Common use of Adverse Event Reporting Clause in Contracts

Adverse Event Reporting. (a) This Section 2.2 shall govern safety reporting arising from the Combined Therapy Clinical Trial. The Recipient will manage all drug safety reporting activities for the Combined Therapy Clinical Trial. (b) The Recipient will forward to BMS at the contact information below via fax or secure e-mail in a format to be agreed to by the Parties all fatal or life threatening SAE reports within four (4) calendar days of Date of First Receipt, all other SAE reports, reports of exposure during pregnancy (maternal and paternal) and reports of suspected transmission of an infectious agent via the BMS Study Drug or Combined Therapy within nine (9) calendars days of Date of First Receipt, in each case for the BMS Study Drug and the Combined Therapy administered in the Combined Therapy Clinical Trial. BMS – Adverse Event Reporting Contact E-mail [ ]* Fax [ ]* Acknowledgment of ICSR receipt: [ ]* (c) Each Party shall collect, use and disclose Personal Data obtained in the course of performing the pharmacovigilance activities under this Section 2.2 solely for the purposes of complying with the regulatory obligations as described in this Agreement, or as otherwise required by Applicable Law or by a court order. Both Parties will use electronic, physical, and other safeguards appropriate to the nature of the information to prevent any use or disclosure of Personal Data other than as provided for by this Agreement and permitted under the ICF. Both Parties will also take reasonable precautions to protect such Personal Data from accidental, unauthorized, or unlawful alteration or destruction. Each Party will notify the other Party promptly of any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access of such Personal Data. (d) The Recipient will promptly make available to BMS upon request such records that the Recipient Controls as is necessary or useful to perform medical assessment of any Adverse Event associated with the use of the BMS Study Drug or Combined Therapy reported during the Combined Therapy Clinical Trial that is forwarded to BMS under this Agreement. The Recipient will designate a single point of contact within its organization (and will provide to BMS the email address of such point of contact prior to the start of the Combined Therapy Clinical Trial) for any pharmacovigilance-related follow-up questions that BMS would have. (e) The Recipient shall perform case level reconciliation to confirm that BMS has received all reports required under this Agreement. The Recipient shall e-mail [ ]* to request a reconciliation report for the Combined Therapy Clinical Trial. The Recipient shall reconcile the cases identified as being transmitted to BMS on BMS’s reconciliation report and those contained in the Combined Therapy Clinical Trial database. The Recipient shall send missing case-level events to BMS Global Pharmacovigilance at [ ]* or by fax at [ ]*. The Recipient shall perform such reconciliation every [ ]*, unless otherwise agreed by BMS in writing. (f) As Sponsor, the Recipient will be responsible for submitting all applicable Individual Case Safety Report (ICSRs) and aggregate report submissions to Regulatory Authorities for the Combined Therapy Clinical Trial. The Recipient will provide BMS with the final version of any aggregate report at the time of submission. The Recipient will also submit appropriate safety letters or safety reports to study investigators, the reviewing IRB and authorized Regulatory Authorities in accordance with Applicable Law. (g) In the event that BMS produces any Development Safety Update Report (“DSUR”) in respect to the BMS Study Drug, BMS will provide to the Recipient upon request, and for the duration of the Combined Therapy Clinical Trial, copies of the executive summary and any line listings of Serious Adverse Drug Reactions extracted from the final DSUR for information purposes only and to assist the Recipient in generation of their own clinical trial aggregate report, where applicable. The Recipient agrees not to forward such BMS DSUR sections to any Third Party, except to its Affiliates, consultants, advisors and contractors under obligations of confidentiality for generation of such a clinical trial aggregate report or as otherwise permitted with respect to BMS Confidential Information under Section 9.3(b), (d), (e), and (f). (h) If the Recipient determines there is a significant Safety Issue or significant Safety Signals arising in a clinical trial that may be associated with the BMS Study Drug or Combined Therapy, the Recipient will disclose such information to BMS promptly after such determination. (i) BMS will ensure that any urgent Safety Issues or Safety Signals relating to the BMS Study Drug will be communicated to the Recipient promptly after such determination.

