Adverse Event Reporting and Safety Data Exchange. At a time determined by the JSC, but in any event prior to the first to occur of (i) the commencement of any Clinical Trial to be conducted by AstraZeneca or (ii) the transfer of the first NDA in the U.S. to AstraZeneca, the Parties shall define and finalize the methods and procedures (based on and consistent where possible with those methods and procedures used by Astellas and FibroGen under the Astellas EU Agreement, unless otherwise mutually agreed) that the Parties shall employ with respect to Products to protect patient safety and promote the appropriate treatment of safety information of Products in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). For clarity, the Pharmacovigilance Agreement shall include all relevant safety data regarding the Product, irrespective of territory or indication. 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 the safety of any Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable laws and regulations. Furthermore, such agreed procedure shall be consistent with GCP and relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. FibroGen shall maintain a global safety database for the Products, the expenses for which will be included in Development Costs and reimbursed by AstraZeneca, to the extent not borne or reimbursed by Astellas. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations. If and to the extent necessary, the Pharmacovigilance Agreement shall be amended by the Parties, or shall be superseded, so that an appropriate commercial-stage pharmacovigilance agreement is in place in advance of the first NDA approval for a Product.
Adverse Event Reporting and Safety Data Exchange. The Parties agree that Takeda shall be responsible for the establishment of the global safety database for the Product in the Licensed Territory and the monitoring of all clinical experiences and submission of all required reports throughout clinical Development and Commercialization of the Product in the Royalty Territory, and that Affymax shall have primary responsibility for the monitoring of all clinical experiences and submission of all required reports concerning the Product in the U.S., provided, however, that Takeda shall have primary responsibility for monitoring all clinical experiences for the Oncology Indications. Specific details regarding the exchange and management of information relating to adverse events related to the use of the Product shall be delineated in a separate agreement that shall be agreed to by the Parties within ninety (90) days after the Effective Date. The pharmacovigilance and product labeling personnel of each Party shall work in good faith together during such time to negotiate an agreement, consistent with each Party’s current standard operating procedures and, to the extent practical, with the then-current agreements between the Parties, that:
(a) identifies which safety information shall be exchanged;
(b) identifies when such information shall be exchanged;
(c) provides that Takeda shall have regulatory reporting responsibilities concerning the Product in the Royalty Territory, and that Affymax shall have such responsibilities concerning the Product in the U.S. (in each case, either itself or through a clinical research organization with which it has contracted);
(d) provides that Takeda shall manage the global safety database;
(e) identifies which Party shall be obligated to obtain follow-up information on incomplete safety reports;
(f) identifies which Party shall review the literature for safety report information;
(g) sets forth the roles and responsibilities of the Parties related to review and approval of safety information for inclusion in the Product Labeling in the Licensed Territory;
(h) sets forth standard operating procedures to be implemented by the Parties in their reporting of safety and other pharmacovigilance information; [ * ] = 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 406 of the Securities Act of 1933, as amended.
(i) sets forth provisions governing access to saf...
Adverse Event Reporting and Safety Data Exchange. No later than [***] prior to the targeted filing date reasonably set by Licensee of an IND for any Product in the Field and in the Territory, the Parties shall enter into a commercially reasonable pharmacovigilance agreement (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement shall include customary 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 the safety of any Product, including any and all Safety Data. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Laws. Furthermore, such agreed procedure shall be consistent with relevant guidelines of the International Conference on Harmonisation, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. The Pharmacovigilance Agreement shall provide for an adverse event database for Products in the Territory to be maintained by Licensee [***]. Licensee shall be responsible for reporting quality complaints, adverse events and safety data related to Products to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Products in the Territory. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted 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 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. As soon as practical, the Parties shall enter into a commercially reasonable pharmacovigilance agreement (the “Safety Data and Exchange Agreement”). The Safety Data and Exchange Agreement shall include customary 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 the safety of any Licensed Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting activities under applicable Laws. Furthermore, such agreed procedure shall be consistent with relevant guidelines of the International Conference on Harmonisation, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. The Safety Data and Exchange Agreement shall provide for an adverse event database for Licensed Products in the Territory to be maintained by CCT at [***] expense. CCT shall be responsible for reporting quality complaints, adverse events and safety data related to Licensed Products to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Territory. Each Party hereby agrees to comply with its respective activities under such Safety Data and Exchange Agreement and to cause its Affiliates to comply with such activities.
