Other Reportable Information definition

Other Reportable Information means any communication or other information that is otherwise required to be reported by Novos to Evoke in accordance with the training to be provided under this Agreement, other than Adverse Events.
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Other Reportable Information means any communication or other information that questions the purity, identity, potency or quality of the Product and all reports of Product exposure during pregnancy and Product overdoses, whether or not (a) resulting in an Adverse Event or (b) the reported effect is (i) described in the full prescribing information or the published literature with respect to the Product or (ii) determined to be attributable to the Product.
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Other Reportable Information has the meaning set forth in Section 2.15(e).
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Examples of Other Reportable Information in a sentence

  • Submissions include all materials associated with new project (initial) applications, scheduled continuing review applications, amendments, adverse events (AEs), Other Reportable Information or Occurrences (ORIO) reports, and research that may qualify for exemption.

  • Unanticipated Problems Involving Risks to Participants or Others, and Other Reportable Information .

  • IRB applications (initial, scheduled continuing review, amendments, and reports of adverse events and Other Reportable Information or Occurrences [ORIOs]) are submitted to IRB- HSBS via the web-based eResearch Regulatory Management System.

  • Refer to HRPP OM Part 12.II.C.1 As noted in the OM, guidelines and reporting procedures for reporting Adverse Events (AEs) and Other Reportable Information or Occurrences (ORIOs), including those AEs and ORIOs that are also unanticipated problems involving risks to participants or others (UaPs), are posted on the IRBMED website.

  • Other Reportable Information: certain information, although not considered an SAE, must be recorded, reported, and followed up as indicated for an SAE.

  • Refer to HRPP OM Part 12.II.C.1As noted in the OM, guidelines and reporting procedures for reporting Adverse Events (AEs) and Other Reportable Information or Occurrences (ORIOs), including those AEs and ORIOs that are also unanticipated problems involving risks to participants or others (UaPs), are posted on the IRBMED website.

  • Certain events that occur in the absence of an AE should be reported to Shire VIROPHARMA Drug Safety as other reportable events using the Other Reportable Information form (paper or electronic) provided by the Sponsor.

  • In compliance with regulatory practices, the PI and Co-Investigators will secure “continuing approval” for the research projects each year from the CMH IRB and will notify the CMH and KUMC IRB’s if any Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Unanticipated Problems Involving Risks to Subjects or Others (UaPs) occur in the conduct of the projects.

  • The report of findings of fact and determinations will be sent to the Principal Investigator and, when relevant, any other affected investigator(s).‌3.9 Unanticipated Problems Involving Risks to Participants or Others, and Other Reportable Information The IRB has and follows written policies and procedures for addressing unanticipated problems involving risks to participants or others, and for reporting these actions, when appropriate.

  • Novos shall cooperate with all of Evoke’s reasonable requests and assist Evoke in connection with Evoke: (i) preparing any and all reports to FDA concerning the Product; (ii) preparing and disseminating all communications to Third Parties concerning the Product; and (iii) investigating and responding to any Product Quality Complaint, Adverse Event, Other Reportable Information, Field Alert, or other compliance inquiry or investigation related to the Product.


More Definitions of Other Reportable Information

Other Reportable Information means any communication or other information that is otherwise required to be reported by Eversana to Zosano in accordance with the training to be provided under this Agreement, other than Adverse Events. 1.42. “Out-of-Pocket Costs” means amounts paid by a Party to Third Parties for goods and services required for such Party to perform its obligations under this Agreement. 1.43. “Patient Access Programs” means programs to assist patients with filling their prescriptions, including, without limitation, through co-pay assistance, through help desks, triage procedures, bailment programs, and reduced cost prescription fulfillment to certain eligible patients in financial need. 1.44. “Patient Assistance Programs” means any program to offer the Product free of charge, or at a significant discount, to individuals who are unable to pay for their medication, alternatively known as indigent drug programs, charitable drug programs or medication assistance programs. 1.45. “PDMA” means the Prescription Drug Marketing Act of 1987, as amended from time to time, together with any rules, regulations and requirements promulgated thereunder and in effect from time to time. 1.46. “Person” means any individual, partnership, limited partnership, limited liability company, joint venture, syndicate, sole proprietorship, corporation, unincorporated association, trust, trustee, executor, administrator or other legal personal representative, or any other legal entity, including without limitation a Governmental Authority. 1.47. “Pre-Commercial Fees” means the total fees (including but not limited to Out-of-Pocket Costs) agreed upon by the Committee to be paid by Zosano to Eversana in accordance with the terms set forth herein, for Eversana to perform the Pre-Commercial Services to the extent such fees and costs are incurred prior to Commercial Launch. 1.48. “Pre-Commercial Budget” means the budget for the conduct of the Pre-Commercial Services by Eversana hereunder as approved by the Joint Management Committee, as 6
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Related to Other Reportable Information

