EC Approvals and Informed Consent Form Sample Clauses

EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Institution and Investigator will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Gilead and the EC before such individual is allowed to be screened for participation in the Trial. Institution or Investigator will ensure that the ICF complies in form and content with applicable laws, regulations and guidance including ICH-GCP and laws governing data protection and
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EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Sponsor will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Gilead and the EC before such individual is allowed to be screened for participation in the Trial. Sponsor will ensure that the ICF complies in form and content with applicable laws, regulations and guidance including ICH-GCP and laws governing data protection and privacy, as well as all relevant terms of the Protocol. Institution or Investigator will promptly supply Gilead or CRO with appropriate evidence of EC approval, a copy of the EC- approved ICF, and any amendments to the ICF later approved by the EC prior to its use by Institution. Any proposed deviations by Institution from Gilead’s model ICF language must be approved by Gilead in advance of any use with subjects in the Trial. Breach of this Section 1.5 will constitute a material breach of this Agreement. The Sponsor prepared and handed over to the Principal Investigator a draft form of the written trial Subject Informed Consent to participate in the Study, which will include information for trial Subjects (regarding the nature, significance, implications and risks of the Study). A sample informed consent is attached to this Agreement.
Sample 1
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Institution will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Gilead and the EC before such individual is allowed to be screened for participation in the Trial. Institution or Investigator will ensure that the ICF complies in form and content with applicable laws, regulations and guidance including ICH-GCP and laws governing data protection and privacy, as well as all relevant terms of the Protocol. Institution or Investigator will promptly supply Gilead or CRO with appropriate evidence of EC approval, a copy of the EC-approved ICF, and any amendments to the ICF later approved by the EC prior to its use by Institution. Any proposed deviations by Institution from Gilead’s model ICF language must be approved by Gilead in advance of any use with subjects in the Trial. Breach of this Section 1.5 will constitute a material breach 1.5 Modulo di consenso informato e Approvazioni del CE. Prima dell’inizio della Sperimentazione presso il Centro della sperimentazione, l’Istituto otterrà l’approvazione per la Sperimentazione, compresa l’approvazione del Protocollo, il modulo di consenso informato e, se pertinente, il modulo di consenso pediatrico (chiamati complessivamente “ICF”), e qualsivoglia emendamento agli stessi, dal Comitato etico interessato (“CE”), in conformità alle leggi, regole e normative applicabili. L’Istituto e lo Sperimentatore otterranno da ciascun individuo (o dal rappresentante legale di ciascun individuo), che debba essere sottoposto a screening per la partecipazione alla Sperimentazione, un ICF debitamente sottoscritto, come approvato da Gilead e dal CE, prima che la partecipazione alla Sperimentazione di tale candidato sia vagliata. L’Istituto o lo Sperimentatore garantirà che l’ICF sia conforme, in forma e contenuto, alle leggi, normative e direttive vigenti, tra cui l’ICH-GCP e le leggi che governano la protezione dei dati e la privacy, oltre che ai relativi termini del Protocollo. L’Istituto o lo Sperimentatore fornirà prontamente a Gile...
Sample 1
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Partieswill obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Gilead and the EC before such individual is allowed to be screened for participation in the Trial. Gilead or CRO will provide ICF template and Institution and Investigator will ensure that the ICF complies in form and content with applicable laws, regulations and guidance including ICH-GCP and laws governing data protection and privacy, as well as all relevant terms of the Protocol. Any proposed deviations by Institution from Xxxxxx’s model ICF language must be approved by Gilead in advance of any use with subjects in the Trial. Breach of this Section 1.5 will constitute a material breach of this Agreement.
Sample 1
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Institution and Investigator will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly odůvodnění do dvaceti čtyř (24) hodin po jejím vzniku a do pěti (5) pracovních dnů po výskytu takového odchýlení podá společnosti Gilead písemnou zprávu. 1.3 Dodržení podmínek ze strany Zkoušejícího. Instituce a Zkoušející tímto prohlašuje, že Zkoušející je jejím zaměstnancem a že podepsal podpisovou stranu Protokolu i této Smlouvy, a xxxx zaručuje, že Zkoušející bude dodržovat veškeré podmínky Protokolu a této Smlouvy.
Sample 1
EC Approvals and Informed Consent Form. Prior to the commencement of the Study, Institution will obtain approval for the Study, including approval of the Protocol, Sponsor’s informed consent form and, if applicable, pediatric assent form (collectively, “ICF”), and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Study, a properly executed ICF, as approved by Sponsor and the EC before such individual is allowed to be screened for participation in the Study. Institution or Investigator will promptly supply Sponsor with
Sample 1
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Institution and Investigator will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be společnost Gilead ústně o takové odchylce a a její odůvodnění do dvaceti čtyř (24) hodin po jejím vzniku a do pěti (5) pracovních dnů po výskytu takového odchýlení podá společnosti Gilead písemnou zprávu. 1.3 D održení podmínek ze strany Zkoušejícího. Instituce a Zkoušející tímto prohlašuje, že Zkoušející je jejím zaměstnancem a že podepsal podpisovou stranu Protokolu i této Smlouvy, a xxxx zaručuje, že Zkoušející bude dodržovat veškeré podmínky Protokolu a této Smlouvy. 1.4 Z astavení činnosti, omezení nebo neschopnost Zkoušejícího. Instituce a Zkoušející bezodkladně písemně uvědomí společnost Gilead, pokud v průběhu Studie: (i) bude Zkoušejícímu zastavena činnost, ztratí svou kvalifikaci nebo obdrží oznámení o jakémkoli vyšetřování ze strany jeho profesionální vedoucí organizace, jakéhokoli regulačního orgánu nebo jiné vládní organizace; (ii) Zkoušející obdrží oznámení o jakémkoli omezení svých klinických privilegií v Instituci; (iii) Zkoušející je sankcionován jakýmkoli regulačním orgánem nebo jinou vládní organizací; (iv) ukončí xxxx xx mu ukončen pracovní poměr nebo jiný smluvní vztah s Institucí; nebo (v) jakkoli jinak xx xxxxx nevhodným, neschopným nebo neochotným plnit své závazky xxxx xxxxx Smlouvou. V případě kterékoli výše popsané situace Instituce zajistí, aby Zkoušející nadále dodržoval podmínky této Smlouvy. Na požádání společnosti Gilead budou Instituce a Zkoušející spolupracovat xxx xxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxxxx nebo převodu Studie do jiné instituce v brzkém termínu tak, aby se Studie nepřerušila.
Sample 1
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EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Provider and Investigator will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Provider and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Sponsor and the EC before such individual is allowed to be screened for participation in the Trial. Provider or Investigator will ensure that the ICF complies in form and content with applicable laws, regulations and guidance including ICH-GCP and laws governing data protection and privacy, as well as all relevant terms of the Protocol. Provider or Investigator will promptly supply Sponsor or CRO with appropriate evidence of EC approval, a copy of the EC-approved ICF, and any amendments to the ICF later approved by the EC prior to its use by Provider. Any proposed deviations by Provider from Sponsor’s model ICF language must be approved by
Sample 1
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Gilead will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Provider and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as provided by Gilead and approved by the EC before such individual is allowed to be screened for participation in the Trial. Provider or Investigator will ensure that the obtained ICF complies in form and content with applicable laws, regulations and guidance including ICH- GCP and laws governing data protection and privacy, as well as all relevant terms of the 1.4 Dodržení podmínek ze strany Zkoušejícího. Poskytovatel a Zkoušející tímto prohlašuje, že Zkoušející je jejím zaměstnancem a že podepsal podpisovou stranu Protokolu i této Smlouvy, a dále zaručuje, že Zkoušející bude dodržovat veškeré podmínky Protokolu a této Smlouvy.
Sample 1

