Common use of Adverse Event Reporting Clause in Contracts

Adverse Event Reporting. Each party shall adhere, and shall require that its Affiliates, licensees, 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 Compound- or Product-related, which occurs or worsens following administration of Compound or Product. Each party and/or its Affiliates, licensees or sublicensees shall provide the other party with copies of all reports of any such adverse event which is serious (any such adverse event involving Compound or Product that results in death, is life-threatening, requires or prolongs 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 such party and/or its Affiliates, licensees or sublicensees has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than 10 business days following (i) such party’s submission of any such report to any Regulatory Authority, or (ii) receipt from such party’s licensee, sublicensee, co-marketer or distributor of any such report to any Regulatory Authority. Each party shall also advise the other party regarding any proposed labeling or registration dossier changes affecting Product. Reports from GBMT to Curis pursuant to this Section 4.6(c) shall be delivered to the attention of Chief Medical Officer, Curis, with a copy to Chief Executive Officer, Curis, at the address set forth in Section 12.9. 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 GBMT, Curis or any Affiliate, sublicensee, co-marketer or distributor of Curis or GBMT.

Adverse Event Reporting. Each party Sage shall adhere, and shall require that its Affiliates, licensees, 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 Compound- Captisol. Probe Study Product-related or Licensed Product-related, which occurs or worsens following administration of Compound Captisol, Probe Study Product or Licensed Product. Each party and/or its Affiliates, licensees or sublicensees Sage shall provide the other party CyDex with copies of all reports of any such adverse event which is serious (any such adverse event involving Compound Captisol, the Probe Study Product or the Licensed Product that results in death, is life-threatening, requires or prolongs in-patient 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)) and which such party and/or its Affiliates, licensees or sublicensees Sage has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than associated with Captisol within 10 business days following (i) such partySage’s submission of any such report to any Regulatory Authorityregulatory agency, or (ii) receipt from such partySage’s licensee, sublicenseeSublicensee, co-marketer or distributor of any such report to any Regulatory Authorityregulatory agency. Each party Sage shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCaptisol. Reports from GBMT to Curis pursuant to this Section 4.6(c) Sage shall be delivered to the attention of Chief Medical Scientific Officer, CurisCyDex, with a copy to Chief Executive OfficerGeneral Counsel, CurisLigand, at the address set forth in Section 12.9. 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 12.914.7. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by GBMTSage, Curis CyDex or any other Affiliate, sublicenseeSublicensee, co-marketer or distributor of Curis CyDex or GBMTSage.

Adverse Event Reporting. Each party Hospira shall adhere, and shall require that its Affiliates, licensees, 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 Compound- Captisol or Finished Product-related, which occurs or worsens following administration of Compound Captisol or Finished Product. Each party and/or its Affiliates, licensees or sublicensees Hospira shall provide the other party CyDex with copies of all reports of any such adverse event which is serious (any such adverse event involving Compound Captisol or the Finished Product that results in death, is life-threatening, requires or prolongs in-patient 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)) and which such party and/or its Affiliates, licensees or sublicensees Hospira has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than 10 business days associated with Captisol within [***] following (i) such partyHospira’s submission of any such report to any Regulatory Authority, or (ii) receipt from such partyHospira’s licensee, sublicenseeSublicensee, co-marketer or distributor of any such report to any Regulatory Authority. Each party Hospira shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCaptisol. Reports from GBMT to Curis pursuant to this Section 4.6(c) Hospira shall be delivered to the attention of Chief Medical Scientific Officer, CurisCyDex, with a copy to Chief Executive OfficerGeneral Counsel, CurisLigand, at the address set forth in Section 12.9. 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 12.912.6. The parties shall mutually cooperate with regard to investigation of any such serious adverse eventevent associated with Captisol, whether experienced by GBMTHospira, Curis CyDex or any other Affiliate, sublicenseeSublicensee, co-marketer or distributor of Curis CyDex or GBMTHospira. 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. Each party Company shall adhere, and shall require that its Affiliates, licensees, 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 Compound- Captisol or Licensed Product-related, which occurs or worsens following administration of Compound Captisol or Licensed Product. Each party Company and/or its Affiliates, licensees Affiliates or sublicensees Sublicensees shall provide the other party CyDex with copies of all reports of any such adverse event which is serious (any such adverse event involving Compound Captisol or the Licensed Product that results in death, is life-threatening, requires or prolongs in-patient 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)) and which such party Company and/or its Affiliates, licensees Affiliates or sublicensees Sublicensees has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than 10 business associated with Captisol within [***] days promptly following (i) such partyCompany’s submission of any such report to any Regulatory Authorityregulatory agency, or (ii) receipt from such partyCompany’s licensee, sublicenseeSublicensee, co-marketer or distributor of any such report to any Regulatory Authorityregulatory agency. Each party Company shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCaptisol. Reports from GBMT to Curis pursuant to this Section 4.6(c) Company shall be delivered to the attention of Vice President, Chief Medical Operating Officer, CurisCyDex, with a copy to Chief Executive OfficerVice President, CurisAssistant Secretary, CyDex, at the address addresses set forth in Section 12.914.6. Reports from Curis to GBMT pursuant to this Section 4.6(c) 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 delivered the subject of a mutually-agreed pharmacovigilance agreement between the parties. Company shall be solely responsible for reporting to the attention regulatory agencies and health authorities, adverse events relating to the Licensed Product and for maintaining the global safety database of Xx. Xxxx, at the address set forth in Section 12.9such 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 GBMTCompany, Curis CyDex or any other Affiliate, sublicenseeSublicensee, co-marketer or distributor of Curis CyDex or GBMTCompany.

Adverse Event Reporting. Each party Sage shall adhere, and shall require that its Affiliates, licensees, 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 Compound- Captisol-related or Licensed Product-related, which occurs or worsens following administration of Compound or Captisol, including if contained in a Licensed Product. Each party and/or its Affiliates, licensees or sublicensees Sage shall provide the other party CyDex with copies of all reports of any such adverse event which is serious (i.e., any such adverse event involving Compound or Product Captisol, including if contained in a Licensed Product, that results in death, is life-threatening, requires or prolongs in-patient 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)) and which such party and/or its Affiliates, licensees or sublicensees Sage has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than associated with Captisol within 10 business days following (i) such partySage’s submission of any such report to any Regulatory Authorityregulatory agency, or (ii) receipt from such partySage’s licensee, sublicenseeSublicensee, co-marketer or distributor of any such report to any Regulatory Authorityregulatory agency. Each party Sage shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCaptisol. Reports from GBMT to Curis pursuant to this Section 4.6(c) Sage shall be delivered to the attention of Chief Medical Scientific Officer, CurisCyDex, with a copy to Chief Executive OfficerGeneral Counsel, CurisLigand, at the address set forth in Section 12.9. 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 12.914.7. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by GBMTSage, Curis CyDex or any other Affiliate, sublicenseeSublicensee, co-marketer or distributor of Curis CyDex or GBMTSage.

Adverse Event Reporting. Each party Sage shall adhere, and shall require that its Affiliates, licensees, 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 Compound- Captisol or Licensed Product-related, which occurs or worsens following administration of Compound Captisol or Licensed Product. Each party and/or its Affiliates, licensees or sublicensees Sage shall provide the other party CyDex with copies of all reports of any such adverse event which is serious (any such adverse event involving Compound Captisol or the Licensed Product that results in death, is life-threatening, requires or prolongs in-patient 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)) and which such party and/or its Affiliates, licensees or sublicensees Sage has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than 10 business days associated with Captisol within [***] following (i) such partySage’s submission of any such report to any Regulatory Authorityregulatory *** 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 such partySage’s licensee, sublicenseeSublicensee, co-marketer or distributor of any such report to any Regulatory Authorityregulatory agency. Each party Sage shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCaptisol. Reports from GBMT to Curis pursuant to this Section 4.6(c) Sage shall be delivered to the attention of Chief Medical Scientific Officer, CurisCyDex, with a copy to Chief Executive OfficerGeneral Counsel, CurisLigand, at the address set forth in Section 12.9. 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 12.914.7. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by GBMTSage, Curis CyDex or any other Affiliate, sublicenseeSublicensee, co-marketer or distributor of Curis CyDex or GBMTSage.

