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. 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. All other communications with Regulatory Authorities shall be governed by the License Agreement, including Article 6 of the License Agreement.
Communication with Regulatory Authorities. (a) 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 Licensed Candidates, Licensed Products or Licensed Diagnostic Products within the ROW Territory. Celgene shall promptly notify Juno (which may be through the JRDC or the JSC) of any material oral or written communications to or from Regulatory Authorities on matters related to the Licensed Candidates, Licensed Products or Licensed Diagnostic Products, or which may reasonably be deemed to impact the Development, Manufacture, marketing, Regulatory Approval or Commercialization of Licensed Candidates, Licensed Products or Licensed Diagnostic Products outside the ROW Territory, and shall provide 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 to the foregoing, Celgene shall give Juno reasonable opportunity to review and comment on any proposed response to any such oral or written communications to or from Regulatory Authorities prior to submitting any response thereto, and provide Juno with a copy of the final response as specified herein.
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. For purposes of this ARTICLE 5, “Responsible Party” means, with respect to regulatory filings and Regulatory Approvals, the Party preparing, making and maintaining such filings pursuant to Articles 4.6 and 5.1. Upon the Responsible Party’s request, the other Party shall provide reasonable assistance with respect to regulatory filings and each Party shall have full rights of reference with respect to the other Party’s regulatory filings and Regulatory Approvals for Licensed Products for purposes of making its own regulatory filings with respect to Licensed Products pursuant to and in accordance with this Agreement. The Responsible Party shall be responsible for and act as the sole point of contact with the Regulatory Authorities in connection with its regulatory filings. The Responsible Party shall invite a qualified representative from the other Party to participate in and contribute to all meetings with the Regulatory Authorities relating to the Licensed Products. The Responsible Party shall provide the other Party with copies of its regulatory filings and applications [* * *] prior to their submission to the Regulatory Authorities and shall consider to include in such filings and applications any reasonable comments made and provided by the other Party. Notwithstanding the foregoing, material issues, such as but not limited to label scope, in communications with Regulatory Authorities shall be discussed by the Parties and approved at JSC prior to actual implementation, except that final determination with respect to the Sarcoma Program shall be made by Threshold acting reasonably and in good faith and in furtherance of the Parties’ joint interest to successfully Develop and Commercialize the Licensed Product in the Field in the Territory. The Responsible Party shall promptly provide the other Party with all copies of any written communication between the Responsible Party and the Regulatory Authorities relating to the Licensed Products. Upon Regulatory Approval of the Licensed Product for the STS Indication in the US, Licensor shall assign the related regulatory filings and Regulatory Approvals to Merck.
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. 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.