Adverse Event Reporting. 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 (aincluding an abnormal laboratory finding), syndrome or disease, whether or not considered Captisol or Licensed Product-related, which occurs or worsens following administration of Captisol or Licensed Product. 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 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)) This which Company and/or its Affiliates or Sublicensees has reason to believe are associated with Captisol within [***] days promptly following (i) Company’s submission of any such report to any regulatory agency, or (ii) receipt from Company’s Sublicensee, co-marketer or distributor of any such report to any regulatory agency. Company shall also advise CyDex regarding any proposed labeling or registration dossier changes affecting Captisol. Reports from Company shall be delivered to the attention of Vice President, Chief Operating Officer, CyDex, with a copy to Vice President, Assistant Secretary, CyDex, at the addresses set forth in Section 2.2 14.6. 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 govern 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 arising from to the Combined Therapy Clinical Trialregulatory agencies and health authorities, adverse events relating to the Licensed Product and for maintaining the global safety database of such adverse events. The Recipient will manage all drug safety reporting activities for the Combined Therapy Clinical Trial. (b) The Recipient will forward parties shall mutually cooperate with regard to BMS at the contact information below via fax or secure e-mail in a format investigation of any such serious adverse event believed to be agreed to by the Parties all fatal or life threatening SAE reports within four (4) calendar days of Date of First Receipt, all other SAE reports, reports of exposure during pregnancy (maternal and paternal) and reports of suspected transmission of an infectious agent via the BMS Study Drug or Combined Therapy within nine (9) calendars days of Date of First Receipt, in each case for the BMS Study Drug and the Combined Therapy administered in the Combined Therapy Clinical Trial. BMS – Adverse Event Reporting Contact E-mail [ ]* Fax [ ]* Acknowledgment of ICSR receipt: [ ]* (c) Each Party shall collect, use and disclose Personal Data obtained in the course of performing the pharmacovigilance activities associated with Captisol supplied under this Section 2.2 solely for the purposes of complying with the regulatory obligations as described in this Agreement, whether experienced by Company, CyDex or as otherwise required by Applicable Law any other Affiliate, Sublicensee, co-marketer or by a court orderdistributor of CyDex or Company. Both Parties will use electronic, physical, *** Certain information on this page has been omitted and other safeguards appropriate to the nature of the information to prevent any use or disclosure of Personal Data other than as provided for by this Agreement and permitted under the ICF. Both Parties will also take reasonable precautions to protect such Personal Data from accidental, unauthorized, or unlawful alteration or destruction. Each Party will notify the other Party promptly of any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access of such Personal Data. (d) The Recipient will promptly make available to BMS upon request such records that the Recipient Controls as is necessary or useful to perform medical assessment of any Adverse Event associated filed separately with the use of the BMS Study Drug or Combined Therapy reported during the Combined Therapy Clinical Trial that is forwarded to BMS under this AgreementCommission. The Recipient will designate a single point of contact within its organization (and will provide to BMS the email address of such point of contact prior to the start of the Combined Therapy Clinical Trial) for any pharmacovigilance-related follow-up questions that BMS would have. (e) The Recipient shall perform case level reconciliation to confirm that BMS Confidential treatment has received all reports required under this Agreement. The Recipient shall e-mail [ ]* to request a reconciliation report for the Combined Therapy Clinical Trial. The Recipient shall reconcile the cases identified as being transmitted to BMS on BMS’s reconciliation report and those contained in the Combined Therapy Clinical Trial database. The Recipient shall send missing case-level events to BMS Global Pharmacovigilance at [ ]* or by fax at [ ]*. The Recipient shall perform such reconciliation every [ ]*, unless otherwise agreed by BMS in writing. (f) As Sponsor, the Recipient will be responsible for submitting all applicable Individual Case Safety Report (ICSRs) and aggregate report submissions to Regulatory Authorities for the Combined Therapy Clinical Trial. The Recipient will provide BMS been requested with the final version of any aggregate report at the time of submission. The Recipient will also submit appropriate safety letters or safety reports to study investigators, the reviewing IRB and authorized Regulatory Authorities in accordance with Applicable Law. (g) In the event that BMS produces any Development Safety Update Report (“DSUR”) in respect to the BMS Study Drug, BMS will provide to the Recipient upon request, and for the duration of the Combined Therapy Clinical Trial, copies of the executive summary and any line listings of Serious Adverse Drug Reactions extracted from the final DSUR for information purposes only and to assist the Recipient in generation of their own clinical trial aggregate report, where applicable. The Recipient agrees not to forward such BMS DSUR sections to any Third Party, except to its Affiliates, consultants, advisors and contractors under obligations of confidentiality for generation of such a clinical trial aggregate report or as otherwise permitted with respect to BMS Confidential Information under Section 9.3(b), (d), (e), and (f)omitted portions. (h) If the Recipient determines there is a significant Safety Issue or significant Safety Signals arising in a clinical trial that may be associated with the BMS Study Drug or Combined Therapy, the Recipient will disclose such information to BMS promptly after such determination. (i) BMS will ensure that any urgent Safety Issues or Safety Signals relating to the BMS Study Drug will be communicated to the Recipient promptly after such determination.

