Common use of Adverse Event Reporting Clause in Contracts

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 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. Sage Each party shall adhere, and shall require that its Affiliates, Sublicenseeslicensees, 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 Compound- or Licensed Product-related, which occurs or worsens following administration of Captisol, Probe Study Product Compound or Licensed Product. Sage Each party and/or its Affiliates, licensees or sublicensees shall provide CyDex the other party with copies of all reports of any such adverse event which is serious (any such adverse event involving Captisol, the Probe Study Product Compound or the Licensed Product that results in death, is life-threatening, requires or prolongs inpatient in-patient 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)) and which Sage such party and/or its Affiliates, licensees or sublicensees has reason to believe are associated with Captisol within reasonably attributable to Compound or Product as soon as possible and in no event later than 10 business days following (i) Sagesuch party’s submission of any such report to any regulatory agencyRegulatory Authority, or (ii) receipt from Sagesuch party’s Sublicenseelicensee, sublicensee, co-marketer or distributor of any such report to any regulatory agencyRegulatory Authority. Sage Each party shall also advise CyDex the other party regarding any proposed labeling or registration dossier changes affecting CaptisolProduct. Reports from Sage GBMT to Curis pursuant to this Section 4.6(c) shall be delivered to the attention of Chief Scientific Medical Officer, CyDexCuris, with a copy to General CounselChief Executive Officer, LigandCuris, at the address set forth in Section 14.712.9. Reports from Curis to GBMT pursuant to this Section 4.6(c) shall be delivered to the attention of ▇▇. ▇▇▇▇, at the address set forth in Section 12.9. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by SageGBMT, CyDex Curis or any other Affiliate, Sublicenseesublicensee, co-marketer or distributor of CyDex Curis or SageGBMT.

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 Captisol or Licensed Product-related, which occurs or worsens following administration of Captisol, Probe Study Product Captisol or Licensed Product. Sage shall provide CyDex with copies of all reports of any such adverse event which is serious (any such adverse event involving Captisol, the Probe Study Product Captisol 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 *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. EXECUTION COPY 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. Sage Each 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, 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 CAPTISOL or Licensed Product-related, which occurs or worsens following administration of Captisol, Probe Study Product CAPTISOL or Licensed Product. Sage Each party shall provide CyDex the other party with copies of all reports of any such adverse event which is serious (any such adverse event involving Captisol, the Probe Study Product CAPTISOL 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 either party has reason to believe are associated with Captisol CAPTISOL within 10 [**] business days following (i) Sage’s submission of any such report to any regulatory agency, or (ii) receipt from Sage’s such party's Sublicensee, co-marketer or distributor of any such report to any regulatory agency. Sage Company shall also advise CyDex regarding any proposed labeling or registration dossier changes affecting CaptisolCAPTISOL. Reports from Sage Company shall be delivered to the attention of the Chief Scientific Executive Officer, CyDex, with a copy to General Counselthe Director, LigandQuality Control, CyDex, at the address set forth in Section 14.7SECTION 14.7 (Notices). CyDex shall inform Company within [**] business days of any adverse events following administration of CAPTISOL of which CyDex learns in accordance with CyDex's obligations as a supplier of CAPTISOL, and provide Company with copies of all relevant reports. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by SageCompany, CyDex or any other Affiliate, Sublicensee, co-marketer or distributor of CyDex or SageCompany.

