SPONSOR Review Sample Clauses

SPONSOR Review. Unless otherwise specified in the applicable SOW, the Institution and the Principal Investigator shall submit a copy of any proposed manuscript, abstract, presentation or other document with respect to a Study, including any Multi-Center Publication of which the Principal Investigator is an author, to SPONSOR for review and comment at least forty-five (45) days prior to its submission for publication or presentation. Institution and/or Principal Investigator shall reasonably consider SPONSOR’s comments on the proposed publication or presentation and shall remove any Confidential Information and correct any inaccurate technical information that may be identified by the SPONSOR in writing. Notwithstanding the foregoing, any analyses performed by the Principal Investigator using the Site Data (or, in the case of a Multi-Center Study, any Multi-Center Study Analyses) or that have been disclosed in a publication or presentation authorized pursuant to this Section 18 or pursuant to another clinical study agreement under the Study, shall not be deemed Confidential Information for purposes of this Section 18. If requested in writing by SPONSOR, the Institution and the Principal Investigator shall withhold material from submission for publication or presentation for an additional sixty (60) days to allow for the filing of a patent application or the taking of other measures to establish and preserve SPONSOR’s proprietary rights. Notwithstanding the foregoing, in no event shall Institution or Principal Investigator be required to delay a submission for publication or presentation for more than one hundred twenty (120) days after first submission of a complete publication or presentation to SPONSOR for review. Institution agrees to submit such publication in form that allows SPONSOR to conduct a review sufficient to remove any Confidential Information, correct any inaccurate technical information, and determine if delay is necessary to pursue submission of a patent application. Unless otherwise agreed to in the body of an SOW, to the extent that any provision of this Section 18 may be inconsistent in any respect with any statements about publication policy set forth in a Protocol, the provisions of this Section 18 shall control.
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SPONSOR Review. Subject to Section 7.3 hereof, Hospital and Principal Investigator reserve the right to publish Results. Before publishing, however, Hospital and Principal Investigator shall submit copies of any proposed publication or presentation to Sponsor for review at least 60 days in advance of submission for publication or presentation to a publisher or other third party. Sponsor shall review the data provided in the proposed publication against the Study database for consistency. Sponsor shall also review the proposed publication and reserves the right to delete any Confidential Information from the proposed publication or presentation. In addition, Sponsor may extend such review period for up to another 60 days to allow for filing of patent applications or take other steps to protect the Sponsor's intellectual property interests, or to otherwise avoid a breach of law, or to remove from the proposed publication or presentation any language that is incorrect or otherwise detrimental to Sponsor's intellectual property interests or that discloses any Confidential Information. Sponsor, and any participating center designated by Sponsor, shall be entitled to use any clinical data that Hospital or the Principal Investigator has acquired from the Study and has submitted for publication.
SPONSOR Review. Dartmouth shall provide to Sponsor for prior review a draft of any manuscript, abstract or presentation that first publicly discloses Research Information or information relating to Intellectual Property resulting from the Project. Within thirty (30) days of receipt of such a manuscript, or seven (7) of receipt of such an abstract or presentation (“Review Period”), Sponsor shall notify Dartmouth of any Sponsor Confidential Information contained in such proposed publication or presentation, and Dartmouth shall make modifications as necessary to avoid disclosure of Sponsor Confidential Information, except to the extent that Sponsor Confidential Information is required for meaningful publication of Research Information in accordance with generally accepted research and educational standards. Dartmouth shall then have the right to submit such manuscript, abstract or presentation for publication without further delay, subject only to Section 5.3 below.
