Subject Information and Consent Sample Clauses

Subject Information and Consent. The informed consent form and any changes to the informed consent form made during the course of the trial must be agreed to by VIVUS, Inc. or designee and the IRB/IEC prior to its use and must be in compliance with all ICH-GCP, local regulatory requirements and legal requirements. The investigator must ensure that each trial subject is fully informed about the nature and objectives of the trial and possible risks associated with participation and must ensure that the subject has been informed of his/her rights to privacy. The investigator will obtain written informed consent from each subject before any trial-specific activity is performed and should document in the source documentation that consent was obtained prior to enrollment in the trial. The original signed copy of the informed consent form must be maintained by the investigator and is subject to inspection by a representative of VIVUS, Inc., their representatives, auditors, the IRB/IEC and/or regulatory agencies. A copy of the signed informed consent form will be given to the subject.
Sample 1
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Subject Information and Consent. Voluntary written informed consent will be obtained from one parent/legal representative of each subject prior to performing any study-related procedures. Each parent/legal representative will be given both verbal and written information describing the nature and duration of the clinical study. The informed consent process will take place under conditions where the parent/legal representative has adequate time to consider the risks and benefits associated with the child’s participation in the study. Subjects will not be screened or treated until the parent/legal representative has signed an approved informed consent written in a language that is understandable to the subject’s parent/legal representative. The IEC/IRB approved informed consent form will be signed and personally dated by the parent/legal representative and the person who conducted the informed consent discussion. Each parent/legal representative is to receive a copy of the signed and dated written informed consent form and any other written subject information. The signature of an impartial witness is to be obtained in the event the subject or the subject’s legally acceptable representative is unable to read. Additional signatures on the informed consent form may be required in accordance with IEC/IRB requirements or those of the Sponsor (or an authorized representative). The Investigator is responsible for assuring the appropriate content of the informed consent form and that informed consent is obtained from each parent/legal representative in accordance with the applicable regulations and guidelines. The original signed informed consent is to be retained in the study documentation files. The Investigator shall maintain a log of all parent(s)/legal representative(s) who sign the informed consent form and indicate if the subject received study drug or, if not, the reason why. The subject’s medical records should also document that the informed consent form was signed and dated prior to any study-related procedures being performed.
Sample 1
Subject Information and Consent. Prior to any testing under this protocol, including screening tests and elevations, written informed consent will be obtained from the subject in accordance with local practice and regulations. Whenever possible, the investigator will also be involved in this procedure. The background of the proposed study and the benefits and risks of the procedures and study will be explained to the subject. A copy of the informed consent document signed and dated by the subject must be given to the subject. Confirmation of a subject's informed consent must also be documented in the subject's medical records prior to any testing under this protocol, including screening tests and evaluations.
Sample 1
Subject Information and Consent. Assent‌ The informed consent form and any changes to the informed consent form during the course of the trial must be agreed to by VIVUS and the IRB/IEC and must be in compliance with ICH GCP, local regulatory requirements, and legal requirements. The investigator or designee(s) must ensure that each clinical study subject is fully informed about the nature and objectives of the clinical trial and possible risks associated with participation. The investigator or designee(s) will obtain written informed consent from each subject before any trial-specific activity is performed. The informed consent form used in this clinical trial, and any changes made during the course of the trial, must be prospectively approved by both the IRB/IEC and VIVUS before use. The original signed copy of the informed consent form must be maintained by the investigator and is subject to inspection by a representative of VIVUS, their representatives, auditors, the IRB/IEC and/or regulatory agencies. A copy of the signed informed consent form will be given to the subject. Parental consent and/or subject assent will be obtained according to IRB/IEC guidelines.
Sample 1

Related to Subject Information and Consent

  • Access, Information and Confidentiality (a) From the date of this Agreement, until the date when the Investor no longer beneficially owns at least fifty percent (50%) or more of all of the Purchased Shares (a “Qualifying Ownership Interest”), subject to applicable law or regulatory requirements, the Company will use reasonable efforts to afford the Investor and its representatives (including employees of the Investor, and counsel, accountants, investment advisors and other professionals retained by the Investor) such access during normal business hours to its and the Company Subsidiaries’ books, records, properties and personnel and to such other information as the Investor may reasonably request. (b) Each party to this Agreement will hold, and will cause its respective subsidiaries and their directors, officers, employees, agents, consultants, and advisors to hold, in strict confidence, unless disclosure to a Governmental Entity (and, solely with respect to the Company, the Bankruptcy Court) is necessary or appropriate in connection with any necessary regulatory approval or unless compelled to disclose by judicial or administrative process or by other requirement of law or the applicable requirements of any Governmental Entity (and, solely with respect to the Company, the Bankruptcy Court), all nonpublic records, books, contracts, instruments, computer data and other data and information (collectively, “Information”) concerning the other party hereto furnished to it by such other party or its representatives pursuant to this Agreement (except to the extent that such Information can be shown to have been (1) previously known by such party on a nonconfidential basis, (2) in the public domain through no fault of such party, or (3) later lawfully acquired from other sources by the party to which it was furnished), and neither party hereto shall release or disclose such Information to any other person, except its auditors, attorneys, financial advisors, other consultants, and advisors and, to the extent permitted above, to bank regulatory authorities. Prior to any disclosure of Information permitted by the prior sentence, the party proposing to disclose such Information shall, to the extent legally permissible, provide notice to the other party so that the other party may, at its own expense, seek an protective order or other appropriate remedy and/or waive compliance with the provisions of this Section 3.2(b). If such protective order or other remedy is denied, the party proposing to disclose such Information shall (x) furnish only that portion of the Information that, based upon the advice of counsel, is necessary to be disclosed in connection with such necessary regulatory approval or is compelled to be disclosed by such judicial or administrative process or by such other requirement of law or such applicable requirements and (y) use its reasonable best efforts to obtain assurances that confidential treatment will be accorded to the Information.

