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.
Adverse Event Reporting. The Institution and the Investigator shall comply with all adverse event reporting requirements under relevant Applicable Laws and Regulations, namely Sec. 58 of the Pharmaceuticals Law, this Agreement and the Protocol.
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 Event Reporting. Unless otherwise agreed by the Parties, the rights and obligations of the Parties with respect to safety and related reporting activities with respect to Product and the related Subject Constructs will be set forth in a safety agreement to be entered into between the Parties (or their respective Affiliates) no later than the [***] of the Product Schedule Date (or such later date as the Parties may agree). Such agreement will set forth terms and conditions with respect to such activities that are reasonable and customary in the industry for agreements of that nature, and will be based on AstraZeneca’s standard form of safety agreement. Pursuant to the safety agreement, AstraZeneca will be responsible for adverse event reporting relating to Product and the related Subject Constructs to applicable Regulatory Authorities in the Territory, and will be responsible for maintaining the global safety database with respect to Product and the related Subject Constructs. Moderna will assist AstraZeneca by reporting and providing to AstraZeneca all information relating to adverse events to the extent that Moderna has any such data. Such data and other information will be provided in such a manner, time and format, and to such person(s) or department(s), as may be designated by AstraZeneca from time to time, so as to enable AstraZeneca to comply with applicable Law. Moderna and AstraZeneca will reasonably cooperate to ensure that Moderna’s adverse event reporting processes will efficiently communicate such adverse event information in such manner, time and format. [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED A&R OPTION AGREEMENT
Adverse Event Reporting. Each party shall promptly notify the other party of any information that comes to such party’s attention concerning any serious or unexpected adverse event, injury, toxicity or sensitivity reaction, or any unexpected incidence, and the severity thereof, associated with the clinical uses, studies, investigations, tests and marketing of PH20 Drug, the Intrexon Biologic or the Product. For purposes of this Section 6.3, “serious” shall mean an experience which (a) results in the death, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, in-patient hospitalization or prolongation of hospitalization, or (b) is a congenital anomaly, the result of an overdose or life threatening (only if unrelated to primary disease); and “unexpected” shall mean (x) for a nonmarketed Product, an experience that is not identified in nature, severity or frequency in the current clinical investigator’s confidential information brochure, and (y) for a marketed product, an event which is not listed in the current labeling for such product, and includes an event that may be symptomatically and pathophysiologically related to an experience listed in the labeling but differs from the event because of increased frequency or greater severity or specificity. Each party further shall immediately notify the other party of any information received regarding any threatened or pending action by an agency that may affect the safety and efficacy claims of the Product. Upon receipt of any such information, the parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action; provided, however, that nothing contained herein shall restrict either party’s right to make a timely report of such matter to any government agency or take other action that it deems to be appropriate or required by applicable law, regulation or court order. Each party shall take all reasonable steps to protect the confidentiality of any patient health and medical information that it has access to and to comply with applicable state and federal privacy laws, as such laws apply to such party.
Adverse Event Reporting. (a) Each Party shall, and shall require its respective Affiliates to:
Adverse Event Reporting. As between the Parties and in accordance with Section 4.4, BMS shall be responsible for the timely reporting to the appropriate Regulatory Authorities of all Adverse Events and any other information concerning the safety of Products, in each case, in accordance with Applicable Law of the relevant countries.
Adverse Event Reporting. (a) This Section 2.2 shall govern safety reporting arising from the Combined Therapy Clinical Trial. The Recipient will manage all drug safety reporting activities for the Combined Therapy Clinical Trial.
Adverse Event Reporting. Licensee shall advise Vital Images, by telephone or facsimile, within twenty-four (24) hours after it becomes aware of any adverse event from the use of any Product or malfunction of any Product. Unless otherwise required by applicable local laws, Licensee shall advise Vital Images of any such adverse event prior to any report or filing being made with the U.S. Food and Drug Administration (“FDA”) or any other comparable regulatory body elsewhere in the world.
Adverse Event Reporting. Either party 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. In the event that either party becomes aware of any adverse event relating to either the Licensed Product or Captisol, the party shall timely inform the other party of any such adverse event.