Adverse Event Reporting and Safety Data Exchange. After the Effective Date but in no event later than the initiation of the Studies, the Parties shall define and finalize the actions that the Parties shall employ to protect study subjects and promote their well-being 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 the safety of Apixaban and PRT064445 in combination. Such guidelines and procedures shall be in accordance with, and enable both Parties to fulfill, local and national regulatory reporting obligations under Applicable Laws and regulations. In addition, in the case of safety issues relating to Apixaban, or as needed to meet BMS’ or Pfizer’s requirements for reporting to Regulatory Authorities relating to Apixaban, Portola shall promptly provide BMS and Pfizer with any Case Report Forms or data and analysis from the Studies as reasonably necessary for BMS and Pfizer to evaluate such safety issue or comply with any such regulatory requirement.
Adverse Event Reporting and Safety Data Exchange. No later than one hundred eighty (180) days following the submission of the first Regulatory Approval Application for the Products in any country in the Licensee Territory, the Parties shall define and finalize the actions that the Parties shall employ with respect to the Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). In the event of any inconsistency between the provisions of the Pharmacovigilance Agreement and the provisions of this Agreement, the wording of the Pharmacovigilance Agreement shall govern any and all patient safety matters and this Agreement shall govern all other matters.
Adverse Event Reporting and Safety Data Exchange. The Parties have entered into certain safety data exchange or pharmacovigilance agreements and such agreement will be terminated in accordance with the Amended and Restated Pharmacovigilance Agreement Termination Agreement as set forth in the Master Agreement.
Adverse Event Reporting and Safety Data Exchange. At any time after the Effective Date, any adverse event (any unwanted or unintended experience in a person that is associated with the use of a drug, whether or not that experience is caused by that drug, including any known side effects) or any Product complaint (any physical or organoleptic defect to the Product itself and/or package) received by Transcept regarding a Product originating from the U.S. Territory will be forwarded to the Purdue Drug Safety Operations Group as soon as possible, but no later than two (2) calendar days after Transcept receives such adverse event or complaint, by telephone (000-000-0000 prompt 2), fax (000-000-0000) or secure E-mail (xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxx.xxx). At any time after the Effective Date, Purdue shall provide Transcept with any serious adverse event information received by Purdue regarding a Product originating from the U.S. Territory as soon as reasonably practicable, but in any event no later than ten (10) days following receipt, and shall promptly provide Transcept with such other information reasonably requested by Transcept to comply with its reporting obligations in connection with the Development of Product in support of Regulatory Approval in the Transcept Territory, including any reporting obligations imposed as a result of Transcept holding an IND in the U.S. Territory. Purdue and Transcept (or its licensee, as appropriate) shall enter into a pharmacovigilance agreement containing specific terms, conditions and obligations of the Parties with respect to collection, reporting and monitoring of all adverse drug reactions, adverse events, product complaints, medical inquiries and other relevant drug safety matters, sufficient to enable each Party to comply with its reporting obligations and regulatory submissions in its respective territory, not later than the date of transfer of the NDA to Purdue pursuant to Section 4.2(c).
Adverse Event Reporting and Safety Data Exchange. If ISU has exercised its rights pursuant to Section 2.4, no later than [* * *] after the filing of the first NDA for the Product, Catalyst or Catalyst’s sublicensee(s) (if applicable) and ISU shall enter into a commercially reasonable pharmacovigilance agreement (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement shall include customary 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 the safety of any Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Laws. Furthermore, such agreed procedure shall be consistent with relevant guidelines of the International Conference on Harmonisation, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall
