Zkoušející bude povinen získat od všech pracovníků klinického hodnocení písemný souhlas (v podobě, na níž se dohodne s Quintiles) se shromažďováním, využíváním a sdělováním jejich osobních údajů a předat ho Quintiles.
AutoNDA by SimpleDocs
Zpracování dat. Each Party shall be responsible for its own processing of Personal Data and IQVIA and Sponsor shall ensure that any Personal Data relating to a Study Subject, Investigator and/or Study Staff, is collected, stored, used, disclosed and transferred in accordance with all applicable supranational and national privacy laws and with the informed consents that are or will be obtained from Study Subjects. Každá smluvní Strana nese odpovědnost za vlastní zpracovávání osobních údajů. IQVIA a Zadavatel zajistí, aby byly osobní údaje Subjektů studie, Zkoušejícího a případně Studijního personálu shromažďovány, ukládány, využívány, sdělovány a předávány v souladu s platnými mezinárodními a národními předpisy o ochraně soukromí a v souladu s informovaným souhlasem, který byl nebo bude získán od Subjektů studie. The Institution shall appoint a person that shall act as a primary point of contact and shall respond to all Data Subjects’ rights exercised by the Study Subjects and/or the Study Staff in respect to the processing of their Personal Data in relation to this Agreement (“Data Subject’s Request”). The Institution and/or Investigator shall inform the Sponsor and/or IQVIA and request its assistance in responding to a Data Subject’s Request only to the extent the Institution or Investigator is unable to manage and respond to the Data Subject’s Request without information which could only be provided by the Sponsor and/or IQVIA. To the extent, the Sponsor and/or IQVIA needs to provide information to the Institution or Investigator, the Institution or Investigator shall inform the Zdravotnické zařízení jmenuje osobu, která bude primární kontakt a bude odpovídat na všechny žádosti či dotazy vznesené v rámci uplatňování těch práv Subjektů studie, které tyto subjekty mají jako Subjekty údajů, a/nebo práv Studijního personálů ve vztahu ke zpracování jejich Osobních údajů v souvislosti s touto Smlouvou (dále jen „Žádost Subjektu údajů“). Zdravotnické zařízení a/nebo Zkoušející uvědomí Zadavatele a/nebo společnost IQVIA o Žádosti Subjektu údajů a vyžádá si jejich součinnost při odpovídání na takovou žádost, avšak pouze v tom rozsahu, v jakém Zdravotnické zařízení nebo Zkoušející nemohou tuto Žádost Subjektu údajů zpracovat nebo na ni odpovědět bez informací, které může poskytnout pouze Sponsor and/or IQVIA within five (5) days upon receiving the Data Subject’s Request. Under such circumstances, the Sponsor and/or IQVIA shall cooperate with the Institution or Investigator and sh...
Zpracování dat. Each Party shall be responsible for its own processing of Personal Data and IQVIA and Sponsor shall ensure that any Personal Data Každá smluvní Strana nese odpovědnost za vlastní zpracovávání osobních údajů. IQVIA a Zadavatel zajistí, aby byly osobní relating to a Study Subject, Investigator and/or Study Staff, is collected, stored, used, disclosed and transferred in accordance with all applicable supranational and national privacy laws and with the informed consents that are or will be obtained from Study Subjects. údaje Subjektů studie, Zkoušejícího a případně Studijního personálu shromažďovány, ukládány, využívány, sdělovány a předávány v souladu s platnými mezinárodními a národními předpisy o ochraně soukromí a v souladu s informovaným souhlasem, který byl nebo bude získán od Subjektů studie. The Institution shall appoint a person that shall act as a primary point of contact and shall respond to all Data Subjects’ rights exercised by the Study Subjects and/or the Study Staff in respect to the processing of their Personal Data in relation to this Agreement (“Data Subject’s Request”). The Institution and/or Investigator shall inform the Sponsor and/or IQVIA and request its assistance in responding to a Data Subject’s Request only to the extent the Institution or Investigator is unable to manage and respond to the Data Subject’s Request without information which could only be provided by the Sponsor and/or IQVIA. To the extent, the Sponsor and/or IQVIA needs to provide information to the Institution or Investigator, the Institution or Investigator shall inform the Sponsor and/or IQVIA within five (5) days upon receiving the Data Subject’s Request. Under such circumstances, the Sponsor and/or IQVIA shall cooperate with the Institution or Investigator and shall provide the Institution or Investigator with, subject to applicable laws, the requested information and undertake any reasonable actions to enable the Institution or Investigator to respond to the Data Subject’s Request. The Institution and/or Investigator shall, upon the reasonable request by Sponsor and/or IQVIA, provide Sponsor and/or IQVIA with any information, undertake any actions or provide assistance to the Sponsor and/or IQVIA as may be required by the Sponsor and/or IQVIA to respond to a Data Subject’s Request. Zdravotnické zařízení jmenuje osobu, která bude primární kontakt a bude odpovídat na všechny žádosti či dotazy vznesené v rámci uplatňování těch práv Subjektů studie, které tyto subj...
Zpracování dat. Každá smluvní strana nese odpovědnost za vlastní zpracovávání osobních údajů. Společnost Quintiles zajistí, aby byly osobní údaje Subjektů studie, Zkoušejícího a případně Studijního personálu shromažďovány, ukládány, využívány, sdělovány a předávány v souladu s platnými mezinárodními a národními předpisy o ochraně soukromí a v souladu s informovaným souhlasem, který byl nebo bude získán od Subjektů studie. Zkoušející bude povinen získat od všech členů Studijního personálupísemný souhlas (v podobě, na níž se dohodne se společností Quintiles) s využíváním a sdělováním jejich osobních údajů a předat ho společnosti Quintiles.

