Complaints and Adverse Event Reporting Sample Clauses

Complaints and Adverse Event Reporting. 3.2.1 Each PARTY shall PROMPTLY notify the other of any information coming into its possession concerning the safety, quality, efficacy, and actual or pending regulatory action regarding the SELECTED REAGENT. Any determinations on how to address the information provided by NEKTAR AL, including communication with regulatory authorities, shall be the responsibility of COMPANY. In addition, NEKTAR AL shall provide to COMPANY such other information specifically relating to safety of the SELECTED REAGENT as is reasonably necessary to comply with requirements of applicable regulatory authorities.
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Complaints and Adverse Event Reporting. 5.2.1. Diosynth shall promptly notify Neose of any information coming into its possession concerning the quality of previously released Batch(es). Any determinations on how to address the information impacting product quality and safety including communication with regulatory authorities shall be the responsibility of Neose.
Complaints and Adverse Event Reporting. KBI BioPharma will promptly notify Client of any information coming into its possession concerning the quality of previously released API or drug product. Any determinations on whether a regulatory notification is necessary and the resulting communication with the regulatory authorities will be the responsibility of the Client Quality Contact. QUALITY HEAD APPROVALS CLIENT Written Signature: Printed Name: Hector J. Gomez Tixxx: CMO --- Date: March 28, 2006 KBX XXXXXXXXX, XXX. Xritten Signature: __________________________________________ ------------------------------------------ Printed Name: __________________________________________ ------------------------------------------ Title: __________________________________________ ------------------------------------------ Date: __________________________________________ ------------------------------------------ PROPOSAL FOR PT-401 DEVELOPMENT AND PRODUCTION
Complaints and Adverse Event Reporting. KBI Biopharma will promptly notify the Client of any information coming into its possession concerning the quality of previously released Client Product. Any determinations on whether a regulatory notification is necessary and the resulting communication with the regulatory authorities will be the responsibility of the Client Quality Contact. Client to notify KBI Biopharma within one (1) business day of any complaints or regulatory findings where the Client determines that the complaint or regulatory finding relates to or impacts Product manufactured by KBI Biopharma. KBI Biopharma will provide the requested assessments within agreed upon timeframe to meet regulatory reporting requirements.
Complaints and Adverse Event Reporting. 3.2.1 Each PARTY shall promptly notify the other of any information coming into its possession concerning the safety, quality, efficacy, and actual or pending regulatory action regarding the SELECTED REAGENT. If NEKTAR AL believes it has information that potentially requires an NDA Field Alert or BPDR (Biological Product Deviation Report), NEKTAR AL shall notify COMPANY within two (2) days. Any determinations on how to address the information impacting SELECTED PRODUCT quality and safety, including communication with regulatory authorities, shall be the responsibility of COMPANY.
Complaints and Adverse Event Reporting. During the Co-Promotion Period:
Complaints and Adverse Event Reporting. 7.21 Each Party shall maintain a record of any and all complaints and Adverse Events it receives with respect to the Products as required by applicable Regulatory Requirements.
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Complaints and Adverse Event Reporting 

Related to Complaints and Adverse Event Reporting

  • 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.

  • 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.

  • Incident Reporting Transfer Agent will use commercially reasonable efforts to promptly furnish to Fund information that Transfer Agent has regarding the general circumstances and extent of such unauthorized access to the Fund Data.

  • 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.

  • Material Adverse Events Since the date of the latest audited financial statements included within the SEC Reports, except as specifically disclosed in a subsequent SEC Report filed prior to the date hereof, (i) there has been no event, occurrence or development that has had or that could reasonably be expected to result in a Material Adverse Effect, (ii) the Company has not incurred any liabilities (contingent or otherwise) other than (A) trade payables and accrued expenses incurred in the ordinary course of business consistent with past practice and (B) liabilities not required to be reflected in the Company’s financial statements pursuant to GAAP or required to be disclosed in filings made with the Commission, (iii) the Company has not altered its method of accounting, (iv) the Company has not declared or made any dividend or distribution of cash or other property to its stockholders or purchased, redeemed or made any agreements to purchase or redeem any shares of its capital stock and (v) the Company has not issued any equity securities to any officer, director or “Affiliate” (defined as any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 144 under the Act), except pursuant to existing Company stock option plans. The Company does not have pending before the Commission any request for confidential treatment of information. No event, liability or development has occurred or exists with respect to the Company or its Subsidiaries or their respective business, properties, operations or financial condition, that would be required to be disclosed by the Company under applicable securities laws at the time this representation is deemed made that has not been publicly disclosed at least 1 Trading Day prior to the date that this representation is deemed made.

  • Account Reporting Information Italian residents who, at any time during the fiscal year, hold foreign financial assets (including cash and shares of Common Stock) which may generate income taxable in Italy are required to report these assets on their annual tax returns (UNICO Form, RW Schedule) for the year during which the assets are held, or on a special form if no tax return is due. These reporting obligations will also apply to Italian residents who are the beneficial owners of foreign financial assets under Italian money laundering provisions.

  • Material Adverse Event The occurrence of a MATERIAL ADVERSE EVENT.

  • 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.

  • Financial Information and Reporting (a) The Company will maintain true books and records of account in which full and correct entries will be made of all its business transactions pursuant to a system of accounting established and administered in accordance with generally accepted accounting principles consistently applied (except as noted therein or as disclosed to the recipients thereof), and will set aside on its books all such proper accruals and reserves as shall be required under generally accepted accounting principles consistently applied.

  • Information and Reporting The Adviser shall provide the Trust and its respective officers with such periodic reports concerning the obligations the Adviser has assumed under this Agreement as the Trust may from time to time reasonably request.

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