  • Authorization to Release and Transfer Necessary Personal Information The Grantee hereby explicitly and unambiguously consents to the collection, use and transfer, in electronic or other form, of the Grantee’s personal data by and among, as applicable, the Company and its Subsidiaries for the exclusive purpose of implementing, administering and managing the Grantee’s participation in the Plan. The Grantee understands that the Company may hold certain personal information about the Grantee, including, but not limited to, the Grantee’s name, home address and telephone number, date of birth, social security number (or any other social or national identification number), salary, nationality, job title, number of Award Units and/or shares of Common Stock held and the details of all Award Units or any other entitlement to shares of Common Stock awarded, cancelled, vested, unvested or outstanding for the purpose of implementing, administering and managing the Grantee’s participation in the Plan (the “Data”). The Grantee understands that the Data may be transferred to the Company or to any third parties assisting in the implementation, administration and management of the Plan, that these recipients may be located in the Grantee’s country or elsewhere, and that any recipient’s country (e.g., the United States) may have different data privacy laws and protections than the Grantee’s country. The Grantee understands that he or she may request a list with the names and addresses of any potential recipients of the Data by contacting his or her local human resources representative or the Company’s stock plan administrator. The Grantee authorizes the recipients to receive, possess, use, retain and transfer the Data, in electronic or other form, for the sole purpose of implementing, administering and managing the Grantee’s participation in the Plan, including any requisite transfer of such Data to a broker or other third party assisting with the administration of Award Units under the Plan or with whom shares of Common Stock acquired pursuant to the vesting of the Award Units or cash from the sale of such shares may be deposited. Furthermore, the Grantee acknowledges and understands that the transfer of the Data to the Company or to any third parties is necessary for the Grantee’s participation in the Plan. The Grantee understands that the Grantee may, at any time, view the Data, request additional information about the storage and processing of the Data, require any necessary amendments to the Data or refuse or withdraw the consents herein by contacting the Grantee’s local human resources representative or the Company’s stock plan administrator in writing. The Grantee further acknowledges that withdrawal of consent may affect his or her ability to vest in or realize benefits from the Award Units, and the Grantee’s ability to participate in the Plan. For more information on the consequences of refusal to consent or withdrawal of consent, the Grantee understands that he or she may contact his or her local human resources representative or the Company’s stock plan administrator.

  • Project Information describing each Eligible Project that started, ended, or was ongoing in the reporting year.

  • Confidentiality of Contractor Information The Contractor acknowledges and agrees that this Contract and any and all Contractor information obtained by the State in connection with this Contract are subject to the State of Vermont Access to Public Records Act, 1 V.S.A. § 315 et seq. The State will not disclose information for which a reasonable claim of exemption can be made pursuant to 1 V.S.A. § 317(c), including, but not limited to, trade secrets, proprietary information or financial information, including any formulae, plan, pattern, process, tool, mechanism, compound, procedure, production data, or compilation of information which is not patented, which is known only to the Contractor, and which gives the Contractor an opportunity to obtain business advantage over competitors who do not know it or use it.

  • Exclusions from Confidential Information Receiving Party's obligations under this Agreement do not extend to information that is: (a) publicly known at the time of disclosure or subsequently becomes publicly known through no fault of the Receiving Party; (b) discovered or created by the Receiving Party before disclosure by Disclosing Party; (c) learned by the Receiving Party through legitimate means other than from the Disclosing Party or Disclosing Party's representatives; or (d) is disclosed by Receiving Party with Disclosing Party's prior written approval.

  • Information and Confidentiality 18.1 Each party recognises that under this Agreement it may receive Confidential Information belonging to the other. 18.2 Each party agrees to treat all Confidential Information belonging to the other as confidential and not to disclose such Confidential Information or any other confidential information relating to the GLA arising or coming to its attention during the currency of this Agreement to any third party without the prior written consent of the other party and agrees not to use such Confidential Information for any purpose other than that for which it is supplied under this Agreement. 18.3 The obligations of confidence referred to in this Condition 18 shall not apply to any Confidential Information which: 18.3.1 is in, or which comes into, the public domain otherwise than by reason of a breach of this Agreement or of any other duty of confidentiality relating to that information; 18.3.2 is obtained from a third party without that third party being under an obligation (express or implied) to keep the information confidential; 18.3.3 is lawfully in the possession of the other party before the date of this Agreement and in respect of which that party is not under an existing obligation of confidentiality; or 18.3.4 is independently developed without access to the Confidential Information of the other party. 18.4 Each party will be permitted to disclose Confidential Information to the extent that it is required to do so: 18.4.1 to enable the disclosing party to perform its obligations under this Agreement; or 18.4.2 by any applicable Law or by a court, arbitral or administrative tribunal in the course of proceedings before it including without limitation any requirement for disclosure under FOIA, EIR or the Code of Practice on Access to Government Information and the Grant Recipient acknowledges that any lists or schedules provided by it outlining Confidential Information are of indicative value only and the GLA may nevertheless be obliged to disclose such Confidential Information; or 18.4.3 by any Regulatory Body (including any investment exchange and the Regulator) acting in the course of proceedings before it or acting in the course of its duties; or 18.4.4 in order to give proper instructions to any professional adviser of that party who also has an obligation to keep any such Confidential Information confidential. 18.5 Each party shall ensure that all Confidential Information obtained by it under or in connection with this Agreement: 18.5.1 is given only to such of its employees, professional advisors or consultants engaged to advise it in connection with this Agreement as is strictly necessary for the performance of this Agreement and only to the extent necessary for the performance of this Agreement; 18.5.2 is treated as confidential and not disclosed (without the other party's prior written approval) or used by any such staff or professional advisors or consultants otherwise than for the purposes of this Agreement; 18.5.3 where it is considered necessary in the opinion of the other party, the relevant party shall ensure that such staff, professional advisors or consultants sign a confidentiality undertaking before commencing work in connection with this Agreement. 18.6 Nothing in this Condition 18 shall prevent the either party from: (a) the examination and certification of its accounts; or (b) any examination pursuant to Section 6(1) of the National Audit Xxx 0000 of the economy, efficiency and effectiveness with which the GLA has used its resources; or

  • Customer Information and Release Authorization Throughout this Agreement, you authorize Clearview Energy or its agents to obtain and review information from credit-reporting agencies regarding your credit history and information from the Utility relating to you and your account that includes, but is not limited to: account name and number; billing history; payment history; rate classification; historical and future electricity usage; meter readings; and characteristics of electricity service. Clearview Energy will not provide or sell such information to any other party without your consent unless required to do so by law, or it is necessary to enforce the terms of this Agreement. Clearview Energy reserves the right to reject your enrollment, or terminate this Agreement, in the event you rescind these authorizations.

  • Company Creation and Use of Confidential Information The Executive understands and acknowledges that the Company has invested, and continues to invest, substantial time, money and specialized knowledge into developing its resources, creating a customer base, generating customer and potential customer lists, training its employees, and improving its product offerings in the field of financial services. The Executive understands and acknowledges that as a result of these efforts, the Company has created, and continues to use and create Confidential Information. This Confidential Information provides the Company with a competitive advantage over others in the marketplace.

  • Trade Secrets and Confidential Information/Company Property Employee reaffirms and agrees to observe and abide by the terms of the Confidentiality Agreement, specifically including the provisions therein regarding nondisclosure of the Company’s trade secrets and confidential and proprietary information, and nonsolicitation of Company employees. Employee’s signature below constitutes his/her certification under penalty of perjury that he/she has returned all documents and other items provided to Employee by the Company, developed or obtained by Employee in connection with his/her employment with the Company, or otherwise belonging to the Company.

  • Treatment of Proprietary and Confidential Information A. Both parties agree that it may be necessary to provide each other during the term of this Agreement with certain confidential information, including trade secret information, including but not limited to, technical and business plans, technical information, proposals, specifications, drawings, procedures, customer account data and like information (hereinafter collectively referred to as “Information”). Both parties agree that all Information shall either be in writing or other tangible format and clearly marked with a confidential, private or proprietary legend, or, when the Information is communicated orally, it shall also be communicated that the Information is confidential, private or proprietary. The Information will be returned to the owner within a reasonable time. Both parties agree that the Information shall not be copied or reproduced in any form. Both parties agree to receive such Information and not disclose such Information. Both parties agree to protect the Information received from distribution, disclosure or dissemination to anyone except employees of the parties with a need to know such Information and which employees agree to be bound by the terms of this Section. Both parties will use the same standard of care to protect Information received as they would use to protect their own confidential and proprietary Information. B. Notwithstanding the foregoing, both parties agree that there will be no obligation to protect any portion of the Information that is either: 1) made publicly available by the owner of the Information or lawfully disclosed by a nonparty to this Agreement; 2) lawfully obtained from any source other than the owner of the Information; or 3) previously known to the receiving party without an obligation to keep it confidential.

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