Review of Regulatory Documentation Clause Samples

The "Review of Regulatory Documentation" clause establishes the parties' obligations and rights regarding the examination and assessment of documents required for regulatory compliance. Typically, this clause outlines which party is responsible for preparing, submitting, or reviewing filings, permits, or approvals needed from government agencies, and may set timelines or procedures for sharing drafts and comments. Its core function is to ensure that all necessary regulatory paperwork is properly managed and reviewed, reducing the risk of non-compliance and facilitating smooth project or transaction approvals.
POPULAR SAMPLE Copied 1 times
Review of Regulatory Documentation. Each Party shall keep the JDC reasonably informed in connection with all Regulatory Interactions, preparation of all Regulatory Documentation, Regulatory Authority review of Regulatory Documentation, Regulatory Approvals, annual reports, including annual safety reports to the respective health authorities, annual re-assessments, and any subsequent variations and changes to labeling, in each case with respect to the Licensed Products. Each Party shall respond within a reasonable time frame to all reasonable inquiries by the other Party with respect to any information provided pursuant to this Section 5.2(a) (and sufficiently promptly for the other Party to provide meaningful input with respect to responses to Regulatory Authorities).
View SourceView Similar (8)
Review of Regulatory Documentation. To the extent the JRC or JDC has oversight of a Program, each Party shall keep the JRC and JDC, as applicable, reasonably informed in connection with the preparation of all Regulatory Documentation, Regulatory Authority review of Regulatory Documentation, Regulatory Approvals, annual reports, including annual safety reports to the respective health authorities, annual re-assessments, any subsequent variations and changes to labeling, in each case with respect to Collaboration Compounds, Licensed Compounds and Licensed Products. Each Party shall respond within a reasonable time frame to all reasonable inquiries by the other Party with respect to any information provided pursuant to this Section 5.2(a) (and sufficiently promptly for the other Party to provide meaningful input with respect to responses to Regulatory Authorities).
View SourceView Similar (2)
Review of Regulatory Documentation. During the Term, Celgene shall keep Vividion reasonably informed of all Regulatory Interactions, preparation of all Regulatory Documentation, Regulatory Authority review of Regulatory Documentation, Regulatory Approvals, annual reports, including annual safety reports to the respective health authorities, annual re-assessments, and any subsequent variations or changes to labeling, in each case with respect to the Licensed Products and Companion Diagnostics. Celgene shall respond within a reasonable timeframe to all reasonable inquiries by Vividion with respect to any information provided pursuant to this Section 5.3 (and sufficiently promptly for Vividion to provide meaningful input with respect to responses to Regulatory Authorities).
View SourceView Similar (2)
Review of Regulatory Documentation. During the Research Term, for so long as Histogen has responsibility under Section 2.4.2, above, for Regulatory Interactions, Histogen shall (i) keep the JDC reasonably informed of all material Regulatory Interactions, preparation of regulatory documentation, Regulatory Authority review thereof, annual reports, and the like, and (ii) afford Amerimmune a reasonable opportunity to review and comment thereon and to provide meaningful input with respect to responses to any Regulatory Authority. Once any of Histogen’s responsibility under Section 2.4.2, above, is transferred to Amerimmune or a ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ or the Strategic Partner, as the case may be, shall (i) keep Histogen reasonably informed of all material Regulatory Interactions, preparation of regulatory documentation, Regulatory Authority review thereof, annual reports, and the like, and (ii) provide Histogen with a reasonable opportunity to review and comment thereon and to provide meaningful input with respect to responses to any Regulatory Authority.
View SourceView Similar (2)
Review of Regulatory Documentation. During the PD-1 Term, Celgene shall keep Jounce reasonably informed of all Regulatory Interactions, preparation of all Regulatory Documentation, Regulatory Authority review of Regulatory Documentation, Regulatory Approvals, annual reports, including annual safety reports to the respective health authorities, annual re-assessments, and any subsequent variations and changes to labeling, in each case with respect to the Licensed Candidates, Licensed Products and Licensed Diagnostic Products. Celgene shall respond within a reasonable time frame to all reasonable inquiries by Jounce with respect to any information provided pursuant to this Section 2.4 (and sufficiently promptly for Jounce to provide meaningful input with respect to responses to Regulatory Authorities).
View SourceView Similar (2)
Review of Regulatory Documentation. During the Term, Celgene shall keep Agios reasonably informed of all Regulatory Interactions, preparation of all Regulatory Documentation, Regulatory Authority review of Regulatory Documentation, Regulatory Approvals, annual reports, including annual safety reports to the respective health authorities, annual re-assessments, and any subsequent variations and changes to labeling, in each case with respect to the Compounds, Licensed Products and Companion Diagnostics. Celgene shall respond within [**] to all reasonable inquiries by Agios with respect to any information provided pursuant to this Section 5.3 (and sufficiently promptly for Agios to provide meaningful input with respect to responses to Regulatory Authorities).
View Source
Review of Regulatory Documentation. ▇▇▇▇▇▇▇ shall provide Fate with advance drafts of any material documents or other material correspondence pertaining to Regulatory Filings with respect to the Profit Share Product [***], that ▇▇▇▇▇▇▇ plans to submit to any Regulatory Authority in the U.S. Fate may provide comments regarding such material documents and other material correspondence before their submission. [***] ▇▇▇▇▇▇▇ shall provide Fate with copies of all material submissions it makes to, and all material correspondence (including written summaries of material oral correspondence) it receives from, a Regulatory Authority in the U.S. in accordance with this Section 4.3.2. Notices, copies of material submissions and material correspondence, and other materials to be given in advance as provided in this Section 4.3.2 shall be provided to Fate a reasonable time in advance in order to allow Fate a reasonable amount of time to review such notices, copies of submission and correspondence and materials before their submission to the applicable Regulatory Authority, and in any event at least [***] Business Days in advance, unless circumstances necessitate a shorter time period. Material correspondence and other material documents received from a Regulatory Authority in the U.S. must be provided to Fate as soon as practicable, and in any event within [***] Business Days.
View Source

