EXTRAMURAL RESEARCH AND DATA Sample Clauses

EXTRAMURAL RESEARCH AND DATA. In pursuing the development of Agent pursuant to this CRADA, NIH may utilize extramural investigators for part or all of the completion of this Research Plan through either Federal Grants or Federal Contracts. Participation by extramural contract or grantee investigators shall be determined after competitive solicitation and review of study protocols by NIH. However, said extramural contract or grantee investigators are not Parties to this CRADA, and this CRADA does not address rights to intellectual property created by such investigators. Nonetheless: a. Subject to the other provisions of Article 8 of this CRADA, NIH shall maintain, to the extent permitted by law, all IND, Clinical Data and Results and Raw Data in NIH's Possession and Control as Proprietary and CONFIDENTIAL, and make them available co-exclusively to RPRP and Introgen for each Party's (including sublicensees and affiliates) own use and for use in obtaining FDA approval for the commercial marketing of Subject Inventions and Agent products. Accordingly, said data shall not be transferable to an Entity without the written permission of the NCI. b. NIH shall not execute a Contract for preclinical studies or clinical trials for the development of Agent unless the extramural contract investigator agrees to confidentiality provisions at least as restrictive as provided in this CRADA and to the co-exclusive use of data, by RPRP and Introgen, in accordance with Article 8.8 (a), for each Party's own use and for use in obtaining FDA approval for
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EXTRAMURAL RESEARCH AND DATA. In pursuing the development of Agent pursuant to this CRADA, NIH may will utilize extramural investigators for part or all of the completion of this Research Plan. through Funding Agreements. Participation by extermural investigators shall DC determined after competitive solicitation and review of study protocols by NIH. However, said extramural investigators are not Parties to this CRADA, and this CRADA does not address rights to intellectual property created by such investigators. Nonetheless: a. To the extent permitted by law and subject to the other provisions of Article 8 of this CRADA, NIH shall maintain all IND, Clinical Data and Results, and Raw Data in NIH’s Possession and Control as Proprietary and CONFIDENTIAL, and make them data related to NCI Protocol 00-C-0050 (P-92) available exclusively to the Collaborator, for its own use and for use in obtaining FDA approval for the commercial marketing of Subject Inventions and Agent products. Accordingly, said data shall not be transferable to any third party by Collaborator without the written permission of the NCI, which will not be unreasonably withheld. b. NIH shall not execute a Funding Agreement for preclinical studies or clinical trials for the development of Agent unless the extramural investigator agrees to confidentiality provisions at least as restrictive as provided in this CRADA and to the Collaborator’s exclusive use of data, in accordance with Article 8.8 (a), for its own use and for use in obtaining FDA approval for the commercial marketing of Agent. c. To the extent permitted by law, Clinical Data and Results and Raw Data will be made available exclusively to Collaborator, the NCI and the FDA, as appropriate and for use in obtaining pharmaceutic regulatory approval for the commercial marketing of Agent. d. Until NCI Protocol #00-C-0050 (P-92) is transferred to Collaborator, in In seeking direct access to Clinical Data and Results and Raw Data or any other information that is in the possession of extramural investigators under a Funding Agreement working with Agent under the sponsorship of NCI, Collaborator shall first contact the Regulatory Affairs Branch, (RAB) NCI [telephone: 300-000-0000]. Subsequent to authorization by RAB, Collaborator may directly contact the extramural investigators. Costs associated with providing Clinical Data and Results or Raw Data to Collaborator in customized formats shall be borne by Collaborator. e. Collaborator’s exclusive access under subsection (a) abo...
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EXTRAMURAL RESEARCH AND DATA. In pursuing the development of Agent pursuant to this CRADA, NIH utilized extramural investigators for part or all of the completion of this Research Plan. However, said extramural investigators are not Parties to this CRADA, and this CRADA does not address rights to intellectual property created by such investigators. Nonetheless, to the extent permitted by law and subject to the other provisions of Article 8 of this CRADA, NIH shall maintain all IND, Clinical Data and Results, and Raw Data in NIH’s Possession and Control as Proprietary and CONFIDENTIAL, and make data related to NCI Protocol 00-C-0050 (P-92) including the follicular lymphoma vaccine clinical data and results and raw data in NIH’s possession and control as defined in Article 2.16 and safety data generated from the use of the Agent that is in the possession and control of NIH as needed to support the registration of the Agent by the FDA in this disease referenced in Article 3.7 of Appendix C and Item 6 under NCI Contributions of Appendix A available to the Collaborator, for its own use and for use in obtaining FDA approval for the commercial marketing of Subject Inventions and Agent products. Accordingly, said data shall not be transferable to any third party by Collaborator without the written permission of the NCI, which will not be unreasonably withheld.