  • Disclosure Information As defined in the Pooling and Servicing Agreement.

  • Balance Information We use the daily balance method to calculate the interest on the account. This method applies a daily periodic rate to the principal in the account each day. You must maintain a minimum balance of $1,000.00 in the account each day to obtain the disclosed annual percentage yield. Limitations: You must deposit $1,000.00 to open this account. You may not make additional deposits into this account. You may not make withdrawals from your account until the maturity date. Time Account Information: Your account will mature in the term of the Certificate of Deposit. If you withdraw any of the principal before the maturity date, we may impose a penalty of 180 days interest on the amount withdrawn. This account will automatically renew. You will have 10 CALENDAR DAYS after the maturity date to withdraw funds without penalty. If you do not withdraw the funds, each renewal term will be for an identical period of time as the original term.

  • Form 8-K Disclosure Information As defined in Section 11.07.

  • Tangible Information means information that is contained in written, electronic or other tangible forms.

  • Issuer Information shall have the meaning set forth in Section 5(a) hereof.

  • Statement of Additional Information means, respectively, the form of prospectus and statement of additional information with respect to the Fund filed by the Investment Company as part of the Registration Statement, or as they may be amended or supplemented from time to time.

  • Private information means **personal information in combination with any one or more of the following data elements, when either the personal information or the data element is not encrypted or encrypted with an encryption key that has also been acquired:

  • Servicer Information As defined in Section 11.07(a).

  • Generally Available Information means information that is accessible to the public on a non-discriminatory basis.

  • Publicly available information means information that is

  • Due Diligence Information means any information supplied to the Supplier by or on behalf of the Customer prior to the Call Off Commencement Date;

  • Seller Information As defined in Subsection 34.04(a).

  • Insurance Information means the insurance information required by the Access Provider pursuant to Clause 5(b)(xi) hereof.

  • Standard Usage Information means the usage data that is made generally available by the gas utility to all similarly situated Customers on a regular basis, delivered by the gas utility in a standard format.

  • Exempt Information means any information or class of information (including but not limited to any document, report, Agreement or other material containing information) relating to this Agreement or otherwise relating to the Provider, which potentially falls within an exemption to FOIA (as set out therein);

  • Service Information means information concerning the Services provided by the Contractor to the Authority in accordance with Clause 32.1 for inclusion in the Authority's catalogue and/or any Beneficiary's catalogue from time to time;

  • Parent Reports has the meaning set forth in Section 4.5(a).

  • Information Memorandum means the Confidential Information Memorandum dated March, 2011 relating to the Borrower and the Transactions.

  • Information has the meaning specified in Section 10.07.

  • Data Room Information means the information and documents listed in the index of documents contained in the Data Site attached to the Company Disclosure Letter;

  • Company Financial Information As defined in Section 2(a)(ii).

  • Agent’s Information means, solely, the following information in the Prospectus: the third sentence of the eighth paragraph and the tenth paragraph under the caption “Plan of Distribution” in the Prospectus. This indemnity agreement will be in addition to any liability that the Company might otherwise have.

  • Remittance Information means the information that must specify the Billing Account Numbers (BANs) paid; invoices paid and the amount to be applied to each BAN and invoice.

  • Appendix Information means the information which must be provided for the selected modules as set out in the Appendix of the Approved EU SCCs (other than the Parties), and which for this Addendum is set out in:

  • Required Financial Information means, with respect to the applicable Calculation Date, (i) the financial statements of the Consolidated Parties required to be delivered pursuant to Section 7.1(a) or (b) for the fiscal period or quarter ending as of such Calculation Date, and (ii) the certificate of an Executive Officer of the Borrower required by Section 7.1(c) to be delivered with the financial statements described in clause (i) above.