Adverse Event Reporting. Sage Hospira 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 Captisol or Licensed Finished Product-related, which occurs or worsens following administration of Captisol, Probe Study Product Captisol or Licensed Finished Product. Sage Hospira shall provide CyDex with copies of all reports of any such adverse event which is serious (any such adverse event involving Captisol, the Probe Study Product Captisol or the Licensed Finished 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 Hospira has reason to believe are associated with Captisol within 10 business days [***] following (i) SageHospira’s submission of any such report to any regulatory agencyRegulatory Authority, or (ii) receipt from SageHospira’s Sublicensee, co-marketer or distributor of any such report to any regulatory agencyRegulatory Authority. Sage Hospira shall also advise CyDex regarding any proposed labeling or registration dossier changes affecting Captisol. Reports from Sage Hospira 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 14.712.6. The parties shall mutually cooperate with regard to investigation of any such serious adverse eventevent associated with Captisol, whether experienced by SageHospira, CyDex or any other Affiliate, Sublicensee, co-marketer or distributor of CyDex or SageHospira. This Section 6.3 applies both before the First Commercial Sale (e.g., without limitation, in respect of use of the Finished Product in clinical studies) and after the First Commercial Sale.

Adverse Event Reporting. Sage Company 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 Captisol or Licensed Product-Product- related, which occurs or worsens following administration of Captisol, Probe Study Product Captisol or a Licensed Product. Sage Each party shall provide CyDex the other with copies of all reports it obtains (either directly or through any Sublicensee or licensee) of any such adverse event which is serious (e.g., any such adverse event involving Captisol, the Probe Study Product Captisol or the a 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 such party has reason to believe are associated with Captisol within 10 business 14 days following (ia) Sage’s submission of any such report to any regulatory agency, or (iib) receipt from Sagesuch party’s Sublicensee, licensee, co-marketer or distributor of any such report to any regulatory agency. Sage Company shall also advise CyDex regarding any proposed labeling or registration dossier changes affecting Captisol. Reports from Sage Company shall be delivered to the attention of Chief Scientific Officer, CyDex, with a copy to General CounselChief Executive Officer, LigandCyDex, at the address set forth in Section 14.7 and reports to Company shall be delivered to the attention of Chief Medical Officer, with a copy to Chief Executive Officer of Company 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 SageCompany, CyDex or any other Affiliate, Sublicensee, sublicensee, co-marketer or distributor of CyDex or SageCompany.

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 including if contained in a Licensed Product. Sage shall provide CyDex with copies of all reports of any such adverse event which is serious (i.e., any such adverse event involving Captisol, the Probe Study Product or the including if contained in a Licensed Product 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. 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 an 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 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 SageS▇▇▇, CyDex or any other Affiliate, Sublicensee, co-marketer or distributor of CyDex or Sage.

Adverse Event Reporting. Sage Company 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 Captisol or Licensed Product-related, which occurs or worsens following administration of Captisol, Probe Study Product Captisol or Licensed Product. Sage Company and/or its Affiliates or Sublicensees shall provide CyDex with copies of all reports of any such adverse event which is serious (any such adverse event involving Captisol, the Probe Study Product Captisol 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 Company and/or its Affiliates or Sublicensees has reason to believe are associated with Captisol within 10 business [***] days promptly following (i) SageCompany’s submission of any such report to any regulatory agency, or (ii) receipt from SageCompany’s Sublicensee, co-marketer or distributor of any such report to any regulatory agency. Sage Company shall also advise CyDex regarding any proposed labeling or registration dossier changes affecting Captisol. Reports from Sage Company shall be delivered to the attention of Vice President, Chief Scientific Operating Officer, CyDex, with a copy to General CounselVice President, LigandAssistant Secretary, CyDex, at the address addresses set forth in Section 14.714.6. By no later than [***] following the Effective Date and not later than the initiation of any clinical studies involving the Licensed Product, the parties shall enter into a formal safety agreement for the mutual exchange of adverse event reports and safety information associated with Captisol. Details of the operating procedure respecting such adverse event reports and safety information exchange shall be the subject of a mutually-agreed pharmacovigilance agreement between the parties. Company shall be solely responsible for reporting to the regulatory agencies and health authorities, adverse events relating to the Licensed Product and for maintaining the global safety database of such adverse events. The parties shall mutually cooperate with regard to investigation of any such serious adverse eventevent believed to be associated with Captisol supplied under this Agreement, whether experienced by SageCompany, CyDex or any other Affiliate, Sublicensee, co-marketer or distributor of CyDex or SageCompany.

Adverse Event Reporting. Sage Company 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 Captisol or Licensed Product-related, which occurs or worsens following administration of Captisol, Probe Study Product Captisol or Licensed Product. Sage Each party shall provide CyDex the other with copies of all reports it obtains (either directly or through any Sublicensee or licensee) of any such adverse event which is serious (e.g., any such adverse event involving Captisol, the Probe Study Product Captisol 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 such party has reason to believe are associated with Captisol within 10 business 14 days following (i) Sage’s submission of any such report to any regulatory agency, or (ii) receipt from Sagesuch party’s Sublicensee, licensee, co-marketer or distributor of any such report to any regulatory agency. Sage Company shall also advise CyDex regarding any proposed labeling or registration dossier changes affecting Captisol. Reports from Sage Company shall be delivered to the attention of Chief Scientific Officer, CyDex, with a copy to General CounselChief Executive Officer, LigandCyDex, 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 SageCompany, CyDex or any other Affiliate, Sublicensee, sublicensee, co-marketer or distributor of CyDex or SageCompany.

Adverse Event Reporting. Sage Company 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 Captisol or Licensed Product-related, which occurs or worsens following administration of Captisol, Probe Study Product Captisol or Licensed Product. Sage Each party shall provide CyDex the other with copies of all reports it obtains (either directly or through any Sublicensee or licensee) of any such adverse event which is serious (e.g., any such adverse event involving Captisol, the Probe Study Product Captisol 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 such party 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 Sagesuch party’s Sublicensee, licensee, co-marketer or distributor of any such report to any regulatory agency. Sage Company shall also advise CyDex regarding any proposed labeling or registration dossier changes affecting Captisol. Reports from Sage Company shall be delivered to the attention of Chief Scientific Officer, CyDex, with a copy to General CounselChief Executive Officer, LigandCyDex, 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 SageCompany, CyDex or any other Affiliate, Sublicensee, sublicensee, co-marketer or distributor of CyDex or SageCompany.

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 Captisol or Licensed Product-related, which occurs or worsens following administration of Captisol, Probe Study Product Captisol or Licensed Product. Sage shall provide CyDex with copies of all reports of any such adverse event which is serious (any such adverse event involving Captisol, the Probe Study Product Captisol 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 *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. EXECUTION COPY 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. Sage Each party shall adhere, and shall require that its Affiliates, Sublicenseessublicensees, 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-to be related to CAPTISOL or Licensed Product-relateda product containing CAPTISOL, which occurs or worsens following administration of Captisol, Probe Study Product CAPTISOL or Licensed Producta product containing CAPTISOL. Sage Each party shall provide CyDex the other party with copies of all reports of any such adverse event which is serious (any such adverse event involving Captisol, the Probe Study Product CAPTISOL or the Licensed Product a product containing CAPTISOL 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 such party has reason to believe are is associated with Captisol CAPTISOL or a product containing CAPTISOL within 10 [***] business days following (i) Sagesuch party’s submission of any such report to any regulatory agency, or (ii) receipt from Sagesuch party’s Sublicenseesublicensee, customer, co-marketer or distributor of any such report to any *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. regulatory agency. Sage Each party shall also advise CyDex the other party regarding any proposed labeling or registration dossier changes affecting CaptisolCAPTISOL. Reports from Sage a party shall be delivered to the attention of Vice President, Chief Scientific Officer, CyDexOfficer of the other party, with a copy to General CounselChief Executive Officer, Ligandof the other party, at the address set forth in Section 14.712.5 hereof. The parties shall mutually cooperate with each other with regard to investigation of any such serious adverse event, whether experienced by SagePrism, CyDex or any other Affiliate, Sublicenseesublicensee, customer, co-marketer or distributor of CyDex or SagePrism.