Periodic Safety Update Reports Sample Clauses

Periodic Safety Update Reports. PSURs): a PSUR is a systematic review of the global safety data of an approved medicine that becomes available to Principal/Distributor during a defined time period. PSURs are also referred to as Periodic Benefit–Risk Evaluation Reports (PBRERs). PSURs are required for certain registered medicines. The requirement to submit PSURs can be applied as a condition of registration under sectionArticle 28(2B) of the Act when the medicine is included on the ARTG. PSURs are not required for all medicines, only those on which this specific condition is imposed. There is an internationally agreed format for producing a PSUR. A PSUR should present a comprehensive and critical analysis of the benefit–risk balance of a medicine and take into account new and emerging significant safety findings, in the context of cumulative information on benefits and risks. Safety Report covered by the Agreement is those arising from use of the Product(s) within the terms of the marketing and those arising from the use outside the terms of the marketing authorisation. Serious Adverse Drug Reactions A serious adverse drug reaction is any medical occurrence that in relation to a medicine, at any dose: results in death is life-threatening* results in inpatient hospitalisation or prolonged hospitalisation results in persistent or significant disability or incapacity is associated with a congenital anomaly or birth defect is a medically important event or reaction. *NOTE: The term “life-threatening” in the definition of “serious” refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/ reaction which hypothetically might have caused death if it were more severe.
Sample 1
AutoNDA by SimpleDocs
Periodic Safety Update Reports. Oscient will provide Pfizer, when requested, copies of Periodic Safety Update Reports (PSUR) that Oscient has submitted to the FDA. For biannual PSUR reporting to the Mexican Federal Department of Health, Oscient will provide Pfizer with a copy of two (2) quarterly PSUR reports as equivalents. Oscient will not aggregate safety data to create a six-month report.
Sample 1
Periodic Safety Update Reports. (PSURS) Aptalis will be responsible for the preparation and submission of Periodic Adverse Drug Experience Reports (PADERs) for the Territory and shall provide them to Strakan within two (2) weeks of submission. Strakan will be responsible for the preparation and submission of Periodic Safety Update Reports (PSURs) outside the Territory and shall provide them to Aptalis within two (2) weeks of submission. Specific safety concerns documented in a Regulator Authority’s PADER/PSUR Assessment Report will be exchanged by the Parties in order to facilitate any collaboration on proactive or due diligent medical safety surveillance practices of a safety concern.
Sample 1
Periodic Safety Update Reports. (PSURS) CONNETICS will be responsible for preparing PSURs according to the current ICH and U.S. FDA guidelines and regulatory requirements.
Sample 1
Periodic Safety Update Reports. (PSUR) Stellar Xxxxxx License December 06 PSUR will be generated by Stellar according to legal requirements. Copies of PSUR generated by Stellar will be provided to Xxxxxx.
Sample 1

Related to Periodic Safety Update Reports

  • Late Reports If the General Partner does not fulfill its obligations under Section 14.2 within the time periods set forth therein, the General Partner, using its own funds, shall pay as damages the sum of $100 per day (plus interest at the rate established by Section 6.4 of this Agreement) to the Limited Partner until such obligations shall have been fulfilled. If the General Partner does not fulfill its obligations under Section 14.3 within the time periods set forth therein, the General Partner, using its own funds, shall pay as damages the sum of $100 per week (plus interest at the rate established by Section 6.4 of this Agreement) to the Limited Partner until such obligations shall have been fulfilled. If the General Partner shall so fail to pay, the General Partner and its Affiliates shall forthwith cease to be entitled to any fees hereunder (other than the Development Fee) and/or to the payment of any Net Operating Income or Sale or Refinancing Proceeds to which the General Partner may otherwise be entitled hereunder. Payments of fees and Distributions shall be restored only upon payment of such damages in full.

  • Technical Reports deliver to the Agent, and shall procure that the Manager shall deliver to the Agent, on request copies of the latest complete technical reports in respect of the Vessels.

  • 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.

  • Inspection; Reports A "full inspection report" comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A "detailed report" responds to specific queries about a firm by the other Party.

  • 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.

  • 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.

  • Auditor Report; Right to Audit (a) Within the time period permitted for the examination audit pursuant to 12 CFR Section 363 after the end of each fiscal year during which the Receiver makes any payment to the Assuming Institution under this Single Family Shared-Loss Agreement, the Assuming Institution shall deliver to the Receiver a report signed by its independent public accountants stating that they have reviewed the terms of this Single Family Shared-Loss Agreement and that, in the course of their annual audit of the Assuming Institution’s books and records, nothing has come to their attention suggesting that any computations required to be made by the Assuming Institution during such fiscal year pursuant to this Article II were not made by the Assuming Institution in accordance herewith. In the event that the Assuming Institution cannot comply with the preceding sentence, it shall promptly submit to the Receiver corrected computations together with a report signed by its independent public accountants stating that, after giving effect to such corrected computations, nothing has come to their attention suggesting that any computations required to be made by the Assuming Institution during such year pursuant to this Article II were not made by the Assuming Institution in accordance herewith. In such event, the Assuming Institution and the Receiver shall make all such accounting adjustments and payments as may be necessary to give effect to each correction reflected in such corrected computations, retroactive to the date on which the corresponding incorrect computation was made.

  • Servicer Compliance Statement On or before March 1 of each calendar year, commencing in 2007, the Servicer shall deliver to the Owner and any Depositor a statement of compliance addressed to the Owner and such Depositor and signed by an authorized officer of the Servicer, to the effect that (i) a review of the Servicer’s activities during the immediately preceding calendar year (or applicable portion thereof) and of its performance under this Agreement and any applicable Reconstitution Agreement during such period has been made under such officer’s supervision, and (ii) to the best of such officers’ knowledge, based on such review, the Servicer has fulfilled all of its obligations under this Agreement and any applicable Reconstitution Agreement in all material respects throughout such calendar year (or applicable portion thereof) or, if there has been a failure to fulfill any such obligation in any material respect, specifically identifying each such failure known to such officer and the nature and the status thereof.

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