Common use of Communication with Regulatory Authorities Clause in Contracts

Communication with Regulatory Authorities. Subject to Sections 2.4.5 and 2.4.7, Celgene shall be responsible for handling all complaints and communications (including with Regulatory Authorities) relating to Co-Co Products for U.S. Administration and ROW Administration. Without limiting the foregoing, Celgene as the Regulatory Lead Party shall promptly notify Jounce (which may be through the JSC or the JCC) of any material oral or written communications to or from Regulatory Authorities, and any Regulatory Materials or filings on matters related to the Co-Co Products, or which may reasonably be deemed to impact the Development, Manufacture, marketing, Regulatory Approval or Commercialization of Co-Co Products in the United States, and shall provide Jounce with copies of any such material written communications within [***], or earlier as specified in the Pharmacovigilance Agreement, of receipt or delivery of such communication, as the case may be, or such earlier date as required by Applicable Laws, the FDA, or other relevant Regulatory Authority. In addition Celgene shall provide Jounce with copies of draft Regulatory Materials for the United States, including any material regulatory filings or communications, at least [***] days in advance of any proposed filing, and shall give Jounce an opportunity to review and comment on such regulatory communications or filings. In addition to the foregoing, Celgene shall give Jounce reasonable opportunity (not to be less than [***]) to review and comment on such draft Regulatory Materials or filings, or on any proposed response to any such oral or written communications to or from Regulatory Authorities prior to submitting any response thereto. Celgene shall consider in good faith any reasonable comments made by Jounce in relation to such Regulatory Materials, provided that Celgene shall have the final decision-making right with respect to the nature and content of any Regulatory Materials, communications or filings or the administration of Co-Co Products, and Celgene shall provide Jounce with a copy of the final response, filing or communications, as specified herein.

Communication with Regulatory Authorities. Subject to Sections 2.4.5 and 2.4.7, Celgene shall be responsible for handling all complaints and communications (including with Regulatory Authorities) relating to Co-Co Products for ROW Administration, and Jounce shall be responsible for handling all complaints and communications (including with Regulatory Authorities) relating to Co-Co Products for U.S. Administration and ROW Administration. Without limiting the foregoing, Celgene each Party when acting as the Regulatory Lead Party shall promptly notify Jounce the other Party (which may be through the JSC or the JCC) of any material oral or written communications to or from Regulatory Authorities, and any Regulatory Materials or filings on matters related to the Co-Co Products, or which may reasonably be deemed to impact the Development, Manufacture, marketing, Regulatory Approval or Commercialization of Co-Co Products in Products, outside the United StatesRegulatory Lead Party’s territory, and shall provide Jounce the other Party with copies of any such material written communications within [***], or earlier as specified in the Pharmacovigilance Agreement, of receipt or delivery of such communication, as the case may be, or such earlier date as required by Applicable Laws, the FDA, the EMA or other relevant Regulatory Authority. In addition Celgene the Regulatory Lead Party shall provide Jounce the other Party with copies of draft Regulatory Materials for the United StatesMaterials, including any material regulatory filings or communications, at least [***] days in advance of any proposed filing, and shall give Jounce such other Party an opportunity to review and comment on such regulatory communications or filings. In addition to the foregoing, Celgene each Party shall give Jounce the other Party reasonable opportunity (not to be less than [***]) to review and comment on such draft Regulatory Materials or filings, or on any proposed response to any such oral or written communications to or from Regulatory Authorities CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. prior to submitting any response thereto. Celgene The Regulatory Lead Party shall consider in good faith any reasonable comments made by Jounce the other Party in relation to such Regulatory Materials, provided that Celgene the Regulatory Lead Party shall have the final decision-making right with respect to the nature and content of any Regulatory Materials, communications or filings to the extent solely relating to such Regulatory Lead Party’s territory, or the administration of Co-Co ProductsProducts in such Regulatory Lead Party’s territory, and Celgene the Regulatory Lead Party shall provide Jounce the other Party with a copy of the final response, filing or communications, as specified herein.

Communication with Regulatory Authorities. Subject to Sections 2.4.5 2.3.4 and 2.4.72.3.6, Celgene shall be responsible for handling all complaints and communications (including with Regulatory Authorities) relating to Celgene Program Co-Co Products for U.S. both NA Territory Administration and ROW Territory Administration. Without limiting the foregoing, Celgene as the Regulatory Lead Party shall promptly notify Jounce Juno (which may be through the JSC JRDC or the JCCJSC) of any material oral or written communications to or from Regulatory Authorities, and any Regulatory Materials or filings on matters related to the Celgene Program Co-Co Products, or which may reasonably be deemed to impact the Development, Manufacture, marketing, Regulatory Approval or Commercialization of Celgene Program Co-Co Products in the United StatesProducts, and shall provide Jounce Juno with copies of any such material written communications within [***], or earlier as specified in the Pharmacovigilance Agreement, of receipt or delivery of such communication, as the case may be, or such earlier date as required by Applicable Laws, the FDA, the EMA or other relevant Regulatory Authority. In addition Celgene shall provide Jounce Juno with copies of draft Regulatory Materials for the United StatesMaterials, including any material regulatory filings or communications, at least [***] days in advance of any proposed filing, and shall give Jounce Juno an opportunity to review and comment on such regulatory communications or filings. In addition to the foregoing, Celgene shall give Jounce Juno reasonable opportunity (not to be less than [***]) to review and comment on such draft Regulatory Materials or filings, or on any proposed response to any such oral or written communications to or from Regulatory Authorities prior to submitting any response thereto. Celgene shall consider in good faith any reasonable comments made by Jounce Juno in relation to such Regulatory Materials, provided that Celgene shall have the final decision-making right with respect to the nature and content of any Regulatory Materials, communications or filings or throughout the administration of Co-Co Products, North America Territory and the ROW Territory. Celgene shall provide Jounce Juno with a copy of the final response, filing or communications, as specified herein.