Related to Zpracování dat

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Pharmacovigilance Licensee shall maintain until the termination of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled) pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement. Licensee shall ensure that it will comply with all Applicable Law regarding Licensed Product in the Territory, including, without limitation, those laws and regulations relating to risk management, drug safety and pharmacovigilance. If Licensee becomes aware of any adverse reaction relating to Licenced Product in connection with this Agreement, Licensee shall inform MPP and Pfizer within twenty-four (24) hours of its becoming aware and cooperate with Pfizer in fulfilling Pfizer’s reporting responsibilities under Applicable Law. Licensee will be responsible for fulfilling all pharmacovigilance activities pursuant to the local regulations and requirements for the Licenced Products in the Territory and provide MPP and Pfizer with a report containing information regarding all such activities. Such report shall be provided annually, on February 1 of each year, and otherwise on reasonable request by MPP or Pfizer to both MPP and Pfizer’s pharmacovigilance contact as may be designated by Pfizer from time to time. Licensee shall notify MPP and Pfizer forthwith of the receipt of an enquiry from an Agency in the Territory relating to Licensed Product that concerns any safety issue. If Licensee becomes aware of any action that may be, will be or has been taken by an Agency for a safety reason connected with Licensed Product, it shall immediately, and in any event no later than twenty-four

  • Pharmacovigilance Agreement Subject to the terms of this Agreement, and at a date to be determined by the JDC, Facet and Trubion shall define and finalize the actions the Parties shall employ to protect patients and promote their well-being in a written agreement (hereinafter referred to as the “Pharmacovigilance Agreement”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Collaboration Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations to Governmental Authorities. Furthermore, such agreed procedures shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. The Pharmacovigilance Agreement will provide for a worldwide safety database to be maintained by the Party appointed by the JDC. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement (as the Parties may agree to modify it from time to time) and to cause its Affiliates and permitted sublicensees to comply with such obligations.

  • Reverse Engineering The Customer must not reverse assemble or reverse compile or directly or indirectly allow or cause a third party to reverse assemble or reverse compile the whole or any part of the software or any products supplied as a part of the Licensed System.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Manufacturing Technology Transfer Except as the Committee ------------ --------------------------------- may otherwise agree in writing, in order to effectuate an orderly transition of the uninterrupted availability of Product to LILLY for purposes contemplated under this Agreement, MEGABIOS, at least ninety (90) days prior to completion of the Project or completion of Phase I Clinical Trials, whichever is earlier, shall transfer to LILLY all information and instructions concerning the manufacturing process and related matters in MEGABIOS' possession which may be necessary for LILLY to manufacture Product (including information regarding obtaining necessary Lipids related thereto) for clinical trials and commercialization as contemplated hereunder including, but not limited to, analytical and manufacturing methods. MEGABIOS shall also provide assistance (in the form of consultation) to LILLY with respect to manufacturing matters for a period of [ * ] months after completion of the initial transfer of information and instructions as provided below. Such transfer and assistance by MEGABIOS will be referred to herein as the "Manufacturing Transfer." All such information, methods and instructions transferred to LILLY under this Section 4.3 shall be referred to herein as the "Manufacturing Information," and shall be maintained in confidence by LILLY pursuant to Section 7.1, except that LILLY's obligation to maintain in confidence such Manufacturing Information shall survive for ten (10) years following expiration or termination of this Agreement. LILLY agrees that it will use all such transferred Manufacturing Information only for the manufacture of the Products and shall not disclose or transfer such Manufacturing Information to any third party manufacturer except as provided in Section 2.10. MEGABIOS shall provide, and bear its costs for, up to [ * ] FTEs for a period of up to [ * ] months [ * ] in aggregate) to accomplish the Manufacturing Transfer. Such FTEs, at LILLY's request, shall include visits to LILLY's facilities by MEGABIOS personnel including up to [ * ] from MEGABIOS' head of manufacturing. MEGABIOS shall furnish any additional reasonable assistance beyond the assistance described above regarding manufacturing matters that LILLY may request and that MEGABIOS is able to provide, for up to [ * ] after the initial transfer of Manufacturing Information, providing that LILLY [ * ] incurred with respect to such additional assistance.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.

