Adverse Experience Reporting. 6.1 The responsibilities of the Parties for reporting of adverse drug experiences related to the Licensed Product to regulatory authorities in the Target Countries shall be performed in accordance with local laws and regulations. The responsibilities of the Parties for safety related or Licensed Product related inquiries shall be performed in accordance with local laws and regulations. 6.2 Without prejudice to Section 6.1: (a) Licensee undertakes that it will maintain until the termination or expiration of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled), pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement. (b) Licensee undertakes that it will ensure that it will comply with all applicable laws and regulations regarding the Licensed Product in the Target Countries including without limitation those laws and regulations relating to risk management, drug safety and pharmacovigilance. (c) Licensee will hold and maintain a safety database regarding the Licensed Product sold in the Territory. (d) Licensee will be responsible for fulfilling all pharmacovigilance activities in accordance with the local regulations and requirements for the Licensed Product in the Target Countries (this includes but is not limited to collating Adverse Events and expedited and periodic reporting to regulatory agencies in the Target Countries, literature review, performing safety evaluation and signal detection on all available Adverse Events, etc.). (e) Licensee shall provide Licensor and Ferring with a report containing information regarding Adverse Events which are associated with the Licensed Product, and which have been received by Licensee, from both spontaneous reporting and clinical trial sources. Such report shall be provided annually and otherwise on reasonable request by the Licensor and/or Ferring. (f) Licensee shall notify the Licensor and Ferring forthwith of the receipt of an enquiry from a regulatory authority in the Target Countries relating to the Licensed Product that concerns any safety issue. If Licensee becomes aware of action that may or will be or has been taken by a regulatory authority for a safety reason connected with the Licensed Product, it shall immediately and in any event no later than twenty-four (24) hours after receiving such notice from a regulatory authority notify Licensor and Ferring in writing (including, but not limited to email communications) with available details regarding the same. (g) Notwithstanding Section 19, notices to be provided pursuant to this Section 6 shall, in addition, also be sent to: Department: Global Pharmacovigilance Address: Amager ▇▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ E-Mail: ▇▇▇-▇▇-▇▇▇▇@▇▇▇▇▇▇▇.▇▇▇
Appears in 1 contract
Sources: Memorandum of Understanding
Adverse Experience Reporting. 6.1 The responsibilities of the Parties for reporting of adverse drug experiences related to the Licensed Product Products to regulatory authorities in the Target Countries Territory shall be performed in accordance with local laws and regulations. The responsibilities of the Parties for safety related or Licensed Product related inquiries shall be performed in accordance with local laws and regulations.
6.2 Without prejudice to Section Clause 6.1:
(a) 6.2.1 Licensee undertakes that it will maintain until the termination or expiration of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled), ) pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement.
(b) 6.2.2 Licensee undertakes that it will ensure that it will comply with all applicable laws and regulations regarding the Licensed Product Products in the Target Countries Territory including without limitation those laws and regulations relating to risk management, drug safety and pharmacovigilance.
(c) 6.2.3 Licensee will hold and maintain a safety database regarding the Licensed Product sold Products in the Territory.
(d) 6.2.4 Licensee will be responsible for fulfilling all pharmacovigilance Pharmacovigilance activities in accordance with as per the local regulations and requirements for the Licensed Product Products in the Target Countries Territory (this includes but is not limited to collating Adverse Events AE, and Pregnancy Reports, expedited and periodic reporting to regulatory agencies in the Target CountriesTerritory, literature review, performing safety evaluation and signal detection on all available Adverse Events, AE and Pregnancy data etc.).
(e) 6.2.5 Licensee shall provide Licensor and Ferring ViiV with a report containing information regarding Adverse Events AEs and Pregnancy Reports which are associated with the Licensed Product, Products and which have been received by Licensee, from both spontaneous reporting and clinical trial sources. Such report shall be provided annually and otherwise on reasonable request by the Licensor and/or Ferring.ViiV.
(f) 6.2.6 Licensee shall notify the Licensor and Ferring ViiV forthwith of the receipt of an enquiry from a regulatory authority in the Target Countries Territory relating to the Licensed Product that concerns any safety issue. If Licensee becomes aware of action that may or will be or has been taken by a regulatory authority for a safety reason connected with the Licensed Product, it shall immediately and in any event no later than twenty-four (24) hours after receiving such notice from a regulatory authority notify Licensor and Ferring ViiV in writing (including, but not limited to email communications) with available details regarding the same.
(g) 6.2.7 On conclusion of any clinical research relating to the Products, Licensee undertakes to submit to Licensor and ViiV copies of the clinical trial reports generated by or on behalf of Licensee relating to such clinical research.
6.2.8 Notwithstanding Section 19Clause 20, notices to be provided pursuant to this Section clause 6 shall, in addition, also be sent to: Department: Global Pharmacovigilance Address: Amager VP, Safety & Pharmacovigilance, ViiV Healthcare ▇▇▇ ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇. With a copy to: ▇▇▇▇▇ E-Mail: ▇▇▇-▇▇-▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇▇ or such person as shall be nominated by him in writing from time to time.
Appears in 1 contract
Sources: Licensing Agreement
Adverse Experience Reporting. 6.1 7.1 The responsibilities of the Parties for reporting of adverse drug experiences related to the Licensed Product Products to regulatory authorities in the Target Countries Territory shall be performed in accordance with local laws and regulations. The responsibilities of the Parties for safety related or Licensed Product related inquiries shall be performed in accordance with local laws and regulations.
6.2 7.2 Without prejudice to Section 6.1Clause 7.1:
(a) 7.2.1 Licensee undertakes that it will maintain until the termination or expiration of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled), ) pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement.
(b) 7.2.2 Licensee undertakes that it will ensure that it will comply with all applicable laws and regulations regarding the Licensed Product Products in the Target Countries Territory including without limitation those laws and regulations relating to risk management, drug safety and pharmacovigilance.
(c) 7.2.3 Licensee will hold and maintain a safety database regarding the Licensed Product sold Products in the Territory.
(d) 7.2.4 Licensee will be responsible for fulfilling all pharmacovigilance Pharmacovigilance activities in accordance with as per the local regulations and requirements for the Licensed Product Products in the Target Countries Territory (this includes but is not limited to collating Adverse Events AE, and Pregnancy Reports, expedited and periodic reporting to regulatory agencies in the Target CountriesTerritory, literature review, performing safety evaluation and signal detection on all available Adverse Events, AE and Pregnancy data etc.).
(e) 7.2.5 Licensee shall provide Licensor and Ferring ViiV with a report containing information regarding Adverse Events AEs and Pregnancy Reports which are associated with the Licensed Product, Products and which have been received by Licensee, from both spontaneous reporting and clinical trial sources. Such report shall be provided annually and otherwise on reasonable request by the Licensor and/or Ferring.ViiV.
(f) 7.2.6 Licensee shall notify the Licensor and Ferring ViiV forthwith of the receipt of an enquiry from a regulatory authority in the Target Countries Territory relating to the Licensed Product that concerns any safety issue. If Licensee becomes aware of action that may or will be or has been taken by a regulatory authority for a safety reason connected with the Licensed Product, it shall immediately and in any event no later than twenty-four (24) hours after receiving such notice from a regulatory authority notify Licensor and Ferring ViiV in writing (including, but not limited to email communications) with available details regarding the same.
(g) 7.2.7 On conclusion of any clinical research relating to the Products, Licensee undertakes to submit to Licensor and ViiV copies of the clinical trial reports generated by or on behalf of Licensee relating to such clinical research.
7.2.8 Notwithstanding Section 19Clause 21, notices to be provided pursuant to this Section 6 clause 7 shall, in addition, also be sent to: Department: Global VP, Safety & Pharmacovigilance Address: Amager ViiV Healthcare ▇▇▇ ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇. With a copy to: ▇▇▇▇▇ E-Mail: ▇▇▇-.▇.▇▇-▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇▇ or such person as shall be nominated by him in writing from time to time.
Appears in 1 contract
Sources: Licensing Agreement
Adverse Experience Reporting. 6.1 The responsibilities of the Parties for reporting of adverse drug experiences related to the Licensed Product to regulatory authorities in the Target Countries shall be performed in accordance with local laws and regulations. The responsibilities of the Parties for safety related or Licensed Product related inquiries shall be performed in accordance with local laws and regulations.
6.2 Without prejudice to Section 6.1:
(a) Licensee undertakes that it will maintain until Until the termination or expiration Regulatory Materials are transferred to Buyer, Seller shall be responsible for the adverse experience and safety reporting for the Product in compliance with the requirements of this Agreement applicable Law (orincluding Healthcare Laws). After the Regulatory Materials are transferred to Buyer, Buyer shall assume such responsibility. Buyer and Seller agree to meet promptly after the Closing Date to determine mutually agreeable reporting procedures to communicate the information as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled), pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations required under this AgreementSection 5.15.
(b) Licensee undertakes that it will ensure that it will comply with Until the Regulatory Materials are transferred to Buyer, Seller shall be responsible for (i) maintaining the global safety database for the Seller Compounds, (ii) monitoring of all applicable laws clinical experiences for the Seller Compounds and regulations regarding the Licensed Product in the Target Countries (iii) safety monitoring, pharmacovigilance surveillance, compliance and filing of all required safety reports to Regulatory Authorities, including without limitation those laws annual safety reports, as and regulations relating to risk managementthe extent required by applicable Law (including Healthcare Laws) for any study conducted by or for Seller with respect to the Seller Compounds. On or before the Closing Date, drug safety and pharmacovigilance.
(c) Licensee will hold and maintain a safety database regarding the Licensed Product sold in the Territory.
(d) Licensee will be responsible for fulfilling all pharmacovigilance activities in accordance with the local regulations and requirements for the Licensed Product in the Target Countries (this includes but is not limited to collating Adverse Events and expedited and periodic reporting to regulatory agencies in the Target Countries, literature review, performing safety evaluation and signal detection on all available Adverse Events, etc.).
(e) Licensee Seller shall provide Licensor and Ferring Buyer with a report containing information regarding Adverse Events which are associated with the Licensed Product, and which have been received by Licensee, from both spontaneous reporting and clinical trial sources. Such report shall be provided annually and otherwise on reasonable request by the Licensor and/or Ferring.
(f) Licensee shall notify the Licensor and Ferring forthwith summary of the receipt of an enquiry from a regulatory authority in the Target Countries information relating to the Licensed Product that concerns investigation and reporting of adverse experiences regarding Seller Compounds and any existing material safety issuedata sheets with respect to the Seller Compounds as of the Closing Date. If Licensee becomes aware After the Closing Date and until the Regulatory Materials are transferred to Buyer, Buyer agrees to submit to Seller all adverse drug experience information brought to the attention of action that may Buyer with respect to the Seller Compounds, as well as any material events and matters concerning or will be affecting the safety or has efficacy of the Seller Compounds brought to the attention of Buyer, via facsimile to the attention of Seller. After the Regulatory Materials have been taken by a regulatory authority for a safety reason connected transferred to Buyer, Seller shall assist Buyer with the Licensed Productprovision of data relating to adverse experiences for the Seller Compounds after such transfer to Buyer. Additionally, it after the transfer of the Regulatory Materials to Buyer, Seller shall immediately provide Buyer with all adverse drug experience information brought to the attention of Seller with respect to the Seller Compounds, as well as any materials events and in any event no later than twenty-four (24) hours after receiving such notice from a regulatory authority notify Licensor and Ferring in writing (includingmatters concerning or affecting the safety or efficacy of the Seller Compounds brought to the attention of Seller, but not limited via facsimile to email communications) with available details regarding the sameattention of Buyer.
(g) Notwithstanding Section 19, notices to be provided pursuant to this Section 6 shall, in addition, also be sent to: Department: Global Pharmacovigilance Address: Amager ▇▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ E-Mail: ▇▇▇-▇▇-▇▇▇▇@▇▇▇▇▇▇▇.▇▇▇
Appears in 1 contract