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

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 safety information and coordination with regard to information reporting to the applicable Regulatory Authorities; (j) identifies which Party shall prepare required periodic safety updates; and (k) identifies any other details required to appropriately manage safety information for the Product, the Peptide, [ * ] or Hematide.

Adverse Event Reporting and Safety Data Exchange. The Parties agree that Takeda Collaborator shall be primarily 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 filing of all required reports throughout clinical Development and Commercialization of the Product in the Royalty Licensed Territory, and that Affymax or its Third Party Partner(s) shall have primary responsibility for the monitoring of all clinical experiences and submission filing 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 IndicationsAffymax Territory. 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 one hundred eighty (90180) days after the Effective Date, but in no event later than thirty (30) days prior to the first dosing to the first patient in the clinical trial conducted by Collaborator hereunder in or for the Licensed Territory of the Product. 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, agreement that: (a) identifies which safety information shall be exchanged; (b) identifies when such information shall be exchanged; (c) provides that Takeda Collaborator shall have regulatory reporting responsibilities concerning the Product in the Royalty Licensed 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)) or its Third Party Partner(s) shall have regulatory reporting responsibilities in the Affymax Territory; (d) provides that Takeda Affymax (or its Third Party Partner(s)) 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 safety information and coordination with regard to information reporting to the applicable Regulatory Authorities; (jh) identifies which Party shall prepare required periodic safety updates; and (ki) identifies any other details required to appropriately manage safety information for the Product, the Peptide, [ * ] or Hematide.

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 '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 safety information and coordination with regard to information reporting to the applicable Regulatory Authorities; (j) identifies which Party shall prepare required periodic safety updates; and (k) identifies any other details required to appropriately manage safety information for the Product, the Peptide, [ * [*] or Hematide.

Adverse Event Reporting and Safety Data Exchange. The Parties agree that (1) During the period commencing on receipt of written notice of termination (or agreement to terminate if termination is pursuant to Section 15.2) until the transition activities contemplated in this Section 15.8(a) are complete, Takeda shall shall, in accordance with all Applicable Laws, be responsible for monitoring all clinical experiences, maintaining the establishment global safety database, safety monitoring, pharmacovigilance surveillance, compliance and filing of all required safety reports to Regulatory Authorities in the Terminated Countries with respect to the Products, including annual safety reports. In the event this Agreement is terminated in its entirety or the U.S. is a Terminated Country, Takeda shall transfer to TBIL (or its Designee) the global safety database for the Product Products; provided, that, in all other circumstances, the Parties shall discuss whether the global safety base should be transferred to TBIL or retained by Takeda. Notwithstanding the foregoing, the Parties shall enter into a new (or amend the current) PVA within [***] days after the effective date of termination to govern the exchange of safety data between the Parties with respect to Products in the Licensed Territory Terminated ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. Countries, and upon effectiveness thereof, such agreement will supersede the monitoring terms of this Section 15.8(a)(vi)(i). (2) In the event the global safety database is transferred to TBIL, at the time of transfer, Takeda shall confirm in writing that all clinical experiences and submission of all required reports throughout clinical Development and Commercialization of safety data related to the Product Products is accurately reflected in the Royalty Territory, global safety database then-existing and that Affymax shall have primary responsibility for being maintained by Takeda. Until such time as the monitoring of all clinical experiences global safety database is transferred to TBIL hereunder and submission of all required reports concerning the Product thereafter in the U.S.event Takeda receives any safety updates, provided, however, that Takeda shall have primary responsibility for monitoring all clinical experiences for the Oncology Indications. Specific details regarding prepare and provide to TBIL on a timely basis any safety updates received by or on behalf of Takeda or any of its Affiliates, Sublicensees and/or Subcontractors; provided that in no case shall the exchange and management of information relating related to adverse events occur later than [***] days for any fatality and/or life-threatening safety event, [***] days for other 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 Territoryserious adverse events, and that Affymax shall have such responsibilities concerning the Product in the U.S. (in each case[***] days for other, 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 follownon-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 amendedserious adverse events. (i) sets forth provisions governing access to safety information and coordination with regard to information reporting to the applicable Regulatory Authorities; (j) identifies which Party shall prepare required periodic safety updates; and (k) identifies any other details required to appropriately manage safety information for the Product, the Peptide, [ * ] or Hematide.

