Review of Research Activities Sample Clauses

Review of Research Activities. GSK shall provide the IRO with a list of all Research activities (as defined in Section III.B.3.u of the CIA) that were “active” (as classified in GSK’s tracking system) during the IRO Reporting Period, and the IRO shall select a sample of 40 such activities, which sample shall include a review of each type of Research (i.e., GSK-Sponsored post-marketing clinical trials, other GSK-Sponsored post- marketing studies, and post-marketing investigator-sponsored studies (ISSs).) The IRO shall review samples of each type of Research in proportion to the relative number of each type of Research that occurred during the reporting period. GSK shall provide the IRO with documents relating to the Research activities sufficient for the IRO to conduct the reviews outlined below. For each sampled Research activity, the IRO will review whether: (i) the activity was approved consistent with GSK’s standards, policies, procedures and processes regarding sponsorship or support of Research, including obtaining required approval for the Research by GSK’s medical and/or research organizations and ensuring that the Research was conducted for the purpose of fostering increased understanding of scientific, clinical or medical issues; (ii) there is an executed written agreement with the Researcher that meets the requirements of GSK’s standards, policies and procedures and, among other things, requires the Researcher to disclose in any publication of Research, GSK’s support and any financial interest the researcher may have in GSK; and (iii) GSK’s sales, marketing, or other commercial personnel did not participate in the design, conduct, or publication of the Research activity except as permitted under the limited exceptions in GSK’s policies and procedures.
Sample 1Sample 2Sample 3See All (4)
AutoNDA by SimpleDocs
Review of Research Activities. The J&J Pharmaceutical Affiliates shall provide the IRO with a list of all Research activities (as defined in Section III.B.3.t of the CIA) that occurred during the Reporting Period. The IRO shall select a sample of 25 HCPs or HCIs involved in such activities, which sample shall include a review of each type of Research (i.e., post-marketing clinical trials, other post-marketing studies, and post-marketing investigator-initiated studies (IISs)). The IRO shall review samples of each type of Research in proportion to the relative number of each type of Research that occurred during the reporting period. The J&J Pharmaceutical Affiliates shall provide the IRO with documents relating to the Research activities sufficient for the IRO to conduct the reviews outlined below. For each sampled Research activity, the IRO will review whether: (i) the activity was approved consistent with the J&J Pharmaceutical Affiliates’ standards, policies, procedures and processes regarding sponsorship or support of Research, including obtaining required approval for the Research and ensuring that the J&J Pharmaceutical Affiliates funded the Research in order to address a legitimate scientific question or need;
Sample 1Sample 2
Review of Research Activities. Amgen shall provide the IRO with a list of all Research activities (as defined in Section III.B.3.s of the CIA) that occurred during the Reporting Period. The IRO shall select a sample of 20 such activities, which sample shall include a review of each type of Research (i.e., post-marketing clinical trials, other post-marketing studies, and post-marketing investigator-sponsored studies (ISSs)). The IRO shall review samples of each type of Research in proportion to the relative number of each type of Research that occurred during the reporting period. Amgen shall provide the IRO with documents relating to the Research activities sufficient for the IRO to conduct the reviews outlined below. For each sampled Research activity, the IRO will review whether: (i) the activity was approved consistent with Amgen’s standards, policies, procedures and processes regarding sponsorship or support of Research, including obtaining required approval for the Research and ensuring that Amgen funded the Research in order to address a legitimate scientific question or need; (ii) there is an executed written agreement with the Researcher that meets the requirements of Amgen’s standards, policies and procedures and, among other things, requires the Researcher to disclose in any publication of Research, Amgen’s support and any financial interest the researcher may have in Amgen; and (iii) Amgen’s commercial personnel did not participate in the approval, design, conduct, or publication of the Research activity except as permitted under the limited exceptions in Amgen’s policies and procedures. In addition, if Amgen prematurely discontinues any clinical study for a Government Reimbursed Product during a Reporting Period, Amgen shall provide the IRO with copies of notifications that Amgen provided to the relevant institutional review board, ethics committee, and investigators about the discontinuation of the study. The IRO shall review the notifications to determine whether Amgen notified the applicable entities and investigators in accordance with Amgen standards, policies, procedures, and processes.
Sample 1

Related to Review of Research Activities

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Collaboration We believe joint effort toward common goals achieves trust and produces greater impact for L.A. County’s youngest children and their families.

  • Program Activities Grantee must use the Grant Funds as set forth in Exhibit A (the “Program”).

  • Professional Development Activities Professional development activities are activities initiated by individual faculty members or groups of faculty members and may include attendance at conferences, workshops or seminars which facilitate the following:

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Professional Development Program (a) The parties agree to continue a Professional Development Program for the maintenance and development of the faculty members' professional competence and effectiveness. It is agreed that maintenance of currency of subject knowledge, the improvement of performance of faculty duties, and the maintenance and improvement of professional competence, including instructional skills, are the primary professional development activities of faculty members.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Research Project 3.1 These Materials and Data will be used by Recipient's PI solely in connection with the Research Project, as named and described in the attached research application (insert Research Project name below):

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK Firms and/or individuals that assisted in the development or drafting of the specifications, requirements, statements of work, or solicitation documents contained herein are excluded from competing for this solicitation. This shall not be applicable to firms and/or individuals providing responses to a publicly posted Request for Information (RFI) associated with a solicitation.

Time is Money Join Law Insider Premium to draft better contracts faster.