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 Xx. Xxxx, 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 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 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.

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 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 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 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 SageSxxx, CyDex or any other Affiliate, Sublicensee, co-marketer or distributor of CyDex or Sage.

Adverse Event Reporting. Sage (a) Proteolix 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 confirmed diagnosis, symptom, sign (including an abnormal laboratory finding)sign, 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 Proteolix shall provide CyDex with copies of all reports of any such adverse event which is serious (any such adverse event directly involving Captisol, the Probe Study Product or the Licensed Product 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 Proteolix has reason to believe are associated with Captisol CAPTISOL within 10 [ ** ] business days following Proteolix’ (ia) Sage’s submission of any such report to any regulatory agency, or (iib) receipt from Sage’s its Sublicensee, co-marketer or distributor of any such report to any regulatory agency, as the case may be. Sage Proteolix shall also advise CyDex regarding any proposed labeling or registration dossier changes affecting CaptisolCAPTISOL. Reports from Sage Proteolix shall be delivered to the attention of Vice President, Chief Scientific Officer, CyDex, with a copy to General CounselCEO, LigandCyDex, at the address set forth in Section 14.714.7 (Notices). The parties shall mutually cooperate with regard to investigation of any such serious adverse eventevent which is believed to be directly associated with CAPTISOL, whether experienced by SageProteolix, CyDex or any other Affiliate, Sublicensee, co-marketer or distributor of CyDex or SageProteolix. (b) CyDex 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 confirmed diagnosis, symptom, sign, syndrome or disease, whether or not considered CAPTISOL-related, which occurs or worsens following administration of CAPTISOL alone or upon administration of a CAPTISOL-enabled formulated product. CyDex shall provide Proteolix with copies of all reports, some content of which may be redacted solely to protect the confidential information of third parties, of any such adverse event directly involving 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 CyDex has reason to believe are associated with CAPTISOL within [ ** ] business days following CyDex’ (a) submission of any such report to any regulatory agency, or (b) receipt from its Sublicensee, co-marketer or distributor of any such report to any regulatory agency, as the case may be. Reports from CyDex shall be delivered to the attention of Vice President of Development, Proteolix, with a copy to Chief Scientific Officer, Proteolix, at the address set forth in Section 14.7 (Notices). The parties shall mutually cooperate with regard to investigation of any such serious adverse event which is believed to be directly associated with CAPTISOL, whether experienced by Proteolix, CyDex or any other Affiliate, Sublicensee, co-marketer or distributor of CyDex or Proteolix. Such written notification to Proteolix as well as assistance [ ** ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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 ***Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 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.