Adverse Event Reporting. Each party Sage shall adhere, and shall require that its Affiliates, licensees, 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 Compound- Captisol or Licensed Product-related, which occurs or worsens following administration of Compound Captisol or Licensed Product. Each party and/or its Affiliates, licensees or sublicensees Sage shall provide the other party CyDex with copies of all reports of any such adverse event which is serious (any such adverse event involving Compound Captisol or the Licensed Product that results in death, is life-threatening, requires or prolongs in-patient 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)) and which such party and/or its Affiliates, licensees or sublicensees Sage has reason to believe are reasonably attributable associated *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to Compound or Product as soon as possible and in no event later than 10 business days the omitted portions. EXECUTION COPY with Captisol within [***] following (i) such partySage’s submission of any such report to any Regulatory Authorityregulatory agency, or (ii) receipt from such partySage’s licensee, sublicenseeSublicensee, co-marketer or distributor of any such report to any Regulatory Authorityregulatory agency. Each party Sage shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCaptisol. Reports from GBMT to Curis pursuant to this Section 4.6(c) Sage shall be delivered to the attention of Chief Medical Scientific Officer, CurisCyDex, with a copy to Chief Executive OfficerGeneral Counsel, CurisLigand, at the address set forth in Section 12.9. 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 12.914.7. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by GBMTSage, Curis CyDex or any other Affiliate, sublicenseeSublicensee, co-marketer or distributor of Curis CyDex or GBMTSage.

Adverse Event Reporting. Each party shall adhere, and shall require that its Affiliates, licensees, 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 Compound- CAPTISOL or Licensed Product-related, which occurs or worsens following administration of Compound CAPTISOL or Licensed Product. Each party and/or its Affiliates, licensees or sublicensees shall provide the other party with copies of all reports of any such adverse event which is serious (any such adverse event involving Compound CAPTISOL or the Licensed Product that results in death, is life-threatening, requires or prolongs in-patient 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)) and which such either party and/or its Affiliates, licensees or sublicensees has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than 10 associated with CAPTISOL within [**] business days following (i) such party’s submission of any such report to any Regulatory Authorityregulatory agency, or (ii) receipt from such party’s licensee, sublicensee's Sublicensee, co-marketer or distributor of any such report to any Regulatory Authorityregulatory agency. Each party Company shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCAPTISOL. Reports from GBMT to Curis pursuant to this Section 4.6(c) Company shall be delivered to the attention of the Chief Medical Executive Officer, CurisCyDex, with a copy to Chief Executive Officerthe Director, CurisQuality Control, CyDex, at the address set forth in Section 12.9SECTION 14.7 (Notices). Reports from Curis to GBMT pursuant to this Section 4.6(c) CyDex shall be delivered to the attention inform Company within [**] business days of Xx. Xxxxany adverse events following administration of CAPTISOL of which CyDex learns in accordance with CyDex's obligations as a supplier of CAPTISOL, at the address set forth in Section 12.9and 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 GBMTCompany, Curis CyDex or any other Affiliate, sublicenseeSublicensee, co-marketer or distributor of Curis CyDex or GBMTCompany.

Adverse Event Reporting. Each party Company shall adhere, and shall require that its Affiliates, licensees, 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 Compound- Captisol or Product-Licensed Product- related, which occurs or worsens following administration of Compound Captisol or a Licensed Product. Each party and/or its Affiliates, licensees or sublicensees shall provide the other party 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 Compound Captisol or a Licensed Product that results in death, is life-threatening, requires or prolongs in-patient 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)) and which such party and/or its Affiliates, licensees or sublicensees has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than 10 business associated with Captisol within 14 days following (ia) such party’s submission of any such report to any Regulatory Authorityregulatory agency, or (iib) receipt from such party’s Sublicensee, licensee, sublicensee, co-marketer or distributor of any such report to any Regulatory Authorityregulatory agency. Each party Company shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCaptisol. Reports from GBMT Company shall be delivered to Curis pursuant the attention of Chief Scientific Officer, CyDex, with a copy to this Chief Executive Officer, CyDex, at the address set forth in Section 4.6(c) 14.7 and reports to Company shall be delivered to the attention of Chief Medical Officer, Curis, with a copy to Chief Executive Officer, Curis, Officer of Company at the address set forth in Section 12.9. 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 12.914.7. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by GBMTCompany, Curis CyDex or any other Affiliate, Sublicensee, sublicensee, co-marketer or distributor of Curis CyDex or GBMTCompany.