Related to EC Approvals and Informed Consent Form

  • Third-Party Agreements and Information Executive represents and warrants that Executive’s employment by the Company does not conflict with any prior employment or consulting agreement or other agreement with any third party, and that Executive will perform Executive’s duties to the Company without violating any such agreement. Executive represents and warrants that Executive does not possess confidential information arising out of prior employment, consulting, or other third party relationships, that would be used in connection with Executive’s employment by the Company, except as expressly authorized by that third party. During Executive’s employment by the Company, Executive will use in the performance of Executive’s duties only information that is generally known and used by persons with training and experience comparable to Executive’s own, common knowledge in the industry, otherwise legally in the public domain, or obtained or developed by the Company or by Executive in the course of Executive’s work for the Company.

  • Tax Returns and Information The Partnership shall timely file all returns of the Partnership that are required for federal, state and local income tax purposes on the basis of the accrual method and the taxable period or year that it is required by law to adopt, from time to time, as determined by the General Partner. In the event the Partnership is required to use a taxable period other than a year ending on December 31, the General Partner shall use reasonable efforts to change the taxable period of the Partnership to a year ending on December 31. The tax information reasonably required by Record Holders for federal, state and local income tax reporting purposes with respect to a taxable period shall be furnished to them within 90 days of the close of the calendar year in which the Partnership’s taxable period ends. The classification, realization and recognition of income, gain, losses and deductions and other items shall be on the accrual method of accounting for federal income tax purposes.