SPONSOR Review. The Institution and the Principal Investigator shall submit a copy of any proposed manuscript, abstract, presentation or other document with respect to the Study, including any Multi-Center Publication of which the Principal Investigator is an author, to SPONSOR for review and comment at least sixty (60) days prior to its submission for publication or presentation. No publication or presentation with respect to the Study shall be made unless and until all of SPONSOR’s comments on the proposed publication or presentation have been considered by the Principal Investigator and any Confidential Information has been removed; provided that any analyses performed by the Principal Investigator using any Multi-Center Study Analyses (or the Site Data) or that have been disclosed in a publication or presentation authorized pursuant to this Section 17 or pursuant to another clinical study agreement under the Study, shall not be deemed Confidential Information for purposes of this Section 17. If requested in writing by SPONSOR, the Institution and the Principal Investigator shall withhold material from submission for publication or presentation for an additional ninety (90) days to allow for the filing of a patent application or the taking of other measures to establish and preserve SPONSOR’s proprietary rights. To the extent that any provision of this Section 17 may be inconsistent in any respect with any statements about publication policy set forth in the Protocol, the provisions of this Section 17 shall control.
SPONSOR Review. Subject to Section 7.3 hereof, University and Principal Investigator reserve the right to publish Results. Before publishing, however, University and Principal Investigator shall submit copies of any proposed publication or presentation to Sponsor for review at least 60 days in advance of submission for publication or presentation to a publisher or other third party. Sponsor shall review the data provided in the proposed publication against the Study database for consistency. Sponsor shall also review the proposed publication and reserves the right to delete any Confidential Information from the proposed publication or presentation. In addition, Sponsor may extend such review period for up to another 60 days to allow for filing of patent applications or take other steps to protect the Sponsor's intellectual property interests, or to otherwise avoid a breach of law, to remove from the proposed publication or presentation any language that is incorrect or otherwise detrimental to Sponsor's intellectual property interests or that discloses any Confidential Information. Sponsor shall be entitled to use any clinical data that University or the Principal Investigator has acquired from the Study and has submitted for publication.
SPONSOR Review. The Sponsor will review all data collected from the prior month at the beginning of each month. If there are serious AEs, she will report them to the necessary institutions. DSMB Review. The DSMB consists of four volunteer experts in the following fields: obstetrics, clinical trials, law, and ethics. Because they are volunteers, they do not stand to benefit from continuing the trial if it is not in the best interest of participants. The Sponsor will compile a document with enrollment data, lists of all adverse events, and summary statistics of data collected up to that date on a monthly basis. All information will be de-identified. The Sponsor will distribute the document via email to the members of the DSMB on the last Friday of each calendar month for the prior month’s data. The DSMB members will review the document. If there are unexpected or serious AEs, the DSMB will determine whether continuation of the trial is safe. They will have the power to discontinue the trial at any time if they feel continuation is not in the best interest of patients. The Sponsor will be responsible for reporting a trial discontinuation due to safety concerns to the necessary regulatory bodies. NIH/ Funding Institution & Center (IC). This trial has been accepted for funding from a STTR grant. The funding IC for this trial is the Xxxxxx Xxxxxxx Xxxxxxx National Institute of Child Health & Human Development (NICHD). The Sponsor will submit a monitoring plan to the NICHD Program Officer (PO) before the trial begins. During the trial, the Sponsor will inform the NICHD PO of any recommendations and activities that emanate from monitoring activities. The Sponsor will submit summary reports of the DSMB’s discussions to the NICHD PO on a monthly basis as they become available. All unanticipated problems and serious adverse events will be reported to the NICHD PO within one month of the IRB’s receipt of the report of the problem from the Sponsor.