Related to Review of Regulatory Documentation

  • Licensed Documentation If commercially available, Licensee shall have the option to require the Contractor to deliver, at Contractor’s expense: (i) one (1) hard copy and one (1) master electronic copy of the Documentation in a mutually agreeable format; (ii) based on hard copy instructions for access by downloading from the Internet

  • Regulatory Filing In the event that this Interconnection Service Agreement contains any terms that deviate materially from the form included in Attachment O of the Tariff, Transmission Provider shall file the Interconnection Service Agreement on behalf of itself and the Interconnected Transmission Owner with FERC as a service schedule under the Tariff within thirty days after execution. Interconnection Customer may request that any information so provided be subject to the confidentiality provisions of Section 17 of this Appendix 2. An Interconnection Customer shall have the right, with respect to any Interconnection Service Agreement tendered to it, to request (a) dispute resolution under Section 12 of the Tariff or, if concerning the Regional Transmission Expansion Plan, consistent with Schedule 5 of the Operating Agreement, or (b) that Transmission Provider file the agreement unexecuted with the Commission. With the filing of any unexecuted Interconnection Service Agreement, Transmission Provider may, in its discretion, propose to FERC a resolution of any or all of the issues in dispute between or among the Interconnection Parties.

  • Review of Documentation The Depositor, by execution and delivery hereof, acknowledges receipt of the Mortgage Files pertaining to the Mortgage Loans listed on the Mortgage Loan Schedule, subject to review thereof by ▇▇▇▇▇ Fargo Bank National Association, LaSalle Bank National Association, Deutsche Bank National Trust Company and U.S. Bank National Association as applicable (each, a “Custodian” and, together, the “Custodians”), for the Depositor. Each Custodian is required to review, within 45 days following the Closing Date, each applicable Mortgage File. If in the course of such review the related Custodian identifies any Material Defect, the Seller shall be obligated to cure such Material Defect or to repurchase the related Mortgage Loan from the Depositor (or, at the direction of and on behalf of the Depositor, from the Trust Fund), or to substitute a Qualifying Substitute Mortgage Loan therefor, in each case to the same extent and in the same manner as the Depositor is obligated to the Trustee and the Trust Fund under Section 2.02(c) of the Trust Agreement.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Instructional Materials A. The Board recognizes that appropriate texts, library reference facilities, maps and globes, laboratory equipment, audio-visual equipment, art supplies, athletic equipment, current periodicals, standard tests and questionnaires, computers, and similar materials are the tools of the teaching profession. B. Efforts shall be continued to seek and use instructional materials which reflect the contribution and presence of diverse ethnic and cultural groups. C. 1. Selection of instructional materials for each school shall be made by a committee of teachers chosen by the faculty within that school.