Response to Complaints and/or Adverse Drug Events Sample Clauses

Response to Complaints and/or Adverse Drug Events. Pursuant to a reported complaint and/or adverse drug event, if the nature of the reported complaint and/or adverse drug event requires testing, Aventis will, at Purchaser’s reasonable request, perform analytical testing of corresponding retention samples and provide the results thereto to Purchaser as soon as reasonably practicable. Such testing shall be performed using testing procedures as set forth in Applicable Law or Product Approval or otherwise required by applicable Governmental Authorities. If it is determined that Aventis is responsible for such reported complaint and/or adverse drug event, then Aventis shall bear the reasonable cost of such testing. Otherwise, Purchaser shall pay the reasonable cost associated with such testing.
Sample 1Sample 2
Response to Complaints and/or Adverse Drug Events. In the event of a reported complaint and/or adverse drug event, if the nature of the reported complaint and/or adverse drug event requires testing, Solvay shall, at [ * ] (unless the event was the result of [ * ], in which case [ * ]), investigate and perform all requested testing including without limitation, analytical testing of corresponding retention samples, and provide the results thereto to Jazz Pharmaceuticals as soon as reasonably practicable. Such testing shall be performed using the approved testing procedures as set forth in the API Specifications.
Sample 1
Response to Complaints and/or Adverse Drug Events. (a) Pursuant to a reported complaint and/or adverse drug event, if the nature of the reported complaint and/or adverse drug event requires testing during the period, Inyx will, upon King’s request and approval and at Inyx’s reasonable expense, perform analytical testing of corresponding retention samples and provide the results thereto to King as soon as reasonably practicable. King as the party holding the applicable NDA shall remain responsible for reporting to the FDA or any other Regulatory Authority. Such testing shall be performed using NDA approved testing procedures as set forth in the applicable NDA. (b) If the parties disagree as to which party is responsible, Inyx and King representatives shall attempt to resolve such dispute. If the representatives cannot resolve such dispute, the retention samples shall be submitted by Inyx and King to a mutually agreed-to qualified laboratory for testing, and the test results obtained by such laboratory shall be final and controlling. The fees and expenses of such laboratory testing shall be borne entirely by the party whose analysis was in error.
Sample 1
Response to Complaints and/or Adverse Drug Events. In the event of a reported complaint and/or adverse drug event, if the nature of the reported complaint and/or adverse drug event requires testing, Solvay shall, at Jazz Pharmaceuticals’ reasonable request and expense (unless the event was the result of Solvay’s failure to manufacture API in accordance with the terms hereof, in which case the reasonable costs of such testing shall be borne by Solvay), investigate and perform all requested testing including without limitation, analytical testing of corresponding retention samples, and provide the results thereto to Jazz Pharmaceuticals as soon as reasonably practicable. Such testing shall be performed using the approved testing procedures as set forth in the API Specifications.
Sample 1

Related to Response to Complaints and/or Adverse Drug Events

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.

  • Complaints Investigation The employee who complains of harassment under the provisions of the Human Rights Code must first comply with the Employer’s harassment policy procedures before filing a grievance or human rights complaint.

  • Litigation, Environmental and Labor Matters (a) Except as set forth on Schedule 3.06, (i) there are no actions, suits or proceedings by or before any arbitrator or Governmental Authority pending against or, to the knowledge of the Borrower, threatened against or affecting the Borrower or any Restricted Subsidiary that could reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect and (ii) none of the Borrower or any Subsidiary has treated, stored, transported, Released or disposed of Hazardous Materials at or from any currently or formerly owned real property or facility relating to its business in a manner that could reasonably be expected to have a Material Adverse Effect. (b) Except with respect to any matters that, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect, none of the Borrower or any Restricted Subsidiary (i) has failed to comply with any Environmental Law or to obtain, maintain or comply with any permit, license or other approval required under any Environmental Law, (ii) has, to the knowledge of the Borrower, become subject to any Environmental Liability, (iii) has received written notice of any claim with respect to any Environmental Liability or (iv) has, to the knowledge of the Borrower, any basis to reasonably expect that Holdings, the Borrower or any Restricted Subsidiary will become subject to any Environmental Liability. (c) Except with respect to any matters that, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect, (a) there are no strikes or other labor disputes against Holdings, the Borrower or any Restricted Subsidiary pending or, to the knowledge of the Borrower, threatened in writing and (b) none of the Borrower or the Restricted Subsidiaries have been in violation of the Fair Labor Standards Act or any other Requirements of Law dealing with wage and hour matters.

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

  • FLORIDA CONVICTED/SUSPENDED/DISCRIMINATORY COMPLAINTS By submission of an offer, the respondent affirms that it is not currently listed in the Florida Department of Management Services Convicted/Suspended/Discriminatory Complaint Vendor List.

  • Environmental and Safety Laws To its knowledge, the Company is not in violation of any applicable statute, law or regulation relating to the environment or occupational health and safety, and to its knowledge, no material expenditures are or will be required in order to comply with any such existing statute, law or regulation.

  • Complaints and Appeals As a Premera member, you have the right to offer your ideas, ask questions, voice complaints and request a formal appeal to reconsider decisions we have made. Our goal is to listen to your concerns and improve our service to you. If you need an interpreter to help with oral translation, please call us. Customer Service will be able to guide you through the service. We would like to hear from you. If you have an idea, suggestion, or opinion, please let us know. You can contact us at the addresses and telephone numbers found on the back cover. Please call us when you have questions about a benefit or coverage decision, our services, or the quality or availability of a healthcare service. We can quickly and informally correct errors, clarify benefits, or take steps to improve our service. We suggest that you call your provider of care when you have questions about the healthcare they provide.

  • Investigation of Accidents The Occupational Health and Safety Committees, as provided in Clause 22.2, shall be notified of each accident or injury and shall investigate and report to the Union and Employer on the nature and cause of the accident or injury. In the event of a fatality the Employer shall immediately notify the President of the nature and circumstances of the accident.

  • Notice of Suits, Adverse Events Furnish Agent with prompt notice of (i) any lapse or other termination of any Consent issued to any Borrower by any Governmental Body or any other Person that is material to the operation of any Borrower's business, (ii) any refusal by any Governmental Body or any other Person to renew or extend any such Consent; and (iii) copies of any periodic or special reports filed by any Borrower with any Governmental Body or Person, if such reports indicate any material change in the business, operations, affairs or condition of any Borrower, or if copies thereof are requested by Lender, and (iv) copies of any material notices and other communications from any Governmental Body or Person which specifically relate to any Borrower.

  • Professional Development; Adverse Consequences of School Exclusion; Student Behavior The Board President or Superintendent, or their designees, will make reasonable efforts to provide ongoing professional development to Board members about the adverse consequences of school exclusion and justice-system involvement, effective classroom management strategies, culturally responsive discipline, appropriate and available supportive services for the promotion of student attendance and engagement, and developmentally appropriate disciplinary methods that promote positive and healthy school climates, i.e., Senate Bill 100 training topics. The Board will conduct periodic self-evaluations with the goal of continuous improvement. New Board Member Orientation The orientation process for newly elected or appointed Board members includes: