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. 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. Voluntary written informed consent will be obtained from one parent/caregiver of each subject prior to performing any study-related procedures. Each parent/caregiver 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/caregiver 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/caregiver has signed an approved informed consent written in a language that is understandable to the subject. The participation of the study should be discussed with the subject <14 years of age according to the child’s age and ability and verbal assent should be obtained. The informed consent will be given by the signature of one parent. Voluntary written informed assent will be obtained from adolescents ≥ 14 years in addition to parent’s written informed consent. Each subject will be given both verbal and written information describing the nature and duration of the clinical study. The informed assent process will take place under conditions where the subject has adequate time to consider the risks and benefits associated with the participation in the study. Subjects will not be screened or treated until the subject has signed an approved informed assent written in a language that is understandable to the subject. The IEC/IRB approved informed consent/assent form will be signed and personally dated by the parent/caregiver (or legally acceptable representative, when appropriate) and the person who conducted the informed consent discussion. Each parent/caregiver 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/caregiver 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 o...
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 (i) From the Signing Date until the date on which all of the Preferred Shares have been redeemed in whole, the Company will permit, and shall cause each of the Company’s Subsidiaries to permit, Treasury, the Oversight Officials and their respective agents, consultants, contractors and advisors to (x) examine any books, papers, records, Tax returns (including all schedules attached thereto), data and other information; (y) make copies thereof; and (z) discuss the affairs, finances and accounts of the Company and the Company Subsidiaries with the personnel of the Company and the Company Subsidiaries, all upon reasonable notice; provided, that:

  • 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.

  • Access to Information and Services ..28 Section 7.01. Provision of Corporate Records......................................................28 Section 7.02. Access to Information...............................................................28 Section 7.03.

  • Additional Information and Where to Find It In connection with the proposed acquisition, Hxxxxxx will commence a tender offer for the outstanding shares of Zynerba. The tender offer has not yet commenced. This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Zynerba, nor is it a substitute for the tender offer materials that Harmony and Xylophone Acquisition Corp. (“Purchaser”) will file with the SEC upon commencement of the tender offer. At the time the tender offer is commenced, Harmony and Purchaser will file tender offer materials on Schedule TO, and Zynerba will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. Holders of shares of Zynerba common stock are urged to read the tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other tender offer documents) and the Solicitation/Recommendation Statement when they become available (as each may be amended or supplemented from time to time) because they will contain important information that holders of shares of Zynerba common stock should consider before making any decision regarding tendering their shares. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of shares of Zynerba at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s website at wxx.xxx.xxx. In addition, these materials will be available at no charge on the Enhanced SEC Filings section of the Investor Relations page of Zxxxxxx’s website at wxx.xxxxxxx.xxx and by directing a request to the information agent for the tender offer, whose contact information will be set forth in the Offer to Purchase. 80 X. Xxxxxxxxx Avenue, Suite 300| Devon, PA 19333 | 484-581-7505 | wxx.xxxxxxx.xxx

  • Confidential Information and Restricted Activities Employee has entered into the Company’s Employee Proprietary Information Agreement (“EPIA”) and acknowledges his or her obligations thereunder. The EPIA is specifically incorporated into this Agreement.

  • Access to Information; Cooperation (a) Prior to the earlier of the termination of this Agreement in accordance with its terms and the Closing Date, subject to the terms of the Confidentiality Agreement, Buyer shall be entitled to make such investigation of the properties, businesses and operations of the Company and such examination of the books and records of the Company as it reasonably requests, including as may be reasonably requested by Buyer or, subject to execution of customary confidentiality and non-reliance undertakings, any insurance broker or insurance carrier in connection with Buyer’s consideration of and obtaining the representation and warranty insurance policy to be issued in the name of Buyer (the “R&W Policy”). Any such investigation and examination shall be conducted during regular business hours and under reasonable circumstances, shall be subject to restrictions under applicable Law and shall not unreasonably interfere with the operations of the Company. Seller shall cause the officers, employees, consultants, agents, accountants, attorneys and other representatives of the Company and WS Holdings and its Subsidiaries to reasonably cooperate with Buyer and Buyer’s representatives in connection with such investigation and examination, and Buyer and its representatives shall reasonably cooperate with the Company and its representatives and shall use their reasonable efforts to minimize any disruption to the businesses of the Company. In addition, no such investigation or examination shall be permitted to the extent that (x) it would require Seller or the Company to disclose information subject to attorney-client privilege or (y) legal counsel for the Company reasonably concludes that it may give rise to antitrust or competition law issues or violate a protective order or otherwise may not be disclosed pursuant to applicable Law, and in each such case, the Company will reasonably cooperate with Buyer (at Buyer’s expense) to establish mutually acceptable work arounds to provide Buyer with the broadest access to information practicable under the circumstances. Notwithstanding anything to the contrary contained herein, prior to the Closing, Buyer shall not contact any employees of, suppliers to, customers of, or franchisees of, the Company or any of its Affiliates in connection with the Company or the Transaction without the prior written consent of the Company (such consent not to be unreasonably delayed, conditioned or withheld); provided, that any such contact by Buyer shall be coordinated with Seller, and Seller shall be permitted to participate therein. Nothing contained in this Agreement shall be construed to give to Buyer, directly or indirectly, rights to control or direct the Company’s operations prior to the Closing. Prior to the Closing, the Company shall exercise, consistent with the terms and conditions of this Agreement, complete control and supervision of its operations. From the date hereof until the Closing Date or the earlier termination of this Agreement, Seller shall and shall cause the Company and its other Affiliates engaged in the Business to, preserve and maintain the books and records of the Company and the Business in all material respects in the same manner and same care that the books and records of the Company have been maintained prior to the execution of this Agreement.

