Common use of Pharmacovigilance Clause in Contracts

Pharmacovigilance. Ninety days prior to the submission of a Regulatory Approval Application in any country in the Territory but in no event later than twelve (12) months after the Effective Date, the Parties shall enter into a pharmacovigilance agreement concerning all matters relating to the pharmacovigilance and the exchange of all relevant Information that relates to the safety of the Product worldwide and especially all adverse events. Generally, (a) Licensee shall be responsible for reporting all adverse drug reactions required to be reported to the Regulatory Authorities in the applicable countries in the Territory, in accordance with Applicable Laws; and (b) Coherus, its Affiliates or licensees or sublicensees shall be responsible for submitting all Regulatory Filings and for reporting of all adverse drug reactions, relating to the Product required to be reported to the appropriate Regulatory Authorities outside of the Territory in accordance with the Applicable Laws of the relevant countries. Coherus shall have the right to share any and all information received from Licensee under this Section 4.8 with Coherus’ Affiliates and licensees and sublicensees outside the Territory. Licensee shall have the right to share any and all information received from Coherus under this Section 4.8 with Licensee’s Affiliates and Sublicensees in the Territory. The JSC shall review from time to time Licensee’s pharmacovigilance policies and procedures.

Pharmacovigilance. Ninety days prior to the submission of a Regulatory Approval Application in any country in the Territory but in In no event later than twelve six (126) months after the Effective Date, the Parties shall enter into a pharmacovigilance agreement concerning all matters relating to the pharmacovigilance and the exchange of all relevant Information that relates to the safety of the each Product worldwide and especially all adverse events. Generally, (a) Licensee shall be responsible for reporting all adverse drug reactions reaction experiences required to be reported to the appropriate Regulatory Authorities in the applicable countries in the TerritoryTerritory in which such Product is being Developed or Commercialized, in accordance with the Applicable LawsLaws of the relevant countries and Regulatory Authorities; and (b) CoherusBioGenerics, its Affiliates or licensees or sublicensees shall be responsible for submitting all Regulatory Filings and for reporting regulatory filings, including without limitation any post-marketing reports of all adverse drug reactionsexperiences, relating to the such Product required to be reported to the appropriate Regulatory Authorities regulatory authorities outside of the Territory in [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. accordance with the Applicable Laws of the relevant countries. Coherus BioGenerics shall have the right to share any and all information received from Licensee under this Section 4.8 4.14 (and/or such pharmacovigilance agreement) with CoherusBioGenerics’ Affiliates and licensees and sublicensees outside the Territory. Licensee shall have the right to share any and all information received from Coherus BioGenerics under this Section 4.8 4.14 and/or such pharmacovigilance agreement with Licensee’s Affiliates and Sublicensees in the Territory. The JSC shall review from time to time Licensee’s pharmacovigilance policies and procedures.