Adverse Event Reporting. Each party shall adhere, and shall require that its Affiliates, licensees, 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 Compound- to be related to CAPTISOL or Product-relateda product containing CAPTISOL, which occurs or worsens following administration of Compound CAPTISOL or Producta product containing CAPTISOL. Each party and/or its Affiliates, licensees or sublicensees shall provide the other party with copies of all reports of any such adverse event which is serious (any such adverse event involving Compound CAPTISOL or Product a product containing CAPTISOL that results in death, is life-threatening, requires or prolongs in-patient 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)) and which such party and/or its Affiliates, licensees or sublicensees has reason to believe are reasonably attributable to Compound is associated with CAPTISOL or Product as soon as possible and in no event later than 10 a product containing CAPTISOL within [***] business days following (i) such party’s submission of any such report to any Regulatory Authorityregulatory agency, or (ii) receipt from such party’s licenseesublicensee, sublicenseecustomer, co-marketer or distributor of any such report to any Regulatory Authority*** 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. Each party shall also advise the other party regarding any proposed labeling or registration dossier changes affecting ProductCAPTISOL. Reports from GBMT to Curis pursuant to this Section 4.6(c) a party shall be delivered to the attention of Vice President, Chief Medical Officer, CurisScientific Officer of the other party, with a copy to Chief Executive Officer, Curisof the other party, at the address set forth in Section 12.9. 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 12.912.5 hereof. The parties shall mutually cooperate with each other with regard to investigation of any such serious adverse event, whether experienced by GBMTPrism, Curis CyDex or any other Affiliate, sublicensee, customer, co-marketer or distributor of Curis CyDex or GBMTPrism.

Adverse Event Reporting. Each party Company shall adhere, and shall require that its Affiliates, licensees, 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 Compound- Captisol or Licensed Product-related, which occurs or worsens following administration of Compound Captisol or Licensed Product. Each party and/or its Affiliates, licensees or sublicensees shall provide the other party 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 Compound Captisol or the Licensed Product that results in death, is life-threatening, requires or prolongs in-patient 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)) and which such party and/or its Affiliates, licensees or sublicensees has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than 10 business associated with Captisol within 14 days following (i) such party’s submission of any such report to any Regulatory Authorityregulatory agency, or (ii) receipt from such party’s Sublicensee, licensee, sublicensee, co-marketer or distributor of any such report to any Regulatory Authorityregulatory agency. Each party Company shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCaptisol. Reports from GBMT to Curis pursuant to this Section 4.6(c) Company shall be delivered to the attention of Chief Medical Scientific Officer, CurisCyDex, with a copy to Chief Executive Officer, CurisCyDex, at the address set forth in Section 12.9. 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 12.914.7. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by GBMTCompany, Curis CyDex or any other Affiliate, Sublicensee, sublicensee, co-marketer or distributor of Curis CyDex or GBMTCompany.

Adverse Event Reporting. Each party Hospira shall adhere, and shall require that its Affiliates, licensees, 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 Compound- Captisol or Finished Product-related, which occurs or worsens following administration of Compound Captisol or Finished Product. Each party and/or its Affiliates, licensees or sublicensees Hospira shall provide the other party CyDex with copies of all reports of any such adverse event which is serious (any such adverse event involving Compound Captisol or the Finished Product that results in death, is life-threatening, requires or prolongs in-patient inpatient hospitalization, results in disability, congenital anomaly or is medically important (i.e., may require other *** 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. medical or surgical intervention to prevent other serious criteria from occurring)) and which such party and/or its Affiliates, licensees or sublicensees Hospira has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than 10 business days associated with Captisol within [***] following (i) such partyHospira’s submission of any such report to any Regulatory Authority, or (ii) receipt from such partyHospira’s licensee, sublicenseeSublicensee, co-marketer or distributor of any such report to any Regulatory Authority. Each party Hospira shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCaptisol. Reports from GBMT to Curis pursuant to this Section 4.6(c) Hospira shall be delivered to the attention of Chief Medical Scientific Officer, CurisCyDex, with a copy to Chief Executive OfficerGeneral Counsel, CurisLigand, at the address set forth in Section 12.9. 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 12.912.6. The parties shall mutually cooperate with regard to investigation of any such serious adverse eventevent associated with Captisol, whether experienced by GBMTHospira, Curis CyDex or any other Affiliate, sublicenseeSublicensee, co-marketer or distributor of Curis CyDex or GBMTHospira. 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. Each party Company shall adhere, and shall require that its Affiliates, licensees, 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 Compound- Captisol or Licensed Product-related, which occurs or worsens following administration of Compound Captisol or Licensed Product. Each party Company and/or its Affiliates, licensees Affiliates or sublicensees Sublicensees shall provide the other party CyDex with copies of all reports of any such adverse event which is serious (any such adverse event involving Compound Captisol or the Licensed Product that results in death, is life-threatening, requires or prolongs in-patient 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)) and which such party Company and/or its Affiliates, licensees Affiliates or sublicensees Sublicensees has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than 10 business associated with Captisol within [***] days promptly following (i) such partyCompany’s submission of any such report to any Regulatory Authorityregulatory agency, or (ii) receipt from such partyCompany’s licensee, sublicenseeSublicensee, co-marketer or distributor of any such report to any Regulatory Authorityregulatory agency. Each party Company shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCaptisol. Reports from GBMT to Curis pursuant to this Section 4.6(c) Company shall be delivered to the attention of Vice President, Chief Medical Operating Officer, CurisCyDex, with a copy to Chief Executive OfficerVice President, CurisAssistant Secretary, CyDex, at the address addresses set forth in Section 12.914.6. Reports from Curis to GBMT pursuant to this Section 4.6(c) 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 delivered the subject of a mutually-agreed pharmacovigilance agreement between the parties. Company shall be solely responsible for reporting to the attention regulatory agencies and health authorities, adverse events relating to the Licensed Product and for maintaining the global safety database of Xx. Xxxx, at the address set forth in Section 12.9such 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 GBMTCompany, Curis CyDex or any other Affiliate, sublicenseeSublicensee, co-marketer or distributor of Curis CyDex or GBMTCompany. *** 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.

Adverse Event Reporting. Each party (a) Proteolix shall adhere, and shall require that its Affiliates, licensees, 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 confirmed diagnosis, symptom, sign (including an abnormal laboratory finding)sign, syndrome or disease, whether or not considered Compound- CAPTISOL or Product-related, which occurs or worsens following administration of Compound CAPTISOL or Product. Each party and/or its Affiliates, licensees or sublicensees Proteolix shall provide the other party CyDex with copies of all reports of any such adverse event which is serious (any such adverse event directly involving Compound or Product CAPTISOL that results in death, is life-threatening, requires or prolongs in-patient 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)) and which such party and/or its Affiliates, licensees or sublicensees Proteolix has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than 10 associated with CAPTISOL within [ ** ] business days following Proteolix’ (ia) such party’s submission of any such report to any Regulatory Authorityregulatory agency, or (iib) receipt from such party’s licensee, sublicenseeits Sublicensee, co-marketer or distributor of any such report to any Regulatory Authorityregulatory agency, as the case may be. Each party Proteolix shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCAPTISOL. Reports from GBMT to Curis pursuant to this Section 4.6(c) Proteolix shall be delivered to the attention of Vice President, Chief Medical Scientific Officer, CurisCyDex, with a copy to Chief Executive OfficerCEO, CurisCyDex, at the address set forth in Section 12.9. 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 12.914.7 (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 GBMTProteolix, Curis CyDex or any other Affiliate, sublicenseeSublicensee, co-marketer or distributor of Curis CyDex or GBMTProteolix. (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. Each party Sage shall adhere, and shall require that its Affiliates, licensees, 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 an unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease, whether or not considered Compound- Captisol. Probe Study Product-related or Licensed Product-related, which occurs or worsens following administration of Compound Captisol, Probe Study Product or Licensed Product. Each party and/or its Affiliates, licensees or sublicensees Sage shall provide the other party CyDex with copies of all reports of any such adverse event which is serious (any such adverse event involving Compound Captisol, the Probe Study Product or the Licensed Product that results in death, is life-threatening, requires or prolongs in-patient 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)) and which such party and/or its Affiliates, licensees or sublicensees Sage has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than associated with Captisol within 10 business days following (i) such partySage’s submission of any such report to any Regulatory Authorityregulatory agency, or (ii) receipt from such partySage’s licensee, sublicenseeSublicensee, co-marketer or distributor of any such report to any Regulatory Authorityregulatory agency. Each party Sage shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCaptisol. Reports from GBMT to Curis pursuant to this Section 4.6(c) Sage shall be delivered to the attention of Chief Medical Scientific Officer, CurisCyDex, with a copy to Chief Executive OfficerGeneral Counsel, CurisLigand, at the address set forth in Section 12.9. 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 12.914.7. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by GBMTSxxx, Curis CyDex or any other Affiliate, sublicenseeSublicensee, co-marketer or distributor of Curis CyDex or GBMTSage.

