Pharmacovigilance and Adverse Event Reporting Sample Clauses

Pharmacovigilance and Adverse Event Reporting. Within [***] days of the Closing Date and in any event prior to the commencement of any Clinical Study of Licensed Product by or on behalf of Xxxxxxx or its Affiliates or sublicensees, the Parties shall enter into a mutually acceptable pharmacovigilance agreement, setting forth guidelines and procedures for the receipt, investigation, recording, review, communication, and exchange (as between the Parties) of adverse event reports, technical complaints and any other information concerning the safety of Licensed Product. Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfil, local and international reporting obligations to Regulatory Authorities. Furthermore, such guidelines and procedures shall be consistent with relevant International Committee on Harmonization (ICH) guidelines, except where said guidelines may conflict with reporting requirements of local Regulatory Authorities, in which case local reporting requirements shall prevail. The Parties shall mutually agree within [***] Business Days (or such shorter period as may be required to comply with applicable Law) on the actions necessary to address any safety concerns with respect to Licensed Product about which one Party provides notice to the other Party; provided, however, that if the Parties cannot reach agreement within such period, then [***] Notwithstanding the foregoing provision, such [***] day period shall be shortened if either Party provides notice to the other Party that more urgent action is required. Genmab’s costs incurred in connection with [***] adverse events and other reportable information as provided in such pharmacovigilance agreement shall be treated as Development Costs in accordance with Clause 4.5. Xxxxxxx shall establish and maintain the global safety database for the Licensed Products, including [***] (the “Global Safety Database”) for the Licensed Products. Genmab shall transfer all adverse events information in its possession or Control to Xxxxxxx for entry into the Global Safety Database within a mutually agreed period of time that provides Xxxxxxx with sufficient time to enter all of the data and to obtain validation of the Global Safety Database. [***] Xxxxxxx shall be obligated to provide all reasonable assistance upon request from Genmab for safety information relevant to the Licensed Product to comply with applicable Laws.
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Pharmacovigilance and Adverse Event Reporting. Prior to or concurrent with the Closing Date, the Parties will enter into the Pharmacovigilance Agreement, setting forth guidelines and procedures for the receipt, investigation, recording, review, communication, and exchange (as between the Parties) of adverse event reports, technical complaints and any other information concerning the safety of the Product.
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Pharmacovigilance and Adverse Event Reporting. The Parties will cooperate with each other with regard to the reporting and handling of safety information involving the Licensed Products and Sarepta Diagnostic Products in accordance with Applicable Law, regulatory requirements, and regulations on pharmacovigilance and clinical safety. Prior to the commencement of any activities conducted by or on behalf of Roche or any of its Affiliates in furtherance of any Clinical Trial for any Licensed Product, the Parties will negotiate in good faith and enter into a Pharmacovigilance Agreement related to the Licensed Products and a quality agreement, or such other agreement as the Parties may agree, related to the Sarepta Diagnostic Products, which will define the pharmacovigilance responsibilities of the Parties and include safety data exchange procedures governing the exchange of information affecting the class and products (e.g., Serious Adverse Events, emerging safety issues) to enable each Party to comply with all of its legal and regulatory obligations related to such Licensed Products and Sarepta Diagnostic Products. Sarepta will own and maintain the global safety database for all Sarepta Products and Sarepta Diagnostic Products. 79445843_10
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Pharmacovigilance and Adverse Event Reporting. The Parties shall cooperate with regard to the reporting and handling of safety information involving the Cost Share Products in accordance with Applicable Laws, regulatory requirements, and regulations on pharmacovigilance and clinical safety. At such time as the Parties deem appropriate and to comply with Applicable Law, the Parties shall agree upon pharmacovigilance activities to be conducted by each Party in connection with the Cost Share Products.
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Pharmacovigilance and Adverse Event Reporting. 7.1 Kamada shall be responsible for establishing a pharmacovigilance monitoring system, with the reasonable assistance of the Distributor. Such monitoring system will include (i) provision of minimum pharmacovigilance information regarding a reporter who is identifiable by name, initials and/or address; (ii) an identifiable patient/subject (i.e., identifiable by patient number, date of birth, age, or gender); (iii) at least one suspected substance/medicinal product; and (iv) at least one suspected adverse drug event.
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Pharmacovigilance and Adverse Event Reporting. The Parties shall execute, within [***], a separate pharmacovigilance agreement (the “Pharmacovigilance Agreement”) to specify details of the Parties’ obligations with respect to reporting any adverse events associated with any Product, exchanging adverse event and other safety information relating to the Products, and any other pharmacovigilance obligations.
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Pharmacovigilance and Adverse Event Reporting. The Parties shall cooperate with regard to the reporting and handling of safety information involving the DT Co-Co Products in accordance with the Applicable Laws, regulatory requirements, and regulations on pharmacovigilance and clinical safety. The Regulatory Responsible Party for a DT Co-Co Product in a given Region shall be responsible for all processing of information related to any adverse events for such DT Co-Co Product for the Region. Each Party shall provide to the other Party the relevant safety information it receives (either directly or indirectly) related to a DT Co-Co Product within such time to ensure that all regulatory requirements and timelines are met in the respective territories. The Parties shall negotiate in good faith and enter into a Pharmacovigilance Agreement, which shall define the pharmacovigilance responsibilities of the Parties and include safety data exchange procedures governing the exchange of information affecting the DT Co-Co Products (e.g., Serious Adverse Events, emerging safety issues) to enable each Party to comply with all of its legal and regulatory obligations related to such DT Co-Co Products (the “Pharmacovigilance Agreement”). Moderna shall own and maintain the global safety database for all DT Co-Co Products provided that the Pharmacovigilance Agreement shall provide Metagenomi access to such database and real time notifications and reporting of adverse events, as needed for pharmacovigilance obligations.
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Pharmacovigilance and Adverse Event Reporting. The Parties will cooperate with each other with regard to the reporting and handling of safety information involving the LRRK2 Licensed Products in accordance with applicable law, regulatory requirements, and regulations on pharmacovigilance and clinical safety. Within [***] following the Effective Date or as otherwise agreed by the Parties, the Parties will negotiate in good faith and enter into a pharmacovigilance agreement related to the LRRK2 Licensed Products, which will define the pharmacovigilance responsibilities of the Parties and include safety data exchange procedures governing the exchange of information affecting the class and products to enable each Party to comply with all of its legal and regulatory obligations related to such LRRK2 Licensed Products (the “Pharmacovigilance Agreement”). Following the execution of the Pharmacovigilance Agreement, Biogen will own and maintain the global safety database for all LRRK2 Licensed Products that is created by and held by Biogen, and following the execution of the Pharmacovigilance Agreement, Denali shall transfer the contents and ownership of the global safety database for all LRRK2 Licensed Products created by Denali pursuant to a mutually agreed plan in an electronic format agreed upon by the Parties.
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Pharmacovigilance and Adverse Event Reporting 
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Related to Pharmacovigilance 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.

