PERIODIC SAFETY UPDATE REPORTS Sample Clauses

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.
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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.
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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.
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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
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

Related to PERIODIC SAFETY UPDATE REPORTS

  • 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.

  • Inspection Reports Copies of the incident inspection reports and related documentation shall be distributed as follows:

  • Monthly MWBE Contractor Compliance Report A. In accordance with 5 NYCRR § 142.10, Contractor is required to report Monthly MWBE Contractor Compliance to OGS during the term of the Contract for the preceding month’s activity, documenting progress made towards achievement of the Contract MWBE goals. OGS requests that all Contractors use the New York State Contract System (“NYSCS”) to report subcontractor and supplier payments made by Contractor to MWBEs performing work under the Contract. The NYSCS may be accessed at xxxxx://xx.xxxxxxxxxxxxxx.xxx/. This is a New York State-based system that all State agencies and authorities will be implementing to ensure uniform contract compliance reporting throughout New York State.

  • How to Update Your Records You agree to promptly update your registration records if your e-mail address or other information changes. You may update your records, such as your e-mail address, by using the Profile page.

  • 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.

  • Evaluation Reports Where a formal evaluation of an employee's performance is carried out, the employee shall be provided with a copy to read and review. Provision shall be made on the evaluation form for an employee to sign it. The form shall provide for the employee's signature in two (2) places, one indicating that the employee has read and accepts the evaluation, and the other indicating that the employee disagrees with the evaluation. The employee shall sign in one of the places provided within seven (7) calendar days. No employee may initiate a grievance regarding the contents of an evaluation report unless the signature indicates disagreement with the evaluation. The employee shall receive a copy of the evaluation report at the time of signing. An evaluation report shall not be changed after an employee has signed it, without the knowledge of the employee, and any such changes shall be subject to the grievance procedure.

  • 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.

  • Minimum Site Requirements for TIPS Sales (when applicable to TIPS Sale). Cleanup: When performing work on site at a TIPS Member’s property, Vendor shall clean up and remove all debris and rubbish resulting from their work as required or directed by the TIPS Member or as agreed by the parties. Upon completion of work, the premises shall be left in good repair and an orderly, neat, clean and unobstructed condition. Preparation: Vendor shall not begin a project for which a TIPS Member has not prepared the site, unless Vendor does the preparation work at no cost, or until TIPS Member includes the cost of site preparation in the TIPS Sale Site preparation includes, but is not limited to: moving furniture, installing wiring for networks or power, and similar pre‐installation requirements. Registered Sex Offender Restrictions: For work to be performed at schools, Vendor agrees that no employee of Vendor or a subcontractor who has been adjudicated to be a registered sex offender will perform work at any time when students are, or reasonably expected to be, present unless otherwise agreed by the TIPS Member. Vendor agrees that a violation of this condition shall be considered a material breach and may result in the cancellation of the TIPS Sale at the TIPS Member’s discretion. Vendor must identify any additional costs associated with compliance of this term. If no costs are specified, compliance with this term will be provided at no additional charge. Safety Measures: Vendor shall take all reasonable precautions for the safety of employees on the worksite, and shall erect and properly maintain all necessary safeguards for protection of workers and the public. Vendor shall post warning signs against all hazards created by the operation and work in progress. Proper precautions shall be taken pursuant to state law and standard practices to protect workers, general public and existing structures from injury or damage. Smoking: Persons working under Agreement shall adhere to the TIPS Member’s or local smoking statutes, codes, ordinances, and policies.

  • Periodic Reports, etc For a period of five (5) years from the Effective Date or until such earlier time upon which the Company is dissolved, the Company will furnish to the Representative and its counsel copies of such financial statements and other periodic and special reports as the Company from time to time furnishes generally to holders of any class of its securities, and promptly furnish to the Representative: (i) a copy of each periodic report the Company shall be required to file with the Commission; (ii) a copy of every press release and every news item and article with respect to the Company or its affairs which was released by the Company; (iii) a copy of each Form 8-K or Schedules 13D, 13G, 14D-1 or 13E-4 received or prepared by the Company; (iv) five (5) copies of each Registration Statement; and (v) such additional documents and information with respect to the Company and the affairs of any future subsidiaries of the Company as the Representative may from time to time reasonably request; provided that the Representative shall sign, if requested by the Company, a Regulation FD compliant confidentiality agreement which is reasonably acceptable to the Representative and its counsel in connection with the Representative’s receipt of such information. Documents filed with the Commission pursuant to its Electronic Data Gathering, Analysis and Retrieval System (“XXXXX”) shall be deemed to have been delivered to the Representative pursuant to this section.

  • Usage Reports The Contractor shall submit usage reports on an annual basis to the assigned Deputy Purchasing Agent of the County of Orange user agency/department. The usage report shall be in a format specified by the user agency/department and shall be submitted 90 days prior to the expiration date of the contract term, or any subsequent renewal term, if applicable.

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