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.
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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.
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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.
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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.
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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.

  • Litigation, Environmental and Labor Matters (a) There are no actions, suits, proceedings or investigations 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 of its Subsidiaries (i) as to which there is a reasonable possibility of an adverse determination and that, if adversely determined, could reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect or (ii) that involve this Agreement or the Transactions.

  • Notification of Threatened Action Each Party will immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may affect the safety or efficacy claims of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

  • Adverse Event Reporting Sage shall adhere, and shall require that its Affiliates, Sublicensees, co-marketers and distributors adhere, to all requirements of applicable law and regulations that relate to the reporting and investigation of any adverse event, including without limitation an unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease, whether or not considered Captisol. Probe Study Product-related or Licensed Product-related, which occurs or worsens following administration of Captisol, Probe Study Product or Licensed Product. Sage shall provide CyDex with copies of ***Text Omitted and Filed Separately with the Securities and Exchange Commission Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 230.406 all reports of any such adverse event which is serious (any such adverse event involving Captisol, the Probe Study Product or the Licensed Product that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in disability, congenital anomaly or is medically important (i.e., may require other medical or surgical intervention to prevent other serious criteria from occurring)) which Sage has reason to believe are associated with Captisol within 10 business days following (i) Sage’s submission of any such report to any regulatory agency, or (ii) receipt from Sage’s Sublicensee, co-marketer or distributor of any such report to any regulatory agency. Sage shall also advise CyDex regarding any proposed labeling or registration dossier changes affecting Captisol. Reports from Sage shall be delivered to the attention of Chief Scientific Officer, CyDex, with a copy to General Counsel, Ligand, at the address set forth in Section 14.7. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by Sage, CyDex or any other Affiliate, Sublicensee, co-marketer or distributor of CyDex or Sage.

  • 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.

  • Notification of Events of Default and Adverse Developments The Borrower shall promptly notify the Lender upon obtaining knowledge of the occurrence of:

  • 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.

  • Environmental and Safety Matters Except as disclosed in Schedule 4.13:

  • No Adverse Events Between the date hereof and the Closing Date, neither the business, assets or condition, financial or otherwise, of the Company taken as a whole shall have been materially adversely affected in any manner.

  • Environmental Matters; Environmental Reviews (a) Each Restricted Person will comply in all material respects with all Environmental Laws now or hereafter applicable to such Restricted Person as well as all contractual obligations and agreements with respect to environmental remediation or other environmental matters and shall obtain, at or prior to the time required by applicable Environmental Laws, all environmental, health and safety permits, licenses and other authorizations necessary for its operations and will maintain such authorizations in full force and effect.

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