Common use of Adverse Event Reporting and Safety Data Exchange Clause in Contracts

Adverse Event Reporting and Safety Data Exchange. Within such time period as may be agreed upon by the Parties, but in any event prior to Licensee’s performance of any clinical study of the Product, the Parties (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) shall define and finalize the actions that the Parties shall employ with respect to the Products to protect patients and promote their well-being which shall be recorded in the Pharmacovigilance Agreement entered into pursuant to clause 5.5 below. For the avoidance of doubt, Licensor shall be responsible for global pharmacovigilance activities, including maintaining the global safety database for the Products, at Licensor’s expense, and Licensee shall be responsible for local pharmacovigilance activities in the Territory at Licensee’s expense. Furthermore, Licensee will bear all costs of post-marketing surveillance for the Products required by Applicable Laws in the Territory. To the extent required under and in accordance with the Pharmacovigilance Agreement, Licensee shall also be responsible for reporting adverse events and safety data related to the Products to Licensor for inclusion in the global safety database and Licensor shall be responsible for reporting adverse events and safety data related to the Products to Licensee for Licensee’s information. Each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates to comply with such obligations.

Adverse Event Reporting and Safety Data Exchange. Within such time period as may be agreed upon by thirty (30) days after the Parties, but in any event prior to Licensee’s performance of any clinical study of the ProductEffective Date, the Parties (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) shall define and finalize the actions that the Parties shall employ with respect to the Products to protect patients and promote their well-being which shall be recorded in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement entered into pursuant to clause 5.5 belowAgreement”). For the avoidance of doubt, Licensor shall be responsible for global pharmacovigilance activities, including maintaining the global safety database for the Products, at Licensor’s expense, and Licensee shall be responsible for local pharmacovigilance activities in the Field in the Territory at Licensee’s expense. Furthermore, Licensee will bear all costs of post-marketing surveillance for the Products required by Applicable Laws in the Territory. To the extent required under and in accordance with the Pharmacovigilance Agreement, Licensee shall also be responsible for reporting adverse events and safety data related to the Products to Licensor for inclusion in the global safety database and Licensor shall be responsible for reporting adverse events and safety data related provide Licensee access to the Products global safety database to the extent required for Licensee for Licensee’s informationto comply with its pharmacovigilance obligations in the Territory. Each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates to comply with such obligations.

Adverse Event Reporting and Safety Data Exchange. (a) Within such time period as may be agreed upon by [*] after the Parties, but in any event prior to Licensee’s performance of any clinical study of the ProductEffective Date, the Parties (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) shall define and finalize the actions that the Parties shall employ with respect to the Products to protect patients and promote their well-being which in a written pharmacovigilance agreement (the "Pharmacovigilance Agreement"). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning Product safety. Such guidelines and procedures shall be recorded in accordance with, and enable the Pharmacovigilance Agreement entered into pursuant Parties to clause 5.5 belowfulfill, local and national regulatory reporting obligations under applicable Laws. For the avoidance of doubtFurthermore, Licensor such agreed procedure shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory or safety reporting requirements, in which case local reporting requirements shall prevail. Mundipharma shall be responsible for global pharmacovigilance activitiesreporting quality complaints, including maintaining the global safety database for the Products, at Licensor’s expense, and Licensee shall be responsible for local pharmacovigilance activities in the Territory at Licensee’s expense. Furthermore, Licensee will bear all costs of post-marketing surveillance for the Products required by Applicable Laws in the Territory. To the extent required under and in accordance with the Pharmacovigilance Agreement, Licensee shall also be responsible for reporting adverse events and safety data related to the Products to Licensor for inclusion in the global Field to applicable Regulatory Authorities in the Licensed Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Products in the Field in the Licensed Territory. The Pharmacovigilance Agreement shall also provide for a worldwide safety database and Licensor shall to be responsible for reporting adverse events and safety data related to the Products to Licensee for Licensee’s informationmaintained by Allos. Each Party hereby agrees to comply with its respective obligations under the such Pharmacovigilance Agreement and to cause its Affiliates and sublicensees to comply with such obligations.