  • Return of Confidential Information and Company Property Upon termination of the Executive’s employment for any reason, the Executive shall immediately return all Confidential Information and other Company property to the Company.

  • 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.

  • Confidential Information and Trade Secrets The Participant and the Company agree that certain materials, including, but not limited to, information, data and other materials relating to customers, development programs, costs, marketing, trading, investment, sales activities, promotion, credit and financial data, manufacturing processes, financing methods, plans or the business and affairs of the Company and its Affiliates, constitute proprietary confidential information and trade secrets. Accordingly, the Participant will not at any time during or after the Participant’s employment with the Company (including any Affiliate) disclose or use for such Participant’s own benefit or purposes or the benefit or purposes of any other person, firm, partnership, joint venture, association, corporation or other business organization, entity or enterprise other than the Company and any of its Affiliates, any proprietary confidential information or trade secrets, provided that the foregoing shall not apply to information which is not unique to the Company or any of its Affiliates or which is generally known to the industry or the public other than as a result of such Participant’s breach of this covenant. The Participant agrees that upon termination of employment with the Company (including any Affiliate) for any reason, the Participant will immediately return to the Company all memoranda, books, papers, plans, information, letters and other data, and all copies thereof or therefrom, which in any way relate to the business of the Company and its Affiliates, except that the Participant may retain personal notes, notebooks and diaries. The Participant further agrees that the Participant will not retain or use for the Participant’s own account at any time any trade names, trademark or other proprietary business designation used or owned in connection with the business of the Company or any of its Affiliates. Notwithstanding anything contained herein to the contrary, this Agreement shall not prohibit disclosure of proprietary confidential information if (i) it is required by law or by a court of competent jurisdiction or (ii) it is in connection with any judicial, arbitration, dispute resolution or other legal proceeding in which your legal rights and obligations as an employee or under this Agreement are at issue; provided, however, that you shall, to the extent practicable and lawful in any such event, give prior notice to the Company of your intent to disclose proprietary confidential information so as to allow the Company an opportunity (which you shall not oppose) to obtain such protective orders or similar relief with respect thereto as may be deemed appropriate. Notwithstanding the foregoing, nothing in this Agreement is intended to restrict, prohibit, impede or interfere with the Participant providing information to, or from reporting possible violations of law or regulation to, any governmental agency or entity, from participating in investigations, testifying in proceedings regarding the Company’s past or future conduct, or from making other disclosures that are protected under state or federal law or regulation, engaging in any future activities protected under statutes administered by any government agency (including but not limited, to the Department of Justice, the Securities and Exchange Commission, the Congress, and any agency Inspector General), or from receiving and retaining a monetary award from a government-administered whistleblower award program for providing information directly to a government-administered whistleblower award program. The Participant does not need the prior authorization of the Company to make such reports or disclosures. The Participant is not required to notify the Company that he or she has made any such reports or disclosures. The Company nonetheless asserts, and does not waive, its attorney-client privilege over any information appropriately protected by the privilege.

  • Confidential Information Noncompetition and Cooperation The terms of the Employee Non-Competition, Non-Solicitation, Confidentiality and Assignment Agreement (the “Restrictive Covenant Agreement”), between the Company and the Employee, attached hereto as Exhibit A, shall continue to be in full force and effect and are incorporated by reference in this Agreement. The Employee hereby reaffirms the terms of the Restrictive Covenant Agreement as material terms of this Agreement.

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