  • Environmental Reports and Audits As soon as practicable following receipt thereof, copies of all environmental audits and reports with respect to environmental matters at any Facility or which relate to any environmental liabilities of Holdings or its Subsidiaries which, in any such case, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect;

  • Card Information Updates and Authorizations If you have authorized a merchant to xxxx charges to your card on a recurring basis, it is your responsibility to notify the merchant in the event your card is replaced, your card information (such as card number and expiration date) changes, or the account associated with your card is closed. However, if your card is replaced or card information changes, you authorize us, without obligation on our part, to provide the updated card information to the merchant in order to permit the merchant to xxxx recurring charges to the card. You authorize us to apply such recurring charges to the card until you notify us that you have revoked authorization for the charges to your card.

  • Documents and Information After the Closing Date, the Purchaser and the Company shall, and shall cause their respective Subsidiaries to, until the seventh (7th) anniversary of the Closing Date, retain all books, records and other documents pertaining to the business of the Target Companies in existence on the Closing Date and make the same available for inspection and copying by the Purchaser Representative during normal business hours of the Company and its Subsidiaries, as applicable, upon reasonable request and upon reasonable notice. No such books, records or documents shall be destroyed after the seventh (7th) anniversary of the Closing Date by the Purchaser or its Subsidiaries (including any Target Company) without first advising the Purchaser Representative in writing and giving the Purchaser Representative a reasonable opportunity to obtain possession thereof.

  • Reports and Information Contractor shall at such times and in such forms as the City may require furnish the City such periodic reports as it may request pertaining to the work or services undertaken pursuant to this Agreement, the costs and obligations incurred or to be incurred in connection therewith, and any other matters are covered by this Agreement as specified in Exhibit A and Exhibit E.

  • Environmental Audits and Reports As soon as practicable following receipt thereof, copies of all final environmental audits, investigations, analyses and reports of any kind or character, whether prepared by personnel of Holdings or any of its Subsidiaries or by independent consultants, Government Authorities or any other Persons, with respect to significant environmental matters at any Facility that, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect or with respect to any Environmental Claims that, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect.

  • Field Audits and Examination Reports; Confidentiality; Disclaimers by Lenders; Other Reports and Information By becoming a party to this Agreement, each Lender: (a) is deemed to have requested that Agent furnish such Lender, promptly after it becomes available, a copy of each field audit or examination report (each a "Report" and collectively, "Reports") prepared by Agent, and Agent shall so furnish each Lender with such Reports, (b) expressly agrees and acknowledges that Agent does not (i) make any representation or warranty as to the accuracy of any Report, and (ii) shall not be liable for any information contained in any Report, (c) expressly agrees and acknowledges that the Reports are not comprehensive audits or examinations, that Agent or other party performing any audit or examination will inspect only specific information regarding Borrowers and will rely significantly upon the Books, as well as on representations of Borrowers' personnel, (d) agrees to keep all Reports and other material, non-public information regarding Borrowers and their Subsidiaries and their operations, assets, and existing and contemplated business plans in a confidential manner; it being understood and agreed by Borrowers that in any event such Lender may make disclosures (a) to counsel for and other advisors, accountants, and auditors to such Lender, (b) reasonably required by any bona fide potential or actual Assignee or Participant in connection with any contemplated or actual assignment or transfer by such Lender of an interest herein or any participation interest in such Lender's rights hereunder, (c) of information that has become public by disclosures made by Persons other than such Lender, its Affiliates, assignees, transferees, or Participants, or (d) as required or requested by any court, governmental or administrative agency, pursuant to any subpoena or other legal process, or by any law, statute, regulation, or court order; provided, however, that, unless prohibited by applicable law, statute, regulation, or court order, such Lender shall notify Administrative Borrower of any request by any court, governmental or administrative agency, or pursuant to any subpoena or other legal process for disclosure of any such non-public material information concurrent with, or where practicable, prior to the disclosure thereof, and (e) without limiting the generality of any other indemnification provision contained in this Agreement, agrees: (i) to hold Agent and any such other Lender preparing a Report harmless from any action the indemnifying Lender may take or conclusion the indemnifying Lender may reach or draw from any Report in connection with any loans or other credit accommodations that the indemnifying Lender has made or may make to Borrowers, or the indemnifying Lender's participation in, or the indemnifying Lender's purchase of, a loan or loans of Borrowers; and (ii) to pay and protect, and indemnify, defend and hold Agent, and any such other Lender preparing a Report harmless from and against, the claims, actions, proceedings, damages, costs, expenses, and other amounts (including, attorneys fees and costs) incurred by Agent and any such other Lender preparing a Report as the direct or indirect result of any third parties who might obtain all or part of any Report through the indemnifying Lender. In addition to the foregoing: (x) any Lender may from time to time request of Agent in writing that Agent provide to such Lender a copy of any report or document provided by Borrowers to Agent that has not been contemporaneously provided by Borrowers to such Lender, and, upon receipt of such request, Agent shall provide a copy of same to such Lender, (y) to the extent that Agent is entitled, under any provision of the Loan Documents, to request additional reports or information from Borrowers, any Lender may, from time to time, reasonably request Agent to exercise such right as specified in such Lender's notice to Agent, whereupon Agent promptly shall request of Administrative Borrower the additional reports or information reasonably specified by such Lender, and, upon receipt thereof from Administrative Borrower, Agent promptly shall provide a copy of same to such Lender, and (z) any time that Agent renders to Administrative Borrower a statement regarding the Loan Account, Agent shall send a copy of such statement to each Lender.