Adverse Event Reporting and Safety Data Exchange. (a) Within such time period as may be agreed upon by [ * ] after the Parties, but in any event prior to Licensee’s performance of any clinical study of the ProductEffective Date, the Parties (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) shall define and finalize the actions that the Parties shall employ with respect to the Products to protect patients and promote their well-being which in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning Product safety. Such guidelines and procedures shall be recorded in accordance with, and enable the Pharmacovigilance Agreement entered into pursuant Parties to clause 5.5 belowfulfill, local and national regulatory reporting obligations under applicable Laws. For the avoidance of doubtFurthermore, Licensor such agreed procedure shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory or safety reporting requirements, in which case local reporting requirements shall prevail. Mundipharma shall be responsible for global pharmacovigilance activitiesreporting quality complaints, including maintaining the global safety database for the Products, at Licensor’s expense, and Licensee shall be responsible for local pharmacovigilance activities in the Territory at Licensee’s expense. Furthermore, Licensee will bear all costs of post-marketing surveillance for the Products required by Applicable Laws in the Territory. To the extent required under and in accordance with the Pharmacovigilance Agreement, Licensee shall also be responsible for reporting adverse events and safety data related to the Products to Licensor for inclusion in the global Field to applicable Regulatory Authorities in the Licensed Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Products in the Field in the Licensed Territory. The Pharmacovigilance Agreement shall also provide for a worldwide safety database and Licensor shall to be responsible for reporting adverse events and safety data related to the Products to Licensee for Licensee’s informationmaintained by Allos. Each Party hereby agrees to comply with its respective obligations under the such Pharmacovigilance Agreement and to cause its Affiliates and sublicensees to comply with such obligations.

Adverse Event Reporting and Safety Data Exchange. Within such time period as may be agreed upon by [***] the Parties, but anticipated launch of a Product in any event prior to Licensee’s performance of any clinical study of the ProductLicensed Territory, the Parties (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) shall define and finalize the actions that the Parties shall employ with respect to the Products such Product to protect patients and promote their well-being which in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities shall be recorded in the Pharmacovigilance Agreement entered into pursuant to clause 5.5 below. For the avoidance of doubt, Licensor shall be responsible for global pharmacovigilance activities, including maintaining the global safety database include mutually acceptable guidelines and procedures for the Productsreceipt, at Licensor’s expenseinvestigation, recordation, communication, and Licensee shall exchange (as between the Parties) of adverse event reports, and any other information concerning such Product’s safety. Such guidelines and procedures will be responsible for in accordance with, and enable the Parties to fulfill, local pharmacovigilance activities in the Territory at Licensee’s expenseand national regulatory reporting obligations under Laws. Furthermore, Licensee such agreed procedure will bear all costs of post-marketing surveillance for the Products required by Applicable Laws be consistent with relevant ICH Guidelines, except where said guidelines may conflict with existing local regulatory or safety reporting requirements, in the Territorywhich case local reporting requirements shall prevail. To the extent required under and in accordance with the Pharmacovigilance Agreement, Licensee shall also be responsible for reporting report quality complaints, adverse events and safety data related to the Products to Licensor for inclusion such Product in the global Field to applicable Regulatory Authorities in the Licensed Territory, and shall respond to safety issues and to all requests of Regulatory Authorities relating to such Product in the Field in the Licensed Territory. Licensor shall maintain a worldwide safety database and Licensor shall be responsible for reporting adverse events and safety data related pursuant to the Products to Licensee for Licensee’s informationterms of the Pharmacovigilance Agreement. Each Party hereby agrees to shall comply with its respective obligations under the Pharmacovigilance Agreement and to shall cause its Affiliates and Sublicensees to comply with such obligations.