  • Pharmacovigilance No later than [***] prior to (a) [***] or (b) [***], the Parties will negotiate in good faith and finalize the actions that the Parties will employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports and any other information concerning the safety of any Licensed Product, including recall and withdrawal responsibilities, processes, and procedures. Such guidelines and procedures will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Law. Furthermore, such agreed procedure will be consistent with relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will prevail. Lian will be responsible for reporting quality complaints, Adverse Events, and safety data related to the Licensed Products in the Field to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Field in the Territory. Lyra will be responsible for reporting quality complaints, Adverse Events, and safety data related to Licensed Product to applicable Regulatory Authorities outside the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the Territory. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Lyra at its sole cost and expense, which worldwide safety database will be accessible by Lian and its Affiliates, Sublicensees, and contractors to the full extent necessary for Lian to exercise its rights under this Agreement, comply with its obligations under this Agreement, and comply with all applicable Law. Each Party will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligations.

  • 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.

  • Pharmacovigilance Agreement Within [***] after the Effective Date, BMS and the Company (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being in connection with the use of the Licensed Compound(s) until such time that all pharmacovigilance responsibilities have transferred from BMS to Company. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Licensed Compound(s). Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. Until such guidelines and procedures are set forth in a written agreement between the Parties (hereafter referred to as the “Pharmacovigilance Agreement”), the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound(s) subject to all applicable regulations and guidelines. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled. Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

  • Regulatory Reporting Ultimus agrees to provide reports to the federal and applicable state authorities, including the SEC, and to the Funds’ Auditors. Applicable state authorities are those governmental agencies located in states in which the Fund is registered to sell shares.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company, that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such Permits as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

  • Regulatory Compliance Cooperation (a) CIT/VC agrees to use commercially reasonable best efforts to avoid the occurrence of a Regulatory Problem. In the event that CIT/VC determines that it has a Regulatory Problem, the Company agrees to use commercially reasonable efforts to take all such actions as are reasonably requested by CIT/VC in order (A) to effectuate and facilitate any transfer by CIT/VC of any Securities of the Company then held by CIT/VC to any Person designated by CIT/VC (subject, however, to compliance with Section 3 of this Agreement), (B) to permit CIT/VC (or any Affiliate of CIT/VC) to exchange all or any portion of the voting Securities of the Company then held by such Person on a share-for-share basis for shares of a class of non-voting Securities of the Company, which non-voting Securities shall be identical in all respects to such voting Securities, except that such new Securities shall be non-voting and shall be convertible into voting Securities on such terms as are requested by CIT/VC in light of regulatory considerations then prevailing, and (C) to continue and preserve the respective allocation of the voting interests with respect to the Company arising out of CIT/VC's ownership of voting Securities of the Company and/or provided for in this Agreement before the transfers and amendments referred to above (including entering into such additional agreements as are requested by CIT/VC to permit any Person(s) designated by CIT/VC to exercise any voting power which is relinquished by CIT/VC upon any exchange of voting Securities for nonvoting Securities of the Company); and the Company shall enter into such additional agreements, adopt such amendments to this Agreement, the Company's Charter and the Company's By-laws and other relevant agreements and taking such additional actions, in each case as are reasonably requested by CIT/VC in order to effectuate the intent of the foregoing. If CIT/VC elects to transfer Securities of the Company to a Regulated Holder in order to avoid a Regulatory Problem, the Company shall enter into such agreements with such Regulated Holder as it may reasonably request in order to assist such Regulated Holder in complying with applicable laws, and regulations to which it is subject. Such agreements may include restrictions on the 39. redemption, repurchase or retirement of Securities of the Company that would result or be reasonably expected to result in such Regulated Holder holding more voting securities or total securities (equity and debt) than it is permitted to hold under such laws and regulations.

  • Management Reporting (a) Provide periodic reports, in accordance with agreed upon frequency and content parameters, to the Funds. As reasonably requested by the Funds, the Transfer Agent shall furnish ad hoc reports to the Funds.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

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