Sample 1
EXTRAMURAL RESEARCH AND DATA. In pursuing the development of Agent pursuant to this CRADA, NIH utilized extramural investigators for part or all of the completion of this Research Plan. However, said extramural investigators were not Parties to this CRADA, and this CRADA does not address rights to intellectual property created by such investigators. Nonetheless, to the extent permitted by law and subject to the other provisions of Article 8 of this CRADA, NIH shall maintain all IND, Clinical Data and Results, and Raw Data in NIH’s Possession and Control as Proprietary and CONFIDENTIAL, and make data related to NCI Protocol 00-C-0050 (P-92) including the follicular lymphoma vaccine clinical data and results and raw data in NIH’s possession and control, as defined in Article 2.16, and safety data generated from the use of the Agent that is in the possession and control of NIH, as needed to support the registration of the Agent by the FDA in this disease referenced in Article 3.7 of Appendix C and Item 6 under NCI Contributions of Appendix A, available to the Collaborator, for its own use and for use in obtaining FDA approval for the commercial marketing of Subject Inventions and Agent products. Accordingly, said data shall not be transferable to any third party by Collaborator without the written permission of the NCI, which will not be unreasonably withheld. (1) At the end of Section 8.9, add the following: Collaborator assumes responsibility for storage, maintenance, and recordkeeping of any phase 3 biopsy samples, including any phase 3 biopsy samples transferred from NCI to Collaborator, in accordance with FDA rules and regulations and subject to all of the terms of Article 8 as modified in Appendix C herein. This responsibility will survive termination of the CRADA.
Sample 1
EXTRAMURAL RESEARCH AND DATA. In pursuing the development of the Study Drug under this CRADA, NIH may utilize Extramural Investigator(s) for part or all of the completion of the Protocol(s) through either Grants, including Cooperative Agreements, or Contracts. However, those Extramural Investigator(s) are not parties to this CRADA, and this CRADA does [***], a. To the extent permitted by law and subject to the other provisions of Article 9 of this CRADA, NIH shall [***] all Clinical Data and Research Results [***] as Confidential Information, and make them available [***] to the Collaborator for [***] and for [***]. b. In the case of an Extramural Investigator(s) being funded under a Contract, NIH shall [***] a Contract for preclinical studies or clinical trials for the development of the Study Drug unless the Extramural Investigator(s) agree(s) to [***] and agrees to [***] in accordance with Article 9.8(a) for [***] and for [***]. c. In the case of an Extramural Investigator(s) being funded under a Grant or Cooperative Agreement, NIH shall [***] all Extramural CONFIDENTIAL TREATMENT REQUESTED BY AVIRON [***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES ACT OF 1934, AS AMENDED. Investigator(s) participating in the Studies sponsored by NIH and using the Study Drug to [***] with the Collaborator in providing [***]. However, NIH's [***] will not constitute a [***] a Grant award to the Extramural Investigator(s). d. Collaborator acknowledges that NIH is [***] for management of clinical trials at the Study site of each Extramural Investigator, and NIH acknowledges the [***] by Collaborator to [***] and agrees to [***] Extramural Investigators to [***] to the Collaborator as described in Article 9.8(c). e. In seeking direct access to Raw Data, Clinical Data and Research Results or any other information that is in the possession of Extramural Investigator(s) working with the Study Drug under the sponsorship of NIH, the Collaborator shall first contact the Influenza Program Officer, who currently is [***]. For efficiency, direct contact between Collaborator and Extramural Investigators for certain types of discussions may be arranged by the NIAID Influenza Program Officer and Collaborator on a study by study basis. Subsequent to authorization by DMID, the Collaborator may directly contact the Extramural Investigator(s). Costs associated with providing Raw Data, Clini...
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Related to EXTRAMURAL RESEARCH AND DATA

