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. Gilead shall have the exclusive right to correspond or communicate with Regulatory Authorities regarding the Licensed Products and other regulatory matters under this Agreement. Unless required by Applicable Law, Hookipa, its Affiliates, and its permitted subcontractors shall not correspond or communicate with Regulatory Authorities regarding any Licensed Product without first, in each case, obtaining Gilead’s prior written consent, either during or after the applicable Collaboration Term for a Program; provided, that, upon Gilead’s request, Hookipa or its Affiliates shall attend any meeting with a Regulatory Authority regarding any Licensed Product. If Hookipa, its Affiliates, or its permitted subcontractors receive any correspondence or other communication from a Regulatory Authority regarding a Licensed Product, Hookipa shall provide Gilead with access to or copies of all such material written or electronic correspondence promptly after its receipt.
Communication with Regulatory Authorities. All other communications with Regulatory Authorities shall be governed by the License Agreement, including Article 6 of the License Agreement.
Communication with Regulatory Authorities. GS shall have primary responsibility for dealing with Regulatory Authorities in the Territory, including filing all supplements and other documents with such authorities with respect to obtaining Regulatory Approvals, reporting all adverse drug experiences related to the Product, and handling all Product complaints. At each meeting of the Steering Committee, GS shall provide to the Steering Committee a report describing the regulatory filing status of each Product throughout the Territory.
Communication with Regulatory Authorities. Notwithstanding anything to the contrary in the License Agreement, including but not limited to Article 6 therein, or the Quality Agreement, Takeda shall promptly notify Myovant following receipt by Takeda of any regulatory inquiry or communication, or the occurrence of any inspection, regarding the Manufacture of Drug Substance in compliance with GMP. If Takeda or its Affiliate(s) or Subcontractor(s) receive notice of an inspection or an inspection visit by any Governmental Authority that directly involves Drug Substance or is likely to materially impact Takeda’s ability to supply Drug Substance to Myovant hereunder, Takeda shall give Myovant prompt written notification thereof (but in no event later than [***] after Takeda receives such notice) and Takeda shall provide Myovant with copies of applicable documentation with respect thereto, and Myovant shall have a reasonable opportunity to review and comment on Takeda’s proposed response; provided, however, that Myovant’s opportunity to review and comment shall not be extended so as to cause any response of Takeda to be later than is required by such Governmental Authority. Unless prohibited by Applicable Law, Takeda shall allow a representative of Myovant to be present at and observe any inspection by any Governmental Authority concerning Drug Substance. All other communications with Regulatory Authorities, including without limitations any regulatory audits, shall be governed by the License Agreement and Quality Agreement.
Communication with Regulatory Authorities. Subject to Sections 2.3.5 and 2.3.7, Celgene shall be responsible for handling all complaints and communications (including with Regulatory Authorities) relating to Juno Program Co-Co Products for Celgene Territory Administration, and Juno shall be responsible for handling all complaints and communications (including with Regulatory Authorities) relating to Juno Program Co-Co Products for Juno Territory Administration. Without limiting the foregoing, each Party when acting as the Regulatory Lead Party shall promptly notify the other Party (which may be through the JRDC or the JSC) of any material oral or written communications to or from Regulatory Authorities, and any Regulatory Materials or filings on matters related to the Juno Program Co-Co Products, or which may reasonably be deemed to impact the Development, Manufacture, marketing, Regulatory Approval or Commercialization of Juno Program Co-Co Products, outside the Regulatory Lead Party’s territory, and shall provide 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 the Regulatory Lead Party shall provide the other Party with copies of Regulatory Materials, including any material regulatory filings or communications, at least [***] in advance of any proposed filing, and shall give such other Party an opportunity to review and comment on such regulatory communications or filings. In addition to the foregoing, each Party shall give the other Party reasonable opportunity (not to be less than [***] to review and comment on such 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. The Regulatory Lead Party shall consider in good faith any reasonable comments made by the other Party in relation to such Regulatory Materials, provided that 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 Juno Program Co-Co Products in such Regulatory Lead Party’s territory, and the Regulatory Lead Party shall prov...
Communication with Regulatory Authorities. Each of the Parties agrees that if it or any member of its Group or their respective advisors has any communication with or from any Regulatory Authority in respect of any matter in relation to the business or future operations of the Company or any member of the Company's Group, or on the Proposal or this Agreement, whether formal or informal, it shall, as soon as reasonably practicable after such communication and subject to any confidentiality restrictions imposed by such Regulatory Authority, inform the other Parties of such communication and provide the other Parties with copies of any written documents or correspondence.
Communication with Regulatory Authorities. As between the Parties, Keryx shall have the sole right to communicate with the appropriate Regulatory Authorities relating to Product, and Vendor shall have no right to do so. Vendor shall at Keryx’s costs and expenses provide Keryx or its Affiliate, promptly, all information in Vendor’s (or its Affiliate’s) possession or control concerning Product which is reasonably requested by Keryx (or its Affiliate) and which is reasonably necessary to meet Keryx’s regulatory obligations. Vendor shall, to the extent such notice is not prohibited by Applicable Law, notify Keryx within [***] of any Regulatory Authority request for samples of Product or Batch records or any other information related to Product and, to the extent permissible by applicable laws, will not provide such material, records or information until such notification is made to Keryx.
Communication with Regulatory Authorities. Epirus shall be responsible for reporting all adverse events and handling all complaints and communications (including without limitation with Regulatory Authorities) relating to the Products in the Territory and the Field.
Communication with Regulatory Authorities. The Party assigned regulatory responsibility for a particular Health Registration for a Development Compound shall have primary responsibility for communications with respect to the regulatory authorities having jurisdiction over such Health Registration for the Development Compound. Both Parties shall have the right to participate in all meetings with regulatory authorities. The Party that is not assigned regulatory responsibility for a particular Health Registration for a Development Compound shall have the right to review all correspondence to the applicable regulatory authority prior to submission, unless such correspondence is of a routine nature or is an Adverse Experience report required by applicable law or regulation. Copies of all written correspondence submitted by either Party to regulatory authorities or written reports of discussions with regulatory authorities shall be sent to the other Party promptly after such submission or discussion. The Parties shall enter into further agreement or agreeable standard operating procedures to ensure rapid communication between the Parties regarding all communication to and from regulatory authorities.