Adverse Event Reporting. 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 (aincluding an abnormal laboratory finding), syndrome or disease, whether or not considered Captisol or Licensed Product-related, which occurs or worsens following administration of Captisol or Licensed Product. 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 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)) This which Company and/or its Affiliates or Sublicensees has reason to believe are associated with Captisol within [***] days promptly following (i) Company’s submission of any such report to any regulatory agency, or (ii) receipt from Company’s Sublicensee, co-marketer or distributor of any such report to any regulatory agency. Company shall also advise CyDex regarding any proposed labeling or registration dossier changes affecting Captisol. Reports from Company shall be delivered to the attention of Vice President, Chief Operating Officer, CyDex, with a copy to Vice President, Assistant Secretary, CyDex, at the addresses set forth in Section 2.2 14.6. 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 govern 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 arising from to the Combined Therapy Clinical Trialregulatory agencies and health authorities, adverse events relating to the Licensed Product and for maintaining the global safety database of such adverse events. The Recipient will manage all drug safety reporting activities for the Combined Therapy Clinical Trial. (b) The Recipient will forward parties shall mutually cooperate with regard to BMS at the contact information below via fax or secure e-mail in a format investigation of any such serious adverse event believed to be agreed to by the Parties all fatal or life threatening SAE reports within four (4) calendar days of Date of First Receipt, all other SAE reports, reports of exposure during pregnancy (maternal and paternal) and reports of suspected transmission of an infectious agent via the BMS Study Drug or Combined Therapy within nine (9) calendars days of Date of First Receipt, in each case for the BMS Study Drug and the Combined Therapy administered in the Combined Therapy Clinical Trial. BMS – Adverse Event Reporting Contact E-mail [ ]* Fax [ ]* Acknowledgment of ICSR receipt: [ ]* (c) Each Party shall collect, use and disclose Personal Data obtained in the course of performing the pharmacovigilance activities associated with Captisol supplied under this Section 2.2 solely for the purposes of complying with the regulatory obligations as described in this Agreement, whether experienced by Company, CyDex or as otherwise required by Applicable Law any other Affiliate, Sublicensee, co-marketer or by a court order. Both Parties will use electronic, physical, and other safeguards appropriate to the nature distributor of the information to prevent any use CyDex or disclosure of Personal Data other than as provided for by this Agreement and permitted under the ICF. Both Parties will also take reasonable precautions to protect such Personal Data from accidental, unauthorized, or unlawful alteration or destruction. Each Party will notify the other Party promptly of any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access of such Personal DataCompany. (d) The Recipient will promptly make available to BMS upon request such records that the Recipient Controls as is necessary or useful to perform medical assessment of any Adverse Event associated with the use of the BMS Study Drug or Combined Therapy reported during the Combined Therapy Clinical Trial that is forwarded to BMS under this Agreement. The Recipient will designate a single point of contact within its organization (and will provide to BMS the email address of such point of contact prior to the start of the Combined Therapy Clinical Trial) for any pharmacovigilance-related follow-up questions that BMS would have. (e) The Recipient shall perform case level reconciliation to confirm that BMS has received all reports required under this Agreement. The Recipient shall e-mail [ ]* to request a reconciliation report for the Combined Therapy Clinical Trial. The Recipient shall reconcile the cases identified as being transmitted to BMS on BMS’s reconciliation report and those contained in the Combined Therapy Clinical Trial database. The Recipient shall send missing case-level events to BMS Global Pharmacovigilance at [ ]* or by fax at [ ]*. The Recipient shall perform such reconciliation every [ ]*, unless otherwise agreed by BMS in writing. (f) As Sponsor, the Recipient will be responsible for submitting all applicable Individual Case Safety Report (ICSRs) and aggregate report submissions to Regulatory Authorities for the Combined Therapy Clinical Trial. The Recipient will provide BMS with the final version of any aggregate report at the time of submission. The Recipient will also submit appropriate safety letters or safety reports to study investigators, the reviewing IRB and authorized Regulatory Authorities in accordance with Applicable Law. (g) In the event that BMS produces any Development Safety Update Report (“DSUR”) in respect to the BMS Study Drug, BMS will provide to the Recipient upon request, and for the duration of the Combined Therapy Clinical Trial, copies of the executive summary and any line listings of Serious Adverse Drug Reactions extracted from the final DSUR for information purposes only and to assist the Recipient in generation of their own clinical trial aggregate report, where applicable. The Recipient agrees not to forward such BMS DSUR sections to any Third Party, except to its Affiliates, consultants, advisors and contractors under obligations of confidentiality for generation of such a clinical trial aggregate report or as otherwise permitted with respect to BMS Confidential Information under Section 9.3(b), (d), (e), and (f). (h) If the Recipient determines there is a significant Safety Issue or significant Safety Signals arising in a clinical trial that may be associated with the BMS Study Drug or Combined Therapy, the Recipient will disclose such information to BMS promptly after such determination. (i) BMS will ensure that any urgent Safety Issues or Safety Signals relating to the BMS Study Drug will be communicated to the Recipient promptly after such determination.

Adverse Event Reporting. (aBeginning on the Effective Date and continuing during the Term until such time, if any, that Medicis exercises its PoC Option with respect to a Collaboration Compound, or until such time, if any, that Medicis exercises its right to terminate the Research Collaboration under Section 2.4.1(c), 12.4.1 12.5.2, 12.6.3(c) This Section 2.2 or 13.7, Anacor shall govern safety be responsible, at Anacor’s sole cost, for investigating and monitoring all adverse drug reaction experiences related to a Collaboration Compound in connection with the activities of Anacor under this Agreement and for reporting arising all serious adverse events to the appropriate Regulatory Authorities in the countries in the Territory in which the Collaboration Compound is being Developed, in accordance with the appropriate laws and regulations of the relevant countries and Regulatory Authorities. Anacor shall provide Medicis notice of any serious adverse events within [ * ] and notice of any other adverse events as soon as reasonably practicable, and shall provide copies of all reports of serious adverse events filed with a Regulatory Authority within [ * ] after the applicable event. Anacor shall, at Anacor’s sole cost, comply with any requests for remedial action required by a Regulatory Authority with respect to a Collaboration Compound. Through the JRC, Medicis shall have the right to review from the Combined Therapy Clinical Trialtime to time Anacor’s pharmacovigilance policies and procedures. The Recipient will manage all drug safety reporting activities for the Combined Therapy Clinical Trial. (b) The Recipient will forward Medicis and Anacor agree to BMS at the contact information below via fax or secure e-mail cooperate and use good faith efforts to ensure that data from Anacor’s adverse event database is organized in a format reasonably acceptable to be agreed Medicis. Anacor shall provide to by Medicis consolidated written summaries of the Parties data and information set forth in such database regarding all fatal or life threatening SAE reports within four (4) calendar days of Date of First Receipt, all other SAE reports, reports of exposure during pregnancy (maternal and paternal) and reports of suspected transmission of an infectious agent via adverse events at least quarterly. Commencing on the BMS Study Drug or Combined Therapy within nine (9) calendars days of Date of First Receipt, in each case for the BMS Study Drug and the Combined Therapy administered in the Combined Therapy Clinical Trial. BMS – Adverse Event Reporting Contact E-mail [ ]* Fax [ ]* Acknowledgment of ICSR receipt: [ ]* (c) Each Party shall collect, use and disclose Personal Data obtained in the course of performing the pharmacovigilance activities under this Section 2.2 solely for the purposes of complying with the regulatory obligations as described in this Agreementdate that Medicis exercises its PoC Option, or as otherwise required by Applicable Law until such time, if any, that Medicis exercises its right to terminate the Research Collaboration under Section 2.4.1(c), 12.5.2, 12.4.1, 12.6.3(c) or by a court order13.7, at Medicis’s reasonable request and [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Both Parties will use electronicexpense, physical, and other safeguards appropriate Anacor shall cooperate with Medicis on all matters relating to the nature conduct of the information to prevent any use or disclosure of Personal Data other than as provided for by this Agreement and permitted under the ICF. Both Parties will also take reasonable precautions to protect such Personal Data from accidental, unauthorized, or unlawful alteration or destruction. Each Party will notify the other Party promptly adverse event reporting/pharmacovigilance in respect of any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access of such Personal DataMedicis Development Compound. (d) The Recipient will promptly make available to BMS upon request such records that the Recipient Controls as is necessary or useful to perform medical assessment of any Adverse Event associated with the use of the BMS Study Drug or Combined Therapy reported during the Combined Therapy Clinical Trial that is forwarded to BMS under this Agreement. The Recipient will designate a single point of contact within its organization (and will provide to BMS the email address of such point of contact prior to the start of the Combined Therapy Clinical Trial) for any pharmacovigilance-related follow-up questions that BMS would have. (e) The Recipient shall perform case level reconciliation to confirm that BMS has received all reports required under this Agreement. The Recipient shall e-mail [ ]* to request a reconciliation report for the Combined Therapy Clinical Trial. The Recipient shall reconcile the cases identified as being transmitted to BMS on BMS’s reconciliation report and those contained in the Combined Therapy Clinical Trial database. The Recipient shall send missing case-level events to BMS Global Pharmacovigilance at [ ]* or by fax at [ ]*. The Recipient shall perform such reconciliation every [ ]*, unless otherwise agreed by BMS in writing. (f) As Sponsor, the Recipient will be responsible for submitting all applicable Individual Case Safety Report (ICSRs) and aggregate report submissions to Regulatory Authorities for the Combined Therapy Clinical Trial. The Recipient will provide BMS with the final version of any aggregate report at the time of submission. The Recipient will also submit appropriate safety letters or safety reports to study investigators, the reviewing IRB and authorized Regulatory Authorities in accordance with Applicable Law. (g) In the event that BMS produces any Development Safety Update Report (“DSUR”) in respect to the BMS Study Drug, BMS will provide to the Recipient upon request, and for the duration of the Combined Therapy Clinical Trial, copies of the executive summary and any line listings of Serious Adverse Drug Reactions extracted from the final DSUR for information purposes only and to assist the Recipient in generation of their own clinical trial aggregate report, where applicable. The Recipient agrees not to forward such BMS DSUR sections to any Third Party, except to its Affiliates, consultants, advisors and contractors under obligations of confidentiality for generation of such a clinical trial aggregate report or as otherwise permitted with respect to BMS Confidential Information under Section 9.3(b), (d), (e), and (f). (h) If the Recipient determines there is a significant Safety Issue or significant Safety Signals arising in a clinical trial that may be associated with the BMS Study Drug or Combined Therapy, the Recipient will disclose such information to BMS promptly after such determination. (i) BMS will ensure that any urgent Safety Issues or Safety Signals relating to the BMS Study Drug will be communicated to the Recipient promptly after such determination.

Adverse Event Reporting. (a) This Section 2.2 shall govern safety reporting arising from the Combined Therapy Clinical Trial. The Recipient will manage all drug safety reporting activities for the Combined Therapy Clinical Trial. (b) The Recipient will forward to BMS at the contact information below via fax or secure e-mail in a format to be agreed to by the Parties all fatal or life threatening SAE reports arising in the Combined Therapy Clinical Trial within four (4) calendar days [***] of Date of First ReceiptReceipt of such report, and all other SAE reports, reports of exposure during pregnancy (maternal and paternal) and reports of suspected transmission of an infectious agent via the BMS Study Drug or Combined Therapy within nine (9) calendars days [***] of Date of First Receipt, in each case for the BMS Study Drug and the Combined Therapy administered in the Combined Therapy Clinical Trial. BMS – Adverse Event Reporting Contact E-mail [ ]* [***] Fax [ ]* [***] Acknowledgment of ICSR receipt: [ [***]* (c) Each Party shall collect, use and disclose Personal Data obtained in the course of performing the pharmacovigilance activities under this Section 2.2 solely for the purposes of complying with the regulatory obligations as described in this Agreement, or as otherwise required by Applicable Law or by a court order. Both Parties will use electronic, physical, and other safeguards appropriate to the nature of the information to prevent any use or disclosure of Personal Data other than as provided for by this Agreement and permitted under the ICF. Both Parties will also take reasonable precautions to protect such Personal Data from accidental, unauthorized, or unlawful alteration or destruction. Each Party will notify the other Party promptly of any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access of such Personal Data. (d) The Recipient will promptly make available to BMS upon request such records that the Recipient Controls as is necessary needed or useful for BMS to perform medical assessment of any Adverse Event associated with the use of the BMS Study Drug or Combined Therapy reported during the Combined Therapy Clinical Trial that is forwarded to BMS under this Agreement. The Recipient will designate a single point of contact within its organization (and will provide to BMS the email address of such point of contact prior to the start of the Combined Therapy Clinical Trial) for any pharmacovigilance-related follow-up questions that BMS would havehave as to such Adverse Events. (e) The Recipient shall perform case level reconciliation to