Individual Case Safety Reports Sample Clauses

Individual Case Safety Reports. Format and content for the reporting of one or several suspected Adverse Reactions to a medicinal product that occur in a single patient at a single time point. Marketing Authorisation Holder (MAH) The company which has been granted authorisation(s) by the relevant regulatory authorities, necessary to market the Medicinal Product in a given country/region and therefore the legal responsibility to comply with pharmacovigilance requirements.
AutoNDA by SimpleDocs
Individual Case Safety Reports. The Party holding the Regulatory Authority Authorisation for the Product for clinical trials in a country shall be responsible for submitting SAE reports to the Regulatory Authority in that country according to the current applicable laws, regulations and guidelines, regardless of whether the report originated from that Party or not. Information on which Party holds the Regulatory Authority Authorisation for the clinical trials will be exchanged and updated at the time of the transfer of the reports to the other Party. The Party holding the Regulatory Authority Authorisation for clinical trials shall be responsible for the electronic submission to the EMEA of all reportable cases for the Product to Clinical Trial Modules, as required.
Individual Case Safety Reports. 8.1.1 Licensee shall be responsible for its own medical assessment of the reported ADRs when entering the report into Licensee’s safety database according to local *** CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR CERTAIN PORTIONS OF THIS EXHIBIT. CONFIDENTIAL PORTIONS OF THIS EXHIBIT ARE DESIGNATED BY [**]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION requirements and its internal SOPs. In general, the principle of the implied positive causality (meaning that the report is considered to be related with regard to further Licensee and regulatory submission) shall be applied to all Spontaneous Reports of ADRs. Licensee shall assess the expectedness, seriousness and causality according to local requirements and their internal SOPs. Licensee will provide information about reported ADRs to Oncolytics and solicit comment from Oncolytics for reports to be entered into Licensee’s safety database. Oncolytics will respond promptly to any request for comment received from Licensee.
Individual Case Safety Reports. 3.1.1 Aspen will provide to Iroko case reports for the Medicinal Products that meet the Valid Case criteria as defined in this Agreement.
Individual Case Safety Reports 

Related to Individual Case Safety Reports

  • Required Reports (1) As required in Attachment H, Disadvantaged Business Enterprise or Historically Underutilized Business Program Requirements, the Engineer shall submit Progress Assessment Reports to report actual payments made to Disadvantaged Business Enterprises or Historically Underutilized Businesses. One copy shall be submitted with each billing statement and one copy shall be submitted to the address included in Attachment H, Disadvantaged Business Enterprise or Historically Underutilized Business Program Requirements.

  • Management Reports Promptly upon receipt thereof, copies of all detailed financial and management reports submitted to the Company by independent auditors in connection with each annual or interim audit made by such auditors of the books of the Company.

  • Environmental Compliance and Reports Borrower shall comply in all respects with any and all Environmental Laws; not cause or permit to exist, as a result of an intentional or unintentional action or omission on Borrower's part or on the part of any third party, on property owned and/or occupied by Borrower, any environmental activity where damage may result to the environment, unless such environmental activity is pursuant to and in compliance with the conditions of a permit issued by the appropriate federal, state or local governmental authorities; shall furnish to Lender promptly and in any event within thirty (30) days after receipt thereof a copy of any notice, summons, lien, citation, directive, letter or other communication from any governmental agency or instrumentality concerning any intentional or unintentional action or omission on Borrower's part in connection with any environmental activity whether or not there is damage to the environment and/or other natural resources. Additional Assurances. Make, execute and deliver to Lender such promissory notes, mortgages, deeds of trust, security agreements, assignments, financing statements, instruments, documents and other agreements as Lender or its attorneys may reasonably request to evidence and secure the Loans and to perfect all Security Interests.

  • Progress Reports The Recipient shall submit to the OPWC, at the OPWC's request, summary reports detailing the progress of the Project pursuant to this Agreement and any additional reports containing such information as the OPWC may reasonably require.