Related to SPONSOR Review

  • Independent Review Contractor shall provide the Secretary of ADS/CIO an independent expert review of any Agency recommendation for any information technology activity when its total cost is $1,000,000.00 or greater or when CIO requires one. The State has identified two sub-categories for Independent Reviews, Standard and Complex. The State will identify in the SOW RFP the sub-category they are seeking. State shall not consider bids greater than the maximum value indicated below for this category. Standard Independent Review $25,000 Maximum Complex Independent Review $50,000 Maximum Per Vermont statute 3 V.S.A. 2222, The Secretary of Administration shall obtain independent expert review of any recommendation for any information technology initiated after July 1, 1996, as information technology activity is defined by subdivision (a) (10), when its total cost is $1,000,000 or greater or when required by the State Chief Information Officer. Documentation of this independent review shall be included when plans are submitted for review pursuant to subdivisions (a)(9) and (10) of this section. The independent review shall include: • An acquisition cost assessment • A technology architecture review • An implementation plan assessment • A cost analysis and model for benefit analysis • A procurement negotiation advisory services contract • An impact analysis on net operating costs for the agency carrying out the activity In addition, from time to time special reviews of the advisability and feasibility of certain types of IT strategies may be required. Following are Requirements and Capabilities for this Service: • Identify acquisition and lifecycle costs; • Assess wide area network (WAN) and/or local area network (LAN) impact; • Assess risks and/or review technical risk assessments of an IT project including security, data classification(s), subsystem designs, architectures, and computer systems in terms of their impact on costs, benefits, schedule and technical performance; • Assess, evaluate and critically review implementation plans, e.g.: • Adequacy of support for conversion and implementation activities • Adequacy of department and partner staff to provide Project Management • Adequacy of planned testing procedures • Acceptance/readiness of staff • Schedule soundness • Adequacy of training pre and post project • Assess proposed technical architecture to validate conformance to the State’s “strategic direction.” • Insure system use toolsets and strategies are consistent with State Chief Information Officer (CIO) policies, including security and digital records management; • Assess the architecture of the proposed hardware and software with regard to security and systems integration with other applications within the Department, and within the Agency, and existing or planned Enterprise Applications; • Perform cost and schedule risk assessments to support various alternatives to meet mission need, recommend alternative courses of action when one or more interdependent segment(s) or phase(s) experience a delay, and recommend opportunities for new technology insertions; • Assess the architecture of the proposed hardware and software with regard to the state of the art in this technology. • Assess a project’s backup/recovery strategy and the project’s disaster recovery plans for adequacy and conformance to State policy. • Evaluate the ability of a proposed solution to meet the needs for which the solution has been proposed, define the ability of the operational and user staff to integrate this solution into their work.

  • Request for Review Within sixty (60) days after receiving notice from the Plan Administrator that a claim has been denied (in part or all of the claim), then claimant (or their duly authorized representative) may file with the Plan Administrator, a written request for a review of the denial of the claim. The claimant (or his duly authorized representative) shall then have the opportunity to submit written comments, documents, records and other information relating to the claim. The Plan Administrator shall also provide the claimant, upon request and free of charge, reasonable access to, and copies of, all documents, records and other information relevant (as defined in applicable ERISA regulations) to the claimant’s claim for benefits.

  • Performance Review Where a performance review of an employee’s performance is carried out, the employee shall be given sufficient opportunity after the interview to read and review the performance review. Provision shall be made on the performance review form for an employee to sign it. The form shall provide for the employee’s signature in two (2) places, one (1) indicating that the employee has read and accepts the performance review, and the other indicating that the employee disagrees with the performance review. The employee shall sign in only one (1) of the places provided. No employee may initiate a grievance regarding the contents of a performance review unless the signature indicates disagreement. An employee shall, upon request, receive a copy of this performance review at the time of signing. An employee’s performance review shall not be changed after an employee has signed it, without the knowledge of the employee, and any such changes shall be subject to the grievance procedure of this Agreement. The employee may respond, in writing, to the performance review. Such response will be attached to the performance review.

  • Performance Reviews The Employee will be provided with a written performance appraisal at least once per year and said appraisal will be reviewed at which time all aspects of the assessment can be fully discussed.

  • Contract Review Agent shall have reviewed all material contracts of Borrowers including, without limitation, leases, union contracts, labor contracts, vendor supply contracts, license agreements and distributorship agreements and such contracts and agreements shall be satisfactory in all respects to Agent;

  • Independent Development Receiving Party may currently or in the future be developing information internally, or receiving information internally, or receiving information from other parties that may be similar to the Disclosing Party's Confidential Information. Accordingly, nothing in this Agreement will be construed as a representation or inference that Receiving Party will not develop or have developed products or services, that, without violation of this Agreement, might compete with the products or systems contemplated by the Disclosing Party's Confidential Information.

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