confirm that BMS has received all reports required under this Agreement. The Recipient shall e-mail [ ]* [***] to request a reconciliation report for the Combined Therapy Clinical Trial. The Recipient shall reconcile the cases identified as being transmitted to BMS on BMS’s reconciliation report and those contained in the Combined Therapy Clinical Trial database. The Recipient shall send missing case-level events to BMS Global Pharmacovigilance at [ ]* [***] or by fax at [ [***]*. The Recipient shall perform such reconciliation every [ [***]*, unless otherwise agreed by BMS in writing. (f) As Sponsor, the Recipient will be responsible for submitting all applicable Individual Case Safety Report Reports (ICSRs) and aggregate report submissions to Regulatory Authorities for the Combined Therapy Clinical Trial. The Recipient will provide BMS with the final version of any aggregate report at the time of submission. The Recipient will also submit appropriate safety letters or safety reports to study investigators, the reviewing IRB and authorized Regulatory Authorities in accordance with Applicable Law. (g) In the event that BMS produces any Development Safety Update Report (“DSUR”) in respect to the BMS Study Drug, BMS will provide to the Recipient upon request, and for the duration of the Combined Therapy Clinical Trial, copies of the executive summary and any line listings of Serious Adverse Drug Reactions extracted from the final DSUR for information purposes only and to assist the Recipient in generation of their own clinical trial aggregate report, where applicable. The Recipient agrees not to forward such BMS DSUR sections to any Third Party, except to its Affiliates, consultants, advisors and contractors under obligations of confidentiality for generation of such a clinical trial aggregate report or as otherwise permitted with respect to BMS Confidential Information under Section 9.3(b), (d), (e), and (f)report. (h) If the Recipient determines there is a significant Safety Issue or significant Safety Signals arising in a clinical trial the Combined Therapy Clinical Trial that may be associated with the BMS Study Drug or Combined Therapy, the Recipient will disclose such information to BMS promptly after such determination. (i) BMS will ensure that any urgent Safety Issues or Safety Signals relating to the BMS Study Drug will be are communicated to the Recipient promptly after such determination.

Adverse Event Reporting. (a) This Section 2.2 shall govern safety reporting arising from the Combined Therapy Clinical Trial. The Recipient will manage all drug safety reporting activities for the Combined Therapy Clinical Trial. (b) The Recipient will forward to BMS at the contact information below via fax or secure e-mail in a format to be agreed to by the Parties CIOMS form all fatal or life threatening SAE reports within four (4) calendar days [**] of Date of First Receipt, all other SAE reports, reports of exposure during pregnancy (maternal and paternal) and reports of suspected transmission of an infectious agent via the BMS Study Drug or Combined Therapy within nine (9) calendars days [**] of Date of First Receipt, in each case for the BMS Study Drug and the Combined Therapy administered in the Combined Therapy Clinical Trial. BMS – Adverse Event Reporting Contact E-mail [ [**] Fax [**] Idera – Pharmacovigilance Contact - [**]* Fax [ , Senior Director, Pharmacovigilance Email [**] Telephone [**]* Acknowledgment of ICSR receipt: [ ]* (c) Each Party shall collect, use and disclose Personal Data obtained in the course of performing the pharmacovigilance activities under this Section 2.2 solely for the purposes of complying with the regulatory obligations as described in this Agreement, or as otherwise required by Applicable Law or by a court order. Both Parties will use electronic, physical, and other safeguards appropriate to the nature of the information to prevent any use or disclosure of Personal Data other than as provided for by this Agreement and permitted under the ICF. Both Parties will also take reasonable precautions to protect such Personal Data from accidental, unauthorized, or unlawful alteration or destruction. Each Party will notify the other Party promptly of any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access of such Personal Data. (d) The Recipient will promptly make available to BMS upon request such records that the Recipient Controls as is necessary or useful to perform medical assessment of any Adverse Event associated with the use of the BMS Study Drug or Combined Therapy reported during the Combined Therapy Clinical Trial that is forwarded to BMS under this Agreement. The Recipient will designate a single point of contact within its organization (and will provide to BMS the email address of such point of contact prior to the start of the Combined Therapy Clinical Trial) for any pharmacovigilance-related follow-up questions that BMS would have. (e) The Recipient shall perform case level reconciliation to confirm that BMS has received all reports required under this Agreement. The Recipient shall e-mail [ ]* [**] to request a reconciliation report for the Combined Therapy Clinical Trial. The Recipient shall reconcile the cases identified as being transmitted to BMS on BMS’s reconciliation report and those contained in the Combined Therapy Clinical Trial database. The Recipient shall send missing case-level events to BMS Global Pharmacovigilance at [ ]* [**] or by fax at [ [**]*. The Recipient shall perform such reconciliation every [ [**]*, unless otherwise agreed by BMS in writing. (f) As Sponsor, the Recipient will be responsible for submitting all applicable Individual Case Safety Report (ICSRs) and aggregate report submissions to Regulatory Authorities for the Combined Therapy Clinical Trial. The Recipient will provide BMS with the final version of any aggregate report relating to the Combined Therapy Clinical Trial at the time of submission. The Recipient will also submit appropriate safety letters or safety reports to study investigators, the reviewing IRB and authorized Regulatory Authorities in accordance with Applicable Law. (g) In the event that BMS produces any Development Safety Update Report (“DSUR”) in respect to the BMS Study Drug, BMS will provide to the Recipient upon request, and for the duration of the Combined Therapy Clinical Trial, copies of the executive summary and any line listings of Serious Adverse Drug Reactions extracted from the final DSUR for information purposes only and to assist the Recipient in generation of their own clinical trial aggregate report, where applicable. The Recipient agrees not to forward such BMS DSUR sections to any Third Party, except to its Affiliates, consultants, advisors and contractors under obligations of confidentiality for generation of such a clinical trial aggregate report or as otherwise permitted with respect to BMS Confidential Information under Section 9.3(b), (d), (e), and (f)report. (h) If the Recipient determines there is a significant Safety Issue or significant Safety Signals arising in a clinical trial that may be associated with the BMS Study Drug or Combined Therapy, the Recipient will disclose such information to BMS promptly after such determination. (i) BMS will ensure that any urgent Safety Issues or Safety Signals relating to the BMS Study Drug will be communicated to the Recipient promptly after such determination.