  • Technology Research Analyst Job# 1810 General Characteristics

  • RESEARCH AND PUBLICATION 29 CONTRACTOR shall not utilize information and/or data received from COUNTY, or arising out 30 of, or developed, as a result of this Agreement for the purpose of personal or professional research, or 31 for publication. 32

  • Research Analyst Independence The Company acknowledges that the Underwriters’ research analysts and research departments are required to be independent from their respective investment banking divisions and are subject to certain regulations and internal policies, and that such Underwriters’ research analysts may hold views and make statements or investment recommendations and/or publish research reports with respect to the Company and/or the offering that differ from the views of their respective investment banking divisions. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against the Underwriters with respect to any conflict of interest that may arise from the fact that the views expressed by their independent research analysts and research departments may be different from or inconsistent with the views or advice communicated to the Company by such Underwriters’ investment banking divisions. The Company acknowledges that each of the Underwriters is a full service securities firm and as such from time to time, subject to applicable securities laws, may effect transactions for its own account or the account of its customers and hold long or short positions in debt or equity securities of the companies that may be the subject of the transactions contemplated by this Agreement.

  • Research and Development (i) Advice and assistance in relation to research and development of Party B; (ii) Advice and assistance in strategic planning; and

  • University Any notice may be served upon the University by delivering it, in writing, to the University at the address set forth on the last page of this Agreement, by depositing it in a United States Postal Service deposit box with the postage fully prepaid and with the notice addressed to the University at the aforementioned address, or by sending a facsimile of it to the University facsimile number set forth on the last page of this Agreement.

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.

  • Research Primary Investigator as part of a multi-site study (25 points) • Co-Investigator as part of a multi-site study (20 points) • Primary Investigator of a facility/unit based research study (15 points) • Co-Investigator of a facility/unit based research study (10 points) • Develops a unit specific research proposal (5 points) • Conducts a literature review as part of a research study (5 points)

  • Research Use The Requester agrees that if access is approved, (1) the PI named in the DAR and (2) those named in the “Senior/Key Person Profile” section of the DAR, including the Information Technology Director and any trainee, employee, or contractor1 working on the proposed research project under the direct oversight of these individuals, shall become Approved Users of the requested dataset(s). Research use will occur solely in connection with the approved research project described in the DAR, which includes a 1-2 paragraph description of the proposed research (i.e., a Research Use Statement). Investigators interested in using Cloud Computing for data storage and analysis must request permission to use Cloud Computing in the DAR and identify the Cloud Service Provider (CSP) or providers and/or Private Cloud System (PCS) that they propose to use. They must also submit a Cloud Computing Use Statement as part of the DAR that describes the type of service and how it will be used to carry out the proposed research as described in the Research Use Statement. If the Approved Users plan to collaborate with investigators outside the Requester, the investigators at each external site must submit an independent DAR using the same project title and Research Use Statement, and if using the cloud, Cloud Computing Use Statement. New uses of these data outside those described in the DAR will require submission of a new DAR; modifications to the research project will require submission of an amendment to this application (e.g., adding or deleting Requester Collaborators from the Requester, adding datasets to an approved project). Access to the requested dataset(s) is granted for a period of one (1) year, with the option to renew access or close-out a project at the end of that year. Submitting Investigator(s), or their collaborators, who provided the data or samples used to generate controlled-access datasets subject to the NIH GDS Policy and who have Institutional Review Board (IRB) approval and who meet any other study specific terms of access, are exempt from the limitation on the scope of the research use as defined in the DAR.

  • Laboratory Services Covered Services include prescribed diagnostic clinical and anatomic pathological laboratory services and materials when authorized by a Member's PCP and HPN’s Managed Care Program.

  • Project Administration The Contractor shall provide project administration for all Subcontractors, vendors, suppliers, and others involved in implementing the Work and shall coordinate administration efforts with those of the A/E and ODR in accordance with these Uniform General and Supplementary Conditions and provisions of Division 1 Specifications, and as outlined in the Pre- construction Conference.

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