  • Research Reports Distributor acknowledges that Dealer may prepare research reports relating to the Fund that are not to be used for marketing purposes (“Research Reports”). Distributor hereby authorizes Dealer to use the name of the Fund, Distributor and BREDS in Research Reports.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Statutory Compliance ‌ The Union and the Employer agree to cooperate fully in matters pertaining to the prevention of accidents and occupational disease and in the promotion of the health and safety of all employees. There shall be full compliance with all applicable statutes and regulations pertaining to the working environment.

  • Environmental Audits and Reports As soon as practicable following receipt thereof, copies of all final environmental audits, investigations, analyses and reports of any kind or character, whether prepared by personnel of Holdings or any of its Subsidiaries or by independent consultants, Government Authorities or any other Persons, with respect to significant environmental matters at any Facility that, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect or with respect to any Environmental Claims that, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect.

  • Annual Compliance Statements (a) The Master Servicers, the Special Servicers, the Certificate Administrator, the Trustee (but only to the extent set forth in the last sentence of this paragraph), any Additional Servicer and each Servicing Function Participant (if such Servicing Function Participant is a servicer contemplated by Item 1108(a)(2)(i), (ii) or (iii) of Regulation AB) (each, a “Certifying Servicer”) shall and the Master Servicers and the Special Servicers shall (i) with respect to any Additional Servicer or Servicing Function Participant (if such Servicing Function Participant is a servicer contemplated by Item 1108(a)(2)(i), (ii) or (iii) of Regulation AB) that is a Designated Sub-Servicer of such party, use commercially reasonable efforts to cause, and (ii) with respect to any other Additional Servicer or Servicing Function Participant (if such Servicing Function Participant is a servicer contemplated by Item 1108(a)(2)(i), (ii) or (iii) of Regulation AB), cause, each Additional Servicer and Servicing Function Participant (other than any party to this Agreement) with which it has entered into a servicing relationship with respect to the Mortgage Loans to, deliver to the Depositor, the Certificate Administrator, the Trust Advisor (in the case of a Special Servicer only), the Rule 17g-5 Information Provider (who shall promptly post such report to the Rule 17g-5 Information Provider’s Website pursuant to Section 8.12(c) of this Agreement) on or before March 1st (subject to a grace period through March 15th) of each year, commencing in 2015 (or, in the case of an Additional Servicer or Servicing Function Participant with respect to a Special Servicer, such party shall provide such Officer’s Certificate to such Special Servicer on or before March 1st (subject to a grace period through March 5th)), an Officer’s Certificate stating, as to the signer thereof, that (A) a review of such Certifying Servicer’s activities during the preceding calendar year or portion thereof and of such Certifying Servicer’s performance under this Agreement, or the applicable sub-servicing agreement or primary servicing agreement in the case of an Additional Servicer, has been made under such officer’s supervision and (B) to the best of such officer’s knowledge, based on such review, such Certifying Servicer has fulfilled all its obligations under this Agreement, or the applicable sub-servicing agreement or primary servicing agreement in the case of an Additional Servicer, in all material respects throughout such year or portion thereof, or, if there has been a failure to fulfill any such obligation in any material respect, specifying each such failure known to such officer and the nature and status thereof. The Certificate Administrator, shall prior to March 1st of each year, commencing in 2015, contact the Trustee and inquire as to whether any Advance was required to be made by the Trustee during the preceding calendar year, and if no such Advance was required to be made by the Trustee, then the Trustee shall not be required to deliver any compliance statement required by this Section 11.12(a) for such period.

  • ERISA Reports As soon as possible, and in any event within thirty (30) days after the Borrower knows or has reason to know that any circumstances exist that constitute grounds entitling the PBGC to institute proceedings to terminate a Plan subject to ERISA with respect to the Borrower or any Commonly Controlled Entity, and promptly but in any event within two (2) Business Days of receipt by the Borrower or any Commonly Controlled Entity of notice that the PBGC intends to terminate a Plan or appoint a trustee to administer the same, and promptly but in any event within five (5) Business Days of the receipt of notice concerning the imposition of withdrawal liability in excess of $50,000 with respect to the Borrower or any Commonly Controlled Entity, the Borrower will deliver to each Lender a certificate of the chief financial officer of the Borrower setting forth all relevant details and the action which the Borrower proposes to take with respect thereto.

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