Adverse Event Reporting and Safety Data Exchange. The Parties agree that Takeda shall each Party will 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 for any clinical trial it conducts. AMAG will be responsible for maintaining the global safety database and submission of filing all required reports concerning for the Product to Regulatory Authorities outside the Licensed Territory throughout the Development of the Product. Takeda will be responsible for filing all required reports for the Product to the Regulatory Authorities in the U.S.Licensed Territory throughout the Development of the Product, providedand if AMAG is the Regulatory Lead, however, that AMAG shall cooperate with Takeda as necessary for Takeda to comply with applicable regulatory requirements. Each Party shall have primary responsibility the right to review all such information and reports prepared or maintained by the other Party at reasonable times, upon prior written request. The Parties shall cooperate to develop methods and/or procedures for monitoring all sharing safety information relating to such clinical experiences in accordance with safety reporting requirements of the respective Regulatory Authorities and as necessary for a Party to comply with applicable Laws. In connection with such discussions, the Oncology IndicationsParties may convene any joint working groups in the subject matter to provide recommendations to the Parties. Specific details regarding the exchange sharing and management of information relating to of adverse events related to the use Development and the Commercialization of the Product shall both within and outside the Licensed Territory will be delineated in a separate pharmacovigilance and safety data exchange agreement (the “Pharmacovigilance Agreement”) that shall be agreed to by the Parties within ninety by the earlier of three (903) days months after the Effective DateDate or one (1) month from the IND. Until the Pharmacovigilance Agreement is signed, AMAG shall provide Takeda with AMAG’s quarterly summary, when prepared by AMAG, of AMAG’s monitoring of all clinical experiences for trials of the Products, and such additional related details as reasonably requested by Takeda to evaluate the information contained in the summary. The pharmacovigilance and product labeling personnel of Parties agree that the Pharmacovigilance Agreement shall set forth the procedures by which 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 report and maintain 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 Territorydata and prescription events monitoring, and that Affymax shall have contain customary terms for such responsibilities concerning the Product in the U.S. (in each casean agreement no less stringent than those required by ICH guidelines, 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 applicable Laws 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 amendedapplicable local regulatory requirements. (i) sets forth provisions governing access to safety information and coordination with regard to information reporting to the applicable Regulatory Authorities; (j) identifies which Party shall prepare required periodic safety updates; and (k) identifies any other details required to appropriately manage safety information for the Product, the Peptide, [ * ] or Hematide.

Adverse Event Reporting and Safety Data Exchange. The Parties agree that Takeda Collaborator shall be primarily 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 filing of all required reports throughout clinical Development and Commercialization of the Product in the Royalty Licensed Territory, and that Affymax or its Third Party Partner(s) shall have primary responsibility for the monitoring of all clinical experiences and submission filing 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 IndicationsAffymax Territory. 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, but in no event later than [*] prior to the first dosing to the first patient in the clinical trial conducted by Collaborator hereunder in or for the Licensed Territory of the Product. 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, agreement that: (a) identifies which safety information shall be exchanged; (b) identifies when such information shall be exchanged; (c) provides that Takeda Collaborator shall have regulatory reporting responsibilities concerning the Product in the Royalty Licensed 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)) or its Third Party Partner(s) shall have regulatory reporting responsibilities in the Affymax Territory; (d) provides that Takeda Affymax (or its Third Party Partner(s)) 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 safety information and coordination with regard to information reporting to the applicable Regulatory Authorities; (j) identifies which Party shall prepare required periodic safety updates; and (ki) identifies any other details required to appropriately manage safety information for the Product, the Peptide, [ * ] or Hematide.

Adverse Event Reporting and Safety Data Exchange. The Parties agree that Takeda Collaborator shall be primarily 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 filing of all required reports throughout clinical Development and Commercialization of the Product in the Royalty Licensed Territory, and that Affymax or its Third Party Partner(s) shall have primary responsibility for the monitoring of all clinical experiences and submission filing 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 IndicationsAffymax Territory. 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 one hundred eighty (90180) days after the Effective Date, but in no event later than [*] prior to the first dosing to the first patient in the clinical trial conducted by Collaborator hereunder in or for the Licensed Territory of the Product. 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, agreement that: (a) identifies which safety information shall be exchanged; (b) identifies when such information shall be exchanged; (c) provides that Takeda Collaborator shall have regulatory reporting responsibilities concerning the Product in the Royalty Licensed 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)) or its Third Party Partner(s) shall have regulatory reporting responsibilities in the Affymax Territory; (d) provides that Takeda Affymax (or its Third Party Partner(s)) 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 safety information and coordination with regard to information reporting to the applicable Regulatory Authorities; (j) identifies which Party shall prepare required periodic safety updates; and (ki) identifies any other details required to appropriately manage safety information for the Product, the Peptide, [ * ] or Hematide.