Adverse Event Reporting. (a) This Section 2.2 The Parties agree to meet within [**] after the Effective Date to commence negotiations of a more detailed pharmacovigilance agreement. Such pharmacovigilance agreement shall govern safety reporting arising provide for the exchange by the Parties of any information of which a Party becomes aware in the Territory concerning any side effect, injury, toxicity or sensitivity reaction, or any unexpected incident, in or involving a subject or, in the case of non-clinical studies, an animal in a toxicology study, and the seriousness thereof, whether or not determined to be attributable to any Licensed Product, Compound or Follow-On-Compound (hereinafter “Adverse Experience”), including information regarding Adverse Experiences received by either Party from the Combined Therapy Clinical TrialThird Parties. The Recipient Parties contemplate that initially Licensor will manage all drug safety reporting activities be responsible for the Combined Therapy Clinical Trialreceiving and providing information regarding Adverse Experiences from and to both Merck and Merck & Co. relating to Compounds, subject to confidentiality and other legal obligations. (b) The Recipient will forward With respect to BMS at Adverse Experiences that are serious and associated with the contact information below via fax use of any Licensed Product, whether or secure e-mail in a format not determined to be agreed attributable to any such Licensed Product (hereinafter “Serious Adverse Experience”), (i) in the event Licensor receives a Serious Adverse Experience report from any Third Party, Licensor shall notify Merck in writing within two (2) calendar days of receipt of such report, and (ii) in the event a Serious Adverse Experience report is to be generated by either Party, such Party shall provide its report to the Parties all fatal or life threatening SAE reports other within four (4) calendar days of Date of First Receiptfor death and life threatening, and seven (7) calendar days for all other SAE Serious Adverse Experience reports, reports of exposure during pregnancy (maternal and paternal) and reports of suspected transmission of an infectious agent via the BMS Study Drug or Combined Therapy within nine (9) calendars days of Date of First Receipt, in each case for the BMS Study Drug and the Combined Therapy administered in the Combined Therapy Clinical Trial. BMS – Adverse Event Reporting Contact E-mail [ ]* Fax [ ]* Acknowledgment of ICSR receipt: [ ]*. (c) Each Party With respect to INDs filed by Merck, Merck shall collectbe responsible for reporting to Regulatory Authorities any Adverse Events, use and disclose Personal Data obtained whether in non-clinical or clinical studies for or during commercialization of any Licensed Product in the course of performing the pharmacovigilance activities under this Section 2.2 solely for the purposes of complying Field in compliance with the regulatory obligations as described in this Agreementrequirements of the United States Federal Food, or as otherwise required by Applicable Law or by a court order. Both Parties will use electronic, physicalDrug, and other safeguards appropriate to Cosmetic Act, 21 U.S.C. § 321 et seq., the nature regulations promulgated thereunder, and equivalent foreign Laws. It is understood that these adverse experience reporting requirement provisions are based on the policies and procedures of the information to prevent any use or disclosure of Personal Data other than as provided for by this Agreement Merck and permitted under the ICF. Both Parties will also take reasonable precautions to protect such Personal Data from accidental, unauthorized, or unlawful alteration or destruction. Each Party will notify the other Party promptly of any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access of such Personal Dataregulatory requirements. (d) The Recipient will promptly make available to BMS upon request such records that the Recipient Controls as is necessary or useful to perform medical assessment of any Adverse Event associated with the use of the BMS Study Drug or Combined Therapy reported during the Combined Therapy Clinical Trial that is forwarded to BMS under this Agreement. The Recipient will designate a single point of contact within its organization (and will provide to BMS the email address of such point of contact prior to the start of the Combined Therapy Clinical Trial) for any pharmacovigilance-related follow-up questions that BMS would have. (e) The Recipient shall perform case level reconciliation to confirm that BMS has received all reports required under this Agreement. The Recipient shall relevant information can be transmitted by e-mail [ ]* to request a reconciliation report for mail, facsimile, overnight courier or any other means the Combined Therapy Clinical Trial. The Recipient shall reconcile the cases identified as being transmitted to BMS on BMS’s reconciliation report and those contained Parties agree in the Combined Therapy Clinical Trial databaseseparate pharmacovigilance agreement. The Recipient shall send missing caseTransmission to Licensor: Drug Safety c/o VP of Development Programs 100 Xxxxxx Xxxxxx Cambridge, MA 02139 Drug Safety Mailbox: [**] Facsimile: 600-level events 000-0000 Transmission to BMS Merck: Global Pharmacovigilance at [ ]* or by fax at [ ]Drug Safety Fxxxxxxxxxx Xxxxxx 000 00000 Xxxxxxxxx, Xxxxxxx Drug Safety Mailbox: [*. The Recipient shall perform such reconciliation every [ ]*, unless otherwise agreed by BMS in writing. (f) As Sponsor, the Recipient will be responsible for submitting all applicable Individual Case Safety Report (ICSRs) and aggregate report submissions to Regulatory Authorities for the Combined Therapy Clinical Trial. The Recipient will provide BMS with the final version of any aggregate report at the time of submission. The Recipient will also submit appropriate safety letters or safety reports to study investigators, the reviewing IRB and authorized Regulatory Authorities in accordance with Applicable Law. (g) In the event that BMS produces any Development Safety Update Report (“DSUR”) in respect to the BMS Study Drug, BMS will provide to the Recipient upon request, and for the duration of the Combined Therapy Clinical Trial, copies of the executive summary and any line listings of Serious Adverse Drug Reactions extracted from the final DSUR for information purposes only and to assist the Recipient in generation of their own clinical trial aggregate report, where applicable. The Recipient agrees not to forward such BMS DSUR sections to any Third Party, except to its Affiliates, consultants, advisors and contractors under obligations of confidentiality for generation of such a clinical trial aggregate report or as otherwise permitted with respect to BMS Confidential Information under Section 9.3(b), (d), (e), and (f). (h) If the Recipient determines there is a significant Safety Issue or significant Safety Signals arising in a clinical trial that may be associated with the BMS Study Drug or Combined Therapy, the Recipient will disclose such information to BMS promptly after such determination. (i) BMS will ensure that any urgent Safety Issues or Safety Signals relating to the BMS Study Drug will be communicated to the Recipient promptly after such determination.] Facsimile: 49-6151-72- 6914

Adverse Event Reporting. (a) This Section 2.2 shall govern safety reporting arising from the Combined Therapy Clinical Trial. The Recipient will manage all drug safety reporting activities for the Combined Therapy Clinical Trial. (b) The Recipient will forward to BMS at the contact information below via fax or secure e-mail in a format to be agreed to by the Parties CIOMS form all fatal or life threatening SAE reports within four (4) calendar days [**] of Date of First Receipt, all other SAE reports, reports of exposure during pregnancy (maternal and paternal) and reports of suspected transmission of an infectious agent via the BMS Study Drug or Combined Therapy within nine (9) calendars days [**] of Date of First Receipt, in each case for the BMS Study Drug and the Combined Therapy administered in the Combined Therapy Clinical Trial. BMS – Adverse Event Reporting Contact E-mail [ ]* [**] Fax [ ]* [**] Acknowledgment of ICSR receipt: [ [**]* (c) Each Party shall collect, use and disclose Personal Data obtained in the course of performing the pharmacovigilance activities under this Section 2.2 solely for the purposes of complying with the regulatory obligations as described in this Agreement, or as otherwise required by Applicable Law or by a court order. Both Parties will use electronic, physical, and other safeguards appropriate to the nature of the information to prevent any use or disclosure of Personal Data other than as provided for by this Agreement and permitted under the ICF. Both Parties will also take reasonable precautions to protect such Personal Data from accidental, unauthorized, or unlawful alteration or destruction. Each Party will notify the other Party promptly of any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access of such Personal Data. (d) The Recipient will promptly make available to BMS upon request such records that the Recipient Controls as is necessary or useful to perform medical assessment of any Adverse Event associated with the use of the BMS Study Drug or Combined Therapy reported during the Combined Therapy Clinical Trial that is forwarded to BMS under this Agreement. The Recipient will designate a single point of contact within its organization (and will provide to BMS the email address of such point of contact prior to the start of the Combined Therapy Clinical Trial) for any pharmacovigilance-related follow-up questions that BMS would have. (e) The Recipient shall perform case level reconciliation to confirm that BMS has received all reports required under this Agreement. The Recipient shall e-mail [ ]* [**] to request a reconciliation report for the Combined Therapy Clinical Trial. The Recipient shall reconcile the cases identified as being transmitted to BMS on BMS’s reconciliation report and those contained in the Combined Therapy Clinical Trial database. The Recipient shall send missing case-level events to BMS Global Pharmacovigilance at [ ]* [**] or by fax at [ [**]*. The Recipient shall perform such reconciliation every [ [**]*, unless otherwise agreed by BMS in writing. (f) As Sponsor, the Recipient will be responsible for submitting all applicable Individual Case Safety Report (ICSRs) and aggregate report submissions to Regulatory Authorities for the Combined Therapy Clinical Trial. The Recipient will provide BMS with the final version of any aggregate report relating to the Combined Therapy Clinical Trial at the time of submission. The Recipient will also submit appropriate safety letters or safety reports to study investigators, the reviewing IRB and authorized Regulatory Authorities in accordance with Applicable Law. (g) In the event that BMS produces any Development Safety Update Report (“DSUR”) in respect to the BMS Study Drug, BMS will provide to the Recipient upon request, and for the duration of the Combined Therapy Clinical Trial, copies of the executive summary and any line listings of Serious Adverse Drug Reactions extracted from the final DSUR for information purposes only and to assist the Recipient in generation of their own clinical trial aggregate report, where applicable. The Recipient agrees not to forward such BMS DSUR sections to any Third Party, except to its Affiliates, consultants, advisors and contractors under obligations of confidentiality for generation of such a clinical trial aggregate report or as otherwise permitted with respect to BMS Confidential Information under Section 9.3(b), (d), (e), and (f)report. (h) If the Recipient determines there is a significant Safety Issue or significant Safety Signals arising in a clinical trial that may be associated with the BMS Study Drug or Combined Therapy, the Recipient will disclose such information to BMS promptly after such determination. (i) BMS will ensure that any urgent Safety Issues or Safety Signals relating to the BMS Study Drug will be communicated to the Recipient promptly after such determination.

Adverse Event Reporting. (a) This Section 2.2 Jagotec and Kos shall govern safety reporting arising from the Combined Therapy Clinical Trial. The Recipient will manage all drug safety reporting activities for the Combined Therapy Clinical Trial. (b) The Recipient will forward to BMS at the contact information below via fax or secure e-mail in a format to be agreed to by the Parties all fatal or life threatening SAE reports within four (4) calendar days of Date of First Receipt, all other SAE reports, reports of exposure during pregnancy (maternal and paternal) and reports of suspected transmission of an infectious agent via the BMS Study Drug or Combined Therapy within nine (9) calendars days of Date of First Receipt, in each case for the BMS Study Drug and the Combined Therapy administered in the Combined Therapy Clinical Trial. BMS – Adverse Event Reporting Contact E-mail [ ]* Fax [ ]* Acknowledgment of ICSR receipt: [ ]* (c) Each Party shall collect, use and disclose Personal Data obtained in the course of performing the pharmacovigilance activities under this Section 2.2 solely for the purposes of complying with the regulatory obligations as described in this Agreement, or as otherwise required by Applicable Law or by a court order. Both Parties will use electronic, physical, and other safeguards appropriate report to the nature other any information of the information to prevent which they have knowledge concerning any use or disclosure of Personal Data other than as provided for by this Agreement and permitted under the ICF. Both Parties will also take reasonable precautions to protect such Personal Data from accidental, unauthorized, or unlawful alteration or destruction. Each Party will notify the other Party promptly of any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access of such Personal Data. (d) The Recipient will promptly make available to BMS upon request such records that the Recipient Controls as is necessary or useful to perform medical assessment of any Adverse Event associated adverse drug experience in connection with the use of the BMS Study Drug Product, including the incidence or Combined Therapy reported during the Combined Therapy Clinical Trial that is forwarded severity thereof, associated with non-clinical toxicity studies, clinical uses, Post-Registration Studies, investigations or tests, whether or not determined to BMS under this Agreement. The Recipient will designate a single point of contact within its organization (and will provide to BMS the email address of such point of contact prior be attributable to the start Product. Reports of non-serious adverse drug experiences of the Combined Therapy Clinical Trialtype defined in Section 314.80 (or Section 600.80, as applicable) of Title 21 of the U.S. Code of Federal Regulations shall be exchanged by each Party on a monthly basis for the first three (3) years following Registration and annually thereafter. Reports of Serious Adverse Drug Experiences (as hereinafter defined) shall be made available to the other Party as soon as practicable but in no event more **** after a Party becomes aware of same and shall be submitted as required to the FDA by Kos. Upon receipt of any pharmacovigilance-related follow-up questions that BMS would have. (e) The Recipient such information concerning any Serious Adverse Drug Experience by either Jagotec or Kos, the Parties shall perform case level reconciliation promptly consult each other and use Commercially Reasonable Efforts to confirm that BMS has received all reports arrive at a mutually acceptable procedure for taking such possible actions as appropriate or required under this Agreementthe circumstances. The Recipient Kos shall e-mail [ ]* make the required report or submission to request the FDA, and shall be required to maintain a reconciliation worldwide database and report for the Combined Therapy Clinical Trial. The Recipient shall reconcile same to the cases identified as being transmitted to BMS on BMS’s reconciliation report and those contained in the Combined Therapy Clinical Trial database. The Recipient shall send missing case-level events to BMS Global Pharmacovigilance at [ ]* or by fax at [ ]*. The Recipient shall perform such reconciliation every [ ]*, unless otherwise agreed by BMS in writing. (f) As Sponsor, the Recipient will be responsible for submitting all applicable Individual Case Safety Report (ICSRs) and aggregate report submissions to Regulatory Authorities for the Combined Therapy Clinical Trial. The Recipient will provide BMS with the final version of any aggregate report at the time of submission. The Recipient will also submit appropriate safety letters or safety reports to study investigators, the reviewing IRB and authorized Regulatory Authorities FDA in accordance with Applicable LawLaws, or take any other action that the Parties deem to be appropriate or required by Applicable Laws. (g) In the event that BMS produces any Development Safety Update Report (9.1.1 For purposes of this Agreement, “DSUR”) in respect to the BMS Study Drug, BMS will provide to the Recipient upon request, and for the duration of the Combined Therapy Clinical Trial, copies of the executive summary and any line listings of Serious Adverse Drug Reactions extracted from Experience” means any adverse drug experience occurring at any dose that results in any of the final DSUR for information purposes only and to assist the Recipient in generation following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of their own clinical trial aggregate reportexisting hospitalization, where applicable. The Recipient agrees not to forward such BMS DSUR sections to any Third Party, except to its Affiliates, consultants, advisors and contractors under obligations of confidentiality for generation of such a clinical trial aggregate report or as otherwise permitted with respect to BMS Confidential Information under Section 9.3(b), (d), (e), and (f). (h) If the Recipient determines there is a significant Safety Issue persistent or significant Safety Signals arising in disability/incapacity, or a clinical trial congenital anomaly/birth defect. Important medical events that may not result in death, be associated with life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the BMS Study Drug patient or Combined Therapysubject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition as more fully defined in Section 314.80 (or Section 600.80, as applicable) of Title 21 of the Recipient will disclose such information to BMS promptly after such determination. (i) BMS will ensure that any urgent Safety Issues or Safety Signals relating to U.S. Code of Federal Regulations in the BMS Study Drug will be communicated to the Recipient promptly after such determination.U.S.