Adverse Event Reporting. Each party Company shall adhere, and shall require that its Affiliates, licensees, 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 Compound- Captisol or Licensed Product-related, which occurs or worsens following administration of Compound Captisol or Licensed Product. Each party and/or its Affiliates, licensees or sublicensees shall provide the other party 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 Compound Captisol or the Licensed Product that results in death, is life-threatening, requires or prolongs in-patient 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)) and which such party and/or its Affiliates, licensees or sublicensees has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than 10 business days associated with Captisol within [***] following (i) such party’s submission of any such report to any Regulatory Authorityregulatory agency, or (ii) receipt from such party’s Sublicensee, licensee, sublicensee, co-marketer or distributor of any such report to any Regulatory Authorityregulatory agency. Each party Company shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCaptisol. Reports from GBMT to Curis pursuant to this Section 4.6(c) Company shall be delivered to the attention of Chief Medical Scientific Officer, CurisCyDex, with a copy to Chief Executive Officer, CurisCyDex, at the address set forth in Section 12.9. 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 12.914.7. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by GBMTCompany, Curis CyDex or any other Affiliate, Sublicensee, sublicensee, co-marketer or distributor of Curis CyDex or GBMTCompany.

Adverse Event Reporting. Each party Company shall adhere, and shall require that its Affiliates, licensees, 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 Compound- Captisol or Product-Licensed Product­ related, which occurs or worsens following administration of Compound Captisol or a Licensed Product. Each party and/or its Affiliates, licensees or sublicensees shall provide the other party 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 Compound Captisol or 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 in-patient 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)) and which such party and/or its Affiliates, licensees or sublicensees has reason to believe are reasonably attributable to Compound or Product as soon as possible and in no event later than 10 business associated with Captisol within 14 days following (ia) such party’s submission of any such report to any Regulatory Authorityregulatory agency, or (iib) receipt from such party’s Sublicensee, licensee, sublicensee, co-marketer or distributor of any such report to any Regulatory Authorityregulatory agency. Each party Company shall also advise the other party CyDex regarding any proposed labeling or registration dossier changes affecting ProductCaptisol. Reports from GBMT Company shall be delivered to Curis pursuant the attention of Chief Scientific Officer, CyDex, with a copy to this Chief Executive Officer, CyDex, at the address set forth in Section 4.6(c) 14.7 and reports to Company shall be delivered to the attention of Chief Medical Officer, Curis, with a copy to Chief Executive Officer, Curis, Officer of Company at the address set forth in Section 12.9. 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 12.914.7. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by GBMTCompany, Curis CyDex or any other Affiliate, Sublicensee, sublicensee, co-marketer or distributor of Curis CyDex or GBMTCompany.