  • Documentation and Information Such Stockholder shall not make any public announcement regarding this Agreement or the transactions contemplated hereby without the prior written consent of Parent (such consent not to be unreasonably withheld, conditioned or delayed), except as may be required by applicable Law (provided that reasonable notice of any such disclosure will be provided to Parent, and such Stockholder will consider in good faith the reasonable comments of Parent with respect to such disclosure and otherwise cooperate with Parent in obtaining confidential treatment with respect to such disclosure). Such Stockholder consents to and hereby authorizes Parent to publish and disclose in all documents and schedules filed with the SEC or any other Governmental Entity or applicable securities exchange, and any press release or other disclosure document that Parent reasonably determines to be necessary or advisable in connection with the Offer, the Merger or any other transactions contemplated by the Business Combination Agreement or this Agreement, such Stockholder’s identity, the aggregate number of Subject Shares owned by Stockholders subject to this Agreement, the existence of this Agreement and the nature of such Stockholder’s commitments and obligations under this Agreement, and such Stockholder acknowledges that Parent may, in Parent’s sole discretion, file this Agreement or a form hereof with the SEC or any other Governmental Entity or securities exchange. Such Stockholder agrees to promptly give Parent any information necessary for the preparation of any such disclosure documents, and such Stockholder agrees to promptly notify Parent of any changes with respect to information supplied by such Stockholder specifically for use in any such disclosure document, if and to the extent that any such information shall have become false or misleading in any material respect.

  • Access and Information The Company, on the one hand, and Parent and Acquisition Corp., on the other hand, shall each afford to the other and to the other’s accountants, counsel and other representatives full access during normal business hours throughout the period prior to the Effective Time to all of its properties, books, contracts, commitments and records (including but not limited to tax returns) and during such period, each shall furnish promptly to the other all information concerning its business, properties and personnel as such other party may reasonably request, provided that no investigation pursuant to this Section 6.01 shall affect any representations or warranties made herein. Each party shall hold, and shall cause its employees and agents to hold, in confidence all such information (other than such information that (a) is already in such party’s possession or (b) becomes generally available to the public other than as a result of a disclosure by such party or its directors, officers, managers, employees, agents or advisors or (c) becomes available to such party on a non-confidential basis from a source other than a party hereto or its advisors, provided that such source is not known by such party to be bound by a confidentiality agreement with or other obligation of secrecy to a party hereto or another party until such time as such information is otherwise publicly available; provided, however, that (i) any such information may be disclosed to such party’s directors, officers, employees and representatives of such party’s advisors who need to know such information for the purpose of evaluating the transactions contemplated hereby (it being understood that such directors, officers, employees and representatives shall be informed by such party of the confidential nature of such information), (ii) any disclosure of such information may be made as to which the party hereto furnishing such information has consented in writing and (iii) any such information may be disclosed pursuant to a judicial, administrative or governmental order or request; provided, further, that the requested party will promptly so notify the other party so that the other party may seek a protective order or appropriate remedy and/or waive compliance with this Agreement and if such protective order or other remedy is not obtained or the other party waives compliance with this provision, the requested party will furnish only that portion of such information that is legally required and will exercise its best efforts to obtain a protective order or other reliable assurance that confidential treatment will be accorded the information furnished. If this Agreement is terminated, each party will deliver to the other all documents and other materials (including copies) obtained by such party or on its behalf from the other party as a result of this Agreement or in connection herewith, whether so obtained before or after the execution hereof.

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