  • Contractor Sales Reporting Vendor Management Fee Contractor Reports Cooperative Master Contract Sales Reporting. Contractor shall report total Cooperative Master Contract sales quarterly to Enterprise Services, as set forth below. Cooperative Master Contract Sales Reporting System. Contractor shall report quarterly Cooperative Master Contract sales in Enterprise Services’ Cooperative Master Contract Sales Reporting System. Enterprise Services will provide Contractor with a login password and a vendor number. The password and vendor number will be provided to the Sales Reporting Representative(s) listed on Contractor’s Bidder Profile. Data. Each sales report must identify every authorized Purchaser by name as it is known to Enterprise Services and its total combined sales amount invoiced during the reporting period (i.e., sales of an entire agency or political subdivision, not its individual subsections). The “Miscellaneous” option may be used only with prior approval by Enterprise Services. Upon request, Contractor shall provide contact information for all authorized Purchasers specified herein during the term of the Cooperative Master Contract. If there are no Cooperative Master Contract sales during the reporting period, Contractor must report zero sales. Due dates for Cooperative Master Contract Sales Reporting. Quarterly Cooperative Master Contract Sales Reports must be submitted electronically by the following deadlines for all Cooperative Master Contract sales invoiced during the applicable calendar quarter: Vendor Management Fee. Contractor shall pay to Enterprise Services a vendor management fee (“VMF”) of 1.5 percent on the purchase price for all Cooperative Master Contract sales (the purchase price is the total invoice price less applicable sales tax). The sum owed by Contractor to Enterprise Services as a result of the VMF is calculated as follows: Amount owed to Enterprise Services = Total Cooperative Master Contract sales invoiced (not including sales tax) x .015. The VMF must be rolled into Contractor’s current pricing. The VMF must not be shown as a separate line item on any invoice unless specifically requested and approved by Enterprise Services. Enterprise Services will invoice Contractor quarterly based on Cooperative Master Contract sales reported by Contractor. Contractor is not to remit payment until Contractor receives an invoice from Enterprise Services. Contractor’s VMF payment to Enterprise Services must reference this Cooperative Master Contract number, the year and quarter for which the VMF is being remitted, and Contractor’s name as set forth in this Cooperative Master Contract, if not already included on the face of the check. Contractor’s failure to report accurate total net Cooperative Master Contract sales, to submit a timely Cooperative Master Contract sales report, or to remit timely payment of the VMF to Enterprise Services, may be cause for Enterprise Services to suspend Contractor or terminate this Cooperative Master Contract or exercise remedies provided by law. Without limiting any other available remedies, the parties agree that Contractor’s failure to remit to Enterprise Services timely payment of the VMF shall obligate Contractor to pay to Enterprise Services, to offset the administrative and transaction costs incurred by the State to identify, process, and collect such sums, the sum of $200.00 or twenty-five percent (25%) of the outstanding amount, whichever is greater, or the maximum allowed by law, if less. Enterprise Services reserves the right, upon thirty (30) calendar days advance written notice, to increase, reduce, or eliminate the VMF for subsequent purchases, and reserves the right to renegotiate Cooperative Master Contract pricing with Contractor when any subsequent adjustment of the VMF might justify a change in pricing. Annual Cooperative Master Contract Sales Report. Contractor shall provide to Enterprise Services a detailed annual Cooperative Master Contract sales report. Such report shall include, at a minimum: the Goods/Services sold (including, as applicable, item number or other identifier), per unit quantities sold, items and volumes purchased by Purchaser, shipment/delivery locations by Purchaser, and Cooperative Master Contract price. This report must be provided in an electronic format that can be read by Microsoft (MS) Excel. Such report is due within thirty (30) calendar days of the annual anniversary of the effective date of this Cooperative Master Contract.

  • Contractor Licensing, etc. Notwithstanding Section 14.c, District may terminate this Contract immediately by written notice to Contractor upon denial, suspension, revocation, or non-renewal of any license, permit, or certificate that Contractor must hold to provide services under this Contract.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!